CEO Update Monday 5 March 2018

On Friday the Prime Minister announced that the UK will seek to explore with the EU, the terms on which the UK could remain part the European Medicines Agency, abide by the rules of the agency and make an appropriate financial contribution. It’s good to see the PM articulating  the practical dynamics of our industry of the future, when she said in her speech that ‘membership of the European Medicines Agency would mean investment in new innovative medicines continuing in the UK, and it would mean these medicines getting to patients faster as firms prioritise larger markets when they start the lengthy process of seeking authorisations.’                        

Her language reflects the work that the BIA has undertaken on regulatory cooperation since before the referendum, as well as the desire of patient, NHS Confederation and European coalitions. The PM also stated that it would also be good for the EU because the UK regulator assesses more new medicines than any other member state.                

The speech also covered trade issues around medicines and recognised the importance of ‘ensuring that these products only need to undergo one series of approvals, in one country.’ The PM has also listened to BIA members who have consistently made the case that ‘it is strongly in their interest to have a single set of regulatory standards that mean they can sell into the UK and EU markets.’ There is much work to be done but this is a positive step forward on the future of medicines regulation. You can read more on the BIA’s reaction to the speech on our website.         

Back at base, we’re gearing up for a jam-packed week of events. Our inaugural Chief Medical Officer Summit is taking place as we speak at the Wellcome Collection in London, and is addressing the unique challenges associated with managing Medical Affairs functions with limited resources.

Tomorrow we’ve got the launch of PULSE (Programme for Up and coming Life Sciences Entrepreneurs), our new three-day leadership and entrepreneurship training programme held at the Francis Crick Institute, aimed at aspiring entrepreneurs and new CEOs looking for advanced practical advice, support and feedback from industry leaders.

Then on Thursday it’s International Women’s Day, and we’ll be marking the occasion by holding our first Women in Biotech Networking Evening of 2018, kindly hosted by Instinctif Partners. Women from across the sector will enjoy an evening of networking and thought-provoking presentations from our guest speakers. Professor Joanne Hackett and Dr Jelena Aleksic will explore developments and opportunities in the UK’s genomics industry, focusing of the challenges of data protection and implications for the NHS. 

We’ll be rounding off the week with our Friday webinar: ‘How to communicate your R&D to investors and the public’ covering the key elements of our recently published best practice communications guide, developed in collaboration with Consilium Strategic Communications, Instinctif Partners and Simmons & Simmons. Register here.

In other sector events news, if you’re a Birmingham-based organisation or will be in the area on Friday 9^th March, I’d encourage you to register for an interesting conference being put on by Prosperity UK: "Developing smart approaches so that UK Life Sciences thrive after Brexit", to be held at the Institute for Translational Medicine. They have an impressive line-up of practitioners, policy-makers and investors who’ll be leading plenary sessions and working groups, so its definitely not one to miss.

Also this week, the BIA will be hosting a roundtable with former Life Sciences Minister Lord Prior and other key stakeholders to discuss and debate the extent to which the government has delivered on the ambition and aims of the Accelerated Access Review. It promises to be a great event that can help highlight current challenges and opportunities. The event is timely as the newly established Accelerated Access Collaborative is seeking nominations for an early selection of transformative products that it can start to work with. There is at present no detailed and publicly available information on the criteria for transformative products that the AAC may support. However, we have been made aware that to get the AAC off the ground, the AAC wishes to make an early selection of a number of transformational products that it can start to work with.

For this first tranche of products, the AAC wishes to focus only on those that have an established and mature evidence base and are already on the market in the UK. It will focus on transformative products where uptake and patient access is seen as challenging, despite positive NICE or other relevant guidance being in place. The deadline for companies to put forward products that they feel meet this criteria and which they would like considered by the AAC is tight – this Friday 9 March. If this is of interest, please get in touch with Rachael Mann at [email protected] who can provide further information. We understand that subsequent tranches will consider products in earlier development. As the BIA has stated time and again, it is absolutely vital that the original vision of the AAR is realised and we will be making this point both at our event this week but on an ongoing basis as the parameters of the AAC are further defined.

In finance news, Innovate UK will be holding a series of briefing events across the country throughout March on their £10m manufacturing and materials readiness Innovation Loans competition. Innovation loans are still very new, so these briefing events are a great opportunity to find out more about them.

And finally, a BIA team is training hard for their upcoming ‘Tough Mudder’ challenge to raise money for Parkinson’s UK, our 2018 Charity of the Year. Please do give generously if you can.

Best,

Steve