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Biomarkers have potential to transform drug development and clinical practice. However, the number of validated biomarkers, whose properties and utility are well-understood, remains relatively few. New scientific and regulatory approaches are thus needed to generate or capture the data necessary to validate biomarkers and ensure their safe and reliable use.
The speaker lineup for this one-day event includes leadership from both public and private organizations who are at the cutting edge of clinical data science. Come hear about these exciting initiatives, how they may be able to deliver on the promise of biomarkers, and then engage with us in a discussion of the ethical challenges and opportunities. Co-hosted by PORTAL, the Harvard Medical School Center for Bioethics, and the Harvard Program in Therapeutic Science |
When:
Thursday, October 25, 2018 8:30 AM - 3 PM ET Where: Harvard Medical School Armenise Amphiteater 210 Longwood Ave. Boston, MA 02115 Registration is free, but required to attend. Please register here. A light breakfast and lunch will be provided. |
Conference Agenda
8:30am-9:00am
Morning Coffee
9:00am-9:10am
Welcome Remarks
Aaron Kesselheim, M.D., J.D., M.P.H.
Associate Professor of Medicine, Harvard Medical School
9:10am-9:25am
Terminological and Epistemological Challenges in Biomarker Research
Spencer Hey, Ph.D.
Research Scientist, Brigham and Women’s Hospital
9:30am-10:30am
The FDA’s Biomarker Qualification Program
Christopher Leptak, M.D., Ph.D.
Co-Director Biomarker Qualification Program, FDA
10:30am-11:30am
Global Cumulative Treatment Analysis: A New Approach for Rapid Learning in Precision Oncology
Jeff Shrager, Ph.D.
Director of Research, Cancer Commons
11:30am-12:15pm
Lunch break
12:15pm-1:15pm
The Linked Data Project: Unlocking the Cochrane Data Vault
Chris Mavergames, M.S.
Chief Information Officer and Head of Information and Technology Services, The Cochrane Collaboration
1:15-pm-2:15pm
Vivli.org: A New Global Data Sharing Platform for Individual Patient Data
Rebecca Li, Ph.D.
Executive Director, Vivli: Center for Global Clinical Research Data
2:15pm-3:00pm
Q&A
Morning Coffee
9:00am-9:10am
Welcome Remarks
Aaron Kesselheim, M.D., J.D., M.P.H.
Associate Professor of Medicine, Harvard Medical School
9:10am-9:25am
Terminological and Epistemological Challenges in Biomarker Research
Spencer Hey, Ph.D.
Research Scientist, Brigham and Women’s Hospital
9:30am-10:30am
The FDA’s Biomarker Qualification Program
Christopher Leptak, M.D., Ph.D.
Co-Director Biomarker Qualification Program, FDA
10:30am-11:30am
Global Cumulative Treatment Analysis: A New Approach for Rapid Learning in Precision Oncology
Jeff Shrager, Ph.D.
Director of Research, Cancer Commons
11:30am-12:15pm
Lunch break
12:15pm-1:15pm
The Linked Data Project: Unlocking the Cochrane Data Vault
Chris Mavergames, M.S.
Chief Information Officer and Head of Information and Technology Services, The Cochrane Collaboration
1:15-pm-2:15pm
Vivli.org: A New Global Data Sharing Platform for Individual Patient Data
Rebecca Li, Ph.D.
Executive Director, Vivli: Center for Global Clinical Research Data
2:15pm-3:00pm
Q&A
