FDA/CRCG Workshop on Long-Acting Injectable (LAI) Generics 2026

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Welcome by CRCG & FDA

Anna Schwendeman, University of Michigan · Sam Raney, FDA

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FDA Opening Remarks

Darby Kozak, FDA

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Session 1: Critical Aspects of LAI Development: Speaker Introductions

Young Kuk Jhon, FDA

Talk

Landscape, Progress, and Unresolved Challenges of LAI Generics

Bin Qin, FDA

Talk

Development Challenges and Manufacturing Hurdles in Long-Acting Injectables (LAI) Products

Nirav Khatri, Dr. Reddy's Laboratories Ltd.

Talk

Challenges in Reverse Engineering of Generic LAI Products

Daniel Wehrung, American Regent, Inc.

Talk

Common Drug Product Quality Deficiencies of Generic LAI products

Kai Kwok, FDA

Talk

Excipient Quality Challenges, Standards, and Solutions for LAIs

Peng Zhang, USP

Talk

Q1/Q2 Sameness in LAI Generics: Practical Challenges with Legacy Products and Pathways to Q3 Similarity

Richard Rittenschober, Sandoz

Talk

Peptide Stability in Peptide-PLGA Microspheres

Steve Schwendeman, University of Michigan

Panel

Session 1 Q&A Session with Panel

Young Kuk Jhon, FDA · Nirav Khatri, Dr. Reddy's Laboratories Ltd. · Kai Kwok, FDA · Bin Qin, FDA · Richard Rittenschober, Sandoz · Bhasker Sambar, Alvogen Inc. · Steve Schwendeman, University of Michigan · Daniel Wehrung, American Regent, Inc. · Peng Zhang, USP

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Session 2: Drug Release Mechanism Understanding of LAI products: Speaker Introductions

William (Billy) C. Smith, FDA

Talk

IVRT Methods for Different Types of Dosages

Jankiben Andhariya, FDA

Talk

Challenges in the Development of Generic Microsphere Products

Ajay J. Khopade, Sun Pharmaceutical Industries Limited R&D

Talk

Mechanistic Drug Release as a Foundation for Formulation Design and BE in LAI Generics

Naresh Mittapelly, Certara Predictive Technologies (Simcyp Division)

Talk

Understanding the Complex Interplay of Formulation Aspects, Processing, and Microstructure on Drug Release Mechanisms from LAI Suspensions

Diane J. Burgess, University of Connecticut

Talk

IVRT Method for In Situ Forming System: Best Practice and Method Validation

Haiou Qu, FDA

Talk

IVR and IVIVC in Preclinical Species of In Situ Depot

Jaymin Shah, Pfizer

Talk

Development of Accelerated IVRT for PDMS-based Drug Delivery Systems: Comparison of Empirical and Semi-Empirical Approaches

Coleman Johnson, FDA

Talk

Elucidation of Drug Release Mechanisms of Ethylene Vinyl Acetate Based Implant

Feng Zhang, The University of Texas at Austin

Talk

LAI Microstructure and Drug Release Prediction

Andrew Clark, digiM Solution LLC

Panel

Session 2 Q&A Session with Panel

William (Billy) C. Smith, FDA · Jankiben Andhariya, FDA · Diane J. Burgess, University of Connecticut · Andrew Clark, digiM Solution LLC · Coleman Johnson, FDA · Ajay J. Khopade, Sun Pharmaceutical Industries Limited R&D · Naresh Mittapelly, Certara Predictive Technologies (Simcyp Division) · Haiou Qu, FDA · Dinesh Satone, Orbicular Pharmaceutical Technologies Ltd. · Jaymin Shah, Pfizer · Feng Zhang, The University of Texas at Austin

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Closing Remarks for Virtual Audience

Yan Wang, FDA

Workshop

Session 3: Small Working Group Sessions (In-Person Only)

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Session 4: Alternative Bioequivalence Approaches and Alternative Pharmacokinetics Study Designs: Speaker Introductions and Day 1 Summary

Bin Qin, FDA

Talk

Challenges in Planning and Conducting In Vivo BE Studies for LAI Using Conventional Approaches

Alhan Oraha, Apotex Inc.

Talk

Alternative Study Designs for Conducting PK BE Study for LAI Products

Yuqing Gong, FDA

Talk

Application of Suitable Statistical & Simulation Methods for Two-Stage Design Approach for a Parallel or Replicated (Full/Partial) Crossover Design BE Studies for LAI Products

Hiren Mehta, Veeda Lifesciences Ltd.

Talk

In Vitro BE Approach for LAIs: Waiving PK BE Study

Qiangnan Zhang, FDA

Talk

Classification System for Biopharmaceutics of Long-Acting Parenteral Products

Simone Perazzolo, University of Washington

Panel

Session 4 Q&A Session with Panel

Bin Qin, FDA · Andrew Babiskin, FDA · Yuqing Gong, FDA · Martin Klein, FDA · Hiren Mehta, Veeda Lifesciences Ltd. · Alhan Oraha, Apotex Inc. · Simone Perazzolo, University of Washington · Andrew Shaw, Viatris, Inc. · Qiangnan Zhang, FDA

Workshop

Session 5: Small Working Group Sessions (In-Person Only)

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Session 6: Orientation to Meet and Learn Session

Sam Raney, FDA

Roundtable

Session 6: Meet and Learn Session (In-Person Only)

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Session 7: Accelerating LAI Generic Development Using Model-Integrated Evidence: Speaker Introductions

Yuqing Gong, FDA

Talk

The Emerging Role of Model-Integrated Evidence (MIE) in Generic LAI Development: Industry Perspectives & Case Studies

Sivacharan Kollipara, Dr. Reddy's Laboratories Ltd.

Talk

Integrating Mechanistic Modeling into Successful Development Programs of LAIs: Industry Insights

Sunil S. Iyer, Zydus Lifesciences Limited

Talk

Integrating In Vitro and In Vivo Evidence Using PBPK Modeling for PLGA LAI Product BE Demonstration

Khondoker Alam, FDA

Talk

Mechanistic PBPK Modeling Strategies to Accelerate Generic Long-Acting Injectable Development

James Mullin, Simulations Plus, Inc.

Talk

PBPK Model-Based Virtual Bioequivalence Assessment of LAI Suspensions: A Simcyp-Pirana Workflow

Natalie Morris, Certara

Talk

Modeling to Accelerate LAI Generic Development: Extrapolate Pre-clinical to Clinical/Pilot to Pivotal

Allison Dunn, University of Maryland School of Pharmacy

Panel

Session 7 Q&A Session with Panel

Yuqing Gong, FDA · Tausif Ahmed, Mankind Research Centre · Khondoker Alam, FDA · Allison Dunn, University of Maryland School of Pharmacy · Sunil S. Iyer, Zydus Lifesciences Limited · Sivacharan Kollipara, Dr. Reddy's Laboratories Ltd. · Natalie Morris, Certara · James Mullin, Simulations Plus, Inc. · Prasad N.V. Tata, American Regent Inc. · Eleftheria Tsakalozou, FDA

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Workshop Closeout

Lanyan (Lucy) Fang, FDA