Independent Validation and Verification (IV&V) Services for the REACT Program

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued. Please refer to the attachments for full details. The Advanced Research Projects Agency for Health (ARPA-H) Resilient Systems Office (RSO) requires independent validation and verification (IV&V) services for its Resilient Extended Automatic Cell Therapies (REACT) program. The REACT program is developing wireless implantable medical devices for the surveillance and treatment of chronic diseases that can ultimately make it to the commercial market as an affordable health care device. The objective is for the devices to interface with patients through a software platform, allowing for confirmation of therapy delivery or current disease status. The “Living Pharmacy” device will deliver tunable therapeutic molecules on demand, while the “Living Sentinel” device will track disease biomarker status. A critical component of the devices is engineered and/or differentiated cell lines (herein, “cells”) that deliver therapies or track biomarker status, respectively. IV&V is required by the REACT team to achieve standardization and reproducibility of cells so the program can scale up the manufacturing capability for the Living Pharmacy and Living Sentinel.