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139th National Cancer Advisory Board

internal review boards (IRB) and a series of feedback review loops with individual reviewers. Dr. Chabner added that, in each of the Cancer Centers, there is a scientific review by an IRB that goes back over the whole process before the activation process. Dr. Barker noted that NCI’s recent dialogues with the Food and Drug Administration (FDA) serve as examples of the type of engagement in risk benefit needed to encourage the American people to buy into cancer medications. Dr. Abeloff predicted that this will become the greatest impediment to young researchers, because young faculty members already are frustrated that they cannot work in a more efficient way.

Dr. Ernest T. Hawk, Director, Office of Centers, Training and Resources, said that many of the recommendations mirror what the Translational Research Working Group (TRWG) is developing, and that the SPORE directors and the EDRN group are dealing with similar issues. He applauded the Cancer Centers for taking a leadership role in stimulating activity to support collaboration, coordination, and cooperation.

Dr. Everson asked about new approaches to developing an effective infrastructure to link Cancer Center’s expertise with community hospitals, clinical oncologists, and primary care physicians. Dr. Abeloff answered that this need focuses on developing the infrastructure and the methodologies to determine why this has not happened and how to improve the situation. Dr. Mendelsohn offered that the word “collaboration” should be viewed in a new light; it is possible for a health care system to work where more is shared between physician practices, oncologists, the Cancer Centers, and other groups where a patient would receive the best value of care when a community of doctors becomes the “whole” doctor.

XIV.

REPORT OF THE WORKSHOP TO REVIEW THE NCI’S RAPID ACCESS TO INTERVENTION DEVELOPMENT (RAID) PROGRAM—DRS. JOSEPH E. TOMASZEWSKI, JOHN MENDELSOHN, AND JAMES DOROSHOW

The NCI’s Rapid Access to Intervention Development Program (RAID). Dr. Joseph E. Tomaszewski, Deputy Directory, DCTD, described the RAID program. The concept for this program was reported to the NCAB in December 1997 by Dr. Bob Wittes, who was then the Division Director, DCTD, and approved by the Board of Scientific Advisors (BSA) in February 1998. In March 2000, the BSA endorsed the continuation of the program. In July 2005, a workshop, chaired by Dr. Mendelsohn, was held to review the program, and participants included scientists from academia and the pharmaceutical drug industry. Dr. Tomaszewski explained that, following his introduction, Dr. Mendelsohn would present a report on the 2005 workshop, and Dr. Doroshow would follow with the NCI’s response and the Division’s action plan for implementing the report.

The RAID program was created to promote the development of anti-cancer agents from academic centers. It provided access to what primarily is a preclinical contract research program managed by NCI’s institutions Developmental Therapeutics Program (DTP). This allowed studies to occur under the investigator or academic center sponsorship rather than under NCI’s sponsorship through the Cancer Therapy Evaluation Program (CTEP). Examples of RAID tasks include the acquisition and formulation of bulk drugs, the production of a variety of biologicals, the testing of the efficacy of an agent in a variety of animal models, and the conduct of relevant pharmacology and toxicology studies in an attempt to bridge the gap between a lead discovery and a drug for investigation.

RAID’s unique features include the partnering of NCI internal and contract research and development (R&D) resources with extramural academic scientists needs; it also allows facile access to NCI’s in-house expertise. The output from the program is very tangible, in that it provides data and reports that are suitable for investigative new drug (IND) submissions, data for licensing to third parties,

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