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Contract Research Organizations – CRO in Spain- Updated in 2024
If you are looking for a list of the main Contract Research Organizations – CRO in Spain, this is the right place.
We have prepared a list including their contacts and other CRO information.
We believe it will be useful when looking for a CRO in Spain.
Please contact us if any CRO or important information is not listed.
List of main CROs in Spain :
- Leon Research
- Adelphi Targis
- Advanced Clinical
- Allucent-CRO acquired Pharm-Olam
- Alpha Bioresearch
- Bioclever CRO ( Astrum company)
- Caidya (Clinipace)
- Charles River Laboratories
- Clinical Trials Team
- Clinscience (Experior)
- CTI Clinical Trial and Consulting Services
- Evidence Clinical Research (Dynamic Solutions)
- Geistek pharma
- Icon plc (PRA Health Sciences)
- IQVIA (Clintec)
- Labcorp Drug Development (Covance)
- Linical Co.
- Namsa (AKRN scientific Consulting)
- Novotech cro (East Horn Clinical Services)
- OPIS s.r.l.
- Optimapharm (Syntax for Science)
- Oxon Epidemiology
- Premier Research
- QualitecFarma
- Recerca ( ARN Healthcare )
- RegPharmaClin
- RTI health Solutions
- Syneos Health (Synteract)
- Zurko Research
LIST OF MAIN CRO FOUNDED IN SPAIN
Contact information : Contact page www.leonresearch.com Phone: +34 987 261 064
Location of the CRO in Spain : c/ Nicostrato Vela, s/n, M11.2 Parque Tecnológico de León 24009 León (Spain) c/San Emilio, 6 – Local 1 28017 Madrid (Spain)
Company size: 11 – 50 employees Headquarters: León, Spain Founded: 2007 Specialties: Clinical trials from early to IV phase, Observational studies, Ophthalmology Clinical Studies, Food studies, Regulatory Affairs and EC approval, Pharma Outsourcing, Clinical studies monitoring, Data Management and Pharmacovigilance
adelphitargis.com
Contact information : Contact page Phone: +34 93 452 39 11
Location of the CRO in Spain : C/ Aragó 182, planta 708011 Barcelona (Spain)
Company size: 11-50 employees Headquarters : Barcelona, Spain Founded: 2002 Specialties: Medical Education, Scientific communication, Expert Management, Market Access, Ad Hoc Project, Strategic Consulting, Medical Training, eHealth, Advisory Boards, Medical writing, Expert Meetings, Scale Validation, Delphi Studies, and Generation of Scientific Evidence
www.adknoma.com
Contact information : Contact page Phone: +34 91 417 70 90
Location of the CRO in Spain : Martí i Julià 6-8 Enlo. 3ª dcha 08034 Barcelona (Spain) Capitán Haya, 1 Planta 15 28020 Madrid (Spain)
Company size: 11-50 employees Headquarters : Barcelona, Spain Founded: 2004 Specialties: CRO, Investigación Clínica, Clinical Trial, Fase I, Fase II, Fase III, and Fase IV
www.alphabioresearch.com
Contact information : Contact page Phone: +34 917 452 520
Location of the CRO in Spain: C/López de Hoyos, 155 – 3º puertas 6-7, 28002 Madrid (Spain)
Company size: 11-50 employees Headquarters : Madrid, Spain Founded: 1995 Specialties: Regulatory Affairs, Study set-up, On-site / On-line Monitoring visits, Biostatistics, Data Management, Medical writing, Scientific dissemination, Clinical Trials Phase I – IV, Risk-Based Monitoring, Observational studies, Non interventional studies, e.CRD, CRAs, CTAs, Real World Evidence (RWE), Post Market Surveillance, Pharmacovigilance Assistant, CRAs, CTAs, Project Management, Abstracts, Posters, Project Leader, Outsourcing, and Investigators meeting
anagram-esic.com
Contact information : Contact page
Location of the CRO in Spain: Sant Pau Recinto Modernista Barcelona, Pabellón Sant Manel C. Sant Antoni María Claret 167, 08025, Barcelona (Spain)
Company size: 11-50 employees Headquarters : Barcelona, Spain Founded: 1998 Specialties: CRO, clinical research, project delivery, data management, regulatory medical writing, quality assurance, medical device, project management, observational study, and monitoring
www.anapharmbioanalytics.com
Contact information : Contact page Phone: +34 93 223 86 36
Location of the CRO in Spain: Encuny 22, 2nd floor 08038 Barcelona, (Spain)
Company size: 50-200 employees Headquarters : Barcelona, Spain Founded: 2003 Specialties: Bioanalysis, Phase I-IV Clinical Trials, PK/PD studies, Bioequivalence, biomarker testing, immunogenicity assays, ELISA assays, ADA assessment, and LC-MS/MS bioanalysis
www.apices.es
Contact information : Contact page Phone: +34 91 816 68 04
Location of the CRO in Spain: Avda. Antonio López, 16l 1st floor 28320 Pinto Madrid (Spain)
Company size: 50-200 employees Headquarters : Pinto, Madrid, Spain Founded: 2009 Specialties: Clinical Research, Clinical Trials, CRO, and Health outcomes
www.cabyc.com
Contact information : Contact page Phone: +34 91 659 04 33
Location of the CRO in Spain: Av. Somosierra, 12. Portal Izquierdo. 2º G San Sebastián de los Reyes 28703 Madrid (Spain)
Company size: 11-50 employees Headquarters : San Sebastián de los Reyes, Madrid, Spain Founded: 1998 Specialties: Clinical Research
trialsteam.eu
Contact information : Contact page Phone: +34 658 01 61 25
Location of the CRO in Spain: Ctra. Canillas 138 28043 Madrid (Spain)
Company size: 2-10 employees Headquarters : Madrid, Spain Founded: 2016 Specialties: Clinical Research
distefar.com
Contact information : Contact page Phone: +34 955 776 767
Location of the CRO in Spain: Distefar del Sur S.L. Av. Umbrete, 58, 41110 Bollullos de la Mitación, Sevilla (Spain) Calle de Zurbano, 45, 28010 Madrid (Spain)
Company size: 2-10 employees Headquarters : Bollullos de Mitación, Sevilla, Spain Founded: 2004 Specialties: Management of Clinical Trials, Promotion of Medicines and Health Products, Pharmaceutical Distribution, Medication Management for Research, and Creation of Purchasing Centers
efficecro.com
Contact information : Contact page Phone: +34 912 948 910
Location of the CRO in Spain: Paseo de la Castellana,127 1º D 28046 Madrid (Spain)
Company size: 11-50 employees Headquarters : Madrid, Spain Founded: 2004 Specialties: CRO and Clinical Research
www.evidenze.com
Contact information : Contact page Phone Barcelona: +34 93 351 16 15 Phone Madrid: +34 91 456 11 05
Location of the CRO in Spain: Av. de Josep Tarradellas, 8-10 Planta 5ª, Puerta 4 08029 – Barcelona (Spain) Calle Caléndula, 93 Complejo Miniparc III, Edificio K El Soto de la Moraleja 28109 – Alcobendas, Madrid (Spain)
Company size: 200-500 employees Headquarters : Barcelona, Spain Founded: 1999 Specialties: Clinical trials, studies, observational, post-authorization, epidemiological, e-clinical, and electronic CRD
geistek.com
Contact information : Contact page Phone: +34 615 79 13 55
Location of the CRO in Spain: P.º de la Castellana, 259C, 28046 Madrid (Spain)
Company size: 2-10 employees Headquarters : Madrid, Spain Founded: 2020 Specialties: Pharma, Advanced Therapy, CRO, Investigation, and Pharmaceutical industry
www.kymos.com
Contact information : Contact page Phone: +34 935 481 848
Location of the CRO in Spain: Parc Tecnològic del Vallès. Ronda Can Fatjó 5, Edificio D. 08290 Cerdanyola del Vallès, Barcelona (Spain)
Company size: 50-200 employees Headquarters : Cerdanyola del Vallès, Barcelona, Spain Founded: 2001 Specialties: Bioanalysis of preclinical and clinical studies, Quality Control of ingredients and products, Batch release certifications, Pharmaceutical development, Immunogenicity, Immunoassay, and Bioequivalence studies
www.meditrial.net
Contact information : Contact page Phone: +34 91 069 52 33
Location of the CRO in Spain: C/ Princesa, 70, 2º Izqda. Exterior 28008 Madrid (Spain)
Company size: 11-50 employees Headquarters : Madrid, Spain Founded: 2008 Specialties: Clinical Trials development
Contact information : Contact page Phone: +34 932214135
Location of the CRO in Spain: Torre Glòries – Planta 27, Av. Diagonal, 211, 08018 Barcelona (Spain)
Company size: 51-200 employees Headquarters : Barcelona, Spain Founded: 2012 Specialties: oncology, clinical trials, clinical research, prostate cancer, cancer, lung cancer, breast cancer, ovarian cancer, endometrial cancer, Clinical trial design, International Networking, protocol , Scientific publications, Scientific congress abstracts and posters, Scientific Publications, IIT, Pipelines, Drug discovery, and International Network of KOLs
www.pivotalcr.com
Contact information : Contact page Phone: +34 91 708 12 50
Location of the CRO in Spain: Calle Gobelas 19, La Florida 28023 Madrid (Spain)
Company size: 50-200 employees Headquarters : Madrid, Spain Founded: 2001 Specialties: oncology
www.psyncro.net
Contact information : Contact page Phone: +34 93 301 13 14
Location of the CRO in Spain: Avda. de la Gran Via de les Corts Catalanes, 682, 3-1A 08010 Barcelona (Spain)
Company size: 2-10 employees Headquarters : Barcelona, Spain Founded: 2000 Specialties: neurosciences, neurology, psychiatry, neuropsychology, clinical trials, studies, clinical research, neurosciences, clinical trials, neurology, psychiatry, neuropsychology, clinical research, and cognition
www.qualitecfarma.com
Contact information : Contact page Phone: +34 913 728 399 / +34 913 728 400
Location of the CRO in Spain: C/ Musgo, 2 Edificio Europa II, 2ª planta, oficina G Madrid 28023 (Spain)
Company size: 2-10 employees Headquarters : Madrid, Spain Founded: 2000 Specialties: Clinical Research
recerca.com
Contact information : Contact page Phone: +34 648 78 30 42
Location of the CRO in Spain: Josep Pla, 163, 3º2ª. 08020 Barcelona (Spain)
Company size: 11-50 employees Headquarters : Barcelona, Spain Founded: 1989 Specialties: Clinical Research
www.regpharmaclin.com
Contact information : Contact page Phone Madrid: +34 727 787 065
Location of the CRO in Spain: C/ Ventura Rodríguez 22 3º Izda 28008 Madrid (Spain)
Company size: 2-10 employees Headquarters : Madrid, Spain Founded: 2023 Specialties: CRO, Staff Management, Project Management, Education & Training, Medical Writing, Quality Assurance, Budgeting, Regulatory Affairs, Clinical Operations, Translations, GMP and GDP audits, Laboratory Set Up y GCPs
www.sermescro.com
Contact information : Contact page Phone Madrid: +34 91 375 69 30 Phone Barcelona: +34 93 253 13 80
Location of the CRO in Spain: C/Rufino Gonzaléz, 14 28037 Madrid (Spain) C/Osona, 8 08023 Barcelona (Spain)
Company size: 200-500 employees Headquarters : Madrid, Spain Founded: 1997 Specialties: Clinical Trials, Monitoring, Commissioning, and Advanced Therapies
Location of the CRO in Spain: C/ Fernán González 28 28009 Madrid (Spain)
Company size: 2-10 employees Headquarters : Madrid, Spain Founded: 2016 Specialties: Feasibility, Monitoring, Pharmacovigilance, Data Management, eCRF, Biostatistics
www.sofpromed.com
Contact information : Contact page Phone: +34 607 939 266
Location of the CRO in Spain: 11 Gremi d’Hortelans 3rd Floor, Office 8 07009 Palma de Mallorca (Spain)
Company size: 2-10 employees Headquarters : Palma de Mallorca, Spain Founded: 2012 Specialties: e-CRF, CRO-Clinical Services, e-Sample, e-Image, and e-Registry
www.zurkoresearch.com
Contact information : Contact page Phone: +34 91 521 15 88
Location of the CRO in Spain: Avenida de la Osa Mayor, 4 28023 – Madrid (Spain) C/3, nº 50, Parcel 133-C. Pol. Ind. Romica. PO 626 02080 – Albacete (Spain)
Company size: 50-200 employees Headquarters : Madrid, Spain Founded: 2005 Specialties: cosmetic and cosmeceutical products, as well as medical devices.
MAIN INTERNATIONAL CROs WITH OFFICES IN SPAIN
www.advancedclinical.com
Contact information : Contact page Phone: +34 910 800 928
Location of the CRO in Spain: Calle Serrano, 1ª planta 28006 Madrid (Spain)
Company size: 500-1,000 employees Headquarters : Deerfield, Illinois, USA Founded: 1994 Specialties: CRO Services, Global Feasibility, Functional Service Provider, Data Management, Strategic Staffing Solutions, Biostatistics, Clinical Monitoring, Project Management, Patient Recruitment & Retention, Quality & Validation Services, and eTMF & Document Management
allucent.com
Location of the CRO in Spain: C. de la Antracita, 7, 1, 28045 Madrid (Spain)
Company size: 1,000-5,000 enmployees Headquarters : Cary, North Carolina, USA Founded: 1988 Specialties: Drug Development, Regulatory Affairs and Submissions, Clinical Strategy, Cell & Gene Therapy, Rare Diseases & Orphan Indications, Oncology & Hematology, Study startup & Feasibility, Regulatory Strategy, Small and midsized biotech companies, Biostatistics, Pharmacokinetics (PK) / Pharmacodynamics (PD), Clinical Pharmacology, Medical/Scientific Writing, Protocol and study design, Medical monitoring, Patient recruitment, Pharmacovigilance, Data management, NDA/BLA/MAA, and Product development
www.bioclever.com
Contact information : Contact page Phone Barcelona: +34 934 086 388 Phone Madrid: +34 910 888 877
Location of the CRO in Spain: Rambla Catalunya, 135, 3º 1ª, 08008 Barcelona (Spain) Ronda de Poniente, 10 28760 Tres Cantos – Madrid (Spain)
Company size: 50-200 employees Headquarters : Barcelona, Spain Founded: 2005 Specialties: Nutritional studies, Clinical Developments, Design and start-up of projects Studies
Contact information : Contact page Phone: +34 91 790 4548
Location of the CRO in Spain: Paseo de la Castellan 55, Planta 1, 28046 Madrid (Spain)
Company size: 500-1000 employees Headquarters : Morrisville,NC, USA Founded: 2015 Specialties: clinical research CRO
www.criver.com
Contact information : Contact page Phone: 8883195343
Location of the CRO in Spain: Sant Cugat Business Park. Av. Vía Augusta 15-25. Despacho 10, 4º plta. Edificio B2 8174 Sant Cugat del Vallès, Barcelona (Spain)
Company size: More than 10,000 employees Headquarters : Wilmington, Massachusetts, USA Founded: 1947 Specialties: Research Models & Services, Preclinical Services, Discovery Research Services, Biologics Testing Solutions, Microbial Identificiation, Endotoxin Testing, LAL, Early Discovery, Safety Testing, and Agrochemical
clinscience.com
Contact information : Contact page Phone: +34 961452190
Location of the CRO in Spain: Calle Menendez Y Pelayo 3 Y 5. 46010, Valencia (Spain)
Company size: 51-200 employees Headquarters : Warsaw, Mazowieckie, Poland Founded: 2006 Specialties: Consultancy, Project Management, Decentralized Trials, FSP, Outsourcing, Clinical Operations, Clinical Trials, Biostatistics, Regulatory, Medical Monitoring, Pharmacovigilance, Data Management, Clinical Monitoring, Quality Assurance, Contact Research Organization, CRO Services, Clinical Development, Therapeutic Expertise, Digital Therapeutics, Digital Health, Health Technology, Patient Recruitment, CRO, Clinical Research Technology, and Clinical Studies
www.cromsource.com
Contact information : Contact page Phone: +34 916 750 933
Location of the CRO in Spain: Marqués de Urquijo 26, 3° Izqda 28008 Madrid (Spain)
Company size: 200-500 employees Headquarters : Verona, Italy Founded: 1997 Specialties: Clinical Operations, Early Phase Clinical Research, Project Management, Staffing Solutions, Regulatory Affairs, Site Selection, Logistics & Drug Management, Data Management, Biostatistics, Medical Writing, Quality Assurance, Pharmacovigilance, Pharmaceutical, Medical Devices, and Biotech
www.ctifacts.com
Contact information : Contact page Phone: +34 913 99 07 84
Location of the CRO in Spain: Calle Zurbano, 76 – 4 DR 28010 Madrid (Spain)
Company size: 500-1000 employees Headquarters : Covington, KY, USA Founded: 1999 Specialties: CRO Services
ergomedplc.com
Contact information : Contact page Phone: +44 (0)1483 503 205
Location of the CRO in Spain: Calle Principe de Vergara, 112 – 4 28002 Madrid (Spain)
Company size: 1,000-5,000 employees Headquarters : Guildford, Surrey, UK Founded: 1997 Specialties: Oncology, Neurology, Respiratory diseases, Orphan drugs, Metabolic diseases, Clinical Trials, CRO, Contract Research Organization, Rare diseases, Phase I-V, Drug Development, Pharmaceuticals, Biotechnology, Clinical Trials, pharmacovigilance, covid 19 , clinical safety, Medical Information, and Allergy
www.iconplc.com
Company size: More than 10,000 employees Headquarters : Raleigh, North Carolina, USA Founded: 1990 Specialties: Clinical Research, Phase I-IIa, Phase II-III, Safety & Risk Management, Therapeutic Expertise, Biosimilars, Bioanalytical Laboratories, Rare Disease, Oncology, Immunology, Infectious Disease, Neuroscience, Pain, Pediatrics, Vaccines, Data & Techology Solutions, Early Development Services, Laboratory Solutions, Real World Solutions, Clinical Development, Product Registration, Respiratory, Cardio-metabolic, Digital Health, Health Technology, and Digital Therapeutics
www.iqvia.com
Contact information : Contact Page Phone Madrid: +34 915 578 500 Phone Barcelona: +34 937 496 300
Location of the CRO in Spain: C/Juan Esplandiú 11-6ª 28007, Madrid (Spain) C/ Provença 392-3ª 08025, Barcelona (Spain)
Company size: More than 10,000 employees Headquarters : Research Triangle Park, North Carolina, USA Founded: 1982 Specialties: Technology, Consulting, and Clinical Development
drugdevelopment.labcorp.com
Contact information : Contact page Phone Barcelona: +34 915 901 664 Phone Madrid: +34 91 590 1664
Location of the CRO in Spain: Cloudworks Carrer de Sardenya, 229 08013 Barcelona, (Spain) Parque Empresarial Las Tablas, Calle Federico Mompou, 5, Edificio 1, 5ª planta, 28050 Madrid (Spain)
Company size: More than 10,000 employees Headquarters : Burlington, North Carolina, USA Founded: 1996 Specialties: Drug Development Services , Toxicology Services, Central Labs, Central Laboratory Services , Clinical Trial Management , CRO , Research, Life Sciences, Clinical Research, Phase I-IIa, Phase II-IIIb, Preclinical Solutions, Oncology, Market Access, Rare Disease , Orphan Drugs , Biotech, Pharma, Pharmaceuticals, Crop Protection, Clinical Trial Optimization, Clinical Trials, Cell and Gene Therapy, NASH, Pharmacovigilance, Patient Support, Patient Safety, Infectious Diseases, Immuno Oncology, Commercialization, Pediatrics, Kidney Disease, Inflammation, Bioassays, Bioanalysis , Large Molecule , Small Molecule, Clinical Trial Informatics, Preclinical Services, and Nonclinical Services
www.linical.com
Contact information : Contact page Phone: +34 913 72 60 00
Location of the CRO in Spain: Calle Las Norias 92, 2ª planta. Puerta B. Edificio Nuestra Señora del Pilar 28221 Majadahonda, Madrid(Spain)
Company size: 500-1,000 employees Headquarters : Yodogawa, Fukuoka, Japan Founded: 2005 Specialties: Clinical Monitoring, Pharmacovigilance, Regulatory Affairs, Consulting, Project Management, Clinical Data Management, Biostatistics, Medical Writing, Medical Monitoring, Quality Assurance, Training, and Pharma Resourcing Solutions
www.medpace.com
Contact information : Contact page Phone: +34 91 790 0565
Location of the CRO in Spain: Torre de Cristal Planta 14 Paseo de la Castellana 259 C Madrid, 28046 (Spain)
Company size: 1,000-5,000 employees Headquarters : Cincinnati, OH, USA Founded: 1992 Specialties: Early Phase Clinical Research, Phase II-III Clinical Research, RWE-Late Phase Clinical Research, Medical Device and Diagnostics, Regulatory Affairs, Medical Writing, Clinical Monitoring, Clinical Trial Management, Biostatistics and Data Sciences, Drug Safety and Pharmacovigilance, Quality Assurance, Central Laboratories, Bioanalytical Laboratories, Imaging & ECG Core Labs, Oncology clinical development, Nephrology clinical development, Neuroscience clinical development, Infectious Disease clinical development, Cardiovascular clinical development, Metabolic and endocrine clinical development, Rare disease clinical development, and Cell and gene therapy clinical development
Location of the CRO in Spain: Calle de Fuerteventura 1, 28703 San Sebastián de los Reyes, Madrid (Spain)
Company size: 1,000-5,000 employees Headquarters : Toledo, OH, USA Founded: 1967 Specialties: Analytical Chemistry, Materials Characterization, Efficacy/Functional Testing, Biocompatibility, Sterility Assurance & Microbiology, Clinical Research, Research & Development Support, Lot Release Testing, Sterility Assurance Products, Reimbursement, Medical Devices, MedTech, Product Development Strategy, FDA Regulatory Consulting, and MDR & IVDR Consulting
novotech-cro.com
Location of the CRO in Spain: Calle de la Infanta Mercedes, 31 – 2ª Planta Derecha, 28020, Madrid (Spain)
Company size: 1,000-5,000 employees Headquarters : Sydney, NSW, Australia Founded: 1997 Specialties: Leading Asia Pacific Contract Research Organization (CRO), Clinical Trials (Phase I to IV clinical research), Biostatistics, Data Management, Regulatory Affairs, Audits, Medical Writing, and Commercialization – across all major therapeutic areas
www.opisresearch.com
Contact information : Contact page Phone: +34 91 076 68 45
Location of the CRO in Spain: Avenida de Bruselas, 15 28108 Alcobendas – Madrid (Spain)
Company size: 200-500 employees Headquarters : Desio, Monza Brianza, Italy Founded: 1998 Specialties: Clinical Research, CRO, Clinical Development, Early phase trials, Phase II and III studies, Post market studies, Observational research, Real world evidence studies, investigator initiated trials, medical device clinical investigations, nutraceutical studies, medical affairs and medical writing, Regulatory, Trials Start-Up, Data Management, Pharmacovigilance, Quality Assurance, e-Clinical Platform, Project Control, Statistical Analysis and Consultancy, Staudy Management and Monitoring, Preclinical and Drug Development Consultancy, and Training
optimapharm.eu
Contact information : Contact page Phone: +34 971 910 842/ +34 930 16 01 26
Location of the CRO in Spain: Parc Bit Edifici Disset A2, 07121 Palma de Mallorca, (Spain)
Company size: 200-500 employees Headquarters : Zagreb, Croatia Founded: 2006 Specialties: oncology, metabolic diseases, neurology, psychiatry, cardiovascular diseases, immunology, advanced therapies, rare diseases, pulmonary diseases, hemato-oncology, rheumatology, and steam cell therapies
oxonepi.com
Contact information : Contact page Phone: +34 91 345 9395
Location of the CRO in Spain: Calle Doctor Fleming, 51, 28036 Madrid Madrid (Spain)
Company size: 11-50 employees Headquarters : London, UK Founded: 2008 Specialties: Epidemiology (field, database and registry studies), Safety (statistical and medical signal analysis and benefit-risk analysis), Patient-reported outcomes, Health economics, Data integration, Evidence strategy, Decision modelling, Risk Minimisation, PASS, PAES, Observational Studies, and RWE
www.parexel.com
Contact information : Contact page Phone: +34 913 913 800
Location of the CRO in Spain: Edificio Alfredo Mahou Plaza Manuel Gómez Moreno nº2, 13ª Madrid, 28020 (Spain)
Company size: More than 10,000 employees Headquarters : Raleigh, North Carolina, USA Founded: 1982 Specialties: Regulatory and product development consulting, early phase clinical research, phase II-III clinical research, late phase clinical research, eClinical solutions, patient and site recruitment, medical device consulting, clinical research organization, pharmacovigilance, biotechnology, biotech, and market access
www.ppd.com
Contact information : Contact page Phone: +34 91 774 27 00
Location of the CRO in Spain: Torre Nozar Titan, 15 6th floor 28045 Madrid (Spain)
Company size: More than 10,000 enmployees Headquarters : Wilmington, NC, USA Founded: 1985 Specialties: clinical research, drug development, CRO, patient recruitment, laboratory, pharmaceutical, biotechnology, biopharma, biopharmaceutical, consulting, therapeutics, Functional Service Partnerships, consulting, Early Development, Post-Approval, medical writing, drug information, pharmacovigilance, biostatistics, and bioanalytical
premier-research.com
Contact information : Contact page Phone: +34 91 038 89 00
Location of the CRO in Spain: Camino de la Zarzuela, 19- 1º B 28023, Madrid, (Spain)
Company size: 1,000-5,000 employees Headquarters : Morrisville, NC, USA Founded: 1989 Specialties: Analgesia, CNS/Neuroscience, Rare Disease, Pediatrics, Oncology, Clinical Development Services, Medical Device, Dermatology, Women’s Health, and Diagnostics
www.psi-cro.com
Location of the CRO in Spain: 23 Calle de Castelló, 28001, Madrid, (Spain
Company size: 1,000–5,000 employees Headquarters : Zug, Switzerland Founded: 1995 Specialties: Number One Patient Enrollment CRO, Clinical Research, Clinical Trials, Oncology, Hematology, Multiple Sclerosis, Infectious Diseases, Patient Enrollment, Phase 2 , Phase 3, Pivotal Trials, Global Clinical Trials, and Full-Service Clinical Trials
www.rtihs.org
Contact information : Contact page Phone: +34 93 241 7766
Location of the CRO in Spain: Av. Diagonal, 605, 9-1 08028 Barcelona (Spain)
Company size: 200-500 employees Headquarters : Research Triangle Park, North Carolina, USA Founded: 2000 Specialties: Health Economics, Biostatistics, Market Access, Epidemiology, Consulting, Risk Management, Patient-Reported Outcomes, Clinical & Medical, Surveys & Observational Studies, Database Studies, Economic Modeling, Literature Reviews & Meta-analysis, Conjoint Analysis, Drug Development, Medical Device, Real World Evidence, pharmaceutical consulting, gene therapy, HTA Reimbursement, Health Preference, and Benefit Risk Assessment
www.syneoshealth.com
Contact information : Contact Page Phone: +34 93 25 55 600 Location of the CRO in Spain: Calle Hernani, 59 – PLANTA 3 28020 Madrid (Spain)
Company size: More than 10,000 employees Headquarters : Morrisville, NC, USA Founded: 1998 Specialties: Clinical Trials and Biopharmaceutical Product Lifecycle Management
Contact information : Contact page Phone Barcelona: +34 93 1850 200 Phone Madrid: +34 91 125 05 50
Location of the CRO in Spain: Passeig de Gràcia, 11 – 4a Planta – Escala A 08007 Barcelona (Spain) S.L. Avda. De Burgos 12B ES-28036 Madrid (Spain)
Company size: 500-1,000 employees Headquarters : Lund, Skåne, Sweden Founded: 1996 Specialties: CRO, clinical trials, Scientific and Medical consulting, Contract Placement Solutions (staffing), Regulatory Consulting, Clinical Study Operations, Study/Site Coordinators, Data Management, Biostatistics, Pharmacovigilance, Medical Writing, Quality Assurance, and Training
If you think that Spain fulfils the requirements to receive your clinical trial, you can of course contact us to help you in all the steps to implement your clinical trial in Spain.
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Spain: Becoming a European Clinical Research Leader
Having forged a solid position in clinical research in 2020 and 2021 when it became the fourth nation in the world and the first in Europe for studies conducted around COVID-19, Spain has continued consolidating its status as a leading clinical trials hub and registered over 900 trials in 2022, more than 86 percent of which were initiated by pharma companies, representing an investment of EUR 789 million.
More Trials, Increased Focus on Rare Diseases
According to the Spanish Clinical Trials Registry (REEC), coordinated by the Spanish Agency of Medicines and Medical Devices (Aemps), Spain authorized no less than 924 clinical trials in 2022.
While COVID-19 led to an increase in the number of clinical trials in the country in 2020 and 2021, making Spain the fourth country in the world and the first in Europe with respect to the volume of studies relating to SARS-CoV2, the number for 2022 is higher than those recorded for 2018 and 2019, when 800 and 833 clinical trials were authorised, respectively.
In recent years, Spain has become a global leader in clinical trials, thanks to the commitment of the pharmaceutical industry, and the successful model of public-private collaboration Amelia Martín Uranga, director of Clinical and Translational Research, Farmaindustria
Although more than a third of the 2022 trials (328) were focused on drugs to treat cancer, making oncology the area that saw the largest number of studies, Spain stands out for its rare disease trials. Accounting for 25 percent of 2022’s clinical trials, a total of 230 studies were carried out for rare diseases.
“This data has seen significant growth in recent years, with 73 studies aimed at testing orphan drugs in 2018 and 117 in 2019,” said Amelia Martín Uranga, director of Clinical and Translational Research at Farmaindustria, Spain’s leading pharma industry association, in a recent interview.
Pharma Industry Driving Growth
The industry was behind much of the growth and a large percentage of the trials conducted in Spain in 2022 were initiated by the pharmaceutical companies: 86 percent in total. These studies represented an investment of EUR 789 million, and based on Farmindustria’s latest R&D activities survey , 60 percent of the total R&D investment in the sector in Spain.
Moreover, investment in clinical trials over the past ten years has increased at a cumulative average annual rate of 5.3 percent from EUR 470 million in 2011 to nearly EUR 800 million in 2021.
A Solid Healthcare System
One of the factors attracting investment into clinical research in Spain is the quality of the country’s healthcare system. As Ana Argelich Hesse, Merck Sharp & Dohme’s managing director for Spain asserted in a PharmaBoardroom interview , the fact that the affiliate’s R&D department participates in 80 percent of MSD’s global clinical trials “reflects the excellence of the Spanish healthcare system, one of the best in the world.” For Argelich Hess clearly “the reason why MSD in Spain is a global leader in clinical trials is because of the country’s top-notch physicians, researchers, and hospital infrastructure.”
Apart from its excellent healthcare system, Spain has successfully implemented new European legislation around clinical trials and adapted its own legislation accordingly. “It was the first country in Europe to anticipate this legislation with a national regulation as a result of working together with the Spanish Agency of Medicines and Medical Devices (AEMPS) as well as the hospitals and clinicians to establish a good environment for clinical trials,” said Javier Urzay, deputy general manager of Farmaindustria, in a 2022 PharamBoardroom interview .
The country has also effectively built a public-private collaboration model. “In recent years, Spain has become a global leader in clinical trials, thanks to the commitment of the pharmaceutical industry, and the successful model of public-private collaboration,” claims Farmindustria’s Martín Uranga. “This model, which we have been working on for years with authorities, regulators, research centres, hospitals, healthcare professionals, and patients, is what has set us apart from other countries in our region and made us a global reference in clinical research.”
While Spain has made major strides in becoming a leading clinical research destination, Urzay claims that there is more to be done. “We have the opportunity to further boost Spain’s leadership in this area.”
“If we want to continue gaining ground and consolidate our leadership, we must continue improving infrastructure and increasing resources dedicated to research. It is an opportune time for this, and as a country, we must all work towards achieving it,” Martín Uranga agrees.
Amanda Saionz
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Eight biotech companies you should know about in Spain
Spain might be best known for its sunny beaches, tapas, and flamenco, among many other things, but in the last decade or so, its biotech industry has also quietly become an integral part of the country. The sector has grown dramatically , with international investors taking more of an interest in the country’s scientific landscape, turning it into one of the most competitive industries globally. In this article, we take a look at eight of the top biotech companies based in Spain today.
Table of contents
Aelix therapeutics .
Aelix Therapeutics is a clinical-stage biotech company based in Barcelona, in the northeast of Spain. It is a spin-off of HIVACAT – a Catalan program for the development of therapeutic vaccines and prevention against human immunodeficiency virus (HIV) – and is focused on developing a new therapeutic vaccine for HIV that can be included in cure and eradication strategies.
The company’s vaccine program is based on an innovative T-cell vaccine immunogen design that directs the body’s immune defense to the most vulnerable parts of the HIV virus. The immunogen, called HTI, is based on the observation that T-cell responses to certain HIV regions are enriched in people with a non-progressor clinical phenotype. Therefore, HTI brings these beneficial regions together within a single vaccine.
AELIX-002, the first clinical trial run by the company, started in September 2017. It was a phase 1 trial that studied the HTI vaccine in early diagnosed, early treated HIV-infected individuals. The results showed that the vaccines were well tolerated, refocused killer T cells on more protective epitopes, and showed in a subgroup of participants that those who generated a stronger immune response were able to remain without antiretroviral treatment for longer periods of time and with a lower viral load compared to those who did not receive the vaccine or did not respond to the vaccination.
As part of an ongoing partnership with Gilead, Aelix announced positive topline results last year from its AELIX-003 trial, which evaluated the safety, tolerability, immunogenicity, and efficacy of the company’s vaccine in combination with Gilead’s investigational Toll-Like Receptor 7 (TLR7) agonist – vesatolimod (VES) – in people with HIV on antiretroviral therapy.
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Based in Valencia, Spain, the immuno-oncology biotech company Highlight Therapeutics is targeting anti-PD-1 resistance to try and transform cancer immunotherapy. Stimulation of the immune system using anti-PD-1 antibodies, also known as immune checkpoint inhibitors, significantly improves survival in cancers such as melanoma. However, these therapies are only effective in a subset of patients, leaving a significant portion unresponsive. Highlight believes its lead RNA-based drug candidate, BO-112, has a unique ability to modify tumor-intrinsic pathways and the immune system to make tumors more sensitive to immune checkpoint inhibitors. According to the company, the drug has been demonstrated to initiate a powerful immune response, leveraging a unique multi-target approach to turn ‘cold’ tumors ‘hot’, making them visible to the immune system.
BO-112 is currently being investigated in a range of clinical trials as a monotherapy and in combination with checkpoint inhibitors. It is currently being tested in combination with Merck & Co’s Keytruda. The two companies completed a successful phase 2 study to evaluate intra-tumoral administration of BO-112 and pembrolizumab in mucosal, acral, and cutaneous melanoma patients in August 2021.
The collaboration between Highlight and Merck is ongoing after Highlight signed a second phase 2 trial collaboration with Merck in 2020 to evaluate the BO-112 and Keytruda combination in patients that have progressed on anti-PD-1-based therapy in refractory advanced malignant melanoma.
Minoryx Therapeutics
Minoryx Therapeutics is focused on the discovery and development of novel therapies for severe, orphan genetic diseases of the central nervous system (CNS) with high unmet medical needs. The company’s lead candidate is a PPAR-γ agonist called leriglitazone. The drug has demonstrated brain penetration and a favorable safety profile and showed robust preclinical proof-of-concept in animal models of multiple diseases by modulating pathways leading to mitochondrial dysfunction, oxidative stress, neuroinflammation, demyelination, and axonal degeneration.
Leriglitazone is currently in late-stage trials to treat X-linked adrenoleukodystrophy (X-ALD), an orphan neurodegenerative disease caused by a mutation in the ABCD1 gene. X-ALD presents two main neurologic phenotypes, one of which is cerebral ALD (cALD), characterized by demyelinating brain lesions that may become rapidly progressive, leading to acute neurological decline and death. These lesions can produce severe symptoms such as loss of voluntary movements, inability to swallow, loss of communication, cortical blindness, and total incontinence, as well as death, with a mean survival of three to four years. In a phase 2/3 study , leriglitazone was found to significantly reduce the progression of cerebral lesions and reduce the incidence of progressive cALD in adult X-ALD patients. Last year, the U.S. Food and Drug Administration (FDA) also gave Minoryx the green light to begin a phase 3 trial of leriglitazone to treat X-ALD patients with cerebral adrenoleukodystrophy (cALD).
However, Minoryx announced in May that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended once again not to grant marketing authorization for leriglitazone as a treatment for cALD following the completion of a re-examination procedure. Minoryx’s chief executive officer (CEO) said in the press release update that the company will continue to generate evidence from two ongoing trials in order to get the drug approved.
Ona Therapeutics
A spin-off of the Catalan Institution for Research and Advanced Studies (ICREA) and the Barcelona Institute for Research in Biomedicine (IRB Barcelona), Ona Therapeutics specializes in the development of antibody drug conjugates (ADCs) to attack advanced cancer.
The company currently has its focus on two programs. Its lead candidate is ONA-255, which is an undisclosed first-in-class ADC that is being initially developed for a specific population of refractory breast cancer patients. The company is also developing a monoclonal antibody against CD36, a metabolic regulator of fatty acid transport that has been implicated in multiple aspects of cancer progression.
In 2020, Ona closed a €30 million ($33 million) series A funding round , which at the time, marked the largest round ever achieved by a biotech company in the preclinical stage in Spain.
More recently, in December 2023, the company entered into an agreement with Biocytogen Pharmaceuticals to develop ADCs targeting solid tumors. Under the terms of this agreement, Biocytogen grants Ona access to evaluate its proprietary RenMice-derived fully human antibodies against a specific tumor target, with an option to exclusively license selected antibodies for ADC development, manufacturing, and commercialization in mutually agreed indications and territories.
Oryzon Genomics
Oryzon Genomics is a public clinical-stage biopharmaceutical company focused on the development of innovative epigenetic personalized medicines for the treatment of neurological diseases and cancer.
Epigenetics is the study of how behavioral and environmental factors can cause changes in gene expression without changing an individual’s DNA sequence. Epigenetic switches also occur in normal biological or disease processes. Regulation of gene transcription and translation are key biological determinants for cellular differentiation and function, and transcriptional imbalances play a key role in several human diseases.
Oryzon’s therapeutic strategy is to target lysine-specific demethylase 1 (LSD1), which is a histone-modifying enzyme that is involved in the regulation of the expression of many genes that are important in the onset and progression of cancer and CNS disorders.
The company’s most advanced candidate is called vafidemstat, an oral small molecule that has been optimized for CNS indications and acts as a covalent inhibitor of LSD1. Although the drug recently failed to meet its primary endpoint of improving the symptoms of borderline personality disorder at weeks 8 to 12 as measured by the Borderline Personality Disorder Checklist – which measures instability, recurrent suicidal behavior, gestures, threats or self-mutilating behavior – in a phase 2b trial, it did meet its secondary endpoint of disorder severity across the same time span using a scale called Borderline Evaluation of Severity, and a statistically significant improvement in agitation and aggression was also seen. This has prompted Oryzon to move forward with vafidemstat, with plans to ask the FDA to take it into a phase 3 trial for borderline personality disorder, but with slightly different endpoints.
Peptomyc
Headquartered in Barcelona, Spain, biotech company Peptomyc is working on the development of a Myc inhibitor to treat cancer. Myc is a transcription factor that is expressed in over 70% of human cancers and is central to cancer proliferation, survival, and resistance to treatment.
Peptomycs candidate, OMO-103, is a miniprotein – commonly defined as being less than 100 amino acids long – that targets Myc. It consists of 91 amino acids, which have a unique ability to enter the cancer cell and penetrate its nucleus, meaning that it has the potential to overcome the challenges that small molecule therapeutics have previously encountered in targeting Myc – small molecules cannot recognize a protein that changes its shape all the time. OMO-103, on the other hand, is designed to chop Myc into a shape that cannot change; once Myc binds to OMO-103, it can no longer bind to DNA and therefore becomes inactive.
After a successful phase 1 study , in which 22 patients with various types of advanced tumors were enrolled, OMO-103 is now being tested in a phase 1b trial in combination with the standard-of-care regimen Gemcitabine and Nab-Paclitaxel in metastatic Pancreatic Ductal Adenocarcinoma (PDAC) – the most common form of pancreatic cancer – patients.
SpliceBio’s initial focus is around developing a gene therapy for Stargardt disease , which is a rare genetic eye condition that occurs when fatty material builds up on the central part of the retina, called the macula. The disease primarily affects children and young adults, causing vision loss.
Stargardt disease is caused by an alteration in the ABCA4 gene. With its large size of 6.8kb, it is too large for single adeno-associated virus (AAV) vectors to package enough genetic material to treat it, so SpliceBio is focusing on harnessing the potential of inteins to overcome this limitation. Inteins are a family of proteins that carry out a process known as protein splicing, sticking peptides together to form new proteins, and the company’s co-founders were able to develop engineered split inteins for therapeutic use.
In 2022, SpliceBio raised €50 million ($52.7 million) in oversubscribed series A funding, which will go towards helping it take its lead program for Stargardt disease into phase 1 of clinical development.
Furthermore, in October 2023, the Spanish biotech company entered into a collaboration with Spark Therapeutics – a member of the Roche group – to develop a gene therapy for an undisclosed inherited retinal disease.
Tyris Therapeutics
Another biotech company based in Valencia, on the eastern coast of Spain, Tyris Therapeutics is working on the development of next-generation gene therapies for rare genetic diseases with both systemic and local delivery. The company has a DNA-based medicines platform that includes proprietary technology to produce linear closed DNA, just containing the sequence of interest, and novel non-viral vectors that do not trigger an immune response, have no limitation in cargo capacity, and enable re-administration of any gene therapy treatment. According to the company, this means that its platform can overcome current challenges in viral gene therapy, achieving more efficient and safer therapeutics for any genetic disease.
Tyris has a preclinical pipeline initially focused on dermatological indications, as well as on renal, hematological, and pulmonary indications. It is also exploring further applications for its technology platform to fuel innovation in more prevalent therapeutic approaches, such as vaccines, CAR-T therapies, or monoclonal antibodies (MABs).
In November 2021, Tyris entered into a strategic partnership with Almirall – a Barcelona-based pharmaceutical company focused on medical dermatology – to develop gene therapies for the treatment of debilitating genetic dermatological conditions.
The growing biotech scene in Spain
In 2019, the Spanish biotech sector invested over €940 million ($1.06 billion) in research and development (R&D), having doubled the number in the space of 10 years. And, in 2020, the total funding for biotechs in the country surpassed €150 million ($168.5 million). Furthermore, the country hosts BioSpain , one of the largest international biotech events in southern Europe, which attracts people from within the global biopharma industry. All of these factors are contributing to the growth of the biotech industry in the country. And with more and more biotech companies joining the scene in Spain, the industry will likely continue on its upward trajectory.
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Study of Rapcabtagene Autoleucel and Ibrutinib for Various Blood Cancers in Adults This clinical trial aims to evaluate a new therapy for multiple forms of blood cancer: Chronic Lymphocytic Leukemia (CLL) , Small Lymphocytic Lymphoma (SLL) , Diffuse Large B-Cell Lymphoma (DLBCL) , Acute Lymphoblastic Leukemia (ALL) , and High-Risk Large B-Cell Lymphoma (HR LBCL) . The therapy being tested is called Rapcabtagene Autoleucel (also known as YTB323), both alone and in combination with another drug called Ibrutinib . The main goal is to see if this new therapy is safe and effective in treating these conditions. Participants in the study will receive Rapcabtagene Autoleucel, either alone or with Ibrutinib. The study is divided into two parts: Phase I: This part of the study involves finding the right dose of the therapy by starting with a low dose and then gradually increasing it. It will also look at the safety of the therapy. In this phase, participants will be placed into different groups based on their specific type of blood cancer: CLL/SLL , treated with Rapcabtagene Autoleucel and Ibrutinib. DLBCL , treated with Rapcabtagene Autoleucel alone after failing two or more chemotherapy treatments. ALL , also treated with Rapcabtagene Autoleucel alone after the disease has returned or not responded to standard treatments. Phase II: This part of the study will include more participants and will focus on evaluating the effectiveness of the therapy at the dose determined in Phase I. New groups will include: DLBCL , to further test Rapcabtagene Autoleucel in participants who have previously failed multiple treatments. HR LBCL , in newly diagnosed adults who have certain high-risk factors and have completed two cycles of initial treatment. Participants will be monitored for at least two years to assess both the safety and effectiveness of the therapy. After the study, there will be long-term follow-up monitoring for up to 15 years to ensure continued safety. .ticss-5ad54368 { overflow: hidden; display: -webkit-box; -webkit-line-clamp: 3; /* number of lines to show */ line-clamp: 3; -webkit-box-orient: vertical; } Small Lymphocytic Lymphoma Large B-cell Lymphoma Chronic Lymphocytic Leukemia .ticss-41e9669f { font-size:15px; } Ibrutinib
Study of Iopofosine I 131 in B-Cell cancers for patients who had previous treatments This clinical trial focuses on B-cell malignancies , which are different types of blood cancers. Specifically, it includes Waldenstrom Macroglobulinemia (WM) , Multiple Myeloma (MM) , Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) , Lymphoplasmacytic Lymphoma (LPL) , Marginal Zone Lymphoma (MZL) , Mantle Cell Lymphoma (MCL) , Diffuse Large B-Cell Lymphoma (DLBCL) , and Central Nervous System Lymphoma (CNSL) . The therapy being studied involves a drug called iopofosine I 131 (CLR 131) . This medicine is a targeted radiotherapeutic , meaning it uses radiation to target and kill cancer cells. The drug is designed to be taken up and retained by cancer cells more so than normal cells, making the treatment focused on the malignancy. The main goal of the trial is to examine the effectiveness of iopofosine I 131 in patients who have not responded well to standard treatments or whose disease has returned. This trial is broken down into two parts: Part A aims to evaluate the drug in patients with various B-cell malignancies that have already undergone standard treatment. Part B focuses on patients with Waldenstrom Macroglobulinemia who have already received at least two different treatments. Participants will receive iopofosine I 131 through an intravenous (IV) administration , where it is injected directly into the bloodstream. The study includes different types of dosing: single dose, multiple doses, or fractionated doses (split into smaller amounts given over time). Central Nervous System Lymphoma Lymphoplasmacytic Lymphoma Marginal Zone Lymphoma Iopofosine I 131 single dose Iopofosine I 131 multiple dose Iopofosine I 131 fractionated dose
Study of BGB-16673 for Patients With B-Cell Cancers This clinical trial focuses on several types of B-cell cancers , including Marginal Zone Lymphoma , Follicular Lymphoma , Non-Hodgkin Lymphoma , Waldenström Macroglobulinemia , Chronic Lymphocytic Leukemia , Small Lymphocytic Lymphoma , Mantle Cell Lymphoma , and Diffuse Large B Cell Lymphoma . The study aims to assess the drug BGB-16673 , which is taken orally, for its safety and effectiveness in treating these conditions. The trial is conducted in phases to determine the best dose and gather detailed safety information. Participants will receive BGB-16673 alone in different parts of the study, which include: – Dose Escalation : To find the safest and most effective dose. – Safety Expansion : To gather more safety information at the selected doses. – Further Safety Expansion : To confirm the best dose for certain B-cell cancers. – Monotherapy Expansion : To further evaluate safety and effectiveness at the recommended dose. Each part will help understand how participants respond to the drug, including any side effects they may experience and how well the treatment works against their specific type of cancer. Marginal Zone Lymphoma B-cell Malignancy Small Lymphocytic Lymphoma BGB-16673
Study of Zilovertamab Vedotin alone and in combination for patients with B-cell Lymphomas and Chronic Lymphocytic Leukemia This study focuses on select B-cell lymphomas, which are types of blood cancers affecting the lymphatic system. The diseases involved include mantle cell lymphoma (MCL), Richter’s transformation lymphoma (RTL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL). The main drug being tested is called zilovertamab vedotin (also known as MK-2140). In some groups of this study, it will be combined with another drug called nemtabrutinib . The study aims to assess the safety and effectiveness of these treatments. Participants are divided into six groups based on their specific type of lymphoma and its treatment history: Cohort A: Participants with MCL who have relapsed or resistant disease after at least 2 prior treatments, including a type of drug targeting specific enzymes (BTKi) and cell therapy (CAR-T) or are not eligible for CAR-T therapy. They will receive zilovertamab vedotin every 3 weeks. Cohort B: Participants with RTL who have relapsed or resistant disease after at least 1 prior treatment. They will receive zilovertamab vedotin every 3 weeks. Cohort C: Participants with MCL who have relapsed or resistant disease after at least 1 prior treatment but have not been exposed to non-covalent BTKi. They will receive a combination of zilovertamab vedotin and nemtabrutinib. Cohort D: Participants with relapsed or resistant FL and CLL after at least 2 prior treatments without other available options. They will receive zilovertamab vedotin either every 3 weeks or with additional infusions on specific days of each cycle. Cohort E: Participants with relapsed or resistant FL after at least 2 prior treatments without other available options. The treatment schedule is the same as for Cohort D. Cohort F: Participants with relapsed or resistant CLL after at least 2 prior treatments without other available options. They also receive the same treatment schedule as Cohorts D and E. The goal is to improve the response rate to these treatments, meaning how well the cancer responds to the drug. This study will help determine if these new treatment options are effective for patients whose previous treatments have failed. Richter Transformation Lymphoma Chronic Lymphocytic Leukemia Follicular Lymphoma Nemtabrutinib
Comparing treatments for Chronic Lymphocytic Leukemia (CLL) using Sonrotoclax, Zanubrutinib, Venetoclax, and Obinutuzumab in untreated patients Chronic lymphocytic leukemia (CLL) is a type of blood cancer that affects many people worldwide. Those with CLL often experience enlarged lymph nodes, spleen, or liver, and symptoms such as night sweats, weight loss, and fever. This study will compare the efficacy of two different treatment combinations for participants with previously untreated CLL: Sonrotoclax (BGB-11417) plus Zanubrutinib (BGB-3111) Venetoclax plus Obinutuzumab Participants in this study will receive either venetoclax and obinutuzumab, which is a standard first-line treatment, or a combination of sonrotoclax and zanubrutinib. The goal is to determine if the combination of sonrotoclax and zanubrutinib is more effective in treating CLL than venetoclax and obinutuzumab. The study includes approximately 640 participants from across the globe. Participants will be randomly assigned to receive one of the two treatment combinations. The study primarily aims to compare how long participants live without their CLL worsening when treated with either combination. CLL Sonrotoclax Zanubrutinib Obinutuzumab Venetoclax
Study of Epcoritamab for Patients with Chronic Lymphocytic Leukemia and Richter’s Syndrome This clinical trial focuses on patients with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and Richter’s Syndrome (RS). The therapy being studied is called Epcoritamab , also known by code names EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20) . Epcoritamab can be used on its own or in combination with other treatments: Epcoritamab + Venetoclax, Epcoritamab + Lenalidomide, and Epcoritamab + R-CHOP (combining Rituximab, Cyclophosphamide, Doxorubicin Hydrochloride, Vincristine (Oncovin®), and Prednisone). The purpose of this study is to evaluate the safety and effectiveness of Epcoritamab in treating these conditions. There are two parts to the trial: a dose-escalation phase (Phase 1b) to determine the best dose with minimal side effects, and an expansion phase (Phase 2) to further evaluate the treatment. For patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (R/R CLL/SLL), Epcoritamab will be tested as a single drug or in combination with Venetoclax. For those with Richter’s Syndrome (RS), Epcoritamab will be tested alone or in combination with Lenalidomide or R-CHOP. Epcoritamab will be injected under the skin. Standard combination treatments will be given either orally or directly into the vein. The study duration will be up to five years. Each participant will be in the study for 18-24 months, with visits scheduled weekly, every other week, or monthly, depending on their study group. All participants will receive the active drug in this study. Relapsed/Refractory Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Richter’s Syndrome rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone Lenalidomide Venetoclax
Safety and effectiveness of Nemtabrutinib for blood cancer patients Participants in this study have certain types of blood cancers such as chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), Richter’s transformation , marginal zone lymphoma (MZL), mantle cell lymphoma (MCL), follicular lymphoma (FL), or Waldenström’s macroglobulinemia (WM). The treatment being studied is called nemtabrutinib (MK-1026), which might also be known as ARQ 531. The main goal of the study is to see how safe and effective nemtabrutinib is for treating the mentioned blood cancers. The study will be conducted in two parts. In the first part, researchers will determine the best dose of nemtabrutinib for participants. In the second part, the selected dose will be tested further on different groups of patients with specific types of blood cancers. Patients will be given nemtabrutinib to take orally (by mouth) once daily. The study will carefully monitor participants for any side effects and how well the cancer responds to the treatment. This includes observing participants for any improvements or progression in their condition. Chronic Lymphocytic Leukaemia Non-Hodgkins Lymphoma Waldenstroms Macroglobulinaemia Nemtabrutinib
Customizing Treatment With Ibrutinib and Venetoclax for Patients With Untreated Chronic Lymphocytic Leukemia Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) are types of cancer that affect B cells, a kind of white blood cell. These conditions cause the cells to grow out of control, leading to various health problems. This clinical trial is examining the use of two drugs, Ibrutinib and Venetoclax , in different combinations to treat participants who have not been treated for CLL or SLL before. These drugs are known to help manage the disease by targeting and killing cancer cells in different ways. The trial will compare several treatment plans to see which is the most effective and safest. There are four distinct groups in this study: Group 1a: Participants will take Ibrutinib capsules every day for the first 3 cycles (each cycle lasts 28 days). Starting from the fourth cycle, Venetoclax tablets will be added, slowly increasing the dose. Both drugs will be taken together for a total of 12 cycles. Group 1b: Similar to Group 1a, but with a reduced dose of Ibrutinib when combined with Venetoclax for the 12 cycles. Group 2a: Participants will continuously take Ibrutinib alone until the disease progresses or they experience severe side effects. Group 2b: Participants will start with a higher dose of Ibrutinib for the first cycle, then reduce to a lower dose for continued treatment until disease progression or severe side effects occur. The purpose of the study is to evaluate how well these drugs control the disease and to monitor side effects caused by the treatments. By adjusting the therapy in response to side effects, the study aims to find the best approach to improving participants’ health and quality of life. Leukemia, Lymphocytic, Chronic, B-Cell Small Lymphocytic Lymphoma Ibrutinib Venetoclax
Study on Panzyga for Preventing Infections in Patients with Chronic Lymphocytic Leukemia This study focuses on two diseases: Chronic Lymphocytic Leukemia (CLL) and Hypogammaglobulinemia . Chronic Lymphocytic Leukemia is a type of cancer that affects a specific kind of white blood cells called lymphocytes. Hypogammaglobulinemia is a condition characterized by low levels of antibodies that help fight infections. The therapy being tested is called Panzyga , which is an intravenous immunoglobulin (IVIG) made from human plasma. The study is designed to evaluate the effectiveness and safety of Panzyga in preventing infections in patients with CLL. The study involves two groups of participants: one group will receive Panzyga, and the other group will receive a placebo. Neither the participants, care providers, nor the researchers will know who is receiving Panzyga and who is receiving the placebo. This method is used to ensure that the results are as unbiased as possible. This study is randomized , meaning participants are randomly assigned to one of the two groups. It is also a Phase III study , which means it focuses on confirming the effectiveness and monitoring the side effects of the treatment in a larger group of people. The primary goal is to see if Panzyga can reduce the occurrence of major infections in CLL patients who have low antibody levels. Participants will be monitored for 52 weeks to track infection rates and any side effects. Chronic lymphocytic leukemia Hypogammaglobulinemia
Study of Nemtabrutinib, Venetoclax, and Rituximab for Relapsed or Refractory Chronic Lymphocytic Leukemia Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) are two types of cancer that affect the blood and lymphatic system. These diseases often require treatments called therapies to help control their progression. This study involves the following therapies: Nemtabrutinib (also known as MK-1026), Venetoclax, and Rituximab (or a similar biosimilar). The study aims to find out how safe and tolerable Nemtabrutinib is when combined with Venetoclax. Researchers want to compare this combination to another treatment that uses Venetoclax and Rituximab. Participants will be randomly divided into different groups: one group will receive Nemtabrutinib tablets daily combined with Venetoclax tablets starting from the second cycle of the treatment, and another group will receive Venetoclax tablets daily combined with Rituximab, which will be given as an intravenous infusion starting from the second cycle. The study wants to determine if the new combination (Nemtabrutinib + Venetoclax) is better in controlling the disease compared to the Venetoclax + Rituximab combination. Researchers will monitor the participants’ health and response to these therapies over several months. Participants will be closely observed for any side effects or improvements in their condition. The study aims to find a more effective therapy combination to improve the outcomes for patients with these types of leukemia and lymphoma. SLL CLL Lymphoma, Small Lymphocytic Nemtabrutinib Venetoclax
Study on NT 201 Injections for Nerve Pain Relief After Shingles or Nerve Injury This clinical trial focuses on individuals with chronic nerve pain due to shingles (a viral infection causing a painful rash) or a nerve injury. The study aims to compare the effects of NT 201 injections to placebo injections in reducing this pain. Conditions covered include chronic nerve pain from shingles (postherpetic neuralgia) and chronic nerve pain from an injury to the peripheral nerves (caused by surgery or trauma). Therapies being studied are NT 201 (also known as IncobotulinumtoxinA or Xeomin) and placebo. The main goal is to determine if NT 201 can effectively reduce pain compared to placebo. The trial lasts for 22-23 weeks. Participants will receive either NT 201 or placebo at one injection visit. Follow-up includes two remote visits by phone/video call at 1 week and 12 weeks after the injection, and two on-site visits at 6 weeks and 20 weeks after the injection. Peripheral Neuropathy
Effects of PF-06823859 on people with dermatomyositis and combined treatment with corticosteroids and immunosuppressants The study is for people with active idiopathic inflammatory muscle diseases, including dermatomyositis (DM) and polymyositis (PM). These diseases cause inflammation that leads to muscle weakness. People with DM may also have a characteristic skin rash. The study aims to understand how the investigational drug PF-06823859 works in people with these diseases. Treatment with this drug will be compared with placebo to assess its safety and effectiveness. The investigational drug PF-06823859 and placebo will be given to participants intravenously (directly into the veins) every 4 weeks for 48 weeks. Participants will be randomly assigned to receive the investigational drug or placebo, and neither participants nor study staff will know who is receiving what to ensure the results are objective. The study is for adults who have active DM or PM and are already treated with a stable dose of corticosteroids or traditional immunosuppressive drugs. Corticosteroids and immunosuppressants are drugs that help reduce inflammation and can signal the immune system not to attack the body. Both groups of participants will go through a similar follow-up process that will last about 13 months and include 15 on-site visits. The goal is to compare the experiences of people receiving the study drug with those not receiving it to see if PF-06823859 is safe and effective in treating DM and PM. Myositis PF-06823859 placebo
Study of the efficacy and safety of anifrolumab in patients with dermatomyositis The study is aimed at patients with idiopathic inflammatory muscle diseases, such as polymyalgia (PM) and dermatomyositis (DM). It will test a drug called anifrolumab, administered by subcutaneous injection, in combination with standard treatment, and compare it with placebo, also in combination with standard treatment. The study aims to assess the effectiveness and safety of anifrolumab compared with placebo in patients with moderate to severe disease. All participants will continue to receive standard treatment. The study involves adults aged 18 to 75 years who have been diagnosed with polymyalgia or dermatomyositis according to the 2017 classification criteria. Participants must currently be taking a stable dose of medication such as prednisone or other drugs used to treat these conditions. Polymyositis, Dermatomyositis
Study of Lurbinectedin and Irinotecan in Patients with Advanced Solid Tumors This clinical trial is a Phase I/II study designed to evaluate the safety and effectiveness of a combination of two drugs, Lurbinectedin and Irinotecan , in patients with certain advanced solid tumors. The study is divided into two stages: a Phase I dose escalation stage and a Phase II expansion stage . During the Phase I stage, patients will be divided into three groups, each receiving different dose levels of the drugs. The goal is to determine the Maximum Tolerated Dose (MTD) and the Recommended Dose (RD) for each group. This stage will help identify the safest and most effective dose levels by monitoring for any dose-limiting toxicities (DLTs). Once the MTD and RD are established, the study will move into the Phase II stage. This stage will focus on specific types of tumors that showed signs of activity during the Phase I stage. Approximately 20 patients per tumor type will be treated at the RD to further evaluate the effectiveness of the drug combination. Additionally, a new cohort of patients with neuroendocrine neoplasms (NENs) will be included, with around 40 patients divided into two groups based on the type and grade of their cancer. The study will also expand two specific cohorts due to promising results: patients with small cell lung cancer (SCLC) and those with soft tissue sarcoma (STS) . An Independent Review Committee (IRC) will assess the response to treatment in these cohorts. The primary outcomes of the study include determining the MTD and RD, as well as evaluating the Response Rate , which measures the percentage of patients who experience a partial or complete response to the treatment. This study aims to provide valuable information on the safety and efficacy of Lurbinectedin and Irinotecan in treating advanced solid tumors, potentially offering new treatment options for patients with these challenging conditions. Colorectal Carcinoma Gastric Carcinoma SCLC Irinotecan Lurbinectedin
Study on the Safety and Effectiveness of [177Lu]Lu-NeoB for Treating Glioblastoma This clinical trial is a Phase Ib Dose Finding Study that aims to assess the safety and activity of a new treatment called [177Lu]Lu-NeoB in combination with standard therapies for glioblastoma, a type of aggressive brain tumor. The study is divided into two parts: one for patients with newly diagnosed glioblastoma and another for those with recurrent glioblastoma . For patients with newly diagnosed glioblastoma, the study will combine the standard treatment of Temozolomide (TMZ) and Radiotherapy (RT) with [177Lu]Lu-NeoB. The goal is to improve patient outcomes by adding this new radioligand therapy. Participants will receive [177Lu]Lu-NeoB every four weeks for up to six doses, with the possibility of receiving up to four additional doses if they tolerate and benefit from the treatment. Regular safety and efficacy assessments will be conducted weekly, and MRI scans will be repeated every eight weeks. After the treatment period, participants will be followed for up to five years to monitor safety, disease progression, and survival. Additionally, a PET/CT or PET/MRI scan using [68Ga]Ga-NeoB will be performed at the baseline after surgery or biopsy to assess tumor uptake. For patients with recurrent glioblastoma, the study aims to determine the recommended dose of [177Lu]Lu-NeoB as a single agent. Participants will undergo a [68Ga]Ga-NeoB PET scan during the screening period to assess GRPR expression. [177Lu]Lu-NeoB will be administered every three weeks for up to six doses, with the possibility of up to four additional doses if tolerated and beneficial. The primary objective is to characterize the safety and tolerability of this treatment. The main outcome measure for both groups is the incidence and nature of Dose Limiting Toxicity (DLTs) , which are adverse events or abnormal lab values not related to the disease or other factors. The study will use the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 for grading these toxicities. This study offers a potential new treatment option for glioblastoma patients by combining standard therapies with innovative radioligand therapy, aiming to improve safety and efficacy outcomes. Glioblastoma Multiforme [68Ga]Ga-NeoB [177Lu]Lu-NeoB
Study of Debio 0123 and Temozolomide for Adults with Glioblastoma This clinical trial is designed to evaluate the safety and effectiveness of a new drug combination for treating glioblastoma, a type of brain cancer. The study involves the drug Debio 0123 taken in combination with temozolomide (TMZ) , and in some cases, with radiotherapy (RT) . The trial is divided into two main phases: Phase 1 and Phase 2. In Phase 1 , the primary goal is to determine the dose-limiting toxicities (DLTs) and to assess the safety and tolerability of Debio 0123 when combined with TMZ (Arm A) and with TMZ and RT (Arms B and C). However, Arm B has been permanently halted due to safety concerns. This phase also aims to identify the recommended dose (RD) for further development. Once the RD is established, Phase 2 will begin. The main objective of this phase is to evaluate the efficacy of Debio 0123 at the RD in combination with TMZ, compared to the standard of care (SOC) in adult participants with glioblastoma. Participants in this study will be monitored for various outcomes, including the number of dose-limiting toxicities, treatment-emergent adverse events (TEAEs), and changes in laboratory results, vital signs, and performance status. The study will also measure overall survival (OS) from the start of treatment until death or the end of the study. This trial is open to adult participants with recurrent or progressive glioblastoma and those with newly diagnosed glioblastoma. The drugs involved, Debio 0123 and temozolomide, are administered as capsules. Astrocytoma, Grade III Glioblastoma Multiforme Debio 0123 Temozolomide
Study of INCB161734 for Advanced or Metastatic Solid Tumors with KRAS G12D Mutation This clinical trial is designed to evaluate the safety and tolerability of a new drug called INCB161734 in patients with advanced or metastatic solid tumors that have a specific genetic mutation known as KRAS G12D . The study is open-label and conducted across multiple centers, meaning that both the researchers and participants know which treatments are being administered. The primary goal of the study is to determine how safe INCB161734 is when given alone or in combination with other cancer therapies, specifically cetuximab and retifanlimab . Participants will receive these drugs at doses defined by the study protocol. Researchers will closely monitor participants for any dose-limiting toxicities (DLTs) within the first 28 days of treatment. They will also track any treatment-emergent adverse events (TEAEs) , which are side effects that occur or worsen after the first dose of the study drug, over a period of up to 2 years and 90 days. Additionally, the study will record the number of participants who experience TEAEs that lead to dose modifications or discontinuation of the treatment. Solid Tumors INCB161734 retifanlimab Cetuximab
Study of PF-08046050 for Treating Advanced Solid Tumors This clinical trial is studying advanced solid tumors, which are cancers that start in a part of your body like your lungs or liver instead of your blood. When these tumors grow bigger in one place but haven’t spread, they’re called locally advanced . If the cancer has spread to other parts of your body, it’s called metastatic . When a cancer has grown so big it can’t easily be removed or has spread to other parts of the body, it is called unresectable . These types of cancer are harder to treat. Patients in this study must have cancer that has come back or did not get better with treatment. They must have a solid tumor cancer that can’t be treated with standard of care drugs. This clinical trial uses an experimental drug called PF-08046050 , which is a type of antibody-drug conjugate or ADC . ADCs are designed to stick to cancer cells and kill them, but they may also stick to some normal cells. The study will test the safety of PF-08046050 in participants with solid tumors that are hard to treat or have spread throughout the body. The study will have three parts. Part A and Part B will determine the appropriate dosage of PF-08046050 for participants. Part C will use the information from Parts A and B to see if PF-08046050 is safe and effective in treating certain solid tumor cancers. The primary outcomes of the study include the number of participants with adverse events (AEs), laboratory abnormalities, dose modifications due to AEs, and dose-limiting toxicities (DLTs). The study will monitor these outcomes through 30-37 days after the last study treatment, up to approximately 2 years. Small Cell Lung Carcinoma Stomach Neoplasms Pancreatic Ductal Adenocarcinoma PF-08046050
Combining THC+CBD with Temozolomide and Radiotherapy for Newly Diagnosed Glioblastoma This clinical trial, titled “ TN-TC11G (THC+CBD) Combination With Temozolomide and Radiotherapy in Patients With Newly-diagnosed Glioblastoma ,” aims to explore a new treatment approach for glioblastoma, a type of brain tumor with a very poor prognosis. Despite the best available treatments, the median survival for glioblastoma patients is only about 12 months. The standard treatment currently involves surgery followed by chemoradiotherapy with a drug called temozolomide, and then additional cycles of chemotherapy. In this study, researchers are investigating whether adding a combination of two compounds, THC (Δ9-tetrahydrocannabinol) and CBD (cannabidiol) , to the standard treatment can improve outcomes. Preclinical studies have shown that THC and CBD can work synergistically with temozolomide and radiotherapy to enhance their antitumor effects. These compounds activate specific receptors in the brain and immune system, leading to a process that can cause tumor cells to self-destruct. The trial is a Phase Ib, open-label, multicenter, intrapatient dose-escalation study . This means that it is an early-phase trial designed to assess the safety of the THC+CBD combination when used with temozolomide and radiotherapy. The study will gradually increase the dose of THC+CBD over several weeks to determine the maximum tolerated dose. The trial will recruit 30 patients over 6 months at 8 specialized neuro-oncology centers. Patients will start with a low dose of the THC+CBD combination and gradually increase it over nine weeks. During radiotherapy, patients will also receive temozolomide at a specific dose. After completing radiotherapy, patients will continue to take temozolomide in cycles, with the dose adjusted based on how well they tolerate the treatment. The primary goals of the study are to determine the maximum tolerated dose of the THC+CBD combination and to monitor any treatment-related side effects. The study will track the type and number of adverse events over a 12-month period. Glioblastoma Multiforme Temozolomide Oral Product TN-TC11G
Study on Azeliragon, Radiation, and Temozolomide for Patients with Newly Diagnosed Glioblastoma Glioblastoma (GBM) is a type of brain cancer that is aggressive and challenging to treat. This clinical trial focuses on patients who have been newly diagnosed with glioblastoma. The study aims to assess the safety and preliminary therapeutic effects of combining a drug called azeliragon with standard radiation therapy and a chemotherapy drug named temozolomide (TMZ) . Patients in this study will receive involved field radiation therapy and temozolomide. The radiation therapy will involve daily sessions for six weeks. Temozolomide will be taken daily alongside radiation and continued again after the radiation therapy for six cycles, with each cycle lasting 28 days. In addition to standard treatment, patients will receive azeliragon. The dose of azeliragon may vary as the study aims to find the most beneficial and safe dose. This drug could be administered in doses of 5 mg, 10 mg, or 20 mg, depending on the patient’s response and the phase of the trial. Azeliragon will be continued for up to two years or as long as there is potential for therapeutic benefit as determined by the patient and the study investigator. The purpose of the study is to evaluate how azeliragon can be safely integrated with existing treatments for glioblastoma and to collect early data on its possible benefits in slowing or stopping the progression of the cancer. The research will proceed by gradually increasing the dose, starting with a lower dose and moving to higher doses only if the lower doses prove to be tolerable and safe. Patients will be closely monitored throughout the trial for any adverse effects and to evaluate the cancer’s response to the combination therapy. This monitoring ensures a safe treatment experience for the participants and helps determine the most effective dosage of azeliragon. Glioblastoma Multiforme Azeliragon 20 mg Azeliragon 10 mg Azeliragon 5 mg
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Spain is a key European market for pharmaceutical and healthcare research. The World Health Organization ranks Spain’s healthcare system as the seventh best in the world. Spain is also the world leader in organ transplants. Healthcare expenditures in Spain represent 8.5 percent of the GDP and spending per capita was US$3323.
The 2019 Bloomberg Healthiest Country Index, ranked Spain the healthiest country in the world. Life expectancy in Spain is the highest in Europe and the third highest globally behind Japan and Switzerland. By 2040, Spain is forecast to have the highest lifespan, of nearly 86 years and the aging population will play a significant role in driving Spain’s healthcare sector over the next several years.
The Healthcare System in Spain
The Sistema Nacional de Salud or SNS is a national health system based on the principles of universality, free access, equity, and fairness of financing. The system is laid down by law and applies throughout Spain constitutionally guaranteeing universal coverage with no out of pockets costs except for prescription drugs. Healthcare is either free or low-cost for residents paying social security and their dependents. The national healthcare system covers 99.7% of the Spanish population. The remaining 0.3% only has access to private medical care.
At a national level, the Interterritorial Council of the Spanish National Health Service, Consejo Interterritorial del Servicio Nacional de Salud de España (CISNS) seeks to provide cohesion for Spain’s healthcare services and guarantee the healthcare rights of citizens. It is responsible for certain strategic areas as well as for the overall coordination of the health system, and the national monitoring of performance. However, the healthcare system is mostly decentralized into Spain’s 17 Autonomous Communities . While this has advantages for the health system being able to operate closer to its end users and deliver customized regional solutions, it does result in differences in organization, reforms, priority setting, and DRG (Dangerous Goods Regulations) application. This decentralization, in turn, presents a market access challenge for the industry. Because each region can also vary significantly by culture, population and budget we advise conducting research regionally to gain local insights, particularly where new products are being
The SNS has been seeking to improve the healthcare information system information at all levels; notably, through the expansion of an Abridged Electronic Medical Record of clinical information among the Autonomous Communities, and through the development of the electronic prescription and a registry of professionals.
Healthcare is delivered via a network of public and private facilities. The private sector is an important player in the Spanish health system, providing voluntary health insurance schemes to individuals. The purchase of voluntary health insurance plans is mainly driven by faster access to some services. It is closely intertwined with the public sector; private facilities are contracted to the state to provide various services specifically, in hospital and pharmaceutical care. Not all private facilities are contracted to provide services under the SNS.
Spain boasts a network of high-quality hospitals and medical centers throughout the country. Catalonia, in particular, has a significantly high number of private hospitals.
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Spain, a country of reference in conducting clinical trials
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Clinical trials mobilize financial resources, allow health professionals to add research experience to their care activity and provide patients with early access to new treatments.
This Thursday, May 20, the Clinical Trial Day is celebrated around the world. The pandemic has brought this concept closer to the general society, increasingly familiar with the importance of these studies, as they are the last step to demonstrate the efficacy and safety of a treatment that could change the lives of many patients or, as is being seen with Covid-19, of the world population.
The collaborative work between the Administration, the system and health professionals, patients and pharmaceutical companies, in short, between the public and private initiative, “has made Spain a benchmark country in conducting clinical trials,” explains Javier Urzay, deputy director General of Farmaindustria and co-president of the Technological Platform of Innovative Medicines-. The great research mobilization to seek a therapeutic solution against the coronavirus confirms this reality, the result of years of previous work in other therapeutic areas “.
1,019 approved studies
In fact, Spain has become the fourth country in the world and first in Europe in clinical trials against the coronavirus. Pharmaceutical companies and hospitals in Spain are currently participating in more than 170 studies of potential treatments and vaccines, in around 170 Spanish hospitals, public and private, which have managed to involve some 28,000 patients.
This impulse, linked to the pandemic but also to the research effort of innovative companies in the rest of the therapeutic areas, has allowed the record number of a thousand clinical trials authorized by the Spanish Agency for Medicines and Health Products to be surpassed in 2020 ( Aemps). Specifically, of the 1,019 approved studies, 34% correspond to drugs to treat different types of cancer, followed by trials for Covid-19. “Once again, the collaboration between the health administration, through the Aemps, clinicians and researchers, patients and pharmaceutical companies has been key not only to respond quickly to the launch of treatment trials against Covid-19 – Urzay points out – but so that the crisis, with the collapses in the hospitals and the confinement measures, would not slow down research in non-Covid pathologies. It is a success of all that shows the solidity of the Spanish model of clinical research “.
713 million euros dedicated to clinical studies
The pharmaceutical industry based in Spain, which promotes eight out of ten clinical trials, dedicates 60% of all investment destined to R&D of new drugs to this activity. Of the 1,211 million that were invested in 2019 -the historical maximum-, more than 713 were dedicated to clinical studies, according to the latest Survey on R&D Activities that Farmaindustria carries out each year among its associates. Likewise, investment in research carried out by the pharmaceutical industry in this phase has increased at a cumulative annual average rate of 4.8% in the last 10 years.
It is especially relevant that, of those 713 million invested in clinical research, 36.5% already correspond to early phases (I and II), and this proportion is constantly growing. In fact, according to the latest data from the BEST Project, an initiative of Farmaindustria to promote clinical research in Spain, 56% of the trials promoted last year by pharmaceutical companies in our country already correspond to the early phases. It is a great boost to position Spain as an international reference in the field of early clinical research, as it already is in later phases.
Quality for the healthcare system and opportunities for patients
The most important aspect of this reality is the multiplication of opportunities for patients. In the last decade, Spain has participated in more than 3,400 clinical trials, in which 145,000 patients have taken part. “They are Spanish patients who are being treated with what will be the drugs of the future,” says Javier Urzay. “And this early access of patients to new treatments – he adds – is even more important in cases of serious pathologies that have not responded to the therapies already approved, since it may be the last chance to cure or control the disease” .
Along with the value for patients, clinical trials imply investment of resources in the health system and contribute directly to improving its quality, since they help health professionals be at the scientific forefront and can transfer that research experience to their care work.
The solidity of the health system in Spain, the high qualification of health professionals, the growing involvement of patients and the strong commitment of pharmaceutical companies are some of the keys to the positive evolution, to which Urzay adds the commitment of the Administration sanitary, which has endowed our country with a very agile regulation. In fact, agility, he emphasizes, is another proof of Spanish leadership. Thus, as indicated by the data from the BEST Project, at the end of 2020, the improvements made in the dynamics for conducting clinical trials, such as the digitization of processes, have made it possible to significantly reduce both start-up times and deadlines. of signing contracts between companies and hospitals, going from 175 to 154 days and from 104 to 92 days, respectively, compared to 2019. The reduction of these deadlines has only one purpose: earlier access of patients to promising therapies , which is the ultimate goal of any clinical trial.
This reality, insists the representative of Farmaindustria, should encourage us to continue working, based on cooperation between public and private initiative, and define an appropriate strategy to make Spain a pole of attraction for international investment in biomedical research: “We have the knowledge and experience to make a significant leap.”
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Clinical Research Jobs in Spain
We want to be the Clinical Research Organisation that drives more client projects to market or accelerated decision than anyone else in the industry. In short, to be the partner of choice in drug development. That’s our vision. We’re driven by it. And we need talented people who share it. If you’re as driven as we are, join us. You’ll be working in a great environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry. View our Clinical Research Jobs in Spain here now.
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Description
As a Clinical Research Associate Sponsor dedicated you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
2024-112669
Expiry date
UK, Reading
Clinical Trial Management
Office Based
ICON Full Service & Corporate Support
We are currently seeking a Clinical Trial Manager to join our diverse and dynamic team at ICON Plc. In this critical role, you will be responsible for overseeing the planning, execution, and successfu
As an Oversight Monitor, Sponsor dedicated you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
2024-112628
As a Clinical Research Associate (CRA) you will coordinate all aspects of the clinical monitoring and site management process in accordance with regulatory guidelines, local regulations and standard o
2024-110115
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
2024-112667
Spain, Madrid
We are currently seeking a Senior Clinical Research Associate to join our diverse and dynamic team. As a Senior Clinical Research Associate , you’ll work within a large-scale, fast-paced environment a
Real World Solutions
We are currently seeking a Clinical Research Associate II Specialist to join our diverse and dynamic team. As a Clinical Research Associate II Specialist at ICON, you will play a pivotal role in desig
Spain, Barcelona
Hybrid: Office/Remote
Clinical Trial Support
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance • As a member of staff , the employee is expected to embrace and contribute to
Bulgaria, United Kingdom, Belgium, Netherlands, Germany, France, Spain, Poland, Czech Republic
Clinical Operations Roles
Czech Republic
Netherlands
As a Regulatory Publishing Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
2024-110833
Teaser label
Content type
Publish date
An Evolution of Progress and Success: Zashan's story a Clinical Research Associate (CRA) Having a satisfying career involves finding a company that prioritizes progress, improvement, and chances f
Zashan, who began his journey with us in 2016, has shared his experience and insights.
- Employee Stories -
To excel as a Clinical Research Associate (CRA) in a Clinical Research Organization (CRO), you need a combination of education, skills, and the right mindset. Brazil-based CRA II Debora shares her
Brazil-based CRA II Debora Oh shares her tips on how to become a great CRA and provides insight into life at ICON.
ICON plc's Global CRA Academy Program and the Argentina Success Story In the ever-evolving realm of clinical research, the role of Clinical Research Associates (CRAs) continues to be in a critica
While ICON's CRA Academy program is a global initiative, our focus is on the success story that has unfolded in Argentina.
A better career. A better world. A better you.
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WorldwideEdge™
You are always looking to make improvements in science, and we are too..
Recognized for Excellence.
Find out why we were the highest-rated ph i service provider for overall user preference and the highest-rated ph ii/iii cro for overall performance., discover why your cro search is over.
You and your work matter here.
Accessible partners. Shared commitment. Personalized for you.
Discover why it’s a world of difference at Worldwide.
Clinical research isn’t a straight path. let’s navigate it together..
At Worldwide, we believe a personalized approach is the only way to unlock the power of everyone working on a study – from operational and therapeutic experts to site partners and scientists. That means you’ll always have direct access to our experts. You’ll be able to tap into more than 30 years of therapeutic experience on a global scale. And your mission is our mission – we are dedicated to working with you to meet your goals.
Addressing the Top Concerns & Unmet Needs in Oncology Clinical Research
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Worldwide Clinical Trials Recognized with Coveted 2024 CRO Leadership Awards Based on Customer Feedback for 11th Consecutive Year
Want a cro partner who gives you their full attention, you’re in the right place..
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Michael Murphy, MD, PhD Chief Medical and Scientific Officer
Your extended team…always within reach.
We were founded on an unwavering commitment to therapeutic excellence and personalized attention. And today, that’s more important than ever. That means you have access to our senior-level experts who will work directly with you. It means we listen to you, understand your study’s needs, and actively seek customized solutions that are tailored to your specific project – even if we need to pivot and adapt along the way.
Every study is different. Every path forward is different. And we will partner with you every step of the way.
Aman Khera, MBA, FTOPRA, FRAPS Vice President, Regulatory Science, Strategy and Innovation
Flexible? Check. Responsive and nimble? Absolutely.
We understand that no clinical trial looks the same. Your trials deserve solutions backed by decades of therapeutically relevant and adaptable expertise. That’s exactly what we bring to the table.
When you partner with Worldwide, we’ll stay by your side through the entire lifecycle of product development with nimble, solutions that are never “just off the shelf” but customized for you and your specific needs.
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Pivotal: Contract Research Organization
Trust is the single most important ingredient we put in all clinical trials. Pivotal is a Contract Research Organization that weaves together the scientific insight, the technology and the resources to help customers address both current and future needs. To dive deep into clinical trials. To advance in clinical research.
Our full clinical trials services
We provide full Contract Research Organization (CRO) services and build a flexible client relationship by offering a variety of contracting models, from single source to full service.
Regulatory Affairs
We are local experts, we pave the way
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We provide on the ground targeted support to the clinical sites
Project Management
We are predictive, not reactive
Patient Journey Services
We are patient-centric, it is part of our DNA
Data Management
Data lovers, we leverage the value beyond the numbers
Biostatistics
We understand study data, we deliver the right outcome
Pharmacovigilance
We have a proactive approach which enhances safety risk control
Quality Assurance & Compliance
We strive for excellence in everything we deliver
Medical Services
We help transform science into new therapies
Translate novel science into new clinical treatments
From protocol conception to publications, Pivotal’s scientific team provide tailored risk-management strategies to optimize our clients’ products chances of making it to the market.
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Discover data-driven insights, dive deep into clinical trials
Used the right way, data and analytics can create competitive advantage, re-engineer processes and enhance risk controls.
Seamless Data Integration
Agile devops culture.
Advanced Analytics
Transformative technology, what our customers say about pivotal.
As an independent investigator and head of a Cooperative Group, I have been working with Pivotal since 2014 on 6 projects in GU tumors and what I have encountered is a dedicated team to clinical research, very much attentive to the detailed needs of independent investigators, responsiveness and quality-minded throughout. The team gets it right the first time in all the services being it regulatory and clinical operations, medical and safety monitoring or data management and biostats. Pivotal is my favourite CROs to work with and have no hesitation to recommend for any new trials in Oncology and beyond in Europe. Joaquim Bellmunt Molins MD, PhD Senior Researcher PSMAR/IMIM Hospital del Mar, Barcelona, Spain Associate Professor of Medicine Harvard Medical School
Pivotal continues to be my CRO of choice. They complement our existing team by providing functional area expertise that we do not currently possess. Their personnel are highly engaged, experienced, and proficient in what they do. Pivotal’s leadership team is experienced and, more importantly, incredibly engaged throughout the entire study. These are some of the reasons Pivotal continues to be a trusted partner for us. Randy Brown Formerly Chief Operating Officer Lucid Diagnostics, Inc.
We have worked with Pivotal for more than 4 years now. During this time, Pivotal´s team has been able to accommodate all our specific needs, always providing the right services. They are easily accessible and very dedicated to making things work. Undoubtedly, Pivotal is a key partner for us in the clinical development of our asset Marisol Quintero, PhD CEO Highlight Therapeutics
I have worked with Pivotal on two studies and have been particularly impressed with the care they give studies, their personal attention to the needs of sponsors, and their dedication to getting things right. Pivotal is a closely knit group. There is no bureaucracy, simply the dedication to serving the needs of their biotech clients. They are the closest thing I can find to having my company personnel on the ground in Spain and Europe. M. Scott Harris, MD Chief Medical Officer Altimmune, Inc.
The team at Pivotal operates as a seamless extension of our internal team, building trust with our European clinical trial sites and our confidence in our ability to execute high-quality clinical trials. The Pivotal management team acts as a true partner, equally focused on our objectives to develop innovative therapeutic treatments to patients with serious unmet medical needs. Leslie Barnes Group Vice President Development Sciences Operations
I have worked with Pivotal on international clinical trials both of an ICU therapeutic and a cancer screening device/diagnostic. I cannot think of a better partner. A cost-effective collaborator with deep functional expertise, particularly data management, biostatistics, medical monitoring, pharmacovigilance, and project management, but even more importantly, a company with a culture of problem solving and shared responsibility. Working with Pivotal is never “us” and “them”, it is one shared mission with a group of professionals who simply do whatever it takes to accomplish the goal. This starts at the top, with the credible, expert and ever-present leadership of the CEO, himself a former senior Pharma drug developer, and filters through every layer of the organization. David Wurtman, MD, MBA CEO Lyric Pharmaceuticals, Inc.
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- Comunidad de Madrid 8
- Cataluña 5
- Cantabria 3
- Andalucía 2
- Castilla y León 1
- Castilla-La Mancha 1
- La Rioja 1
- Clinical Operations 6
- Clinical Project Manager 6
- Clinical Research Associate 5
- Pharmacovigilance 4
- Clinical Supplies 2
- Study Site Coordinator 2
- Study Start Up 2
- Clinical Administrator 1
- Euros 29
- GBP 1
- Full Time 30
- Permanent 29
- Contract 1
- Recruitment Consultant 2
- Direct Employer 28
- Experienced (non-manager) 26
- Entry level 3
- Senior Management 1
- CPM 6
- CRA 6
- Project Manager 6
- CTM 2
- CTA 1
Found 30 jobs
Clinical trial supplies manager ** emea based **.
- Madrid, Spain; Homeworking
- Competitive
- Syneos Health
Clinical Trial Supplies Manager ** EMEA based ** Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to acc...
View details Clinical Trial Supplies Manager ** EMEA based **
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- Barcelona, Spain; Homeworking
Head of Cetaphil HCP Strategy
- Barcelona, Spain
The Head of Consumer Dermatology, HCP Strategy, is part of the Global Consumer Business Unit, reporting directly to the Head of GBU. This strategic...
View details Head of Cetaphil HCP Strategy
- 2 days left
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Site Management Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive e
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Senior Clinical Research Associate - Alzheimer’s disease - Spain - Home-based
- Madrid, Spain
- Worldwide Clinical Trials
Who we are Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and
View details Senior Clinical Research Associate - Alzheimer’s disease - Spain - Home-based
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Clinical Research Associate
- Spain, Homeworking
- ICON Strategic Solutions
As a Clinical Research Associate Sponsor dedicated you will be joining the world’s largest & most comprehensive clinical research organisation, powere
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Oversight Monitor
As an Oversight Monitor, Sponsor dedicated you will be joining the world’s largest & most comprehensive clinical research organisation, powered by hea
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Clin Ops Specialist - Contract Specialist. Barcelona or Madrid. Sponsor dedicated
Clinical Operations Specialist Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer s...
View details Clin Ops Specialist - Contract Specialist. Barcelona or Madrid. Sponsor dedicated
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Global Clinical Project Manager II. Spain. Sponsor dedicated
Project Manager II Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We t...
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Senior PV Associate Analytics & Reporting
The Senior PV Associate Analytics & Reporting will be responsible to implement pharmacovigilance plans, processes and policies related to the colle...
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Site Care Partner - Spain - FSP
- Spain;Homeworking
If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to you...
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Medical Information and Adverse Event Intake Specialist with English and Danish language
IQVIA Safety Operations team play an important part in the design, build and execution of end-to-end safety solutions for major pharmaceutical
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Medical Information and Adverse Event Intake Specialist with French and English and additional...
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Clinical Research Coordinator
- Not Specified
A Clinical Trial Solutions provider are working very closely with sites across Spain. They are looking for a Clinical Research Coordinator in J
View details Clinical Research Coordinator
- 12 days ago
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Senior or Clinical Project Manager II. Spain. Sponsor dedicated
View details Senior or Clinical Project Manager II. Spain. Sponsor dedicated
- 13 days ago
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Sponsor Dedicated Clinical Project Manager - Home Based in SPAIN
Sponsor Dedicated Clinical Project Manager - Home Based in SPAIN Experience in Clinical Project management on global studies is required. Syneos He...
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Medical Information and Adverse Event Intake Specialist with German and English language
View details Medical Information and Adverse Event Intake Specialist with German and English language
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Associate Clinical Trial Manager (PhD) - Radiopharmaceuticals
Medpace is currently seeking candidates with PhDs and/or Post-Doctoral Research experience for a full-time, office-based Associate Clinical Trial M...
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- 14 days ago
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Below are actively recruiting clinical trials for Spain. Click on the closest city to find the research studies that are available in your area.
"c/ Feixa Llarga, S/n, Hospitalet De Llobregat
(badalona) Barcelona
(barakaldo) Vizcaya
(multicentric Study)
(mã³stoles) Madrid
(móstoles) Madrid
08041 Barcelona
17007 Girona
28007 Madrid
28041 Madrid
28046 Madrid
46009 Valencia
8190 Barcelona(san Cugat Del V
A Corub B A
A Coruãƒâ±a
A Coruña / Santiago De Compostela
A Coruña [la Coruña]
A Coruña A Coruña
A Picota (mazaricos)
A Pontenova, Lugo
Abadin (casco Urbano)
Abadin (casco Urbano) - Lugo
Abrera, Barcelona
Aceuchal - Badajoz
Aguilas (murcia)
Alacant / Alicante
Alava País Vasco
Albaida (valencia)
Albelda (huesca)
Alburquerque
Alcal De Henares
Alcala De Guadaira
Alcala De Hanares
Alcala De Henares
Alcala De Henares (madrid)
Alcala De Henares Madrid
Alcala La Real
Alcalà De Henares
Alcalà De Henares (madrid)
Alcalá De Guadaira, Sevilla
Alcalá De Henares
Alcalá De Henares (madrid)
Alcalá De Henares, Madrid
Alcalá De Henares-madrid
Alcalá De Henarés
Alcalã¡ De Henares
Alcalã¡ De Henares (madrid)
Alcalã¡ De Henares, Madrid
Alcalã¡ De Henares-madrid
Alcal� De Henares
Alcantarilla
Alcantarilla (murcia)
Alcasser, Valencia
Alcazar De S. Juan
Alcazar De San Juan
Alcazar De San Juan (ciudad Real)
Alcira (valencia)
Alcobendas (madrid)
Alcobendas, Madrid
Alcobendas/madrid
Alcoi Alicante
Alcora/castellã³n
Alcora/castellón
Alcorcon (madrid)
Alcorcon - Madrid
Alcorcon Madrid
Alcorcon(madrid)
Alcorcon, Madrid
Alcorcã³n (madrid
Alcorcã³n (madrid)
Alcorcã³n - Madrid
Alcorcãƒâ³n
Alcorcón (madrid
Alcorcón (madrid)
Alcorcón - Madrid
Alcorcón, Madrid
Alcorcón/madrid
Alcover( Tarragona)
Alcoy (alicante)
Alcoy Alicante
Alcoy/alicante
Alcázar De San Juan
Alcázar De San Juan (ciudad Real)
Alcã¡zar De San Juan (ciudad Real)
Alfara Del Patriarca
Algeciras / Cadiz
Algeciras, Cádiz
Algemesi, Valencia
Algimia De Alfara
Algorta (vizcaya)
Algorta - Getxo
Algorta, Getxo
Alhaurin El Grande-malaga
Alicante N/a
Alicante Orihuela
Alicante, 6ª Planta, Eecc Dermatología, C/pintor Baeza 12
Alicante. Elda
Alicante/alacant
All Participating Sites
Almonte, Huelva
Almu�ecar
Alpuente, Valencia
Alquerãas Del Niã±o Perdido (castellã³n)
Alquerías (murcia)
Alquerías Del Niño Perdido (castellón)
Altos De Nava
Alzira (valencia)
Alzira - Valencia
Alzira Valencia
Alzira, Valencia
Alzira-valencia
Alzira/valencia
An Sebastián De Los Reyes
Antequera (málaga)
Antequera (mã¡laga)
Antequera/málaga
Antequera/mã¡laga
Aparato Digestivo
Aranda De Duero
Aranda De Duero (burgos)
Aravaca (madrid)
Aravaca - Madrid
Arcos De La Fortera
Arcos De La Frontera
Arenys De Mar
Ares (pontedeume)
Argamasilla De Calatrava, Ciudad Real
Arganda Del Rey
Arguineguin
Arrasate-mondragón
Arrecife (lanzarote)
Arrecife, Las Palmas
Arroinas Asturias
Arroyo De La Miel
Arroyomolinos
Artana/castellã³n
Artana/castellón
Arzua-a Coruna
As Pontes - A Coruna
As Pontes De Garcia Rodriguez
As Xubias 84
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Av Campanar 21, Valencia
Av. De Valdecilla, 25
Av. Manuel Siurot
Av.menendez Pidal S/n, Cordoba
Avda Campanar
Avda, Campanar 21
Avda. Blasco Ibaã±ez, 17, Valencia
Avda. Blasco Ibañez, 17, Valencia
Avda. Carlos Haya, S/n, Málaga
Avda. Carlos Haya, S/n, Mã¡laga
Avda. Parc Tauli S/n
Avda. Poeta Muñoz Rojas, S/n Antequera
Avda. Rambleta, S/n Catarroja Valencia
Avda.fernando Abril Martorell,106, Valencia
Avenida Dr. Fedriani, 3, Sevilla
Aviles (asturias)
Aviles - Asturias
Aviles Asturias
Avilés/asturias
Babio - Beade
Bacarot Alicant
Badalona (barcelona)
Badalona - (barcelona)
Badalona - Barcelona
Badalona / Barcelona
Badalona Barcelona
Badalona(barcelona)
Badalona, Barcelona
Badalona, Madrid, Sevilla
Badalona-barcelona
Badalona-barcelone
Badalona. Barcelona
Badalona/barcelona
Badia Del Valles
Badia Del Vallã©s
Badia Del Vallã©s (barcelona)
Badia Del Vallès
Badia Del Vallés
Badia Del Vallés (barcelona)
Badãa Del Vallã¨s - Barcelona
Badía Del Vallès - Barcelona
Bajo Sevilla
Balearic Islands
Balenyà (barcelona)
Balenyã (barcelona)
Baltar, Pontevedra
Baracaldo (vizcaya)
Baracaldo - Vizcaya
Baracaldo / Bilbao
Baracaldo Bilbao
Baracaldo Vizcaya
Baracaldo(vizcaya)
Baracaldo, Bizcaia
Baracaldo, Pais Vasco
Baracaldo, Vizcaya
Baracaldo/vizcaya
Baracaldovizcaya
Barakaldi/vizcaya
Barakaldo (bilbao)
Barakaldo (vizcaya)
Barakaldo Bilbao
Barakaldo Bizkaia
Barakaldo Vizcaya
Barakaldo Vizcaya S/n
Barakaldo, Bilbao
Barakaldo, Bizkaia
Barakaldo, Vizcaya
Barakaldo-biscay
Barakaldo-bizkaia
Barakaldo-vizcaya
Baralla (casco Urbano)
Barbera Del Valles
Barberà Del Vallès
Barberã Del Vallã¨s
Barcelona & Madrid
Barcelona (2 Locations)
Barcelona (2)
Barcelona (3 Locations)
Barcelona (3)
Barcelona (4)
Barcelona (5)
Barcelona (6)
Barcelona - Esplugues De Llobregat
Barcelona / Esplugues De Llobregat
Barcelona / Sabadell
Barcelona 8003
Barcelona Cataluna
Barcelona Ii
Barcelona Iii
Barcelona N/a
Barcelona No. 40
Barcelona Sabadell
Barcelona San Cugat Del V
Barcelona
Barcelona(san Cugat Del V
Barcelona, Cataluna
Barcelona, Catalunya
Barcelona, Hospitalet De Llobregat
Barcelona, Madrid, Torrelavega, Xativa
Barcelona, No. 42
Barcelona-espana
Barcelona/cataluna
Barcelona/cataluña
Barcelona/sabadell
Barceloneta
Barco De Valdeorras
Barranco De La Ballena S/n, Las Palmas De Gran Canaria
Barreiros (casco Urbano)
Barruelo De Santullan - Palencia
Bastiagueiro
Basurto Bilbao
Basurto-bilbao
Basurto/bilbao
Bañaderos, Las Palmas
Beada (vigo)
Beade-pontevedra
Beas De Segura - Jaen
Bedman, Jaén
Begonte (lugo)
Begonte - Lugo
Begíjar, Jaén
Bellaterra, Barcelona
Benaguasil, Valencia
Benalmadena
Benalmadena Costa
Benalmádena
Benalmádena (málaga)
Benalmádena, Málaga
Benamargosa
Benassal (castellón)
Benicasim (castellã³n)
Benicasim (castellón)
Benicassim (castellon)
Benidor / Alicante
Benidorm Alicante
Benidorm-alicante
Benidorm/alicante
Beniel (murcia)
Benigánim, Valencia
Benimamet, Valencia
Berango (vizcaya)
Berga (barcelona)
Bilbao (bizkaia)
Bilbao (vizcaya)
Bilbao - Vizcaya
Bilbao Vizcaya
Bilbao, Vizcaya
Bilbao- Vizcaya
Blanca - Murcia
Blanes (girona)
Boabdilla Del Monte
Boadilla Del Monte
Boadilla Del Monte (madrid)
Boadilla Del Monte - Madrid
Boadilla Del Monte Madrid
Boadilla Del Monte, Madrid
Bobadilla Del Monte
Bohonal De Ibor - C�ceres
Bohonal De Ibor - C�ceres
Boiro (boiro)
Bollullos De La Mitación
Bonavista - Tarragona
Boqueixon (pontella)
Boqueixon (ponteulla)
Borges Del Camp
Borges Del Camp (tarragona)
Borges Del Camp- Tarragona
Bormujo (sevilla)
Bormujos (sevilla)
Bormujos, Sevilla
Breã±a Alta
Bre�a Alta
Buenos Aires
Bueu (pontevedra)
Bullas (murcia)
Bunyola Illes Balears
Burela (lugo)
Burela De Cabo
Burjasot (valencia)
Burjassot - Valencia
C/ Dr. Martin Lagos, S/n, Madrid
C/ Sant Antoni Maria Claret, Barselona
C/ Tossal Del Rei Nº 7 Castellón De La Plana Castellón
C/ Tossal Del Rei N⺠7 Castellã³n De La Plana Castellã³n
C/antonio Maura Montaner, S/n, Edificio Ibis
C/marquesado De Santa Marta, Madrid
Cabezo De Torres
Cabra, Córdoba
Cabuenes - Gijon
Cabuenes-gijon
Caceres / Caceres
Caceres 10003
Caceres N/a
Cadiz, Andalucia
Calde (lugo)
Caldes De Montbui
Caldes Montbui Canovelles
Calella (barcelona)
Calella De La Costa
Calle San Jacinto
Callosa De Segura, Alicante
Calpe- Alicante
Campdevanol (girona)
Campdevànol (girona)
Campdevánol (gerona)
Campdevã nol (girona)
Campdevã¡nol (gerona)
Campot�jar
Canet De Mar
Canet De Mar - Barcelona
Cangas De Narcea
Cangas Del Narcea
Cangas Del Narcea/asturias
Caragena (murcia)
Caravaca De La Cruz
Carballo (carballo)
Carballo, A Coruña
Cardiologia
Carmona, Sevilla
Carrascal De Barregas
Carrascal De Barregas,
Carretera De Canyet
Carretera De Canyet S/n, Badalona
Carretera De Valdemossa
Cartagena (murcia)
Cartagena Murcia
Cartagena, Murcia
Cartagena. Murcia
Cartaya, Huelva
Carvaca De La Cruz
Casar De Caceres
Castell0n De La Plana
Castellar Del Vallès
Castelldefels
Castelldefels - Barcelona
Castello De La Plana
Castellon De La Plan
Castellon De La Plana
Castellon De La Plana/castello De La Plana
Castellã³n De La Plana
Castelló De La Plana
Castellón De La Plana
Castellón De La Plana (castellón)
Castellón De La Plana
Castilla La Mancha
Castilla Y Leon
Castilla Y León
Castilleja De La Cuesta
Castilleja Dela Cuesta Sevilla
Castro Del Rio
Castro Urdiales
Catarroja Esquina Ministro Serrano. Paiporta Valencia
Catarroja, Valencia
Cañaveral (cáceres)
Celestino Villamil, S/n Oviedo
Cenes De La Vega
Centelles (barcelona)
Centelles - Barcelona
Centelles, Barcelona
Central De Asturias
Cerdanyola Del Valles
Cerdanyola Del Valllés
Cerdanyola Del Vallã¨s
Cerdanyola Del Vallès
Cerdanyola Del Vallés / Barcelona
Cerdanyola, Barcelona
Chapela, Pontevedra
Chiclana De La Frontera
Chinchilla De Monte Aragã³n
Chinchilla De Monte Aragón
Churriana De La Vega
Ciempozuelos
Cieza - Murcia
Cities In Spain
Ciudad Real
Ciudad Real,castilla La Mancha
Ciudad Rodrigo Salamanca
Ciudad Universitaria De Cantoblanco
Civdad Real
Clinuvel Investigational Site
Clãnico Universitario Cristal-piã±or
Clãnico Universitario De Santiago
Clínico Universitario Cristal-piñor
Clínico Universitario De Santiago
Collado De Villalba
Collado Villalba
Collado Villalba, Madrid
Collado-villalba
Colloto - Oviedo
Colmenar Viejo
Complejo Hospitalario Xeral Cies
Comunidad Valenciana
Constantina
Contact Sponsor
Corbera De Llobregat
Cordoba-( Espana)
Cordoba-(espana)
Coria Del Río, Sevilla
Cornella De Llobregat
Cornella De Llobregat (bcn)
Cornella De Llobregat - Barcelona
Cornellà De Llobregat
Cornellá De Llobregat
Cornellá De Llobregat (bcn)
Cornellá De Llobregat-barcelona
Cornellã De Llobregat
Cornellã¡ De Llobregat
Cornellã¡ De Llobregat-barcelona
Cornudella De Montsant
Coslada (madrid)
Coslada, Madrid
Crevillente
Cruces (vizcaya)
Cruces - Barakaldo
Cruces / Barakaldo
Cruces-baracado
Cruces-baracaldo
Cruces-barakaldo
Cruces/barakaldo
Ctra. Anfondeguilla, S/n Vall Duixo Castellã³n
Ctra. Anfondeguilla, S/n Vall Duixo Castellón
Cuart De Poblet
Cuarte De Huerva
Cuidad Real
Culleredo - La Coruã±a
Culleredo - La Coruña
Cuntis, Pontevedra
Cã³rdoba Andalucäºa
Cúllar Vega
Daimiel - Ciudad Real
De La Castellana
De Torrevieja (alicante)
Distrito De Les Corts
Doctor Esquerdo 46 , Madrid
Don Benito (badajoz)
Don Benito-villanueva De La Serena
Don Benito/badajoz
Doniostia - San Sebastian
Donosti-san Sebastian
Donosti-san Sebastián
Donostia (gipuzkoa)
Donostia - San Sebastian
Donostia - San Sebastián
Donostia / San Sebastian
Donostia / San Sebastián
Donostia Guipuzcoa
Donostia San Sebastian
Donostia, Gipuzkoa
Donostia- San Sebastian
Donostia-san Sebastian
Donostia-san Sebastián
Donostia-san Sebastiã¡n
Donostia/san Sebastian
Donostia/san Sebastián
Donostia‐san Sebastián
Dos Hermanas
Dos Hermanas (sevilla)
Dos Hermanas, Sevilla
E-41009 Sevilla N/a
Edificio Antigua Escuela De Enfermería, Planta 5
Eibar (guipúzcoa)
Eivissa - Illes Balears
El Canaveral
El Ejido, Almería
El Escorial
El Hospitalet
El Hospitalet De Llobregat
El Monte, Tenerife
El Palmar (el Palmar)
El Palmar (murcia)
El Palmar - Murcia
El Palmar Murcia
El Palmar Murcia N/a
El Palmar, Murcia
El Palmar-murcia
El Palmar. Murcia
El Parador De Las Hortichiuela
El Pla Del Penedes
El Prat De Llobregat
El Prat De Llobregat - Barcelona
El Puerto De Santa Maria
El Puerto De Santa Maria (cádiz)
El Puerto De Santa Marãa-cã¡diz
El Puerto De Santa María
El Puerto De Santa María, Cádiz
El Puerto De Santa María-cádiz
El Vendrell
Elche (alicante)
Elche - Alicante
Elche Alicante
Elche(alicante)
Elche, Alicante
Elche- Alicante
Elche-alicante
Elda (alicante)
Elda Alicante
Elda, Alicante
Elda-alicante
Elexalde, Bizcaia
Elgoibar (guipuzkoa)
Els Hostalets De Balenyà
Els Hostalets De Balenyã
Elx / Elche
Escaldes-engordany
Esp Barcelona
Espana, Canarias
Esparraguera
Esplugas De Llobregat
Espluges De Llobregat
Espluges Del Llobregat
Esplugues (barcelona)
Esplugues De Llobregas
Esplugues De Llobregat
Esplugues De Llobregat (barc)
Esplugues De Llobregat (barcelona)
Esplugues De Llobregat - Barcelona
Esplugues De Llobregat · Barcelona
Esplugues De Llobregat, Barcelona
Esplugues De Llobregat- Barcelona
Esplugues De Llobregat-barcelo
Esplugues De Llobregat. Barcelona
Esplugues De Llobregrat
Esplugues De Llorbregat
Esplugues Del Llobregat
Esplugues Del Llobregat (barcelona)
Esplugues Llobregat
Esplugues Llobregat Barcelona
Esplugues Llobregat(barcelona)
Espluguese De Llobregat
Espluques De Llobregat
Espluques De Llobreqat
Estación De Cártama
Estella (navarra)
Estella/lizarra
Estepona (málaga)
Estepona, Málaga
Eui-planta 2, Pg. Vall D'hebron 119-29, Barcelona
Favara, Valencia
Feixa, Llarga, Sn
Fernán Núñez
Ferrol ( A Coruña)
Ferrol (a Coruna)
Ferrol (a Coruña)
Ferrol, A Coruna
Ferrol, A Coruña
Ferrol. La Coruã±a
Ferrol. La Coruña
Figueres - Girona
Figueres, Girona
Figueres-girona
Figueruelas
Foz (casco Urbano)
Fuenalabrada
Fuencarral-el Pardo
Fuenlabrada
Fuenlabrada (madrid)
Fuenlabrada - Madrid
Fuenlabrada / Madrid
Fuenlabrada Madrid
Fuenlabrada(madrid)
Fuenlabrada, Madrid
Fuenlabrada/madrid
Fuenlanbrada
Fuente Del Arco
Fuente Álamo (murcia)
Fuentes De Ebro
Fuentesnuevas, Ponferrada (leã³n)
Fuentesnuevas, Ponferrada (león)
Fuerteventura
Galdacano Vizcaya
Galdakao (bilbao)
Galdakao (vizcaya)
Galdakao / Vizcaya
Galdakao Vizcaya
Galdakao-vizcaya
Galdakao/vizcaya
Gandia (valencia)
Gandía (valencia)
Gandía (valència)
Garrido Norte
Garrido Sur
Gasteiz / Vitoria
Gava', Barcelona
Gava, Barcelona
Gavá (barcelona)
Gavã¡ (barcelona)
Gernika-lumo
Getafe (madrid)
Getafe -madrid
Getafe Madrid
Getafe, Madrid
Getafe-madrid
Getafe. Madrid
Getafe/madrid
Getxo-vizcaya
Gijon Asturias
Gijã³n (asturias)
Gijã³n. Asturias.
Gijón (asturias)
Gijón. Asturias.
Gipuzkoa - Sansebastian
Gipuzkoa Oeste
Girona 17007
Gran Canaria
Granada, Andalucia
Granada- (espana)
Granollers (barcelona)
Granollers, Barcelona
Granvia De L'hospitalet 199-203
Guadalajara
Guardo (palencia)
Guenes - Vizcaya
Guia De Isora
Guissona (lleida)
Gã¼eã±es - Vizcaya
Güeñes (vizcaya)
Güeñes - Vizcaya
Haddon Heights
Higuera La Real
Hondarribia
Hosp De Llobregat(barcelona)
Hosp. De Llobregat
Hospital De Antequera
Hospital De Donosti
Hospitaled De Llobre
Hospitalet (barcelona)
Hospitalet . Barcelona
Hospitalet De Ilobre
Hospitalet De Ll (barcelona)
Hospitalet De Ll.
Hospitalet De Llbregat
Hospitalet De Llobegrat
Hospitalet De Llobregar
Hospitalet De Llobregat
Hospitalet De Llobregat (barcelona)
Hospitalet De Llobregat - Barcelona
Hospitalet De Llobregat Barcel
Hospitalet De Llobregat(barcel
Hospitalet De Llobregat(barcelona)
Hospitalet De Llobregat,
Hospitalet De Llobregat, Barcelona
Hospitalet De Lobregat
Hospitalet Del Llobregat
Hospitalet Dellobregat
Hospitalet Dellobregat Barcelo
Hospitalet Dellobregat(barcelo
Hospitalet Dellobregat(barcelo)
Hospitalet Llobregat
Hospitalet Llobregat Barcelona
Hospitalet Llobregat,
Hospitalet Llobregat- Barcelona
Hospitalet. Barcelona
Hospitaletdellobregat(barcel
Hostalets De Balenya
Hostalets De Balenyà
Hostalets De Balenyã
Hostalric - Gerona
Hostalric, Girona
Huelma - Jaen
Huercal Olvera
Huercal Overa
Huercal-overa
Igualada, Barcelona
Illes Balears
Illescas-toledo
Instituto Catalan De Oncologia De Hospitalet (ico)
Investigative Site
Isabel De Villena,2 Pabellã³n Valencia
Isabel De Villena,2 Pabellón Valencia
Islas Baleares
Jarez De La Frontera
Jerez (cadiz)
Jerez De Frontera
Jerez De La Frontera
Jerez De La Frontera (cadiz)
Jerez De La Frontera (cádiz)
Jerez De La Frontera (cã¡diz)
Jerez De La Frontera - Cádiz
Jerez De La Frontera / Cadiz
Jerez De La Frontera / Cádiz
Jerez De La Frontera / Cã¡diz
Jerez De La Frontera Cadiz
Jerez De La Frontera- Cádiz
Jerez De La Frontera- Cã¡diz
Jerez De La Frontera-cádiz
Jerez De La Frontera-cã¡diz
Jerezdelafronteracadiz
Jerã©z De La Frontera
Jeréz De La Frontera
Jávea, Alicante
Jã©rez De La Frontera
Jérez De La Frontera
L 'hospitalet De Llobregat
L Hospitalet
L Hospitalet De Llobregat
L Hospitalet Llobregat (bcn)
L' Hospitalet
L' Hospitalet De Llobregat
L' Hospitalet Del Llobregat
L'alfas Del Pi
L'eliana, Valencia
L'hospital De Llobregat (bcn)
L'hospitalet
L'hospitalet (barcelona)
L'hospitalet (bcn)
L'hospitalet - Barcelona
L'hospitalet De
L'hospitalet De Llob
L'hospitalet De Llobrega
L'hospitalet De Llobregat
L'hospitalet De Llobregat (barcelona)
L'hospitalet De Llobregat (bcn)
L'hospitalet De Llobregat , Barcelona
L'hospitalet De Llobregat - Barcelona
L'hospitalet De Llobregat / Barcelona
L'hospitalet De Llobregat Barcelona
L'hospitalet De Llobregat,
L'hospitalet De Llobregat, Barcelona
L'hospitalet De Llobregat, Barceona
L'hospitalet De Llobregat,barcelona
L'hospitalet De Llobregat-barcelona
L'hospitalet De Llobregat.
L'hospitalet De Llobregat. Barcelona
L'hospitalet Del Llobregat
L'hospitalet Llobregat (bcn)
L'hospitalet, Barcelona
L'hospitalet-barcelona
L'hospitatel De Llobregat
L?hospitalet De Llobregat
L` Hospitalet De Llobregat
La Almunia De Dona Godina
La Almunia De Doña Godina, Zaragoza
La Bañeza, León
La Candelaria, Tenerife
La Carlota, Córdoba
La Cañada De San Urbano
La Cañada, Almería
La Coruna Galicia
La Coruna- Galicia
La Coruna-galicia
La Coruã£â€˜a
La Coruã¿a N/a
La Coru�a
La Coruña, La Coruña
La Coruÿa N/a
La Cuesta De Arguijon
La Cuesta, Santa Cruz De Tenerife
La Eliana, Valencia
La Laguna (santa Cruz De Tenerife)
La Laguna (sta Cruz Tenerife)
La Laguna (tenerife)
La Laguna - Tenerife
La Laguna / Santa Cruz De Tenerife
La Laguna Del Marquesado
La Laguna Santa Cruz De Tenerife
La Laguna Sta. Cruz De Tenerife
La Laguna Tenerife
La Laguna Teneriffe
La Laguna, Santa Cruz De Tenerife
La Laguna, Sta. Cruz De Teneri
La Laguna, Tenerife
La Laguna- Tenerife
La Laguna-sta.cruz De Tenerife
La Laguna-tenerife
La Laguna. Santa Cruz De Tenerife
La Laguna/str Cruz De Tenerifa
La Linea De La Concepcion
La Linea De La Concepcion - Cadiz
La Linea De La Concepciã³n
La Linea De La Concepción
La Llagosta
La Línea De La Concepción
La Línea De La Concepción, Cádiz
La Nucia-alicante
La Palma Santa Cruz Tenerife
La Palmas De Gran Canarias
La Pobla De Vallbona
La Pobla Llarga
La Roca Del Valles
La Roca Del Valles (barcelona)
La Roca Del Vallã¨s
La Roca Del Vallã©s (barcelona)
La Roca Del Vallès
La Roca Del Vallés
La Roca Del Vallés (barcelona)
La Roca Del Vall�s - Barcelona
La Roca Del Vall�s - Barcelona
La Roda, Albacete
La Seu D'urgell
La Unión (murcia)
La Vall D'hebron
La Victoria
La Victoria -santa Cruz De Tenerife
La Vila Joiosa
La Vila-joiosa
La Zubia, Granada
La/villajoyosa Vila Joiosa
Lahospitalet De Llobregat
Lahospitalet De Lubregat
Lalaguna, S Cruz Tener
Lalaguna-s. Cruz Tener
Langreo (oviedo)
Langreo-asrurias
Langreo-asturias
Laredo (cantabria)
Laredo, Cantabria
Las Bayas, Elche
Las Cabezas De San Juan
Las Cabezas, Sevilla
Las Palmas De G. C.
Las Palmas De G. Canaria
Las Palmas De G.c.
Las Palmas De Gc
Las Palmas De Gran Canari
Las Palmas De Gran Canaria
Las Palmas De Gran Canarias
Las Palmas Gc
Las Palmas Gran Canarias
Las Torres De Cotillas
Lb B B Hospitalet De Llobregat
Leganes (madrid)
Leganes - Madrid
Leganes, Madrid
Leganes-madrid
Leganã©s (madrid)
Leganã©s, Madrid
Leganés (madrid)
Leganés, Madrid
Leganés. Madrid
Leioa( Vizcaya)
Leioa-bizkaia
Leiro (capital)
Lepe - Huelva
Lerma - Burgos
Les Borges Del Camp
Les Franqueses Del Vallã©s - Barcelona
Les Franqueses Del Vallès
Les Franqueses Del Vallés - Barcelona
Lhospitalet De Llobregat
Lhospitalet Llobregat (bcn)
Librilla (murcia)
Liencres (pielagos)
Linares (jaen)
Linares De Riofrío.
Linares, Jaã©n
Linares, Jaén
Lleida / Lleida
Llerena (badajoz)
Llerena, Badajoz
Llica D'amunt - Barcelona
Lloret De Mar (girona)
Llíria (valencia)
Loeches, Madrid
Loja (granada)
Loja/ Granada
Lora Del Rio
Lora Del Río, Sevilla
Lorca (murcia)
Lorca Murcia
Los Barrios
Los Barrios, Cádiz
Los Boliches
Los Corrales De Buelna
Los Realejos
Los Yebenes
Lucena, Córdoba
Luceni - Zaragoza
Lugar Da Pega
Lugo / Lugo
L´ Hospitalet De Llobregat
L´hospitalet De Llobregat
L´hospitalet Del Llobregat
Lâ´hospitalet De Llobregat
Lâ´hospitalet Del Llobregat
Lã¢â´hospitalet De Llobregat
Madrid & Barcelona
Madrid (2 Locations)
Madrid (espana)
Madrid / Madrid
Madrid 28041
Madrid and 7 Additional Cities
Madrid Madrid
Madrid, Communidad De
Madrid, Espana
Madrid, Madrid
Madrid- Cartagena
Madrid-espana
Madrid-san Lorenzo Del Escorial
Mahadahonda (madrid)
Mahadahonda( Madrid
Mahon Menorca
Mairena Del Aljarafe
Majadahona (madrid)
Majadahonda
Majadahonda (madrid)
Majadahonda (madrid), Espana
Majadahonda (madrid)- (espana)
Majadahonda - Madrid
Majadahonda - Madrid #2
Majadahonda Madrid
Majadahonda( Madrid
Majadahonda,
Majadahonda, Madrid
Majadahonda-madrid
Majadahonda/madrid
Majadanonda
Majdahonda Madrid
Malaga Andalucia
Malaga Malaga
Malaga, Salamanca
Malaga-marbella
Malagon, Ciudad Real
Manacor (islas Baleares)
Manacor (palma De Mallorca)
Manacor- Illes Balears
Manises (valencia)
Manises, Valencia
Manresa (2)
Manresa (barcelona)
Manresa, Barcelona
Mansilla De Las Mulas, León
Many Locations
Manzanares - Ciudad Real
Manzanares Ciudad Real
Marbella (málaga)
Marbella (mã¡laga)
Marbella - Málaga
Marbella . Málaga
Marbella Málaga
Marbella, Malaga
Mas Casanovas
Mas Palomas
Matar(barcelona)
Mataro (barcelona)
Mataro - Barcelona
Mataro / Barcelona
Mataro(barcelona)
Mataro, Barcelona
Matarã³ (barcelona)
Matarã³ - Barcelona
Matarã³, Barcelona
Matarã³-barcelona
Mataró (barcelona)
Mataró - Barcelona
Mataró(barcelona)
Mataró, Barcelona
Mataró-barcelona
Mataró. Barcelona.
Materno Infantil, C/ Xubias De Abaixo, S/n
Mboadilla Del Monte (madrid)
Medina De Rioseco
Medina Del Campo
Medina Del Campo (valladolid)
Meliana, Valencia
Mendaro, Guipuzcoa
Mendaro, Guipúzcoa
Mengibar, Jaén
Merida (badajoz)
Merida Badajoz
Merida Extremadura
Merida, Badajoz
Mijas Costa
Minas De Riotinto
Miranda De Ebro
Miranda De Ebro (burgos)
Moguer Huelva
Molins De Rei
Molins De Rey
Mollet Del Valles
Mollet Del Valles/barcelona
Mollet Del Vallã¨s
Mollet Del Vallès
Mollet Del Vallés
Molã S/n Puã§ol Valencia
Molí S/n Puçol Valencia
Mombeltran - Avila
Moncloa-aravaca
Mondragã³n - Guipãºzcoa
Mondragón - Guipúzcoa
Monforte (casco Urbano)
Monforte De Lemos
Monforte Del Cid
Monistrol De Montserrat
Monover/monovar
Montcada I Reixac
Monteporeiro
Montgat/barcelona
Montornès Del Vallès
Montornés Del Vallès
Montoro, Córdoba
Mora De Ebre
Moralzarzal
Morata De Jalon
Moron De La Frontera - Sevilla
Mostoles (madrid)
Mostoles - Madrid
Mostoles - Madrid -
Mostoles / Madrid
Mostoles Madrid
Mostoles, Madrid
Mostoles-madrid
Mourente (pontevedra)
Mula (murcia)
Multiple Locations
Munguãa (vizcaya)
Munguía (vizcaya)
Murcia (el Palmar)
Murcia - El Palmar
Murias (mieres)
Murias (mieres) - Asturias
Málaga - Marbella
Málaga Málaga
Mã©dico Fernando Moray De La Horra, 2 Acceso Y9 Valencia
Mã©rida (badajoz)
Mã©rida-badajoz
Mã©rida.badajoz.
Mã³stoles (madrid)
Mã³stoles, Madrid
Mã³stoles/madrid
Médico Fernando Moray De La Horra, 2 Acceso Y9 Valencia
Mérida (badajoz)
Mérida / Badajoz
Mérida-badajoz
Mérida.badajoz.
Móra D'ebre
Móstoles (madrid)
Móstoles, Madrid
Móstoles/madrid
Nava De La Asuncion
Navalmoral De La Mata
Navalperal De Pinares
Navarres - Valencia
Neda, Coruña
Novartis Spain
Novelda, Alicante
Nájera (la Rioja)
O Barco De Valdeorras
O Carballiño
O'barco De Valdeorras
Oion (álava)
Oleiros (ribeira)
Olite-navarra
Olleria, Valencia
Olot (girona)
Onda (castellon)
Onda/castellã³n
Onda/castellón
One Investigational Site
One Or Multiple Investigational Sites
One Or Multiple Sites
Orgiva, Granada
Orihuela (alicante)
Orihuela/alicante
Osuna (sevilla)
Osuna, Sevilla
Oviedo (asturias)
Oviedo - Asturias
Oviedo Asturias
Oviedo, Asturias
Oviedo, Principado De Asturias
Pacha De Mallorca
Paiporta, Valencia
Palau-saverdera
Palau-solità I Plegamans
Palazuelos De Eresma (segovia)
Palma (mallorca)
Palma De Allorca
Palma De Gran Canaria
Palma De Majorca
Palma De Mallerca
Palma De Mallorca
Palma De Mallorca (baleares)
Palma De Mallorca (illes Balears)
Palma De Mallorca - Illes Balears
Palma De Mallorca Ibiza
Palma De Mallorca Illes Balear
Palma De Mallorca N/a
Palma De Mallorca, Balearas
Palma De Mallorca, Islas Balea
Palma De Mallorca, Islas Baleares
Palma De Mallorca.
Palma De Mallorcp
Palma De Mayorca
Palma Demallorca
Palma Mallorca
Palma, Mallorca
Palma. Mallorca
Palma. Mallorca.
Palmademallorca
Palmas De Gran Canaria
Palmones (cádiz)
Palos De La Frontera, Huelva
Pama De Mallorca
Pamplona (navarra)
Pamplona (navarra)-espana
Pamplona ,navarra
Pamplona - Navarra
Pamplona Madrid
Pamplona N/a
Pamplona Navarra
Pamplona, Navarra
Pamplona-navarra
Pamplona/ Navarra
Pamplona/iruna
Pamplona/iruña
Pamplona_iruña_
Parador De Las Hortichuelas, Almería
Parets Del Valles
Parets Del Vallès
Parla, Madrid
Partida De Bacarot
Partida De Bacarot (alicante)
Partida La Ceã±uela. Torreviej
Partida La Ceñuela. Torreviej
Passeig De La Vall D'hebron, 119-129
Passeig De La Vall D´hebrón 119-129, Barcelona
Passeig De La Vall Dâ´hebrã³n 119-129, Barcelona
Passeig Maritim 25-29, Barcelona
Passeig Marítim
Passeig Vall D'hebron, Num 119-129, Barcelona
Paterna, Valencia
Pau De Sanchinarro
Pea'arroya-pueblonuevo
Pedralba, Valencia
Pedro S/n Almazora Castellã³n
Pedro S/n Almazora Castellón
Peralada (girona)
Peralada( Girona)
Perales De Tajuña
Petrer (alicante)
Petrer - Alicante
Petrer, Alicante
Petrer/alicante
Peñaranda De Bracamonte
Peñaranda De Bracamonte (salamanca)
Peñíscola, Castellón
Pilas, Sevilla
Pineda De Mar
Pizarra (29560)
Pizarro, 22 Vigo Pontevedra
Placencia De Las Armas-soraluz
Plama De Mallorca
Planta Baja
Plaza Blasco Ibaã±ez, 4 Sagunto Valencia
Plaza Blasco Ibañez, 4 Sagunto Valencia
Plaza De Segovia
Plaza Segovia S/n Valencia
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Pola De Siero
Polinya De Xuquer, Valencia
Pollença, Baleares
Ponferrad A (leon)
Ponferrada (leã³n)
Ponferrada (león)
Pontevedra
Port De Bollenca
Port De Sagunt
Port De Sagunto
Portals Nous
Porto Cristo
Porto Do Son
Portugalete
Portugalete (vizcaya)
Portugalete - Vizcaya
Portugalete, Bizkaia
Portugalete, Vizcaya
Posada De Llanes
Posuelo De Alarcon
Pozo Canada
Pozo Estrecho (murcia)
Pozoblanco/cã³rdoba
Pozoblanco/córdoba
Pozuello De Alarcon
Pozuelo (madrid)
Pozuelo De Alacron
Pozuelo De Alarc0n
Pozuelo De Alarcon
Pozuelo De Alarcon (madrid)
Pozuelo De Alarcon Madr
Pozuelo De Alarcon Madrid
Pozuelo De Alarcon, Madrid
Pozuelo De Alarcon/madrid
Pozuelo De Alarconmadrid
Pozuelo De Alarcã³n
Pozuelo De Alarcã³n - Madrid
Pozuelo De Alarcã³n/madrid
Pozuelo De Alarcãƒâ³n
Pozuelo De Alarcón
Pozuelo De Alarcón (madrid)
Pozuelo De Alarcón - Madrid
Pozuelo De Alarcón, Madrid
Pozuelo De Alarcón. Madrid.
Pozuelo De Alarcón/madrid
Pozuelo De Alarcăłn
Prat De Llobregat
Premià De Mar
Priego De Córdoba
Profesor Beltran Baguena
Puebla De Cazalla, Sevilla
Puebla Larga
Puente Genil
Puerto De La Cruz
Puerto De Sagunto
Puerto De Sagunto (valencia)
Puerto De Santa Maria
Puerto De Sta. Maria
Puerto De Sta. Mar�a
Puerto De Sta. Mar�a
Puerto Del Rosario
Puerto Lumbreras
Puerto Lumbreras, Murcia
Puerto Real
Puerto Real (cadiz)
Puerto Real, Cadiz
Puerto Real, Cádiz
Puertollano
Puertollano, Ciudad Real
Punta Umbría
Pza. De Cruces
Quart De Poblet
Quart De Poblet, Valencia
Quintana De La Serena
Quintanar De La Orden
Quintanar De La Sierra (burgos)
Quintanar Del Rey
Quiroga (casco Urbano)
Ramã³n Y Cajal
Ramón Y Cajal
Raval Sagunto
Redondela (pontevedra)
Redondela - Pontevedra
Reina Victoria
Repãºblica Argentina
Repãºblica Argentina N⺠8, Valencia
República Argentina
República Argentina Nº 8, Valencia
Requena (valencia)
Requena-valencia
Reus (tarragona)
Reus and Tarragona
Reus Tarragona
Reus, Tarragona
Reus,tarragona
Reus-tarragona
Reyes Magos
Rianxo, A Coruna
Ria�o (langreo)
Ria�o (langreo)
Ribadesella
Rincon De La Victoria
Rivas Vaciamadrid
Roca Del Valles
Ronda-malaga
Roquetas De Mar
Rosa De Luxemburgo
Rosales, 23 La Eliana Valencia
Rute, Córdoba
S. Cristobal De La Laguna
Sabadell (badalona)
Sabadell (barcelona)
Sabadell - Barcelona
Sabadell / Barcelona
Sabadell 8208
Sabadell Barcelona
Sabadell Cantaluna
Sabadell(barcelona)
Sabadell, Barcelona
Sabadell, Barcelone
Sabadell, Cataluna
Sabadell- Barcelona
Sabadell-barcelona
Sabino De Arana 1
Sagunto (valencia)
Sagunto - Valencia
Sagunto Valencia
Sagunto(valencia)
Sagunto, Valencia
Sagunto/valencia
Saint Cugat Del Valles
Saint Joan Despi
Saint-sébastien
Saintr Boi De Llobregat
Salamanca Leon
Salamanca N/a
Salamanca, Castilla Y Leon
Salamanca, Castilla Y Leã³n
Salamanca, Castilla Y León
Salamanca-espana
Salceda De Caselas
Salt (gerona)
Salt (girona)
Salt, Girona
Salt-girona
Salvatierra (álava)
Salvatierra De Miño
Sama De Langreo
Sama De Langreo Asturias
San Adria Del Besos
San Agustãn
San Agustín
San Agustín Del Guadalix
San Bartolome
San Bartolome - Orihuela - Alicante
San Bartolomé
San Bartolomé, Alicante
San Boi De Llobregat
San Boit De Llobregat
San Carlos - Madrid
San Cibrán. Aldán (pontevedra)
San Cibrã¡n. Aldã¡n (pontevedra)
San Clemente 12, Valencia
San Cristobal
San Cristobal De La Laguna
San Cristobal De La Laguna Santa Cruz
San Cristã³bal De La Laguna
San Cristã³bal De La Laguna - Sta. Cruz De Tenerife
San Cristóbal De La Laguna
San Cristóbal De La Laguna - Santa Cruz De Tenerife
San Cristóbal De La Laguna - Sta. Cruz De Tenerife
San Cristóbal De La Laguna-santa Cruz De Tenerife
San Cristóbal La Laguna, Tenerife
San Cugat Del Valles
San Cugat Del Valles (barcelona)
San Cugat Del Vallã©s (barcelona)
San Cugat Del Vallès
San Cugat Del Vallés (barcelona)
San Fernando
San Fernando De Henares
San Fernando, Cadiz
San Fernando, Cádiz
San Fernándo
San Javier (murcia)
San José De La Rinconada
San Juan (alicante)
San Juan Alicante
San Juan De Alica
San Juan De Alicante
San Juan De Alicante (alicante)
San Juan(alicante)
San Juan, Alicante
San Juan/alicante
San Juán De Alicante
San Lorenzo
San Lorenzo De El Escorial
San Luis De Sabinillas
San Martin De Luina
San Martin De Porres 4
San Martin De Porres, 4, Madrid
San Pedro Alcántara, Málaga
San Pedro De Alcántara
San Pedro De Alcã¡ntara
San Pedro Del Pinatar
San Sabastian Gipuzkoa
San Sabastian, Pais Vasco
San Sebastain
San Sebastian
San Sebastian (guipuzkoa).
San Sebastian De Los
San Sebastian De Los Reye
San Sebastian De Los Reyes
San Sebastian De Los Reyes ( Madrid)
San Sebastian De Los Reyez
San Sebastian Gipuzkoa
San Sebastian Guipuzcoa
San Sebastian Guipuzcuoa
San Sebastian,
San Sebastian, Guipuzcoa
San Sebastian-donosia
San Sebastian-donosti
San Sebastian-gipuzkoa
San Sebastian-guipuzcoa
San Sebastián
San Sebastián (guipuzcoa)
San Sebastián (guipúzcoa)
San Sebastián De Los Reyes
San Sebastián De Los Reyes (madrid)
San Sebastián De Los Reyes/madrid
San Sebastián Guipúzcoa
San Sebastián(guipuzcoa)
San Sebastián(guipúzcoa)
San Sebastián, Guipúzcoa
San Sebastiã¡n
San Sebastiã¡n De Los Reyes
San Sebastiã¡n De Los Reyes/madrid
San Sebastiã¡n(guipuzcoa)
San Sebastiãƒâ¡n
San Sebastiãƒâ¡n De Los Reyes
San Sebasti�n
San Sebasti�n
San Sebatián De Los Reyes
San T Vicen㧠Del Horts ( Barcelona)
San T Vicenç Del Horts ( Barcelona)
San Vicent Dels Horts
San Vicente
San Vicente De Alcantara
San Vicente De Baracaldo
San Vicente De Barakaldo
San Vicente De Barakaldo-vizca
San Vicente De Raspeig
San Vicente De Raspeig (alicante)
San Vicente Del Raspeig
San Vicente Del Raspeig (alicante)
San Vicente Del Raspeig/alicante
San Vincente Raspeig (alicante)
San Zebastian
Sancchinarro
Sanchinarro
Sancti Spiritus, Salamanca
Sangüesa, Navarra
Sanlucar De Barrameda
Sanlucar De Barrameda - Cádiz
Sanlãºcar De Barrameda
Sanlúcar De Barrameda
Sanlúcar De Barrameda (cádiz)
Sanlúcar De Barrameda - Cádiz-
Sansebastian
Sansebastiandelosreyes
Sant Adria De Besos
Sant Adria De Besos (barcelona
Sant Adria Del Besos
Sant Adrià De Besòs
Sant Adrià Del Besós
Sant Adrià Del Besós (barcelona)
Sant Adrià Del Besós- Barcelona
Sant Adriá De Beyós, Barcelona
Sant Adriã Del Besã³s
Sant Adriã Del Besã³s (barcelona)
Sant Adriã Del Besã³s- Barcelona
Sant Adriã¡ De Beyã³s, Barcelona
Sant Andreu De La Barca
Sant Andreu De Llavaneres
Sant Antoni De Portmany
Sant Boi De Llobrega
Sant Boi De Llobregat
Sant Boi De Llobregat (barcelona)
Sant Boi De Llobregat - Barcelona
Sant Boi De Llobregat, Barcelona
Sant Boi De Lluçanès
Sant Boi Llobregat
Sant Carles De La Rapita
Sant Celoni
Sant Coloma De Gramenet
Sant Coloma Gramenet
Sant Cugal Del Valles
Sant Cugat (barcelona)
Sant Cugat Barcelona
Sant Cugat De Valles
Sant Cugat Del V.
Sant Cugat Del Vallas
Sant Cugat Del Valles
Sant Cugat Del Valles (barcelona)
Sant Cugat Del Valles, Barcelona
Sant Cugat Del Valls
Sant Cugat Del Vallã¨s
Sant Cugat Del Vallã¨s (barcelona)
Sant Cugat Del Vallã©s/
Sant Cugat Del Vallès
Sant Cugat Del Vallès (barcelona)
Sant Cugat Del Vallès, Barcelona
Sant Cugat Del Vallés
Sant Cugat Del Vallés/
Sant Cugat Sesgarrigues
Sant Cugat, Barcelona
Sant Eugenia De Berga, Barcelona
Sant Feliu De Guíxols
Sant Feliu De Llobregat
Sant Fruitos De Bages
Sant Fruitos De Bag�s
Sant Fruitos De Bag�s
Sant Fruitós De Bages
Sant Hilari Sacalm
Sant Hipòlit De Voltregà
Sant Joan D'alacant
Sant Joan D'espi
Sant Joan De Alacant
Sant Joan De Vilatorrada
Sant Joan Despi
Sant Joan Despi (barcelona)
Sant Joan Despi, Barcelona
Sant Joan Despã-
Sant Joan Despã
Sant Joan Despì
Sant Joan Despí
Sant Joan Despí (barcelona)
Sant Joan Despí, Barcelona
Sant Joan Dálacant
Sant Just Desvern
Sant Marti Sarroca
Sant Pere De Ribes
Sant Pere De Ribes (el Garraf)
Sant Sadurní D'anoia
Sant Vicent Del Raspeig
Sant Vicen㧠Del Horts
Sant Vicen㧠Dels Horts /barcelona
Sant Vicenç De Castellet
Sant Vicenç Del Horts
Sant Vicenç Dels Horts
Sant Vicenç Dels Horts /barcelona
Santa Brígida
Santa Coloma
Santa Coloma De Gramanet
Santa Coloma De Gramanet (barcelona)
Santa Coloma De Gramanet - Barcelona
Santa Coloma De Gramenet
Santa Coloma De Gramenet(barcelona)
Santa Coloma De Queralt
Santa Coloma Gramanet, Barcelona
Santa Coloma Gramenet
Santa Cruz D E Tenerife
Santa Cruz De Bezana
Santa Cruz De Mudela - Ciudad Real
Santa Cruz De Tenerfie
Santa Cruz De Tenerife
Santa Cruz De Tenerife,
Santa Cruz De Tenerife.
Santa Cruz De Teneriffe
Santa Cruz De Tenerite
Santa Lucía De Tirajana, Las Palmas
Santa Margarida De Montbui
Santa Margarita
Santa Maria De Corcó
Santa Maria Del Camí
Santa Marina Del Rey
Santa Mª Del Camí, Baleares
Santa Perpetua
Santa Perpètua De Mogoda
Santa Ponsa
Santaigo Compostela
Santander (cantabria)
Santander Cantabria
Santander N/a
Santander, Cantabria
Santander-cantabria
Santiado De Compostela
Santiago C.
Santiago Compostela
Santiago De C
Santiago De C.
Santiago De Comp-coruna
Santiago De Compastela
Santiago De Compestela
Santiago De Composte
Santiago De Compostela
Santiago De Compostela (a Coruña)
Santiago De Compostela (la Cor
Santiago De Compostela (la Coruã±a)
Santiago De Compostela (la Coruã‘a)
Santiago De Compostela (la Coruña)
Santiago De Compostela - A Coruna
Santiago De Compostela A Cor
Santiago De Compostela A Coruña
Santiago De Compostela La Coruña
Santiago De Compostela N/a
Santiago De Compostela(a Coru
Santiago De Compostela, A Coruna
Santiago De Compostela, A Coruña
Santiago De Compostela, La Coruña
Santiago De Compostela-a Coruña
Santiago De Compostela-coruña
Santiago De Compostela. La Coruña.
Santiago De Compostela/la Coruã±a
Santiago De Compostela/la Coruña
Santiago De Compostela; A Coruña
Santiago De Compostella
Santiago De Compostella, La Coruna
Santiago De Compostelle
Santiago De Compotela
Santiago De La Ribera
Santiago Do Compostela
Santiago(a Coruna)
Santiago(a Coruã±a)
Santiago(a Coruña)
Santiago, De Compostela
Santiagode Compostela,a Coruna
Santiao De Compostela
Santomera (murcia)
Santullano De Mieres
Santullano, Asturias
Segorbe - Castellon
Serra / Valencia
Serreria,73 Valencia
Serrerãa I
Serrerãa Ii
Serrería Ii
Servicio De Oftalmologia
Sestao (vizcaya)
Several Locations
Sevilla 41013
Sevilla Andalucia
Sevilla N/a
Sevilla Sevilla
Sevilla- (espana)
Seville, Andalucia,
Seville, Sevilla
Sobrado Dos Monxes
Sodupe (vizcaya)
Son Espases
Son Ferriol
Son Servera
Soto De La Marina
Soutomaior - Pontevedra
Sta Coloma De Gramanet
Sta Coloma De Gramanet (barcelona)
Sta Coloma De Gramanet (bcn)
Sta Coloma De Gramenet (bcn)
Sta Cruz De Tenerife
Sta. Coloma De Gramanet/barcelona
Sta. Coloma De Gramenet
Sta. Cruz De Tenerife
Sueca, Valencia
Sán Crístobál De Lá Láguná
Tacoronte, Tenerife
Talarrubias
Talavera De La Reina
Talavera De La Reina (toledo)
Talavera De La Reina, Toledo
Talavera De La Reina.
Tarragona and Reus
Tarragona N/a
Tarrasa (barcelona)
Tarrasa, Barcelona
Tarrasa-barcelona
Tarrega - Lleida
Tavernes De La Valldigna
Tenerife (la Laguna)
Tenerife, Canary Island
Terrasa (barcelona)
Terrasa Barcelona
Terrasa Barcelona N/a
Terrasa, Barcelona
Terrassa (barcelona)
Terrassa - Barcelona
Terrassa Barcelona
Terrassa(barcelona)
Terrassa, Barcelona
Terrassa-barcelona
Throughout Spain
Titaguas, Valencia
Tolosa-guipuzcoa
Tona/barcelona
Tordesillas
Torre De Don Miguel
Torre Del Campo, Jaén
Torre Del Mar
Torre Pacheco
Torre Pacheco (murcia)
Torreblanca
Torrebonica
Torredelcampo
Torrejon De Ardoz
Torrejon De Ardoz - Madrid
Torrejoncillo
Torrejón Ardoz
Torrejón De Ardoz
Torrejón De Ardoz Madrid
Torrejón De Ardoz, Madrid
Torrelaguna
Torrelavega
Torrelavega (cantabria)
Torrelavega (santander)
Torrelavega Cantabria
Torrelavega, Cantabria
Torrelavega.santander
Torrelavega/santander
Torrelodones
Torrelodones (madrid)
Torrelodones/madrid
Torremolinos
Torremolinos (málaga)
Torremolinos, Málaga
Torres De La Alameda
Torres De Segre
Torrevieja (alicante)
Torrevieja,
Torrrevieja (alicante)
Tortosa (tarragona)
Tortosa, Tarragona
Tortosa-tarragona
Tosa De Mar - Girona
Travesãa Da Choupana, S/n Santiago De Compostela A Coruã±a
Travesía Da Choupana, S/n Santiago De Compostela A Coruña
Tres Cantos
Trobajo Del Camino
Tudela - Navarra
Tudela De Duero (valladolid)
Tudela De Duero.
Tudela, Navarra
Tàrrega (lleida)
Tã rrega
Tã rrega (lleida)
Usansolo Bizkaia
Usansolo, Bizkaia
Valdefuentes, Cáceres
Valdemoro - Madrid
Valdemoro/madrid
Valdepeã±as
Valdepe�as
Valencia / Valencia
Valencia De Alcantara
Valencia De Alcántara
Valencia N/a
Valencia Valencia
Valencia-espana
Vall D' Hebron
Vall D'hebron
Vall D'hebron 119-129
Vall D'uixo
Valladolid N/a
Valladolid.
Vallda (valencia)
Valls (tarragona)
Various Cities
Vejer De La Frontera
Velez Malaga
Velez, Malaga
Velez-malaga
Vera De Bidasoa
Via-real (castellã³n)
Via-real (castellón)
Vic (barcelona)
Vic - Barcelona
Vic/ Barcelona
Vigo ( Pontevedra)
Vigo (pontevedra)
Vigo - Pontevedra
Vigo -pontevedra
Vigo Pontevedra
Vigo(pontevedra)
Vigo, Pontevedra
Vigo-pontevedra
Vigo/ Pontevedra
Vigo/pontevedra
Vila Joiosa, Alicante
Vila-real (castellon Plana)
Vila-real (castellón)
Viladecans,
Viladecans, Barcelona
Vilafranca Del Penedes
Vilafranca Del Penedès
Vilagarcia De Arousa
Vilagarcia-pontevedra
Vilagarcãa De Arosa (pontevedra)
Vilagarcía De Arosa (pontevedra)
Vilagarcía De Arousa
Vilanova (lourenza)
Vilanova I La Geltru
Vilanova I La Geltrãº
Vilanova I La Geltrú
Vilarrodona
Vilassar De Dalt
Vilassar De Mar
Vilassar De Mar- Barcelona
Villa Joiosa
Villa Joyosa
Villafranca De Los Barros
Villafranca Del Penedes
Villagarcia De Arosa
Villagonzalo Pedernales
Villajoyosa
Villajoyosa (alicante)
Villajoyosa - Alicante
Villalba De Los Barros
Villamartin
Villamartín
Villamartín (cádiz)
Villanueva De Gallego
Villanueva De Gállego
Villanueva De La Canada
Villanueva De La Cañada
Villanueva De La Serena
Villanueva Del Ariscal
Villar Del Arzobispo
Villar Del Arzobispo (valencia)
Villarejo De Salvanés
Villaroel, 170, Barcelona
Villarreal (castellón)
Villarroel 170
Villarroel 170,barcelona
Villarrubia De Santiago
Villaseca De La Sagra - Toledo
Villaviciosa De Odon
Villaviciosa De Odón
Virgen De La Arrixaca
Virgen Del Camino
Virgen Del Cortijo
Vitoria (álava)
Vitoria - Gasteiz
Vitoria / Gasteiz
Vitoria Gasteiz
Vitoria- Gasteiz
Vitoria-gasteiz
Vitoria-gasteiz 1009
Vitoria-gasteiz, Álava
Vitoria-gastiez
Vitoria/gasteiz
Vitoria‐gasteiz
Viveiro (casco Urbano)
Vizcaya N/a
Vã©lez-mã¡laga
Vã©lez-mã¡laga / Mã¡laga
Vélez, Málaga
Vélez-málaga
Vélez-málaga / Málaga
Xativa, Valencia
Xativa/valencia
Xinzo De Limia
Xunqueira De Ambia, Ourense
Xàtiva (valencia)
Xátiva-valencia
Xã tiva
Yecla (murcia)
Zalamea De La Serena
Zamudio (vizcaya)
Zaragoza (2)
Zaragoza, Aragon
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Associate Director, Global Regulatory Science - CMC
You will take charge of leading regulatory CMC strategy and execution for one or more transformative medicine programs. This pivotal role involves developing and implementing...
Team Leader Regulatory Affairs & Compliance - Regenerative Solutions
Ensure that all products in scope are designed, manufactured and distributed in such a way that they are safe and effective for their intended use and meet applicable regulatory...
Global Medical Safety Lead
Provide strategic medical safety leadership and practical contributions for assigned product(s) in a cross-functional setting; Perform safety signal management and benefit risk...
Senior Manager Regulatory Affairs Oncology
Act as a specialist in the area of oncology. Represent Regulatory Affairs internally working on a collaborative basis both within Europe and globally as a member of a...
Senior Clinical Research Associate
You will independently control and monitor investigational sites, pro-actively detect issues, provide solutions to ensure clinical studies are performed according to the trial...
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Director, Immunology European Medical Engagement Lead (MEL)
The Director, Immunology European Medical Engagement Lead (MEL) conducts critical activities that support advancing science, educating on evolving clinical practices, transforming...
Medical and PV Audit and Inspection Readiness Professional
Support of the ongoing permanent inspection preparedness and readiness of Global Pharmacovigilance (Patient Safety Pharmacovigilance-PSPV) and country PV offices in anticipation of...
Deputy European Union (EU) Qualified Person for Pharmacovigilance
Provide strategic and technical pharmacovigilance advice to Global Patient Safety (GPS), and other regulatory and medical functions within the Medicines Development Unit; Play an...
Director CMC
Manage, prepare, finalise CMC sections of EU IMPD/MAA and rest of world equivalent documents. Oversee teams preparing content, arrange reviews by regulatory, SME peers, senior...
Manager, Scientific Affairs
Lead design of preclinical and/or clinical studies needed to support health benefit claims. Author, update and maintain relevant scientific documentation. Work closely with Product...
Director, Regulatory Affairs - CMC Biologics
As a Director, you will be responsible for the successful execution of multiple projects and ensuring client satisfaction. You will provide mentorship, leadership and direction to...
Medical Information Director
Management of cases with pharmacovigilance and materiovigilance departments. Regular training of Sales resources (place of the radiopharmaceutical in the strategy tree of...
Senior Clinical Research Scientist, Solid Tumor Team
This position contributes to the implementation of the global development strategy, leading or co-leading one or more clinical trials in a therapeutic area for one or more...
Manager, Global Regulatory Affairs - CCDS
Lead the initial development, approval, and ongoing compliance of product labeling content throughout the product life cycle; track status and maintain documents in controlled...
Clinical Trial Liaison (CTL) - Oncology
The CTL provides regional and country specific insights to support study feasibility, site identification and selection, and patient recruitment and retention initiatives. In...
Director, Global Regulatory Affairs, Pediatrics
Responsible for providing strategic regulatory guidance on the global pediatric development in alignment with and within the overall development of a product; Lead multiple...
Clinical Trial Lab Manager
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Bristol Myers Squibb to Present Data at ESMO Demonstrating Ongoing Leadership in Immuno-Oncology and Progression of Assets from Its Differentiated Research Platforms
Data from proof-of-concept, randomized, Phase 2 RELATIVITY-104 trial exploring the combination of nivolumab, relatlimab (1:1) and chemotherapy as first-line treatment for stage IV or recurrent NSCLC; BMS initiating Phase 3 RELATIVITY-1093 trial
Ten-year follow-up data from CheckMate -067 showed continued durable, long-term survival benefit of Opdivo ® (nivolumab) plus Yervoy ® (ipilimumab) in patients with advanced or metastatic melanoma
Results from several early-phase clinical trials reinforce the strength and diversity of BMS’ oncology portfolio, including novel combinations and modalities, across a wide range of solid tumors
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced the presentation of nearly 60 abstracts of company-sponsored studies, investigator-sponsored studies, and collaborations from across its oncology portfolio and pipeline at the European Society for Medical Oncology (ESMO) Congress 2024 to be held from September 13-17 in Barcelona, Spain.
“Our data at ESMO this year highlight BMS’ enduring impact in oncology and offer insights into our earlier-phase, next-generation assets,” said Samit Hirawat, M.D. , executive vice president, chief medical officer and head of development, Bristol Myers Squibb. “We are proud to continue to expand our oncology leadership and showcase progress within our diversified pipeline, including novel ADCs and protein degraders, to advance the next wave of breakthrough cancer treatments and offer more options for patients across a wide range of tumor types.”
Key data being presented by Bristol Myers Squibb at ESMO Congress 2024 include:
Data supporting our innovative oncology portfolio
- Ten-year follow-up data from the Phase 3 CheckMate –067 trial showed the continued durable, long-term survival benefit of Opdivo ® (nivolumab) plus Yervoy ® (ipilimumab) in patients with advanced or metastatic melanoma. These data represent the longest reported median overall survival from a Phase 3 advanced melanoma trial. (LBA43)
- An update of clinical outcomes from the Phase 3 CheckMate -77T trial evaluating an Opdivo -based perioperative regimen in patients with resectable non-small cell lung cancer (NSCLC) (LBA50)
- Expanded analyses from the CheckMate -9DW trial evaluating Opdivo plus Yervoy vs lenvatinib or sorafenib as first-line (1L) treatment for unresectable hepatocellular carcinoma (uHCC) (965MO)
- Subgroup efficacy and expanded safety data from the Phase 3 CheckMate –8HW trial evaluating Opdivo plus Yervoy as first-line treatment for microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC) (541P)
- Updated efficacy and safety results at approximately 15-months of follow up from the Phase 3 CheckMate –67T trial evaluating subcutaneous nivolumab in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (1691P)
- Efficacy and safety data from the randomized Phase 3 KRYSTAL-12 trial evaluating KRAZATI ® (adagrasib) versus docetaxel in patients with pretreated locally advanced or metastatic NSCLC harboring a KRAS G12C mutation and baseline brain metastases (LBA57)
Studies supporting our advancing pipeline
- BMS is initiating the Phase 3 RELATIVITY-1093 trial evaluating the fixed-dose combination of nivolumab and relatlimab (FDC 1:1) plus chemotherapy versus pembrolizumab plus chemotherapy as a first-line treatment for patients with stage IV or recurrent non-squamous NSCLC with tumor cell PD-L1 expression of 1 to 49%, supported by findings from the RELATIVITY-104 trial
- First data from the randomized, Phase 2 CA001-050 trial evaluating BMS-986012, an anti-fucosyl-GM1 monoclonal antibody, in combination with carboplatin, etoposide, and nivolumab as a first-line therapy in newly diagnosed patients with extensive-stage small cell lung cancer: interim analysis (1786O)
- Updated safety and clinical activity from first-in-human Phase 1 trial evaluating the targeted protein degrader BMS-986365, the company’s potential best-in-class oral dual androgen receptor ligand-directed degrader (AR LDD) and antagonist, in heavily pre-treated patients with metastatic castration-resistant prostate cancer (1597MO)
- Three presentations of data evaluating BL-B01D1, a bispecific antibody-drug conjugate (ADC) targeting both EGFR and HER3 being developed in collaboration with SystImmune, Inc., in locally advanced or metastatic biliary tract cancer, locally advanced or metastatic urothelial carcinoma, and locally advanced or metastatic esophageal squamous cell carcinoma (54P, 1959O and 1426P)
Bristol Myers Squibb will host an investor webcast on Saturday, September 14 at 20:00 CEST (2:00 p.m. EDT) to discuss advancements in our cancer pipeline, including key data at ESMO. Company executives will provide an overview at the meeting and address inquiries from investors and analysts.
Investors and the general public are invited to listen to a live webcast at http://investor.bms.com and are urged to register prior to the webcast.
Those unable to register can access the live conference call by dialing in the U.S. toll-free +1 833-816-1116 or international +1 412-317-0705. Materials related to the call will be available at http://investor.bms.com prior to the start of the conference call.
Please see below for Important Safety Information and full Prescribing Information for Opdualag™ (nivolumab and relatlimab-rmbw), Opdivo plus Yervoy, and KRAZATI .
Summary of Presentations:
Select Bristol Myers Squibb studies at the ESMO Congress 2024 include:
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| Nivolumab (NIVO) plus ipilimumab (IPI) vs lenvatinib (LEN) or sorafenib (SOR) as first-line (1L) treatment for unresectable hepatocellular carcinoma (uHCC): expanded analyses from CheckMate 9DW | Thomas Decaens | Mini oral
965MO | GI tumors, upper | Monday, September 16
08:30 – 10:00 CEST / 2:30 – 4:00 AM EDT |
| Nivolumab (NIVO) plus ipilimumab (IPI) vs chemotherapy (chemo) as first-line (1L) treatment for microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC): subgroup efficacy and expanded safety analyses from CheckMate 8HW | Thierry Andre | Poster
541P | Colorectal cancer | Monday, September 16
Onsite poster display |
| BL-B01D1, an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) | Liu Chang | Poster
1426P | Oesophagogastric cancer | Monday, September 16
Onsite poster display |
| BL-B01D1, an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Biliary Tract Carcinoma (BTC) | Zhihao Lu | Poster
54P | Biliary tract cancer, incl. cholangiocarcinoma | Monday, September 16
Onsite poster display |
| Real-World Data on the Use of Nivolumab plus Chemotherapy for Patients with Metastatic GC/GEJC/EAC: A Canadian Perspective
| Mustapha Tehfe | Poster
1415P | Oesophagogastric cancer | Monday, September 16
Onsite poster display |
| Long-term management and outcomes in gastroesophageal cancer in Norway | Aleksander Kolstad | Poster
1459P | Oesophagogastric cancer | Monday, September 16
Onsite poster display |
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| BL-B01D1, an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Locally Advanced or Metastatic Urothelial Carcinoma (mUC) | Dingwei Ye | Oral
1959O | GU tumors, non-prostate | Friday, September 13
14:00-15:30 PM CEST / 8:00 – 9:30 AM EDT |
| Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients (pts) with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): updated efficacy and safety results from CheckMate 67T | Laurence Albiges | Poster
1691P | Renal cancer | Sunday, September 15
Onsite poster display |
| Clinical activity of BMS-986365 (CC-94676), a dual androgen receptor (AR) ligand-directed degrader and antagonist, in heavily pretreated patients (pts) with metastatic castration-resistant prostate cancer | Dana Rathkopf | Oral
1597MO | GU tumors, prostate | Monday, September 16
10:15 – 11:45 CEST / 4:15 – 5:45 AM EDT |
| Real-world (RW) characteristics and outcomes in patients (pts) with muscle-invasive urothelial carcinoma (MIUC) treated with adjuvant nivolumab (NIVO) with or without neoadjuvant chemotherapy (NAC) | Ebrahimi Hedyeh | Poster
1992P | Urothelial cancer | Sunday, September 15
Onsite poster display |
| Novel serum glycoproteomic biomarkers predict response to nivolumab plus cabozantinib (NIVO+CABO) versus sunitinib (SUN) in advanced RCC (aRCC): analysis from CheckMate 9ER | David A. Braun | Mini oral
1694MO | GU tumors, non-prostate | Sunday, September 15
08:30-10:00 CEST / 2:30-4:00 AM EDT |
| Health-related quality of life from the CheckMate 901 trial of nivolumab as first-line therapy for unresectable or metastatic urothelial carcinoma | Jens Bedke | Oral
1960O | GU tumors, non-prostate | Monday, September 16
08:30-10:00 AM CEST / 2:30 – 4:00 AM EDT |
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| Ten-year survival outcomes of the CheckMate 067 phase 3 trial of nivolumab plus ipilimumab in advanced melanoma | James Larkin | Mini Oral
LBA43 | Melanoma and other skin tumors | Sunday, September 15
14:45 - 16:15 CEST / 8:45 – 10:15 AM EDT |
| Nivolumab plus relatlimab vs nivolumab in previously untreated metastatic or unresectable melanoma: 3-year subgroup analyses from RELATIVITY-047 | Dirk Schadendorf | Poster
1092P | Melanoma and other skin tumors | Saturday, September 14
Onsite poster display |
| Adjuvant nivolumab v placebo in stage IIB/C melanoma: 3-year results from CheckMate 76K | Georgina Long | Mini Oral
1077MO | Melanoma and other skin tumors | Sunday, September 15
14:45 - 16:15 CEST / 8:45 – 10:15 AM EDT |
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| Nivolumab (NIVO) plus relatlimab with platinum-doublet chemotherapy (PDCT) vs NIVO + PDCT as first-line (1L) treatment (tx) for stage IV or recurrent NSCLC: results from the randomized phase 2 RELATIVITY-104 study | Nicolas Girard | Oral
LBA53 | NSCLC, metastatic | Saturday, September 14
08:30 – 10:00 CEST / 2:30 – 4:00 AM EDT |
| Perioperative nivolumab (NIVO) vs placebo (PBO) in patients (pts) with resectable NSCLC: clinical update from the phase 3 CheckMate 77T study | Mariano Provencio | Mini-oral
LBA50 | Non-metastatic NSCLC | Sunday, September 15
10:15 – 11:30 CEST / 4:15 - 5:30 AM EDT |
| Adagrasib versus docetaxel in patients with KRAS G12C-mutated locally advanced or metastatic NSCLC and baseline brain metastases: results from KRYSTAL-12 | Fabrice Barlesi | Mini-oral
LBA57 | NSCLC metastatic
| Saturday, September 14
10:15 – 11:45 CEST / 4:15 – 5:45 AM EDT |
| BMS-986012 (anti-fucosyl-monosialoganglioside-1 [Fuc-GM1]) with carboplatin + etoposide (CE) + nivolumab (N) as first-line therapy in extensive-stage small cell lung cancer (ES-SCLC): interim analysis (IA) of a randomized phase 2 study | Ewa Kalinka | Oral
1786O | Non-metastatic NSCLC
| Friday, September 13
14:00 – 15:30 CEST / 8:00 – 9:30 AM EDT |
| Association between early endpoints and survival outcomes in neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC): A multi-country retrospective study | Mariano Provencio Pulla | Poster
1230P | NSCLC, early stage | Saturday, September 14
Onsite poster display |
| Real-world immunotherapy (IO) rechallenge outcomes with nivolumab (NIVO) in advanced non-small cell lung cancer (aNSCLC) in France: LIST study interim results | Benoit Bodbert | Poster
1317P | NSCLC, metastatic | Saturday, September 14
Onsite poster display |
| Expression Analysis of Fuc-GM1 Ganglioside in First-Line Therapy for Extensive-Stage Small Cell Lung Cancer (ES-SCLC) with BMS-986012, Nivolumab, and Carboplatin-Etoposide | Kenneth J. O'Byrne | Poster
1801P
| SCLC | Saturday, September 14
Onsite poster display |
| KRYSTAL-7: a phase 3 study of first-line adagrasib plus pembrolizumab versus pembrolizumab alone in patients with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation | Marina C. Garassino | Poster
1394TiP | NSCLC, metastatic | Saturday, September 14
Onsite poster display |
| Real-world treatment and overall survival (OS) in patients (pts) with ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) in England between 2014 and 2023 | Alistair Greystoke | Poster
1291P | NSCLC, metastatic | Saturday, September 14
Onsite poster display |
| Nivolumab (NIVO) in the first-line (1L) or second-line (2L) and later (2L+) settings in patients (pts) with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): Updated results from the German non-interventional study (NIS), HANNA | A. Dietz | Poster
873P | Head and neck cancer, excluding thyroid | Saturday, September 14
Onsite poster display |
All regular abstracts, except late-breaking abstracts, are available on the ESMO Congress 2024 website as of 00:05 CEST on Monday, September 9. All late-breaking abstracts will be available on the ESMO Congress 2024 website at 00:05 CEST on the day of presentation.
Bristol Myers Squibb: Creating a Better Future for People with Cancer
Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. Deep understanding of causal human biology, cutting-edge capabilities and differentiated research programs uniquely position the company to approach cancer from every angle.
Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.
OPDIVO INDICATIONS
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma.
OPDIVO® is indicated for the adjuvant treatment of adult and pediatric patients 12 years and older with completely resected Stage IIB, Stage IIC, Stage III, or Stage IV melanoma.
OPDIVO® (nivolumab), in combination with platinum-doublet chemotherapy, is indicated as neoadjuvant treatment of adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with intermediate or poor risk advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
OPDIVO® (nivolumab), as a single agent, is indicated for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection of UC.
OPDIVO® (nivolumab), in combination with cisplatin and gemcitabine, is indicated as first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma.
OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
OPDIVO® (nivolumab) is indicated for the treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.
OPDIVO® (nivolumab) is indicated for the adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in adult patients who have received neoadjuvant chemoradiotherapy (CRT).
OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC).
OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of adult patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.
IMPORTANT SAFETY INFORMATION
Severe and Fatal Immune-Mediated Adverse Reactions
Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune- mediated adverse reactions.
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY. Early identification and management are essential to ensure safe use of OPDIVO and YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.
Immune-Mediated Pneumonitis
OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune- mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune- mediated pneumonitis occurred in 7% (31/456) of patients, including Grade 4 (0.2%), Grade 3 (2.0%), and Grade 2 (4.4%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune- mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune- mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis.
In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12).
Immune-Mediated Colitis
OPDIVO and YERVOY can cause immune-mediated colitis, which may be fatal. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%).
Immune-Mediated Hepatitis and Hepatotoxicity
OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%).
OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients.
Immune-Mediated Endocrinopathies
OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.
In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.3%), Grade 3 (2.5%), and Grade 2 (4.1%). In patients receiving OPDIVO and cabozantinib, adrenal insufficiency occurred in 4.7% (15/320) of patients, including Grade 3 (2.2%) and Grade 2 (1.9%).
In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients, including Grade 3 (0.2%) and Grade 2 (0.3%).
In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypophysitis occurred in 9% (42/456), including Grade 3 (2.4%) and Grade 2 (6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypophysitis occurred in 4.4% (29/666) of patients, including Grade 4 (0.3%), Grade 3 (2.4%), and Grade 2 (0.9%).
In patients receiving OPDIVO monotherapy, thyroiditis occurred in 0.6% (12/1994) of patients, including Grade 2 (0.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, thyroiditis occurred in 2.7% (22/666) of patients, including Grade 3 (4.5%) and Grade 2 (2.2%).
In patients receiving OPDIVO monotherapy, hyperthyroidism occurred in 2.7% (54/1994) of patients, including Grade 3 (<0.1%) and Grade 2 (1.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hyperthyroidism occurred in 9% (42/456) of patients, including Grade 3 (0.9%) and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hyperthyroidism occurred in 12% (80/666) of patients, including Grade 3 (0.6%) and Grade 2 (4.5%).
In patients receiving OPDIVO monotherapy, hypothyroidism occurred in 8% (163/1994) of patients, including Grade 3 (0.2%) and Grade 2 (4.8%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, hypothyroidism occurred in 20% (91/456) of patients, including Grade 3 (0.4%) and Grade 2 (11%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, hypothyroidism occurred in 18% (122/666) of patients, including Grade 3 (0.6%) and Grade 2 (11%).
In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients, including Grade 3 (0.4%) and Grade 2 (0.3%), and 2 cases of diabetic ketoacidosis. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, diabetes occurred in 2.7% (15/666) of patients, including Grade 4 (0.6%), Grade 3 (0.3%), and Grade 2 (0.9%).
Immune-Mediated Nephritis with Renal Dysfunction
OPDIVO and YERVOY can cause immune-mediated nephritis. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.5%), and Grade 2 (0.6%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated nephritis with renal dysfunction occurred in 4.1% (27/666) of patients, including Grade 4 (0.6%), Grade 3 (1.1%), and Grade 2 (2.2%).
Immune-Mediated Dermatologic Adverse Reactions
OPDIVO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug rash with eosinophilia and systemic symptoms (DRESS) has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate nonexfoliative rashes.
YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, SJS, TEN, and DRESS. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous/exfoliative rashes.
Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).
In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients, including Grade 3 (1.1%) and Grade 2 (2.2%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated rash occurred in 28% (127/456) of patients, including Grade 3 (4.8%) and Grade 2 (10%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated rash occurred in 16% (108/666) of patients, including Grade 3 (3.5%) and Grade 2 (4.2%).
Other Immune-Mediated Adverse Reactions
The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received OPDIVO monotherapy or OPDIVO in combination with YERVOY or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions: cardiac/vascular: myocarditis, pericarditis, vasculitis; nervous system: meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; ocular: uveitis, iritis, and other ocular inflammatory toxicities can occur; gastrointestinal: pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis; musculoskeletal and connective tissue: myositis/polymyositis, rhabdomyolysis, and associated sequelae including renal failure, arthritis, polymyalgia rheumatica; endocrine: hypoparathyroidism; other (hematologic/immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis (HLH), systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection.
In addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1% of patients unless otherwise specified: nervous system: autoimmune neuropathy (2%), myasthenic syndrome/myasthenia gravis, motor dysfunction; cardiovascular: angiopathy, temporal arteritis; ocular: blepharitis, episcleritis, orbital myositis, scleritis; gastrointestinal: pancreatitis (1.3%); other (hematologic/immune): conjunctivitis, cytopenias (2.5%), eosinophilia (2.1%), erythema multiforme, hypersensitivity vasculitis, neurosensory hypoacusis, psoriasis.
Some ocular IMAR cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, which has been observed in patients receiving OPDIVO and YERVOY, as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss.
Infusion-Related Reactions
OPDIVO and YERVOY can cause severe infusion-related reactions. Discontinue OPDIVO and YERVOY in patients with severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild (Grade 1) or moderate (Grade 2) infusion-related reactions. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate trial in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30- minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 8% (4/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, infusion-related reactions occurred in 5.1% (28/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, infusion-related reactions occurred in 4.2% (5/119) of patients. In MPM patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, infusion-related reactions occurred in 12% (37/300) of patients.
Complications of Allogeneic Hematopoietic Stem Cell Transplantation
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with OPDIVO or YERVOY. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between OPDIVO or YERVOY and allogeneic HSCT.
Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with OPDIVO and YERVOY prior to or after an allogeneic HSCT.
Embryo-Fetal Toxicity
Based on its mechanism of action and findings from animal studies, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. The effects of YERVOY are likely to be greater during the second and third trimesters of pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO and YERVOY and for at least 5 months after the last dose.
Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone
In randomized clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.
There are no data on the presence of OPDIVO or YERVOY in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 5 months after the last dose.
Serious Adverse Reactions
In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and 36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (≥10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%), colitis (10% and 1.9%), and pyrexia (10% and 1.0%). In Checkmate 238, serious adverse reactions occurred in 18% of patients receiving OPDIVO (n=452). Grade 3 or 4 adverse reactions occurred in 25% of OPDIVO-treated patients (n=452). The most frequent Grade 3 and 4 adverse reactions reported in ≥2% of OPDIVO-treated patients were diarrhea and increased lipase and amylase. In Checkmate 816, serious adverse reactions occurred in 30% of patients (n=176) who were treated with OPDIVO in combination with platinum-doublet chemotherapy. Serious adverse reactions in >2% included pneumonia and vomiting. No fatal adverse reactions occurred in patients who received OPDIVO in combination with platinum-doublet chemotherapy. In Checkmate 227, serious adverse reactions occurred in 58% of patients (n=576). The most frequent (≥2%) serious adverse reactions were pneumonia, diarrhea/colitis, pneumonitis, hepatitis, pulmonary embolism, adrenal insufficiency, and hypophysitis. Fatal adverse reactions occurred in 1.7% of patients; these included events of pneumonitis (4 patients), myocarditis, acute kidney injury, shock, hyperglycemia, multi-system organ failure, and renal failure. In Checkmate 9LA, serious adverse reactions occurred in 57% of patients (n=358). The most frequent (>2%) serious adverse reactions were pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis, and respiratory failure. Fatal adverse reactions occurred in 7 (2%) patients, and included hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia, and massive hemoptysis in the setting of thrombocytopenia. In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 057, fatal adverse reactions occurred; these included events of infection (7 patients, including one case of Pneumocystis jirovecii pneumonia), pulmonary embolism (4 patients), and limbic encephalitis (1 patient). In Checkmate 743, serious adverse reactions occurred in 54% of patients receiving OPDIVO plus YERVOY. The most frequent serious adverse reactions reported in ≥2% of patients were pneumonia, pyrexia, diarrhea, pneumonitis, pleural effusion, dyspnea, acute kidney injury, infusion-related reaction, musculoskeletal pain, and pulmonary embolism. Fatal adverse reactions occurred in 4 (1.3%) patients and included pneumonitis, acute heart failure, sepsis, and encephalitis. In Checkmate 214, serious adverse reactions occurred in 59% of patients receiving OPDIVO plus YERVOY (n=547). The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis. In Checkmate 9ER, serious adverse reactions occurred in 48% of patients receiving OPDIVO and cabozantinib (n=320). The most frequent serious adverse reactions reported in ≥2% of patients were diarrhea, pneumonia, pneumonitis, pulmonary embolism, urinary tract infection, and hyponatremia. Fatal intestinal perforations occurred in 3 (0.9%) patients. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in ≥2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in ≥1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash.
Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last OPDIVO dose, 2 from infection 8 to 9 months after completing OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=236). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in ≥2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration. In Checkmate 274, serious adverse reactions occurred in 30% of patients receiving OPDIVO (n=351). The most frequent serious adverse reaction reported in ≥2% of patients receiving OPDIVO was urinary tract infection. Fatal adverse reactions occurred in 1% of patients; these included events of pneumonitis (0.6%). In Checkmate 901, serious adverse reactions occurred in 48% of patients receiving OPDIVO in combination with chemotherapy. The most frequent serious adverse reactions reporting in ≥2% of patients who received OPDIVO with chemotherapy were urinary tract infection (4.9%), acute kidney injury (4.3%), anemia (3%), pulmonary embolism (2.6%), sepsis (2.3%), and platelet count decreased (2.3%). Fatal adverse reactions occurred in 3.6% of patients who received OPDIVO in combination with chemotherapy; these included sepsis (1%). OPDIVO and/or chemotherapy were discontinued in 30% of patients and were delayed in 67% of patients for an adverse reaction. In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY (n=119), serious adverse reactions occurred in 47% of patients. The most frequent serious adverse reactions reported in ≥2% of patients were colitis/diarrhea, hepatic events, abdominal pain, acute kidney injury, pyrexia, and dehydration. In Checkmate 040, serious adverse reactions occurred in 59% of patients receiving OPDIVO with YERVOY (n=49). Serious adverse reactions reported in ≥4% of patients were pyrexia, diarrhea, anemia, increased AST, adrenal insufficiency, ascites, esophageal varices hemorrhage, hyponatremia, increased blood bilirubin, and pneumonitis. In Attraction-3, serious adverse reactions occurred in 38% of patients receiving OPDIVO (n=209). Serious adverse reactions reported in ≥2% of patients who received OPDIVO were pneumonia, esophageal fistula, interstitial lung disease, and pyrexia. The following fatal adverse reactions occurred in patients who received OPDIVO: interstitial lung disease or pneumonitis (1.4%), pneumonia (1.0%), septic shock (0.5%), esophageal fistula (0.5%), gastrointestinal hemorrhage (0.5%), pulmonary embolism (0.5%), and sudden death (0.5%). In Checkmate 577, serious adverse reactions occurred in 33% of patients receiving OPDIVO (n=532). A serious adverse reaction reported in ≥2% of patients who received OPDIVO was pneumonitis. A fatal reaction of myocardial infarction occurred in one patient who received OPDIVO. In Checkmate 648, serious adverse reactions occurred in 62% of patients receiving OPDIVO in combination with chemotherapy (n=310). The most frequent serious adverse reactions reported in ≥2% of patients who received OPDIVO with chemotherapy were pneumonia (11%), dysphagia (7%), esophageal stenosis (2.9%), acute kidney injury (2.9%), and pyrexia (2.3%). Fatal adverse reactions occurred in 5 (1.6%) patients who received OPDIVO in combination with chemotherapy; these included pneumonitis, pneumatosis intestinalis, pneumonia, and acute kidney injury. In Checkmate 648, serious adverse reactions occurred in 69% of patients receiving OPDIVO in combination with YERVOY (n=322). The most frequent serious adverse reactions reported in ≥2% who received OPDIVO in combination with YERVOY were pneumonia (10%), pyrexia (4.3%), pneumonitis (4.0%), aspiration pneumonia (3.7%), dysphagia (3.7%), hepatic function abnormal (2.8%), decreased appetite (2.8%), adrenal insufficiency (2.5%), and dehydration (2.5%). Fatal adverse reactions occurred in 5 (1.6%) patients who received OPDIVO in combination with YERVOY; these included pneumonitis, interstitial lung disease, pulmonary embolism, and acute respiratory distress syndrome. In Checkmate 649, serious adverse reactions occurred in 52% of patients treated with OPDIVO in combination with chemotherapy (n=782). The most frequent serious adverse reactions reported in ≥2% of patients treated with OPDIVO in combination with chemotherapy were vomiting (3.7%), pneumonia (3.6%), anemia (3.6%), pyrexia (2.8%), diarrhea (2.7%), febrile neutropenia (2.6%), and pneumonitis (2.4%). Fatal adverse reactions occurred in 16 (2.0%) patients who were treated with OPDIVO in combination with chemotherapy; these included pneumonitis (4 patients), febrile neutropenia (2 patients), stroke (2 patients), gastrointestinal toxicity, intestinal mucositis, septic shock, pneumonia, infection, gastrointestinal bleeding, mesenteric vessel thrombosis, and disseminated intravascular coagulation. In Checkmate 76K, serious adverse reactions occurred in 18% of patients receiving OPDIVO (n=524). Adverse reactions which resulted in permanent discontinuation of OPDIVO in >1% of patients included arthralgia (1.7%), rash (1.7%), and diarrhea (1.1%). A fatal adverse reaction occurred in 1 (0.2%) patient (heart failure and acute kidney injury). The most frequent Grade 3-4 lab abnormalities reported in ≥1% of OPDIVO-treated patients were increased lipase (2.9%), increased AST (2.2%), increased ALT (2.1%), lymphopenia (1.1%), and decreased potassium (1.0%).
Common Adverse Reactions
In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO (n=268) was rash (21%). In Checkmate 066, the most common adverse reactions (≥20%) reported with OPDIVO (n=206) vs dacarbazine (n=205) were fatigue (49% vs 39%), musculoskeletal pain (32% vs 25%), rash (28% vs 12%), and pruritus (23% vs 12%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO plus YERVOY arm (n=313) were fatigue (62%), diarrhea (54%), rash (53%), nausea (44%), pyrexia (40%), pruritus (39%), musculoskeletal pain (32%), vomiting (31%), decreased appetite (29%), cough (27%), headache (26%),dyspnea (24%), upper respiratory tract infection (23%), arthralgia (21%), and increased transaminases (25%). In Checkmate 067, the most common (≥20%) adverse reactions in the OPDIVO arm (n=313) were fatigue (59%), rash (40%), musculoskeletal pain (42%), diarrhea (36%), nausea (30%), cough (28%), pruritus (27%), upper respiratory tract infection (22%), decreased appetite (22%), headache (22%), constipation (21%), arthralgia (21%), and vomiting (20%). In Checkmate 238, the most common adverse reactions (≥20%) reported in OPDIVO-treated patients (n=452) vs ipilimumab-treated patients (n=453) were fatigue (57% vs 55%), diarrhea (37% vs 55%), rash (35% vs 47%), musculoskeletal pain (32% vs 27%), pruritus (28% vs 37%), headache (23% vs 31%), nausea (23% vs 28%), upper respiratory infection (22% vs 15%), and abdominal pain (21% vs 23%). The most common immune-mediated adverse reactions were rash (16%), diarrhea/colitis (6%), and hepatitis (3%). In Checkmate 816, the most common (>20%) adverse reactions in the OPDIVO plus chemotherapy arm (n=176) were nausea (38%), constipation (34%), fatigue (26%), decreased appetite (20%), and rash (20%). In Checkmate 227, the most common (≥20%) adverse reactions were fatigue (44%), rash (34%), decreased appetite (31%), musculoskeletal pain (27%), diarrhea/colitis (26%), dyspnea (26%), cough (23%), hepatitis (21%), nausea (21%), and pruritus (21%). In Checkmate 9LA, the most common (>20%) adverse reactions were fatigue (49%), musculoskeletal pain (39%), nausea (32%), diarrhea (31%), rash (30%), decreased appetite (28%), constipation (21%), and pruritus (21%). In Checkmate 017 and 057, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=418) were fatigue, musculoskeletal pain, cough, dyspnea, and decreased appetite. In Checkmate 743, the most common adverse reactions (≥20%) in patients receiving OPDIVO plus YERVOY were fatigue (43%), musculoskeletal pain (38%), rash (34%), diarrhea (32%), dyspnea (27%), nausea (24%), decreased appetite (24%), cough (23%), and pruritus (21%). In Checkmate 214, the most common adverse reactions (≥20%) reported in patients treated with OPDIVO plus YERVOY (n=547) were fatigue (58%), rash (39%), diarrhea (38%), musculoskeletal pain (37%), pruritus (33%), nausea (30%), cough (28%), pyrexia (25%), arthralgia (23%), decreased appetite (21%), dyspnea (20%), and vomiting (20%). In Checkmate 9ER, the most common adverse reactions (≥20%) in patients receiving OPDIVO and cabozantinib (n=320) were diarrhea (64%), fatigue (51%), hepatotoxicity (44%), palmar-plantar erythrodysaesthesia syndrome (40%), stomatitis (37%), rash (36%), hypertension (36%), hypothyroidism (34%), musculoskeletal pain (33%), decreased appetite (28%), nausea (27%), dysgeusia (24%), abdominal pain (22%), cough (20%) and upper respiratory tract infection (20%). In Checkmate 025, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=406) vs everolimus (n=397) were fatigue (56% vs 57%), cough (34% vs 38%), nausea (28% vs 29%), rash (28% vs 36%), dyspnea (27% vs 31%), diarrhea (25% vs 32%), constipation (23% vs 18%), decreased appetite (23% vs 30%), back pain (21% vs 16%), and arthralgia (20% vs 14%). In Checkmate 205 and 039, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=266) were upper respiratory tract infection (44%), fatigue (39%), cough (36%), diarrhea (33%), pyrexia (29%), musculoskeletal pain (26%), rash (24%), nausea (20%) and pruritus (20%). In Checkmate 141, the most common adverse reactions (≥10%) in patients receiving OPDIVO (n=236) were cough (14%) and dyspnea (14%) at a higher incidence than investigator’s choice. In Checkmate 275, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=270) were fatigue (46%), musculoskeletal pain (30%), nausea (22%), and decreased appetite (22%). In Checkmate 274, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO (n=351) were rash (36%), fatigue (36%), diarrhea (30%), pruritus (30%), musculoskeletal pain (28%), and urinary tract infection (22%).In Checkmate 901, the most common adverse reactions (≥20%) were nausea, fatigue, musculoskeletal pain, constipation, decreased appetite, rash, vomiting, and peripheral neuropathy. In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO as a single agent (n=74), the most common adverse reactions (≥20%) were fatigue (54%), diarrhea (43%), abdominal pain (34%), nausea (34%), vomiting (28%), musculoskeletal pain (28%), cough (26%), pyrexia (24%), rash (23%), constipation (20%), and upper respiratory tract infection (20%). In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY (n=119), the most common adverse reactions (≥20%) were fatigue (49%), diarrhea (45%), pyrexia (36%), musculoskeletal pain (36%), abdominal pain (30%), pruritus (28%), nausea (26%), rash (25%), decreased appetite (20%), and vomiting (20%). In Checkmate 040, the most common adverse reactions (≥20%) in patients receiving OPDIVO with YERVOY (n=49), were rash (53%), pruritus (53%), musculoskeletal pain (41%), diarrhea (39%), cough (37%), decreased appetite (35%), fatigue (27%), pyrexia (27%), abdominal pain (22%), headache (22%), nausea (20%), dizziness (20%), hypothyroidism (20%), and weight decreased (20%). In Attraction-3, the most common adverse reactions (≥20%) in OPDIVO-treated patients (n=209) were rash (22%) and decreased appetite (21%). In Checkmate 577, the most common adverse reactions (≥20%) in patients receiving OPDIVO (n=532) were fatigue (34%), diarrhea (29%), nausea (23%), rash (21%), musculoskeletal pain (21%), and cough (20%). In Checkmate 648, the most common adverse reactions (≥20%) in patients treated with OPDIVO in combination with chemotherapy (n=310) were nausea (65%), decreased appetite (51%), fatigue (47%), constipation (44%), stomatitis (44%), diarrhea (29%), and vomiting (23%). In Checkmate 648, the most common adverse reactions reported in ≥20% of patients treated with OPDIVO in combination with YERVOY were rash (31%), fatigue (28%), pyrexia (23%), nausea (22%), diarrhea (22%), and constipation (20%). In Checkmate 649, the most common adverse reactions (≥20%) in patients treated with OPDIVO in combination with chemotherapy (n=782) were peripheral neuropathy (53%), nausea (48%), fatigue (44%), diarrhea (39%), vomiting (31%), decreased appetite (29%), abdominal pain (27%), constipation (25%), and musculoskeletal pain (20%). In Checkmate 76K, the most common adverse reactions (≥20%) reported with OPDIVO (n=524) were fatigue (36%), musculoskeletal pain (30%), rash (28%), diarrhea (23%) and pruritis (20%).
Please see U.S. Full Prescribing Information for OPDIVO and YERVOY .
Clinical Trials and Patient Populations
Checkmate 227—previously untreated metastatic non-small cell lung cancer, in combination with YERVOY; Checkmate 9LA–previously untreated recurrent or metastatic non-small cell lung cancer in combination with YERVOY and 2 cycles of platinum-doublet chemotherapy by histology; Checkmate 649–previously untreated advanced or metastatic gastric cancer, gastroesophageal junction and esophageal adenocarcinoma; Checkmate 577–adjuvant treatment of esophageal or gastroesophageal junction cancer; Checkmate 238– adjuvant treatment of patients with completely resected Stage III or Stage IV melanoma; Checkmate 76K– adjuvant treatment of patients 12 years of age and older with completely resected Stage IIB or Stage IIC melanoma; Checkmate 274–adjuvant treatment of urothelial carcinoma; Checkmate 275–previously treated advanced or metastatic urothelial carcinoma; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Checkmate 142–MSI-H or dMMR metastatic colorectal cancer, as a single agent or in combination with YERVOY; Attraction-3–esophageal squamous cell carcinoma; Checkmate 648—previously untreated, unresectable advanced recurrent or metastatic esophageal squamous cell carcinoma; Checkmate 648—previously untreated, unresectable advanced recurrent or metastatic esophageal squamous cell carcinoma; Checkmate 040–hepatocellular carcinoma, in combination with YERVOY; Checkmate 743–previously untreated unresectable malignant pleural mesothelioma, in combination with YERVOY; Checkmate 037–previously treated metastatic melanoma; Checkmate 066—previously untreated metastatic melanoma; Checkmate 067–previously untreated metastatic melanoma, as a single agent or in combination with YERVOY; Checkmate 017–second-line treatment of metastatic squamous non-small cell lung cancer; Checkmate 057–second-line treatment of metastatic non-squamous non-small cell lung cancer; Checkmate 816–neoadjuvant non-small cell lung cancer, in combination with platinum-doublet chemotherapy; Checkmate 901–Adult patients with unresectable or metastatic urothelial carcinoma; Checkmate 141–recurrent or metastatic squamous cell carcinoma of the head and neck; Checkmate 025–previously treated renal cell carcinoma; Checkmate 214–previously untreated renal cell carcinoma, in combination with YERVOY; Checkmate 9ER–previously untreated renal cell carcinoma, in combination with cabozantinib; Checkmate 205/039–classical Hodgkin lymphoma
OPDUALAG INDICATION
Opdualag™ (nivolumab and relatlimab-rmbw) is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
Immune-mediated adverse reactions (IMARs) listed herein may not include all possible severe and fatal immune-mediated adverse reactions.
IMARs which may be severe or fatal, can occur in any organ system or tissue. IMARs can occur at any time after starting treatment with a LAG-3 and PD-1/PD-L1 blocking antibodies. While IMARs usually manifest during treatment, they can also occur after discontinuation of Opdualag. Early identification and management of IMARs are essential to ensure safe use. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying IMARs. Evaluate clinical chemistries including liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected IMARs, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.
Withhold or permanently discontinue Opdualag depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if Opdualag requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose IMARs are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.
Opdualag can cause immune-mediated pneumonitis, which may be fatal. In patients treated with other PD- 1/PD-L1 blocking antibodies, the incidence of pneumonitis is higher in patients who have received prior thoracic radiation. Immune-mediated pneumonitis occurred in 3.7% (13/355) of patients receiving Opdualag, including Grade 3 (0.6%), and Grade 2 (2.3%) adverse reactions. Pneumonitis led to permanent discontinuation of Opdualag in 0.8% and withholding of Opdualag in 1.4% of patients.
Opdualag can cause immune-mediated colitis, defined as requiring use of corticosteroids and no clear alternate etiology. A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies.
Immune-mediated diarrhea or colitis occurred in 7% (24/355) of patients receiving Opdualag, including Grade 3 (1.1%) and Grade 2 (4.5%) adverse reactions. Colitis led to permanent discontinuation of Opdualag in 2% and withholding of Opdualag in 2.8% of patients.
Immune-Mediated Hepatitis
Opdualag can cause immune-mediated hepatitis, defined as requiring the use of corticosteroids and no clear alternate etiology.
Immune-mediated hepatitis occurred in 6% (20/355) of patients receiving Opdualag, including Grade 4 (0.6%), Grade 3 (3.4%), and Grade 2 (1.4%) adverse reactions. Hepatitis led to permanent discontinuation of Opdualag in 1.7% and withholding of Opdualag in 2.3% of patients.
Opdualag can cause primary or secondary adrenal insufficiency, hypophysitis, thyroid disorders, and Type 1 diabetes mellitus, which can be present with diabetic ketoacidosis. Withhold or permanently discontinue Opdualag depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).
For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. In patients receiving Opdualag, adrenal insufficiency occurred in 4.2% (15/355) of patients receiving Opdualag, including Grade 3 (1.4%) and Grade 2 (2.5%) adverse reactions. Adrenal insufficiency led to permanent discontinuation of Opdualag in 1.1% and withholding of Opdualag in 0.8% of patients.
Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Hypophysitis occurred in 2.5% (9/355) of patients receiving Opdualag, including Grade 3 (0.3%) and Grade 2 (1.4%) adverse reactions. Hypophysitis led to permanent discontinuation of Opdualag in 0.3% and withholding of Opdualag in 0.6% of patients.
Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Thyroiditis occurred in 2.8% (10/355) of patients receiving Opdualag, including Grade 2 (1.1%) adverse reactions. Thyroiditis did not lead to permanent discontinuation of Opdualag. Thyroiditis led to withholding of Opdualag in 0.3% of patients. Hyperthyroidism occurred in 6% (22/355) of patients receiving Opdualag, including Grade 2 (1.4%) adverse reactions. Hyperthyroidism did not lead to permanent discontinuation of Opdualag. Hyperthyroidism led to withholding of Opdualag in 0.3% of patients. Hypothyroidism occurred in 17% (59/355) of patients receiving Opdualag, including Grade 2 (11%) adverse reactions. Hypothyroidism led to the permanent discontinuation of Opdualag in 0.3% and withholding of Opdualag in 2.5% of patients.
Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated. Diabetes occurred in 0.3% (1/355) of patients receiving Opdualag, a Grade 3 (0.3%) adverse reaction, and no cases of diabetic ketoacidosis. Diabetes did not lead to the permanent discontinuation or withholding of Opdualag in any patient.
Opdualag can cause immune-mediated nephritis, which is defined as requiring use of steroids and no clear etiology. In patients receiving Opdualag, immune-mediated nephritis and renal dysfunction occurred in 2% (7/355) of patients, including Grade 3 (1.1%) and Grade 2 (0.8%) adverse reactions. Immune-mediated nephritis and renal dysfunction led to permanent discontinuation of Opdualag in 0.8% and withholding of Opdualag in 0.6% of patients.
Withhold or permanently discontinue Opdualag depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information).
Opdualag can cause immune-mediated rash or dermatitis, defined as requiring use of steroids and no clear alternate etiology. Exfoliative dermatitis, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and Drug Rash with eosinophilia and systemic symptoms has occurred with PD-1/L-1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes.
Immune-mediated rash occurred in 9% (33/355) of patients, including Grade 3 (0.6%) and Grade 2 (3.4%) adverse reactions. Immune-mediated rash did not lead to permanent discontinuation of Opdualag. Immune- mediated rash led to withholding of Opdualag in 1.4% of patients.
Immune-Mediated Myocarditis
Opdualag can cause immune-mediated myocarditis, which is defined as requiring use of steroids and no clear alternate etiology. The diagnosis of immune-mediated myocarditis requires a high index of suspicion. Patients with cardiac or cardio-pulmonary symptoms should be assessed for potential myocarditis. If myocarditis is suspected, withhold dose, promptly initiate high dose steroids (prednisone or methylprednisolone 1 to 2 mg/kg/day) and promptly arrange cardiology consultation with diagnostic workup. If clinically confirmed, permanently discontinue Opdualag for Grade 2-4 myocarditis.
Myocarditis occurred in 1.7% (6/355) of patients receiving Opdualag, including Grade 3 (0.6%), and Grade 2 (1.1%) adverse reactions. Myocarditis led to permanent discontinuation of Opdualag in 1.7% of patients.
The following clinically significant IMARs occurred at an incidence of <1% (unless otherwise noted) in patients who received Opdualag or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions: Cardiac/Vascular: pericarditis, vasculitis; Nervous System: meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy; Ocular: uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other IMARs, consider a Vogt-Koyanagi-Harada–like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss; Gastrointestinal: pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis; Musculoskeletal and Connective Tissue: myositis/polymyositis, rhabdomyolysis (and associated sequelae including renal failure), arthritis, polymyalgia rheumatica; Endocrine: hypoparathyroidism; Other (Hematologic/Immune): hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection, other transplant (including corneal graft) rejection.
Opdualag can cause severe infusion-related reactions. Discontinue Opdualag in patients with severe or life- threatening infusion-related reactions. Interrupt or slow the rate of infusion in patients with mild to moderate infusion-related reactions. In patients who received Opdualag as a 60-minute intravenous infusion, infusion-related reactions occurred in 7% (23/355) of patients.
Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 receptor blocking antibody. Transplant- related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/PD-L1 blockade and allogeneic HSCT.
Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/PD-L1 receptor blocking antibody prior to or after an allogeneic HSCT.
Based on its mechanism of action and data from animal studies, Opdualag can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Opdualag and for at least 5 months after the last dose of Opdualag.
There are no data on the presence of Opdualag in human milk, the effects on the breastfed child, or the effect on milk production. Because nivolumab and relatlimab may be excreted in human milk and because of the potential for serious adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with Opdualag and for at least 5 months after the last dose.
In Relativity-047, fatal adverse reactions occurred in 3 (0.8%) patients who were treated with Opdualag; these included hemophagocytic lymphohistiocytosis, acute edema of the lung, and pneumonitis. Serious adverse reactions occurred in 36% of patients treated with Opdualag. The most frequent serious adverse reactions reported in ≥1% of patients treated with Opdualag were adrenal insufficiency (1.4%), anemia (1.4%), colitis (1.4%), pneumonia (1.4%), acute myocardial infarction (1.1%), back pain (1.1%), diarrhea (1.1%), myocarditis (1.1%), and pneumonitis (1.1%).
Common Adverse Reactions and Laboratory Abnormalities
The most common adverse reactions reported in ≥20% of the patients treated with Opdualag were musculoskeletal pain (45%), fatigue (39%), rash (28%), pruritus (25%), and diarrhea (24%).
The most common laboratory abnormalities that occurred in ≥20% of patients treated with Opdualag were decreased hemoglobin (37%), decreased lymphocytes (32%), increased AST (30%), increased ALT (26%), and decreased sodium (24%).
Please see U.S. Full Prescribing Information for Opdualag .
KRAZATI INDICATIONS
KRAZATI in combination with cetuximab is indicated for the treatment of adult patients with KRAS G12C -mutated locally advanced or metastatic colorectal cancer (CRC), as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.
KRAZATI , as a single agent, is indicated for the treatment of adult patients with KRAS G12C -mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.
These indications are approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for these indications may be contingent upon verification and description of a clinical benefit in confirmatory trials.
WARNINGS AND PRECAUTIONS
Gastrointestinal Adverse Reactions
- KRAZATI can cause severe gastrointestinal adverse reactions.
- Monitor and manage patients using supportive care, including antidiarrheals, antiemetics, or fluid replacement, as indicated. Withhold, reduce the dose, or permanently discontinue KRAZATI based on severity.
QTc Interval Prolongation
- KRAZATI can cause QTc interval prolongation, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death.
- Avoid concomitant use of KRAZATI with other products with a known potential to prolong the QTc interval. Avoid use of KRAZATI in patients with congenital long QT syndrome and in patients with concurrent QTc prolongation.
- Monitor ECGs and electrolytes, particularly potassium and magnesium, prior to starting KRAZATI, during concomitant use, and as clinically indicated in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, and in patients who are unable to avoid concomitant medications that are known to prolong the QT interval. Correct electrolyte abnormalities. Withhold, reduce the dose, or permanently discontinue KRAZATI, depending on severity.
Hepatotoxicity
- KRAZATI can cause hepatotoxicity, which may lead to drug-induced liver injury and hepatitis.
- Monitor liver laboratory tests (AST, ALT, alkaline phosphatase, and total bilirubin) prior to the start of KRAZATI, and monthly for 3 months or as clinically indicated, with more frequent testing in patients who develop transaminase elevations. Reduce the dose, withhold, or permanently discontinue KRAZATI based on severity.
Interstitial Lung Disease/Pneumonitis
- KRAZATI can cause interstitial lung disease (ILD)/pneumonitis, which can be fatal.
- Monitor patients for new or worsening respiratory symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever) during treatment with KRAZATI. Withhold KRAZATI in patients with suspected ILD/pneumonitis and permanently discontinue KRAZATI if no other potential causes of ILD/pneumonitis are identified.
ADVERSE REACTIONS
- Serious adverse reactions occurred in 57% of 116 patients who received adagrasib in NSCLC patients. The most common adverse reactions in NSCLC patients (≥20%) were diarrhea, nausea, fatigue, vomiting, musculoskeletal pain, hepatotoxicity, renal impairment, dyspnea, edema, decreased appetite, cough, pneumonia, dizziness, constipation, abdominal pain, and QTc interval prolongation.
- Serious adverse reactions occurred in 30% of 94 patients who received adagrasib in combination with cetuximab. The most common adverse reactions in CRC patients (≥20%) were rash, nausea, diarrhea, vomiting, fatigue, musculoskeletal pain, hepatotoxicity, headache, dry skin, abdominal pain, decreased appetite, edema, anemia, dizziness, cough, constipation, and peripheral neuropathy.
DRUG INTERACTIONS
- Strong CYP3A4 Inducers: Avoid concomitant use.
- Strong CYP3A4 Inhibitors: Avoid concomitant use until adagrasib concentrations have reached steady state (after ~8 days).
- Sensitive CYP3A4 Substrates: Avoid concomitant use with sensitive CYP3A4 substrates.
- Sensitive CYP2C9 or CYP2D6 Substrates or P-gp Substrates: Avoid concomitant use with sensitive CYP2C9 or CYP2D6 substrates or P-gp substrates where minimal concentration changes may lead to serious adverse reactions.
- Drugs That Prolong QT Interval: Avoid concomitant use with KRAZATI.
Please see Drug Interactions Section of the Full Prescribing Information for additional information.
USE IN SPECIFIC POPULATIONS
Females and Males of Reproductive Potential
- Infertility: Based on findings from animal studies, KRAZATI may impair fertility in females and males of reproductive potential.
- Advise not to breastfeed.
Please see U.S. Full Prescribing Information for KRAZATI .
About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn , Twitter , YouTube , Facebook and Instagram .
Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to date, that the treatments and combination treatments described in this release may not receive regulatory approval for the indications described in this release, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such treatments and combination treatments for such indications will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2023, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
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Jazz Pharmaceuticals to Present Advancements in Solid Tumor Oncology Research at ESMO 2024
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Sep 09, 2024, 07:58 ET
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New and updated data from an ongoing Phase 2 trial of zanidatamab, an investigational dual HER2-targeted bispecific antibody, in combination with chemotherapy for first-line treatment of HER2-positive metastatic gastroesophageal adenocarcinoma (mGEA)
DUBLIN , Sept. 9, 2024 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) today announced that the Company, along with its partners, will present five abstracts at the European Society for Medical Oncology (ESMO) Congress 2024 from September 13-17, 2024 , in Barcelona, Spain . Presentations include data from trials of zanidatamab and Zepzelca ® (lurbinectedin).
New and updated data with longer follow-up, including overall survival findings, will be presented from an ongoing Phase 2 trial of zanidatamab, an investigational dual HER2-targeted bispecific antibody, in combination with chemotherapy for the first-line treatment of HER2-positive metastatic gastroesophageal adenocarcinoma (mGEA). Additional data from a Phase 2 study evaluating zanidatamab in combination with chemotherapy and bevacizumab as first-line treatment in HER2-positive metastatic colorectal cancer demonstrating encouraging antitumor activity will be presented as a mini-oral presentation at the congress.
"We look forward to presenting new and more mature data from our oncology solid tumor clinical development program at this year's ESMO congress, in particular for zanidatamab in HER2-positive metastatic gastroesophageal adenocarcinoma," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. "We look forward to continuing to advance our clinical development program for zanidatamab in GEA, including the Phase 3 clinical trial expected to read out in the second quarter of 2025 that could support global regulatory submissions."
Data on Zepzelca will also be presented at the congress, including findings from a Phase 2 trial evaluating the safety and efficacy of lurbinectedin and irinotecan in relapsed small cell lung cancer (SCLC) patients, including those with CTFI (Chemotherapy-Free Interval) 30-90 days, who typically have a poor prognosis. These findings support the rationale for this combination in the ongoing LAGOON confirmatory trial.
The full ESMO abstracts for posters are available at: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal_2/presentation
The full ESMO abstracts for presentations are available at: ESMO Congress 2024 - Conference Calendar - ESMO Congress 2024 (ctimeetingtech.com)
The full list of Jazz or partner-supported presentations at the 2024 ESMO Congress includes:
Zanidatamab Presentations
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Zanidatamab + Chemotherapy for First- | Elena Elimova, | Poster Monday, September 16 1432P |
Zanidatamab (Zani) + Chemotherapy | Sun Young Rha, | Mini Oral session Saturday, September 14, #516MO |
HERIZON-BTC-02: A Phase 3 Study of | Tesca | Poster Monday, September 16 62TiP |
Zepzelca Presentations
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Phase 2 data of lurbinectedin and | Jon | Poster Saturday, September 14 1790P |
LINNOVATE: A phase 1/2 study of | Erlinda Gordon | Poster Saturday, September 14 1739P |
About Zanidatamab Zanidatamab is an investigational dual HER2-targeted bispecific antibody that simultaneously binds to two distinct sites on HER2, known as biparatopic binding. This unique design and enhanced binding results in multiple mechanisms of action, including HER2 and HER3 signal inhibition, removal of HER2 protein from the cell surface and enhanced immune effector functions, such as complement-dependent cytotoxicity (CDC), which leads to encouraging antitumor activity. Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by Jazz and BeiGene, Ltd. (BeiGene) under license agreements from Zymeworks, which first developed the molecule.
The U.S. Food and Drug Administration (FDA) has granted priority review for the Biologics License Application (BLA) for zanidatamab for the treatment of previously treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC) with a Prescription Drug User Fee Act (PDUFA) target action date of November 29, 2024 . The FDA granted Breakthrough Therapy designation for zanidatamab development in patients with previously treated HER2 gene-amplified BTC, and two Fast Track designations for zanidatamab: one as a single agent for refractory BTC and one in combination with standard of care chemotherapy for 1L gastroesophageal adenocarcinoma (GEA). Additionally, zanidatamab has received Orphan Drug designations from FDA for the treatment of BTC and GEA, as well as Orphan Drug designation from the European Medicines Agency for the treatment of BTC and gastric cancer. Zanidatamab was also granted Breakthrough Therapy designation from the Center for Drug Evaluation (CDE) in China .
About Zepzelca ® (lurbinectedin) Zepzelca is an alkylating drug that binds guanine residues within DNA. This triggers a cascade of events that can affect the activity of DNA binding proteins, including transcription factors, and DNA repair pathways, resulting in disruption of the cell cycle and eventual cell death. 1
The FDA approved Zepzelca under accelerated approval in June 2020 for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. The approval is based on overall response rate (ORR) and duration of response demonstrated in an open-label, monotherapy clinical study. In December 2021 , Jazz and PharmaMar announced the initiation of LAGOON, a confirmatory Phase 3 clinical trial of Zepzelca for the treatment of patients with relapsed small cell lung cancer. If positive, LAGOON could confirm the benefit of Zepzelca in the treatment of small cell lung cancer (SCLC) when patients progress following 1L treatment with a platinum-based regimen and support full approval in the U.S.
Zepzelca is a prescription medicine used to treat adults with SCLC that has spread to other parts of the body (metastatic) and who have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working. Zepzelca is approved based on response rate and how long the response lasted. Additional studies will further evaluate the benefit of Zepzelca for this use.
Important Safety Information for ZEPZELCA
Before receiving ZEPZELCA, tell your healthcare provider about all of your medical conditions, including if you:
- have liver or kidney problems.
- are pregnant or plan to become pregnant. ZEPZELCA can harm your unborn baby.
Females who are able to become pregnant:
- Your healthcare provider should do a pregnancy test before you start treatment with ZEPZELCA.
- You should use effective birth control (contraception) during treatment with and for 6 months after your last dose of ZEPZELCA.
- Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with ZEPZELCA.
Males with female partners who are able to become pregnant should use effective birth control during treatment with and for 4 months after their last dose of ZEPZELCA.
- are breastfeeding or plan to breastfeed. It is not known if ZEPZELCA passes into your breastmilk. Do not breastfeed during treatment with ZEPZELCA and for 2 weeks after your last dose of ZEPZELCA. Talk to your healthcare provider about the best way to feed your baby during treatment with ZEPZELCA.
Tell your healthcare provider about all the medicines you take, i ncluding prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how ZEPZELCA works.
What should I avoid while using ZEPZELCA? Avoid eating or drinking grapefruit, Seville oranges, or products that contain grapefruit juice and Seville oranges during treatment with ZEPZELCA. ZEPZELCA can cause serious side effects, including:
- Low blood cell counts. Low blood counts including low neutrophil counts (neutropenia) and low platelet counts (thrombocytopenia) are common with ZEPZELCA, and can also be severe. Some people with low white blood cell counts may get fever, or an infection throughout the body (sepsis), that can cause death. Your healthcare provider should do blood tests before you receive each treatment with ZEPZELCA to check your blood cell counts.
Tell your healthcare provider right away if you develop:
- fever or any other signs of infection
- unusual bruising or bleeding
- pale colored skin
- Liver problems. Increased liver function tests are common with ZEPZELCA and can also be severe. Your healthcare provider should do blood tests to check your liver function before you start and during treatment with ZEPZELCA.
Tell your healthcare provider right away if you develop symptoms of liver problems including:
- loss of appetite
- nausea or vomiting
- pain on the right side of your stomach area (abdomen)
- Leakage of ZEPZELCA out of your vein during the infusion. If ZEPZELCA leaks into the tissues around your infusion site, it can cause damage and death of tissue cells around the infusion site. You may need to have surgery to remove any dead tissue. Tell your healthcare provider right away if you see any ZEPZELCA leaking out of your vein or around the catheter during your infusion, or if you notice any redness, swelling, itching or discomfort at the infusion site at any time.
- Severe muscle problems (rhabdomyolysis). Tell your healthcare provider if you have severe muscle pain or weakness.
Your healthcare provider may temporarily stop treatment, lower your dose, or permanently stop ZEPZELCA if you develop serious side effects during treatment with ZEPZELCA.
The most common side effects of ZEPZELCA include:
- low white and red blood cell counts
- increased kidney function blood test (creatinine)
- increased liver function blood tests
- increased blood sugar (glucose)
- decreased appetite
- muscle and joint (musculoskeletal) pain
- low level of albumin in the blood
- constipation
- trouble breathing
- low levels of sodium and magnesium in the blood
- diarrhea
These are not all of the possible side effects of ZEPZELCA.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 . You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568 .
Please see full Prescribing Information including Patient Information , and discuss with your doctor.
ZEPZELCA is a trademark of Pharma Mar, S.A. used by Jazz Pharmaceuticals under license.
About Jazz Pharmaceuticals Jazz Pharmaceuticals plc (Nasdaq: JAZZ ) is a global biopharma company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life-changing medicines for people with serious diseases—often with limited or no therapeutic options. We have a diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments. Our patient-focused and science-driven approach powers pioneering research and development advancements across our robust pipeline of innovative therapeutics in oncology and neuroscience. Jazz is headquartered in Dublin, Ireland with research and development laboratories, manufacturing facilities and employees in multiple countries committed to serving patients worldwide. Please visit www.jazzpharmaceuticals.com for more information.
Jazz Media Contact: Kristin Bhavnani Head of Global Corporate Communications Jazz Pharmaceuticals plc [email protected] Ireland +353 1 637 2141 U.S. +1 215 867 4948
Jazz Investor Contact: Andrea N. Flynn , Ph.D. Vice President, Head, Investor Relations Jazz Pharmaceuticals plc [email protected] Ireland +353 1 634 3211 U.S. +1 650 496 2717
SOURCE Jazz Pharmaceuticals plc
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Buy Rating for Viridian Therapeutics Backed by Positive Clinical Results and Strong Market Prospects
Viridian Therapeutics ( VRDN – Research Report ), the Healthcare sector company, was revisited by a Wall Street analyst today. Analyst Rami Katkhuda from LifeSci Capital maintained a Buy rating on the stock and has a $46.00 price target.
Rami Katkhuda has given his Buy rating due to a combination of factors surrounding Viridian Therapeutics’ recent clinical successes and the potential market impact of their products. Viridian announced positive results from their Phase III THRIVE study for veligrotug in treating Thyroid Eye Disease (TED) which showed significant efficacy and safety, comparable to the current standard of care but with a shorter treatment regimen and faster onset of action. Additionally, the asset’s shorter infusion times are a notable improvement over existing treatments, making it a strong candidate in the market. Furthermore, the success of veligrotug also serves to derisk the development of VRDN-003, which shares similar properties and is part of the REVEAL program with expected results in the first half of 2026. This program’s potential success positions Viridian Therapeutics to capture a significant portion of the market for TED treatments, which is valued at over $3.5 billion. The superior clinical data and the strong market potential for their portfolio of IGF-1R inhibitors are key reasons for Katkhuda’s optimistic Buy rating on Viridian Therapeutics.
In another report released today, Wedbush also maintained a Buy rating on the stock with a $42.00 price target.
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Viridian Therapeutics (VRDN) Company Description:
Miragen Therapeutics, Inc. is a clinical stage biopharmaceutical company, which engages in the development of proprietary RNA-targeted therapeutics. Its product pipelines include MRG-106 that focuses on the treatment of blood cancer; and MRG-201 deals with the treatment of pathological fibrosis. The company was founded by William S. Marshall and Bruce L. Booth in February 2006 and is headquartered in Boulder, CO.
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InVitro International is a pioneer in the development and application of proprietary non-animal testing alternatives for the determination of eye irritation, skin irritation and skin toxicity. The Company develops and markets in vitro assay kits and... View full profile
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Working together, we can reimagine medicine to improve and extend people’s lives.
Principal Data Scientist Imaging and Vision AI Researcher
About the role.
Key responsibilities
- Lead AI research projects independently, focusing on imaging and vision applications within pharmaceutical research and development using scientific, rigorous, and reproducible methodology
- Develop and implement state-of-the-art AI algorithms for image processing, analysis, segmentation, and interpretation, focusing on data modalities such as MRI, histopathology, echocardiograms, lab animal video data or other image modalities used in biological research.
- Collaborate with other AI specialists, data architects, software engineers, business analysts, user interface designers within RX on products in the Image/Vision domain
- Act as an Imaging and data science subject matter expert, to help commodify AI and data analytics expertise and assets into impactful analysis workflows and software products, and to help make our research data FAIR
- Engage with diverse stakeholders in clinical as well as non-clinical settings
- Serve as an ambassador for AI/Data Science by presenting and publishing articles.
- Build a bridge between academia, technology, and industry partners.
- Keep ahead of latest developments in the field and mentor associates .
- Be a part of a truly unique organization, work with an inter-disciplinary team of highly accomplished scientists and push the AI frontiers for disease understanding and drug discovery.
This opportunity is located at the Novartis Cambridge (MA) site and will not have the ability to be located remotely. Relocation assistance may be available.
The pay range for this position at commencement of employment is expected to be between $144,000 and $216,000 per year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Role Requirements
- Ph.D. in Computer Science, AI, Machine Learning, or a related field with a focus on imaging and vision applications.
- Minimum of 5 y ears of experience in AI research, specifically in imaging and vision applications.
- Applied knowledge of image/vision data modalities used in biological research or clinical settings
- Minimum of 4 y ears of relevant publication track record in machine learning applications and AI/ML methods
- Proven experience in leading AI research projects independently.
- Strong understanding of advanced machine learning algorithms and AI systems.
- Extensive experience in using AI for image analysis, particularly in a pharmaceutical setting.
- Proficient in programming in AI platforms such as TensorFlow, PyTorch, or Keras.
- Strong ability to communicate technical concepts to a variety of audiences, including scientists, engineers, and non-technical stakeholders.
- Familiarity with pharmaceutical research processes and requirements.
- Strong problem-solving skills and the ability to think creatively and innovatively.
Why Novartis? 766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com or call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message. Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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Genprex collaborators to present positive preclinical data on the use of reqorsa® gene therapy at the 2024 eortc-nci-aacr symposium on molecular targets and cancer therapeutics.
Poster Presentations to Focus on Reqorsa as a Potential Treatment for Ras Inhibitor Resistant Lung Cancer, Mesothelioma and Glioblastoma
AUSTIN, Texas , Sept. 9, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX ), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its research collaborators were selected to present at the upcoming 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics being held October 23-25, 2024 in Barcelona, Spain . The collaborators will present posters on positive preclinical data from studies of its lead drug candidate, Reqorsa ® Gene Therapy (quaratusugene ozeplasmid), for the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma.
"We are very pleased that these studies with our academic partners have been selected for presentation, which expands the growing body of preclinical evidence supporting REQORSA's potential to treat a variety of cancers," said Ryan Confer , President and Chief Executive Officer at Genprex. "We look forward to these presentations next month which will share the compelling data that support the potential for new clinical studies evaluating Reqorsa as a potential treatment for additional types of lung cancer, mesothelioma and glioblastoma."
Featured Genprex-supported posters to be presented at the 2024 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics include:
Title: "TUSC2 gene therapy in KRASG12C mutant NSCLC overcomes acquired resistance to sotorasib" Collaborator: The University of Texas MD Anderson Cancer Center Catalog Number: 384 Presentation Number: PB372
Title: "TUSC2 Suppresses Tumorigenic Properties in Malignant Pleural Mesothelioma Cells" Collaborator: New York University Langone Health Catalog Number: 364 Presentation Number: PB352
Title: "Efficacy of Quaratusugene Ozeplasmid TUSC2 Gene Therapy in Glioblastoma" Collaborator: The University of Texas Health Science Center at Houston Catalog Number: 130 Presentation Number: PB118
Genprex has filed two provisional patent applications based on data from two of the presentations. One application involves using REQORSA to treat mesothelioma and the other to treating glioblastoma. Genprex is a co-owner of the applications along with the respective institutions. TUSC2 is the tumor suppressor gene used in REQORSA. REQORSA consists of a TUSC2 gene expressing plasmid encapsulated in non-viral lipid-based nanoparticles in a lipoplex form (the Company's Oncoprex ® Delivery System), which has a positive charge. REQORSA is injected intravenously and specifically targets cancer cells. REQORSA is designed to deliver the functioning TUSC2 gene to negatively charged cancer cells while minimizing uptake by normal tissue. Laboratory studies conducted at MD Anderson show that the uptake of TUSC2 in tumor cells in vitro after REQORSA treatment was 10 to 33 times the uptake in normal cells.
About Genprex, Inc.
Genprex, Inc. is a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes. Genprex's technologies are designed to administer disease-fighting genes to provide new therapies for large patient populations with cancer and diabetes who currently have limited treatment options. Genprex works with world-class institutions and collaborators to develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches. Genprex's oncology program utilizes its systemic, non-viral Oncoprex ® Delivery System which encapsulates the gene-expressing plasmids using lipid-based nanoparticles in a lipoplex form. The resultant product is administered intravenously, where it is taken up by tumor cells that then express tumor suppressor proteins that were deficient in the tumor. The Company's lead product candidate, Reqorsa ® Gene Therapy (quaratusugene ozeplasmid), is being evaluated in two clinical trials as a treatment for NSCLC and SCLC. Each of Genprex's lung cancer clinical programs has received a Fast Track Designation from the FDA for the treatment of that patient population, and Genprex's SCLC program has received an FDA Orphan Drug Designation. Genprex's diabetes gene therapy approach is comprised of a novel infusion process that uses an AAV vector to deliver Pdx1 and MafA genes directly to the pancreas. In models of Type 1 diabetes, GPX-002 transforms alpha cells in the pancreas into functional beta-like cells, which can produce insulin but may be distinct enough from beta cells to evade the body's immune system. In a similar approach, GPX-002 for Type 2 diabetes, where autoimmunity is not at play, is believed to rejuvenate and replenish exhausted beta cells.
Interested investors and shareholders are encouraged to sign up for press releases and industry updates by visiting the Company Website , registering for Email Alerts and by following Genprex on Twitter , Facebook and LinkedIn .
Cautionary Language Concerning Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of management, are not guarantees of performance and are subject to significant risks and uncertainty. These forward-looking statements should, therefore, be considered in light of various important factors, including those set forth in Genprex's reports that it files from time to time with the Securities and Exchange Commission and which you should review, including those statements under "Item 1A – Risk Factors" in Genprex's Annual Report on Form 10-K for the year ended December 31, 2023 .
Because forward-looking statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding: Genprex's ability to advance the clinical development, manufacturing and commercialization of its product candidates in accordance with projected timelines and specifications; the timing and success of Genprex's clinical trials and regulatory approvals; the effect of Genprex's product candidates, alone and in combination with other therapies, on cancer and diabetes; the effects of any strategic research and development prioritization initiatives, and any other strategic alternatives or other efforts that Genprex takes or may take in the future that are aimed at optimizing and re-focusing Genprex's diabetes, oncology and/or other clinical development programs including prioritization of resources, and the extent to which Genprex is able to implement such efforts and initiatives successfully to achieve the desired and intended results thereof; Genprex's future growth and financial status, including Genprex's ability to maintain compliance with the continued listing requirements of The Nasdaq Capital Market and to continue as a going concern and to obtain capital to meet its long-term liquidity needs on acceptable terms, or at all; Genprex's commercial and strategic partnerships, including those with its third party vendors, suppliers and manufacturers and their ability to successfully perform and scale up the manufacture of its product candidates; and Genprex's intellectual property and licenses.
These forward-looking statements should not be relied upon as predictions of future events and Genprex cannot assure you that the events or circumstances discussed or reflected in these statements will be achieved or will occur. If such forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should not regard these statements as a representation or warranty by Genprex or any other person that Genprex will achieve its objectives and plans in any specified timeframe, or at all. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Genprex disclaims any obligation to publicly update or release any revisions to these forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release or to reflect the occurrence of unanticipated events, except as required by law.
Genprex, Inc. (877) 774-GNPX (4679)
GNPX Investor Relations [email protected]
GNPX Media Contact Kalyn Dabbs [email protected]
View original content to download multimedia: https://www.prnewswire.com/news-releases/genprex-collaborators-to-present-positive-preclinical-data-on-the-use-of-reqorsa-gene-therapy-at-the-2024-eortc-nci-aacr-symposium-on-molecular-targets-and-cancer-therapeutics-302241636.html
SOURCE Genprex, Inc.
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Global Contract Research Organizations in Spain. Axonal-Biostatem. Axonal-Biostatem has been delivering top-notch management of clinical and epidemiological research projects in France and Europe for more than 30 years. Axonal-Biostatem is a full service CRO providing all services internally and able to integrally p... View full profile
Phone Barcelona: +34 93 351 16 15. Phone Madrid: +34 91 456 11 05. Location of the CRO in Spain: Av. de Josep Tarradellas, 8-10 Planta 5ª, Puerta 4 08029 - Barcelona (Spain) Calle Caléndula, 93 Complejo Miniparc III, Edificio K El Soto de la Moraleja 28109 - Alcobendas, Madrid (Spain) Company size: 200-500 employees.
List of Clinical Research Service Companies in Spain Clinical Research Service Companies in Spain in alphabetical order. Alira Health. A full spectrum of patient-centric data and tech-enabled services to accelerate innovation and deliver tomorrow's standard of care. Our team of scientists, strategists, economists, clinicians, and ...
The rise of Spain: A key player in global clinical trials
Having forged a solid position in clinical research in 2020 and 2021 when it became the fourth nation in the world and the first in Europe for studies conducted around COVID-19, Spain has continued consolidating its status as a leading clinical trials hub and registered over 900 trials in 2022, more than 86 percent of which were initiated by pharma companies, representing an investment of EUR ...
Aelix Therapeutics . Aelix Therapeutics is a clinical-stage biotech company based in Barcelona, in the northeast of Spain. It is a spin-off of HIVACAT - a Catalan program for the development of therapeutic vaccines and prevention against human immunodeficiency virus (HIV) - and is focused on developing a new therapeutic vaccine for HIV that can be included in cure and eradication strategies.
PPD: Global Pharmaceutical Contract Research Organization ...
This clinical trial is designed to evaluate the safety and effectiveness of a new drug combination for treating glioblastoma, a type of brain cancer. The study involves the drug Debio 0123 taken in combination with temozolomide (TMZ), and in some cases, with radiotherapy (RT). The trial is divided into two main phases: Phase 1 and Phase 2.
MFAR is a services company focused on Academic Clinical Research. A multidisciplinary team formed by people with highly qualifier profiles and with an extensive experience on clinical research, technology applied to investigation, so as in communication and event management. At MFAR we are conscious of the social and integrative role of several ...
Moreover, in 2020 Spain showed remarkable results in the number of authorized Clinical Trials by the Spanish Agency of Medicine and Medical Devices - 1 019 Trials approved, 34% of which were related to Research on different types of cancer. For sure, Spain has much more to contribute to the global knowledge in the Therapeutic Area of Oncology.
Spain today holds the position of the world's tenth-largest pharmaceutical market, valued in 2017 at EUR 26.15 billion (USD 29.55 billion). This is a result of Spain's economy maintaining a solid pace of expansion, significantly improved market access, high quality and affordable manufacturing capabilities, and a mature clinical research base.
ICON plc | Clinical Research Organisation (CRO ...
The pharmaceutical industry based in Spain, which promotes eight out of ten clinical trials, dedicates 60% of all investment destined to R&D of new drugs to this activity. Of the 1,211 million that were invested in 2019 -the historical maximum-, more than 713 were dedicated to clinical studies, according to the latest Survey on R&D Activities ...
Roche. We have been committed to improving lives since the company was founded in 1896 in Basel, Switzerland. Today, Roche creates innovative medicines and diagnostic tests that help millions of patients globally. Roche was one of the first companies to... 💻 Website ↗ 📞 +34913248100 View all details.
Madrid. ICON Full Service & Corporate Support. Clinical Monitoring. We are currently seeking a Clinical Research Associate II Specialist to join our diverse and dynamic team. As a Clinical Research Associate II Specialist at ICON, you will play a pivotal role in desig. Read more. IHCRA. Barcelona. Madrid.
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Good insurance options for those with different family circumstances. Sep 4, 2024. Current Director in Wilmington, DE, Delaware. Expensive and the drug benefit plan is below industry average. High copays and formulary exclusions. Search Clinical research jobs in Spain with company ratings & salaries. 338 open jobs for Clinical research in Spain.
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Bioinformatics (13) Biotechnology and Genetics (22) Clinical Data Management (1) Clinical Research (71) Data, ... Madrid, Spain. Posted 24 days ago Save this Job . Senior Clinical Monitoring Lead. Ipsen Pharma. Cambridge, United Kingdom. Posted 25 days ago ...
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced the presentation of nearly 60 abstracts of company-sponsored studies, investigator-sponsored studies, and collaborations from across its oncology portfolio and pipeline at the European Society for Medical Oncology (ESMO) Congress 2024 to be held from September 13-17 in Barcelona, Spain.
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InVitro International. InVitro International is a pioneer in the development and application of proprietary non-animal testing alternatives for the determination of eye irritation, skin irritation and skin toxicity. The Company develops and markets in vitro assay kits and... View full profile.
Key responsibilities Lead AI research projects independently, focusing on imaging and vision applications within pharmaceutical research and development using scientific, rigorous, and reproducible methodologyDevelop and implement state-of-the-art AI algorithms for image processing, analysis, segmentation, and interpretation, focusing on data modalities such as MRI, histopathology ...
Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today ...