They Trust US
A large Range of clients
Since its creation in 2019, Biotherapy Partners has been assisting biotech companies in various fields including Non-clinical, CMC, translation/Clinical, management, regulatory, operations.
Over the last few years, we have been working with a wide range of clients: VCs, large biotechs, small biotechs, academic laboratories, CROs.
The projects on which we have been able to bring our expertise concern various biological or biotechnological products (such as Gene Therapy, Cell Therapy, Live Biotherapeutic Product, MAbs or recombinant protein) for a wide range of indications (Immuno-Oncology, Neurology, Cardiology, Dermatology…) but also enabling technologies.
Smart Imune
“Biotherapy Partners provided Smart Immune with a valuable support for the IND of its SMART 101 program“
Karine Rossignol, CEO
EDUCO LIFE
“Educo Life Sciences chose Biotherapy Partners to design and deliver comprehensive Gene & Cell Therapy training programs“
Alexander Pearce, Director
Case studies
Regulatory and operational support
Cell Therapy
Support for the preparation of an IND package
The request
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.
Strategic and operational support
Live Biotherapeutic Product
Strategic and operational support for the non-clinical development of a LBP (Live Biotherapeutic Product)
The request
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.
Strategic and operational support
Gene therapy
Strategic and operational support for the non-clinical development of a CAR T cell drug product
The request
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.
Coaching & Training
Gene therapy
Cell and Gene Therapies: introduction to manufacturing and regulatory processes
The request
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.
Due Diligence
Cell Therapy
Due diligence for cell therapy
The request
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.
