Plenary Session II - Regulatory Provisions of USFDA for Approval of Pharma & Biosimilar Drugs

Scarlet

Moderator - 
- Mr. Timothy H. Kratz Partner Kratz & Barry Atlanta - The 505(b)(2) pathway and strategies arising therefrom

Speakers - 
- Mr. Edward D. Pergament, Pergament & Cepeda LLP - Five Generic Cases
- Dr. Anil Patel, Partner, K & L Gates - Forfeiture of 180-day First Filer Exclusivity
- Mr. Arshad Jamil, Global Head - IPR, Biocon - Hatch Waxman Litigations and Biosimilars Litigation
- Mr. Gautam Bakshi, Head - IPM, Unichem Laboratories Limited - Drug Price Restoration – Hatch – Waxman disputes
- Mr. Matthew Fedowitz, Shareholder, Buchanan Ingersoll & Rooney PC - Solutions for the Distressed Generic Industry in the US
- Ms. Barbara A. Binzak Blumenfeld, Shareholder – FDA & Biotechnology, Buchanan Ingersoll & Rooney PC - Follow-On Biologics at USFDA