A biotech startup requested a support to review, supplement and complete the necessary documentation for a clinical trial application

Biotherapy Partners approach

A review of the existing documentation was acomplished, a gap analysis was done, additional studies were performed if necessary, reports were written, the dossier for clininical trial application was prepared filed to regulatory agency, questions from the agency were answered and the clinical trial was initiated.

Results

BP identified the gaps, proposed supplementary studies and contributed to finalize a successful clinicical trial application for FDA.

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.

This training course provides an overview of considerations in the industry of cell and gene therapies. It is designed to create a solid framework for anyone looking to embark in the sector.

Biotherapy Partners approach

BP prepared an overview of gene and cell therapy fundamentals and delivered it through interactive sessions

Results

Delegates develped their knowledge in cell and gene therapy and asked questions.

The training was a great opportunity to address questions and discuss topics reltated to ATMPs.

Client was looking to complement its internal team with seasoned experts in cell therapy.

Biotherapy Partners approach

BP reviewed existing data, focussing on critical, potentially deal-breaking data and interacts with third-party SMEs.

Results

BP pintpointed during due diligence key success factors for the deal & next steps.