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CEO Update|Monday 26 October
BIA Board elections
Last Wednesday we conducted our first virtual Annual General Meeting (AGM) with a really encouraging turnout. Our Chair, Ruth McKernan, announced that the following members will join the Board of Directors next January: David Atkins of Congenica, Olivia Cavlan of Alchemab, and Deborah O’Neil of NovaBiotics. Jackie Hunter of BenevolentAI and Clare Terlouw of LifeArc were re-elected and will continue their tenure. The Board is a fantastic group from which a number of long-standing Directors will step down at the end of December - Kyriacos Mitrophanos, Keith Thompson and Sue Charles, who have brought distinct and valuable industry viewpoints. Jane Osbourn will also stand down having served since 2014 as a Director and having done two terms as the Chair. Finally, two people who have been stalwarts of the Board and the Executive Board Committee; serving as Directors with great distinction across nine years and three Board terms are also bowing out– Will West and Diana Sternfeld. Thank you all for your support.
BIA Advisory Committee Chairs meeting
It was a privilege to join Ruth McKernan and other members of the Board in a meeting with our Advisory Committee Chairs and Vice-Chairs last Friday to discuss strategic priorities for 2021. The BIA’s eight Advisory Committees are a community of experts who are at the heart of our ability to influence on behalf of biotech companies and the life sciences. Our Committees’ work informs and guides BIA policy and priorities, ensuring that member needs are met. I encourage members to get involved with our Committees,; you can find more details on our website here, including contact details for the Secretariats should you be interested in participating.
Brexit
Last week we hosted our latest Brexit Briefing webinar which focussed on the regulatory guidance for the end of transition and we were joined by the Chair of Regulatory Affairs Advisory Committee, Emma Du Four. You can now watch the webinar on our YouTube channel here. We are also regularly updating our Brexit Portal with guidance on the UK's future relationship with the EU for biotech businesses and the life sciences sector. Take a look here.
MHRA guidance for end of Brexit transition period
The Medicines and Healthcare products Regulatory Agency (MHRA) published last week updated guidance for the end of the Brexit transition period, adding information about Northern Ireland. This follows MHRA engagement with the BIA and the wider sector to identify any issues with the first batch of guidance issued on 1 September. Specifically, there is greater clarity on supplying medicines to Northern Ireland from 1 January 2021 and on how manufacturers and wholesalers can use Article 41 of the Withdrawal Agreement to sell medicines already placed on the market before the end of the transition period. The updated guidance can be accessed in the importing and exporting section of the MHRA collection of guidance for industry from 1 January 2021.
Today, the MHRA added to its collection a letter on the Conversion of Community Marketing Authorisations (CAPs) to Great Britain Marketing Authorisations (MAs), which was emailed on 23 October to all Community MA holders, providing guidance on the conversion process for the continued authorisation of medicinal products at the end of the transition period.
Brexit BEIS Life Sciences Support Webinar
BEIS is hosting a webinar specifically aimed at the life sciences sector. The webinar is taking place at 11am on Tuesday 27 October and will provide information on the actions to take to prepare your business for the new arrangements from 1 January 2021. Register here.
Brexit -Sign up for more information
The Department of Health and Social care has an invitation-only eXchange platform which is used to host guidance, webinars and other end-of-transition related resources. The Office for Life Sciences also has a weekly bulletin which highlights new and updated transition and COVID-19 guidance. If you would like to sign up to either of these resources then please email Tim Windle at [email protected].
DIT UK-Gulf Joint Trade & Investment Review – Life Science survey
The Department for International Trade is conducting a Joint Trade and Investment Review with the Gulf Cooperation Council. One of their priority sectors for the review is life sciences. There is a survey which life sciences companies are asked to complete here.
COVID-19 developments
It was promising to hear that a new analysis of the Oxford/AstraZeneca vaccine (AZD1222) undertaken by scientists at Bristol University provides greater evidence that the vaccine works. The new method of analysis allowed scientists to check that the vaccine was properly designed to replicate the parts of the COVID-19 make-up needed to train the immune system, to fight the disease.
BIA members continue to be at the forefront of COVID-19 solutions and last week Oxford Immunotec was selected to provide their innovative T cell testing technology to the UK Vaccines Taskforce. Immunotec’s T-SPOT® technology will assess the immunogenicity of COVID-19 vaccines and to assist in the continued discovery of the role that T cells play in the response and immunity to the virus.
The world’s first ‘human challenge’ trials of a COVID-19 vaccine are planned to take place in the UK early next year, with an initial £33.6m of government funding invested in a partnership between Imperial College London, hVIVO, and the Royal Free London NHS Foundation Trust. The aim is to speed up vaccine development by infecting participants with coronavirus in a secure clinic, a month or so after vaccination. As with all clinical studies in the UK, the proposed research will be carefully considered by regulators including the MHRA and the NHS Health Research Authority.
We are also starting to see outcomes of other COVID-19 therapeutics. Gilead’s remdesivir has received full approval from the US Food and Drug Administration (FDA) to treat Covid-19 patients in hospitals. However, less positive news has come from an analysis of COVID-19 blood plasma therapy.
Secondment Opportunity at Government Office for Science on Covid modelling
The Government Office for Science (GO-Science) is hoping to identify professionals with relevant skills who can be seconded to support GO-Science and work as embedded academics within the evidence teams who support the subgroups of SAGE. Vacancies exist for a scientist to support the GO-Science COVID-19 Response Team in each of the following areas: Behaviours team, Health and Clinical team & Modelling and Interventions team. Interested candidates should send an email entitled ‘Application for role in (add name of team)’ to [email protected]; and include a CV and a one-page statement of suitability, to be received by 6pm Friday 6 November 2020.
Upcoming BIA events
Our next Women in Biotech networking event is coming up this November, usually we would be heading up to Manchester but instead we will be meeting virtually to hear from some inspiring women in our sector based in the North West. Our speakers include Lisa Anson of Redx Pharma and Bhavna Hunjan of C4X Discovery. Find out more and register here.
In December we will be holding the 17th Annual bioProcessUK Conference. The programme will follow the same format we had in previous years and include informative talks, awards, student poster competition and networking. There will be virtual exhibitors’ stands, as well as a one-to-one meeting scheduling tool. We have put together a beer tasting experience for the evening of the 1 December and we are arranging for attendees to receive a small food hamper right to their doorstep! Have a look at the programme and sign up here.
The bioProcessUK Conference runs a popular Bursary Poster Competition where approximately 25-30 high calibre postgraduate students and post-doctoral researchers have an opportunity to display a poster, showcasing their research in biological medicines and bioprocessing. The deadline for applications has been moved to 30 October 2020, find out more here.
Best,
Steve Bates OBE
What does your role at BIA involve?
Steve Bates is the CEO of the UK Bioindustry Association, the UK’s Trade Association for innovative life science companies with over 550 members. Steve is the visible face of the vibrant UK life sciences industry to government and media. He serves on the UK Government’s Life Sciences Council and the UK Biosecurity Leadership Council. Steve was a founder member of the UK Government’s Vaccine Taskforce in the Covid crisis, sitting on its steering Board alongside Kate Bingham. He is active member and former chair the International Council of Biotech Associations and has been a board member of EuropaBio since 2015.
Previous experience & achievements
Steve has championed, with government, effective industrial incentives like the Biomedical Catalyst, which have crowded in private sector investment into UK SMEs. He is a driving force behind the scale up agenda, spearheading policy agenda to unlock UK pension fund capital into productive UK growth in life sciences. He has forged several links for the sector across the USA, Europe and in China. In his time at the BIA, Steve has developed new member groups focused on cell and gene therapy, genomics and engineered biology. A strong advocate of partnership working, Steve champions sector collaboration with research charities and academia. Proud to lead an organisation with a diverse Board with over 40% female representation, Steve is committed to next generation talent and developing the skills needed for the sector to flourish. Before joining the BIA in 2012, Steve worked for Genzyme and was advisor to the UK Government of Tony Blair working on NHS reform and the Northern Ireland peace process. He was made OBE for services to innovation in 2017 and became a Fellow of the Academy of Medical Science in 2020.