Discovery & Enrichment Series: Making Medicines: How New [censored] Are Developed

Library : Brewster Ladies' Library

Location : Auditorium Brewster Ladies' Library, 1822 Main Street, Brewster, MA, 02631

Start : Wednesday 14th of May 2025 2:00 PM

End : Wednesday 14th of May 2025 3:30 PM

Description :

Uncover the history of the FDA’s oversight of the development of new medications, and the evolution of a regulatory system created in reaction to cases like thalidomide. Dr. Lindsay McNair, a physician and research ethicist, will lead a discussion about the complex journey pharmaceutical companies take to develop new medicines, the rigorous process of submitting data to the FDA for review, and the decision making behind drug approvals.  Dr. McNair is the Principal Consultant at Equipoise Consulting, LLC. From 2013 to 2023, she was the Chief Medical Officer for the WIRB-Copernicus Group (WCG), including the WCG Institutional Review Board (IRB). As part of the WCG IRB Executive Committee, she oversaw IRB member selection and training as well as IRB policy development, and helped to maintain regulatory and accreditation compliance. She also consulted with institutions and pharma/biotech companies on a wide range of issues related to protocol design, regulatory compliance, human subject protection, and ethical policy development.  Dr. McNair is a Senior Fellow at the Tufts Center for the Study of Drug Development within the Tufts University School of Medicine and is an adjunct faculty member at Boston University School of Public Health, where she teaches graduate students about the scientific design of clinical research studies. She is a graduate of the University of Connecticut School of Medicine, the Boston University School of Public Health, and Clarkson/Union Graduate College. Her areas of research interest and expertise include the regulatory oversight of drug development clinical trials, and ethical issues related to human participant research and novel study designs. brewsterladieslibrary.assabetinteractive.com/calendar/discovery-enrichment-series-[censored]-ethics-and-clinical-trials/