CEO Update|Monday 19 October

It’s our Annual General Meeting this week which you can join on Zoom and I’m expecting a big week for Brexit.

Thank you to members who stood for and voted in our Board election in recent weeks. The results will be announced at our first virtual AGM this Wednesday and I invite all members to join. For the full meeting details and password, please email Nick Gardiner [email protected] He will also be circulating these details to all main members shortly.

I’ll also review the work the BIA has done over the past year, which has been an incredibly busy one. Our latest quarterly report, published today, is a great summary of all the work the team has been doing on your behalf, which you can read here.

 

Brexit update

Our next Brexit Briefing webinar is taking place this Thursday and you can register to join us here. The last week has been one of deadlines. The European Council concluded its meeting on 15 October. This was the deadline set by the Prime Minister for an agreement with the EU, and so on 16 October the Prime Minister’s spokesperson announced that trade talks with the EU are over. However, the Prime Minister’s exact words were that talks would not continue unless there was a ‘fundamental change of approach’ and Michael Gove suggested the door remains ‘ajar’ on re-engagement. The UK’s Chief Negotiator, David Frost, suggested on Friday that there was no need for the EU’s Chief Negotiator, Michel Barnier, to come to London this week for further talks. However, a call is taking place this afternoon to discuss the structure of future talks.

The Government has launched a new ‘time is running out’ campaign to encourage businesses to prepare for the end of transition on 1 January 2021. Regardless of whether or not a deal is agreed, there will be additional checks and paperwork for businesses trading with Europe. The Government’s website specifically urges businesses to prepare for ‘Australia-style arrangements’. We will discuss these further on our webinar.

The Department for Transport has announced it has procured Government-Secured Freight Capacity (GSFC) away from areas of potential border disruption. Medicines are considered category one goods and so will be able to access this freight capacity. You are urged to register to access this capacity. Information on ticketing will be published in the week commencing 16 November.

We have a meeting with Ministers this Friday regarding preparations for the end of transition, so I am particularly keen to ensure I’ve correctly captured members views on the evolving situation this week.

 

UK Bioscience Forum reflection

Thank you to all who attended our premier conference, the UK Bioscience Forum last week, with its focus on novel data technologies changing our industry and the businesses which are leading those changes. The keynotes from Professor Dame Ottoline Leyser, Chief Executive of UKRI, and former Prime Minister, Tony Blair, stay strong in my mind for both the clarity of vision on COVID-19 and a systems approach to research and innovation. I also learnt much from the panel on diversity in data for drug discovery and clinical applications, which was incredibly thought-provoking and was, I know appreciated by many members.

For more information on the work of the Tony Blair Institute for Global Change we encourage members to read these papers and if you would like to discuss further, please contact the Institute’s Strategic Advisor, Ryan Wain on [email protected]

Next up for us as the BIA continues to put on sector-leading events, is our bioProcess UK conference in December, where you will hear first-hand the extraordinary story of our manufacturing community’s efforts to support COVID-19 vaccines and therapeutics. Please sign up here.

 

COVID-19 developments

Last week we saw several announcements of increased local restrictions across the UK with a new system of tiers for particular areas in England, as COVID-19 testing and hospitalisations continue to increase.

Vaccine development continues which led to headlines last week on the pause of the Johnson & Johnson clinical trials. This news, like the AstraZeneca pause in their vaccine trials a few months ago, shows me the robustness of our regulatory processes that enable issues like this to be identified early. As we know, pauses like this are routine in drug discovery and development. I remain optimistic that 2021 will see significant deployment of COVID-19 vaccines into the UK but this remains a long journey with no doubt more twists and turns ahead.

I was also heartened to hear the story of how some of the innovations in COVID-19 testing technologies are moving ahead and would flag this Radio 4 programme ‘ The World this Weekend’ from Sunday looking at LAMP technology development, well worth a listen. The recording can be found here (discussion starts 6 minutes in).

 

UK international cooperation with Australia, Canada, Singapore and Switzerland regulators

The MHRA is building international collaborations and announced last week that it is joining the work-sharing Australia-Canada-Singapore-Switzerland (ACSS) Consortium, which will now be known as the Access Consortium which will bring timely access to medicines to a larger population of approximately 145 million. The MHRA will begin working with Consortium partners as a full member from 1 January 2021, with a period of shadowing during the remaining Brexit transition period. An updated guidance for biopharmaceutical companies on how to apply to have products considered for marketing authorisation across the five member countries is expected for January 2021.

This initiative announced on 14 October comes one week after the Health Secretary's announcement that the MHRA will join US FDA-led Project Orbis which focuses on innovative cancer medicines. Dr June Raine, MHRA Chief Executive, said: "We are committed to working together to ensure that UK patients are among the first to benefit from promising life-saving treatments. Through our commitment to international cooperation and innovation in regulation, the MHRA continues to be at the forefront of new developments as a global hub for life sciences."

 

Member news

It was fantastic to see BIA member, Ori Biotech announce the successful close of a $30 million Series A financing round, bringing the company’s total funding to date to $41 million. The new funding will be used to help bring Ori’s innovative manufacturing platform to the market. The Ori platform delivers scalable solutions to flexibly address the critical clinical and commercial manufacturing needs of cell and gene therapy (CGT) developers.

BIA member NovaBiotics has secured £1m in funding from Innovate UK as part of NIHR’s ‘Call for ideas to address COVID-19’. The funding will be used to support the clinical development of Nylexa for COVID-19. Nylexa targets both the infection and hyperinflammation and acts against bacterial lung infections that, in some cases, can occur in COVID-19 patients. The ingredients of the treatment should also make it easily scalable in the near-term. Nylexa will now proceed directly into phase 2 clinical studies and is being considered for inclusion into global platform trials.

 

Trinity Challenge

 Trinity Challenge, led by Dame Sally Davies, officially launched last week, which aims to better protect the world against health emergencies. The challenge focuses on generating, identifying and recognising insights through data and analytics. To be accepted into the challenge, all applicants will have to provide ideas and concepts addressing at least one of three areas: better identification, better response and better recovery. More information can be found here.

 

Academy of Medical Sciences COVID-19 database

The Academy of Medical Sciences has launched a new resource for early stage UK COVID-19 preclinical therapeutics research, to boost collaboration and map the preclinical discovery landscape. The project asks researchers from across academia and industry to submit their research projects through a short online form and will publish the results through an open access database on their website. For more information, please visit the website.

 

IVD Regulation Survey

Innovate UK has commissioned a survey to understand the how the EU IVD Regulation (IVDR) will impact on diagnostics companies.  This is an opportunity for you to provide feedback to Innovate UK to enable them to develop support mechanisms for the industry (if needed) associated with implementation of the IVDR. The deadline for completion of the survey is 6 November. No company-specific information will be divulged, and the findings will be shared with the participants. More can be found here.

 

BIO-EUROPE

BIO-EUROPE is taking place virtually later this month and BIA members can receive 15% off their ticket if purchased through BioPartner. Find out more here. BIO-EUROPE is a great opportunity to identify new business opportunities and develop strategic relationships.

 

Next week, SynbiTECH 2020 is going virtual. The conference will focus on the greatest opportunities and challenges for building a multibillion-dollar syn bio industry that will contribute to the fast-growing bioeconomy. BIA has a thriving syn bio community and is sponsoring the conference. For more info and to sign up, see here.

Best,

 Steve Bates OBE

Steve Bates OBE

Chief Executive Officer