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 Woodco*ck, MD Acting Commissioner, FDA
Introduction to the 2021 GDUFA Public Workshop
Robert Lionberger, PhD Director, Office of Research and Standards (ORS), OGD, FDA
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-Pharmaco*kinetics 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
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, PhDExecutive 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.
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, PhDExecutive 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.
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 Pharmaco*kinetic/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
Robert Lionberger, PhD Director, Office of Research and Standards (ORS), OGD, FDA
