Federal Bid

Last Updated on 15 Sep 2021 at 8 PM
Solicitation
Beltsville Maryland

Natural History of BK Virus Infection in Renal Transplant Recipients

Solicitation ID RFQ-FDA-SOL-21-1244304
Posted Date 15 Sep 2021 at 8 PM
Archive Date 05 Oct 2021 at 4 AM
NAICS Category
Product Service Code
Set Aside No Set-Aside Used
Contracting Office Fda Office Of Acq Grant Svcs
Agency Department Of Health And Human Services
Location Beltsville Maryland United states 20705

The Contractor shall provide the existing Kidney Transplant Database being developed by the Critical Path Institute under an existing BAA contract with the Agency to collect multicenter, retrospective patient-level data regarding BKV management practices and clinical outcomes (Aim #1). These data will be summarized to fill in knowledge gaps, identify possible surrogate endpoints, and develop a model for predicting BKVN (Aim #2). It is hoped that the information garnered from this project will help establish a regulatory pathway to approval for BKV therapeutics and spur interest in developing drugs for this indication.

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