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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


Janet Woodcock, M.D.
Janet Woodcock M.D.

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.

 
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