CEO Update - 9 October 2023
Dispatches from the party conferences
I’m writing this week’s newscast from the Labour Party conference in Liverpool, where life sciences have already made an appearance in Shadow Chancellor Rachel Reeves’s keynote speech.
BIA is taking a keen interest in each of the party political conferences this year and hosted an excellent fringe event with Science Minister George Freeman at the Conservative Party conference last week, focusing on the exciting role engineering biology can play in reaching Net Zero.
BIA panel at Conservative Party Conference featuring (L-R): Dr Virginia Corless (moa Technology), Science Minister George Freeman, Anna Dickinson (Onward) & Insiya Jafferjee (Shellworks)
The Future of UK Regulation Conference
The MHRA’s summer backlog has been cleared and clinical trial recruitment, including commercial clinical trial recruitment, is significantly up and even ahead of pre-pandemic levels. Just some of the key insights I gleaned from our excellent regulatory conference last week.
We will be publishing detailed blogs summarising the content in the coming weeks but thank you to all who came and contributed. It was fantastic to see regulators not just from the UK, but around the world engaged and discussing the future of regulatory innovation with BIA members, both from the podium and over coffee.
L-R: Steve Bates OBE, CEO, BIA, Dr June Raine DBE, CEO, MHRA, Dr Jörg Schläpfer, Head of Management Services and International Affairs, Swissmedic, Shannon Thor, Deputy Director of the Europe Office, FDA, Julian Beach, Interim Executive Director of Healthcare Quality and Access, MHRA.
mRNA Revolution report publication and RNA Conference
It was a privilege to attend the Imperial College London and CPI-organised RNA Vaccines and Therapeutics conference at the Royal Academy of Engineering last week. A packed hall, despite rail strikes, heard the latest on the scientific developments in this key technology, as well as the biomanufacturing and scaleup challenges that will be crucial for the future of this industrial segment. I hope the mRNA Revolution: A New Generation of Medicine report helps to develop a broader understanding of the UK’s capability in this crucial technology which, although famous for COVID-19 vaccines, is applicable far more widely.
Orchard Therapeutics sale and Brandon Capital fundraising
It’s good to see sector news, continuing to flow at pace. Congratulations to Orchard Therapeutics on the acquisition by Kyowa Kirin to accelerate MPS pipeline and early research programs, including a severe form of Crohn's disease and frontotemporal dementia (FTD). At an earlier stage, I’m delighted to see member company AstronauTx sealing their £48 million Series A with Brandon Capital amongst other investors to create new treatments for Alzheimer’s disease.
Next step EU law
Last week important staging post was reached as the ENVI Committee produced their draft reports on the revision of the EU Pharmaceutical Legislation. Overall, the draft report has improved the text compared to the original document issued in April but there is still a long journey for it to be adopted as EU law. If you are following the details, major changes have been made to Regulatory Data Protection (RDP) (AM 8-14-16-20-21-104-105-106-107): baseline at 9 years from date of MA, +12 months if medicine addresses an unmet medical need +6 months for a comparative clinical trial. (No change to other modulation numbers, namely +1-year RDP per new indication and 2 years of market protection. Launch conditionality (AM 88-89-108): removed, replaced by an obligation to apply.
EU law matters to UK-based life sciences companies not only because it is a major market, but also because of the potential for dynamic divergence between UK and EU positions. We continue to engage with Brussels-based policymakers via EuropaBio to monitor and address this issue.
Response to DSIT consultation on engineering biology
In response to the Department for Science, Innovation and Technology's (DSIT) consultation on Engineering Biology, BIA has welcomed the opportunity to shape the development of the UK's engineering biology policy. We called for more cooperation between government, academia, industry, investors, and other stakeholders to create a coherent narrative around engineering biology in the UK, to drive commercial uptake and shape public perception, and to position engineering biology as a solution to global sustainability and health challenges. Overall, BIA asked for more Government support to foster the growth of new companies and to incentivise existing industry to embrace engineering biology.
Board elections
If your company hasn’t yet used its members' vote in the BIA Board elections, can I encourage you to do so as the deadline is fast approaching? Once again it has been humbling to see the range of talented individuals who have put themselves forward to stand and help move our association forward. Do check out the candidates and their statements.
Have a good week.
Steve Bates OBE
CEO, BioIndustry Association
