The National Heart, Lung, and Blood Institute (NHLBI) is planning a competitive renewal for the Production Assistance for Cellular Therapies (PACT) program for the production and testing of novel somatic (biological) cell therapies. This program will fund up to six geographically dispersed Cell Processing Facilities (CPFs) and one Coordinating Center (CC) in the U.S. with the capacity to provide consulting, manufacturing, preclinical study and early phase clinical trial study design, and administrative and regulatory expertise necessary for the development of novel cellular therapies in the area of heart, lung and blood cellular therapy research. The CC will be the monitor and coordinator for organizational and regulatory aspects of the PACT Program. The PACT CPFs will be established to serve investigators as performance centers for translational research related to cellular therapies and manufacturers of cellular therapy products. These CPFs will evaluate and prioritize requests for service based on their ability to fulfill the request. PACT CPFs will receive funding from the NHLBI to manufacture cellular therapy products for investigators from academia and industry needing manufacturing support. Product requests for clinical grade products and translational research will be received, evaluated, and, if approved, assigned to a CPF for manufacture. The cellular products are primarily intended for clinical use within the U.S. Products may be released by the CPF for clinical use only under an Investigational New Drug (IND).

Agency
National Institute of Health (NIH)
Type
Research and Development Contracts (N01)
Project #
268201000010C-6-0-1
Application #
8605124
Study Section
Project Start
2010-01-15
Project End
2015-01-14
Budget Start
Budget End
Support Year
Fiscal Year
2013
Total Cost
$1,464,804
Indirect Cost
Name
University of Wisconsin Madison
Department
Type
DUNS #
161202122
City
Madison
State
WI
Country
United States
Zip Code
53715