Archives for the month of: January, 2016

On Tuesday, BIA CEO Steve Bates appeared before the House of Lords Science and Technology Committee to give evidence on the influence of EU membership on UK science, building on the BIA response we submitted to the inquiry at the end of last year.

Watch the evidence session by clicking on the image below.

Steve2_HoL

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Nooman_Haque_2015_editBringing January to a close, in today’s guest blog Nooman Haque, Silicon Valley Bank, takes a look at the outlook for the sector over the remaining months of 2016.

There are good reasons to hope 2016 will be brighter after the healthcare financial markets ended 2015 in negativity. Broad macroeconomic fears started the decline in September but the sector created its own controversy when Turing’s price rise prompted an unsurprising response from Presidential hopeful Hilary Clinton and a storm engulfed Valeant across several fronts. The issues around Theranos opened the sector to accusations of style over substance and with impeccable timing, Martin Shrekli, the sector’s favourite pantomime villain returned in time for seasonal festivities, arrested for securities fraud in mid-December.

The impact was felt on both sides of The Atlantic; IPOs were pulled and suddenly, the funding climate went into abrupt deterioration. Are there positive signs in 2016 or will we experience a pervasive sectoral hangover?

Firstly, let’s acknowledge the challenges all companies face in going public today. In the US, appetite from some “crossovers” is waning, as many recorded mark-to-market losses and lowered their appetite for further risk. But perversely there’s a crude Darwinian argument here that bodes well: since 2011 equity has been cheap and prices stable (and rising). At times it seemed anybody with an idea and some early scientific results could go public and when these conditions persist, momentum investing is the result. And in such a market prices becomes detached from fundamentals.

Prices convey information in capital markets and it’s essential that those prices are driven as much as possible by fundamentals to give investors the best shot at accurately gauging risk. When momentum exists, the information aspect of prices is diminished and markets are less efficient as a result. This doesn’t help companies or investors.

Conversely, volatility acts as a check on companies and investors by forcing diligence, research and thus more accurate pricing. A high bar for equity ensures a minimum quality level that prevents the weak from flooding the market with their bad price genes. In my view, this doesn’t mean that early stage companies can’t get out, it just means that the risk will be appropriately priced when they go public. In short: you need fear as well as greed for a market to function properly.

This is no consolation to those IPOs caught up in the market turmoil. However the market will lurch to a new mean and I’m confident that whilst some companies won’t find it as easy to go public in 2016, the market will be better for it. And I strongly believe that if we do have a sensibly priced US market with higher average quality, the information that conveys to other international investors will actually make for better UK and European markets.

Originally written for Consilium Strategic Communications

Jane OsbournAs we hurtle towards the end of January and the first BIA board meeting for 2016, new BIA board chair Dr Jane Osbourn shares her vision for the organisation and the British biotech sector.

The BIA has set out a very challenging and ambitious vision for 2025, and it is important that we as an industry push ourselves so we continue to build our globally competitive edge. The aims set out in the vision are for the long-term. Our industry works on long development times and we need to build our capabilities for sustainability.

As UK biotech looks at how it can evolve, it’s vital that we learn from the more established clusters around the world and see what has worked for them. One of the most important roles that the BIA board plays is building relationships at international level so that we can share ideas and learn from the best in the business wherever they may be. Although it’s important to differentiate ourselves, we don’t want to reinvent the wheel.

There is also a lot we can learn by collaborating more in the UK and this is something that I will be personally encouraging through my tenure as chair of the BIA board. Throughout my career I’ve interacted with the BIA and reaped the benefits of working with its advisory committees – by working together we can help drive success in the industry. To find out more about the work of each of the committees and where you and your organisation could be part of their work, why not join us for the committee summit in February.

The BIA has been at the forefront of creating an environment that makes the UK stand out from international competitors. The UK is home to two of the world’s top three universities for life sciences and we’ve got a very strong connection between that academic base and small biotech. The Biomedical Catalyst scheme has helped us build small biotech and done a great job of translating academic excellence. A key focus in 2016 will be to lobby for fit for purpose funding schemes following the 2015 comprehensive spending review.

There are 4,398 life sciences companies and their sites developing, manufacturing and marketing products and services to the UK and global markets. The collaborative opportunities in the UK are really exciting, across academia, biotech and big pharma, who have been adapting their collaborative approaches to become more flexible and open about information sharing. In addition in the UK, we’re also getting more creative and ambitious about how our biotechs are evolving their business models. The focus has moved from early exits for biotechs to scaling up the business in a long-term, sustainable way.

The economic environment is also working to support the industry and the UK government has done a really good job in providing an optimal fiscal environment for the sector. It is a great result to see that, following the Government’s Spending Review at the end of last year that the science budget has been protected in real terms.

If we are going to scale our sector with the level of ambition that we’ve put out there, we’re going to need well over a hundred new companies and they’re going to have to be taking candidate drugs into the clinic. In 2016 the BIA will be looking at how we can support growing our biotech talent pool, building our managerial depth and experience in the UK, and ensuring we keep that talent in the UK to help our sector grow. We will also be looking at how our sector can more proactively engage with the investment community to ensure the growth opportunity is understood. And finally we have an opportunity that differentiates us from all other competitors, the NHS. We can use the NHS to deliver real patient benefits and we want to work at the interface to help support schemes that enable rapid patient access to innovative medicines.

Our sector has a great track record in the UK and it’s important that we celebrate our successes in solving unmet patient need so that the importance of our sector is recognised by as wider audience as possible. We have the capability to be one of the top three biotech clusters in the world, and if we work together across the sector to support UK growth we will deliver this vision.

I look forward to working with you all over my two year tenure and seeing many of you this week at the BIA Gala Dinner.

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The new £40 million Apollo Therapeutics fund launches today. The fund is a unique collaboration between BIA members AstraZeneca, GlaxoSmithKline and J& J Innovation, and the technology transfer offices of Imperial College London, University College London and the University of Cambridge, to support the translation of ground-breaking academic science into innovative new medicines for a broad range of diseases.

It’s fantastic to see these partners, across industry and academia, coming together to support the development of UK science. The fund will add to a growing momentum behind life sciences investment in Britain, providing support for high-risk early stage innovations to ultimately develop the treatments of the future. BIA Board member Ian Tomlinson will chair it, and if successful, I hope could broaden or lead to similar initiatives with other universities.

The buzz around the UK sector will continue through the week with many BIA member presenting at the 2nd Annual Future of Healthcare Investor Forum at the London Stock Exchange on Wednesday and our Gala Dinner this Thursday, where over 650 of us will be catching up with key contacts, making new ones and saying our fond farewells to Dippy the dinosaur  – updates following both to come next week.

Our sector was also in the global spotlight at the World Economic Forum in Davos, Switzerland last week. More than 80 leading international pharmaceutical companies and key industry bodies, including the BIA and many of our members, joined forces to sign a declaration to tackle antimicrobial resistance (AMR). The UK innovation ecosystem has a lot to contribute to this global challenge. BIA members that have signed up so far include: Absynth Biologics Ltd, AstraZeneca plc, Auspherix Ltd, Discuva Ltd, GlaxoSmithKline plc, Novabiotics and RedX Pharma. The Declaration sets out how governments and industry need to work with one another to support sustained investment in new products needed to beat the challenges of rising drug resistance. This is the first time that commercial drug developers have agreed on a common set of principles for global action to support conservation measures and the development of new drugs. The declaration also makes the call for all governments around the world to move forward from existing statements of intent and to work with the industry to take concrete action. Your company can still sign up at www.amr-review.org.

NHS England Chief Executive Simon Stevens also chose Davos to launch the first wave of NHS Innovation ‘Test Beds’. First outlined in the NHS Five Year Forward View, these collaborations between the NHS and innovators aim to harness technology to address some of the most complex issues facing patients and the health service. The idea is that successful innovations will then be available for other parts of the country to adopt and adapt to the particular needs of their local populations. It’s great to see BIA member MSD teaming up with Verily Life Sciences (formerly Google Life Sciences) on one of the projects to be delivered alongside NHS Heywood Middleton and Rochdale Clinical Commissioning Group. In a sense it’s a shame that the thinking here hasn’t extended to early access to medicines yet and I look forward to hearing more about the projects as they progress. You can find out more about the initiative here, including details on the five NHS Test Beds chosen.

Our latest quarterly review of BIA policy and regulatory affairs activities is now available to download here, covering the period from October to January. This great summary document  includes details on Spending Review outcomes, further developments with PRIME and the Accelerated Access Review, our recent ATMP briefing and the implementation of the EU Clinical Trials Regulation. Our analysis of implications following the Spending Review also touches upon the Nurse Review and, for further detail, we have produced a summary table – available to view here.

A quick reminder that early bird rates for SynBioBeta London, taking place this year from 6 – 8 April, are available until 6 February. You can view the agenda here for further information.

And finally, I’d like to draw your attention to a recent announcement from the Home Office that there are seven vacancies to be filled on the Animals in Science Committee. Do take a look and apply if of interest.

I look forward to catching up with many of you through the course of the week

Best

Steve

Action to tackle anti-microbial resistance was stepped up a notch this week as more than 80 leading international pharmaceutical companies and key industry bodies, including the BIA and many of our members, joined forces through the signing of a declaration at the World Economic Forum in Davos, Switzerland. Read yesterday’s blog to find out more.

Today’s video comes from BIA member, Public Health England, as Chief Medical Officer, Professor Dame Sally Davies, comes together with Dr Hilary Jones, Dr Rosemary Leonard, Dr Sarah Jarvis, Dr Ellie Cannon and Dr Carol Cooper to explain the consequences of a world without effective antibiotics but also to offer advice to parents on how they can keep their families well this winter and help play a part in preserving the antibiotics that we have now.

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

Action to tackle anti-microbial resistance was stepped up a notch today as more than 80 leading international pharmaceutical companies joined forces through the signing of a declaration today at the World Economic Forum in Davos, Switzerland.

The Declaration on Combatting Antimicrobial Resistance sets out how governments and industry need to work with one another to support sustained investment in new products needed to beat the challenges of rising drug resistance.

This is the first time that commercial drug developers have agreed on a common set of principles for global action to support conservation measures and the development of new drugs. The declaration also makes the call for all governments around the world to move forward from existing statements of intent and to work with the industry to take concrete action.

Why is the declaration so important? 

The independent review on AMR chaired by the economist Lord Jim O’Neill, estimated that the rise of drug resistant infections could claim 10 million lives each year by 2050 and result in a cumulative loss from global output of 100 trillion dollars unless effective action is taken.Comparative deaths

What does the declaration say?

The declaration covers three areas that signatories must commit to:

  • Reducing the development of drug resistance: encouraging better and more appropriate use of existing antibiotics by working with the World Health Organisation and by supporting improved education for clinicians. They will also work to promote a more judicious use of antibiotics in livestock as part of a one health approach
  • Increasing investment in R&D that meets global public health needs: continuing and extending collaborative initiatives between industry, academia and public bodies to improve how R&D in the field is done and provide greater opportunities to overcome the scientific barriers of antibiotic discovery.
  • Improve access to high quality antibiotics for all: supporting initiatives aimed at ensuring affordable access to antibiotics in all parts of the world at all levels of income


WorldMapChief Executive of the BIA, Steve Bates commented on the declaration:
“The ever-growing threat to world health from antimicrobial resistance cannot be tackled unless industry and governments around the world work together in new ways. It’s fantastic to see so many key organisations already signed up to the declaration and the UK innovation ecosystem has a lot to contribute to this global challenge”

BIA members that have signed up so far include: Absynth Biologics Ltd, AstraZeneca plc, Auspherix Ltd, Discuva Ltd, GlaxoSmithKline plc, Novabiotics and RedX Pharma. For more information on the declaration or to sign up your company please go to www.amr-review.org

Following JP Morgan week, we caught up with friends and members of the BIA who travelled out to San Francisco, asking for some of their key takeaways from the conference. Read them below…

Steve Bates, BIA CEOSteve Bates, CEO, BIA

“As always, San Francisco provided a great backdrop for the hectic week of meetings, presentations and receptions, that was JP Morgan week. The conference jolted into action on Monday with BIA member Shire’s long-awaited announcement that it will combine with Baxalta in a $32 million takeover. As Flemming Ørnskov, CEO of Shire put it “If I were British, I’d be pretty proud of the fact that someone can start a small company 30 years ago and, through the same strategy, basically get to be close to a top 10 company in the FTSE…It shows that growth and innovation does not just happen in the US.”

From our community there were plenty of positive discussions to be had around the UK sector and whispers of upcoming announcements – watch this space.”

MaryClarkMary Clark, Managing Director, International Healthcare, Hume Brophy

“It was a game of two halves at this year’s Annual JP Morgan meeting:  in the first half the corridors were as busy as ever and there wasn’t even standing room in the presentations.  In the second half, many investors had left to go back to their desks and stare at the red screens…”

KevinCoxKevin Cox, CEO, Imanova and BIA Board member

“A key observation for me at the Biotech Showcase was the increased interest in CNS diseases, particularly dementia. For the first time it seemed that people actually entered a room for CNS company presentations, rather than the exodus experienced in prior years!

Indeed, the whole event kicked off at an ungodly hour with a discussion on Alzheimer’s disease: Has the tide turned? King Kanute notwithstanding, the general consensus of the panel, with representatives from all industry stakeholders, was positive – albeit a little fragile. However, significant set-backs with some of the current amlyoid buster trials may turn the tide back in the wrong direction! Pleasingly, all the panelists were emphatic about the need for suitable biomarkers to demonstrate tissue delivery, target engagement and pharmacological response – the so called 3 pillars of drug survival. A heartening message for a biomarker development company.”

HHarrietFeararriet Fear, CEO, One Nucleus

“It was great to see members of One Nucleus, BIA, BioPartner, Bionow and MediWales at the drinks hosted by myself and Steve at the Clift on the Sunday evening before the week formally began. Record numbers and a good way for us to get over jet lag together and chat about the opportunities around the corner.”

Supriya BW jpgSupriya Mathur, Director International Healthcare, Hume Brophy

“The Biotech Showcase was the real star of the show at JP Morgan this year, especially with the excitement surrounding European companies announcing key deals last week. Interest in UK and European companies remained high, with many investors, brokers and big pharma turning their sights to the great science and potential in European biotech. Now to see whether the excitement will be sustained!”

Melanie Toyne-Sewell, Partner, Life Sciences, Instinctif PartnersMelTS

“The conference was as busy as ever, with the usual running between hotels and up hills to meetings. In particular, it was great to see so many European companies there with full schedules of investor and BD meetings, despite the volatility of the markets.”

 

New MHRA_2016 720x215 MoreSome notes from last week’s trip to San Francisco to kick off the blog this week. Hopefully you’ve all recovered from any jet lag over the weekend.

As always, San Francisco provided a great backdrop for the hectic week of meetings, presentations and receptions, that was JP Morgan week. It was great to see so many of you at the United Life Sciences’ informal kick off drinks hosted by myself and Harriet Fear on the Sunday evening before the conference began in earnest, and also at the BIA/AstraZeneca/MedImmune reception on Wednesday evening.

The conference jolted into action on Monday with BIA member Shire’s long-awaited announcement that it will combine with Baxalta in a $32 million takeover. As Flemming Ørnskov, CEO of Shire put it “If I were British, I’d be pretty proud of the fact that someone can start a small company 30 years ago and, through the same strategy, basically get to be close to a top 10 company in the FTSE…It shows that growth and innovation does not just happen in the US.”

The state of global stockmarkets in the first couple of the weeks of the year concerned many at the conference.  I sensed from discussions in San Francisco that the outcome of the US presidential elections will occupy the minds of many there up until 8 November, with the potential to impact US investment thinking. The flipside of political deadlock in the US is that the inability to reform tax there helps ensure our regime remains competitive and attractive, a strong advantage for the UK.

From our community there were plenty of positive discussions to be had around the UK sector and whispers of upcoming announcements – watch this space. One thing I will be watching with interest through 2016 is the establishment of London as the global hub for life science related IP commercialisation IPOs, something we’ve already seen in 2015. Research into the microbiome looks set to be a hot topic for the coming year.

Overall a great week which has provided much food for thought – see our blog tomorrow for more of the new collaborations and others key takeaways from the week.

Very sad news from France this week with the death of a volunteer in a clinical trial in Rennes and the hospitalisation of five others. The MHRA have put out a statement which makes clear that “there is no clinical trial taking place in the UK with this product nor has it been used in a clinical trial in the UK in the past.” We will keep a watching brief as investigations for any regulatory or policy implications.

Last Wednesday was a busy one with our Parliamentary roundtable co-hosted with MRC, AMRC, ABPI and BIVDA on the shape and future of the UK medical research landscape post-Spending Review, plus the NIHR Parliament Day and BIS annual stakeholder reception.

The roundtable was a great opportunity to discuss the outcomes of the Spending Review and Nurse Review and recent Government proposals on higher education, with a particularly engaged group from across the political spectrum. Liberal Democrat Lord Sharkey chaired the meeting and the nine MPs – Conservatives, Labour, SNP and DUP – asked many insightful questions. Attendees included senior representatives from each of the organising bodies, including Prof Sir John Savill on behalf of the MRC. Proposals on Innovate UK grants and the establishment of Research UK were hot topics and, notably, a common thread throughout the discussion was the need for more detail and clarity on proposed changes to the landscape. For more detail, take a look at BIA’s submission to a related Government consultation on the proposed changes.

The BIA was also pleased to attend the NIHR’s inaugural Parliament Day, celebrating its 10th birthday, hearing from both George Freeman and Sally Davies and checking out some of its latest successes. The NIHR have also written us a blog this week looking at the growing influence of technology in healthcare – do take a look here. From there we hotfooted it to the Science Museum for the BIS annual stakeholder reception with Sajid Javid.

This month the BIA will be finalising its input to the 2016 Budget. One element we will be raising is how a new relief on capital investments could positively impact the medicines manufacturing sector as part of the BIA’s support for the MMIP partnership. I’d be very grateful if you could take just 2 minutes to complete the a short survey which will help strengthen the case we put to the Treasury. The deadline is midnight 26 January.

Next week I will be appearing before the House of Lords Science and Technology Committee to give evidence on the influence of EU membership on UK science, building on the BIA response we submitted to the inquiry at the end of last year. I think it will be a great opportunity to explain some of the practical considerations for our sector in the context of a forthcoming EU membership referendum and I look forward to speaking to more of you on this important issue as that agenda evolves.

Those of you who with a current or potential R&D interest in London – commercial property advisory company Creative Places is leading a study to explore how London should develop to promote better collaboration, productivity and growth for companies involved in life sciences R&D. The company is working with MedCity, university and NHS partners, the London Enterprise Panel and the GLA to analyse how London can deliver what industry, research centres and health services need in order to underpin the innovation pipeline – from research to the adoption of new products and services. Life sciences and healthcare companies with a current or potential R&D interest in London are asked to provide input by participating in this five minute online study.

A couple of items for your diary towards the end of 2016, as I’m pleased to announce that this year’s Annual bioProcessUK Conference will be taking place at St James Park in Newcastle on the 23-24 November – more details to follow. Also announced last week, the Inaugural UK Regenerative Medicine Conference will take place on the 20-21 September – details are available on the UK Regenerative Medicine Platform website.

I’m looking forward to seeing many of you next week for one of our busiest weeks of the year, with the 2nd Annual Future of Healthcare Investor Forum, the Gala Dinner and the first Board meeting for 2016.

Best

Steve

Have you ever wondered what happens to a brain when it’s donated to medical research? How is it handled to make sure it is in the best possible state to use in research?

In today’s video showcase from the Medical Research Council (MRC), Dr Candida Tasman and Dr Laura Palmer from the South West Dementia Brain Bank at the University of Bristol explain.

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

Brain Injury HTC_headToday’s guest blog from the National Institute of Health Research (NIHR) examines the growing influence of technology in healthcare and the role of the NIHR in helping to bring these innovative developments to patients faster.  

The nation’s healthcare costs are rising fast, fuelled by growing rates of obesity, dementia and the increasing number of people with multimorbidities. The UK was faced with a medicines bill of over £13 billion in 2014/2015 and spending this year is expected to increase. Research and innovation in the NHS is critical for addressing these challenges, with healthcare technology a key focus due to its ability to transform patient experience while also making efficiency savings.

This opportunity to improve patients’ lives and reduce costs can be demonstrated through simple applications such as using SMS to remind patients about appointments, wearable devices that wirelessly monitor patients’ vital signs and technologies that improve patient experiences, like the neck collar for patients with Motor Neurone Disease (MND) and associated neck muscle weakness.

As the research arm of the NHS, a key focus of the National Institute of Health Research (NIHR) is to help bring these innovative healthcare technologies to patients faster. The NIHR funds leading-edge research and provides the facilities and people to conduct first class research in the NHS that spans the innovation pathway. For example, through eight dedicated NIHR Healthcare Technology Co-operatives (HTCs), the NIHR is working collaboratively with industry, charities and patients to carry out early phase research that will pull through the development of medical technologies into clinical practice. These HTCs provide centres of excellence in clinical areas, or themes of high morbidity, such as brain injury, wound prevention and treatment, trauma management and colorectal therapies.

Brain Injury HTCThe HTCs are able to access expertise in, for example, nanotechnology, biosensing and engineering that can aid the development of a range of medical technology solutions and support collaboration with industry. The UK SME community provides a hot-bed of innovation that is providing solutions to healthcare challenges. This is not only good news for the health of the nation; it can also benefit the economy. The UK medical technology sector boasts an annual turnover of £18bn from more than 3,000 companies, employing an estimated 88,000 people across the UK. The NIHR’s integrated research system is embedded within a unique National Health Service (NHS) and therefore provides a significant competitive advantage for attracting investment.

The NIHR Brain Injury HTC brings patients, carers, academics, engineers, doctors and nurses together with industry to develop innovative technology to prevent and treat brain injuries and their after-effects. It has organised a special Technology Showcase and Think Tank event on Wednesday 27 January 2016 themed on ‘technologies for independent living’ following brain injury. The event will provide an opportunity to tap into the HTC’s expertise and explore potential collaborations between industry, academics and clinicians. It will also give tech innovators and SME’s the opportunity to showcase their concepts, products and services to an audience of expert clinicians, service providers, academics and the public. The showcase will be immediately followed by interactive Q&A’s focussed on the technologies.

Registration for the event is by application and applications are encouraged from companies and project teams with healthcare technologies that would like to take the opportunity to provide a short presentation followed by expert Q&A. If you are interested in contributing to this showcase and networking event, please contact Talissa Gasser.

Brain scanTo find out more, click here

To find out more about working with other areas of the NIHR, contact the NIHR Office for Clinical Research Infrastructure.