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PREVENT Cancer Preclinical Drug Development Program

PREVENT Governance Structure

Recognizing the importance of an integrated approach to preventative drug development, there is a unified Governance Structure for the PREVENT Program responsible for coordinating and integrating available resources. With the goal of reaching go/no-go decisions as efficiently as possible, the purpose is to ensure a pragmatic approach to drug development and a clear path to market.

PREVENT governance structure flowchart starting with submitted application and ending with the IND goal.

PREVENT Cancer Program applications are accepted into the program. A Scientific Review Panel reviews and ranks the applications. The Management and Administration Committee receives the prioritized applications, makes "go/no-go" decisions, obtains the recommendations and advice of the External Steering Panel, and oversees all projects. Division of Cancer Prevention Portfolio Managers make data-driven decisions at consecutive stages during the development and testing required for the Food and Drug Administration Investigational New Drug application process. Outside members, federal employees and contractors may also be involved.

With the governance structure and unified PREVENT program mission, NCI will make data-driven decisions to maximize potential for success at each consecutive stage. As such, the PREVENT Program is envisioned to streamline the development and testing of promising new cancer preventative agents and expedite their delivery to bedside.

In addition to an integrated governance structure, the PREVENT Program has a variety of mechanisms for managing confidentiality, intellectual property (IP) and licensing. These approaches are tailored to comply with Federal Law (most notably the Federal Technology Transfer Act) while offering our collaborators the opportunity to protect their IP position in a complex, collaborative environment. IP rights and licensing frameworks may vary based on the stage an agent enters the pipeline as well as the mechanism by which resources are allocated to that agent's development. More detailed information on IP and data sharing within the PREVENT Program is included on the IP and Data Access Web site.

All applications from academia, private sector, government agencies (including NCI) will be accepted into the PREVENT program twice a year and be reviewed and ranked by a Scientific Review Panel (SRP). The SRP will have 15-20 external chemoprevention scientists and drug development experts who will score and prioritize applications. This prioritized list will be presented to the internal Management and Administration Committee (MAC) made up of senior NCI scientists (including DCP, DCTD and CCR) who will discuss the science, set reasonable milestones, make go/no-go decisions, authorize NCI resources allocations and oversee the project from its inception to completion or termination. The External Steering Panel (ESP) will be comprised of 10-12 distinguished leaders in drug development from academia and private sector recommend and advise on areas of focus, priorities, and strategic planning.

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