Launch of BIA regenerative medicines booklet for investors

It was great to see so many members in Vienna last week at BIO Europe and at the ambassadors breakfast. I was delighted to be able to discuss some great ideas for our life science manifesto and do the European launch our new booklet, “Realise Returns from the UK’s regenerative medicine and cell therapy industry“, which shows why the UK is the must-go-to location for regenerative medicine research and development. Our launch event at the Cell Therapy Catapult (pictured above) discussed how the UK regenerative medicines sector is reaching the inflection point between spirited pioneering and true commercialisation, so there are opportunities for investors as the UK leads the world in healthcare, finance and stem cell R&D. The integration of these major assets, combined with robust government support for regenerative medicine, makes the UK the prime location to invest in cell therapy as it rapidly grows into a multibillion pound sector on a par with pharma and biotech.

Its certainly proving to be a busy month of travel as hot on the heels of a successful mission to Ausbiotech, BIA and UKTI are leading a mission to China this week including the BIO Convention in China and I’ll be joining the UK’s first ever synthetic biology mission to SynbioBeta in San Francisco.

Our Head of Regulatory Affairs Christiane Abouzeid took part in the Workshop on Biosimilars organised by the European Medicines Agency (EMA) on the revision of three overarching guidelines on similar biological medicinal products. It brought together 200 delegates from across the EU and other regions, to hear the views from both regulators and innovator and biosimilar industry. The BIA submitted comments on the draft revised guideline highlighting that the evaluation of biosimilar medicines should be subject to the same scientifically robust regulatory standards that are applied to the innovator product in order to ensure that patient safety is not compromised.

Here at home last week, the Department of Health and the Association of the British Pharmaceutical Industry (ABPI) published their heads of agreement for the new voluntary Pharmaceutical Price Regulation Scheme (PPRS) and the government’s statutory scheme, alongside significant announcements from Shire and Novartis. Although the fundamentals of the UK sector are strong, and schemes like the patent box and biomedical catalyst help encourage investment here, I fear this agreement will stifle life sciences investment in the UK. The deal shows a worrying lack of joined-up thinking about a key sector for the UK’s future economic growth.

We have repeatedly warned that the government’s pricing proposals for pharmaceuticals put at risk future investment in the UK R&D base, as the perception of the UK as a market for innovative products has an important bearing on the global investment decisions of multinational biopharmaceutical companies. So, it is extremely disappointing to see that the Department of Health “believes there is no reason to expect that changes in UK prices would significantly affect the UK’s attractiveness as a location for R&D”. I will provide further briefing on this to members in the coming weeks and would be keen to hear from any affected by the announcement.

Last year the BIA was one of more than 40 organisations involved with life science in the UK to sign a Declaration on Openness on Animal Research. We are now involved in developing a concordat that sets how organisations will be more open about the ways in which they use animals in scientific, medical or veterinary research in the UK. Understanding Animal Research is now seeking comments from the public on the concordat and I would encourage you to complete their questionnaire. If the work of your organisation involves research using animals or might do in the future, either directly or indirectly, it is important to make sure your voice is heard. The BIA is well placed to feed your views into working groups on this topic, so if you would like your organisation’s interests to be represented please contact Zoe Freeman.

Finally, I am delighted to say that we have chosen Fight for Sight as our supported charity for 2014. Fight for Sight is a charity committed to using research to make a difference to people’s lives and I have written a blog to explain in more detail why we chose to support them. The first event for the partnership will be the BIA’s flagship Gala Dinner on 30 January 2014, for which more than 500 guests are already registered.

Best
Steve