Download the Agenda – Speaker Bios
Day 1: September 12:
| Opening Remarks Kathleen Uhl, MD |
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| SESSION 1: Overview of Pre-ANDA Program for Complex Generic Drug Products | |
|
Pre-ANDA program overview Lei Zhang, PhD (OGD/ORS) |
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| Pre-ANDA logistics and best practices Kris Andre, MS (OGD/ORS) |
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| Pre-ANDA review perspectives: Office of Pharmaceutical Quality (OPQ) experience Suneela Prodduturi, PhD (OPQ/IO) |
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| Q&A and Panel Discussion | View Recording |
| SESSION 2: Complex Active Pharmaceutical Ingredients (APIs) | |
| Resolving peptide drug challenges through Pre-ANDA processes Eric Pang, PhD (OGD/ORS) |
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| Considerations in demonstrating complex API sameness Deyi Zhang, PhD (OGD/ORS) |
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| Common issues in complex drug substance review for generic drug products Jane Chang, PhD (OPQ/OPF) |
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| Q&A Panel Discussion | View Recording |
| SESSION 3: Complex Formulations/Dosage Forms | |
| Considerations for establishing Q1/Q2 sameness of complex formulations Bin Qin, PhD (OGD/ORS) |
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| Considerations and expectations for in vitro release testing of complex formulations Yan Wang, PhD (OGD/ORS) |
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| Liposomes: Physicochemical characterization and in vitro drug release testing Soumyarwit Manna, PhD (OGD/ORS) |
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| Iron carbohydrate colloid drug products: Characterization and impurity considerations Yiwei Li, PhD (OPQ/OLDP) |
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| Application of modeling and simulation in establishing appropriate bioequivalence limits for complex formulations Satish Sharan, PhD (OGD/ORS) |
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| Equivalence testing of complex particle size distribution profiles based on earth mover’s distance Meng Hu, PhD (OGD/ORS) |
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| Q&A and Panel Discussion | View Recording |
| SESSION 4: Complex Route of Delivery: Ophthalmic | |
| In vitro bioequivalence testing for topical ophthalmic suspension products Darby Kozak, PhD (OGD/ORS) |
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| Product quality testing for topical ophthalmic suspension products Patricia Onyimba (OPQ/OLDP) |
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| Physiologically-based pharmacokinetic modeling and simulation used in assessing bioequivalence for generic ophthalmic products Andrew Babiskin, PhD (OGD/ORS) |
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| Q&A and Panel Discussion | View Recording |
Day 2: September 13:
| SESSION 5: Complex Route of Delivery/Dosage Forms: Topical and Transdermal | |
| Overview of current science-based regulatory standards Sam G. Raney, PhD (OGD/ORS) |
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| Product development considerations for generic topical products Priyanka Ghosh, PhD (OGD/ORS) |
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| How to resolve current challenges in ANDAs for topical products a. Common deficiencies – OPQ considerations Kelley Burridge, PhD (OPQ/OLDP) b. Common deficiencies – OGD considerations Usha Katragadda, PhD (OGD/OB) |
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| Physiologically-based pharmacokinetic modeling and simulation used in assessing bioequivalence for generic dermatological products Eleftheria Tsakalozou, PhD (OGD/ORS) |
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| Q&A and Panel Discussion | View Recording |
| Product development considerations for generic transdermal delivery systems (TDS) Tannaz Ramezanli, PhD (OGD/ORS) |
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| How to resolve current challenges with ANDAs for TDS a. Common deficiencies-OPQ considerations Robert Berendt, PhD (OPQ/OLDP) b. Common deficiencies-OGD considerations Ying Fan, PhD (OGD/OB) c. Common deficiencies-Statistical considerations Stella Grosser, PhD (OTS/OB) |
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| Q&A and Panel Discussion | View Recording |
| SESSION 6: Complex Generic Drug-Device Combination Products and Complex Abuse Deterrent Formulations | |
| Developing generic drug-device combination products: Regulatory considerations for user-interface and the role of comparative analyses Andrew LeBoeuf, MS, JD (OGD/OGDP) Kimberly Witzmann, MD (OGD/ORS) |
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| In vitro and in vivo abuse deterrence evaluation of generic opioid products Xiaoming Xu, PhD (OPQ/OTR) Dajun Sun, PhD (OGD/ORS) |
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| SESSION 7: Complex Routes of Delivery: Orally Inhaled and Nasal Drug Products (OINDPs) | |
| Current product-specific guidances and common questions in pre-ANDA communications Denise Conti, PhD (OGD/ORS) |
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| Common bioequivalence deficiencies for orally inhaled drug products in ANDAs Tian Ma, PhD (OGD/OB) Michael Spagnola, MD (OGD/OB) |
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| OPQ’s perspective on quality considerations for generic orally inhaled drug products Dhaval Gaglani, MS (OPQ/OLDP) |
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| Batch-to-batch pharmacokinetic variability of orally inhaled drug products Zhichuan (Matt) Li, PhD (OGD/ORS) |
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| Computational fluid dynamics (CFD) modeling for product development of generic OINDPs and for supporting novel BE approaches Ross Walenga, PhD (OGD/ORS) |
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| Q&A and Panel Discussion | View Recording |
| Panel Discussion: All Topics & Closing Remarks Robert Lionberger, PhD (OGD/ORS) Kris Andre, MS (OGD/ORS) Dale Conner, PharmD (OGD/OB) Kamal Tiwari, PhD (OPQ/OPF) Katherine Tyner, PhD (OPQ/IO) |
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