Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx) (U24 Clinical Trial Not Allowed)

The National Institute of Dental and Craniofacial Research (NIDCR), with other NIH Institutes and Centers (ICs), intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for the formation of extramural Resource Centers (RCs) whose purpose is to support promising strategies and products for tissue engineering and regenerative medicine (TE/RM). 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 (including adult stem cell-based treatments), sensors, and diagnostics. This funding cycle will support the RC infrastructure and ITPs in their validation, manufacturing, and preclinical testing of the most promising products, which may include, but are not limited to products for detecting and/or treating tissue damage caused by congenital defects, traumatic injury, or chronic disease. Products that support early detection of chronic pathologies, monitoring of validated biomarkers of health and/or disease, as well as approaches to reduce or prevent resulting chronic damage, are especially encouraged. The outcome of APEx 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. Applications are not being solicited at this time. Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects. This NOFO will utilize the U24 activity code. Investigators with expertise and insights in TE/RM are encouraged to begin to consider applying for this new NOFO.