BioScience Today 27 by Distinctive Media Group Ltd

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ageing r&d • the big interview • thought leadership • INDUSTRY FIRST • PERSONALISED MEDICINE

ISSUE27

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www.biosciencetoday.co.uk

| foreword |

foreword Karen Southern

UK accounts for a third of all European private biotech investment

Editor in chief

Editor Karen Southern karen.southern@distinctivegroup.co.uk

Design Distinctive Media Group Ltd, 3rd Floor, Tru Knit House, 9-11 Carliol Square, Newcastle, NE1 6UF Tel: 0191 580 5990 distinctivegroup.co.uk

Advertising Distinctive Media Group Ltd, 3rd Floor, Tru Knit House, 9-11 Carliol Square, Newcastle, NE1 6UF Tel: 0191 580 5477 e: liz.hughes@distinctivegroup.co.uk distinctivegroup.co.uk

Well, it certainly looks like life sciences in the UK are thriving. The first quarter of the year was the best ever for UK biotech venture capital (VC) financing, outstripping both the US and China. Over £450m has been raised in that timeframe alone, according to a new report by the BioIndustry Association (BIA) and Clarivate. The report also celebrates a number of significant developments which help maintain the UK’s status as a global hub for the biotech and life sciences sector. For example, Altos Labs, backed by Jeff Bezos, which has chosen Cambridge as its European base, and EyeBio, founded by American entrepreneurs and chaired by Dame Kate Bingham, which has also established a UK footprint. Also highlighted in the report is the tremendous regulatory success scored in innovative therapies with the recent FDA approval of the CAR-T therapy by Oxford biotech Immunocore. There’s also been sizeable manufacturing investment with the opening of Cytiva’s £300m facility in Cardiff, and Jazz Pharmaceuticals’ £75m investment at Kent Science Park. As Steve Bates OBE, Chief Executive of the BIA, points out: “In 2022 the UK is the place in the world where global biotech capital works hardest. This quarter the UK continues to attract investment because companies engaged in and operating from here are able to be operationally more efficient than elsewhere in the globe.

Distinctive Media Group Ltd or BioScience Today cannot be held responsible for any inaccuracies that may occur, individual products or services advertised or late entries. No part of this publication may be reproduced or scanned without prior written permission of the publishers and BioScience Today.

“That’s because the UK has depth in great science, quality talent, vital genomics and AI capability, modern and growing infrastructure,

a competitive tax regime, a collaborative regulator, and a proven entrepreneurial track record of being able to do complex things fast – demonstrated by the Vaccine Taskforce way of delivering. This strong base enables UK life science firms to outcompete peers in other clusters. “As a result, our sector is well poised to deliver further economic benefit to UK taxpayers and local economies, with laboratory space set to be a key part of the British high street and office space, and sector investments occurring in all areas of the UK delivering high skilled well-paid jobs. Dr Martin Turner, Head of Policy and Public Affairs at the BIA, added: “While the IPO window may be closed for now, the vast majority of companies have healthy cash runways and will benefit from the talented scientists, data and infrastructure that make the UK ecosystem unique. This recipe for success is why the UK once again accounts for a third of all European private biotech finance raised and demonstrates comparative advantages to make it the best place in the world to start and grow a biotech company.” In the issue of Bioscience Today, we are more than happy to celebrate homegrown success stories such as Immunotec, the only company in the world offering regulated ELISPOT assays for T cell measurement. We also delve into the world of synthetic DNA through the revolutionary research carried out by Evonetix, and also Actigen, whose admirable work focuses on identifying and developing biological medicines for the 300m people affected globally by diseases with unmet medical needs, such as Hunter syndrome.

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| contents |

features

A Tale of Two Crises

16 8 Cellular protein factories may contribute to ageing and related diseases

Potential breakthrough in treatment of rare disease

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| contents |

contents / www.biosciencetoday.co.uk / issue 27 /

Foreword

4-5

Contents

8-9

ageing r&d Research finds that the cellular assembly line that produces proteins can stall with age, triggering a snowball effect that increases the output of misfolded proteins. In humans, clumps of misfolded proteins contribute to age-linked Alzheimer’s and Parkinson’s diseases. Taylor Kubota discusses the Stanford University study.

12-15

the big interview Peter Wrighton-Smith, CEO of Oxford Immunotec, talks to Bioscience Today about growing understanding of the importance of T cells in protecting us from disease, as well as their critical role in measuring immune responses to infection.

20-21

thought leadership A Tale of Two Crises: Unfortunately, it appears that being slow to recognise a crisis is part of the human condition, and medical research has had its fair share. Often there needs to be a key event (or series of events) to highlight the situation and signal a turning point. Robert Hewitt, MB BS, PhD, of Biosample Hub, looks at two examples with differing outcomes.

26-27

INDUSTRY FIRST In an industry first, biotech pioneers PacBio announce significant enhancements to the Sequel II/IIe platform include methylation calling in native DNA, greatly accelerated sample preparation, and support for gene therapy applications.

28-29

PERSONALISED MEDICINE Precision medicine using personalised treatments has entered mainstream healthcare. Closed Loop Medicine Ltd aims to level the playing field further with its drug and digital combination products.

28 Closing the Loop on personalised healthcare

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| industry contributors |

Alex is a UK and European qualified patent attorney with extensive experience in identifying and protecting innovations, and has spent many years working in-house in the medical device and diagnostic field. Through his work with big corporates and multinationals Alex is able to bring a wealth of knowledge to his work with SMEs and start-ups to provide leading strategic IP advice.

Dr Peter Wrighton-Smith Chief Executive Officer and founder of Oxford Immunotec Oxford Immunotec is a global, high-growth diagnostics company and part of the PerkinElmer group. Oxford Immunotec is uniquely placed as the only company in the world offering regulated ELISPOT assays for T cell measurement. Since 2002, Peter has led Oxford Immunotec from the foundation stages, through product development to regulatory approval in over 50 countries, and subsequent worldwide commercialisation. Peter has a Masters in Engineering, Economics & Management, and a Doctorate in Medical Engineering both from Oxford University.

Dr Robert Hewitt Founder and Director of Biosample Hub He has a longstanding interest in connecting the biospecimen provider in the public sector, with the requester in the private sector. Robert qualified in medicine in 1983. He has a first-class honours degree in immunology & microbiology. He also has a PhD in virology. He received ISBER’s Outstanding Achievement in Biobanking Award in 2012.

to advertise or contribute to the next edition advertising: liz.hughes@ distinctivegroup.co.uk editorial: karen.southern@ distinctivegroup.co.uk

BIO

SCIENCETODAY

Alex Bone Patent Attorney, Partner, AA Thornton

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| news |

Cancer cell ‘switch-off’ could aid deadly brain tumour treatment Researchers believe they may have found a way to strengthen possible treatments for glioblastoma and reduce the speed at which the aggressive tumour progresses. Glioblastoma is the most common primary brain tumour in adults, and, as often resistant to treatment, the most fatal too. But researchers at the University of Sussex have demonstrated the potential impacts of differentiation therapy, which can effectively ‘switch off’ the malignant properties of cancerous cells and limit tumour growth. A new study published in the journal Oncogene, suggests that an inhibitor drug which targets a particular cell protein, could refine therapeutic strategies against glioblastoma, making them more effective.

conventional strategies, including surgery and chemotherapies.” In the study, the researchers tested different drugs which belong to a family of proteins called ‘kinases’. They identified an inhibitor which targets a particular protein (PDGFR) and by altering the expression of downstream targets, it is able to switch glioblastoma cancer cells, and glioblastoma cancer stem cells, into neuronal-like cells and ultimately reduce their proliferation and invasion abilities. Furthermore, through in-vivo studies, the team then showed that treatment with this particular drug improved the effect of temozolide (TMZ), the main chemotherapeutic drug used to treat brain cancers like Glioblastoma.

Professor of Cancer Cell Signalling Georgios Giamas and doctoral researcher Rosemary Lane at the University of Sussex, worked with researchers from Imperial College London; the Royal College of Surgeons and Beaumont Hospital in Dublin, Ireland; Sun Yat-Sen University in Guangzhou China; and Genentech and the University of Southern California, in America.

Professor Giamas said: “New treatment options are urgently needed for glioblastoma and over recent years, differentiation therapy has been proposed as an alternative bringing new hope to researchers, medical professionals and patients alike.

Their research, funded by the charity Action Against Cancer, focused on differentiation therapy; a method in which malignant cells are ‘switched’ into a more benign composition using drugs. The cells then divide and grow more slowly, limiting tumour growth. Professor of Cancer Cell Signalling at the University of Sussex, Georgios Giamas explained: “By slowing or limiting the growth of tumour cells, we essentially make glioblastoma an easier target for more

“We’ve not only identified a potential drug which limits the tumour growth by effectively ‘switching off’ their malignant characteristics, but also demonstrated an improved effect on an existing chemotherapeutic cancer drug. “As a result, we believe that differentiation therapy holds great promise as a treatment option which could greatly benefit glioblastoma patients in the future and improve their quality of life during the treatment stages. But, as ever, more research is now needed to explore this area further.”

“New treatment options are urgently needed for glioblastoma and over recent years, differentiation therapy has been proposed as an alternative bringing new hope to researchers, medical professionals and patients alike.” Georgios Giamas, Professor of Cancer Cell Signalling, University of Sussex

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| ageing r&d |

Cellular protein factories may contribute to ageing and related diseases Research finds that the cellular assembly line that produces proteins can stall with age, triggering a snowball effect that increases the output of misfolded proteins. In humans, clumps of misfolded proteins contribute to age-linked Alzheimer’s and Parkinson’s diseases. Taylor Kubota discusses the Stanford University study. Ageing leads to a decline in cellular fitness and loss of optimal protein function. Many age-related ailments, including Alzheimer’s and Parkinson’s diseases, are caused by protein aggregation, a result of errors in protein folding. Yet, the mechanisms underlying how ageing causes proteins to aggregate has largely remained a black box. In new research published in Nature, researchers at Stanford University have traced this problem to age-dependent impairment of the machinery that produces new proteins. Researchers in the lab of Judith Frydman, the Donald Kennedy Chair in the School of Humanities and Sciences focused on how age affects the functioning of ribosomes – the cellular machinery responsible for converting messenger RNA into proteins. They used two well-established models of human ageing, yeast and roundworms. Through a combination of experiments and computational data analysis, they found that ribosome function degrades with age in both organisms. The increased load of defective proteins with age overwhelms the protective quality control fail-safes that would otherwise prevent protein aggregation. “We’ve known that protein aggregation with age is a problem linked to many diseases. At the moment, treatments try to address it by trial-and-error testing,” said Kevin Stein, lead author of the paper and a former postdoctoral scholar in the Frydman Lab. “Getting down to the basic-biology of these diseases, and understanding what mechanisms cause them, can help us make better decisions about what therapies could be effective before we test them.”

A VULNERABLE TIME When folded correctly, proteins carry out their functions and remain soluble in the environment of the cell. Misfolded proteins, by contrast, cannot function properly and tend to stick to each other and other proteins, clogging up cellular processes and generating toxic aggregates. Protein aggregation has been specifically implicated in a wide variety of ageing-linked diseases, including Alzheimer’s, Parkinson’s, frontotemporal dementia, Huntington’s disease and ALS (amyotrophic lateral sclerosis). To guard against the continual production of misfolded proteins, cells have dedicated “quality control” machinery for fixing or degrading misfolded proteins. Previous research has shown that shortcomings in these processes can lead to aggregation. This research is the first to show the folding

defect during ageing starts early in the journey of a protein, when it is made by the ribosome. Because ribosomes are constantly producing large amounts of proteins, these defects cause a subsequent snowball of disfunction. “One of the most vulnerable and key times in the life of a protein – where it’s most prone to misfolding – is when it’s made,” said Frydman, who is a professor of biology and of genetics. To start, the researchers used a technique called ribosome profiling, which allowed them to see exactly how ribosomes are moving on the messenger RNA during the act of translation. Amassing data from all the genes translated in young and aged Caenorhabditis elegans roundworms and yeast, the researchers noticed that in older cells ribosomes periodically moved more slowly and were more likely to stall and bump into each other. As one might expect, the researchers saw that decreases in proper ribosome performance aligned with increases in the ageing-dependent aggregation of misfolded proteins. One important insight was that the increase in stalling and misfolding overwhelmed the cell’s cleaning-up-andclearing-out quality control failsafes. “There is a two-pronged situation where ageing leads to increased stalling and increased ribosome collisions, but the cell loses the safety net to deal with it,” explained Stein. In follow-up experiments in worms, the researchers found that even if the overall fraction of newly made proteins with altered translation during ageing is low (~10%), this small effect can still be enough to overwhelm the quality control system and trigger significant aggregation that can disrupt many different cellular components or processes. “Every cell normally makes millions of these newly translated proteins,” said Frydman. “So very slight changes in the efficiency of folding with age will escalate in a vicious cycle where defects in translation lead to an overload of the system, which in turn leads to increased protein aggregates with age that are themselves also toxic.” To make matters worse, through further experiments in yeast and C. elegans, the researchers showed that these problems affect the very proteins that cells use to aid in translation and to help correct misfolding issues.

MILLIONS OF QUESTIONS While this research revealed, for the first time, some intriguing insights about the mechanisms of ageing, it inspires many questions for the future. Perhaps the most

| BIOSCIENCE TODAY |

| ageing r&d |

Ageing impairs the ability of ribosomes to efficiently synthesize proteins and leads to protein misfolding and aggregation, which disrupts cellular health and is a hallmark of many age-related diseases. (Image credit: Felipe Serrano) pressing one: Why does ageing affect ribosomes? Also, what can be done about it? Given the similarities between ageing in yeast, C. elegans and other organisms, the researchers are optimistic that their findings will translate also to humans. One direction for future work will be the application of insights from this study to the development of possible treatments for age-related diseases associated with protein aggregation. Excitingly, the study showed that analysis of mutations that extend lifespan “rejuvenated” ribosomal function in aged yeast. “This is only the beginning of a very fascinating future,” said Fabián Morales-Polanco, a co-author of the research

and a postdoctoral scholar in the Frydman lab. “We set a precedent for something new, and there are millions of questions – and probably hundreds of papers – that will follow.” This research was funded by the Glenn Foundation for Medical Research, the National Institutes of Health and the Pew Charitable Trusts. Additional Stanford co-authors of the paper are visiting graduate student Joris van der Lienden and former postdoctoral scholar T. Kelly Rainbolt. Frydman is also a member of Stanford Bio-X, the Stanford Cancer Institute and the Wu Tsai Neurosciences Institute and a faculty fellow of Stanford ChEM-H.

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| news |

Could ‘bee glue’ combat drug-resistant bacteria? A remarkable material known as propolis - found in beehives - is the subject of a new two-year study by the University of Bradford and Whitby-based natural remedy company Nature’s Laboratory. Propolis is a biscuity brown, crumbly substance used in the construction of hives, but it has astonishing medicinal properties. It is used to seal the hive against infection and create a sterile environment, due to its antibacterial and anti-fungal properties. This makes it useful in the treatment of a number of medical conditions. In fact, there is evidence to suggest it has been used for thousands of years both as a supplement and in mummification. Professor Anant Paradkar, from the University’s Centre for Pharmaceutical Engineering Science, has worked with propolis for more than 30 years, helping to bring a number of products to market which use the substance, including mouth ulcer treatment BGel (which is safe for children, unlike some other products). A Knowledge Transfer Partnership project with Nature’s Laboratory has shown that propolis increases the susceptibility of resistant bacteria to drugs which have become ineffective. Prof Paradkar says that while it may well prove to be a wonder-cure and could even help in the fight against antibiotic immunity, it is virtually impossible to synthesise. In other words, if we want to use it, we need bees to make it. Prof Paradkar says: “Bees are the real pharmacists. They are the best formulators. They instinctively know when their hives are infected by bacteria or insects, and what pollen to gather in order to combat those threats. “There is no one formula for propolis. There is significant regional variability in its composition of propolis, and this depends on a great many things, including the available fauna. So, propolis varies from region to region.” But, he says, one thing is common - propolis is made of hundreds of chemicals, all of which are gathered by bees from plants, then processed through their enzymatic system and combined with wax. He goes on: “It is not possible for us to make propolis, simply because it is made up of hundreds of different chemicals and it has many antioxidants and flavonoids. So, we will always need bees if we want to use it.” The two-year study - funded by a £180,000 grant from Innovate UK - will explore ways in which propolis can be used to develop new health products, which could include food supplements and topical gels. Prof Paradkar has already worked on a number of products, including turning propolis into a food supplement for yogurts, and B-Gel. Now he says the focus is on using the material to overcome antibiotic resistance and combat bacteria in general. He says: “One of the challenges at the moment is finding ways to overcome the biofilm bacteria create when they group together. This is a thin membrane that protects them from things like drugs we might use to treat infections. If we can disrupt this biofilm, we can target the bacteria. Propolis can be used to do that.”

Professor Anant Paradkar Bradford University’s Centre for Pharmaceutical Engineering Science

“Bees are the real pharmacists. They are the best formulators. They instinctively know when their hives are infected by bacteria or insects, and what pollen to gather in order to combat those threats.” 10

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| intellectual property |

Why is Diligent Due Diligence Important? Alex Bone

Patent Attorney, Partner, AA Thornton

BACKGROUND Biopharma merger and acquisition activity was lower in 2021 than in recent years, but the top 10 deals still reached a combined value of over $50 billion. The main value of such deals rarely lies in tangible property like buildings or stock inventory but often lies in intellectual property (IP), and patents in particular. It is common practice for companies to monitor the R&D activities of others and consider acquiring them, or their IP, when development of the product or process has reached a desired level. This can provide an exit for the founders of the company being acquired and provides a way of reducing development risk for the acquiring company. In some instances, acquisition of the IP may not be an option and a license to the IP could be obtained instead. As the value of these deals is often driven by gaining access to, or control over, third party IP, it is important to understand the nature of that IP to ensure that you are getting value for money and this is where IP Due Diligence is important.

WHAT IS IP DUE DILIGENCE? IP Due Diligence is essentially an audit of the IP assets of interest and, depending upon the purpose of the exercise, can include a review of how IP is generated, captured, protected, and reviewed. IP due diligence is most often carried out by a company considering purchasing or licensing IP assets. IP due diligence can also be carried out by a company on its own IP assets, for example to ensure that everything is in order in preparation for a deal or potential litigation. An IP due diligence can be considered as the IP equivalent of the searches and survey that may be undertaken for a house purchase. When buying a house searches are typically carried out to check formal issues, for example that the property is owned by the person offering to sell it, or that planning permission or a building permit was obtained where necessary. A survey can be carried out to look at the substance of the house. A basic survey might check to ensure that the walls are sturdy and that the roof does not leak. A more detailed survey might look at particular aspects of the property such as the quality of the plumbing, or age of the wiring.

FORMAL IP CHECKS As with a house purchase, some formal checks can be made by carrying out searches in relation to the IP rights of interest. IP registers in the relevant territories can be consulted to ensure that any necessary renewal fees have been paid to keep the right in force and that it isn’t being challenged. Checks can be made to ensure that the registered owner is as expected and that the chain of ownership from the inventors to the current owner is correct. The registers can also be consulted to look for transaction records such as licenses or mortgages which might affect the value, and to look for any non-standard modifications, for example alterations to the duration of the right.

SUBSTANTIVE IP CHECKS Like a building survey, the substantive checks assess the right itself. Substantive IP checks typically involve a specialist IP attorney reviewing the rights in detail. The scope of each right can be analysed to confirm that it will provide the protection desired and to identify potential internal issues that might affect scope or validity. Searches can be carried out to look for potential external issues that might negatively affect the right and to determine whether making use of the protected subject matter of the right, for example the patented invention, might infringe the rights of third parties.

IP PROCESS CHECKS In some circumstances, particularly if reviewing your own IP, it can be useful to review the processes in place to capture and protect IP that is generated and to identify third party risks. The review should ensure that the processes remain fit for purpose so that potentially important assets or issues are not overlooked.

ASK QUESTIONS AND SEEK CONFIRMATION It is common for a prospective purchaser or licensee to provide a questionnaire concerning the IP and to seek warranties regarding certain issues. The questionnaire and warranties are normally designed to uncover any issues that are already known to the rights holder.

CONCLUSION It is not a requirement that due diligence is undertaken as part of a transaction, but completing a diligent due diligence can reduce the risk that the IP rights being purchased or in-licensed are not as valuable as anticipated. If you have any queries regarding this topic, or other pharmaceutical or biotechnological matters, please contact Alex Bone at amtb@aathornton.com or visit aathornton.com

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| the big interview |

| BIOSCIENCE TODAY |

| the big interview |

T cells: their increasing significance in infectious disease diagnosis and research Peter Wrighton-Smith, CEO of Oxford Immunotec, talks to Bioscience Today about growing understanding of the importance of T cells in protecting us from disease, as well as their critical role in measuring immune responses to infection.

| BIOSCIENCE TODAY |

| the big interview |

he coronavirus (COVID-19) pandemic, caused by the SARS-CoV-2 virus, has been responsible for many things, but perhaps one of the few positive outcomes of the pandemic is the unprecedented level of collaboration amongst the scientific community. Thanks to significant funding and a global urgency, some of the world’s foremost scientific minds came together to develop a collective understanding of the transmission, detection and protection against the novel coronavirus. This global collaboration has had astounding results, including the rapid development of vaccines and an increased understanding of the significance of T cells in immune responses to viral infection and vaccination. This renewed interest in T cells may prove to be clinically significant in a variety of applications in the coming years. T cells are white blood cells, named such as they mature in the thymus, and they play a crucial role in orchestrating the immune response as well as directly destroying pathogens. In the past, including in the early days of the pandemic, T cells were often overlooked as a monitoring device for the immune response in favour of antibodies. However, the extensive research carried out into immune responses to SARS-CoV-2 demonstrated the limitations of antibodies and the importance these T cells have in protecting us from disease, as well as the critical role that they can play in measuring immune responses to infection. Recent evidence has demonstrated that the measurement of T cells can provide valuable information about the ability of individuals to mount an effective, durable immune response following natural infection or vaccination. For example, studies have shown that when detecting adaptive immune responses to SARS-CoV-2 infection, T cell testing may offer a more robust analysis than serology tests. Serology testing detects antibodies, indicating past exposure, but antibodies may weaken over time and some individuals have been shown to not develop antibodies at all. On the other hand, T cell detection identifies SARS-CoV-2 specific T cells in the majority of PCR-positive cases and also picks up some individuals who test negative by serology. SARS-CoV-2 specific T cell responses may also be longerlasting than antibodies, and thus may provide valuable information on the longevity of immune responses. Further, T cells have been shown to be more resistant to the mutations that occur in COVID-19 variants of concern, meaning that T cells may prove to be a more accurate measure of durable protection as the virus continues to mutate. Antibodies and T cells both have a complementary function in the immune system, representing two different but complementary sides to humans’ adaptive immune response. When exposed to a new infection, both B and T cells are activated. B cells result in the production of antibodies, while T cells differentiate into one of two types: helper T cells which have several functions, including assisting B cells with the production of antibodies; and cytotoxic T cells, which fight viral infections. The role of T cells in the immune system is becoming more widely understood, but it’s already clear they have an important part to play in a number of clinical functions. For example, T cells play a central role in infectious diseases like tuberculosis or viral infections like COVID-19. They are also important in transplantation where their role is complex, as they’re necessary for fighting off infections but can also be involved in transplant rejection. In the field of immune oncology T cells are central to the body’s ability to regulate cancer. Conversely, in autoimmune diseases, T cells’ regulation malfunctions as the immune system mistakenly attacks the body.

As science uncovers more about T cells, it is no understatement to say that the importance of measuring T cells is becoming more widely recognised across drug and vaccine development, diagnosis, prognosis and monitoring of different clinical conditions. However, mainstream clinical use has been limited to date, as measuring T cells has several technical challenges that have restricted its widespread adoption. Two key requirements have been particularly difficult to overcome. Firstly, measuring T cells requires a very sensitive methodology, as the specific T cells that need to be measured can be extremely rare. Secondly, T cell tests measure T cell function, so live cells are needed. As a result of these factors, T cell tests have historically been challenging to perform in the lab. They have been largely

| BIOSCIENCE TODAY |

| the big interview |

Spot Counting in the laboratory manual and complex procedures with expertise needed to isolate the T cells required and handle them without disrupting their function. The logistics of sample handling has also presented difficulties, as cells need to be alive when they reach the lab, and typically require processing very soon after arrival, which makes it difficult to fit the tests into routine and large-scale applications. Our focus over the past 20 years has been to make working with T cells much simpler and easy to perform while maintaining the exceptional sensitivity required to obtain accurate, reproducible results. We have invented and pioneered a number of technologies which have been developed to overcome these key challenges. The first has been improvements to the highly sensitive ELISPOT technique, which isolates T cells and interrogates them in vitro (with specially designed peptide pools) to identify those rare T cells which produce the tell-tale chemical messenger (IFN-gamma) in response, identifying them as being specific for the infection. Once complete, the test readout is a number of spots in a well of a microtiter plate – each one representing just one of those rare T cells – which can simply be counted to indicate the test result. This process has been simplified into Oxford Immunotec’s T-SPOT® technology platform, making the test easier to run in a standard routine laboratory. The recent introduction of automation to this procedure has simplified the process further, and reduced the labour and expertise required to run the test – making large scale trials and routine

clinical use more tractable. The same technology used to allow automation also enables the extension of sample stability, so there is more time for samples to arrive at the lab, significantly expanding the geographical catchment for samples. This and the potential for sample batching, also streamlines integration into the laboratories’ existing procedures. We and others will continue to invest in developing these tests further, making the most sensitive of assays even more automated and even more simple to run. Combine this with the continued increase in our understanding of the role of T cells in infection and in immunity against infection, and it is clear that the use of T cells will become more widespread, particularly in vaccine development and in understanding immunity in a wide range of infectious diseases in 2022 and beyond.

“it is no understatement to say that the importance of measuring T cells is becoming more widely recognised across drug and vaccine development, diagnosis, prognosis and monitoring of different clinical conditions.” 15

| BIOSCIENCE TODAY |

| clinical development |

| BIOSCIENCE TODAY |

| clinical development |

Potential breakthrough in treatment of rare disease

Biotech company Actigen has initiated a clinical development programme for GNR-055, a potentially breakthrough treatment for the life-limiting, rare disease mucopolysaccharidosis II (MPS II) (also known as Hunter syndrome). Occurring in around 1 in 100,0000–170,000 births, MPS II presents almost exclusively in males and has a major impact on the physical and neurological health of those affected.

| BIOSCIENCE TODAY |

| clinical development |

PS II is one of more than 6,000 rare diseases affecting approximately 300 million people worldwide. Like many other orphan diseases, MPS II has limited treatment options due to a prior absence of resources needed to investigate the disease. Based in Cambridge, Actigen’s work focuses on identifying and developing biological medicines for human diseases with unmet medical needs. Actigen’s forthcoming clinical trial with GNR-055 presents an opportunity to find a more comprehensive treatment option for MPS II, which could significantly improve patients’ physical and cognitive functions, and enhance their quality of life. This rare, debilitating disease is caused by a deficiency of the key enzyme responsible for breaking down sulfated sugar molecules called glycosaminoglycans (GAGs) in cells throughout the body. If left untreated, this leads to a progressive deterioration of organ systems across the body, including the heart, lungs, brains, bone and cartilage. Brain deterioration leads to cognitive and behavioural issues such as disturbed sleep, hyperactivity, poor concentration, disruptive behaviour and poor temper control. The current treatment options available, such as enzyme replacement therapy, only offer a partial solution. While they can help improve the functioning of internal organs and improve patients’ quality of life, their inability to cross the blood-brain barrier means that GAGs continue to build up in the brain, resulting in ongoing neurological issues. GNR-055 uses an innovative combination of the missing enzyme and an antibody fragment to access brain cells. The antibody has a particularly important function binding to the human insulin receptor on capillary cells to cross the brain-blood barrier. Once in the brain, GNR-055 is expected to break down the GAGs that cause the neurological issues. This novel treatment fulfils an unmet clinical need and could offer life-changing improvements for patients affected by MPS II. Actigen’s Managing Director, Michael Braunagel, said, “MPS II is just one of thousands of rare diseases that have lacked clinical awareness, resources and treatment options. At Actigen, it is our mission to improve the lives of individuals with rare diseases, and we hope that GNR-055 will be the start of many more trials. Actigen’s clinical trial on GNR-055 will be undertaken as part of a global strategic partnership with Generium, a leading pharmaceutical company. Actigen’s team possesses specialist expertise in clinical trials and antibodies for rare diseases, and previously worked on development of a therapeutic antibody for global pharma giants Roche. Michael Braunagel added, “We are establishing an exciting approach to clinical trials with GNR-055 and are working with our partner to bring products to global markets. MPS II is very debilitating condition for those affected and we are hopeful that the trial will establish the treatment’s efficacy. GNR-055 is the first therapeutic in our innovative development pipeline and we are thrilled to be working with Generium, who is a major player in the industry.”

Michael Braunagel Managing Director, Actigen

“MPS II is just one of thousands of rare diseases that have lacked clinical awareness, resources and treatment options. At Actigen, it is our mission to improve the lives of individuals with rare diseases, and we hope that GNR-055 will be the start of many more trials.”

REFERENCES Da Silva E, Strufaldi M, Andriolo R et al. Enzyme Replacement Therapy with Idursulfase for Mucopolysaccharidosis Type II (Hunter Syndrome). Cochrane Database of Systematic Reviews. 2016 ;2(2):CD008185. doi: 10.1002/14651858.CD008185.pub4 NIHR Horizon Scanning Research & Intelligence Centre, University of Birmingham. Intrathecal Idursulfase (Elaprase) for Hunter Syndrome (Mucopolysaccharidosis Type II). http://www.io.nihr.ac.uk/wp-content/uploads/migrated/Idursulfase-IT-March2016.pdf Accessed Feb 2022 Cimaz R and La Torre F. Mucopolysaccharidoses. Current Rheumatology Reports 2014;16:389. Mayo Clinic. Hunter syndrome. https://www.mayoclinic.org/diseases-conditions/hunter-syndrome/symptoms-causes/syc-20350706 Accessed Feb 2022 Hampe C, Yund B, Orchard P, et al. Differences in MPS I and MPS II Disease Manifestations. Int J Mol Sci. 2021; 22(15): 7888 Boado R, Ka-Wai Hui E, Zhiqiang Lu J, Pardridge W. Insulin Receptor Antibody-Iduronate 2-Sulfatase Fusion Protein: Pharmacokinetics, Anti-Drug Antibody, and Safety Pharmacology in Rhesus Monkeys. Biotechnol Bioeng. 2014; 111(11): 2317–2325 Actigen Data on File

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| news |

Durham University launches new degree in Plant Biotechnology and Enterprise Durham University has launched a new MSc in Plant Biotechnology and Enterprise designed to provide the fundamental knowledge and skills to produce future scientists specialising in plant biotechnology. Students’ will gain the technical and scientific skills needed to support increased agricultural productivity and the development of new biotechnological innovations whilst also delivering a commercial approach through the business-related enterprise element of the course.

“One of the principal challenges that our society faces is the need for increased agricultural productivity via improved crop protection and plant biotechnology.” Dr Miguel de-Lucas, Programme Director

Alongside taught modules and practical lab-based experience offering one to one mentoring, this programme will enable students to develop their own research project, access vital training in business development and create links with leading biotech industries whilst developing essential skills for the employment market. “One of the principal challenges that our society faces is the need for increased agricultural productivity via improved crop protection and plant biotechnology. Given the quality of the UK Plant-science research and education system, the socio-economical context and the increase in global warming-associated natural catastrophes, there has never been a more important time to train new scientists in plant biotechnology, to underpin economic growth,” says programme director, Dr Miguel de-Lucas. This degree is especially for Biosciences graduates that often finish their degree with limited practical and experimental skills, providing transferable skills beyond those established in their first degree. The programme consists of five compulsory taught modules, including ‘Technology in the BioSciences’, and a research project. More information about this new programme here: durham.ac.uk/study/courses/c2k009

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| thought leadership |

A Tale of Two CrisEs

Unfortunately, it appears that being slow to recognise a crisis is part of the human condition, and medical research has had its fair share. Often there needs to be a key event (or series of events) to highlight the situation and signal a turning point. Robert Hewitt, MB BS, PhD, of Biosample Hub, looks at two examples with differing outcomes. BIOBANKING A number of crises have shaped the field of biobanking. One of the most noteworthy was the UK organ retention scandal of 1999 (Bauchner & Vinci, 2001). The problem came to light because a bereaved mother investigating the death of her child, demanded a copy of her medical records. Here she found a letter revealing the fact her child’s heart had been removed at autopsy and retained without permission (The Guardian, 2003). From the public inquiry that followed, it emerged that it was common practice in many hospitals for pathologists performing autopsies on infants to retain whole organs like the brain and heart for education and research purposes, without having the informed consent of the parents. When this information was publicised in the news media, parents who had already suffered a bereavement came to learn that their child’s organs had been retained without their knowledge. This resulted in a huge public outcry; it became obvious that major cultural change was necessary. The report of the Royal Liverpool Children’s inquiry, published in January 2001, made many recommendations including amendment of national law to clarify the fact that informed consent is required for organ retention at autopsy. In response to these and other recommendations, the Human Tissue Act of 2004 came into force. In addition, a regulatory body called the Human Tissue Authority (HTA) was set up in 2005. The

HTA serves to regulate organisations that remove, store and use human tissue for research, medical treatment, post-mortem examination, education and training, and display in public (HTA website). Its aim is to ensure that such organisations follow legal requirements and so it promotes understanding of these requirements through codes of practice and other guidance.

BIOSAMPLES Biotech companies play a vital role in medical research. But three years ago, the annual report of a UK agency called Medicines Discovery Catapult (MDC) came up with a disturbing finding: 80% of small to medium sized biotechs found accessing samples from the National Health Service unexpectedly difficult with the result that 75% imported samples from abroad (SODN, 2018). We need to see this for the crisis it is. There is no shortage of samples—in the UK there are more than 150 hospital-associated biobanks—but there is a failure to share samples with biotech companies. This is partly because public sector biobanks are established by hospitals and universities to support research in academic centres rather than industry. This is not just a UK issue, it is global. It is well-known that biotech companies around the world rely mainly on commercial tissue brokers to obtain clinical samples. Commercial brokers serve a valuable purpose in that they provide biotech companies with

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REFERENCES Bauchner H and Vinci, R. What have we learnt from the Alder Hey affair? British Medical Journal 322, 309-310 (2001).

vital clinical samples for their research. However, in general brokers have the disadvantage that for business reasons they will not reveal the source of their samples, because to do so would risk circumvention and loss of income. This obviously means that their clients will tend to lack reliable provenance information on the samples they receive. This poses a serious problem for manufacturers of medical devices who must use samples with reliable provenance information to validate their devices in order to be compliant with the new European IVDR regulations. It seems there are two main ways in which we can respond to this sharing crisis – both require cultural change. 1. We embrace the commercialisation of biosample procurement. This would mean that hospitals in Western Europe put aside ethical concerns and supply samples to commercial brokers, who in turn provide samples to biotech companies. This would reduce the need for brokers to source samples from other less developed parts of the world. 2. Public sector biobanks – or rather their management committees – accept it as their responsibility to share samples with biotech companies. This would be the ideal, because biotech companies must have access to high quality samples with reliable provenance information. We need to decide which path to follow.

Blow, N. Biobanking: freezer burn. Nature Methods volume 6, 173–178 (2009). https://www.nature.com/articles/ nmeth0209-173 Compton, C. Garbage In, Garbage Out: The hidden reason laboratory test results may not be as reliable as they seem. The Pathologist 03.16.2018 https://thepathologist.com/diagnostics/ garbage-in-garbage-out Editorial: ‘Thank you for sharing’. Nature Biotechnology 38, 1005 (2020). Human Tissue Authority website. https://www.hta.gov.uk/ Marshall, M. Why we find it difficult to recognise a crisis. BBC Future. 14 April 2020. https://www.bbc.com/future/article/20200409-why-we-findit-difficult-to-recognise-a-crisis SODN. State of the Discovery Nation 2018. A report by the Medicines Discovery Catapult and the BIA. https://md.catapult.org.uk/resources/report-state-of-thediscovery-nation-2018/ The Guardian: ‘What happened next?’ 18th May 2003. https://www.theguardian.com/society/2003/may/18/ observermagazine.theobserver

THE AUTHOR Robert Hewitt, MB BS, PhD, is the founder of Biosample Hub, a platform that connects Biotech companies looking for samples, with Biobanks that have ethically sourced samples available. Web: biosamplehub.org LinkedIn: linkedin.com/in/hewittr/ Twitter: twitter.com/rhbio

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Electronics inspired by the qualities of human skin Human interactions with robots could soon be revolutionised with ‘skin-inspired’ electronics. Chemical engineers at Stanford have already discovered a groundbreaking way to create an elastic light-emitting polymer. Now they have developed stretchy colour displays which could transform the way users interact with TVs, smartphones and other electronic devices. Zhenan Bao and her research team at Stanford have been working on skin-inspired electronics that are soft and stretchy. Now they have shown proof of principle towards a stretchable, potentially reshapable display in a paper published recently in Nature. Their invention hinges on the discovery of a method to produce a high-brightness elastic light-emitting polymer, which functions like a filament in a lightbulb. The group’s resulting display is made entirely of stretchy polymers – synthetic plastic materials. The device has a maximum brightness at least two times that of a cellphone and can be stretched up to twice its original length without tearing. “Stretchable displays can allow a new way of interactive human-machine interface,” said Bao, the K. K. Lee Professor in the School of Engineering and senior author

“The resulting all-polymer film can be adhered to an arm or finger and doesn’t rip during bending or flexing. This will allow wearable trackers to have their display directly attached to the skin.”

The flexible light-emitting film, featuring a Stanford logo, displayed on a finger knuckle to show how it can hold up to flexing and wrinkling. (Image credit: Zhitao Zhang and Jiancheng Lai of Bao Group Research Lab)

of the paper. “We can see the image and interact with it, and then the display can change according to our response.” About three years ago, however, postdoctoral scholar Zhitao Zhang discovered that a yellowcolored light-emitting polymer called SuperYellow not only became soft and pliable but also emitted brighter light when mixed with a type of polyurethane, a stretchy plastic. “If we add polyurethane, we see SuperYellow form nanostructures,” said Zhang, the first author of the study. “These nanostructures are really important. They make the brittle polymer stretchable, and they make the polymer emit brighter light because the nanostructures are connected like a fishnet.” Unlike adding rubber, the interconnected net of nanoscale fibers that make the SuperYellow stretchy don’t inhibit electricity flow – which is key to developing a bright display. After this discovery, the group also created elastic red, green and blue light-emitting polymers. While it was challenging to figure out the right materials to match electronically for high brightness and stretchability, the final display now contains seven layers which work together to produce a photon – a particle of light. The resulting all-polymer film can be adhered to an arm or finger and doesn’t rip during bending or flexing. This will allow wearable trackers to have their display directly attached to the skin. Bao sees a variety of additional potential uses for a stretchable display. It could be used to produce reshapable interactive screens or even form threedimensional landscapes on a map. “Imagine a display where you can both see and feel the three-dimensional object on the screen,” she said. “This will be a completely new way to interact with each other remotely.”

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Evonetix demonstrates novel enzymatic DNA synthesis method Proprietary thermally-controlled synthesis chemistry will enable production of high quality DNA at scale, making it a key milestone in the development of Evonetix’s benchtop DNA synthesis platform. EVONETIX LTD (‘Evonetix’), the synthetic biology company specialising in semiconductor technology for DNA synthesis, has achieved enzymatic DNA synthesis capability with its proprietary, thermally controlled synthesis chemistry. The culmination of a three-year development program, supported by Innovate UK and in collaboration with Durham University, the results demonstrate that Evonetix’s unique, semiconductor array-based platform is compatible with both chemical and enzymatic DNA synthesis, enabling the production of scarless DNA sequences that are directly compatible with downstream processing. Synthetic biology is expected to impact many industries, but the production of high-fidelity DNA at scale, without the need for post-synthesis error correction, has remained a challenge. Evonetix‘s novel approach re-engineers traditional phosphoramidite synthesis chemistry to use thermal, rather than acidic, control of deprotection reactions. This approach enables parallel synthesis of thousands of sequences on a single chip. The research was directed by Dr Raquel Sanches-Kuiper, VP of Technology at Evonetix, whose enzyme engineering team has focussed on the development of enzymes that can incorporate Evonetix modified nucleotides efficiently. The programme was completed in collaboration with Dr David Hodgson, Associate Professor of Chemistry at Durham University, whose group was involved in developing the modified nucleotides for enzymatic synthesis in Evonetix silicon arrays. Dr Raquel Sanches-Kuiper, VP of Technology at Evonetix, said: “We have, for the first time, demonstrated thermally controlled enzymatic DNA synthesis. Our approach brings together thermally controlled synthesis and error detection, allowing for high-throughput assembly of high-fidelity gene-length DNA at scale. Our synthesis platform can now be used with both enzymatic and chemical synthesis, allowing us to smoothly integrate our enzymatic approach as this technology develops. Our unique, on-chip, synthesis and error correction platform will overcome many of the

Dr Raquel Sanches-Kuiper, VP of Technology at Evonetix,

“We have, for the first time, demonstrated thermally controlled enzymatic DNA synthesis. Our approach brings together thermally controlled synthesis and error detection, allowing for highthroughput assembly of high-fidelity gene-length DNA at scale. existing challenges in current approaches to de novo gene synthesis.” Dr David Hodgson, Associate Professor of Chemistry at Durham University, added: “We have been able to combine our world leading expertise in nucleotide chemistry with the novel Evonetix approach for enzymatic DNA synthesis, enabling cleaner, simpler synthesis reactions that will ultimately allow for scaled production of high-quality synthetic DNA with revolutionary applications across industry and research.” Simon Rowland, Innovate UK, commented: “Engineering Biology was identified in the 2021 UK Innovation Strategy as one of the key technologies that will deliver future economic success in the UK. The rapidly growing synthetic biology market is estimated to reach $40 billion by the mid-2020s. Innovate UK supports businesses and research institutions to drive business investment into R&D and is proud to have supported Evonetix and the development of this gamechanging innovation in DNA synthesis.” Details at evonetix.com.

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| clinical trials |

New treatment on horizon against ‘parasite’ mitochondria

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| clinical trials |

A groundbreaking study has solved the old enigma in mitochondrial DNA disorders and advances the prospect of enhanced treatments for patients. It not only resolves a long-standing conundrum in the molecular pathology of mitochondrial disease, but offers an exciting opportunity for rapid translation of this discovery into real patient benefit. An international team involving Newcastle University has identified small molecules that purge cells of mutant mitochondrial DNA molecules thereby restoring mitochondrial function. Mitochondria are known as the powerhouses of the cell, and their small circles of DNA are essential to produce energy from the food we eat. Consequently, mutant mitochondrial DNAs are responsible for a variety of devastating and incurable human diseases. An international team report in Nature Communications the identification of small molecules that purge cells of mutant mitochondrial DNA molecules thereby restoring mitochondrial function. Exceptionally, this is akin to a ‘gene therapy’ with small molecules. The findings are of considerable importance as they represent a possible treatment for the future. Professor Robert Taylor, from the Wellcome Centre for Mitochondrial Research, Newcastle University, said: “In identifying the cellular metabolic constraints that can influence mitochondrial DNA replication, this groundbreaking study not only resolves a long-standing conundrum in the molecular pathology of mitochondrial disease, but offers an exciting opportunity for rapid translation of this discovery into real patient benefit through repurposing a compound that has already been tested in human subjects.” More than 30 years ago, researchers at the Queen Square Institute of Neurology (QS IoN), who have led this study, identified the first human diseases caused by mutations in the DNA inside the mitochondria. Since then, hundreds of mutations in the mitochondrial DNA (mtDNA) have been associated with a variety of diseases affecting almost every organ of the body, at any stage of life. Current treatments are only symptomatic and there are no disease-modifying therapies for mtDNA diseases. A team at the Wellcome Centre for Mitochondrial Research, Newcastle University, along with Antonella Spinazzola of QS IoN and the surviving

member of the original team, Ian Holt, have discovered a means to counteract mitochondria that harbour mutant mtDNAs. A typical cell contains hundreds of mitochondria each with several copies of mtDNA. Many patients with mitochondrial DNA disorders carry a mixture of mutant and normal mtDNAs, and it has long been a puzzle why the mutant mitochondria persist and even thrive. The new study shows that the defective mitochondria ‘steal’ energy and other resources from the rest of the cell; as such, they behave like parasites. However, when resources (nutrients) are in short supply, and each and every mitochondrion has to ‘fight for itself’, the defective mitochondria are disadvantaged. This insight enabled the researchers to demonstrate that healthy mitochondria can be selected with chemicals that restrict nutrient metabolism and dramatically inhibit the replication of the mutant mtDNAs. The small molecules targeting nutrient metabolism are potential new drugs that are equivalent to a gene therapy, in that they act specifically on the mutant mDNAs, albeit without directly interacting with them. Experts, including Professors Robert Taylor and Bobby McFarland from Newcastle University, are already building on the new findings, setting up an experimental medicine study as the next step towards developing the small molecules as treatments for these currently incurable diseases. Professor Antonella Spinazzola, senior author of the study, from QS IoN, said: “Discovering that nutrient levels can have such a dramatic effect on the replication of mutant mtDNA, and that we can manipulate them with the small molecules, represent two major steps towards understanding and developing treatments for a group of human diseases we have been wrestling with for decades.” Co-senior author, Professor Ian Holt, added: “As well as achieving our long-term goal of identifying potential drugs that specifically inhibit the replication of mutant mitochondrial DNAs, we have opened up a new area of research: the regulation of mitochondrial DNA metabolism, and thus mitochondrial energy production and cell function, via the manipulation of nutrients”. 2-Deoxy-D-glucose couples mitochondrial DNA replication with mitochondrial fitness and promotes the selection of wild-type over mutant mitochondrial DNA. Boris Pantic et al. Nature Communications. Doi: 10.1038/s41467-021-26829-0

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| industry first |

Breakthrough access to epigenome and streamlines workflows In an industry first, biotech pioneers PacBio announce significant enhancements to the Sequel II/IIe platform include methylation calling in native DNA, greatly accelerated sample preparation, and support for gene therapy applications. Californian-based Pacific Biosciences (PacBio) has revealed the release of a transformative capability to detect DNA methylation using the Sequel IIe and Sequel II Systems. PacBio develops and manufactures gene sequencing solutions. Their HiFi sequencing technology has now been extended to include access to the epigenome, a second layer of genomic information often left unexplored due to fundamental limitations of common sequencing technologies. PacBio’s single-molecule approach provides a much more holistic view of molecular behavior during sequencing. Subtle patterns in this rich information allow detection of modified bases in native DNA during standard HiFi sequencing. As a result, scientists gain access to the epigenome with zero additional cost, effort, or complexity. The company claims this advance will unlock important new opportunities across a broad range of applications in fundamental and applied biological science. This update also includes a wide range of workflow improvements for enhanced customer experience, such as simplified, unified, and accelerated library preparation workflows and consumables, live instrument performance monitoring, and on-instrument analysis support for recombinant adeno-associated virus (rAAV) genome sequencing, a rapidly growing biopharmaceutical application relevant to gene therapy and vaccine development research. “With each product release we continue to improve the utility and value of the Sequel II and IIe platform, providing researchers with unique capabilities that differentiate PacBio HiFi sequencing from all other sequencing technologies,” said Christian Henry, President and CEO of PacBio. “Our latest enhancements to the Sequel II and IIe platform, including 5-base sequencing and improved workflows are expected to both simplify the ability to generate high quality data and enable deeper insights into the complexity of the genome.” “Multiple tests are currently required to evaluate rare disease cases for sequencing and methylation variation.

HiFi sequencing has the potential to change that by measuring both genetic and epigenetic variation across the full genome in a single experiment. We have had success using 5-base HiFi sequencing at Children’s Mercy Kansas City to identify abnormal methylation in repeat expansion cases, and we plan to apply it to all the future genomes we sequence. It is exciting to access another aspect of the genome without needing to change sample handling or sequencing procedures,” said Emily Farrow, PhD, CGC, Director of Laboratory Operations at Children’s Mercy Kansas City and Associate Professor of Pediatrics at University of Missouri Kansas City School of Medicine. “We found that the CpG methylation patterns detected in tomato and maize genomes using HiFi sequencing are highly concordant to standard bisulfite sequencing but bring power to resolve transposable elements and other sequences that are out of reach with short reads. When combined with the incredible capabilities of HiFi sequencing for genome assembly and variation analysis, this creates an unmatched opportunity for ultra-highquality genome and epigenome analysis of plant and

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| industry first |

vertebrate genomes from a single datatype,” said Michael Schatz, PhD, Bloomberg Distinguished Professor of Computer Science and Biology at Johns Hopkins University. PacBio’s HiFi sequencing technology offers a comprehensive view of genomes and transcriptomes. But DNA contains much more information subtly encoded as “epigenetic” modifications to DNA bases. This epigenome influences how genes are expressed and plays a major role in determining biological function in both health and disease. Historically, access to the epigenome has been difficult and required sacrifices in read lengths, accuracy, and completeness while adding workflow complexity. By including automatic detection of the key modified base in humans and many other species (5mC in CpG motifs) PacBio sequencing technology provides access to the combined genome and epigenome without sacrificing read

lengths, accuracy, or completeness, and without requiring additional workflow steps. Streamlining workflows is a key focus for PacBio, and this latest update makes it easier to perform HiFi sequencing. The company’s new SMRTbell prep kit 3.0 is capable of reducing workflow time for whole-genome sequencing applications by 50 percent or more and reducing required DNA inputs by 40 percent (to three micrograms per human genome). SMRTbell prep kit 3.0 is suitable for a wide range of applications and supports automation and batch processing of samples. PacBio also introduced a new singlereaction sequencing plate and SMRT Cell 8M tray that better enables customers to run samples at their convenience. More information about the sequel system can be found at pacb.com

“Our latest enhancements to the Sequel II and IIe platform, including 5-base sequencing and improved workflows are expected to both simplify the ability to generate high quality data and enable deeper insights into the complexity of the genome.” Christian Henry, President and CEO of PacBio.

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| personalised medicine |

“Participants, some over 80 years of age, became very attached to their remote app.”

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| personalised medicine |

Closing the Loop on personalised healthcare Precision medicine using personalised treatments has entered mainstream healthcare. Closed Loop Medicine Ltd aims to level the playing field further with its drug and digital combination products. The Cambridge-based healthcare company is developing drug and digital therapeutic combination products centred on dose optimisation. Their most recent study aims to validate development of a novel product that links a drug to a smart phone app, enabling patients with hypertension to personalise and optimise their therapy routine. The trial, PERSONAL COVID BP, was part-funded by Innovate UK and overseen at Queen Mary University of London. Technology used in the study allowed patients shielding from COVID-19 to report COVID-19 infection-related symptoms as well as control their blood pressure remotely, on a daily basis, from home. Closed Loop Medicine evolved its approach to continue studies throughout lockdown, by designing studies to run remotely and through technology development, including the uMED decentralised clinical trial platform. Patients received drug therapy while using an app to monitor blood pressure and any potential side-effects. The data will be used to develop a product which will deliver precision control of blood pressure at population health scale. The aim is to address the number one killer in the western world (1), high blood pressure - which, even in the pre-vaccination year of COVID-19 in 2020, killed more people than cancer or COVID-19 (2). Preliminary data from this study was presented at the ACC 71st Annual Scientific Session, April 2-4, live in Washington, D.C. It will also be published online in the Journal of the American College of Cardiology (JACC). Closed Loop Medical secured a place on the Association of British HealthTech Industries (ABHI) US Accelerator programme in January 2022, and the Company is exploring additional clinical opportunities within the US healthcare system. Dr Hakim Yadi OBE, CEO and co-founder of Closed Loop Medicine, said: “This represents a key milestone for the company, the last patient dosed and follow-up treatment completed in our interventional clinical study. Our aim is to improve patient outcomes while

Dr Hakim Yadi OBE, CEO and cofounder of Closed Loop Medicine

Dr David Collier, Lead investigator

supporting health systems to better manage patients with long-term conditions through linked remote monitoring and precision drug intervention. The trial design allowed greater patient participation from the comfort and safety of their own home. I am delighted that we were able to successfully complete recruitment, despite the constraints of the COVID-19 pandemic. We look forward to presenting the results of this important trial alongside our partners at Queen Mary University of London.” Dr David Collier, lead trial investigator from Queen Mary University of London, added: “This is an important study in that it allows patients and physicians to collect real-world data to help better inform treatment decisions and monitor patient outcomes. Some of the drugs we use are great at preventing heart attacks and strokes, but frequently cause unwanted side-effects, something this trial sets out to address. “We are demonstrating through this study that one size does not fit all, but that by using technology in this combined way, we can personalise treatment for the individual. This personalisation seems to have potential to change participants relationship to treatment, as they see the effect of different levels of treatment on their blood pressure whilst carefully checking for unwanted effects. This “personalised dose-response curve” has a meaning for participants and clinicians and we’re excited to confirm its impact on the whole group. “Participants, some over 80 years of age, became very attached to their remote app and despite it prompting for daily blood pressure recording for three months were upset that they had to delete it at the end of the trial. ‘It was like an angel at my shoulder,’ said one participant.” 1.

https://www.cdc.gov/bloodpressure/facts.htm

https://jamanetwork.com/journals/jama/fullarticle/2778234

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The time is now: how bioscience can build its talent pipeline Benn Chacksfield, Head of Propositions at Tiro, says employers should consider alternative avenues of recruitment to avert the looming skills crisis. The bioscience sector has never been more prominent in public consciousness in the wake of the nation’s COVID-19 testing and vaccination effort, and with investment into the sector at a high. But staffing shortages are creating issues for employers taking on new contracts. With the sector more well-respected and recognised than ever before, employers have the opportunity to use this influx of investment to showcase the opportunities available, and develop a sustainable talent pipeline by drawing in young talent. But where to start?

THE CURRENT CLIMATE The UK’s response to COVID-19 was severely hampered by the country’s laboratory capacity, not caused by a lack of equipment or chemicals to conduct the tests, but a shortage of skilled staff. And while many may think that this is a new issue that emerged due to the pandemic and will simply shrink back into obscurity once it is over, it’s not as simple as that. The chronic shortage of skilled laboratory technicians has stunted the growth of UK businesses for many years. It has reduced the efficiency and output of key growth sectors, inhibited innovation, and reduced our competitiveness on the world stage. The National Audit Office was clear in its diagnosis: the problem lies in low participation in technicianlevel vocational education. The workforce is currently oversupplied by graduates, who lack the technical skills for these roles, and undersupplied by vocational learning options. This was confirmed in our own survey of senior laboratory technicians. Only 11% had engaged in vocational education, the vast majority (84%) learnt on the job and 57% agreed that there is a lack of options for laboratory technicians to gain recognition for their technical skills and knowledge.

huge loss of skills at risk in the future. Last year alone the number of people employed in a bioscience role was 95,800 which has been steadily declining from its 104,500 peak back in 2015. In addition to this, hiring opportunities are often missed out on and high costs of sub-contraction are used to supplement this. All of this combines to stunt industry growth. In short, the government isn’t going to meet its ambitions without the people. Investment will be wasted without the people to deliver it. And companies are missing out on opportunities to grow because they are stuck in an oldfashioned mindset where graduates - and only graduates - are the solution to all their workforce issues.

THE SOLUTION Attracting talent early in their career and training candidates to an organisation’s own standards can create a more sustainable talent pipeline via a culture of continuous on the job learning. The next step would be to develop a workforce agile to future changes and uncertainties akin to the ones we’ve experienced over the last few years. There is a growing admission in the UK that a university degree isn’t always superior. From our work with employers, we understand some of the frustrations and associated expenses of using graduates to fill vacancies. Instead, work-based training coupled with recruitment that seeks out the right values and motivations can better equip a bioscience candidate to meet the needs of their employer,when the right training is deployed. In addition to allowing organisations to tailor-make the employees they need, apprenticeships can foster loyalty, boost engagement and productivity across the entire business, and allow future talent to benefit from the experience and skills of longstanding employees. It’s never been more crucial for the world of bioscience in a postcovid world not to miss out.

THE OPPORTUNITY The UK government has been very clear on its ambitions to become a science and research superpower in the coming years, and the attention brought by the sector’s involvement in the COVID effort has attracted welcome investment. But the shortage of new recruits for the industry remains a problem and may lead to an ageing workforce with a

FOOTNOTES 1. BMJ: Covid 19 - what’s going wrong with testing in the UK? 2. House of Lords (2018) Treating Students Fairly 3. National Audit Office (2018) Delivering STEM report Statista (2021) Estimated number of biological scientists and biochemists in the United Kingdom from 2010 to 2021

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Benn Chacksfield Science and Technology Apprenticeship Specialists Tiro

“The workforce is currently oversupplied by graduates who lack the technical skills for these roles, and undersupplied by vocational learning options.”

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| opinion|

The future of healthcare: enabling a culture of prevention though tech Our existing healthcare systems are in need of an overdue shift in focus, says Simon Pavitt, Chief Operating Officer, London Technology Club. While the compassion, energy and dedication of healthcare workers should never be undervalued, the reality is that the projected future burden on health systems is unsustainable. Take the most advanced and powerful economy in the Western world as an example. In the US, the cost of chronic diseases is equivalent to one-fifth of its entire economy. In 2016, the financial toll of cardiovascular conditions alone to the US economy was $1.46 trillion. In the same year, 39.8% of the US adult population was considered obese or overweight.1 Despite new treatments and increased knowledge, healthcare systems in the most advanced economies continue to be strained.

are being made all of the time. Innovative testing tools such as LetsGetChecked – a health insights platform – allow consumers to access laboratory testing and clinical support services at home. They provide a menu of more than 30 athome tests, for areas such as cortisol, cholesterol, vitamin D, iron, omega, thyroid, and sexual health.

In this context, COVID-19 was a wakeup call for the world. Exposing weaknesses across health systems, it highlighted how we – as a society – must better understand how to prevent against different types of chronic diseases. Indeed, it is a shocking reality that each year millions of people die from preventable illnesses. By 2030, the proportion of total global deaths due to chronic diseases is expected to increase to 70%. Yet up to 80% of chronic diseases can be avoided.2

Since 2015, LetsGetChecked has administered more than 2.5 million tests, detecting more than 135,000 infections across 28 markets to help prevent illnesses from worsening. This type of innovative tech ushers in a wave of immediacy and access when it comes to healthcare testing. It shows the scalability of at-home diagnostics, and that this approach is a long-term alternative to traditional in-person medical visits. Indeed, direct testing is one step towards people taking more control of their health, looking at their predispositions with the aim of understanding themselves more in order to stay healthier for longer.

SHIFTING THE FOCUS TO PREVENTION

MONITORING

At the London Technology Club, we are interested in how nascent health technologies can enable a culture of prevention when it comes to combatting illness and disease. We believe that the advent of emerging technologies can support three pillars of prevention: health testing, health monitoring and the harnessing of data.

Personalised monitoring through the use of pioneering tech can help people to see the impact of their risk behaviours (e.g. smoking, poor diet, lack of sleep, gut health). This information can encourage positive lifestyle changes that prevent health issues from developing.

Together, these three factors can help us better predict and prevent against illness.

TESTING Firstly, technological advancements in testing can help people to better understand what health conditions they are genetically more likely to struggle with. Knowing about a family history of disease can motivate people to take steps that lower their chances of developing it. If someone is at higher risk of developing a disease – such as cancer or heart disease – then they can be offered more frequent monitoring and earlier intervention, and be supported to change their behaviours.

Good progress is being made here: the adoption of wearables – devices that can be worn on the body to monitor health data – surged in 2020 and 2021. According to the Stanford Centre for Digital Health, ownership of wearables has accelerated. In 2015 they were used by 17% of the US population, rising to 43% in 2020.3 This uptake is reflected in the size of the global wearable technology market, which grew from $40.65 billion in 2020 to $47.89 billion in 2021 – and is projected to grow to $118.16 billion by 2028.4 More than 320 million consumer wearables are expected to be shipped in 2022 alone, around 50% of which will be from Apple.

The testing of genetics and DNA has a fundamental part to play here, and we have already come a long way. While the first patent on a home pregnancy test was granted back in 1969, Covid-19 and the widespread use of lateral flow home test kits has embedded a culture of self-testing that can help prevent against illness.

Wearables can help us to monitor our lifestyle, make better choices and adopt healthy behaviours. For example, they can help users to meet their sleep goals, monitor hear rate variability, check blood oxygen levels, measure energy levels and encourage hand washing. Whether it is a relatively simple Fitbit tracker or a high-performance WHOOP, these devices transmit information in real time – allowing us to assess data in the moment. They allow us to set health goals and track our progress towards them.

We are beginning to normalise the diagnosis of health issues at home and technology will only fuel this trend further. The scientific cavalry continues to advance, and breakthroughs

Ultimately, this level of monitoring is a fundamental part in the shift from reactive to preventative health. It means that we can centre healthcare on the individual; identifying and

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| opinion |

managing issues early to help reduce the long-term burden on the wider healthcare system. Monitoring is the second step towards people taking more control of their health, with people able to track their biomarkers to receive early warning signs that encourage earlier intervention and positive behavioural change.

physical, biochemical and electrical creature are already helping with the simulation of drugs and can enter mainstream healthcare. Initially something harnessed by professional athletes, they also assess the bones and muscle parameters and simulates running, walking and other activities.

EMPOWERING PEOPLE TO TAKE CONTROL OF THEIR HEALTH

HARNESSING DATA Approximately 30% of the world’s total data volume is generated by the healthcare industry, and data management is becoming a crucial aspect of healthcare that can fuel a transformation in preventative health. 5 The data generated from the likes of DNA testing and wearables is creating what is referred to as an individual’s ‘dataome’. With the proliferation of mobile devices, wearables, trackers, sensors, and testing kits comes the expanded ability to track and gain access to increased consumer data. In 2020, the average number of digital device interactions per person reached 1,400 per day. By 2025, that figure could reach 5,000 per day.6 Drawing on this cleaner, richer, more readily accessible data, advanced technologies like AI and machine learning can accelerate healthcare innovation that can help people to gain greater insight into their own health needs. AI’s advancements will undoubtedly change preventative health. It is accelerating our capacity to glean important insights from data. For example, Human Digital Twins are transforming the application of health data; they allow a complete picture of health data to be gathered about a person (i.e., blood tests, imaging data etc.). This ‘digital twin’ enables more frequent monitoring and earlier intervention to current and future medical problems. These digital representations of humans as a very complex

Technology holds the key to enabling people to take control of their healthcare and reduce the need for sick care. It can empower them to understand their predispositions and to monitor their lifestyles. The ever-increasing amount of health data will hasten medical innovation too. The hope is that the pandemic has accelerated an acceptance that people can, and must, take more control of their own health to stay well for longer. Clearly, there are signs that people are more willing to embrace digital health tools that aid testing and monitoring – but a further shift to a prevention mindset is still needed. This next phase of progress can be driven by serious, long-term investment in health tech. This can provide technological solutions that shifts consumer attitudes towards a total focus on prevention. Crucially, this can help people to live longer, healthier lives.

REFERENCES 1 Milken Institute 2 United Nations 3 CB Insights 4 Grand View Research 5 RBC Capital Markets 6 RB Capital Markets

| BIOSCIENCE TODAY |

| news |

What happens in our brain when we die? Neuroscientists have recorded the activity of a dying human brain and discovered rhythmic brain wave patterns similar to those during dreaming, memory recall, and meditation. A new study suggests an explanation for vivid life recall in near-death experiences. Maryam Clark investigates.

Imagine reliving your entire life in the space of seconds. Like a flash of lightning, you are outside your body, seeing memorable moments of your life. Known as ‘life recall’, it can be similar to a near-death experience. What happens inside your brain during and after death have puzzled neuroscientists for centuries. However, a study published to Frontiers in Aging Neuroscience suggests that your brain may remain active and coordinated during and even after the transition to death, and be programmed to orchestrate the whole process. When an 87-year-old patient developed epilepsy, Dr Raul Vicente of the University of Tartu, Estonia, and colleagues used continuous electroencephalography (EEG) to detect the seizures and treat the patient. During these recordings, the patient had a heart attack and passed away. This unexpected event allowed the scientists to record the activity of a dying human brain for the first time ever. “We measured 900 seconds of brain activity around the time of death and set a specific focus to investigate what happened in the 30 seconds before and after the heart stopped beating,” said Dr Ajmal Zemmar, a neurosurgeon at the University of Louisville, US, who organised the study. “Just before and after the heart stopped working, we saw changes in a specific band of neural oscillations, so-called gamma oscillations, but also in others such as delta, theta, alpha, and beta oscillations.” Brain oscillations (more commonly known as ‘brain waves’) are patterns of rhythmic brain activity normally present

in living human brains. The different types of oscillations, including gamma, are involved in high-cognitive functions, such as concentrating, dreaming, meditation, memory retrieval, information processing, and conscious perception, just like those associated with memory flashbacks. “Through generating oscillations involved in memory retrieval, the brain may be playing a last recall of important life events just before we die, similar to the ones reported in near-death experiences,” Zemmar speculated. “These findings challenge our understanding of when exactly life ends and generate important subsequent questions, such as those related to the timing of organ donation.” While this study is the first of its kind to measure live brain activity during the process of dying in humans, similar changes in gamma oscillations have been previously observed in rats kept in controlled environments. This means it is possible that, during death, the brain organises and executes a biological response that could be conserved across species. These measurements are based on a single case and stem from the brain of a patient who had suffered injury, seizures and swelling, which complicate interpretation of the data. Nonetheless, Zemmar plans to investigate more and sees the results as a source of hope. “Something we may learn from this research is: although our loved ones have their eyes closed and are ready to leave us to rest, their brains may be replaying some of the nicest moments they experienced in their lives.”

“Through generating oscillations involved in memory retrieval, the brain may be playing a last recall of important life events just before we die, similar to the ones reported in near-death experiences.” Dr Ajmal Zemmar, neurosurgeon at the University of Louisville, US

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91.224

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104

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140.116

Th 232.03806

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Protactinium

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107

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Seaborgium

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190.23

108

Hs (270)

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102.9055

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Hassium

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Np (237)

Neptunium

150.36

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151.964

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110

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111

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200.59

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28.0855

112

Cn (285)

Ge 72.64

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204.3833

113

Nh (284)

Copernicium

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114

Fl (289)

Nihonium

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115

Mc (288)

Flerovium

164.93032

Er 167.259

Holmium 2 8 18 32 28 8 2

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Californium

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100

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2 8 18 31 8 2

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101

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116

2 8 18 32 32 8 2

103

102

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2 8 18 32 18 7

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117

(294)

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118

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39.948

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126.90447

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173.054

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168.93421

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79.904

127.6

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20.1797

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35.453

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78.96

208.9804

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32.065

121.76

2 8 18 32 18 4

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Sulfur 34

2 7

18.9984032

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207.2

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74.9216

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Arsenic

118.71

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30.973762

15.9994

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114.818

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69.723

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158.92535

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196.966569

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195.084

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63.546

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58.6934

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101.07

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58.933195

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186.207

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144.242

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50.9415

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47.867

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88.90585

137.327

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BioScience Today 27

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INDUSTRY FIRST

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Foreword

PERSONALISED MEDICINE

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