On Highlights Autumn 2014

Autumn 2014

Welcome What a difference a year makes It’s fantastic to be at the heart – or the nucleus if you prefer! - of the life science and healthcare sector at the moment. Companies having IPO-ed; companies thinking of going public; AstraZeneca working hard on their plans for their global HQ down the road from us at Addenbrooke’s; members claiming this year’s BIO to have been ‘one of the best’. Who would have thought it just 12 months ago.

us in the collaboration all have the same reason for involvement – to serve our members and UK plc in a way that provides benefit against a backdrop of mutual trust and respect, a bit like a team of Huskies!

Of course One Nucleus has other collaborations too – both internationally and at home. Many of these are profiled in this edition of ON Highlights including MedCity, the AHSN’s and the Innovation Forum. I’d like to give a shout-out to the work of the Local Enterprise Partnerships (LEPs) within our main catchment area of Cambridge and London. I sit on Business Advisory Group’s for both I’m not suggesting that everything is and am incredibly impressed by the beautifully sorted, but when I talk commitment from their teams, and with battle scarred members and they also the London Stansted Cambridge tell me that things haven’t been so Consortium (LSCC) who I work closely positive for ages, it is hugely exciting. with. The LSCC comprises an impressive group of organisations At One Nucleus we rightly spend the across the corridor all working majority of our time focusing on together to establish the needs of member value and tangible benefit. business into the future, particularly I’m over the moon that our around the thorny subject of membership has risen to nearly 500 infrastructure/transport/housing. One member organisations in the last five Nucleus is working with them on the years and we have a world class issues affecting life science and range of Sponsors and Partners (see healthcare companies with a particular page 30). In terms of international emphasis on a commissioned report impact, better deal-flow between which will showcase the current members, and credibility - size does demand for growth space and matter, but of paramount importance anticipated future need – analysis to us is to show at the end of the year fuelled by a meeting Sir William that we have helped our members Castell of the Wellcome Trust and I maximise their global had with the group last year. competitiveness.

One of our main objectives in this regard is to work collaboratively for mutual member benefit and I hope you enjoy my article introducing United Life Sciences (page 9). I’m incredibly proud that One Nucleus is a founder member and joining the dots among membership groups and trade associations can only be a good thing for the sector and the UK. The four of

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A Model for Pharma Partnership

Patrick Verheyen, of the Johnson & Johnson Innovation Centre talks to One Nucleus.

great colleagues from Stockholm/ Uppsala Life Sciences and featured a high level panel debate on the subject of ‘How can patient registries be used to enhance R&D and better healthcare outcomes’.

Watch out for One Nucleus’ plans at the JP Morgan/Biotech Showcase in January and don’t forget we have a great deal for our members travelling to San Francisco via our relationship with the Flight Centre.

We undertake a wide range of activities with like-minded membership organisations, governments and business groups across Europe, Australia, the Americas and Asia – it’s a very important part of the One Nucleus dynamic. We can connect you across the globe – just drop us a line and put us to the test as we’ve not yet been unable to make an appropriate connection for one of our members overseas!

So, the times they are a changing, to quote Dylan and to show my age!

Long may it continue and One Nucleus looks forward to continuing to serve our members to the best of our ability and to collaborate with organisations that have a similar spirit of partnership to us, wherever they may be located.

Further afield we continue to enjoy a very warm relationship with our overseas friends. This year saw One Nucleus once again host our Dinner at BIO with BayBIO, MassBIO and BIOCOM, supported by BIA, CCRA and MedCity, and sponsored by Imanova and Biotec Services International. The One Nucleus Breakfast the following morning was in collaboration with our

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Stratified Medicine

Dr Eddie Blair talks about the Past, Present and Future of Healthcare.

the 6 Growing Golden Triangle’s Discovery Engine

An introduction to MedCity

Member News

Autumn 2014

A Model for Pharma Partnership Patrick Verheyen, Head of the Johnson & Johnson Innovation Centre

create a window on the science throughout Europe. We also have satellite offices in Israel and Russia.

We seek to establish collaborations with academia, clinical centres, venture capital, or in biotech companies aimed at delivering transformative products to patients and consumers. Another important goal is to be engaged partners in the life science community to broadly encourage and support a diverse environment for the translation of great science.

Within an increasingly collaborative and open healthcare environment, Patrick Verheyen, Head of the Johnson & Johnson Innovation Centre, London, speaks to One Nucleus on the Company’s approach to partnership.

What’s the objective of London Innovation Centre?

Johnson & Johnson (J&J) Innovation and the Innovation Centres were established to advance healthcare by catalysing collaborations between regional innovators and the J&J family of companies with the ultimate aim of improving healthcare.

We provide scientists, entrepreneurs and emerging companies with one-stop access to science and technology experts who can facilitate collaborations across J&J. Our goal is to deliver value to patients and customers through products across our consumer, pharmaceutical and device businesses that are truly transformative.

One of the core objectives of our Innovation Centre in London is to

What does J&J gain from its investment in open innovation?

Are partners tied into J&J or can you facilitate deals and partnerships outside the company?

J&J has tremendous scientific expertise internally, but our expertise and knowledge represents just a fraction of the global scientific innovation landscape. We believe that by working together with the global To sum it up, we need to create a healthcare community we can do a window on the science, know where better job identifying new and the science is leading us, enter into valuable products for patients and partnerships that are set up to best consumers. That is what the advance that science and then work Innovation Centres around the together with the community to lift world were set up to do - deliver everything to a higher level in products that promote longer and terms of efficiency, and product healthier lives. We are led by the differentiation. And I think we can science so once we identify a do that by extending our network project that we think is exciting and across the industry so that we can has the potential to be put the right experts together to transformative, we will look at what solve big problems. would help develop that idea

‘One

of the core objectives of our Innovation Centre in London is to create a window on the science throughout Europe.’

How does the J&J model differ from other innovation hubs and even TT organisations?

For us, one of the most important things has been locating many of our scientific leaders in the life science hot spots around the world so that they can work shoulder to shoulder with innovators and entrepreneurs in the region. Having our people on the ground helps us to create a window on the science in areas of interest to J&J across our pharmaceuticals, devices, diagnostics, and consumer products businesses.

efficiently and effectively. If the project would benefit from additional collaborators outside of J&J – we are absolutely open to that.

Tell us about a few exciting projects you are working on currently Since establishing the Innovation Centre in London approximately 18 months ago, we have made great progress in integrating with the regional scientific landscapes and (Continued on page 3)

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Member News entering into new and exciting collaborations. We have established a network of UK partnering offices, set up alliances with emerging companies and academic centres in autoimmune and inflammatory disease, Alzheimer’s, oncology, the microbiome and more. With other industry partners and the support of the government, we’ve established a biotech incubator in Israel.

But I think we are just scratching the surface. There is tremendous science here and that means a lot of opportunity to help advance new ideas to the clinic and on to patients and consumers.

Autumn 2014 The cities where we have established innovation centres all act as hubs for broad regional collaboration. We believe proximity to where the innovators are is critical. Being able to collaborate easily on a daily basis is an important way we can accelerate new ideas. So for example here in the London Innovation Centre, we have team members who are based in Israel and Russia and we have also established partnering offices in Cambridge, Oxford, Stevenage, Edinburgh, Cardiff and Manchester.

The Asia Pacific innovation centre has team members located in Singapore, Tokyo and Sydney. Our

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How can One Nucleus members engage further?

Get in touch! Our scientists and business people are very active and you can find us at many conferences throughout Europe. We have a regular presence at our network of partnering offices in Cambridge, Oxford, Stevenage, Edinburgh, Cardiff and Manchester - so come out and meet us there!

Or take a look at our website, www.jnjinnovation.com and learn about the areas we focus on across our three business sectors and send us an email about your idea.

‘There is tremendous science here and that means a lot of opportunity to help advance new ideas to the clinic and on to patients and consumers.’

You have hubs in London, Boston, California, and Shanghai – what and where next?

California IC is located in Menlo Park but that is a hub for all of California and the Western US. Similarly, Boston is a hub for the East Coast of the US. The variety of support that J&J Innovation brings to an external collaboration with the aim of delivering a valuable new product to patients and consumers.

Member News

Autumn 2014

Stratified Medicine – The Past, Present and Future of Healthcare Dr Eddie Blair, Managing Director, Integrated Medicines Ltd

Patient stratification is a compelling concept in drug development but how is it being used to bring more effective medicines to patients faster?

Dr Eddie Blair is an entrepreneurial life-scientist and Managing Director of Integrated Medicines Limited (IML). He talks to One Nucleus on just a few of his business ventures, the Scottish referendum and his involvement in Genesis 2014.

Tell us a little about Integrated Medicines, its history and your role.

I formed IML in 2003 to use some of the intellectual capital that we’d developed within the Predictive Medicine Group at GSK. GSK had decided to focus largely on genotyping and SNP analyses whereas Predictive Medicine had evolved plans for wider genomic-, proteomic- and imaging-based diagnostics to aid development and commercialisation of therapeutics; it was this broader technological thinking that created IML. I had also hoped to develop some IP that I invented in GSK – a smart inhaler to configure medicines released based on bio-sensing of asthma disease status – but this proved impossible. So IML acted

largely as a consultancy until we licenced some IP from Scottish Enterprise on magnetic proteins, allowing us to set up Integrated Magnetic Systems (IMSL) in Dundee in 2009. At about the same time, we successfully bid for a Small Business Research Initiative (SBRI) contract with the Technology Strategy Board (TSB), and so Janette Thomas and Belinda Clarke joined IML as directors to help IML operate on two fronts. I also coerced Belinda into joining me on the faculty of the Masters in Bioscience Enterprise programme run by Linda Allan and Sabine Bahn of Cambridge University’s Institute of Biotechnology, as the teaching there really keeps you on top of current developments in your field (personalised medicines and systems biology, in our case).

IML has looked at how theoretically diagnostic tests might aid better selection of medicines for faster development and expedited commercialisation of new therapeutics. Our modelling suggested a net present value (NPV) uplift of about $1.8bn over the life of a near-blockbuster medicine, ie. peak sales of $1bn, which concurred with the findings of McKinsey and PWC. However, all this modelling and theorising means nothing until you can pinpoint examples.

Despite infectious disease being the area where ‘test-and-treat’ approaches were best proven, the best example of diagnosticenhanced development come from oncology. An example is a drug called Zelboraf, also known as vemurafenib or PLX-4032, for treatment of malignant melanoma.

Incidentally, the SBRI contract – managed overall by Janette - ends When Roche licenced PLX4032 from Plexxicon in 2006, the drug had this December, and through subjust received IND approval for contracting with the University of Phase 1 clinical studies and by Manchester, and Luton and August 2011, after four months Dunstable A&E, we hope to review by the FDA, it received full commercialise a model of regulatory approval for the 60% of clinically-, temporally- and economically-optimised sepsis care. melanomas that carry the B-raf V600E mutation. The key to We are now also involved with expedited development and GeneFirst Ltd, a molecular approval was a test to identify the diagnostic company operating in V600E B-raf mutation. the stratified medicines space, although strategic consulting in the The recent data published by CRUK, UK, EU and USA remains our bread indicating that 50% of cancer and butter. patients now survive for more than 10 years, credits earlier diagnosis (Continued on page 5)

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Member News and more targeted therapy with these better outcomes, including breast and prostate cancers.

However, other high incidence cancers, notably lung cancer, retain a poor prognosis and so much work by diagnostic companies, such as GeneFirst, and pharma/biotech companies remains to be done. In addition, academics and industry are looking beyond infectives and oncology to develop better, ie. stratified, medicines for respiratory, metabolic and neurodegenerative diseases.

As a proud Scot, I’m sure you’ve been watching the referendum closely. In your view will the result be good or bad for medical research and scientific collaboration?

Autumn 2014 Stratified Medicine Innovation Platform and the Biomedical Catalyst Fund, not that I think TSB funding would be affected by independence, currency issues aside.

As a member of the Royal Society of Medicine, I hear clinical fellows old and young talking about personalised medicine, big data and next generation sequencing. These will also be key themes at Genesis.

Scots education, Scots law enforcement and Scots healthcare are already successfully administered independently, and so the independence debate really has to focus on long term impact of a vote either way.

In terms of the plenary session, Tony Jones, as always, has used his network to pull together a group of timely but thought provoking topics. Adrian [Towse] is one of the best health economists in the personalised medicine space and his papers with Lou Garrison from Seattle are excellent. I’ve known Andrew [Morris] since his time at Dundee where he helped create a ten-year database of all Scottish diabetics and all the interventions that they received in that period; he more than anyone has a grasp on how bioinformatics can improve healthcare.

One Nucleus is delighted that you are involved in Genesis 2014 as Plenary Chair. What can we expect from the session?

The biggest challenge will be muzzling Harriet [Fear] so that we can start the plenary on time!

(Interview with Eddie was held in Actually, the biggest challenge early Sept, ahead of the vote) might be getting people to come to I was saddened that I couldn’t see the session as Genesis is renowned the first live debate as an expat for its excellent 1-to-1 partnering. living in England, and also I won’t My own view is that we have been have a vote. It is a very hard call talking too long about personalised as most Scots’ hearts might say medicine being the future of ‘Yes’ but heads might be more healthcare. Sure, it is the future, sanguine and vote ‘No’. I am proud but it is also the present, and to of my Scottish education – a many, particularly the HIV and HCV Renfrewshire comprehensive and infectious disease community, it is my local University, Glasgow – and also the recent past. Thus, through our work at IMSL have personalised medicine isn’t seen how forward-thinking Scotland something that is over the horizon has been in managing and far away, but is actually happening modernising healthcare. now.

Rowan [Gardner] is always interesting and entertaining, whether analysing the healthcare sector, mentoring businesses or championing corporate roles for women; if she says ‘lean-in’, I’ll claim a fiver. I’ve heard Mike Ward over several years at Genesis and other conferences, and again, he is always entertaining, thought provoking and armed with incredibly accurate stats from the Scrip network. Missing this session would be a big mistake.

Patient stratification for public dialogue – see www.innovateuk.org/stratified-medicine-final-report

In addition, we have found Scotland to be well-endowed with a fabulous medical services industry and willing clinical collaborators at all of Scotland’s University medical schools - Glasgow, Edinburgh and Dundee in particular. However, in my view, the one organisation that has done more for UK healthcare industry and its collaborating academics, is the Swindon-based TSB (Technology Strategy Board).

Scots, Irish, Welsh and English SMEs have all benefited from a variety of programmes such as the

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Member News

Autumn 2014

Growing the Golden Triangle’s Discovery Engine Boris Johnson, The Mayor of London

grown companies can develop and grow. And fundamental to that is access to finance.

There’s a myth that it’s hard to unlock investment for life sciences in the UK. That’s not true; a good proposition will almost certainly find funding. What we don’t have is the kind of liquidity you find in Boston or San Francisco – and that is what creates, retains and grows a critical mass of exciting young companies.

In healthcare, the past is two years ago and the future is six months from now. The convergence of medicine and technology is changing our relationship with our own health, and opening new avenues for truly personalised medicine.

It’s an exciting environment in which an agile entrepreneur with a great idea can quickly make an impact - as long as they have access to the resources and funding they need to get it off the ground.

regulators, and a strong financial sector. And it has an ethnically and genetically diverse population supported by a National Health Service increasingly keen to simplify and speed up the process of establishing clinical research projects.

It’s a challenge that is top of MedCity’s list of priorities. Right now we are working with the financial sector on initiatives to nurture a community of investors who understand life sciences, are confident they know what a company with legs looks like, and are excited about the opportunity to create wealth through investment that also improves lives. There is great potential here to make the golden triangle a centre for life sciences investment, thereby building up our homegrown enterprise base and attracting others to create a thriving ecosystem of life sciences innovation.

What the region has not had until now is a one-stop-shop for the many different people wanting to do business here. It can be a complex place, and hard to navigate – with such richness of talent and ideas, how do you locate Fundamentally, MedCity has been Taking a new drug or health established because we all know the right partners? technology to market requires the that the more we work together, combined efforts of an average of The answer is MedCity – a the stronger we are. In an 29 professions, from medical collaborative initiative for London, extremely competitive global researchers and clinicians to Oxford and Cambridge, connecting market, this is already renowned as chemists and engineers, plus of the leading research and academic a region where leading-edge course financial analysts and centres to local government, the research and innovation is done. lawyers. Your best chance of NHS, the charitable sector and We have a tremendous opportunity success is to be located at the heart business. Our job is to provide a now to set a decisive course that of the action, where all those single portal for all of London’s vast will see this become one of the professions are at the top of their life sciences expertise and world’s top undisputed life sciences game and understand the communicate our offer to the world. clusters. environment.

Our ambition is to create within the golden triangle a thriving life That makes England’s greater south sciences cluster that competes on a east – the ‘golden triangle’ as it’s global stage. known – a great place to do business. It has a rich cluster of That means attracting exciting leading research institutions and companies from around the world business parks. It has a tax to work and invest here. Just as environment that supports importantly, it also means creating Contributed by Dr Eliot Forster, innovation, access to the key an environment in which homeChairman, MedCity

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Member News

Autumn 2014

New Cancer Diagnostic Device role in metastasis, the main cause of cancer-related deaths. The system is designed to help cancer researchers better understand CTCs and cancer metastasis biology, and to potentially develop new cancer treatments.

of cancer and ultimately improve patient care.’

The ClearCell FX System is labelfree and uses biomechanical properties to isolate intact, viable CTCs without the need for biochemical markers. The fullyCambridge Consultants helped to automated system integrates with translate Clearbridge Biomedics’ downstream assays making it design into a commercial prototype. simple to use and saving both time ‘This commercial launch of the and manpower. The device is highly ClearCell FX System marks a new sensitive and enables researchers milestone in the project after a to achieve reproducible results.

A new cancer diagnostic device has successful transfer from design and With the ClearCell FX System, a been launched as a result of a development to manufacturing,’ partnership between product simple blood test could provide said John Pritchard, Head of development firm Cambridge clinicians and researchers with realDiagnostics at Cambridge Consultants and Singapore-based time monitoring of a patient’s Consultants. cancer progression. This is critical Clearbridge Biomedics.

‘It’s the latest example of our as cancers are complex, The ClearCell FX System is able to expertise in diagnostic heterogenous and constantly isolate and capture circulating instrumentation, coupled with our evolving with each treatment and tumour cells (CTCs) from a blood long track record of helping clients over time. sample at concentrations as low as bring innovative products to market one in a billion blood cells. This is fast. In this case it has helped crucial for both research and clinical create a device that has the purposes as CTCs play a significant potential to increase understanding

The Emergence of HealthTech Tarquin Bennett-Coles Principal Consultant with the global Life Science practice of Odgers Berndtson

new cluster of companies joining long standing players who are looking to benefit from the massive volumes of big data that exist. We are witnessing a shift in action that is leading to greater cross sector collaboration and an increased number of partnerships and alliances between public and private organisations. This is being driven by four factors: ●

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The healthcare market is changing, and at executive search firm Odgers Berndtson the technology, healthcare and life sciences practices have been closely watching the market develop. The convergence of technology has not only brought internal teams together but has created a whole

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These new companies will need the very things that have made the Cambridge and London clusters so successful - access to money and the best talent, office and lab space, tax incentives, a buoyant job market, affordable housing, good international schools, competitive businesses, professional service organisations and a vibrant networking environment. One Nucleus, as an The need for countries to international membership manage healthcare spending organisation, sits within this ecoThe rise of hand held devices system and with a strong presence able to record, store and in both locations is ideally placed to send real time wearer help support and enable companies information to find the right business partners to accelerate innovation and Increased spending in the potential business growth. The sports supplements, Cambridge region alone now has monitoring, nutrition and well more than 500 life science firms -being markets with an additional 300 support The impact of the ‘internet of businesses. This would not have things’ been lost on pharma giant (Continued on page 8)

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Member News

Autumn 2014

AstraZeneca when it chose the Cambridge Biomedical Campus for its new global headquarters.

research, London and Cambridge consistently attract a diverse globally focused population. This is particularly important when you are According to Prof Michael Kitson, an trying to bring in the best talent economist at Cambridge from across the world. At Odgers University's Judge Business School, Berndtson they are seeing a new it helps new innovative models of international breed of decision business when you also have a maker and business leader emerge. concentration of academic These individuals are experts in excellence. managing multiple partnerships, ‘Cambridge depends on a lot of projects and stakeholders. They public sector activity. It has two know how to utilise the right universities and a hospital... they persuasion and influencing attract private sector activity into strategies to work effectively with the area. For instance, Microsoft’s other parties and have the European HQ for Research is based language capabilities and networks in Cambridge - partly because it is to work across borders. a source of good ideas.’

Facilitation of early adoption of new In addition to being an attractive technologies will need the right hub for bioscience and decision makers at the helm of technological innovation and businesses and organisations.

These leaders will need to be alive and open to disruptive and innovative thinking, comfortable in tailoring their communication style to suit their target audience, and prepared to take some measured risks. As ever the success of this new ‘HealthTech’ market in the next few years will be driven by people.

Odgers Berndtson is looking for those who want to be at the forefront of this brave new world.

To find out more contact one of the HealthTech team at http:// www.odgersberndtson.co.uk/gb/our -team/find-a-consultant/unitedkingdom/healthtech/

Success of Domainex’s Lead Compound in Pre-clinical Model of COPD Secures £1.4m Biomedical Catalyst Award Dr Trevor Perrior, Research Director at Domainex

successfully won a £1.4m Biomedical Catalyst Award to support further development towards Phase I clinical studies.

Roflumilast is a PDE4 inhibitor, known to have clinical benefit in COPD patients, and the p38 inhibitor is currently in late-stage clinical development. In the present study, Domainex compared the effect of oral doses of its compound with the same oral doses of either roflumilast or a p38 inhibitor in a COPD model that is widelyrecognised to be the ‘gold standard’ pre-clinical study. The Domainex compound showed more than twice Domainex Ltd, a Cambridge-based the effect of the comparator drugs drug discovery company developing in reducing the cigarette smokefirst-in-class small-molecule induced influx of inflammatory inhibitors, recently announced that cells, particularly neutrophils, into its lead compound has the lung. demonstrated a more potent effect in a key model of chronic Dr Trevor Perrior, Research Director obstructive pulmonary disease at Domainex, said: ‘These are very (COPD) than either roflumulast or a exciting results which suggest that p38 inhibitor. It has also our programme could lead to an

oral drug for the treatment of COPD with a much better antiinflammatory effect than existing medicines. This could provide the first truly-effective diseasemodifying treatment for COPD, which would have an enormous impact on the management of this debilitating condition.’

Keith Powell, Chairman of Domainex commented: ‘We are very grateful for the £1.4m awarded by the Technology Strategy Board via the Biomedical Catalyst, which will now enable Domainex to progress the COPD programme to IND. In parallel with the company’s ongoing discussions with potential corporate partners, Domainex plans to seek funding to explore utility in other inflammatory diseases and take the programme through to clinical proof of concept.’

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Member News

Autumn 2014

United Life Sciences: A New Partnership underestimated.

One of the outputs from the collaboration (as well as joint events we have run around the UK and overseas) is the delivery of the Manifesto 2015 – 2020. Led by the BIA, the four organisations have worked closely together it to pinpoint the key issues affecting As many of you will be aware from our members. We’ve run previous ON Highlights and our workshops around the UK and the activities, One Nucleus is delighted feedback from those meetings and to be a member of a strategic in-depth discussions with members partnership between One Nucleus, too have led to a document that the BIA, Bionow and BioPartner. We will be presented to each of the formally launched United Life parties seeking election in 2015.

Sciences at the BIA BioScience Other plans for United Life Sciences Forum last week. Together these include a series of UK roadshows, four organisations have over 1000 mutual profiling of each other’s life science and healthcare events, discounts for members on members across the UK and further each other’s activities and a afield. We meet at least quarterly combined approach to large face-to-face but also in between, as international events as we saw with you would expect, to discuss a BIO this year. Click here for the range of important matters press release. affecting both our members and the wider UK sector.

So, for those of you who aren’t We have been working closely aware of the activities of our three together for a number of years. colleague organisations, here is a So why collaborate? snapshot, which shows their strengths and where we all fit in Well apart from it being in my DNA with each other in a constructive to support the UK after 21 years of and positive way for the good of serving my country as a diplomat, the sector: collaboration, as so many of our members are aware, is vitally important. It avoids duplication of effort, it recognises that all our members are stretched in terms of their time and resources and it recognises the strengths and expertise of each of the four of us and what we bring to the table for BIA: Since its founding in 1989, at our members and UK Plc. the infancy of biotechnology, the Importantly the collaboration also BIA has made progress on many provides a united front (one voice) fronts, helping to shape a better to HM Government in terms of the environment for the UK bioscience lobbying/advocacy role that the BIA sector. BIA's relentless advocacy undertakes. All four organisations has prompted important legislative are fully committed to this. I know and policy changes that have from my time in the Foreign Office enhanced their members' ability to that the Treasury and others in research, develop, commercialise Whitehall want and need clarity of and deliver new and innovative issues, and the ‘One Voice’ that we therapies that save and improve bring under BIA auspices is hugely lives, strengthen the UK economy powerful and should not be and drive bioscience growth.

Significant engagement by the BIA over the last 20 years has led to: ●

Improved access to finance

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Ensuring a supportive regulatory environment for research and clinical development

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Enhanced environment for science

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Establishment of the Office for Life Sciences and its initiatives

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Publication of key sector communications

BIONOW: Bionow is the life sciences membership organisation for the North of England and supports business growth, competitiveness and innovation within the biomedical and life science sectors. Bionow’s mission is to provide the tools and support for organisations within the biomedical and life sciences sector in the North of England to become amongst the most competitive in the industry.

As part of the programme of support that Bionow delivers they host a number of key events in the life sciences calendar and over the coming months Bionow have an outstanding calendar of activities, including the recent BioCap 2014 the only specialist life science investment and showcase conference in the North of England, BioInfect 2014 setting the global anti-infectives agenda and the prestigious Bionow Annual Awards Dinner. For more information visit www.bionow.co.uk/events.

BIOPARTNER: BioPartner UK is an accredited trade organisation (ATO) that promotes international (Continued on page 10)

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Member News partnering for trade, investment and collaborations with UK life science companies. They bring an international perspective to the round table group, facilitating access to overseas markets for their members and those of the partner organisations including One Nucleus.

One of their main roles is to promote UK expertise at key international conferences. They are currently planning a delegation to BioSpain, arranging networking and financial assistance at BioPharm America in Boston, and preparing the UK Pavilion at Bio-Europe in Frankfurt.

Autumn 2014 BioPartner UK gives new and growing UK companies an edge when going international; managing applications for UK Trade & Investment’s ‘TAP’ grants that offset the cost of attending some events, and brokering discounts with event organisers for UK delegates.

Working closely with their round table partners, BioPartner promote UK bioscience as a whole, as well as individual companies on their UK Exhibition Stands and online directories, and via social media.

BIA’s UK Bioscience Forum and Genesis, and find out about grants and discounts available to offset your costs when travelling overseas; or visit their website. www.biopartner.co.uk

Do catch up with them at forthcoming UK events including the

Eva Diagnostics wins OneStart Competition The Eva Diagnostics team celebrates success at the OneStart finals night gala. From left to right Dan Perez (OBR), Rob Balfour (EVA), Millie Clive-Smith (EVA), Toby Basey-Fisher (EVA), Matthew Foy (SR One)

prototype testing and location specific market trials,’ said CEO Toby Basey-Fisher, a PDRA at Imperial College London.

The second annual OneStart competition took place in May at the Barbican Centre, London, with over 200 attendees from industry, academia, venture capital firms and other non-scientific organisations.

This year’s competition saw over 250 applications, with 35 semifinalist teams carefully selected to be guided and mentored by industry experts and leaders. Ten Winner of the annual OneStart blood cell count and has a variety finalist teams presented their competition, Eva Diagnostics is a of causes. It affects around a business plans to the panel of medical design and engineering quarter of the global population and judges with the winning team company that is commercialising is endemic in developing nations. It taking home the grand prize of diagnostic systems that can is the world’s second leading cause £100,000 and 12 months of free lab space. improve the lives of anaemia of disability; however, once the sufferers across the globe. Their cause is known, it is often curable.

Judging the competition this year leading product, AnemiStat, is a AnemiStat offers a significant were Jens Eckstein, President of SR low cost, compact device that is advancement in point of care One, Daniel Perez, Founder and capable of differentiating types of President of OBR; Patrick Verheyen, anaemia diagnosis within resource anaemia and assisting clinicians in limited settings. It offers clinicians Head of Johnson & Johnson diagnosing a cause. The device is a simple diagnostic test with Innovation in London, Ian handheld, robust, minimally accuracy comparable to goldTomlinson, Head of invasive, and easy to use. From a standard hospital tests, all within a Biopharmaceuticals R&D and drop of blood AnemiStat is able to handheld device.

Worldwide Business Development provide sufficient information for a at GSK, Martin clinician to infer a probable cause of ‘We are delighted with the award Murphy, CEO of anaemia and thereby offer patient- and would like to say a big thank Syncona Partners, tailored treatments. you for the amazing support and and Matthias guidance we have received. We are Anaemia is defined by a low Essenpreis, CTO of now ready to take our idea to the Roche Diagnostics. haemoglobin level or a reduced red next level which will include

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Member News

Autumn 2014

Acquisition of Argenta and BioFocus Extends Reach of Charles River

During their time as Galapagos service divisions, Argenta and BioFocus evolved to become two highly regarded early-stage discovery service providers. In early 2014, Charles River Laboratories, a leading US contract research organisation, acquired Argenta and BioFocus.

Onno van de Stolpe, CEO of Galapagos, commented: ‘We are pleased to sell the Argenta and BioFocus divisions to Charles River, one of the premier life science service providers in the world.

These newly acquired capabilities

are fully complementary to the services provided by Charles River, and Charles River therefore provides a logical and excellent home for Argenta and BioFocus.’

services to support the drug discovery and development continuum. It will enable us to engage with our clients earlier in the drug discovery process.’

For Charles River, the deal is the final segment in a continuous supply chain of contract research service offerings that commence with discovery and follow on to an investigational new drug (IND) application.

Bringing to the table target discovery through to delivery of clinical candidate capabilities, Argenta and BioFocus enable Charles River to offer unrivalled integrated services with expertise in an array of therapeutic indications, formidable drug discovery track records and a high quality of delivery.

James Foster, Chairman, President and CEO of Charles River, said: ‘The acquisition of Argenta and BioFocus is precisely in line with our strategy to build a broader portfolio of essential products and

For further information please visit www.criver.com.

MRC Technology Collaborates to Bring New Treatments to Patients One Nucleus BioNewsRound Award Winner - Duncan Young, Business Development Manager, MRC Technology, presented the news to the judging panel and received the award on behalf of MRC Technology and ARUK

MRC Technology (MRCT) was pleased to hear that Keytruda (pembrolizumab), the antibody which was first humanised by MRCT’s antibody engineering group and is now being developed by Merck Sharp Dohme (MSD), has recently received FDA approval and

so will be commercially available in bringing this new cancer treatment the US for the treatment of patients to patients. Clinical investigators with advanced melanoma. involved in trialling Keytruda have described the treatment’s potential Considered a breakthrough cancer as “exciting and striking” and a treatment, clinical trials have “paradigm shift” for cancer therapy. shown significant improvement in This is good news for cancer the prognosis for Keytruda-treated sufferers and represents a patients even in the most advanced significant milestone in the stages of melanoma. treatment of highly invasive tumors such as advanced melanoma.’

Keytruda is the first to market in the USA of a new generation of The UK government’s Life Sciences PD-1 therapies that block the Minister George Freeman said: ‘We biological pathways cancers use to are proud to see UK scientists once disguise themselves from the again playing a vital role in immune system. It acts by making developing an exciting new drug, the cancer cell ‘visible’ to the which has such potential for impact immune system and thus the cell on patients’ lives. This success can be destroyed by the body’s serves to highlight the importance natural defence mechanisms. of continued support for the life science sector in the UK.’ Dave Tapolczay, MRC Technology’s CEO, said: ‘We are delighted by this An application for European (EMA) news and proud that MRC approval has been made (June Technology scientists played a 2014). The therapy also holds great significant early-stage role in (Continued on page 12)

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Member News potential for treatment of an array of different cancers, and by the end of 2014 it will be in 24 clinical trials for 30 tumor types, involving an estimated 6,000 patients.

Autumn 2014 preclinical studies.

Earlier this year MRCT was delighted to receive the One Nucleus BioNewsRound Award, at the On Helix conference, on behalf MRC Technology has humanized of the Dementia Consortium. The over 55 antibodies to date, award, celebrating the most including four marketed products, creative, significant and exciting Tysabri (natalizumab), Actemra news stories from One Nucleus (tocilizumab), Entyvio member companies, was given for (vedolizumab) and Keytruda the announcement of the formation (pembrolizumab). A further five are of a £3m Dementia Consortium in in clinical trials and two more in collaboration with Alzheimer’s

Research UK (ARUK), and pharma partners Eisai and Lilly. The consortium was launched to boost dementia drug discovery and unites charity, academic and private sectors in the search for new treatments.

SBRI Healthcare Programme – Supporting a Sea Change in Patient Care growth.’

SBRI Healthcare Showcase Event, 10 December, QE II Conference Centre, London

The SBRI Healthcare programme is a key part of the government’s commitment to support the life science industry, encouraging economic growth and healthcare innovation.

healthcare value from a committed investment from NHS England of £20m.

Karen Livingstone, Director of SBRI Healthcare, commented: ‘SBRI Healthcare has seen steady growth Over the past year SBRI Healthcare since it was developed back in has doubled in size and become a 2007. This last year has seen a truly national initiative overseen by rapid expansion, both in terms the Academic Health Science of the number of companies Network’s (AHSN’s) newly formed involved and the level of funding. programme management board This funding growth is testament to bringing oversight and integration the programme’s success and to their innovation agenda. The reaffirms NHS England’s programme is led and managed by commitment to healthcare the Eastern AHSN and One Nucleus innovation and evidencing the member, the Eastern Innovation contribution of the NHS to the Hub – Health Enterprise East. wider economy. Through SBRI Healthcare we are seeing exciting Plans for the coming year include new technologies and products that the launch of two new competition will bring a sea change in patient rounds, supporting over 60 new care. The programme is also company products and developing building successful business in the existing company partnerships. This life science sector – vital for UK will provide patient benefit and

As part of this year’s Genesis Fringe, the SBRI Healthcare Showcase event brings together Industry, AHSNs, NHS leaders and clinicians, alongside SBRI Healthcare competition winners.

The event will showcase SBRI funded companies giving an insight into new innovations currently in development, the economic impact to date and the NHS partnerships being established. A series of presentations and panel discussions will aim to review the benefits of the programme from a NHS, economic and clinical perspective.

One Nucleus members and attendees of Genesis will receive a 15% discount when registering for the SBRI Healthcare Showcase Event.

For more information on this conference visit sbrihealthcare.co.uk or contact chris.armstrong@hee.co.uk

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Horizon Discovery Reports Strong Progress in Interim Results

Horizon Discovery Group has announced its first interim report since the Company’s recordbreaking listing on the AIM market of the London Stock Exchange earlier this year. Outlining strong progress in delivering on its strategic plan, Horizon’s management team says they are ‘excited by the continued prospects for growth’.

Since the IPO Horizon has continued to develop the breadth and depth of its intellectual property portfolio by adding two additional key pieces of CRISPR intellectual property, from ERS Genomics and The Broad Institute.

Horizon now believes it has the most comprehensive suite of CRISPR IP of any organisation, ensuring its customers unencumbered access to the gene

editing technology. Aligned with this strategy is GENASSIST, a comprehensive suite of products and services designed to enable customers to generate their own genetically-modified cell lines. To support the democratisation of gene editing, Horizon launched its Free CRISPR Guide programme.

value of the acquisition was subsequently confirmed when Horizon CombinatoRx announced the signing of an $835,000 collaboration agreement with Otsuka Pharmaceutical Development and Commercialisation.

Darrin Disley, Horizon’s Chief Executive Officer, said: ‘Horizon has made significant progress over the first half of 2014, with financial performance in line with expectations and continued robust revenue growth. We are confident of delivering a strong performance for the full year. In testament to Horizon’s status as a leader in gene engineering and the enablement of personalised medicine, we have The Company also added novel been pleased to be able to welcome phenotypic cell-based screens to its Dr. Susan Galbraith and Susan offering through the acquisition in Searle to Horizon’s Board as NonJune of the CombinatoRx service Executive Directors, as well as business from Zalicus Inc., which adding three of the world’s includes the unique cHTS platform foremost experts in gene editing and Chalice analytics software and and recognised inventors of provides Horizon with a base for CRISPR, Drs Charpentier, Joung, future growth of business and Zhang, to our SAB.’ operations in North America. The The aim of the programme is to enable the global academic research community to access high -quality, validated gene-editing reagents, and to generate thousands of new geneticallydefined cell lines which they can then deposit into the Horizon cell line inventory to be made available to researchers globally.

Global Spread for Lab Relocation Experts

Laboratory relocation specialist Andrew Porter Limited is enjoying an increased global market share, with a host of worldwide contract wins during 2014. The firm, headquartered in North West England, has so far delivered projects in Europe, the USA, Canada, the Middle East, China and Singapore this year.

unique service offerings. ‘It is fantastic for us that our reputation for delivering integrated laboratory relocation services, all of which are managed to GxP standards, is spreading and developing throughout the globe,’ John commented. ‘From fully project managed moves, through to the relocation of individual pieces of equipment and instrumentation, the variety of services we are being asked to deliver abroad is also increasing.’

Sales director John Best says the growing international spread of work is down to the firm’s range of

So far During 2014 Andrew Porter Limited has delivered turnkey project management solutions to

clients in seven different countries: the UK, Canada, Abu Dhabi, Italy, Ireland, the USA and Switzerland.

These have included full project management of vendors and OEMs, relocation of sensitive and valuable instrumentation, movement of temperature controlled specimens and dangerous goods, plus relocation of data and cleanroom setups.

Andrew Porter Limited has also been appointed to carry out a number of specialist temperature controlled services within recent (Continued on page 14)

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often require exacting declarations and statements. Andrew Porter Limited has recently completed international transfer projects in the USA, Singapore, China and Switzerland. Regional cross-border operations have been carried out within Europe, including Ireland, Germany, France and Italy.

international relocations, in destinations such as Switzerland, Ireland, Italy, Germany and France.

Uniquely, the firm is able to offer temperature controlled relocation solutions for all ranges including frozen, chilled and temperate with packaging systems validated for up

to 120 hours.

In addition, Andrew Porter Limited has been able to assist with international transfers in cases where specialist customs clearance has been required. This can be particularly crucial for the transport of research samples, which can

John added: ‘We would like to thank all of the new international customers with which we have worked this year. We are looking forward to forming long-lasting working relationships and to spreading our wings into additional countries in the coming months.’

For more information do check www.andrewporterltd.co.uk/ labrelocation.

Zyme Continues to Expand with Eight New Client Wins

Zyme Communications, the public relations and marketing agency specialising in the life science sector, continues to expand with eight new client wins in recent months. New clients include Absolute Antibody, BioRad, Capillary Film Technology, Cancer Research Technology, DefiniGEN, Enigma Diagnostics, Owlstone and Sentinel Oncology.

Commenting on the recent expansion, Lorna Cuddon, Zyme’s Managing Director said: ‘I am

Founded in 2010, Zyme provides communications support ranging from small press release projects, through to fully integrated marketing communications

programmes involving strategy and planning, branding, digital, design and development. Zyme’s team of life science communications specialists has both in-house and agency-side experience, and offers the flexibility to support both earlystage companies and large multinationals.

To find out more, visit zymecommunications.com or contact info@zymecommunications.com

Zyme manages the press area at ELRIG 2014 and other life science events including One Nucleus’ Genesis

On the back of this growing business success, Zyme has recently announced the appointment of Ellen PammenterFry as Account Executive to assist the senior team in providing clients with a wide range of PR and communications support. Ellen has a degree in Environmental Science and Geology and brings over 15 years of industry experience.

delighted to be working with such an exciting and varied list of new clients. Zyme is a specialist team with a strong track record and I am confident that our experience and network of contacts will add real value. We welcome Ellen to the team and look forward to her being part of Zyme’s future success and that of our clients.’

Member News

Autumn 2014

Abzena – The Times are A’Changing Abzena marks its debut on the AIM market at the LSE

many companies, and Antitope’s Composite Human Antibodies platform has been used to generate five products that are now in clinical development, including Gilead’s simtuzumab and Opsona Therapeutics’ OPN-305 - both in Phase 2.

Abzena has relocated its London operations to the Babraham Research Campus in the heart of the UK’s leading life sciences cluster to benefit from the colocation of the majority of its team.

The group has expanded into additional lab space within Antitope’s existing building on the Following the acquisition of that has already seen the group Campus and also leased a second Cambridge-based Antitope by work with the majority of the major building; Abzena is now one of the PolyTherics last year and the biopharmaceutical companies, largest companies on the Campus. subsequent creation of Abzena as including One Nucleus member Further expansion of the scientific the group holding company, the MedImmune. team and technology offering can team, led by John Burt, has taken Abzena’s core service and be foreseen and the company’s IPO the next step in its evolution and technology offerings are announcements made it clear that completed its IPO on the AIM immunogenicity assessment, further acquisitions will be part of market in July. Raising £20 million protein engineering, cell line its plans for future growth. of new capital including an development and bioconjugation to investment from Neil Woodford’s Whilst Abzena’s mission is to enable produce antibody-drug conjugates new fund, as well as continued better biopharmaceuticals, for the (ADCs). Antitope’s EpiScreen investors John Burt likes to support from Invesco Perpetual and immunogenicity assessment is now Imperial Innovations, Abzena will describe the business as ‘a picks an important part of the continue to build its service and and shovels business with a royalty therapeutic antibody and protein technology provider business model on the gold.’ candidate selection process for

Gates Foundation and Wellcome Trust back Kymab in $40M Series B Fundraising Cambridge based antibody company Kymab recently raised $40 million in funding from the Bill and Melinda Gates Foundation and existing investor the Wellcome Trust. The Series B financing will allow Kymab to maximise the potential of its Kymouse platform to advance its pipeline of proprietary therapeutic antibodies in areas of significant unmet medical need including immuno-oncology and immunology. Kymab will also collaborate with the Gates Foundation and its partners on

vaccine antigen discovery R&D with against challenging disease targets. an initial focus on malaria.

Recent data published in Nature Biotechnology demonstrate that the Dr Christian Grøndahl, CEO of Kymouse technology yields an Kymab, said: ‘We are delighted to antibody library constituted from attract investment from two of the 100 trillion different antibodies, and world’s largest foundations. This is from this deep library rare, higha strong financial and scientific quality antibodies can be selected endorsement of Kymab as we advance our proprietary pipeline of first-in-class therapeutics.’

The Kymouse technology is capable of rapidly generating an exceptionally broad diversity and quality of fully human antibodies

(Continued on page 16)

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16 Dr Christian Grøndahl, CEO of Kymab with Dr Stephen Dowd, Director, Business

and developed into therapeutics.

Trevor Mundel, the Gates Foundation's global health president, said Kymouse was ‘one of the most comprehensive transgenic technologies to date.’

To complement the growth of its internal pipeline of programmes, Kymab will seek to enter into a limited number of strategic collaborations with big pharma to identify and develop therapeutic antibodies in a range of diseases.

Applying a Distinctive Approach to Drug Discovery

Over the past 15 years, Vernalis Research has developed and applied a distinctive approach to fragment and structure-based drug discovery.

A particular strength of the Vernalis approach is the ability to develop

Currently disclosed collaborations include: ●

Novartis, a collaboration on the Hsp90 target. The lead molecule, AUY922, is now in phase II clinical studies.

●

Servier, one development stage (the Bcl-2 candidate) and two research stage collaborations on other undisclosed targets

●

Lundbeck, a research collaboration targeting LRRK2

●

Asahi Kasei Pharmaceuticals, a research collaboration targeting Rheumatoid Arthritis

For more information – visit http:// www.vernalis-research.com

Different representations of protein structure

Fragment-based methods identify low molecular weight molecules which make key interactions with the target binding site.

Experimental methods (such as NMR spectroscopy) identify which fragments bind; the structure of such ‘hit’ fragments is determined

by X-ray crystallography or, if required, advanced NMR methods.

This structural information on the fragment hits can then be combined with information on how other compounds bind to the target, such as those identified by high throughput screening (HTS).

This combination of structural information allows for detailed structure-based design from which potent ligands, and eventually drugs, can be developed.

innovative assays and approaches to make progress against novel, challenging classes of targets.

Large multi-protein complexes have long been a challenge in drug discovery. These are increasingly emerging as attractive targets which are implicated in diseases for which there is an acute unmet medical need for new drugs. The Vernalis approach is to carefully consider and validate the binding and functional assays, deploying a range of biophysical and structural methods to combine with medicinal chemistry to solve the problems that emerge in the early stages of drug discovery against such targets. The recent success on Bcl-2 is a disclosed example of this approach delivering a clinical candidate.

Member News

Autumn 2014

Using Magnetic Particles to Improve Cancer Care products are the SentiMag and Sienna+, both CE-approved medical devices. The SentiMag is an ultrasensitive hand-held probe for tracking injected Sienna+ to help locate lymph nodes in the process of cancer staging.

Endomagnetics was founded to improve patient experience and clinical outcomes in cancer care through the use of magnetic nanoparticles and advanced device systems. The company is already delivering on the promise of ‘nanomedicine’ with its products being sold across the EU and Australasia. Endomagnetics’ first

The company markets the only lymph node localisation technology that removes radioisotopes from the operating room, but without changing clinical procedures or outcomes. Of the more than 2.6 million patients in the West that could benefit from lymph node localisation, only around 50% have access to the standard of care. The advantages of removing radioisotopes are to resolve the availability of the standard of care, improve procedural convenience and put the surgeon in control. In regions where radioisotope supply is particularly challenging, such as Australasia, Endomagnetics has found significant interest in the technology and increasing access to

the standard of care.

The system has demonstrated clinical equivalence in ten clinical studies and trials with over 1,500 patients across 12 European countries since 2012. Sales have grown steadily across the EU since market introduction in November 2012, and Endomagnetics is currently expanding into global markets including the start of its US pivotal trial in late 2014.

Alongside these first products, Endomagnetics is developing a pipeline that spans diagnostics to therapeutics, improving cancer care while addressing markets in excess of £10 billion. Supporting its pipeline is a growing intellectual property portfolio currently comprising 16 patent families.

Innovation Leaders Conference 2015 Cambridge, 16 -17 April 2015 The Innovation Leaders Conference (ILC) brings together 300 academics, business leaders, disruptive entrepreneurs, policymakers and venture capital to stimulate communication and catalyse partnering for the next generation of innovative technology.

Confirmed speakers include: Dr Darrin Disley CEO, Horizon Discovery Kieran Murphy CEO & President, GE Healthcare Life Sciences Professor Sir Tom Blundell Bioentrepreneur, BBSRC chairman

and Professor of Biochemistry, University of Cambridge Dr Ian Tomlinson Head of Biopharmaceuticals R&D and Worldwide Business Development, GlaxoSmithKline Dr David Cleevely Angel Investor and Founding Director, Centre for Science & Policy, University of Cambridge This two-day event is hosted by the Innovation Forum, an international network of multidisciplinary innovative talent. The Innovation Forum seeks to promote the translation of cutting edge research into leading products and services by building bridges between

academia, industry and government and linking innovative minds across disciplines.

For more information, sponsorship opportunities and early-bird registration, please visit: www.inno-forum.org

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Ergomed Lists on AIM Dr. Miroslav Reljanovic, CEO of Ergomed plc, joined Marcus Stuttard of London Stock Exchange, to open trading in London on 15th July 2014

world’s largest drug developers) to biotech and generic companies, and comprises two complementary businesses. The Services Business is a well-established, clinical research business providing services to the pharmaceutical and biotechnology industry. The Co-Development Business is a growing portfolio of partnerships with pharmaceutical and biotech companies, providing its drug development services on a selected basis in exchange for a carried interest in any revenues attributable to the drug asset, including out-licensing milestones as well as sales of the product.

Ergomed, a profitable UK-based drug development services company, dedicated to the provision of global, specialised services to the pharmaceutical and biotech industry, recently listed on the London Stock Exchange’s AIM stock market with a market cap of £46 million, raising £11 million in equity.

At IPO, Ergomed acquired its sister company PrimeVigilance, a leading drug safety and medical information service business focused on postapproval services for late stage and approved drugs.

Chief Executive Dr. Miroslav Reljanovic said: ‘Ergomed's fundraising and admission to AIM is a very important landmark for the company as we look to become one of the leading global providers for rare disease/orphan drug development services, postmarketing services and to expand our portfolio of co-development partnerships.’

Ergomed has particular expertise in oncology, neurology, immunology and the development of orphan drugs, and believes its approach to clinical trials is differentiated from that of other providers by its innovative Study Site Management model and the use of Study Physician teams.

Ergomed operates in more than 40 countries across the world and its clients range from pharmaceutical companies (including some of the

DefiniGEN Launches Custom Metabolic Disease Models and Partners with Leading EU Pharma (induced pluripotent stem cell) bank will act as a central storage and distribution facility for human iPSCs, to be used by researchers across academia and industry in the study of disease and the development of new therapeutics.

DefiniGEN’s role will be to validate EBiSC iPSC lines by generating liver hepatocyte cells for toxicology, disease modelling, and regenerative medicine applications.

disease modelled liver cells. The service is targeted towards Pharmaceutical drug discovery clients looking to obtain high quality human liver cells from patients of particular ethnic genetic backgrounds and specific disease genotype. The cells can be used to test and identify promising lead compounds in early preclinical drug development.

DefiniGEN recently announced it has joined the European Bank for induced pluripotent stem cells (EBiSC) consortium. EBiSC has been newly-formed with support from the Innovative Medicines Initiative (IMI) and the European Federation of Pharmaceutical Industries and Associations Human iPSC based disease models (EFPIA). The consortium comprises DefiniGEN has also announced can help reduce the use of animal 26 partners including EFPIA launch of its Custom Cell Production models and overcome their often pharmaceutical companies, SMEs Service for human iPSC derived (Continued on page 19) and academia. The EBiSC iPSC

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Member News poor predictability due to species differences and the inability to develop test platforms mirroring diverse human genotypes. Human iPSC based disease models should also deliver more accurate mechanistic information predictive

Autumn 2014 of the in vivo state than is available using the widely used immortalized cells lines whose biology is necessarily perturbed.

DefiniGEN can generate iPS cells from blood or skin fibroblast

samples provided by the client from their cohort sets and differentiating them into terminally differentiated functional liver cells using its proprietary OptiDIFF platform developed at the University of Cambridge.

Co-Development Collaborations Help Progress Sareum’s Disease Programmes Front Row: Dr Tim Mitchell, CEO, Sareum; Mr Ya Fei Wang, General Manager, HMUBEC. Back Row: Mr Yu He Zhao, HMUBEC; Dr John Reader, CSO, Sareum; Prof. Donggang Liu, Deputy General Manager, HMUBEC; Ms Nadine Su, Link China Pharma Solutions

Sareum has been advised and assisted by Cambridge-based technology brokerage Link China Pharma Solutions (LCPS). LCPSs’ network of contacts within China and its understanding of Chinese business requirements have supported Sareum in identifying the partner, reaching the agreement and managing the ongoing relationship.

Under the terms, HMUBEC will be responsible for the IND-enabling preclinical studies of Sareum’s Aurora+FLT3 kinase programme targeting haematological cancers.

HMUBEC will have these studies performed to international standards and, in return, will have the right to carry out clinical studies and market any approved products in Greater China. Sareum will be able to use the data generated by HMUBEC to facilitate its clinical and commercialisation activities in the rest of the world.

Sareum, the AIM-listed drug discovery and development company, has entered into a series of co-development collaborations to help progress its cancer and autoimmune disease programmes through preclinical and clinical development.

HMUBEC’s capabilities include GLP laboratories, CGMP manufacturing and well-established sales distribution channels in Greater China. The company is based in Shijiazhuang, the capital of Hebei province, situated 180 miles south west of Beijing.

Having signed agreements with the CRT Pioneer Fund for its Checkpoint Kinase 1 cancer programme and with SRI International for its TYK2 autoimmune disease programme, Sareum announced its latest agreement with China’s Hebei Medical University Biomedical Engineering Center (HMUBEC).

The agreement matches HMUBEC’s desire to add novel medicines to its pipeline of generic and traditional Chinese medicine products with Sareum’s search for codevelopment partners to fund ongoing research in return for revenue share.

Sareum’s CEO, Dr Tim Mitchell, explained: ‘These co-development collaborations are a key part of Sareum’s development strategy.

They spread development risks and reduce Sareum’s funding requirements, as well as providing validation for the company’s research programmes and adding expertise that may not be available within the company.’

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Ignite: A Catalyst for Innovation and Growth in Biobusiness Dr Hermann Hauser CBE talks to Ignite delegates

provided me with critical strategy guidance for entering global markets. I developed a wider network, gaining advice from experienced entrepreneurs and experts who have proved very helpful while making strategic decisions about attracting new investors and signing contracts with clients. I also further advanced my knowledge of prosecuting and protecting Intellectual Property (IP) and how important successful IP management can be in determining the outcome of collaborations with large corporations.’

Meeting the challenges of a rapidly changing global environment and tapping into new opportunities has meant developing new strategies, approaches, collaborations and skills for those working in the biotechnology, pharmaceutical and medical technology sectors. The Ignite training programme, managed by the Centre for Entrepreneurial Learning at Cambridge Judge Business School, enables companies to develop the entrepreneurial flair and skills to understand the opportunities for successful translation and commercialisation of innovations within a highly regulated environment. It is a highly structured, intensive, one-week course including workshops and mentor sessions tailored to meet specific industry requirements and the needs of those looking to develop internal business projects.

Ignite has established a track record of enabling entrepreneurial ambitions and fuelling success. In the last ten years, over 600 participants from 26 countries across Europe, Asia and America

Novo Informatics has won business from global pharmaceutical companies and raised seed funding have attended the programme. It is from Kilitch Drugs (India) Ltd. estimated that approximately 170+ Director and Co-Founder Sahil business ventures have been Kapoor said: ‘Ignite came with an created by Ignite alumni and are ecosystem of innovators that I've still up and running. Based on a never experienced before. I was 2013 alumni survey, more than able to network with CEOs and £120 million in funding has been CTOs from various companies in raised by Ignite alumni ventures and around Cambridge in a really and approximately 2500+ jobs short period of time. I gained a were created from 2011-2013. better understanding of the Around 20-30% of Ignite alumni international market, ways of doing have come from the life sciences partnerships and how international sector. Some of the successful product strategies are developed alumni ventures include before launch. This has influenced BlueGnome; Oval Technologies; our approach to business Orthomimetics (acquired by development and marketing the TiGenix); DanioLabs (acquired by product.’

VASTox plc); Cambridge Temperature Concepts; Novo The next Ignite programme will Informatics (NI); and Apeiron take place from 5 July to 10 July Synthesis.

2015 in Cambridge, UK. If you would like to request a brochure, Polish start-up Apeiron Synthesis, a discuss the programme further or provider of fine chemicals and find out how to apply, please email catalysts, has raised $5 million the team at ignite@jbs.cam.ac.uk (US) from grants and investors to or visit our web site at become the first European http://www.cfel.jbs.cam.ac.uk/ metathesis technology business to programmes/ignite/index.html establish a branch in the USA. Cofounder Michał Bieniek said: ‘The Ignite programme experience gave me a far broader outlook and

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UKTI Focusses on MSBs support include: ●

●

●

●

For some Mid-Size Businesses ● (MSBs), international business development is the means to deliver far greater profitable growth than is available through a focus on ● the UK market alone.

Some of the UK’s European competitors, including Germany and France, benefit from a stronger ● export performance from MSBs than is currently the case in the UK. Experience at UK Trade & Investment (UKTI) shows that a strategy built on international growth frequently brings significant challenges and questions. This is true both for new exporters and for ● an MSB seeking to penetrate new, more difficult markets. For this reason, UKTI are now providing a specific service for MSBs. The East of England now has a new, dedicated team of experienced and specially recruited advisers ready to work with MSBs, to discuss questions such as market prioritisation, routes to market, business culture issues, financial tools, and IP. Advice and referrals are not limited to sources with UKTI, of course, and their advisers seek to provide links and contacts where possible beyond UKTI. Some of the specific ways in which UKTI might offer advice and

Access to the new mid-sized business offer from UK Export Finance Advice on alternative routes to market (eg. agents, licensing, outward investment, joint ventures) Specific tools to facilitate overseas market prioritisation and selection Access to UKTI’s unrivalled global network in over 100 overseas markets where commercially focused staff can undertake work on your behalf Use of prestigious Foreign Office buildings and residences for company events Access to high value opportunities such as the opportunity to become part of the supply chain for major overseas projects Participation in mid-sized business trade missions, often with sector focus and led by a government minister

Market specific advice and

information on business culture and language from our specialist adviser ●

Regional mid-sized business focused events and activities, including:

 Webinars – a series of 15+ webinars on specific issues faced by MSBs

 One day MSB conference at Cranfield University

 Sector and high value opportunity focused seminars and dinners If your business has a turnover of £25 million or more, or if you are growing fast towards that size, please contact UKTI at info@uktieast.org.uk or visit www.gov.uk/ukti

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Cambridge News Re-launched with a Fresh New Design knowledge and involvement in awards and peer recognition.

The daily title has been revamped with a vibrant new look and new sections covering sport, business, entertainment and lifestyle. There are greater opportunities for readers to get involved, contributing content and debating the issues that matter to them.

A bigger and brighter Cambridge News hit the streets in September.

The Cambridge News now appeals to a broader audience beyond the immediate city limits. The changes are being delivered from a strong base and are ‘Bigger, Brighter, Better’ reflecting the voice of the community rather than just the voice of Cambridge.

Richard Duxbury, Managing Director of Cambridge Newspapers said: ‘The new paid for daily editions are great news for the local area. The Cambridge News is great product that just got even better.

Extensive research has gone into the new title’s design and content and it now mirrors what’s important to the people who live in the communities we serve.’

As part of the re-launch, three additional Cambridge News editions have been published covering Royston, Saffron Walden and Huntingdon/St Ives/St Neots.

These paid-for daily editions replace the existing free weeklies and provide these communities with up-to-date news coverage.

Cambridge News Editor Paul Brackley said: ‘We have brought The new Cambridge News has been our readers a bigger, brighter and designed to build greater better Cambridge News, featuring a involvement in print, online and fresh design and more content. through e-communications; Daily editions of the title will enable through greater brand recognition us to reflect what is happening in across Cambridge News, Cambridge our local communities, while the Magazine and Cambridge Business; new sections provide a focus for and through greater connection key areas of people’s lives in the with business through a broader region.’

The Longitude Prize - The Race is on to Find a Solution In 1714 the British government threw down the gauntlet to solve one of the great scientific challenges of that century – how to pinpoint a ship’s location at sea by knowing its longitude.

Commemorating the 300th anniversary of the 1714 Longitude Act, Longitude Prize 2014 was launched by the Prime Minister at G8 2013 and is being run by Nesta with support from Innovate UK, the new name for the Technology

Strategy Board, as launch funding partner.

Tackling an important scientific challenge The British public voted for one of six major issues to become the focus of the prize, which had been shortlisted by the Longitude Committee (www.longitudeprize.org/ committee). The six challenges were: water (ensuring everyone can have access to safe and clean

water); flight (reducing the environmental impact of air travel); paralysis (restoring movement to those with paralysis); dementia (helping people with dementia live independently for longer); food (improving access to nutritious food); and antibiotics (managing the rise of resistance to antibiotics).

At the end of June 2014, the British public chose the rise in antibiotic resistance as the problem that they (Continued on page 23)

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Member News thought the Longitude Prize should tackle. The challenge is now set to create an affordable, accurate, rapid and easy-to-use a diagnostic test that will help to reduce inappropriate use of antibiotics.

From this autumn, anyone anywhere has up to five years to enter the Prize for the chance of winning the multimillion-pound prize fund.

Autumn 2014 effectiveness by putting pressure on bacteria to acquire antibiotic resistance.

It took about 22 years for the first cases of penicillin resistance in pneumonia to develop, 15 years for

erythromycin and 12 years for gentamicin. The first cases of resistance to linezolid outside of clinical trials were reported in 2001, only one year after its regulatory approval in 2000.

The problem with antibiotics Antibiotics underpin much of modern medicine. The World Health Organisation has estimated that the development of antibiotics has added an average of 20 years to our lives, but no new class of antibiotics has come to market since the end of the 1980s. In the 80 years since the discovery of penicillin, the overuse and inappropriate use of antibiotics is rapidly diminishing their

SCANurse Reaches Final Stage in Global Qualcomm Tricorder X Prize The original Star Trek Tricorder

capable of diagnosing a set of 15 medical conditions and capturing five vital health metrics with minimal patient invasion.

SCANurse, founded by Anil Vaidya, was specifically set up to enter the competition. ‘We have engaged with experts with a broad range of experience to contribute leadingedge technologies to SCANurse.

Drawing on my medical engineering background and understanding of the bipharma and diagnostics field, I am confident that we can develop a winning and ultimately successful The fictional medical device from device. SCANurse aims to be a Star Trek, the Tricorder, came leader in the digital healthcare closer to being a reality as new One market by putting medical Nucleus’ member SCANurse, a diagnostics into the hands of the London based digital health user.’ company, was announced as finalist in the Qualcomm Tricorder X Prize. SCANurse utilises novel existing technological solutions to solve The prestigious $10 million multiple sensing challenges, from Qualcomm Tricoder X Prize breath analysis to movement and competition is a 3.5-year global visual analysis. Their technical competition sponsored by the approach has avoided the need to Qualcomm Foundation to develop a take biological samples such as user-focused, mobile device

blood, to maintain simplicity for the user. The team has also avoided blue sky technological thinking to ensure faster regulatory and market acceptance.

Typical examples of existing technology being used include the use of CCD cameras to image vital areas such as the skin or throat, using pattern recognition algorithms to perform the analysis.

A UX interface encourages long term device user interaction, together with a simple and easy to understand display of results.

SCANurse now has until Spring 2015 to build the device and submit prototype machines for testing and evaluation in the USA. The company is actively talking to investors and looking for further support both financial and technical.

For further information visit www.scanurse.com

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Member News

Autumn 2014

Life Science and Healthcare Industry Employers Urged to Seize Training and Skills Opportunity have not always felt they have had an input into the national training agenda.

SIP programmes include Workforce Development, which offers government co-investment to upskill employees. This means that companies will receive a contribution for up to 50% of training costs, as well as being able to benchmark their performance online and access endorsed training solutions. The SIP also offers higher education programmes, including an Industry Degree Scheme, which provides employers with a vocational training that includes two paid summer placements and Modular Masters, a flexible programme of Master’s level training in formulation.

The science industries, including life sciences, have welcomed the news of a £32.6 million government coinvestment into skills and companies are urged to lose no time in accessing it. The news of the funding to establish a Science Industry Partnership (SIP), which is being facilitated by Cogent the national skills body, marks the culmination of months of effort by a science industry group to secure a stronger influence over the skills agenda.

Now SIP has been established by a leading group of employers to provide a way forward through a range of skills programmes – from entry level through to Masters.

Skills gaps and skills shortages across the science-using sector have been much reported. Criticism is directed at a range of bodies from schools through to academic institutions, with a particular focus on a lack of practical skills for the workplace. Employers too have borne the brunt of such criticism; with some commentators suggesting that entry level ‘on the job’ training has gone out of fashion over the last few decades. Many science companies of course provide excellent practical training but some are frustrated by the lack of fit for purpose training on offer.

David Willetts, the University and Science Minister, attended the The biggest funded strand in the launch of the SIP, and stressed its Partnership is about importance stating that higher skills apprenticeships - with 1,360 places are the key driver of success in the available over two years. It offers science industry sector. This was employers tailored Apprenticeship aptly summed up by Malcolm Training Plans which are designed Skingle, GSK Director and Chair of around the actual job rather than the SIP, ‘ultimately the SIP will help the qualification and can include into preserve the UK’s reputation as a house training. New traineeships world leader in an extremely can also be accessed as a stepping competitive area. stone to an apprenticeship or job. www.scienceindustrypartnership.co Critically the SIP doesn’t just m include large companies, but incorporates SMEs, many of which

The Government has made it clear that employers need to be much more involved in the skills landscape, and is supporting the SIP with a £32.6 million grant. This will be matched by employer contributions to the tune of £20 million as well as in kind contributions worth a further £31 million.

In the case of the graduate scheme and the apprenticeship programme, Cogent can also employ the individual, complete employment administration and take care of HR requirements. This typically includes contracts of employment, terms & conditions, management of sickness and absence, payroll and the monitoring of employees progress against objectives.

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One Nucleus News

October 2011

Autumn 2014

25 25

there was a good balance between commerce and science.’ Claire Thompson, Nanoscientium, added ‘It was the best conference I have been to in years! I don't know how you fitted so much into the day.’

The second ON Helix conference took place on 2 July this year at Churchill College, Cambridge, with an impressive range of presentations confirming our One Nucleus translational research event as a ‘must attend event’ for the life science community.

A key issue for many life science researchers is how to overcome innovation gaps. Although this has been covered at other conferences, ON Helix is the first to bring the life science industry and academia together at a dedicated event to discuss how to bridge the gap between basic research and marketable product.

Centring on real life case studies, experience sharing and interactivity, the programme for the day included many of the big translational research names in the industry - MSD, Neusentis, GE Healthcare, Horizon Discovery,

Sir Gregory Winter, Master, Trinity College, Cambridge, Professor Sir Tom Blundell, Hermann Hauser, serial Cambridge entrepreneur and venture capitalist, and Sir Mike Rawlins Chairman of the EAHSN and President of the Royal Society of Medicine.

After an inspiring keynote address from Mene Pangalos, Executive Vice President Innovative Medicine and Early Research at AstraZeneca, on the company’s plans to support and develop an environment in which science thrives, the morning kicked off in style with our three Sirs VIP panel debate. Cambridge serial entrepreneur and Venture Capitalist Hermann Hauser, Sir Mike Rawlins, Chair of the EAHSN, Sir Gregory Winter, Master at Trinity College, and Professor Sir Tom Blundell, University of Cambridge, addressed the controversial question ‘Is translational research working in the UK?’. Some of the main translational research challenges discussed included a focus on directed care, research governance, funding, and conflicting interests, which led to one of the best quotes of the day from Hermann Hauser ‘if you don’t have a conflict of interests then you’re not doing anything interesting!’.

Networking is a key element of ON Helix, and this year, in addition to EMBL-EBI, J&J, MedImmune, Astex the many informal networking Pharmaceuticals, Domainex and breaks and our one-to-one Covergence Pharmaceuticals. One partnering system, we organised a panel addressed target pre ON Helix Reception to gather identification - a key link in the delegates for a networking drink translational value chain - and and our first Summer discussed the relevance of various BioNewsRound Awards. Hosted by technologies in enabling Chesterford Research Park, the researchers to secure the required BioNewsRound Award event data to validate a target. The showcased a range of short-listed second panel discussion gave us organisations who pitched a recent hugely insightful success stories, news story all beautifully and highlighted key decision evidencing what was creative, making points in the development significant and exciting about their of a company, the relevance of story. The judges were their networks, and the importance of audience! And so with some peer accurate asset packaging. pressure, we announced that the The day ended with a final panel winner was MRC Technology for discussion on funding and support their announcement of the new option for translational research, dementia consortium they have which attracted enough delegates formed with Alzheimers Research to pack out the auditorium and kept UK, Eisai and Lilly. the delegates’ attention ON Helix 2014 went so well that we throughout. SROne, Syncona are already planning for ON Helix Partners and the Wellcome Trust 2015 (14 July) at the Wellcome and CRT all offered their views on Trust Genome Campus, the funding gaps, challenges and Cambridge. This year’s success opportunities. confirmed the relevance and ON Helix wouldn’t be such a quality importance of an event that not event without its high profile only addresses translational speakers and delegates. We have research challenges, but also had extensive glowing feedback on brings the right delegates from the content of the conference and business and academia together quality of the networking. Philip all under one roof for one day.

Oliver from MedImmune said ‘I For more information visit thought the programme and www.onhelix.com or please speakers were excellent, and that contact aline@onenucleus.com

One Nucleus News

October 2011

Autumn 2014

Introducing Genesis 2014 Now in its 14th year, Genesis continues to develop as one of the must attend events in the life science calendar. The theme for Genesis 2014, to be held in London on 9 December, is built around how to convert world class research into world class healthcare solutions and commercial success. The core format of plenary sessions, tailored breakout sessions, 1-2-1 meetings, exhibition and networking remains the constant, but the benefit is in the detail. Success in our sector relies upon accessing the right partnerships, raising capital and developing products that will gain market access and reimbursement.

We are delighted that the agenda at Genesis this year will see experts addressing all the following aspects.

industry model must change. The breakout sessions will contain debate on financing models, external partnerships, innovative technology areas, regulation and the now traditional case study deal sessions lead by Scrip Intelligence.

Two plenary sessions and 12 breakout leadership sessions means depth of insight for all attendees.

1-2-1 Partnering A new online meeting system is being deployed this year through our partners at EBD since we will be using their GroupsPLUS meeting scheduler within the partnering360 service. Nearly 1000 meetings took place last year during the 7 hours of meeting slots available.

The Programme

2014 BioNewsRound Award

The plenary session will look at the models of value-based pricing, integration of public health and patient data into a meaningful innovative medicines strategy, winners and losers of 2014 and a disruptive look at how the Pharma

There is a change to process by which we will be delivering the BioNewsRound Award this year.

Previously held the preceding day, 2014 will see the award move mainstream. The format of entrants

having four minutes to describe why their news from the previous 12 months was exciting, significant and good for patients will remain.

The competition entry will open in October with a semi-final of the presentations taking place at the 12 November BioWednesday. The delegates attending the semi-final will vote to select the final six finalists. Voting will then open online between 13 November and 9 December at Genesis. This provides a month for the finalists to drum up support and allows the widest possible voting pool to select the most worthy winner. The announcement of the winner and award presentation will take place during the lunch session at Genesis.

Exhibition We again expect 70+ exhibitors displaying their product and service offerings that range from facilities, professional services, innovative technologies and contract research.

Stand spaces are allocated on a first come first served basis with (Continued on page 27)

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One Nucleus News

October 2011

they want to meet, they always leave events feeling they may have missed opportunities that weren’t initially on their radar. It seems unfortunate if opportunities are missed through lack of awareness or connectivity and by not maximising resource efficiency. To this end, participants in the Source Lounge will receive:

many already booked as you would expect. If you would like to exhibit and raise your profile at Genesis, please contact us as soon as possible.

●

A4 literature displayed on the Source Innovation Hub

●

Pre-event promotion of their participation and product offer which would include the names of their attending delegates in order for interested industry delegates to target 1-2-1 meetings via the online system

●

The Source Lounge – New for 2014 The Source Lounge which will be an area in the main exhibition hall with four innovation hubs covering (i) Access to Finance; (ii) Access to R&D services; (iii) Access to International Opportunities; and (iv) Access to Innovation.

The Source Lounge has emerged from feedback indicating that whilst delegates are very comfortable that they can use the 1-2-1 meetings system to target potential clients, partners or investors they know

●

Registered delegates can apply to participate in the Source Lounge and receive the above benefits which are free to One Nucleus members and £175 + VAT to non-members Additional delegate passes at the applicable rate (£195 - £325 + VAT), but included as named targets within the pre-event promotion.

Genesis Fringe

Autumn 2014

order to capitalise on our larger gathering in London at that time.

For 2014 we have elected to somewhat formalise such requests by inviting them to become part of the Genesis Fringe. We will list details of the Fringe events on the Genesis website and keep you updated. They won’t usually be One Nucleus events, but links will direct visitors to the appropriate registration pages and contacts. To date, the Genesis Fringe will include: Developing Biologics in UK and Australia – Australia House, 8 December Genesis Welcome Reception The Ambassador of Belgium’s Residence, 8 December Contract and Licensing Masterclass for CROs - Charles Russell and UBIFrance, 8 December SBRI Healthcare Showcase – QE2 Conference Centre, 10 December European Lead Factory Seminar – Queen Mary Innovation Centre, 10 December Highlights of last year’s event can be viewed at http:// www.genesisconference.com/2013highlights/.

Over the years, there have been numerous groups that have approached us as organisers of Genesis to ask if we can promote an Full details available at event they are delivering on the www.genesisconference.com days either side of our event in

One Nucleus Appoints Hannah Merriman One Nucleus has appointed Hannah Merriman to the position of Marketing Manager. Hannah will manage delivery of the brand and all marketing communications.

name a few.

Hannah has a wealth of experience in managing the complex and fastmoving print projects for T-Mobile in addition to her six years agency background.

Prior to joining us, Hannah worked at KISS Communications where for many years One Nucleus was one of Contact Hannah at her clients, along with Argenta, hannah@onenucleus.com BioFocus, Horizon Discovery, Bidwells and Johnson Matthey to

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One Nucleus News

October 2011

Autumn 2014

Our Life Science Leadership Series One Nucleus’ Life Science Leadership Series events each attract up to 100 executives, clinicians and researchers to debate current trends and strategies around a particular theme. The last six months have seen ‘Personalised Medicine’ held at Chesterford Research Park, and ‘Treatment of Pain’ hosted in London by Eversheds.

Personalised medicine is one of the main themes across all therapeutic areas when it comes to developing improved treatments and securing better patient outcomes, including the technologies being deployed to stratify patients. As the Personalised Medicine event, the day was opened by Dame Professor Janet Thornton, Alan Wookey, an Executive Director at the lead sponsor LabCorp and Dimitar Tonev. With expertise in genomics, companion diagnostics development and partnering the panel provided informative discussion.

to be factored into development of a biomarker or companion diagnostic, including the advantages of deciding to follow a laboratory developed test (LDT) rather than full IVD development pathway. Alan spoke of LabCorp’s work with Celldex, a partner that came to LabCorp when its development programme was at Phase 2. Leveraging LabCorp’s expertise meant they could jointly

engagement, including greater understanding by patients of their particular status and prognosis, and assurance that they are getting the optimum drug combinations.

Tim Pitfield of Janssen Pharmaceuticals summarised the commercial challenges in companion diagnostics by addressing the question ‘Can you deliver the CDx into the “Real

The aim of the Leadership Series is to take delegates on a journey from great science, through development, to commercial strategies for success.

approach the FDA to ensure full alignment of the technical requirements. Moreover, commercialisation of the resultant LDT could be considered at an earlier stage than is usual for a companion diagnostic. In common with all such partnerships, open and transparent communication was key to the success of the programme, along with regular Dame Janet talked us through the clinical development updates and pivotal role the European an effective and balanced steering Bioinformatics Institute plays within group. initiative to link pharmacogenomics This final point led nicely into Dr to protein function and ultimately Tonev’s presentation, describing his clinical outcomes, as part of the involvement with HCV Research UK, 1000 Genomes project. She also which is funded by the MRC outlined the significant challenges Foundation and engaged almost 50 in integrating data sets from the clinical sites with HCV patients. The project with the immense NGS data collaboration has already delivered sets being published globally each a rich database, a biobank of day. In addition, there are material, and 400 patients per regulatory and ethical challenges month with a ten year follow up of associated with use of the secured a total of 10,000 patients. The data sets. However, Dame Janet programme offers a valuable asserted a high degree of resource to move forward with confidence that these hurdles will research and patient stratification. be overcome, and that the deep The collaboration continues to research required to truly capitalise grow, and the latest call, STOPon NGS technologies, advances in HCV, represents a new model of proteomics and bioinformatics and academia-industry collaboration drug development will lead to a that will allow integration of bright future in terms of outcomes scientific data generated on the for patients and healthcare same samples but from different providers. research strands. STOP-HCV aims Alan Wookey provided an overview to contribute toward development of the technical, regulatory and of new analytical methodologies financial considerations that need and meaningful patient

World” to the same quality as the Clinical Study?. Looking at case studies of different payer models, different regulatory barriers across geographies, low uptake of new tests in the clinical setting, and variable practices in patient sample collection and quality, it was clear there is still some way to go.

However, it is also clear that we are heading in the right direction.

Eddie Blair of Integrated Medicines rounded out the day by summarising recent progress, and challenged the delegates to think about what we may expect to see over the next ten years. Eddie’s predictions were that progress will be delivered by a combination of harmonised regulation, connectivity and mobility in healthcare and genomics.

Perhaps the best way to end an article on Personalised Medicine is to repeat a quote from Hippocrates used by Tim Pitfield during his presentation: ‘It is more important to know what sort of person has a disease than to know what sort of disease a person has.’

All of the presentations from the day can be viewed at www.onenucleus.com/onenucleusevents?id=763.

Director of Business Development

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Member News

Autumn 2014

One Nucleus Partner Programme Update The One Nucleus Partner Programme offers a fully integrated value proposition to organisations seeking to play an influential opinion leadership and visible role in the development of the life science community. The key benefits to the Partner are manifold and include: raising the profile of the Partner with potential alliance targets, clients and stakeholders; positioning of the Partner as a key thought leader in the sector; providing access to significant savings over the normal costs of benefits; and access to training courses, special interest groups and events at significantly reduced cost to enable their own and the sector’s staff development The Partner Programme has expanded over the past 6-12 months to now represent end-toend coverage across innovation,

incubation, product development and commercialisation aspects to support this highly innovative sector. We are delighted to include Babraham Bioscience Technologies, London Bioscience Innovation Centre, Queen Mary Bioenterprises and Biomed Realty among our Partners, each offering facilities and incubation support to the nascent and established life science companies. Product development is supported in a technical capacity by our Partners, PPD and BioReliance, both global players in the CRO sector. Commercialisation and regulatory strategy support is available through CambridgeIP and Global Regulatory Services, whilst ensuring companies are able to structure their deals effectively we have Penningtons Manches and Charles Russell. We have also recruited Partners in the

commercial intelligence, training and recruitment spaces in the shape of Scrip Intelligence, Pharmaceutical Training International and Nature Jobs, respectively.

Of course, supporting our members in developing their innovation into commercial and healthcare benefits is also dependent on their engagement with the large pharma, biotech and healthcare players in order to license, partner or sell their products. We are delighted to have Johnson & Johnson Innovation, AstraZeneca, Amgen and Norgine as One Nucleus Partners, each providing clear messages of their own and also the market needs and feedback to the sector’s innovators and investors on where their resources are best placed for future returns.

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One Nucleus News

October 2011

Autumn 2014

Ask One Nucleus Update – Timely Sharing of Member Expertise 24/7

Ask One Nucleus is a ‘dashboard’ that provides members developing a growing life science business with a one-stop-shop helpline for easily accessible advice from approved experts across a variety of specialised areas. By submitting an enquiry online, members can seek the sort of rapid expert guidance they would expect to find when asking such an expert in person at a network meeting or conference.

Intellectual Property Strategy provided by CambridgeIP; National and EU Grant Funding provided by Deloitte’s Grants and Incentives Team; Corporate and Commercial Law provided by Taylor Wessing’s Life Sciences Group (see below); Human Capital provided by a combination of PTI, One Nucleus and Cambridge Employment Law; Facilities Management provided by Andrew Porter Ltd (see below) and One Nucleus; Logistics and Transportation provided by World Courier; Regulatory provided by Global Regulatory Services; and International Business provided by Flight Centre Business Travel, EBD Group, UK Trade & Investment and Biopartner.co.uk

News from our dashboard advisors Ask One Nucleus coverage currently in recent months includes Taylor provides access to advice on Wessing publishing their monthly

newsletter with hot topics, advice and a tool kit of support called Synapse. The most recent edition included insights on asset-centric special purpose vehicles, EMA policy on publication of clinical trial data and infringement of second medical use claims in Germany.

Planning a laboratory relocation?

Want to understand more about how to approach some of the key critical factors including how to maintain regulatory compliance? Andrew Porter Limited now offers One Nucleus members a free, no obligation consultancy service at their premises, providing potential solutions, from how best to approach a relocation to how to build a strong project team. Email bestj@andrewporterltd.co.uk for details.

One Nucleus Training 2014 has been a busy year for training at One Nucleus with a record number of courses having taken place and it looks set to continue into the autumn, with dates already set for 2015.

We have continued to add new content to the training portfolio throughout the year and have welcomed a number of new soft skill training providers to further enrich the training offering.

We continue to work in partnership with Pharmaceutical Training International (PTI), a global interactive training provider.

Between the portfolios of One Nucleus and PTI, members can access discounts on over 80

tailored training courses covering the breadth of the life science industry.

15 October Introduction to Drug Discovery – from idea to clinical candidate

Softer Skills including Powerful 2015 Presentations, Project Management, 3 and 4 March Biological Safety: Negotiation and Communication.

Management and Practice (IOSH All of our courses can be adapted and ISTR Accredited) and tailored to meet your needs, 5 March The Safe Use and and can be delivered cost Management of Laboratory Gases effectively in-house so please 9 March Introduction to Drug contact training@onenucleus.com Development for Scientific to find out more.

Professionals Training Calendar 2014 14 October A BioSafety Masterclass: Building and Maintaining Competence in BioSafety

12 March Introduction to Drug Development for Non-Scientific Professionals 18 and 19 March Introduction to Managing Life Science Projects

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Member News

Autumn 2014

Facilities Management Richard Dickinson, Director of Specialist Services, One Nucleus

Don’t forget that One Nucleus offers Facilities Management consultancy to members at a highly discounted rate.

Richard Dickinson, One Nucleus' Director of Specialist Services, has over 15 years’ experience as a Facilities Manager and has worked for more than 20 years in the life science sector.

Currently consulting at Cantab Biopharmaceuticals, Fahy Gurteen Laboratories and Iontas Ltd, Richard has previously consulted for a number of One Nucleus members on various projects including Astex Therapeutics, Babraham Bioscience Technologies, Pathology Diagnostics, Zoragen, PolyTherics Ltd and Spirogen Ltd. Richard can provide help by phone or email as well as providing full onsite consultancy.

Richard provides project management for office and laboratory fit-outs and can advise on equipment service contracts, maintenance contracts, cleaning contracts, utility bills, insurance, purchasing and budgeting

richard@onenucleus.com or 01223 896453

Gold Members

Silver Members

Non Members

£500

£600

£750

Consultancy Day Rate

Purchasing and Support Suppliers (SSAs) One Nucleus has launched a new Private Medical Insurance (PMI) Programme as part of its wider Insurance Programme, offering members 7.5% discount. The new programme is being delivered in partnership with La Playa Financial Management, sister firm of our insurance supplier La Playa Science & Technology.

The exclusive agreement entitles One Nucleus members to a 7.5%* price-beater deal when they switch existing insurance to ‘like-for-like’ cover with Aviva, Health Insurance Awards Best Group PMI Provider 2013. For companies new to PMI, a full brokering exercise will be undertaken to establish the best terms available.

‘High quality benefits such as PMI

are an important way for our members to attract and retain talented people working in life sciences,’ says Richard Dickinson.

‘It’s great that we can offer such excellent terms and benefits.’

For details contact Jessica Hiscock on 01223 200650, or email jessica.hiscock@laplaya.co.uk.

‘PMI is really valued by employees and for an employer, providing it demonstrates a sense of care for staff and their families. It makes good business sense too; staff can get treatment swiftly and can be effective and back in work sooner after an illness or injury’, says La Playa’s Jess Hiscock. ‘According to a BUPA patient survey, the main reasons for choosing to be treated privately are the desire to avoid long waiting lists and a fear of superbugs, such as MRSA, and general hospital cleanliness.’

The Support Suppliers continue to grow in number and offer discounts to all One Nucleus members. For the full list please see the Purchasing pages on the One Nucleus website and here for the latest suppliers.

*subject to acceptable claims history

We can perform a cost-benefit analysis for Silver members thinking of upgrading or new companies wishing to join as Gold members. Please contact Richard Dickinson on 01223 896453 or Richard@onenucleus.com

New SSA Agreements Company

SSA

Contact

Email

Phone

Fluorochem

Chemical Intermediates

Lee Jones

leej@fluorochem.co.uk

01457 860111

Kinesis

Chromatography Products and Services

Angelica Chhiba

angelicac@kinesis.co.uk

01480 479957

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One Nucleus News

October 2011

New Members ● Advantum Solutions ● Apta Biosciences Ltd ● Aptus Clinical Ltd ● Aqdot Ltd ● Ariana Pharmaceuticals SA ● Aspire 2 ● Avitus Europe ● BARC ● BioReliance Inc (Partner) ● BioStrata Marketing ● Broad Associates Ltd ● Brown Rudnick LLP ● Browne Jacobson ● Cambridge Cell Networks Ltd ● Cambridge Healthcare Research ● Cambridge Innovation Capital ● Cipher Surgical Ltd ● Consultant - Dr Ajay Mistry ● Covance Laboratories Ltd ● Creative Places LLP ● Crescendo Enterprises ● David Flanders:Life Science Consultancy and Interim Management ● DoseMe

● Dr Carlos Pittol ● Dr Nick Murrall ● Endomagnetics Ltd ● Excivion Ltd ● Fluorochem Ltd ● Greaves Brewster LLP ● Healx3 Ltd ● INC Research (UK) Ltd ● Inivata Ltd ● Insights in Life Sciences Ltd ● Ispire Motivational Coaching ● Johnson Matthey Catalysis and Chiral Technologies ● Kinesis Ltd ● LabCorp Clinical Trials ● Nabarro LLP ● Norgine Ltd (Partner) ● Olswang ● OxSyBio Ltd ● P.A.S.M. Limited ● Pennington Manches LLP ● Perla Development Ltd ● Philips Research Laboratories ● PhoreMost Ltd ● Phospho Biomedical Animation

Autumn 2014

One Nucleus Sponsors ● PPD (Partner) ● ProductLife Ltd ● Pulmocide Ltd ● Quintiles Ltd ● Quotient Clinical Ltd ● RD Connect Ltd ● Reekie Management and Research Ltd ● Research Applications Ltd ● Retroscreen Virology Ltd ● Roundcape Ltd ● Samten Consulting Ltd ● SCANurse ● Sherwood Forest Freeze Dry Ltd ● Sholmes Consulting Ltd ● Stabilitech Ltd ● Stellar Learning ● Talisman Therapeutics Ltd ● Topivert Pharma Ltd ● University of Bristol, School of Chemistry ● University of OxfordMedical Sciences Business Development ● West Suffolk ● Westbourne IT Global Services

Corporate Patron

Corporate Sponsors

Partners

One Nucleus Events Date

Event

Venue

15 Oct 14

Network Meeting

12 Nov 14

BioWednesday

19 Nov 14

Network Meeting

Mills & Reeve

25 Nov 14

Joint Cambridge Wireless and One Nucleus Event

Cambridge

9 Dec 14

Genesis

QEII Conference Centre, London

7 Jan 15

BioWednesday Social

London

28 Jan 15

Network Meeting Social

Cambridge

4 Feb 15

BioWednesday

Queen Mary Bioenterprises

12 Feb 15

Life Science Leadership Series— Immunotherpy

Babraham

4 Mar 15

BioWednesday

Cambridge IP

25 Mar 15

Network Meeting

Cambridge Airport

29 Apr 15

Network Meeting

Taylor Vinters

Stevenage Bioscience Catalyst Queen Mary Bioenterprises

Media Partners

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