Karin Pihel, PhD
SR. DIRECTOR, CMC REGULATORY AFFAIRS, ENZYVANT
Cambridge, Massachusetts, United States
Karin Pihel is currently Sr. Director of CMC Regulatory Affairs at Enzyvant Therapeutics, a biopharmaceutical company focused on the development and commercialization of regenerative medicines. She has over 20 years of experience in biopharmaceutical development with a wide variety of products. At Enzyvant, she led the regulatory CMC strategy for the BLA filing of RETHYMIC®, a tissue-based regenerative medicine, resulting in FDA approval of Enzyvant’s first commercial product. Karin received her PhD in analytical chemistry from the University of North Carolina at Chapel Hill and her BS in chemical engineering from Rensselaer Polytechnic Institute in Troy, NY.
3:00 PM - 4:00 PM (PDT)
Wednesday, June 15
Development of Points to Consider: Comparability Considerations for Advanced Therapy Medicinal Products Subject to Changes in their Manufacturing Process
This session will focus on considerations for evaluating the comparability of cell and gene therapy…