Learning Tracks

Regulatory Science Challenges for Complex Generics

Tuesday, October 3, 2023

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
Lead Mathematical Statistician, 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