Ghp July 2015 pdf

July 2015

www.ghp-magazine.com

What Can Doctors Learn From Bankers?

Does the NHS Discharge System Need Remodelling?

Addressing accusations of discrimination, poor judgment and lack of communication

Organ Donation: Why are the Numbers Dropping?

The WHO Global Action Plan to Combat

Antimicrobial

Resistance Minister for Health Care, Public Health and Sport for the Swedish Social Democratic Party, Gabriel Wikstrรถm, speaks aboutAntibiotic Resistance global health care systems and innovation.

Nordic Life Science Days

Register now at www.nlsdays.com

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editor’s note

this month’s features

inside this issue

Welcome to the July Issue of GHP Magazine.

04 News

This month we have a speech by Gabriel Wikström, the Swedish Minister for Health, discussing antimicrobial resistance and the Swedish government’s actions against it.

14 Working Towards Improved Wound Management in Europe

We also take a look at the Nordic Life Science days, a global event bringing together leaders in the global life science industry.

Focusing on diabetes, we pinpoint a clinical trial which shows the benefits of Biocool, a foot bath product, for treating foot issues often prevalent among diabetes sufferers.

Innovative new treatment for tendinopathy is analysed this month as we examine the potential effects that CollPlant’s new product could have on healthcare.

The WHO Global Action Plan to Combat Antimicrobial Resistance Gabriel Wikström, Minister for Health Care, Public Health and Sport for the Swedish SDP, recently spoke about Antibiotic Resistance, the global health care systems and innovation.

Page 18

We hope you enjoy this issue!

22 Nordic Life Science Days 24 BREXIT: Implications for the Life Sciences Industry 28 New Funding Gives Boost to the Ontario Institute for Regenerative Medicine 30 Organ Issue NHS reports that for the first time in over a decade the number of deceased organ donors has dropped, leaving services stretched with demand still high.

We turn the spotlight on the NHS, examining a new Healthwatch report which shows that the discharge procedures within the service need drastic remodelling.There is also a report about the drop in organ donation and the effect this is having on an already strained service.

There is also a piece about how a potential British exit from the Euro could affect the life sciences industry and we have an exclusive interview with Dr Rossant of the Ontario Institute for Regenerative Medicine, who outlines the effects that new government funding will have on the research being done at the institute.

20 Diabetes Innovation BioCool, a medicated foot bath which offers relief from mild foot problems.

NHS Discharge System Needs Remodelling

Report from Healthwatch England shows that from 2012 to 2013 there were over 1 million emergency readmissions within 30 days of discharge, costing the service an estimated £2.4 billion.

Page 26

“Our capacity to compete globally depends on how well we can harness our research, innovation and entrepreneurial strengths. ” Reza Moridi, Minister of Research and Innovation, Ontario Canada p.28

32 Seven Years on: Three ways project finance has changed since the financial crisis 34 Potential Breakthrough in Treatment of Tendinopathy 36 What can Doctors Learn from Bankers?

40 Can UAE Reach Ambitious 2021 Health Goals?

42 Johns Hopkins Bloomberg School of Public Health to Lead $17 Million Canadian Project 44 Ongoing Challenges in Identifying and Tackling Food Fraud Are Vital to Safeguarding Public Health

Global Health & Pharma, 39A Birmingham Road, Blakedown, Worcestershire, DY10 3JW Tel: +44 (0) 1234 567 890 | Email: info@ghp-magazine.com | Web: www.ghp-magazine.com

news

Air Pollution in London Serious Risk New report shows that pollution levels in the UK’s capital have reached fatal levels.

The findings by King’s College London have shown that in 2010 52, 630 life-hours, equivalent to 3537 actual deaths, occurred owing to the impact London’s pollution levels are having on the city’s inhabitants.

The report also stated that the economic costs of the pollution was estimated at between £1.4 and £3.7 billion.

The research examined the combined impact that nitrogen dioxide (NO2) and a particulate matter known as PM2.5 had on human health to produce their estimate of the scale of the problem.

The report, produced for Transport for London and the greater London authority, ultimately estimated that around 9,400 people had died in 2010 as a direct result of exposure to this pollution.

most affected, with an estimated 5330 deaths in that age group.

These results could have a significant impact on the healthcare industry, with new means of treating pollution related diseases required to help combat the growing problem. Although many businesses and transport industries are being called upon to help lower the amount of air pollution, pharmaceuticals firms could capitalise on the problem by working towards ways of combating the issue internally.

The full report by King’s College London can be accessed here.

The full report by Public Health England can be accessed here.

These results echo a report by Public Health England which indicates that in London in 2010 the death toll exceeded 10,000, with those over the age of 25 being

4 | ghp July 2015

Doctors Call for Reinstatement of Lung Cancer Awareness Campaign Healthcare experts have called on Jeremy Hunt to bring back the Be Clear on Cancer lung cancer awareness campaign.

Medical professionals from the front line of lung cancer services have demanded clarity on the future of the Be Clear on Cancer lung cancer awareness campaign.

The campaign, which was funded by the department of health in 2012, raised public awareness of persistent cough as a key lung cancer symptom.

This led to more patients being urgently referred by their GPs, and an increased number of lung cancers being diagnosed.

However there has yet to be any information about whether the campaign will be returning despite this success. The industry professionals have written an open letter to the Secretary of State for Health, Jeremy Hunt, seeking answers.

‘We are disappointed that the Department of Health does not appear to be building on the success of its own nationwide lung cancer awareness initiative, and that the campaign seems to have been shelved’ Mr Richard Steyn stated.

Mr Steyn is the Chair of the UK Lung Cancer Coalition (UKLCC) and Consultant Thoracic Surgeon and Associate Medical Director, Surgery, at the Heart

of England NHS Foundation Trust and one of the signatories of the letter.

Other specialists who signed include Professor Michael Lind, Professor of Oncology, Head of Centre for Cancer, Hull Medical School; Professor Dean A Fennell; Department of Cancer Studies and Molecular Medicine, University of Leicester & Leicester University Hospitals and Dr Andrew Wilcock, Clinical Reader in Palliative Medicine and Medical Oncology, Nottingham University Hospitals NHS Trust.

The letter states that despite the marked improvement in services over the recent years, wide variations in lung cancer treatment and care continue to persist across the UK, which means that treatment and survival rates are lagging behind other comparable countries in Europe.

The letter also declares that the restoration of the campaign is vital to saving patients from lung cancer.

‘We are therefore disappointed that the Department of Health does not appear to be intending to build on the success of its own nationwide lung cancer awareness initiative and we call on the new Government to re-instigate the campaign immediately - in order to encourage early diagnosis and save British lives.’

CEO Cancer Gold Standard Reaccreditation Awarded to PPD CEO Roundtable on Cancer has bestowed Pharmaceutical Product Development with CEO Cancer Gold Standard reaccreditation for maintaining a strong commitment to the health of company employees.

The firm, which a leading global contract research organization providing drug discovery, development, lifecycle management and laboratory services, encourages employee participation in health and wellness programs.

These include cancer prevention and screening, nutrition coaching and fitness classes, to promote healthy lifestyles and empower employees to take an active role in managing their health.

The CEO Roundtable on Cancer developed the Gold Standard as an employee wellness framework based on concrete actions for companies to take in five key areas: establishing policies and programs to reduce cancer risk by prohibiting tobacco use and supporting tobacco cessation efforts; promoting physical activity, healthy nutrition and weight management; providing health insurance options that include detecting cancer at its earliest stages, access to quality care and participation in clinical trials; promoting employee awareness of these initiatives; and supporting the needs of cancer survivors in the workplace.

Nearly 200 private, non-profit and government employers in a wide range of occupational categories have earned Gold Standard accreditation, including the National Cancer Institute (NCI) and a number of NCI-designated cancer centers. These firms act as standards for other employers to follow with regards to employee health and wellbeing.

Hematology and oncology form one of PPD’s leading therapeutic areas for clinical research.

PPD has conducted in excess of 420 hematology and oncology studies in the past five years at more than 23,000 research sites involving greater than 100,000 patients. PPD has a global network of more than 8,000 hematology and oncology investigators.

PPD provides a tobacco-free workplace, health screenings, education and promotion of healthy lifestyles and other initiatives critical to helping detect and prevent cancer.

David Simmons, chairman and chief executive officer of PPD, made it clear that the company was committed to employee heath and was honoured by the award. ‘“PPD is committed to the fight against cancer.

As a global contract research organization with deep expertise in oncology, we are dedicated to helping biopharmaceutical clients deliver safe treatments to patients more quickly, cost-effectively and with the highest possible quality. We’re pleased the CEO Roundtable on Cancer has recognized our efforts in employee health and wellness, and we applaud their worthy mission.’

ghp July 2015 | 5

news

KalVista Raises Finances to Fund Research The pharmaceuticals firm has announced it has raised further funds which will be used to support its research and clinical development programs.

The company, which is a research-led pharmaceutical company, will use the funds to advance its proprietary portfolio of plasma kallikrein inhibitors for treating diabetic macular edema and hereditary angioedema.

Alongside the existing investors, Novo A/S and SV Life Sciences, the round included additional international healthcare investors experienced in plasma kallikrein targeted mechanisms led by RA Capital Management and including Longwood Fund and Venrock.

Rajeev Shah, the Managing Director and Portfolio Manager at RA Capital and Rich Aldrich, who is co-founder and Partner of Longwood Fund, will both join the KalVista Board of Directors. Bong Koh, a Partner at Venrock, and Tomas Kiselak, a Managing Director at RA Capital, will also join the Board as observers.

Shah commented on the reasons behind RA Capital’s decision to invest in the research.

‘We are delighted to conclude this financing, and are very excited to be joining the Board of KalVista at a time of great progress and pipeline expansion in the Company. We were attracted to this investment

by KalVista’s scientific leadership in this area and its significant progress towards its goal of bringing bestin-class, small molecule plasma kallikrein inhibitors to the market. Together with the Longwood Fund and Venrock as new investors alongside SVLS and Novo, the syndicate brings considerable experience in the company’s areas of interest. We look forward to helping KalVista execute its ambitious business plan.’

The pharmaceuticals firm is also rapidly advancing orally delivered inhibitors through pre-clinical testing.

These drugs will not only expand the therapeutic options for DME patients but also enable KalVista to expand its disease portfolio into the treatment of HAE and other kallikrein-related disorders. In addition to this the company continues to expand its small molecule portfolio towards additional therapeutic targets which will enable them to fully exploit their research expertise with serine proteases for the treatment of unmet clinical needs.

Andrew Crockett, KalVista’s CEO, was optimistic about the research and emphasized that the new funding would benefit this greatly.

‘This financing round attracted significant demand from major healthcare investors and we are delighted with this vote of confidence in our strategy to develop best-in-class plasma kallikrein inhibitors in serious diseases. This financing will allow us to rapidly advance our programs in DME and HAE towards important clinical proof of concept milestones and bring much-needed treatments to patients. We are now in a very strong position to drive the growth of KalVista, and achieve the full potential of our therapeutic pipeline.’

KalVista has developed and patented a diverse pipeline of highly selective and potent plasma kallikrein inhibitors designed for different routes of administration. The Series B financing will enable the Company to accelerate the advancement of these drug candidates through to clinical testing for multiple disease indications. The most advanced program, an intravitreally administered plasma kallikrein inhibitor has just completed its first-in-human study and will move into Phase 2 trials in 2016 for the treatment of diabetic macular edema (DME).

6 | ghp July 2015

New Research Shows High TTIP Support in Pharmaceutical Industry Corporate Europe Observatory have published infographics which show that pharmaceuticals firms have increased their lobbying for the reforms drastically in 2013-2014.

The results show that 2.4% of the Director General for trade in Europe one-to-one lobby meetings on TTIP were with big pharma in the preparatory phase of the negotiations, which ran from January 2012 to March 2013, but the sector’s share in lobby meetings jumped to 16.5% in the following period, April 2013 to February 2014.

TTIP, or The Transatlantic Trade and Investment Partnership, is currently a series of negotiations to create a trade deal between Europe and America. Some unions and non-profit organisations are critical of the proposed trade partnership, which would see a reduction of trade barriers between the US and Europe.

During the crucial early negotiations, between January 2012 and February 2014, the Director General for trade in Europe held 597 behind-closed-door meetings with lobbyists to discuss the negotiations, according to internal Commission files obtained by the survey ‘via access to information requests’.

528 of those meetings or 88% were with business lobbyists while only 53, which equates to 9%, were with public interest groups. Therefore, for every meeting with a trade union or consumer group,

the Director General held ten with companies and industry federations.

The main issue which many critics have with TTIP, particularly the protest group War on Want, believe that it could potentially jeopardise many public service, notably the NHS. War on Want have been particularly vocal about their issues with the proposed deal: “TTIP is a threat to jobs, the environment and much more. It would open up public services to irreversible privatisation, and grant foreign investors a new right to sue governments for any loss of profits resulting from public policy decisions.”

The Transatlantic Trade and Investment Partnership could potentially harm the NHS because if it is not exempted from the partnership then there is the potential for the deal to lead to a privatisation of the public health service, similar to the system which is already in place in the US. It would also have an impact on other regulations such as food and drink, jobs and political policy.

Details of the study are available here.

ghp July 2015 | 7

Evidence Shows New Technique Spares More Breast Cancer Suffers’ Nipples A new study published in the journal Plastic and Reconstructive Surgery proves that more breast cancer patients can qualify for a complex nipple-saving surgery which was previously unavailable to them.

More breast cancer patients, particularly women with large or sagging breasts who previously did not qualify for certain surgeries, are now candidates for the most complex nipple sparing breast reconstructive surgery using the body’s own tissue.

Some sufferers were previously not able to have the surgery because due to the inability to elevate the nipple position after mastectomy. The findings in the peer-reviewed journal present compelling evidence that perforator flap reconstruction is often better than implant reconstruction for women undergoing nipple sparing mastectomy.

Surgeons at the Centre for Restorative Breast Surgery have now pioneered this stunning technology that completely overcomes limitations, allowing more breast cancer patients to take advantage of the surgery.

In the article, Dr DellaCroce, the chief author of the paper, and his team describe the pioneering technique that allows for a full breast lift or breast reduction after nipple sparing mastectomy. The technology that makes this possible means that women who were previously denied preservation of their nipple at the time of mastectomy no longer have to be excluded due to pre-existing poor nipple position or breast size. This advancement has the capacity to produce results that were previously unachievable with better breast appearance after mastectomy than before.

Dr DellaCroce made it clear that this new procedure would drastically improve patient choice.

‘Implant reconstructions outweigh natural tissue reconstruction by nearly 5 times in the U.S., and some of that is because we don’t do a good enough job of informing women of what is possible with living fat transplant procedures. It is essential that women know about this advancement before being talked into cutting away their nipples to tighten the extra skin over an implant-based procedure. No-one thought this was possible before now, and the importance of this discovery cannot be overstated. As nipple sparing mastectomy becomes more common, we can now offer the same extraordinary outcomes to women with drooping breasts or those with very large breasts. These women, who were previously denied nipple sparing mastectomy due to poor nipple position, can now have a full breast lift or reduction as a part of their overall surgery while still protecting their natural nipple.

The key point that women must understand, is that this is impossible to accomplish with an implant reconstruction, but completely possible with a microsurgical flap reconstruction.’

news

Plastic Surgery Fashions Revealed WhatClinic.com has offered a mid-year overview of the latest trends in cosmetic plastic surgery procedures.

Cosmetic plastic surgery procedures are often shaped by fashion and trends, as customers copy celebrities and fashion trends induce clients to appreciate the features of previously hidden body parts.

New research from private healthcare search engineWhatClinic.com has isolated the current trends in cosmetic procedures. The research examined the number of enquires across its site over the last year, then compared this to the data from the same period of the previous year.

Full abdominoplasty, the operation which involves the removal of excess skin and fat from the middle and lower abdomen, is the fastest emerging trend, with enquiries for the procedure increasing by an impressive 264% in just six months.

Another procedure which saw increased enquires from potential patients was arm lifts, or brachioplasty, which saw the second highest growth in interest with an astonishing 239% over six months. The procedure, which is a form of body contouring, is normally performed on patients with loose or sagging skin on the upper arms which is often colloquially known as ‘bingo wings’.

Breast implants have remained the most popular enquired after procedure, top of both last year’s and this year’s current lists, with a 98% increase in enquires since 2014.

The popularity of some procedures was not so enduring, with demand for bottom implants only increasing by 15% since last year. Other surgeries have even seen their demand decrease as their popularity wanes, with areola (nipple) reduction interest falling by 36% and interest in hymenoplasty (is the surgical restoration of the hymen) dropping by 22%.

Emily Ross, the Director of WhatClinic.com, highlighted the fact that despite alternative solutions becoming more readily available clients there is still a high demand for plastic surgery.

‘Despite the fact that the range of non-surgical alternatives available to UK consumers has broadened considerably, full surgical procedures for cosmetic purposes are more popular than ever. Breast augmentation is by far the most common plastic surgery treatment being sought by UK patients, though we are also seeing more men seeking treatment for male breast reduction.’

By exposing the current trends in plastic surgery procedures this study offers private plastic surgery firms the chance to alter marketing campaigns around the current trends and prepare themselves for an onslaught of bookings for certain procedures as demand soars.

8 | ghp July 2015

Precyse Acquisition Boosts Pamplona’s Portfolio Pamplona Capital Management has added Precyse, the healthcare management specialists, to their growing collection of healthcare firms making them a key player in the healthcare industry.

Precyse, a leader in Health Information Management services, education and technology, is being purchased from Altaris Capital Partners and NewSpring Capital for an undisclosed sum.

The new acquisition will be an impressive addition to Pamplona’s expanding health investment portfolio which also encompasses: Spreemo, a firm that is bringing cost transparency and quality metrics to the workers compensation specialty benefits management industry with an initial focus on radiology; Intralign, which helps hospital and surgeons achieve a rep-less, optimized surgical episode by combining assessment with clinical support and operational tools; Magnacare, a leading healthcare administrative services company focused on self-insured employers and workers comp plans in the New York and New Jersey regions; and Privia Health, a physician practice management and population health technology company. The firm previously owned Alvogen, a high growth generic drugs company, but sold the majority of their stake in the firm in June to a consortium of investors.

Dr. Jeremy Gelber, a Pamplona Capital Management partner who is leading the investment, made it clear that the new acquisition would benefit both of the firms involved as well as their customers.

‘Precyse has established itself as a leader in Health Information Management with the ability to fully outsource HIM departments, provide services or tech-

nology on an as-needed basis, and supply education tools to help hospitals achieve better outcomes. We and Precyse have a shared vision in expanding the business beyond the company’s traditional offerings into other areas that positively impact providers’ clinical and financial outcomes, both in Health Information Management and beyond.’

Precyse is certainly a shrewd investment for the firm and also represents a large section of the American healthcare market, delivering a robust combination of experienced, highly trained people, premier technology solutions, and industry-leading education which they target at all clinical and financial aspects of Health Information Management. Collectively, this equips healthcare organizations to achieve enhanced, sustainable operational performance.

The CEO of Precyse, Chris Powell, was keen to establish that being acquired by Pamplona would allow the firm scope to grow and increase their influence in the industry.

‘We are delighted to be partnering with Pamplona Capital at this exciting time in Precyse’s evolution.

Precyse has a wide range of services, education and technology solutions that enable us to help healthcare organizations thrive. Pamplona will help us meet our growth objectives as we continue to build on our successful solutions today and expand our offerings in the future to help healthcare organizations reach new levels of operational success.’

Global Drug Delivery Tech Market Will Offer Investors Relief A new report by visiongain predicts that the world market for drug delivery technologies will reach $159.3 billion in 2015.

The forecast appears in ‘Drug Delivery Technologies Market Forecast 2015-2025: Prospects for Leading Companies’.

The global market for drug delivery technologies has experienced strong growth in recent years, and visiongain expects this growth to continue over the forecast period used in the report, which extends between 2015 and 2025.

The market will be boosted by the increasing number of biological drugs on the market as they are inherently difficult to administer by traditional drug delivery methods. Furthermore, the use of vaccines with innovative delivery platforms such as nasal sprays and transdermal patches is set to expand significantly over the next decade.

Transdermal and injectable drug delivery technologies will witness the highest growth over the forecast period, obtaining market shares from oral drug delivery technologies. A number of manufacturers are increasingly shifting their focus to biological drugs, which normally require injection.

A key example of this is Eli Lilly, a big contender in the global pharmaceuticals industry, is strengthening its pipeline of biological drugs and a new drug delivery innovation centre will be built.

The report states that developed countries in North America and Europe are currently dominating the drug delivery technologies market, owing to their establishment in the pharmaceuticals sector and the fact that they are financially stable. Emerging markets such as China and India continue to grow rapidly, obtaining market share from western countries.

The market for drug delivery technologies has experienced strong growth in recent years, and the report expects this growth to continue over the forecast period of 2015 to 2025. The market will be boosted by the increasing number of biological drugs on the market as they are inherently difficult to administer by traditional drug delivery methods.

Additionally, the use of vaccines with innovative delivery platforms such as nasal sprays and transdermal patches is set to expand significantly over the next decade as customers reject more painful, traditional methods of taking drugs in favour of more simpler, more modern techniques.

Drug manufacturers in the drug delivery sector are continuously striving to develop drug delivery options that provide patient-friendly dosage forms. Consequently, drug delivery technology will continue to play an important role in developing next generation drugs, particularly in biologics and vaccines, as patients continue to require easier means of taking medicines and companies continue to develop their technology.

ghp July 2015 | 9

news

Trial Results Show New Treatment Could Rival Preparation-H Peritech’s PP-110 product granted US patent for composition and methods of treatment following positive pivotal trial results.

The product is a novel over-the-counter anti-haemorrhoidal product. PP-110 was found to be effective in treating haemorrhoids and superior to conventional treatment. The results were published on-line in Molecular and Cellular Therapies.

The randomized, open label study compared the safety and efficacy of PP-110, with the US golden standard, Preparation-H Maximum Strength Cream, in the treatment of grade two to three haemorrhoids.

Over 100 patients participated in the 14 day study that was conducted in seven sites by a team of physicians headed by Professor Ehud Klein, Director of Surgery Service Line at Maccabi Health Services, Tel-Aviv, Israel.

PP-110 (in gel and wipes form) was provided to some patients once daily, while other patients received Preparation-H Extra Strength according to label instructions (i.e. three to four times per day). Patients receiving PP-110 gel reported statistically significant better results in the three most prevalent clinical parameters relating to common symptoms of haemorrhoids, namely pain, bleeding and itching, compared to patients treated with the Preparation-H. The head of the trial, Prof. Ehud Klein, made it clear that the results of the trial were exciting.

‘The pivotal trial results are very encouraging and exceed our expectations. We found that the unique formulation of PP-110 provides a long lasting effect, and were extremely pleased to see that even once-daily application is sufficient, which offers patients a true improvement over current topical treatment.’

Peritech has received a U.S. Patent No. 9,072,747 from the United States Patent and Trademark Office, which includes claims protecting the use of PP-110’s compositions and methods of treatment for anorectal disorders. The granted patent has a term extending to March 2034.

Dr. Eran Eilat, CEO of Peritech Pharma Ltd commented on the results.

‘Our novel film-based formulation provides a slow-release mechanism, and as a consequence, a prolonged therapeutic window. We are very pleased with the pivotal trial results that clearly demonstrate the benefits our product offers hemorrhoid patients.

Together with the recently granted US patent, and under the monograph regulatory track, PP-110 is ready to be marketed and is now well positioned to revolutionize the hemorrhoids OTC market, especially in the United States.’

10 | ghp July 2015

Investigation into Pricing-Fixing of Generic Drugs The Department of Justice believes price-fixing between makers of generic pharmaceuticals is widespread according to PaRR. The legal intelligence firm has published concerns from the Department of Justice that the investigation due to be conducted into the matter is being hindered by pharmaceutical firms, with none applying for amnesty, which could potentially mean that companies have not found enough evidence in their own internal investigations to warrant cooperation with the government.

However, according to PaRR their source states that the Department of Justice believes this to be simply a case of ‘bad lawyering’.

The investigation into generic drug pricing has been in operation for a year already but some of the manufacturers under investigation are still yet to retain antitrust counsel.

Up in Smoke Brighton and Hove City Council have proposed to ban smoking from external public areas in a bid to lower the risk of passive smoking related health problems.

The ban will include the famous tourist destination Brighton beach, with the council keen to emphasise that the proposed ban is motivated by a desire to protect children from the effects of passive smoking.

Daniel Yates, chair of Health and Wellbeing Board was keen to emphasise the positive affect this ban could have on the health of children.

‘The health benefits of smoke free areas and protecting children from second-hand smoke are well established. We’re keen to keep people safe from the effects of smoking in public areas, especially children who are most vulnerable. However we also want to ensure any measures taken have support of residents in the city.’

The council stated that voluntary smoking ban already exists in all 42 of the city’s children’s playgrounds, with the proposed consultation on further enforcement of this set to gauge whether there is wider public support for extending the smoke free areas across the city.

The ban proposal highlights the growing public awareness of the health issues around smoking, with campaigns from charities and the government increasing public knowledge of the dangers of the habit.

Dr Tom Scanlon, Director of Public Health cited regulations in the US as a potential model for the council’s plans.

“Tobacco smoke typically contains over 170 toxins including carcinogens and air pollutants. The benefits of smoke-free indoor areas are well established and accepted. Outdoor tobacco smoke dissipates more quickly than indoor smoke, but in certain concentrations and weather conditions it still poses an additional health risk to non-smokers. Several States in the US have adopted legislation to limit outdoor smoking in certain settings such as cafés, parks and places where there are children playing. The time is right to have the debate in Brighton & Hove as to whether we wish the same here.”

The 2013 Household survey showed that smoking in Brighton & Hove is at 25.2%, which is above the average in England of around 18%.

ghp July 2015 | 11

PaRR claims to have been in communication with ‘a half dozen attorneys who are still seeking to retain corporate or individual clients in the generic pharmaceutical industry, a fact they said is unusual given the length of the ongoing investigation.’

The source for PaRR also claims that the department believes that this investigation could potentially be its largest to date, owing to the vast number of different generic drugs in the market.

The investigation is believed to have originated from a congressional inquiry into the same issues and extensive media coverage of rapidly increasing generic drug prices. In January 2014, the National Community Pharmacists Association sent letters to congressional committees requesting hearings on the matter.

In October of the same year, Senator Bernie Sanders, alongside US Representative Elijah E. Cummings, launched an investigation requesting information from 14 generic drug companies on pricing issues relating to a variety of products. A hearing was held in November.

The investigation served Lannett, a Delaware-based generic drugs firm, with a subpoena in November of last year ‘relating to a federal investigation of the generic pharmaceutical industry into possible violations of the Sherman Act’.

Any ruling in this case has the potential to drastically alter the way in which the American pharmaceuticals market operates and could lead to tighter controls on the sale of generic drugs.

news

Pamplona Acquires Health Information Management Expert Precyse LONDON/NEW YORK – Pamplona Capital Management (“Pamplona”) is pleased to announce that it has signed an agreement to acquire Precyse, a leader in Health Information Management services, education and technology, from Altaris Capital Partners and NewSpring Capital. Precyse’s industry-leading expertise and technologies empower healthcare organizations to most effectively capture, organize, secure and analyze clinical data to improve financial performance and the quality of care delivered.

Precyse, founded in 1999, has enabled nearly 5,000 healthcare facilities and systems across the United States to improve efficiency and deliver tangible outcomes. The company delivers a robust combination of experienced, highly trained people; premier technology solutions; and industry-leading education, targeted at all clinical and financial aspects of Health Information Management. Collectively, this equips healthcare organizations to achieve enhanced, sustainable operational performance.

“We are delighted to be partnering with Pamplona Capital at this exciting time in Precyse’s evolution,” said Precyse CEO, Chris Powell. “Precyse has a wide range of services, education and technology solutions that enable us to help healthcare organizations thrive. Pamplona will help us meet our growth objectives as we continue to build on our successful solutions today and expand our offerings in the future to help healthcare organizations reach new levels of operational success.”

“Precyse has established itself as a leader in Health Information Management with the ability to fully outsource HIM departments, provide services or technology on an as-needed basis, and supply education tools to help hospitals achieve better outcomes,” said Pamplona Capital partner, Dr. Jeremy Gelber, who is leading the investment. “We and Precyse have a shared vision in expanding the business beyond the company’s traditional offerings into other areas that positively impact providers’ clinical and financial outcomes, both in Health Information Management and beyond.”

In addition to Precyse, Pamplona’s healthcare investment portfolio currently includes Spreemo, a company that is bringing cost transparency and quality metrics to the workers compensation specialty benefits management industry with an initial focus on radiology; Intralign, which helps hospital and surgeons achieve a rep-less, optimized surgical episode by combining assessment with clinical support and operational tools; Magnacare, a leading healthcare administrative services company focused on self-insured employers and workers comp plans in the New York and New Jersey regions; and Privia Health, a physician practice management and population health technology company.

Earlier this month, Pamplona sold the majority of its controlling stake in Alvogen, a high growth generic drugs company, to a consortium of investors.

The Precyse investment is being made from Pamplona’s fourth private equity fund, Pamplona Capital Partners IV LP, a USD 4 billion investment vehicle, raised last year. Pamplona was advised by Deutsche Bank Securities Inc. and received legal advice from Simpson Thacher & Bartlett LLP.

12 | ghp July 2015

DoJ Believes Collusion over Generic drug Prices WidespreadSource The Department of Justice (DoJ) believes price-fixing between makers of generic pharmaceuticals is widespread, a source briefed by a federal prosecutor involved in an ongoing criminal investigation told PaRR.

In a SEC filing on 6 November, Delaware-based Lannett disclosed that a sales executive received a grand jury subpoena three days earlier “relating to a federal investigation of the generic pharmaceutical industry into possible violations of the Sherman Act.” The subpoena is related to competitor communications about generic drug sales but is not limited to any time period or product. On 7 November, California-based Impax disclosed receiving a similar subpoena. In March, New Jersey-based Par Pharmaceutical disclosed a 5 December 2014 subpoena from the DoJ relating to digoxin and the antibiotic doxycycline.

As previously reported by PaRR, no company has been granted amnesty in exchange for its cooperation with the investigation. That could mean that companies have not found enough evidence in their own internal investigations to warrant cooperation with the government.

However, the source briefed by the prosecutor said the DoJ views the lack of an amnesty applicant as “bad lawyering”. But only a handful companies involved have retained antitrust counsel, and the healthcare focused attorneys retained by some may not be aware of the amnesty process, the source said.

Although the probe into generic drug pricing has been underway for over a year, some manufacturers under investigation are still looking to retain antitrust counsel.

PaRR spoke with a half dozen attorneys who are still seeking to retain corporate or individual clients in the generic pharmaceutical industry, a fact they said is unusual given the length of the ongoing investigation.

A former federal antitrust prosecutor said one company could have an amnesty marker but is still “perfecting” it. Companies seeking amnesty from criminal prosecution place a “marker” with the DoJ to ensure another company does not take their spot.

They then must provide all the information they have as quickly as possible, a process known as “perfecting the marker”.

The former prosecutor, who prosecuted some of the auto parts cartel cases while at the DoJ, said that one of the markers in those investigations took years to perfect.

The belief inside the DoJ is that this investigation could become the next auto parts investigation, according to the source briefed by the prosecutor. In that probe, the DoJ’s largest prosecution to date, the department has extracted plea deals from dozens of companies and executives involved in a multitude of different conspiracies on individual parts.

With untold numbers of different generic drugs on the market, it may be possible for prosecutors to move from one drug to another in a similar cascading fashion.

The source said that prosecutors are taking a close look at trade associations as part of their investigation as having been one potential avenue for facilitating the collusion between salespeople at different generic producers.

The DoJ’s investigation is believed to stem from a congressional inquiry into the same issues and media coverage of rapidly increasing generic drug prices. In January 2014, the National Community Pharmacists Association sent letters to congressional committees requesting hearings on the matter. In October, Senator Bernie Sanders (I-VT) and US Representative Elijah E. Cummings (D-MD) launched an investigation requesting information from 14 generic drug companies on pricing issues relating to a variety of products. A hearing was held in November.

According to materials published by Senator Sanders’ office, some generic drug prices jumped as much as 8,000% between October 2013 and April 2014.

ghp July 2015 | 13

Inadequate Mental Health Support in UK says Report Statistics collated by Chrysalis Not for Profit Ltd highlight a worrying rise in UK residents suffering from a mental health condition, with a recent Care Quality Commission review showing that people who need urgent mental healthcare in England are receiving inadequate support.

Chrysalis Courses, a top UK trainer in talking therapies, has published a new infographic which highlights need for more mental health care experts by illustrating just how common mental health conditions are in the UK. The not for profit organisation’s statistics show that one in ten British people suffer from either depression or anxiety during their life time, whilst the numbers of people turning to counselling continue to rise with a 4% increase in the past year.

The infographic offers a visualised representation of the statistics and illustrates the vastness of the issue.

Chrysalis’s Head of Hypnotherapy, Karen Ferguson, cited the stigma around mental ill health as a key issue in treating it.

‘Mental health is a serious issue and more needs to be done to help sufferers. Sadly, there is a lot of stigma attached to people suffering from a condition, which sometimes prevents people from receiving adequate help.

We commissioned this infographic to visualise just how common these conditions are, so people will be more inclined to come forward and seek help.

Thankfully, recent data suggests that more people are seeking counselling and therapy.

However, as the CQC reported, adequate support isn’t always readily available which is why we trying to encourage those who want to help to use the training infrastructure available to put you on the right track to becoming a counsellor or therapist.’

Working Towards Improved Wound Management in Europe

By Severin L채uchli, President of the European Wound Management Association (EWMA) 14 | ghp July 2015

public health Non-healing wounds are a significant problem for healthcare systems worldwide and typically account for 2-4% of healthcare budgets. These figures are expected to rise in conjunction with an increased elderly and diabetic population (1-3). However, many of the challenges and costs related to the management of chronic wounds may be reduced by the adoption of available guidelines and recommendations for the organisation of care which are already available. This article introduces the different types of challenges and the initiatives taken by EWMA in order to work towards a removal of the existing barriers to improved wound management.

Efficient organisation of chronic wound management The increasing need to establish the most efficient care pathways is not unique to the domain of wound management. However, due to the often complex aetiology of chronic wounds and the various medical problems of individuals suffering from them, the challenges related to inefficient management have been a focus area within this domain for many years (4). Most recently, the efforts to reduce health care sector costs by moving health care services from the hospitals into community care have further stressed the need to establish clear treatment pathways for wound patients (5).

Based on this outline, specific challenges related to organisation of wound management include: • Barriers to establishment of multidisciplinary teams: Chronic wounds need a careful diagnostic evaluation which often requires input from different specialities. Their treatment addresses a variety of underlying factors and usually involves different medical professions (physicians, nurses, physiotherapists, etc.). The benefit of multidisciplinary interventions for many chronic diseases (6), including wound care (7), is well proven. However, actually achieving the establishment of a multidisciplinary team approach to wound care within all relevant clinical settings remains a challenge throughout Europe.

• The barriers include variation in the interest and involvement of relevant medical specialities in the domain of wound care, leading to confusion as to who is responsible for different aspects of wound management. Furthermore, difficulties related to implementing appropriate referral routes also present an obstacle, as do variations in the level of education within the domain of wound care. This is because the domain is not defined as an independent speciality for physicians or nurses (with a nurse specialisation in tissue viability in the UK being an exception).

• The EWMA Document Managing Wounds as a Team, published in 2014 (8), proposes a universal model for the adoption of a team approach to wound management. To address the challenges related to variations in the educational level of the health care professionals specialised within relevant medical specialities such as dermatologists, endocrinologists as well as orthopaedic and plastic surgeons, EWMA has recently developed a curriculum for physicians which was adopted by the European Union of Medical Special-

ists (UEMS) in April 2015. EWMA is currently initiating similar activities to support a common European level in the basic education of nurses.

• Challenges related to ensuring a high quality of wound management in community care: As described above, transfer of health care services from the hospitals to community care is generally supported by health care authorities. Reference to the quality of life and costs related benefits of providing patient care within the home environment is taken into account. It has thus become increasingly important to ensure that health care staff members in community care settings attain the minimum skills required to deliver effective wound care and ensure that they have easy access to communication with wound specialists in the wound clinics. A recent document published

by EWMA, Home Care – Wound Care, published in 2014 (5), describes these challenges and provides recommendations for how to meet them. Use of telemedicine services to support remote consultations between community care staff members and wound care specialists in the hospitals is increasing. This approach also provides the benefit of greater involvement of general practitioners and informal carers in the patients home, in addition to enhancing the role of the patient in their own care (9, 10).

Inconsistent implementation of guidelines Both of these challenges related to organisation of wound management are partly connected to the fact that the available European and/or national evidence based guidelines which exist for most of the primary types of chronic wound management - Diabetic foot ulcers (11), pressure ulcers (12) and venous leg ulcers (13) - are not systematically implemented into clinical practice around Europe. Typical barriers to implementation of these guidelines include; lack of the required budget for, or management recognition of the value of evidence based guideline adoption within the given domain; that the mix or level of skills available in the group of health care staff members does not match the recommendations; lack of systematic training programmes; lack of awareness that the guideline exists and or lack of communication between the health care system organisations. As the organisation and mix of competencies involved in wound management varies greatly between local treatment settings, these factors are all relevant. To address some of these challenges, EWMA is working on a document that will also address the barriers to

ghp July 2015 | 15

16 | ghp July 2015

public health implementation of guidelines for leg ulcers (more information available at www.ewma.org). EWMA also collaborates with other societies, such as the International Working Group on the Diabetic Foot (IWGDF) and the European Pressure Ulcer Advisory Panel (EPUAP) to actively support large scale implementation of the available European guidelines.

Focus on prevention – a patient safety issue Pressure ulcers are a preventable, yet common problem. Internationally, prevalence rates vary from 8.8% to 53.2 %, while incidence rates from 7 % to 71.6 % (14). Thus the prevention of pressure ulcers does constitute an important patient safety issue and potentially, significant resource savings if the appropriate prevention measures are effectively implemented.

Another area with the potential for great improvements for the patients, as well as resource savings is nosocomial infections. Even though the focus on patient safety has increased in recent years, owing to, among other things, the focus on this topic in the EU Commission1 (15), there is still a long way to go with regards to prevention of pressure ulcers. Insufficient prevention measures relate back to the lacking adoption of evidence based guidelines, including appropriate risk assessment tools. To enhance the recognition of pressure ulcers as a significant patient safety issue, and thereby promote the adoption of evidence based guidelines for pressure ulcer management, EWMA initiated a series of activities promoting pressure ulcers to be mentioned as a specific focus area within the communications of the EU Commission2 (15).

Challenges related to the prevention and management of nosocomial infections are further covered in the next section.

Supporting appropriate use of antimicrobials in wound management Wounds are predisposed to infection, as the exposure of subcutaneous tissue following a loss of skin integrity provides a moist, warm, and nutrient-rich environment that is conducive to microbial colonisation and proliferation. Consequently, the use of antimicrobial agents is important in wound management.

Inappropriate use of antimicrobials, however, creates an environment for resistance against the currently available antimicrobial products. This may have supported cases of non-use, where antimicrobials could have supported more efficient treatment of the infection and decreased the risk of complications and death. On the opposite side, over-use of antimicrobial agents is a well-known general problem contributing to the development of antimicrobial resistance, as well as an ineffective use of health care resources (16).

At present, there is a lack of a consistent approach to defining, evaluating, and measuring the appropriate and adequate use of antimicrobials locally/topically in wound management. This represents a challenge with regards to ensuring effective wound management.

These problems are outlined in a recently published document by the European Wound Management Association (EWMA): Antimicrobials and Non-healing Wounds (17). To further support the antimicrobial resistance agenda at implementation level, EWMA is currently launching a European Antimicrobial Stewardship Programme which aims to reduce inappropriate use of antimicrobials by promoting, facilitating and teaching good antimicrobial practice in wound management.

Conclusion Non-healing wounds are one of the most frequent problems in health care across Europe, concerning a large number of medical specialties and professions.

The consequent implementation of existing treatment guidelines by an interdisciplinary and multidisciplinary team would help to reduce the suffering of those afflicted with such a wound, as well as reduce the economical burden that non-healing wounds represent.

1

2

The European Commission within the Public Health Programme co-funded and supported the establishment of The European Union Network for Patient Safety and Quality of Care, PaSQ Joint Action, http://www.pasq.eu/ http://ewma.org/english/ewma-activities/advocacy-activities.html (Visited June 2015)

References 1. Dale, J.J., et al., Chronic ulcers of the leg: a study of prevalence in a Scottish community. Health Bull (Edinb), 1983. 41(6): p. 310-4.

2. Posnett, J., et al., The resource impact of wounds on health-care providers in Europe. J Wound Care, 2009.

18(4): p. 154-161.

3. Hjort, A. and F. Gottrup, Cost of wound treatment to increase significantly in Denmark over the next decade.

J Wound Care, 2010. 19(5): p. 173-84.

4. Gottrup, F., A specialized wound-healing center concepts: importance of a multidisciplinary department structure and surgical treatment facilities in the treatment of chronic wounds. Am J Surg, 2004. 187: p. 38-43.

5. Probst S. Seppänen S., Gethin G et.al. EWMA Document: Home Care – Wound Care, J. Wound Care 2014; 23 (5 Suppl.): S1-S44.

6. Holland, R., Battersby, J., Harvey, I., et al., Systematic review of multidisciplinary interventions in heart failure.

Heart 2005; 91: 899-906.

7. Larsson, J., Apelqvist, J., Agardh, C.D., et al., Decreasing incidence of major amputation in diabetic patients: a consequence of a multidisciplinary foot care team approach? Diabet Med 1995; 12: 9, 770-6.

8. Moore, Z., Butcher, G., Corbett, L. Q., McGuiness, W., Snyder, R. J., van Acker, K. AAWC, AWMA, EWMA Position Paper: Managing Wounds as a Team. J Wound Care 2014; 23 (5 suppl.): S1-S38.

9. Moore Z, eHealth in Wound Care – overview and key issues to consider before implementation, J Wound Care, 2015, 24, 5 S1-S44 10. Quinn EM, Corrigan MA, O’Mullane J, Murphy D, Lehane EA, Leahy-Warren P, et al. Clinical unity and community empowerment: the use of smartphone technology to empower community management of chronic venous ulcers through the support of a tertiary unit. PloS one. 2013;8(11):e78786.

11. IWGDF Guidance on the management and prevention of foot problems in diabetes, 2015, http://iwgdf.org/ guidelines/ (Visited June 2015) 12. Prevention and treatment of pressure ulcers: Clinical Practice Guideline, Developed by the National Pressure Ulcer Advisory Panel (NPUAP), European Pressure Ulcer Advisory Panel (EPUAP) and Pan Pacific Pressure Injury Alliance (PPPIA), 2014, http://international-pressure-ulcer-guidelines.myshopify.com/pages/frontpage (Visited June 2015) 13. Management of chronic venous leg ulcers . A national clinical guideline, Published by SIGN (Scottish Intercollegiate Guidelines Network), August 2010, http://www. sign.ac.uk/pdf/sign120.pdf (Visited June 2015) 14. Moore Z, Cowman S and conroy R M, A randomised controlled clinical trial of repositioning, using the 30 tilt, for the prevention of pressure ulcers. J Clin Nurs, 2011. 20(17-18): pp 2633-2644 15. REPORT on the report from the Commission to the Council on the basis of Member States’ reports on the implementation of the Council Recommendation (2009/C 151/01) on patient safety, including the prevention and control of healthcareassociated infections (2013/2022(INI)) 16. Gottrup F, Wound certainties and Subtleties. Present problems in the use of local antimicrobial agents in non-healing wounds, European Medical Hygiene (EMH), February 2014 17. Gottrup, F., et al., EWMA Document: Antimicrobials and Non-healing Wounds - Evidence, Controversies and Suggestions. J Wound Care, 2013. 22((5 suppl.)): p.

1-92.

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Gabriel Wikström has been the Minister for Health Care, Public Health and Sport for the Swedish Social Democratic Party, Government of Sweden since 2014.

He was born in 1985 and lives in Västerås.

He has studied Political science and Economics at Uppsala University which helped to begin his political career in Swedish Social Democratic Youth League in Västmanland County in 2006, prior to which he was a substitute teacher.

the WHO Global Action Plan to Combat

Antimicrobial

Resistance 18 | ghp July 2015

public health Gabriel Wikström, Minister for Health Care, Public Health and Sport for the Swedish Social Democratic Party, recently spoke about Antibiotic Resistance within his speech that was held in Uppsala. Also discussing the global health care systems and innovation.

“Every year AMR (Antimicrobial resistance) already kills half a million people worldwide. The costs, in human and in financial terms are already huge. A heavy price for poorer countries who can least afford it.”

“We are heading back to before Lister and Pasteur.

Back to when infection was a routine killer. Because of ignorance, but also because of convenience, laziness, perverse financial incentives and sheer bad luck.” Here Wikström throws accusation at first world countries that, despite their advanced knowledge, still don’t use systems which could prevent hundreds of hospitalisations.

“Sweden fully supports a strong WHO. It seems self-evident that only a strong World Health Organisation can deal with global threats to health. An organisation that must, and will adapt and evolve. And an organisation that will support Member States in building strong and resilient health systems. Because without such health systems worldwide, as Ebola taught us, we simply cannot fight global health threats like AMR.” Wikström outlined how the representatives of different sections of healthcare had to come together to help in the fight against AMR. “You also represent very different stakeholders. Which makes your own experience and your own perspectives of the greatest value to us all. Because for the Global Action Plan to work – to work with the many complex challenges AMR involves worldwide – will involve collectively, and worldwide, all our efforts.”

Wikström also highlighted that this campaign was not restricted to Sweden, “globally, how can we best approach tackling the differences in situations and needs worldwide?”

While we are speaking on the vital importance of strong health systems at the World Health Assembly (WHA), Genève, Gabriel spoke about what happens with weak and fragile health systems, such as the medical staff and victims of Ebola in Liberia, or Guinea, or Sierra Leone. He stated that, “This is why building systems in every country, that will work when really needed, must be at the very centre of our attention, for both the WHO, and for all of us member states.

As far as bacteria and viruses are concerned, there are no borders. Instead we are left with humans whom have weaknesses to identify, explore, and exploit.

Therefore we simply must have a strong World Health Organisation that adapts and evolves. We also need to ensure that we have a WHO that supports member states so that they can build and sustain strong and resilient health systems. Also a WHO that has the capacity to act at both global and local levels.

To get to this stage, we cannot abandon overwhelmed nations with fragile health systems. This also means that we cannot leave global health security to private organisations with limited resources. Inevitably, we cannot tie strings to our funding and turn our backs.”

The WHO must learn from past mistakes, just as it must be the WHO that leads and coordinates in global health. He also highlighted that one of the main points

that he was trying to get across in this speech was that, “We must never forget that any success or failure of the WHO is a shared responsibility. A responsibility for us all, every member state, as well as the Secretariat. So failure in the eyes of patients and relatives, or medical staff caught up in the brutal realities of Ebola, or the global spread of AMR, is our failure. Any lack of trust, or confidence, or determination is also ours. The WHO is simply a mirror of our individual - as well as our collective efforts. Perhaps the greatest threat to future global health is not a lack of knowledge, but neglecting to act on what we know. So for the WHO to succeed we need to focus a little more on what WHO reflects of ourselves. When this assembly adopts the Global Action Plan on AMR we are showing the world that we Member States take this problem seriously and are prepared to act. No action today - no cure tomorrow. So I hope that this session will also reflect on what we need to see about ourselves, s individuals, as member states, and together. What can we really do, and on what we really must do? This should inevitable allow us to have the WHO that the world needs.”

Finally, in another speech, this time in Stockholm 2014, Gabriel’s reference to Alexander Fleming’s message of warning opens the speech on a grave note, setting the tone of what he terms ‘the sombre issues’ on which he is speaking.

“The determination to muster enough common action.

For the hope we might still avoid the worst - a post-antibiotic dark age.”

“Apocalyptic tone appropriate to the vastness of the idea that all infections could eventually be resistant to all antibiotics. Which is why tackling antimicrobial resistance, and above all antibiotic resistance has been a priority for Sweden for many years. This is not just a priority for me as the minister for public health and health care. It is a priority for the whole Swedish government.”

Wikström emphasised the scale importance which is placed on the issue. “Just spreading information is not going to be enough. Even if every doctor knew the risks. Even if every patient knew the risks. It still would not be enough.” Here Wikström highlighted the need for research and the issue that this is not preventable merely at individual level- is a larger problem.

“In human terms, in facing sickness and suffering, how can we lay the responsibility for these stark choices on the shoulders and heart of just one individual? On a patient? Or on a parent? Or even on a doctor? After all, the individual did not create the problem – the reason for these hard choices. The problem is systematic. The problem is structural.” Wikström makes a passionate case for the revaluation of global health practises using the emotive example of individual challenges. To solve a structural problem, we need common structures and common guidelines, “So the WHO Global Action Plan to combat antimicrobial resistance will be absolutely key.

The key to our common international efforts. So it is therefore crucial we all support WHO in its work to fully develop and implement the Global Action Plan. Today, as we all know, we do not have a global programme to collect that data for AMR surveillance.”

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Diabetes Innovation

20 | ghp July 2015

industry insight Dr Gunnar Sandström and his Programme Committee at the Huddinge Department of Laboratory Medicine Division of Clinical Microbiology at the Karolinska Institutet and Karolinska University Hospital have been investigating BioCool, a medicated foot bath which offers relief from mild foot problems. The results of these studies could have vast implications for the treatment diabetes sufferers.

Dr Sandström’s research has proved that Biocool has improved the active daily life of patients with both minor and more server foot problems, including many of those which often affect diabetic patients. The tests were carried out on a non-randomised selection of patients from a regular office practice, all of whom had onychomycosis covering 60% or more of the nail bed of the great toes.

The product is a powder which, when dissolved in water and used to bathe feet, can considerably reduce the impact of various types of foot fungus, as well as improving the integrity of the skin.

BioCool was found to kill Trichophyton rubrum, which is one of the most common causes of athlete’s foot.

This was tested on both patients as well as in a lab experiment which showed that when a piece of the fungus was placed in 1ml of Biocool at room temperature no growth was recorded in the fungus spores.

The fungus was found to be dead within one to three hours of the application of the Biocool.

Patients suffering from warts on their feet also saw a significant improvement when treated with Biocool and those with onychomycosis, a fungal nail infection, also saw dramatic improvements under the same treatment.

These results have vast implications for the treatment of these fungi in diabetic patients. Whilst previously these treatments have been thought to be cosmetic and trivial because of the unsightly growths which these fungi often produce, these minor issues in diabetics can quickly escalate and cause bacterial infections as well as more serious foot injuries. They can also lead to more serious blood born infections.

Due to problems with the nerves and circulation to the feet, diabetics are often more prone to mild foot problems which are not direct symptoms of the condition, but which are increased because of reduced circulation in the feet and nerve issues caused by diabetes.

Often these problems are caused by other symptoms of diabetes, such as calluses and corns which may develop due to abnormal alignment of the feet or abnormal gait and hammertoes, or bent toes which are often caused by muscle weakness. Other issues include tinea pedis, or athlete’s foot, bunions and ingrown toenails.

There are also more serious, life-threatening implications of these foot problems for diabetes, such as the development of ulcers caused by a combination of decreased sensation and reduced blood flow to the feet. If these

ulcers remain starved of oxygen then tissue death, also known as gangrene, can occur, which is potentially fatal.

Other potentially serious problems that may develop include cellulitis and osteomyelitis; sepsis is also possible.

The results of this research could reduce the suffering and infection rate in many patients suffering from diabetes who develop such foot problems. The use of Biocool to treat these infections could improve the daily lives of diabetic patients and could also reduce the risk of bacterial infections and further, more serious foot problems developing out of the smaller infections.

The study also found that the skin on sufferer’s feet was generally left in an improved condition after the prolonged use of Biocool, which could help diabetes patients to stave off repeat infections and improve the overall health of their skin. The fungal pathogen which causes Trichophyton rubrum is currently poorly understood which means that sufferers often experience other dermatological problems such as various forms of dermatophytosis alongside it, which can be improved by the use of Biocool.

Affected areas, including infected nails, show a marked improvement when treated with Biocool which will help diabetics to reduce the rate of infection in their feet and to help them to contain the infection before it spreads to further nails or other areas of their feet. It could also reduce the risk of more serious foot problems in diabetics which could potentially lead to the loss of feet in sufferers of the disease.

There are already several systemic antifungal treatments available for these infections but they are often accompanied by side-effects which include headaches, itching, loss of sensation of taste, gastrointestinal symptoms, rashes, fatigue and abnormal liver function which could all cause serious harm to diabetic patients. Also the slow growth of the nails often means that even after successful treatment using systemic antifungal treatments the nail does not return to its usual appearance.

Therefore, Dr Sandström and his team’s study will have broad ramifications for the treatment of foot infections in diabetes sufferers and could potentially go further, with the findings suggesting that ingredients from Biocool could be isolated to harness their healing capabilities to help diabetes patients repel other forms of fungal infection. In addition, the uses of this cream could be expanded upon to include other skin problems which could improve the lives of both diabetes sufferers and those without the disease.

ghp July 2015 | 21

Nordic Life Science Days The Waterfront Convention Center in Stockholm, Sweden will proudly play host to some of the world’s most innovative biotech, medtech and pharma companies in September of this year.

22 | ghp July 2015

industry insight The Nordic Life Science Days, the largest Nordic partnering event within the global Life Science industry, will bring together the top talents in Life Sciences, offering amazing net-working and partnering opportunities, providing inputs and content on the most recent trends to industry insiders, set within the beautiful surrounding of Stockholm city.

The event garners attention from key players in the Life Sciences sector, not only from biotech, pharma and medtech but also from finances, research, policy and regulatory authorities making it a varied and engaging conference.

Hosting this prestigious event will be Bionordic, an international firm specialising in Life Science event planning and SwedenBIO, the Swedish Life Science industry organization, alongside co-hosts ScanBalt BioRegion, Swedish Medtech and LIF, the research-based pharmaceutical industry organisation. The hosts predict, using attendance of previous Nordic Life Science days as a guide, that this year’s event will attract as many as 1000 or more international delegates.

The 2015 conference will involve a new and interactive design which will allow visitors more connection to those exhibiting as well as a new Company Presentation format which enriches the experience for both the presenter and the viewer.

There will also be new partnering areas which will allow privacy and comfort for those engaging in discussions. This is linked to the event’s adoption of the partneringONE (EBD Group) software, which enables users to prepare for partnering with another firm six weeks before the event, then select and schedule partnering meetings with registered companies. Once the user has imputed details such as when they are available for meetings and created a profile of themselves, they are able to accept or decline invitations or send their own. After that the software takes care of all the scheduling and arranging, as well as making your own personalised schedule so the user is able to easily access information about their meetings. There are also helpful tutorials available for participants new to partnering. Last year’s event saw 1,600 successful scheduled face-to-face meetings.

In addition to this there will also be numerous networking opportunities, allowing both companies and individuals the chance to expand their industry connections. As well as offering a central networking area the event also hosts an Official Networking Reception followed by a downtown special event which will offer the opportunity for participants to meet in relaxed, informal environment.

‘Super Sessions’, which include: ‘Rare Diseases Development trends and strategies of orphan drugs’; ‘The Baltic Sea Region as one test site for the development of health care products and services’; ‘The Future Health: New Players and New Possibilities in the Digital Era’ and ‘Nordic Stars Awards and Nordic Life Science Landscape’. There is a session for everyone, with widely varied topics designed to stimulate discussion and debate.

Workshops are also being held allowing visitors a more in-depth look at specific sectors and to learn new ideas and theories from a group of experts in an interactive, informal setting.

These sessions will be a key opportunity for visitors to the Nordic Life Science days to learn about the latest trends and success stories during sessions focused on specific sessions including research and development, business development and investment. There will also be the chance to connect to key executives speaking at the event, which will allow a participants greater participation in the conference.

70+ Companies are also given the opportunity to present at the conference, with a variety of engaging and thought-provoking discussions. The firms will pitch products and services and give an insight into their company practises during their presentations. See the final presenters list on www.nlsdays.com/presenters.

Specially selected candidates will also have the opportunity to showcase their knowledge and display their newest projects, as well as get an immediate feedback during a six or twelve minute presentation, providing the audience with deeper insight in to the vital work going on throughout their industry.

An intense and vivid exhibition entitled ‘The Life Science Value Chain’ will run through the centre of the main networking area, showcasing the work of many companies and allowing visitors to view the firm’s technologies, regions, companies and services. The exhibition will feature both regional and country pavilions (clusters and bioregions), allowing companies from around the world the opportunity to showcase their work.

The event will run between 9th and 10th of September 2015 at the picturesque Waterfront Convention Center Stockholm, Sweden.

Contact: Olivier Duchamp Managing Director NLSDays CEO, Bionordic Services olivier.duchamp@bionordic.com

There is a plethora of speakers from around the globe, with confirmed speakers including Dr. Stefan Simianer, Senior Director International Clinical Development AbbVie, USA, Dr. Timothy Fisher, Director, Search and Evaluation, BMS, USA, Dr. Olaf Ritzeler R&D Partnership Director, Strategy, Science Policy & External Innovation, Sanofi, Ms. Wills Hugues-Wilson, SVP, Chief Patient Access Officer SOBI, USA, Mr. David Phillips, VP and Partner, SROne GSK Corporate Venture, UK. Global Life Science companies including AstraZeneca, MSD, Pfizer, Sanofi, and Johnson and Johnson.

The program includes a number of interestingly titled

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BREXIT: Implications for the Life Sciences Industry

24 | ghp July 2015

industry insight Andrew Skipper, Partner, and Jane Summerfield, Senior Associate at Hogan Lovells discuss how the potential British exit from the euro could affect the life science industry.

The life sciences industry, comprising pharmaceuticals, medical technology and medical biotechnology, is one of the UK’s leading manufacturing sectors, employing in the region of 90,000 people and with exports of pharmaceuticals alone valued at over £21 billion.

If the UK were to leave the EU, a so-called ‘Brexit’, it could result in disruption to supply chains, additional quality control testing, new export charges and uncertainty regarding elements of the regulatory regime going forward, such as the validity of crucial EU regulatory authorisations.

The UK currently has amongst the lowest prices for medicines in the EU. Any increase in the complexity of ensuring regulatory compliance and/or additional charges to export products to the EU would likely impact on the UK industry’s competitiveness.

The life sciences industry is highly regulated and the rules for clinical trials and the authorisation, manufacture, distribution, supply, labelling and advertising of medicinal products and the classification, assessment and CE marking of medical devices are (in most part) harmonised at EU level. The UK legal framework governing medicines and medical devices derives from EU legislation. Some EU legislation is directly effective in the UK, while other legal instruments are implemented in the UK by national legislation, such as the Human Medicines Regulations 2012 and the Medical Devices Regulations 2002. If the UK were to leave the EU, there would be uncertainty as to the application of key parts of regulatory regime governing medicines and medical devices going forward.

Taking the specific example of centrally authorised medicines, currently such products are assessed at EU level by the European Medicines Agency (“EMA”) (which is based in the UK) and are granted a single marketing authorisation which allows that product to be placed on the market throughout the EU/EEA. A complete Brexit and EEA would mean that EU legislation would no longer apply directly, potentially meaning that such products could no longer, at least technically, be legally marketed in the UK until a national authorisation had been granted.

The UK regulator, the Medicines and Healthcare products Regulatory Agency (“MHRA”) currently plays a major role in EU regulatory activities, taking a lead role in approximately 15% of applications via the centralised procedure and is the Reference Member State leading the assessment in the decentralised procedure in over 40% of cases. The ability of the MHRA to remain in this role would also depend on the exact outcome of any Brexit.

In the medical devices sector, once products are assessed and certified as complying with EU medical device legislation requirements and CE marked, they

can be sold freely throughout the EEA. Again, if the UK were to leave the EU, it might no longer be automatically possible to sell a CE marked device in the UK. Even if issues such as these could be resolved relatively quickly, longer term questions as to the UK’s continuing relationship with the EU and the interplay between the UK and EU regulatory regimes for medicines and medical devices would need to be addressed.

One option would be for UK to retain its membership of the EEA and follow the examples of Norway, Iceland and Lichtenstein, which are members of the EEA but not the EU. As a condition of the EEA Agreement, the EEA countries have adopted the complete body of EU legislation on medicinal products and are parties to the associated EU procedures. So, for the UK, this would involve agreeing to continue to implement EU legislation in this area and an ability to comment on the development of new EU legislation, though perhaps without the same negotiating strength as at present.

Alternatively, the UK could decide not to be part of the EEA and instead agree a trade deal with the EU. Switzerland has taken this approach and issues separate Swiss marketing authorisations for medicines, based on national requirements that closely mirror EU legislation. In relation to medical devices, Switzerland has transposed the EU Medical Devices Directives into its national law, allowing the free movement of CE marked medical devices in Switzerland. There are also mutual recognition agreements in place between the EU and countries such as Australia, Canada and New Zealand, covering issues such as the recognition of the outcomes of GMP inspections carried out in each country and acceptance of batch certificates without additional control inspections on import.

However, this would likely include conditions such as adhering to the EU’s regulatory regime in all material respects, meaning the UK could agree to continue to comply with EU regulatory requirements but no longer have the same ability to influence these as it does at present. Currently, the MHRA plays an active role in the development of EU pharmaceutical and medical device regulation.

A further option is that the UK might start to develop its regulatory regime separately from that of the EU. Any resulting increase in regulation could be burdensome for businesses. Any decrease in legislation would need to be considered carefully in a sector where safety and quality are paramount, particularly given that the current EU regulatory framework for medicines and medical device is regarded as one of the most comprehensive and sophisticated in the world. Any divergence between the UK and EU regulatory requirements would almost certainly increase compliance costs for companies operating across markets.

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NHS Discharge System Needs Remodelling 26 | ghp July 2015

public health Report from Healthwatch England shows that 2012 to 2013 there were over 1 million emergency readmissions within 30 days of discharge, costing the service an estimated £2.4 billion.

The report indicated that the most vulnerable patients, such as the elderly, the homeless and those with mental health problems, were most at risk because of the health service’s poor discharge policy.

Many of the 3,495 people surveyed in a recent YouGov report cited by the Healthwatch study were often left feeling adrift after leaving hospital, with 12% stating that they did not feel they were able to cope in their own home after being discharged from hospital and 24% saying they did not feel their friend or relative was able to cope following their discharge.

The report also discussed the issue with 120 NHS healthcare trusts, finding that almost all had a discharge checklist but less than half check whether people have a safe home/place to go when discharged, or whether there are necessities such as food, water and heating.

The report also found that one in three trusts do not ensure notes about new medication are properly recorded and passed on to GPs or carers and one in ten do not routinely notify relatives and carers that someone has been discharged.

There was also a lack of support and information available for these penitents with 14% telling the survey that they did not know who to contact for further help following treatment and 18% of people feeling that their friend or relative did not know who to contact.

However these issues were doubles created by the confusion caused by the fact that the report established that the trusts used a variety of guidance from around 57 different documents, highlighting the need for standardised discharge guidelines for NHS trusts which are regularly updated and provided to staff.

In addition to this 18% of people who have been discharged from hospital in the last three years did not feel they received all the social care support they required after leaving hospital and 26% feeling the same way about a friend or relative’s post discharge care.

Anecdotal evidence was collated within the report to provide an understanding of the effect these issues have on the patients who experience them, with many respondents to the survey offering accounts of poor care from the system and providing examples to reinforce the data collated within the report.

The issues were even evident prior to the patient’s discharge, with 21% of those surveyed declaring that they did not feel they were fully involved in decisions concerning hospital treatment and planning discharge, with a similar proportion, 22% feeling their friend or relative was not fully involved as an equal partner in their care and discharge.

Estimates on the financial impact of the problems highlighted within the report put the cost of the emergency readmissions caused by the poor discharges practises at around £2.4 billion a year, making change to these systems a vital aspect of improving patient care, as it will improve both their wellbeing and the financial status of the health service.

Participants in the Healthwatch England report defined several key reasons why their care was inadequate, notably a chaotic atmosphere in the hospitals with many patients experiencing delays and a lack of co-ordination between different services. This lead to patients feeling left without the services and support they need after discharge.

The results were not entirely negative with the report showcasing examples of hospices, charities and initive which aim to provide a better standard of healthcare to patients, particularly the most vulnerable.

These issues are structural problems within the service which could be resolved with the application of more funding and greater communication links being established between different departments.

However, there were also a number of issues identified by respondents to the survey which would require further training for staff, as well as instilling a greater atmosphere of respect throughout the service, as some of the patients who participated in the report stated that they felt stigmatised and discriminated against and that they are not treated with appropriate respect because of their conditions and circumstances. Some also felt that their full range of needs is not considered.

Overall Healthwatch England were keen not to offer recommendations on change but instead highlighting the issues and presenting the health service with a challenge. The aim of the report by the consumer champion for health and social care was to ensure that these issues were noticed by the authorities within the service to help improve care for vulnerable patients.

The widespread issues identified by the report will require resolving if the service is ever to attain any sort of patient satisfaction. With constant threats to the service as the government constantly cuts the money to pay for the NHS, managers within the trusts need to work on fixing these problems for the sake of their patients.

The report could potentially be utilised within the private sector of healthcare also, with a view to improving patient care and discharge services across the board.

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New Funding Gives Boost to the Ontario Institute for Regenerative Medicine Government’s combined investment of $209 million offers vital rejuvenation to research groups.

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research The money will support scientific research and commercialization within the Ontario Institute for Regenerative Medicine (OIRM), which operates across the province with four primary institutions: University of Toronto; McMaster University in Hamilton; Western University in London, Ontario and the University of Ottawa in Ottawa. The Institute was formally announced in November 2014.

The primary focus of the research is the use of stem cells in regenerative medicine. The grants will be particularly vital to ensuring that Ontario is a leader in the development and commercialization of stem cell products and therapies, with a combined goal to take science into the clinic and to further enhance an associated regenerative medicine industry.

The Centre for Commercialisation of Regenerative Medicine (CCRM), the institute’s commercialisation partner, will use a proportion of the funding to strengthen their partnerships with industries worldwide who are interested in exploring the potential for stem cells as therapeutics and as a means of testing drugs. CCRM will continue to enhance their industry-facing platforms which help attract more of the regenerative medicine industry into Ontario to work with the institute as well as bringing clinical trials to Ontario.

The money will also provide catalyst funds for disease teams, with a focus on projects that will provide real breakthroughs in regenerative medicine. Dr Janet Rossant, the Executive Director of the OIRM believes that cardiac, diabetes, vision and arthritis will all be key areas of research over the coming years.

Breakthroughs are key to the future of the research, therefore the institute will also use some of the governmental investment to provide small new ideas grant which enable researchers to bring new and innovative ideas to the table.

The projects will be thoroughly scrutinised by Canadian and international academic and industry experts, with the successful research teams needing to demonstrate progress annually in order to receive continued funding.

have had a heart attack to see if they could prevent the of damage that traditionally occurs after such an illness. The future goal is not just to prevent the damage but to repair the damage, with the institute keen to move forward with the generation of new heart cells from stem cells.

Many different types of stem cells have the capacity for self-renewal and repair, so the OIRM encourages their disease teams to explore stem cell based treatments in many innovative ways with the goal of providing breakthrough treatments in areas of unmet medical need.

Translational research is a key aspect of the institute’s approach to innovation, with a focus on moving cell therapies towards clinical trials, with commercialization of discoveries and tools generating economic opportunities and enhancing clinical activities Partnerships also play vital roles in accumulating further funding for the research, with the institute using discoveries and new ideas garnered via their studies to partner with health charities that offer funding in the area linked with these discoveries, as well as with various institutions, philanthropy and other agencies, which provide focused project based funds.

Overall, the funding ensures the continuation of vital and extraordinary research with implications for all aspects of healthcare. The work conducted by the institute impacts on all sectors of the global healthcare industry, from pharmaceuticals through to healthcare providers. Dr Rossant added a final comment on the impact of the funding.

“We are very pleased by the support of the government of Ontario for the Ontario Institute for Regenerative Medicine. It recognises that this is a fundamentally important and exciting area of research with huge clinical and commercial impact. It also recognises that Ontario and Canada have always been leaders in stem cell research and that we are poised to continue to keep that leadership role. At the same time we are also open and excited about partnering internationally to achieve the goal of treating and curing disease with new regenerative medicine therapies .”

Reza Moridi, Minister of Research and Innovation, made it clear that the funding was a key investment for the government, with the quality of the research and the institute’s leadership in the field enabling prosperity in other areas.

“Our capacity to compete globally depends on how well we can harness our research, innovation and entrepreneurial strengths. Through these investments, Ontario is mobilizing and preparing our researchers to succeed, compete and create the jobs of the future.”

Stem cell research and regenerative medicine is a very fast-moving area, because the potential of stem cells to provide a renewable resource of cells to treat many kinds of diseases.

A key example of this is the institute’s research into the use of stem cells to repair heart, with several groups currently looking at the ability to take stem cells and use them to actually repair damaged hearts. Current and planned trials in Ontario use a variety of types of stem cells to treat patients who

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Organ Issue

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public health NHS reports that for the first time in over a decade the number of deceased organ donors has dropped, leaving services stretched with demand still high.

The Organ Donation and Transplantation Activity Report 2014/ 2015 shows that the number of transplants has decreased from 4,655 in 2013/ 2014 to 4,431 in 2014/ 2015, representing a 5% decrease on last year.

These figures means that 224 fewer people received an organ transplant. The number of people donating their organs has fallen for the first time in over 11 years despite 4,431 people in the UK having had their lives saved or improved by an organ transplant in 2014/ 2015.

Of the transplants carried out, 1,092 were made possible by living donors who gave a kidney or part of their liver, while 3,339 patients benefitted from organs donated after death. The NHS relies heavily on organs provided by deceased donors because there is a wider variety of organs which can be harvested as they are no longer required, whereas living donors can only spare a limited number of organs.

The reason for these poor results was twofold. Firstly, fewer people died in circumstances where they could donate last year, with potential donors being at 8,157 in 2013/ 2014 compared to 7,450 in 2014/ 2015.

This represented a decrease of 8.7%.

Secondly there has been no improvement in the consent/ authorisation rate, which remains below 60% despite targeted campaigns by various charities and the NHS to encourage people to sign up the organ donation service. This includes a launched a seven year organ donation and transplantation strategy launched in 2003 by the UK Governments and NHS Blood and Transplant.

Although the first of these two issues is unavoidable, the second is a real problem which affects the health service and could potentially be combated by greater education and a reduction in the stigma around discussing organ donation with friends and relatives.

NHS Blood and Transplant, the organisation that published the report and leads organ donation across the UK, is calling for everyone in the UK to discuss organ donation and decide what they would do if called on to donate. If there are fewer potential donors then gaining consent/authorisation from everyone is even more important. The trust is keen to emphasise that unless there is a change in attitudes to organ donation people waiting for a transplant will continue to die needlessly.

of ten families said yes when their loved one’s decision to donate was known, for example either via the NHS Organ Donor Register or via a previous discussion with them about organ donation. But even when their decision to donate was known, 120 families felt unable to honour their loved one’s decision to donate.

Sally Johnson, NHS Blood and Transplant’s Director of Organ Donation and Transplantation, stated that the findings indicate that the drop in figures was putting a huge strain on the service, as well as drastically affecting patients.

‘We are truly grateful to the families of the 1,282 deceased donors and to each of the 1,092 living donors who made transplants possible last year. Their donations allowed over 4,400 people to get the organ transplant they’ve been waiting for to save or vastly improve their lives.

We have always known that because the opportunities to donate are so small, it is essential to increase the number of people who say yes to organ donation. If the pool of potential donors is reduced then this is even more important.’

She continued: ‘We understand that families are expected to consider donation in their darkest hour. So we would remind everyone to tell those closest to you now if you want to donate your organs - and then record that decision on the NHS Organ Donor Register.

Should the time come, your family will know you want to donate your organs to help to save others.

The decreases we can see across all types of organ transplant will lead to more deaths if we do not reverse this trend going forward. We know there is a combination of reasons for the decreases, but we cannot hope to save more lives unless UK citizens talk about organ donation with their families and agree to donate if ever they are asked.’

The lack of NHS organs for donation has ramification across the healthcare industry, with private clinics also struggling with demand, as the NHS has priority over donated organs and therefore the reduction in donations affects them as well.

Firms which deal in aftercare products for such procedures will also see a limited demand for their products if this decline continues.

The report has indicated that discussion is key to improving these figures, with the statistics published in the report stating that families are much more likely to agree to donation going ahead if they know it is what their loved one wanted. Last year, nearly nine out

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industry insight

Seven years on: 3 Ways Project Finance has Changed Since the Financial Crisis David Rose, Head of Advisory at Operis, outlines how the market has evolved.

It’s been over seven years since the financial crisis reared and shook all aspects of global finance. Like many sectors, the project finance industry is still feeling the ramifications to this day.

In the years since the crisis, international banks have relinquished their status as the de-facto source of funding for PPP projects, which created an opening for many alternative providers. But what are the other major shifts the project finance industry has experienced since the financial crisis?

1. Moving from an underwriting and syndicating model to club deals One of the most notable changes has been the change from a large scale underwriting and syndicating model towards club deals.

Before 2008, most major project finance deals were funded by leading investment banks who had the resources and balance sheet to underwrite the entirety of the needed debt and would then syndicate the loan by selling smaller participations to other parties.

Bankers were confident in their ability to price risk and make a profit on parcelling out the loan.

Obviously, the large amount of risk this put on the primary lender has become far less attractive post-crisis, and difficult to perform under regulatory rules. Bringing a larger number of funders into deals minimises risk – so in recent years loans have been increasingly funded by larger clubs of banks with each lending a smaller amount of the total.

Working with a large bank club can be challenging for sponsors and advisors on a deal as the due diligence effort is increased to answer more questions and satisfy numerous credit processes and committees.

The size of loans required for larger projects is not the only challenge to banks operating as before. The length of maturity for major infrastructure investments, for example, which can extend past 35 years, is also punishing. Regulation such as Basel III has made it far more capital intensive for banks to extend funds over such long tenors. This has led to increased popularity for unwrapped bonds, where pension funds, asset managers, and insurers can get involved.

The M8 motorway project was one such example of this. At the time (2014), it was the largest project to close under the Scottish Non-Profit Distributing model and involved the completion of an eight mile missing link between Glasgow and Edinburgh.

The £350 million debt package for this project comprised a bond from Allianz Global Investors and an EIB senior loan, making it the first UK roads project involving bond financing since the global financial crisis in 2008.

This is a project where Operis provided model auditing services for the consortium in charge of the project, including a full tax and accounting review for both the bid and financial close stages of the project.

3. The rise of economic infrastructure Over the last five years, the types of deals being sought and funded have also changed. We have seen a trend from investment from ‘social’ investments in schools and hospitals to more economic infrastructure such as transportation or energy projects. This has been a noticeable movement in the UK and Europe, but can often mean very intricate and complicated deals. Road projects are massively disruptive to existing infrastructure during construction and require long timescales to recoup costs and energy projects have to carefully factor the changing price of power.

2. Unwrapping the bond market The decline in banks’ appetite for project finance assets and the downgrading of monoline insurance companies has seen the rise of an unwrapped bond market in the UK and continental Europe.

The rise in these more complicated projects and their associated complex funding structures puts more pressure on lenders to be able to interpret incredibly detailed project models incorporating multiple trends and variables.

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Potential Breakthrough in Treatment of Tendinopathy

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project development CollPlant reports Vergenix STR trial was unqualified success, with 80% of patients tested reporting improved functionality and reduced pain, which could offer relief for millions of sufferers.

Vergenix STR, intended for the treatment of a range of tendon injuries, has had a successful interim clinical trial, offering hope for millions of sufferers and potential ground breaking results for the healthcare industry.

The 20 patient trial in which all patients have now been enrolled and treated, is a prospective, open label, single arm study. The objective of the trial, which is ongoing and being conducted at three leading Israeli hospitals, is to demonstrate the safety and performance of Vergenix™STR in patients suffering from inflammation of the elbow tendon, also known as tennis elbow.

Vergenix™STR, which is intended for the treatment of a range of tendon injuries, incorporates CollPlant’s recombinant human collagen in combination with platelet-rich plasma derived from the patient’s blood.

Following its injection into the injured site, the product transitions from a fluid to a solid phase, whereupon it releases, in a controlled fashion, platelet-derived proteins. These proteins, in combination with collagen, induce the healing effect on the tendon which relieves the symptoms of pain and inflexibility.

All patients will be followed for a total of six months after initial treatment to examine the effects the product has had on their long-term symptoms.

Product performance will be assessed by measuring reduction in pain, recovery of motion in the form of a strength test and a specific patient related tennis elbow questionnaire known as ‘PRTEE’.

Interim clinical results for the first 10 patients who reached their three month follow up, indicate that the vast majority, 80%, of subjects reported improvement in pain and arm functionality, including an increase in arm strength. The Company intends to submit an application for CE Mark approval in Europe during 2015, which would allow the firm to sell the product as a treatment for Tendinopathy.

Tendinopathy is pain and stiffness in the joints which is often a result of overuse. Yehiel Tal, Chief Executive Officer of CollPlant, made it clear that the launch of this product could potentially allow the firm access to a huge market, with sufferers of the condition willing to pay large sums in order to relieve their pain.

CollPlant’s technology is mostly produced using plant-based rhCollagen technology and is specifically developed for the creation and commercialization of tissue repair products, initially aimed at the orthobiologics and advanced wound care markets. Given that CollPlant’s rhCollagen is identical to the type one collagen produced by the human body, it offers significant advantages compared to currently marketed tissue-derived collagen, including improved biofunctionality, superior homogeneity and reduced risk of immune response. CollPlant is also in the process of producing Vergenix™FG, a flowable gel which acts as a wound filler, for treatment of acute and chronic wounds, and Vergenix™BVF, a bone void filler, for use in spinal fusion procedures and trauma.

The results of the new trial will affect healthcare firms who are often used to putting patients through surgery in order to alleviate serious symptoms. In more minor cases the condition is often treated simply using pain killing medication. This new product could offer industry potential for related products or treatment cycles which revolve around the product.

A reduction in surgical procedures used to treat this condition could reduce the costs in the healthcare industry, and the use of natural collagens in the product will doubtless induce a new line of study into the affects this can have on the body’s healing process.

Tendon pains are often the result of sporting injuries, which could potentially lead to a more commercial line for the product. Currently there are numerous gels, pastes and pills designed to help relieve the symptoms of tendinopathy but few which actually have proven results as good as the ones reported by CollPlant.

However, the trials are still in the very early stages and there is still much more still to be done before this is hailed as a true miracle of modern science.

For now, there is much potential for academic interest and commercial healthcare providers will have to wait to find out just how effective the product truly is.

‘Vergenix™STR is a product with unique modeof-action, which enables a focused and effective treatment of tendinopathy. The positive interim trial results reported today, testify to the performance of the product that is directed to a worldwide market currently estimated as a $2 billion total.’

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industry insight

What can doctors learn from bankers?

By Richard Jones, partner at transformation consultancy Moorhouse.

Doctors can learn from bankers? Really? While at first glance banking and healthcare may not seem to have much in common, when you take a closer look the transformational overhaul experienced by banks may have lessons to benefit our frontline health service. The retail banking sector is almost unrecognisable from how it interacted with its customers 20 years ago. Back then, you had a local branch, which you would visit during opening hours to withdraw and deposit money. You would talk to your local bank manager who you would know by name and could trust to discuss your personal financial situation.

Now, you rarely speak to the same person or visit the same branch, if your bank even has branches.

Where once branch banking was the only method available to seek the service you required, technology now enables a completely different approach with phone banking, online banking and mobile apps, to name just a few. So, can the patient and healthcare provider interact in a similar way? And, will this help the NHS budget go further at the same time as delivering higher quality patient care?

The scale of transformation in retail banking has been impressive and this is largely due to market competition driving innovation in service delivery models, as well as the adoption of new technologies as enablers of these new models. This in turn has been driven by customer needs and desires, with the banks that best meet these becoming market leaders. Those not moving with the times have lost customers - or disappeared from the banking landscape. There have also been a number of new entrants – ‘challenger banks’ – that have embraced technology and new operating models as a means to seize share from complacent incumbents.

In comparison, the service delivery model for GP services hasn’t changed for many years – despite the world around it changing at an ever increasing pace. This is causing significant tensions, not least with ‘customer’ expectations of what services should be provided, and how and when they should be accessible. In addition to patient demands, there is also significant political pressure on GPs to provide longer opening hours during the week and to be open over weekends. While this is one part of the answer it is not a panacea for all challenges faced by the health sector.

In the same way that banks have developed products and services to suit the needs and expectations of

different customer groups, the health service can also benefit from segmenting its patients in a similar fashion. By this we mean responding to the different needs and expectations of disparate groups of patients in ways that best meet those needs and expectations. Take these three over-simplified illustrations for how a one-size-fits-all approach may be both unnecessarily costly and unsatisfactory for the patient.

Firstly, a generally healthy middle-aged person with a lingering sore throat may not be inclined to take time off work to spend a morning sitting in their GP’s waiting room; a Skype consultation with a doctor or a visit to a specialist nurse would be more convenient.

Our second example is a child with a sore throat whose parent is likely to be more risk averse, less likely to be content with a phone call and will want to see a doctor in person. And finally, the stereotypical frail elderly person with complex health needs - who may not have spoken with another person all week - is likely to appreciate 30 minutes or so with a doctor. So, while the first two examples may be more transactional, albeit different interactions, the latter sees the GP playing a far broader role and becoming inherently involved with wider well-being matters.

It is right to focus on longer GP opening hours as a means by which patients can access care at times that it’s needed. Indeed, there is a direct correlation between improving access to primary care and a decreasing attendance at A&E units. So, greater access to GPs can benefit the wider health system and add further opportunity to reducing the financial burden on our stretched acute hospitals. However, longer GP opening hours, whilst centrally important, are not the only answer to the question of ‘access’.

There is huge focus on relieving the pressure on A&E units, with some people misusing the service as they can’t (or won’t) see a GP – or they know that they will be seen in four hours rather than four days. Today’s world is one of immediacy; our expectations are set by those industries that enable access 24 hours a day and seven days a week, whether that is to access your bank account and make payments, or to order a book on-line on a Sunday for delivery on Monday.

Those very same expectations are carried through to healthcare – “why can’t I see my GP today?”

There appears to be a broadening acceptance that the traditional ways of providing care are no longer the answer, and that we must put an end to juggling and reallocating resources in order to maintain the

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industry insight status quo. In essence, it is the organisation of care around demand rather than around supply, that will drive innovative care models and new ways of working that ultimately will achieve better results for patients and enable efficiencies to be realised.

While technology is an important enabler both as a channel for providing healthcare, and as a means by which the patient can understand more about how and where they can be cared for, workforce is the most important component of effecting sustainable change. It is in the hands of our precious health service workforce that those who are at their most vulnerable and at their time of greatest need will be cared for.

Generally, people enter patient-facing roles because they want to care for people. If things are going wrong, it is often due to blockages in the system that prevent them from providing this care, such as being overloaded with work or not being able to access the right resources. Technology can help solve these problems but it’s not the place to start. Rather, start with the workforce, empowering doctors, nurses and healthcare leaders to define what they need to best address the care needs of a patient.

For example, there has been success in piloting online portals and regular phone contact between high need patients and NHS staff as means by which a relatively small number of clinicians can care for a large number of patients.

What really makes these initiatives work is not the technology, but the fact that the people assigned to each patient are able to coordinate with different providers, whether that is a community nurse, a GP familiar with the patient’s history or a secondary care provider. Initiatives such as these put the patient at the heart of everything they do, improving quality of care and creating efficiencies in the system. Let’s revisit our frail elderly person who is cared for at home in order to ensure that the right medicines are taken, that they remain nourished and that they can be relatively active. This home care goes a long way to avoiding unnecessary hospital admission where that individual will become far more susceptible to infection, is likely to face mental health challenges, and will experienced a delayed discharge due to the increased complexity of being cared for at home. By organising care around the demands of the individual, that individual can be cared for in a more efficient and high quality manner.

Let’s move on from examples of patient care, and explore the macro-system context. Rather than the top down approach to driving change that has been deployed for many years, there is now an emerging freedom and flexibility in the system which was, in part, triggered by the Health & Social Care Act 2012.

While its critics may point to the resultant unmanageable fragmentation that makes change more challenging, this assumes that the only way things can change is via mandate from the top. The fact that different commissioners, providers and other groups can now collaborate in fluid combinations means that they are better able work in more targeted ways to tackle the many health challenges that do not acknowledge organisational boundaries. There is still some way to go for these new-ish system arrangements to mature and to become fully effective – however, there is the potential for real transformation

driven by those who are closest to the patients and can commission services in the most effective way.

There have also been other nudges to encourage a flexible approach. The Dalton Review 2014 questioned whether foundation trusts continue to be the solution for delivering high-quality acute care and, unusually for the NHS, makes no recommendations for what should be done. Rather, it encourages health leaders to think innovatively about what would work best in their organisation to meet their patients’ needs. By the same token, the Five Year Forward View also encourages different approaches to be explored and leaves it to the leaders of healthcare providers to propose what would work best for their local communities. While this represents a huge cultural change for the NHS, the conditions for social entrepreneurialism are being encouraged and nurtured.

This year NHS England invited applications for a £200m investment programme which seeks to embrace and encourage innovation. Leaders from healthcare organisations were invited to apply to become ‘vanguard’ sites, and 29 across the country were selected to develop new models of integrated services. Critics may point out that investment is being directed towards those organisations that are already performing well, rather than those needing increased support to help them succeed. However, working on the hypothesis that things must change and that those closest to the provision of care know best, this is a great way to discover new ways of working that will be shared with other areas with similar ambitions. It also indicates that the NHS is becoming more accepting of risk. There are of course many different types of risk and no one is suggesting taking risks with patient care. But, by encouraging small pilots that can explore new ways of working the health system is making it clear that it is willing to try new things. Of course not every pilot will be a success and this is part of finding new ways of working. However, for a fraction of the total NHS budget, this must be a sensible way forward. After all, if the system does not invest in change, it will have to invest significantly more to plug performance gaps and to prop up failing health economies. We will watch with interest to see whether the lessons that will be learned from the vanguard experiment can inform a new direction for how care is provided.

As the NHS continues to grapple with huge challenges in the 21st century and works hard to do more with less, there are encouraging signs that the system is moving in the right direction. In much the same way as banking has transformed over the past two decades, the NHS is now asking itself how it can adapt to better meet diverse patient needs and expectations. While technology is an important part of this transformation, the key is to create the conditions for the workforce and the healthcare leaders to put the patient at the heart of everything the system is looking to achieve.

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