Scientific Advisory Committee Advisor
Phil Lavin, PhD
Well-known biostatistician with a long history supporting clinical trials. He has worked with Janet Campbell for over 10 years in the development of laser-based solutions for breast cancer diagnosis.
Dr. Lavin co-founded Boston Biostatistics in 1983 which became Aptiv Solutions in 2011 before being acquired by ICON plc in 2014. He served as CEO for 24 years. He founded Boston Biostatistics Research Foundation in 1988. He currently serves as Executive Director. He founded Lavin Consulting LLC in 2013 offering high end strategic advice to design, analyze, report, present, and defend drugs, devices, and biologics for regulatory and reimbursement approval. He currently is the Principal.
He earned his Ph.D. in Applied Mathematics from Brown University. He was a faculty member at Harvard School of Public Health and Harvard Medical School for 28 years.
He has served as the Lead Biostatistician for 61 major FDA approvals to date including 40 PMAs, 14 NDAs, 6 BLAs, and an HDE with more pending. These approvals have resulted in >$25B in increased client valuations.
He has also advised FDA since 1983 on product approvals and matters of public policy.
He has also authored or co-authored 168 peer-reviewed publications in the medical and statistical literature. These represent many therapies, disciplines, and methodologies.
He is the only person to be elected a Fellow of the American Statistical Association and the Regulatory Affairs Professional Society reflecting his many contributions to statistics, regulatory approvals, and medicine.
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