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  • All
  • Monday, November 8, 2021
  • Tuesday, November 9, 2021
  • Wednesday, November 10, 2021
9:30 a.m. – 9:45 a.m. EST
State of AAM Address

Dan Leonard
President and CEO, AAM

9:45 a.m. – 10:00 a.m. EST
FDA Commissioner Keynote Address

Janet Woodcock, M.D.
Acting Commissioner, Food and Drug Administration

10:00 a.m. – 10:30 a.m. EST
CMS Keynote Address: Promoting Competition through Payment and Coverage Policy

Kristi Martin
Senior Advisor, Center for Medicare, Centers for Medicare & Medicaid Services

10:30 a.m. – 11:00 a.m. EST
Networking Break
11:00 a.m. – 11:30 a.m. EST
CDER Keynote Address

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

11:30 a.m. – 12:00 p.m. EST
Biosimilars Keynote Address

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

Noon – 1:00 p.m. EST
Networking Break
2:30 p.m. – 3:30 p.m. EST
3:30 p.m. EST
Day 1 Concludes
9:00 a.m. – 10:00 a.m. EST
OGD/OPQ/OC Keynote Address

Sally Choe, PhD
Director, Office of Generic Drugs (OGD), CDER, FDA

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

Donald Ashley, JD
Director, Office of Compliance (OC), CDER, FDA

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
OSE Keynote Address

Gerald Dal Pan, M.D., MHS
Director, Office of Surveillance and Epidemiology (OSE), CDER, FDA

11:00 a.m. – 12:00 p.m. EST
Networking Break
Noon – 1:30 p.m. EST
GRx+Biosims Learning Tracks
1:30 p.m. – 2:30 p.m. EST
2:30 p.m. – 3:30 p.m. EST
3:30 p.m. EST
Day 2 Concludes
9:00 a.m. – 9:30 a.m. EST
The Role of Quality in Accessible Medicines

Ronald Piervincenzi, PhD
Chief Executive Officer, United States Pharmacopeia

9:30 a.m. – 11:00 a.m. EST
Manufacturers’ Roundtable – Ensuring Biosimilars Sustainability

In this session, senior industry leaders will explore the sustainability of biosimilar development in the context of evolving manufacturing, policy and commercial considerations.

Table Setter: Anil Okay
Chief Commercial Officer, Alvotech

Moderator: Christine Simmon
Executive Director, Biosimilars Council
Executive Vice President, Policy and Strategic Alliances, AAM

Keren Haruvi
President of Sandoz US and Head of North America, Sandoz Inc.

Anshuman Patwardhan, PhD, MBA
Senior Vice President, Global Licensing & Business Development – Biologics, Lupin Pharmaceuticals

Paul Thomas
Chief Commercial Officer – United States, Biocon Biologics Inc.

11:00 a.m. – 12:00 p.m. EST
Networking Break
Noon – 1:00 p.m. EST
2:30 p.m. – 3:30 p.m. EST
GRx+Biosims Workshop

*Agenda is subject to change

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