T1D-RAID is a cooperative program of the NIDDK and NCI designed to facilitate translation to the clinic of novel, scientifically meritorious therapeutic interventions. It will do this by making available, on a competitive basis, NCI resources for the pre-clinical development of drugs, natural products, and biologics. A partial listing of those services includes: high-throughput screening, studies in animal models, formulation, pharmacology and toxicology studies, and bulk substances acquisition.
T1D-RAID is intended to remove the most common barriers between laboratory discoveries and clinical trials of new molecular entities. The goal of T1D-RAID is to support the preclinical work needed for the clinical "proof of principle" which is the study that will determine if a new molecule or novel approach is a viable candidate for expanded clinical evaluation.
There are novel ideas and candidate molecules in the scientific community that deserve expeditious clinical testing. Often an alliance with a corporate partner will adequately and expeditiously achieve this goal. However, where resources or priorities are limiting progress, T1D-RAID will help bridge the gap between discovery and clinical testing. This will facilitate efficient translation of promising discoveries even in the absence or lack of availability of development capacity or clinical expertise in the organization where the discovery was made. T1D-RAID should therefore enable entry into the clinic of promising molecules that are not otherwise likely to receive an adequate and timely clinical test.
T1D-RAID is designed to accomplish the tasks that are rate-limiting in bringing discoveries from the laboratory to the clinic. Once a project has been approved, NIDDK staff interact directly with the Principal Investigator (PI). NCI contractors perform the T1D-RAID-approved tasks under the direction of NIDDK and NCI staff. The required tasks will vary from project to project. In some cases T1D-RAID will support only one or two key missing steps necessary to bring a compound to the clinic; in other cases it may be necessary to supply the entire portfolio of development requirements needed to file an IND. Examples of tasks that can be supported by T1D-RAID include, but are not limited to:
The output of T1D-RAID activities will be both products and information that will be made fully available to the originating investigator for support of an IND application and clinical trials. T1D-RAID does not sponsor clinical trials.
The following are acceptable types of organizations that can request program resources:
Investigators whose projects are supported through T1D-RAID must first provide a Statement of Commitment to development of the supported project, setting out milestones to move the development progressively toward IND clinical trials. The Statement of Commitment should include a description of the product(s) or method(s) to be developed through T1D-RAID, and for each product or method to be developed, a description of expected product research and development, including, where relevant, major preclinical, clinical, regulatory, manufacturing and marketing stages; monetary and personnel commitments for each development stage; and the project time to accomplish each stage of commercial development.
In exchange for the support provided by the T1D-RAID program, the Investigator's Organization must agree that in the event that the Organization's commitment to development toward IND clinical trials ceases for a progressing project, as evidenced by a lack of commitment of resources to achieve the milestones set out in the Statement of Commitment as initially provided, or as amended and accepted by the NIDDK, the Organization will grant to the NIDDK a royalty-free, irrevocable, nonexclusive license under any patent on such compound or product or process for use of such, to manufacture and/or use the invention for purposes related to or connected with therapy or diagnosis of type 1 diabetes and its complications. Further, in such event, the Organization agrees that at the request of the NIH, Organization will license responsible applicants to manufacture and/or use the invention for purposes related to or connected with therapy or diagnosis of type 1 diabetes and its complications, including for commercial purposes, under terms that are reasonable under the circumstances.
It is anticipated that the majority of Requests submitted will involve a potential therapeutic that either already has protected intellectual protection or will be in the public domain. Please contact T1D-RAID@niddk.nih.gov for more information about intellectual property rights.
As noted previously, in conducting a portion of the T1D-RAID research, it may be necessary for NIDDK or NCI to use the services of one of the NIDDK's or NCI's contractors or subcontractors under a funding agreement as defined by 35 U.S.C. §201(b). Under the Bayh-Dole Act (35 U.S.C. §200 et. seq.), a contractor may elect and retain title to subject inventions developed under a funding agreement. As a term and condition of their funding agreements, certain NCI and NIDDK contractors involved with the RAID programs have agreed to offer Provider a first option to negotiate a license to subject inventions made using the Research Material(s). Certain other NCI contractors or subcontractors may be subject to a Determination of Exceptional Circumstances (35 U.S.C. §202(a)(ii)), through which their rights in subject inventions made using the Research Material(s) may be assigned to the Provider. Should an invention occur with one of these contractors, the Organization will thereby have acquired a valuable potential ally in commercializing the subject of the research and may have acquired additional intellectual property if it was the result of collaborative research. NIH Materials Transfer Agreements will form the basis for sharing confidential information with NIDDK and NCI.Back to Table of Contents
Requests will be reviewed for support by a specially convened T1D-RAID Review Panel consisting of outside experts from academia and industry. NIDDK staff will participate in an advisory capacity, and not as voting members of the T1D-RAID Review Panel. T1D-RAID Review Panel members are bound by confidentiality agreements customary for review of NIH grants.
The number of projects to be supported in any review cycle will be a function of:
A specially convened ad hoc T1D-RAID Review Panel of experts from academia and industry will initially evaluate the Requests in a confidential manner for scientific and technical merit. The T1D-RAID Panel will review and prioritize each Request on the basis of the following evaluation criteria:
Requests will receive a secondary level of review by the NIDDK internal oversight committee. NIDDK and NCI projects will be compared with tasks currently assigned to NIH contractors and a final prioritization of projects will be made taking into consideration the following additional factors:
Projects that request production of biological materials require additional review by a T1D-Biological Resources Branch Oversight Committee (T1D-BRB-OC) The T1D-BRB-OC addresses technical and feasibility issues unique to the production of biopharmaceuticals.
The T1D-RAID Review Committee has the authority to scale back an investigator's request based on development or feasibility concerns and to recommend approval of only a portion of the requested tasks. Reviewers will score the Request based on the revised set of tasks. NIDDK will commit to development of those projects accorded high merit by the Review Process. The number of projects to be supported in any review cycle will be a function of the level of merit and availability of funds.
In the event that a T1D-RAID project is encountering problems or overrunning its projected budget in a way that will not readily lead to a desired data endpoint or clinical trials candidate, a status review group will be convened to consider the likelihood that further work in the project area will be fruitful. The investigator and NIDDK staff will present progress to date in a face-to-face forum to between three and five extramural scientists knowledgeable in the area and bound by identical conflict of interest guidelines. Following the presentations, the review group will meet in closed session to determine whether T1D-RAID efforts should continue with new project milestones or the project should be concluded.
The NIDDK expects to convene a T1D-RAID Oversight Committee consisting of outside advisers and a subgroup of its own members. This group will periodically review the progress and direction of the T1D-RAID program and explore opportunities for program development and enhancement.Back to Table of Contents
If you have questions about any aspect of the T1D-RAID program, please contact:T1D-RAID