Workshop | Mixed

Event Title

Advancing Generic Drug Development: Translating Science to Approval 2024

September 24 - 25, 2024

Date:: September 24 - 25, 2024
Day1:: Tue, Sep 24 8:30 a.m. - 04:35 p.m. ET
Day2:: Wed, Sep 25 9:00 a.m. - 04:15 p.m. ET

Topics & Presentations Day 1	Speakers
Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 1 – Part 1
Keynote	Robert M. Califf, MD, MACC Commissioner U.S. Food and Drug Administration (FDA)
IVRT Methods for In Situ Depot-Forming Long-Acting Injectable Products	Agm (Abu) Mostofa, PhD Pharmacologist Division of Bioequivalence I (DBI) Office of Bioequivalence (OB) Office of Generic Drugs (OGD) \| CDER
Nano-Size Complex Products In Vitro Release Testing (IVRT)	Thilak Mudalige, PhD Research Chemist Arkansas Human & Animal Food Laboratory (ARLHAF) Office of Human & Animal Food Laboratory Operations (OHAFLO) Office of Regulatory Science (ORS) Office of Regulatory Affairs (ORA)
Application of Adaptive Perfusion as In Vitro Release Testing Method to Improve Understanding and Assessment of Complex Drug Products	Dongkai Zhu, PhD Visiting Associate Division of Pharmaceutical Quality Research VI (DPQR VI) Office of Pharmaceutical Quality Research (OPQR) Office of Pharmaceutical Quality (OPQ) \| CDER
Session 1: Q&A Panel	Agm (Abu) Mostofa, Thilak Mudalige, Dongkai Zhu And Hee Sun Chung, PhD Lead Pharmacologist DBIDBI \| OB \| OGD \| CDER Xiaoming Xu, PhD Division Director Division of Pharmaceutical Quality Research V (DPQR V) OPQR \| OPQ \| CDER
Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 1 – Part 2
Current Trends in Product-Specific Guidance (PSG) Development & Revisions for Topical Products	Megan Kelchen, PhD Senior Pharmacologist Division of Therapeutic Performance I (DTP I) ORS \| OGD \| CDER
Enhanced Understanding of Structure Performance Relationship Using Modeling and Simulation- A Case Study with Dapsone Topical Gel	Eleftheria Tsakalozou, PhD Lead Pharmacologist Division of Quantitative Methods and Modeling (DQMM) ORS \| OGD \| CDER
Approaches for Evaluation of Formulation Differences on Performance of Topical Products	Tannaz Ramezanli, PhD, PharmD Senior Pharmacologist DTP I \| ORS \| OGD \| CDER
Session 2: Q&A Panel	Megan Kelchen, Eleftheria Tsakalozou, Tannaz Ramezanli And Hiren Patel, PhD Senior Staff Fellow Division of Bioequivalence II (DBIDBII) Office of Bioequivalence (OB) OGD \| CDER Pahala Simamora, PhD Division Director Division of Product Quality Assessment IX (DPQA IX) Office of Product Quality Assessment II (OPQA II) OPQ \| CDER
Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 1 – Part 3
Orally Inhaled Drug Product PSGs: General Considerations Using the Alternative Bioequivalence (BE) Approach In Lieu of Comparative Clinical Endpoint (CCEP) BE Study for Suspension-Based Metered Dose Inhaler	Liangfeng Han, MD, PhD Clinical Analyst DTP I \| ORS \| OGD \| CDER
Orally Inhaled Drug Product PSGs: Considerations for Using Modeling and Simulation with Alternative BE Approaches	Ross Walenga, PhD Senior Chemical Engineer DQMM \| ORS \| OGD \| CDER
OPQR Testing & Research to Support Guidance Development of Inhalation Products	Changning Guo, PhD Supervisory Chemist Division of Pharmaceutical Quality Research II (DPQR II) OPQR \| OPQ \| CDER
Session 3: Q&A Panel	Liangfeng Han, MD, Ross Walenga, Changning Guo And Elizabeth Bielski, PhD Senior Pharmacologist DTP I \| ORS \| OGD \| CDER Zhen Xu, PhD Senior Staff Fellow Division of Bioequivalence (DBIII) OB \| OGD \| CDER
Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 1 – Part 4
Drug-Device Combination Products – A New Methodology for Evaluation	Christina Streets, MD Senior Physician Division of Clinical Review (DCR) Office of Safety & Clinical Evaluation (OSCE) OGD \| CDER Betsy Ballard, MD Medical Officer Division of Therapeutic Performance I (DTP I) ORS \| OGD \| CDER
Approaches to Analyzing Comparative Use Human Factors Studies	Jing (Jenny) Wang, PhD Visiting Associate DQMM \| ORS \| OGD \| CDER
Session 4: Q&A Panel	Christina Streets, Betsy Ballard, Jing (Jenny) Wang And Somesh Chattopadhyay, PhD Lead Mathematical Statistician Division of Biometrics VIII (DB VIII) Office of Biostatistics (OB) Office of Translational Sciences (OTS) \| CDER William Chong, MD Director OSCE \| OGD \| CDER
Day One Closing Remarks	Sau (Larry) Lee, PhD Deputy Director of Operations OPQ \| CDER

Topics & Presentations Day 2	Speakers
Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 2 – Part 1
Teriparatide Injection First Generic Approval: Quality-Related Review Considerations	Tina Jiao, MS Chemist Division of Product Quality Assessment IV (DPQA IV) Office of Product Quality Assessment (OPQA) OPQ \| CDER
Quality Considerations for First Generic Oral Solutions	Maria Flynn, PhD Senior Pharmaceutical Quality Assessor Division of Product Quality Assessment VIII (DPQA VIII) OPQA II \| OPQ \| CDER
Quality Considerations for First Generic Tiotropium Bromide Capsule-Based Dry Powder Inhalers (DPIs)	Nashwa El-Gendy, PhD Senior Pharmaceutical Quality Assessor Division of Product Quality Assessment V (DPQA V) Office of Product Quality Assessment I (OPQA I) OPQ \| CDER
Session 5A: Q&A Panel	Tina Jiao, Maria Flynn, Nashwa El-Gendy, And Yili Li, PhD Senior Pharmaceutical Quality Assessor Division of Product Quality Assessment XI (DPQA XI) OPQA II \| OPQ \| CDER Bryan Newman, PhD Lead Pharmacologist DTP I \| ORS \| OGD \| CDER
Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 2 – Part 2
Totality of Evidence Including Physiologically Based Pharmacokinetic (PBPK) Modeling to Support BE Assessment and Approval of Mesalamine Delayed Release Tablets Approval of Mesalamine Delayed Release Tablets	Yang Lu, PhD Senior Staff Fellow DBIII \| OB \| OGD \| CDER Fang Wu, PhD Senior Pharmacologist DQMM \| ORS \| OGD \| CDER
Challenges and Progress in Emerging Complex Generic Oligonucleotide Products	Likan Liang, PhD Supervisory Chemist Division of Product Quality Assessment X (DPQA X) OPQA II \| OPQ \| CDER
The Journey of First Approvals of Complex Generic Long-acting Injectable Products	Yan Wang, PhD Lead Pharmacologist / Acting Deputy Division Director DTP I \| ORS \| OGD \| CDER
Session 5B: Q&A Panel	Yang Lu, Fang Wu, Likan Liang, Yan Wang And Hansong Chen, PharmD Senior Interdisciplinary Scientist Division of Product Quality Assessment XII (DPQA XII) OPQA II \| OPQ \| CDER
Advancing Generic Drug Development: Translating Science to Approval 2024 – Day 2 – Part 3
Guidance for Industry: Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs	Greg Huang, PhD Senior Chemist DPQA IX \| OPQA II \| OPQ \| CDER
Analysis of First Cycle ANDA Approval and Major Deficiencies Encountered from In Vitro and In Vivo Bioequivalence Study Perspectives In Vivo Bioequivalence Study Perspectives	Fang Lu, PhD Lead Pharmacologist DBI \| OB \| OGD \| CDER Priyanka Ghosh, PhD Lead Pharmacologist DTP I \| ORS \| OGD \| CDER
ICH M13A: First ICH Guideline for Bioequivalence	Lei Zhang, PhD Deputy Director ORS \| OGD \| CDER
Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs: First-Year Review	Yuqing Gong, PhD Senior Pharmacologist DQMM \| ORS \| OGD \| CDER
Session 6: Q&A Panel	Greg Huang, Fang Lu, Priyanka Ghosh, Lei Zhang, Yuqing Gong And Nilufer Tampal, PhD Associate Director for Scientific Quality OB \| OGD \| CDER Rachel Erdman, JD Regulatory Counsel Division of Policy Development (DPD) Office of Generic Drug Policy (OGDP) OGD \| CDER
Closing Remarks	Robert Lionberger, PhD Director ORS \| OGD \| CDER

Agenda

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KEYNOTE SPEAKER

Robert M. Califf M.D., MACC
Commissioner of Food and Drugs

ABOUT THIS MEETING (Hosted by CDER SBIA)

Join us for the 2024 Advancing Generic Drug Development Workshop! FDA experts will demonstrate the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program’s transformative impact on generic drug development, regulation, and approval. Dissect complex scientific challenges in ANDAs alongside FDA experts, and gain insights into GDUFA III progress, GDUFA science and research on complex products and scientific issues to product-specific guidance development, pre-ANDA and ANDA meeting discussions. The workshop will also highlight innovative science and cutting-edge methodologies in generic drug development both within the U.S. and globally.

We're thrilled to offer this workshop in a hybrid format this year!

In-person attendees will enjoy:

Interactive poster sessions with FDA scientists, featuring topics like guidance development, advanced analytics, and PBPK modeling
Lively discussions and Q&A with FDA experts

Virtual attendees will have access to all presentations and panel discussions, minus the poster session.

Don't miss this unique opportunity to learn about critical aspects to improve your generic drug development!

TOPICS COVERED

Advancement in vitro characterization methodologies
Research to support guidance development on complex products including drug-device combination products, topical products, and inhalation products
Spotlights on recent generic drug review and approval by the FDA
Efforts to ensure efficient and consistent high quality generic drug development

LEARNING OBJECTIVES

Stay current with the latest advancements in science, research, guidance development, and regulatory evaluation related to generic drug products.
Summarize and explain the key enhancements and changes introduced in GDUFA III and their potential impact on ANDAs
Recognize and explain how the FDA's research can be leveraged to support and inform generic drug development.
Utilize various strategies and methodologies to facilitate efficient generic drug development

INTENDED AUDIENCE

Scientists, researchers, current and prospective generic drug applicants, and regulatory affairs professionals who work on or have an interest in the development of generic drugs, including complex generic products.

FDA RESOURCES

GDUFA Science and Research
Generic Drug Development
GDUFA III Reauthorization
Pre-ANDA Program
Product-Specific Guidances for Generic Drug Development
Guidances Related to Generic Drugs (under topics, choose “generic drugs ”)