CEO Update | Monday 25 March 2019

It was a pleasure to welcome up-and-coming life sciences entrepreneurs to The Crick for our PULSE programme – a 3 day workshop and networking event in partnership with the Crick designed to encourage innovative entrepreneurs to develop their life science business ideas last week. The number of talented, young, innovative leaders emerging out of the UK life sciences sector is truly exciting and several of them will now  be presenting at our CEO investor forum in June. I was delighted to chair a panel with Charlotte Casebourne CEO of Theolytic, Oliver Hardick CEO of Puridify and Toby Basey-Fisher CEO of Entia where they talked about the challenges they faced when beginning their business, the successes they had and how the next generation of leaders can get off to the right start. 

On Brexit, which will no longer happen this week, the next EU cut-off date is now 12 April. To avoid Brexit on that day the UK will need to pass the Withdrawal Agreement or agree to hold European Parliamentary elections and seek a longer extension. Our latest webinar which summarises the position as of last Friday will available here from Tuesday 26 March. We will continue to inform members of developments with the next key events being the BIA/ABPI Brexit Lead network on 9 April for members (with speakers from the DHSC’s Medicines Supply Chain Contingency Planning Programme, DExEU and the Home Office)  and our next webinar, open for all, will be 12 April.

The political circumstances the UK finds itself in is unprecedented and until no deal is legally ruled out the government has asked companies to continue with their no deal contingency planning, albeit against a new date. There is a lot of information being published by Government, including MHRA no deal guidance, contingency planning programme information and cross-sector information, we are adding daily to our BIA Brexit website to keep it up to date.   

The EMA Management Board noted at the March meeting that the number of EU centrally authorised medicines at risk of shortages continues to decrease because more companies are taking the necessary steps to ensure that their medicines can remain on the market. Despite the proactive approach by the European medicines regulatory network, there is still a high risk of supply issues with some medicines if the UK were to leave the EU without a withdrawal agreement. The EMA will publish shortly a questions-and-answers document for patients, healthcare professionals and the general public on the preparatory work that EU authorities are doing to prevent medicines shortages due to Brexit. Please follow this link for further information.

Despite the uncertainty of Brexit our sector continues to show its strength, today we and Informa Pharma Intelligence have published our latest quarterly finance report which shows a strong start to 2019 for venture capital investment in UK biotech. The UK life sciences eco system remains an attractive destination for investors. 

The World Health Organisation’s first committee on human genome editing agreed last week to seek to develop a global standard for human gene editing, following the principles of transparency, inclusivity and responsibility. The committee stopped short of calling for a moratorium, as some scientists had advocated, but urgently recommended a registry for all human gene editing research. Expect a broad ranging consultation over the next couple of years.

In other sector news, the British Phamacopeia has a survey open where they are asking for feedback on future developments, which will help British Pharmacopoeia meet users’ future needs.

The BIA and the Forum for Innovative Regenerative Medicine (FIRM) have agreed to collaborate to foster the development of regenerative medicine in the UK and Japan. FIRM is the Japanese  industry organisation with a mission to accelerate research and commercialisation of regenerative medicine. A new Memorandum of Understanding (MoU) between the BIA and FIRM has recently been signed, with the objective of helping to enable Japanese companies in regenerative medicine and cell and gene therapy and related industry to collaborate with UK companies and vice versa. The collaboration will primarily be via the BIA’s CGTAC and will involve sharing information on best practice in commercialization, regulation and reimbursement, influencing policymakers and enabling Japanese and UK companies to work cooperatively to solve problems and accelerate mutual commercial outcomes that generate health and wealth gains for our countries.  The MoU will run for three years and builds on a previous agreement between the BIA and FIRM.

It was great to participate in the Department for International Trade’s China roadshow at Medcity in London last week and see the interest in from member companies in doing business with this key market and global science powerhouse. If you missed the event I’ve summarised my contribution in a blog here.