CBSET’s Michael Naimark will be addressing the clinicians and researchers at St. Jude Children’s Research Hospital on the topic: “Serving the Gap: Combining GLP Preclinical Standards with Academic Rigor for FDA Review.” Michael will be discussing fundamental principles of preclinical program development with an eye towards clinical testing and market approval through the FDA and its branches. He will emphasize 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.
If you would like more information about this topic or about CBSET, please contact Michael.
Related CBSET brochures:
World Pharma Today: Stem Cell and Regenerative Therapies for Hearing Loss
by Michael Naimark, MS, Director of Business Development at CBSET, Inc. and Marie-Pierre Pasdelou, PharmD, Founder and Chief Development Officer at CILcare
World Pharma Today, Cell-based Therapy and FDA Review: Partnering for Success at Your pre-IND Meeting
by Michael Naimark, MS, Director of Business Development at CBSET, Inc.