Regulatory Science Challenges for Complex Generics
1:15 p.m. - 2:30 p.m.
This panel will explore complex generic drug products FDA has approved and the regulatory science that can support further approvals related to comparative use human factors studies (CUHFS), long-acting injectables, complex API characterization, and other areas. This session also will provide updates from the Center for Research on Complex Generics (CRCG). Other topics for discussion in this area include oligonucleotides, combination products, guidance on in-vitro and PK BE studies as alternatives for pharmacodynamic and clinical endpoint BE studies, and topical and inhalation products.
Speakers:
Jaya Ayyagari, M.S, MBA
Senior Director and Head, Regulatory Affairs, Dr. Reddy’s Laboratories Inc.
Somesh Chattopadhyay, PhD
Team Leader, Division of Biometrics VIII, OB, OTS, CDER, FDA
Krishna Chimalakonda, M.S., PhD
Associate Director, Clinical Regulatory Affairs, Amneal Pharmaceuticals Pharmaceuticals
Sophie Edmonds-Allen
Principal Scientist CPD Human Factors, Teva Pharmaceuticals
Jason Flint, MBA, PMP
Deputy Director & Associate Director for Human Factors (Acting), Division of Medication Error Prevention and Analysis I, OMEPRM, OSE, CDER, FDA
Darby Kozak, PhD
Deputy Division Director, Division of Therapeutic Performance I, ORS, OGD, CDER, FDA
Vipra Kundoor, PhD
Pharmacologist, Division of Bioequivalence I, OB, OGD, CDER, FDA
James Polli, PhD
Professor and Ralph F. Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics, University of Maryland School of Pharmacy
Panelists:
Partha Roy, PhD
Director, Office of Bioequivalence, OGD, CDER, FDA
Xiaoming Xu, PhD
Division Director, Division of Product Quality Research, OTR, OPQ, CDER, FDA
