Client obtained an inconclusive in vivo proof of concept study while literature offered ample supporting translational data.

Biotherapy Partners approach

Biotherapy Partners reviewed existing data, analyzed the literature to provide a preclinical strategy & plan.

BP executed the plan: RFI & RFP to select appropriate CROs, conctracting and supervision of study to obtain critical preclinical proof of concept

Results

The client obtained in vivo proof of concept of efficacy enabling to secure its path towards clinical trials.

A major investor requested experts of Biotherapy Partners to perform due diligence on academic created startup. A second phase, resulting from the Due Diligence, was to be the elaboration of a development plan and the strategic and operational support in the implementation of this plan.

Biotherapy Partners approach

Their needs ranged from setting up a TPP, risk analysis and different early-stage procedures, to operational support in non-clinical, CMC and project management.

Biotherapy Partners team was involved at various levels in order to successfully develop the product developed by the partner company.

It has called upon its members with various expertises to resolve the various challenges encountered on the way to submitting the CTA.

It also provided strong operational support through the leadership of the R&D team and project management.

Results

Our action allowed the company to secure the path to its first CTA submission, by eliminating or streamlining the various risks related to the product.