CEO Update Monday 8 October 2018

It was fantastic to see Greg Winter, serial entrepreneur and founder of BIA member Bicycle Therapeutics jointly awarded the Nobel Prize for Chemistry. His ground-breaking work humanising antibodies led to the production of Humira, the best selling prescription drug last year. The Nobel Prize in Physiology or Medicine was awarded jointly to James P. Allison and Tasuku Honjo for their discovery of cancer therapy by inhibition of negative immune regulation. The two breakthroughs together provide the scientific underpinning for the fantastic work our sector has done to translate this science into practical therapies for patients.

Understanding the biology of negative immune regulation led to the development of “checkpoint inhibitors”.  Humanised antibodies are the key tool used to deliver these therapies. And the UK biotech scene has been at the heart of this translational work.  These therapies scupper cancer cells’ clever methods of hiding from the body’s immune system. Cancer cells exploit checkpoints within the immune system that are designed to prevent it from going into overdrive, effectively dampening the immune response. Checkpoint inhibitors release these immune system “brakes”, allowing the body’s defence network to spot and attack invasive tumour cells.

Merck’s Keytruda, (pembrolizumab) became the first of the checkpoint inhibitors to receive US regulatory approval in 2014, and now many more therapies are using similar approach to tackle cancer. And Astra Zeneca’s MedImmune research division based in Cambridge UK has had a good run of approvals using these insights. Nobel Prizes are great – but what we as a sector can be proud of is building on those insights and turning them into practical therapies. For more see our website here.     

NHS England and NICE made history last week in giving the go-ahead for the first CAR-T tharapy for use in adults in Europe. To-date, CAR-T therapies have only been available to patients in Europe through clinical trials. This news follows the announcement last month of Kymriah’s approval for use in rare childhood leukemia. Yescarta, a CAR-T therapy from BIA member Gilead, has been approved for use in patients who have large-cell lymphoma and have stopped responding to other treatments. The treatment will be used on up to 200 patients per year, and NICE along with NHS England have been able to approve the drug’s entry into NHS England’s Cancer Drugs Fund. The treatment will be available in coming weeks in London, Manchester, Bristol, Birmingham and Newcastle. Trials have indicated the therapy could cure up to 40% of patients.

EuropaBio’s Biotech SME awards have extended their deadline to October 21. Winners will receive a cash prize as well as two years free membership to EuropaBio. This is the 9^th edition of the awards. Past UK-based winners and BIA members NovaBiotics claimed victory in the 2017 healthcare category. Applications are welcome in healthcare (red biotech), agricultural (green biotech) and industrial (white biotech) categories and you can find out more about how to apply here.

In Brexit news, the Medicines and Healthcare products Regulatory Agency is now consulting on EU exit no-deal legislative proposals. This looks to examine how UK legislation and MHRA regulatory processes would have to be modified in the event of the UK not securing a deal with the EU. Our discussions with regulators over the last few months around EU exit contingency planning for the regulation of medicines and clinical trials fed into the no-deal Statutory Instruments and consultation documents issued on 4 October on the DHSC website. The overall approach is for the MHRA to be a stand-alone regulator, taking any decisions and carrying out any functions currently done at EU level. This would include decisions on marketing authorisation applications currently authorised through the Centralised Procedure, paediatric investigation plans and orphan designation, as well as pharmacovigilance responsibilities. The BIA is working with its members in partnership with ABPI to respond to the MHRA consultation which closes on 1 November. Please contact BIA Head of Regulatory Affairs Christiane Abouzeid if you would like to contribute to the consultation response.

I will be joining the senior panel of a Pharmaphorum-IQVIA webinar tomorrow, discussing difficulties in the path to market. You can sign up for the webinar, which takes place at 3pm, here. Joining me on the panel are Sheela Upadhyaya of NICE, Fred Jacobs of TYG, Dean Summerfield of NEMEA IQVIA and moderator Paul Tunnah from Pharmaphorum. We’re hoping to delve into the complex landscape modern companies must navigate in the journey from molecule discovery to market, and to address the best methods to overcome those challenges.

We were delighted to announce our partnership last week with Scientist.com, which is the world’s largest and most established marketplace for outsourced research services. Our dedicated BIA marketplace will help streamline the R&D process for our members. Members will also receive promotional rebates on platform spend. If you’d like to find out more about our partnership with Scientist.com, please get in touch with Michael McGivern, or come along to at UK Bioscience Forum 2018.

Speaking of which, we are now less than 10 days away from Bioscience Forum 2018 on 18 October. We are gearing up for an exciting agenda, with panels on advanced therapies, engineering biology, practical workshops for SMEs, innovative funding strategies and how to stay ahead after Brexit. We have some excellent speakers joining us from across the life sciences sector, beginning with Sir Mark Walport giving us an update on UKRI and how they are supporting the sector into the future. Our annual BioProcess UK conference planning is also well under way, kicking-off on 20 November with the popular pre-conference networking evening. We will gather together at Edinburgh Castle for an evening of drinks and catching-up, followed by a packed two-day agenda touching on the latest news, updates and developments within the manufacturing and biologics arena. We have now launched our new Gala Dinner website, with tables selling out fast for 24 January get your tickets now to avoid disappointment!

Best

Steve