Archives For author

The blood brain barrier is essential for good health, but prevents many medicines reaching the brain. How do you get past this biological barrier?

Over recent months, several exciting NHS funding opportunities have been announced which is great news for the sector. As well as new competitions that encourage medical innovation, the government announced £86m in funding for new medicine and technology. Speaking in his keynote address at the joint BIA and MHRA conference on 14 July, Lord O’Shaughnessy revealed the major government investment that will speed up patient access to innovative medicines and technology. This will help small UK companies get their innovations into the NHS more quickly to benefit patients – something the BIA has long campaigned for.

This funding will be divided into the following four packages:

  • £39 million of funding to the Academic Health Science Networks (ASHNs), enabling them to assess the benefits of new technologies and support NHS uptake of those that deliver real benefits to patients according to the local need
  • £35 million Digital Health Technology Catalyst for innovators – this will match-fund the development of digital technologies for use by patients and the NHS
  • up to £6 million over the next three years to help SMEs with innovative medicines and devices get the evidence they need by testing in the real world, building on existing opportunities such as the Early Access to Medicine Scheme (EAMS)
  • £6 million Pathway Transformation Fund, which will help NHS organisations integrate new technologies into everyday practices – this will help overcome more practical obstacles such as training staff on how to use new equipment

You can find out more about the funding here and our response to the announcement here.

As well as this significant injection of funding, the NHS is currently running competitions to further encourage innovation.

The latest three opportunities are:

NICE – AdviSeME Prize

The NICE AdviSeME Prize is specifically aimed at SMEs, charities, and academic research groups and offers the winning applicant a free Light Scientific Advice service (valued at £15,000) that will:

  • Provide detailed feedback on the company’s evidence generation plans from a NICE perspective
  • Help to integrate cost-effectiveness considerations into the company’s evidence generation plans
  • Provide insights from NICE-appointed experts
  • Help the company to prepare for future NICE evaluations of their product

The competition for the NICE AdviSeME Prize is now open. Find out more here.

Innovation and Technology Payment – Call for Applications 

Launched at the National Confederation Conference by Simon Stevens on 15th June 2017 and as part of NHS England’s commitment to the Five Year Forward View, NHS England has developed the Innovation and Technology Payment (ITP) 2018/19. The aim of the ITP is to help deliver on the commitment detailed within the Five Year Forward View – creating the conditions and cultural change necessary for proven innovations to be adopted faster and more systematically through the NHS, and to deliver examples into practice for demonstrable patient and population benefit. The application process is now open.

Successful innovation or technology themes will be identified through a competitive process and NHS England will then identify ways of supporting adoption of these across the NHS, for example through introducing a reimbursement for usage or centrally procuring items. Find out more here.

Diagnosing cancer earlier and faster: apply for funding 

A total of up to £1.1 million is available to UK businesses for projects that transform screening and speed up the diagnosis of cancer.

NHS England is to invest in new innovative ideas to:

  • transform cancer screening
  • enable earlier and faster diagnosis of cancer

Read the full announcement here and visit the competition website here.

You can view all of the funding opportunities on our website here.

 

By Centre of the Cell

Wartime Medicine and Innovation, funded by the Heritage Lottery Fund, has brought together a team of young people aged 14-18 from across east London to investigate the WW1 medical history of the East End.

They have used what they learned on three different projects: a medical history trail, a family workshop and creating animations. The project is supported by the Heritage Lottery Fund and delivered in partnership with the Royal London Hospital Museum and Archives, and the Science Museum.

After conducting research at the Royal London Hospital Museum and Archives and the Science Museum Archives, the young people worked with Lorena from The Art Trolley to create stop-motion animations about medical innovations arising from WW1.

This involved the young people exploring their artistic skills – take a look at their animations to see how they got on!

Last week, the government published its long-awaited public consultation for the Patient Capital Review. Entitled, Financing growth in innovative firms, it takes an in-depth look at the current availability of finance in the UK, the root-causes of low investment and short-termism, and proposes initiatives that could remedy the problem. The BIA will be responding and we are keen to hear your views to inform our submission.

What is the Patient Capital Review?

In November 2016, the Chancellor announced a review to “identify barriers to access to long-term finance for growing firms, supported by an advisory panel led by Sir Damon Buffini”. The public consultation was expected earlier this year but was delayed by the general election.

The review defines patient capital as: long-term investment (acknowledging that in some sectors this can be as long as 10 to 15 years), in innovative firms that are producing new to market products and run by ambitious entrepreneurs who want to build large-scale businesses. As called for in the BIA’s industrial strategy paper, the focus of the review is very much on scale-up capital as well as long-term investment.

The BIA met with the Treasury team in January to discuss the review in its early stages and hosted an open discussion event for members in April. We have also facilitated stakeholder meetings for the Treasury and Office for Life Sciences, and two BIA members are on Sir Damon’s industry advisory panel.

The scale of the challenge

The analysis in the consultation document is extensive and certainly worth reading. It estimates the gap in UK venture capital provision to be £4 billion compared to the US, meaning the challenge is to double the current total VC available. It shows that the UK matches the US for number of investments (adjusted for the size of the economy) but they are typically much smaller, especially in later funding rounds. The life sciences is highlighted as a sector that particularly struggles to attract sufficiently-sized successive funding rounds and often exits through trade sales rather than scaling-up.

A lack of critical mass in parts of the UK’s capital markets is identified as the root cause, which results in inefficient capital allocation (pages 29-34). The document also looks at the different sources of capital, which are each impeded by different barriers to investing for the long-term (pages 35-42).

Proposed solutions

The government proposes a series of initiatives that could address the challenges the report identifies:

  • A large new government-backed National Investment Fund to provide patient capital, this would replace or complement the European Investment Fund and could operate as a public-private evergreen vehicle, a fund of funds, a standalone fund of purely government money managed by the British Business Bank, or simply an increase in BBB funds distributed through existing programmes
  • Working with the Financial Conduct Authority to reduce regulatory barriers to setting up new patient capital funds (like IP Group and Touchstone), which the government believes pose specific challenges due to their atypical approach to investing
  • Encouraging pension funds to allocate a proportion of their money to patient capital (they state there are no regulatory/legal barriers to this and it is purely cultural risk aversion that could potentially be remedied through a communications exercise or similar)
  • Increasing investor capability, for example by using government funds to attract and nurture new fund managers
  • Increasing retail investment through reliefs, however the government is minded not to do this as it calculates that option 1 (a fund) is a more cost-effective means of encouraging investment. Specifically, it rules out an ISA-like vehicle to increase retail investment 

Help inform the BIA’s response

We will be responding to the consultation, expanding on the challenges that biotech companies face raising capital, commenting on the proposals and highlighting other BIA policies that could support our sector. We are keen to hear your views to inform our response, in particular:

  1. Which, if any, of the government’s proposed structures for the National Investment Fund is preferable, and what other rules should be applied to the fund to ensure it best supports the biotech sector and grows the investor base?
  2. How can the number of specialist fund managers knowledgeable in the life sciences be increased in the UK, and how can existing ones be supported to raise greater sums of capital to invest?
  3. What changes to existing schemes, especially Venture Capital Trusts, can be made to target more money into patient capital investments?
  4. How can pension and insurance funds be encouraged to invest in innovative businesses (including through intermediary investment vehicles) that are perceived to be riskier, long-term investments?
  5. Later and larger fundraises (for scale-up) are identified to be a notable UK weakness, how can this be addressed?

We are keen to hear your views on these questions and any other thoughts you have on the Patient Capital Review. Please email Martin Turner.  

Further information

The consultation document and further information can be found on the government’s website.

If you’re an investor, you can join us for a special panel event on 29 September to discuss the Patient Capital Review and other factors that will impact the growth of the UK biotech sector in the coming years. We’ll be joined by ex-science and Treasury minister Lord David Willetts to give his personal insight and experience, alongside other experts on the sector. Go to the BIA website for more information and to register.

Last month, we published our quarterly update report ‘Influencing and shaping our sector’. This latest report 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 April-July 2017.

The report covers a busy quarter for the sector, which included the snap general election that led to the Conservative Party losing its parliamentary majority. Before the election the BIA published a series of blogs looking at the election and what different outcomes could mean for the industry. Following the result, we also issued a press release with our response and wrote a blog on the result and its impact on our sector. Staying with politics, in July, we held our 17th Annual Parliament Day that brought together senior representatives from the UK’s life science industry and policy makers in Westminster.

Parliament Day 3

The report also highlights our work on Brexit, which has resulted in some welcome developments from government, in particular Jeremy Hunt MP and Greg Clark MP’s letter to the FT stating that the UK government would pursue co-operation with the EU on medicines regulation post-Brexit (industry responded with this letter). Later that month on 14 July, Lord O’Shaughnessy, Under Secretary of State for Health, gave a keynote address on the future of medicines regulation at the annual joint BIA and MHRA.

Lord O_Shaughnessy

In terms of finance, tax and investment, the BIA published its annual finance report ‘Building something great: UK’s Global Bioscience Cluster 2016’, which demonstrates that the UK maintained its strong leadership position in European biotech funding in 2016 and has the strongest pipeline for future drug development in Europe. Furthermore, the UK is in a strong position to close the gap on the leading US life sciences clusters and maintain its European lead if current momentum can be sustained. A total of £1.13 billion was raised by UK-based biotech companies from private and public sources in 2016.

UK proportion of venture capital raised in Europe

This quarter’s report also celebrates BIA CEO Steve Bate’s award of an OBE for innovation that he received on 16 June at Buckingham Palace. Steve even promoted the bioscience sector at his investiture, wearing a tie made from synthetic spider silk.

Steve

The full report goes into more detail on all of these topics, as well as our work around areas including skills, people and talent, intellectual property and technology transfer and medicine regulation. You can read the report here.

Last week the Treasury launched its ‘Financing growth in innovative firms’ consultation, which seeks views on how to increase the supply of capital to growing innovative firms. The consultation is part of the Patient Capital Review and closes on Friday 22 September. This is a critical piece of work that we hope could lead to a step-change in financial support for our sector. The BIA has been engaged with the Treasury since the review was announced in the later part of 2016 and we will also be formally responding to the consultation. Keep an eye out on our blog for your opportunity to input. You can find out more about the consultation here.

There’s more for you to get involved with this week. The ScaleUp Institute, of which the BIA is the life science member, is conducting a business survey as part of its ongoing work to focus attention on the UK’s high growth firms to ensure that the UK is the best place in the world for companies to both start up and scale-up. It’s vital that our sector is represented in this work as our business models are often somewhat different in scale and timescale to the average app developer.  Please consider using a summer 15 minutes to complete the survey here.

Applications also opened last week for two competitions in this year’s Biomedical Catalyst. Innovate UK and the Medical Research Council (MRC) will invest up to £12 million in new and novel healthcare solutions. The competitions are for UK micro, small and medium-sized enterprises for feasibility and early stage projects. You can read all of the competition information here.

Staying with Innovate UK, the organisation is working on a campaign around women and innovation and recently presented a UK female entrepreneur role models exhibition. The exhibition included a health and life science section which featured entrepreneurs including Fiona Marston, CEO of Absynth Biologics. Fiona features in Innovate UK’s video ‘What’s it like to be a female entrepreneur in the health tech sector?’ which featured in Friday’s BIA video showcase. Watch the video here.

You may have seen our blog last month on the publication of Home Office’s ‘annual statistics on the number of animals being used in research’ report for 2016. The NC3Rs is launching its CRACK IT Challenges at an event on 7 September in central London. There will be three CRACK IT challenges and the event will provide the opportunity to find out more meet the sponsors and potential collaborators, and find out what makes a good application. You can find out more and register for the event here.

In case you missed it last week, we are now inviting nominations from senior individuals from BIA members interested in joining the BIA Board. Nominations must be received by close of business on Wednesday 6 September 2017. If interested the details are all here in last week’s update.

Unless industry news compels us otherwise Newscast will now take a summer break and be back with you after the August Bank Holiday.

Emma Sceats is the chief executive of CN Bio Innovations and a winner of Innovate UK’s ‘infocus’ women in innovation award.

Find out about her story and what it’s really like to be a female entrepreneur in the health tech sector.

Removing barriers for female entrepreneurs

The proportion of UK women in entrepreneurial activity is around half the level of men. Boosting female entrepreneurship could deliver approximately £180 billion to the UK economy.

Innovate UK’s infocus campaign is an umbrella initiative to encourage diversity in innovation. The competition aims to address an important barrier to female entrepreneurship – having limited access to relevant role models and identification with entrepreneurs as ‘women like me’.

Women are also less likely to seek external sources of finance than men. The campaign is a way of increasing awareness of how simple it is to apply for game-changing funding.

This week from BIA Director of Public Affairs and Communications, Pamela Learmonth

Steve is on leave this week, so I am stepping in to write this week’s update.

As many of you will be aware, one of the many issues that the BIA tracks and engages upon on behalf of the membership is technology transfer. Since the publication of the Dowling Review in 2015, this work has intensified with evidence to the Parliamentary Select Committee reviewing the area. The work has been driven by the Science and Innovation Advisory Committee (SIAC). Last week, the Wellcome Trust issued a statement on technology transfer collaborative commitments which are generally aligned with SIAC’s thinking. You can read the statement here.

Another important area of consideration for the industry is the use of animals in scientific research.  Earlier this month, the Home Office published its ‘annual statistics on the number of animals being used in research’ report for 2016. The report shows that 3,936,723 procedures were conducted on animals for medical, veterinary, scientific and environmental research in the UK, a decline of 5% from 2015. You can read more in our blog here and access the full report here. The BIA is a signatory of the Concordat on Openness on the Use of Animals in Research, an agreement supported by a range of organisations to commit to being open about the use of animals in research in the UK.

Last week the European Medicines Agency (EMA) published its guidance on first-in-human clinical trials, which extends the existing guidance to address first-in-human and early phase clinical trials with integrated protocols. The revision was carried out in cooperation with the European Commission and the representatives of EU Member States through the EU Clinical Trials Facilitation Group (CTFG). This guidance document addresses non-clinical issues for consideration prior to the first administration of an investigational medicinal product in humans, as well as the design and conduct of trials in the initial phase of single and ascending doses during the clinical development

Moving on to this week, applications for the Digital Health Technology Catalyst 2017 open today. Innovate UK will invest up to £8 million in projects that develop new digital technology solutions to healthcare challenges. You can find out more and apply on the government website here. If you are thinking of applying, it is important to familiarise yourself with the scope and eligibility criteria, so that your application meets all of the necessary requirements.

Finally, we are delighted to invite nominations from individuals interested in joining the BIA Board. Nominations must be received by close of business on Wednesday 6 September 2017.

This year, there are five places up for election – four for ‘Corporate’ members and one for ‘Other’ members. The elections will take place during September, and pending approval at the AGM in the autumn, those elected will join the BIA’s Board commencing 1 January 2018 and will serve a three-year term. Please notify any of your colleagues who you think may be interested.

To be eligible to stand as a Corporate member, nominees shall, at the time of their election, be Chief Executive Officers, or divisional chiefs (or their equivalent) or chairmen of a Corporate member company (except in the case of a Corporate Member which is a UK branch or subsidiary of a foreign corporation, in which case a senior representative of the UK branch or subsidiary may be appointed). Within the ‘Other’ Member category nominees shall, at the time of their election, be employees of either an Associate Member company or a Network Member company.

Only one representative from any member company may be appointed to the Board.

Please submit your nomination by the end of the day, Wednesday 6 September 2017, together with a photograph and brief biography. These should be sent to Nick Gardiner, Company Secretary: ngardiner@bioindustry.org (please cc Kelly Oxenham: koxenham@bioindustry.org). If you have any questions, please contact Nick Gardiner in the first instance.

Best,

Pamela

The National Institute for Health Research (NIHR) improves the health and wealth of the nation through research. Find out more at www.nihr.ac.uk

Research using animals plays an invaluable and legally-mandated part in the drug development process. Animal research has been key to the development of numerous medical breakthroughs, including the development of vaccines for Malaria, Ebola and cervical cancer. As well as helping scientists understand human biology and the diseases which affect us, researchers are legally required to test the safety and efficacy of promising new medicines in animals before conducting clinical research in humans.

In the UK, research using animals is regulated via the Animals (scientific procedures) Act 1986, which is enforced via the Animals in Scientific Research Unit (ASRU) in the Home Office. Earlier this month, ASRU published their annual statistics on the number of animals being used in research. In 2016, 3,936,723 procedures were conducted on animals for medical, veterinary, scientific and environmental research in the UK. This is a decline of 5% when compared to the 2015 numbers.

Which species are most used?
In 2016, 3,867,528 animals were used in research. The most common types of animals used in procedures are mice (72.8%), fish (13.6%), rats (6.3%) and birds (3.9%). These four constitute 96.6 % of research procedures. Research was also conducted on frogs, guinea pigs, sheep, primates and other species.

Animal research stats

Infographic created by Understanding Animal Research

 

Who does experiments?
Universities and medical schools are the greatest users of research animals, conducting 49.2% of the total number of procedures. Commercial organisations are next, with 25.3%. Government departments, public bodies, NHS hospitals and public health labs conduct around 12.3% with the remaining 13:2% conducted by non-profits like charities.

What is the purpose of this research?

Of the 3,936,723 procedures conducted on animals last year, 51% (2.02 million) were experimental procedures and 49% (1.91 million) related to the creation/breeding of genetically altered animals2 not used in further experimental procedures. Regulatory testing accounted for 13.5% (531,509) of the procedures.

The BIA’s position on animal research

The BIA is a signatory of the Concordat on Openness on the Use of Animals in Research, an agreement supported by a range of organisations – including universities, companies, research funders and umbrella organisations – to commit to being open about the use of animals in research in the UK.

Concordate logo

The UK has among the highest standards in the world for the welfare of animals used in research, including a commitment to the 3Rs – the reduction, replacement and refinement of animals used in research. The BIA supports the aims of the Concordat, which will help the research community to communicate about the benefits, limitations and nature of animal research to ensure the public has the information they need to develop informed views on this topic.