Production Assistance for Cellular Therapies (PACT)

Coordinating Center
Project Status
Active
Project Lifespan
12/31/2009 to 06/30/2021
Objective

The NHLBI-funded program, Production Assistance for Cellular Therapies (PACT), was formed to advance cellular therapy research in the areas of heart, lung and blood cellular therapy research. PACT provides assistance for IND-enabling pre-clinical studies and translational services support research and the manufacture of cellular therapy products that aid in the repair and regeneration of damaged/diseased tissues, organs, and biologic systems.

PACT supports the development of novel cell therapy products through funding contracts for manufacturing cell products at five PACT cell processing facilities. These cell processing facilities offer scale-up capability and expertise in the translational development needed to produce cell therapy products under cGLP and cGMP/cGTP regulations. The Coordinating Center (CC), The Emmes Corporation coordinates the application submission and review process and provides regulatory support to approved applicants in the development of their FDA submissions, including INDs. The CC assists with the management and coordination of PACT, including the steering committee, education initiatives, technical projects and PACT-related publications in addition to facilitating communications between the facilities and NHLBI.

PACT provides education and training to the cell therapy community. PACT education initiatives focus on three major areas: translational development; scale-up and manufacture of cell therapy products; and quality assurance and regulatory issues.

Centers

Center for Cell and Gene Therapy, Baylor College of Medicine (HHSN268201600015I) – PI: Adrian Gee, MI Biol
Center for Biomedicine and Genetics, City of Hope (HHSN268201600011I) – PI: Joseph Gold, PhD
Interdisciplinary Stem Cell Institute Cellular Manufacturing Program (ISCI-CMP), University of Miami, Miller School of Medicine (HHSN268201600012I) – PI: Joshua Hare, MD
University of Minnesota, Molecular and Cellular Therapeutics (HHSN268201600014I) – PI: David H. McKenna, Jr., MD
Moffitt Cancer Center (HHSN268201600013I) – PI: Linda Kelley, PhD

Products
eClinical
Drupal Website
Services
Project Management
Meeting Coordination and Support
Quality Assurance
Section 508 Compliance
Regulatory Affairs
Training and CE Credit