AAM’s Fall Tech Conference November 6 and 7 focused on Abbreviated New Drug Application (ANDA) review, GDUFA II enhancements, drug pricing, bioequivalence and data integrity were the main topics of AAM’s Fall Tech Conference.
The Fall Tech Conference brought together industry leaders and decision makers, including FDA Commissioner Scott Gottlieb, M.D., who outlined the Drug Competition Action Plan and declared,
“I think this is a win-win. What’s good for the generic drug industry and policies we are trying to craft is especially good for consumers.”
Other FDA presenters included:
- Kathleen Uhl, M.D., Director, Office of Generic Drugs
- Giuseppe Randazzo, MS, Director, Office of Program and Regulatory Operations, Office of Pharmaceutical Quality
- Ellen Morrison, Assistant Commissioner, Medical Products and Tobacco Operations, Office of Regulatory Affairs
AAM President and CEO Chester “Chip” Davis, Jr. delivered a State of the Industry Address, highlighting the progress being made toward the goal of prescription drug accessibility while recognizing threats from well-intentioned but misguided legislation and anti-competitive practices from some brand-name drug companies.
A panel on International Regulatory Harmonization, moderated by AAM’s David Gaugh, featured:
- Nicholas Cappuccino, Jr., PhD, Vice President, Head of Quality and Scientific Affairs, Dr. Reddy’s Laboratories, Inc.; and Chair, Science Committee, International Generic and Biosimilar Medicines Association (IGBA; formerly IGPA)
- Sergio Napolitano, LLM, Legal and External Relations Director, Medicines for Europe
AAM’s Craig Burton moderated a panel on Rising Drug Prices: Opportunities for Generics, featuring:
- Allan Coukell, Senior Director, Health Programs, The Pew Charitable Trusts
- Alex Brill, CEO and Founder, Matrix Global Advisors, LLC
- Matthew Eyles, Senior Executive Vice President and Chief Operating Officer, America’s Health Insurance Plans (AHIP)
“Driving Competition to Improve Lives” is the theme of AAM's annual meeting: Access! 2018. Register today!