Archives for the month of: March, 2017

BMC booklet pic

(Image from BIA and the Biomedical Catalyst )

On Tuesday, Innovate UK and the MRC published an independent evaluation of the Biomedical Catalyst -they have produced a summary of the report that draws out some of the key points below.   

The Biomedical Catalyst (BMC) scheme officially launched in April 2012 and aimed to de-risk innovative science and accelerate the progress of novel products to market, enabling them to attract onward investment and “bridge the valley of death”. To deliver the scheme, Innovate UK was allocated £120m of additional funding over four years, which was aligned with matching MRC funds.

Since the launch, more than £250M has been jointly committed by MRC and Innovate UK leveraging significant amounts of private co-investment and increasing onward financing. Over 300 projects, including over 60 first in human studies of novel therapies and diagnostics, have been supported and more than £120m in matched private funding has been leveraged.

Information collated by MRC and Innovate UK indicates that funded academics and companies have subsequently realised more than £1.3bn through additional financing, licensing deals, or as a result of acquisition. With over 40% of the funded SMEs originating from the university sector, pull-through of academic research into a commercial setting is being facilitated.

Independent evaluation scope and design

In 2014, Innovate UK and the MRC jointly commissioned an independent evaluation of the BMC conducted by Ipsos Mori. The key aims of the baseline phase of the evaluation, which has now been completed, were to review the BMC delivery process, to provide a baseline measure of assessment, and to set out a clear framework for future evaluation of impact. The resulting report provides a summary of the emerging and surrogate impacts visible in early 2015 for the first six rounds of funding.

The second phase of the evaluation is scheduled to begin in 2017 and will build upon the baseline study to report on the outcomes and impacts realised since launch. Importantly, the framework recognises that the development of life sciences products and services takes many years and that the maximal impact of the BMC is unlikely to be realised even by 2017.

Baseline evaluation findings

The balance of opinion canvassed by Ipsos Mori was that the processes adopted in the delivery of the programme were highly effective in supporting its aims. Applicants agreed that the application process was straightforward and encouraged a high quality of submissions. High levels of ‘penetration’ into the biopharma and academic communities were reported, indicating that marketing and promotion of the scheme has been successful. However, it was noted that there is potential to improve outreach to the MedTech community and emerging sectors such as digital health.

Notwithstanding that the majority of projects are in their earliest phases, and so findings should be considered to be provisional, the outcomes of the evaluation are broadly positive. Significantly, projects awarded funding reported accelerated technical progress. The report also suggests that the Biomedical Catalyst ‘badge’ has acted as an external ‘stamp of approval’, helping awardees to raise additional follow-on funding. The evidence also indicates that the BMC may have stimulated companies to switch their R&D focus from projects with a low risk/low return profile to projects with a high risk/higher return.

Summary

The Biomedical Catalyst has efficiently provided support to both academically and commercially led research and development, being uniquely positioned as the only non-dilutive response mode funding for UK life sciences SMEs. Although too early to draw any firm conclusions on ultimate impact, delivery of the scheme has been highly effective to date and is already accelerating the pace of product development and leveraging significant further investment into the life sciences sector.

You can read the full report on the gov.uk website.

Last week, the House of Lords Science and Technology Committee held an oral evidence hearing to look at funding and investment for science and technology within the Government’s Industrial Strategy.

Sir Mark Walport, the newly appointed CEO of UK Research and Innovation (UKRI), was the first to be questioned. UKRI will, subject to legislation currently in Parliament, incorporate seven Research Councils, Innovate UK and the Higher Education Funding Council for England (HEFCE) and be formed in April 2018. UKRI has been described by Innovate UK as “an unprecedented opportunity to fuse together world leading UK science with cutting edge innovation from British businesses”.

mark walport

Sir Mark Walport speaking at the Committee evidence hearing (photo taken from the Parliament TV recording of the hearing).

Walport welcomed the strong vision for research and innovation that the Government set out in its Green Paper on the Industrial Strategy. He stated that the UK is “building on strength”, while emphasising that we must “continue to raise our game” in support for science and research.

UKRI will strive to become a strong voice for research and innovation, both nationally and internationally, said Walport. He explained that this will involve UKRI “getting out there” to visit areas not just within the golden triangle, and to understand the different industrial landscapes with the aim to support science and innovation across the country. A key part of this will include getting to know the areas where niche expertise already exists and engaging with academia and businesses to develop new expertise. UKRI will also engage widely with external and internal stakeholders. This feeds into the Government’s aim to drive growth across the whole country with the Industrial Strategy and is welcomed by the BIA.

Jackie Hunter, CEO of BenevolentBIO, and Neil Woodford, founding partner of Woodford Patient Capital Trust, were questioned in the second session. They both spoke about a missing link between the UK’s excellent science base and start-up culture and the successful commercial scale-up of companies in the life sciences. Woodford suggested that the Government could stimulate investment in innovative companies by creating fiscal incentives, such as tax cuts, for investors committing to long-term investment. He stated that while biotech is poorly understood among investors, the financial sector is fast and dynamic to learn new areas where the right incentives exist. Following the session, Woodford expanded on this by advocating for “tech ISAs”, a concept that the BIA has promoted as Citizens’ Innovation Funds.

Hunter argued for the need to “innovate in the middle”. This could be done by copying an Australian model, where pension funds invest in R&D. A similar model in the UK, along with fiscal incentives for investors, could provide biotech companies with the large capital and long-term view required to scale-up and become global success stories.

The House of Commons’ Department for Business, Energy and Industrial Strategy (BEIS) Committee recently launched an inquiry on how to help small business to scale-up, so there is some clear indication that these ideas are being considered in the Industrial Strategy. In addition, the effectiveness of primary markets for science and tech companies is being reviewed by the Financial Conduct Authority. The Patient Capital Review, led by the Treasury, is also ongoing. The BIA is currently working on our industry responses to these consultations.

You can watch the full Committee evidence session here.

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This week will see the next phase of the Brexit process taking place as Article 50 is expected to be triggered by the UK government on Wednesday. The team here will be keeping a close eye on proceedings and will update on sector relevant developments across the usual BIA channels. For a more in depth analysis on all things Brexit you can sign up for our next Brexit webinar taking place on Friday April 7th at 4pm – full details and registration can be found on the BIA website.

On Tuesday, Innovate UK and the MRC published an independent evaluation of the Biomedical Catalyst. It shows the policy works. Grant winners have found it easier to attract follow-on funding, and have increased turnover and workforce growth. The key conclusion for me is that the BMC continues to address a market failure at the early commercialisation stage where investors are wary to venture alone. However, it also says that application reviewers themselves are too risk-averse when the underpinning science is uncertain. It’s great to see Innovate UK subjecting itself to this assessment and we look forward to working with them on improving this valuable scheme for our sector.

The Biomedical Catalyst 2017 round 2 late stage funding competition opened on Friday and UK businesses can apply for a share of up to £12 million to develop innovative ideas that will help solve healthcare challenges. The aim of this competition is to develop innovative healthcare technologies and processes that will help provide one or more of the following: disease prevention and proactive management of health and chronic conditions, earlier and better detection and diagnosis of disease, leading to better patient outcomes, tailored treatments that either change the underlying disease or offer potential cures. This competition has 1 late stage award. It is seeking projects that test a well-developed concept and show effectiveness in a relevant environment. For more information and to apply go to Gov.uk

It was great to be able to welcome Lord Prior, the life science Minister in the department of BEIS to see modern medicine manufacture at AZ’s plant on Macclesfield as part of the Medicines Manufacturing Industry Partnership (MMIP) conference. The event saw stakeholders from across the sector come together to find out what MMIP (a partnership of the BIA, ABPI and the KTN) has achieved to date and find out about plans for the future – you can find out more about MMIP on the BIA website.

On Thursday, we held a workshop for BIA members to help shape our response to the Government’s Industrial Strategy consultation (pictured above). It was great to have companies covering the full breadth of our membership attend, from small discovery-end companies, service SMEs and large drug manufacturers. It was important to hear all your views on the challenges and opportunities for our sector. Thank you to all of those who attended and to Simmons & Simmons for hosting – this will now inform our submission which is sought by government by Easter.

Thanks to those of you who enquired about the BIA team’s wellbeing around the events in Westminster last Wednesday, normal service continued here uninterrupted – as the Prime Minister said, it’s in the million acts of normality that we defeat those who would try to terrorise us.

The next epidemic could start anywhere, reach anyone, and wipe out millions. But together we can #OutsmartEpidemics. Video from the Wellcome Trust as part of the Coalition for Epidemic Preparedness Innovations http://cepi.net/

mmip full logo

Looking back at National Apprenticeship Week and National Careers Week (6 – 12 March), Alex Felthouse from Eisai, and MMIP Skills Chair, discusses what we need to do next to ensure the UK has the STEM skills it needs.

There is significant focus on STEM (Science, Technology, Engineering, Maths) skills right now. These are needed to support our current pharmaceutical industry and to ensure the UK remains a world-leader in innovative Life Sciences as new technologies and products change the way we work and manufacture medicines.

Identified as one of the ten ‘pillars’ in the most recent Industrial Strategy Green Paper, the Government have made clear that addressing the gaps that exist in STEM skills is a priority: their focus and recognition shows that we are moving in the right direction, but how big is the challenge we face?

Well, if you take the industry-specific demand figures from the Science Industry Partnership (SIP) Skills Strategy, and the Government’s recently published ‘Strengths and Opportunities Report’ for the Medicines Manufacturing Industry workforce, you can boil the challenge down to:

The Medicines Manufacturing Industry needs to attract 3 new people for every 100 it employs each year from now till 2025!

This is clearly quite a significant demand and something all manufacturers need to be considering to ensure our industry is able to thrive in the future.

All parts of the education system need to work and do their bit; schools and colleges need to inspire and raise the standards of STEM education, Universities need to ensure adequate balance between theory and practical skills and we, the Industry, must engage at all levels to inspire and attract students to work in our sector.

The questions I pose to employers reading this are thus; are you doing your bit; do you engage with Schools through a STEM programme such as the SIP Ambassadors; do you host work experience; do you have an apprenticeship programme; do you engage with Universities and have an Industrial Placement programme? We must promote our great industry and push the opportunities and rewarding careers that are on offer. This is a win / win situation for students and the country.

With an increasingly mobile workforce, ensuring we have the skills as an industry to thrive may only be achieved by everyone doing their bit… three in a hundred every year till 2025!

Alex Felthouse is the General Manager of Eisai Manufacturing Ltd (EML) based in Hatfield, UK. 

Alex is a Chartered Engineer and has worked in the pharmaceutical industry for 24 years. He has always had a keen interest in skills development, he currently chairs the MMIP Skills Workstream and is a Board member of the Science Industry Partnership (SIP).

This week: Manchester, Circassia, Astex, NICE and NHS response, Switzerland, Science and Technology Committee’s report into managing intellectual property and technology transfer.

Writing Newscast can sometimes feel like a commentary on what’s happening in Westminster so this week I want to start with a different perspective. In 2017 BIA companies are week in, week out celebrating major milestones and it’s right and important for us to both celebrate with them and tell their stories of success to others to show the strengths of our ecosystem. Two different examples this week that I hope we can all share with colleagues and networks – and which should be the talk of BioEurope in Barcelona.

First great news for the UK’s Astex Pharmaceuticals, as Novartis’s Kisqali gets FDA breakthrough approval. This new breast cancer drug was discovered in a collaboration with Astex – so is great news for patients from British science and innovation, with an interesting corporate story from well-funded UK biotech listed on NASDAQ via M&A, now owned by Japanese Otsuka. Astex today not only makes a milestone but employs over 200 people in Cambridge and is expanding. Its science is at the heart of a potentially very significant new therapy coming from UK innovation in partnership with the world.

Secondly, Circassia’s announcement on Friday that it has secured the US commercial rights to two COPD products from AZ is a significant moment as a key UK company makes an important commercial play through an interestingly structured deal.  Circassia now has a world-class respiratory business and can leverage its existing portfolio whilst AZ can focus on its core priorities. The products are a clear strategic fit with Circassia’s focus on respiratory medicines and will leverage and enhance their commercial infrastructure. So two key moments – two deals moving forward between global pharma and great UK biotechs – all BIA members.

It was great to see so many of you at our Manchester event last week where we updated on the progress on Industrial Strategy and heard [presentations from BioNow and the Medicines Discovery Catapult. For more information on the BIA’s regional events go to the events section of the BIA website.

You will have seen the ongoing media coverage of the NICE and NHS England decision to change the arrangements for evaluating and funding drugs and other healthcare technologies assessed through NICE’s technology appraisal and highly specialised technologies programme.  We will continue conversations with government on the industrial strategy for the life sciences sector and this decision will feed into these discussions – we will update you on the progress.

It’s vital that businesses of all sizes feed in their concerns around industrial strategy, and this week BIA members will be helping us shape our response to the Government’s Industrial Strategy consultation. Spaces are still available for the workshop on 23 March. This is your opportunity to influence our policy development and campaigning in 2017. It will be kindly hosted by Simmons and Simmons, EC2Y 9SS, from 9am to 1pm. Email Martin at mturner@bioindustry.org to reserve your place.

With the UK industry facing major changes around Brexit, the BIA in collaboration with Tekiu Ltd, is guiding a delegation of UK decision makers from across the UK biotech ecosystem to explore the sector in Switzerland. The delegation is made up of representatives from industry, government and the regulatory authorities, who will all be meeting with their Swiss counterparts to see how Switzerland operates outside the EU and what lessons can be learned for the UK. In view of Brexit, it is timely to examine the policies that allow both big and small businesses in Switzerland’s Life Sciences sector to flourish. Alongside BIA member companies, the delegation will include representatives from the Office for Life Sciences and the MHRA. The trip will also offer BIA members the chance to explore new business opportunities in Switzerland. You can read more about this on the blog. We also have strong BIA representation at Bio Europe Spring this week and we will round up on all our highlights next week.

Best,

Steve

Healthcare biotechnology creates and delivers innovative treatments and preventive interventions for the benefit of patients and healthcare systems across Europe. The achievements outlined in this video reinforce the European biotech industry’s commitment to continue delivering innovative therapies that make an impact on patients’ lives, and to work with policymakers to ensure the sustainability of Europe’s healthcare systems while fostering biotech innovation.

 

 

The UK BioIndustry Association (BIA) in collaboration with Tekiu Ltd, is guiding a delegation of UK decision makers from across the UK biotech ecosystem to explore the Swiss biotechnology sector.

The delegation is made up of representatives from industry, government and the regulatory authorities who will all be meeting with their Swiss counterparts to see how Switzerland operates outside the EU and see what lessons can be learned for the UK. In view of Brexit, it is timely to examine the policies that allow both big and small businesses in Switzerland’s Life Sciences sector to flourish. Alongside BIA member companies, the delegation will include representatives from the Office for Life Sciences and the MHRA. The trip will also offer BIA members the chance to explore new business opportunities in Switzerland.

BIA CEO, Steve Bates, said: “This trip offers organisations from across the UK’s vibrant UK bioscience ecosystem to meet with potential collaborators and learn from innovative solutions within biotechnology. It will be particularly interesting to learn about Swiss policies that promote biotech development, including tax and regulation to see whether any of these polices can be replicated in the UK to support UK bioscience businesses.”

Switzerland has a very different political system to the UK with a lot of decentralised power across the 26 cantons, which have some autonomy over issues that have an impact on the industry such as regulation and taxes. Learning about such a different way of operating will offer potential lessons that the UK could explore in the future.

Ted Fjallman, Executive Director of Tekiu Ltd said: “This delegation will help to build relationships between the delegates themselves and with their counterparts in Switzerland, and will allow them to gain new perspectives and to explore subjects in depth. Often all the representatives on this group would only meet once or twice a year and this visit will allow them to experience things together, have conversations about key issues for the sector and to synthesise the information from the hosts.”

The delegation will cover off some key issues that are relevant to the sector including technology transfer and will visit the tech transfer office at ETH University where they will learn different perspectives on how tech transfer works in Switzerland from representatives from academia and industry.

Representatives for the UK will meet a cross section of Swiss companies from SME’s such as Zurich based NeurImmune up to larger pharmaceutical companies like Novartis where they will meet experts from regulatory affairs, strategy and innovation and venture funding on a tour of the Novartis campus in Basel.

On the last day of the visit there will be a workshop for delegates to come together to discuss all of their individual learnings from the trip and discuss how any learnings can be implemented on their return to the UK.

The BIA will update on the delegation on the BIA blog.

About Tekiu

Tekiu is a knowledge transfer broker focusing on bespoke international visits for delegates from industry, government and academia. Tekiu’s vision is a world where companies, organisations and governments are actively engaging with their counterparts internationally to benchmark and learn from each other’s successes and failures. Tekiu has specific technical expertise and contacts in healthcare and biotech, environmental science, engineering disciplines, as well as education and innovation management. Geographically, the company focuses on the UK, Scandinavia and German-speaking countries.

By Liz Jenkinson and  Mandy Harding

In 1915 biochemist Chaim Weizmann patented a new technology for the production of solvents using microbial fermentation. His discoveries exploited the solventogenic capabilities of Clostridium acetobutylicum to produce acetone, butanol and ethanol (ABE) from starch-based feedstocks.  During the wars, production of acetone by this method was crucial in the manufacture of munitions and over the next few years ABE process facilities were established globally. Alas, by the 1980’s, the last ABE plants closed their doors (with the exception of a handful in China which clung on until the 2000’s) as this fermentation production method, primarily for butanol and acetone, was unable to compete with petrochemically derived counterparts. Fast-forward to 2016, and after 10 years of research and development and 18 months of plant engineering, the team at Green Biologics celebrated as the first tankers of bio-butanol left Central Minnesota Renewables (CMR), our company’s first ABE plant and the first to operate in the US since the 1940’s.

green biologics

So what’s changed? Firstly, technology. At Green Biologics we have access to hundreds of clostridial microbes characterised in terms of genetic information and feedstock utilisation that work in conjunction with our Advanced Fermentation Process (AFP™). Secondly, the marketplace. Acetone and butanol produced by microbial fermentation contain fewer contaminants than petro-derived equivalents giving us performance advantages in high value markets. And thirdly, there is much greater awareness and a desire to seek alternative, non-fossil fuel sources for everyday chemicals. In combination, this has enabled us to produce acetone and butanol at scale competitively.

The ultimate aim of Green Biologics is to become a renewable chemicals company, which means having the capability to diversify our product portfolio. Our experience with clostridia tells us that they are robust, industrial microbes with a unique anaerobic biochemistry, and they have the capacity to use a wide range of sustainable and/or renewable feedstocks. This makes them ideal platform strains for engineering products beyond butanol. However, this is no easy task. The clostridial genetic toolkit lacks the decades of research that have gone into model strains such as E. coli and until fairly recently, engineering any changes into the genome required stamina and an impressive dedication to the cause. All that changed with the emergence of CRISPR/Cas technology.

At Green Biologics we have developed and patented CLEAVE™, which is based on native clostridial systems rather than applying non-endogenous CRISPR/Cas9. The success of our technology has enabled us to generate strains engineered for enhanced performance in a matter of weeks rather than months (or occasionally years). We have succeeded in making strains that carry a single base pair change, all the way through to complex deletions, and have demonstrated the power of CLEAVE by introducing a new pathway to generate a strain capable of making a non-native high value product. The advantages of CLEAVE are 1) its specificity, the desired modification is the only modification we get, and 2) our ability to layer genetic changes whilst removing plasmid DNA results in markerless, process ready strains. Currently, our industrial ABE process uses lab-evolved clostridial microbes optimised for their performance in the AFP™. In the future, new chemical processes will use CLEAVE engineered strains carrying targeted genetic changes.

In this week’s CEO update: what does last week’s Budget mean for biotech; an international outlook; BIA Industrial Strategy workshop; S&T Committee report of their inquiry into IP and TTOs; and BIA in Manchester this week…

Putting Britain at the “cutting edge of the global economy” was the theme of the Chancellor’s first and last Spring Budget. However, there were few giveaways after an Autumn Statement last November that delivered significant new funding for research and innovation. Some of the key announcements for the life science sector included the allocation of the first tranche of the Industrial Strategy Challenge Fund, investment in STEM talent and administrative changes to the R&D tax regime.

The Chancellor is right to focus on keeping the UK at the cutting edge of the global economy by investing in biotechnology and skills. The £270 million to keep the UK at the forefront of disruptive technologies like biotech, gives us a real opportunity to lead the world in new industries such as advanced therapy manufacturing – highly specialised production techniques that allow us to use cells and genes to treat a wide range of diseases from cancer to dementia.

The Chancellor also announced £90 million for 1,000 PhD places in Science, Engineering, Technology and Maths (STEM) subjects and £200 million to support new fellowships for early and mid-career researchers, in areas identified as important to the industrial strategy (including biotechnology and medicines manufacturing); £50 million of this will be for programmes to attract “top global talent”. Industry must be involved in the design and delivery of training to ensure these investments properly allow the UK to stay at the cutting edge of the global economy.

 

The review of R&D tax credits provided an opportunity to enhance the system to put it head and shoulders above other highly-competitive regimes, such as Belgium and France. It’s a shame the government hasn’t taken that opportunity but we are pleased that it listened to the BIA’s call to reduce the admin burden for businesses claiming R&D tax reliefs.

As promised by the Chancellor himself, this was a low-key Budget. However, it’s great to hear him put biotechnology first in the list of areas the industrial strategy will support. We are working hard in partnership with the government and our members to ensure public investment and support is well-targeted to grow our sector. The fruits of this are paying off with investment today to implement the proposals of the Advanced Therapies Manufacturing Action Plan, which the BIA helped produce and it was great to hear Virginia Acha of the ABPI making these points on Radio 4 this morning.

Having had the chance to understand more of the Chancellor’s thinking last week, I think he is fully committed to both the scale up agenda for UK SME’s and leading the world in free trade – so I think we need to watch carefully any government reaction to, or intervention in, acquisitions of UK owned companies in strategic sectors for implications for our own sector. Finally, it’s worth noting that the robust growth of the UK economy reported today combined with the reducing corporation tax rate and commitments to invest in sciences and innovation – including the Biomedical Catalyst – demonstrates that the UK remains a highly competitive place to invest in and grow biotechnology companies.

Read our analysis in full on the blog here.

I joined BiotechCanada colleagues last week for their Investor conference. It was great to build the network (which already has strong links) , and understand that the Canadian biotech community faces several of the same challenges we do. Talent, access to finance and the impact of changes in the USA are common conversations in both countries – and I was able to gain some insight into what its like to negotiate a free trade deal with the EU from the outside.

We need your input to shape our response to the government’s Industrial Strategy at a workshop on 23 March. This is a year of opportunity for the bioscience sector and this is your chance to tell us what to campaign for. The workshop is for all BIA corporate members and Advisory Committee Chairs. It will be kindly hosted by Simmons and Simmons, EC2Y 9SS, from 9am to 1pm. Email Martin at mturner@bioindustry.org to reserve your place.

The House of Commons Science and Technology Committee has released a report today on managing intellectual property and technology transfer that states that improvements are needed to the commercialisation of university research. You can read the BIA reaction to this here.

This week we’re in Manchester, defining the biotech lab of the future on Wednesday with VWR International and we’re also holding the latest in our series of networking breakfasts at Alderley Park on Thursday morning. We’ll be joined by Dr Geoff Davison, Chief Executive of Bionow on regional opportunities within the Industrial Strategy, Dr Andy Jones, Vice President Pharmaceutical Innovation at AstraZeneca and Chris Molloy, CEO of the Medicines Discovery Catapult who will update on the Catapult as regional and national asset for the sector. Looking forward to seeing many of you there.

Best, Steve