Isaac Rodriguez-Chavez

Dr. Isaac R. Rodriguez-Chavez is a biomedical and regulatory leader with expertise in decentralized clinical trials (DCTs) and Digital Medicine Tools applied to multiple therapeutic areas including Infectious Diseases, Viral Immunology, Viral Oncology, and Vaccinology. Currently, he is an independent consultant for Scientific-, Clinical-, Regulatory-affairs, and digital medicine for modern trials such as DCTs enabled by Digital Health Technologies (DHTs). Past positions in the last 20+ years include: Senior Vice President for Scientific, Clinical Affairs, leading the Strategy of the Global Center of Excellence for DCTs and Digital Medicine at PRA Health Sciences and ICON plc; FDA, CDER Senior Officer for Clinical Research Methodology, Regulatory Compliance and Policy Development modernizing clinical research through Real World Evidence and DCTs enabled by DHTs and electronic Clinical Outcome Assessments (eCOAs); CEO and Founder, 4Biosolutions Biomedical Consulting Firm; Vice President, Research, Texas Biomedical Research Institute; Director of HIV Clinical Research Programs at National Institute of Allergy and Infectious Diseases (NIAID) and National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH); Senior Clinical Scientist, Schering Plough Corp. – Merck & Corp.; Scientist, Columbia University; Scientist, Polar Biotechnology Company and Venezuelan Institute for Scientific Research (IVIC). He has a PhD in Virology and Immunology; a MS in Microbiology; a MHS in Clinical Research and Health Sciences; and a B.S. in Biology. He also has 5 years of postdoctoral specialty experience in Clinical Research (phases 1 & 2 trials) linked to AIDS Malignancies, Immuno-Oncology and Viral Immunology (Infectious Diseases) done at the U.S. NIA and NCI, NIH. Dr. Rodriguez-Chavez is a Founding Board Member of the Digital Medical Society (DiME). He is also a co-chair of the DiME’s Research Committee, driving digital medicine globally. He is an Advisory Board Member of BlueCloud by HealthCarePoint; a regulatory Advisor and Vice-Chair of the Institute of Electrical and Electronics Engineers (IEEE) fostering industry standards on DCTs and DHTs. He is a former Leadership Council Board Member of the Decentralized Trials & Research Alliance (DTRA). He is a Board Member of the Hypertrophic Cardiomyopathy Association (HCMA) and a Health Equity Board Council Member for equity, diversity and inclusion in rare diseases at the Global Genes. He is a global content editor for regulatory science and an Editorial Board Member of the DIA Global Forum Magazine. He is also an active member of sixteen professional associations, including the Infectious Disease Society of America, American Federation for Medical Research, 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.