AGENDA
- All
- MONDAY, OCTOBER 27, 2025
- TUESDAY, OCTOBER 28, 2025
- WEDNESDAY, OCTOBER 29, 2025
MONDAY, OCTOBER 27, 2025
8:00 a.m. – 4:30 p.m.
Registration
MONDAY, OCTOBER 27, 2025
8:00 a.m. – 9:00 a.m.
Networking Breakfast
MONDAY, OCTOBER 27, 2025
9:00 a.m. – 9:10 a.m.
Welcome and Introduction
John Murphy III
President & CEO, AAM
MONDAY, OCTOBER 27, 2025
9:10 a.m. – 9:45 a.m.
General Session
MONDAY, OCTOBER 27, 2025
9:45 a.m. – 10:15 a.m.
OGD Keynote Address
Iilun Murphy, M.D.
Director, Office of Generic Drugs, CDER, FDA
MONDAY, OCTOBER 27, 2025
10:15a.m. – 10:45 a.m.
Networking Break
MONDAY, OCTOBER 27, 2025
10:45 a.m. – Noon
MONDAY, OCTOBER 27, 2025
12:00 p.m. – 1:15 p.m.
Networking Luncheon
MONDAY, OCTOBER 27, 2025
1:15 p.m. – 2:15 p.m.
MONDAY, OCTOBER 27, 2025
2:15 p.m. – 2:30 p.m.
Networking Break
MONDAY, OCTOBER 27, 2025
2:30 p.m. – 3:30 p.m.
GRx+Biosims Learning Tracks
CUHFS: Exploring More Efficient Human Factors Evaluation Methods
How Industry and FDA Can Collaborate and Work Together to Make Generic Drugs Available to Patients Sooner
Biosimilar Interchangeability and Utilization Management Strategies
MONDAY, OCTOBER 27, 2025
3:30 p.m. – 4:45 p.m.
Networking Break
MONDAY, OCTOBER 27, 2025
3:45 p.m. – 4:45 p.m.
GRx+Biosims Learning Tracks
MONDAY, OCTOBER 27, 2025
4:45 p.m. – 6:00 p.m.
Networking Reception
TUESDAY, OCTOBER 28, 2025
8:00 a.m. – 9:00 a.m.
Science and Regulatory Working Group (members only)
TUESDAY, OCTOBER 28, 2025
8:00 a.m. – 9:00 a.m.
Networking Breakfast
TUESDAY, OCTOBER 28, 2025
9:00 a.m. – 9:30 a.m.
Biosimilars Keynote Address Fireside Chat
Sarah Yim, M.D.
Director, Office of Therapeutic Biologics and Biosimilars, OND, CDER, FDA
Moderator: Giuseppe Randazzo
Senior Vice President, Sciences and Regulatory Affairs, AAM
TUESDAY, OCTOBER 28, 2025
9:30 a.m. – 10:30 a.m.
General Sessions
TUESDAY, OCTOBER 28, 2025
10:30 a.m. – 11:00 a.m.
Networking Break
TUESDAY, OCTOBER 28, 2025
11:00 a.m. – 12:15 p.m.
TUESDAY, OCTOBER 28, 2025
12:15 p.m. – 1:30 p.m.
Networking Lunch
TUESDAY, OCTOBER 28, 2025
1:30 p.m. – 2:45 p.m.
GRx+Biosims Learning Tracks
TUESDAY, OCTOBER 28, 2025
2:45 p.m. – 3:00 p.m.
Networking Break
TUESDAY, OCTOBER 28, 2025
3:00 p.m. – 5:00 p.m.
GRx+Biosims Exposition
TUESDAY, OCTOBER 28, 2025
5:00 p.m. – 6:00 p.m.
Networking Reception
TUESDAY, OCTOBER 28, 2025
6:00 p.m. – 8:00 p.m.
Dinner & Entertainment
WEDNESDAY, OCTOBER 29, 2025
7:45 a.m. – 8:45 a.m.
Biosimilars Council Meeting (members only)
WEDNESDAY, OCTOBER 29, 2025
7:45 a.m. – 8:45 a.m.
Networking Breakfast
WEDNESDAY, OCTOBER 29, 2025
8:45 a.m. – 9:00 a.m.
State of the Industry Keynote
Keren Haruvi
AAM Board Chair
WEDNESDAY, OCTOBER 29, 2025
9:00 a.m. – 9:30 a.m.
Fireside Chat
WEDNESDAY, OCTOBER 29, 2025
9:30 a.m. – 10:15 a.m.
Biosimilars Market Leaders Discussion
WEDNESDAY, OCTOBER 29, 2025
10:15 a.m. – 10:30 a.m.
Networking Break
WEDNESDAY, OCTOBER 29, 2025
10:30 a.m. – 11:30 a.m.
Global and U.S. Generics and Biosimilars: Trends, Issues and Outlook
Scott Biggs
Director, Supplier Services, IQVIA
WEDNESDAY, OCTOBER 29, 2025
11:30 a.m. – 12:30 p.m.
Ask a Regulator
Ali M. Al-Samil, PhD
Chair of Biotech and Biosimilar Department, Saudi Food and Drug Authority
Denis Arsenault
Manager, Policy Development, Health Canada
Steffen Thirstrup, M.D., PhD
Chief Medical Officer, European Medicines Agency
Sarah Yim, M.D.
Director, Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, CDER, FDA
WEDNESDAY, OCTOBER 29, 2025
12:30 p.m. – 1:00 p.m.
CDER Keynote Address
Jacqueline Corrigan-Curay, JD, M.D.
Acting Director, Center for Drug Evaluation and Research, FDA
WEDNESDAY, OCTOBER 29, 2025
1:00 p.m.
Closing Remarks
John Murphy III
President & CEO, AAM
WEDNESDAY, OCTOBER 29, 2025
1:00 p.m. – 2:00 p.m.
Farewell Luncheon – Grab + Go
WEDNESDAY, OCTOBER 29, 2025
2:00 p.m.
Conference Concludes
*Agenda is subject to change
