Task V03: Immunogenicity and Efficacy Testing of Medical Countermeasures (Vaccines and Other Biologics) against BSL-4 Pathogens in Non-Human Primates

NIH RePORTER · NIH · N01 · $488,832 · view on reporter.nih.gov ↗

Abstract

The Evaluation and Testing Services (ETS) for Vaccines and Other Biologics for Infectious Diseases contract provides a variety of product development services from early feasibility studies through activities required for the submission of Biologic License Application (BLA) and/or Investigational New Drug (IND) applications. Task areas include: 1) administrative management and technical support including training and workshops, and quality oversight and management (site visits, critical stage audits, and final study report audits), 2) development, qualification and validation of immune assays, 3) immunogenicity and efficacy testing, 4) non-clinical and clinical sample testing, and 5) safety/toxicology studies. These services will facilitate the development and introduction of new vaccine candidates and biologics (regulated by CBER) against a wide array of infectious diseases.

Key facts

NIH application ID
10329712
Project number
272201800013I-P00004-759301900131-1
Recipient
BATTELLE CENTERS/PUB HLTH RES & EVALUATN
Principal Investigator
THOMAS RUDGE
Activity code
N01
Funding institute
NIH
Fiscal year
2021
Award amount
$488,832
Award type
Project period
2019-08-01 → 2022-07-31