Program Administration

Governance Structure

Because of the importance of an integrated approach to preventative drug development, the PREVENT program is administered through a unified governance structure for coordinating and integrating available resources. With the goal of reaching go or no-go decisions as efficiently as possible, the governance ensures a pragmatic approach to drug development and a clear path to market.

Approved applications are assigned to Portfolio Managers (DCP staff) to implement, manage, and oversee the requested drug development tasks by government contractors. These tasks may include in vitro and in vivo testing, efficacy testing, and toxicology and pharmacology testing. Once all the necessary information is obtained and approved, an application can be made to the FDA for investigational new drug (IND) status.

PREVENT Cancer Program Applications

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Scientific Review Panel (SRP)

Outside Members

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The Scientific Review Panel reviews all applications submitted to the PREVENT Program. The Panel is made up of 30-35 external members who are experts in molecular biology, chemoprevention animal efficacy testing, medicinal chemists, immunologists, toxicologists, pharmacologists, drug development, and ad hoc members as needed. This panel reviews, scores and ranks applications. With 2 receipt dates per year, the panel meets twice yearly.
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Management and Administration Committee (MAC)

Federal Employees

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The Management and Administration Committee is made up of 15-20 Senior Scientists in the DCP staff, Division Leadership, staff from the NCI’s Division of Cancer Treatment and Diagnosis and the Center for Cancer Research. Primarily this group will determine NCI resource allocation, make go/no-go decisions during development, oversee projects from Discovery, Development, Prioritization plans, and make presentations to the External Steering Panel, and implement strategic objectives.
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External Steering Panel (ESP)

Outside Members

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The External Steering Panel provides strategic input for areas of focus (Biomarkers, Targets, Cancers), including how agents are selected and developed, the prioritization process, identification of gaps in the chemopreventive drug development pipeline, recommend implementation of new emerging technologies, review clinical development plans, and review the agent portfolio and progress. The ESP provides guidance to efficiently develop the most promising agents and, ultimately, increase the predictive value of preclinical testing, resulting in the design of more successful phase I and II trials. The 10-12 members of the ESP have expertise in such areas including: drug development, pharmacology, immunology, chemoprevention, medicinal chemistry, molecular biology, and biostatistics. In addition: subject matter experts, DCP staff, Principal Investigators, and members of Advocacy groups may be invited.

Portfolio Managers

Federal Employees

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Efficacy & Intermediate Endpoint Biomarkers

Contractors

Toxicology & Pharmacology

Contractors

CGMP Production of Vaccines/Biologicals

Contractors

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IND Application

Technology Transfer Considerations for the PREVENT Program Studies

Please visit the PREVENT Program Technology Transfer Considerations section that specifies the general technology transfer considerations for the PREVENT applicants related to the intellectual property (IP) and licensing mechanisms applicable to the studies in the PREVENT Program.