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Workshop

Event Title
FDA Public Workshop: Topical Drug Development - Evolution of Science and Regulatory Policy - Day 1 - 07/29/2019
July 29, 2019

Date:
July 29, 2019
Time:
08:30 AM - 05:00 PM EDT

The U.S. Food and Drug Administration (FDA) in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) will host a two-day public workshop entitled “Topical Drug Development - Evolution of Science and Regulatory Policy” on July 29-30, 2019. This workshop will bring together stakeholders from the FDA, academia, and industry to discuss the underpinnings of the Maximal Usage Study (MUsT) program, the successful incorporation of MUsT in drug development, and the utilization of in vitro methods in product development.

Date and Location:

Date:                    July 29-30, 2019
Time:                    8:30 am – 5:00 pm (Monday, July 29th)
                               9:00 am – 1:00 pm (Tuesday, July 30th)
Location:            University of Maryland School of Pharmacy, 20 N. Pine Street,
                                Baltimore, MD 21201

Background:

The assessment of dermal absorption in topical drug development is a relative new-comer to clinical pharmacology and pharmacokinetics, in general. This has historically been due to the lack of both sufficient analytical models and standardized assessment protocols. In the early 1990s, the FDA initiated the development of a MUsT paradigm designed to both assist in the evaluation of in vivo safety by providing direct assessment of plasma levels following application of topical products, and to provide information on the effects of disease and formulation on dermal penetration. Since its introduction, the MUsT paradigm has been used in the development program of every topically applied New Drug Application in the U.S. The increased scrutiny of topical antiseptics and sunscreens has led to the adoption of the MUsT paradigm into the area on non-prescription drug products via both draft and final rules for antiseptics, a safety and effectiveness guidance for sunscreens, the draft and pending final rule for sunscreens, and the recently published final guidance for industry entitled "Maximal Usage Trials for Topically Applied Active Ingredients Being Considered for Inclusion in an Over-the-Counter Monograph: Study Elements and Considerations.” In parallel, in vitro permeation methods have progressed to the point where they can be used, in conjunction with the in vivo MUsT paradigm, as a tool in the successful development of topical drugs.

Workshop Objectives:

  1. To present the background of the current regulatory policy in the area of dermal absorption and its underpinnings.
  2. To provide examples of the successful incorporation of both in vivo (Maximal Usage Trials) and in vitro (percutaneous permeation studies, i.e., IVPT) in drug development.
  3. To facilitate discussion as to the design elements and concerns of both in vivo and in vitro methods in the new drug and over-the-counter(OTC) drug space.
  4. To stimulate discussion between interested parties in the evolution of science in the area of topical drug development and dermal absorption testing.

Additionally, data from the recent FDA publication of their pilot sunscreen MUsT program will be discussed along with how this information can be used to augment and improve the development of non-prescription drugs, both under the rubric of an NDA and the OTC Monograph system.

Registration:

Registration can be accessed at https://www.eventbrite.com/e/topical-drug-development-evolution-of-science-and-regulatory-policy-tickets-62326579477. In addition to the live program, the workshop will be broadcasted via a livestream webinar on July 29-30, 2019. Individuals who cannot attend the event in-person but wish to view the webinar are still required to complete registration for the conference. Registration to view the webinar is free.

Meeting Information:

Additional information about this workshop, including an agenda, poster submission instructions, and parking and directions, is available at https://www.pharmacy.umaryland.edu/centers/cersievents/topical/.

Please note that those individuals desiring to attend in person (fee based) MUST pre-register by July 25th at which time registrations will close and no additional registrations will be allowed.  On-site registration will NOT be available. Webinar registration will be open throughout the end of the workshop to accommodate those wishing to dial in remotely.

Special Accommodations:

If special accommodations at the workshop are needed due to a disability, please email Ann Anonsen at aanonsen@umd.edu at least seven (7) days in advance of the workshop. Requests for sign language interpretation or Computer Aided Realtime Translation (CART)/captioning should be made two (2) weeks in advance of the workshop, and should be sent directly to the FDA Interpreting Services Staff at interpreting.services@oc.fda.gov.

Contact:

E. Dennis Bashaw, PharmD.
Senior Science Advisor
Office of Clinical Pharmacology
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Phone: 301-796-1502
Email: edward.bashaw@fda.hhs.gov