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September 2015

MHRA / BIA Joint Report 2015

Novel therapeutics are at the heart of the UK knowledge economy, but drug development is increasingly recognised as being inappropriately lengthy, expensive and inefficient.  To address such challenges, the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK BioIndustry Association (BIA) held their annual joint conference on 11 June 2015 at the Wellcome Trust in London, entitled the "Pathway of Innovation from Research to Patients".

On 16 July 2015, the BIA and MHRA published a joint conference report, setting out a number of recommendations on how to improve the path from research and development to licensed drugs.  We summarise some of these recommendations, including novel programmes to speed delivery of treatments and a shift to a patient-centred approach.

Expediting approvals and controlling costs

Sir Michael Rawlins, Chair of the MHRA, identified projects targeting speedy delivery of approvals, such as the European Medicines Agency's Adaptive Pathways programme.  This pilot programme marries experimental and observational approaches to cut the cost of development.  Approvals may be granted on the basis of safety and efficacy demonstrated in a subgroup, with later expansion of the label allowed in line with observation of how the therapy performs in practice.

Sir Michael also advocated for the use of novel types of trial design, such as basket and umbrella trials, in the development of targeted drugs.  In accord with the MHRA view, Steve Bates, CEO of the BIA, emphasised the importance of industry awareness of these new approaches.  The joint report recommends that biotech companies ready their investors for potential changes in approach:

• "Biotech companies need to align the expectations of their investors, who may prefer to invest over a longer time frame in order to obtain traditional phase III data, rather than fund a novel trial design as part of a pilot.  Working with regulators to develop case studies would be one means of getting this message across."

Shift to a patient-centred approach

The conference analysed the response to the Ebola epidemic, observing that the current regulatory system has the ability to get products to patients quickly when necessary.  The attendees concluded that the key to increasing overall efficiency will be putting the patient at the centre of drug development:

• "Patient involvement should be across the life cycle, from scoping R&D programmes, to agreeing meaningful outcomes and providing feedback on how a drug works in real world use."

Outlook

The BIA and the MHRA plan to work together to reshape existing drug development and regulation processes for more cost-effective, timely routes from lab to patient.  Stakeholders are aligned in emphasising patient-focused development as the key to increased efficiency. To implement this approach, the report recommends the development of robust processes and agreed criteria for factoring the patient voice into the development process.

Further information

Read the full text of the report.

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