Fiscal Year 2025 Generic Drug Science and Research Initiatives Public Workshop June 3 - 4, 2025

Workshop | Mixed

• Date: June 3 - 4, 2025
• Day1: Tue, Jun 3
• Day2: Wed, Jun 4

On this page: About This Workshop | Workshop Recordings | Presentation Downloads | Meeting Transcripts

About This Workshop

The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from the generic drug industry, academia, patient advocates, professional societies, and other interested parties, as it fulfills its commitment under the Generic Drug User Fee Amendments of 2022 (GDUFA III) to develop an annual list of science and research initiatives specific to generic drugs. FDA will consider the information from the public workshop when developing its Fiscal Year (FY) 2026 Generic Drug User Fee Amendments (GDUFA) science and research priorities.

Topics discussed during the workshop will focus on research that is needed to address scientific knowledge gaps and associated challenges impacting the development and regulatory assessment of generic products, including complex generics. The sessions of this year’s workshop will focus on what research is needed to clarify implementation details and potential guidance recommendations related to, but not limited to:

• Complex active pharmaceutical ingredients, potentially including immunogenicity issues
• Complex products, potentially including inhalation products, complex injectable products, and drug device combination products
• Oral products, potentially including considerations relevant to ICH M13A, challenges with BCS Class IV drugs, and the feasibility of waiver approaches for modified release products

A common theme across the sessions of the workshop will be to consider what research is needed to overcome challenges for generic product development by establishing approaches that integrate evidence from empirical tests or studies with evidence from computational modeling and simulation. Each session of this year’s workshop will include presentations and a panel discussion with representatives from the generic drug industry, academia, and FDA.

Audience

Members of the generic drug industry, scientists/researchers, clinicians, regulatory affairs professionals, and patient advocates who work on or are interested in research that advances the development of generic drugs.

FDA wants your input

FDA seeks ideas on generic drug research topics from the drug industry, academia, patient advocates, professional societies, and other interested parties. FDA is particularly interested in receiving public input about the FY 2026 research priorities for generic drugs. You may submit your ideas for potential topics for the FY 2026 GDUFA Science and Research Priorities by submitting a comment on the public docket (FDA-2023-N-0119) on or before 11:59 p.m. Eastern Time at the end of July 7, 2025.

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Workshop Recordings

Opening Session

• Opening Remarks and Overview of the GDUFA Science and Research Program

Session 1: Assessment Challenges with Complex Active Ingredients: Peptides & Oligonucleotides 

• Presentations and Panel Discussion

Session 2: Tackling Formulation Sameness and Advancing In Vitro Characterization for Bioequivalence of Complex Generic Products 

• Presentations and Panel Discussion

Session 3: Future Horizons for Assessing the Bioequivalence of Complex Products: Challenges in the Next Five Years 

• Presentations and Panel Discussion

Session 4: Implementation of the M13A Guidance: Lessons Learned and Advances for Immediate Release Products 

• Presentations
• Panel Discussion

Session 5: Challenges and Opportunities for Modified Release Generic Products

• Presentations
• Panel Discussion and Closing Remarks

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Presentations

Opening Session

• Opening Remarks, Office of Pharmaceutical Quality (PDF – 940 KB)
  Susan Rosencrance, PhD 
  Deputy Super Office Director, OPQ, CDER, FDA
• Opening Remarks, Office of Generic Drugs (PDF – 726 KB)
  Iilun Murphy, MD 
  Super Office Director, OGD, CDER, FDA
• Overview of the GDUFA Science and Research Program (PDF – 655 KB)
  Robert Lionberger, PhD 
  Director, ORS, OGD, CDER, FDA

Session 1: Assessment Challenges with Complex Active Ingredients: Peptides & Oligonucleotides

• Immunogenicity Risk Assessment of Peptides: Progress and Remaining Challenges (PDF – 656 KB)
  Eric Pang, PhD 
  Senior Chemist, DTP I, ORS, OGD, CDER, FDA 
• Generic Oligonucleotides – Challenges and Opportunities (PDF – 670 KB)
  Likan Liang, PhD 
  Supervisory Pharmaceutical Scientist, DPQA X, OPQA II, OPQ, CDER, FDA
• Challenges in Immunogenicity Risk Assessment for Complex Active Ingredients (PDF – 1 MB)
  MK Pananchukunnath, MCP
  Chief Scientific Officer, Biocon Ltd.
• Research Initiatives for Harmonization of Immunogenicity Risk Assessments for Generic Peptides (PDF – 1.8 MB)
  Andrew Graves, MS, SCYM
  Director, Immunogenicity Assessment, Teva Pharmaceutical Industries Ltd.
• Immunogenicity of Oligonucleotides (PDF – 2.9 MB)
  Sudhir Agrawal, DPhil
  President, ARNAY Sciences; Affiliate Professor, University of Mass.
• Immunological Challenges Associated with Nucleic Acid-Based Therapeutics (PDF – 8.1 MB)
  Raman Bahal, PhD 
  Associate Professor, Univ. of Connecticut 

Session 2: Tackling Formulation Sameness and Advancing In Vitro Characterization for Bioequivalence of Complex Generic Products

• Challenges with Method Standardization for Inhalation and Nasal Drug Products (PDF – 1.6 MB)
  Susan Boc, PhD
  Pharmacokineticist, DTP I, ORS, OGD, CDER, FDA
• Biopredictive In Vitro Characterization to Correlate Quality Attributers to In Vivo Performance (PDF – 923 KB)
  Hailing Zhang, PhD 
  Division Director, DPQA XII, OPQA II, OPQ, CDER, FDA
• Advancing In Silico Methods & Understanding the Impact of Compositional Differences on Performance (PDF – 420 KB)
  Ross Walenga, PhD
  Senior Chemical Engineer, DQMM, ORS, OGD, CDER, FDA
• Research Opportunities to Support Further PSG Development for Orally Inhaled Products (PDF – 884 KB)
  Andrew Cooper, PhD 
  Sr. Director, Development for In-Vitro Performance Lead, Viatris Inc.
• Enhanced PBPK-Based IVIVE Method to Support the Development of Pulmonary Drug Products (PDF – 3.1 MB)
  Maxime Le Merdy, PhD 
  Director, PBPK Research and Collaboration, Simulations Plus
• Microstructural Techniques for Demonstrating Bioequivalence in Dry Powder Inhalers (PDF – 1.8 MB)
  Nuria Manzano Jurado, BSc 
  Specialist, R&D Pharma Services, Nanopharm
• Application of Mechanistic PBPK Modeling to Understand Drug Release from PLGA-Based Solid Implants (PDF – 1.3 MB)
  Naresh Mittapelly, PhD 
  Research Scientist II, Certara UK Ltd, United Kingdom
• The Utility of In Silico Modelling and Substitution Risk for Generic Orally Inhaled Drugs (PDF – 1.3 MB)
  Clare Butler, BSc, PhD 
  Principal Product Development Scientist, Respiratory R&D, Teva Pharma

Session 3: Future Horizons for Assessing the Bioequivalence of Complex Products: Challenges in the Next Five Years

• Establishing Equivalence of TDS and OIDPs (PDF – 1.6 MB)
  Priyanka Ghosh, PhD 
  Lead Pharmacologist, DTP I, ORS, OGD, CDER, FDA
• FDA’s Perspectives on Current Quality and Bioequivalence Challenges for Complex Products (PDF – 913 KB)
  Andre O’Reilly Beringhs, PhD
  Staff Fellow, DTP I, ORS, OGD, CDER, FDA
  and
  Renishkumar Delvadia, PhD
  Senior Staff Fellow, DPQA VIII, OPQA II, OPQ, CDER, FDA
• Challenges and Opportunities for Complex Generic Products (PDF – 1.1 MB)
  Brandon Wood, BSc 
  Sr. Director, RA I & Combination Products Liaison, Teva Pharma USA, Inc.
• Evolving Technologies Shaping New Research Needs for Future Pulmonary and Nasal Generics (PDF – 1.8 MB)
  Carla Vozone, PharmD, MBA 
  Vice President Specialty Drug Delivery, Catalent Pharma Solutions
• A Taxonomy for Categorizing User Interface Design in Medical Device Development: Human Factors Application, Development Opportunities, and Potential Integration of AI and Machine Learning (PDF – 3.2 MB)
  Megan Conrad, PhD
  Associate Professor of Mechanical Engineering, University of Detroit Mercy
  and
  Mary Beth Privitera, MDes, PhD 
  Professor, Biomedical Engineering, University of Cincinnati
• Industry Insight: Clarity and Consistency for Complex Generics (PDF – 328 KB)
  Russell J. Rackley, PhD
  Global Head, Clinical Pharmacology, Viatris

Session 4: Implementation of the M13A Guidance: Lessons Learned and Advances for Immediate Release Products

• Amorphous Solid Dispersion (ASD) Products and Potential Alternative BE Approaches (PDF – 1.9 MB)
  Girish Nihalani, MS 
  Associate Director, Product Development at Hikma Pharmaceuticals USA Inc.
• Dissolution of Amorphous Solid Dispersions and Absorption of Poorly Soluble Drugs (PDF – 6.2 MB)
  Geoff G. Z. Zhang, PhD,
  FAAPS Founder, Chief Technical Director, ProPhysPharm LLC
• Modeling & Simulation Tools as Alt. BE Approaches for BCS IV & High-Risk Prods: Generic Industry Perspective (PDF – 3.7 MB)
  Sivacharan Kollipara, MS 
  Head, Biopharmaceutics, Dr. Reddy’s Laboratories Ltd., India
• Advancing IVIVC in Lipid-Based Formulations: Addressing In Vitro Dissolution Challenges for BA Correlations (PDF – 2 MB)
  Sandip Tiwari PhD 
  Head of Technical Services, Pharma Solutions, NA, BASF Corporation
• Enhancing Patient BE Studies Using Model-Integrated Evidence (MIE) (PDF – 516 KB)
  Yuqing Gong, PhD 
  Senior Pharmacologist, DQMM, ORS, OGD, CDER, FDA

Session 5: Challenges and Opportunities for Modified Release Generic Products

• Considerations for Additional Strength Waivers of MR Products (PDF – 329 KB)
  James E. Polli, PhD 
  Co-Director, CRCG and Prof., University of Maryland
• Unlocking Strength Scaling for Extended-Release Tablet Development: Research Gaps and Opportunities (PDF – 4.1 MB)
  Jie Shen, PhD 
  Associate Professor of Pharmaceutical Sciences, Northeastern University
• Advancing Generic MR Product Development Using Tiny-TIMsg to Predict In Vivo Performance (PDF – 1.3 MB)
  Lieke van den Elsen, PhD 
  Scientific Advisor, InnoGI Technologies
• Criteria to Decide Whether pAUCs Are Appropriate BE Metrics and Alternatives When They Are Not (PDF – 386 KB)
  Charles E. DiLiberti, MS 
  President, Montclair Bioequivalence Services, LLC
• Opportunities and Challenges with IR/MR Dosage Forms in Lipid-Based Formulations (PDF – 3.3 MB)
  Karunakar (Karu) Sukuru, RPh, PhD
  Global VP, Pharma Product Development, Catalent Pharma Solutions
• Quality Control of 3D Printed Controlled Release Dosage Forms in Distributed Manufacturing Networks (PDF – 2.7 MB)
  Stephen Hoag, PhD 
  Professor, University of Maryland at Baltimore

Closing Session

• Challenges and Opportunities Related to the Development of Generic Drugs (PDF – 25.3 MB)
  Anna Schwendeman, PhD 
  Co-Director, CRCG and Prof., Univ. of Michigan

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Meeting Transcripts

Transcripts were generated by artificial intelligence and may contain errors

Day 1

• Opening Remarks (PDF – 204 KB)
• Session 1 (PDF – 373 KB)
• Session 2 (PDF – 346 KB)
• Session 3 (PDF – 346 KB)

Day 2

• Session 4 (PDF – 331 KB)
• Session 5 and Closing Remarks (PDF – 352 KB)

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Event Materials

Title	File Type/Size
FY 2025 gdufa public workshop agenda	pdf (221.66 KB)
FY25 GDUFA Public Workshop Speaker Biographies	pdf (285.67 KB)