newscast april3

This week the Brexit Process moved onwards as the Prime Minister triggered Article 50. We welcomed the PM’s commitment to make the UK one of the best places for science and innovation. So far, the UK government has demonstrated its commitment to innovation, and this was further shown through its support for the sector in the Budget announcements these included the investment in UKRI and the refilling of the Biomedical Catalyst. We look forward to building on this engagement via the life science response to the Industrial Strategy. It was also encouraging to see the Prime Minister’s letter mention the importance of prioritising ‘how we manage the evolution of our regulatory frameworks to maintain a fair and open trading environment.’

Now that Article 50 has been triggered, we enter a two-year political negotiation that is likely to result in a period of press speculation, bombast and rhetoric. Early agreement on key issues like: the regulation of medicines; the regime to enable non-UK nationals to work and contribute to the UK life science ecosystem; trade; finance support; market and intellectual property rules; would be the best way to ensure speedy and continuing global investment into the UK and EU. It would also be in the best interest of patients who require access to innovative healthcare.  To find out the latest on the Brexit process join us for the BIA Brexit webinar this Friday.

I am in Switzerland this week with BIA members and representatives from the MHRA and Office for Life Sciences to see what lessons can be learned that could help with the UK negotiations. I will update in next week’s newscast.

On Wednesday, the Medicines Discovery Catapult celebrated its launch at the University of Warwick. One initial focus of the work being undertaken on site will be the increasing threat of anti-microbial resistance (AMR). The site at Warwick has been developed alongside facilities at the Catapult’s headquarters in Alderley Park, Cheshire. They will both drive innovative, fast-to-patient drug discovery supporting collaborations between industry, academic teams and medical research charities, and will help drive UK health and wealth in line with the government’s Life Sciences strategy. You can find out more on their website.

On Thursday, the BIA’s Science & Innovation Advisory Committee (SIAC)brought together representatives from across the biotech/healthcare community to discuss technology transfer (pictured above).  This followed the recent Dowling Report, and also the evidence given and the subsequent report by the House of Commons Science and Technology Select Committee on managing academic intellectual property.  The BIA’s intention is to address some of the issues highlighted, such as friction around IP licencing, by bringing together all the relevant parties and encouraging open dialogue.

Finally, BIA’s Head of Regulatory Affairs joined the DIA EuroMeeting in its 29th year in Glasgow. The overall theme ‘Translational Healthcare: From Bench to Bedside and Back’ reflected the growing impact of back translation of learnings and patient data into research and development of innovative medicines. The conference discussed and shared insights into the evolving European and global healthcare environments from alternative regulatory pathways to developments in HTA and access, bringing together more than 1,500 healthcare professionals from industry, regulatory agencies and patient organisations.

Best, Steve

Scientists at the Francis Crick Institute have uncovered how tumours are able to grow despite significant damage to the structure and number of the chromosomes in cancer cells.

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.