Preparing for success in modernizing the science behind the development and regulation of medical products
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 |