Access to the services outlined in the AIDS Therapies Resource Guide follow this general procedure:
- Investigator contacts one of the NIAID staff members listed as Points of Contact in the Resource Guide 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
Data packages additionally should address the following items specific to the service(s) being requested:
Requests for In Vitro Efficacy Evaluations
- 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
Requests for In Vivo Efficacy Evaluations
- In vitro efficacy profile against the pathogen used in the animal model
- Experience formulating product (and placebo) for animal use
- Drug stability in solution and in vivo
- Knowledge of in vivo metabolite formation
- Data from animal studies that might help guide dose selection and route and frequency of administration
Requests for Chemical Synthesis
- 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 (planned studies and quantities needed)
Requests for Analytical Chemistry
- Availability of API reference standard
- Previous efforts to develop analytical methods for the product and difficulties encountered
Requests for Drug Formulation and Manufacturing
- Need for a matching placebo
- Intended use of formulation (e.g., animal studies vs. clinical use; route of administration)
- Potential sources and pricing of API if not to be provided by Investigator
- Amount of API per unit dose, total number of dosage units, type of packaging needed
- Availability of API reference standard
- Previous efforts to formulate the product and difficulties encountered
- Analytical assays available for quantitation of API in the formulation
- Confirmation of availability of clinical trial funding and documented feedback by FDA regarding clinical trial design for products being manufactured for human use
Requests for Animal Pharmacology and Toxicology
- Composition of any formulated product proposed for study
- Availability of API reference standard
- Analytical assays available for quantitation of API in formulations and animal plasma or tissues
- Proposed clinical trial design for later-stage IND-enabling studies
Content last reviewed on July 8, 2009