Researcher using a rotary evaporator to remove a solvent and concentrate. Courtesy of NCI. 1980.

Rapid Access to Intervention Development (RAID) Program

Until 1998, to gain access to DTP drug development resources, a cancer researcher had to garner the approval of NCI and commit to NCI-sponsored clinical trials. A 1998 NCI review committee recommended that DTP expand the availability of its drug development resources to academic investigators who wanted to conduct their own clinical trials. In response, DTP began the Rapid Access to Intervention Development (RAID) Program to facilitate the translation of novel anticancer therapeutics from the academic community to the clinic.

To participate in the program, academic investigators submit a brief application to a review panel of extramural experts who assess the strength of hypothesis, scientific novelty, and cost-benefit ratio of the project. Once a project is accepted, DTP provides drug development resources, including GMP-synthesized material, pharmacology methods, and IND-directed toxicology, to the originating investigator for support of an investigator-held IND application and clinical trials.

With RAID assistance, the median project completion time is 24 months for small molecule projects and 37 months for biologic projects, regardless of whether DTP helped with preclinical development or provided full support for PI-sponsored clinical trials. So far, the RAID program has approved 104 projects, through which 13 small molecule and 11 biologic agent projects have proceeded to clinical trials.

A fermentation laboratory used to produce biologics at the Frederick Cancer Research Facility in large quantities for clinical trials. Courtesy of NCI. 1980.

Edward Sausville, M.D., Ph.D.
Former Associate Director, DTP
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Mary Wolpert, Ph.D.
Chief, GCOB, DTP
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Transcripts

The RAID program was instrumental to the efforts of Dr. Leisha Emens of Johns Hopkins University as she began a clinical trial of an allogeneic DM-CSF–secreting breast cancer vaccine given sequentially with immunomodulatory doses of cyclophosphamide and doxorubicin in patients with metastatic breast cancer. Immune responses to HER-2/neu were used as a marker of vaccine-activated immunity and as a potential surrogate for antitumor immunity.

RAID support included formulation, packaging, and release-testing of three peptides: two HER-2/neu-derived peptides and one mutated k-ras peptide as a negative control. Five hundred vials of material were produced, quality-control tested, and shipped to Dr. Emens in late 2003.

Dr. Emens filed an IND with the FDA in 2003. In October 2004, Dr. Emens reported that her team had vaccinated six patients. Assays revealed evidence of vaccine-activated immunity in at least four patients.