November 9-11, 2020 | Virtual Conference

Learning Tracks

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:

  1. What are Complex Generic Drugs and how does GDUFA II aid their development
  2. 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
  3. 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
Development (DPD), Office of Generic Drug Policy (OGDP), 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

Get Started + Register

Whether you are an AAM member, general attendee, speaker or exhibitor, you can be part of the premier scientific and regulatory conference for the U.S. generics and biosimilars industry.

Get Started + Register

Whether you are an AAM member, general attendee, speaker or exhibitor, you can be part of the premier scientific and regulatory conference for the U.S. generics and biosimilars industry.

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