AGENDA
- All
- Monday, October 21, 2024
- Tuesday, October 22, 2024
- Wednesday, October 23, 2024
Monday, October 21, 2024
7:30 a.m. – 4:30 p.m.
Registration
Monday, October 21, 2024
7:30 a.m. – 8:45 a.m.
Networking Breakfast
Monday, October 21, 2024
8:45 a.m. – 9:00 a.m.
Welcome and Introduction
David Gaugh, RPh
Interim President & CEO, AAM
Monday, October 21, 2024
9:00 a.m. – 9:30 a.m.
Dr. Janet Woodcock: A Legacy of Leadership
Join us for a special session reflecting on the remarkable career of Dr. Janet Woodcock, who recently retired from the U.S. Food and Drug Administration after 38 years of service. Dr. Woodcock been called one of the most powerful and influential drug regulators who has left a historic mark on the pharmaceutical industry and public health.
This session, hosted by Women in Health Policy (WiHP) and powered by the Association for Accessible Medicines (AAM), will dive into Dr. Woodcock’s impactful contributions to the generic and biosimilars industry and her legacy within the FDA. We will discuss her leadership, achievements, and the lasting impact of her work on drug regulation and accessibility.
Janet Woodcock, M.D.
Former Principal Deputy Commissioner, FDA
Moderator: David Gaugh, RPh
Interim President & CEO, AAM
Monday, October 21, 2024
9:30 a.m. – 10:00 a.m.
Keynote Address
Monday, October 21, 2024
10:00 a.m. – 10:30 a.m.
OGD Keynote Address
Iilun Murphy, M.D.
Director, Office of Generic Drugs (OGD), CDER FDA
Monday, October 21, 2024
10:30 a.m. – 11:00 a.m.
Networking Break
Monday, October 21, 2024
11:00 a.m. – 12:00 p.m.
GRx+Biosims Learning Tracks
Monday, October 21, 2024
12:15 p.m. – 1:30 p.m.
Networking Luncheon
Monday, October 21, 2024
1:30 p.m. – 3:00 p.m.
GRx+Biosims Learning Tracks
Monday, October 21, 2024
3:00 p.m. –3:15 p.m.
Networking Break
Monday, October 21, 2024
3:15 p.m. – 4:15 p.m.
GRx+Biosims Learning Tracks
Monday, October 21, 2024
4:15 p.m. –5:30 p.m.
Networking Reception
Tuesday, October 22, 2024
8:00 a.m. – 9:00 a.m.
Networking Breakfast
Tuesday, October 22, 2024
8:00 a.m. – 9:00 a.m.
Science and Regulatory Working Group (members only)
Tuesday, October 22, 2024
9:00 a.m. – 9:30 a.m.
Biosimilars Keynote Address
Sarah Yim, M.D.
Director, Office of Therapeutic Biologics and Biosimilars (OTBB), Office of New Drugs (OND), CDER, FDA
Tuesday, October 22, 2024
9:30 a.m. – 10:00 a.m.
Keynote Address
Tuesday, October 22, 2024
10:00 a.m. – 10:30 a.m.
ORA Keynote Address
Elizabeth Miller, PharmD
Assistant Commissioner for Medical Products and Tobacco Operations, Office of Regulatory Affairs (ORA), FDA
Tuesday, October 22, 2024
10:30 a.m. – 11:00 a.m.
Networking Break
Tuesday, October 22, 2024
11:00 a.m. – Noon
GRx+Biosims Learning Tracks
Tuesday, October 22, 2024
Noon – 1:15 p.m.
Networking Lunch
Tuesday, October 22, 2024
1:15 p.m. – 2:30 p.m.
GRx+Biosims Learning Tracks
Tuesday, October 22, 2024
2:30 p.m. – 4:30 p.m.
GRx+Biosims Exposition
An interactive knowledge sharing session that brings together multiple levels of scientific disciplines from diverse sectors, industry, academia and agency. The expo is geared toward facilitating one-on-one interaction among these sectors to increase understanding on a scientific level.
Tuesday, October 22, 2024
3:30 p.m. – 5:00 p.m.
Biosimilars Council Meeting (members only)
Tuesday, October 22, 2024
5:00 p.m. – 6:00 p.m.
Networking Reception
Tuesday, October 22, 2024
6:00 p.m. – 9:00 p.m.
Dinner & Entertainment
Wednesday, October 23, 2024
7:30 a.m. – 8:30 a.m.
Networking Breakfast
Wednesday, October 23, 2024
8:30 a.m. – 9:00 a.m.
Keynote Address
Wednesday, October 23, 2024
9:00 a.m. – 10:00 a.m.
Biosimilars Leadership Roundtable
Wednesday, October 23, 2024
10:00 a.m. – 10:30 a.m.
Networking Break
Wednesday, October 23, 2024
10:30 a.m. – 12:30 p.m.
General Session
Wednesday, October 23, 2024
12:30 p.m. – 1:00 p.m.
CDER Keynote Address
Jacqueline Corrigan-Curay, JD, M.D.
Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER), FDA
Wednesday, October 23, 2024
1:00 p.m. – 2:00 p.m.
Networking Lunch
Wednesday, October 23, 2024
2:00 p.m.
Conference Concludes
*Agenda is subject to change
