Conference | Virtual

Event Title

Advancing Generic Drug Development: Translating Science to Approval 2023

September 13 - 14, 2023

Date:: September 13 - 14, 2023
Day1:: Wed, Sep 13 9:00 AM - 5:00 PM ET
Day2:: Thu, Sep 14 9:00 AM - 5:00 PM ET

Topics & Presentations Day 1	Speakers
Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 1 – Part 1
Keynote	Robert M. Calif, MD, MACC Commissioner of Food and Drugs U.S. Food and Drug Administration (FDA)
General Guidances Related to Characterization-Based Bioequivalence Approaches for Topical Products – Part I.pdf	Priyanka Ghosh, PhD Lead Pharmacologist Division of Therapeutic Performance I (DTP I) Office of Research and Standards (ORS) Office of Generic Drugs (OGD) Center for drug Evaluation and Research (CDER)
General Guidances Related to Characterization-Based Bioequivalence Approaches for Topical Products – Part II.pdf	Hiren Patel, PhD Senior Staff Fellow Division of Bioequivalence II (DB II) Office of Bioequivalence (OB) OGD \| CDER
An Overview of the Current Product-Specific Guidances for Topical Products.pdf	Megan Kelchen, PhD Senior Pharmacologist DTP I \| ORS \| OGD \| CDER
How Research Supports Product-Specific Guidances for Topical Products.pdf	Ahmed Zidan, PhD Senior Staff Fellow Division of Product Quality Research (DPQR) Office of Testing and Research (OTR) Office of Pharmaceutical Quality (OPQ) \| CDER
Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 1 – Part 2.pdf
Overview and Changes to Guidance for Industry: Topical Dermatology Corticosteroids In Vivo Bioequivalence.pdf	Ke Ren, PhD Deputy Division Director Division of Bioequivalence III (DB III) OB \| OGD \| CDER
ANDA Challenges Related to Vasoconstrictor Studies.pdf	Kairui (Kevin) Feng, PhD Senior Chemical Engineer Division of Quantitative Methods and Modeling (DQMM) ORS \| OGD \| CDER
Session 1: Q&A Discussion Panel	Priyanka Ghosh, Hiren Patel, PhD, Megan Kelchen, Ahmed Zidan, Ke Ren, Kairui (Kevin) Feng, and Markham C. Luke, MD, PhD Division Director DTP I \| ORS \| OGD \| CDER Sam Raney, PhD Associate Director for Science ORS \| OGD \| CDER Pahala Simamora, PhD Division Director Division of Liquid-Based Products II (DLBP II) Office of Lifecycle Drug Products (OLDP) OPQ \| CDER \| FDA Rong Wang, PharmD, PhD Associate Director Division of Bioequivalence I (DB I) OB \| OGD \| CDER
Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 1 – Part 3.pdf
Complex Nasal Suspension PSG: Utilization of Newly Recommended In Vitro Only Bioequivalence Option.pdf	Susan Boc, PhD Pharmacokineticist DTP I \| ORS \| OGD \| CDER
Complex Nasal Suspension: Utilization of In Silico PK Studies to Support Development and Approval.pdf	Ross Walenga, PhD Senior Chemical Engineer DQMM \| ORS \| OGD \| CDER
Loxapine Inhalation Powder: OTR Research Conducted to Inform the PSG Recommendations.pdf	Nathan Reed, PhD Chemist Division of Complex Drug Analysis, Branch 2 (DCDA B2) Office of Testing and Research (OTR) OPQ \| CDER \| FDA Elizabeth Bielski, PhD Senior Pharmacologist DTP I \| ORS \| OGD \| CDER
Session 2: Q&A Discussion Panel	Susan Boc, Ross Walenga, Nathan Reed, Elizabeth Bielski, Ahmed Zidan, and Vipra Kundoor, PhD Pharmacologist DB I \| OB \| OGD \| CDER Mai Tu, PhD Chemist Liquid-Based Branch IV (LBB4) DLBP II \| OLDP \| OPQ \| CDER \| FDA
Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 1 – Part 4.pdf
In Vitro Approaches for Injectable Suspension Products: Medroxyprogesterone Acetate & Triamcinolone Acetate.pdf	Qiangnan Zhang, PhD Staff Fellow DTP I \| ORS \| OGD \| CDER
Risk-based PSG Recommendations for Comparative Immunogenicity and Impurity Profile Assessment.pdf	Eric Pang, PhD Senior Chemist DTP I \| ORS \| OGD \| CDER
Session 3: Q&A Discussion Panel	Qiangnan Zhang, Eric Pang, and Dapeng Cui, PhD Lead Pharmacologist DB I \| OB \| OGD \| CDER Cameron Smith, PhD Branch Chief Division of Liquid-Based Products I (DLBP I) OLDP \| OPQ \| CDER
Cyclosporine & Difluprednate Ophthalmic Emulsions - Part 1.pdf Cyclosporine & Difluprednate Ophthalmic Emulsions - Part 2.pdf	Qiuxi Fan, PhD Pharmaceutical Scientist DLBP II \| OLDP \| OPQ \| CDER Yoriko Harigaya, PharmD Senior Staff Fellow DB II \| OB \| OGD \| CDER
Amphotericin B Liposome: Changes Identified.pdf	Bin Qin, PhD Senior Chemist DTP I \| ORS \| OGD \| CDER
Phytonadione – Self-Assembled System & Thermodynamics Systems.pdf	William Smith, PhD Research Scientist Division of Product Quality Research (DPQR) OTR \| OPQ \| CDER
Session 4: Q&A Discussion Panel	Qiuxi Fan, Yoriko Harigaya, Bin Qin, William Smith, and John Jiang, PhD Chemist DLBP II \| OLDP \| OPQ \| CDER Hee Sun Chung, PhD Lead Pharmacologist DB I \| OB \| OGD \| CDER Khondoker Alam, PhD Senior Pharmacologist DQMM \| ORS \| OGD \| CDER Xiaoming Xu, PhD Supervisory Chemist DPQR \| OTR \| OPQ \| CDER
Day One Closing Remarks	Lei Zhang, PhD Deputy Director ORS \| OGD \| CDER

Topics & Presentations Day 2	Speakers
Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 1
Innovative Technology: Particle Image Velocimetry (PIV) and High-Speed Imaging to Support Approval of Generic Orally Inhaled Drug Products.pdf	Steven Chopski, PhD Staff Fellow DQMM \| ORS \| OGD \| CDER
First Generic Drug Approval: Budesonide & Formoterol Fumarate Dihydrate Inhalation Aerosol (RLD: Symbicort): A Bioequivalence Perspective.pdf	Zhen Xu, PhD Staff Fellow DB III \| OB \| OGD \| CDER
First Generic Drug Approval: Budesonide & Formoterol Fumarate Dihydrate Inhalation Aerosol (RLD: Symbicort): A Quality Perspective.pdf	Fang Yuan, PhD Senior Chemist Immediate Office (IO) OLDP \| OPQ \| CDER
Post-Approval Impact of Generic Fluticasone Propionate & Salmeterol Inhalation Powder (RLD: Advair Diskus).pdf	Andrew Clerman, MD, PhD Senior Physician DTP I \| ORS \| OGD \| CDER
Session 5: Q&A Discussion Panel	Steven Chopski, Zhen Xu, Fang Yuan, Andrew Clerman, and Srinivas Behara, PhD Chemist Division of Immediate and Modified Release Products III (DIMRP III) OLDP \| OPQ \| CDER Tian Ma, PhD Senior Staff Fellow DB I \| OB \| OGD \| CDER Elizabeth Bielski, PhD Senior Pharmacologist DTP I \| ORS \| OGD \| CDER
Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 2
Bioequivalence for Oral Locally Acting Gastrointestinal Drug Products.pdf	Wei-Jhe Sun, PhD Senior Staff Fellow DTP II \| ORS \| OGD \| CDER
Q1/Q2 Recommendation (Sucralfate).pdf	Manar Al-Ghabeish, PhD Staff Fellow DTP II \| ORS \| OGD \| CDER
Non-Q2 Sucralfate Suspension Approval.pdf	Suman Dandamudi, PhD Senior Pharmacologist DB III \| OB \| OGD \| CDER
Session 6 Q&A Discussion Panel	Wei-Jhe Sun, Manar Al-Ghabeish, Suman Dandamudi, and Alicia Hoover, PhD Supervisory Chemist Division of Pharmaceutical Analysis (DPA) OTR \| OPQ \| CDER Fang Wu, PhD Senior Pharmacologist DQMM \| ORS \| OGD \| CDER Hongfei Zhou, PhD Senior Pharmacologist DB III \| OB \| OGD \| CDER
Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 3
GDUFA Research Program: Research Priorities to Support Generic Drug Development.pdf	Sam Raney, PhD Associate Director for Science ORS \| OGD \| CDER
Identify Research Needs and PSG Development for Complex Products.pdf	Xiaoming Xu, PhD Division Director DPQR \| OTR \| OPQ \| CDER
Enhance Communication in Using Modeling Approaches in ANDAs.pdf	Liang Zhao, PhD Division Director DQMM \| ORS \| OGD \| CDER
Session 7: Q&A Discussion Panel	Sam Raney, Xiaoming Xu, Liang Zhao, and Darby Kozak, PhD Deputy Division Director DTP I \| ORS \| OGD \| CDER Robert Lionberger, PhD Director ORS \| OGD \| CDER Zhen Zhang, PhD Master Pharmacologist DB I \| OB \| OGD \| CDER
Advancing Generic Drug Development: Translating Science to Approval 2023 – Day 2 – Part 4
The Generic Drug Cluster Program and the Path to Global Harmonization.pdf	Sarah Ibrahim, PhD Associate Director for Global Affairs OGD \| CDER
Supporting the First Harmonized Bioequivalence Guideline under ICH -Considerations for Future Implementation.pdf	Nilufer Tampal, PhD Associate Director for Scientific Quality OB \| OGD \| CDER
FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Drug Products.pdf	Lei Zhang, PhD Deputy Director ORS \| OGD \| CDER
Data Reliability – Inspection, Global Collaboration.pdf	Brian Folian, JD, MS Deputy Director Office of Study Integrity and Surveillance (OSIS) Office of Translational Sciences (OTS) \| CDER
Session 8: Q&A Discussion Panel	Nilufer Tampal, Lei Zhang, Sarah Ibrahim, Brian Folian, and Wenlei Jiang, PhD Senior Advisor for Innovation and Strategic Outreach ORS \| OGD \| CDER Xiaojian Jiang, PhD Deputy Division Director DB II \| OB \| OGD \| CDER Myong-Jin Kim, PharmD Division Director DTP II \| ORS \| OGD \| CDER
Day Two Closing Remarks	Robert Lionberger, PhD Director ORS \| OGD \| CDER

Agenda

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS EVENT

The purpose of this public workshop is to communicate how FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program outcomes guide and facilitate generic drug development, regulatory assessment, and approval. This workshop will focus on common issues seen in abbreviated new drug applications (ANDAs), GDUFA III updates, GDUFA science and research on complex products and scientific issues to product-specific guidance development, pre-ANDA, and ANDA meeting discussions, and examine various areas of innovative science and cutting-edge methodologies behind generic drug development.

INTENDED AUDIENCE

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

TOPICS COVERED

Generic product approval and supporting research, featuring:

Products with complex active pharmaceutical ingredients (APIs)
Complex injectable product
Topical drug products
Ophthalmic emulsion products
Orally inhaled drug products
Noteworthy guidance development and updates
New process/research/assessment tools to support generic product development and post-market surveillance
Global collaboration to support efficient generic product development and regulatory assessment

LEARNING OBJECTIVES

Comprehend new developments in science, guidance, and regulatory assessment experience for generic drug products
Keep up to date on GDUFA III enhancements and changes
Understand FDA’s perspectives, research, and regulatory assessment relating to generic drug development
Apply various mechanisms and methodologies that drug developers can use to facilitate generic drug development

ABOUT THIS EVENT

INTENDED AUDIENCE

TOPICS COVERED

LEARNING OBJECTIVES

FDA RESOURCES