Faculty 2018–2019 Cycle 11

Washington, DC

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 pharmaceutical medicine, medical product development, and regulatory sciences.

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
Sir Alasdair Breckenridge, FRSE, FMedSci former MHRA chairman London, United Kingdom
Melissa Brand, JD Biotechnology Innovation Organization Washington, DC
Gilbert Burckart, MD US Food and Drug Administration Silver Spring, MD
Emer Cooke, MBA World Health Organization Geneva, Switzerland
Theodore Danoff, MD, PhD Clarus Therapeutics Philadelphia, PA
Daniela Drago, PhD, RAC The George Washington University Washington, DC
Sue Duvall, RN, MPA Mylan S Haven, MI
Sara Eggers, PhD US Food and Drug Administration Silver Spring, MD
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
Charlie T. Gombar, PhD Bill and Melinda Gates Foundation Seattle, WA
Charles Grudzinskas, PhD NDA Partners, LLC Annapolis, MD
Florence Houn, MD, MPH, FACP Celgene Washington, DC
Marian Iwamoto, MD, PhD Merck and Co, Inc. Rahway, NJ
Diane K. Jorkasky, MD, FACP Complexa Inc. Philadelphia, PA
Kenneth Kaitin, PhD Tufts University Boston, MA
Kurt Karst, JD Hyman, Phelps & McNamara, PC Washington, DC
Richard Kenley, PhD Pladd Consulting LLC Poway, CA
Jack Kloeber, PhD Kromite Philadelphia, PA
Paul Kluetz, MD US Food and Drug Administration Silver Spring, MD
Andy Lee Merck Research Laboratories Rahway, NJ
Zili Li, MD, MPH US Food and Drug Administration Silver Spring, MD
 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
Bernard Munos Innothink Ctr for Res. in Biomed. Innovation Indianapolis, IN
Mark Noguchi, MBA Consultant So San Francisco, CA
Sally Okun, RN, MMHS PatientsLikeMe Cambridge, MA
Saileta Prabhu, PhD Genentech South San Francisco, CA
Carl C. Peck, MD University of California, San Francisco San Luis Obispo, CA
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
Robert Ruffolo Jr, PhD Ruffolo Consulting   
David Savello, PhD NDA Partners, LLC Palo Alto, CA
Sarah Schrieber, PhD US Food and Drug Administration Silver Spring, MD
Mary Frances Schubert, MD Merck & Co., Inc. North Wales, PA
Steven Shafer, MD Stanford University Stanford, CA
Vikram Sinha, PhD Merck and Co., Inc. Philadelphia, PA
Zachary Skrivanek Eli Lilly and Company Indianapolis, IN
Brian Smith, PhD Novartis Boston, MA
Catherine Sohn, PharmD Sohn Health Strategies LLC Philadelphia, PA
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 MedImmune Cambridge, UK
Kert Viele, PhD Berry Consultants Austin, TX
Theo Vos, MD, PhD University of Washington Seattle, WA
Yaning Wang, PhD US Food and Drug Administration Silver Spring, MD
Robert Willette, PhD PoC Pharma Consulting Pottstown, PA
Islam Younis, PhD MS Astellas Pharma Global Development Silver Spring, MD
Judith Zander, MD US Food and Drug Administration Silver Spring, MD

Faculty in other years

See Faculty.