AUG 13 - USP Panel Findings on Development of a Novel In Vitro TDS Adhesion Test

In 2019, the United States Pharmacopeia (USP) created an Expert Panel (New Advancements in Product Performance Testing) to conduct a gap analysis on the need for, and possible creation of, tests and/or standards to characterize the quality or performance of topical and transdermal products. The results of this analysis were described in a 2023 USP Stimuli Article: Advances in Product Quality and Performance Tests for Topical and Transdermal Products - View of the USP Expert Panel, which sought feedback about the need new tests and/or standards in three specific areas:

• In vitro adhesion tests for transdermal and topical delivery systems (collectively called TDS)
• In vitro quality and performance tests for microneedle array systems
• Physicochemical and structural (Q3) characterization tests for topical drug products

The purpose of this webinar is to offer a brief update summarizing the insights and recommendations provided to USP in each of the three specific areas of the stimuli article. Thereafter, the webinar will focus on a deeper dive into the first of these three areas, discussing research activities that have been initiated to develop a new and improved approach to in vitro TDS adhesion testing. The goal of the webinar is to facilitate an interactive dialogue and solicit further input about user requirements and scientific considerations that can guide the development of a novel in vitro test method that is predictive of the in vivo adhesion performance of TDS products. Specifically, input is sought from investigators who work with TDS products to clarify what intrinsic properties and extrinsic factors are most likely to influence in vivo adhesion performance.

Kevin Warner, Ph.D.

Dr. Warner has 20 years experience in drug delivery platform development, small molecule formulation development, and manufacturing process development. He is an expert in formulation and process development and has played integral roles in obtaining FDA approval of several products. He is currently Vice President, Pharmaceutical Development at Alucent Biomedical Inc. In previous roles, Dr. Warner led chemistry, manufacturing and controls (CMC) product development teams at ZARS Pharma, and Allergan, Inc. Dr. Warner is a member of the USP, General Chapters Dosage Form Expert Committee and 2024 Chair of the AAPS Topical and Transdermal Community. Dr. Warner holds a BS degree in Chemistry from Brigham Young University, and a Ph.D. in Pharmaceutics and Pharmaceutical Chemistry from the University of Utah.

Sam Raney, Ph.D.

Dr. Sam Raney has over 30 years of experience as a researcher and adjunct professor in academia, as a principal or sub investigator on over 400 pharmaceutical product studies, as a USP expert on multiple expert committees and panels, and in senior management roles within industry. He is the Associate Director for Science in the FDA’s Office of Research and Standards, and the Chief Scientific Advisor for topical bioequivalence in FDA’s Office of Generic Drugs. Dr. Raney holds a Bachelor’s Degree in Molecular Biophysics & Biochemistry from Yale University, and a Ph.D. in Biochemistry & Molecular Biology from the University of British Columbia.

Yousuf Mohammed, Ph.D.

Dr Yousuf Mohammed completed his PhD in pharmaceutics and skin drug delivery in 2013. He is a research leader within Frazer Institute at the University of Queensland. He has been working within the field of skin drug delivery, regulatory sciences, novel technologies and devices, microneedles and nanomaterials and has contributed significantly to the field with over 80 high impact publications, book chapters and over 50 conference presentations. His work with the U.S FDA, Office of Generic Drugs and Centre for Drug Evaluation and Research has translated into several product specific guidances. In the United States and Europe alone, more than 80 regulatory guidance documents and guidelines now recommend the use of these new techniques to develop topical and transdermal products. Dr Mohammed has a global standing which is evident by his current position as the Vice-Chair of the Topical and Transdermal Community within the American Association of Pharmaceutical Scientists (AAPS). He is also invited to serve as an expert on transdermal products to guide research during the next 5 years through the Centre for Research on Complex Generics (CRCG).