Advancing Innovative Science in Generic Drug Development Workshop
September 29 & 30, 2020

The goal of this science-focused workshop is to help the generic industry pave a clear scientific pathway for generic drug development. We will focus on common scientific issues seen in Abbreviated New Drug Applications (ANDAs), commonly known as generic drug applications. We will link GDUFA science and research on complex products and complex scientific issues to product-specific guidance development, discuss pre-ANDA meetings and assessment, and examine various areas of the science behind generic drug development.

Session Recordings:

The session recordings will be linked below once they have been processed.

Day One:

• Keynote – Stephen M. Hahn
• Update on GDUFA Science and Research – Robert Lionberger
• March 2020 Transition Under the BPCI Act: Impact on Generics – Mindy Ehrenfried
• Related Impurities Assessment Considerations for APIs in the Generic Complex Peptide Products – Manivannan Ethirajan
• Non-clinical Evaluation of Immunogenicity Risk of Generic Complex Peptide Products – Eric Pang
• Session 1, Topic 1: Q&A Panel
• Developing and Validating Advanced Microscopy Methods for Supporting Complex Product Equivalence – Changning Guo
• Developing and Validating Commonly Employed Particle Sizing Methods to Support Bioequivalence (BE) and Product Quality – Xiaoming Xu
• Quantitative Methods for Determining Equivalence of Particle Size Distributions – Meng Hu
• Session 1, Topic 2: Q&A Panel
• Assessment of Complex Drug Product – Physicochemical Characteristics to Support In Vitro Bioequivalence Studies – Asif Rasheed
• In Vitro Release Testing for Complex Generics: A Bioequivalence Perspective – Yan Wang
• In Vitro Bioequivalence Studies of Topical Drug Products: Challenges and Promises of In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) – Hiren Patel
• Session 1, Topic 3: Q&A Panel
• Navigating Formulation Assessments: From General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness – Darby Kozak
• Calculating Maximum Daily Dose (MDD) for Orally Administered Drug Products – Amanda Jones
• What’s New in the Inactive Ingredient Database (IID)? – Susan Zuk
• Local Toxicity Considerations for Qualifying Excipients in Generic Drugs – Yongcheng Huang
• Session 2: Q&A Panel

Day Two:

• Advancements in In Vitro Studies for Alternative BE Approaches to Comparative Clinical Endpoint BE Studies – Elizabeth Bielski
• The Potential of Pharmacokinetic Bioequivalence (BE) Studies in Detecting Regional Deposition with Orally Inhaled Drug Products – Liangfeng Han
• Regional Deposition and Systemic Pharmacokinetic Data of OINDPs with Modeling and Simulation – Ross Walenga
• Session 3, Topic 1: Q&A Panel
• When Do Formulation Differences in Topical Dosage Forms Impact Their Function: Emerging Insights and Implications for Bioequivalence Approaches – Sam Raney
• In Vivo Dermal Microperfusion & Microdialysis Bioequivalence Approaches – Tannaz Ramezanli
• Non-Invasive Raman Spectroscopy-Based Bioequivalence Approaches – Priyanka Ghosh
• Session 3, Topic 2: Q&A Panel
• Physiologically-based Pharmacokinetic Modeling to Guide Study Design and Product Development for Generic Dermatological Products – Eleftheria Tsakalozou
• Model-Informed and Model-Integrated Approach in BE Assessment of Long-Acting Injectable Products – Satish Sharan
• Session 3, Topic 3: Q&A Panel
• Biopharmaceutics Classification System Class 3 Waiver – Yi Zhang
• Using Physiologically-based Pharmacokinetic Absorption Modeling to Support Biopharmaceutics Classification System Class 3 Drug Waiver – Fang Wu
• Alternatives to f2 Testing for Dissolution Similarity – f2 Bootstrapping and MSD Method – Xiajing (Jean) Gong
• Session 4, Topic 1: Q&A Panel
• A Closer Look into the Nasogastric and Gastric Feeding Tube Study Recommendations – Katherine Tyner
• In Vitro Enteral (Nasogastric and Gastric) Feeding Tube Testing of Generic Drug Products: Case Studies – Mamta Kapoor
• Practical Considerations for Bioequivalence of GI Locally-Acting Products – Minglei Cui
• Session 4, Topic 2: Q&A Panel

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