Advancing Generic Drug Development: Translating Science to Approval Keynote Address
Janet Woodcock, MD
Acting Commissioner of Food and Drugs
Food and Drug Administration
COVID-19 Impact on Generic Drug Regulation and Evaluation
Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency
Alternative Bioequivalence Approaches for Data Analysis Due to COVID-19 Related Study Interruptions
Quality Considerations in the Development of FDA Guidance “Temporary Policy on Repackaging or Combining Propofol Drug Products During the COVID-19 Public Health Emergency”
Applications and Lessons Learned for Conducting Adaptive Designs on Generic Drug Development
Q&A Panel
Mitchell Frost, MD
Acting Deputy Director
Division of Therapeutic Performance II (DTP II)
ORS | OGD | CDER
Yuqing Gong, PhD
Pharmacologist
DQMM | ORS | OGD | CDER
Gloria Huang, PhD
Lead Chemist
Division of Liquid-Based Products II (DLBP II)
Office of Lifecycle Drug Products (OLDP)
Office of Pharmaceutical Quality (OPQ) | CDER
Kairui (Kevin) Feng, PhD
Staff Fellow
DQMM | ORS | OGD | CDER
Kimberly Witzmann, MD
Acting Director
Division of Clinical Review (DCR)
Deputy Director
Office of Safety and Clinical Evaluation (OSCE) | OGD | CDER
Stella C. Grosser, PhD
Director
Division of Biometrics VIII
Office of Biostatistics (OB)
Office of Translational Sciences (OTS) | CDER
Considerations in Assessing Generic Drug Products of Oral Dosage Forms
Nasal Pharmacokinetic Study of Abuse-Deterrent Oxycodone HCl ER Products Following Insufflation of Physically Manipulated Products
Advancement in the In-Vitro Evaluation of Abuse-Deterrent Formulations for Opioid Analgesics: Research and Assessment Perspectives
Physiological Based Pharmacokinetic Modeling and Simulation Absorption Modeling and Virtual Bioequivalence to Support Generic Drug Development and Regulatory Decision Making for Oral Products
Safety Assessment of Flavors in Generic Drug Products
Q&A Panel
Saeid Raofi, MS
Pharmacologist
DTP II | ORS | OGD | CDER
Manar Al-Ghabeish, PhD
Staff Fellow
Division of Product Quality Research (DPQR)
OTR | OPQ | CDER
Fang Wu, PhD
Acting Team Lead
DQMM | ORS | OGD | CDER
Melanie Mueller, PharmD, PhD
Team Lead
Division of Pharmacology/Toxicology Review (DPTR)
OSCE | OGD | CDER
Xiaoming Xu, PhD
Supervisory Chemist
DPQR | OTR | OPQ | CDER
Heather Boyce, PhD
Acting Team Lead
DTP II | ORS | OGD | CDER
Complex Generics_Complex Injectables, Opthalmic, and Otic Products, Part 1
Advances in Iron Colloid Products: Product-Specific Guidance (PSG) Discussion
Advances in Iron Colloid Products: Quality Considerations When Conducting Comparability Studies
Injectable Suspensions: Tools and Methods Bridging the In Vivo and In Vitro Gap
Q&A Panel
Wenlei Jiang, PhD
Senior Science Advisor
Immediate Office (IO)
ORS | OGD | CDER
Yiwei Li, PhD
Branch Chief
Division of Pharmaceutical Manufacturing IV (DPMAIV)
Office of Pharmaceutical Manufacturing Assessment (OPMA)
OPQ | CDER
Bin Qin, PhD
Staff Fellow
DTP I | ORS | OGD | CDER
Bruce Lerman, PhD
Lead Pharmacologist
DB I | OB | OGD | CDER
Darby Kozak, PhD
Deputy Director
DTP I | ORS | OGD | CDER
Complex Generics_Complex Injectables, Opthalmic, and Otic Products, Part 2
Challenges in the Approval of Complex Otic and Ophthalmic Generic Products: Bioequivalence Perspectives
Challenges in the Approval of Complex Otic & Ophthalmic Generic Products: Quality Perspectives
Physiological Based Pharmacokinetic Modeling and Simulation to Support Generic Ophthalmic Drug Product Development and Regulatory Decision Making
Q&A Panel
Chunsheng Zhao, PhD
Bioequivalence Reviewer
Division of Bioequivalence III (DB III)
OB | OGD | CDER
Poonam Chopra, PhD
Review Chemist
DLBP II | OLDP | OPQ | CDER
Mingliang Tan, PhD
Staff Fellow
DQMM | ORS | OGD | CDER
Yan Wang, PhD
Acting Team Lead
DTP I | ORS | OGD | CDER
Asif Rasheed, PhD
Senior Chemist
DLBPI | OLDP | OPQ | CDER
Kai Kwok, PhD
Senior Pharmaceutical Quality Assessor
DLBPII | OLDP | OPQ | CDER
Advancing Generic Drug Development: Translation Science to Approval, Day One Closing Remarks
Lei Zhang, PhD
Deputy Director
ORS | OGD | CDER
Cutting Edge Science in Complex Generics
Utility of Artificial Intelligence to Facilitate the Development and Regulatory Assessment of Complex Generic Drugs
Model-Integrated Evidence for Bioequivalence Assessment of Complex Generic Drugs
Scanning Electron Cryomicroscopy (Cryosem) for Characterization of Complex Drug Products
Advanced Imaging and Data Analysis to Support Compositional Structure Similarity of Polymeric Formulations
Q&A Panel
Meng Hu, PhD
Acting Team Lead
DQMM | ORS | OGD | CDER
Miyoung Yoon, PhD
Acting Team Lead
DQMM | ORS | OGD | CDER
Huzeyfe Yilmaz, PhD
Staff Fellow
Division of Complex Drug Analysis (DCDA)
OTR | OPQ | CDER
Yan Wang, PhD
Acting Team Lead
DTP I | ORS | OGD | CDER
Robert Lionberger, PhD
Director
ORS | OGD | CDER
Daniel Willett, PhD
Chemist
DCDA | OTR | OPQ | CDER
Complex Generics_Nasal and Inhalation Products
Product-Specific Considerations for Alternative Bioequivalence (BE) Approaches to Comparative Clinical Endpoint BE Studies
Approaches for studies interrupted due to COVID-19 for Nasal and Inhalation Products
Demonstrating Bioequivalence with Inhalation Spray Drug Products
Comparative Analyses for Generic Oral Inhalers
Q&A Panel
Susan Boc, PhD
Scientific Researcher
DTP I | ORS | OGD | CDER
Vipra Kundoor, PhD
Pharmacologist
DB I | OB | OGD | CDER
Sneha Dhapare, PhD
Visiting Associate
DTP I | ORS | OGD | CDER
Michael Spagnola, MD
Lead Physician
DCSS | OSCE | OGD | CDER
Bryan Newman, PhD
Acting Team Lead
DTP I | ORS | OGD | CDER
Changning Guo, PhD
Supervisory Chemist
DCDA | OTR | OPQ | CDER
Bing Cai, PhD
Director
DLBP I | OLPD | OPQ | CDER
Complex Generics_Topical Products, Part 1
“No Difference” Standard vs. Q1|Q2 Sameness for Topical Drug Products
Use of Q3 Characterization Tests for Topical Semisolid Drug Products
Recent Research Related to Q3 Characterization of Topical Products Containing Porous Microparticles
Challenges and Considerations with Model-based Virtual Bioequivalence Assessments for Generic Dermatological Products
Q&A Panel
Megan Kelchen, PhD
Pharmacologist
DTP I | ORS | OGD | CDER
Sam Raney, PhD
Associate Director for Science
IO | ORS | OGD | CDER
Ahmed Zidan, PhD
Senior Pharmacologist
DPQR | OTR | OPQ | CDER
Eleftheria Tsakalozou, PhD
Staff Fellow
DQMM | ORS | OGD | CDER
Khondoker Alam, PhD
Staff Fellow
DQMM | ORS | OGD | CDER
Markham Luke, MD, PhD
Director
DTP I | ORS | OGD | CDER
Complex Generics_Topical Products, Part 2
Common Issues Identified in In-vitro Release Test (IVRT) and In-vitro Permeation Test (IVPT) Studies Submitted in ANDA to Support Bioequivalence for Topical Products
Theoretical Principles and Best Practices: In Vitro Release Test
Theoretical Principles and Best Practices: In Vitro Permeation Test
Q&A Panel
Josephine Aimiuwu, PhD
Pharmacologist
DB II | OB | OGD | CDER
Tannaz Ramezanli, PhD, PharmD
Pharmacologist
DTP I | ORS | OGD | CDER
Priyanka Ghosh, PhD
Acting Team Lead
DTP I | ORS | OGD | CDER
Markham Luke, MD, PhD
Director
DTP I | ORS | OGD | CDER
Sam Raney, PhD
Associate Director for Science
IO | ORS | OGD | CDER
Advancing Generic Drug Development: Translation Science to Approval, Day Two Closing Remarks
Robert Lionberger, PhD
Director
ORS | OGD | CDER
