Independent Validation and Verification (IV&V) Services for the REACT Program   2

Background
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 aims to develop wireless implantable medical devices for the surveillance and treatment of chronic diseases, ultimately making them affordable healthcare devices in the commercial market. The devices will interface with patients through a software platform to confirm 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 these devices involves engineered and/or differentiated cell lines that deliver therapies or track biomarker status. IV&V is essential for achieving standardization and reproducibility of cells, enabling the program to scale up manufacturing capabilities for both the Living Pharmacy and Living Sentinel.

Work Details
The Contractor must provide Independent Validation & Verification (IV&V) support services for the REACT program, which includes:
1. Characterizing production of unmodified pancreatic cells to establish an approach for producing differentiated cells;
2. Characterizing production of REACT performer cells;
3. Validating performance characteristics of performer Living Pharmacy therapeutic production and Living Sentinel biomarker sensing;
4. Preparing technical reports with analytical characterization of performer cells and/or validation of performance, along with recommendations on optimizing cell differentiation protocols to align with FDA requirements.

Period of Performance
02/23/2026 to 08/22/2028

Place of Performance
Washington, DC