Executive Summary

Keynotes

Patient-Centered Datasharing:  An Imperative for Agile Innovation
Paul Howard, PhD, Senior Advisor to the Commissioner, FDA

NCI Clinical Data Initiatives: Building Coalitions
Jeff Abrams, MD, National Cancer Institute

Main Sessions

Best Methods for Developing an External Control Arm

• Brian Alexander, MD, MPH, Harvard/Dana Farber
• Kathryn Lang, MBBS, MRCP, Pfizer
• Yuan-Li Shen, PhD, FDA
• Richard Simon, DSc, NCI

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Key Considerations for Small Cell Lung Cancer

• Brian Alexander, Harvard/Dana Farber
• Renzo Canetta, MD, Senior Oncology Advisor
• Jennifer Christian, PharmD, MPH, PhD, FISPE, IQVIA
• Andrea Ferris, MBA, LUNGevity
• Ariel Lopez-Chavez, MD, Roche

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Attendees
Amgen
Asana BioSciences
AstraZeneca
Bristol-Myers Squibb
Center for Medicare Services
Columbia University Medical Center
Cota Healthcare
Dana-Farber Cancer Institute
Eli Lilly & Co.
EMD Serono
Genentech
Hogan Lovells US LLP
In-Q-Tel
IQVIA
Janssen Research and Development
The Leukemia & Lymphoma Society
Life Sciences Consortium
Loxo Oncology
LUNGevity
Massachusetts General Hospital
MD Anderson Cancer Center
Merck & Co., Inc.
National Cancer Institute, NIH
Novartis
Pfizer
Roche
R Simon Consulting