Job title: Director, Division of Dermatology & Dental Products Division of Dermatology & Dental Products
Kendall Marcus is the Director of the Division of Dermatology and Dental Products at FDA and a board-certified specialist in Infectious Diseases. Dr. Marcus first joined the FDA as a Medical Officer in the Division of Antiviral Products (DAVP) in 2000. She served in DAVP as a Medical Team Leader from 2003-2009 and then as the Deputy Director of Safety from 2009-2014 before joining DDDP as Director in 2014. She received a B.S. from University of Maryland at College Park and an M.D. from the University of Maryland School of Medicine.
Panel Discussion: Developing Conversations Among Regulators & Industry Experts 9:30 am
Exploring the regulators’ current expectations in the present time Reviewing common challenges faced by industry leaders in the dermatology drug development space Exploring virtual clinical trials concerning regulatory guidance Looking ahead – predicting the future of dermatology drug developmentRead more
day: Day Two
Drug Development for Hidradenitis Suppurativa & Rare Diseases, a Regulatory Perspective 9:00 am
Demonstrating efficacy for the treatment of Hidradenitis Suppurativa Exploring the development of endpoints that are fit-for-purpose Incorporating patient perspectives Analyzing evidentiary standards for rare diseases Examining potential development strategiesRead more
day: Day Two