Workshop
Event Title
Advancing Generic Drug Development: Translating Science to Approval
September 20 - 21, 2022
- Date:
- September 20 - 21, 2022
- Day1:
- - ET
- Day2:
- - ET
Topics & Presentations Day 1 |
Speakers |
---|---|
Advancing Generic Drug Development: Translating Science to Approval - Day 1 – Keynote and Session 1 |
|
Keynote |
Robert Califf, MD |
Guidance for Peptide Products and Assessing Immunogenicity Risk |
Eric Pang, PhD |
Common Deficiencies Associated with Comparative Peptide Impurity Profile Studies and Qualification of Impurity Levels and Proposed Limits |
Yili Li, PhD |
Assessing Impurities to Inform Peptide Immunogenicity Risk: Developing Informative Studies |
Daniela Verthelyi, MD, PhD |
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 |
In-Depth Impurity Assessment of Synthetic Oligonucleotides Enabled by High Resolution Mass Spectrometry |
Kui Yang, PhD |
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 |
Conducting a Comparative Analysis When the RLD is Not Available |
Stephanie Soukup, MD |
Future Challenges: Electronic Devices, PDURS, Impacts on Generic Development and Substitution |
Betsy Ballard, MD |
Session 2 Question & Answer Panel |
Kathryn Hartka, Stephanie Soukup, Betsy Ballard, and Lisa Bercu, JD Markham Luke, MD, PhD CDR Andrew Fine, PharmD |
Advancing Generic Drug Development: Translating Science to Approval – Day 1 – Session 3 |
|
Q1/Q2 Assessment and Requirements for Biowaiver of Injectables |
Xinran Li, PhD |
Current Thinking and Research On In Vitro Only Approaches for Injectable Suspensions of Drug Substances– A Scientific Discussion |
Bin Qin, PhD |
Challenges and Considerations in Developing In Vitro Release Testing Methods for Parenteral Suspensions |
William Smith, PhD |
MAPP 5019.1 - Allowable Excess Volume/Content in Injectable Drug and Biological Products |
Hongna Wang, PhD |
Session 3 Question & Answer Panel |
Xinran Li, Bin Qin, William Smith, and Hongna Wang, and Utpal Munshi, PhD David Anderson, PhD Janice Brown, MS |
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 |
Application of Quantitative Modeling and Simulations to BE Determination for Long-Acting Injectables – Sharing Research Progress and Regulatory Experience |
Kairui (Kevin) Feng, PhD |
Mechanistic Modeling of Complex Injectables: Recommendations to Navigate Regulatory Challenges |
Khondoker Alam, PhD |
Recommendation of Partial Area Under the Curve Metrics in Product- Specific Guidances for Long-Acting Injectable Drug Products |
Sherin Thomas, PhD |
Session 4 Question & Answer Panel > |
Dapeng Cui, Kairui (Kevin) Feng, Khondoker Alam, Sherin Thomas, Lucy Fang, Bing Li, and Hao Zhu, PhD |
Day One Closing Remarks |
Lei Zhang, PhD |
Topics & Presentations Day 2 |
Speakers |
---|---|
Advancing Generic Drug Development: Translating Science to Approval – Day 2 – Session 5 |
|
In-Vitro Binding Studies for Bioequivalence Demonstration |
Wei-Jhe Sun, PhD |
Assessing API “Sameness” |
Hongmei Li, PhD |
In Vitro Assessments that Support In Vitro Binding Studies in Demonstrating Bioequivalence of Locally Acting Gastrointestinal Drugs |
Manar Al-Ghabeish, PhD |
Common Deficiencies and Case Studies of In-Vitro Binding Bioequivalence Studies |
Hongfei Zhou, PhD |
Session 5 Question & Answer Panel |
Wei-Jhe Sun, Hongmei Li, Manar Al-Ghabeish, Hongfei Zhou, and Hongling Zhang, PhD |
Advancing Generic Drug Development: Translating Science to Approval – Day 2 – Session 6 |
|
Nasal Products: Current Landscape and Recent Advancements |
Bryan Newman, PhD |
Alternative BE Approaches and Considerations for Nasal Products |
Susan Boc, PhD |
Mechanistic Modeling and Realistic In Vitro Models to Facilitate Development of Generic Nasal Drug Products |
Ross Walenga, PhD |
In Vitro Characterization of Nasal Powder Drug Products |
Nick Holtgrewe, PhD |
Session 6 Question & Answer Panel |
Bryan Newman, Ross Walenga, Nick Holtgrewe, and Ke Ren, PhD |
Advancing Generic Drug Development: Translating Science to Approval – Day 2 – Session 7 |
|
Alternative Model-Based Data Analysis Approach to Demonstrate BE |
Yuqing Gong, PhD |
Evaluation and Application of New/Novel Data Imputation Approaches to Support BE Assessment |
Jing Wang, PhD |
Challenges and Opportunities on Using Oral PBPK To Support Risk Assessment and Biowaiver in Regulatory Submissions |
Fang Wu, PhD |
Dermal PBPK Modeling for a Transdermal Delivery System to Assess the Impact of the Application Site on In Vivo Performance |
Eleftheria Tsakalozou, PhD |
Session 7 Question & Answer Panel |
Yuqing Gong, Jing Wang, Fang Wu, Eleftheria Tsakalozou, Zhen Zhang, and Stella Grosser, PhD |
Advancing Generic Drug Development Translating Science to Approval Day 2–Session 8 & Closing Remarks |
|
Suitability Petitions Enable Generics |
Robert Lionberger, PhD |
Suitability Petitions: A Policy Perspective |
Susan Levine, JD |
Best Practices for Submitting a Suitability Petition |
Rosanne Pagaduan, PharmD |
Bridging the Difference: Bioequivalence Assessments for Suitability Petitions |
Pamela Dorsey, PhD Heather Boyce, PhD |
Session 8 Question & Answer Panel |
Robert Lionberger, Susan Levine, Rosanne Pagaduan, Pamela Dorsey, Heather Boyce, and Arlene Figueroa, JD |
Day Two Closing Remarks |
Robert Lionberger, PhD |
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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