Patient-centred approach to innovation and clinical development proposed by BIA and MHRA

Collaborative approaches to supporting innovation and to facilitating clinical development and timely access to new treatments and vaccines for patients were unveiled in a new report this week.

The report, from the UK BioIndustry Association (BIA) and Medicines and Healthcare products Regulatory Agency (MHRA) follows their annual conference – ‘Pathway of Innovation from Research to Patients’ – in London last month.

The event was attended by over 140 delegates from patients’ groups, MHRA, the National Institute for Biological Standards and Control, the life science industry, the Wellcome Trust, the Jenner Institute, academic institutions and clinical trial units.

Key topics of discussion included: (i) the value of a patient-centred approach in informing and accelerating drug development and lessons learnt from the unprecedented response to the recent Ebola epidemic; (ii) the establishment of a patient-centred system for drug development with strong patients’ groups becoming increasingly involved in regulatory processes, health technology assessments and commissioning decisions.

Commenting on the publication of the report, Steve Bates, BIA CEO, said: “Following another successful joint conference with the MHRA, the publication of our first report from the event will provide a great lasting resource for SMEs, increasing awareness of the potential impact that patient engagement could have on regulatory pathways.”

Dr Siu Ping Lam, director of the licensing division at the MHRA, said: “This was a hugely productive conference. It is increasingly recognised that patients have a key role to play in regulatory decisions. This goes to the heart of MHRA’s mission of encouraging, supporting and enabling innovation”.

“We will continue to use our scientific and regulatory expertise to advise industry and make drug development programmes as efficient as possible, facilitating safe and timely patient access.”



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