Description
The National Institutes of Health (NIH) is soliciting applications for the formation of extramural Resource Centers (RCs) to support promising strategies and products for tissue engineering and regenerative medicine (TE/RM). The RCs will capitalize on their available clinical, scientific, industrial, regulatory, and commercialization expertise to select, support, and guide Interdisciplinary Translational Projects (ITPs) in the areas of therapeutics, sensors, and diagnostics. The funding cycle will support the RC infrastructure and ITPs in their validation, manufacturing, and preclinical testing of the most promising products.
• The RCs will focus on tissue engineering and regenerative medicine products, including those for detecting and/or treating tissue damage caused by congenital defects, traumatic injury, or chronic disease.
• The outcome of the APEx program will be TE/RM products with their regulatory approvals in place for first-in-human studies, along with associated clinical study protocols, and synthesis and manufacturing protocols ready for initiation of clinical trials.
• The NIH will have substantial programmatic involvement in the project, including serving as a liaison between the recipient and other government agencies, providing policy assistance and feedback, and monitoring progress.