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 |
|---|---|---|
| Philip Ambery, MD FRCP | AstraZeneca | Sweden |
| Brian Arey, PhD MS | Bristol Myers Squibb | Princeton, NJ |
| Eric Brodsky, MD | US Food and Drug Administration | Silver Spring, MD |
| Kevin Bugin, PhD MS | Amgen | Washington, DC |
| Stephen Carl, PhD | Bristol Myers Squibb | Matawan, NJ |
| Aloka Chakravarty, PhD FASA | Eli Lilly and Company | Washington, DC |
| Danielle H. Corwin, PhD | Sanofi | Bridgewater, NJ |
| Theodore Danoff, M, PhD | Clinical Consultant and former CMO | Philadelphia, PA |
| Corinne de Vries | European Medicines Agency | Amsterdam, Netherlands |
| Daniela Drago, PhD RAC | NDA Partners | Cambridge, MD |
| Michael Dyszel | CSL Behring | Long Valley, NJ |
| Bruce Ellsworth, PhD | Novartis | Princeton, NJ |
| Lola Fashoyin-Aje, MD MPH | AstraZeneca | Gaithersburg, MD |
| Jill Fiedler-Kelly, MS | Simulations Plus | Buffalo, NY |
| Leslie C. Floren, PharmD | University of California, San Francisco | San Francisco, CA |
| Joshua Galanter, MD | Genentech | S. San Francisco, CA |
| Christine Garnett, PharmD | US Food and Drug Administration | Silver Spring, MD |
| Charlie T. Gombar, PhD | ACDRS Director | Philadelphia, PA |
| Thomas E. Gwise, PhD | Consultant | Silver Spring, MD |
| Brandon W. Higgs, PhD | Danaher | Baltimore, MD |
| Glen Huang, MD | US Food and Drug Administration | Silver Spring, 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 |
| Jae Kim, JD | DLA Piper | Washington, DC |
| Jacqueline Kinyamu-Akunda, DVM PhD | Incyte | Washington, DC |
| Antti Kourula, MD MSc | CSL | Philadelphia, PA |
| Leila Lackey, DEnv MHS | Pfizer | Washington, DC |
| Andy Lee | Retired -former SVP GCTO Merck | Old Lyme, CT |
| Jean Lee | Lee PPM Consulting | Old Lyme, CT |
| Lois D. Lehman-McKeeman, PhD ATS | Bristol Myers Squibb | Philadelphia, PA |
| Chris Leptak,MD PhD | ELIQUENT | Washington, DC |
| Rajanikanth Madabushi, PhD | US Food and Drug Administration | Silver Spring, MD |
| Michael Maitland, MD PhD | M4 Consulting & Advisory Services | Falls Church, VA |
| Craig H. Mallinckrodt, PhD | Pentara | Cambridge, MA |
| Claudia Manzo, PharmD | AbbVie | Washington, DC |
| Eric Moss, MBA | Lundbeck | Amsterdam |
| Adora Ndu, PharmD JD | BridgeBio | Clarksville, MD |
| Mark Noguchi, MBA | Chugai | Boston, MA |
| David Ohlssen, PhD | Novartis | East Hanover, NJ |
| Andrew Parsons, PhD | Amgen | Cambridge, MA |
| Richard Payne, PhD | Eli Lilly and Company | Indianapolis, IN |
| Juan Pinelli, MMS | Pfizer | Seattle, WA |
| Saileta Prabhu, PhD | Regeneron | New York, NY |
| 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 |
| Alka Shaunik, MD MBA | Catalyst | Philadelphia, PA |
| Steven Silverman, JD | The Silverman Group | Washington, DC |
| Dominic G. Spinella, PhD | Translational Medicine Partners, Inc. | San Diego, CA |
| Nicole St. Jean, MBA | GSK | Washington, DC |
| Stacey Tannenbaum, PhD FISoP | SJTPharm LLC | Northbrook, IL |
| Olivia Uitto, JD | Partner, Goodwin Proctor LLP | Boston, MA |
| Paolo Vicini, PhD | Confo Therapeutics | Brussels, Belgium |
| Kert Viele, PhD | Berry Consultants | Austin, TX |
| Scott Wasserman, MD | Kailera | Thousand Oaks, CA |
| Janet Wittes, PhD | Consultant | Washington, DC |
| Kimberly Wolfram, MS | Biogen | Cambridge, MA |
| Wendy (Xiaojun) Yan, MBA | BeOne Medicines | China |
| Zheng Yang, PhD | Excelsius LLC | Cambridge, MA |
| Islam Younis, PhD | Merck | Washington, DC |
| Sarah Zaidi, MD | US Food and Drug Administration | Silver Spring, MD |
| Michelle Zucatti, MHA | 3D Communications | Washington, DC |
Additional case study proctors (ACDRS alumni):
| Name | Affiliation | Location |
|---|---|---|
| Ryan Berry, MD | Authority Health | Detroit, MI |
| Lisa Boyette, MD PhD | Eli Lilly | Pittsburgh, PA |
| Hassan Chami, MD | AstraZeneca | Gaithersburg, MD |
| Joan Dunlop, MD MHS | J&J Innovative Medicine | Washington, DC |
| Diala El-Maouche, MD MS | Amgen | Washington, DC |
| John Kelly, MD PhD FAAD | GSK | Providence County, RI |
| Dustin Little, MD | AstraZeneca | Gaithersburg, MD |
| Kofi Mensah, MD PhD | BMS | Cambridge, MA |
| Divya Mohan, MD PhD | Genentech | S San Francisco, CA |
| Julie Mund, MS PhD | Eli Lilly | Indianapolis, IN |
| Armina Omole, MD PhD | GSK | Philadelphia, PA |
| Nicole Teig, PharmD RPh | Eli Lilly & Company | Indianapolis, IN |
| Javier Valero Elizondo, MD | Amgen | TX |
| others to be confirmed |