I was pleased to welcome today’s announcement of a one stop shop to provide regulatory advice for those working in regenerative medicine in the UK. The BIA has called for a single UK research regulator for regenerative medicine since the Academy of Medical Sciences’ review of regulation and governance of medical research in 2010 and this was a central argument we made to the McCracken review of the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Authority (HTA) in 2013. This positive step has the potential to encourage inward investment and incentivise start ups in the field of regenerative medicine and shows that the UK is serious about being the preeminent place in the world to develop advanced therapies.
On Friday the EMA held an exchange day with EuropaBio as part of European Biotech Week, attended by around 50 stakeholders from companies and the EMA itself. Some interesting discussion came out of the session on Facilitating Innovation. Professor Guido Rasi, Executive Director of the EMA, emphasised the need to strike the right balance to enable innovation while ensuring patient safety. He said that, while the EMA is not expanding its remit, he would like to see a more homogenous approach to linking Health Technology Assessment (HTA) with regulatory assessment, and that industry should proactively seek parallel scientific advice between the EMA and HTA bodies from early on in the R&D process. Jordi Llinares-Garcia from the EMA’s Scientific Support Department for human medicines R&D, spoke of reinforcing EMA support for innovation, saying that EMA scientific advice is considered a ‘flagship’ of innovation and emphasising the increasingly important role of patient input in the scientific advice process. To read up on the EMA’s latest policy on publication of clinical data, take a look at our new blog from Lincoln Tsang from the BIA’s Regulatory Affairs Advisory Committee.
Last week, Mayor of London Boris Johnson has called for the establishment of an International Dementia Research Institute in London, supporting the Prime Minister’s pledge back in June for new action to accelerate progress on dementia drugs, with a focus on patents, funding and patient access to new medicines. Parliament was back in session today, and we’ll be working up our engagement with policymakers over the coming weeks and months using the Life Sciences Manifesto 2015-20.
For many of us, waking up on Friday 19 September to find out that Scotland had voted to stay within the Union was a great relief given the many uncertainties independence would have brung for key issues in the sector such as where and how would drugs be regulated. However a vote for no is not a vote for the status quo as it has initiated an unprecedented debate around devolution, not just for Scotland but for throughout the UK. Join me at our webinar this Friday at 3pm to understand better the process for the next 6 months as these issues are debated in Parliament and discuss your key concerns, ideas and questions about the impact of the devolution debate on your business.
Also on the events front, the annual bioProcessUK Conference is almost fully booked – so do act quickly to secure your spot as there are just a handful of places left.
Finally, this week is Biology Week, organised by the Society of Biology. I hope you’re all celebrating the best of bioscience across the UK – particularly following last week’s announcement that UCL researcher John O’Keefe was jointly awarded the Nobel Prize in Physiology or Medicine. Great to see him raising the need for the UK to have sound policies on immigration and animal research in this BBC news article.