Objective

To enable the Grantee to initiate first-in-human studies in the most time and cost efficient manner.

Background Rationale

Grantee is developing a novel technology that can have an application in beta cell replacement/transplantation for T1D patients, and thus is eager to initiate first-in-human clinical trials to evaluate clinical efficacy of the technology.

Description of Project

Dark Horse Consulting (DHC) is an expert consultancy who will provide consultative support to the Breakthrough T1D Grantee as they advance a novel technology with potential application for T1D patients to first-in-human clinical trials, with the goal of enabling the Grantee to advance their efforts in the most time and cost efficient manner.

Anticipated Outcome

Regulatory approval of the clinical trial.

Relevance to T1D

Grantee is developing a novel technology that can have an application in beta cell replacement/transplantation for T1D patients.