Introduction
Recognizing the emerging field of therapeutic cell-based treatments for a growing number of diseases, including the field of regenerative medicine, the National Heart, Lung, and Blood Institute (NHLBI) held a workshop in 2002, where experts in cellular product manufacturing and clinical trial design came together to discuss the state of the cellular therapy field and identify bottlenecks to its advancement.1 A consensus emerged that improved access to current Good Manufacturing Practice (cGMP) facilities, regulatory assistance, and training would foster the transition of cellular therapies into the clinic. The Production Assistance for Cellular Therapies (PACT) program was launched in 2003 with three cell processing facilities (Baylor College of Medicine, University of Minnesota, and University of Pittsburgh) and a coordinating center. The program was expanded in 2010 to five cell processing facilities. The goal of the PACT program is to facilitate the translation of promising cell therapies from the bench to bedside, provide leadership in the emerging field of cellular therapy, and provide education to researchers, clinicians and healthcare professionals in this rapidly expanding therapeutic area.2, 3 In this report we review the first 10 years of the NHLBI-funded PACT program in cell and tissue therapies.
Participating institutions
Initially consisting of three cell processing facilities, PACT was expanded in 2010 to meet the increasing needs of the scientific community. Currently, 5 cell processing facilities are contracted to provide cell therapy production and translational services support for the PACT program. They are located at the Baylor College of Medicine, Center for Cell and Gene Therapy in Houston, TX, Boston Children’s Hospital, Center for Human Cell Therapy in Boston, MA, City of Hope, Center for Applied Technology in Duarte, CA, the University of Minnesota, Molecular and Cellular Therapeutics Facility in St. Paul, MN, and the University of Wisconsin, Waisman Biomanufacturing in Madison, WI. The EMMES Corporation in Rockville, MD, serves as the Coordinating Center. A Steering Committee comprised of representatives from each cell processing facility, the Coordinating Center, NHLBI, and an independent NHLBI-appointed Chair, provides overall governance for the program and oversees the conduct and maintenance of PACT projects.
See the entire article here: https://ascpt.onlinelibrary.wiley.com/doi/full/10.1111/cts.12148