Faculty 2019-2020 Course 12

Washington, DC & transition to virtual during pandemic

The American Course on Drug Development and Regulatory Sciences (ACDRS) teaching faculty are science-driven and highly experienced international faculty members with a network of experts in regulatory sciences and pharmaceutical, biologic, device, and other innovative medical product development.

     
Name Affiliation Location
Kevin Beaumont Pfizer Cambridge, MA
Bruce S. Binkowitz, PhD Shionogi Florham Park, NJ
Lauren Black, PhD Charles River Laboratories Baltimore, MD
Ashley Boam, MSBE US Food and Drug Administration Silver Spring, MD
David Burt, PhD Aclaris Therapeutics Spring City, PA
Gregory Campbell, PhD Independent Consultant Silver Spring, MD
Danielle Carreon, MPH Bristol-Myers Squibb Summit, NJ
Emer Cooke, MBA World Health Organization Geneva, Switzerland
Theodore Danoff, MD, PhD Complexa Berwyn, PA
Daniela Drago, PhD, RAC Biogen Cambridge, MD
Michael Dyszel Mallinckrodt Pharmaceuticals Bedminster Township, NJ
Sara Eggers, PhD US Food and Drug Administration Silver Spring, MD
Ellen G. Feigal, MD NDA Partners San Francisco, CA
Dennis Fisher, MD The “P Less Than” Company San Francisco, CA
Leslie C. Floren, PharmD University of California, San Francisco San Francisco, CA
Michael J. Fossler, PharmD, PhD Trevena King of Prussia, PA
Joshua Galanter, MD Genentech So San Francisco, CA
Christine Garnett, PhD US Food and Drug Administration Silver Spring, MD
Charlie T. Gombar, PhD Bill and Melinda Gates Foundation Seattle, WA
Charles Grudzinskas, PhD NDA Partners, LLC Annapolis, MD
Richard Heaslip, PhD
Programmatic Sciences LLC
 Philadelphia, PA
Florence Houn, MD, MPH, FACP Bristol-Myers Squibb Washington, DC
Ian Hudson, MD former MHRA chief executive London, United Kingdom
Eric A. Hughes, MD, PhD Novartis Basel, Switzerland
Marian Iwamoto, MD, PhD Merck and Co, Inc. Kenilworth, NJ
Jonathan Jarow, MD
FDA Solutions, LLC
 Chevy Chase, MD
Diane K. Jorkasky, MD, FACP Independent Consultant. Philadelphia, PA
Kenneth Kaitin, PhD Tufts University Boston, MA
Amrita Kamath, PhD, MBA Genentech South San Francisco, CA
Murray M. Lumpkin, MD, MSc Bill and Melinda Gates Foundation Seattle, WA
David Macarios, MBA Allergan Bridgewater, NJ
Craig H. Mallinckrodt, PhD Biogen Idec Cambridge, MA
Diane Maloney, JD US Food and Drug Administration Silver Spring, MD
Daniel Meyer, PhD Pfizer Groton, CT
Bernard Munos, MBA Innothink Ctr for Res. in Biomed. Innovation Indianapolis, IN
Mark Noguchi, MBA Chugai Tokyo, Japan
Sally Okun, RN, MMHS PatientsLikeMe Cambridge, MA
Lihua Pan Novartis Washington, DC
Carl C. Peck, MD University of California, San Francisco San Luis Obispo, CA
William P. Prucka, PhD Eli Lilly and Company Indianapolis, IN
Jack Reynolds, DVM JAReynolds & Associates Madison, CT
Frank Rockhold, PhD Duke University Raleigh-Durham, NC
Malcolm Rowland, PhD, DSc University of California, San Francisco London, United Kingdom
Stephen J. Ruberg, PhD Analytix Thinking, LLC Indianapolis, IN
Hansjorg Sauer, MS PhD JD Biotechnology Innovation Organization Washington, DC
David Savello, PhD NDA Partners, LLC Palo Alto, CA
Sarah Schrieber, PhD US Food and Drug Administration Silver Spring, MD
Steven Shafer, MD Stanford University Stanford, CA
Vikram Sinha, PhD Merck and Co., Inc. Berwyn, PA
Gary Skiles, PhD Independent Consultant Thousand Oaks, CA
Brian Smith, PhD Novartis Boston, MA
Dominic G. Spinella, PhD AnaptysBio, Inc. San Diego, CA
Peter Stein, MD US Food and Drug Administration Silver Spring, MD
Tania Teixeira, PharmD  European Medicines Agency Silver Spring, MD
Toshiyoshi Tominaga, PhD Japan Self Medication Industry Tokyo, Japan
Brian Tseng, MD, PhD Novartis Cambridge, MA
Paolo Vicini, PhD KyMab Cambridge, UK
Kert Viele, PhD Berry Consultants Austin, TX
Theo Vos, MD PhD University of Washington Seattle, WA
John Warren, JD McDermott+Consulting Washington, DC
Robert Willette, PhD PoC Pharma Consulting Pottstown, PA
Lynne Yao, MD US Food and Drug Administration Silver Spring, MD
Judith Zander, MD US Food and Drug Administration Silver Spring, MD