Topical Drug Development: Evolution of Science and Regulatory Policy II | Center of Excellence in Regulatory Science and Innovation

Co-Sponsored by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the U.S. Food and Drug Administration (FDA).

Online Event: July 23–24, 2020

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.	Slides
	Panel Discussion
	Quesion & Answer Session
Daily Closing Remarks	Audra Stinchcomb, Ph.D. Professor, UMSOP

Friday, July 24, 2020

Morning Welcome & Housekeeping Remarks	Audra Stinchcomb, Ph.D. Professor, University of Maryland School of Pharmacy (UMSOP) E. Dennis Bashaw, Pharm.D. Senior Science Advisor, Office of Clinical Pharmacology (OCP), FDA	Day 2 Meeting Recording* *Password: topical
Morning Session: Dermal Absorption of Sunscreens and FDA Rulemaking: Moving Forward Session Chair: E. Dennis Bashaw (FDA)
AAD and Sun Protection	Henry Lim, M.D. Former Chair, Department of Dermatology; Senior Vice President, Academic Affairs, Henry Ford Health System	Slides
An Overview of Absorption and Skin Factors	Sheila Friedlander, M.D. Professor of Dermatology and Pediatrics, University of California, San Diego School of Medicine	Slides
Current Program Update	E. Dennis Bashaw, Pharm.D. Senior Science Advisor, OCP, FDA	Slides
FDA Sunscreen Absoprtion Study Part 2	Murali Matta, Ph.D. Division of Applied Regulatory Sciences, FDA	Slides
FDA Sunscreen Study of Totality of Data	Jeff Florian, Ph.D. Division of Applied Regulatory Sciences, FDA	Slides
Afternoon Session: Current Methods and Looking Forward Session Chair: Soo Shin, Ph.D. (FDA)
MUsT and Dermal New Drug Applications	Chinmay Shukla, Ph.D. OCP, FDA	Slides
Master MUsT Elements	Luke Oh, Ph.D. OCP, FDA	Slides
FDA Modeling of Sunscreen	Da Zhang, Ph.D. OCP, FDA	Slides
FDA In Vitro Testing of Sunscreen Permeation	Yang Yang, Ph.D. Office of Pharmaceutical Quality, FDA	Slides
	Panel Discussion
	Question & Answer Session All Speakers
Closing Remarks	E. Dennis Bashaw, Pharm.D. (FDA)

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