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

Panel

Session 2 Q&A Session with Panel

Tue, Dec 1, 2026 · 2:45–3:30 PM EST The Universities at Shady Grove, Building II

Speakers

  • William (Billy) C. Smith

    Research Scientist, DPQR V, OPQR, OPQ, CDER · FDA

    Moderator

  • Jankiben Andhariya

    Senior Scientific Reviewer, DB II, OB, OGD · FDA

    Panelist

  • Diane J. Burgess

    Distinguished Professor of Pharmaceutics, Pfizer Distinguished Endowed Chair in Pharmaceutical Technology · University of Connecticut

    Panelist

  • Andrew Clark

    Senior Director, Research and Strategy · digiM Solution LLC

    Panelist

  • Coleman Johnson

    Postdoctoral Research Fellow, OPQR, OPQ, CDER · FDA

    Panelist

  • Ajay J. Khopade

    Vice President & Head, Formulation Development (Non-Orals) · Sun Pharmaceutical Industries Limited R&D

    Panelist

  • Naresh Mittapelly

    Senior Research Scientist, Mechanistic Modelling & Simulation · Certara Predictive Technologies (Simcyp Division)

    Panelist

  • Haiou Qu

    Staff Fellow, OPQR, OPQ, CDER · FDA

    Panelist

  • Dinesh Satone

    General Manager · Orbicular Pharmaceutical Technologies Ltd.

    Panelist

  • Jaymin Shah

    Senior Research Fellow and Global Head of Biopharmaceutics, Pharmaceutical Sciences Small Molecules · Pfizer

    Panelist

  • Feng Zhang

    Associate Professor, Molecular Pharmaceutics & Drug Delivery, College of Pharmacy · The University of Texas at Austin

    Panelist