Program Administration

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.

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 Food and Drug Administration for Investigational New Drug (IND) status.

PREVENT Cancer Program Applications

 

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 15-20 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.

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.

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

 

Efficacy Testing

Contractors



Toxicology and Pharmacology

Contractors

 

IND Application

 

Technology Transfer Considerations for the PREVENT Program Studies

The following outlines the various technology transfer considerations, including intellectual property and licensing mechanisms applicable to studies of third-party agents in the PREVENT Program.  Please note that the NCI DCP PREVENT Program will work with the NCI Technology Transfer Center to determine the appropriate agreement and applicable terms and conditions for each study approved by the PREVENT Program.

PREVENT Collaboration Agreement

Applicants entering the pipeline for projects post lead compound development but prior to clinical trials will be expected to execute an agreement that memorializes the collaboration between the NCI and the applicant’s institution (PREVENT Collaborator).   This Collaboration Agreement (Word version [30 KB], PDF version [64 KB]), outlines the obligations of NCI and the PREVENT Collaborator. 

Intellectual Property and Licensing

NCI

The NCI will inform the PREVENT Collaborator of any inventions made by its employees during the conduct of the PREVENT study that are directed to the PREVENT Collaborator’s proprietary materials and/or data, and after consultation with the PREVENT Collaborator, the NCI will decide whether or not to file a patent application on any such invention.  If the NCI does file a patent application, the PREVENT Collaborator will be given an opportunity to negotiate for a license in accordance with the procedures set forth in 37 CFR Part 404.  NCI does not have the authority to grant research licenses in advance for the PREVENT collaborations, but it is consistent with NCI’s policies for the PREVENT Collaborator to use any patentable inventions that might result from the collaboration for non-profit research and teaching purposes at no cost to the PREVENT Collaborator.

In exchange for the NCI’s contribution under the PREVENT Program, the NCI shall have a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced, throughout the world by or on behalf of the Government for research or other Government purposes, to any inventions developed by the PREVENT Collaborator during the conduct of the PREVENT project.  The PREVENT Collaborator is free to license these inventions, given that any license agreement with a third-party provides for the rights granted to the Government under this Article.

Contractor(s)

In conducting a portion of the PREVENT project, NCI may utilize the services of one or more of NCI’s contractors or subcontractors under a funding agreement as defined by 35 U.S.C. § 201(b).  NCI will inform the PREVENT Collaborator of the results of the NCI contractor's or subcontractor's research that uses or encompasses the PREVENT Collaborator's proprietary materials and/or data.  Inventions made by NCI contractors are subject to the Bayh-Dole Act; however, to encourage applicants to participate in the PREVENT Program, such NCI contractors and subcontractors have agreed to include as a term and condition of their funding agreements, an agreement to offer to the PREVENT Collaborator a first option to negotiate a license to subject contractor or subcontractor inventions made using the PREVENT Collaborator's proprietary materials and/or data.  Certain other NCI contractors or subcontractors may be subject to a Determination of Exceptional Circumstances (35 U.S.C. § 202(a)(ii)), through which their rights in inventions made using the PREVENT Collaborator’s materials and/or data may be assigned to the Government. The PREVENT Collaborator may apply to NCI for a license to such inventions in accordance with 37 CFR Part 404.