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Biobanking The promise of medical breakthroughs

UK & World News

Infection Protection


Drug Discovery

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How biobanking is helping to unlock secrets Welcome to the latest edition of Bioscience Journal and there are two major themes running through a couple of our features, both to do with the way that the bioscience community is embracing changes that offer great promise for the future. One theme is a determination not to waste precious data and one of our features looks at biobanking, which is an exciting field because, for a long time, one of the biggest challenges facing medical science has been how to manage the vast amount of patient data collected in hospitals, surgeries and research institutions.

John Dean

Editor in chief

It has long been suspected that answers to medical puzzles lurk in databanks and biobanking has a key role to play because it allows the storage of samples and the presentation of data in easily-accessible ways that can prove invaluable to researchers as they attempt to identify trends and patterns. The capacity to look back over previouslytaken samples and compare them with new ones gives scientists invaluable information. Just as an archaeologist needs to refer to previously collected shards of pot and scraps of leather to draw conclusions or detectives can benefit from advances in forensic science to glean new information from old to solve long-standing crimes so medical scientists can garner crucial information from stored biosamples. Our feature examines the way that the sector is expanding to meet the challenges; indeed, business analysts Visiongain predict that the world biobanking market will generate $27.5bn in 2020 as demand grows for samples for use by pharmaceutical companies in preclinical research. The potential is indeed huge. In areas ranging from research into dementia to studies in autism, investigations into cancer to work on heart attacks and strokes, as documented in our feature, the role of biobanking can only assume ever-greater importance as science


improves the way it manages and stores information. Running alongside the development of biobanking is an impressive and growing commitment to the widest possible dissemination of information and one of our other features looks at drug development where the theme that emerges time and time again is the need to share data with as many scientists as possible. Yes, there has to be an acknowledgement that data can often be confidential, and yes there are commercial considerations – developing a drug that eradicates a major killer is worth billions to a pharmaceutical company – but there is nevertheless a growing acceptance that the old adage ‘two heads are better than one’ is as sound today as the day it was first uttered. That is where biobanking comes into its own because the willingness among scientists to co-operate combined with the capacity to make available a vast reservoir of stored data and samples can prove a compelling combination. The approach is already proving its worth with scientists around the globe reporting that the wider availability of information and the ability to work with other experts is leading to the development of new drugs and therapies. Many of those breakthroughs are mentioned on our feature pages and in our news sections and each one of them lifts the spirits because, in a world where ill-health casts such a long shadow, including in countries where increasing longevity brings its own problems, each of these stories offers real encouragement. At the heart of all of these initiatives is a better understanding of the causes of disease and biobanking is playing its part. Unlocking secrets indeed.



BioScience JOURNAL



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Contents 22






UK News


World News

22-29 Biobanking 30-33 Infection Control


34-40 Drug Discovery and Development

30 Editor

John Dean



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John Dean & Francis Griss


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Team unlocks secrets of infections A team led by Oxford University has identified genes that make some children more susceptible to bacterial infections, by performing a large genome-wide association study in African children. Bacteraemia, bacterial infection of the bloodstream, is a major cause of illness and death in sub-Saharan Africa but little is known about whether human genetics play a part. The leading bacterial cause of death in young children worldwide is Streptococcus pneumoniae (pneumococcus), and 14.5 million episodes of serious pneumococcal disease occur in young children annually. A global network of researchers, coordinated from the Wellcome Trust Centre for Human Genetics in Oxford, carried out a genomewide study to identify which genes might be associated with an increased likelihood of developing bacteraemia. Dr Anna Rautanen, from the Wellcome Trust Centre for Human Genetics at Oxford, said: ‘A key question is why only a proportion of individuals develop invasive disease despite widespread exposure and asymptomatic carriage of bacteria.

“We know that genetic differences contribute to individuals’ chances of developing more serious disease. However, the relevant genes for bacteraemia susceptibility remain largely unknown.’ The study looked at DNA samples from more than 4,500 Kenyan children from the Kilifi area, where Oxford and the Welcome Trust have a joint research centre with the Kenya Medical Research Institute, and where there is a high occurrence of bacteraemia. Just over 4000 children were healthy, while slightly more than 500 had pneumococcal bacteraemia. The study found an area of two long intergenic noncoding RNA (lincRNA) genes that was associated with susceptibility to pneumococcal bacteraemia. LincRNAs are RNA transcripts that are longer than 200 nucleotides but are not translated into proteins. LincRNAs are still little understood, although it is believed that the human genome


has more than 10,000 of them. Dr Rautanen said: ‘One of the associated lincRNA genes, called AC011288.2, is expressed only in neutrophils, cells that are known to have a key role in clearing pneumococcal disease. Although the role of lincRNAs in human infections is unknown, recent mouse studies have indicated that some lincRNAs can act in immune cells to regulate an individual’s susceptibility to bacterial and viral infections. ‘The genetic variants we identified are found only in African populations. This is one of only a few large scale genetic studies carried out in Africa and the results show why such studies must be carried out in diverse populations. ‘Critically, the genetic variants we have identified carry a doubled risk of developing bacteraemia when infected with the Streptococcus pneumoniae bacteria. This discovery, therefore, provides clues in the pressing search for new ways to target the disease.”



Scientists drafted in to help protect trees

Two new projects have received a share of £2m for research to help combat threats to trees and plants as part of the Tree Health and Plant Biosecurity Initiative (THAPBI).


Global threats from Phytophthora spp,: understanding drivers of emergence and opportunities for mitigation through nursery best practice - Led by Dr Sarah Green, Forest Research


Understanding and forecasting causes and consequences, management for future climates - Led by Dr Rob Jackson, University of Reading

New drug shows promise against muscle wasting disease A new drug to treat the muscle wasting disease inclusion body myositis (IBM) reverses key symptoms in mice and is safe and well-tolerated in patients. The study led by the MRC Centre for Neuromuscular Diseases at University College London (UCL) and the University of Kansas Medical Center found that the new drug Arimoclomol reversed the disease’s effects at the cellular level and improved muscle strength in mice.

on these cells. They then used genetically modified mice whose muscle cells and symptoms closely resembled the human disease. An Arimoclomol trial in these mice found that it was well-tolerated, reversed key features of the disease and, importantly, improved muscle strength.

A safety trial in 24 IBM patients conducted in London and Kansas found that the drug was safe and well-tolerated.

Following a successful patient safety trial, there are plans to begin a full-scale randomized controlled clinical trial to formally assess if the drug is effective in slowing disease progression in people with IBM.

IBM is the most common muscle disease in people over 45. It is incurable and causes progressive muscle degeneration leading to severe disability, paralysis and dependency. The precise cause is unknown and there are currently no effective treatments. In the study, the research team pursued a new treatment approach based on observations that muscle tissue from IBM patients contains many misfolded proteins. The team started by creating cells in a petri dish that mimic the muscle tissue of IBM patients, and successfully tested Arimoclomol

Lead basic scientist and co-senior author Professor Linda Greensmith, Head of the Sobell Department of Motor Neuroscience and Movement Disorders at the UCL Institute of Neurology, said: “We are actively pursuing this promising approach of manipulation of the heat shock response in IBM as well as other neurodegenerative diseases such as motor neurone disease, in collaboration with the MRC Centre and Danish biotech company Orphazyme ApS.”


Board appointed

The Centre for Process Innovation has established an industry-led advisory board for the National Centre for Healthcare Photonics, which is set to open in 2018 at NETPark, County Durham. The centre will provide open access capabilities to help companies of all sizes to develop their photonics based technologies for healthcare. The Board brings together a wealth of expertise in the areas of photonics technologies, healthcare innovation and bringing new medical technology products to market.



Research throws light on racehorse injuries

Scientists at Queen Mary University of London (QMUL) are a step closer to preventing the kind of injuries that affect ageing race horses. For the first time, the team at QMUL’s School of Engineering and Materials Science were able to show how the types of proteins differ in parts of the tendon, and how this changes as the tendon ages. All tendons are made of subunits containing rope-like collagen surrounded by a material called the interfascicular matrix (IFM), which binds them together. The IFM is a soft, extendible material that allows the subunits to slide past one another, enabling the whole tendon to stretch. The researchers identified which proteins are present and how rapidly many of the proteins in the IFM are refreshed in young tendons. As tendons become older, the IFM becomes stiffer making it harder for the subunits to slide past each other. The results of this study indicate that the rate of proteins renewal drops with ageing in the IFM.

Co-author Dr Chavaunne Thorpe said: “When a horse runs, its muscles generate a massive amount of energy that is stored and released by the tendons in their legs. “These can be likened to massive elastic bands that absorb energy as they are stretched, and release it again when they recoil. “The key to the effectiveness of tendons is the ability of the fibres that they are made up of to slide across each other. When this ability to slide is reduced, the energy damages the tendon instead of being stored and released by it. “In this new study, we have identified specific proteins that help the tendon fibres to slide, and this research shows that these proteins are replaced less quickly as aging occurs. This makes injuries of the type that ended Rock on Ruby’s career more likely.”


Rock on Ruby, the 2012 Cheltenham Champion Hurdle winner, famously went on to win the Coral Hurdle at Ascot despite suffering a career ending tendon injury during the race, which resulted in the untimely retirement of the champion hurdler. Co-author Professor Hazel Screen, said: “Our research proves that the increase in tendon injuries as horses age may be directly related to the slowdown in the renewal of specific proteins within their tendon tissues.” Tendon injury is common in horses as well as humans, with an economic impact of more than £3bn a year in horse racing. About 16,000 horses are in training each year and the tendon injury rate is as high as 43% with few horses returning to racing after injury. The research is funded by BBSRC and was carried out with the University of Liverpool.



‘Time to take action on antibiotics’

University’s Thailand link

The School of Life Sciences at Sussex University has been awarded British Council funding to develop its teaching and research collaboration with Mahidol University, one of the leading research institutions in Thailand. The School received the award under the UK-Thailand Transnational Education Development Project, delivered by the British Council in collaboration with Thailand’s Office of the Higher Education Commission and eight Thai research universities. The award will fund the exchange of up to seven academics in pharmaceutical science, neuroscience and biotechnology.

Reviews call for better education for young scientists.

Two eminent British academics have published recommendations to improve the job prospects of graduates in science, technology, engineering and maths (STEM) degrees. Reviews by Professor Sir Nigel Shadbolt and Professor Sir William Wakeham said that students would benefit from universities and employers working together to expand work experience opportunities.

Experts from around the world met in London to discuss how best to prevent antimicrobial resistance (AMR) in animals and humans through changes to the prescribing of antibiotics for humans and animals. Among those addressing the conference, held at the Royal Society, was the Prince of Wales, a long-standing advocate of sustainable agriculture. The conference heard that for decades, humans and animals have relied on antibiotics and other antimicrobials but, as a result, infections are developing resistance to the drugs. If this continues, it is estimated that by 2050 the world will face an additional 10 million deaths due to antibiotic resistant infections at a cost of $100 trillion to the global economy. Chief Medical Officer Professor Dame Sally Davies and Chief Veterinary Officer Professor Nigel Gibbens hosted the event. Dame Sally said: “It’s has long been my personal goal to encourage responsible use of antibiotics in human and animal health, and the agriculture, farming, fisheries and environmental sectors. When we use antibiotics inappropriately, we are increasing

the opportunities for the bugs to develop resistance – the biggest threat to human health today.” This meeting was one of a series of events leading up to the UN General Assembly meeting on antimicrobial resistance in New York in September, to seek high level support for global action to tackle antimicrobial resistance. Chief Veterinary Officer Nigel Gibbens said: “The conference not only highlighted the need to tackle the significant and growing threat of antimicrobial resistance, but also the international commitment to tackling it. It’s only by working together that we can reduce the development of AMR. “We need to minimise disease risks in animals, enable accurate diagnosis and ensure that when animals do get sick they can be treated in a way that does not put human health at risk.”


Sharing information

Crown Bioscience Inc., a global drug discovery and development services company, has reached an agreement with UK’s University of York to exclusively license and commercialize the university’s unique collection of patient-derived xenograft (PDX) models for prostate cancer. Jean-Pierre Wery, PhD., president of Crown Bioscience, said: “This agreement benefits cancer researchers around the world because these models will now become more widely available,” “With this agreement, we can offer researchers one of the largest, if not the largest, collection of well-validated prostate cancer PDX models.”



Dementia research initiative attracts funding

A quarter of a billion pounds has been pledged towards the UK’s first ever Dementia Research Institute (DRI), after two UK charities announced £100 million of new investment. The Alzheimer’s Society and Alzheimer’s Research UK have both pledged £50 million each towards the work of the Institute, led by the Medical Research Council (MRC), in one of the single biggest financial commitments to dementia research in the history of both charities. Announced by Prime Minister David Cameron in his Challenge on Dementia 2020 last year, the Institute has been backed by £150 million of government investment. It will bring together scientists and experts from across the globe to transform dementia research. Set to be fully up and running by 2020, the Institute will have a central UK hub with a network of regional centres and is expected to engage hundreds of scientists. The involvement of the country’s two leading dementia charities will draw together the work of scientists and medical professionals with experience of people living with dementia across the country. Universities and Science Minister Jo Johnson said: “This government has been crystal clear that we want Britain to lead the way in

tackling this terrible condition, and scientific research and understanding is crucial to this. “This Institute, with unprecedented funding from government and leading charities, presents a unique opportunity to pull together the UK’s world leading scientists and cutting edge research tools to get on with the job of defeating this disease for good.” Jeremy Hughes CBE, Chief Executive of the Alzheimer’s Society said: “The UK Dementia Research Institute heralds an exciting era for global dementia research as it launches an unprecedented collaboration of world-leading dementia expertise and provides the largest single investment in dementia research to date. “Alzheimer’s Society is working to create a better world for those living with dementia and their families and this significant investment emphasises how important research is in achieving our ambitions. We are offering people affected by dementia, and all of us, hope for a better future in much the same way that cancer research has transformed how we diagnose, treat and care for those living with cancer.”


Hilary Evans Chief Executive of Alzheimer’s Research UK said: “Alzheimer’s Research UK’s £50 million commitment to the UK Dementia Research Institute as a founding partner adds major impetus in our drive to deliver new dementia treatments. As the largest joint effort in dementia research the UK has ever seen, this commitment sends a strong signal that we are serious about taking the fight to the condition. “Through world-leading research we can transform the lives of people with dementia, and our investment will help accelerate progress, as well as uniting the brightest scientific minds to focus on this great medical challenge. Alzheimer’s Research UK’s existing strategic initiatives, such as our Drug Discovery Alliance, will ensure promising breakthroughs made at the Institute are fed directly into the development of much-needed new treatments. The Institute, the power of the partnership around it and the potential it holds to transform UK research mark the next major step in our journey towards defeating dementia.”



Setting up a Bio Science business – getting finance This is the third short article in our series on setting up a new business in the bio science space Most businesses need some initial capital but if you cannot self finance what can you do?

recovery risk. There are other schemes eg based on a finance house buying inventory on your behalf.

The first step is to prepare a detailed business plan and cash flow analysis. Try to get as accurate estimates as possible and do not forget to include a budget for professional services, patenting and basic running costs such as IT and travel, all of which can mount up. Are there any pinch points in your plan? Have you provided for a contingency fund?

Often over looked is the potential for commercial partnering whereby you work with another usually larger business to finance the project. This can be straightforward cost sharing but alternatively a manufacturer may be persuaded to take on some of the costs perhaps in relation to prototyping or scale up in return for an exclusive manufacturing contract or a company with an existing marketing and sales force might agree to cover some of the development costs in return for distribution rights – however you must be careful not to give away so much that you are in effect simply working for that other company.

Once you know the magnitude and timescale you can start to consider your options. First option is usually grant funding. Grant funding tend to be small and for specific purposes such as hiring staff or undertaking proof of concept studies. If you are developing your technology from a very early stage then while the risk of failure remains high, grants may be your only viable option. The next option to consider is taking a loan. Bank finance is difficult unless you can offer up some collateral but in some areas local government backed schemes allow you to borrow for particular purposes such as the purchase of machinery at very favourable terms. If you are revenue generating you may be able to use invoice financing whereby a finance house buys your invoices at a discount and then takes the

Sometimes there is no alternative but equity funding ie you grant shares in your business to the investors in return for their support. Depending on how much you are seeking to raise you will likely be approaching High Net Worth individuals, Angel Syndicates and Venture Capital Funds however crowd funding is becoming more popular even for more industrial products so this should at least be considered. To make a success of crowdfunding you need a compelling story and be willing to put a great deal of effort and

imagination into marketing to ensure you stand out from the masses and engage your target audience. It is generally believed that you need a number of investors lined up to come in right at the beginning to gain traction. Generally approaches are made to High Net Worths where the “ask” is less than £150,000, Angel Syndicates for sums of around £150,000 to £300,000 and beyond that to venture capital funds. There is a gap in the market between about £250,000 and £1milliion as Angels struggle to find these larger amounts but the total remains rather low for venture funds. There are investors who cover this space in a first round but it is a smaller pool with more limited choice. In our next article we will look at how to approach professional investors. Telephone: 0131 202 6527 Email:

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Study offers new hope for cancer sufferers The largest-ever study to sequence the whole genomes of breast cancers has led scientists to declare that they now have the most comprehensive picture ever of how the disease develops. Researchers uncovered five new genes associated with the disease and 13 new mutational signatures that influence tumour development, as part of work led by Dr Serena Nik-Zainal of the Wellcome Trust Sanger Institute.

distinctive from each other and were also very different to other breast cancers. This discovery could be used to classify patients more accurately for treatment.

The team analysed 560 breast cancer genomes, 556 from women and four from men, in an international collaboration including breast cancer patients from around the world, including the USA, Europe and Asia.

Dr Zainal said:” In the future, we’d like to be able to profile individual cancer genomes so that we can identify the treatment most likely to be successful for a woman or man diagnosed with breast cancer. It is a step closer to personalised healthacre for cancer.”

Each person’s cancer genome is a historical account of the genetic changes that they have acquired throughout life. As a person develops from a fertilised egg into adulthood, the DNA in their cells gather genetic changes along the way.

The work has been funded through the ICGC Breast Cancer Working group by the Breast Cancer Somatic Genetics Study (BASIS), a European research project funded by the European Community.

Dr Nik-Zainal’s team hunted for mutations that encourage cancers to grow and looked for mutational signatures in each patient’s tumour.

Collaborator Dr Ewan Birney, from the European Bioinformatics Institute, said: “We know genetic changes and their position in the cancer genome influence how a person responds to a cancer therapy.

They found that women who carry the BRCA1 or BRCA2 gene, and so have increased risk of developing breast and ovarian cancer, had whole cancer genome profiles that were highly

“For years we have been trying to figure out if parts of DNA that don’t code for


anything specific have a role in driving cancer development. This study both gave us the first large scale view of the rest of the genome, uncovering some new reasons why breast cancer arises, and gave us an unexpected way to characterize the types of mutations that happen in certain breast cancers.” Professor Sir Mike Stratton, Director of the Wellcome Trust Sanger Institute, said: “All cancers are due to mutations that occur in all of us in the DNA of our cells during the course of our lifetimes. Finding these mutations is crucial to understanding the causes of cancer and to developing improved therapies. “This huge study, examining in great detail the many thousands of mutations present in each of the genomes of 560 cases brings us much closer to a complete description of the changes in DNA in breast cancer and thus to a comprehensive understanding of the causes of the disease and the opportunities for new treatments.”


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Study will help treat malaria in pregnant women A four-year study has shown that four available antimalarial treatments are safe to use in pregnancy. The PREGACT study (PREGnancy Artemisininbased Combination Treatments) compared four artemisinin-based combination treatments (ACTs), amodiaquine-artesunate (AQAS), dihydroartemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL), and mefloquine-artesunate (MQAS). Led by the Belgian Institute of Tropical Medicine Antwerp (ITM) and coordinated by Professor Umberto D’Alessandro, the study included women in Burkina Faso, Ghana, Malawi and Zambia. A total of 3,428 pregnant women with malaria in the second and third trimester were randomly assigned to one of these four antimalarial treatments. The researchers concluded that all four treatments, which are already used in adults and children, were effective and safe. DHAPQ was found to be the most effective treatment for uncomplicated malaria in pregnancy, with good safety, and longer protection from reinfection after treatment. Dr Pedro Alonso, Director of the Global Malaria Programme at the World Health Organization,

said: “Pregnant women in Africa are at increased risk of malaria infection and its harmful consequences for both themselves and their foetus. Identifying safe and effective treatment regimens is a priority for malaria control programmes.” Few studies on antimalarial drugs have been carried out in pregnant women. As a high-risk group, pregnant women are excluded from most clinical trials, so information on the safety and efficacy of current antimalarials in pregnancy is scarce, especially in Africa. Professor D’Alessandro, director of the MRC Unit, The Gambia, and affiliated with the ITM and the London School of Hygiene and Tropical Medicine, said: “We hope that the use of these ACTs among pregnant women will now increase. “These results provide strong support for the use of ACTs in the second and third trimester of pregnancy and will help African countries in either confirming or changing their treatment guidelines for pregnant women with malaria. Even though ACTs are already recommended for pregnant women in the second and third trimester, some of them may still receive


quinine, an old drug with many side effects.” The study results also provide information on which treatment to use in different situations. For example, in regions where the malaria presence is intense, including Burkina Faso, women can experience several infections in a limited time span. In such cases, a treatment providing several weeks protection, such as DHAPQ, would be the best choice. Where transmission is less intense, other treatments could be used. Professor Feiko ter Kuile, coordinator of the Malaria in Pregnancy Consortium, said: “The results of this trial, which is the largest comparative malaria treatment trial for pregnant women in Africa to date, is excellent news for policy makers and pregnant women as it shows that all four commonly used artemisinin-based antimalarial combinations appear safe and have excellent efficacy in treating malaria in this high risk group.” The study was funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) and the Bill & Melinda Gates Foundation.



Encouraging results

US firm Aytu BioScience, a healthcare company focused on urological and related conditions, has observed encouraging data from two studies of its MiOXSYS System as a tool for measuring oxidation-reduction potential to assess the degree of oxidative stress levels in human semen. Oxidative stress has been implicated as a major cause of male infertility.

The right berry

New research from the University of Agriculture in Krakow, Poland, says that people in Central Europe looking for superfoods high in healthy antioxidantrich foods should opt for black raspberries. Antioxidants are beneficial to humans as they prohibit, or prevent the oxidation of molecules in the body, protecting against free radicals, which according to the researchers are closely linked with heart disease, cancer, arthritis, stroke, or respiratory diseases.

Drug go-ahead

African researchers fabricate anti-malaria soap in a bid to save 100,000 lives

A mosquito-repellent soap invented by a young African engineer is at the centre of a campaign to eradicate malaria in the developing world. The soap, which has been developed by social start-up business Faso Soap based in Burkina Faso in West Africa, contains a blend of naturally-occurring essential oils and repels mosquitoes for at least six hours after use, according to its creators. The project, which won the Global Social Venture Competition at UC Berkeley in 2013, was developed by the young engineer while he was at ITECH, a French engineering school based in Lyon which provided support in the creation of the first prototypes of the soap and worked on improvements to its smells and feel. Gérard Niyondiko, the founder of Faso Soap, who has been raising funds to take the project onto its next stage, said. “Not only is it a stable

product but it is something that people use every day in Africa. Soap is used to wash both bodies and clothes and is one of the few products to be in 95% of African households. “It is now time to move funding from the lab to commercial operations and finalise the most efficient formula against mosquitoes transmitting malaria.” The soap is part of the company’s ‘100,000 Lives’ campaign that aims to save 100,000 people from malaria by the end of 2018 by putting mosquito-repellent soap in the hands of Africa’s most vulnerable people.


French company InFlectis BioScience has been granted orphan drug designation by the European Commission for the drug IFB-088, also known as Sephin1, used in the treatment of Charcot-Marie-Tooth disease (CMT). The decision provides incentives for the development of IFB-088, including assistance in the development of clinical protocols and an exclusive ten-year marketing period in European Union. CMT is a common inherited neurological disorder that effects the peripheral nerves, causing progressive weakness of the limbs, muscle wasting, deformities, and loss of sensation



Planning for an ebola vaccine Health organisations have started to plan a campaign of use for a vaccine against the deadly ebola disease. The work is being done by the World Health Organization (WHO), its partners and affected countries after the Ebola outbreak that struck Guinea, Liberia, and Sierra Leone in 2014 prompted the search for a vaccine. Although there has been more than one promising candidate, the vesicular stomatitis virus-ebola virus (VSV-EBOV) vaccine was selected for a Phase III trial in Guinea and Sierra Leone. Dr Marie-Pierre Preziosi, Medical Officer, Initiative for Vaccine Research, WHO, said: “We can now look ahead and say yes, there will most likely be an Ebola vaccine on the market. The question is when? “At present, we believe it will take more than one to two years for this to happen. Once a product is licensed we should be prepared to move swiftly and with clear operating procedures and agreement between countries worldwide.” To plan for its use, WHO convened a Global Ebola Vaccine Implementation Team, which includes partner organisations’ technical experts and representatives from Guinea, Liberia and Sierra Leone and countries previously affected by an Ebola outbreak, Democratic Republic of Congo, Sudan and Uganda. The strategy envisages using the vaccine as part of the response to an outbreak, beginning

with protection of high-risk individuals, primarily health workers and frontline workers but also the likes of cleaners and workers involved in burial of the dead. The second stage will be to protect the circle of people around someone sick with Ebola, including friends and family. Dr Dennis Mark Child Health EPI Manager, Ministry of Health and Sanitation, Sierra Leone, said: “The vaccine will only be useful for cutting short an outbreak if we identify any cases that occur promptly and then swing into action. Above all, we must stay alert and do superb surveillance. “It is exciting to have an effective vaccine in the pipeline but knowledge about Ebola is evolving. Early in Sierra Leone’s outbreak, we believed that the virus remained in semen for no more than three months among male survivors of Ebola. Now it appears the virus can stay in the semen for as long as a year. This finding has an impact on how we will use the vaccine to protect the sexual partners of people who recovered from Ebola. “The vaccines that have been tested tend to make some people feel quite sick for 1-2 days with fever, aches and fatigue. This could affect acceptability. We already have problems with vaccine hesitancy in our country. “But something interesting happened during the outbreak. There was one local man who


volunteered to participate in the trial of the vaccine. Afterwards, his wife was in contact with a person who was sick with Ebola. She did not want to take the vaccine – until he came forward publicly in favour of it. So now we believe that former trial participants can serve as champions for the new vaccine.” Dr Jane Seward, Senior Adviser, Sierra Leone Trials to introduce a vaccine against Ebola, with the United States Centers for Disease Control and Prevention, said: “People should be aware that in an emergency, we could already use this vaccine, under a clinical or research trial protocol and emergency use licensure. This should be reassuring to the public. “But we also need to recognise that bringing a vaccine to market usually takes at least seven years. This vaccine is being pushed forward under emergency conditions, but we still have quite a way to go. “For now, we know that based on preliminary results from the Guinea trial, the VSV-EBOV vaccine is likely to provide good shortterm protection. It will be useful to have information about longer-term protection, which will be needed to protect groups at risk, such as healthcare workers, before they are ever exposed to Ebola. “Also, there are other vaccines in clinical trials that may complete testing and be licensed for use in the future. That is to be hoped for.”



Encouraging results

Research carried out in America says that a high dose of vitamin D is safe and may be beneficial for patients with multiple sclerosis (MS). The study looked at 40 people with relapsing-remitting MS. They either received a high dose of 10,400 IU vitamin D supplements per day, or a lower dose of 800 IU per day for six months. The current recommended daily allowance for vitamin D for people aged 1 to 70 years is 600 IU.

Funding allocated to tackle the Zika virus The Medical Research Council (MRC), the Newton Fund and the Wellcome Trust have joined forces to tackle the global threat posed by the Zika virus. Their move comes after the Zika Rapid Response Initiative launched by the UK-based MRC in February, which saw £1m of funding made available through the Government’s Global Challenges Research Fund. Following this, an additional £1m and up to £2m was contributed by the Wellcome Trust and the Newton Fund respectively plus additional support in Brazil provided by the São Paulo Research Foundation FAPESP. The MRC-led Rapid Response received a total of 103 proposals and funding was awarded to 26 projects with a combined value of £3.2m. Successful projects were deemed able to provide novel insights into the nature of the virus and/or potential avenues for its management or prevention. Since the World Health Organization (WHO) declared the cluster of microcephaly cases and other neurological disorders a health emergency on 1 February, substantial new clinical and epidemiological research has strengthened the association between Zika infection and the occurrence of fetal malformations and neurological disorders. In addition, the geographical distribution of the disease is now wider. There are currently 52 countries which have reported local transmission of the Zika virus.

Applicants were encouraged to work in conjunction with colleagues in affected countries and the successful funding will go towards a wide range of projects across several countries including Brazil, Columbia, Ecuador, Cape Verde, Kenya and Uganda. Awards include the development of an online data-sharing platform for images of fetal and newborn heads, improved diagnosis for Zika virus infection through a shared laboratory partnership and further investigation of the link between Zika virus infection and neurological disease. Professor Sir John Savill, the MRC’s chief executive, said: “Two very important elements needed to come together in order to respond to the global health threat from the Zika virus – agility and capacity. “Our Rapid Response Initiative allowed us to allocate funding to this global research challenge within a very short time frame, and valuable contributions from the Wellcome Trust and the Newton Fund created the capacity to match the remarkably strong response we received from the research community. Working in partnership is vital if we are to successfully tackle the health risks posed by emerging infections such as the Zika virus.” Universities and Science Minister Jo Johnson said: “This government’s decision to invest in science and innovation and protect science spending means we are able to react to emerging global threats like the Zika virus and allow the world class scientists we have here in the UK to conduct ground breaking and potentially life-saving research. By increasing this funding, and with the support of the Wellcome Trust, more of this vital work can now get started.”


Study author Peter A. Calabresi, M.D. of Johns Hopkins University said. “More research is needed to confirm these findings with larger groups of people and to help us understand the mechanisms for these effects, but the results are promising.”

Biology course to run

Professors in the Coastal Biology Flagship Program at the University of North Florida have been awarded a grant for more than $300,000 by the National Science Foundation to continue the development of a research internship for undergraduate students from all over the country to study coastal ecosystems. Ten undergraduate students are being recruited to participate in a 10-week summer programme, which is focused on coastal biology, particularly threats including ecological and economic damage due to invasive species, climate change, pollution, overharvest of fisheries resources and habitat loss due to overdevelopment.

Investment secured

American company Zivo Bioscience has secured $1 million in funding advances from investors and lenders to help it develop projects and studies focused on commercialization of its proprietary algal products. The work includes developing bovine feed additives to improve milking productivity for cattle herds.



Paving the way for pioneering gene therapy

World-class gene therapy researcher reveals how changes in the UK’s clinical research landscape are helping to drive cutting-edge research. The UK’s National Health Service is envied by many countries because of the free at the point of delivery principle which reduces inequalities in care. Add to that a world-class, government-funded research infrastructure plus a collaborative research community, and it’s no wonder that the UK is home to pioneers in rapidly advancing areas of medicine and clinical research such as gene therapy. Meet Professor Eric Alton. He wears many research hats, one of which is chief investigator of the ‘Multi-dose’ study. This research project hit global headlines last July when The Lancet Respiratory Medicine published the results revealing a significant breakthrough in the treatment of cystic fibrosis using gene therapy. Alton prefers to view the advance as a “step forward”: “We, and others, have been looking to see whether one dose of gene therapy improves

surrogate markers for cystic fibrosis, in other words does it improve the underlying basic defect? The key question is if you give repeated doses for long enough, can gene therapy improve lung function? This is something that really matters to the patient. So the big step-change is to ask a different question – one about improving lung function, rather than improving the underlying pathophysiology.” The goal of gene therapy for cystic fibrosis is to deliver healthy copies of the cystic fibrosis gene to target lung tissues. In this study researchers used 40 minute inhalations, once a month for a year, with a nebulising spray containing liposomes wrapped around healthy synthetic copies of the cystic fibrosis gene. The results showed that the patients receiving the gene therapy had a modest but significant benefit when compared to the placebo group of patients; the lung function of the placebo group deteriorated whereas the gene therapy group remained stable. The hope, and expectation, is that stability could be maintained with continued gene therapy. Plans are underway for an extension study, in which Alton believes there are more avenues to explore: “There are three things we can do – give a higher dose of gene therapy, give it more often, and look for synergies when used in combination with drugs like Ivacaftor.”


Developed by the pharmaceutical company Vertex, in conjunction with the Cystic Fibrosis Foundation, Ivacaftor was labelled the ‘most important drug of 2012’ because it treats the underlying cause rather than the symptoms of cystic fibrosis in patients with a specific mutation. Alton describes the potential of combining the two treatments: “The cystic fibrosis gene makes a protein called CFTR which acts as a channel through which chloride ions move. Across the channel is a gate and Ivacaftor keeps the gate open for longer in a small percent (4-5%) of cystic fibrosis patients. It’s possible that there might be a synergistic effect between the normal CFTR protein that we make with our gene therapy and agents like Ivacaftor. “We are also exploring another technique for delivering the healthy gene. Using liposomes was our ‘Wave One’ product with which we hoped to prove the principle that gene therapy can make a difference to lung function. We always assumed that we might need a more potent way to deliver the CF gene. ‘Wave Two’ which we developed in parallel is looking at delivering the same gene using a novel virus that we have created. The lab results look promising – it could be considerably more effective than using liposomes. We have just received funding confirmation for a first in man phase 1/2a study next year which will take place in the NIHR-



funded Biomedical Research Unit at the Royal Brompton Hospital in London.” Alton speaks highly of the NIHR – the National Institute for Health Research – the research arm of the UK’s National Health Service. Wholly government-funded, it invests over £1billion per year into research infrastructure and funding programmes. Alton has fully embraced the opportunities presented by the NIHR and is engaged in this national research infrastructure in more ways than one. But how do these roles help Alton to drive forward cutting edge research? He elaborates: “I have the privilege of being the Director of the Brompton/Imperial NIHR Respiratory Biomedical Research Unit. This is the engine. It’s here that we take the brilliant science from the University and pull it through into early phase clinical trials. “To do those trials you are clearly going to need patient cohorts who are well phenotyped; in other words understanding the patient’s key characteristics. The NIHR Rare Diseases Translational Research Collaboration has been developed to undertake just this across rare diseases. By coordinating the respiratory arm of this we are developing this valuable resource which will speed-up clinical trials both by pharmaceutical companies and academics. This phenotyping needs to be coordinated with genotyping; in other words understanding the patient’s genetic makeup. The Genomics England 100,000 genomes project is focused on this aspect and I am trying to align these two aspects so that once the Biomedical Research Unit’s bring through a research idea a well understood group of patients is available to take that idea forward. “Once that research is ready to deliver into bigger patient populations, that’s where the NIHR Clinical Research Network comes into play. The Network has a workforce of over 11,000 skilled research support staff based throughout the NHS in England to support patient recruitment and assist in the performance management of academic and commercial contract studies. With a talented team of experts I help to oversee this delivery of the research. Because the NIHR has put in place this seamless infrastructure you can take something right through from the bench to bedside efficiently.” The NIHR turns 10 years old this year. With over 20 years of experience at the forefront of

gene therapy, Alton has seen first-hand the impact that government research policy has had: “The NIHR is doing exactly what it says on the tin. It’s providing the infrastructure to allow us to conduct these studies more efficiently and more rapidly. It would have been very difficult to do a phase 2b clinical trial using gene therapy off our own back – without the research infrastructure provided by the Biomedical Research Unit and also without pharma involvement.” Supporting the life-sciences industry is a key priority for the NIHR. It works with other government agencies to ensure the UK is a globally competitive and accessible market. In 2015/16 the NIHR Clinical Research Network recruited nearly 34,500 participants to studies sponsored by the life-sciences industry and supported delivery of 1,787 new studies 650 of which were commercial contract research. According to Alton the NIHR’s work to nurture this collaborative environment is a crucial component of advancing cutting-edge research: “We are getting better at identifying genetic


causes for diseases, especially rare diseases. And once you have diagnosed the cause, the next question the patient is going to ask is ‘what are you going to do about it doctor?’ Gene therapy opens all sorts of doors but we simply can’t answer those complex questions on our own. We all need to work together; government, health services, life-sciences and universities. The NIHR fosters that collaboration by bringing the UK’s research community and health services together.” Find out more about NIHR Study Support Service:

Professor Eric Alton



Personalised medicine takes a step closer

Researchers at the University of California (UCLA), in Los Angeles, have taken a big step towards creating drug doses and combinations that are tailored to people’s specific diseases and body chemistry. The researchers, from the UCLA schools of dentistry, engineering and medicine, developed a revolutionary technology platform called phenotypic personalised medicine, or PPM, which can accurately identify a person’s optimal drug and dose combinations throughout an entire course of treatment. Unlike other approaches to personalised medicine currently being tested, PPM doesn’t require complex, time-consuming analysis of a patient’s genetic information or of the disease’s cellular makeup. Instead, it produces a drug regimen based on information about a person’s phenotype — biological traits that could include anything from blood pressure to the size of a tumor or the health of a specific organ. Dean Ho, who holds appointments in oral biology and medicine at the UCLA School of Dentistry, and in bioengineering at the UCLA Henry Samueli School of Engineering and Applied Science, said that one of the platform’s remarkable capabilities is its ability to produce graphs personalized for each individual patient that represent precisely how they respond to treatment. A corresponding author on the study, he said: “This study demonstrated the ability to use a patient’s phenotype to personalise their treatment in an actionable manner without the need for genome profiling. We also have

shown that PPM can be extended to optimize combination therapy for a wide spectrum of diseases.” The technique can be used for diseases ranging from cancer to infectious diseases, or following an organ transplant and Dean Ho said: “Among other things, the approach will allow doctors to prescribe the precise amount of medicine needed to shrink a tumor or ensure the body doesn’t reject an organ, for example, as opposed to using a higher, “standard” dose that’s recommended based on an average of how all patients have responded in the past.” Another benefit of PPM is that it can be recalibrated in real time to adapt to changes during treatment — for example if a person undergoes surgery or develops an infection, or if their organ function changes over time, any of which could mean that drug dosages or combinations need to be modified. The platform can use the patient’s new data to provide doctors with a new parabola and revised recommendations. The new study was based in part on evaluation of eight people who had recently received liver transplants. Dr Ali Zarrinpar, assistant professor of surgery in the UCLA division of liver and pancreas transplantation and a corresponding author of the study, said: “Properly managing patients’ immunosuppression can have profound long-


term impacts on the survival of the organ and the patient. “This study shows that we can pinpoint drug doses that can substantially improve patient outcomes. The ability to confidently and systematically guide the treatment of each patient is a critical advance in minimising the chance that transplant recipients will reject their new organs, while also avoiding drug side effects.” Chih-Ming Ho, who is UCLA Engineering’s Ben Rich–Lockheed Martin Professor, and a corresponding author of the study, said. “Our ability to calibrate how individual patients respond to treatment and to use that information to robustly guide their regimen based on the parabola-based approach has made personalised medicine a reality.” The team is using PPM in several other clinical trials, some of which are already under way, including for treating cancer and infectious diseases. Support for the project was provided in part by the National Cancer Institute, the National Institutes of Health, the National Science Foundation, the V Foundation for Cancer Research, the Wallace H. Coulter Foundation, the Society for Laboratory Automation and Screening, Beckman Coulter Life Sciences, and the Endowment Fund of the Ben Rich– Lockheed Martin Chair Professorship.



Research tool will help veterans

Company is acquired

US-based Twist Bioscience Corporation, a company which develops DNA synthesis systems, has acquired Genome Compiler Corporation, an Israeli-based company providing software for genetic engineers, molecular and synthetic biologists. Twist Bioscience says it will use Genome Compiler’s technology and expertise to develop a digital products portfolio to help researchers with design and build synthetic DNA projects.

Funding for projects

A $1 million Connecticut Innovations programme in the United States is to fund projects including work on artificial salivary gland and a light imaging system that detects ovarian cancer faster. The BioScience Pipeline Program is a joint venture between Connecticut Innovations, UConn, Yale and Quinnipiac University to encourage the creation of biomedical devices from Connecticut universities and colleges.

Cleaning up

Bioscience is being used to help war veterans in America cope with post-traumatic stress disorder (PTSD). Cohen Veterans Bioscience, Exaptive Inc. and Fraunhofer Institute for Algorithms and Scientific Computing have announced a new initiative to improve access to research for scientists. About eight million adults in the US alone both civilian and military populations—will experience PTSD in a given year, according to the U.S. Department of Veterans Affairs’ National Center for PTSD. According to a 2013 World Health Organization report, an estimated 3.6% of the world’s population had suffered from PTSD in the previous year. Despite a number of groups actively investigating PTSD, there is currently no easy way for researchers, policymakers and others to know what areas of study are most active, who is working on what, and where funding is or should be going. The PTSD KnowledgeMap will bring together research on clinical symptoms, biomarkers, genetic variation, epidemiological studies and many other factors deemed relevant for PTSD. I

Magali Haas, MD, PhD, CEO & President of Cohen Veterans Bioscience, the lead funder of the initiative, said: “There has been and will continue to be a wealth of PTSD studies conducted around the globe yet there is no main repository to catalogue the valuable findings that will result. “Many research endeavors overlap. Our goal is to centralise information and produce a blueprint for global PTSD research.” Dave King, Founder and CEO of Exaptive, said: “Despite popular opinion, just amassing data will not by itself lead to insight. Without the ability to quickly and easily navigate data, the information remains largely unusable.” Martin Hofmann-Apitius, PhD, Head of the Department of Bioinformatics at Fraunhofer Institute for Algorithms and Scientific Computing, said: “The consortium brings together world-class expertise in the area of PTSD and computational neurology, the competency for visualisation of complex processes and relationships and the expertise in the area of information retrieval and disease modelling.”


A promising new drug-making technique designed to reduce serious allergic reactions and other side effects from anticancer medicine, testosterone and other drugs administered with a needle has been unveiled. Developed by University at Buffalo researchers in New York, the method removes potentially harmful additives -- primarily soapy substances known as surfactants -- from common injectable drugs.




biobanking industry offers promise of medical breakthroughs For a long time, one of the biggest challenges facing medical science was ‘how do you manage the vast amount of patient data collected in hospitals, surgeries and research institutions’? It felt like the answers to big questions could be lying somewhere in information already gathered if only researchers knew where to look for it. One of the answers to the problem is biobanking, which is fast becoming one of the most important tools in the armoury of health researchers working to find new treatments for diseases. The industry has developed to provide research teams with the raw materials they need when investigating patterns in human health and it is a growing sector, according to a new report by business analysts Visiongain. Their researchers concluded that biostorage systems form an important resource that supports fields including genomics and personalised medicine, letting companies store and use samples such as stem cells.

Visiongain’s study predicts that the world biobanking market will generate $27.5bn in 2020 as rising demand for samples for use by pharmaceutical companies in preclinical research grows. In a powerful example of the potential, the world’s largest health imaging study, funded by the Medical Research Council (MRC), Wellcome Trust, and the British Heart Foundation (BHF), has been launched. It will create the biggest collection of scans of internal organs and those behind the initiative say it will transform the way scientists study a wide range of diseases, including dementia, arthritis, cancer, heart attacks and strokes. The £43m study will involve imaging the brain, heart, bones, carotid arteries and abdominal fat of thousands of current participants of UK Biobank, a project set up in 2006 by the MRC and Wellcome Trust to create a research resource of half a million people across the UK to improve health. The scans will provide data for all health scientists to access. For the past ten years UK Biobank has gathered data on 500,000 participants – including their lifestyle, weight, height, diet, physical activity and cognitive function, as well as genetic data from blood samples. Creating links to a wide range of health records is also under way, including data from general practices.


Cathie Sudlow, Professor of Neurology and Clinical Epidemiology at the University of Edinburgh, and UK Biobank’s Chief Scientist, said: “This very large number of participants involved in the multimodal imaging study is impressive enough but what makes it truly transformational is the opportunity to combine the rich imaging data with the wealth of other information already available or being collected from participants, particularly their health and diseases, for many years to come.” UK Life Sciences Minister George Freeman MP said: “Stunning advances in imaging and informatics are opening up new ways to diagnose, treat and potentially prevent diseases like dementia, heart disease and cancer.” For Professor Paul Matthews, Head of the Division of Brain Sciences at Imperial College London, the samples will offer invaluable help for scientists investigating dementia. Prof Matthews, who chairs the group of academic experts who have been supporting UK Biobank, said: “One of the crucial questions we can start to answer is, what happens in the brain years before dementia, stroke or other disorders are diagnosed? Can we understand it and find new ways to treat or prevent the onset? Scientists will also be better able to discover how brain diseases such as depression, stroke or Alzheimer’s disease are affected by our genes, environments and lifestyles.








“The availability of so much imaging data will help put the findings from smaller but important imaging studies already undertaken in context. Researchers can now test ideas quickly, armed with no more than a good idea, appropriate software and access to the necessary computational resource.”

determinants of osteoporosis in relation to other common chronic non-communicable diseases such as diabetes, atherosclerosis, hypertension, dementia, and sarcopenia (muscle loss). This is a unique research opportunity and promises to deliver ground breaking scientific information.”

His views are echoed by Professor Stephen Smith, of the Oxford University Centre for Functional MRI of the Brain, who leads the brain imaging component of the study.

Biobanking samples also cast new light on heart conditions, according to Professor Steffen Petersen, of Barts Heart Centre and Queen Mary University of London, who led the development of the heart imaging protocol.

He said: “UK Biobank will be by far the largest brain imaging study ever conducted. It will not only provide valuable insight into common conditions like dementia, but also capture early markers of more rare neurological disorders like motor neuron disease. We aim to discover new early signs and risk factors of disease, in the hope that earlier targeted treatment, or changes in lifestyle, could prevent major diseases from ever happening.”

He said: “This imaging study offers us real insight into the heart itself on a scale hitherto impossible to imagine. This is a fantastic resource for researchers both in the UK and overseas. I know many who can’t wait to see the data and start using it to improve health.” Professor Jeremy Pearson, Associate Medical Director at the BHF, which funded the pilot

project of the heart imaging protocol, said: “These scans will allow researchers to investigate heart health in greater detail than has ever been done before. This study could not only help us to better prevent and treat heart disease in the future but make current MRI techniques for scanning the heart faster and more effective. Improving diagnosis of heart disease will save lives by driving earlier and more targeted treatment to prevent heart attacks.” To drive forward the programme, an initial study of 8,000 participants has just been completed at a purpose-built scanning facility at UK Biobank’s headquarters in Stockport, which is now being used for the main study. The people scanned do not receive any feedback about their health, unless potentially serious abnormalities are spotted during the imaging.

One of the other areas in which biobanking will provide invaluable is research into conditions that affect bone strength. Nicholas Harvey, Professor of Rheumatology and Clinical Epidemiology at the Medical Research Council (MRC) Lifecourse Epidemiology Unit, at the University of Southampton, leads the musculoskeletal component. Prof Harvey said he hoped that the study will help prevent the huge number of broken bones resulting from osteoporosis (thinning of the bones), which costs the UK economy more than £3 billion a year. He said: “The really exciting thing about these imaging data is that we will have the opportunity to study bone mass and

Stunning advances in imaging and informatics are opening up new ways to diagnose, treat and potentially prevent diseases like dementia, heart disease and cancer. George Freeman,

Head of the Department of Bioinformatics




Australian biobanking initiative to help autism research All over the world, the potential of biobanking is being recognised. In Australia, for example, the first Autism Biobank has just been launched by the Cooperative Research Centre for Living with Autism (Autism CRC). The Australian Autism Biobank will contain a detailed phenotypic and genotypic profile of each donor providing a unique dataset of almost 5,000 individuals, developing a valuable asset for Australian researchers and their international collaborators. Autism CRC Chair Ms Judy Brewer said: “The Biobank is a highly valuable resource for Australian researchers which has the potential to put them at the forefront of biological discoveries related to autism.

Storage crucial to American cancer initiative

The management of information is also at the heart of The Genomic Data Commons (GDC) initiative in the United States, a system backed by the US Government to promote sharing of genomic and clinical data between researchers seeking a cure for cancer. Run by the University of Chicago, the centre is part of the National Cancer Institute (NCI) which is a component of the US Government’s recently launched National Cancer Moonshot. The GDC will centralise and make accessible data from large-scale NCI programmes and Acting NCI Director Douglas Lowy, M.D. said: “The power of data in the GDC will grow over time as data from more patients are included, and ultimately the GDC will accelerate our efforts in precision medicine.”

The GDC is is being run in collaboration with the Ontario Institute for Cancer ResearchExit Disclaimer, all under an NCI contract with Leidos Biomedical Research, Frederick, Maryland. Louis M. Staudt, M.D., Ph.D., of the NCI, said. “With each new addition, the GDC will evolve into a smarter, more comprehensive knowledge system that will foster important discoveries in cancer research and increase the success of cancer treatment for patients.”


“Autism CRC researchers will use Biobank data to pursue our goal of earlier and more accurate diagnosis of autism. Currently the majority of children are diagnosed after the age of four. We aim to dramatically reduce the age of diagnosis to under two years of age. “A greater awareness of autism and changes in the diagnostic criteria have led to increasing numbers of children diagnosed with autism in the past 10 years. However, with no established biomarker for autism, diagnosis relies solely on behavioural profiling. “Biobank information will allow us to make sense of the various biological pathways that are related to autism and assist in developing a national, standardised, accurate diagnostic protocol, enabling tailored support at the earliest possible stage.” Stored at the ABB Wesley Medical Research Tissue Bank, the Australian Autism Biobank will be an asset highly sought after by researchers from around the world. Professor David Paterson, CEO of Wesley Medical Research, said: “The Australian Autism Biobank is a wonderful example of the advantages of cooperative clinical research. Banks suchas these link clinical information with biological specimens, allowing scientists and doctors to join forces in their research.” Among those who will be contributing data to the Biobank are Telethon Kids Institute, University of Western Australia, La Trobe University, University of New South Wales, Mater Research, University of Queensland and The Queensland Brain Institute, University of Queensland is also involved.



The MCRC Biobank facilitates high quality cancer research

The MCRC Biobank facilitates high quality cancer research by bringing a flexible and committed approach to ethical sample and data collection. The Manchester Cancer Research Centre Biobank is a multi-centre biobank set-up to collect human samples from cancer patients in the Greater Manchester area, with the ultimate aim of making high quality tissue collection and retrieval easier for the researcher. It routinely collects F FPE and frozen tumour and normal tissue, with matched bloo d and urine, from patients undergoing surgery at five NHS Trusts in the Greater Manchester area. As well as the solid tumour arm of the Biobank, blood and bone marrow are also collected from patients with blood disorders such as leukaemia. The Biobank has evolved a flexible model to ensure researcher needs can be accommodated for prospective sample collection for specific projects, in addition to use of banked samples. This includes facilitating the prospective collection of fresh tissue for culture and in-vivo work, and mining the vast pathology archives available to construct large cohort tissue microarrays linked to clinical data.

The MCRC Biobank is licensed by the Human Tissue Authority and holds a Research Tissue Bank Ethics approval which can confer ethics approval to researchers approved to use banked or prospective samples by the Access Committee. To maintain a robust approach to sample quality, Biobank Technicians are embedded within each hospital to ensure systems for collecting samples are standardised. Trusts covered by the MCRC Biobank include The Christie NHS Foundation Trust – a leading cancer treatment centre with a strong track record in radiotherapy research and treatments, as well as in hosting early stage clinical trials. It has been named as a joint Movember Centre of Excellence with Queen’s University Belfast, and The Christie’s Neuroendocrine Tumour service was also awarded European Centre of Excellence status in March 2011. Biobank Technicians are also based at the University Hospital of South Manchester, which is part of the Cancer Research UK’s Lung Cancer Centre of Excellence, where nearly 500 lung cancer operations are performed annually, and Salford Royal NHS Foundation Trust which is a national Centre of Excellence for large bowel surgery. The MCRC Biobank’s research tissue bank ethics approval allows a single consent to enable serial collections of samples, which has facilitated research studies involving the


collection of blood from patients throughout the course of their treatment. This consent can be used for the collection of alternative, non-invasive sample types, such as ascites, pleural fluid and plucked hair from patients, and allows for access to the samples across different industries, including academic institutions and commercial companies. The Health Research Authority has also granted Section 251 Support permission to the MCRC Biobank, which allows linkage of large archival tissue sample cohorts, which fall outside of the consent provisions of the Human Tissue Act, to be married to clinical datasets. This can be used to link follow-up and outcome data to the tissue samples, which can be used as a resource for research looking at markers for survival and disease progression. The MCRC Biobank has: • An established network model with existing infrastructure and pathways for sample collection • Excellent clinical engagement across all cancer disease types • A robust governance framework for tissue and data • A proven track record of providing quality samples Biobank


If you wish to use the MCRC Biobank resource please make a formal expression of interest to the MCRC Biobank Business Manager (see details below) via phone or email, detailing a summary of the research idea, and types and numbers of samples required. From here, the MCRC Biobank will support you in making a formal application to the Biobank for samples.

Although the MCRC Biobank does not benefit financially from supplying samples to researchers, it does make a charge per sample to cover its costs. The cost of access to samples will be discussed when a formal expression of interest is made.

Please contact Jane Rogan, MCRC Biobank Business Manager on 0161 446 3659, or email for all enquires.



Educational needs of Biobankers The academic and commercial demand for access to high quality tissue and data from biobanks continues unabated as cornerstones in the development of biomarkers as we strive towards personalized medicine. Whilst biobanks endeavour to fulfil their legal and quality management obligations, little thought is given to educating and developing the staff so they can set up and run a successful and collaborative facility. The majority of staff start with a bioscience or biomedical science background, so have technical and some management skills to collect and process materials but may lack knowledge and experience in the medicolegal and management aspects of biobanking. Biobanks that are integrated into other departments, such as pathology, may be able to utilize the quality or business manager, but

where the biobank is independent the skills have to be learnt and systems implemented often by small numbers of staff with a limited budget. Biobanking in the UK is entwined in legal (Human Tissue Act 2004), ethical (Health Research Authority) and contractual requirements. It is imperative that the biobanker understands what is or is not permissible, particularly as we increasingly move towards wide-ranging consent activities and international sample movement. An error leading to the release of samples without donor consent may have both legal consequences and reputational repercussion, impacting on current and future collaborations. The role of biobanker is to ensure that the terms and conditions under which material is collected are passed on to the user, yet staff in biobanks may have limited understanding of the legislation, research ethics or contract requirements of sample collections and movement. This is not conventionally taught as part of a bioscience undergraduate programme. An increasing number of organisations have in-house training, covering the implications of Human Tissue Act 2004, but courses covering research ethics of biobanking are very limited and those for contractual arrangements virtually non-existent.


The modern biobank manager needs to be conversant with not only medico-legal aspects but also quality, project and financial management. Demonstration of a quality management system and regular audit activities are a requirement of every biobank. Yet, biobankers often use a system they’ve experienced in their past, without necessarily thinking about whether it is truly fit for purpose. Application and release of sample and data from a biobank have both project and financial management requirements. A defined project management process from application through to sample or data processing and release, should be in place. If cost recovery is included, then part of the financial management may include generation of quotations and invoices. The biobanker certainly has specialist educational requirements if the Biobank is to meet its potential and be able to adapt to a changing environment. Yet we are still heavily reliant on the informal visit or word-of-mouth to obtain the knowledge to implement a management system. We may seek formal training but not necessarily for a biobank application. In the past the UK Confederation of Cancer Biobanks have arranged themed study days with lectures on quality management, consent or information


technology. Whilst these provide useful insight, they are not all designed to help biobankers weigh up the pros and cons of implementing systems into their own environment. The expansion of specialist education for biobank staff is paramount to support the diverse activities of the role and reflect the emerging discipline of biobank science. The delivery of this education must also meet the needs of staff, students and employers alike. For those who wish to become biobankers or establishments wishing to set up a research biobank, postgraduate programmes are available. These programmes all play a part but there remain precious few training opportunities for existing and future biobank staff to obtain both the theoretical knowledge and practical implementation skills required for many biobanks to reach their potential. Whilst introductory biobank courses are beneficial to not only new biobankers but also other clinical or research staff who wish to understand the function and processes of the biobank, there is certainly a lack of training opportunities for more experienced staff or those requiring training in specific topics. Where does the biobanker go for training on cost recovery model design and application, auditing, fundraising, public/patient involvement, project monitoring or legislation on international sample or data transfer? As a


biobank community we need to address this unmet need if we are to advertise our quality systems and fully utilise our sample and data collections for the most appropriate research. There are considerable benefits in attending postgraduate programmes, specifically having an intensive year learning about biobank science whilst also gaining experience in different biobanking facilities. However, the cost both in fees and time away from work may be prohibitive to some employers, so there are practical aspects of how biobanking education should be delivered. There are financial and practical benefits to online learning and increasingly lectures are being delivered in a virtual learning environment. A modular approach would fulfil the

requirements for those wishing to not only achieve a postgraduate masters, diploma or certificate level qualification but would also be suitable for experienced biobankers to select specific modules or even just to access lectures. Biobanking is a profession where staff must have access to specialist education. This will allow biobanks to maximise tissue and data quality, attract international academic and commercial users and, importantly, maximise the research value of donated bioresources. Cheryl Gillett Head of Biobanking Programme Director MSc Research Biobanking King’s College London

There are considerable benefits in attending postgraduate programmes, specifically having an intensive year learning about biobank science whilst also gaining experience in different biobanking facilities.





infection a major priority worldwide Preventing infection is a major challenge facing healthcare workers today. To meet that challenge, an industry has developed specialising in training people at all levels, from carers in homes for the elderly to senior hospital medics, to adopt proven safe practice.

everyone who could do so recognises their role or takes it seriously.

Keeping up with the evolution of drugresistant pathogens and research into the best techniques means that it is essential to refresh knowledge regularly and for organisations to ensure that staff are following the advice from their training.

“Because much care is delivered by informal carers and family members there are currently approximately six million unpaid carers in the UK, a number that is likely to increase with an aging population - this guideline is as applicable to them as it is to healthcare professionals.

Family members caring for the sick and injured at home are also being targeted as a possible source of infection and front line defenders in the battle against it. Research into the effectiveness of infection control techniques has highlighted the size of the challenge and the fact that not

The National Institute of Heath and Clinical excellence (NICE) issued guidance in 2012 and that guidance is due to be reviewed at the end of 2016. Christine Carson, programme director at the Centre for Clinical Practice at NICE, said: “As a result of the rapid turnover of patients in acute care settings, complex care is increasingly being delivered in the community. This includes the care given to a large population group living at home and in care homes who have long-term conditions and who need to use catheters and venous access devices. Infection prevention in these settings is, therefore, just as important as in hospital.

“The guideline states that everyone involved in providing care, including patients themselves, should be educated about the standard principles of infection prevention and control and trained in hand decontamination, the use of personal protective equipment, and the safe use and


disposal of sharps. These issues should be at the top of the agenda for anyone who provides care for a patient, regardless of setting and regardless of whether they are a healthcare professional, an informal carer or a family member." Despite this advice and similar recommendations in other countries, the American Association for Professionals in Infection Control and Epidemiology recently issued a statement saying research in the state of New Mexico at 15 separate outpatient departments had shown hand washing was skipped in one third of cases. The authors of the study stated: “This project highlights the importance of assessing both the report of recommended infection prevention policies and practices, as well as behaviour compliance through observational audits. This is critical because there have been outbreaks and infection transmission to patients reported in outpatient settings due to these types of infection prevention breaches, including transmission of hepatitis B and C.” In every instance observed hand hygiene supplies had been readily available, according to the team.






The end of hand-shaking in healthcare?

One interesting way of avoiding the transmission of pathogens is in changing the amount or the style of hand-to-hand contact - most simply by stopping shaking hands. Researchers at Aberystwyth University trialled alternative greetings and settled on the fist bump so beloved of sportsmen and women. In the experiment, a greeter immersed a sterile gloved hand into a container of germs. Once the glove was dry, the greeter exchanged a handshake, fist bump, or high five with a sterile gloved recipient. Exchanges randomly varied in duration and intensity of contact.

free, and more hygienic alternative to the handshake.”

After the exchange, the receiving gloves were immersed in a solution to count the number of bacteria transferred during contact.

Similar research in Scotland demonstrated that the six-step hand-hygiene technique recommended by the World Health Organization is superior to a three-step method suggested by the U.S. Centers for Disease Control and Prevention in reducing bacteria on healthcare workers’ hands.

Nearly twice as many bacteria were transferred during a handshake compared to the high five, and significantly fewer bacteria were transferred during a fist bump than a high five. In all three forms of greeting, a longer duration of contact and stronger grips were further associated with increased bacterial transmission.

During the randomized controlled trial overseen by Jacqui Reilly, PhD, professor of infection prevention and control at Glasgow Caledonian University in Scotland in an urban, acute-care teaching hospital, researchers observed 42 physicians and 78 nurses completing hand-washing using an alcoholbased hand rub after delivering patient care.

Author David Whitworth, PhD said: “Adoption of the fist bump as a greeting could substantially reduce the transmission of infectious diseases between individuals.

The six-step technique was determined to be microbiologically more effective for reducing the median bacterial count (3.28 to 2.58) compared to the three-step method (3.08 to 2.88). However, using the six-step method required 25% more time to complete (42.50 seconds vs. 35 seconds).

“It is unlikely that a no-contact greeting could supplant the handshake; however, for the sake of improving public health we encourage further adoption of the fist bump as a simple,


Jacqui, lead author of the study, said: “One of the interesting incidental findings was that compliance with the six-step technique was lacking. Only 65% of providers completed the entire hand hygiene process despite participants having instructions on the technique in front of them and having their technique observed. This warrants further investigation for this particular technique and how compliance rates can be improved.” The researchers recommend authors of international guidance should consider this evidence when making official recommendations on best practices in hand hygiene. Their work was published through a partnership between the Society for Healthcare Epidemiology of America and Cambridge University Press.



System could tackle resistant bugs Once resistant bugs are established in an environment, it can be difficult to eliminate them using ordinary cleaning methods but specialist companies have developed techniques for cleansing an area or individuals. Rooms and whole departments can be treated with hydrogen peroxide vapour to eliminate pathogens where they are causing a persistent problem. Such treatment systems are mobile or can be fixed in situations such as operating theatres and research labs where regular treatments may be desired. The systems are now being subjected to EU regulations which will test their efficacy, process, toxicity and risks. By February 2017 manufacturers of such equipment will have to submit a technical dossier to a European Competent Authority to see if their system complies with EU Regulation 528/2012 Biocidal Products Regulations.

Surface research could help control infection Another front in the war against infection is the introduction of antimicrobial surfaces into hospitals. By making the environment more hostile to pathogens such as Clostridium difficile and Staphilococcus aureus there will be less chance that they will be spread around by casual contacts. Surfaces such as beds, door handles, pens and keyboards are possible sources of transfer.

Tests which subjected silicone infused with crystal violet, methylene blue and gold nanoparticles to infection shoed the most potent antibacterial effect ever observed in such a surface while having no significant effect on the properties of the silicone.

Professor Ivan Parkin of UCL, part of a team working on antimicrobial dyes which work in low light levels and even in the dark, said: “There are certain dyes that are known to be harmful to bacteria when subjected to bright light.

Sacha Noimark, lead author of the paper which reported the results, said: “Despite contaminating the surface with far more bacteria than you would ever see in a hospital setting, placed under a normal florescent light bulb, the entire sample was dead in three to six hours, depending on the type of cacteria.

“The light excites electrons in them, promoting the dye molecules to an excited triplet state and ultimately produces highly reactive oxygen radicals that damage bacteria cell walls. “Our project tested new combinations of these dyes along with gold nanoparticles, and simplified ways of treating surfaces which could make the technology easier and cheaper to roll out.”


“That was an excellent result, but the bigger surprise was the sample which we left in the dark. That sample, too, showed significant reductions in bacterial load, albeit over longer timescales of about three to eighteen hours.”



Overcoming the barriers to more effective

drug research The success or failure of health advancement stands and falls on the capacity of the pharmaceutical industry to continually bring forward new drugs. It always has, it probably always will. From the herbalists of ancient times to the scientists working on cutting edge 21st Century genome therapies, the success of healthcare has relied on new treatments that are better than the previous version. However, with the promise of potentially lucrative breakthroughs comes challenge and that means overcom ing barriers, including the realisation that drugs must be better targeted at specific patients rather than general diseases, improving the sharing of information and beating drug-resistant health conditions.









Improving the targeting of drugs Among those confronting the challenge is AstraZeneca and its global biologics research and development arm, MedImmune, which recently announced a genomics initiative to transform its drug discovery work. AstraZeneca believes that embedding genomics across its research and development will allow it to deliver insights into the biology of diseases, enable the identification of new targets for medicines and allow patients to be matched with treatments more likely to benefit them. As part of the work, AstraZeneca is creating an in-house Centre for Genomics Research based in its corporate headquarters in Cambridge, UK, which will work closely with the international genomics community. The initiative includes new collaborations with Human Longevity, Inc., of the US, the Wellcome Trust Sanger Institute in the UK and The Institute for Molecular Medicine, Finland. Menelas Pangalos, Executive Vice President, Innovative Medicines & Early Development at AstraZeneca, said: “Using the power of genomics is the foundation of our ambition to develop the most innovative and impactful treatments for patients.  “With the advent of next generation sequencing and the increased sophistication of data analysis, the time is now right to immerse ourselves fully in the international genomics community through these pioneering collaborations and through the creation of our own genome centre. “We will leverage information from up to two million genome sequences, including more than 500,000 from our own clinical trials, to drive drug discovery and development across all our therapeutic areas. Genomics will be fundamental to our laboratory research, our clinical trials and the launch of our medicines for patients.” AstraZeneca will establish a research team led by a genomics expert of international reputation, based at The Wellcome Trust Sanger Institute’s world-renowned Genome Centre in Cambridge.

AstraZeneca will also collaborate with The Institute for Molecular Medicine, Finland, and its partners in Finland and the US, to study genes of interest in the Finnish population, which is known to carry a higher than normal frequency of rare variants. Bahija Jallal, Executive Vice President, MedImmune, said: “The fields of genetics and genomics evolve so rapidly that no single company can internalise this type of research and do it all themselves. “We are acutely aware of this, which is why we have chosen to work with the genomics community to leverage external expertise in genomic analyses and the design of large-scale genetic studies. Together, with the rich clinical data from our biobank, we will translate these


findings into better understanding of disease and ultimately, more effective treatments for patients.” In line with AstraZeneca’s “open innovation” approach, research findings from all collaborations across its genomic platform will be published in peer-reviewed journals, contributing to the broader scientific understanding of the genetic influence of disease.



Team edges closer to breakthrough

Finding a way to defeat drug-resistance is driving many research projects, including at the University of East Anglia where scientists say they are getting closer to solving the problem of antibiotic resistance.

New research has revealed the mechanism by which drug-resistant bacterial cells maintain a defensive barrier, findings that pave the way for a new wave of drugs that kill superbugs by bringing down their defensive walls rather than attacking the bacteria itself. It means that in future, bacteria may not develop drugresistance at all. Unravelling this mechanism could also help scientists understand more about human cell dysfunctions linked to disorders such as diabetes, Parkinson’s and other neurodegenerative diseases.

The team, supported by the Wellcome Trust, used Diamond Light Source, one of the world’s most advanced scientific machines, to investigate a class of bacteria called 'Gramnegative bacteria'. Diamond produces intense light 10 billion times brighter than the sun, allowing scientists to explore almost any material in atomic detail. Gram-negative bacteria is particularly resistant to antibiotics because of its cells' impermeable lipid-based outer membrane. This outer membrane acts as a defensive barrier against attacks from the human immune system and antibiotic drugs. It allows the pathogenic bacteria to survive, but removing this barrier causes the bacteria to become more vulnerable and die.

The research team previously found what they describe as an ‘Achilles heel’ in this defensive barrier but how this defensive cell wall is built and maintained – the ‘assembly machinery’ was unknown until now. Lead researcher Prof Changjiang Dong, from UEA’s Norwich Medical School, said: “Bacterial multi-drug resistance, also known as antibiotic resistance, is a global health challenge. Many


current antibiotics are becoming useless, causing hundreds of thousands of deaths each year. The number of super-bugs is increasing at an unexpected rate. “Gram-negative bacteria is one of the most difficult ones to control because it is so resistant to antibiotics. “All Gram-negative bacteria have a defensive cell wall. Beta-barrel proteins form the gates of the cell wall for importing nutrition and secreting important biological molecules.   “The beta-barrel assembly machinery (BAM) is responsible for building the gates (beta-barrel proteins) in the cell wall. Stopping the betabarrel assembly machine from building the gates in the cell wall cause the bacteria to die. Our work paves the way for developing newgeneration drugs.” The research was funded by the Wellcome Trust. Collaborators included Dr Neil Paterson of Diamond Light Source (UK), Dr Phillip Stansfield from the University of Oxford, and Prof Wenjan Wang of Sun Yat-sen University (China).



Improving the way information is shared

Effective sharing of information is at the heart of work to develop the world’s largest database for cancer drug discovery, which has been revolutionised by adding 3D structures of faulty proteins and maps of cancer’s communication networks. According to Cancer Research UK, the canSAR database developed at The Institute of Cancer Research, London, will allow scientists working across the globe to design new cancer treatments more effectively. The canSAR database was launched in 2011 by researchers in the Cancer Research UK Cancer Therapeutics Unit at The Institute of Cancer Research (ICR) with the goal of building a detailed picture of how the majority of known human molecules behave. canSAR has already collated billions of experimental measurements mapping the actions of one million drugs and chemicals on human proteins, and has combined the data with genetic information and results from clinical trials. The new version of canSAR uses artificial intelligence to identify nooks and crannies on the surface of faulty cancer-causing molecules as a key step in designing new drugs to block them. It also allows scientists to identify communication lines that can be intercepted within tumour cells, opening up potential new approaches for cancer treatment.

Dr Bissan Al-Lazikani, team leader in computational biology at The Institute of Cancer Research, London, who led the Cancer Research UK-funded team that developed canSAR, said: “Our database is constantly growing with information and is the largest of its kind – with more than 140,000 users from over 175 countries. “We regularly develop new artificial intelligence technologies that help scientists make predictions and design experiments. Our aim is that cancer scientists will be armed with the data they need to carry out lifesaving research into the most exciting drugs of the future. “Scientists need to find all the information there is about a faulty gene or protein to understand whether a new drug might work. These data are vast and scattered but the canSAR database brings them together and adds value by identifying hidden links and presenting the key information easily.” Professor Paul Workman, chief executive of The Institute of Cancer Research, London, and a Cancer Research UK Life Fellow, said: “SAR


is a massively powerful resource that’s used globally by researchers to gain rapid and easy to use access to a huge wealth of integrated knowledge in biology, chemistry and cancer medicine. “This latest research has greatly enhanced the power of canSAR to enable scientists to select the best possible targets for future cancer drug discovery and also to help them develop really innovative drugs much more rapidly and effectively than ever before for the benefit of cancer patients worldwide.” Dr Kat Arney, Cancer Research UK’s science information manager, said: “This database makes masses of detailed scientific information about cancer available to scientists all over the world, and will speed up crucial advances in drug discovery – ultimately saving more lives. Finding new treatments for cancer can be a long and expensive process, so anything that cuts times and costs will help to bring the next generation of therapies to patients even sooner.”



Concerns expressed on drug-resistant infections

Another major concern for those developing new drugs is the risk that illnesses become resistant to them, with significant worries about antibiotics. More than 80 leading international pharmaceutical, generics, diagnostics and biotechnology companies, as well as key industry bodies, recently came together to call on governments and industry to work together against drug-resistant infections – so-called ‘superbugs’ – with a joint declaration launched at the World Economic Forum in Davos, Switzerland. The statement called on governments and industry to support sustained investment in the new products needed to beat the challenges of rising drug resistance. The Declaration on Combating Antimicrobial Resistance – drafted and signed by 85 companies and nine industry associations across 18 countries – saw commercial drug and diagnostic developers for the first time agreeing on a common set of principles for global action to support antibiotic conservation and the development of new drugs, diagnostics, and vaccines. The Declaration called for action targeted at: • Reducing the development of drug resistance. The companies commit to encouraging better and more appropriate use of new and existing antibiotics. This support extends to promoting more judicious use of antibiotics in livestock, as part of a ‘one health’ approach • Increasing investment in R&D that meets global public health needs and removing the scientific barriers to antibiotic discovery to be overcome • Improving access to high-quality antibiotics for all Lord Jim O’Neill, Chairman of the Review on Antimicrobial Resistance, said: “This Declaration from industry is a major step forward in establishing a properly global response to the challenges of drug resistance. I’m really impressed that such a wide range of companies have been able to agree on a common set of principles and commitments across these important issues: this is a level of consensus that we have not previously seen from the industry on this topic. “The pharmaceutical industry, as well as society at large, cannot afford to ignore the threat of antibiotic resistance, so I commend those companies who have signed the Declaration for recognising the long-term importance of revitalising R&D in antibiotics, and for their leadership in overcoming the difficult issues of collective action at play here.”

Sir Andrew Witty, Chief Executive of GlaxoSmithKline plc, said: “Antibiotic resistance is the sort of global healthcare challenge that this industry should be using its expertise to tackle. “At GSK we have a long heritage and expertise in antibiotics, we've been researching and providing these medicines since the Second World War and we remain committed to continuing in this area. “We are already taking a more open and collaborative approach to our antibiotic research, working in pre-competitive collaborations alongside other companies and academics, to overcome the scientific and technical barriers to developing these medicines.”


We are already taking a more open and collaborative approach to our antibiotic research, working in pre-competitive collaborations alongside other companies and academics, to overcome the scientific and technical barriers to developing these medicines.



Collaboration key as consortium targets Autism breakthroughs Everywhere you look in the world of drug discovery, the talk is of collaboration, of sharing knowledge for the wider good. Collaboration is certainly key to the work done by an international consortium of scientists, led by Roche, King’s College London, and Autism Speaks, which is working on one of the largest ever academic-industry research projects to find new methods for the development of drugs for autism spectrum disorder (ASD).  European Autism Interventions – A Multicentre Study for Developing New Medications(EU-AIMS) is the largest single grant for autism research in the world and the largest for the study of any mental health disorder in Europe.  The project, which will take place over the next five years, brings together top scientists from universities around the world, experts from Autism Speaks – the world’s leading autism science and advocacy organization – as well as major global drug companies from

the European Federation of Pharmaceutical Industry Associations including Roche, Eli Lilly, Servier, Janssen Pharmaceutica, Pfizer and Vifor Pharma. Autism Spectrum Disorders (ASD) affects an estimated 1% of children worldwide and more children will be diagnosed with autism this year than with AIDS, juvenile diabetes and pediatric cancer combined. Robert Ring, Vice President of Translational Research for Autism Speaks, said: “The lack of effective pharmacological treatments for ASD has a profound effect on patients’ lives. We are excited that with this unique collaboration we may see a real shift in future treatment for this devastating disorder.” EU-AIMS will focus on the development and validation of research approaches for the advancement of novel therapies for ASD, the development of expert clinical sites across Europe to run clinical trials and the creation of an interactive platform for ASD professionals and patients. King’s College London leads an academic partnership of 14 European centres of excellence comprising Biozentrum Universität Basel (Switzerland), Birkbeck College, University of London (UK), Cambridge


University (UK), Central Institute of Mental Health Mannheim (Germany), Commissariat à l’Energie Atomique et Aux Alternatives (France), the European Molecular Biology Laboratory (Germany), Institut Pasteur (France), Institute of Education (UK), Karolinska Institute (Sweden), Max-Planck Institute of Experimental Medicine (Germany), Radboud University Nijmegen Medical Centre (The Netherlands), University "Campus BioMedico” (Italy), University Medical Centre (The Netherlands) and University Ulm (Germany). Two other pharmaceutical small and mediumsized enterprises, deCode Genetics (Iceland) and NeuroSearch (Denmark) will be involved and GABO:mi (Germany) will manage the project. Professor Declan Murphy, of King’s College London, said: “This ground-breaking integrated research effort is unprecedented and is designed to allow us to change the scientific landscape of autism research and clinical drug development throughout Europe.”



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MRC Harwell Institute: New opportunities for partnerships The Mary Lyon Centre at MRC Harwell has developed into a centre of excellence for the creation, breeding, archiving and phenotyping of the laboratory mouse. It continues to advance, harnessing new technologies, such as those in genome engineering, to provide a wide range of services and training for mouse genetics research. The Centre now stands as a mature research facility with the capacity to accommodate new partnership programmes with both academia and industry. The Mary Lyon Centre opened in 2004 as a large, purpose-built mouse facility. It is integrated within MRC Harwell, a site with a long history of research in mouse genetics, including the discovery of X-chromosome inactivation by the eminent geneticist Mary Lyon. Today, MRC Harwell conducts innovative, translational research into many aspects of mouse genetics. The Centre houses approximately 50,000 mice and one of the largest repositories of frozen genetically altered mouse lines in the European Mouse Mutant Archive (EMMA). It is a major partner in the International Mouse Phenotyping Consortium (IMPC). We offer a comprehensive range of services for using the mouse for biomedical research. Our portfolio covers services for the creation, breeding, housing and archiving of genetically altered mice. We provide a wide range of specialist phenotyping support, including the analysis of embryonic developmental defects, metabolism, behaviour and sensory assessment, clinical chemistry, haematology and pathology. In addition to these services, the Centre also offers an extensive range of training opportunities for those who use the mouse as

a laboratory animal, including training courses in Home Office modules, cryopreservation of sperm and embryos, and conditional transgenic techniques. The Centre has demonstrated its capability through its key contribution to the IMPC, which has the ambitious goal of creating and phenotyping knockout mouse lines for every gene in the mouse genome, providing a wealth of functional genomic data and novel mouse models for medical research. Data from this can be freely accessed and mouse lines ordered at A considerable proportion of these lines were produced and phenotyped by the Centre. The MRC Harwell Institute has recently launched Genome Editing Mice for Medicine (GEMM), a bespoke genetically modified mouse service. GEMM will exploit the technical and logistical expertise developed at Harwell, together with recent advances in genome editing, to deliver novel mouse lines that will advance knowledge of human disease and/or be of widespread use in biomedical science. We are sponsors for the CRACK-IT initiative established by the NC3Rs, and are developing


a novel phenotyping paradigm to promote the ethical use of mice in biomedical research in partnership with both academia and industry. CRACK-IT supports the development of new technologies and approaches that will contribute to the reduction and refinement of animals in bioscience research. The home cage monitoring system, one of the CRACK-IT Challenges, is being tested at MRC Harwell to allow behavioural phenotypes to be identified with minimal intervention, by enabling assessment of the activity, behaviour and interaction of mice in the cages they were reared in. Through these initiatives and others, the Mary Lyon Centre at MRC Harwell has shown itself to be an exceptional facility. It has demonstrated its capacity to accommodate new collaborative programmes, and is now looking to establish new partnerships with both academia and industry.

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