Objective
DHC is a world-renowned specialist consulting practice with deep expertise in nonclinical, CMC, and clinical development for cell and gene therapy products. By engaging DHC to work with Minutia in preparation of the IND package, BT1D is looking to de-risk any potential clinical hold and increase the likelihood of the clinical trial being approved to proceed.
Background Rationale
Having worked on hundreds of IND applications for their advanced therapeutics clients, DHC experts can help Minutia anticipate and address any potential pitfalls in their IND application, proactively de-risking the application process.
Description of Project
BT1D grantee Minutia is biotechnology company developing a transplantable therapy for the treatment of Type 1 diabetes (T1D) that combines stem cell–derived insulin-producing islet cells with integrated nanosensor technology. Minutia is planning to submit an IND application to the FDA to enable a first in human clinical trial of this novel technology, and with support from BT1D, will engage Dark Horse Consulting Group (DHC) to assist them in preparation of the application.
Anticipated Outcome
Development of an IND package positioned to be well-received by the US FDA
Relevance to T1D
Technology being developed by Minutia has the potential to offer a novel, drug-independent treatment for type 1 diabetes. Enabling streamlined commencement of first-in-human clinical trial accelerates the development of this asset.