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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 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 Â鶹´«Ã½ÊÓƵÍøÕ¾ 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:ÌýÂ鶹´«Ã½ÊÓƵÍøÕ¾ retains the therapeutic but grants license to company for marketing
• SPIN-OUT:ÌýÂ鶹´«Ã½ÊÓƵÍøÕ¾B investment establishes a separate commercial entity to market the therapeutic

Â鶹´«Ã½ÊÓƵÍøÕ¾ Support:

The Â鶹´«Ã½ÊÓƵÍøÕ¾ 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

• Contact the TRG

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

Â鶹´«Ã½ÊÓƵÍøÕ¾ Support:

Â鶹´«Ã½ÊÓƵÍøÕ¾ has implemented and is growing strategic platform partnerships to facilitate the accelerated development, commercialisation and adoption of therapeutics into the NHS.Ìý