Bernstein Training Courses

Linking Good Science and Regulatory Expectations:
Streamlining Early CMC Drug Development

A 2-day comprehensive educational program:
Understanding and interpreting current FDA and EU regulations
to facilitate approval of IND and CTA IMPD regulatory submissions

Instructors:  John Simmons, Ph. D. and David Bernstein, Ph. D.

This is an in-house customized course. Please contact David Bernstein for more details.

John Simmons recently retired from the FDA after 20 years of service. His most recent responsibilities were as Director, Division Division of Pre-Marketing Assessment II & Manufacturing Science in the Office of New Drug Quality Assessment.  Some of his major achievements have been the review, inspection and approval of Gleevec, a new class of oncology drug in 45 days, which required collaborative and innovative approaches to working with a pharmaceutical manufacturer. He has also been involved with the review and approval of the first major combination products Mylotarg (a monoclonal antibody with a cytotoxic agent) and the Cypher drug eluting stent (a drug-device combo).  He has served in the Office of New Drug Chemistry, Office of Generic Drugs, Division of Cardio-Renal Drug Products and the Division of Biopharmaceutics. His current areas of interest include PAT and Combination Products. He has over 125 publications and presentations in the areas of analytical methodology to evaluate drugs in vitro and in vivo. Prior to FDA, he was on the faculty at the Universities of Pittsburgh, School of Pharmacy and the University of Kansas, School of Pharmacy, Center for Biomedical Research. He holds degrees from Temple University and the University of Pittsburgh.  

David Bernstein is the principal consultant at Bernstein CMC Regulatory Consulting. He has 17 years of hands-on industrial and 15 years of CMC regulatory consulting experience. Dr. Bernstein is a regulatory and technical consultant to several biotechnology and pharmaceutical companies and provides guidance in conceptual and implementation strategy and tactics for expediting the drug development process through integrating pre-clinical formulation efforts, preparation of investigational drug supplies with the clinical development plan. He is the principal liaison between numerous virtual organizations and their CMC contractors.  He has authored over 160 CMC sections of IND, NDA, CTA and has represented numerous pharmaceutical and biotech firms at the FDA. Dr. Bernstein conducts GLP/GMP audits and has prepared numerous firms for their first FDA PAI inspections, all of whom passed this milestone. He has published extensively on techniques to expedite drug development, GMPs in R&D, GMPs for Clinical Trial Materials. He holds a BS in Pharmacy from Columbia University and MS and PhD in Pharmaceutical Sciences from the University of Michigan.

Objective:

• provide a framework for understanding current global regulatory expectations for CMC sections of US IND and CTA IMPD regulatory submissions; what are the similarities and differences in the amount and extent of CMC information required
• interpret global regulations and guidance for GXP in clinical phases 1, 2 and 3
• present techniques for efficient and effective CMC activities in early development
• describe typical scientific and technical challenges in early development and how they can be minimized or circumvented