Archives for the month of: April, 2016

Genetube is a space dedicated to shaping fresh, informative, surprising and shareable bite sized insights about DNA and genetics. It’s not for profit; just for humankind.

Its aim is to help shape and inspire everyday conversations that, whilst still rooted in the science, resonate with people. There are also survey questions alongside the videos to help find out how to make ‘genomics’ click for people who may not know anything about it yet.

The research is funded by a joint partnership between the Wellcome Genome Campus, Wellcome Trust and Genomics England and has received Research Ethics Committee approval from the West Midlands Solihull Research Ethics Committee.

bia video genome

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

Q1 2016 reportOngoing BIA engagement enables our members’ voices to be heard at the highest levels. Our latest quarterly update gives an overview of key policy developments and the BIA’s continued engagement with policymakers, regulatory authorities and wider stakeholders on behalf of the UK life sciences industry, from January to April 2016.

In the update, you can read up on key issues for the life sciences industry such as:

The EU referendum and how BIA has engaged in the debate – With the EU referendum set for 23 June, the BIA has been working to ensure that the voice of the UK life sciences industry is heard loud and clear. BIA members have said they believe the industry will be stronger if we remain in Europe and we have conveyed this message through policy and media routes.

The new MMIP_logoministerial and industry taskforce securing the UK’s manufacturing environment for advanced therapies – A new Advanced Therapies Manufacturing Taskforce was launched by the Medicines Manufacturing Industry Partnership (MMIP) to secure the future of manufacturing advanced therapies in the UK. The taskforce will be co-chaired by George Freeman MP and Ian McCubbin, GlaxoSmithKline.

The latest developments from the EMA on the PRIME priority medicines access scheme and clinical trial data transparency – The new PRIME (PRIority MEdicines) scheme, launched by the European Medicines Agency on 7 March, has got off to a good start with 18 applications as of 21 April. We understand that 60% of the applications were from SMEs, an important target audience of the scheme. Also in March, the EMA published detailed guidance on the implementation of its policy on the publication of clinical trial data. This detailed guidance has been finalised following an extensive consultation with stakeholders concerned throughout 2015, including the BIA.

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An update on BIA Advisory Committee 2016 priority policy areas – Our annual Committee Summit took place on 25 February, during which each of BIA’s eight advisory committees held their Q1 meeting. In a plenary session with fellow BIA members, each committee’s focus areas for 2016 were set out. The quarterly report details the specific policy priorities of each committee for the year.

BIA Committee Chairs 2016

While November’s Comprehensive Spending Review may now seem like a distant memory, details are now starting to emerge about some of the spending policy changes it led to. We’ve updated our Spending Review outcomes table to summarise the current state of play in areas including the BIS budget, the research and innovation public funding landscape, regional devolution deals and more.

To learn more about BIA’s policy, public affairs and regulatory affairs work, see our previous quarterly policy updates, our consultation responses, or email Zoë with any questions.

SBC open innovation summit

Earlier this month, the Stevenage Bioscience Catalyst (SBC), a joint venture between the Department for Business Innovation and Skills, GlaxoSmithKline, the Wellcome Trust and Innovate UK, hosted its 4th Annual Open Innovation Summit. The SBC’s open innovation culture aims to accelerate the discovery of cutting-edge healthcare solutions and place the UK bioscience sector at the forefront of worldwide biomedical innovation. Find out more in today’s blog…

The Stevenage Bioscience Catalyst’s 4th Annual Open Innovation Summit gave all attendees genuine insight into what SBC does for the companies that are based there. SBC encourages open innovation by offering opportunities for collaboration, incubation, scientific support as well as business and financial guidance. The day’s two panels and company pitches proved that the combination of all these things helps to increase the flow of good science.

The first panel, chaired by Emma Palmer Foster, saw the experts discussing their own experiences of developing and managing collaborations and it was packed with solid advice for companies. Dr Zahid Latif, Head of Healthcare at Innovate UK, Dr Mary Kerr, CEO of NeRRe Therapeutics, Dr Richard Weaver CEO of Xenogesis and Stuart Pollard, Associate Vice President and Principal, Sunrise, Sanofi shared their top tips on everything from starting your own business to accessing funding:

  • You need to have clarity over what you have got to offer and you need to be talking about your technology in the language of your prospective partner
  • You have to kiss a few frogs before you find your prince/princess but the Knowledge Transfer Network (KTN) and Catapults are there to help de-risk this frog kissing and to help companies to take a long term view to their collaborations
  • Constant communication is vital between you and your partners so that neither of you diverge from the path that you have agreed
  • Considering cultural differences is vital – don’t just focus on the money when you are looking at who to partner with
  • Biohubs like Stevenage provide an excellent environment for collaboration – bringing together a range of organisations and offering them support and guidance

OISummit

The panel was followed by some excellent pitches from SBC companies profiling their new treatments and therapies. BIA members Puridify talked through their platform purification technology FibroSelect, and brand new company VisusNano – Winner of the 2016 BioStars Competition – gave an excellent pitch on their drug eluting lens for use after cataract surgery.

Chaired by Dr Claire Thompson, Director of Agility Health Tech, the second panel featuring Dr Keith Thompson, CEO of the Cell and Gene Therapy Catapult, Dr Kris Famm, Head of Bioelectronics R&D Unit, GlaxoSmithKline and Steve Gardner, CEO, RowAnalytics Ltd, discussed the role of technology convergence in the future of healthcare.

  • Bioelectronics: If you have a compelling enough product then then you can knock down many of the hurdles in your way – however the biggest hurdle for bioelectronics is integration
  • Regenerative medicine: With the new Catapult manufacturing site opening next to SBC, the UK is taking a leading role in terms of the manufacturing cell and gene therapies and decreasing capital investment for companies whilst allowing them to keep their processes proprietary. The key issues for cell and gene therapy continue to be reimbursement and adoption.
  • Big data: This is the hardest time to be a doctor as there is so much data out there but it’s very difficult to navigate. Looking at how data can be used to personalise treatment for patients – there are challenges in getting tech embraced throughout the healthcare system. Access to patient data continues to be the biggest barrier.

For tweets from the event, check out #oisummit16 and full details on the day can be found here.

London Breakfast 2016

It was great to see so many of you at the latest BIA breakfast in London last Thursday. With the Mayoral elections taking place in a couple of weeks, we heard the views of Kit Malthouse MP, Jonny Ohlson, Keith Powell and Sarah Haywood on what the next Mayor can do for life sciences in London.

As Chair of the All Party Parliamentary Group for Life Sciences and previous Deputy Mayor for Business and Enterprise, Kit Malthouse emphasised the importance of the life science sector to London’s economy. With Mayoral powers developing in terms of health, he sees an important role for the new Mayor in opening up the health service to be more innovative and welcoming to private sector research.

During his time in City Hall, Kit saw the creation and launch of MedCity under current Mayor, Boris Johnson. As CEO of MedCity, it was great to hear an update on the achievements of the organisation from Sarah Haywood, who highlighted the importance of utilising the capital city as an entry point and magnet to attract companies and investment to the whole UK sector.

Biotech entrepreneur Keith Powell discussed the lack of interest in the sector from the two leading mayoral candidates – a shame considering the tremendous research base in and around the capital.

Investment and funding were also key topics on the morning. Jonny Ohlsen, CEO, Touchlight Genetics describing the significance of EIS and his experience over the past decade – their importance echoed by Kit Malthouse.

Many thanks to BIA member Taylor Wessing for hosting and look out for our blog of highlights and pictures in the coming weeks.

On IP matters, last week the BIA filed an Amicus – or friend of the court – Brief to the US Supreme Court supported by an international coalition of biotechnology trade organisations, arguing that the decision of the Federal Circuit in the case of Sequenom v. Ariosa Diagnostics should be reconsidered. The Federal Circuit court ruled in 2015 that Sequenom’s foetal DNA test was not eligible for patenting.

The BIA has taken the lead in making this international argument because the invention on which this particular test case rests is British, originally from work at the University of Oxford. Sequenom’s patent has been awarded in a number of countries and was successfully defended at the European Patent Office. If the Federal Circuit’s ruling is upheld, US patent case law would be inconsistent with laws in Europe, Canada, Australia and Japan, among others.

Creating a divide between US patent law and the rest of the world is bad for the global biotechnology industry and bad for patients. It will disincentivise investment in the development of new diagnostics and medicines that save and improve the lives of patients. The US Supreme Court is expected to rule in June whether to take the case up for review – we’ll keep you posted on any developments.

The EU debate continues apace. Last week saw the intervention of US president Barack Obama whilst visiting the UK and, as predicted, the House of Lords report on EU membership and UK science was formally published – read it in full here. The debate will continue to move over the coming weeks with the House of Commons Health Select Committee also launching an inquiry into the impact of membership of the EU on health policy in the UK.

We’ve been watching out for more details on the Government’s National Innovation Plan since it was first mooted some months ago, and today the Department of Business, Innovation and Skills (BIS) has opened a ‘call for ideas’. This consultation is open until Sunday 22 May and is seeking ideas on how to encourage innovation and investment, and how to support companies to scale up the best ideas. The questions address regulation, access to finance, IP, infrastructure and more. These are all themes that are close to the heart of many, if not all, BIA member companies and we will of course be submitting a response. To find out more or get involved, do get in touch.

Elsewhere in the sector, congratulations to Dr Belinda Quinn on becoming the new CEO of the Precision Medicine Catapult – we look forward to working with her going forward.

Best

Steve

An internet quiz by Understanding Animal Research of over 4,000 people has revealed that only 38% of respondents are aware that it is illegal to test cosmetics or their ingredients on animals in the UK. The UK ended this practice in 1998 and a 2013 EU-wide ban means that it illegal for any cosmetic product to be sold in any EU country if either the product or its ingredients are tested on animals.

Understanding Animal Research went out to the streets of London to ask the public questions from the quiz – watch the results below.

Find out more information about cosmetic testing on animals here.

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

SynBioBetaLondon2016_1

Earlier this month, the great and the good of the synthetic biology community gathered at Imperial College for this year’s SynBioBeta London, a key two-day conference on synthetic biology and its applications. Below, we summarise some of the highlights and key announcements from the event.

Now in its fourth year, the Annual SynBioBeta London Conference, hosted by Innovation and Knowledge Centre SynbiCITE, was as vibrant as ever with 600 attendees from the UK and overseas, spanning industry, academia and the investment community.

SynBioBetaLondon2016_2The synthetic biology industry has flourished over the last few years. Between 2009 and 2015, European synthetic biology companies raised over $900 million in private investment, of which just over $200 million was raised in 2015 alone. Further information on Europe’s thriving synbio start up scene is available from SynbiCITE’s handy ‘5 minute guide’ infographic.

This thriving industry was witnessed in the quality and quantity of developments being showcased at the conference. Plenty of BIA members were in attendance at the event and key announcements included the official opening of SynbiCITE’s £2m ‘Foundry’ automation lab. Funded by RCUK, the Foundry is at the core of SynbiCITE’s facilities hub and is specifically designed to support the commercialisation of synthetic biology. The Foundry has been created and built to operate as a ‘cloud lab’ to support synthetic biologists across the UK – watch it in action in this report from Sky News.

In another key announcement, BIA member Synthace announced a strategic partnership that will team their Antha language and operating system for biology with Microsoft’s cloud analytics and machine learning – a significant development for the London based company and the UK synbio sector.

SynBioBetaLondon2016_3 Beatriz

Elsewhere at the conference, Thursday’s panel session on responsible innovation included Professor Paul Freemont, SynbiCITE, and Beatriz San Martin, Fieldfisher, who is a member of BIA’s Intellectual Property and Cell Therapy and Regenerative Medicine Advisory Committees.

Investment is crucial to the success of a biotech company and was a key topic for discussion over the conference, including a breakfast in the House of Lords on Friday to top off the week. The synbio community and investors gathered to hear from host Lord Willetts, former Science Minister and synthetic biology champion.

SynBioBetaLondon2016_4Following the launch of the updated Synthetic Biology Roadmap in February, now evolved into “Biodesign for the Bioeconomy: The UK Synthetic Biology Strategic Plan”, Lionel Clarke from the Synthetic Biology Leadership Council outlined the next phase of strategic direction for this growing technology area in the UK. You can download the new UK strategic plan here and watch Minister for Life Sciences George Freeman MP launch the document here. 

You can look back over tweets from the conference on #SBBUK16.

Science Council debate

Last Thursday the Science Council hosted the first debate between the two official lead campaigns for the EU referendum, on the subject ‘UK Science Doesn’t Need the European Union’. Here Dr Martin Turner, Policy and Projects Manager at the BIA, gives an overview of the debate.

Fact, fiction, and supposition

The Science Council’s EU debate was full of well-rehearsed arguments from both sides. Each contained some facts, some fiction, and a lot of supposition.

Take the issue that much of the argument centred on: whether the UK would continue to be able to access EU research funding on the same terms as it does now. Truth is, we just don’t know. According to the Royal Society, Associated Countries in the Horizon 2020 programme access funding on an equal basis to full Member States but do not get to shape funding programmes. So the UK would probably lose influence, but perhaps we would negotiate a clever deal of the likes never seen before. Both the leave and remain side could only suppose.

The only certainty is uncertainty

As no country has left the EU, it is impossible to predict what will happen. What it is possible to predict is the uncertainty that would follow the decision to leave. Businesses and investors do not like uncertainty.

The likelihood and timeline of achieving necessary new arrangements are unknown. The Comprehensive Economic and Trade Agreement (CETA) between Canada and the EU took five years from negotiations beginning in 2009, to agreement in 2014; and it is yet to be ratified by the EU and Canada so that it can be implemented. Companies would have to factor the risk of new agreements being less favourable or delayed into their business decisions, which would have an unknown but most-likely negative impact on investment for the UK.

The EU is of net benefit to UK life sciences

If the EU were not beneficial then it might be worth taking this risk but, as the BIA set out in its submission to the House of Commons Science and Technology Committee, on balance EU membership works well for the UK life sciences sector.

Over a generation, regulators and legislators have built up an integrated European regulatory framework for clinical research and the development of new, innovative medicines. It is corner-stoned in the UK, and has significant UK input. London is also the home of the EU-wide regulator, the European Medicines Agency (EMA). And the EU is also in the process of building an integrated Unitary Patent system, which will have a key presence in the UK through a London-based Court for pharmaceutical patents.

If the UK were to leave the EU it would risk unpicking all of that successful work. Work that the UK has heavily influenced. The UK would be in the paradoxical situation of having a world-leading regulator (the MHRA) that is only able to create regulation for 3% of the global market (compared to the 27% that the EU represents), and whose work would be informed by a European framework that it cannot influence, rather than the other way around.

Brexit could also pose significant risks to the UK’s attractiveness for inward investment and as a location for the world-leading talent the life sciences sector depends upon. All of this would have negative consequences for the UK and its economy.

Does UK science need the EU?

The motion of the debate was “UK science doesn’t need the European Union”. If I were to be pedantic – which I usually am – I would say that of course UK science doesn’t need the EU. We are undoubtedly a superpower in our own right.

But the UK has worked hard with the EU to make sure that it works for us. From diverse funding streams for basic research to a regulatory system that speeds up safe access to new, innovative medicines for patients, we can better exploit our strength in science from inside the EU than out.

Results from the exit poll of attendees were as follows: 84% voted to Remain, 16% voted to Leave.

Read what happened at the debate and on the Science Council Storify page.

This blog was originally posted on the Science Council blog.

SBC open innovation summit

With the official campaigns chosen, Vote Leave and Stronger In, we are now less than ten weeks away from the date of the EU Referendum.

For a summary of BIA’s work on the referendum and the views of the UK life science industry, we’ve compiled our resources into a handy web page. This includes a helpful new guide, produced by the BIA Communications Advisory Committee, that outlines the key issues for companies to consider when preparing to engage with the EU Referendum debate. The simple flow chart leads you through the thought process for preparing a statement – download it here.

On Friday we completed our submission to the House of Commons BIS Select Committee’s inquiry into business views on EU Referendum – you can read the response in full here, which largely draws on similar arguments from our previous responses on the topic. There has been a huge amount of interest from policymakers on this issue – our most recent submission marking our third written response on the subject, in addition to the two oral evidence sessions earlier this year. This week will see the second evidence session as part of the House of Commons Science and Technology Select Committee inquiry into the impact of European regulation on UK life sciences, with contributions from Cancer Research UK, the MHRA and Minister George Freeman. We also expect to see the House of Lords Science and Technology Select Committee publish its report on EU membership and UK science this week, so lots of movement in the run up to the 23 June.

Also on Europe, the BIA was in attendance at last Thursday’s Science Council debate between the two official lead campaigns for the EU referendum, on the subject ‘UK Science Doesn’t Need the European Union’. You can read some of the best tweets and post-debate reaction on Storify, and a summary of the event on the Science Council blog from BIA’s Policy and Projects Manager, Martin Turner.

Some great news for the Stevenage Bioscience Catalyst last week as Sanofi announced the creation of a new partnering office at the site to engage and collaborate with the network of bioscience companies and academia that form part of the UK’s vibrant life sciences ecosystem. The announcement came as the SBC hosted its 4th annual Open Innovation Summit (pictured) where two panels discussed developing and managing collaborations, and the future of healthcare. There were also excellent pitches from existing and future BIA member companies profiling their new treatments and therapies.

Across in the US, Chancellor George Osborne was in Washington to discuss international action to tackle the growing problem of antimicrobial resistance. Noting that reimbursement models for antibiotics and diagnostics are “broken”, he backed a proposal from Jim O’Neill to create market entry rewards – lump sums paid to a company, or set of companies, that successfully get a new antibiotic or diagnostic to market. The Review on AMR, led by Lord O’Neill, is expected to publish its final recommendations next month. You can watch the panel session with the Chancellor on our blog here, where he appears alongside experts including Dr Margaret Chan, Director General of the World Health Organisation, and Larry Summers, the former US Treasury Secretary who is Charles W. Eliot University Professor and President Emeritus, Harvard University; and Chair, Board of Directors, Center for Global Development.

The annual BIO International Convention returns to San Francisco, California on 6-9 June 2016. This year the BIA is working with our United Life Sciences (ULS) partners One Nucleus and BioPartner UK, as well as with UK Trade & Investment (UKTI) to enable UK companies to get the most out of the event. BIA members can benefit from $200 off either Convention Access or Convention Access Plus Partnering. More information is available here, space on the UKTI stand is now available, and don’t forget to sign up to our webinar on 26 May, which will take you through an outline of the main BIO networking events, the UK delegation activities, sessions/keynotes and details on some of the main activities happening throughout the four days so you can plan your time in San Francisco effectively.

I’m looking forward to some great discussions around the upcoming Mayoral elections at our London breakfast this week. Previous London Mayors have accomplished notable achievements in the life science sector, including launching Medcity, a collaboration between the Mayor of London and the universities, businesses and scientists from London. We’ll be discussing some of these past accomplishments and giving some considerations to what the next mayor could bring to the life science sector with our guests Kit Malthouse MP, Sarah Haywood from MedCity, Dr Jonny Ohlson of Touchlight Genetics and Dr Keith Powell, Chairman of Domainex. More info on the event is available here and look out for some highlights from the morning next week.

Finally, the NIHR are running a couple of short surveys – to inform their web presence and ensure that the NIHR CRN meets the needs of the life sciences industry. Both questionnaires are anonymous (unless you choose to leave your email address) and the outputs will be used to support improvement and development of services to further meet your needs. Follow the hyperlinks above to contribute.

Best,

Steve

MMIP update April 2016

Welcome to my first Medicines Manufacturing Industry Partnership (MMIP) update. Throughout 2016 we intend to share more of our activities as we build the medicines manufacturing community voice and promote the drive for growth of medicines manufacturing in the UK.

As a way to help us to connect with you and give more detail about what we do and our work, we have prepared with the Association of the British Pharmaceutical Industry (ABPI), BioIndustry Association (BIA) and Knowledge Transfer Network (KTN) an MMIP overview leaflet which can be accessed here.

At the joint MHRA/ABPI Making the case for UK medicines manufacturing conference in early March, MMIP shared some of our 2015 successes such as:

We also shared the MMIP’s 2016 operating plan. This included work-streams focusing on Technology & Innovation, the Business Environment, the Regulatory Environment and Skills. The focus of these work-streams is on enabling growth in manufacturing as part of our end to end supply chains.

Ian McCubbin, Chair of MMIP, speaking at the ABPI/MHRA conference, "Making the case for UK medicines manufacturing"

Ian McCubbin, Chair of MMIP, speaking at the ABPI/MHRA conference, Making the case for UK medicines manufacturing

We see three groupings of medicines manufacturing, ‘small molecules’, ‘large molecules‘ and advanced therapies. In all of these, the end to end supply chain is critical to the manufacturing success. With this in mind, a ministerial taskforce has been set up, co-chaired by me and George Freeman, Minister for Life Sciences. This taskforce is focused on making recommendations to anchor the manufacture of advanced therapy medicinal products in the UK. It had its first meeting on Tuesday 22 March and more information will be coming soon on its terms of reference, scope and next steps focusing on manufacturing capability and technology, skills, and international competitiveness.

During my key note address at the conference, I outlined the challenge we face in the UK from competing regions. We already have a rich landscape of capability and infrastructure in the UK with national centres and renowned academic research but in an increasingly competitive world, we must offer more to encourage medicines manufacturing in the UK. In this respect, our regulator MHRA is a unique asset in supporting companies that have developed novel medicines or development approaches in their regulation.

I was very encouraged and excited by the alignment of industry, trade bodies and MHRA and the passion there is for the UK medicines manufacturing industry to succeed. We have many of the pieces of our jigsaw already available and with some effort and energy we can push them together to complete the picture and make the UK a more vibrant place to invest in medicines manufacturing.

Future sector MMIP events will be on Digital Design, Continuous Manufacturing and Patient Centric Packaging. We will contact you with more details on these and the opportunity to get involved.

I hope you find this note of interest and we will continue to communicate and create a community of committed likeminded professionals who can help with MMIP. Please contact us at MMIP@bioindustry.org or join our LinkedIn group at http://bia.me/MMIP_LinkedIn. Likewise, if you have any colleagues you feel would be interested in learning more about the work of MMIP then please ask them to get in touch with us or sign up to our mailing list here.

Ian McCubbin

Chairman, Medicines Manufacturing Industry Partnership

Yesterday Chancellor George Osborne appeared as part of an expert panel in Washington, D.C. to discuss international action to tackle the growing problem of antimicrobial resistance (AMR).

Speaking at the event, the Chancellor said:

“My message here at the IMF meeting in Washington is that we need the world’s governments and industry leaders to work together in radical new ways.

We have to dramatically shift incentives for pharmaceutical companies and others to create a long-term solution to this problem, with new rewards, funded globally, that support the development of new antibiotics and ensure access to antibiotics in the developing world.”

Watch the session in full below.

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