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Wednesday, June 22 • 2:00pm - 3:00pm
#348: Research and Innovation to Enhance Patient Access to Topical Dermatological Products in the US

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-625-L04-P ; CME 1.00; RN 1.00

This session will discuss scientific and regulatory considerations related to topical dermatological product, with a focus on understanding the correlation between product microstructure and drug bioavailability to facilitate drug development.

Learning Objectives

Discuss complexity and challenges associated with different topical dermatological products (TDP); Identify various physicochemical and structural attributes to characterize TDP and methodologies to be able to correlate the characteristics with product performance; Discuss current recommendations for assessing bioavailability and bioequivalence of TDP with insights from industry and FDA.

Chair

Ahmed Zidan, PhD, MS

Speaker

GDUFA Funded Development of Efficient Bioequivalence Approaches for Topical Generics
Sam G. Raney, PhD, MS

Product Development Considerations and Bioequivalence Strategies for Generic Topical Products
Priyanka Ghosh, PhD

Industry Update: Topical Drug Development Paradigms
Vijendra Nalamothu, PhD


Speakers
avatar for Priyanka Ghosh

Priyanka Ghosh

Acting Team Lead, ORS, Office of Generic Drugs, CDER, FDA, United States
Dr. Priyanka Ghosh is a pharmacologist within the Office of Generic Drugs, US FDA. Her specialization is drug products in the topical and transdermal drug delivery area. In her current role, Dr. Ghosh is responsible for the development of regulatory standards for complex generic dosage... Read More →
VN

Vijendra Nalamothu

Chief Executive Officer, Tergus Pharma, United States
Dr. Vijendra Nalamothu is the Chairman & CEO of Tergus Pharma, a North Carolina-based CDMO which specializes in complete topical drug product development and commercial manufacturing. Dr. Nalamothu earned his Ph.D. in Pharmaceutics from the University of the Science’s Philadelphia... Read More →
avatar for Sam Raney

Sam Raney

Associate Director for Science, ORS, Office of Generic Drugs, CDER, FDA, United States
Dr. Sam Raney is a thought leader in topical and transdermal drug products, with over 30 years of experience in skin research, producing numerous research manuscripts, review articles, book chapters and patents in pharmaceutical product development. Dr. Raney has been a researcher... Read More →
AZ

Ahmed Zidan

Senior Staff Fellow (Pharmacologist), OTR, OPQ, CDER, FDA, United States
Dr. Ahmed Zidan is a senior pharmacologist staff in the Division of Product Quality Research of Office of Testing and Research of CDER. Ahmed leads the topical and transdermal drug products laboratories of DPQR. Dr. Zidan leads the regulatory science research related to topical and... Read More →

Wednesday June 22, 2022 2:00pm - 3:00pm CDT
Room 185 AB McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  06: PreClinical Dev-EarlyPhaseCR, Session