Last Wednesday the European Parliament voted through the EU Clinical Trials Regulation. This is a key staging post in the development of new rules for conducting clinical trials in Europe, an issue that the BIA, led by our Head of Regulatory Affairs, Christiane Abouzeid, has been closely involved in for the last nine years. The new regulation will provide a harmonised regulatory framework for clinical trials, the main benefits of which are the EU portal, one submission, joint assessment and one decision at Member State level. It is now critical that the legislation, due to come into force in 2016, is adopted and implemented in a practical and consistent way. The BIA will work with regulators including the MHRA and European Medicines Agency (EMA) to ensure the future EU Portal system is efficient, user friendly and secure. I would encourage companies planning trials in the next couple of years to use the Voluntary Harmonisation Procedure for multinational clinical trials and engage with the BIA as we consult members on implementation measures. The BIA has produced a briefing paper for members detailing the impact of our work in this area, highlighting the final changes to the Regulation and giving guidance on what to expect after publication of the Regulation.
Another related boost here was the decision last monday from Earl Howe to approve funding for the Health Research Authority to deliver a single approval system for all health research studies in England. This promises to simplify the regulation of research and remove complexity for researchers and industry by incorporating assessments by NHS staff alongside independent Research Ethics Committee opinions.
It was great to see so many members of our Synthetic Biology Advisory Committee represented throughout the day at the SynBioBeta conference held at Imperial College last Thursday. They gave presentations on developments in the synthetic biology industry, including its applications in healthcare, and I joined a panel discussing how to foster industry growth. For a flavour of the day, take a look at #SBBLondon on twitter. I’m also pleased to say that one of our synbio members, Oxitec, had some great news in the last couple of weeks as the BBSRC named Luke Alphey their Innovator of the Year. Luke’s work with Oxitec has focused on the genetic control of insect pests, and you can see more about their mosquito control strategy in this TED talk video by CEO Hadyn Parry (pictured above, speaking at SynBioBeta).
Last week I participated in a panel session at the launch of Genetic Alliance UK’s Patient Charter. The Charter outlines 29 recommendations made by 77 patient groups on the new approach the Government and NICE are using to determine whether or not medicines for rare conditions are made available through the NHS as part of NICE’s Highly Specialised Technology (HST) Programme. You can see their guest blog on the charter here, and read our recent report on the difficulties of evaluating drugs for rare diseases.
There have been some encouraging words from influential leaders regarding shaping a commercially sustainable bioscience environment over recent days. I was greatly encouraged to see that the new Head of NHS England, Simon Stevens, who took up his post last week, understands and promotes the importance of the NHS as a driver of the nation’s economic growth. At the Newcastle International Centre for Life, a charitable centre linking scientists, clinicians, educationalists and business people to advance life sciences, he said that, “This Centre embodies a virtuous circle – of cutting-edge British innovation, new NHS treatments and regional economic growth. If like me you believe in a tax-funded NHS, you’ll want the Health Service to play its part in growing our nation’s economy, precisely so we can sustain public health services, for generations to come.”
And Kit Malthouse, Deputy Mayor for London speaking at the SynBioBeta conference stated that “science should be the second pillar of the London economy after financial services”. He asserted that if he has one mission it is to ensure that promising bioscience has access to finance.
Kit’s words give us a preview into what to expect at the launch of the Mayor of London’s MedCity tomorrow which we are very excited about – keep an ear on the BBC Today programme tomorrow morning for a package about it. (If you’d like to see a good recent discussion on UK biotech on the Today programme, just last Tuesday they featured Kate Bingham from SV Life Sciences Advisers, Mene Pangalos from AZ and US entrepreneur Heather Agnew – see here from 06.22:18 to 06.27:50).
I am pleased to confirm the date for one of our flagship events, the UK CEO and Investor Forum will take place on 10th and 11th July. I urge you to sign up now for this must attend event – the UK’s only senior-level bioscience management meeting.
And to finish with some member news, Convergence Pharmaceuticals announced a new research alliance with Evotec, building from Convergence’s £2.4 million Biomedical Catalyst grant for the discovery and development of compounds against a novel GPCR pain target.
Have a good week all.