Norris Pyle
Director CMC, Regulatory Affairs
Norris has over 25 years of experience in the pharmaceutical and biotechnology industries. He is a highly regarded Regulatory Affairs, CMC professional with proven success in investigational and marketing regulatory applications for companies across multiple therapeutic areas, including oncology, and infectious diseases.
Norris has served as a regulatory lead or significant contributor for the approval, launch and maintenance of eight US commercial products, and collaborating within regulatory for commercial approvals in Europe and Australia.
At Syner-G, Norris is responsible for supporting CMC aspects of small molecule and biologic products across all stages of development (IND, CTA/IMPD, BLA, NDA, MAA). His experience includes vaccines, cellular-derived products, antibody-drug conjugates and mRNA products.
Before joining Syner-G, He utilized his regulatory expertise at GSK where he was the US Regulatory Lead for Shingrix. Prior to GSK, he initiated his regulatory experience at Wyeth Pharmaceuticals. His past experience also includes parenteral formulations and manufacturing, as well as heading up the clinical supply department.
Norris earned his BS in Pharmacy from the Philadelphia College of Pharmacy and Science.
Norris Pyle's Recent Articles
Potency Assurance for Cellular and Gene Therapy Products
One of the many challenges around developing cell and gene therapy products is establishing representative potency methods. In 2011, the FDA released the Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products, which supported a phase appropriate approach…