The Production Assistance for Cellular Therapies (PACT) program produces and tests 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)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research and Development Contracts (N01)
Project #
268201600015I-0-26800001-1
Application #
9365887
Study Section
Project Start
2016-08-01
Project End
2017-06-30
Budget Start
Budget End
Support Year
Fiscal Year
2016
Total Cost
Indirect Cost
Name
Baylor College of Medicine
Department
Type
DUNS #
051113330
City
Houston
State
TX
Country
United States
Zip Code
77030