Dr. Isaac Rodriguez-Chavez is a biomedical leader with expertise in Infectious Diseases (Viral Immunology, Viral Oncology, Microbiology), Immunology, and Vaccinology. His expertise spans basic, translational, pre-clinical and clinical research (phase I – IV global trials). He also has expertise in digital health technologies, modern clinical research development and operations, regulatory affairs, approval or licensure of medical products, and quality control and quality assurance.
Dr. Rodriguez-Chavez joined PRA Health Sciences as a Senior Vice President for Scientific and Clinical Affairs, leading the Strategy of PRA’s Global Center of Excellence for Decentralized Clinical Trials (DCTs) using Digital Health Technologies (DHTs). He also has other executive leadership roles across the organization that deal with scientific and medical affairs.
Overall, Dr. Rodriguez-Chavez has over 32 years of work experience in several national and international organizations, including the U.S. Food and Drug Administration (FDA), National Institute of Health (NIH), industry and non-profit research organizations. Recently, he worked at the FDA, Center for Drug Evaluation and Research (CDER) as a Senior Officer for Clinical Research Methodologies, Regulatory Compliance and Medical Policy Development. He led FDA policy development work on DCTs using DHTs, and he was directly involved in programs for the modernization of clinical research that impact multiple disease areas.
Other past positions he held included CEO and Founder of a biomedical consulting firm, 4Biosolutions Consulting; Vice President for Research, Texas Biomedical Research Institute; Director of the AIDS and Immunosuppression Program, National Institute of Dental and Craniofacial Research (NIDCR), NIH; Senior Clinical Scientist, Schering Plough Corporation; Director of Portfolio for HIV Vaccine Programs, National Institute of Allergy and Infectious Diseases (NIAID), NIH; Scientist at St. Luke’s/Roosevelt Hospital, Columbia University; Lead Scientist, Polar Biotechnology Company (Venezuela); and Scientist in Viral Immunology, 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 95 global conferences. He has a B.S. in Biology (Venezuela), M.S. in Microbiology (Venezuela), M.H.S. in Clinical Research (Duke School of Medicine), and a Ph.D. in Virology and Immunology (University of Delaware). He did two post-doctoral specialty trainings in Viral Immunology and Viral Oncology combined with Clinical Research at the National Institute on Aging (NIA) and the National Cancer Institute (NCI) at NIH.
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 member of the Decentralized Trials & Research Alliance (DTRA) and he is a board member of the Hypertrophic Cardiomyopathy Association (HCMA). 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: https://www.linkedin.com/in/isaacrc/