Workshop | In Person

Event Title

Advancing Generic Drug Development: Translating Science to Approval

September 21 - 22, 2021

Scheduled

Date:: September 21 - 22, 2021
Day1:: Tue, Sep 21
Day2:: Wed, Sep 22

Topics & Presentations	Speakers
Advancing Generic Drug Development: Translating Science to Approval Keynote Address	Janet Woodcock, MD Acting Commissioner of Food and Drugs Food and Drug Administration
COVID-19 Impact on Generic Drug Regulation and Evaluation Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency Alternative Bioequivalence Approaches for Data Analysis Due to COVID-19 Related Study Interruptions Quality Considerations in the Development of FDA Guidance “Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency” Applications and Lessons Learned for Conducting Adaptive Designs on Generic Drug Development Q&A Panel	Mitchell Frost, MD Acting Deputy Director Division of Therapeutic Performance II (DTP II) ORS \| OGD \| CDER Yuqing Gong, PhD Pharmacologist DQMM \| ORS \| OGD \| CDER Gloria Huang, PhD Lead Chemist Division of Liquid-Based Products II (DLBP II) Office of Lifecycle Drug Products (OLDP) Office of Pharmaceutical Quality (OPQ) \| CDER Kairui (Kevin) Feng, PhD Staff Fellow DQMM \| ORS \| OGD \| CDER Kimberly Witzmann, MD Acting Director Division of Clinical Review (DCR) Deputy Director Office of Safety and Clinical Evaluation (OSCE) \| OGD \| CDER Stella C. Grosser, PhD Director Division of Biometrics VIII Office of Biostatistics (OB) Office of Translational Sciences (OTS) \| CDER
Considerations in Assessing Generic Drug Products of Oral Dosage Forms Nasal Pharmacokinetic Study of Abuse-Deterrent Oxycodone HCl ER Products Following Insufflation of Physically Manipulated Products Advancement in the In-Vitro Evaluation of Abuse-Deterrent Formulations for Opioid Analgesics: Research and Assessment Perspectives Physiological Based Pharmacokinetic Modeling and Simulation Absorption Modeling and Virtual Bioequivalence to Support Generic Drug Development and Regulatory Decision Making for Oral Products Safety Assessment of Flavors in Generic Drug Products Q&A Panel	Saeid Raofi, MS Pharmacologist DTP II \| ORS \| OGD \| CDER Manar Al-Ghabeish, PhD Staff Fellow Division of Product Quality Research (DPQR) OTR \| OPQ \| CDER Fang Wu, PhD Acting Team Lead DQMM \| ORS \| OGD \| CDER Melanie Mueller, PharmD, PhD Team Lead Division of Pharmacology/Toxicology Review (DPTR) OSCE \| OGD \| CDER Xiaoming Xu, PhD Supervisory Chemist DPQR \| OTR \| OPQ \| CDER Heather Boyce, PhD Acting Team Lead DTP II \| ORS \| OGD \| CDER
Complex Generics_Complex Injectables, Opthalmic, and Otic Products, Part 1 Advances in Iron Colloid Products: Product-Specific Guidance (PSG) Discussion Advances in Iron Colloid Products: Quality Considerations When Conducting Comparability Studies Injectable Suspensions: Tools and Methods Bridging the In Vivo and In Vitro Gap Q&A Panel	Wenlei Jiang, PhD Senior Science Advisor Immediate Office (IO) ORS \| OGD \| CDER Yiwei Li, PhD Branch Chief Division of Pharmaceutical Manufacturing IV (DPMAIV) Office of Pharmaceutical Manufacturing Assessment (OPMA) OPQ \| CDER Bin Qin, PhD Staff Fellow DTP I \| ORS \| OGD \| CDER Bruce Lerman, PhD Lead Pharmacologist DB I \| OB \| OGD \| CDER Darby Kozak, PhD Deputy Director DTP I \| ORS \| OGD \| CDER
Complex Generics_Complex Injectables, Opthalmic, and Otic Products, Part 2 Challenges in the Approval of Complex Otic and Ophthalmic Generic Products: Bioequivalence Perspectives Challenges in the Approval of Complex Otic & Ophthalmic Generic Products: Quality Perspectives Physiological Based Pharmacokinetic Modeling and Simulation to Support Generic Ophthalmic Drug Product Development and Regulatory Decision Making Q&A Panel	Chunsheng Zhao, PhD Bioequivalence Reviewer Division of Bioequivalence III (DB III) OB \| OGD \| CDER Poonam Chopra, PhD Review Chemist DLBP II \| OLDP \| OPQ \| CDER Mingliang Tan, PhD Staff Fellow DQMM \| ORS \| OGD \| CDER Yan Wang, PhD Acting Team Lead DTP I \| ORS \| OGD \| CDER Asif Rasheed, PhD Senior Chemist DLBPI \| OLDP \| OPQ \| CDER Kai Kwok, PhD Senior Pharmaceutical Quality Assessor DLBPII \| OLDP \| OPQ \| CDER
Advancing Generic Drug Development: Translation Science to Approval, Day One Closing Remarks	Lei Zhang, PhD Deputy Director ORS \| OGD \| CDER
Cutting Edge Science in Complex Generics Utility of Artificial Intelligence to Facilitate the Development and Regulatory Assessment of Complex Generic Drugs Model-Integrated Evidence for Bioequivalence Assessment of Complex Generic Drugs Scanning Electron Cryomicroscopy (Cryosem) for Characterization of Complex Drug Products Advanced Imaging and Data Analysis to Support Compositional Structure Similarity of Polymeric Formulations Q&A Panel	Meng Hu, PhD Acting Team Lead DQMM \| ORS \| OGD \| CDER Miyoung Yoon, PhD Acting Team Lead DQMM \| ORS \| OGD \| CDER Huzeyfe Yilmaz, PhD Staff Fellow Division of Complex Drug Analysis (DCDA) OTR \| OPQ \| CDER Yan Wang, PhD Acting Team Lead DTP I \| ORS \| OGD \| CDER Robert Lionberger, PhD Director ORS \| OGD \| CDER Daniel Willett, PhD Chemist DCDA \| OTR \| OPQ \| CDER
Complex Generics_Nasal and Inhalation Products Product-Specific Considerations for Alternative Bioequivalence (BE) Approaches to Comparative Clinical Endpoint BE Studies Approaches for studies interrupted due to COVID-19 for Nasal and Inhalation Products Demonstrating Bioequivalence with Inhalation Spray Drug Products Comparative Analyses for Generic Oral Inhalers Q&A Panel	Susan Boc, PhD Scientific Researcher DTP I \| ORS \| OGD \| CDER Vipra Kundoor, PhD Pharmacologist DB I \| OB \| OGD \| CDER Sneha Dhapare, PhD Visiting Associate DTP I \| ORS \| OGD \| CDER Michael Spagnola, MD Lead Physician DCSS \| OSCE \| OGD \| CDER Bryan Newman, PhD Acting Team Lead DTP I \| ORS \| OGD \| CDER Changning Guo, PhD Supervisory Chemist DCDA \| OTR \| OPQ \| CDER Bing Cai, PhD Director DLBP I \| OLPD \| OPQ \| CDER
Complex Generics_Topical Products, Part 1 “No Difference” Standard vs. Q1\|Q2 Sameness for Topical Drug Products Use of Q3 Characterization Tests for Topical Semisolid Drug Products Recent Research Related to Q3 Characterization of Topical Products Containing Porous Microparticles Challenges and Considerations with Model-based Virtual Bioequivalence Assessments for Generic Dermatological Products Q&A Panel	Megan Kelchen, PhD Pharmacologist DTP I \| ORS \| OGD \| CDER Sam Raney, PhD Associate Director for Science IO \| ORS \| OGD \| CDER Ahmed Zidan, PhD Senior Pharmacologist DPQR \| OTR \| OPQ \| CDER Eleftheria Tsakalozou, PhD Staff Fellow DQMM \| ORS \| OGD \| CDER Khondoker Alam, PhD Staff Fellow DQMM \| ORS \| OGD \| CDER Markham Luke, MD, PhD Director DTP I \| ORS \| OGD \| CDER
Complex Generics_Topical Products, Part 2 Common Issues Identified in In-vitro Release Test (IVRT) and In-vitro Permeation Test (IVPT) Studies Submitted in ANDA to Support Bioequivalence for Topical Products Theoretical Principles and Best Practices: In Vitro Release Test Theoretical Principles and Best Practices: In Vitro Permeation Test Q&A Panel	Josephine Aimiuwu, PhD Pharmacologist DB II \| OB \| OGD \| CDER Tannaz Ramezanli, PhD, PharmD Pharmacologist DTP I \| ORS \| OGD \| CDER Priyanka Ghosh, PhD Acting Team Lead DTP I \| ORS \| OGD \| CDER Markham Luke, MD, PhD Director DTP I \| ORS \| OGD \| CDER Sam Raney, PhD Associate Director for Science IO \| ORS \| OGD \| CDER
Advancing Generic Drug Development: Translation Science to Approval, Day Two Closing Remarks	Robert Lionberger, PhD Director ORS \| OGD \| CDER

Download Slides

Agenda

View the updated agenda

KEYNOTE SPEAKER

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

The purpose of the public workshop is to communicate how outcomes from FDA research conducted under the Generic Drug User Fee Amendments (GDUFA) guide and facilitate generic drug development, regulatory assessment, and approval. The workshop will focus on common issues seen in Abbreviated New Drug Applications (ANDAs), link GDUFA science and research on complex products and scientific issues to product-specific guidance development and pre-ANDA meeting discussions, and examine various areas of the science and cutting-edge methodologies behind generic drug development.

This workshop is part of the SBIA Regulatory Education for Industry (REdI) series and is being offered as part of FDA’s Drug Competition Action Plan, which aims to increase competition and make it easier and more efficient for drug developers to bring more generics into the marketplace, while maintaining FDA’s high standards for quality and scientific rigor.

Topics

Sessions and topics will be divided across different product types and key topics present in today’s environment.
Sessions will cover the following products and topics:

COVID-19 Impact on Generic Drug Regulation and Evaluation
Assessing Generic Drug Products of Oral Dosage Forms
Complex Generics: Complex Injectables, Ophthalmic and Otic Products
Cutting-Edge Science in Complex Generics
Complex Generics: Nasal and Inhalation Products
Complex Generics: Topical Products

Learning Objectives

Apply various mechanisms and processes that industry can use to obtain advice from FDA to facilitate generic drug development.
Comprehend new developments in science, guidance, and review experience for specific types of generic drug products.

Intended Audience

Scientists, researchers and regulatory affairs professionals who work on or are interested in working on the development of generic drugs including complex generic products that are more challenging to develop.

FDA Resources

CDER Small Business & Industry Assistance (SBIA)

For more comprehensive resources for information on human drug development in regulation, visit CDER Small Business and Education.