Requesting Access to DAIDS Services Program to Accelerate Drug Development

Investigators seeking access to resources for in vitro testing and screening of HIV compounds, evaluations in small animal models, formulation development and manufacture of clinical dosage forms, and preclinical pharmacology and toxicology services are encouraged to submit applications through PAR-22-185 Resources Access for Preclinical Integrated Drug Development (RAPIDD) Program.

In addition to the RAPIDD Program, access to the services offered by the DAIDS Services Program to Accelerate Drug Development follows this general procedure:

  1. Investigator contacts the DAIDS Preclinical Therapeutic Development Committee (DPTDC; niaiddaidsdptdc@mail.nih.gov) to discuss the services of interest and the appropriateness of the request; upon receipt of a request, the DPTDC assigns a Point of Contact from the committee.
  2. DPTDC Point of Contact provides Investigator with a Confidential Disclosure Agreement (CDA) for negotiation and signature. This document specifies the terms under which confidential information is to be shared with NIAID staff for an assessment of the request for services.
  3. After the CDA is executed, Investigator submits a written request to the DPTDC Point of Contact for the desired service(s) accompanied by a data package to support the request.
  4. Requests are reviewed in a confidential manner by NIAID staff. Criteria used in evaluating requests include:
    • Scientific merit of the proposed therapy or prevention strategy (rationale, disease impact, novelty)
    • Relevance of the proposed therapy or prevention strategy to NIAID's research agenda
    • Soundness of the development plan and importance of the request in advancing that plan
    • Evidence of investigator commitment to the product’s development (amount of preliminary data, concurrent studies being performed, interactions with the Food and Drug Administration (FDA) for future clinical trials)
    • Ability of the NIAID contract resources to fulfill the objectives of the request
    • Competing workload priorities within the individual contracts
  5. DPTDC Point of Contact notifies Investigator of the outcome of the NIAID staff review.
  6. If request has been approved, DPTDC Point of Contract provides Investigator with a Material Evaluation Agreement (MEA), if appropriate for the requested service, for negotiation and signature. This document specifies the services to be provided and addresses issues of confidentiality, disclosure of results, and intellectual property.
  7. DPTDC Point of Contact coordinates transfer of products, data and information between Investigator and NIAID contractors.

Investigators seeking access to these services must have a defined product of known chemical structure and must have relevant biological data obtained with that specific product that NIAID believes warrants the continued development of the product. These services are not intended for Investigators seeking to develop untested ideas or ideas based on extrapolation of data obtained with structurally—or functionally—similar products. NIAID supports these latter types of activities via one of its grant mechanisms.

Data packages must contain the following information regarding the Investigator’s product:

  1. Detailed description of the specific assistance being requested
  2. Chemical structure, molecular formula, and molecular weight of product’s active pharmaceutical ingredient (API)
  3. Analytical data to support the product’s proposed identity
  4. For in vitro testing and screening requests:
    • Proposed mode of action of product
    • Assessment of product’s efficacy against the requested pathogen or a closely related pathogen, or activity in a biochemical or cell-based screen that supports the proposed mode of action
    • Assessment of product’s cytotoxicity against uninfected cells
  5. For chemical synthesis requests:
    • Synthetic schemes used in the past to make product, including representative yields for each step
    • Potential sources and pricing of unusual/unique reagents
    • Outline of how synthesized material will be used, including planned studies and quantities needed
  6. For evaluations in small animal models:
    • In vitro efficacy profile against HIV, HBV, HCV or TB
    • Experience formulating product (and placebo) for animal use
    • Drug stability in solution
    • Knowledge of in vivo metabolite formation
    • Data from animal studies that might help guide dose selection and route and frequency of administration
  7. For animal pharmacology and toxicology services:
    • Composition of any formulated product proposed for study
    • Availability of API reference standard
    • Analytical and bioanalytical assays to enable quantitation of API in tested products and biological matrixes
    • Proposed clinical trial design for later-stage IND-enabling studies
  8. For formulation development and clinical dosage forms manufacture:
    • Description of the processes used in the past to manufacture targeted products
    • Analytical methods to support process development, manufacturing, and stability studies
    • Availability of reference standards for the API, final or prototype products
  9. Estimate of amount of API or product available for the requested services and clarification whether the available API/product is GMP-grade
  10. Clarification of the intellectual property status of product (are patents under consideration, submitted and pending, or issued?)
  11. Discussion of the funding sources available to the Investigator to develop the product outside the assistance of NIAID contract services

Intellectual Property:

It is expected that the originating investigator, institution, or a collaborating partner will have acquired or be in the process of acquiring appropriate intellectual property protection prior to application to these DAIDS Services Programs. Resource services will be provided through existing DAIDS preclinical contracts. While it is unlikely the NIH staff will make an inventive contribution to any intellectual property developed under the DAIDS Services Programs, in accordance with 37 CFR Part 501, the government has rights to any invention made by federal employees and its employees have a duty to report all inventions. If the NIH does file a patent application claiming one or more inventions developed under the DAIDS Services Programs, the originating investigator institution will be given the opportunity to negotiate for an exclusive license under procedures set forth in 37 CFR Part 404.

NIH contractors, under the Bayh-Dole Act, may elect to retain rights for a contribution they make that rises to the level of invention. However, some contractors, as a term of their funding agreements, have agreed to offer a first option to the originating investigator institution for license negotiation. If the applicant is selected for resource support, a Material Evaluation Agreement or other agreement may be required prior to initiation of work, which will define how intellectual property is managed under the specific contract(s) under which such support would be provided. Questions or concerns about Intellectual Property should be discussed with NIAID staff prior to application.

Related Resources

Content last reviewed on