Faculty 2016–2017 Cycle 9

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
Ramsey Baghdadi	Prevision Policy	Washington, DC
Robert Ball, MD, MPH, ScM	US Food and Drug Administration	Silver Spring, MD
Scott Berry, PhD	Berry Consultants	Austin, TX
Bruce S. Binkowitz, PhD	Merck and Co., Inc.	Rahway, NJ
Lauren Black, PhD	Charles River Laboratories	Baltimore, MD
Sir Alasdair Breckenridge, FRSE, FMedSci	former MHRA chairman	London, United Kingdom
Edward J. Calabrese, PhD,	UMass Amherst	Amherst, MA
Joseph C. Caminiti	Publicis Healthcare Communications Group	New York, NY
Louis R. Cantilena, MD, PhD	Medical Strategic Initiatives, LLC	Bethesda, MD
Emer Cooke, MBA	World Health Organization	Geneva, Switzerland
Tim Coté, MD, MPH	Coté Orphan Consulting	Washington, DC
Theodore Danoff, MD, PhD	Clarus Therapeutics	Philadelphia, PA
Patricia Evans, PhD	Independent Consultant	Los Altos, CA
David W. Feigal, Jr, MD, MPH	Arizona State University School of Law	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	University of California, San Francisco	San Francisco, CA
Mark J. Goldberger, MD, MPH	Consultant	Washington, DC
Philip Goliber, PhD	NDA Partners	Canandaigua, NY
Charlie T. Gombar, PhD	Bill and Melinda Gates Foundation	Seattle, WA
Michael J. Gresser, PhD	ImmunGene	Los Angeles, CA
Charles Grudzinskas, PhD	NDA Partners, LLC	Annapolis, MD
Florence Houn, MD, MPH, FACP	Celgene	Washington, DC
John Jenkins, MD	US Food and Drug Administration	Silver Spring, MD
Diane K. Jorkasky, MD, FACP	Complexa Inc.	Philadelphia, PA
Kenneth Kaitin, PhD	Tufts University	Boston, MA
Amrita Kamath, PhD	Genentech	So San Francisco, 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
Christopher Lipinski, PhD	Melior Discover	Waterford, CT
Murray M. Lumpkin, MD, MSc	Bill and Melinda Gates Foundation	Seattle, WA
David Macarios, MBA	Lifecell Corporation	Bridgewater, NJ
Mark Noguchi, MBA	Genentech	So San Francisco, CA
Sally Okun, RN, MMHS	PatientsLikeMe	Cambridge, MA
Mary Thanh Hai, MD	US Food and Drug Administration	Silver Spring, MD
Lihua Pan	Novartis	Rockville, MD
Carl C. Peck, MD	University of California, San Francisco	San Luis Obispo, CA
Gene Pennello, PhD	US Food and Drug Administration	Silver Spring, MD
William Prucka	Eli Lilly & Company	Indianapolis, IN
Frank Rockhold, PhD	Duke University	Raleigh-Durham, NC
Malcolm Rowland, PhD, DSc	University of California, San Francisco	London, United Kingdom
Stephen J. Ruberg, PhD	Eli Lilly and Company	Indianapolis, IN
Hansjorg Sauer, MS, PhD, JD	Biotechnology Industry Organization	Washington, DC
Steven Shafer, MD	Stanford University	Stanford, CA
Jennifer Sims, PhD, ERT	Integrated Biologix GmbH	Basel, Switzerland
Vikram Sinha, PhD	Merck and Co., Inc.	Philadelphia, PA
Zachary Skrivanek	Eli Lilly and Company	Indianapolis, IN
Brian Smith, PhD	Novartis	Boston, MA
Dominic G. Spinella, PhD	Amgen	Thousand Oaks, CA
Peter Stein, MD	US Food and Drug Administration	Silver Spring, MD
S. Aubrey Stoch, MD	Merck and Co., Inc.	Rahway, NY
Toshiyoshi Tominaga, PhD	Pharmaceuticals and Medical Devices Agency	Tokyo, Japan
Paolo Vicini, PhD	MedImmune	Cambridge, UK
Theo Vos, MD, PhD	University of Washington	Seattle, WA
Yaning Wang, PhD	US Food and Drug Administration	Silver Spring, MD
John Warren, JD	McDermott Will & Emery LLP	Washington, DC

Faculty in other years

See Faculty.