Faculty 2025 Course 17

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, PhD Lee PPM Consulting Old Lyne, 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 South 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
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
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