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Isaac Rodriguez-Chavez, Ph.D., M.H.Sc., M.Sc.

Isaac Rodriguez-Chavez, Ph.D., M.H.Sc., M.Sc.

U.S. Food and Drug Administration

Dr. Rodriguez-Chavez is an officer for clinical research methodology, regulatory compliance and policy development at the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration (FDA). Prior to this position he was chief executive officer and founder of 4Biosolutions Consulting where he provided services on project and program management in science and technology, business development, pre-clinical and clinical research, development and operations, regulatory affairs and FDA/EMA licensure submissions, quality control and quality assurance, and project funding for startups, small companies, non-profit organizations and universities.

He is a biomedical leader with expertise in infectious diseases, virology, microbiology, immunology, vaccinology and oncology, with over 20 years of experience at the National Institutes of Health, industry and non-profit research organizations. Past positions he has held include vice president for research at the Texas Biomedical Research Institute, director of the AIDS and Immunosuppression Program at the National Institute of Dental and Craniofacial Research, NIH, senior clinical scientist at Schering Plough Corporation, and director of portfolio for HIV Vaccine Programs at the National Institute of Allergy and Infectious Diseases.

He has managed basic, translational, pre-clinical and clinical research (phase I – IV clinical trials) projects connecting global health with the fields of infectious diseases, virology, microbiology, immunology, vaccinology, and oncology, and has led multidisciplinary teams of professionals in international clinical networks that have developed novel prevention, vaccine and therapeutic interventions. He has managed multi-million-dollar funds and resources for programs and projects to improve public health, and has designed, implemented and overseen clinical trials, clinical research organizations, other vendors and public health policies in support of HIV/AIDS research.

Dr. Rodriguez-Chavez has managed grants, cooperative agreements and contracts for the federal government and has led management for global operations and regulatory affairs of clinical laboratories supporting HIV vaccine clinical trials and HIV comorbidities and malignancies, creating and implementing guidelines for good clinical laboratory practices. He is a regulatory compliance expert, and has led clinical assay development in multiple platforms and formats, including rapid tests and point-of-care devices for clinical diagnosis of infectious diseases and for the detection of biomarkers related to immunological and cancer-related diseases.

He has served as a co-investigator in Phase I-III clinical trials testing new drugs for AIDS malignancies and respiratory diseases and has published multiple funding opportunity announcements at NIH to fund and manage thousands of research projects, influencing HIV/AIDS, comorbidities and malignancies research globally. He has led multiple teams of editors for scientific publishing in virology and viral oncology. He has published numerous papers and has been an invited speaker at multiple international scientific events, and has led major national and international scientific conferences and collaborative projects to improve global, public health.

Dr. Rodriguez-Chavez earned a Ph.D. in animal science (models), virology and immunology from the University of Delaware, a master’s of science in microbiology from the Venezuelan Institute for Scientific Research, and a master’s in health sciences in clinical research from Duke University.