Webcast | Virtual

Event Title

FY 2021 Generic Drug Science and Research Initiatives Public Workshop

June 23, 2021

Date:: June 23, 2021

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Presentation	Presenters
Welcome, Keynote, and Industry Survey Results - GDUFA Science and Research Initiatives Public Workshop	Welcome to the 2021 GDUFA Public Workshop Sally Choe, PhD Director, Office of Generic Drugs (OGD), FDA Keynote Speaker for the 2021 GDUFA Public Workshop Janet Woodcock, MD Acting Commissioner, FDA Introduction to the 2021 GDUFA Public Workshop Robert Lionberger, PhD Director, Office of Research and Standards (ORS), OGD, FDA Generic Industry Perspectives: A Summary of Survey Feedback from Industry Stakeholders James Polli, PhD Co-Director, Center for Research on Complex Generics (CRCG) A Summary of Interview Feedback from Industry Stakeholders Anna Schwendeman, PhD Co-Director, CRCG
Generic Industry Challenge Perspectives - GDUFA Science and Research Initiatives Public Workshop	Generic Industry Challenges #1: Model-Integrated Evidence for Generic Drug Development Community Trust in Modelling & Simulation: The Move from Scientific Curiosity to Ingrained Industrial Applications Amin Rostami, PhD Prof. of Systems Pharmacology, Univ. of Manchester / CSO, Certara Model-Integrated Evidence for Generic Drug Development Liang Zhao, PhD Director, DQMM, ORS, OGD, FDA Generic Industry Challenges #2: Complex Product Characterization/Analysis Complex Product Characterization and Analysis Challenges for Oligonucleotide and Liposomal Drug Products Zdenko Casar, PhD Head Early Stage Development Slovenia, Lek Pharm. d.d., Sandoz Pharm. Scientific Approaches for the Analytical Characterization of Complex Generic Products Rachel Dunn, PhD Director, DPA, OTR, OPQ, FDA Generic Industry Challenges #3: In Vitro & In Vivo BE Approaches: Challenges & Opportunities Challenges and Opportunities of Complex Clinical Bioequivalence Studies Beatriz North, MPH Senior Director, Global Clinical Affairs, Perrigo Pharm. Advancing Regulatory Science Through Innovative Bioequivalence Approaches Partha Roy, PhD Director, OB, OGD, FDA
Public Comment - GDUFA Science and Research Initiatives Public Workshop	Prepared Public Comments
Panel Discussion with Generic Industry - GDUFA Science and Research Initiatives Public Workshop	Generic Industry Perspectives: A Panel Discussion Moderator: Robert Lionberger, PhD Director, ORS, OGD, FDA Panelists: James Polli, PhD Co-Director, CRCG Anna Schwendeman, PhD Co-Director, CRCG Amin Rostami, PhD Prof. of Systems Pharmacology, Univ. of Manchester / CSO, Certara Pradeep Bhadauria, MPharm CSO, Cipla Pharm. Molly Ventrelli, PhD Senior VP, Regulatory Affairs, Fresenius Kabi Janet Vaughn VP Regulatory Affairs, Teva Pharm. Rosario LoBrutto, PhD Executive Director, Head of Scientific Affairs, Sandoz Pharm. Karthik Balasubramanian, PhD Director, Generic Combination Product Development, Teva Pharm. Kiran Krishnan, PhD Senior VP Global Regulatory and Medical Affairs, Apotex Corp. Beatriz North, MPH Senior Director, Global Clinical Affairs, Perrigo Pharm. Zdenko Casar, PhD Head Early Stage Development Slovenia, Lek Pharm. d.d., Sandoz Pharm.
Model-Integrated Evidence for Generic Drug Development – Session 1A	Current Limitations in Producing a Fully Mechanistic PBPK Model for a Highly Soluble Orally Inhaled Drug Product That Exhibits Slow Lung Absorption Danny Brinkley, BSc Director, Global Inhalation, R&D, Teva Pharm. Integrated Computational Fluid Dynamics-Physiology-Pharmacokinetics Tools for Development and Evaluation of Orally Inhaled Drug Products Andrzej Przekwas, PhD CTO, CFD Research Corporation Panel Discussion (Sub-Session 1A) Moderator: Andrew Babiskin, PhD Team Lead, DQMM, ORS, OGD, FDA Panelists: Danny Brinkley, BSc Director, Global Inhalation, R&D, Teva Pharm. Andrzej Przekwas, PhD CTO, CFD Research Corporation Guenther Hochhaus, PhD Prof., Department of Pharmaceutics, Univ. of Florida Ross Walenga, PhD Reviewer, DQMM, ORS, OGD, FDA Andrew Cooper, PhD Head of Analytical Control & Development, Viatris Global Respiratory Group
Model-Integrated Evidence for Generic Drug Development – Session 1B	Model Integrated Methods for Generic LAI Product Development and Regulatory Assessment: Current Status and Future Research Directions Andrew Hooker, PhD Prof. of Pharmacometrics, Uppsala Univ. How Can Model Integrated Evidence Accelerate LAI Generic Availability? Joga Gobburu, PhD Prof., School of Pharmacy and Medicine, Univ. of Maryland Panel Discussion (Sub-Session 1B) Moderator: Lanyan (Lucy) Fang, PhD Deputy Director, DQMM, ORS, OGD, FDA Panelists: Andrew Hooker, PhD Prof. of Pharmacometrics, Uppsala Univ. Joga Gobburu, PhD Prof., School of Pharmacy and Medicine, Univ. of Maryland Liang Zhao, PhD Director, DQMM, ORS, OGD, FDA Keith Gallicano, PhD Pharmaceutical Consultant Xiaoming Xu, PhD Lab Chief, Branch III, DPQR, OTR, OPQ, FDA
Model-Integrated Evidence for Generic Drug Development – Session 1C	Artificial Intelligence in Pharmaceutics Defang Ouyang, PhD Assistant Professor, Univ. of Macau Artificial Intelligence in Generic Drug Development – Experience and Opportunities Jerneja Opara, PhD Leading Scientist, Sandoz Pharm. Improving Generic Drugs and Streamlining Their Approval Through Artificial Intelligence Charlie DiLiberti, PhD President, Montclair Bioequivalence Services, LLC Panel Discussion (Sub-Session 1C) Moderator: Meng Hu, PhD Team Lead, DQMM, ORS, OGD, FDA Panelists: Defang Ouyang, PhD Assistant Prof., Univ. of Macau Jerneja Opara, PhD Leading Scientist, Sandoz Pharm. Charlie DiLiberti, PhD President, Montclair Bioequivalence Services, LLC Stella Grosser, PhD Director, DB-VIII, Office of Biostatistics, OTS, FDA Liang Zhao, PhD Director, DQMM, ORS, OGD, FDA Robert Lionberger, PhD Director, ORS, OGD, FDA Donald Mager, PhD Prof. and Vice Chair, Department of Pharmaceutical Sciences, SUNY Robert Bies, PhD Associate Prof., Department of Pharmaceutical Sciences, SUNY
Complex Product Characterization/Analysis - Session 2A	Industry Perspective on the Gaps in Complex Generic Product Characterization and Future Directions Rosario LoBrutto, PhD Executive Director, Head of Scientific Affairs, Sandoz Pharm. Panel Discussion (Sub-Session 2A) Moderator: Markham Luke, MD, PhD Director, DTP-I, ORS, OGD, FDA Panelists: Rosario LoBrutto, PhD Executive Director, Head of Scientific Affairs, Sandoz Pharm. Darby Kozak, PhD Deputy Director, DTP-I, ORS, OGD, FDA A Malleswara Reddy, PhD Head Analytical R&D, Dr. Reddy’s Laboratories Limited Pahala Simamora, PhD Director, DLBP-II, OLDP, OPQ, FDA Ravi Patel, MS Assistant VP and Head Of R&D, Cosette Pharm. Dama Venugopala Rao, PhD Analytical Expert, Dr. Reddy’s Laboratories Limited Ramnarayan Randad, PhD Branch Chief, Branch II, DLAPI, ONDP, OPQ, FDA Kevin Hawkins, PhD Senior Director, Drug Development R&D Operations (Steriles), Teva Pharm.
Complex Product Characterization/Analysis - Session 2B	Demonstrating Complex Generic Product Equivalence: Benefits & Considerations When Using New Analytical Methods Darby Kozak, PhD Deputy Director, DTP-I, ORS, OGD, FDA Panel Discussion (Sub-Session 2B) Moderator: Markham Luke, MD, PhD Director, DTP-I, ORS, OGD, FDA Panelists: Rosario LoBrutto, PhD Executive Director, Head of Scientific Affairs, Sandoz Pharm. Darby Kozak, PhD Deputy Director, DTP-I, ORS, OGD, FDA A Malleswara Reddy, PhD Head Analytical R&D, Dr. Reddy’s Laboratories Limited Pahala Simamora, PhD Director, DLBP-II, OLDP, OPQ, FDA Ravi Patel, MS Assistant VP and Head Of R&D, Cosette Pharm. Dama Venugopala Rao, PhD Analytical Expert, Dr. Reddy’s Laboratories Limited Ramnarayan Randad, PhD Branch Chief, Branch II, DLAPI, ONDP, OPQ, FDA Kevin Hawkins, PhD Senior Director, Drug Development R&D Operations (Steriles), Teva Pharm.
Complex Product Characterization/Analysis - Session 2C	Analytical Methods to Support Generic Drug Bioequivalence A Malleswara Reddy, PhD Head Analytical R&D, Dr. Reddy’s Laboratories Limited Panel Discussion (Sub-Session 2C) Moderator: Markham Luke, MD, PhD Director, DTP-I, ORS, OGD, FDA Panelists: Rosario LoBrutto, PhD Executive Director, Head of Scientific Affairs, Sandoz Pharm. Darby Kozak, PhD Deputy Director, DTP-I, ORS, OGD, FDA A Malleswara Reddy, PhD Head Analytical R&D, Dr. Reddy’s Laboratories Limited Pahala Simamora, PhD Director, DLBP-II, OLDP, OPQ, FDA Ravi Patel, MS Assistant VP and Head Of R&D, Cosette Pharm. Dama Venugopala Rao, PhD Analytical Expert, Dr. Reddy’s Laboratories Limited Ramnarayan Randad, PhD Branch Chief, Branch II, DLAPI, ONDP, OPQ, FDA Kevin Hawkins, PhD Senior Director, Drug Development R&D Operations (Steriles), Teva Pharm.
In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3A	Mechanistic Assessment of Excipient Changes for Biopharmaceutics Classification System (BCS) 1 Class and 3 Drug Products Talia Flanagan, PhD Head of Biopharmaceutics, UCB BCS Class 3 Compounds: In Vivo Experience with Non-Q1/Q2 Formulations Igor Legen, PhD Head of Clinical Development, Sandoz Pharm. Panel Discussion (Sub-Session 3A) Moderator: Heather Boyce, PhD Reviewer, DTP-II, ORS, OGD, FDA Panelists: Talia Flanagan, PhD Head of Biopharmaceutics, UCB Igor Legen, PhD Head of Clinical Development, Sandoz Pharm. Paul Seo, PhD Director, Division of Biopharmaceutics, ONDP, OPQ, FDA Bing Cai, PhD Director, DLBP-I, OLDP, OPQ, FDA Sid Bhoopathy, PhD President and COO, Absorption Systems Fang Wu, PhD Scientific Lead, DQMM, ORS, OGD, FDA Tausif Ahmed, PhD Director, Global Clinical Management, Dr. Reddy's Laboratories Sandra Suarez-Sharp, PhD VP, Regulatory Affairs, Simulations Plus, Inc.
In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3B	Complexities Involved in Conducting Patient Pharmacokinetic/Pharmacodynamic/Clinical Endpoint Studies and Alternate Proposals to Have Simplified Study Designs Nageshwar Thudi, PhD Senior Director, Global Generic/Biosimilar Clinical Dev/Ops, Teva Pharm. Clinical Development of Orally Inhaled Products: Bioequivalence Study Designs, Conduct, Subject Attributes and Analysis - Challenges and Opportunities Bill Brashier, MBBS & DTCD Group Head, Respiratory Clinical Development, Sandoz Pharm. Panel Discussion (Sub-Session 3A) Moderator: Mitchell Frost, MD Deputy Director, DTP-II, ORS, OGD, FDA Panelists: Nageshwar Thudi, PhD Senior Director, Global Generic/Biosimilar Clinical Dev/Ops, Teva Pharm. Siddharth Chachad, MBBS, MSc EVP & Head, Global Clinical Management, Dr. Reddy’s Laboratories Ltd. Yu Chung Tsang, PhD CSO, Biopharmaceutics & Biostatistics, Apotex Inc. William Chong, MD Associate Director for Clinical Affairs, OGD, FDA Raja Velagapudi, PhD Head, Clinical Development, Sandoz Pharm. Bill Brashier, MBBS Group Head, Respiratory Clinical Development, Sandoz Pharm. Beatriz North, MPH Senior Director, Global Clinical Affairs, Perrigo Pharm. Kachikwu Illoh, MD Director, DCR, OSCE, OGD, FDA
Closing Remarks	Robert Lionberger, PhD Director, Office of Research and Standards (ORS), OGD, FDA

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KEYNOTE SPEAKER
Janet Woodcock M.D.
Acting Commissioner of Food and Drugs
Food and Drug Administration

This conference is FREE and part of the SBIA Regulatory Education for Industry (REdI) series.

About This Meeting

The purpose of the public workshop is to provide an overview of the status of current science and research initiatives for generic drugs and an opportunity for public input on these initiatives. The public workshop also fulfills FDA’s commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its FY 2022 Generic Drug User Fee Amendments (GDUFA) Science and Research Initiatives.

FDA is particularly interested in receiving input from industry and other interested stakeholders on the following five topic areas:

What research is needed to determine how formulation differences in generic injectable products (that are not qualitatively (Q1) and quantitatively (Q2) the same as their reference listed drug products) affect the substitutability of these products?
What research is needed to prepare for generic versions of oligonucleotide drug products (e.g., siRNA, chemically modified, antisense oligonucleotides)?
What research relating to artificial intelligence (including machine learning) and/or the use of integrated data from multiple areas may facilitate and modernize the development of generic products?
What research is needed to bridge the gap between existing scientific insights from GDUFA-funded research (e.g., related to product characterization techniques or modeling and simulation tools) and the development of suitable test procedures, study designs, model integrated evidence, and/or approaches for developing generic products?
What research is needed to support identification of best bioequivalence practices and convergence of global bioequivalence standards?

Specific presentations and discussions at this workshop will be announced at a later date and may differ from the topics above.

Breakout Sessions
The workshop includes three interactive breakout sessions with speakers from the generic drug industry and a panel discussion.

Session 1: Model-Integrated Evidence for Generic Drug Development
This session will focus on:

Assessing the regulatory utility and knowledge gaps related to implementing modeling and simulation (e.g., computational fluid dynamics coupled with PBPK models) for orally-inhaled products.
Leveraging model integrated evidence for long-acting injectables to reduce regulatory barriers.
Identifying opportunities and challenges for utilizing artificial intelligence (e.g., machine learning and natural language processing) to support generic drug development and review.

Session 2: Complex Product Characterization and Analysis
This session will focus on:

Exploring the main gaps that industry and others see in complex generic product characterization and analysis, and clarifying the types of products that should have more focus.
Discussing which new analytical methods are promising for generic drug development, screening, quality surveillance, etc. These discussions will consider access and availability by industry, cost, and acceptance, and identify which plans or considerations need to be put in place to encourage adoption of new technologies by the generic drug industry.
Assessing analytical methods currently seen to be most useful, and discussing what can be done to better develop these technologies. The rationale for sampling and the numbers of batches to assess for batch-to-batch variability for various types of complex products will also be discussed.

Session 3: In Vitro and In Vivo Bioequivalence Approaches: Challenges and Opportunities
This session will focus on:

Considering the utility of in vitro characterization and modeling approaches to support biowaivers for certain (e.g., non-Q1/Q2) formulations of prospective generic products.
Discussing the design, conduct and data analysis of in vivo bioequivalence studies, including the study design and the selection of appropriate subject or patient populations for studies that support a demonstration of bioequivalence for complex products, including oncologic products.

INTENDED AUDIENCE

Generic drug industry stakeholders including 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 RESOURCES

Event Materials

Title	File Type/Size
2021 GDRS Agenda Final	pdf (296.44 KB)