Sean Khozin, MD, MPH Office of Hematology and Oncology Products, FDA as an incubator for driving innovation and agile technology development to support cancer moonshot priorities and to promote and protect the public health Sean Khozin, MD, MPH Office of Hematology and Oncology Products, FDA Sean.Khozin@fda.hhs.gov The views in this presentation are my own and do not necessarily reflect the policies of FDA

Problem www.fda.gov

Solution Disseminate and scale www.fda.gov

Data exported for further analysis if needed Sponsor Transformation* Clinical trials Formal submission Transformation* Real world, biometrics, omics, social media Direct Premarket safety Business informatics Data exchange/visualization/analytics* Real world data working group Data exported for further analysis if needed *Technology and software development

Research and Development Incubator INFORMED Networking Mentorship Technical Assistance Co-working Space Research and Development Technology Transfer

Intrapreneur & Entrepreneurs Incubator Z Y X Intrapreneur & Entrepreneurs recruited via established mechanisms: Entrepreneur-in-Residence, Details, Fellowships, etc. Ideate Design Implement Scale Cancer moonshot priorities Product/study, pilot Develop/conduct Deploy/disseminate, publish