Workshop | Virtual

Event Title

Advancing Generic Drug Development: Translating Science to Approval

September 20 - 21, 2022

Date:: September 20 - 21, 2022
Day1:: Tue, Sep 20 8:00 a.m. - 05:10 p.m. ET
Day2:: Wed, Sep 21 8:00 a.m. - 05:00 p.m. ET

Topics & Presentations Day 1	Speakers
Advancing Generic Drug Development: Translating Science to Approval - Day 1 – Keynote and Session 1
Keynote	Robert Califf, MD Commissioner of Food and Drugs Food and Drug Administration (FDA)
Guidance for Peptide Products and Assessing Immunogenicity Risk	Eric Pang, PhD Senior Chemist DTP I \| ORS \| OGD \| CDER
Common Deficiencies Associated with Comparative Peptide Impurity Profile Studies and Qualification of Impurity Levels and Proposed Limits	Yili Li, PhD Chemist LBB II \| DLBP I \| OLDP \| OPQ \| CDER
Assessing Impurities to Inform Peptide Immunogenicity Risk: Developing Informative Studies	Daniela Verthelyi, MD, PhD Chief, Laboratory of Immunology DBRR III \| OBP \| OPQ \| CDER
Session 1A Question & Answer Panel	Eric Pang, Yilli Li, Daniela Verthelyi, and Cameron Smith
Advancing Generic Drug Development: Translating Science to Approval – Day 1 – Session 2
Oligonucleotides: Current Thinking and Analytical Challenges Identified in the Nusinersen PSG Development	Deyi Zhang, PhD Senior Chemist DTP I \| ORS \| OGD \| CDER
In-Depth Impurity Assessment of Synthetic Oligonucleotides Enabled by High Resolution Mass Spectrometry	Kui Yang, PhD Senior Research Scientist DCDA \| OTR \| OPQ \| CDER
Session 1B Question & Answer Panel	Deyi Zhang, Kui Yang, and Daniela Verthelyi
Comparing Device User Interfaces and Seeking Advice in the Pre-ANDA Period	Kathryn Hartka, Pharm D, PhD Pharmacologist DTP I \| ORS \| OGD \| CDER
Conducting a Comparative Analysis When the RLD is Not Available	Stephanie Soukup, MD Physician DCR \| OSCE \| OGD \| CDER
Future Challenges: Electronic Devices, PDURS, Impacts on Generic Development and Substitution	Betsy Ballard, MD Medical Officer DTP I \| ORS \| OGD \| CDER
Session 2 Question & Answer Panel	Kathryn Hartka, Stephanie Soukup, Betsy Ballard, and Lisa Bercu, JD Regulatory Counsel DPD \| OGDP \| OGD \| CDER Markham Luke, MD, PhD Director DTP I \| ORS \| OGD \| CDER CDR Andrew Fine, PharmD Senior Advisor DCR \| OSCE \| OGD \| CDER
Advancing Generic Drug Development: Translating Science to Approval – Day 1 – Session 3
Q1/Q2 Assessment and Requirements for Biowaiver of Injectables	Xinran Li, PhD Staff Fellow DB II \| OB \| OGD \| CDER
Current Thinking and Research On In Vitro Only Approaches for Injectable Suspensions of Drug Substances– A Scientific Discussion	Bin Qin, PhD Staff Fellow DTP I \| ORS \| OGD \| CDER
Challenges and Considerations in Developing In Vitro Release Testing Methods for Parenteral Suspensions	William Smith, PhD Research Fellow DPQR \| OTR \| OPQ \| CDER
MAPP 5019.1 - Allowable Excess Volume/Content in Injectable Drug and Biological Products	Hongna Wang, PhD Chemist DIPAP \| OPPQ \| OPQ \| CDER
Session 3 Question & Answer Panel	Xinran Li, Bin Qin, William Smith, and Hongna Wang, and Utpal Munshi, PhD Director DBI \| OB \| OGD \| CDER David Anderson, PhD Branch Chief DMAII \| OPMA \| OPQ \| CDER Janice Brown, MS Branch Chief DIPAP \| OPPQ \| OPQ \| CDER
Advancing Generic Drug Development Translating Science to Approval Day 1–Session 4 & Closing Remarks
Q1/Q2 Challenges from a BE Assessment Perspective	Dapeng Cui, PhD Pharmacologist DBI \| OB \| OGD \| CDER
Application of Quantitative Modeling and Simulations to BE Determination for Long-Acting Injectables – Sharing Research Progress and Regulatory Experience	Kairui (Kevin) Feng, PhD Senior Chemical Engineer DQMM \| ORS \| OGD \| CDER
Mechanistic Modeling of Complex Injectables: Recommendations to Navigate Regulatory Challenges	Khondoker Alam, PhD Senior Pharmacologist DQMM \| ORS \| OGD \| CDER
Recommendation of Partial Area Under the Curve Metrics in Product- Specific Guidances for Long-Acting Injectable Drug Products	Sherin Thomas, PhD Pharmacologist DQMM \| ORS \| OGD \| CDER
Session 4 Question & Answer Panel	Dapeng Cui, Kairui (Kevin) Feng, Khondoker Alam, Sherin Thomas, Lucy Fang, Bing Li, and Hao Zhu, PhD Deputy Director DPM \| OCP \| OTS \| 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 – Day 2 – Session 5</a>
In-Vitro Binding Studies for Bioequivalence Demonstration	Wei-Jhe Sun, PhD Pharmacologist DTP II \| ORS \| OGD \| CDER
Assessing API “Sameness”	Hongmei Li, PhD Senior Pharmaceutical Quality Assessor LBB1 \| DLBPI \| OLDP \| OPQ \| CDER
In Vitro Assessments that Support In Vitro Binding Studies in Demonstrating Bioequivalence of Locally Acting Gastrointestinal Drugs	Manar Al-Ghabeish, PhD Staff Fellow DTP II \| ORS \| OGD \| CDER
Common Deficiencies and Case Studies of In-Vitro Binding Bioequivalence Studies	Hongfei Zhou, PhD Pharmacologist DB III \| OB \| OGD \| CDER
Session 5 Question & Answer Panel	Wei-Jhe Sun, Hongmei Li, Manar Al-Ghabeish, Hongfei Zhou, and Hongling Zhang, PhD Division Director DB II \| OB \| OGD \| CDER
Advancing Generic Drug Development: Translating Science to Approval – Day 2 – Session 6
Nasal Products: Current Landscape and Recent Advancements	Bryan Newman, PhD Team Lead DTP I \| ORS \| OGD \| CDER
Alternative BE Approaches and Considerations for Nasal Products	Susan Boc, PhD Scientific Researcher DTP I \| ORS OGD \| CDER
Mechanistic Modeling and Realistic In Vitro Models to Facilitate Development of Generic Nasal Drug Products	Ross Walenga, PhD Senior Chemical Engineer DQMM \| ORS \| OGD \| CDER
In Vitro Characterization of Nasal Powder Drug Products	Nick Holtgrewe, PhD Chemist DCDA \| OTR \| OPQ \| CDER
Session 6 Question & Answer Panel	Bryan Newman, Ross Walenga, Nick Holtgrewe, and Ke Ren, PhD Supervisory Pharmacologist DB III \| OB \| OGD \| CDER
Advancing Generic Drug Development: Translating Science to Approval – Day 2 – Session 7
Alternative Model-Based Data Analysis Approach to Demonstrate BE	Yuqing Gong, PhD Pharmacologist DQMM \| ORS \| OGD \| CDER
Evaluation and Application of New/Novel Data Imputation Approaches to Support BE Assessment	Jing Wang, PhD Research Fellow DQMM \| ORS \| OGD \| CDER
Challenges and Opportunities on Using Oral PBPK To Support Risk Assessment and Biowaiver in Regulatory Submissions	Fang Wu, PhD Senior Pharmacologist/Scientific Lead DQMM \| ORS \| OGD \| CDER
Dermal PBPK Modeling for a Transdermal Delivery System to Assess the Impact of the Application Site on In Vivo Performance	Eleftheria Tsakalozou, PhD Senior Pharmacologist DQMM \| ORS \| OGD \| CDER
Session 7 Question & Answer Panel	Yuqing Gong, Jing Wang, Fang Wu, Eleftheria Tsakalozou, Zhen Zhang, and Stella Grosser, PhD Director DB VIII \| OB \| OTS \| CDER
Advancing Generic Drug Development Translating Science to Approval Day 2–Session 8 & Closing Remarks
Suitability Petitions Enable Generics	Robert Lionberger, PhD Director ORS \| OGD \| CDER
Suitability Petitions: A Policy Perspective	Susan Levine, JD Deputy Director DPD \| OGDP \| OGD \| CDER
Best Practices for Submitting a Suitability Petition	Rosanne Pagaduan, PharmD Supervisory Pharmacist DFR \| ORO \| OGD \| CDER
Bridging the Difference: Bioequivalence Assessments for Suitability Petitions	Pamela Dorsey, PhD Pharmacologist DB III \| OB \| OGD \| CDER
Bridging the Difference: Case Studies that Demonstrate Bioequivalence Assessments for Approved Suitability Petitions	Heather Boyce, PhD Acting Team Lead DTP II \| ORS \| OGD \| CDER
Session 8 Question & Answer Panel	Robert Lionberger, Susan Levine, Rosanne Pagaduan, Pamela Dorsey, Heather Boyce, and CDR Andrew Fine, PharmD Senior Advisor DCR \| OSCE \| OGD \| CDER Arlene Figueroa, JD Regulatory Counsel DLRS \| OGDP \| OGD \| CDER
Day Two Closing Remarks	Robert Lionberger, PhD Director ORS \| OGD \| CDER

Agenda

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ABOUT THIS CONFERENCE

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), 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 innovative science and cutting-edge methodologies behind generic drug development. This workshop will also provide some insight into upcoming GDUFA III enhancements.

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

TOPICS COVERED

Peptide and Oligonucleotide Active Pharmaceutical Ingredient (API) Sameness and Impurity Assessment Considerations
Drug-Device Combination Products
Long-Acting Injectables
Oral Complex Drug Products
Nasally Administered Products
Quantitative Methods and Model-Integrated Bioequivalence Approaches
Suitability Petitions

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.

LEARNING OBJECTIVES

Comprehend new developments in science, guidance, and regulatory assessment experience for generic drug products
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

FDA RESOURCES

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