Faculty 2024 Course 16

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
Yumiko Asano, MSc Chugai Tokyo, Japan
Bruce S. Binkowitz, PhD Arcutis Biotherapeutics Florham Park, NJ
Eric Brodsky, MD (to be confirmed) US Food and Drug Administration Silver Spring, MD
Theodore Danoff, M, PhD Pathalys Pharma, Inc. Philadelphia, PA
Daniela Drago, PhD RAC NDA Partners Cambridge, MD
Michael Dyszel CSL Behring Long Valley, NJ
Sara Eggers, PhD US Food and Drug Administration Silver Spring, MD
Lola Fashoyin-Aje, MD MPH US Food and Drug Administration Silver Spring, MD
Margaret Faul, PhD Amgen Thousand Oaks, 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 Cytel King of Prussia, PA
Joshua Galanter, MD Genentech S. San Francisco, CA
Christine Garnett, PharmD US Food and Drug Administration Silver Spring, MD
Jeremy Goldberg, MBA Arsenal Capital Partners New York, NY
Charlie T. Gombar, PhD ACDRS Director Philadelphia, PA
Gioia Guerrieri, DO DFAPA FASA US Food and Drug Administration Silver Spring, MD
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
Kurt Karst, JD Hyman, Phelps & McNamara, PC Washington, DC
Jacqueline Kinyamu-Akunda, DVM PhD The Janssen Pharmaceutical Companies of Johnson & Johnson Springhouse, PA
Andy Lee Merck & Co, Inc. Rahway, NJ
Lois D. Lehman-McKeeman, PhD ATS Bristol Myers Squibb Philadelphia, PA
Mark Levenson, PhD US Food and Drug Administration Silver Spring, MD
Bennet Levitan, MD PhD J&J Innovative Medicine Washington Crossing, PA
Qi Liu, PhD MStat FCP US Food and Drug Administration Silver Spring, MD
David Macarios, MBA MS Becton Dickinson Franklin Lakes, NJ
Craig H. Mallinckrodt, PhD Pentara Cambridge, MA
Anabela Marcal, PharmD  (to be confirmed) European Medicines Agency Amsterdam, Netherlands
K. Kimberly McCleary The Kith Collective, LLC Arlington, VA
CAPT David Moeny, RPh MPH US Food and Drug Administration Silver Spring, MD
Adora Ndu, PharmD JD BridgeBio Clarksville, MD
Mark Noguchi, MBA Chugai Boston, MA

K. Liane Ong, PhD

Institute for Health Metrics and Evaluation, University of Washington

 Seattle, WA
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 (to be confirmed) US Food and Drug Administration Silver Spring, MD
Frank Rockhold, PhD Duke University Raleigh-Durham, NC
Stephen J. Ruberg, PhD Analytix Thinking LLC Indianapolis, IN
Anindita (Annie) Saha US Food and Drug Administration Silver Spring, MD
Hansjorg Sauer, MS PhD JD Biotechnology Innovation Organization Washington, DC
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
Peter Stein, MD US Food and Drug Administration Silver Spring, MD
Stacey Tannenbaum, PhD FISoP

Metrum Research Group

 Simsburg, CT
Mary T. Thanh Hai, MD US Food and Drug Administration Silver Spring, MD
Paolo Vicini, PhD Confo Therapeutics Brussels, Belgium
Kert Viele, PhD Berry Consultants Austin, TX
Prabha Viswanathan, MD US Food and Drug Administration Silver Spring, MD
Geoffrey Walford, MD Merck Boston, MA
Christina Webber, PhD US Food and Drug Administration Silver Spring, MD
Janet Wittes, PhD Consultant Washington, DC
Kimberly Wolfram, MS Biogen Cambridge, MA
Michelle Zucatti, MHA 3D Communications Washington, DC
others to be confirmed    

Additional case study proctors (ACDRS alumni):

Name Affiliation Location
Phil Ambery, PhD AstraZeneca Sweden
Cynthia DeKlotz, MD FAAD Janssen R&D Bethesda, MD
Kristin Fiorino, MD AstraZeneca Gaithersburg, MD
John Kelly, MD PhD FAAD GSK Providence County, RI
Adam Levy, MD BMS Summit, NJ
Kofi Mensah, MD PhD BMS Cambridge, MA
Divya Mohan, MD PhD Genentech S. San Francisco, CA
Robert Nadeau, PhD Walter Reed Army Institute of Research Silver Spring, MD
Amrita Pati, PhD Amgen Belmont, CA
Shira Perl, MD AstraZeneca Gaithersburg, MD
Jorge Safi Jr., MD PhD Novartis East Hanover, NJ
Jennifer S. Thompson, MD Boehringer Ingelheim Ridgefield, CT
Nicole Teig, PharmD RPh Eli Lilly & Company Indianapolis, IN
Christopher Vinnard, MD MPH MSCE MS Gates Medical Research Institute Cambridge MD
Islam Younis, PhD Merck Silver Spring, MD
others to be confirmed