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Commercial Adoption (Cell & Gene Therapy)

UCL support towards commercial adoption and NHS uptake of translational projects.

Cell gene therapies roadmap

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GOING TO MARKET:

Having completed the primary clinical safety and efficacy evaluation, regulatory authorities require manufacturers to ensure they do the following:

  • Undertake further clinical investigations in the wider population
  • Lock-down commercial manufacturing process
  • Validate all in-process and release assays
  • Regulatory body (MHRA/EMA/FDA) approval
  • NICE approval

In practice, the resources required for such an undertaking are often beyond UCL and the therapeutics would be expected to be commercially adopted:

  • SELL-OUT: Therapeutic sold in entirety for one-off deal to a company/manufacturer
  • LICENSED OUT: UCL retains the therapeutic but grants license to company for marketing
  • SPIN-OUT: UCLB investment establishes a separate commercial entity to market the therapeutic

UCL Support:

The UCL Translational Research Group (TRG) provide core support to investigators in the strategic development of their ideas so that they identify and mitigate risks early on, accelerate product progression from ‘bench-to-bedside’ and maximise attractiveness for public fund, philanthropic and industry investment to ensure patient benefit. 

Beyond this, UCLB will assist with commercialising therapeutics, helping to bring to market innovations that have a real and positive impact on people’s lives.

Target
NHS ADOPTION:

Be mindful of the key ‘facets’ to be developed for successful adoption. 

Key tips to facilitate adoption:

  • FISCAL OPPORTUNITY: Clearly defined and attractive market potential
  • SYSTEM OPERATIONS: Awareness and solutions to operational challenges of delivering the healthcare
  • COMMUNICATION: Effective publicity of the therapeutic throughout its lifetime
  • HUMAN FACTORS: Minimized use-related hazards, risks and inconvenience wherever practically possible
  • PROOF: Provision of ‘work as done’ evidence (i.e. in both clinical and laboratory scenarios)
  • IPR: Secure intellectual property rights (IPR) as early as possible, then drive for market adoption as soon as possible 

UCL Support:

UCL has implemented and is growing strategic platform partnerships to facilitate the accelerated development, commercialisation and adoption of therapeutics into the NHS.