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Thursday, July 23, 2020

Welcome & Introduction	Audra Stinchcomb, Ph.D. Professor, University of Maryland School of Pharmacy (UMSOP) Janet Woodcock, M.D. Director, Center for Drug Evaluation and Research (CDER), FDA	*Day 1 Meeting Recording\| Slides** *Password: topical
Summary of First Meeting	E. Dennis Bashaw, Pharm.D. Senior Science Advisor, Office of Clinical Pharmacology (OCP), FDA
Morning Session: Challenges in Topical Drug Development – Harnessing In Vitro Methods Session Chair: Audra Stinchcomb, Ph.D. (UMSOP)
Advances in Topical Bioequivalence Assessments: Characterization-Based Approaches	Sam Raney, Ph.D. Lead for Topical and Transdermal Drug Products, Office of Generic Drugs, FDA	Slides
*Environmental Harmonization in Multi-Application Sunscreen Use: In Vitro* Permeation Testing to Healthy Volunteers**	Audra Stinchcomb, Ph.D. Professor, UMSOP	Slides
*Trifarotene Creme (AKLIEF): Formulation Screening from In Vitro* Permeation to Testing to Clinical Studies**	Nathalie Wagner, M.S. Senior Clinical Pharmacokinetics Manager, Global Clinical Development, Galderma, TX	Slides
	Panel Discussion
Afternoon Session: Challenges in Topical Drug Development: Harnessing In Silico Methods Session Chair: Da Zhang, Ph.D. (OCP, FDA)
Modeling Dermal Drug Absorption from Complex Semisolid Formulations: Insights from Multi-Phase, Multi-Layer MechDermA Model	Sumit Arora, Ph.D. Senior Research Scientist, Certara UK Limited	Slides
Computational Modeling of Absorption from Complex Topical Formulations	Jessica Spires, Ph.D. Senior Scientist II, Simulations Plus, Inc., Lancaster, CA	Slides
A Workflow for Mechanistic Dermal Model Optimization and In Vitro-In Vivo Inference	Abdullah Hamadeh, Ph.D. University of Waterloo School of Pharmacy
Hand Sanitizer Speaker	TBA
Design of MUsT and Leveraging MIDD	Vivek Purohit, Ph.D. Senior Director, Clinical Pharmacology, Global Product Development, Pfizer, Inc.
	Panel Discussion
	Quesion & Answer Session
Daily Closing Remarks	Audra Stinchcomb, Ph.D. Professor, UMSOP

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