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139th National Cancer Advisory Board

ensure that investigators meet specific deadlines and milestones, or exit the project. (3) NCI staff should be delegated with greater authority over the process when investigators accept funds and then delay in meeting research targets, ignore recommendations, or lose interest. (4) NCI drug development staff should have authority to oversee contractors selected at FCRDC. (5) A two-tiered peer review system is proposed, such that the committee that provides the second (technical) review would be charged with oversight, including an annual review of progress. (6) NCI staff should exercise the authority to check the quality of compounds developed by investigators and contractors and to review data from their laboratories to make decisions. (7) Investigators should agree to accept (or formally address) advice and expertise provided by the NCI, in a joint and collaborative effort to move their discoveries into the clinic; investigators, however, would retain intellectual property rights.

Dr. Mendelsohn concluded with several comments about the workshop. (1) NCI staff who made presentations clearly understood the complexities of drug development. The participants felt that there are too few such individuals with the required experience and expertise to expeditiously move new drugs in the various NCI intramural and extramural programs into the clinic. Because of competition with big pharmaceutical and biotechnology companies, pay levels may have to be higher and authority may have to be increased. (2) The primary review process must be stringent in accessing the capability and commitment of the investigator and his/her institution to take a research discovery and perform the experiments required to move it into the clinic. Strict timelines should be established, with the opportunity for NCI experts to move into a strong mentoring position, or—if necessary—to take over the project (but not the intellectual property). (3) This program has major challenges: coordinating a research project involving an academic researcher, NCI staff and resources, and contractors performing specific stages in the process. (4) Throughout the process, the NCI should be friendly, supportive, but firm.

DCTD RAID Action Plan: Response to RAID Workshop Report and Recommendations. Dr. Doroshow focused on three points in describing the implementation of the recommendations to improve the RAID program: (1) improving the decision making process; (2) enhancing management support; and (3) increasing infrastructure support. He began with a graphic that illustrated the reorganization of RAID drug development. To maximize RAID’s return on investment, it was perceived that better definition and communication in the areas of scientific priority focusing on disproportionate unmet needs—particularly rare cancers, pediatric cancer, classes of biologics, and natural products—was needed.

The two-tiered evaluation process that Dr. Mendelsohn outlined will be implemented shortly. A new Evaluation and Oversight Committee will provide input on project recommendations and pipeline prioritization, and subcommittees will be established to address small molecules and biologicals. DTP staff will be involved in addition to ad hoc experts. This plan will begin with RAID’s Cycle 18 review in the winter of 2007. Regarding the initiation of the projects, it is important for all involved parties to understand what the RAID program will and will not do, as well as how decisions about the projects will be managed, including “no-go” decision points. To improve the deployment of RAID resources, the principal investigator’s organizational and intellectual property capabilities and ability to file an IND will be assessed. Moreover, comprehensive project plans will need to be developed and the feasibility of assisting with clinical trial planning will be examined. A DCTD project management office is being established to lead in the development and implementation of comprehensive drug development plans and reinforcement of milestones and deliverables. Two of four planned project managers have been recruited to lead trans-divisional teams. Dr. Doroshow displayed a chart that illustrated the project development plan and timeline from an NIH RAID cancer-related project.


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