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November 2016

www.ghp-magazine.com

Lace Up with TRI Take the Lead in Your Clinical Study Page 19

Sharing Innovation Sharing Ethical Digital Content with Vendit. Page 16

Black Bag

Emergency Medical Care on All 7 Continents. Page 10

Cancer Moonshot Trial Runners and the Paediatric Consortium: Putting the Pieces Together. Page 14

Keeping their Eye on the Prize. Page 24


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ghp

Research, Translation, Commercialisation

editor’s note

this month’s feature 04 News

Welcome to the November issue of GHP Magazine. With 2016 drawing to a close, it is as good a time as any to reflect upon the achievements that been made, the milestones reached, and the barriers broken, in all of the facets of the ever-evolving, constantly changing medical industry.

Health & Social Care 10 Emergency Medical Care on All 7 Continents 12 Making True Patient Centricity Possible 14 Cancer Moonshot and the Paediatric Consortium: Putting the Pieces Together

This newest monthly issue of GHP aims to reflect in particular upon this month’s most prolific contributions to the vast field, whilst also drawing attention to the innovations on the not-too-distant horizon, that will play their part in improving healthcare and its access for people all across the world.

Innovation & Technology 16 Sharing Ethical Digital Content with Vendit 20 SCICOMVISUALS

Of course, with new technologies becoming available almost daily, and the regular updating of practices in consequence, it might be all too easy to become lost in this quickening pace. To combat this, there are a number of firms that have made it their mission to deliver the science behind the science.

Research & Development 22 Eye on the Prize 23 Leading the Way Through Diligent Research 24 Solving Healthcare Challenges 26 A Research Consortium Will Receive a Grant of €1.5 Million 28 A Urine Test for Creutzfeldt-Jakob Disease May Be Possible

This, in particular, is the domain of Tangent90, whose Vendit program provides crucial clinical trial data in support of the global life science and healthcare sectors, in what is a highly important aspect of modern healthcare. Other institutions, such as Amsterdam-based Scicomvisuals, have embraced and honed the capability to present detailed infographics that offer compelling breakdowns of new technologies for the benefits of generating new ideas in the process. Healthcare, then, is a circularly flowing, constantly ebbing industry, where innovation breeds creation, resulting in a flourishing of understanding and the daring to push the boundaries even further still. The last 20 years alone have been paramount for demonstrating the versatility of modern medicine, and we at GHP aim to provide that essential gateway into the intricacies of this vast industry, to document its evolution and to help you, our readers, to stay on top of it. Jonathan Miles, Editor

inside this issue

Sharing Ethical Digital Content with Vendit The Vendit mission is to put science at the forefront of relationships between industry and professionals by reliably delivering key clinical trial data wherever it is needed.

Educatrion & Skills 30 Overseas Doctors Welcome in Scotland 32 Top Expert Tips - What Cyclists Should and Shouldn’t Eat

We spoke to Richard Lucas to find out more. Page 16

“What really drives me is my grandfather, Arnold, who started his business from a wheelbarrow in Lawton Street, Liverpool. He was a successful businessman who in 1968 was diagnosed with Parkinson’s Disease.” Richard Lucas, Founding Director of Innovation

Global Health & Pharma, Floor 1, Suite F, The Maltsters, 1-2 Wetmore Road, Burton On Trent, Staffordshire, DE14 1LS Tel: +44 (0) 1234 567 890 | Email: info@ghp-magazine.com | Web: www.ghp-magazine.com


news

Repeal of the ‘Cadillac Tax’ Provides Opportunity On 10th November the Alliance to Fight the 40, a broad-based coalition committed to repealing the 40% tax on employersponsored health benefits, the so-called ‘Cadillac Tax’ issued the following statement on the election results. Repealing the ‘Cadillac Tax’ has broad bipartisan support in Congress. In the House of Representatives 154 Republicans and 156 Democrats are co-sponsors of repeal legislation and the Senate voted 90-10 to repeal the tax. Congress should repeal the ‘Cadillac Tax’ as quickly as possible, as a commitment to improving health care for the 175 million hardworking Americans who depend on employer-sponsored insurance. Given the broad Congressional and stakeholder support, repeal of the ‘Cadillac Tax’ is an achievable goal and is poised to be an essential part of the ‘first 100-day agenda.’ The ‘Cadillac Tax’ is a 40% tax on the cost of employer-sponsored health coverage that exceeds certain benefit thresholds – initially, projected to be $10,800 for self-only coverage and $29,100 for family coverage in 2020. More than just premiums are counted when determining the ‘cost’ of the plan. The cost of wellness programs, on-site clinics and

other plan features designed to reduce plan expenses are also included, so that virtually everyone in an employer-sponsored plan, including low income workers and families with chronic or catastrophic health conditions, will eventually be hit with the tax. The Alliance to Fight the 40 is a broad-based coalition comprised of patient advocates, businesses, consumer and employer organisations and other stakeholders that support employer-sponsored health coverage. This coverage protects over 175 million Americans across the United States. The Alliance seeks to repeal the 40% tax on employee health benefits to ensure that employer-sponsored coverage remains an effective and affordable option for working Americans and their families. For more information on the 40% Tax on Health Benefits, visit the website at www.fightthe40.com or follow us on Twitter @Fightthe40.

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Doctor CEOs Hinder Innovation in Start-Ups Medical doctors with executive roles in medical device start-ups can hinder innovation, finds new research from UCL School of Management and Stanford University, but have a positive impact if they are inventors or board members. The study, accepted for publication in the Academy of Management Journal and funded by InHealth, looked at 231 US surgical instrument ventures over a 25-year period and found that companies achieved more patents and FDA product approvals when they employed medical professionals in technical or governance (board) roles. Despite frequent involvement in executive roles, the researchers found that doctors are likely to block innovation as CEOs because they stick to familiar products and technologies rather than exploring new ideas. On average, companies with non-doctor CEOs secured one more product approval per year than those with doctor CEOs. “As inventors, doctors’ professional experience helps transform inventive ideas into products. This information helps develop a product that better fits the customer, often tapping into relevant networks and assisting in positioning the product,” said Professor Thatchenkery.

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“Placing the right people in the right roles is key to success. We recommend that startup companies hire doctors in technology roles early on and appoint them to governance roles as the company becomes more established.” Currently, only 20% of technologies that underlie medical devices are developed by or with professional end-users, such as doctors, and recent legislative efforts in the US have sought to reduce the involvement of doctors even further to reduce conflicts of interest. The researchers state that separating the involvement of professional users, such as doctors, from company innovation would hinder the development of lifesaving surgical instruments produced by young firms. They warn that the recent legislative changes in the US show no appreciation for the doctors working as inventors and a more nuanced policy that acknowledges their key role in product development would help sustain innovation.


news

The Queen Opens New Francis Crick Institute Building The Queen and The Duke of Edinburgh, accompanied by The Duke of York, opened the £650 million Francis Crick Institute in London on 10th November.

During a tour of the new biomedical facility, The Queen started the sequencing of Sir Paul Nurse’s genome – all three billion letters in his DNA code. The Crick is the biggest biomedical research institute under one roof in Europe and is investigating the fundamental biology underlying human health and disease. The Institute was formed on 1 April 2015 and is a registered charity. Its founding partners are the MRC, Cancer Research UK, Wellcome, UCL (University College London), Imperial College London and King’s College London. Paul Nurse, director of the Crick, former president of the Royal Society and Nobel laureate said, “it was a delight to welcome the Queen to our new building for the Francis Crick Institute and show her some of the science that we are carrying out to understand the human body better in health and disease.”

Construction of the new building for the Crick was completed in August 2016. Researchers will continue moving into the new building from the Crick’s legacy institutes until the end of the year. As a world-leading centre of biomedical research and innovation, it has scale, vision and expertise to tackle the most challenging scientific questions underpinning health and disease. The aim is to find new ways to prevent, diagnose and treat conditions such as cancer, heart disease and stroke, infections and neurodegenerative conditions like motor neurone disease. The Crick also has a strong national role. By taking a collaborative approach, training future science leaders, taking forward discoveries towards new treatments for patients and engaging with schools and the public, the Crick aims to boost UK science and help drive the UK economy.

He added, “as part of the visit, she sequenced my genome and we’ll find out the results in the coming weeks. In our normal work at the Crick, we use this type of advanced sequencing to understand more about genetic influences on disease.” The Queen and The Duke of Edinburgh toured the new building for the Crick next door to St Pancras and the British Library. They saw some of the state-ofthe-art facilities for research, including the advanced sequencing and peptide chemistry laboratories. They met many of the scientists and staff of the Crick, along with major donors who contributed to the Crick via a Cancer Research UK fundraising campaign. The Queen and The Duke of Edinburgh were also introduced to representatives of each founding partner. The Royal party met artist Robert Ballagh and unveiled his portrait of Francis Crick, a portrait commissioned by James Watson, who worked with Crick on the structure of DNA. The visit finished with the Queen unveiling a plaque to mark the opening of the institute. The Crick is bringing scientists together from across disciplines to tackle the pressing health concerns of the 21st century. It will be home to 1,250 scientists and a further 250 support staff at full capacity in 2017.

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Bionical Acquires Global Clinical Research Organisation Emas Pharma Bionical, the integrated outsourced specialist to the pharmaceutical, biotechnology and public health industry, announces the strategic acquisition of Emas Pharma (Emas), a global Clinical Research Organisation. Emas, which provides pharmaceutical development and clinical research services to biotech, medical device and specialised pharmaceutical companies worldwide, will join Bionical’s existing fast growing clinical services business. Financials were not disclosed.

The acquisition is part of Bionical’s strategy to provide high quality clinical, commercial and communications services to pharmaceutical, biotech and public health companies in the global healthcare industry. The acquisition of Emas and the addition of Clinical Research, Pharmacovigilance, Regulatory, Medical Information and Medical Affairs capabilities will support Bionical’s mission to deliver improved health outcomes for patients. Bionical’s clinical division currently provides the supply of comparator products for clinical trials as well as nurse educator teams and public health services and has a wide base of clients internationally. Emas, which has a significant client base of emerging and specialised biopharma companies, brings an extended global footprint, with offices in the UK, USA, Canada, Australia and Ireland. Graham McIntosh, CEO of Bionical commented, “Emas Pharma is a fantastic business with great people and an excellent reputation. Emas’s services are highly complementary to Bionical’s existing clinical trial services and the acquisition creates opportunities for both businesses to bring enhanced services to their clients. We are very pleased Peter Kennerley, Liz McCann and the Emas team are now a part of Bionical and I look forward to working with them to continue the global growth of Emas.”

Dr Peter Kennerley, CEO of Emas Pharma added, “we are delighted to join the Bionical group, which is a perfect synergy for Emas Pharma. Being part of a wider family of companies means that we will be offering our clients an even broader range of services to complement our current offerings; from nurse specialists to help track patients lost to follow up, to call centres for Medical Information and from Clinical Trial Supply support to healthcare communications. Liz and I are proud of the excellent reputation for high quality, cost effective support that Emas has built up over the years. We know that joining Mac and the Bionical team will help us extend that reputation even further.” Emas will continue to operate as a separate business under the existing leadership of Peter Kennerley and Peter will join the Bionical Board. Emas is Bionical’s third strategic acquisition in little over a year, following the successful acquisitions in 2015 of UK based North 51 and US based McCallan Healthcare. These earlier acquisitions brought public health, digital, educational and further commercial services to the rapidly-strengthening Bionical brand, ahead of the current EMAS acquisition which unifies and completes Bionical’s patient-centric service portfolio. www.bionical.com

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news

Janssen’s NextGeneration Biologic Guselkumab Shows Promise in the Treatment of Psoriatic Arthritis Janssen-Cilag International NV (Janssen) announced in midNovember positive efficacy and safety results from a Phase 2 study investigating guselkumab, an anti-interleukin (IL)-23 monoclonal antibody administered by subcutaneous injection, for the treatment of active psoriatic arthritis. According to findings presented at the 2016 American College of Rheumatology (ACR) Annual Meeting, 58% of patients receiving guselkumab achieved at least a 20% improvement in signs and Data from the trial also showed statistically significant improvements in all secondary endpoints including physical function, psoriatic skin lesions and other health related outcomes, compared with patients receiving placebo. The guselkumab Phase 2 results in active psoriatic arthritis follow positive Phase 3 study results in moderate to severe plaque psoriasis recently presented at the European Academy of Dermatology and Venereology Congress in Vienna. “Guselkumab is one of a new class of biologic therapies which target the protein interleukin (IL)-23, and the Phase 2 results are promising as they demonstrate a significant improvement in the treatment of active psoriatic arthritis,” said Atul Deodhar, MD, MRCP, FACP, FACR, Professor of Medicine, Oregon Health & Science University and lead study author.* “It’s encouraging to see how well patients responded to guselkumab in this study with respect to improvements in disease signs and symptoms, as early as week four, and in other healthrelated quality of life outcomes, including measures of physical and mental health.” Patients treated with guselkumab had significantly greater improvements in enthesitis (inflammation of the entheses, the sites at which tendons or ligaments attach to bone) and dactylitis (inflammation of the fingers or toes), and in health-related quality of life as measured by SF-36 physical component summary (SF36-PCS) scores and mental component summary (SF36-MCS) scores compared with patients treated with placebo at week 24. In addition, a greater

percentage of patients in the guselkumab group achieved MDA (Minimal Disease Activity) compared with the placebo group at week 24 (23% versus 2%, respectively, [P = 0.001]). MDA for psoriatic arthritis is a composite measure encompassing clinically important aspects of the disease, including arthritis, psoriasis, enthesitis, pain, patient-assessed global disease activity, and physical function. Safety observations through week 24 showed that 36.0% versus 32.7% experienced adverse events (AEs), in the guselkumab and placebo groups, respectively. The most common AEs were infections. Two serious AEs were reported including one knee injury and one myocardial infarction. Investigators remain blinded to individual treatment group assignments, as the study is ongoing. In both treatment groups, there were no reported serious infections, malignancies, or deaths through week 24. “The efficacy and safety results from this Phase 2 study show the potential of guselkumab in the treatment of active psoriatic arthritis,” said Newman Yielding MD, head of immunology development, Janssen. “We plan to advance guselkumab into a Phase 3 psoriatic arthritis development programme next year to further characterise this novel monoclonal antibody’s profile in the treatment of this complex inflammatory disease.”

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About the Phase 2 Guselkumab Psoriatic Arthritis Trial The Phase 2, randomised, double-blind, placebo– controlled, multicenter trial was designed to evaluate the efficacy and safety of guselkumab compared with placebo in adult patients with active psoriatic arthritis and a body surface area (BSA) of plaque psoriasis greater than or equal to three percent, despite current or previous treatment with standardof-care therapies, including those previously exposed to anti-tumour necrosis factor (TNF)-alpha agents. Patients (n=149) were randomised in a two-to-one ratio to receive guselkumab 100 mg or placebo by subcutaneous injection at weeks 0, 4 and then every 8 weeks thereafter, followed by a 20-week active treatment period.

as measured by the Psoriasis Area Severity Index (PASI 75) at 24 weeks, change from baseline in the health assessment questionnaire disability index (HAQ-DI) at 24 weeks, change in baseline measures of physical and mental health reported by patients through the Medical Outcomes Study Short Form-36 questionnaire (SF-36), percent change from baseline in Leeds Enthesitis Index (LEI) at 24 weeks, percent change from baseline in dactylitis score at 24 weeks, and proportion of patients achieving Minimal Disease Activity (MDA) at 24 weeks. •

• At week 16, patients from either group with less than five percent improvement from baseline in both swollen and tender joint counts were eligible for early escape to open-label ustekinumab. At week 24, all remaining placebo patients crossed over to receive guselkumab 100 mg, which was administered again at week 28, and then every 8 weeks thereafter through week 44. In addition to meeting the primary endpoint of the study, all secondary endpoints achieved statistical significance in comparisons between the guselkumab and placebo groups. Secondary endpoints included ACR20 response at 16 weeks, ACR50 response at 24 weeks, the proportion of patients with 75% or greater improvement from baseline in psoriatic skin lesions

ACR20 response was achieved by 60%of patients receiving guselkumab compared with 16.3% of patients receiving placebo (P < 0.001) at week 16. ACR50 response was achieved by 34% of patients receiving guselkumab compared with 10.2% of patients receiving placebo (P = 0.002) at week 24. PASI 75 response was achieved by 78.6% of patients receiving guselkumab compared with 12.5% of patients receiving placebo (P < 0.001) at week 24. Mean change from baseline in HAQ-DI scores were -0.42 for the guselkumab group compared with -0.06 for the placebo group (P < 0.001) at week 24.

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About Guselkumab Guselkumab is a human monoclonal antibody with a novel mechanism of action that targets the protein interleukin (IL)-23 and is in Phase 3 development as a subcutaneously administered therapy for the treatment of moderate to severe plaque psoriasis. About Psoriatic Arthritis Psoriatic arthritis (PsA) is a chronic, immunemediated inflammatory disease characterised by both joint inflammation and the skin lesions associated with psoriasis, the latter of which affects 125 million people worldwide. An estimated 600,000 Americans—and more than 12 million people worldwide—have PsA. While estimates of the prevalence of psoriatic arthritis among people living with psoriasis vary, up to 30% may develop inflammatory arthritis. The disease causes pain, stiffness and swelling in and around the joints and commonly appears between the ages of 30 and 50, but can develop at any time. Though the exact cause of psoriatic arthritis is unknown, genes, the immune system and environmental factors are all believed to play a role in the onset of the disease. Learn more at www.janssen.com/EMEA.


Healthcare & Pharmaâ&#x20AC;&#x2122;s Leading Experts

Emergency Medical Care on All 7 Continents

Black Bag is a private, emergency medical consultancy that works with wealthy families, family offices, and senior executives to provide immediate care guidance wherever they may be. Whether they travel for work or pleasure, we accommodate their lifestyle by coordinating medical care around the globe. To date, we have provided emergency medical coverage to over 250 clients in 90 different countries, on all seven continents.

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Health & Social Care We are emergency medical physicians. Black Bag specialises in physician-directed care and advice concerning emergencies, hospitalisation, and evacuation for clients travelling abroad. Essentially, we help them make ‘stay or go’ decisions when it comes to the quality and availability of medical care they need at the time. If evacuation or transfer is necessary, we help coordinate the medical and logistical requirements. This is all done on a very elite level. As a private emergency medical consultancy, you need to be able to pull a team together as the situation calls for it. Our network includes evacuation companies, security experts, translators, and more. We know who to call and when. Connections count. Black Bag’s success depends on the trust we build with other advisors and the clients to whom they refer us. We are quite pleased with the number of individual clients we have been asked to assist. We have also branched out into group travel needs. For instance, we worked with former Secret Service team members to provide medical support for ABC News members traveling to dangerous areas of Africa. The dedication of Black Bag ‘s staff members to client care is obvious. They take a holistic view of each client, not just the clinical information in their records. Their interpersonal skills are top-notch. Clients experience this first-hand and respond positively to it. It makes all the difference. Innovation In terms of innovation, electronic documentation plays a key role in global communication. Black Bag has created a medical summary document with Lynxcare. The Health Care Navigator is the only MD-verified medical summary available today. This can be securely carried by the patient or sent to the treating healthcare providers. Also, in terms of performance, Black Bag were invited to be part of the Domestic Estate Managers Association (DEMA) Security Council and present at their national event this year. Added to that, Family Wealth Advisor named us as one of two preferred providers they recommend to their clients. That type of recognition by independent third parties speaks volumes about our performance.

networking assistance to a number of charities including Room to Read, World of Children and Worldwide Orphanage.

Client Testimonial - Our Holiday Experience with Black Bag My wife’s overseas medical emergency

While on holiday in Spain, my wife suffered a cerebral haemorrhage and was rushed into the local hospital and placed into intensive care. With health care staff that spoke very limited English, ahead of us was an unknown journey. Now, at 2 a.m. with my wife in the hospital, I was frantically calling relatives not knowing the standard of healthcare with which I had left her. The medical staff was advising me of the treatment options and the prognosis but I had no one to help with the decisions or share my concerns. My day-to-day work is around managing risk in the oil industry, but this melts into insignificance when trying to manage risk with your loved one. Then, through a relative of mine, I came in contact with Dr. Chris Sidford at Black Bag. Calmly collecting information about the illness, the location, the hospital and the physicians, within a short period of time, Dr. Sidford was able to respond with confirmation that the hospital and physicians were of the highest standard and that the proposed treatment was in line with expert opinion. This gave me confidence in the decisions I had to make. What’s more, when circumstances changed, his 24/7 availability was like having an expert alongside me in Spain. Thank you, Dr., Sidford and Black Bag. - Julian Hockney, England

Company: Black Bag Name: Dr. Christopher Sidford, M.D. Email: csidford@emergencyblackbag.com Web Address: www.emergencyblackbag.com Address: Atkinson Building, 29 Water Street, Newburyport, MA 01950 Telephone: +1 978 518 3203

Shaping the future of the healthcare sector Innovation, in our business, and is directly related to our ability to offer an alternative to the more ‘traditional’ delivery of medicine. When it comes to concierge medicine, patients are essentially paying physicians to be more available to meet their particular needs, including the ability to provide international medical care and assistance for those who travel. In terms of what Black Bag does, I believe we are literally pioneering a new frontier. Black Bag’s biggest challenge is keeping up with technology, with constant advances in telehealth being made on a daily basis. Implementing the changes and keeping our own system secure is of the utmost importance. As a result, we employ IT and medical record security experts to guide our firm’s evolution. Just to bring home the point that we truly are a visionary and global organisation, Black Bag is committed to supporting a number of philanthropic efforts. We offer pro bono medical, logistical, and

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Health & Social Care

1609JC01

Making True Patient Centricity Possible Driven by heavy market, social and cost pressures, patient support and management have in recent years become top of agenda for the healthcare industry globally. All converging with magnitudes of population growth, aging and corresponding chronic disease – and care systems and patient experiences that have become fragmented and frustrating.

In the wake of rising patient expectations in a world of digital consumerism, the burning question is how to move effectively into a mode of true patientcentric engagement and personalized, connectedcare experiences. In our view, it requires a mindset shift throughout the healthcare universe. To thinking that’s holistic, and synergistic. Adopting creative digital care models that are fully open, integrated, and interconnected everywhere – with the patient at the absolute core. And, cross-collaboration among different entities; sharing strategies, technologies and best practices for a common good – improving the health and lives of individuals, and the wellness of entire populations. Now is the time to step back and see the bigger picture. Though companies have been investing heavily in new technology and programs to become more patient-centric, the majority haven’t been satisfied with their results. Many life sciences companies are struggling to achieve deep patient engagement and uncover meaningful patient insights; contend with privacy issues, determine the right structures and processes, and create clear success metrics. Healthcare providers, except the largest, have been stymied by implementation— like cost and integration—issues. Medical device businesses are challenged by interoperability, device security, and regulatory constraints. Before going farther down the wrong roads, it’s time to realize how to achieve the best outcomes for your business and end-patients. The answers and opportunities begin with the facts. That emerging innovations from Google, Apple and other technology innovators are too siloed. Asheesh Shukla, Global Head of Life Sciences at Wipro, says, “the domain direction and experience design of new tools and programs are rarely being made with a deeper, real-world understanding of the kind of engagement, value or effectiveness

needed in this space.” There’s no tailoring to each hospital, network et al., where no two objectives are the same. None of these advances are end-to-end solutions, developed with a fully ecosystemic patientcare, patient-core consciousness and connectivity. Patients want a holistic wellness solution, that’s taking care of, coordinating, correlating everything, from medication to monitoring; giving them control and confidence, and allowing them to make betterinformed decisions. Just as the quality of their lives have benefited and been empowered by the advent of digital platforms like Amazon, e-Bay, mobile banking, Uber et al., they want the same level of technology, immediacy and transparency around their healthcare – value that’s been absent. A holistically, ecosystemically connected care platform has come on stream. In response to this urgent marketplace need, we’ve formed a community of progressive thinkers and doers, and developed and fielded a holistic digital platform. An open system, based on active and interactive collaboration; that can integrate and leverage all forms of technology and design experience innovation available and emerging. It’s pointing the way to what’s possible. This Collaborative Care Platform is device-agnostic, and can connect with the entire healthcare universe; including Google, Apple, Microsoft, pharmas, device companies et al. It engages and gives patients ready access in and across all channels of information and options they want; digitally, on demand. It yields a wealth of meaningful desired data and analysis, to show providers and patients alike what an individual patient needs, needs more of or needs differently – and exactly when, around their given treatment or care, active and preventive. Including raising disease awareness among patients that enables early diagnosis and speed-to-therapy, treatment adherence… and better outcomes.

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It also provides a solution for population health management. And, incorporates all critical functional capabilities, and non-functional ones: from data privacy to compliance to security. As importantly, it’s tailorable and scalable to each individual customer, to their unique ecosystem and desired outcomes; as well as to given countries’ cultures, demographics and payer, provider, compliance contexts. A versatile design reflects our deep and active learning and best practices in and across many industries; which translates into wiser guidance for customers as they navigate this equally challenging and promising new landscape. Ideally, it offers a welcome paradigm for everyone engaged in the healthcare continuum; from providers and payers to governments and thought leaders; technology innovators and our own peers. As we guide customers into this rapidly evolving territory, we ask them to approach it as holistically as possible: with a more encompassing strategy, not just in terms of tactical elements like apps or smart devices, or business or patient information sites. In ways that facilitate vital, valued collaboration between patients, caregivers, payers and patient representatives, advocates. Our frontline experience has shown us that once they change to a wider, wiser lens, they can more effectively restructure and alter processes around patients’ individual needs and expectations, their treatment lifecycle and their entire healthcare journey—and be able to map and meet them one-onone, across the board. There are epic rewards for those groups that get it right. We believe company leaders need to inspire and shepherd this change to connected care from the top down. Some have already begun. We invite you to join them; and to reach out to us for more information, insights and Company: Wipro Limited Name: Nitin Raizada, Shalini Sharad Contact: health-sciences@wipro.com Web Address: www.wipro.com Address: Doddakannelli, Sarjapur Road, Bangalore 560 035, India

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Health & Social Care

Cancer Moonshot and the Paediatric Consortium: Putting the Pieces Together In 2015, Vice President Joe Biden declared, “I believe that we need a moon shot in this country to cure cancer,” a historical nod to President John F. Kennedy’s famous 1962 declaration to put a man on the moon. In September, Biden reiterated his call for action to fast-track the nation’s most comprehensive cancer collaborative initiative aimed at accelerating genomics and immunotherapy as the next-generation standard of care for cancer patients. “There is a lack of coordination among efforts, a failure to share information both rapidly and effectively, and an antiquated culture of research and funding,” he said.

At Phoenix Children’s in Phoenix, Ariz., we are working to change this dynamic and transform cancer care for children. In fact, we have made an institutional commitment to be at the forefront of eradicating paediatric cancer both at home and abroad. To that end, our organization developed a joint venture with renowned doctor and health care entrepreneur Patrick Soon-Shiong, who is a leader in the Moonshot mission. Earlier this year, he named Phoenix Children’s the lead institution for the Cancer Moonshot 2020 Paediatrics Consortium. Phoenix Children’s joins nine world-class children’s hospitals from across the U.S. in a shared mission to advance bench-to-bedside translation of genomic technology to prevent, treat and manage paediatric diseases, first in cancer and then in other conditions. The founding members of this alliance are working to adopt the approach of the larger Moonshot 2020 effort by expanding knowledge sharing, increasing collaboration and driving synergy and effective integration among health care, medical, academic and scientific communities. Our partners include: • • • •

Ann & Robert H. Lurie Children’s Hospital of Chicago / North-western, Ill. Children’s Healthcare of Atlanta, Ga. Children’s Hospital of Orange County, CA Aflac Cancer & Blood Disorders Centre, Children’s Hospital of Orange County, Calif., Children’s Hospital of Pittsburgh of UPMC, Pa. Duke Department of Paediatrics – Duke University School of Medicine, N.C.

• •

Floating Hospital for Children at Tufts Medical Centre, Mass. Huntsman Cancer Institute at the University of Utah and Intermountain Primary Children’s Hospital, Utah Sanford Health, S.D.

Cancer’s chokehold on Americans’ health is overwhelming: according to the National Cancer Institute, nearly 40 percent of men and women will be diagnosed with cancer at some point during their lifetime. Statistics of paediatric cancer are especially grim. In 2016 alone, 10,380 U.S. children under the age of 15 will be diagnosed with the disease. Cure rates for some paediatric cancers remain below 50 percent, and survivors often experience serious or even lifethreatening side effects from the toxic protocols used to treat cancer today. But Cancer Moonshot offers new hope. Leaders in health care, research, education and business are joining an expanding coalition of difference-makers to fundamentally transform the way cancer is treated. Moonshot’s ultimate goal is to transform cancer care as we know it by initiating randomized Phase II trials in 20 tumour types for 20,000 patients at all stages of disease within the next three years, ultimately developing an effective vaccine-based immunotherapy for cancer by 2020. At the heart of the initiative is the role of precision medicine in fighting cancer.

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Utilizing genomic analysis, which unlocks a patient’s genetic and proteomic makeup, researchers can customize therapies by analysing patients’ susceptibility to disease and predicting their response to a particular drug. As data is collected and disseminated to researchers, we hope to uncover pharmaceutical combinations that increase efficacy in treating cancer – and with fewer side effects for patients. Evolution Central to the work of the Paediatric Consortium is the Chan Soon-Shiong Children’s Precision Medicine Institute at Phoenix Children’s Hospital, a joint venture that launched in 2014. The Institute offers whole genome sequencing, RNA sequencing and proteomics. It also offers an advanced technological infrastructure that will move the work of the Consortium forward. Our High-Performance Computing Platform allows the Institute to offer high-throughput, complex genomic analysis to researchers across the country; a direct high-speed “fibre” connection enables rapid transfer of genomic data; and a comprehensive cancer population management platform was created not only to collect and analyse clinical data, but to actively assist in the comprehensive clinical management of patients’ lives.

making our biorepository one of only three children’s hospitals nationwide with CAP-accreditation. Now, we are working toward certification from the Clinical Laboratory Improvement Amendments. Once this certification is in place, Phoenix Children’s will be the only U.S. children’s hospital with both CAP accreditation and CLIA certification. These accomplishments will position the Consortium with the finest research capabilities and capacity in the country. In the future, we envision that personalized medicine will not be reserved for a select few; genomic screening will be available to all children under the care of a Phoenix Children’s provider. Our vision will be reality very soon; physicians will help identify children who are more highly prone to paediatric diseases. Oncologists, cardiologists, neurologists, genetic counsellors and other experts will weave this data into the standard of care they provide.

Our first step for the Consortium was to enable real-time information sharing of patient outcomes, clinical trial data, genomic and proteomic sequencing analyses and treatment efficacy. This knowledge dissemination is critical to the design of Moonshot and promotes synergy among participants.

Conclusion Much has been accomplished, yet so much work remains for the Consortium. Cancer Moonshot is a bold endeavour and the year 2020 is fast approaching, but we remain undaunted as we strive for the seemingly impossible -- to break down conventions in pursuit of a world that is cancer-free. I am reminded of what President Kennedy said about the 1960s Moonshot. “We choose to go to the moon. We choose to go to the moon in this decade, and do the other things, not because they are easy, but because they are hard, because that goal will serve to organize and measure the best of our energies and skills, because that challenge is one that we are willing to accept, one we are unwilling to postpone, and one which we intend to win.”

The next step in the blueprint is certification. Last year, the Phoenix Children’s Biospecimen Sciences Program was accredited by the College of American Pathology,

Robert L. Meyer is President and CEO of Phoenix Children’s Hospital.

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Innovation & Technology

Sharing Ethical Digital Content with Vendit The Vendit mission is to put science at the forefront of relationships between industry and professionals by reliably delivering key clinical trial data wherever it is needed. The Vendit team support the global life science and healthcare sectors in delivering the science behind scientific claims. Commercial copyright content is an essential, and overlooked, component of a multi-channel digital strategy.

Remember when attending a congress, clinicians could be seen struggling under the weight of academic paper content they needed to collect. Unwieldy and ephemeral, this important paper would often end up stuffing the bins of congress halls, hotels and airports. And yet, the Peer-reviewed clinical trial summaries that are traditionally delivered on paper from leading publishers, are required by doctors to make their own assessment of the data behind product claims. To solve this problem, Tangent 90 built a digital copyright licensing platform and delivered content to 87% of the delegates at its first educational meeting. The feedback from the doctors was simply, â&#x20AC;&#x153;why havenâ&#x20AC;&#x2122;t I been able to do this before?â&#x20AC;? The solution is now called Vendit and is in its fourth generation. In order to deliver a service that meets the needs and challenges of the industry, Vendit has formed a Gold partnership with Health Media Europe (HME), a leading media and reprints agency that has supported the pharmaceutical industry for more than 35 years. Due to strong relationships with over 100 STM publishers, HME brings to Vendit a cost-effective, strategic and seamless content procurement service. This aligned with innovative country media solutions, in-house ad-serving and a multi-channel distribution service, enhances the reach and messaging of HME clients: from traffic driving through to distribution and follow-up engagement. The platform has grown thanks to a partner ecosystem led by companies such as HME, who acquire copyright content for distribution from over 150 publishers. Vendit and HME are headline sponsors at London Info International and will be exhibiting at Excel on the 6th and 7th December 2016. The team will be

demonstrating multi-channel copyright content sharing with Veeva Systems as well as new services for the delivery of validated patient materials and creation of narrated content. Tangent 90 are a Veeva Silver Technology Partner. Veeva Systems are a leader in cloudbased software for the global life sciences industry. This exciting and innovative partnership ensures copyright ePrints can be distributed when new results are published - where demand for educational materials and key trial data is at its highest. In recent times the Vendit platform has demonstrated the need for scientific data sharing at over 50 of the largest global and regional congresses in 2015 and 2016. There has been a clear demand for scientific and educational content from both enterprise and attendees. Jump forward to 2020, when 67% of Healthcare professionals will be born digital. The Vendit platform is already the compliant multichannel distribution solution for the Life Sciences industry to deliver published digital content. This SaaS platform ensures key copyright publications are disseminated reliably, across multiple touch points, from anywhere in the world and via any device. Industry has a duty to track what is being shared, with whom it is being shared, when it is shared, and through which channel it is shared. Vendit and partners have co-ordinated a multichannel approach that guarantees flexibility across all touch points, whilst simultaneously ensuring documented consent, including full auditing and transfer of value tracking (Sunshine Act compliance).

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support materials to their community and gives his thoughts on the future of mobile healthcare: In Lucas’ view, many mobile apps and devices haven’t yet been validated to prove that they provide real clinical evidence of efficacy. Clinical evidence of safety and efficacy are a real and current focus of healthcare systems such as the NHS. Such focus should be the mantra of every health and wellbeing app developer. Evidence of beneficial effect is your real differentiator.” Lucas also believes that individualised optimum wellness should surely be the goal of apps and platforms in the mobile health space. “Precision medicine and sustainable care are creating new pathways for the mobile generation. Advances are also needed in interoperability, content licensing and security, not to mention communication of the evidence based information sources and products already out there. “For us, the expanding levels of transparency in the sector are opening up new and exciting opportunities. The Vendit team have recently partnered with BigChainDb to build a public transparency ledger. Wouldn’t it be easier for enterprise, doctors and regulators if regulated transparent value transfers were immediately placed on an immutable public ledger when the contract is signed and the transaction is recognised?” Richard Lucas, Founding Director of Innovation adds, “sharing copyright ePrints of publications ensures doctors are able to assess the available data and to evaluate the treatment choices they are making for patients. Doctors interact with copyright content through field force, at congresses and conferences, via websites, mobile apps, in print and other channels. This vital scientific information must be made available wherever doctors need it and in compliance with copyright, industry rules and government regulation”. As well as making content available via conventional channels Lucas also stresses how Vendit “integrates easily with brand websites, portals and eDetailing platforms”. Lucas added, “what really drives me is my grandfather, Arnold, who started his business from a wheelbarrow in Lawton Street, Liverpool. He was a successful businessman who in 1968 was diagnosed with Parkinson’s Disease.” “This long term chronic condition defined the last 17 years of my grandfather’s life. I grew up hearing the stories of how well this frail old man had run and managed his business and yet, when I knew him, he couldn’t hold a conversation or walk down the street. “Everyone has stories like this and we all want to know that the specialists treating our loved ones have the latest data at their fingertips to ensure the best available treatments are employed.” Tangent 90 currently provide services to the UK NHS for the distribution of patient materials from healthcare professionals. The latest platform, built in partnership with Nexgen Healthcare, Ltd. will be presented in the Disruptor Zone at London International 2016. The platform enables scientists to organise, narrate and share clinical posters with their audience. Lucas would like to encourage more professionals to use the SaaS platform to share evidence based patient

The team behind the Vendit Saas platform, Tangent 90 have built apps to support patients from conditions only affecting one in a million through to maternity education of all expectant mothers. Providing real utility to the users of the app and a record of care for the clinician are the gold standards that every developer should strive for. Tangent 90 have built structured content collections for all stakeholders in the sector. These range from clinical trial investigators through to disease awareness for the public. Tangent 90 have also built remote diagnosis and treatment sites for the NHS, corporate websites, training sites for investigators, individual brand and country portals, as well as a wide array of portals for healthcare. The Tangent 90 team has delivered across a range of sectors and won awards for the platforms created. Every brief starts with a conversation, which develops into a discussion document and iterates into a quotation. The team run ‘innovation’ labs and ‘hackathons’ to generate novel solutions to market challenges. In every case, they work to clarify the business model so that it delivers a validated solution to meet the needs of all the stakeholders. When it comes to evidence based discussion online, Lucas calls into question the value of forums and social media, recognising that it is welcome for holistic support but has huge potential for mis-leading the vulnerable. “Community-based social media is a powerful force for change with which industry can, understandably, struggle to engage. Tangent 90 encourage all community moderators to check claims with fact checking sites such as Quackwatch.com and uphold the principles of HON.ch as a minimum. From patient information through to information provided to doctors, it is imperative to educate and inform the guardians of these communities, to ensure they operate responsibly for their users, and provide access to ethical educational content where appropriate.”

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Innovation & Technology Vendit fulfils the obligation of responsible delivery of medical content through all channels. The software enables marketers to reach all healthcare professionals, across all mediums, with the data that underpins product claims. Vendit enables busy clinicians to consume this content when it is most relevant. Balancing regulatory compliance with the need to provide evidence is the challenge that Vendit has been built for. There are many stakeholders in the distribution chain of ethical content and it is important to engage IT functions to make them aware that Global Life Science companies don’t own commercial copyright content from publishers and that Vendit, which is a Copyright Licensing Platform (CLP), is the comprehensive answer to giving evidence from publishers to doctors. In short, doctors take responsibility for their own educational journey and make their own mind up about the scientific data behind claims. Global Life Science companies must compliantly provide that data. Vendit is the connection in this critical path and the closeknit Vendit team are passionately working to transform commercial digital distribution of copyright content. Company: Tangent 90 Ltd Name: Richard Lucas Email: sales@vendit.global Web Address: www.vendit.global London Info International registration link: www.tangent90.co.uk/LII2016 Address: 27 Pegasus Court, Herschel Street, Slough. SL1 1PA UK Telephone: +44 1753 822 922

“In my procurement role, managing global content acquisition at GlaxoSmithKline, I was responsible for identifying a digital platform that could deliver copyrighted materials from our sales reps to doctors globally. The Vendit platform is secure, reliable, easy to use and, in my opinion, the most innovative product of its kind on the market.” - Philip Ditchfield. Vendit will be exhibited at Veeva European Commercial Summit in Madrid 29th November to 1st December 2016, with Tangent 90 as a Veeva Silver Technology partner. Vendit and lead gold partner HME will be exhibiting at London Info International (LII) on 6th-7th of December 2016 at ExCeL London.

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Lace up with TRI. Take the lead in your clinical study.

TRI expedites your clinical study start-up to minimize costs and avoid delays. LI160032

Visit www.tech-res.com or call 301.897.1724 for more information. ghp November 2016 | 19


Innovation & Technology

SCICOMVISUALS SCICOMVISUALS is an agency specialized in scientific communication, with a focus on visualization. We develop all kinds of visuals, from detailed infographics describing client’s technologies to compelling cover illustrations, professional scientific posters and presentations. In addition, SCICOMVISUALS can translate complex messages into convincing 3D animations, movies, websites or communication strategies.

How would you define your client base? SCICOMVISUALS’ clients range from research groups at university to (private as well as public) biotech and pharma companies in the biomedical and agricultural sector. What makes your firm unique? There are not many companies with a clear focus on content visualization aimed at clients in biotechnology and university. SCICOMVISUALS builds on deep scientific understanding of biomedical research, with over 20 years of experience in different areas of fundamental research as well as product development. With well over 10 years of experience in biotech industry, SCICOMVISUALS offers broad experience in all areas of product positioning, with services including graphic design, but also scientific writing, education, and public relations. What are the major challenges facing your business at present? Progress in the biotech sector is going really fast. At another level, the possibilities to visualize content grow rapidly as well. To ensure visualizations remain relevant and focused, it is important to stay up-to-date with major developments in science and design. Looking ahead, what is the main objective for your business? SCICOMVISUALS is still a young company – established only three years ago. With SCICOMVISUALS my aim is to become known as one of the world’s experts in content visualization. What business or business person do you most admire and why? The biotechnology sector provides a dynamic environment in which science and bright ideas can truly flourish. It is great to be part of a business that is committed to develop solutions that really help to deal with todays’ challenges.

Name: Joost M. Bakker, Ph.D. Company: Scicomvisuals Email: joost@scicomvisuals.com Web Address: www.scicomvisuals.com Address: Duivendrechtsekade 85-A Telephone: +31 (0)6 415 13 558

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Research & Development

Eye on the Prize Trial Runners is a highly innovative ophthalmology contract research organisation (CRO), providing biotechnology and pharmaceutical companies with clinical research management services. Trial Runners have worked on over 50 clinical studies researching innovative ways to manage or cure diseases related to the eye.

Any industry leader will tell you that they prefer finding cures, rather than finding temporary solutions to any indication of the eye. At Trial Runners, we feel the exact same way. We want to help the community affected by ailments of the eye, but our goal is to help find cures and help people. We have been doing this for over 10 years now, specialising in clinical trials from phase I to IV, especially in the field ophthalmology and rare disease. What has made us become the leaders in our industry, is simply that we have stayed true to our message of providing the very best possible service. As such, Trial Runners has developed a strategic approach to clinical research that maintains the focus of the programme so that it stays within budget, is on time, and is always ethically sound. Providing the best possible services involves working on a number of different elements. Firstly, we are always looking out for our sponsorâ&#x20AC;&#x2122;s benefit. Secondly, we always have the right staff for each project, who are always highly trained and ready to hit the ground running. Our way of working is to have all hands-on deck, where our staff are available to handle any ad hoc requests (for example data review, data locking, extra monitoring visits) and changing objectives quickly and efficiently. In addition, communication is key for any of these endeavours. We maintain a highly level of communication across all areas, and believe that when you hire Trial Runners, you hire the entire company.

Company: Trial Runners LLC Name: Jill Healy Email: jillhealy@trialrunners.com Web Address: www.trialrunners.com Address: 116 W Villard, Dickinson ND, 58601 Telephone: +1 (701) 483 3599

Lastly, but certainly not least, we have a high level of adaptability, which is so important as no 2 projects are ever the same. We are 100% adaptable, and in our 10 years of history have had the privilege of working with several companies more than once. The results simply speak for themselves. We have completed 59 Clinical trials with over 10,000 patients treated in our field. In addition to this we have worked in over 16 countries, adding to our global capabilities as a company. Ultimately, we care about the field of ophthalmology, our clients and the community we serve.

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Leading the Way Through Diligent Research

Director of the Year, Switzerland

For 125 years, MSD has been a global healthcare leader working to help the world be well. Switzerland is one of their central locations. The 600 employees of MSD’s human healthcare division in Switzerland markets prescription medicines and biopharmaceuticals in the treatment areas of anti-infectives – these include HIV/Aids, antibiotic resistance, and hepatitis C, but also covers such crucial healthcare issues as cancer, cardiovascular disorders, diabetes, immunology, neuroscience, and respiratory diseases. MSD Switzerland is closely engaged in clinical research and manufacturing medicines for commercial and clinical trial use, and is regarded as one of the leaders of R&D-based pharmaceutical companies. MSD is active in a wide range of different therapeutic areas, meaning that its people are reaching patients from right across the country.

There are still many challenges for MSD to reach, and there will always be people to assist in providing life-saving treatments. In addition, the intersection of healthcare and technology presents us with new opportunities for the healthcare ecoystem to enhance quality of life of patients. Mark thinks especially of immuno-oncology or Alzheimer’s, areas in which MSD is highly active.

As a Director at MSD, Mark McKechnie believes that the company’s work is really all about collectively driving innovative therapeutics to market that advance as the best opportunity for patients’ quality of life. “We are already looking beyond the horizon in the use of digital technologies such as clinical decision support, remote patient monitoring, analytics and augmented reality, will enable the organization to effectively bring therapeutics to market that help the world be well.”

“In terms of public health in general and Health Technology Assessments specifically,” he summarises, “it will be increasingly important to recognize the value of new therapies. It will be important to take on an encompassing view combining social and economic perspectives. Also, in order to constantly improve the quality of healthcare by better, more innovative medicine around the therapy digital health solutions will be crucial for R&D-based healthcare companies such as MSD and the scope of these investments.”

Expanding on the commitment to a legacy in Research & Development, Mark addresses the company’s aim of tackling some of the world’s most urgent global health challenges, in order to save and improve lives. “We also stay committed to increasing access to healthcare through farreaching policies, programs and partnerships. In addition, we see ourselves as a partner to define and deliver comprehensive and innovative healthcare solutions. In Switzerland, for instance, we do this in cooperation with various healthcare partners.”

Company: MSD Name: Mark McKechnie Web Address: http://www.msd.com

By strengthening health literacy as well as health economics, MSD also engages with the community in which it works, directly and supportively. This highlights the personality of MSD as that of a highly inclusive organisation, and indeed, any success and achievement is recognition for the team as a whole. According to Mark, it takes the collective talents of many people to bring our latest therapeutics to market for the most complex diseases and in a fast changing digitally enabled healthcare environment.

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Research & Development

Solving Healthcare Challenges

The Institute of Health Economics (IHE) was founded in 1995 on the belief that the best solutions to healthcare problems are the result of a collaborative approach between government, academia, and industry. Over two decades later, the IHE remains an independent and not-for-profit organisation, that is uniquely governed by a board of directors comprised of key influencers and decision-makers from each of these three groups. The IHE is committed to supporting both public and private sector organisations to achieve their objectives by producing, synthesising, and disseminating evidence-based findings from health economics, health policy, health technology assessment, and comparative effectiveness research. Key Partnerships • INAHTA: IHE hosts the Secretariat of International Network of Agencies for Health Technology Assessment. More than 50 agencies in 33 countries are involved; • HTAi: IHE hosts the Secretariat of Health Technology Assessment International, which has more than 60 organisations and 1,200 individual members worldwide. IHE also hosts and the Scientific Secretariat for HTAi Policy Forum; • WHO: IHE is a technical member of WHO Health Evidence Network; • CADTH: IHE is a member of the Canadian Agency for Drugs and Technologies in Health Technology Exchange; • NOAHE: IHE hosts the Secretariat of the Network of Alberta Health Economists; • Alberta Ministry of Health: IHE serves as the provincial program for health technology assessment; and • IHE partners with health economists around the globe. Core Services The IHE provides a wide range of high quality and credible technology assessment and economic

and policy analysis services via both internal staff and external national and international network resources. Given a unique structure representing both the public and private sectors, the IHE also acts in the capacity of a neutral convenor for health policy dialogues and engagements between government, academia, and industry utilising mature conference and publication series vehicles. The core services include: • Health technology assessment; • Health technology management; • Health economics, modelling & analytics/ decision support; • Budget impact assessment; • Health care costing; • Policy impact evaluation; • Transformative health delivery multistakeholder project management; • Public/private sector convening & engagement; • Knowledge Translation & Evidence Dissemination; • Reimbursement. IHE Industry Program Area The IHE has a pan-Canadian program area dedicated to issues and topics of strategic importance to the private sector life sciences

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industry and will launch a similar program internationally. The program area employs a unique and robust stakeholder engagement model to enable collaboration between government, industry and academia and the co-development of solutions to complex health care challenges. The structure of the IHE, its unique positioning as a â&#x20AC;&#x2DC;neutral brokerâ&#x20AC;&#x2122; within the health care ecosystem, broad competencies, mature engagement and communication vehicles, and network leadership enable the program area to support industry to maximise economic and clinical opportunities in the life sciences sector. Commissioning The Institute of Health Economics can be contracted by both public and private sector organizations in any area of core service. The IHE has deep competencies in health economics and technology assessment to produce, synthesise or generate evidence and decision supports, and offers neutrality and unique capabilities to enable collaboration between sectors and the development of consensus and shared purpose in healthcare as well as in social services, educational and human services, and in the criminal justice system. Please contact us to discuss how we can be engaged in support of evidence-informed healthcare and other sector policy and practice. Egon Jonsson Egon Jonsson is the executive director and CEO of the Institute of Health Economics (IHE) in Edmonton, Canada, and Adj Professor of health economics at the University of Alberta and the University of Calgary. He was trained at the Stockholm School of Economics, Sweden, (PhD) and as a research associate at Harvard School of Public Health, US. Egon Jonsson is an elected member of the US National Academy of Medicine. Until recently he was co-editor, with Prof Stanley Reiser, Uof Texas, of the International Journal of Technology Assessment in Health Care, Cambridge University Press. For many years, he was the CEO of the Swedish Agency on Health Technology Assessment (SBU), and professor of Health Economics at the Department of Medicine, the Karolinska Institute, Stockholm, Sweden. He later worked for WHO as a leader in establishing The Health Evidence Network (HEN).and a health policy advisor at the Ministry of Health in Vietnam. In 2005 he moved to Canada to take on the position he still holds at the IHE in Edmonton, Canada. His main field of research and policy development is in health technology assessment including economic, social and ethical implications of both new and established medicines, devices, procedures, and programs.

ghp November 2016 | 25


Research & Development

A Research Consortium Will Receive a Grant of €1.5 Million A research consortium will receive a Grant of €1.5 million from the European Fund for Regional Development and the Federal State of North Rhein-Westphalia. The LifeSciences NRW called for consortia of small and medium-sized companies and academic groups within North Rhein-Westphalia to compete in making proposals for developing solutions to solve current challenges within the field of biomedical sciences. Of the 51 submissions, the project of the consortium under the direction of

This proposal, entitled NeuRoWeg, was developed together with the University Hospitals in Cologne and Bonn, and a small specialist company, Life & Brain in Bonn, and will be supported with a grant of €1.5 million over the next three years. The aim is to improve the treatment of patients suffering from neuropathic pain, as this is only inadequately managed with currently available therapeutic agents. The €1.5 million funding by the EU and the State of NRW will be used to support research into the molecular basis of neuropathic pain, and to develop novel test systems which will allow the efficacy of new analgesics for patients to be assessed more accurately and rapidly. This is reflected in the title of the NeuRoWeg project, “Innovative test systems for identifying curative analgesics with reliable efficacy in patients”. Neuropathic pain arises as a result of nerve injury caused by diseases such as diabetes, or by chemotherapy, or by accidents or surgery. It is suffered by approximately 7% - 10% of the general population [1], a very large number of people, and its incidence increases with age, especially in women. Dr. Klaus-Dieter Langner, chief scientific officer of Grünenthal said, “I am looking forward to the results of this research project. I am also delighted that with the University Hospitals of Cologne and of Bonn, and with Life & Brain, we will have excellent partners within NRW at our side to jointly improve the prospects for developing better drug therapies for patients suffering from neuropathic pain.”

Dr. Gregor Bahrenberg, the NeuRoWeg project coordinator and Laboratory Head at Grünenthal, added, “we continually strive to identify novel test systems with which we can more reliably and more rapidly characterise whether new drugs will be effective in humans. In order to achieve this, we want to collaborate with our partners to establish innovative assays employing stem cells derived from human skin or blood cells to advance the means for identifying novel pain medications which can cure patients. To this end, we will combine the expertise of renowned specialists with cuttingedge technologies. The ultimate aim is to predict the efficacy of new drugs in order to select the most suitable of the many research compounds for clinical development.” Dr. Petra Bloms-Funke is head of the department of medical intelligence and innovation partnerships and responsible for the acquisition of non-dilutive research funding for Grünenthal Innovation, the research and development unit. She added,” our cooperative project NeuRoWeg will enhance our understanding of pain as a disease and how to cure it. A key problem in the development of new medicines is the poor ability of currently available test systems to predict efficacy in patients. This can lead to high failure rates during clinical development. We anticipate a considerable improvement with the highly innovative test systems we have planned. The consortium was founded because the success of this highly complex project will require coordinated contributions from highly specialised experts from different areas. Together

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we can advance and accelerate the development of new and effective pain medications, and make them available to patients more quickly than possible today. We are greatly looking forward to this interdisciplinary collaboration.” Consortium Research Project Under the direction of Grünenthal, the University Hospital Cologne, the University Hospital Bonn, and the company Life & Brain in Bonn will each contribute their respective expertise to improve the development of new and effective drugs: •

Grünenthal, Aachen (Dr. Petra Bloms-Funke, Dr. Gregor Bahrenberg) - emergence and therapy of neuropathic pain; characterisation of specific target proteins in cells (pain targets); identification and selection of new drugs. University Hospital Bonn (Prof. Oliver Brüstle, Dr. Michael Peitz) - generation and differentiation of stem cells for therapeutic use in the treatment of and research into neurological disorders. Life & Brain, Bonn (Prof. Oliver Brüstle, Dipl. Biol. Simone Haupt) - application of stem cell technologies for the development of predictive biological test systems. University Hospital Cologne (Prof. Tim Hucho) application of a special microscope technology, the so-called High Content Screening procedure, to investigate pain mechanisms and drug effects in pain cells.

Funding of bio-medical research and development in North Rhein-Westphalia with resources from the EU and of the Federal State of NRW The Federal State of North Rhein-Westphalia (NRW) initiated the Leitmarktwettbewerb LifeSciences. NRW, a funding competition, in 2015 to develop solutions to challenges in the field of health and well-being for our aging population. This initiative offers funding opportunities for groups of small and medium-sized enterprises, academic institutions and pharmaceutical companies in North RheinWestphalia, for innovative projects in research and development with resources provided by the EU and the State of North Rhein-Westphalia. By supporting innovation, the State of North Rhein-Westphalia wishes to secure sustainable growth and employment opportunities, and increase its international visibility as a leading location for Life Sciences. www.grunenthal.com

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Research & Development

A Urine Test for Creutzfeldt-Jakob Disease May Be Possible Researchers at the MRC Prion Unit at UCL have found that it may be possible to determine whether or not a person has sporadic Creutzfeldt-Jakob Disease (sCJD) by testing their urine for the presence of abnormal prion proteins. Prions are infectious agents that cause invariably fatal brain diseases such as CJD in humans, scrapie in sheep and BSE (bovine spongiform encephalopathy or ‘mad cow disease’) in cattle. They are a rare but important cause of dementia and it is increasingly recognised that the fundamental process involved in these diseases – prion proteins changing shape and sticking together to form fibres or polymers that damage the brain – is also what happens in the much more common dementias such as Alzheimer’s disease, Parkinson’s disease and other neurodegenerative diseases. CJD is a degenerative neurological disease that is currently incurable. Variant CJD (vCJD) was identified in 1996 and is linked to the consumption of meat infected with bovine spongiform encephalopathy (BSE). There are also inherited forms of human prion disease linked to mutations of a prion protein gene and cases caused by infection via medical or surgical treatments (iatrogenic CJD). Sporadic CJD is the most common form of the disease and represents about 85% of all CJD cases. In the UK the lifetime risk for sCJD is around 1 in 5000 the cause of which remains unclear. Currently, the only ways to determine in life whether or not a patient has sCJD are complex and may include MRI scans, brain biopsy and sampling of cerebrospinal fluid. These procedures are usually only performed when there is already a high likelihood that a patient has the disease, and sadly, the patient may have just weeks to live by the time the diagnosis is confirmed. In all forms of CJD, abnormal infectious prion proteins accumulate through a mechanism of ‘misfolding’. While previous work has shown that the abnormal proteins can be detected in the blood of patients with vCJD, the process was unable, until now, to detect them in patients with the sporadic form of the disease. In this study, published in the journal JAMA Neurology, the researchers used a modification of a test developed

for blood samples to test the urine of patients known to have CJD. They analysed anonymised samples from 162 people - 91 ‘controls’ (patients known not to have the disease), 34 patients with non-prion neurodegenerative disease, and 37 patients with prion disease, 20 of whom had sCJD. The results showed a very high specificity for the prion target, and correctly identified 40% of sCJD cases. The researchers hope to be able to increase the performance of the test by isolating the molecule or molecules in urine that are present in patients with sCJD. Dr Graham Jackson from the MRC Prion Unit and lead author of the study said, “although there is currently no cure for this disease, an accurate and early diagnosis is extremely important for patients and their families. In the future, as trials of potential therapies become available, the earlier a patient can be diagnosed the more effective any treatment is likely to be. “This test could be a critical step forward in being able to identify disease sufferers early using a simple test, perhaps at the first signs of being unwell or even as part of routine screening. By studying the nature of these disease-specific forms of the prion protein we hope to be able to improve the reliability and speed of the test to a point where it could one day be routinely used by clinicians including GPs to detect all forms of CJD.” Dr Nathan Richardson from the MRC, which funded the study added, “although we currently have no cure for CJD, or for other neurodegenerative diseases such as Alzheimer’s, understanding the early biomarkers for these can be extremely important in identifying targets for the eventual development of drugs treatments.” www.mrc.ac.uk

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Education & Skills

Overseas Doctors Welcome in Scotland Scotland’s Health Secretary, Shona Robison, said on 4th October that doctors from abroad will be welcome to train and work in the NHS north of the border. Ms Robison condemned comments from the UK Government this morning that overseas doctors will only be able to stay in the NHS until they are replaced by UK doctors. Ms Robison said, “these are irresponsible comments that will hamper NHS efforts to recruit doctors to vacancies and training places now – and that in turn could have a real impact on patient care. “As such, the UK Government’s position is short-sighted in the extreme. Medical professionals from outside this country have played a vital and valued part in our NHS for decades, and continue to do so, and their contribution should not be dismissed in this way. “In Scotland we want the best and the brightest from around the world to stay, build their careers here and contribute to the economy and our society. Of course it is also very important to invest in our workforce at home too. That is why we have already announced an additional 50 medical student places in Scottish Universities from August 2016, and a new Graduate Entry Medical programme with up to 40 places available. “Our young doctors want good quality, attractive training places which offer rewarding experiences and flexible working. But it has also long been a common practice that young doctors go abroad to experience the different opportunities and challenges of health services across the world – we shouldn’t deprive them of these experiences, because the UK Government’s actions also risk shutting down such opportunities for our own young medics.” www.gov.scot

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Education & Skills

Top Expert Tips What Cyclists Should and Shouldn’t Eat A survey conducted by Merlin Cycles has shown that 49 per cent said they would steer well clear of carbs in order to lose weight. This food group tends to get a bad rap, although a recent study undertaken in Italy showed that pasta – when eaten sensibly – can help to stimulate weight loss.

George Pounis, who co-authored the report said, “our data shows that enjoying pasta according to individuals’ needs contributes to a healthy body mass index, lower waist circumference and better waist-hip ratio.” Removing carbs from your diet in their entirety isn’t sensible. They help to fuel our body and give us the energy needed to stay active. That being said, many of us struggle to strike the right balance. What to Eat Before Cycling? If it’s a particularly long-haul trip, Florida-based sports nutritionist Barbara Lewin (R.D) told ‘Bicycling’ that a meal “rich in mixed carbohydrates, plus a little protein and healthy fat” is the way forward. It’s important to note that the harder you ride, the more glycogen (carbohydrates) you require. Farah Fonseca – England’s Strongest Woman in the under 63kg category – gave us some dietary pointers, “you want to try to make sure you consume a protein source of some kind, whether it be fish, eggs, legumes, meat or beans to prevent any blood sugar fluctuations. People are now noticing how much more affected by wheat and gluten they are, with bloating and fatigue being one of the major symptoms. Sticking to quinoa, root vegetables, brown rice, oats and rice pasta is what I would recommend.” You don’t want to feel bloated when you’re trying to beat your personal best – for this reason, avoid refined sugars and stick with whole wheat carbs instead. When to Eat Before Cycling? A lot depends on how far you’re planning to travel and how hard-going your ride will be. In the beginning, it can be a game of trial and error before you nail down what works for you and your goals. It’s worth it in the end, though. Dave Smith, a national and Olympic coach and founder of Velocity and Vitality, said that timing is key when fuelling up for a race or particularly strenuous trip.

“Nutrition should be geared towards what the goal of the ride is. Do you want to go as far and as fast as possible, do you want a greater training adaptation, do you wish to lose body fat? All of these can totally change your eating plan around a ride or event. A hard interval session in a fasted state may lack power and speed, but give a greater subsequent adaptation. I’ve done nine-hour rides fuelled only by a large breakfast, and short rides using gels. Consider the goal of the ride, and work back from there.” He added, “you should aim to start a race or intense training session with an empty stomach, which usually means eating three hours before. However, for lowerintensity rides you can eat an hour before without any problems. Generally, the more intense the session, the more important it is not to have food in the stomach.” Farah Fonseca added, “carbohydrates for most people are a worry. When should I consume them and what type of carbs should I be eating? For most people I always recommend to try and keep carbohydrates after you’ve been most active or ‘post workout’. It gets utilised in the body quicker and more efficiently at that time.” By combining carbs with your proteins post-workout, you ensure a more exponential recovery time, allowing you to get back on the road as soon as possible. What Shouldn’t Be in A Cyclist’s Diet? Salad In terms of supplying pure energy, it’s important for cyclists not to waste their time with empty foods. While a salad may shout ‘healthy eating’, it does very little for a cyclist as it’s extremely low in carbohydrates and won’t take you that far in terms of energy. Cereal Although cereal might not seem like an obvious red flag, the most popular brands have high GI ratings, meaning that they won’t sustain you for too long before burning the energy off.

32 | ghp November 2016


Jakiya Rahman 01204 977001 Jakiya@bringdigital.co.uk

ghp November 2016 | 33


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