This week the UK’s Ministerial Industry Strategy Group (MISG) meets. It’s a high-level policy advisory group, which meets twice a year and upon which the BIA sits with Ministers from BIS, Treasury and the Department of Health. It aims to promote a strong and profitable UK-based bio-pharmaceutical industry capable of sustained research. I’ll be championing the needs of our members as always, and for the first time in years a paper on the UK’s important biopharma manufacturing capabilities has been prepared and will be discussed. I’ll update next week on progress.
It’s timely because next week the 10th Annual bioProcessUK Conference ‘Biopharmaceutical Innovation, a Vision for the Future’ will take place in London. Delegates at this event, which is now fully booked, will hear about how companies innovate to improve their global competitiveness in biopharmaceuticals, as well as understanding future bioprocessing needs, and more. If you’re there, do stop me to say hello.
Last Friday in an unusual move the UK government announced that it plans to hold a public consultation on what was until now a private members Medical Innovation Bill. The bill promoted by Lord Saatchi seeks to encourage innovation in the medical treatment of patients by reducing the risk of litigation for doctors who try an alternative treatment option. Currently, the law obliges doctors to follow standard procedures, which means that new discoveries can only be tested with a risk of being charged with medical negligence. Now there is a public consultation on the proposal in early 2014, so the BIA will be feeding in views. Together with the recent call from the Experts Group for healthcare regulation that government implement an Earlier Access to medicines Scheme, there are positive signs that making UK healthcare more innovation-friendly is on the political agenda.
The Genesis conference is now only a couple of weeks away, on Thursday 12 December. Our partners One Nucleus are focusing on ‘Innovative Strategies to Bridge the R&D Gap in Life Sciences’. BIA members receive a 10% discount on the non member delegate rate.
Finally, last week saw some sad news in the passing of two-time Nobel prize winner Frederick Sanger (pictured above), at the age of 95. As the so-called ‘father of genomics’ and the namesake of the Wellcome Trust Sanger Institute, Sanger’s work – entirely done in the UK – was instrumental in the modern revolution in understanding of genetics and genomics which underpins the biotechnology sector today.
Last week I joined the UK’s first ever Synthetic Biology Trade Mission to San Francisco and the Bay area. It’s thanks to the BIA that UKTI supported this mission and it’s great to see our emerging companies making contact with and doing business with Californian counterparts. The UK roadmap in synbio is attracting real interest in the USA and we are perceived as a UK community – academic, policy and business – to be well positioned and on a roll. The photo above shows the UK group at Agilent Technologies. A highlight was meeting Steve Jurveston of DFJ Venture (the man who backed Tesla electric cars) who is a keen supporter of the sector. I’m also delighted that the next SynBioBeta conference will be in London next April so we’ll be able to both host the global synbio community and showcase UK companies.
We submitted our Autumn Statement submission to HM Treasury last week. It reflects the needs of our member companies and calls on the government to consider introducing Citizens’ Innovation Funds (CIFs), implement a properly funded Earlier Access to medicines Scheme (EAS), and to work towards improving access to the public markets by bioscience companies. The government will announce its Autumn Statement on 5 December. In fact, urging government to launch an Early Access to Medicines Scheme as soon as possible was the number one recommendation of the Report of the Expert Group on Innovation in the Regulation of Healthcare, which was published on Friday by the MHRA. The Expert Group, on which the BIA’s Christiane Abouzeid has been working hard, was set up following the Prime Minister’s 2011 Strategy for UK Life Sciences.
I was delighted to see last week that AstraZeneca would be making a £120 million commitment to medicines manufacturing in the UK. The commitment comes at a time when other companies have reduced their UK capabilities and is particularly timely as next week the results of a project looking at how the government and industry can work together to enhance the medicines manufacturing landscape in the UK will be presented to the Ministerial Industry Strategy Group. Our Manufacturing Advisory Committee has been highly engaged in the process and I believe the recommendations of the project working group will lead to a stronger medicines manufacturing industry in the UK.
Finally, later today (Monday at 16.10 and repeated at 17.40) I will be on the RNIB’s Insight Radio talking about why the BIA chose Fight for Sight as its charity partner for 2014. Do take a few minutes to listen in.
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.
On Tuesday 22 October a free BIA workshop – ‘Voluntary Harmonisation Procedure for multinational clinical trials in Europe and perspectives for the future‘ – brought together senior experts from regulatory agencies and professionals from industry, contract research organisations, academic institutions/clinical trial units and medical research charities to share their experience of the Voluntary Harmonisation Procedure (VHP).
The VHP delivers significant benefits for the conduct of multinational clinical trials in Europe, and the event – which was kindly supported by Pfizer and hosted by law firm Taylor Wessing – was evidently timely given the interest from the life sciences community, as well as the important improvements to the VHP process which have been introduced by the Clinical Trials Facilitation Group (CTFG), a working group of the EU Heads of Medicines Agencies.
Read more about the day and view the presentations to discover the background of the VHP and hear views from clinical trials sponsors.
The BIA has chosen Fight for Sight as its supported charity next year.
Fight for Sight, may not have the profile that some of the charities we have worked with in the past have, but I believe that its dedication to funding pioneering research to prevent sight loss and treat eye disease fits well with the goals of the BIA membership.
There are almost 1 million people – from children with inherited blindness to adults with age-related macular degeneration (AMD) – in the UK alone living with sight loss that can’t be avoided. This number is set to double, as we live longer, by 2050.
Fight for Sight’s mission is to fund pioneering research to prevent sight loss and treat eye disease. Its current research programme covers common conditions including AMD, glaucoma, cataract, diabetic retinopathy, corneal disease and trachoma, as well as inherited eye diseases, childhood eye conditions and rare eye diseases. This pioneering research is being conducted by research groups attached to 28 universities and hospitals across the UK.
Fight for Sight has been responsible for:
- key research helping save the sight of premature babies
- establishing the UK Corneal Transplant Service enabling 52,000 corneal transplants to take place
- supporting the research team responsible for the world’s first clinical trials for gene therapy to treat Leber’s congenital amaurosis (an inherited retinal disorder)
- funding the research leading to the world’s first clinical trial for choroideremia (an inherited retinal disorder)
- funding the research team that identified a new gene involved in the development of keratoconus (a degenerative disease of the cornea that causes the cornea to thin and change in shape)
- research leading to more effective treatment for children with amblyopia (lazy-eye)
I hope that by being our supported charity in 2014, Fight for Sight will not only benefit from our fundraising activities, but also from a partnership with us which I hope will:
- raise the profile of the charity as the main charity in the UK funding eye research
- showcase their research to BIA members potentially leading to relationships developing for mutual benefit
- share the results of its consultation of patients and eye health professionals for research priorities with BIA members
- allow BIA members to share their expertise to help develop Fight for Sight’s research strategy
The first event for our partnership with Fight for Sight will be our flagship Gala Dinner on 30 January 2014, for which more than 500 guests are already registered.
A number of our members supported Fight for Sight’s application to work with us in 2014:
“Fight for Sight relies on voluntary donations to support medical research into a wide range of eye conditions. It is so important that we support research into sight loss, a growing and little known problem that currently affects one in nine people over 60. By funding research at ground level we can provide a better understanding of the causes of eye diseases and ultimately develop new treatments.”
Susan Searle ex-CEO, Imperial Innovations and Trustee, Fight for Sight
“As the largest UK eye research charity, Fight for Sight plays a key role in supporting pioneering treatments which can improve the lives of millions of people. We, at Oxford BioMedica, know first-hand how important it is to develop new treatments for macular degeneration, glaucoma and childhood blindness. We are committed to finding new weapons to fight blindness, and determined to help people see. And we commend our industry colleagues, clinicians and organisations like Fight for Sight who are doing the same.”
Lara Mott, Head of Corporate Communications, Oxford BioMedica
“The research that Fight for Sight funds will ultimately improve the quality of life and range of treatments for people with sight loss, as well as ensuring that visual impairment isn’t an inevitability for many people who otherwise may have lost their sight. Through the wide range of interesting and challenging fundraising events available, in which I am delighted to have participated in a personal capacity, Fight for Sight’s supporters are helping to change the prospects of future generations. As a charity that relies solely on donations, Fight for Sight must continue to receive support in order to carry on this pioneering research.”
Sanjay Jawa, COO Europe, Middle East and Africa, FTI Consulting
“Eye disease is something that everybody will come across at some point in their lives, directly or indirectly, and because of this Fight for Sight is such an important charity to support.”
Deborah Harland, Partner, SR One
“The development of new therapies, including cell based therapies, for eye diseases is increasingly important and Fight for Sight is a leader in supporting research in this area. At the Cell Therapy Catapult we identified this as an important sector with high potential for the early success that will lead the industry forward.”
Matthew Durdy, Chief Business Officer, The Cell Therapy Catapult
“Fight for Sight is helping to keep eye research at the forefront of people’s minds, as well as giving hope to people with sight loss.”
Kate Bingham, Managing Partner, SV Life Sciences
I look forward to working with them all in our partnership with Fight for Sight in 2014.
Last week, following our Board meeting, I was pleased to announce that the BIA will not be increasing its membership fees for 2014. As we approach our 25th anniversary in 2014, I am able to report that the BIA is in a robust financial position and has sufficient reserves to ensure that we will continue to represent members’ interests in the years ahead. Our Board members understand that the business environment continues to be challenging, and as a result of members’ feedback we have chosen not to increase membership fees over the next 12 months.
George Freeman MP has stepped down as the life sciences advisor to the government. George has been a tremendous supporter for our sector over the last couple of years and our engagement with him on our campaign to re-fund the Biomedical Catalyst earlier this year paid dividends. George will be continuing as a life sciences champion alongside Chris Brimsmead and John Bell and we will continue to engage with him in this role.
In funding news last week it was good to see Polar Capital launching a new global biotech fund – the task now is to ensure UK based companies are well represented. We also learned that the Rainbow Seed Fund will be establishing a £10 million seed fund for synthetic biology.
Following a successful week for the UK delegation at AusBiotech 2013, this week Alastair Carrington and I will be supporting the UK delegation to BioEurope in Vienna, led by Biopartner UK. I look forward to seeing many of you there.