This contract provides gap-filling support services for HIV prevention drug developers including academic (investigators), for-profit and not-for-profit small and large companies, and other product innovators (henceforth identified as Sponsors) for the development of HIV non-vaccine biomedical prevention (nBP) strategies and products. The types of nBPs supported include, but are not limited to, topical microbicides, pre-exposure prophylaxis (PrEP) and Multipurpose Prevention Technologies (MPT’s) for the purpose of preventing HIV transmission and acquisition in adolescents, women, men and transgender individuals.
Main Areas of Focus
- To address specific gaps in a Sponsor’s HIV nBP drug development plan for development of a drug or strategy to prevent HIV infection which act as a roadblock for advancement to clinical testing and product licensure
- Does not provide support for basic research, but may address critical issues blocking advancement of a drug substance or drug delivery system (e.g., in vivo delivery system optimization/verification, dose selection, drug transporter/exporter involvement, etc.)
- Performance of non-GLP and GLP IND/NDE-enabling in vitro and in vivo animal safety, toxicity and pharmacology studies
- Performance of non-human primate and humanized mouse efficacy and PK studies for dose selection and product characterization
- Focused GMP manufacturing to enable IND or NDE required safety and toxicity studies and/or support first-in-human clinical trials
- Development and performance of analytical methods to support specific IND/NDE-enabling studies. Does not support requests to quantify drug concentrations in stored or existing samples from non-CRMP studies
- Physical characterization of drug products and substances to support CMC submissions.
- QA/QC oversight and audits of GLP and GMP activities
- Support for pre-IND/NDE and IND/NDE submissions
- These services are provided at no cost to the Sponsor
Sponsors seeking these services receive no funding from NIAID, but instead receive products or information generated by NIAID-funded contractors on their behalf. Data and reports are provided in a format that supports a regulatory filing.
Who Can Use This Resource
- Sponsors must have a defined need or gap that is delaying or blocking further advancement of their product to clinical testing and/or licensure.
- Sponsors need preliminary data and/or regulatory agency input supporting a justification for the requested support.
- If in support of a specific grant activity, the Sponsor needs to demonstrate a critical need to the advancement of the grant objectives that cannot be met by rebudgeting or administrative supplement, if applicable.