Archives for the month of: October, 2016


This week: BIA Q3 report – A Brexit special, bioprocess awards and a Royal Celebration of our Charity partner JDRF turning 30

This month we are working hard with member experts and the government to prepare documents that will inform the next round of life science industry Ministerial meetings due at the end of the month, building on the work we’ve done in the summer on regulation, trade, people and finance for the sector. Our latest quarterly update, Influencing and shaping our sector: BIA update July – October 2016, is now available to download and gives a great update on the detail we are focused on. Unsurprisingly it’s a Brexit special this time but also covers key developments and BIA activities in the policy, public affairs and regulatory landscape.

In this edition we have provided a key section focusing on Theresa May’s Government, Industrial Strategy and Brexit, and we also celebrate the Chancellor’s commitment to re-fill the Biomedical Catalyst scheme – a very welcome result after years of advocacy by BIA and our members. Do take the time to have a look through the document, it provides a great summary of some of the key areas we’ve been working on over the past few months – and there are quite a few!

Also covered briefly in the update is the Health Service Medical Supplies (Costs) Bill. The Government is introducing legislation to give new powers to the Secretary of State for Health to control prices of unbranded medicines sold by companies that are in the voluntary Pharmaceutical Price Regulation Scheme (PPRS). It will also allow them to gather more cost data from companies in the supply chain supplying the NHS.

The Bill had its first debate by MPs (2nd reading) on 24 October and was broadly supported by Labour and other parties. It will now be scrutinised in detail by a committee of MPs, who are requesting written evidence from the public and business. See the Parliament website for details on how to submit. You can also contact Martin at the BIA with your evidence to inform the BIA’s position.

In advance of the annual bioProcess UK Conference on 23-24 November, last week I was delighted to reveal the recipients of two awards to be presented at the conference. The seventh annual Peter Dunnill award for Outstanding Contribution to UK Bioprocessing will this year be presented to Professor Nigel Titchener-Hooker, Dean of the Faculty of Engineering Sciences at UCL. This year’s conference will also feature a new award for individuals or groups who are making an impact on the bioprocessing sector, entitled the Richard Wilson Impact Award named in honour of Richard Wilson, co-inventor of the Lonza GS system who passed away last year. The first winner of this award is Dr Tony Bradshaw, managing director of Bradshaw TM.

This year’s award winners have made huge contributions to our sector. Nigel has helped boost the profile of UK bioprocessing through his research partnerships that have bought together grant funding alongside industry and in-kind contributions. He is one of the key UK academics who has been willing and capable of significant industry engagement. Tony established the bioProcessUK conference when he worked with the BIA and KTN and it is testament to his hard work that this event – and crucially the culture he established – continues to flourish bringing together the top talent in UK bioprocessing. If you haven’t already registered, then there’s still time to join us and celebrate Nigel and Tony’s well-deserved awards. More details here.

November is a busy one for sector events, and kicking things off this week we have BioInfect at Alderley Park and the ARM EU Investor Day in London, at which I’ll be chairing a panel discussing how to build a successful environment for translating cell and gene therapies. Highlights to come next week.

Finally, I’d like to wish a happy 30th birthday to BIA’s charity of the year for 2016, JDRF, who celebrated in style last week at the London Guildhall in the presence of Her Royal Highness The Duchess of Cornwall. The Prime Minister Theresa May was there and I was delighted to be able to explain the BIA’s partnership with JDRF to her personally and thank her for her government’s continued support for our sector in general and for the biomedical catalyst in particular. For a flavour of the research the type one diabetes charity funds, watch our recently published video on their collaboration with BIA member Arecor, creating concentrated insulin.



Congratulations to our charity of the year JDRF who celebrated their 30th birthday this week!

Our video today explores the collaboration between JDRF and BIA member Arecor, who are working to develop concentrated insulin for use in the treatment of type one diabetes. Hear from Simon Vinnicombe, whose son George has type one, as he discusses the potential impact for patients.

Learn more about the ‘Celebrating UK Bioscience’ campaign here.

Do you have a video you would like the sector to see? Contact us.


The Government is introducing legislation to give new powers to the Secretary of State for Health to control prices of unbranded medicines sold by companies that are in the voluntary Pharmaceutical Price Regulation Scheme (PPRS). It will also allow them to gather more cost data from companies in the supply chain supplying the NHS. The Medical Supplies (Costs) Bill is being scrutinised by MPs who have requested written evidence on its potential impact.

What does the Bill do?

The Bill closes a loophole that currently means the Government is unable to regulate the price of unbranded medicines supplied to the NHS by companies in the voluntary PPRS.

Currently, any medicine not covered by the scheme (e.g. an unbranded generic medicine) is exempt from price controls if it is produced by a manufacturer that is a member of the PPRS. The Bill will make it possible for the Secretary of State to control the prices of these medicines through repayments or reducing the price directly, as it can do for companies in the statutory system.

It also amends existing legislation so that all pricing control powers apply to medical supplies as well as medicines. Medial supplies are defined as “surgical, dental and optical materials and equipment.”

Finally, the legislation gives new powers to the Secretary of State to request data from any company involved in the supply chain of medicines being sold to the NHS. The Government says this is to inform reimbursement payments to pharmacies and GPs and to determine if the NHS is getting value for money.

The BIA understands that the data collection requirements are not intended to apply to companies involved in the R&D of medicines but will seek more concrete assurances. The precise details of what data and what type of companies this will apply to will be set out in secondary legislation Regulations once the bill is passed by Parliament. The BIA is representing our members at meetings to discuss the Bill at the Department of Health and will be monitoring its passage through Parliament.

Why was this Bill introduced?

The Times reported in June 2016 that certain pharmaceutical companies were buying the production rights of medicines that were out of patent and producing and marketing them as unbranded generics. As they were the sole supplier, these companies were able to substantially increase prices, apparently by over 1000% in some cases. This was reported as costing the NHS an extra £262 million a year. The Bill is intended to prevent this from happening in the future. The Competition and Markets Authority has also launched an investigation.

What next?


The Bill had its first debate by MPs (2nd reading) on 24 October and was broadly supported by Labour and other parties. It will now be scrutinised in detail by a committee of MPs, who are requesting written evidence from the public and business. See the Parliament website for details on how to submit. You can also contact Martin at the BIA with your evidence to inform the BIA’s position.

The Bill is expected to receive Royal Assent in spring/summer 2017 subject to Parliamentary business. The Regulations will then also need to be produced, consulted on and Parliament given opportunity to object to them. It is therefore expected that changes will not be introduced until the 2017/18 financial year.

For more information you can read the Department of Health’s factsheet or a briefing produced by the House of Commons Library.

It was an action-packed conference season this year as each political party faced its own challenges and opportunities resulting from Brexit. The BIA attended four conferences to meet and influence policy makers at this critical time for our sector. Here we take a look back at the key speeches for life sciences, fringe events and private meetings that we attended.  

The Conservative Party


There was recognition of the importance of the life sciences to the UK’s future in speeches and events across the Conservative Party conference.

In her keynote address, the new Prime Minister, Theresa May, hinted that the life sciences would feature prominently in the new industrial strategy, saying “we will identify the sectors of the economy – financial services, yes, but life sciences, tech, aerospace, car manufacturing, the creative industries and many others – that are of strategic importance to our economy, and do everything we can to encourage, develop and support them.”

May’s sentiments were echoed by the former Life Sciences Minister, George Freeman, in fringe events, as well as senior figures in the new Government. David Davis, the new Secretary of State for Exiting the European Union, said that the UK is “a science superpower. A world leader in research and the arts. A trailblazer in biotech, in digital, in pharmaceuticals.”

More good news for the life sciences was formally announced by Philip Hammond MP in his first conference speech as Chancellor. In a sign that the Government is listening to the evidence put forward by the BIA and our members, he acknowledged that the Biomedical Catalyst was a “Government intervention that works” and committed £100 million to continue the scheme.

BIA members were able to put forward more evidence to policy makers at a private roundtable meeting that we hosted, with discussion focussed on how we can maintain the UK’s world-leading position in the life sciences after Brexit. As in previous years, the BIA partnered with the AMRC, BIVDA and ABPI and invited our members along with a range of stakeholders from academia and the NHS to meet with MPs and policy makers. We were joined by five Conservative MPs: Kit Malthouse, Chair of the APPG for Life Sciences; John Glen, Parliamentary Private Secretary to the Chancellor; Maggie Throup; Jo Churchill; and David Rutley. All were keen to hear about the opportunities and challenges of Brexit faced by our sector, and to discuss how they and the Government can help, including ensuring medicines regulation is high-up on the Brexit negotiation agenda, increasing access to finance, and using the NHS to drive progress through better uptake of innovation.

The BIA also met privately with Nicola Blackwood MP, the Health Minister with responsibility for NHS innovation and data, to discuss Brexit and the Accelerated Access Review, among other things.

The Labour Party


Fresh from re-election, the Labour leader Jeremy Corbyn used his conference speech to say that his party would raise UK R&D spending to 3% of GDP and launch its own Industrial Strategy review. Elsewhere, Labour’s Shadow Minister for Higher Education, Gordon Marsden, said that the reorganisation of Innovate UK and the Research Councils should be put on hold in light of the challenges created by Brexit.

At the roundtable hosted by the BIA with our partners, ex-university researcher and current member of the Commons Science & Technology Committee, Dr Roberta Blackman-Woods, spoke with BIA members about the value of international collaboration, international employees and the ability to conduct Europe-wide clinical trials, particularly for rare diseases.

The Scottish National Party

Up in Glasgow, all minds were firmly fixed on the future of Scotland’s relationship with the EU and the rest of the UK. SNP leader Nicola Sturgeon once again promised to hold a second Scottish referendum if she believes the Brexit deal struck by the UK Government doesn’t work for Scotland.

Sturgeon highlighted the life sciences as an industry in which Scotland excels and we met with a number of SNP MPs and Members of the Scottish Parliament keen to discuss how the sector could be strengthened and protected, as set out in the Transition Programme report produced by the BIA and ABPI over the summer.

The Liberal Democrats

At the Liberal Democrat conference, their EU spokesperson Nick Clegg emphasised that industry sectors need to make clear to the Government what their particular challenges and complexities of Brexit will be. He is producing a collection of ‘Brexit Challenge’ papers to help communicate some of the issues.



As trailed by Simon Stevens in his keynote address at our UK Bioscience Forum last Thursday, today saw the long-awaited publication of the final report from the Accelerated Access Review (AAR). The recommendations include a funded Early Access to Medicines Scheme (EAMS), for which the BIA has long advocated.

We welcome the Review’s recommendation for a funded EAMS for small and scaling companies, it’s a key step in making the UK a great location to clinically develop highly innovative therapies at pace. We now need to see a rapid response from the Government to fulfil these recommendations followed by a timely implementation from NHS England.

Click here to access the news from the Department of Health and download the report.

We had a fantastic event last Thursday at our annual UK Bioscience Forum – many thanks to all who came along, our speakers and supporters for making the day such a success.

The opening keynote speech from NHS England Chief Executive Simon Stevens set the scene for the day, emphasising the importance and shared public interest in the life science sector. UK bioscience plays a central role in developing the treatments needed for future generations here and around the globe, from investing in and carrying out research and development, to getting drugs from the lab and into patients. Industry news often focuses on finance and regulation and it’s vital that we stop and take a moment to remember and celebrate the fantastic work being undertaken within the sector.

With this in mind, the latest phase of our ‘Celebrating UK Bioscience’ campaign was launched at the UK Bioscience Forum last week. The aim of this campaign is to showcase the great work taking place in the sector – focusing on the potential human benefits of treatments that are currently in research and development – and to bring a greater understanding of the UK biotechnology sector to new audiences. A series of videos and infographics accompany the report, which explore behind the scenes in the labs of some of our members to see what they are researching and developing and the possible patient benefits these treatments could have in the future. The campaign takes a look at five treatment areas: cancer, antimicrobial resistance, type one diabetes, dementia and Duchenne muscular dystrophy.

The videos, played throughout the Forum, contain first-hand insights from patients and their families who have shared their personal stories and what they hope UK biotech will be able to achieve. I’d encourage you to take a look – if you are an SME you could share them with your team at a staff meeting – it’s a wonderful reminder of the impact our sector can make on the lives of others. Click here to view the videos and to learn more about the campaign, visit our website.

Elsewhere at the Forum, our panels of experts offered their thoughts and opinions on a range of important sector topics ranging from the importance of effective media relations to access to orphan medicines and, of course, Brexit. The session on AMR was well attended and if you want to learn more BioInfect is next week at Alderley Park. It was also fantastic to be able to celebrate the recent Biomedical Catalyst win with you at our Autumn Reception. We’ll be publishing a blog in due course summarising some of the highlights from the day and will signpost you to it once up.

Last Wednesday the House of Commons Science and Technology Select Committee announced their newly elected Chair – following on from Nicola Blackwood MP’s move to a ministerial role – as Stephen Metcalfe MP. We will be reaching out to him to ensure he is up to date on our sector’s policy priorities.

That same afternoon, several  members of BIA’s cell and gene therapy and manufacturing communities gave evidence to MPs as part of the Select Committee’s inquiry into Regenerative Medicine. They did a great job discussing the opportunities presented by the sector for the UK while also emphasising the need for strong UK advanced therapies manufacturing capacity, as well as clear routes for NHS uptake and reimbursement of these types of medicines. It’s great to see cell and gene therapies recognised in the AAR report in the context of the proposed Accelerated Access Pathway and that NICE will be looking at how to address cases where the evidence base is immature but shows strong potential.

On the subject of regenerative medicine, we are looking forward to supporting the Alliance for Regenerative Medicine’s 4th annual European Advanced Therapies Investor Day on 3 November – to catch up on these issues, join us there.

Finally, as a signatory to the Concordat on openness on animal research, it’s always encouraging to see articles such as this from the BBC with organisations or universities providing access into their facilities – a good demonstration of how far things have travelled on this issue.



In lieu of a video, this week we’re showcasing an infographic from our ‘Celebrating UK Bioscience’ campaign, depicting the drug development process.

UK bioscience plays a central role in developing the treatments needed for future generations here and around the globe, from investing in and carrying out research and development, to getting drugs from the lab and into patients. Find out more about our campaign on the BIA website and watch the accompanying videos on our YouTube channel.


Get involved with the campaign and tweet about your UK biotech successes using #BIAcelebrate


Today the BIA launched the next phase of its Celebrating UK Bioscience campaign. The aim of this campaign is to showcase the great work taking place in the sector – focusing on the potential human benefits of treatments that are currently in research and development – and to bring a greater understanding of the UK biotechnology sector to new audiences.

Biotechnology is technology based on biology, the science of life. Scientists in our sector work with living organisms to drive the development and manufacture of drug treatments, advanced therapies and diagnostic tests to support patients in the UK and beyond. The BIA is the trade association for innovative healthcare companies rooted in the UK’s bioscience base. The sector continues to evolve, investing in research and development activities, and translating research from the UK’s world leading science base into medicines to treat patients.

There is great depth and breadth in UK biotechnology: from a strong and emerging regenerative medicine and cell therapy sector, to specialist biomanufacturing companies developing therapies for cancer treatment, to personalised treatments and new antimicrobials. Advances in technologies such as synthetic biology are impacting upon the development of new types of therapeutics and new production methods. UK bioscience is not only changing lives, but saving them. It is vital that the sector continues to get the support it needs to keep this essential research and development going, now and in the future.

This campaign takes a look behind the scenes in the labs of some of our members to see what they are researching and developing and what the possible patient benefits these drugs and treatments could have in the future. The report is divided into five treatment areas: cancer, antimicrobial resistance, type one diabetes, dementia and Duchenne muscular dystrophy. Most people will be familiar with cancer and dementia, but this project wanted to look at less understood areas such as type one diabetes and antimicrobial resistance, as well as a rare disease, Duchenne muscular dystrophy, to demonstrate the breadth of scientific research and development taking place in our sector.


A number of charities that took part in this project are directly funding research in BIA member companies. Collaborations between industry and medical research charities are increasingly recognised as a mutually beneficial relationship. This brings the patient perspective to companies and enables patients to access clinical trials or to stay informed about R&D, and even allows vital funds to be channelled into clinical research.

Alongside the report, there is a series of infographics and videos, which add further insight into each condition and what BIA members are doing to tackle them. You will hear first-hand from patients and their families who have shared their personal stories and what they hope UK biotech will be able to achieve. Go to to view and download all the resources.


Earlier this month we travelled to San Francisco for SynBioBeta 2016 – a great opportunity to meet and hear from some of the innovative businesses in the growing synthetic biology sector. It’s been 40 years since Herbert Boyer and Robert Swanson founded Genentech in San Francisco in 1976, by expressing synthetic DNA containing the insulin gene in E.coli, and the synbio industry continues to go from strength to strength. Here, we take a look at some of the innovations on show at the conference.

According to Professor Klaus Schwab, Founder and Executive Chairman of the World Economic Forum, we are on the brink of the fourth industrial revolution – characterised by a range of new technologies that are “fusing the physical, digital and biological worlds”. The rapidly growing field of synthetic biology exemplifies this definition, developing world-changing technologies at the interface of multiple sectors.

Synbio encompasses a diverse range of applications – reflected in the variety of organisations in attendance at this year’s SynBioBeta conference. Sessions examined its application in other exciting areas of growth within life sciences including engineered cell therapies and antibodies, on which UK company Oxford Genetics took to the stage, and engineering the microbiome. Utilising and exploring the microbiome is arguably the hottest area in the biotech industry at the moment. In recent years, a number of companies have made advances in the engineering of these microbes for new applications – including using genetic engineering to make new antimicrobials, and engineering gut bacteria to combat metabolic disease.


DNA storage was another focus for discussion, establishing a completely different role for the material which carries our genetic information. The vast amount of digital data we generate is outpacing the amount of storage available – we need more space. Utilising DNA as a storage medium offers advances in storage density and durability over current methods. There are still challenges to overcome to improve its practicality for use, with regards DNA synthesis and sequencing, but with advances in the biotech industry coming thick and fast, DNA storage is becoming a realistic (and necessary) alternative.

The conference provided the opportunity to showcase a number of different tools and technologies, with UK representatives in this space including BIA member Sphere Fluidics and their picodroplet liquid handling technology.

Synbio has a large influence on industrial biotechnology, an enabling technology that uses biological substances, systems and processes to produce materials, chemicals and energy. On the UK front the Industrial Biotechnology Innovation Centre (IBioIC) announced the winners of its synthetic biology accelerator funding at the conference, part of a $1.5 million investment for synbio projects. Among the winning projects were BIA members Synpromics, for their research with the University of Edinburgh which will enable to ability to switch on gene expression in specific tissues for gene therapies, and Ingenza, whose project with the University of Glasgow will develop a game-changing technology to monitor and control biotech processes.

The applications of synthetic biology are widespread and it was fantastic to see such a range of companies on show at SynBioBeta – and witness the growth of many regular attendees from previous years. This growth shows no signs of slowing, as new startups continue to spring out of incubators and accelerators, including the UK’s SynbiCITE. If you’re a startup or entrepreneur in the field, SynbiCITE and Rainbow Seed Fund recently launched Bio-Start to incentivise innovative early-stage companies and people with great engineering biology ideas. The not-for-profit competition offers the winner a combination of £100k cash plus laboratory space, a ten-week accelerator programme with mentorship, consumables and professional services valued at ~£100k. If you’re interested, find out more here.

SynBioBeta London will take place from 4 – 6 April 2017.


It’s fantastic to see BIA Chair, Dr Jane Osbourn, named in this year’s Fierce Women in Biopharma 2016 – many congratulations to Jane. A great role model for the industry, and for the UK sector in particular. You can read more about it here.

On 23 November, Philip Hammond MP will stand up at the dispatch box to deliver his first Autumn Statement as Chancellor of the Exchequer. In our submission in advance of the Autumn Statement, the BIA presented a range of policies to the Treasury that will support the life sciences sector.

BIA and industry welcomed the Chancellor’s announcement of an additional £100 million for the Biomedical Catalyst, which demonstrated Government’s commitment to the life sciences sector. By adopting our further proposals, the Government can not only send another strong signal to the international life sciences community that it remains committed to this vital sector, but also demonstrate to all global decision makers that the UK is open for business and a primary destination for starting and growing an innovative business.

Our submission called for maintenance and expansion of the R&D Tax Credit scheme, a funded Early Access to Medicines Scheme, a Citizens’ Innovation Fund, an Investor Visa Fund and expansion of the Enterprise Innovation Scheme. For full details download our submission in full here or read our summary blog here to find out more.

Also on innovation, the CBI is undertaking a major piece of research on business innovation activity and the wider innovation landscape in the UK. If you’re interested in contributing, they have designed a very short survey that should be completed before 31 October. Please click here to fill in the survey.

Last Wednesday we held the latest in our series of CEO dinners (pictured), with a discussion around Brexit and the work of the UK EU Life Sciences Transition Programme. Many thanks to Jo Pisani, PwC, for her presentation and stimulating a lively discussion amongst the tables.

Parliamentarians referred to the work of the Transition Programme in a recent Westminster Hall debate on the future of the EMA that’s worth a read, including a positive endorsement from the Parliamentary Under-Secretary of State for Health, David Mowat MP, who said “over the next few months [the Steering Group] will be responsible for informing our negotiating position”, and “I recommend everyone reads [the report], on the structure and future of the life sciences industry post-Brexit… It is a good start in setting out a number of issues we have heard about today and the importance of getting the process right.”

We were also up in Glasgow last week for the Scottish National Party Conference where all minds were firmly fixed on the future of Scotland’s relationship with the EU and the rest of the UK. Ministers, MPs and MSPs we met were all very interested to hear about our Transition Programme report and to discuss how Scotland’s and the UK’s life sciences sector can be protected during the Brexit negotiations. With party conference season drawing to a close, keep an eye out for our blog of the highlights for the life science sector in the coming weeks.

Last week NHS England and NICE published two documents for consultation. One is a joint document on “Proposals for changes to the arrangements for evaluating and funding drugs and other health technologies appraised through NICE’s technology appraisal and highly specialised technologies programmes” which proposes introducing a new £100,000 QALY limit for highly specialised technologies and the ability for NHS England to seek the phasing in of any new technology that NICE have approved and has a budget impact of greater than £20 million. NHSE has separately published “Commissioning Policies: Funding of Treatment outside of Clinical Policy or Mandated NICE Guidance” which includes proposals around funding after clinical trials. BIA is currently considering the best way to respond to these consultations and is seeking member companies who may potentially want to be involved. Please contact Laura Collister if you are interested in working with BIA on a response.

With the publication of these two documents, and the AAR being possibly imminent, our UK Bioscience Forum this Thursday has a timely appearance from Simon Stevens – a great opportunity to ask him in person about NHSE’s work. If you’re not already due to attend, there are still a few last minute spots available. Unfortunately, on the topic of the Forum, Lord O’Neill is no longer able to speak on Thursday. However AMR will still be covered in depth with a dedicated parallel track of sessions to include speakers from Public Health England, the Review on AMR, the AMR Centre, GSK and Novabiotics – check out the agenda here. A final reminder that the BIA’s AGM is also on Thursday – between the close of the Forum and the evening reception – it’s always good to have strong member engagement in the running of your Association so do please attend if you can.

I’m looking forward to catching up with many of you there. We’ll be tying off the day with a celebration of the Biomedical Catalyst at the Autumn Reception, following the recent announcement that it will be re-filled. I do hope you can join us for what promises to be a great day and evening.



This week’s video comes from Innovate UK, the UK’s innovation agency.

Innovative businesses are not only the lifeblood of the biotech sector, but the whole UK economy. Watch the video below to find out more.

In advance of the Autumn Statement on 23 November, the BIA has presented a range of policies to the Treasury to ensure UK support for innovative businesses remains globally competitive. Find out more in our blog post and press release.

Do you have a video you would like the sector to see? Contact us.