VALIDATION OF BIOANALYTICAL ASSAYS AND IND- ENABLING GLP PD/PK TOXICOLOGY STUDIES

NIH RePORTER · NIH · N01 · $1,553,595 · view on reporter.nih.gov ↗

Abstract

The URGenT Network Services indefinite delivery, indefinite quantity (IDIQ) contract provides neuroscience product developers/innovators with a full range of industry-style, biologic and drug development services and expertise for their development of therapeutics for neurological diseases. These product developers/researchers are funded through other programs at the National Institutes of Health (NIH) but may lack the entire suite of capabilities necessary to advance their candidate product to a phase I clinical trial. Therefore, the IDIQ contract augments the progress of the candidate product by providing the support required at the specific stage of its development and optimization path. The services offered through this contract are bioanalytical assay services and GLP dose-escalation for investigational new drug (IND)-enabling toxicological studies, and support through phase I clinical trial.

Key facts

NIH application ID
11212584
Project number
75N95022D00021-0-759502400001-1
Recipient
BATTELLE CENTERS/PUB HLTH RES & EVALUATN
Principal Investigator
JAMES GRIDLEY
Activity code
N01
Funding institute
NIH
Fiscal year
2024
Award amount
$1,553,595
Award type
Project period
2024-03-11 → 2027-03-10