1. 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
The views in this presentation are my own and do not necessarily reflect the policies of FDA

2. Problem

3. Solution
Disseminate and scale

4. 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

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

6. 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