By: Ronald A. Salerno, PhD, Kerin Ablashi, MS, Debra Barngrover, PhD, RAC and Kelly Reich MS, RAC
For those developing a new biologic or pharmaceutical product, Pre-Investigational New Drug Application (pre-IND, PIND) meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan to address the CMC requirements for Phase 1 clinical studies. By having these conversations directly with regulators at the FDA early in the development process, the Sponsor is able to minimize regulatory risk and better position the product for clinical and ultimately, commercial success.
In this paper, the authors call upon their years of experience preparing meeting requests and meeting packages, participating in pre-IND meetings, and reviewing and responding to pre-IND meeting comments from the FDA in order to provide recommendations to organizations looking to make the most out of their pre-IND meeting with FDA.
In this paper, you will find:
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Ronald A. Salerno, PhD, Group Leader of CMC Development at Biologics Consulting, has twenty-six years of experience in Regulatory Affairs for Vaccines, Biologics and Drugs including regulatory strategy and submissions for product development and licensure. Since joining Biologics Consulting in 2008, he provides regulatory affairs strategy and submissions support for small and large biopharmaceutical companies developing vaccines, biologics, drugs or IVDs. Prior to Biologics Consulting, Ronald worked as the Global Regulatory Therapeutic Area Head for Wyeth Vaccines. He completed a MS in Biology from Villanova University, a MS in Zoology from University of Maryland, College Park and a PhD in Zoology from University of Maryland, College Park.
Kerin Ablashi, MS, Consultant at Biologics Consulting, has been working in the biotech industry since 1990 and joined Biologics Consulting in 2005. As a CMC Technical Writer at Biologics Consulting, Ms. Ablashi utilizes her GMP manufacturing, quality, and project management experience to assist clients with the preparation of CMC portions of their regulatory submissions to the FDA, EMA, and other regulatory bodies. Specifically, Ms. Ablashi writes and reviews the Quality Overall Summary (QOS, CTD Section 2.3) and CTD Module 3 sections of pre-IND, IND, BLA, NDA, PAS, and Master Files in accordance with ICH M4Q. She received a MS in Environmental Biology from Hood College in 2000.
Debra Barngrover, PhD, RAC, Senior Consultant at Biologics Consulting, has over 25 years of experience in the biopharmaceutical industry. Prior to joining Biologics Consulting, she was Vice President, Technology, at Genzyme Corporation where she led the process development team for a recombinant protein from initial product concept through approval to market launch in over 40 countries, and managed the Technology Development group responsible for development of more than 15 small molecule, protein and viral vector products, including seven commercial products. As a Senior Consultant at Biologics Consulting, Debra utilizes her broad technical and project management expertise to assist clients in various stages of strategy, planning and development of a wide range of products. She received her PhD in Nutritional Biochemistry from Cornell University.
Kelly Reich MS, RAC, Regulatory Project Manager at Biologics Consulting, has over 15 years of experience providing project management and regulatory support to Sponsors regulated by CBER and CDER. This primarily includes helping Sponsors organize their product development source information into a clear, comprehensible application. Ms. Reich completed a MS in Biotechnology and Regulatory Affairs at Johns Hopkins University in 2007 and achieved her Regulatory Affairs Certification (RAC) in 2010.