FDA-PDS Symposium I: Prostate Cancer DREAM Challenge

FDA-PDS Symposium I: Prostate Cancer DREAM Challenge Keynote Thoughts on the Future of Medical Evidence Generation Robert M. Califf, MD, Deputy Commissioner, FDA Main Sessions Project Data Sphere Initiative, Overview & Demonstration Charles Hugh-Jones, MD, Sanofi Joseph Morrell, Project Data Sphere Martin Murphy, [...]

FDA-PDS Symposium II: From Silos to Solutions

FDA-PDS Symposium II: From Silos to Solutions Keynote Advancing Cancer Research Through Collaborations between Academia, Industry and Regulatory Science Richard Pazdur, MD, Director, Office of Hematology & Oncology Products, FDA Main Sessions Project Data Sphere Initiative Update Monica Bertagnolli, [...]

FDA-PDS Symposium III: Intermediate Endpoints in Immuno-Oncology

FDA-PDS Symposium III: Intermediate Endpoints in Immuno-Oncology Keynote The Role of Data Sharing in Fulfilling FDA’s Vision of an Evidence Generation System Robert M. Califf, MD, Commissioner, FDA Main sessions Project Data Sphere Initiative Update: Outcomes Since Symposium II [...]

FDA-PDS Symposium VI: Small Cell Lung Cancer (SCLC) External Control Arm

Symposium VI: Small Cell Lung Cancer (SCLC) External Control Arm: A Paradigm Shift in Cancer Drug Evaluation/Registration Executive Summary Keynotes Patient-Centered Datasharing:  An Imperative for Agile Innovation Paul Howard, PhD, Senior Advisor to the Commissioner, FDA NCI Clinical Data [...]

FDA-PDS Symposium IX: Rare Tumor Registries

Executive Summary PDS Symposium IX on rare cancer registries was a virtual meeting held on Oct. 7, 2020. For the first time in our annual symposia series, we are met online. As a result, more of you were able to engage which will help [...]

FDA-PDS Symposium X: Data Sharing

Executive Summary Overview: For the last 6 years, the CEO Roundtable on Cancer’s Project Data Sphere (PDS) has actively partnered with the FDA through a series of symposia focused on building consensus within the scientific community in support of advanced [...]

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