AGENDA

David Gaugh, RPh
Executive Vice President, AAM

John Murphy, III
President & CEO, AAM

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
Executive Vice President, AAM

Iilun Murphy, M.D.
Director, Office of Generic Drugs (OGD), CDER FDA 

Interchangeability

ANDA Deficiency Trends: Common Issues to Improve ANDA Submission Quality

Solving Drug Shortages – Causes for Optimism?

Streamlining Biosimilars Development

Drug shortages: An Agency Perspective
Nitrosamines and Harmonization

Legal Overview of the BIOSECURE Act

Device Requirements for Biosimilars and Interchangeable Biosimilars

Best Practices for Securing Timely Approvals of ANDAs

Updates on Electronic Submissions

USP Excipient Nomenclature and Advanced Analytical Procedures for Characterization of Polymeric Excipients

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

Moderator: Giuseppe Randazzo
Senior Vice President, Sciences and Regulatory Affairs, AAM

Michael Rogers, MS
Associate Commissioner for Regulatory Affairs, Office of Inspections and Investigations (OII), Food and Drug Administration

Elizabeth Miller, PharmD
Deputy Associate Commissioner Medical Products, Office of Inspections and Investigations (OII), FDA

Multi-attribute method and non-clinical immunogenicity studies

Generic Drug-Device Combination Products – Evaluating Generic Combination Products and Navigating Differences
Product & Quality Threats and Opportunities: Extractables/Leachables

Biosimilars: Does Interchangeability Really Matter?

Regulatory Science Challenges for Complex Generics
Best Practices for Post-Approval Changes

Humira Biosimilar Adoption: Hints of Progress or Signs of Doom?

An interactive knowledge sharing session that brings together multiple levels of scientific disciplines from diverse sectors, industry, and agency. The expo is geared toward facilitating one-on-one interaction among these sectors to increase understanding on a scientific level. This year’s exposition is set to feature over 60 project managers from FDA’s OGD, OPQ, OTBB and OND providing a valuable opportunity for attendees to learn from these esteemed groups.

Highlighted Topics and Sessions at the Exposition:

o Office of Generic Drugs (OGD)
o Office of Pharmaceutical Quality (OPQ)
o Office of Management (OM)
o Office of Therapeutic Biologics and Biosimilars (OTBB)
o Office of New Drugs (OND)
o Comparative Use Human Factors Studies (CUHFS): An Alternative Approach
o Driving Efficiency of Pre-ANDA Communications
o Engaging the FDA to Improve the Quality of ANDA Submissions
o FDA Electronic Submissions
o Get to Know Generic Drug Structured Assessment – Bioequivalence (GDSA-BE)
o IRs and/or DRLs Late in the Review Cycle
o Get to know OGD’s Office of Safety and Clinical Evaluation
o Learn more about the Information Request (IR) and Discipline Review Letter (DRL) Regulatory Process
o Office of Compliance – Office of Drug Security, Integrity, and Response (Exports, Imports, Recalls, & Supply Integrity)
o OPQ: Best Practices for Securing Timely Approvals of ANDAs
o Overview of Generic Drug Application Review – USA FDA and Health Canada
o Per- and polyfluoroalkyl Substances (PFAS)
o Risk Evaluation and Mitigation Strategy (REMS)
o What GDUFA Research Can Do For You!

Welcome to AAM’s Tokyo Underground themed Karaoke Dinner & Entertainment, where the eclectic vibes of Tokyo meet the underground music scene! Warm up your vocal cords and join us for live band karaoke. Get ready to sing and dance the night away!

Robert Califf, M.D., MACC
 Commissioner, Food and Drug Administration

Moderator: David Gaugh, R.Ph.
Executive Vice President, AAM

Keren Haruvi
AAM Board Chair

Sonia Oskouei, PharmD
Vice President & U.S. Head, Biosimilars and Specialty, Sandoz

Mary Pietryga
Vice President, Global Marketing, Teva Pharmaceuticals

Joshua Salsi
Head of North America Commercial, Biocon Biologics Ltd.

Moderator: Craig Burton
Senior Vice President, Policy and Strategic Alliances, AAM
Executive Director, Biosimilars Council

CAPT Tara Gooen Bizjak 
Director, Manufacturing Quality Guidance and Policy Staff, OC, CDER, FDA

Alonza Cruse 
Director, Office of Human and Animal Drug Inspectorate, OII, FDA

Sarah Ibrahim, PhD 
Associate Director for Stakeholder and Global Engagement, IO, OGD, CDER, FDA

Emanuela Lacana, PhD
Deputy Director, OTTB, OND, CDER, FDA

Rakhi Shah, PhD 
Associate Director, OPMA, OPQ, CDER, FDA

Moderator: Giuseppe Randazzo
Senior Vice President, Sciences and Regulatory Affairs, AAM

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

John Murphy, III
President & CEO, AAM