All pending applications will be reviewed for support, but no new applications will be accepted effective November 5, 2008.

Abstract

The Rapid Access to NCI Discovery Resources (R·A·N·D) program assists academic and nonprofit investigators in the discovery stage of anticancer drug research. R·A·N·D can assist in the discovery of small molecules, biologics, or natural products through such mechanisms as the development of high-throughput screening assays, computer modeling, recombinant target protein production and characterization, and chemical analog generation.

Applications of 15 pages or less are accepted twice a year, on April 1 and October 1. Investigators are encouraged to submit a one- to two-page letter of intent summarizing the proposed project at least 30 days before the application deadline. Within 10 weeks following the deadline, an internal review panel will review applications for strength of the hypothesis, novelty, and cost/benefit ratio. Although the review panel considers the estimated costs in relation to possible payoffs, the applicant should not request specific funds or estimate costs. Approved projects are placed in DTP contract laboratories or in-house laboratories, and all output from the project is returned to the originator. Please note that R·A·N·D is not a grant mechanism.

Table of Contents

1. About R·A·N·D
2. 1. Background
   2. Distinctions Among R·A·N·D and Other DTP Programs
   3. Services
   4. Intellectual Property Rights
   5. Eligibility
3. Application Process
4. 1. Overview
   2. Application Components
5. Review Process
6. How to Contact Us
7. Frequently Asked Questions
8. Oversight
9. Successful R·A·N·D Applicants

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About R·A·N·D

Background

For many years, the Developmental Therapeutics Program (DTP) of NCI has provided in-house anticancer screening services to the research community. In the last ten years, simultaneous advances in chemistry, molecular biology, bioinformatics, and high-throughput screening methods have dramatically altered the manner in which both basic research and drug discovery is performed. In response to this change, the Rapid Access to NCI Discovery Resources (R·A·N·D) program was initiated to provide a broad range of early preclinical assistance for anticancer therapeutic discoveries, whether synthetic small molecules, natural products or biologics, which arise in an academic laboratory. R·A·N·D is also designed to assist in the development of target-based high-throughput screening assays from pilot screens, the synthesis of chemical analogs based on lead structures, computer modeling, pre-formulation studies, determination of drug target levels at efficacious doses, and determination of maximum tolerated dose.

Applications to R·A·N·D are accepted twice yearly, April 1 and October 1. An internal panel reviews applications within approximately 10 weeks of receipt based on strength of hypothesis, scientific novelty, and cost relative to expected benefit from NCI involvement. Successful applications result in the placement of projects either in DTP contract laboratories or in-house laboratories depending on the specific requirements of the project. Note that R·A·N·D is NOT a grant program, in that funds are not, except in very rare cases, provided to the successful applicant. All output from the project is returned to the originator of the project as, for example, synthesized or isolated materials, high-throughput screening, pharmacokinetic methods, or in vivo screening results.

Distinctions among R·A·N·D and Other DTP Programs

The NCI Rapid Access to NCI Discovery Resources (R·A·N·D) program assists investigators in the discovery of small molecules, biologics, or natural product hits. Once the optimal compound is selected, the Rapid Access to Intervention Development (RAID) program facilitates further preclinical development. RAID aims to generate clinical "proof of principle" that a new molecule or approach is a viable candidate for expanded clinical evaluation. However, RAID does not sponsor clinical trials.

Services

R·A·N·D provides the following assistance:

• Development of target-based, high-throughput screening assays based on existing low-throughput screens.
• Computer-assisted drug design
• Recombinant production and characterization of molecular target proteins
• Bioassay-directed natural product isolation and characterization
• Synthesis of structural analogs based on lead compounds
• In vivo efficacy studies
• Pre-formulation, determination of drug target levels at efficacious doses, and determination of maximum tolerated dose.

Intellectual Property Rights

All output from the project is returned to the originator of the project as, for example, synthesized or isolated materials, high-throughput screening or pharmacokinetic methods, informatics output or in vivo screening results. Normally, NCI will not acquire intellectual property rights to inventions made by its employees with research materials under R·A·N·D, unless the originating investigator and NCI mutually agree that it is in the best interest of the originating investigator. If an NCI contractor is in a position to file an invention report and elects to retain rights under the Bayh-Dole Act, the contractor will, as provided by their contract, offer the principal investigator a first option to negotiate a license to the invention.

Click here for an Intellectual Property Report Form.

Eligibility

R·A·N·D provides assistance to academic and nonprofit research laboratories. Please note that projects for which intellectual property has been licensed to a large pharmaceutical company are ineligible for R·A·N·D.

Application Process

Overview

The NCI will announce two application cycles per year, deadlines for which will be April 1 and October 1. A Letter of Intent (LOI) may be submitted via e-mail no less than 30 days (March 1 and September 1) prior to the application receipt deadline. LOIs are used to assure that the project is within the scope of the program, as well as to initiate the assemblage of the review panel. The LOI should be a one to two page summary of the proposed project and should include:

• Project title
• Investigator name, address, phone and FAX number and e-mail.
• Hypothesis
• Outline of tasks to be requested
• Please submit the LOI via e-mail to: ncidtprandinfo@mail.nih.gov

Resubmitted proposals must include a response to reviewer critiques of the original application. An application may be submitted three times; after the third unsuccessful attempt, the application will be returned unreviewed.

Application Components

Applications should be 15 single-spaced pages or less, plus no more than three preprints, reprints, or portions of relevant patents. The application should include:

• Abstract: 300 words or less.
• Background: Describe the potential agent or strategy and its intended use.
• Hypothesis: A clear statement of the hypothesis(ses) that forms the basis for the discovery opportunity.
• Requested Task(s): List the specific tasks being requested from NCI.
• Applicant Resources: list all current, anticipated, and hoped for sources of support for the project. This includes a summary of the status of past, planned, or ongoing negotiations with companies related to licensure or future development of the product.
• Feasibility and Production Issues: For applications requesting production of research material, has the product been made before? In what quantities?

If biologic, what were the production properties (g/ml) of best producing strain? What vector will produce the product? (submit sequence, if known)

How was the product defined? What assay will define a biologic product's successful use? What are the specifications for a biologic product's performance?

If non-biologic, what level of purity is required?

• Intellectual Property: Identify any patents issued or pending with respect to the product. Each R·A·N·D application must include a letter from an authorized staff member (i.e., Technology Transfer Office, Office of Research Administration) at the applicant's institution verifying that they have reviewed the application and that any intellectual property associated with the proposed project has not been licensed to a large pharmaceutical company. A brief discussion as to how the opportunity is unique and non-duplicative of work in known (public domain) drug development programs should be included.
• Appendix: Background preprints or reprints (maximum of three; these are not included in the page limitation).

Note that the applicant is NOT expected to request specific funds or even estimate costs. A central function of NCI staff in the R·A·N·D Review Process will be to outline costs utilizing U.S. Government internal or external contract sources to achieve the desired goals.

Please email the application to the R·A·N·D program to: ncidtprandinfo@mail.nih.gov

Review Process

Applications will be reviewed by an internal NCI panel. R·A·N·D Review Panel members will be bound by confidentiality agreements customary for review of NIH grants. Each application will be assigned a numeric score, and the number of projects supported by NCI in any review cycle will be a function of the level of merit and availability of funds.

Reviews will be completed by mid-to-late June and December for requests received April 1 and October 1, respectively.

Applications will be reviewed based on the following criteria:

• Strength of the hypothesis: do the requested tasks relate to a compelling hypothesis that merits development?
• Novelty: will the proposal enable preclinical discovery and early development of new approaches to cancer that have not been adequately explored and which require R·A·N·D assistance?
• Costs and Benefits: are the anticipated costs appropriate in light of the possible payoffs?

How to Contact Us

If you have questions about any aspect of the R·A·N·D Program, please contact:

R·A·N·D Office of the Associate Director
Developmental Therapeutics Program
Division of Cancer Treatment & Diagnosis, NCI
6130 Executive Blvd., Suite 8024
Rockville, MD 20852

Telephone:	301-496-8720
Fax:	301-402-0831
Email:	ncidtprandinfo@mail.nih.gov

Frequently Asked Questions

• Who is eligible to apply to R·A·N·D?
  Academic and nonprofit research laboratories.
• Is there a limit to the number of applications I can submit during one cycle?
  Yes—only two applications may be received from any one principal investigator during a review cycle.
• If my application is not approved, may I resubmit? Yes—but after three unsuccessful attempts, subsequent applications will be returned without review.
• I am an academician or researcher at a nonprofit institute. If I am collaborating with a large pharmaceutical firm, can I still apply to R·A·N·D? Yes—as long as the material in question has not been licensed to the large pharmaceutical firm.
• Can I negotiate a licensing agreement with a large pharmaceutical firm while my R·A·N·D project is proceeding? Yes—once the license is issued, however, the project will be drawn to an orderly conclusion and data or product delivered to the originating laboratory.
• I am an academician or researcher at a non-profit institute. If I am collaborating with a small business (as defined by NIH as eligible for "Small Business Innovation Research" grants), can I apply to R·A·N·D for support on the same project? Yes —even if the product is licensed to the small business, you may still apply to R·A·N·D for support.
• Can I obtain funding for my lab from R·A·N·D? R·A·N·D is not meant to function as a grant to research labs. Only in rare cases, where the approved project can only be performed in the principal investigators laboratory, will contract research or grant supplement funds be considered for allocation to the applicant.
• Does the NCI acquire intellectual property from R·A·N·D? Normally, NCI will not acquire intellectual property rights to inventions made by its employees with research materials under R·A·N·D, unless the originating investigator and NCI mutually agree that it is in the best interest of the originating investigator. If an NCI contractor is in a position to file an invention report and elects to retain rights under the Bayh-Dole Act, the contractor will, as provided by their contract, offer the principal investigator a first option to negotiate a license to the invention.
• If my project is approved, is NCI then committed to developing my material to clinical trials? No—First, R·A·N·D is designed to facilitated academic researchers in the discovery stage of anticancer drug research, not the development stage. Second, a project approved under the R·A·N·D program will have specific tasks which will serve as deliverables and will not reach beyond those tasks. Third, applications to the Rapid Access to Intervention Development (RAID) program might be considered for late development tasks such as IND-directed toxicology and pharmacology.

Oversight

The NCI Board of Scientific Advisors will convene a R·A·N·D Oversight Committee consisting of outside advisers and a subgroup of its own members. This group will periodically review the status of all projects conducted in the R·A·N·D program. This will include assessment of progress and determination whether particular projects should be continued or terminated, based on progress, likely progress, or difficulties in reaching the desired project goal.