Faculty 2022 Course 14

Virtual

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
Cynthia Afshari, PhD The Janssen Pharmaceutical Companies of Johnson & Johnson Springhouse, PA
Jennifer Allen Amgen Thousand Oaks, CA
Bruce S. Binkowitz, PhD Arcutis Biotherapeutics Florham Park, NJ
Lauren E. Black, PhD Charles River Laboratories Baltimore, MD
Ashley Boam, MSBE US Food and Drug Administration Silver Spring, MD
Wilson Bryan, MD US Food and Drug Administration Silver Spring, MD
Gregory Campbell, PhD Independent Consultant Silver Spring, MD
Michelle Casey, PhD Pfizer Groton, CT
Theodore Danoff, M, PhD Pathalys Pharma, Inc. Philadelphia, PA
Daniela Drago, PhD RAC Aurion Biotech Cambridge, MD
Sue Duvall, RN MPA Duvall Limited LLC Haven, MI
Michael Dyszel Pyxis Long Valley, NJ
Sara Eggers, PhD US Food and Drug Administration Silver Spring, MD
Janice Evans Eli Lilly and Company Indianapolis, IN
Margaret Faul, PhD Amgen Thousand Oaks, CA
Ellen G. Feigal, MD NDA Partners 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 Genentech So San Francisco, CA
Christine Garnett, PharmD US Food and Drug Administration Silver Spring, MD
Charlie T. Gombar, PhD ACDRS Director Philadelphia, PA
Brett Giroir, MD Former Assistant Secretary for Health and Admiral, US Public Health Service Commissioned Corps College Station, TX
Agi Hamburger, PhD A2 Biotherapeutics Newbury Park, CA
Richard Heaslip, PhD

Programmatic Sciences LLC

 Philadelphia, PA
Florence Houn, MD MPH FACP Consultant Washington, DC
Elaine Hughes Bristol Myers Squibb Lawrenceville, NJ
Eric A. Hughes, MD PhD Vertex Cambridge, MA
Diane K. Jorkasky, MD FACP Consultant to Pharma Philadelphia, PA
Kenneth Kaitin, PhD Tufts University Boston, MA
Andy Lee Merck Rahway, NJ
Zili Li, MD, MPH Janssen Research & Development, LLC Beijing, China
Murray (Mac) M. Lumpkin, MD MSc Bill and Melinda Gates Foundation Seattle, WA
David Macarios, MBA EMD Serono New York City, NY
Craig H. Mallinckrodt, PhD Pentara Cambridge, MA
Anabela Marcal, PharmD European Medicines Agency Amsterdam, Netherlands
Bernard Munos, MBA FasterCures Indianapolis, IN
Adora Ndu, PharmD JD BridgeBio Clarksville, MD
Mark Noguchi, MBA Chugai Tokyo, Japan
Sally Okun, RN MMHS Duke University Cambridge, MA
Richard Payne, PhD Eli Lilly and Company Indianapolis, IN
Carl C. Peck, MD University of California, San Francisco San Luis Obispo, CA
Christiane Pering, MD Bayer Pharmaceuticals Berlin, Germany
Saileta Prabhu, PhD Takeda Cambridge, MA
William P. Prucka, PhD Eli Lilly and 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 Analytix Thinking, LLC Indianapolis, IN
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 (Professor Emeritus) Stanford, CA
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 Astellas Pharma US Northbrook, IL
Mary T. Thanh Hai, MD US Food and Drug Administration Silver Spring, MD
Toshiyoshi Tominaga, PhD

Keio University

 Tokyo, Japan
Brian Tseng, MD, PhD Vertex Cell and Gene Therapy Cambridge, MA
Paolo Vicini, PhD Confo Therapeutics Brussels, Belgium
Kert Viele, PhD Berry Consultants Austin, TX
Theo Vos, MD PhD University of Washington Seattle, WA
Geoffrey Walford, MD Merck Boston, MA
Janet White, MBA MA Bill & Melinda Gates Foundation San Diego, CA
Lynne Yao, MD US Food and Drug Administration Silver Spring, MD
Judith Zander, MD US Food and Drug Administration Silver Spring, MD

Additional case study proctors (ACDRS alumni):

Name Affiliation Location
Siddique Abbasi, MD MSc FACC Amgen Thousand Oaks, CA
Daniel Abramzon, MBS Genentech S. San Francisco, CA
Lawrence Allan US Food and Drug Administration Silver Spring, MD
Jesse Anderson, MPH US Food and Drug Administration Silver Spring, MD
Kemal Asik, PhD Genentech S. San Francisco, CA
Yelizaveta Babayan, PhD Eli Lilly and Company Indianapolis, IN
Lisa Boyette, MD PhD Recursion Pittsburgh, PA
Breena Berté, MSS MEd US Department of Defense Washington, DC
Lauren Brunke, PharmD RPh Eli Lilly and Company Indianapolis, IN
Janelle Burnham, MD Pfizer Washington, DC
David Chu, MD Arcutis San Diego, CA
Cynthia Marie Carver DeKlotz, MD FAAD Janssen R&D Bethesda, MD
William Haddock, MDMPH MSHS Ovid Therapeutics Cambridge, CA
Dustin Little, MD AstraZeneca Gaithersburg, MD
Anna Kasmar, MD MSc Genentech S. San Francisco, CA
Anandi D. Kotak, MD MS MPH FACOG US Food and Drug Administration Silver Spring, MD
Rebecca Kunder, MD PhD Genentech S. San Francisco, CA
Nicholas Langevin, MS RAC Sunovion Burleson, TX
Bryan McGill, MD PhD Novartis Institute for Biomedical Research Cambridge, MA
Kofi Mensah, MD PhD Bristol Myers Squibb Cambridge, MA
Magda Michna, PhD AcuFocus, Inc. Irvine, CA
Todd Page, PhD DABT Eli Lilly and Company Indianapolis, IN
Melicent Peck, MD PhD Genentech S. San Francisco, CA
Marco Petrillo, PhD Takeda Cambridge, MA
Dinko Rekić, PhD AstraZeneca Sweden
Lieutenant Commander Melissa A. Reyes, MD MPH FAAD DTMH US Food and Drug Administration Silver Spring, MD
Jorge Safi Jr., MD PhD Novartis East Hanover, NJ
Lauren Schrier, MBA Immunovant New York, NY
Robert Schuck, PharmD PhD US Food and Drug Administration Silver Spring, MD
Kaycee M. Sink, MD MAS Genentech S. San Francisco, CA
Edmond Teng, MD PhD Genentech S. San Francisco, CA
Alice Wang, MD Bristol Myers Squibb Cambridge, MA