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

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

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