LifeArc & MRC are making £16m available to establish Gene Therapy Innovation Hubs.

 

KTN welcomes the news that LifeArc and the Medical Research Council (MRC) are providing £16m funding to establish a network of Gene Therapy Innovation Hubs. The Hubs were borne out of a recommendation from the Medicines Manufacturing Industry Partnership Advanced Therapies Manufacturing Taskforce which led to a BioIndustry Association workshop back in 2018 sponsored by Cobra Biologics, British Society for Gene and Cell Therapy (BSGCT), Cell and Gene Therapy Catapult, KTN, and Oxford Biomedica.

 

These hubs will provide access to clinical grade viral vector and translational support or early phase academic-led gene therapy clinical trials and aim to amplify the discoveries of academic researchers, harnessing the capabilities, materials and resources that are essential to progressing innovative research towards patient trials.

 

The UK has an outstanding academic base in the field of gene therapies which has expanded rapidly over the past decade. However, translation of UK initiated gene therapies into clinical and financial value has been inhibited by a lack of facilities to support the development of these therapies through early stage clinical trials. The funding from MRC and LifeArc to UK-based research organisations and/or businesses will:

  • Accelerate the translation of new therapies including those for rare disease patients in desperate need of new treatment options,
  • Increase UK capacity for GMP viral vector manufacturing to support academically led translation by expanding or repurposing existing facilities and enabling new facilities
  • Expand the UK skills base in gene therapy development, technology transfer, medicines translation and GMP grade vector manufacturing,
  • Establish a coordinated national network linking the facilities,
  • Enable improved coordination of vector manufacturing process development, ensuring access to advanced manufacturing methods and shared IP for the UK academic network which also aligns to support rapid transition to commercial scale.

 

The creation of a network of translational Hubs will provide critical support that academics require to progress their gene therapy development projects to the point they make attractive commercial investments (potentially for LifeArc or other investors’ Seed or Venture Funds). This will include GMP grade viral vector manufacture for academic-led early phase clinical trials for genetic medicines. These Hubs will enable knowledge transfer of commercially scalable products from academic labs into GMP manufacturing via direct provision of appropriate manufacturing platforms, facilitated delivery of regulatory toxicology studies (through partners) and expert support for onward development into early phase clinical trials. The Hubs will support academic researchers throughout translation of their projects from the academic lab into patient trials. A key output of the network will be to train and retain expert staff and creating a talent pool to fill the new high-value jobs which will be created (and required by SMEs and industry).

 

The call is currently open and has a closing date of 3rd September 2020, with expressions of interest closing on 1st June 2020.

 

Find out more here.

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