A schedule of events for the All-Inclusive Topical Drug Bioequivalence and Bioavailability Summit is provided below for your convenience.

This one-day conference at the University of Maryland School of Pharmacy is open to the public. For a printable agenda, please download the conference brochure.

TimePresentation
9:25-9:30am Welcome
Audra Stinchcomb, PhD
Professor of Pharmaceutical Sciences
University of Maryland School of Pharmacy
9:30-10:00am "Current FDA Perspective"
Ethan Stier, RPh, PhD
Pharmacologist
Deputy Director, Division of Bioequivalence II
Office of Generic Drugs
Food and Drug Administration (FDA)
10:00-10:30am "Current Generic Pharma Perspective"
Ken Miller, PhD
Senior Vice President, Research & Development
IGI Laboratories (Buena, NJ)
10:30-11:00am "Dermatopharmacokinetics and Tape Stripping the Stratum Corneum: Origins and Problems"
Richard H. Guy, PhD
Professor of Pharmaceutical Sciences
University of Bath
11:00-12:00pm Discussion:
  • What were the conclusions from the USP meeting?
  • What actions are companies taking to proceed with ANDAs and NDAs?
  • Has the FDA changed any guidances?
  • Will guidances be changed in the future?
12:00-1:00pm Lunch is Provided
1:00-1:30pm "Dermatopharmacokinetics and Tape Stripping the Stratum Corneum: State-of-the-Art and Potential"
Annette L. Bunge, PhD
Professor Emeritus
Colorado School of Mines
1:30-2:00pm "In Vitro Permeation Studies and Bioequivalence"
Ken Walters, PhD
Chief Executive Officer
An-eX (Taunton, UK)
2:00-2:30pm "Comprehensive Approach to Topical Bioequivalence"
Thomas J. Franz, MD
Dermtech International (San Diego, CA)
2:30-2:45pm Break
2:45-4:30pm Panel and Audience Discussion
  • What research is needed?