The National Heart, Lung, and Blood Institute (NHBLI) is requesting information from scientific and research organizations as well as other interested parties regarding the benefit of renewing the Production Assistance for Cellular Therapies (PACT) program. The PACT program aides cell therapy researchers with clinical services that are excluded from research project grant applications. These services can include the augmenting cell manufacture to numbers appropriate for clinical trial, establishing a master cell bank for clinical production, and satisfying FDA requirements by creating clinical grade cells for Investigational New Drug (IND) studies. Additionally, the PACT program provides scientists in early phase clinical trials with clinical grade supplies that comply with appropriate regulatory requirements.
The current PACT program will expire on January 15, 2015 and the NHLBI would like feedback from the community regarding the value of the PACT program and whether it should be renewed.
Comments can include but are not limited to the following areas of concern:
- Benefits to the scientific community from the continuation of a program such as PACT.
- Provision of the following translational services is under consideration:
- Transfer and optimize cell manufacturing protocols from pre-clinical laboratory to GMP clinical production methods
- Produce GLP/GMP cell products for use in relevant animal safety studies
- Develop purity/potency assays and other release criteria for cell products
- Establish GMP-compliant cell production standard operating procedures (SOPs)
- Preparation for IND submission and assist in Chemistry, Manufacturing, and Controls (CMC) section development
- Preparation for a phase I trial
Comments can describe the usefulness of these services to investigators conducting research in the areas of heart, lung and blood diseases with an interest in cellular therapies. Comments can also include additional services that would be helpful.
- Any ancillary services that a program such as PACT should provide, for example, testing scaffolds for cell therapy that has the goal of tissue regeneration and/or conducting and publishing the results of technical studies that could benefit the cell therapy community.
- Resources (information and services) for HIV-related cell therapy needed for the scientific community.
- Possibility of a “catalogue” of cell therapy products including publicly available data about cell source, manufacturing practices, potency assays, and clinical studies (domestic and international) as a useful resource for the scientific community.
ASH plans to submit comments and seeks member input. Please contact ASH Senior Manager for Scientific Affairs, Ulyana Desiderio, PhD, to email@example.com or (202) 776-0544 with your thoughts and concerns by February 15, 2013.
Please see the RFI for more information.