CEO Update: Monday 2 July

At the mid-year point, how is our sector doing? Can the UK successfully scale a biotech company to launch and market its products on the global stage? Yes we can. Last week’s news that BIA member GW Pharmaceuticals plc gained FDA Approval for EPIDIOLEX® (cannabidiol) oral solution – the first plant-derived cannabinoid prescription medicine for seizures associated with two rare, severe childhood-onset epilepsies – shows what is possible. Congratulations to all the team there. 

Is 2018 the year that we see cell and gene therapy breaking out of research, and getting into commercial use in Europe? Yes it is. Two CAR-T cell therapies, Novartis’ Kymriah and Gilead’s Yescarta, both got the green light from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on Friday. Remember Oxford Biomedica is the sole global manufacturer of the lentiviral vector that encodes Kymriah viral vector technology. These were the first products to be approved with support from the so-called Priority Medicines program, or PRIME, to speed approvals for innovative drugs that fulfil unmet needs. The BIA has long championed this.

The CHMP recommended they be approved to treat a different variety of lung cancers and a type of non-Hodgkin’s lymphoma in adults. The UK has a really strong pipeline in this key technology of the future. 

And does biotech remain a high risk, high reward business? Yes it does.  I was really sad to see Summit halt work on ezutromid, their drug that had been in development for the treatment of Duchenne Muscular Dystrophy (DMD). In a press release that followed our best practice guide to the letter, Chief Executive Officer Glyn Edwards said: “While we believe utrophin modulation could still have a place in the treatment of DMD, it is clear that ezutromid is not providing a benefit for patients”. This news is very disappointing for patients living with DMD as there are virtually no treatment options available. 

Brexit remains a top policy priority for the BIA – we look forward this week to the UK government’s white paper on the future relationship, expected July 9th – and hope to be able to provide insight as to what it means for our sector as soon as it is published. We discussed our latest take on negotiations in our Brexit briefing webinar which was recorded on Friday. I was able to update colleagues at EuropaBio on (the lack of) developments last week in Brussels, but industry remains consistent and of one voice in seeking close continued co-operation.  

It was interesting to see NHS Chief Executive, Simon Stevens, note the planning going on for medicines supply for the NHS in the event of a no deal Brexit in his keynote interview at the weekend with Andrew Marr.  He said “There is now significant planning going on around all the scenarios including these medicine supply scenarios. I think nobody's in any doubt whatsoever that top of the list in terms of continuing supplies for all the things we need in this country, right at the top of the list will be those medical supplies. There's extensive work underway between the Department of Health, other parts of Government, the life sciences industry, the pharma companies, so nobody's pretending this is a desirable situation, but if that's where we get to it will not have been unforseen.” Important and noteworthy. Good to see NHS England understand the issue. 

 We are pleased to be hosting our annual BIA and MHRA Conference in conjunction with the MHRA at Euston Square this Thursday July 5th. The key themes this year centre around Brexit and the regulatory environment, working together in the accelerated access pathway to improve the delivery of innovative therapies to patients, and drug & device combinations and the regulatory challenges posed. As always there will be plenty of opportunity for discussion and networking. Last chance to book here.  

 Ahead of parliament day next week, we’ve spotted the government publishing its response to the House of Lords Science and Technology Select Committee Report on life sciences industrial strategy. The response features a quote from the BIA, in reference to the importance of effective implementation. This week, the BIA also submitted a short response to the Health and Social Care Select Committee inquiry on Antimicrobial Resistance, highlighting the need for effective market incentives to enable companies to help tackle this challenge.

It was great also be in Oxford last Monday for the grand final of the PanaceaStars Accelerator 2018. A great evening with fantastic young entrepreneurs pitching ground breaking businesses. Congratulations to Neuroloom, weaving biology and electronics to revolutionise 'electroceuticals' to win the main prize of £100K-worth non-dilutive package. I look forward to them developing over the coming months and it’s great to see fantastic talent emerging from a key UK cluster. 

There was more positive news this week for science leaders who want to pursue a career in both academia and business. UK Research and Innovation announced it is inviting Panel College applications for Future Leaders Fellowships. You can read more information at UKRI website and find out more about how to apply to be a member of the college here.

In addition to this, small and medium enterprises can apply for the Precision Medicine Investment Accelerator starting July 23rd. The aim of the accelerator is to co-fund private investment in companies that have innovative ideas at the cutting edge across the whole of the UK. These investment opportunities are critical for companies to continue to develop methods by which we can accurately diagnose, monitor and treat diseases, and all feed into the shared goal of improving patient outcomes.



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