NB: Concepts represent early planning stages for PAs, RFAs, or RFPs for Council 's input. Council approval does not guarantee that a concept will become an initiative.
If NIAID publishes an initiative from one of these concepts, we link to it below. For a full list of initiatives, go to NIH Funding Opportunities Relevant to NIAID.
Table of Contents
Master Contract for Non-Clinical Microbicide Development
For the published initiative, see the October 17, 2008, solicitation, Comprehensive Resources for HIV Microbicides and Biomedical Prevention.
Request for Proposals
Contact: Cassandra Ellis
Phone: 301-451-3691
Email: ellisca@niaid.nih.gov
Objective: The objectives of this contract are to: (1) advance highly promising HIV/AIDS topical microbicide candidates into human clinical trials by gap-filling resources, and (2) develop the preliminary platform for a future microbicide quality assurance program.
Description: This contract initiative will have two main areas of focus in support of program’s topical microbicide development goals. The primary focus will be to provide resources to support the conduct of non-clinical research that includes in vitro assessments; IND-enabling studies; preparation of INDs required for new entry candidates into Phase I trials; and the administration, oversight, and assurance of proper performance of its subcontractors. When a substantial production and/or development need is identified, the contractor will subcontract microbicide production and/or development to a qualified subcontractor. This contract will enhance the existing microbicide development resources to (1) further support critical preclinical safety evaluations, including carcinogenicity, chronic toxicity, and reproductive toxicity testing of microbicide candidates, as well as rabbit vaginal irritation, genotoxicity, absorption, and local reactivity of an additional two candidates each year, (2) further support the synthesis, generic, and custom formulation, production (Phase I only), packaging, and/or stability testing for at least one additional candidate each year, and (3) support routine screening for microbicide activity against STIs known or suspected to potentiate HIV transmission.
The second focus of this contract will be to begin to develop the infrastructure needed to support a future microbicide quality assurance program. This activity will take the form of encouraging the formation of focused working groups of microbicide investigators to begin standardization of techniques and methodologies needed to assess potential surrogate and/or biomarkers of HIV transmission or microbicide safety, efficacy, and acceptability. Once potential markers are identified, the preliminary work and infrastructure-building can be focused toward specific clinical trial-identified biomarkers. Investigators will be invited to participate in cooperative groups to assess: (1) critical parameters (assay conditions and reagents) for the performance of microbicide efficacy and safety assays, (2) comparison of assays and alternate detection methodologies (ELISA, Luminex, and other multiplex detection methods) for potential sensitivity and compatibility in detecting biomarkers, and (3) gaps in available detection methodologies, kits, and procedures necessary to address full implementation of biomarker assessment activity. These efforts would form the core of a microbicide quality assurance program that could be proposed in the future to support microbicide trials network efforts.
|
