National Cancer Institute
Among its many resources, NCI has deep experience in the pre-clinical development of drugs, biologics, and vaccines — from toxicity testing, to pharmacodynamics, histopathology, and the production of materials that meet FDA Good Manufacturing Practice standards for testing in humans. Launched in 1998, NCI’s Rapid Access to Intervention Development (RAID) program makes those formidable resources available to academia, providing a bridge between discovery of a new agent and its introduction into Phase 0 or Phase I human clinical trials. Drug company scientists may have such services at their disposal, but many academic researchers do not.
In addition, RAID supports principal investigators who are working on rare diseases and pediatric malignancies, and who are attempting to validate new therapeutic targets. The RAID program is currently developing significant upgrades, including mentoring and training for principal investigators, regulatory assistance in the filing of Investigational New Drug applications with the FDA, and even conducting initial clinical trials at the NIH Clinical Center. To better enable the success of the research projects it supports, the RAID program is establishing a business model approach — complete with firm timelines, developmental milestones, and regular reviews to make important go or no-go decisions on research projects.
So far, the RAID program has approved 133 projects which resulted in 21 small molecule and 25 biologic investigational new drug approvals. The RAID program was instrumental to the efforts of Leisha Emens, M.D., Ph.D., of Johns Hopkins University as she began a clinical trial of a breast cancer vaccine for patients with metastatic breast cancer. RAID support included formulation, packaging, and release-testing of three peptides. Five hundred vials of material were produced, quality-control tested, and shipped to Dr. Emens so that her team could begin vaccination. Early results in six patients revealed evidence of vaccine-activated immunity in at least four patients.
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