CEO Update|Monday 10 September

Last week we had some great news from NICE and NHS England who made the decision to fund Novartis’ drug Kymriah for patients up to 25 years of age who are living with certain types of leukaemia. The decision shows that the UK is well set to be the best country in the world in which to invent, trial, develop, manufacture and market next generation immuno-oncology therapies. These therapies are at the cutting edge of cancer, harnessing the power of the human immune system to fight the diseases that hide from it. The decision to fund the drug was made within just a few weeks of the treatment receiving regulatory approval and is one of the fastest decisions on drug funding in the history of the NHS. It made front page news and was the centrepiece of NHS chief Exec Simon Stevens keynote speech to NHS Expo – showing his commitment to this agenda. The UK is set to be the first country in Europe where patients will be able to gain full access to these treatments, thanks in large part to groundwork laid by the NHS. Many BIA members are engaged with the process of helping the NHS advanced therapy treatment centres establish which is key to enabling the healthcare system adopt these therapies. You can read our full response to this news here. NHS England is to have a new Chair Lord David Prior. Lord Prior is a former Health Minister and spoke at the BIA gala dinner 2 years ago. He is being interviewed by the Commons Health committee later today. It was good to be able to catch up with him while touring the cell and gene therapy manufacturing Catapult site in Stevenage last week. He brings a passion for innovation and a positive attitude to our sector to his new role.   

BIA CEO Steve Bates at the Stevenage Networking Lunch Thursday 6 September

On Brexit, the European Commission issued its latest Brexit notice to stakeholders in the field of clinical trials. This notice unsurprisingly provides a strict interpretation of EU law, based on the assumption that the UK will become a third country from 30 March 2019, as we have seen for previous Brexit related guidance and Q&As. This means that, after the UK leaves the EU, the sponsor or legal representative for any clinical trial conducted in the EU-27 will need to be based in the EU-27. An import authorisation will be needed for any investigational medicinal products (IMPs) and comparator IMPs coming from the UK, and QP release of these IMPs and comparator IMPs would need to take place in an EU country. It’s worth noting that information on paediatric trials conducted in the UK as part of an agreed Paediatric Investigation Plan (PIP) will continue to be submitted to the EU clinical trials database EudraCT, as required for non-EU/EEA studies.  We’ll discuss the implications of this at our next Brexit lead network next week and you can register for our next Brexit Briefing webinar which will be on 28 September. This week we’ll also seek an update from the UK government on Brexit medicine supply preparedness, since the industry deadline for response to their survey is today.  

On Tuesday, an oral evidence session was held on antimicrobial resistance (AMR) by the House of Commons Health and Social Care Select Committee. Chief Medical Officer Professor Dame Sally Davies gave some stark warnings in her overview and evaluation of threat posed by AMR. She warned that we would “lose modern medicine” if we fail to address the reality of the problem.  She also raised valuable questions: Do PhD students see a viable career path in AMR research and development? What should we do to re-energise the currently empty pipeline of antimicrobials in industry? How can we improve vaccination rates to reduce the number of people who contract infections?

Both Dame Sally and Lord O’Neill highlighted the interdisciplinary nature of the problem of AMR, and expressed frustrations with the level of progress made since the publication of his landmark report in 2013. There is little use in companies developing a portfolio of anti-cancer drugs which cannot be used in isolation from antibiotics in those with weakened immune systems. Conversation then focused on ways in which we can support industry to develop new antimicrobials and bring them to market, as well as attracting sustainable investment into their development. Market entry rewards and transferable patent vouchers were touched on. We look forward to hearing more from the valuable work on this inquiry – their final report could be with us before the end of the year.   

I am excited to announce that we will be running our early-stage entrepreneurs’ workshop, PULSE, again next year on 18 - 20 March 2019. Last week saw the launch of the website, which is open for applications. The workshop will be held at the Francis Crick Institute with sessions run by experienced life science professionals and seasoned entrepreneurs.  We hope to have around 25 up-and-coming life science entrepreneurs participating from different stages of early stage research commercialisation to pre-seed investment from around the country. If you are looking for help, advice or pitching practice for your entrepreneurial journey, apply now through the website. The workshop is completely free to all delegates, to which we can thank our kind supporters; Horizon, LifeArc, Johnson & Johnson Innovation and MedImmune.

Last year’s cohort have seen a number of success stories in the last year; Noor Shaker, CEO of GTN, has been mentioned widely in the media recently and accepted onto a number of business programmes. Founded in 2017, GTN's software uses AI to build upon techniques from the world’s of machine learning and quantum physics to discover molecules that can be used to create new medicines. The London-based company has now raised £2.1 million in funding. Jolyon Martin and the team at PetMedix are developing therapeutic antibodies with a twist by focusing on animal health. There is a $14B market opportunity in animal health that is poorly served by existing drugs, only one of which is antibody-based. Caroline Godfrey from PepGen spun out from University of Oxford early last year. PepGen is focused on improving the delivery and effectiveness of exon skipping drugs as a way of restoring dystrophin.