Customer was a niche biotech diagnostic manufacturer with an Alzheimer’s biomarker test in late development. Customer needed a registration- reimbursement and commercialization strategy for USA.

Critical Issues

Customer was a pure R&D company, University spin off and did not have the infrastructure to accomplish this. There was no budget for the necessary longitudinal trials and subsequent registration process

The commercial solution

We sourced a partner Biopharma Company that would integrate this biomarker as a companion diagnostic in its clinical development plan. We designed the project for the CCDP and LCCDP.

Results

The test was integrated as companion diagnostic in the clinical development program of Alzheimer’s disease drug, of a top 5 pharma.
Pharma partnered to undertake all the development and RRC of the companion diagnostic