Description and Objectives of the Program
The Rapid Access to Preventive Intervention Development (RAPID) Program makes the contract resources from NCI's Division of Cancer Prevention available to academic and academically-affiliated investigators for preclinical and early clinical drug development. RAPID objectives are to:
- assist expeditious movement of novel molecules and compounds from the laboratory through Phase 1 clinical trials
- assist investigators who submit successful requests by providing any, or all, of the preclinical and phase 1 clinical developmental requirements needed to move forward into phase 2 clinical efficacy trials
- support further development of the chemoprevention field
- develop prerequisites for filing IND applications to initiate clinical trials
- provide material for proof of principle clinical testing
Oversight
The Division of Cancer Prevention's Cancer Prevention Agent Development Committee periodically reviews the status of all projects conducted in the program. This includes assessments of progress and determination of whether particular projects should be continued or terminated, based on progress, likely progress, or difficulties in reaching the desired project goal.
RAPID Is Not...
RAPID is not intended to be a pipeline for materials for NCI-held INDs.
RAPID is not an unconditional commitment to develop a particular compound for the clinic. Development will proceed sequentially in a logical order and the start of one segment of the process (e.g., toxicology) will depend on satisfactory completion of preceding segments (e.g., bulk synthesis). Insurmountable difficulties in one segment may force abandonment of individual projects.
RAPID does not commit NCI to support the full-scale development of a particular product. The goal of RAPID is to provide the materials for proof-of-principle clinical testing. Once this is accomplished, the NCI can consider further involvement in the clinic, as part of its general clinical trials program.
RAPID is not a grant program to a particular laboratory. The majority of resources committed through RAPID are NCI new agent development contracts and NCI staff expertise.
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Frequently Asked Questions
Who can use RAPID?
RAPID is intended for academic laboratories. Most applicants will have an appointment or affiliation within an institution with an NIH-assured Institutional Review Board, or have formal collaborations with a staff member of such an institution. This allows facile access to a potential location for clinical trials. Existing research collaborations between academic investigators and companies does not automatically preclude for consideration of support for individual products. However, products arising primarily from the research and development activities of industry are considered for further development by the Division of Cancer Prevention through collaborative Clinical Trials Agreements outside of the RAPID program.
What can RAPID do?
RAPID accomplishes the tasks that are rate-limiting in bringing discoveries from the laboratory to the clinic. Ordinarily, these tasks will be accomplished by the use of NCI chemopreventive agent development contracts and will be facilitated by direct consultation of the originating laboratory with NCI staff. Such rate limiting tasks, necessary to accomplish project goals, will vary from project to project and will be evaluated for support on a case by case basis. In some cases, RAPID will support only one or two key missing steps necessary to bring a compound into clinical efficacy testing; in other cases, it may be necessary to supply the entire portfolio of development tasks needed to file an IND. Examples of tasks that can be supported by RAPID include, but are not limited to:
- Conduct of in vitro and in vivo preclinical pharmacology and efficacy studies
- Development of analytical methods for agent in neat form and in plasma and tissue
- Acquisition of bulk substance (GMP and non-GMP)
- Scale-up production from lab-scale to clinical-trials lot scale
- Development of suitable formulations
- Production of dosage forms
- Conduct of stability testing program for dosage forms
- Conduct of IND-directed toxicology
- Consultation for planning of clinical trials
- Consultation for regulatory affairs and IND application
- Support for early phase 1 pharmacokinetic and safety clinical studies in healthy volunteers
Project output comprises both products and information which are to be made fully available to the originating investigator for support of an IND application and clinical trials. The RAPID program will function as a collaboration between NCI and the originating laboratory.
Is RAPID competing with private industry?
No. The prevention, reversal, or delay of early cancer has profound public health implications, yet the scientific field of cancer prevention through the use of interventional agents is relatively young. RAPID is intended to provide support to help further establish the field of cancer chemoprevention. Operations are likely to add value by leveraging the risk of NDA-directed clinical trials. Molecules whose clinical development has been promoted by RAPID are likely to be attractive licensing candidates for industry.
Does NCI acquire intellectual property from RAPID?
No. It is expected that originating parties will have acquired intellectual property protection prior to involvement of NCI. In the event of "added value" by an NCI contractor (e.g., a novel formulation or dose form), such a development may rise to the level of invention as determined by patent law, and the contractor may elect to pursue patent protection of their invention under Bayh-Dole provisions. Obviously, the originating academic party will thereby have acquired a valuable potential ally in commercializing the subject of the research. Standard NIH Materials Transfer Agreements will form the basis for sharing confidential information with NCI.
How is RAPID different from other NCI chemoprevention programs?
Products of the RAPID program are, in general, returned directly to the originating laboratory for conduct of the clinical efficacy trials. NCI's Division of Cancer Prevention has interacted for many years with academia and industry through the Chemopreventive Agent Development Research Group, the Chemoprevention Agent Development Committee, and the Community Oncology Program. These mechanisms are similar to RAPID in that decisions are made to expend contract research resources. However, these mechanisms in most cases assume NCI holds the relevant INDs and sponsors any clinical trials with products emerging from the development process.
Does RAPID actually sponsor clinical trials?
Yes, in some cases. While RAPID is intended primarily to develop the prerequisites for filing an IND application to initiate clinical testing; it is clear that many clinical trial proposals, submitted under existing peer-reviewed mechanisms, remain undone or receive lower priority for funding because data to support safe dose selection for clinical efficacy evaluations are inadequate. Since only a minimal range of agent-associated side effects will be acceptable in most cancer preventive settings, the RAPID program considers supporting early phase 1 human studies in healthy volunteers to obtain pharmacologic and safety data. It is anticipated that prominent support by RAPID for early clinical pilot data will increase enthusiasm for funding the phase 2 & 3 efficacy clinical trials through existing mechanisms. In those circumstances where an early phase 1 clinical study is supported by RAPID, it is anticipated that the NCI would also serve as Sponsor for the IND for only the supported study.
Does RAPID discourage industry involvement?
Not at all. Applicants are still free to negotiate with industry for licensing opportunities while RAPID projects are underway.
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