Richard Barker, Director of CASMI, sets out his vision for a development and approval pathway for high impact innovations.
As champion for accelerated development, I’m delighted to have the chance to share early thinking on my area of the review, whose key goal is: to lay out the new development and approval pathway for high impact innovations that will make a real difference to NHS patients.
Science is on our side in this endeavor – in 2 ways.
Firstly, we are seeing a wave of very exciting new therapies and accompanying diagnostics for some of the previously most intractable of human conditions. Immuno-therapies for cancer – either in the form of the new checkpoint inhibitors or the CAR-T cells tailored to specific tumour types – show huge promise. The advent of genomic medicine is giving us new ways to profile patients and so deliver ‘precision medicine’. And digital technology will extend this precision to how each of us manages our own health.
Secondly, scientific and technological advances are enabling advances in the innovation process itself – in screening patients for clinical trials, enabling new clinical trial designs, reporting their results more cost-effectively, guiding patients in their adoption and then tracking the outcomes through real-world data generated during routine health care.
With the current colossal costs and lengthy timescales of product development, we know there is real scope for improvement, in fact, for radical change. But we will only achieve this with all the stakeholders, including patients, clinical trialists, regulators and reimbursement agencies around the table.
We need to move from a system in which each plays a siloed role – dictated by either government guidance or their own custom and practice – to one in which everyone involved teams up to hasten high value innovations from bench to bedside, and evaluates their contribution to patients and the NHS.
Nothing less than this teamwork will do, if the UK is once again to lead in life science innovation.
So the core of the process will be collaborative design of the new pathway – and how it can take the fullest advantage of the deep expertise across the UK among clinical investigators, regulators, health economists and data scientists. And, of course, the expertise among the academic researchers and life science companies whose inventiveness sets us both the challenge and the opportunity.
To me, though, it will be the patients who will be the ultimate arbiters of our success, which is why the patient voice underlies all our work on the review. The question we will need to ask ourselves will be: have we found a process and a formula that gives UK patients earliest, affordable access to transformative health technology while making UK life sciences the economic powerhouse it can and should be?