Michael Naimark. “Serving the Gap: Combining GLP Preclinical Standards with Academic Rigor for FDA Review.“
Summary: Michael discussed the fundamental principles of preclinical program development with an eye towards clinical testing and market approval through the FDA and its branches. He emphasized new regulatory strategies for novel therapeutic approaches in regenerative medicine including the RMAT designation, manufacturing concerns, and how interacting with CBER differs from traditional approaches to market access for small molecule drugs and traditional medical devices.
More information on this topic is available in related CBSET publications:
Related CBSET brochures:
by Michael Naimark, MS, Director of Business Development at CBSET, Inc. and Marie-Pierre Pasdelou, PharmD, Founder and Chief Development Officer at CILcare
by Michael Naimark, MS, Director of Business Development at CBSET, Inc.