Faculty 2025 Course 17 | American Course on Drug Development and Regulatory Sciences

Washington DC & Virtual (Hybrid)

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
Jennifer Allen	Amgen	Thousand Oaks, CA
Philip Ambery, MD FRCP	AstraZeneca	Sweden
Yumiko Asano, MSc	Chugai	Tokyo, Japan
Eric Brodsky, MD	US Food and Drug Administration	Silver Spring, MD
Kevin Bugin, PhD MS	Amgen	Washington, DC
Danielle H. Corwin, PhD	Sanofi	Bridgewater, NJ
Theodore Danoff, M, PhD	Pathalys Pharma, Inc.	Philadelphia, PA
Corinne de Vries	European Medicines Agency	Amsterdam, Netherlands
Daniela Drago, PhD RAC	NDA Partners	Cambridge, MD
Michael Dyszel	CSL Behring	Long Valley, NJ
Sara Eggers, PhD	Consultant, former US Food and Drug Administration	Silver Spring, MD
Lola Fashoyin-Aje, MD MPH	Parexel	Washington, DC
Margaret Faul, PhD	Amgen	Thousand Oaks, CA
Leslie C. Floren, PharmD	University of California, San Francisco	San Francisco, CA
Jonathan French, PhD	Johnson & Johnson Innovative Medicine	New London, CT
Joshua Galanter, MD	Genentech	S. San Francisco, CA
Christine Garnett, PharmD	US Food and Drug Administration	Silver Spring, MD
Charlie T. Gombar, PhD	ACDRS Director	Philadelphia, PA
Thomas E. Gwise, PhD	Consultant	Silver Spring, MD
Agi Hamburger, PhD	A2 Biotherapeutics	Newbury Park, CA
Brandon W. Higgs, PhD	Genmab	Baltimore, MD
Elaine Hughes	Bristol Myers Squibb	Lawrenceville, NJ
Eric A. Hughes, MD PhD	Teva	Parsippany, NJ
Telba Irony, PhD	J&J Innovative Medicine	Bethesda, MD
Diane K. Jorkasky, MD FCP	Consultant to Pharma	Philadelphia, PA
Kenneth Kaitin, PhD	Tufts University	Boston, MA
Annie Kennedy	EveryLife Foundation	Washington, DC
Jacqueline Kinyamu-Akunda, DVM PhD	The Janssen Pharmaceutical Companies of Johnson & Johnson	Springhouse, PA
Andy Lee	Merck & Co, Inc.	Rahway, NJ
Jean Lee	Lee PPM Consulting	Old Lyme, CT
Lois D. Lehman-McKeeman, PhD ATS	Bristol Myers Squibb	Philadelphia, PA
Mark Levenson, PhD	US Food and Drug Administration	Silver Spring, MD
Qi Liu, PhD MStat FCP	US Food and Drug Administration	Silver Spring, MD
Murray (Mac) Lumpkin, MD MSc	Gates Foundation	Seattle, WA
David Morris, MD	UCSF	San Francisco, CA
Craig H. Mallinckrodt, PhD	Pentara	Cambridge, MA
Giuliana Montenegro, MBA	GSK	Jersey City, NJ
Adora Ndu, PharmD JD	BridgeBio	Clarksville, MD
Mark Noguchi, MBA	Chugai	Boston, MA
David Ohlssen, PhD	Novartis	East Hanover, NJ
Richard Payne, PhD	Eli Lilly and Company	Indianapolis, IN
Saileta Prabhu, PhD	Regeneron	New York, NY
William Richards, PhD	23andMe	S. San Francisco, CA
Donna Rivera, PharmD MSc	former US Food and Drug Administration	Silver Spring, MD
John Scott, PhD	US Food and Drug Administration	Silver Spring, MD
Fortunato (Fred) Senatore, MD PhD FACC	US Food and Drug Administration	Silver Spring, MD
Gary Skiles, PhD	Independent Consultant	Thousand Oaks, CA
Dominic G. Spinella, PhD	Translational Medicine Partners, Inc.	San Diego, CA
Bradley Stolshek, PharmD	Innopiphany	Irvine, CA
Stacey Tannenbaum, PhD FISoP	Consulting & Coaching for MIDD Practitioners and Teams	Northbrook, IL
Olivia Uitto, JD	Partner, Goodwin Proctor LLP	Boston, MA
Sepideh Farivar Varon, PhD MPH	Novartis	Irvine, CA
Paolo Vicini, PhD	Confo Therapeutics	Brussels, Belgium
Kert Viele, PhD	Berry Consultants	Austin, TX
Scott Wasserman, MD	Kailera	Thousand Oaks, CA
Janet Wittes, PhD	Consultant	Washington, DC
Kimberly Wolfram, MS	Biogen	Cambridge, MA
Islam Younis, PhD	Merck	Washington, DC
Sarah Zaida, MD	US Food and Drug Administration	Silver Spring, MD
Michelle Zucatti, MHA	3D Communications	Washington, DC

Additional case study proctors (ACDRS alumni):

Name	Affiliation	Location
Lisa Boyette, MD PhD	Eli Lilly	Pittsburgh, PA
Cynthia DeKlotz, MD FAAD	Janssen R&D	Bethesda, MD
Kristin Fiorino, MD	AstraZeneca	Gaithersburg, MD
David Holtzman, MD PhD	Gates Medical Research Institute	Cambridge, MA
John Kelly, MD PhD FAAD	GSK	Providence County, RI
Leila Lackey		Silver Spring, MD
Adam Levy, MD	BMS	Summit, NJ
Dustin Little, MD	AstraZeneca	Gaithersburg, MD
Jiajun (JJ) Liu, PharmD	Eisai	Washington, DC
Kofi Mensah, MD PhD	BMS	Cambridge, MA
Ki Lee Milligan, MD	Novartis	Washington, DC
Jorge Safi Jr., MD PhD	Novartis	East Hanover, NJ
Liudmila Schafer, MD FACP	MacroGenics	Gaithersburg, MS
Julie Schneider, PhD		Washington, DC
Nicole Teig, PharmD RPh	Eli Lilly & Company	Indianapolis, IN
Graham Thompson	AstraZeneca	Washington, DC
Christopher Vinnard, MD MPH MSCE MS	Gates Medical Research Institute	Cambridge MD
Presley Warner, JD	Gibson, Dunn & Crutcher UK LLP	London, UK
Sule Yavuz, MD	AstraZeneca	Washington, DC