AGENDA

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  • All
  • Monday, October 2, 2023
  • Tuesday, October 3, 2023
  • Wednesday, October 4, 2023
8:00 a.m. – 4:30 p.m. EST
Registration
8:00 a.m. – 9:00 a.m. EST
Networking Breakfast
9:00 a.m. - 9:15 a.m. EST
Welcome and Introduction

David Gaugh, RPh
Interim President & CEO, AAM

9:15 a.m. – 9:45a.m. EST
Fireside Chat with FDA Commissioner

Robert Califf, M.D., MACC
Commissioner, Food and Drug Administration

Moderator: David Gaugh, RPh
Interim President & CEO, AAM

9:45 a.m. – 10:45 a.m. EST
OGD/OPQ/OC Keynote Address

Iilun Murphy, M.D.
Director, Office of Generic Drugs (OGD), CDER FDA

Michael Kopcha, PhD, RPh
Director, Office of Pharmaceutical Quality (OPQ), CDER, FDA

Francis Godwin, MBA
Director, Office of Manufacturing Quality, Office of Compliance (OC), CDER, FDA

10:45 a.m. – 11:15 a.m. EST
Networking Break
11:15 a.m. – 12:15 p.m. EST
11:15 a.m. – 12:15 p.m.
11:15 a.m. – 12:15 p.m. EST
11:15 a.m. – 12:15 p.m. EST
11:15 a.m. – 12:15 p.m. EST
12:15 p.m. – 1:30 p.m. EST
Networking Luncheon
1:30 p.m. – 3:00 p.m. EST
1:30 p.m. – 3:00 p.m. EST
1:30 p.m. – 3:00 p.m. EST
1:30 p.m. – 3:00 p.m. EST
3:00 p.m. –3:15 p.m. EST
Networking Break
3:15 p.m. – 5:15 p.m. EST
USP Forum

Join us to learn more about USP’s efforts to support generic manufacturers bringing quality medicines to market. The Forum will feature insights from USP’s CEO as well as other senior industry leaders, as well as how standards and other USP resources may be used to respond to industry challenges surrounding mitigation of impurities and creating efficiencies in the development of sterile injectables.

Ronald T. Piervincenzi, PhD
Chief Executive Officer, U.S. Pharmacopeia

Anthony Lakavage, J.D.
Senior Vice President, Global External Affairs, U.S. Pharmacopeia

Desmond Hunt, PhD
Senior Principal Scientist, U.S. Pharmacopeia

Rebecca Cambronero, MBA, MSL, PMP
Senior Director, Regional General Manager, North America, U.S. Pharmacopeia

Michael Eakins, PhD
Principal Consultant, Eakins & Associates
Vice-Chair, USP General Chapters Packaging and Distribution Expert Committee

Mark Schweitzer, PhD
Principal, Mark Schweitzer Consulting, LLC
Chair, USP Microbiology Expert Committee

Maryll Toufanian, J.D.
Senior Vice President, Regulatory Strategy and Government Affairs, Amneal Pharmaceuticals

Kiran Krishnan, PhD
Senior Vice President| Global Regulatory Affairs, Apotex Corp.

5:15 p.m. – 6:15 p.m. EST
Networking Reception

Welcome to the conference’s opening networking reception, proudly sponsored by USP. Kickstart your experience by mingling with fellow attendees, industry experts, and thought leaders. This is the perfect chance to connect, exchange ideas, and build new relationships

8:30 a.m. – 9:30 a.m. EST
Networking Breakfast
8:30 a.m. – 9:30 a.m. EST
Science and Regulatory Working Group

AAM Members Only 

9:30 a.m. – 10:00 a.m. EST
State of the Industry Keynote

Christine Baeder, MBA
AAM Board Chair

 

10:00 a.m. – 10:30 a.m. EST
ORA Keynote Address

Elizabeth Miller, PharmD 
Assistant Commissioner for Medical Products and Tobacco Operations, Office of Regulatory Affairs (ORA), FDA

10:30 a.m. – 11:00 a.m. EST
Networking Break
11:00 a.m. – 12:00 p.m. EST
11:00 a.m. – 12:00 p.m. EST
11:00 a.m. – 12:00 p.m. EST
11:00 a.m. – 12:00 p.m. EST
12:00 p.m. – 1:15 p.m. EST
Networking Luncheon
1:15 p.m. – 2:30 p.m. EST
1:15 p.m. – 2:30 p.m. EST
1:15 p.m. – 2:30 p.m. EST
1:15 p.m. – 2:30 p.m. EST
1:15 p.m. – 2:30 p.m. EST
2:30 p.m. – 4:30 p.m. EST
GRx+Biosims Exposition

An interactive knowledge sharing session that brings together multiple levels of scientific, regulatory and policy disciplines from diverse sectors, industry, academia and health authorities. The expo is geared toward facilitating one-on-one interaction among these sectors to increase understanding and knowledge sharing. This year’s expo will also feature over 50 project managers from FDA’s OGD and OPQ who will participate in an information exchange opportunity with attendees.

  • Office of Generic Drugs (OGD)
  • Office of Pharmaceutical Quality (OPQ)
  • Drug Shortage Staff (DSS)
  • Office of Compliance – Exports, Imports, and Recalls
  • FDA Electronic Submissions – What’s New?
  • OM Division of User Fee Management
  • Injectable Drugs Deficiency Trend Analysis
  • Product Marketing and Supply Notifications
  • Regulatory Requirements and Challenges – High Molecular Weight Species in Peptides: Process Considerations, Characterization and Regulatory Requirements for an ANDA
  • The cumulative impact of developments in the environmental regulation of PFAS and pharmaceutical propellants
  • GDUFA Science and Research Program
  • Benefits of the SD File Format
  • Exception Excipients and pH adjusters: Controlled Correspondences
  • Post approval changes on complex generic and respiratory products
  • Nitrosamines in Pharmaceuticals – What does the future look like?
  • FDA Careers

Click here for more information

3:30 p.m. – 5:00 p.m. EST
Biosimilars Council Meeting

Biosimilars Council Members Only 

5:00 p.m. – 6:00 p.m. EST
Networking Reception
6:00 p.m. - 6:30 p.m.
Depart for Offsite Dinner
6:30 p.m. – 9:30 p.m. EST
GRx+Biosims Dinner & Entertainment

Join us for a festive evening of dinner and entertainment at Sports & Social Bethesda. Enjoy the sports tavern ambiance and timeless games, along with delicious food options. We’ll unwind, network, and have fun with live entertainment that will add a unique twist to your conference experience. Don’t miss the opportunity to connect, relax, and have a fantastic time at this engaging venue.

8:30 a.m. – 9:30 a.m. EST
Networking Breakfast
9:30 a.m. – 10:00 a.m. EST
Biosimilars Fireside Chat

Sarah Yim, M.D.
Director, Office of Therapeutic Biologics and Biosimilars (OTBB), Office of New Drugs
(OND), CDER, FDA

Moderator: Craig Burton
Senior Vice President, Policy and Strategic Alliances, AAM
Executive Director, Biosimilars Council

10:00 a.m. -11:30 a.m. EST
10:00 a.m. - 11:30 a.m.
10:00 a.m. -11:30 a.m. EST
10:00 a.m. -11:30 a.m. EST
10:00 a.m. – 11:30 a.m.
11:30 a.m. – 11:45 a.m. EST
Networking Break
11:45 a.m. – 12:15 p.m. EST
CDER Keynote Address

Jacqueline Corrigan-Curay, JD, M.D.
Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER), FDA

12:15 p.m. – 12:30 p.m. EST
Closing Remarks

David Gaugh, RPh
Interim President & CEO, AAM

12:30 p.m. – 1:30 p.m. EST
Networking Luncheon
1:30 p.m. EST
GRx+Biosims 2023 Concludes

*Agenda is subject to change