Ïã¸ÛÁùºÏ²Ê support towards commercial adoption and NHS uptake of translational projects.
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 investigationsÌýin 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 Ïã¸ÛÁùºÏ²Ê 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:ÌýÏã¸ÛÁùºÏ²Ê retains the therapeutic but grants license to company for marketing
- SPIN-OUT:ÌýÏã¸ÛÁùºÏ²ÊB investment establishes a separate commercial entity to market the therapeutic
Ïã¸ÛÁùºÏ²Ê Support:
The Ïã¸ÛÁùºÏ²Ê Translational Research Group (TRG)Ìýprovide core support toÌýinvestigators 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.Ìý
Beyond this, will assist with commercialising therapeutics, helping to bringÌýto marketÌýinnovations that have a real and positive impact on people’s lives.
NHS ADOPTION:
Be mindful of the key ‘facets’ to be developed for successful adoption.Ìý
Key tips to facilitate adoption:
- FISCAL OPPORTUNITY: Clearly defined and attractive market potential
- SYSTEM OPERATIONS:ÌýAwareness and solutions to operational challenges of delivering the healthcare
- COMMUNICATION:ÌýEffective publicity of the therapeutic throughout its lifetime
- HUMAN FACTORS:ÌýMinimized use-related hazards, risks and inconvenience wherever practically possible
- PROOF:ÌýProvision of ‘work as done’ evidence (i.e. in both clinical and laboratory scenarios)
- IPR:ÌýSecure intellectual property rights (IPR) as early as possible, then drive for market adoption as soon as possibleÌý
Ïã¸ÛÁùºÏ²Ê Support:
Ïã¸ÛÁùºÏ²Ê has implemented and is growing strategic platform partnerships to facilitate the accelerated development, commercialisation and adoption of therapeutics into the NHS.Ìý
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