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 |