The Role of Digital Health Technologies in Drug Development: A Workshop
TUESDAY, March 24, 2020
| 10:00 a.m. (EST) | Welcome |
| Robert Califf, Verily Life Sciences | |
| Geoffrey Ginsburg, Duke University School of Medicine | |
| Opening Remarks | |
| Jennifer Goldsack, Digital Medicine Society | |
| Joseph Menetski, Foundation for the National Institutes of Health | |
| Briefing: Ethical Considerations | |
| 10:15 a.m. | Ethicist Perspective |
| Camille Nebeker, University of California, San Diego | |
Session I: Digital Tools for Characterizing Disease
Effy Vayena, Health Ethics and Policy Lab, ETH Zurich, Moderator
| 10:45 a.m. | Nonprofit Perspective/Platform Research Perspective |
| Larsson Omberg, Sage Bionetworks |
| National Institutes of Health Perspective | |
| Chris Lunt, All of Us Research Program, National Institutes of Health | |
| Patient Engagement Perspective | |
| Alicia Staley, Medidata Solutions | |
| Developer Perspective | |
| Luca Foschini, Evidation Health | |
| 11:25 a.m. | Panel Discussion with Speakers and Workshop Participants |
| 11:45 a.m. | Break |
Session II: Digital Tools for Recruitment and Safety Trials
Deven McGraw, Ciitizen Corporation, Moderator
| 12:00 p.m. | Regulatory Perspective |
| Christopher Leptak, Center for Drug Evaluation and Research, U.S. Food and Drug Administration | |
| Industry Perspective | |
| Yvonne Yu-Feng Chan, Otsuka Pharmaceutical | |
| Developer Perspective | |
| Chris Benko, Koneksa Health | |
| Academic Perspective | |
| Eric Perakslis, Duke University | |
| 12:40 p.m. | Panel Discussion with Speakers and Workshop Participants |
| 1:00 p.m. | Break |
| Fireside Chat | |
| Jennifer Goldsack, Digital Medicine Society, Moderator | |
| 1:30 p.m. | Regulatory Perspective |
| Amy Abernethy, U.S. Food and Drug Administration | |
Session III: Digital Tools for Pivotal Trials
Husseini Manji, Janssen Research & Development, LLC, Moderator
| 2:00 p.m. | Industry Perspective |
| Sean Khozin, Janssen Research & Development, LLC | |
| Developer Perspective | |
| Ritu Kapur, Verily Life Sciences | |
| Regulatory Perspective | |
| Leonard Sacks, Center for Drug Evaluation and Research, U.S. Food and Drug Administration | |
| 2:30 p.m. | Panel Discussion with Speakers and Workshop Participants |
| 2:50 p.m. | Break |
Session IV: Digital Tools for Post-Market Surveillance
Christina Silcox, Duke-Margolis Center for Health Policy, Moderator
| 3:00 p.m. | Industry Perspective |
| Michelle Crouthamel, AbbVie Inc. | |
| Patient Engagement Perspective | |
| Sally Okun, UnitedHealth Group Research & Development | |
| Clinician/Health System Perspective | |
| Edmondo Robinson, Moffitt Cancer Center | |
| 3:30 p.m. | Panel Discussion with Speakers and Workshop Participants |
| Key Reflections and Next Steps | |
| 3:45 p.m. | Key Reflections and Next Steps |
| Jennifer Goldsack, Digital Medicine Society | |
| Joseph Menetski, Foundation for the National Institutes of Health | |
| 4:15 p.m. | Adjourn |
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