Faculty 2023 Course 15

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
Bruce S. Binkowitz, PhD Arcutis Biotherapeutics Florham Park, NJ
Ashley Boam, MSBE US Food and Drug Administration Silver Spring, MD
Patrick Collins, PhD 23andMe S. San Francisco, CA
Freda Cooner, PhD Eli Lilly & Company Indianapolis, IN
Theodore Danoff, M, PhD Pathalys Pharma, Inc. Philadelphia, PA
Asha Das, MD US Food and Drug Administration Silver Spring, MD
Matias Diez Sanofi Bridgewater, NJ
Daniela Drago, PhD RAC NDA Partners Cambridge, MD
Sue Duvall, RN MPA Duvall Limited LLC Haven, MI
Michael Dyszel Pyxis Oncology Long Valley, NJ
Sara Eggers, PhD 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
Carlos O. Garner, PhD Eli Lilly & Company Indianapolis, IN
Charlie T. Gombar, PhD ACDRS Director Philadelphia, PA
Dionna Green, MD FACP US Food and Drug Administration Silver Spring, MD
Agi Hamburger, PhD A2 Biotherapeutics Newbury Park, CA
Richard Heaslip, PhD

Programmatic Sciences LLC

 Philadelphia, PA
Elaine Hughes Bristol Myers Squibb Lawrenceville, NJ
Eric A. Hughes, MD PhD Teva Parsippany, NJ
Telba Irony, PhD Janssen Bethesda, MD
Diane K. Jorkasky, MD FCP Consultant to Pharma Philadelphia, PA
Kenneth Kaitin, PhD Tufts University Boston, MA
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
Qi Liu, PhD MStat FCP US Food and Drug Administration Silver Spring, MD
David Macarios, MBA Becton Dickinson Franklin Lakes, NJ
Craig H. Mallinckrodt, PhD Pentara Cambridge, MA
Anabela Marcal, PharmD European Medicines Agency Amsterdam, Netherlands
CAPT David Moeny, RPh MPH US Food and Drug Administration Silver Spring, MD
Bernard Munos, MBA FasterCures Indianapolis, IN
Adora Ndu, PharmD JD BridgeBio Clarksville, MD
Mark Noguchi, MBA Chugai Boston, MA
Sally Okun, RN MMHS Duke University Cambridge, MA

Lihua Pan

 Novartis Washington DC
Richard Payne, PhD Eli Lilly and Company Indianapolis, IN
Carl C. Peck, MD University of California, San Francisco San Luis Obispo, CA
Saileta Prabhu, PhD Regeneron New York, NY
William P. Prucka, PhD Eli Lilly and Company Indianapolis, IN
Donna Rivera, PharmD MSc US Food and Drug Administration Silver Spring, MD
William Richards, PhD 23andMe South San Francisco, CA
Frank Rockhold, PhD Duke University Raleigh-Durham, NC
Stephen J. Ruberg, PhD Analytix Thinking LLC Indianapolis, IN
Estelle Russek-Cohen, PhD ERCStat LLC Silver Spring, MD
Hansjorg Sauer, MS PhD JD Biotechnology Innovation Organization Washington, DC
Fortunato (Fred) Senatore, MD PhD FACC US Food and Drug Administration Silver Spring, MD
Steven Shafer, MD Stanford University Stanford, CA
Mirat Shah, MD US Food and Drug Administration Silver Spring, MD
Gary Skiles, PhD Independent Consultant Thousand Oaks, CA
Brian Smith, PhD Novartis Boston, MA
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
Theo Vos, MD PhD

Institute for Health Metrics and Evaluation, University of Washington

 Seattle, WA
Geoffrey Walford, MD Merck Boston, MA
Wenquan Wang, PhD Pfizer Collegeville, PA
Michelle Zucatti, MHA 3D Communications Washington, DC

Additional case study proctors (ACDRS alumni):

Name Affiliation Location
Jaspreet Arora, PhD Concert Boston, MA
Siddique Abbasi, MD MSc FACC Amgen Thousand Oaks, CA
Gideon Blumenthal, MD Merck Washington. DC
Janelle Burnham, MD Pfizer Washington, DC
David Chu, MD Arcutis San Diego, CA
Cynthia DeKlotz, MD FAAD Janssen R&D Bethesda, MD
Sean Downing, PhD Takeda Pharmaceuticals Boston, MA
Maria Flynn, PhD US Food and Drug Administration Silver Spring, MD
Brian Gilleland

AbbVie

 North Chicago, IL
Maria Jison, MD AstraZeneca Gaithersburg, MD
Dustin Little, MD AstraZeneca Gaithersburg, MD
Jiajun (JJ) Liu, PharmD MSc US Food and Drug Administration Silver Spring, MD
Kofi Mensah, MD PhD Bristol Myers Squibb Cambridge, MA
Ki Milligan, MD Novartis Washington, DC
Jorge Safi Jr., MD PhD Novartis East Hanover, NJ
Victoria Sanjurjo, MD Ionis Fort Lauderdale, FL
Jennifer S. Thompson, MD Boehringer Ingelheim Ridgefield, CT