AGENDA

John Murphy III
President & CEO, AAM

Leveraging AI and Automation to Strengthen Regulatory Processes
Sterility Assurance Expectations for Generic and Biosimilar Sterile Products

What ICH M18 Must Deliver: Framing Global Convergence on Streamlined Biosimilar Development

Legislative Outlook: Riders to the User Fee Packages and Other Topics

Advancing Generic and Biosimilar Development, Review, Approval, and Market Entry
Best Practices for Post-Approval Changes (PACs/SUPAC)

Innovation and Next Generation Biosimilars

RFID

Device Considerations for Therapeutic Equivalence and Interchangeability
GDUFA IV Updates
The Future of Quality and Supply: Site Transfers, and Manufacturing Resilience

Biosimilars and Healthcare Practitioner Education

Evolving Bioequivalence Approaches for Complex Generics and Long-Acting Injectables
Scaling U.S.-Based Generic Drug Manufacturing: From Policy Signals to Practical Adoption

BsUFA IV Updates

Elizabeth Miller, PharmD 
Acting Deputy Associate Commissioner for Inspections and Investigations (DACII), FDA 

Enhancing Inspection and Remote Assessment Efficiencies to Reduce Approval Delays
Peptides: Harmonization, Nonclinical Immunogenicity, and Post-Approval Requirements

Streamlined Biosimilar Development: Front-Loading Analytical Similarity and Decisions about Clinical Efficacy Studies

Drug Shortages

This workshop will explore new opportunities and approaches for directly engaging industry experts in the GDUFA research program. Participants will discuss potential mechanisms for industry experts to inform the assessment of research projects, and to collaborate on the conduct of research activities. The workshop will also solicit generic drug industry input to inform FDA’s prioritization and development of product-specific guidances (PSGs). Discussions will also address what scientific and procedural details would make PSG recommendations clearer and more actionable, including recommended tests and studies, study-design considerations, analytical methods, and approaches for conducting and interpreting relevant assessments. A distinguishing feature of this year’s workshop will be structured small-group discussions that allow participants to engage directly with FDA, provide candid feedback, and develop practical recommendations for enhancing the GDUFA Research Program.

**Registration is required to attend. Space is limited and available on a first-come, first-served basis.**

Bing Cai, PhD
Division Director, OPQA I/OPQ/CDER/FDA FDA, OPQ

Orit Katzir , M.S.
Senior Director, Regulatory & Business Continuity, Sun Pharmaceuticals

Sam Raney, PhD
Associate Director for Science and Chief Scientific Advisor, ORS, OGD, CDER, FDA

Pahala Simamora, PhD
Division Director, DPQA IX, OPQA II, OPQ, CDER, FDA

Biopharmaceutics Risk Assessment Frameworks for Oral Solid Dosage Forms: Evolving Dissolution Testing and Regulatory Expectations
Forfeiture Analysis of 180-Day Paragraph IV Exclusivity: Industry Perspective

Pharmacovigilance and Biosimilar Naming: Practical Experience and Emerging Considerations

Red Tape Elimination and CES Bill

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.

Booth #1 Suitability Petition Pathway for ANDA – Key Considerations and Challenges
Booth #2 Inactive Ingredient Database (IID)
Booth #3 Use of Foreign RLD Comparators for ANDA/505(b)(2) Submissions
Booth #4 FDA Electronic Submissions
Booth #5 Bioequivalence Assessment Process and Strategy
Booth #6 Product Specific Guidance
Booth #7 Let’s Talk Filing
Booth #8 Unbranded Labeling for Biosimilars and the Differences From Authorized Generics
Booth #9 OGD Meet Your Regulatory Project Managers
Booth #10 Division of User Fees
Booth #11 Communicating with the Division of Labeling Review
Booth #12 Streamlining Biosimilar Development – Moving Beyond Phase III
Booth #13 Office of Therapeutic Biologics and Biosimilars Staff
Booth #14 Project Management Small Molecule
Booth #15 Timing Matters: How FDA Acknowledgment and Classification of Supplements Impacts Supply Continuity
Booth #16 Generic Drug Structured Assessment
Booth #17 Project Management Perspective
Booth #18 Pre-ANDA Meetings
Booth #19 Regulatory Science Program

Step into an evening where science meets celebration at the GRx+Biosims 2026 Dinner and Entertainment event. Enjoy a dynamic atmosphere inspired by innovation, collaboration, and discovery while USP’s house band, The Impurities, delivers a high-energy performance featuring rock-and-roll, punk, country, and pop favorites spanning decades—plus original material of their own. Known for energizing USP events, local venues, and major industry gatherings, The Impurities will keep the momentum going with a setlist designed to bring colleagues and industry peers together for a memorable night of music, connection, and fun.

Sponsored By:

Bob Hoffman
AAM Board Chair

Scott Biggs 
Director, Supplier Services, IQVIA

Sam Park, JD
General Counsel, Hikma Pharmaceuticals USA

Brandon Rockwell
President & COO, PAI Pharma

Arunesh Verma
President, Fresenius Kabi USA, LLC

Moderator: Bob Hoffman
AAM Board Chair

John Murphy III
President & CEO, AAM