A tentative agenda for "Topical Drug Development -- Evolution of Science and Regulatory Policy" is available below for the convenience of conference attendees.
This two-day workshop is scheduled for July 29-30, 2019. It will be held at the University of Maryland School of Pharmacy, located at 20 N. Pine Street in Baltimore, Md.
To view the webinar recordings from this conference, please use the following links:
- July 29 Webinar Recording: https://umaryland.webex.com/recordingservice/sites/umaryland/recording/1b82a58bad5a4019836728c63eafb39e
- July 30 Webinar Recording: https://umaryland.webex.com/recordingservice/sites/umaryland/recording/2d7789d4f2e24725b84a4b5d62ade9a7
Monday, July 29, 2019
| Time | Activity |
|---|---|
| 8:30 – 9 a.m. | Welcome and Opening Remarks Audra Stinchcomb, PhD (Professor, UMSOP) E. Dennis Bashaw, PharmD (FDA) |
| Morning Session | Challenges in Topical Drug Development Session Chair: E. Dennis Bashaw, PharmD (FDA) |
| 9 – 10 a.m. | An Overview of Absorption and Skin Factors Sheila Fallon Friedlander, MD Professor of Dermatology and Pediatrics University of California, San Diego School of Medicine A History of Dermal Absorption Assessment at the FDA: Quo Vadis? E. Dennis Bashaw, PharmD Senior Science Advisor to Immediate Office Office of Clinical Pharmacology U.S. Food and Drug Administration |
| 10 – 10:15 a.m. | Coffee Break |
| 10:15 – 11:15 a.m. | Clinical Experience in the NDA Setting with the Maximal Usage Study Paradigm Chinmay Shukla, PhD Dermatology Team Leader Office of Clinical Pharmacology U.S. Food and Drug Administration Current Regulatory Perspectives for Dermal Absorption Under the OTC Monograph Luke Oh, PhD Special Monograph Team Office of Clinical Pharmacology U.S. Food and Drug Administration |
| 11:15 – 11:45 a.m. | Panel Discussion Moderator: Sojeong Yi, PhD |
| 11:45 – 12:55 p.m. | Lunch and Networking Includes Selected Poster Session |
| Afternoon Session | Considerations in Topical Drug Development in the OTC and NDA Setting Session Chair: Chinmay Shukla (FDA) |
| 1 – 2 p.m. | The FDA Sunscreen Study: Lessons Learned and to be Learned Murali Matta, PhD Bioanalytical Lead, Division of Applied Regulatory Science Office of Clinical Pharmacology U.S. Food and Drug Administration Dermal Absorption in the Setting of OTC Rulemaking Theresa M. Michele, MD Director, Division of Nonprescription Drug Products U.S. Food and Drug Administration Jane J. Sohn, PhD Pharmacology Team Leader Division of Nonprescription Drug Products U.S. Food and Drug Administration |
| 2 – 2:15 p.m. | Coffee Break |
| 2:15 – 3:15 p.m. | MUsT: Must-Have Study in Topical Drug Development Nathalie Wagner, MSc Senior Clinical Pharmacokinetics Manager Global Clinical Development Nestle’ Skin Health Analysis and Interpretation of Systemic Exposures from Topical Agents: Learnings from Crisaborole Ointment Vivek Purohit, PhD Director, Clinical Pharmacology Global Product Development Pfizer, Inc. |
| 3:15 – 3:45 p.m. | Panel Discussion Moderator: Da Zhang, PhD |
| 3:45 – 4 p.m. | Break |
| 4 – 5 p.m. | Q&A with All Speakers |
| 5 p.m. | Daily Close Audra Stinchcomb, PhD Professor of Pharmaceutical Sciences University of Maryland School of Pharmacy |
Tuesday, July 30, 2019
| Time | Activity |
|---|---|
| Morning Session | In Vitro Methods and Application in Topical Drug Development Session Chair: Audra Stinchcomb, PhD |
| 9:15 – 10:45 a.m. | Heat Effects on Multi-Application Sunscreen Use: IVPT to Healthy Volunteers Audra Stinchcomb, PhD Professor of Pharmaceutical Sciences University of Maryland School of Pharmacy A Generic Perspective on the Use of In Vitro Assessment Methods Sam Raney, PhD Lead for Topical and Transdermal Drug Products Office of Generic Drugs U.S. Food and Drug Administration In Vitro Permeation Test: Practical Considerations in Its Method Development and Implementation Leandro L. Santos, MSc Associate Director, Clinical Sciences Incyte Corporation |
| 10:45 – 11 a.m. | Coffee Break |
| 11 – 12:30 p.m. | The Use of IVPT as a Tool in Developing Topical Drug Products Vijendra Nalamothu, PhD Chief Executive Officer Tergus Pharma Integration of IVPT and MUsT into the Safety Assessment of OTC Products Sojeong Yi, PhD Special Monograph Team Office of Clinical Pharmacology U.S. Food and Drug Administration Utility of Quantitative Pharmacology and Pharmacometrics in Investigating Active Sunscreen Ingredients Absorption Da Zhang, PhD Special Monograph Team Office of Clinical Pharmacology U.S. Food and Drug Administration |
| 12:30 – 1 p.m. | Panel Discussion Moderator: Sojeong Yi, PhD |
| 1 p.m. | Closing Remarks and Next Steps E. Dennis Bashaw, PharmD Senior Science Advisor to Immediate Office Office of Clinical Pharmacology U.S. Food and Drug Administration |