In the midst of election fever, the British Science Association have teamed up with journalist Susan Watts, former science editor of Newsnight, to interview the science spokespeople from the main political parties in the run-up to the General Election on Thursday 7 May.

Science spokespeople from the major UK political parties were questioned on their policies and manifestos for the next Government if their party were to be elected. The questions are centered around the effect their policies will have on the public, and what difference they would see if a particular party were to come to power.

Watch the full series below.

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“Without animal research, medicine as we know it today wouldn’t exist.”  This is a line taken directly from the website of a campaigning group in favour of continued animal testing. In many respects they’re right; to date, research in animals has provided instrumental data in the development of many life-changing pharmaceutical and non-pharmaceutical chemicals, for understanding their impact on the environment, and for advancing our basic knowledge of human and animal health and disease. However, times are changing, and there is increasing recognition from the industry that animal models may no longer be sophisticated enough to meet the needs of drug development in the 21st century. But according to some groups who oppose animal research, this shouldn’t be a problem because there are “very obvious and more appropriate non-animal methods of research that could have been used instead”. So why aren’t pharmaceutical companies and the biotechnology sector adopting these non-animal approaches more readily? The truth is not as black and white as some of these groups may lead us to believe. Dr Anthony Holmes, Programme Manager – Technology Development at the NC3Rs, explores why.

There are considerable scientific, regulatory, practical and technological hurdles to overcome before non-animal approaches can be adopted. However, driven by the realisation that unless something changes, the pharmaceutical industry is at risk of entering an ice age, the sector is embracing these challenges. The drug development process is long and expensive. High attrition rates due to safety liabilities and lack of efficacy observed in the clinic, but which were not identified during preclinical development is a major contributor to the escalating costs and reduced productivity of the industry. Current preclinical testing paradigms rely predominantly on animal models, including rodents, dogs and non-human primates. However, the high rate of attrition has called in to question the utility of some of these models and demands for more predictive tools.

Companies have tried since the 1970s to address this by frontloading their discovery and development processes with in silico and in vitro approaches. The aim is to identify compounds with undesirable characteristics as early as possible and remove them from development before they enter regulatory animal testing and clinical trials – fail fast, fail cheap is the mantra. This has been successful in reducing attrition due to poor pharmacokinetics and bioavailability, but the simple two-dimensional single cell-type cultures (often using transformed cells) are not sufficient for reliably determining efficacy and safety in modern drug development.  Increasingly, the research community is saying ‘goodbye flat biology’ and embracing advances in tissue engineering and microfluidic technologies to represent the multicellularity of organs in vivo; creating potentially more physiologically relevant three-dimensional cell and tissue cultures for early screening.

It is outwith the scope of this article to provide detailed case studies of how these technologies are being applied, but two excellent recent reviews in Nature Reviews Drug Discovery and Advanced Drug Delivery Reviews, cover this in great detail.

It is still early days in terms of the wider application of these technologies, but they hold great potential and there is real interest from the pharmaceutical sector in their development. The Wyss Institute in Boston, USA is leading the way, but there is increasing activity in Europe and the UK to capitalise on the growing excitement. However, for the full potential of these technologies to be realised, three steps need to be taken:

  1. Companies need to engage collaboratively with the international regulatory agencies. Regulators are keen to support companies in applying these new in vitro approaches and shouldn’t be seen as a barrier to innovation. To maximise the benefit of guidance regulators can provide, industry needs to engage with them early, and regularly as data emerges and the technology grows, to demonstrate its utility and justify its use.
  2. Companies need to take a leap of faith. Industry is currently maintaining a watching brief as these technologies develop, but to affect a paradigm shift, greater willingness to adopt and validate these approaches for their specific needs, is required. This is starting to happen, and as the results of these studies emerge we will start to see more companies embracing these alternative approaches.
  3. Greater cross-sector collaboration. Academics can be naive of the challenges faced by industry, and industry is often unaware of the advances being made in the science base which could benefit their business. More effective collaboration between these communities will ensure that the technologies emerging from the science base can be translated for industry application.

Opportunities are emerging to support industry in meeting these steps. New guidance from the European Medicines Agency to support companies in applying non-animal models through a ‘safe harbour’ approach has recently been drafted, and examples exist where drugs have entered clinical trials without having to go through standard regulatory animal studies (see Megit S. Immunocore pioneers new safety studies. In MedNous. 2011;5:14–15). The UK Government, through Innovate UK (formerly the Technology Strategy Board) and the major research funding councils, is investing in non-animal technologies to transform business and improve product development across a range of bioscience industries. This new initiative provides funding to support companies in working collaboratively with other businesses and the public sector to advance the development and application of novel, more predictive technologies. Finally, open innovation initiatives like CRACK IT from the NC3Rs is connecting researchers across sectors in highlighting industry challenges and providing considerable funding to support research and development of the solutions and a route to market.

John_Cumbers_SBBNext week SynBioBeta will return to London for its third year, supporting and showcasing the burgeoning field of synthetic biology. John Cumbers, founder of SynBioBeta, takes the opportunity to reflect on the explosive growth of the industry since he launched the conference three years ago and what you can expect from this year’s offering.

Three years ago, the UK Department for Business, Innovation & Skills identified “Eight Great Technologies” as strategic areas that the government would invest in, seeing them as future engines of economic growth. One of those key areas was synthetic biology, and not long after the BioIndustry Association (BIA) formed a new group to support companies working on this emerging area. The field of synthetic biology hopes to make biology easier and faster to engineer, offering the potential to address some of the major technological challenges of our century- energy, agriculture, environment and healthcare. The market is already growing at a substantial rate. Globally, the sector has exceeded £1.8 billion and is slated to quadruple over the next five years.

A couple of years back, synthetic biology was seen merely as an academic pursuit with only a handful of companies in the sector. To give you an example of how participation in this field has grown, this April at the SynBioBeta conference in London, over 45 emerging and established companies will be exhibiting.

I started SynBioBeta out of my living room because I wanted to create a platform for synthetic biology entrepreneurs to gather, share ideas, and learn how to overcome hurdles in a still uncertain landscape.  I joked at our first meeting in 2012 that it was a ‘self-help group’ for synthetic biology startups. I had to beg investors to speak on stage. No one wanted to invest or even discuss investing in the field.

In the last 12 months alone, some of those first attendees have made impressive investment announcements and our meetings are no longer geared just toward startups. Some of our initial attendees from that meeting who have had great success in the last 12 months are Twist Bioscience who has raised $26 million in a series B, while Ginkgo Bioworks and Synthace have raised $9 million and £2.2 million respectively in series A’s and newcomer Riffyn, who recently raised a $1.8 million seed round.

My team and I have been running SynBioBeta events at Imperial for the last two years, and have had the pleasure to be invited to return for a third.  Our host SynbiCITE, funded by the UK government, is an Innovation and Knowledge Centre dedicated to promoting the industrial adoption of synthetic biology. It was started by Professors Richard Kitney and Paul Freemont, bioengineers from Imperial College London, and has newly appointed a CEO Steve Chambers.

SynBioBeta panelThe conference will include a broad range of participants from the UK, US, and other countries across Europe with representation from a variety of industries including automation, pharma and healthcare, food and agriculture, and more.

This year, Emily Leproust, the founder and CEO of Twist Bioscience, will be giving the keynote address. She’ll discuss the company’s DNA synthesis platform expected to launch later this year. This is an unprecedented occasion as it will be the first time anyone from Twist has spoken about the platform in public.  In addition, we will have exciting new product launches from Synbiota, which makes user-friendly genetic engineering kits, and Glowing Plant, one of the first consumer-focused synthetic biology products.

We also have some impressive UK investors speaking at the event. Andy Smith of Mann Bioinvest will be discussing biotech startups and what he looks for in the companies he funds. Meanwhile, Oliver Sexton, investment manager of the £24 million Rainbow Seed Fund, will describe why he’s excited about the next generation of synthetic biology companies.

Together, we as innovators and investors in synthetic biology have come a long way since the first SynBioBeta conference in 2012. As stronger automation platforms come into play and the price of DNA synthesis drops, these new tools will speed up the designàbuildàtest cycle to bring the vision of an engineerable biology ever closer. SynBioBeta will be there, along with the BIA to nurture the synthetic biology community and build partnerships within the industry and beyond.

You can learn more about the SynBioBeta London conference at www.synbiobeta.com

SynBioBeta banner

BBC_Crowdfunding_FINALA warm welcome back to you all following the Easter break – time to start to gearing up for Q2!

Since our last Newscast, Parliament has been dissolved and we’ve officially entered the General Election campaign period. We’ll be keeping an eye out for party pledges that bear relevance to the UK science and business environment, and will communicate the most important points over the coming weeks. Parties will publish their manifestos in the coming week and Nature have published an interesting article that sets out the minority parties’ standpoints on science, and the British Science Association have just released a series of films of in-depth interviews with science spokespeople from each of the six major parties.

Over the weekend the Conservatives pledged to guarantee an £8 billion increase in NHS spending each year above the rate of inflation, aiming to meet the £30 billion funding gap identified by NHS chief executive Simon Stevens by the end of the decade. This brings the party into line with the Liberal Democrats, who have made the same commitment. But at the launch of the Labour manifesto today, Miliband called the Tories’ pledge an unfunded ‘IOU’.

In line with BIA’s areas of lobbying activity, the Labour health manifesto states that the party will ensure there is a clear route into routine commissioning for innovative treatments, as well as supporting the work of the Health Research Authority to streamline the process for setting up clinical trials and ensuring that NICE is fit for the future.

The full Manifesto makes no commitment to protecting the science budget ringfence, which is something many science policy campaigners have called for, although it does mention the importance of scientific discovery and says Labour will ‘introduce a new long-term funding policy framework for science and innovation, providing the stability and continuity that our companies and research institutes need to succeed’. It also mentions strong links between industry and universities, establishing a British Investment Bank to improve access to finance for SMEs, maintaining the most competitive corporate tax rates in the G7, and that membership of the European Union is central to our prosperity and security.

In an encouraging mark of investor support in the sector, it was great to hear that Woodford Investment Management has raised the ceiling of its Patient Capital Trust to £800 million and is expected to close this week. The investment trust, which will invest in early stage businesses and scientific IP emerging from British universities, had an initial target of £200 million with the option to increase to £500 million but was increased due to high demand. If successful in raising the full amount, Woodford Patient Capital Trust would enter the FTSE 250 and become the 40th biggest investment trust in the UK – a great boost for the sector.

Also on fundraising, over the Easter weekend the BBC broadcast a short report into crowdfunding in the biotech sector, featuring an interview with myself and UK biotech Venomtech, who are based at BIA member Discovery Park. For those of you who weren’t up at the crack of dawn on Good Friday to watch it, the clip is available here for the next few weeks – skip to 5’ 40’’ to catch the feature.

Our sister organisation, EuropaBio, carried out a survey in partnership with the Deerfield Institute on the current state of regulatory and health technology assessment (HTA) advice with a special focus on small and medium sized enterprises (SMEs). The survey report, published in March, provides SMEs with some useful advice on regulatory/HTA interfaces as well as assisting them in developing a strategy on how best to approach regulators and payers alike. I believe this will improve access to innovative medicines in Europe. As we possibly move towards a pan-European assessment of relative effectiveness, we need to ensure that the regulatory part of the process continues to be based on demonstration of quality, safety and efficacy of the medicine.

The Academy of Medical Sciences recently launched a ‘call for input’ as part of a major working group project on the Health of the Public in 2040. The project aims to explore aspirations for the UK’s future health and identify the key factors likely to drive the direction of travel over the next 25 years. The Academy hope to use this insight to focus in on the research evidence that will be needed to address current gaps and uncertainties and to identify the broader requirements for supporting, delivering and realising the value of this research, in order to maximise public wellbeing. If you’re interested in providing your views, the call for input can be accessed here.

Finally, on upcoming events – the first in a series of medicines manufacturing workshops, to be delivered by the KTN in partnership with the Medicines Manufacturing Industry Partnership (MMIP), supported by the BIA and ABPI, will be taking place on 6 May in Liverpool. Hosted by Actavis, the interactive workshop will explore and discuss supply chain challenges and examine supply chain issues faced in the manufacture of small molecule, biologic and cell therapy medicines. It will also bring together experts from other sectors with a view to sharing best practice and considering next generation supply chains. For further information do get in touch with Mark Bustard and request registration via Jean Aligorgi.

Best,

Steve

Following a number of high profile fundraisings, crowdfunding in the bioscience sector is heating up and is expected to continue to grow in popularity through 2015.

Earlier this year, Cardiff based start-up Cell Therapy raised a record breaking £691 000 to finance its stem cell medicine, Heartcel. More recently, Venomtech – based at BIA member Discovery Park – completed a £353 296 fundraise on crowdfunding site, SyndicateRoom.

Today’s video features a BBC World Business report into biotech crowdfunding, including an interview with Steve Bates, BIA CEO and Steve Trim, Managing Director at Venomtech.

Skip to 5′ 40” for the feature.

BBC_Crowdfunding_FINAL

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

Last month, in his final Budget before the General Election, the Chancellor George Osborne announced a £20 million grant for the Northern Health Science Alliance Ltd (NHSA) to establish the first phase of the Health North initiative – Connected Health Cities. Here, Dr Hakim Yadi, Chief Executive of the NHSA, discusses the role of the programme in driving digital health innovation in the North of England and across the UK.

Our health and social care systems are at a crossroads and the UK has a range of health challenges which need to be addressed. The poor health of the North, the escalating costs of healthcare and concerns about the quality of care services are all issues facing policymakers. However the UK healthcare environment also has a number of opportunities, including the availability of data at scale and the UK’s technical capability in data science. These challenges coupled with these opportunities have created the conditions for a transformation in health and care, which can be powered by the development of a trillion dollar market in digital health. Data-intensive health and social care is now at a tipping point where the UK can grasp a significant advantage.

But how can we tap into the opportunities presented by the establishment and growth of the digital health market? This is something that the Northern Health Science Alliance (NHSA), a network of the leading Northern universities, teaching hospitals, Trusts and Academic Health Science Networks (AHSNs), has been working hard to capitalise on in order to address the important health challenges facing the UK. The NHSA believes that the North can act as a successful test bed site for the UK, utilising our world class scientists as well as our real world patient populations to provide solutions to the challenges facing our health system.

In January this year, the NHSA was tasked by the Government to deliver their “Health North” programme to unlock healthcare innovations in the English regions with the greatest health challenges.  This was followed by the announcement of £20 million for the programme by the Chancellor in his final Budget before the General Election, to establish a scalable pilot network of “Connected Health Cities” across the North, to be run by the NHSA. This scalable network will build on existing partnerships and investments, as well as the North’s thriving digital and life science sectors. The North is currently the home to over 1,000 life science businesses, supports approximately 38,000 high skilled jobs and has a turnover of £10.8 billion underpinned by world leading science and technology. In addition there are over 100,000 students currently enrolled in life sciences programs in the North, and the leading eight Northern universities have produced over 100 publications ranked amongst the global top 1% in areas including Big Data, between 2008-12.

The “Connected Health Cities” will be a world first in civic partnerships sharing existing information to improve health and social care. They will assemble data, experts and technology in secure locations to generate new information that shapes health and social care services to deliver better outcomes for patients and communities by allowing us to follow patients through different services and extract information from many different organisations and databases.

In addition the “Connected Health Cities” will also enable new medical discoveries by working with the national Farr Institute of Health Informatics Research. This collaboration will ensure that the benefits can be rapidly shared across other regions. By replicating emerging research findings across a variety of well understood local populations, the UK will be able to perform more powerful studies than are currently possible with national databases, which lack information about local environments, services and other contextual factors.

For example, lets take Jean, a 49 year old woman with high blood pressure and depression who recently gave up her job to care for her mother who has dementia. Upon visiting her GP Jean’s drug treatment options are explained to her, with her GP tailoring the doses based on genomic profiling. However, the best choice of drug remains uncertain. Under the new “Connected Health Cities” scheme, a research protocol from the project runs over anonymous information and alerts the GP that she has a patient who might want to take part in a trial comparing seemingly equivalent drugs – the GP (but not researchers) can see that patient is Jean. Jean agrees to take part and to give regular feedback to the researchers, including home monitoring of blood pressure and her experiences via a mobile app. At the end of the trial, an alert is sent to Jean and her GP through part of the app she has been using for the trials, which promotes physical activity among carers. Jean is also offered targeted respite from social care workers. As a result, she takes up regular swimming while a care worker sits with her Mum. After a year Jean no longer needs antidepressants and her blood pressure is much better controlled.

Examples such as this demonstrate how “Health North” will work to provide social and economic benefits to the North and the rest of the UK, by acting as the much needed platform for rapid feasibility analysis and recruitment into clinical trials deployed over our 15 million population. The NHSA believes that the “Connected Health Cities” programme will be the catalyst for driving digital health innovation for the rest of the UK from the North of England and enable the UK to position itself as the leader in digital health market.

Several enhancements to the Seed Enterprise Investment Scheme (SEIS), Enterprise Investment Scheme (EIS) and Venture Capital Trusts (VCTs) were announced as part of this year’s Budget. Here, Richard Turner, Managing Director for Tax and Innovation at FTI Consulting, gives his view on the latest SEIS/EIS consultation.

You can see our response to the previous consultation here and also our press release mentioning this point in response to the Budget statement here. If you are interested in inputting to the latest consultation, please get in touch with Pamela Learmonth.

This year’s Budget announced several enhancements to the Seed Enterprise Investment scheme (SEIS), Enterprise Investment Scheme (EIS) and Venture Capital Trusts (VCTs). On balance the changes are positive. For Life Science companies the transition between SEIS and EIS will now be smoother and new thresholds will favour knowledge intensive companies that should apply to most companies in the sector. The draft legislation did not appear within the Finance Bill but was published as a separate document on the 24th March, available here.

In summary the new legislation, which remains subject to State Aid approval, will:

  • increase the employee limit for ‘knowledge-intensive’ companies to 499 employees, from the current limit of 249 employees;
  • remove the requirement that 70% of the funds raised under SEIS must have been spent before EIS or VCT funding can be raised;
  • limit initial EIS or VCT investment to companies whose first commercial sale took place within the previous 12 years except where the investment will lead to a substantial change in the company’s activity;
  • introduce a cap on total investment received of £15 million, increasing to £20 million for ‘knowledge-intensive’ companies.

This is largely good news but it brings with it a raft of new definitions and the odd tripwire. Believe it or not, many advisers would wish dearly to answer a simple question such as ‘will the company qualify for EIS status’ with a resolute ‘yes’ or ‘no’ but, unfortunately, the checklist gets ever longer.

By way of illustration, the definition of a ‘knowledge-intensive’ company requires it to satisfy one or both of two ‘operating costs conditions’ in addition to one or both of the new ‘innovation condition’ or the ‘skilled employee condition’. Broadly speaking, to satisfy the ‘operating costs conditions’ at least 15% of the company’s operating costs must be attributable to R&D in one of the preceding three years or at least 10% in all of the three preceding years. The ‘innovation condition’ is that the company must be engaged in IP creation and the ‘skilled employee condition’ is that at least 20% of full-time employees are ‘skilled’ whether that be a single company or within a group.

Perhaps understanding and learning the definition of a knowledge-intensive company should be enough to satisfy the condition in its own right.

The draft legislation introduces eight substantially new definitions including new concepts such as; the ‘FTE group skilled employee number’, a ‘relevant HE qualification’ and an ‘independent expert.’ This can all be worked through and, in most cases, the final answer will be the same as an intuitive guess.

It is unlikely that many life sciences companies will be caught by the 12 year rule due to the simple fact that most will not yet be making commercial sales. It is also important to note that the 12 year rule only applies to the first EIS of VCT investment. If the test is passed on the first round, follow-on funding will not be caught.

Notwithstanding these grumbles, the incentives remain highly attractive and worthwhile, but for those companies wanting to benefit from them on a recurring basis, here are four tips:

  1. Set out all the qualifying criteria
  2. Document the basis on which you satisfy each one
  3. Set out all the reasons why qualification might be withdrawn
  4. Keep it handy and check it every few weeks

This way, the details will become less intimidating and the incentive should hopefully continue to drive new investment.

MHRA_banners_720x215_find_moreAs is typically seen in run up to the end of a parliament and the official government announcement shutdown called “purdah”, we saw a flurry of last minute government announcements released last week. It was great to see BIA members Autifony Therapeutics and eXmoor Pharma Concepts amongst the industry winners in the latest round of Biomedical Catalyst funding. With total investment now at £350 million, the Biomedical Catalyst has helped accelerate the development of a number of innovative treatments and products to enable real patient benefits over the last few years. It’s critical that whoever holds the keys to power after the General Election gets behind the continuation of this scheme that has done so much to drive innovation.

Also on funding, the latest round of Industrial Biotechnology Catalyst awards were announced last week, and Vince Cable revealed details of 20 projects given conditional offers for the Advanced Manufacturing Supply Chain Initiative (AMSCI) – including an exciting new manufacturing design processes project campaigned for by the Medicines Manufacturing Industry Partnership (MMIP). This is a fantastic achievement arising out of the MMIP. The investment is a positive step towards increasing the UK’s prominence in medicine manufacturing and also in safeguarding and creating jobs. It was also great to see a further £6.2 million grant awarded to a consortium of BIA members – the Centre for Process Innovation, UCB Celltech, Lonza Biologics, Sphere Fluidics, Horizon Discovery and Alcyomics – as part of a project to adopt innovative technologies emerging from UK SMEs to improve the supply chain for biologic medicinal products.

Congratulations to all who received funding, and also to RedX Pharma who successfully listed on AIM last Friday.

In other government news, the Regenerative Medicine Expert Group (RMEG) report was published on Tuesday. As part of the panel, alongside BIA’s Cell Therapy and Regen Med Advisory Committee Chair Professor Chris Mason, I’ve been closely involved with the group, representing the needs of the UK’s regen med industry. The report addresses important issues that directly affect the UK’s attractiveness as a location to develop regenerative medicines – one of the Chancellor’s eight great technologies – and it rightly recognises that effective uptake in the NHS is absolutely critical for this. You can read more on our response to the report in our press release, and BIA member Pinsent Masons have written us a guest blog discussing the report, which you can find here. A member briefing is being prepared by our Head of Regulatory Affairs, Christiane Abouzeid.

Also taking place last Tuesday, I was delighted to be invited along to Guy’s hospital to hear more about Life Science Minister George Freeman’s Accelerated Access Review of Innovative Medicines and Medical Technologies (formerly known as the Innovative Medicines and Med Tech Review). In his speech, Freeman was keen to emphasise that the review would focus on tangible outcomes – the overall objective being for the UK to be the best place in the world to innovate and develop med tech and medicines and for “the FDA to look to the UK with fear”. Interim recommendations are expected to be published around September/October. We also heard details on the appointment of the Advisory Board – a stellar cast of 17, to include Kate Bingham, of BIA member SV Life Sciences. The Advisory Board will split itself and the work, as set out in the Terms of Reference, into workstreams which will be developed in partnership with the civil service secretariat team during purdah. The BIA will continue to engage with the review and we’ll keep you updated on any developments as and when they occur.

In another move to inspire innovation across healthcare in the UK, NHS England and the government  have launched their ‘test bed’ initiative to trial new ways of improving care for patients as part of the NHS Five Year Forward View, and are calling for expressions of interest from innovators from any sector in the UK and overseas who want to test their ideas to deliver health services in better ways at scale and in a real clinical setting. You can find out more on the initiative here.

There was also progress on the 100 000 Genomes Project, as Genomics England announced the first ten companies – including BIA members AbbVie, AstraZeneca, Biogen, GSK, Takeda and UCB – to come forward to create the GENE Consortium. The consortium will undertake a year-long industry trial involving a selection of whole genome sequences across cancer and rare diseases, discovering how best to collaborate with clinicians and researchers, and identify the most effective way of bringing industry expertise into the project in order to realise the potential benefits for patients.

On the regulatory front, the fifth MHRA Innovation Office case study, featuring BIA member BTG and developed with the support of our Manufacturing Advisory Committee, was published on Thursday. The study details the MHRA’s involvement in the development of a UK manufacturing site for a novel drug-device combination product – click here to view the case study and have a read.

From next week government goes into purdah, so we can expect a bit of a breather from announcements. We’ll continue to work on the ongoing Nurse Review and the NHS England consultation on specialised services. If you’d like to engage please contact Zoe Freeman.

A quick reminder that if you missed Thursday’s webinar on the Budget, it’s now available to view online here. And finally, Newscast will be taking a break over Easter – we’ll be back on 13 April.

Enjoy the Easter break,

Steve

OneStart, co-organised by SR One and the Oxbridge Biotech Roundtable, is the world’s largest life science startup accelerator programme. This year the competition received 638 applications, across 50 different countries.

On the 6th and 7th of February, 35 of the best startups were invited to London to take part in a ‘Biotech Bootcamp’ – two intensive days of seminars, panel discussions, pitching and networking – designed to equip young entrepreneurs with the skills to nurture their innovative ideas into a biotech company.

Watch the video below to learn more about the initiative, featuring footage from the Bootcamp.

Footage of the seminars and panel discussions from the London Biotech Bootcamp can be found here.

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

Earlier this week, the Regenerative Medicine Expert Group (RMEG) published their report ‘Building on our own potential: a UK pathway for regenerative medicine’. The report is the culmination of work by the RMEG, in consultation with other stakeholders, to develop a strategy and action plan to make the NHS ready to deliver regenerative medicines. In the post below, Helen Cline, Legal Director, Pinsent Masons takes a closer look at the report.

Complex regulation must be streamlined and commercial incentives improved for the UK to remain a hub for regenerative medicine.

The UK Government has identified regenerative medicine as one of the UK’s “Eight Great Technologies”, due to its “huge opportunities for technological advance” and potential economic benefit. The RMEG report rightly concludes that the UK has the “industrial base, the academic excellence and the clinical know-how that is necessary” as well as previous experiences of success in advanced medicine and treatments to “consolidate and build upon its position as a world leader in regenerative medicine”. Even so, challenges remain.

The RMEG is tasked with developing an NHS strategy for regenerative medicine, which it defines as “methods that replace or regenerate human cells, tissues or organs in order to restore or establish normal function”. The report sets out what additional steps are necessary to help researchers develop, and clinicians utilise, technologies that improve the human body’s ability to repair itself.

Regenerative medicine is the “future of medicine” and the proposals in the RMEG report to make navigating the regulatory environment easier are welcome.  Regulation in the area of regenerative medicines is complex, reflecting the nature of the technologies and their risks. For example, in the UK there are four regulatory bodies, each regulating distinct aspects of the development of regenerative medicine under different pieces of legislation, as well as a range of other agencies with an oversight role. One of the practical problems for researchers in regenerative medicine is the division of regulatory responsibility between these different bodies. There have already been steps taken towards the streamlining of regulatory advice, with a single point of access, for advice on regenerative medicine rules, available from the Innovation Office within the Medicines and Healthcare Products Regulatory Agency. Regulators have also collaborated on providing guidance on regenerative medicines issues, including developing the UK Stem Cell Tool Kit  to provide clear guidance on the regulatory pathways that must be followed in developing a regenerative product derived from stem cells. However, the RMEG’s report correctly highlights that “further steps are needed to ensure that standardisation of processes, and streamlined regulation, are guiding principles in advancing regenerative medicine”.

The RMEG, like the House of Lords’ Science and Technology Committee in their 2013 report,  also identifies funding issues as a barrier to the growth of regenerative medicines, and calls on the UK government and industry to come together to develop “an innovative business model that supports the early adoption of regenerative medicines”. It also calls for reviews to be carried out on “the funding for excess treatment costs for cell therapy trials”, with the aim of finding “a mechanism … to ensure that meeting of these costs is not a barrier to clinical trials or the early adoption of technologies”.

While debate in the past has been on the legality of funding research, at least in the US, debate today is on how best to regulate the clinical translation and support the commercialisation of these innovative technologies.

The nature of regenerative medicine research involves creating personalised precision therapies that may provide a cure rather than merely alleviating symptoms. There are, in many cases, high up-front costs associated with these individualised therapies that raise challenges around evaluation, funding and adoption. Unnecessary, excessively complex or burdensome regulation, together with unclear evaluation and funding pathways, could stifle the promise of regenerative medicine. That said, moves to streamline regulation to enable innovation must not put patients at risk of harm and damage the reputation of this field of research at a crucial point in its history.

Ethical and patent issues have also created challenges in the development of regenerative medicines. A ruling by the Court of Justice of the EU last year on the patentability of inventions that emerge from research on human embryonic stem cells highlights some of the divergent opinions on the issues.

Research in the field of regenerative medicine is emotive, especially when it concerns human embryonic stem cells. The debates around regulation and commercialisation include a diversity of opinion on the many ethical, regulatory and legal considerations; one example being patient consent in clinical trials, as the line between research and treatment is blurred in this area of medicine.

The UK Government has demonstrated its commitment to the growth of regenerative medicines research in the UK. Centres of excellence around cutting-edge technology are being assembled with a view to combining research and catapulting it forward; examples include the Cell Therapy Catapult and the new Precision Medicines Catapult. However, for regenerative medicine to flourish, and for the UK to retain its strong position in Europe and globally, a strict but enabling legislative and regulatory framework that facilitates innovation is essential. The current approach to regulation of medicines poses particular challenges in the era of ‘stratified medicines’. There are practical challenges in building the clinical evidence base necessary for approval under current regulatory mechanisms where patient populations are very small. The current regulatory and evaluation processes and policies need to evolve in response to, and in anticipation of, scientific developments that will be critical for the development of the UK’s regenerative medicines industry and the move to a stratified and more personalised approach to developing precision medicines.

The original article is available from Out-Law.com, legal news and guidance from Pinsent Masons.

Read the BIA press release welcoming the publication of the report here.

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