Please join Vivli at the National Academy of Medicine in Washington, DC on November 16, 2023 in Washington, D.C. for a strategic meeting to collectively reflect on the seminal 2015 IOM report Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk to see how far we have come and chart a course to meet the challenges and opportunities that lie ahead.
Session topics will focus on the following areas:
- Welcome by Victor J Dzau, NAM President
- IOM Report – 2015 Recommendations and Challenges Ahead
- The value of data sharing realized –Use Cases
- Credit and incentivizing the academic culture
- Key technologies that will influence data sharing (machine learning, AI)
- Regulations and policies to promote data sharing and re-use
- Shaping inputs and directions for the next 10 years
We look forward to welcoming researchers, data contributors, publishers, funders and other interested stakeholders to this event as we work together to set a direction for data sharing and develop an action plan for the next 10 years.
This event is free, but registration is mandatory. Please register as soon as possible, as in-person space is limited. Virtual attendees will be able to view and ask questions of presenters. For virtual attendees, participation in the breakout groups and direction setting sessions will be limited. Please email support@vivli.org with any questions.
Agenda
Dr. Robert Califf, FDA Commissioner, will address the meeting as the morning keynote speaker; and Dr. Monica Bertagnolli, Director of the National Institutes of Health (NIH), will join as the lunchtime keynote speaker on Thursday, November 16th. Dr. Bertagnolli’s lunchtime keynote presentation will be available to those participants attending in person.
Dr. Bertagnolli is the second woman to lead the NIH on a permanent basis. Previously, Bertagnolli served as Director of the National Cancer Institute and has served as the Richard E. Wilson Professor of Surgery in the field of surgical oncology at Harvard Medical School, a surgeon at Brigham and Women’s Hospital, and a member of the Gastrointestinal Cancer Treatment and Sarcoma Centers at Dana-Farber Cancer Institute. She has also contributed to multiple initiatives focused on transforming the data infrastructure for clinical research.
Dr. Robert M. Califf was confirmed as the 25th Commissioner of Food and Drugs in 2022. He also served in 2016 as the 22nd Commissioner, and immediately prior to that as the FDA’s Deputy Commissioner for Medical Products and Tobacco. He has spent a good portion of his career affiliated with Duke University, where he served as a professor of medicine and vice chancellor for clinical and translational research, director of the Duke Translational Medicine Institute, and was the founding director of the Duke Clinical Research Institute.
The 2015 IOM Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk Recommendations and Challenges ahead
Should we collectively set a new “north star” for the next 10 years?
Moderator: Bernard Lo, M.D., Professor of Medicine Emeritus, University of California San Francisco
- Jeffrey M. Drazen, M.D. NEJM Group Editor, The New England Journal of Medicine
- Professor Arti K. Rai, Elvin R. Latty Professor of Law, Duke Law
- Ida Sim M.D., Ph.D., Professor of Medicine and Computational Precision Health, University of California San Francisco; Vivli co-founder
- Joanne Waldstreicher, M.D., Independent Director, Becton Dickinson and Structure Therapeutics; Former Chief Medical Officer, Johnson & Johnson (retired); Faculty Affiliate, Division of Medical Ethics, New York University School of Medicine
The Value of Data Sharing Realized
This session will focus on real-life case studies that show the fruition of efforts to share data and its impact on science.
Moderator: Murray Stewart, M.D., Chief Medical Officer, Rhythm Pharmaceuticals, Inc., Vivli Board member
- Ricardo Jorge de Oliveira Ferreira, Ph.D., Auxiliary Researcher at the Nursing Research, Innovation and Development Centre of Lisbon (CIDNUR), Nursing School of Lisbon (ESEL)
- Richard Liwski, Chief Technology Officer and Director, Critical Path Institute’s Data Collaboration Center
- Rebecca Li, Ph.D., CEO and co-founder, Vivli
- Sarah Nevitt, Ph.D., Senior Research Fellow, Centre for Reviews and Dissemination, University of York
- Ronald Summers, M.D., Ph.D., Senior Investigator, Imaging Biomarkers and Computer-Aided Diagnosis Laboratory, NIH Clinical Center
Credit and Incentivizing the Academic Culture
With the recent policy announcements by the White House and the newly updated NIH Data Management and Sharing Policy, movements are afoot to prompt academic researchers to share. What more can be done to encourage academic researchers to share their data by leveraging incentives?
Moderator: Barbara Bierer, M.D., Faculty Director, MRCT Center, Brigham and Women’s Hospital; Professor of Medicine, Harvard Medical School; Director Regulatory Foundations, Ethics and Law, Harvard CTSA; Vivli co-founder
- Elliott Antman, M.D., Director, Harvard Postgraduate Program in Clinical/Translational Science, Professor of Medicine, Harvard Medical School
- Daniel Ernest Ford, M.D., M.P.H., Director & Professor of Medicine, Senior Associate Dean for Clinical and Translational Research, Johns Hopkins Institute for Clinical and Translational Research
- Benjamin Pierson, Deputy Director, Enterprise Data, Bill & Melinda Gates Foundation
Key Technologies that will Influence Data Sharing (Machine learning, AI)
What role with key technologies such as Generative AI and other key technological advances play in data sharing? What are the key motivating factors and obstacles that will need to be addressed?
Moderator: Ida Sim M.D., Ph.D., Professor of Medicine and Computational Precision Health, University of California San Francisco; Vivli co-founder
- Joshua C. Mandel, M.D., Chief Architect for Healthcare, Microsoft; Lecturer on Biomedical Informatics, Harvard Medical School
- Philip Payne, Ph.D., FACMI, FAMIA, FAIMBE, FIAHSI, Director, Institute for Informatics, Data Science and Biostatistics (I2DB); Chief Data Scientist and Associate Dean of Health Information & Data Science; Washington University School of Medicine in St. Louis
- Jane Perlmutter, M.B.A., Ph.D., President and Founder, Gemini Group Consultancy
Regulations and Policies to Promote Data Sharing and Re-Use
Given recent shifts in national policies to promote data re-use as well as efforts by publishers to promote data reuse, what more can be done by regulators, national governments, publishers and other key actors to advance data sharing and subsequent re-use?
Moderator: Michael Stebbins, Ph.D., President Science Advisors. Vivli Board Chair
- Steven Kern, Ph.D., Executive Director, Global Health Labs
- Michael Lauer, M.D., Deputy Director for Extramural Research, NIH Office of the Director
- Deven McGraw, J.D., M.P.H, LLM, Lead, Data Stewardship and Data Sharing, Invitae
- Sharon Terry, M.A., Chief Executive Officer, Genetic Alliance