Last Wednesday, the BIA and MHRA were delighted to welcome delegates to our sixth joint regulatory conference on Accelerated Development and Access to Innovative Medicines for Patients at the Royal Society of Medicine in London.
The conference addressed the latest developments to support innovation and optimise pathways and timely access to new medicines, with delegates hearing the very latest thinking from senior experts and leading speakers from the MHRA, the European Medicines Agency (EMA), the life science industry, the NHS, NICE, academia, patient organisations and investment firms.
Our stellar line up of speakers opened with an update on the Accelerated Access Review (AAR) from Sir Hugh Taylor, Independent Chair of the AAR, and Professor Sir John Bell, Chair of the review’s Expert Advisory Group. Both expressed their thanks for the level of engagement with the review, which will release its final report following the EU Referendum. As Sir John Bell puts it, we’re in an age of fantastic development in science and the AAR hopes to capitalise on this and ensure that the best innovations are identified early, given adequate support and ultimately pulled into the healthcare system to deliver benefits to patients.
Two years on from its launch, the UK’s Early Access to Medicines Scheme (EAMS) was under the spotlight at the conference with views from the MHRA, industry, NICE, NHS England and charity Cancer Research UK. The overarching view from across the panel was that it was encouraging to see the scheme growing and evolving. However there is still a question to address in terms of whether the success of EAMS is limited in its currently un-funded format.
Over the course of the afternoon, we heard from speakers on the early access tools available at a European and US level, including an update on the EMA’s adaptive pathways pilot project and new PRIME initiative. Dr Jordi Llinares, EMA, confirmed that following the second submission deadline last week, a total of 26 applications have been received for PRIME across a wide range of therapeutic indications. He also revealed that of the 18 applications made under the first submission deadline, 11 were from SMEs – great news for the scheme.