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
Scientific Review Panel (SRP)
Management and Administration Committee (MAC)
External Steering Panel (ESP)
Efficacy & Intermediate Endpoint Biomarkers
Toxicology & Pharmacology
CGMP Production of Vaccines/Biologicals
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.