"The trusts most likely to succeed in experimental medicine will be those that have a broad understanding of their specialist competencies and clinical /data assets."
ANDY MULLINS, HEALTH CONSULTING, PA CONSULTING GROUPAndy Mullins
The concept of open innovation (OI); in which organisations collaborate on research has the potential to contribute to improvements in the quality and safety of healthcare. It is increasingly recognised in the NHS, but how can trusts get involved?
A key application of the OI approach in health is experimental medicine in which academic researchers, clinicians and industry collaborate – typically with patients at the centre of their work.
In experimental medicine, partners jointly progress the research and development of medicines or diagnostics in a way that positively impacts on patients but can also generate additional income for reinvestment and enables trusts to attract and retain specialist clinical expertise in key therapeutic areas.
The key drivers of the experimental medicine approach reflect the rapidly changing nature of medicines research and development and include:
the demise of traditional pharmaceutical R&D focussed on “blockbuster drugs” and a renewed focus on medicines and diagnostics targeting smaller groups of patients with specific unmet needs
the convergence of technology with biology and the collection, analysis and sharing of data sets that record clinical insight relating to patient care and response to treatments. Typically, data collection now takes place over longer periods and can extend into primary care in order to provide a ‘whole system’ evidence base for new medicines and the outcomes they enable
the increasing plurality of funding sources, including from research councils, NHS Innovations and commercial entities
the rise of the empowered patient and the growing trend for them to seek greater involvement in decisions relating to choice of treatment and care.
Where is experimental medicine being used today?
Experimental medicine is a well established concept that enables international institutions such as the Karolinska Institute in Sweden and the Johns Hopkins Hospital in the USA to play leading roles in the development of safe and effective medicines and to become recognised centres of disease excellence.
Closer to home examples of high profile collaborations include:
GSK and the Hammersmith Hospital which established a unique £30m Clinical Imaging Centre
the University of Cambridge, the MRC and Cambridge University Hospitals Trust which are researching obesity, diabetes and metabolic disorders
NHS Trusts in Scotland and Wyeth Pharmaceuticals which established a £50m Experimental Medicine project.
How can NHS trusts benefit from participation in experimental medicine?
The experimental medicine approach offers significant opportunities for trusts to benefit from and participate in open innovation. These benefits include:
generating income from complex patients and receiving investment in new specialist facilities to integrate research and treatment of distinct patient groups, for example with common therapeutic needs or ethnicity. New facilities can also act as a fulcrum for the strategic redesign of pathways and integration of care settings by bringing together diagnostics, treatment and research
developing disease specific centres of excellence that enable trusts to attract and retain clinical expertise to treat specific patient groups with unmet needs and expand market share in key therapeutic areas
demonstrating leadership to commissioners through the use of advanced research led diagnostic and treatment capabilities to provide outcome based differentiation in therapeutic service lines
developing, licensing and commercialising new intellectual property, for example new processes and interventions that may have applications outside of trusts’ own care settings.
How can my trust identify experimental medicine opportunities?
Many trusts maintain clinical capabilities and hold assets that have inherent value and potential for use in experimental medicine research initiatives.
To assess the scope for collaborating with external partners, trusts should:
assess clinical services to identify significant clinical leadership or excellence in outcomes
review local patient demographics to identify unique characteristics, for example local populations with unusually high morbidity or a high prevalence of disease that is attributable to ethnicity
determine the scope for developing tissue banks or samples that have been given with clear consent for use in future research
assess the potential value of data held on patients in key therapy areas, particularly where additional the data provides detailed patient insight. Data use must be carefully controlled but in some cases, the ability of a Trust to identify patients with specific combinations of treatments, medications or diagnostics can be valuable
appoint a coordinator to hold the responsibilities for proactively engaging industry and research partners and articulating the value of local capabilities and clinical assets.
The trusts most likely to succeed in experimental medicine will be those that have a broad understanding of their specialist competencies and clinical /data assets and the ability to tailor these to the research and development needs of partners.
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