Appendix B
Workshop Agenda
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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