About me
Dr. Isaac R Rodriguez-Chavez is a scientific and regulatory leader with expertise in Infectious Diseases, Viral Immunology, Viral Oncology, Microbiology, Vaccinology and rare diseases. 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 an independent consultant for clinical research and digital medicine. Past positions over the last 30 years include being a Senior Vice President for Scientific & Clinical Affairs, leading strategies and operations for Decentralized Clinical Trials (DCTs) and Digital Medicine at ICON plc; FDA, CDER Senior Officer for Clinical Research Methodology, Regulatory Compliance and Policy Development, modernizing clinical research through DCTs enabled by Digital Health Technologies (DHTs); 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 is a board member of BlueCloud by HealthCarePoint, Reveles Clinical Research, Digital Medical Society (DiMe), and the Hypertrophic Cardiomyopathy Association (HCMA). He is a Rare Disease Health Equity Council member for Global Genes, global content Editor for Regulatory Science at the DIA Global Forum Magazine, Co-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), and a former Co-Chair of DTRA’s Regulatory Council. He is a former Co-Chair of the DiMe’s Research Committee, driving digital medicine globally. He is also an active member of sixteen professional associations, published over 60 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 BS in Biology. He has 5 years of post-doctoral specialty training in Infectious Diseases, Viral Immunology, Viral Oncology linked to Clinical Research.