Dan Leonard
President and CEO, AAM

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

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

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

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

Streamlined Biosimilar Development: Global Challenges and Opportunities

The Post-COVID Inspection World: New Tools, Lessons Learned and Future Challenges

In Vitro Characterization Based Approaches for Demonstrating Equivalence of Locally Acting Complex Generic Drug Products

Medicare Part D and Opportunities to Increase Biosimilars and Generics Utilization

Improving Collaboration for REMS

CARES Act – Additional Reporting Requirements for Manufactures

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

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

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

In Vitro Immunogenicity Methods for Biosimilars

Combination Products & Similarity

Patient Centric Dissolution Testing: Biopharmaceutics Risk Framework

Increasing Biosimilars Adoption: Providers’ and Patients’ Perspectives

Approval Pathways for Complex Generics – 505(j) vs. 505(b)(2)

1:30 p.m. – 3:30 p.m. EST

Nitrosamines in Pharmaceuticals: Where the Industry and Agency Stands

Generic Drug Case Law

Commonly Occurring BE Inquiries in Post Complete Response Letter Meetings: Case Studies

Ronald Piervincenzi, PhD
Chief Executive Officer, United States Pharmacopeia

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.

Outstanding Legal & Regulatory Issues for Biosimilars

Understanding Regulatory Expectations for Post-Approval Changes in ANDAs

Generic Drug Cluster – FDA Global Efforts

ICH Q12:  Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management: Industry and FDA Perspectives

1:00 p.m. – 3:00 p.m.

Best Practices and Strategies for Communication with FDA

Innovation in Generic Drug Development and Assessment

Complex Generics Town Hall