- Investigator contacts Dr. Joe Fitzgibbon, the NIAID point-of-contact (POC), to discuss the services of interest and the appropriateness of the request.
- If requested by the i6nvestigator, NIAID POC 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.
- Investigator submits a written request to the NIAID POC for the desired service(s) accompanied by a data package to support the request. Requests will be reviewed in a confidential manner by NIAID staff. Criteria used in evaluating requests include
- Scientific merit of the proposed technology (rationale, disease impact, novelty, advantages compared to standard methodologies and other alternative methodologies);
- Relevance of the proposed technology to NIAID goals, including: a) expected cost and availability of kits and reagents, b) stability of kits and reagents, c) expected cost and availability of any special equipment to run the assay, d) assay throughput, and e) expected needed operator expertise and training to run the assay
- Soundness of the development plan and importance of the request in advancing that plan
- Preliminary validation data, concurrent studies/evaluations being performed, interactions with FDA or other regulatory groups
- Ability of the NIAID contract resources to fulfill the objectives of the request
- Competing workload priorities within the individual contracts
- The NIAID POC will notify the investigator of the outcome of the NIAID staff review.
- If the request is approved, the NIAID POC will provide the 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.
- The NIAID POC will coordinate the transfer of products and data between the investigator and NIAID contractors.
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