Complex Workshop
Tuesday, November 10, 2020
12:30 p.m. - 5:30 p.m.
*Limited to first 200 sign-ups.
The availability of generic drug products can mitigate the risk of drug shortages, help make prescription drugs more affordable and enhance patient access to medicines. GDUFA II added new ways to interact with FDA during the development of complex generic drug products (CGDPs).
The complexity of CGDPs may be associated with the active pharmaceutical ingredient (API), the formulation, the dosage form, the route of delivery and/or the nature of the drug-device combination product. To encourage CGDP development, the FDA is actively engaging with prospective developers of CGDPs through pre-ANDA meetings to discuss specific issues of scientific or regulatory complexity, and to clarify the FDA’s bioequivalence (BE) standards and recommendations.
This practical, active-participation workshop will help participants learn how to approach development of CGDPs and how to engage with the FDA during the development of a CGDP. Workshop participants will learn how to efficiently de-risk CGDP development, increase certainty about regulatory decision making and enhance patient access to high-quality CGDPs. Workshop participants will gain hands-on experience discussing CGDP development approaches with FDA experts in mock pre-ANDA meetings.
The meetings will be structured as fun, simulated experiences where all workshop participants can interact directly with FDA experts. Each breakout session will hold a mock pre-ANDA meeting for the hypothetical CGDP they will have developed with their mentors, and the participants from the other breakout sessions will observe as FDA experts answer questions and provide constructive, critical feedback.
Overview of the workshop:
- What are Complex Generic Drugs and how does GDUFA II aid their development
- Breakout sessions for specific types of Complex Drug Products, each will contain a hypothetical case study to help learn the GDUFA II pre-ANDA program for complex products
- Share session on Questions and Answers to key issues identified in the breakouts
Markham Luke, M.D., PhD
Director, DTP, ORS, OGD, CDER, FDA
Robert Lionberger, PhD
Director, ORS, OGD, CDER, FDA
Kris Andre
Regulatory Project Manager, ORS, OGD, CDER, FDA
Karen Bengtson
Regulatory Project Manager, ORS, OGD, CDER, FDA
Lei Zhang, PhD
Deputy Director, ORS, OGD, CDER, FDA
Bing Cai, PhD
Division Director, Division of Liquid-Based Products I (DLBP I), Office of Lifecycle Drug Products (OLDP), Office of Pharmaceutical Quality (OPQ), CDER, FDA
Dhaval Gaglani
Branch Chief, DIMRP III, OLDP,, OPQ, CDER, FDA
Liang Zhao, PhD
Division Director, DQMM, ORS, OGD, CDER, FDA
Lanyaon Fang, PhD
Associate Director, DQMM, ORS, OGD, CDER, FDA
Breakout Sessions
Breakout 1: Parenteral and Ophthalmic Drug Products
Yan Wang, PhD
Acting Team Lead, DTP, ORS, OGD, CDER, FDA
Bin Qin, PhD
Reviewer, DTP, ORS, OGD, CDER, FDA
Eric Pang, PhD
Senior Chemist, DTP, ORS, OGD, CDER, FDA
Deyi Zhang, PhD
Reviewer, DTP, ORS, OGD, CDER, FDA
Qi Li, PhD
Chemist, DTP, ORS, OGD, CDER, FDA
Satish Sharan, PhD
Reviewer, DQMM, ORS, OGD, CDER, FDA
Elizabeth Friedman, J.D., LLM
Regulatory Counsel, DPD, OGDP, OGD, CDER, FDA
Cameron Smith, PhD
Branch Chief, DLBP I, OLDP, OPQ, CDER, FDA
Pinaki Desai
Chemist, Division of Immediate and Modified Release Products III (DIMRP III), OLDP, OPQ, CDER, FDA
CAPT Jeff Tworzanski
Regulatory Health Project Manager, DTP, ORS, OGD, CDER, FDA
Breakout 2: Orally Inhaled and Nasal Drug Products
Bryan Newman, PhD
Reviewer, DTP, ORS, OGD, CDER, FDA
Liangfeng Han, M.D., PhD
Methods and Modeling (DQMM), ORS, OGD, CDER, FDA
Darby Kozak, PhD
Deputy Division Director, DTP, ORS, OGD, CDER, FDA
Sharon Ahluwalia, M.D.
Reviewer, Division of Therapeutic Performance (DTP), Office of Research Standards (ORS), Office of Generic Drugs (OGD), CDER, FDA
Jieon Lee, PhD
Reviewer, DQMM, ORS, OGD, CDER, FDA
Andrew Babiskin, PhD
Lead Chemist, Division Quantitative Methods and Modeling (DQMM), ORS, OGD, CDER, FDA
Melissa Mannion, PharmD, J.D.
Regulatory Counsel, DPD, OGDP, OGD, CDER, FDA
Fang Yuan, PhD
Chemistry Reviewer, DIMRP III, OLDP, OPQ, CDER, FDA
Caliope Sarago, MHSA
Senior Regulatory Health Project Manager, IO, ORS, OGD, CDER, FDA
Breakout 3: Topical Drug Products
Sam Raney, PhD
Lead for Topical and Transdermal Drug Products, DTP, ORS, OGD, CDER, FDA
Tannaz Ramezanli, PharmD, PhD
Reviewer, DTP, ORS, OGD, CDER, FDA
Priyanka Ghosh, PhD
Senior Pharmacologist, DTP, ORS, OGD, CDER, FDA
Mengmeng Niu, PhD
Reviewer, DTP, ORS, OGD, CDER, FDA
Megan Kelchen, PhD
Reviewer, DTP, ORS, OGD, CDER, FDA
Eleftheria Tsakalozou, PhD
Reviewer, DQMM, ORS, OGD, CDER, FDA
Mindy Ehrenfried, J.D.
Regulatory Counsel, DPD, OGDP, OGD, CDER, FDA
Hailing Zhang, PhD
Branch Chief, Division of Liquid-Based Products II (DLBP II), OLDP, OPQ, CDER, FDA
Wendy Good, PhD, MBA
Senior Regulatory Health Project Manager, ORS, OGD, CDER, FDA
Breakout 4: Device Considerations for Complex Drug-Device Combination Products
Denise Conti, PhD
Reviewer, DTP, ORS, OGD, CDER, FDA
Elizabeth Bielski, PhD
Chemist, DTP, ORS, OGD, CDER, FDA
Betsy Ballard, M.D.
Medical Officer, DTP, ORS, OGD, CDER, FDA
Ross Walenga, PhD
Chemical Engineer, DQMM, ORS, OGD, CDER, FDA
Lisa Bercu, J.D.
Regulatory Counsel, Division of Policy Reviewer, DTP, ORS, OGD, CDER, FDA
Richard Chang, PhD
Chemist, DLBP I, OLDP, OPQ, CDER, FDA
Savita Nigam
Regulatory Project Manager, IO, ORS, OGD, CDER, FDA