NHLBI accepts applications involving cardiovascular repair and disease, lung repair and disease, hematologic disease and hematopoietic cell transplantation, outside of primary treatment for malignancy.
Investigators requesting cell products to be manufactured under cGMP/cGLP conditions for use in proof-of-principle, IND-enabling research and early phase clinical trials in heart, lung, blood and sleep indications will be considered by PACT.
PACT will consider conducting activities that will bring proof-of-concept discoveries into the translational development stage. These activities include scale-up, optimizing manufacturing processes, SOP development, CMC section development and cell product manufacturing for relevant animal model studies and other IND-enabling studies conducted by the requesting investigator. PACT requires scientific, technical, and logistic details required to manufacture the requested product.
For clinical applications, PACT requires that you position your product as intended for use in an early phase human clinical trial and that you supply evidence of sufficient and/or petitioned funding to support the clinical trial.
Other NIH Institutes may sponsor applications to utilize PACT services. Please consult with your program officer prior to initiating a PACT application. You will be asked to provide the program officer’s contact information in the application.
Please contact firstname.lastname@example.org with questions about the application process.