TrakCel, software developer for cell and gene therapy supply chain tracking and orchestration, announced it will be the organisation responsible for tracking and documentation of cell and gene therapy products for the Northern Alliance Advanced Therapies Treatment Centre.
The Northern Alliance is a partnership of advanced therapy companies, NHS organisations and academic groups in the North of England and Scotland. The partnership of 20 organisations will be led by the Newcastle upon Tyne NHS Hospitals, NHS Foundation Trust and the Scottish National Blood Transfusion Service.
The alliance has received an Industrial Strategy Challenge Fund 3 year grant award from Innovate UK. The grant totals £7 million with an expected additional £2 million contributions from commercial partners.
The Northern Alliance has been tasked with facilitating the development, commercialisation and adoption of cell, gene and tissue engineered therapies in the UK. Specifically, this collaboration will create ‘state-of-art’ infrastructure that includes technology, logistics, storage, manufacturing and supply of clinical sites, evaluation, funding and adoption.
“TrakCel now provides tracking and orchestration to numerous global cell and gene therapy companies across the industry. It is now established across the global industry that all major cell therapy projects require a traceability and management solution for operating their clinical development and furthering their commercialisation strategies,” said Ravi Nalliah, CEO, TrakCel.
“As a result, the TrakCel platform will be critical to the success of the development of therapies by the Northern Alliance that could help countless patients across the UK and globally. This is a responsibility that we take incredibly seriously.”
It is widely anticipated that the first cell therapy CAR-T product will be approved by the European Medicines Agency (EMA) in the next 12 months.
The NHS will need a fully integrated network to safely and efficiently deliver these therapies.
The solutions developed by the Northern Alliance will increase the capacity of the NHS to deliver these medicines by developing systems and processes within the trusts and hospitals capable of delivering advanced therapies to patients. The resultant systems could potentially be rolled out across the UK and globally.
TrakCel will provide the Northern Alliance with a digital backbone for tracking and documenting the movement of samples throughout the collection, logistics and manufacturing process.
This comprehensive log of all activities will be vital for managing traceability and the chain of custody across the multiple organisations and teams involved in the partnership. TrakCel will also create a digital infrastructure across each hospital and the wider partnership to co-ordinate and manage the cell and gene therapy products.
TrakCel is dedicating a development team for the majority of the product timeline, and a project manager and business analyst throughout the project. The TrakCel senior management and the wider organisation will be intensely involved throughout the project.