The Science Behind Innovations in Topical Generic Drug Assessment: Opportunities and Challenges

Program

Welcome

Jamie Breslin, PhD Executive Director, Advancing Innovation in Dermatology, Inc.

1:00 PM

Innovation and Topical Generic Drug Science:
A Case of Targeted and Planned Innovation

Markham C Luke, MD, PhD, FAAD Supervisory Physician & Director, FDA

1:05 PM

(recording timestamp - 0:05:48)

Translating Science to Regulatory Tools: Novel Approaches for Characterizing and Evaluating the Performance of Topical Drug Products

Tannaz Ramezanli, Pharm D, PhD Senior Pharmacologist at Office of Research & Standards, FDA

1:25 PM

(recording timestamp - 0:16:00)

Impact of GDUFA Regulatory Science and Research Program on Topical Product Availability

Priyanka Ghosh, PhD Lead Pharmacologist at Office of Research & Standards, FDA

1:45 PM

(recording timestamp - 0:45:20)

Moderated Q&A with Speakers

William Ju, MD, FAAD President, Advancing Innovation in Dermatology, Inc.

2:05 PM

(recording timestamp - 1:05:00)

Webinar registration is complimentary because of the generosity of AID's sponsors.

Webinar Takeaways

Appreciate the scientific advances being made in assessment of topical drugs, tying in formulation science, sparse sampling methods, spectroscopy, and physical/chemical analysis
Learn how approval of generic drugs, including topical drugs applied to the skin, are based on bioavailability/bioequivalence assessments and means to adequately demonstrate bioequivalence
Discover how to become involved in the research program with FDA (GDUFA research initiatives)
Understand the impact of generic topical drugs on the drug ecosystem in the United States

Tannaz Ramezanli, Pharm.D., Ph.D.

Senior pharmacologist, U.S. Food & Drug Administration (FDA)

Dr. Tannaz Ramezanli is a senior pharmacologist within the Office of Research and Standard (ORS) at Office of Generic Drugs (OGD) at the U.S. FDA. She specializes in topical and transdermal products. She is responsible for the development of product-specific bioequivalence guidances, reviewing and responding to controlled correspondences, citizen petitions, and Pre-ANDA meeting packages. She also leads multiple regulatory science research initiatives related to development of bioequivalence standards for complex topical drug products through FDA-funded collaborations with research institutions around the world. She received her Ph.D. in Pharmaceutical Sciences from Rutgers University and her Pharm.D. from Tehran University of Medical Sciences.

Priyanka Ghosh, Ph.D.

Lead Pharmacologist in the Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Centre for Drug Evaluation and Research (CDER), U.S. Food & Drug Administration (FDA)

Dr. Priyanka Ghosh is a lead pharmacologist within the Division of Therapeutic Performance, ORS, OGD. Her areas of expertise include products in the topical and transdermal drug delivery area. In her current role, Dr. Ghosh leads regulatory science research initiatives related to topical, transdermal and transmucosal drug products, under the GDUFA regulatory science program. Dr. Ghosh also leads the development of general and product-specific guidances, review strategies for industry meeting requests and citizen petitions and is the co-chair of the Bioequivalence Standards for Topicals Committee within OGD. Prior to joining FDA, Dr. Ghosh completed her Bachelor’s degree in Biotechnology from West Bengal University of Technology (India) and a Ph.D. in Pharmaceutics and Drug Design from the University of Kentucky.

Markham C. Luke, MD, PhD, FAAD

Supervisory Physician & Director, U.S. Food & Drug Administration (FDA)

Dr. Luke is a Supervisory Physician and Director of the Division of Therapeutic Performance (DTP1) in the Office of Research and Standards, Office of Generic Drugs at FDA. DTP1 is responsible for facilitating pre-application development of generic drugs by conducting and promoting regulatory science research to establish standards to ensure therapeutic equivalence of new generic drug products. Markham has an MD and a PhD in Pharmacology from Johns Hopkins University and is a dermatologist by training. Markham has been at FDA since 1998 serving various roles