Vaccine and Treatment Evaluation Units (VTEU): Task for Overall Administration, Clinical Operations Support, Protocol Development, Implementation and Assays

NIH RePORTER · NIH · N01 · $108,243 · 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 potential agents of bioterrorism and emerging and re-emerging infectious diseases.

Key facts

NIH application ID
11158534
Project number
272201300016I-P00008-759301900132-1
Recipient
CINCINNATI CHILDRENS HOSP MED CTR
Principal Investigator
ROBERT FRENCK
Activity code
N01
Funding institute
NIH
Fiscal year
2024
Award amount
$108,243
Award type
Project period
2019-07-12 → 2025-07-31