ITHS is offering an Early-Stage Product Development (ESPD) Award to help translate clinically relevant research discoveries toward development of commercial products that improve human health. Projects should be designed to demonstrate or strengthen critical evidence that the envisioned product accomplishes its health-related purpose with respect to safety, efficacy, scalability, feasibility or clinical utility (i.e., proof of concept).
As examples, funds for devices could be used to create or refine prototypes, evaluate usability, assist with regulatory filings, or conduct an early-stage clinical study. Funds for therapeutic products could be used to identify or develop suitable animal models, produce small batches of the product, evaluate toxicology, pharmacokinetics or pharmacodynamics or prepare for IND submission. Funds for mobile health products could be used to evaluate effects of human factors, assess interface design, develop software coding, assist with regulatory filings, or conduct an early-stage clinical trial. Funds for diagnostic products could be used for assay development, reagent formulation, device or reader prototype design, interface design, or software coding.