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
9:05 a.m. – 9:15 a.m.
Welcome and Introduction
John Murphy III
President & CEO, AAM
MONDAY, OCTOBER 27, 2025
9:15 a.m. – 9:45 a.m.
OGD Keynote Address
Iilun Murphy, M.D.
Director, Office of Generic Drugs, CDER FDA
MONDAY, OCTOBER 27, 2025
9:45 a.m. – 10:15 a.m.
OII Keynote Address
Elizabeth Miller, PharmD
Acting Deputy Associate Commissioner for Inspections and Investigations (DACII), 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.
MONDAY, OCTOBER 27, 2025
3:30 p.m. – 3:45 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, M.S.
Senior Vice President, Sciences and Regulatory Affairs, AAM
TUESDAY, OCTOBER 28, 2025
9:30 a.m. – 9:45 a.m.
Lifetime Achievement Award
Paul Schwartz, PhD
Food and Drug Administration (Retired)
TUESDAY, OCTOBER 28, 2025
9:45 a.m. – 10:30 a.m.
IGBA Project Update: Single Global Development for Generic and Biosimilar Medicines
James Polli, PhD
Co-Director, CRCG
Professor, Ralph F. Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics, Department of Pharmaceutical Sciences, University of Maryland School of Pharmacy
Anna Schwendeman, PhD
Co-Director, CRCG
Larry and Ann Hsu Professor, Professor of Pharmaceutical Sciences, College of Pharmacy, University of Michigan College of Pharmacy
Moderator: Aaron Josephson, MS
Senior Director, Global Regulatory Policy, Teva Pharmaceuticals
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
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.
Make sure to visit all the booths at the exposition:
| Booth #1 | Pre-ANDA Meetings |
| Booth #2 | FDA Electronic Submissions |
| Booth #3 | Challenges in Immunogenicity Risk Assessment for Complex Products Like Peptides |
| Booth #4 | AgencyIQ by POLITICO |
| Booth #5 | Office of Drug Security, Integrity, and Response |
| Booth #6 | GDUFA III Meetings: An Industry Perspective |
| Booth #7 | OTBB Project Managers |
| Booth #8 | ANDA Filing Project Managers |
| Booth #9 | ANDA Labeling Project Managers |
| Booth #10 | Tracking ANDAs: Tools, Tactics, and Timelines |
| Booth #11 | OPQ Project Managers |
| Booth #12 | Development of a Cell-Based In Vitro Method to Assess Innate Immune Responses to Host Cell Proteins (HCPs) in Recombinant Peptide Therapeutics |
| Booth #13 | BE Assessment Process and Strategy |
| Booth #14 | Product Specific Guidance – Industry Perspective |
| Booth #15 | Product-Specific Guidance (PSG) |
| Booth #16 | Meet Your Regulatory Project Managers |
| Booth #17 | Bridging Global Gaps in Biosimilar Development: A Multi-Stakeholder Analysis of Regulatory Convergence and Quality Assurance |
| Booth #18 | Inactive Ingredient Database (IID) |
| Booth #19 | GDSA-BE and AI Applications |
| Booth #20 | GDUFA User Fees |
| Booth #21 | GDUFA Science and Research |
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
8:00 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.
USP Fireside Chat
Ronald Piervincenzi, PhD
CEO, USP
Moderator: John Murphy III
President & CEO, AAM
WEDNESDAY, OCTOBER 29, 2025
9:30 a.m. – 10:00 a.m.
FDA Commissioner Fireside Chat
Marty A. Makary, M.D., M.P.H.
Commissioner, FDA
Moderator: John Murphy III
President & CEO, AAM
WEDNESDAY, OCTOBER 29, 2025
10:00 a.m. – 10:30 a.m.
Networking Break
WEDNESDAY, OCTOBER 29, 2025
10:30 a.m. – 11:00 a.m.
Biosimilars Market Leaders Discussion
Sam Leo, PharmD
Senior Director, U.S. Commercial, Biosimilar Operations, Teva Pharmaceuticals
Sean McGowan
Senior Vice President, Biosimilars & Branded Oncology, Amneal Pharmaceuticals
Matte Wilhelm
Senior Director, Head of North America Strategy & Operations, Biocon Biologics
Moderator: Alex Keeton
Executive Director, Biosimilars Council
Senior Vice President, Policy, AAM
WEDNESDAY, OCTOBER 29, 2025
11:00 a.m. – 12:00 p.m.
Ask a Regulator
Denis Arsenault
Manager, Policy Development, Health Canada
João Tavares Neto
Specialist in Regulation and Health Surveillance
General Management of Biological Products (GGBIO)
Brazilian Health Regulatory Agency (ANVISA)
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
Moderator: Giuseppe Randazzo, M.S.
Senior Vice President, Sciences and Regulatory Affairs, AAM
WEDNESDAY, OCTOBER 29, 2025
12:00 p.m. – 1:00 p.m.
Global and U.S. Generics and Biosimilars: Trends, Issues and Outlook
Scott Biggs
Director, Supplier Services, IQVIA
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
