Professional Profile
Dr. Michael Kelsh formerly directed a major pharmaceutical company’s efforts on the use of observational research applied to novel large- and small-molecule therapeutics. In this role, he oversaw epidemiologic research that addressed the development, efficacy, and safety of oncology therapeutics. He provided leadership and mentoring to professional staff and collaborated with numerous cross-functional clinical, developmental, safety, and regulatory teams. Dr. Kelsh was a member of the observational research department’s senior leadership team and chaired its “Observational Research Review Group,” a scientific committee that reviewed and approved all of the company’s observational research protocols. In this work and previous consulting experience, he has participated in various meetings with the U.S. FDA and the European Medicines Agency (EMA).
With specialized expertise in epidemiology and biostatistics in the areas of pharmaceutical, occupational, and environmental health research, Dr. Kelsh has extensive experience in the design, implementation, analysis, and interpretation of epidemiologic studies. His research has included studies of cancer, cardiovascular disease, respiratory and neurological disease, injury/musculoskeletal conditions, and numerous occupational and environmental exposures. These studies are published in more than 80 peer-reviewed scientific articles.
In the consulting arena, Dr. Kelsh has provided technical and epidemiologic guidance on pharmaceutical and occupational/ environmental health projects, served as an expert witness in occupational and environmental health litigation, and designed and conducted a variety of health studies.
Dr. Kelsh has served as an Adjunct Professor at the UCSF Department of Epidemiology and Biostatistics and the UCLA School of Public Health. He also has international public health experience gained through consulting, research projects, and volunteer work in Latin America. He has served on Scientific Advisory Panels covering a variety of environmental health issues for the California Department of Health Services, the New York Department of Environmental Health, and the Oregon Department of Human Services.