One child dies from malaria every minute in Africa, 83% of which are under the age of five.

Last week, the world’s first malaria vaccine, developed by GlaxoSmithKline, won a green light from European drugs regulators for the prevention of malaria in young children in sub-Saharan Africa. The World Health Organisation (WHO) will now assess how the vaccine might be used alongside other tools to prevent malaria.

In today’s video showcase, GlaxoSmithKline detail their 30-year quest to develop a malaria vaccine.

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

Beagles_animal_research

Earlier this month, B&K’s new breeding facility in East Yorkshire was approved following an intervention by Local Government and Communities secretary Greg Clark. In the blog below, adapted from an original article on Huffington Post UK’s blog, Tom Holder, Campaigns Manager for Understanding Animal Research and Director of Speaking of Research, examines the crucial role of animal research in the development of medicines and the benefits of having a new breeding facility based in the UK.

Where do medicines come from?

It’s not a question most of us bother with when we take advantage of the huge array of medical treatments available to us.

All modern medicine is built on the ‘basic research’ which allows us to understand our physiology, and the diseases we suffer. Much of this research has been done, and continues to be done, in animals. Had Mering and Minowski not shown the causal link between the pancreas and diabetes in dogs, we might never have discovered insulin (much more work was conducted in dogs by Banting and Best who later won the Nobel Prize for the discovery of insulin). Had Pasteur not shown how dogs could be vaccinated using weakened samples of the virus (made from rabbits), we would not have both the veterinary and human rabies vaccines.

Animals are also used to develop and refine medical techniques. Dogs and guinea pigs played a key role in perfecting artery to vein blood transfusions, as well as showing that citrated blood could be safely transplanted (thus preventing the blood from clotting). More recently, 23 pet dogs with paralysing spinal injuries were able to regain some use of their rear legs thanks to a novel stem cell transplant treatment. This research had originally been done in rats, and last year was used to successfully treat a paralysed man in what could prove to be one of the biggest medical advances of the decade.

By law, animals must also be used to test the toxicity and safety of new drug compounds before they can be given to human volunteers. A pharmaceutical company will have used the findings of basic research studies to identify types of drugs which might be effective against certain diseases. They will then use a variety of non-animal tests – computer modelling, cell cultures and more – to identify the most promising drug candidates. Those compounds will then be tested in animals. If they are deemed safe enough, they may then be moved forward to human trials.

Milestones_animal_testingGiven public misconceptions on the issue, it is worth being clear and saying that in the UK, and across the rest of the EU, it is illegal to use animals to test cosmetic products or their ingredients. The UK ban came into force in 1998, one year after a ban on tobacco research using animals. The Government has also announced a ban on using animals for testing household products.

Regulations?

In the UK, 98% of procedures are conducted on mice, rats, fish or birds. Special protections exist for dogs, cats, primates and horses, meaning researchers must justify to the Home Office why another species, such as a mouse, fish or sheep, cannot be used instead of a dog. All research must be approved by an ethical review board, who will work to ensure the implementation of the 3Rs (Replacement, Refinement and Reduction of animals in research). The researcher, the institution and the individual procedure must each be licensed by the Home Office.

Despite the examples used in this article, dogs are not used that much in research in the UK. They account for less than 0.1% of all animals used in the UK each year. The video below, produced by Understanding Animal Research, shows dogs in a typical pharmaceutical laboratory in the UK.

So why a breeding facility?

Currently, around 20% of the dogs used in research in the UK are imported from abroad. This is because the UK breeding facilities cannot provide all the dogs used in the UK. These dogs have to endure long and potentially stressful flights from other countries. Surely it is better to breed them here in the UK, where we have some of the highest standards of laboratory animal welfare in the world and where our facilities can be easily monitored by the Animals in Science Regulation Unit inspectors? Petitioning the Government to reverse their decision on approving the beagle facility in Hull is misguided. It will not reverse our need to use animals in research, or even change the number of dogs used in the UK. What it will do is force another generation of puppies to take long flights from other countries, having been bred in older breeding facilities away from the UK inspectorate.

Animal research may not be something we want to think about when we take our medicines – but it is something necessary for those medicines to exist. Instead of trying to ban animal research, let’s continue to improve it – for the welfare of the animals and the quality of the science.

Tom’s original article, ‘Why people are wrong to oppose the new beagle breeding facility’, is available on the Huffington Post UK blog here.

APPG_launch

It’s been a week since the Westminster launch of the new All-Party Parliamentary Group for Life Sciences. A packed room of over 130 heard from Kit Malthouse MP, the Chair of the Group and Life Sciences Minister George Freeman MP and it was great to see political support for the importance of this group underlined in such a way. The Secretariat for the Group will be provided by Life Sciences UK, which comprises the BIA, alongside the ABPI, ABHI and BIVDA and the objective of the group is to be a Westminster home for discussion and awareness building of the sector with Parliamentarians. It was great to have such support for the Group’s first event and we’ll keep you posted on future plans for the Autumn.

Last week also saw Amgen’s first partnering day in the UK – with Senior execs from one of our larger members flying in to London to explain their strategy whilst strengthening their relationship with the UK ecosystem. It was good to see many BIA members at the event which our United Life Science partner One Nucleus took the lead on organising – partnership in practice. The feedback from both Amgen and smaller companies has been positive and I think it testament to the strength of the UK that Amgen see value in building their equity investments, joint ventures, early-stage partnerships, limited partnership investments, collaborations, in- and out-licensing, and acquisitions here. I hope for future similar events and would welcome feedback from those who attended.

The findings of the MHRA triennial review were published last week, following the submission of our response and feedback in January this year. Our feedback was positive, emphasising the need for the MHRA’s role to be re-confirmed and that the Agency should be adequately resourced to continue its functions and maintain its position as a leading regulatory authority with the ability to influence internationally. Therefore we were pleased to see the review conclude that the MHRA performs well in the delivery of its functions and should continue to operate as an executive agency of the Department of Health.

We look forward to working with the MHRA in taking forward Recommendation 10 from the review, which states that the Agency contributes “by working in partnership with industry, medical research bodies and other organisations” “to develop approaches for early engagement in the medicines and devices development process”; I’m delighted to see this government endorsement of our joint working approach which should now lead to close cooperation during the development of the Accelerated Access Review. You can download the full report here, with details of all recommendations.

In other government news, the new Science and Technology Committee took oral evidence on 15 July from Jo Johnson MP, the minister for science, as well as national academies and also launched its first inquiry last Tuesday into the science budget. The Committee invites written submissions by Wednesday 26 August so please get in touch if you’d like to input. This is a key inquiry ahead of the upcoming Spending Review (now confirmed to take place on 25 November) and Committee sessions will take place in the autumn.

The Department for Business, Innovation and Skills (BIS) is also running a stakeholder survey on the Register of People with Significant Control (PSC register), a requirement for UK companies under the Small Business, Enterprise and Employment Act 2015 from January 2016. BIS is further assessing the costs and benefits of the PSC register protection regime and welcomes your help in gathering further evidence by completing a short questionnaire.

CaSE is also running a survey, asking for evidence of the the impact of immigration on UK science and engineering, and the effect of Government policy on the UK’s ability to attract the best scientists and engineers from around the world which I’d encourage you to take a look at.

Finally, ending on a couple of sector news stories from last week. You can’t have missed the coverage on Eli Lilly’s Alzheimer’s candidate, solanezumab, from the Alzheimer’s Association International Conference, indicating it may slow the pace of the disease in those with early stage Alzheimer’s. It’s hard not to be optimistic, however further trial results due to report next year should indicate whether we are on the brink of the first disease-modifying medication for Alzheimer’s.

I’d also like to draw your attention to this article from the Huffington Post, following the approval of B&K’s new breeding facility in Yorkshire earlier this month. If you have ten minutes over lunch, I’d highly recommend giving it a read to find out more about animal testing in the UK and the arguments for having such a facility based here.

Best,

Steve

Earlier this week, The Royal Society published six case studies about businesses using science in the UK. Together, they demonstrate the diverse ways in which science inspires innovation, and how this supports businesses to turn new knowledge into benefits for society. One such case study features BIA member, Immunocore, who are harnessing the body’s own immune cells to fight cancer.

The biotechnology underpinning Immunocore is based on the science of founder Dr Bent Jakobsen, who led his own research team at Oxford’s Institute of Molecular Medicine until 2000. That work is now paying dividends, with positive results for their first clinical trials recently announced. Immunocore’s ambition is to become a premier global biotechnology company and a leader in the field of cancer immunotherapy. Watch the video below to find out more.

The full collection of stories about businesses using science in the UK, ‘Inspiring innovations’ is available to read on The Royal Society website.

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

Fujifilm_insideThe Medicines and Healthcare products Regulatory Agency (MHRA) Innovation Office is publishing a series of case studies, showcasing how they have helped companies to move forward with innovative health plans by providing regulatory advice early on in the process. Working with the Medicines Manufacturing Industry Partnership (MMIP) and the BIA’s Manufacturing Advisory Committee (MAC), the most recent case study featured FUJIFILM Diosynth Biotechnologies. Here, Dr Stephen Taylor, Senior Vice President Commercial, FUJIFILM Diosynth Biotechnologies, discusses the evolution of medicines manufacturing and the importance of the MHRA in ensuring more of tomorrow’s medicines are made in the UK.

The world of drug manufacturing has changed massively since I joined the game in the 1980’s. Then it was all about dedicated single-product facilities, pharma doing most of the higher value manufacturing work with little outsourcing and of course it was a small-molecule dominated market. “Biologics were just going to be a transient blip” as one pharma R&D director said to this young impressionable scientist.

Well here we are in 2015 and the sector has changed, albeit at the pace of a turning oil tanker when compared to IT, and biologics now represent the majority of the top ten selling drugs – including first place. The global pipeline of future biologic medicines is well over 1000 and we have a thriving outsourcing sector, with some biologic CDMOs (contract development and manufacturing organisations – I hate it when the ‘D’ isn’t used!) knowing more about biologics processes and manufacturing than many pharma companies do. Biologics won’t replace small molecules and no more will cell therapy replace biologics in the next decade, but the healthy 50/50 balance we are moving towards, with more hybrid products (so a win-win for both bio and chemistry communities), feels like a sustainable projection to me.

Fujifilm_smallAnd what happened to dedicated single product facilities? Today our focus is more about multi-product operations with emphasis on campaigns and fast change-over between products. Of course there will continue to be future Humira’s which can command their own steel edifices, but my crystal ball says the impact of personalisation and technological advances increasing process productivity, will inexorably lead us down the path towards more flexible manufacturing of small and medium volume biologics and creating facilities to make multiple different biologic products, but not actually knowing what they will be when designing. It’s not surprising to me that ‘single use’ and disposables technologies are going viral in support of this drive.

That’s why it was so important to us at Fujifilm, when expanding our mammalian cell culture cGMP capacity, that we were able to have a great dialogue with the Medicines and Healthcare products Regulatory Agency (MHRA) and ensure that what we built could provide for patient safety, manufacturing efficiency, adoption of new technologies and be able to make the 10 or so different, but still unknown, biologic APIs each year for our customers. With their advice we were able to create an operation that should stand the test of time.

Having an informed and accessible regulator is surely a jewel in the crown of the UK, and the Medicines Manufacturing Industry Partnership (MMIP) rightly has this centre stage. In MMIP we want to see more medicines manufacturing being done in the UK and we hope that the MHRA’s Innovation Office case studies, like the one citing the Fujifilm experience, can help with educating our market. The UK really is a great place for such work.

Fujifilm’s role of course is another of those somewhat unrecognised changes of the past 20 years. I believe that more biologics are now being made in ‘contract’ facilities than in those of pharma – both clinical and commercial. My own estimate is that the combined pipeline of clinical development biologics being made by Fujifilm and Lonza (the two largest UK based biologics CDMOs) in Billingham and Slough for our respective customers, is far larger than the UK pharma biologics pipeline.

We all want more of tomorrow’s medicines to be made here in the UK, so finding ways to persuade companies like Fujifilm and Lonza and our customers to retain their manufacturing in the UK as that pipeline transitions to commercial approved new drugs, is the great route and ought to be a priority.

Fujifilm_external

Earlier this month, over 80 CEOs and investors gathered in Weybridge for our annual UK CEO and Investor Forum. It was great to see so many faces, old and new, meeting to discuss the latest opportunities and challenges in the sector, including some of our newest BIA members – Vasgen, Calchan and IONTAS.

Some interesting discussions were had on driving value through diversity and corporate culture – something the BIA continues to be interested in hearing members’ views and experience on.

To coincide with the event, the BIA also published a new report with market intelligence firm Evaluate. The report, UK Biotech: a 10 year horizon contains some interesting and useful data sets for the sector, including the headline that this year and last are setting new records in financing for the sector.

The CEO forum provided the chance to discuss the new data, including the argument that the UK biotech funding ecosystem is doing things differently this time around – meaning that the UK financing system for innovative companies is better able to withstand a cyclical change than that in the US.

As always, some captivating discussions and debates from one of our flagship events. Check out some pictures from the forum below.

 

IMG_1607_600300Following last week’s update, the focus on finance and investment in the sector continues with some great news for BIA member Immunocore, who secured £205 million in the biggest private fundraising by a European biotech company. The fundraise marks a significant step for the company, and further emphasises the findings from our report with Evaluate which indicates a current peak in biotech financing and a trend towards fewer, larger financing deals.

Also on financing, last Thursday we held the latest in our series of Investor Ready breakfasts in London – many thanks to Fasken Martineau for hosting. It was fantastic to see so many of you there, including many starting new companies, with some great discussion around the sources of funding available for UK biotech. BIA member Cell Therapy Ltd provided some insight into the challenges of crowdfunding after they hit the headlines earlier in the year, raising almost £700 000 on Crowdcube – a UK record for crowdfunding in the life sciences sector. Our next breakfast will be at Stevenage Bioscience Catalyst in September, do join us.

On policy matters, today marks the launch of the All-Party Parliamentary Group for Life Sciences, a newly formed APPG to bring together parliamentarians and industry colleagues with a broad range of stakeholders to discuss the current issues and challenges facing the life sciences sector over the next Parliament. The launch of the APPG provides a timely opportunity to discuss how the UK can become a truly global centre to develop, market and give access to these essential and innovative medicines and technologies that benefit patients and the wider public. On which, further to recent updates on the government’s Accelerated Access Review – a topic for one of the meetings at this year’s BIA Parliament Day last month – the interactive site is now live here. Stakeholders are asked to feed in comments by 4 September to inform the interim report of this independent review. BIA will be developing an input over the summer so please get in touch with any views.

Following our fifth joint annual BIA MHRA conference in June, a report on the event is now available to download here. This is the first time we’ve come together to publish a report from the event, which we hope will provide a great lasting resource for SMEs, increasing awareness of the potential impact that patient engagement could have on regulatory pathways. Further information and materials from June’s conference, including presentation slides, can be found on the event website.

Also on event reports, earlier in the year I participated in a panel discussion as part of the “Eye on Bio” summit, hosted by Sidley Austin, MedCity and King’s College. A round up of the discussions from the day have now been published, debating the opportunities and challenges for biotech growth in the South East – available here.

At this Thursday’s webinar, we’ll be hearing from a number of BIA members on their efforts in tackling antimicrobial resistance. It’s not too late to register and listen to some of the UK companies leading the charge on such an important global issue.

Finally, the Wellcome Trust currently has an open call for future topics for Frontiers meetings – which Wellcome use to inform their thinking and strategic direction. They’re keen to hear ideas on future topics, so do take a look and contribute if you’re able. Further information is available from the Wellcome Trust.

Best

Steve

Earlier this week, fifty years on from its inception, the Yellow Card Scheme entered the digital age, as Life Sciences Minister, George Freeman MP, launched a new free-access mobile app.

The Yellow Card Scheme was established in 1964 by Sir Derrick Dunlop, Chair of the Committee on the Safety of Drugs, following the thalidomide disaster, to provide an early warning of possible hazards through the collection and monitoring of suspected adverse drug reactions.

Yellow Cards are used alongside other scientific safety information to help the MHRA make changes, if necessary, to the warnings given to people taking a medicine or vaccine, or to the way they are used, to minimise potential risks.

Watch George Freeman talk about the benefits of the new app in this week’s video, below.

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

TaylorWessingJust this week, GlaxoSmithKline announced an open innovation alliance with the new Francis Crick Institute to explore new avenues of medical research and drug discovery across a broad range of diseases. In today’s blog, Amanda Rowell, Taylor Wessing, takes a look at open innovation and some of the ways it is being adopted in the life sciences sector.

Companies were once reliant on developing strong in-house research and development capabilities in order to generate innovation and fill their product pipelines. Increasingly, larger companies and big Pharma are looking to build their pipelines by looking outside their organisation for other opportunities to pursue. This is consistent with the growing movement of “open innovation” to find solutions to problems.

What is “Open Innovation?”

Open innovation is a business paradigm that the in-flow and out-flow of research is not confined by organisational boundaries.

The benefit of adopting such a model is that it increases the pool of possible research opportunities, and draws on a wider range of skills and experiences than possible when limiting R&D to within organisational boundaries. It also allows smaller organisations to find ways of exploiting and commercialising their research output in another setting.

In many respects, this has been an approach in the life sciences sector for some time. Establishing joint ventures and collaborations between industry and academia have existed for some time and have yielded successful products. However, technology has changed how potential collaborators can be identified meaning the net can be cast far wider than ever before. The mobility of our modern day work force also means that inventors may be less likely to remain working in one organisation for their research career or may be more interested in collaborating with an organisation outside the traditional framework of a standard employment contract. The role of venture capital in funding smaller organisations has meant there is also growth in R&D output outside of the traditional larger players in the sector.

Innovative Medicines Initiative

The Innovative Medicines Initiative (IMI) is a partnership between the European Commission and the European pharmaceutical industry (represented by EFPIA, the European Federation of Pharmaceutical Industries and Associations) and is a form of brokerage service bespoke to the pharma sector. The IMI was established in 2008, with the aim of improving the efficiency and effectiveness of the drug development process with a focus on areas of unmet need. Unlike collaborations where one partner funds the other(s), the IMI provides financial support to enable the participation of academia, SMEs and non-governmental organisations in projects. Participating EFPIA members receive no financial support, but contribute “in kind” to projects through researcher time and the use of facilities. Between 2007 and 2013, the IMI saw the investment of nearly €2 billion in a variety of areas such as antimicrobial resistance, neurological diseases and diabetes. The budget for 2014 to 2024 is now €3.3 billion, half of which is from Horizon 2020, the EU’s framework programme for research and innovation.

As a first step, the IMI engages with stakeholders to determine upcoming priorities for investment. The IMI then advertises the particular problems and calls for submissions. From these submissions, a team is assembled to take the project forward. The IMI has guidelines in place regarding the ownership and licensing of IP developed by project participants. The general approach is that project participants retain ownership of their background IP and the IP generated by them in the project, subject to the grant of cross-licences to the other participants to use such IP rights in connection with the project or for research purposes. Alternatively, ownership and licensing can be determined on a project-by-project basis. This allows a degree of flexibility and as the IMI funds the participation of academia or NGOs (rather than the larger commercial participants), in principle this places such organisations in a stronger position to exploit their IP than if the commercial partner was funding their research in the area. The model grant agreement also sets out that beneficiaries of IMI funding are obliged to disseminate their results and ensure open access to peer-reviewed publications that publish the results.

In a recent example, the IMI has responded to the Ebola crisis by establishing eight projects directed at the development of a vaccine, vaccine manufacture and improved rapid diagnostic tests. The projects have a combined budget of €215 million and have brought together over 40 partners from the pharmaceutical & diagnostics industries, academia, small biotech companies and non-governmental organisations from Europe, Africa and the United States. The call for proposals was made in November 2014 and the selected projects launched two months later, demonstrating that the IMI is able to fast track proposals where needed and attract a range of participants from different geographies and areas of expertise.

The full version of this article is available from Synapse, Taylor Wessing. If you have any questions on this article please get in touch with the team.

Chancellor George Osborne visits BIA member, RedX Pharma

Chancellor George Osborne visits BIA member, RedX Pharma

Last week was a busy and productive one, especially in the field of finance and investment in the sector.

I was delighted to welcome over 80 CEOs and investors to our annual CEO Forum last week down in Weybridge. It was great to see so many faces, old and new to discuss the latest opportunities and challenges in the sector. It was great to learn more about some of our newest members including Vasgen, Calchan and IONTAS. I was struck in particular on the discussions we had on driving value through diversity and corporate culture and I continue to be interested in members’ views and experience on this important issue.

To coincide with the event, the BIA also published a new report with market intelligence firm Evaluate which you may have seen reported in last Thursday’s FT.  The report, UK Biotech: a 10 year horizon contains some interesting and what I hope are useful data sets for the sector including the headline that this year and last are setting new records in financing for the sector. In the foreward I argue that the UK biotech funding ecosystem is doing things differently this time around and that this might mean that the UK financing system for innovative companies is better able to withstand a cyclical change than that in the US. I tested this with some of you who attended the event and I look forward to hearing more feedback from the wider community.

Our report came hot on the heels of another key financial event: the Budget Statement. The focus of this Statement was how the Chancellor intended to make £17billion in savings through cuts to the welfare bill and from tackling tax evasion and avoidance. The political thesis articulated by the Chancellor was that he wanted to create a higher wage, lower tax and lower welfare economy. Throughout his Statement there was a mix of announcements intended to make it reality – incentives to work, lower tax for businesses and individuals but coupled with measures to boost wages and increase investment in training.

The key announcement to note is the plan to reduce the level of corporation tax from 20% to 19% in 2017 and then to 18% in 2020. The Statement also confirmed intentions to introduce a new category of ‘knowledge intensive companies’ in current tax-advantaged venture capital schemes which we have previously called for and welcomed at the March Budget Statement. However it is important to note that the Budget only looked at half the savings the government aim to make over the course of this Parliament. We will find out how the other half will be met in the Comprehensive Spending Review in the Autumn and we continue to work with the wider science and research community on the importance of sustained investment. In the meantime, do check out our full analysis of last week’s Budget on the BIA blog.

Further to his performance at the ballot Box, it was also fantastic to see the Chancellor visiting BIA member RedX yesterday and acknowledging their work on Antimicrobial Resistance. (CEO Neil will explain more on our webinar next week, click here to register. The visit coincided with the long-awaited announcement of the establishment of the Precision Medicine Catapult, which will be centred in Cambridge but work with other UK centres of excellence. It was great to see the appointment of John McKinley as CEO, who we were delighted to welcome to our recent BIA Parliament Day. Also announced was a new Medicines Technologies Catapult which will be based at Alderley Park. Read the announcement in full here.

Continuing the funding and investment theme, it was also great to see new figures from UKTI stating that 2014 had seen stellar results for inward investment, showing that the UK is the #1 destination in Europe for foreign direct investment (FDI). Adding together traditional FDI and R&D collaborations, the UKTI LSO team and partners supported more than 180 international businesses to invest in the UK last fiscal year, which will create more than 5,500 new jobs in the life sciences sector and deliver more than £2.2bn in new investment. Find out more here.

I look forward to discussing this all at our Investor Ready breakfast in London on Thursday and look forward to seeing many of you there.

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