Access to the services offered by the DAIDS Services Program to Accelerate Drug Development follow this general procedure:
- Investigator contacts the NIAID staff member(s) listed as Point(s) of Contact on the individual service/resource page to discuss the services of interest and the appropriateness of the request.
- 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.
- After the CDA is executed, Investigator submits a written request to the Point of Contact for the desired service(s) accompanied by a data package to support the request.
- 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 Adminsitration (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
- Point of Contact notifies Investigator of the outcome of the NIAID staff review.
- If request has been approved, 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.
- Point of Contact coordinates transfer of products and data 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:
- Chemical structure, molecular formula, and molecular weight of product’s active pharmaceutical ingredient (API)
- Analytical data to support the product’s proposed identity
- Detailed description of the specific assistance being requested
- Estimate of amount of API or product available for the requested services and clarification whether the available API/product is GMP-grade
- Clarification of the intellectual property status of product (are patents under consideration, submitted and pending, or issued?)
- Discussion of the funding sources available to the Investigator to develop the product outside the assistance of NIAID contract services