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 | US Food and Drug Administration | Silver Spring, MD |
| Danielle H. Corwin, PhD | Sanofi | Bridgewater, NJ |
| 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 | 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 | 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 |
| Nashat Rasheed, PhD MEng MS | US Food and Drug Administration | Silver Spring, 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 |