Agenda

A tentative agenda for "Topical Drug Development - Evolution of Science and Regulatory Policy II" is provided below for the convenience of event attendees.

Scheduled for July 23-24, 2020, "Topical Drug Development - Evolution of Science and Regulatory Policy II" is a two-day workshop hosted by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI).

PLEASE NOTE: This is an online event. Individuals who register to attend will receive instructions about how to access conference presentations as the event approaches.

Thursday, July 23

To access the webinar recording from July 23, please use this link and the password topical: https://umaryland.webex.com/recordingservice/sites/umaryland/recording/67bbd1b9931e4bbb9fabce5230c9a411

Time	Activity
9 – 9:15 a.m.	Welcome and Opening Remarks Audra Stinchcomb, PhD Professor, University of Maryland School of Pharmacy Welcome from FDA Janet Woodcock, MD Director, Center for Drug Evaluation and Research, FDA
9:15 – 9:45 a.m.	Summary of First Meeting E. Dennis Bashaw, PharmD Senior Science Advisor, Office of Clinical Pharmacology, FDA
Morning Session: Challenges in Topical Drug Development – Harnessing In Vitro Methods Session Chair: Audra Stinchcomb, PhD (UMSOP)
9:45 – 10:20 a.m.	Advances in Topical Bioequivalence Assessments: Characterization-Based Approaches Sam Raney, PhD Lead for Topical and Transdermal Drug Products Office of Generic Drugs, FDA
10:20 – 10:35 a.m.	Break
10:35 – 11:35 a.m.	Environmental Harmonization in Multi-Application Sunscreen Use: In Vitro Permeation Testing to Healthy Volunteers Audra Stinchcomb, PhD Professor, University of Maryland School of Pharmacy Trifarotene Cream (AKLIEF®): Formulation Screening from In Vitro Permeation Testing to Clinical Studies Nathalie Wagner, MS Senior Clinical Pharmacokinetics Manager Global Clinical Development, Galderma, TX
11:35 – 11:50 a.m.	Panel Discussion
11:50 – 12:30 p.m.	Break
Afternoon Session: Challenges in Topical Drug Development — Harnessing In Silico Methods Session Chair: Da Zhang, PhD (OCP, FDA)
12:30 – 1:30 p.m.	Modeling Dermal Drug Absorption from Complex Semisolid Formulations: Insights from Multi-Phase, Multi-Layer MechDermA Model Sumit Arora, PhD Senior Research Scientist, Certara UK Limited Computational Modeling of Absorption from Complex Topical Formulations Jessica Spires, PhD Senior Scientist II, Simulations Plus, Inc., Lancaster, CA
1:30 – 1:45 p.m.	Break
1:45 – 2:45 p.m.	A Workflow for Mechanistic Dermal Model Optimization and In Vitro-In Vivo Inference Abdullah Hamadeh, PhD University of Waterloo School of Pharmacy Design of MUsT and Leveraging MIDD Vivek Purohit, PhD Senior Director, Clinical Pharmacology Global Product Development, Pfizer, Inc.
2:45 – 3:15 p.m.	Panel Discussion
3:15 – 3:30 p.m.	Break
3:30 – 4:30 p.m.	Question & Answer Session All Speakers
4:30 p.m. - Close	Daily Closing Remarks Audra Stinchcomb, PhD Professor, University of Maryland School of Pharmacy

Friday, July 24

To access the webinar recording from July 24, please use this link and the password topical: https://umaryland.webex.com/recordingservice/sites/umaryland/recording/da72b2abb5f94e03bed52681dbf50ab5

Time	Activity
9 – 9:15 a.m.	Morning Welcome and Housekeeping Remarks Audra Stinchcomb, PhD Professor, University of Maryland School of Pharmacy E. Dennis Bashaw, PharmD Senior Science Advisor, Office of Clinical Pharmacology, FDA
Morning Session: Dermal Absorption of Sunscreens and FDA Rulemaking — Moving Forward Session Chair: E. Dennis Bashaw (FDA)
9:15 – 10:15 a.m.	AAD and Sun Protection Henry Lim, MD Former Chair, Department of Dermatology Senior Vice President, Academic Affairs Henry Ford Health System An Overview of Absorption and Skin Factors Sheila Friedlander, MD Professor of Dermatology and Pediatrics University of California, San Diego School of Medicine Current Program Update E. Dennis Bashaw, PharmD Senior Science Advisor, Office of Clinical Pharmacology, FDA
10:15 – 10:30 a.m.	Break
10:30 – 11:30 a.m.	FDA Sunscreen Absorption Study Part 2 Murali Matta, PhD Division of Applied Regulatory Sciences, FDA FDA Sunscreen Study Totality of Data Jeff Florian, PhD Division of Applied Regulatory Sciences, FDA
11:30 - Noon	Panel Discussion
Noon – 1 p.m.	Break
Afternoon Session: Current Methods and Looking Forward Session Chair: Soo Shin, PhD (FDA)
1 – 2 p.m.	MUsT and Dermal New Drug Applications Chinmay Shukla, PhD Office of Clinical Pharmacology, FDA Master MUsT Elements Luke Oh, PhD Office of Clinical Pharmacology, FDA
2 – 2:15 p.m.	Break
2:15 – 3:15 p.m.	FDA Modeling of Sunscreen Da Zhang, PhD Office of Clinical Pharmacology, FDA FDA In Vitro Testing of Sunscreen Permeation Yang Yang, PhD Office of Pharmaceutical Quality, FDA
3:15 – 3:45 p.m.	Panel Discussion
3:45 – 4:15 p.m.	Question & Answer Session All Speakers
4:15 – 4:30 p.m.	Closing Remarks E. Dennis Bashaw, PharmD (FDA)