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2 - 4 November 2021
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Isaac Rodriguez-Chavez
Senior Vice President, Scientific & Clinical Affairs, Global Center of Excellence for Decentralized Clinical Trials at ICON


Dr Isaac R. Rodriguez-Chavez is a biomedical leader with expertise in Infectious Diseases, Viral Immunology, Viral Oncology, Microbiology, and Vaccinology.  His experience covers the entire life cycle of medical products from basic, preclinical, interventional clinical research (phase I – IV), non-interventional clinical research, and post-marketing studies. Currently, he is a Senior Vice President for Scientific & Clinical Affairs, leading the Strategy of the Decentralized Clinical Trials, ICON plc. Past positions in the last 33 years include FDA, CDER Senior Officer for Clinical Research Methodology, Regulatory Compliance and Policy Development modernizing clinical research through Decentralized Clinical Trials enabled by Digital Health Technologies; CEO/Founder, 4Biosolutions Biomedical Consulting Firm; Vice President, Research, Texas Biomedical Research Institute; Director of HIV Clinical Research Programs, NIH; Senior Clinical Scientist, Schering Plough Corp.; Scientist, Columbia University; Scientist, Polar Biotechnology Company and Venezuelan Institute for Scientific Research (IVIC). He issued the first U.S. Good Clinical Laboratory Practice (GCLP) Guidelines to improve the consistency of clinical laboratory endpoints supporting trials globally, published numerous scientific and technical articles, and has been an invited speaker in over 100 global conferences.  He has a PhD in Virology and Immunology; an MS in Microbiology; an MHS in Clinical Research; and a B.S. in Biology.  He has 5 years of post-doctoral specialty training in Infectious Diseases, Viral Immunology, Viral Oncology, and Clinical Research.  Dr. Rodriguez-Chavez is a Board Member of the Scientific Leadership of the Digital Medical Society (DiME).  He is also a co-chair of the DiME’s Research Committee, driving digital medicine globally.  He is a regulatory Advisor and Vice-Chair of the Institute of Electrical and Electronics Engineers (IEEE) fostering initiatives on DCTs and DHTs.  He is a Leadership Council Board member of the Decentralized Trials & Research Alliance (DTRA) and Co-Chair of DTRA’s Regulatory Council; a Board Member of the Hypertrophic Cardiomyopathy Association (HCMA); and a Rare Disease Health Equity Board Council member of the Global Genes.  He is a Global Content Editor for Regulatory Science at the DIA Global Forum Magazine.  He is also an active member is fourteen professional associations, including the American Association of Immunologists, American Society for Virology, American Society of Microbiology, Society of Quality Assurance, Association of Clinical Research Professionals, New York Academy of Sciences, International AIDS Society, International Association for Dental Research, American Association for Dental Research, and Regulatory Affairs Professional Society.  LinkedIn:

Agenda Sessions

  • Optimizing Efficiencies in Clinical Research and Data Management by Implementing Technology-enhanced Decentralized Clinical Trials as a Care Option for Patients

  • PANEL: Strategy for Decentralized Trials from Different Stakeholders Perspectives