Regulatory Education for Industry: 2019 Complex Generic Drug Product Development Workshop – Sep. 25-26, 2019 September 25 - 26, 2019

Workshop | Mixed

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• Date: September 25 - 26, 2019
• Time: 8:30 a.m. - 5:10 p.m. ET
• Location: The Hotel; at the University of Maryland; 7777 Baltimore Ave.; College Park, MD 20740; United States

• Organized By: Center for Drug Evaluation and Research (CDER)

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Session	Speaker
Keynote with Sally Choe	Sally Choe, Ph.D. Director of the Office of Generic Drugs
Pre-ANDA Program Update	Karen Bengtson Office of Research and Standards (ORS) Office of Generic Drugs (OGD) | CDER Suneela Prodduturi Office of Pharmaceutical Quality (OPQ) | CDER
FDA’s Inactive Ingredient Database	Susan Zuk Office of Policy for Pharmaceutical Quality (OPPQ) | OPQ | CDER
Panel Discussion	Karen Bengtson, Suneela Prodduturi, Susan Zuk, Kris André (ORS | OGD), Robert Lionberger (ORS | OGD), Jonathan Hughes (Office of Generic Drug Products (OGDP) | OGD)
Generic Topical and Transdermal Products	Sam Raney ORS | OGD | CDER
Bioequivalence for Generic Topical and Transdermal	Priyanka Ghosh ORS | OGD | CDER
Strategies for Generic Topical Product Development	Tannaz Ramezanli ORS | OGD | CDER
Quality for Transdermal Delivery Systems	Brock Roughton Office of Lifecycle Drug Products (OLDP) | OPQ | CDER
Questions and Answers	Sam Raney, Priyanka Ghosh, Tannaz Ramezanli, Brock Roughton
Strategies to Demonstrate Complex API Sameness	Deyi Zhang ORS | OGD | CDER
Complex Peptide ANDAs: Test/Reference Comparability	Cameron Smith OLDP | OPQ | CDER
Considerations of Particle Analysis	Xiaoming Xu Office of Testing and Research (OTR) | OPQ | CDER
Questions and Answers	Deyi Zhang, Cameron Smith, Xiaoming Xu, Ram Randad (ONDP | OPQ), Darby Kozak (ORS |OGD)
BE Approaches for Long Acting Drug Products	Yan Wang ORS | OGD | CDER
Strategies to Demonstrate Complex Excipient Sameness	Bin Qin ORS | OGD | CDER
In Vitro Drug Release Testing for LA Drug Products QC	Vidula Kolhatkar Office of New Drug Products (ONDP) | OPQ | CDER
Questions and Answers	Yan Wang, Bin Qin, Vidula Kolhatkar, Bing Cai (OLDP | OPQ)
What Constitutes Complex Drug-Device Combination	Lisa Bercu OGDP | OGD | CDER
Overview of Comparative Analyses - Clinical Perspective	Michelle Lin Office of Bioequivalence (OB) | OGD | CDER
Quality View on Injectable Product Considerations	Bita Mirzai Azarm OLDP | OPQ | CDER
Comparative Analyses: Injectable Combination Products	Andrew Fine OB | OGD | CDER
Questions and Answers	Lisa Bercu, Bing Cai, Kimberly Witzmann (OB | OGD), Steven Hertz (Office of Process and Facilities (OPF) | OPQ), Alan Stevens (Center for Devices and Radiological Health (CDRH)
PSG Recommendations and Updates for OINDPs	Bryan Newman ORS | OGD | CDER
Pre-ANDA Meeting Requests for Orally Inhaled/Nasal Drugs	Denise Conti ORS | OGD | CDER
Comparative Analyses: Device and User Interface	Kimberly Witzmann ORS | OGD | CDER
BE for Bridging Studies with Orally Inhaled/Nasal Drugs	Tian Ma OB | OGD | CDER
CMC Updates for Orally Inhaled Drugs	Fang Yuan OLDP | OPQ | CDER
Questions and Answers	Bryan Newman, Denise Conti, Kimberly Witzmann, Tian Ma, Fang Yuan, Bhagwant Rege (OLDP | OPQ)
Quantitative Methods and Modeling	Liang Zhao ORS | OGD | CDER
PK/PD Meta-analysis of Abuse Deterrent Opioid Drugs	Lanyan (Lucy) Fang ORS | OGD | CDER
Dose-Scale Analysis in Pharmacodynamic Equivalence	Xiajing Gong ORS | OGD | CDER
Physiologically-based Pharmacokinetic Modeling	Eleftheria Tsakalozou ORS | OGD | CDER
Credibility for Computational Fluid Dynamics Models	Ross Walenga ORS | OGD | CDER
Quantitative Clinical Pharmacology in LA Injectables	Satish Sharan ORS | OGD | CDER
Panel Questions and Discussion	Liang Zhao, Yaning Wang (OCP | OTS), Robert Lionberger (ORS | OGD), Murray Ducharme (Learn and Confirm, Inc.)

About

As a continuation from the 2018 workshop on complex generic drug products, the goal of this science-focused workshop is to communicate to the generic industry how FDA research outcomes guide and facilitate complex generic drug product development. FDA will link GDUFA science and research on complex drug products to product-specific guidance development, discuss pre-ANDA meetings and review, and examine various areas of complex product science.

Complex drug products often have features that make them harder to develop as generics under traditional approaches. These challenges can mean these ANDAs may undergo more assessment cycles than other ANDAs for non-complex generic drug products before receiving FDA approval, which, in turn, may result in limited competition. That is why the FDA has made facilitating the development and approval of complex generic drug products a major focus of the FDA’s Drug Competition Action Plan, which is aimed at encouraging generic drug competition in an effort to help reduce drug prices. It is our hope that the Complex Generic Drug Product Development Workshop will help facilitate the development and approval of ANDAs for complex generic drug products and the introduction of more generic medicines to the complex drug marketplace.

Topics Covered

• Pre-ANDA program update
• FDA’s inactive ingredient database: improvements on the path to 2020
• Scientific and regulatory advances for generic topical and transdermal drug product development
• Characterization of complex injectable active pharmaceutical ingredient API and formulations
• Bioequivalence approaches for complex injectable API and formulations
• Complex drug-device combination products – injectable drug products
• Complex drug-device combination products – orally-inhaled and nasal drug products
• Quantitative methods and modeling-informed regulatory decision making

Intended Audience

Scientists, researchers, and regulatory affairs professionals who work on or are interested in working on the development of complex generic drugs.

Learning Objectives

After this workshop, participants will be able to:

• Explain various mechanisms and processes that industry can use to obtain advice from the FDA to facilitate complex generic drug product development; and
• Summarize new developments in science, guidance, and review experience for specific types of complex generic drug products.

FDA Resources

• Generic Drug Science and Research
• Guidance for Industry, Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA
• Draft Guidance for Industry, Controlled Correspondence Related to Generic Drug Development
• Draft Guidance for Industry, Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA
• Product-Specific Guidances for Generic Drug Development
• Upcoming Product-Specific Guidances for Complex Generic Drug Product Development
• Draft Guidance for Industry, Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products - Quality Considerations
• Guidance for Industry, Safety Considerations for Product Design to Minimize Medication Errors

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