GHP October 2015

ghp

October 2015

www.ghp-magazine.com

Research, Translation, Commercialisation

Getting into a

SPIN®

We explore a revolutionary new sales technique for the healthcare industry.

New Technology in Pathology Richard McCann meets Queen Alexandra Hospital’s Colin Walker to discuss the hospital’s use of wireless monitoring and data recording technology.

New Direction in Infection Public Health England looks to raise laboratory standards when dealing with infectious diseases.

Technology in Pharma Sales How technology can future proof pharma sales.

editor’s note

this month’s features

Welcome to the October issue of ghp Magazine.

This month, Tony Hughes, CEO of Huthwaite International, explains Urgo Medical’s revolutionary new sales in healthcare technique.

Richard McCann meets Queen Alexandra Hospital’s Colin Walker and explores how their wireless monitoring and data recording technology is changing the way their pathology department works for the better.

We put the spotlight on the UK health service, showcasing a number of new schemes from Public Health England, Monitor and the NHS. Elsewhere, recruiters are put under the spotlight as we explore what it means to be audit ready and if firms are doing enough and trends in the global healthcare market are outlined by Nooman Haque, Director of Healthcare & Life Sciences for the Silicon Valley Bank UK Branch.

Finally, managing the care of serious brain injuries can be a difficult task, but as we show you, a new partnership between Philips and the Massachusetts Institute of Technology could be about to change that.

We are always happy to hear your feedback, please feel free to get in touch with the editor, Hannah Stevenson: hannah.stevenson@aiglobalmedia.com

Selling Success for the Healthcare Industry – Measurably Two leading companies in their field have worked together to show that better skills create better sales, and have produced conclusive numbers to prove it. Page 08

inside this issue 04 News 08 Selling Success for the Healthcare Industry – Measurably 12 3 Ways That Technology Can Future-Proof The Pharma Sales Force Today 16 Philips and Massachusetts Institute of Technology Team up to Make Managing Brain Injuries Less of a Headache for Doctors and Patients 18 Healthcare recruiters: Are you audit-prepared?

22 Good Laboratory Standards Developed for Dealing with Infectious Diseases 24 Third Quarter Results Show NHS in Need of Funding Certainty 26 Genzyme Introduces “vs.MS” 28 Investigating Wireless Monitoring and Data Recording Technology in Pathology 32 Trends in Healthcare Investments and Exits – a UK Outlook 36 Glossa - Our Company in 60 Seconds

We hope you enjoy this issue.

“Healthcare professionals need fresh ideas and creative insights to ad dress the complex problems they face. They need solutions to problems, not product features.”

Tony Hughes, CEO of Huthwaite International

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

63% of US Healthcare Organisations Failing to Adequately Identify Individual User Access to Patient Data Just 37% of healthcare employees are restricted from logging on to multiple devices concurrently, while 30% do not even have a unique login ID. Concurrent logins, manual logoffs, password sharing and the lack of unique logins are putting patient records at risk, new research has revealed. A report by security software provider IS Decisions found that despite HIPAA’s security rules on imposing restricted access to electronic patient health information, 63% healthcare staff are still able to logon to different devices and workstations concurrently, 49% are required to manually logoff, and 30% do not have unique logins.

The report, ‘Healthcare: data access compliance’, highlights the several issues that have a direct effect to security of information within the healthcare industry. Access to personal data can be life-dependent but there has to be a reliable access management procedure and system in place.

According to the report, 82% have access to patient data, which is worrying considering 30% do not have unique logins for this access, making proper user identification impossible. A surprising 37% are restricted from concurrent access, a requirement given attribution is difficult when users can be logged in from multiple devices and locations.

Derek Brink, vice president and research fellow at Aberdeen Group, said: “This guide is an excellent example of how to simplify compliance. It describes a set of basic security practices for healthcare organisations that will help safeguard sensitive patient data, and satisfy an array of compliance requirements from the Health Insurance Portability and Accountability Act (HIPAA).”

The report also details security training, for both on-boarding new employees and those who have settled into their jobs. It showed that 29% of healthcare professionals did not receive any security

training when they were employed and only 55% of existing employees received IT security training.

The figures around access, logins and password sharing as well as the IT security training shows the need to firstly, implement a good access management system and secondly train staff to raise awareness and build accountability.

David Childers, fellow at Open Compliance & Ethics Group (OCEG), said: “70% of data losses in healthcare are caused by human error. Both Ponemon and Experian in their latest reports regarding data breach and protection challenged healthcare organisations to ‘step up’ their security posture. Not only did these studies cite the increase in breach event activity but noted the likely rise in legal and regulatory scrutiny that will come in 2016.”

Francois Amigorena, CEO of IS Decisions commented, “Unlike an office where employees have designated computers and workstations, doctors and nurses are always on the go, moving from operating theatres to patient rooms and so on. Healthcare organizations need to protect the patient’s right to privacy while ensuring healthcare professionals get the necessary access to provide the best treatment for their patients.

“Information of this critical and confidential nature should only be accessible by authorized users and it really should not be a complicated process. This can be easily achieved with the right combination of implementing access control policies, applying user identity verification and improving user activity auditing.”

4 | ghp October 2015

Jaguar Animal Health Signs Crofelemer Formulation Development and Manufacturing Contract with Patheon Contract secured in preparation for pivotal trial and expected launch of Jaguar’s prescription drug candidate, Canalevia.

Jaguar Animal Health, Inc., an animal health company focused on developing and commercializing first-inclass gastrointestinal products for companion and production animals, announced today that it has signed a crofelemer formulation development and manufacturing contract with Patheon, a leading global provider of drug development and delivery solutions to the global pharmaceutical and biopharma industries. Crofelemer is an active pharmaceutical ingredient (API) in Canalevia™, Jaguar’s prescription drug product candidate for the treatment of various forms of acute diarrhea in dogs.

Under the terms of the contract, Patheon will provide enteric-coated crofelemer tablets for Jaguar for use in animals. The tablets will be used in Jaguar’s pivotal efficacy trial for Canalevia™, scheduled to begin in the fourth quarter of this year. Jaguar expects to use safety and effectiveness data from this trial in support of the initiation of the filing of a new animal drug application (NADA) with the FDA for Canalevia™ in 2016 for the indication of acute diarrhea in dogs. A Jaguar proof-of-concept study completed earlier this year provided statistically significant results indicating that Canalevia™ is superior to a placebo for the treatment of acute diarrhea in dogs.

As Jaguar announced this past August, it has submitted to the FDA all required major technical sections towards a conditional NADA for Canalevia™ for dogs suffering from chemotherapy-induced diarrhea (CID), a minor use in a major species (MUMS). MUMS is an FDA drug designation, similar to the orphan drug designation in humans, which is typically limited to the use of a drug to treat disease that occurs infrequently or in a small number of animals. FDA encourages sponsors to seek MUMS designation and conditional approval of qualifying drugs to address unmet medical needs in the veterinary industry. Jaguar is preparing for the expected commercial launch of Canalevia™ for CID in the first half of 2016.

“Our contract with Patheon is a key component of our carefully-crafted formulation and manufacturing

Crofelemer is isolated and purified from the Croton lechleri tree, which is sustainably harvested by Jaguar.

Jaguar is also developing formulations of Canalevia™ for cats and horses.

Patheon is the manufacturer of Fulyzaq®1, a human-specific, enteric-coated formulation of crofelemer that was approved by the FDA in 2012 for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.

Members of Jaguar’s management team developed crofelemer while working at Napo Pharmaceuticals, Inc. (Napo), where the drug was initially developed.

In 2014 Jaguar entered into a license agreement with Napo which, among other things, assigned to Jaguar Napo’s rights of reference to the information included in the FDA-approved human new drug application of crofelemer to support Jaguar’s regulatory submissions for global veterinary purposes.

ghp October 2015 | 5

plan for Canalevia™,” stated Lisa Conte, Jaguar’s president and CEO. “The Chemistry, Manufacturing and Controls section of our NADA for Canalevia™ for CID leverages the fact that we will be utilizing the same cGMP-compliant manufacturers that produce the crofelemer product approved for human use, and we plan to take the same approach with our Canalevia™ NADA for acute canine diarrhea. This plan was discussed during our meeting with the FDA’s Center for Veterinary Medicine earlier this year.”

The Company announced last month that it recently signed a manufacturing and supply agreement with a leading, India-based pharmaceutical company, and Jaguar intends to use this firm as its primary manufacturer of the crofelemer API for animal health use.

news

Caribou Biosciences and DuPont Announce Strategic Alliance Caribou Biosciences and DuPont have jointly announced that they have formed a strategic alliance designed to advance the two companies’ respective CRISPR-derived genome editing technology platforms.

This multi-faceted agreement includes the cross-licensing of key intellectual property, a research collaboration, and financial investments by DuPont in Caribou, a developer of CRISPR-Cas technologies.

“DuPont has been responsible for numerous breakthroughs in CRISPR biology and has amassed an impressive array of expertise developing and applying genome editing technologies in promising commercial areas” Under the terms of the collaboration and license agreement, Caribou and DuPont have engaged in cross-licensing of their CRISPR-Cas-based intellectual property portfolios. Both DuPont and Caribou control patent portfolios covering multiple foundational CRISPR-Cas technologies. The cross-license enables Caribou to develop and utilize CRISPR-Cas technology for product development in multiple fields including human and animal therapeutics, diagnostics, industrial biotechnology, research tools, and certain agriculture segments.

The DuPont license to Caribou includes rights to the Cas9-mediated genome editing intellectual property owned by Vilnius University and exclusively licensed to DuPont.

Caribou and DuPont will engage in a multi-year research collaboration, funded by DuPont, under which researchers from the two organizations will collaborate and share insights on how to drive

improvements to their respective technology platforms. The companies also announced today that DuPont has made a minority equity investment in Caribou as part of Caribou’s recent Series A financing round. Terms of the research funding and equity investments were not disclosed. Caribou and DuPont are each eligible to receive milestone payments for products commercialized in certain fields.

“DuPont has been responsible for numerous breakthroughs in CRISPR biology and has amassed an impressive array of expertise developing and applying genome editing technologies in promising commercial areas,” said Rachel Haurwitz, Ph.D., president and chief executive officer of Caribou.

“We are thrilled to partner with DuPont on this initiative and to work collaboratively with the company to speed our product development and actualize the significant promise that CRISPR-Cas genome editing holds for patients and consumers.”

“Caribou is at the forefront of CRISPR-Cas technology and we are pleased to be collaborating with them to advance this important breakthrough in biology,” said James C. Borel, executive vice president, DuPont. “Genome editing, through the use of CRISPR-Cas technology, is of particular interest to DuPont as a way to accelerate plant breeding and address the need for increased global food production.”

6 | ghp October 2015

Germ Killing Robot Proven to Have Positive Effect on Health Care-Associated Infections Tru-D SmartUVC Proven decrease incidence of infection from superbugs in nine hospital randomized clinical trial.

A ground breaking study on UVC disinfection was presented at IDWeek 2015 in San Diego, and the results show that Tru-D SmartUVC significantly reduces health care-associated infections (HAIs) caused by common multidrug-resistant organisms (MDRO) in hospitals. Tru-D SmartUVC has the proven ability to reduce environmental pathogens by measuring the necessary reflective dose required to thoroughly disinfect a hospital room, and therefore, Tru-D was the UVC device selected for this study.

Results of the landmark Benefits of Enhanced Terminal Room Disinfection study showed that the three enhanced terminal room disinfection strategies decreased the cumulative incidence of MDROs by 10 to 30 percent, and the largest decreases were seen when a UVC emitting device was added to the standard cleaning strategy. Such reduction rates, validated through the largest randomized clinical trial, differentiate Tru-D technology.

The study’s primary outcome showed the clinical incidence of an MDRO in the next patient to occupy the room for at least 24 hours after disinfection. It also showed that incorporating Tru-D into hospital disinfection protocols for the rooms at highest risk to harbor pathogens was seamless. Furthermore, adding a cycle of measured-dose UVC light only added up to 10 minutes to the total room turnover time.

“The hospital environment is an important component to patient care,” said Deverick J. Anderson, MD, MPH, of Duke University Medical Center, during his presentation at IDWeek. “For example, several studies have demonstrated that risk of acquisition is higher in patients who enter rooms recently vacated by a patient with MDROs. This risk likely comes from two important factors. First, these organisms can persist in the environment, and second, these organisms are often allowed to persist in the environment, as the status quo of room cleaning is often inadequate.”

ghp October 2015 | 7

Anderson also reported that the room turnover time increased by five to ten minutes with the use of the UVC emitting device, and hospitals did not see an increase in the amount of time patients spent in the emergency room or an increase in the rates of diversion.

“We want to thank the skilled team of researchers at Duke Medicine for dedicating their time and expertise to validating the efficacy of measured-dose UV light,” said Chuck Dunn, president and CEO of Tru-D Smart LLC. “It remains undeniable that Tru-D SmartUVC is a proven method in eradicating HAIs, and we look forward to arming hospital leaders with this newly published study as they and their staff continue the battle against multidrug-resistant organisms.”

The staggering numbers of HAI’s are driving health care leaders to enhance existing disinfection efforts.

Validated by multiple independent peer-reviewed studies, Tru-D SmartUVC is the pioneer in the UVC disinfection space and is proud to be the go-to technology changing health care today and well into the future.

8 | ghp October 2015

industry insight

Selling Success for the Healthcare Industry – Measurably Two leading companies in their field have worked together to show that better skills create better sales, and have produced conclusive numbers to prove it.

In today’s UK health service, many patient care professionals are reeling from constant change and challenges created by budget constraints, policy evolution and bureaucratic requirements – to say nothing of an ageing, care-hungry, population.

Sales people in the healthcare products industry often face stressed and overworked clinical staff. In many cases, familiar products are ordered and familiar suppliers retained simply because healthcare professionals don’t have the time to consider alternatives – unless, of course, sellers of those alternatives have the skills to do something about it. But having a great product is not enough unless you can also actively engage the decision-makers in discussions as to why they should consider change.

To generate that level of engagement you need to understand the pressures that the healthcare professionals face and what the key triggers for change are likely to be. That understanding needs to encompass both the healthcare professional and the patient.

Healthcare professionals need fresh ideas and creative insights to address the complex problems they face.

They need solutions to problems, not product features.

They need a trusted advisor, not a product demonstrator. And developing trust requires more than talent at building relationships and knowing your product/service inside out. The most successful sales professionals operating in healthcare are those that start with the impact on patients and the healthcare organisation.

This was clearly illustrated by Urgo Medical, a leader in the European wound care and dressings industry.

Urgo Medical already had an efficient sales team that possessed a good technical understanding of their products and how to use them. However, it was keen to strengthen its position in the market as well as increase the group’s turnover. So Urgo Medical decided to engage Huthwaite International, renowned for research-based insights into successful sales performance, and experienced in changing people’s behaviour to achieve that success.

Helping people to improve their selling skills is all about training them to make persuasive cases for

their products and services, by proving that they understand, and can meet, their customers’ needs better than the competition. Learning and practising the very specific consultative skills that produce such conversations – based on a real analysis of needs – has been the central aim of Huthwaite International’s SPIN® Suite.

Huthwaite’s expert trainers spent a week-long intensive training session with the Urgo Medical’s entire UK sales team in early spring 2014. During that time the sales team was trained in SPIN® Selling, the marketing team in SPIN® Marketing and the managers in SPIN® Selling and SPIN® Coaching.

So, what is SPIN®? In short, the model uses a questioning framework to enable sellers to identify a true opportunity, consultatively extract the vital information, build a persuasive customer proposition, and get the customer to articulate the value they can see themselves getting from the product or solution.

By using the SPIN® methodology, Urgo Medical’s salespeople learned how to develop customer conversations about long-term efficacy and the payoffs they could expect from the solutions their products could provide. They learned how to change their existing customer relationships to focus on the value they could deliver.

The introduction of a common language to identify and classify types of customer need, and to plan and chart where each sales call has led them within the overall sales process, gives sellers the practical skills to build a simple but effective framework for generating new business.

Of course in any organisation, if the sales people are saying one thing to individual customers, and the marketing team doesn’t echo those messages in the wider buyer community, much of the impact is lost.

So, to avoid this outcome Huthwaite International’s experts ran a parallel workshop, looking at how the core SPIN® framework, and use of persuasive language, should be applied within the marketing department– from social media to promotional literature, and from briefing agencies to dealing with the press.

ghp October 2015 | 9

1010| ghp | ghpSeptember October 2015 2015

industry insight Before that programme, product collateral was mainly focused on technical features. Afterwards, the marketing team was able to create brochures, presentations and web content that had a narrative which still incorporated technical information but also highlighted the value of the Urgo Medical solution and the healing outcome benefits for patients and health professionals alike. This highlighted the clinical and personal gains that a better solution could bring.

“The SPIN® programme has helped us review the way we were briefing agencies, producing marketing collateral and delivering public messages. It has given the entire UK business a sales infrastructure we’ve never had. Now the ‘users and choosers’ of products like ours are amenable to new ideas if we can be clear about their core benefits and long term advantages.

This has helped us to be persuasive in all customer-facing parts of the business.”

Nonetheless, the behavioural and commercial improvement isn’t down to the training phase alone.

Coaching is crucial to making sure that the post-training behaviour change is sustained.

And ultimately, Justin Cole, Managing Director, Urgo Medical noticed: “Huthwaite are cautious about over-claiming revenue and profit outcomes, because their key measure is the behaviour change; so maybe it’s for Urgo Medical to declare the bottom-line impact. Well, from where I sit, the best SPIN® practitioners we have here are the people producing the best sales results, in terms of bigger deals, more orders and satisfied customers.”

If a company decides to make a significant investment in training the sales team, it’s imperative to give people the opportunity to practise the new techniques consistently. They also need to understand why the new approach is better and more efficient than what they used to do before Huthwaite International was involved.

Coaching is an essential part of sustaining behaviour change. Coaching sessions should not be an information exchange but instead should focus on the ‘coachee’ identifying for themselves the actions that will enable them to achieve the goals they have set.

This type of transformational coaching can have a real impact on performance and bring about sustained behaviour change. That’s why coaching is also a skill that needs to be properly taught.

As Farida Sollitt, Urgo Medical UK Training Manager said when evaluating the early impact of the project: “As the sales team gradually gains confidence in the use of SPIN® we are starting to see a positive change in the call quality and also in engagement from the customer. The desire of the sales person to rush in and excitedly talk ‘product’ before understanding and acknowledging the real problems and needs of our customer is now something we see less of....a change is definitely taking place.”

These changes flagged by Farida soon started to impact the whole business and Robin Nicholson, Marketing Manager, Urgo Medical UK remarked:

The proof is in the numbers. Urgo Medical’s sales team started to get bigger deals, more orders and customer satisfaction improved significantly. By the end of 2014, the company saw its sales rate grow by 19.6% and so far, in 2015, they have already registered a 15% rise in sales compared to the previous year.

What we should take from Urgo Medical’s example is that if a company invests in its sales people, chooses the right training model and then carefully measures and evaluates the results, they can successfully navigate even one of the most challenging markets.

About the author: Tony Hughes is CEO of Huthwaite International best known as the creator of SPIN® Selling – helping salespeople in all countries and most languages to improve their performance. It has a client list of 1,000s of companies worldwide and trains some 14,000 people each year. Besides the SPIN® Suite, Huthwaite International offers training and reinforcement based on its own original research models in negotiation skills, communication skills, customer service skills. www. huthwaite.co.uk info@huthwaite.co.uk +44 (0)1709 710081 Twitter = @Huthwaite_Intl

ghp October 2015 | 11

12 | ghp October 2015

innovation & technology

3 Ways That Technology Can Future-Proof The Pharma Sales Force Today The future viability of the current pharmaceutical sales force model ranges from a doomsday scenario of no more pharmaceutical sales representatives at all to predictions of a return to the glory days where the pharmaceutical sales representative was at the center of the brand-commercialization universe.

It’s safe to say that the only certainty regarding the pharma sales model is uncertainty.

One thing is for sure, there will be change and that continued change will be increasingly fueled by technology.

In fact, advancing technology promises to transform the role of the pharmaceutical sales representatives into a critical linchpin within the overall commercial strategy of a brand – elevating customer engagement via three differentiating factors of high transparency, high context and high touch.

High Transparency – deployments of pharmaceutical sales representatives will require higher transparency around RIO. WHAT. Pharmaceutical executives commercializing brands are increasingly called on to move from deploying pharmaceutical sales representatives with low transparency regarding return on investment (ROI) to deploying pharmaceutical sales representatives with high transparency around ROI. WHY. Simply put, the “pharmaceutical sales representative” channel is the most expensive channel leveraged to commercialize brands. With the continued margin pressure across the pharmaceutical industry, the “financial squeeze” will create the conditions where the more expensive channels will be asked to provider higher levels of ROI transparency.

HOW TECH HELPS. The use of electronic aids and modern engagement tools such as mobile customer relationship management (CRM) systems create an easy to report-on and export-for-analysis “digital exhaust” of all activities a pharmaceutical sales representative conducts. In addition, the quality and precision of data regarding the behaviors of healthcare professionals (HCP) such as scrip writing and sampling continues to improve as well. As a result, sales managers will increasingly be able to include more granular details on the activities of pharmaceutical sales representatives and more granular data regarding HCP behavioral insights. These critical inputs were previously unavailable, yet are the key to ROI calculations driving transparency and decision making regarding resource management of life sciences’ “most expensive channel”, the pharmaceutical sales representative.

Technology provides the digital exhaust to increase the transparency, precisions, and confidence when investing in the most expensive channel, the pharmaceutical sales representative.

High Context – pharmaceutical sales representatives will conduct less low-impact, low-context activities and more high- value, high-context activities to drive HCP engagement.

WHAT. The impact of a single pharmaceutical sales representative engagement will transition from merely creating soft brand awareness for customers seeking answers, to creating hard evidence for HCPs seeking outcomes.

ghp October 2015 | 13

14 | ghp October 2015

innovation & technology WHY. The high level design of the information flow of the pharmaceutical industry has changed from one of questions and answers, to one of context and evidence. In the past pharmaceutical sales representatives engaged with its customers to provide answers to questions.

As technology increasingly advances, HCPs are leveraging as “evidence” newly democratized healthcare information streams from digital sources such as WikiPedia, WebMD and Medscape. These customers are making self-directed decisions based on partial or biased information. Pharmaceutical sales representatives need high levels of context to unravel the self-derived conclusions that HCPs have made based on abundant, yet often incomplete or inaccurate online healthcare information.

The challenge is not merely addressing this informational inertia point-by-point, but rather gaining context about the HCP’s practice, priorities, history and strategy. It’s about the sales rep being the most important and trusted healthcare information stream the HCP has - towering in context and credibility over crowd-sourced digital streams of such as WikiPedia or WebMD. HOW TECH HELPS. Much like the HCP has access to new online streams of healthcare information, pharmaceutical sales representatives have new information streams as well. For example, some of these new information streams provide invaluable insights into an HCPs “ecosystem.” That ecosystem includes the HCPs’ preferences, practice attributes, patient populations, influencers, payer interactions, provider/hospital relationships as well as accountable care organization (ACO) or integrated delivery network (IDN) affiliations.

In addition, the pharmaceutical sales representative can place those ecosystem insights within the broader context of competitor brands, public sentiment, policy change and global issues.

While HCPs leverage consumer technologies such as mobile devices, social networks and crowd wisdom to access healthcare information to make self-directed decisions and conclusions; information, insight and analytics vendors within the life sciences can leverage Big Data technologies and other sophisticated analytic tools to “arm the pharmaceutical sales representative” with enhanced context beyond the unstructured data of the democratized web.

Savvy pharmaceutical sales representatives can share that augmented context with HCPs who lack access and time to curate it – advancing the trust and value of the relationship in the eyes of the customer.

Technology provides the integration, synchronization, dissemination, and consumption of new information sources in near-real time to arm the pharmaceutical sales representative of the future with high levels of context about an HCP’s “ecosystem.”

High Touch – issues surrounding healthcare access, delivery and outcomes will shift the pool of life sciences’ customers, requiring a higher touch from pharmaceutical sales representatives.

ACO/IDN models within the U.S. and other parts of the world. Pharmaceutical sales representatives will increasingly need to engage with new stakeholders beyond HCPs. They’ll need to develop skills and insights to interact with administrators in large organizations; decision makers on formulary committees or even policy makers.

WHY. As healthcare access, delivery and reimbursement continue to evolve, the types of stakeholders and organizations influencing how doctors and patients access a brand are fundamentally changing as well.

These new stakeholders such as administrators in large organizations or decision makers on formulary committees require the type of attention and engagement from pharmaceutical sales representatives that is different from what HCPs require. Administrators in large organizations or decision makers on formulary committees require an “account based” selling model with ongoing, connected “high touch” to an “account,” instead of episodic and sometimes disconnected “calls” to doctors.

HOW TECH HELPS. In the same way that technology empowers pharmaceutical sales representatives to better understand HCPs via relevant data and tools, technology will also help the pharmaceutical sales representative better understand new non-HCP stakeholders with new information sets, and software to enable true account-based selling. The ability to be “high touch” is enabled by software systems that collect, synchronize and share information on multiple-channels across multiple-stakeholders across various locations. Software systems in sales, marketing, and home office functions that are fully integrated will enable pharmaceutical sales representatives to “orchestrate” the high-touch engagement with new stakeholder. This concept of orchestrated customer engagement (OCE) will be driven by software systems that are designed from the ground up to enable hightouch, account-based selling models to new non-HCP stakeholders who will play increasingly larger roles across the healthcare decision matrix.

Technology will enable Orchestrated Customer Engagement delivering high touch to new stakeholder types by brining sales, marketing and home office functions closer aligned across multiple channels and stakeholders.

Ultimately, predictions regarding how and if the pharmaceutical sales force of the future will expand, contract or evolve into something yet unseen are sure to continue.

However, we can see today that pharmaceutical sales representatives will have to adapt to demands for higher transparency, higher context and higher touch in the future.

We can also see that advancing technology, analytics and real-world data insights will help meet those demands. Visionary brands don’t need to wait for the future to decide their fate tomorrow, technology empowers them to dictate their future today.

By Richie Etwaru, Chief Digital Officer of IMS Health.

WHAT. The complexity of market access to commercialize brands continues to increase with major shifts in payer and policy changes as well as the creation of

ghp October 2015 | 15

16 | ghp October 2015

research & development

Philips and Massachusetts Institute of Technology Team up to Make Managing Brain Injuries Less of a Headache for Doctors and Patients Research project combines ultrasound technology, computer modeling & neurosurgery experts to find a better way to measure intracranial pressure from the football field to the battlefield.

Royal Philips has announced it has teamed up with the Massachusetts Institute of Technology (MIT) to research the use of Philips ultrasound technology and MIT physiological modeling as a less invasive way to measure intracranial pressure (ICP), an essential tool in managing patients with brain injuries. It could also allow doctors to use the measurement on less critical patients, who might not normally be considered for such monitoring. During the study, Philips, a diversified health and well-being company, will work with leading experts in the field of neurosurgery to test a core estimation algorithm that has been developed by the Integrative Neuro-monitoring and Critical Care Informatics Group in MIT’s Institute for Medical Engineering and Science (IMES).

Current standard ICP measurement procedures require surgical penetration of the skull or lumbar spine and insertion of a catheter into the cerebrospinal fluid space or neural tissue posing a high risk of infection and damage to vital brain structures. Due to the invasive nature of the procedure, only a small number of patients who may require ICP monitoring are typically tracked and benefit from it – often those suffering from the most severe head injuries. This trial could create the opportunity to take ICP measurements in an expanded group of patients who would not routinely be monitored because of the health risks involved with measuring ICP. “The current invasive method of measuring ICP is used only in the sickest patients, but knowledge of ICP is potentially important in a much broader population,” says Thomas Heldt, the Hermann L.F. von Helmholtz Career Development Professor at MIT’s IMES and assistant professor in MIT’s Department of Electrical Engineering and Computer Science, who is principal investigator of the study. “Our goal is to develop a noninvasive method of measuring ICP that could be used in treating a much wider range of conditions. This project gives us an exciting opportunity to test innovative hardware and modeling techniques at the bedside in real time.”

Over the next two years, Philips will work with MIT to research a fully non-invasive and calibration-free approach to estimating ICP and thereby enable better

diagnosis and triage in cases where a patient has suffered a brain injury (football field, ambulance, battlefield, and emergency room). Using Philips portable ultrasound technologies and monitoring technologies, as well as the MIT model-based estimation approach, researchers hope to get the value of ICP without penetrating the skull. Further, researchers hope to expand the use of the technology to non-traditional patients, such as those with unexplained headaches, mild and moderate traumatic brain injury, or even coma patients, who normally would not have access to this type of procedure, but who could potentially benefit from it.

Philips recently announced the opening of its new Philips Research headquarters for North America in Cambridge, Massachusetts, where it will perform these types of research projects in close collaboration with local academic and healthcare partners. Focused on understanding how medical technologies can be adapted to tackle some of society’s most pressing issues, Philips hopes that this type of research can lead to meaningful innovations that can help reduce care costs and improve patient results.

“Today it is very difficult to gauge the level of head trauma someone has sustained at the scene of an incident, because there is no quick and effective way to gauge the pressure inside the skull,” said Dr. Joseph Frassica, Chief Science Officer of Philips Research North America. “Through this research, we hope to use the same technology most people associate with the first images of their child, in a way that has the potential to help us to differentiate a concussion from a serious traumatic brain injury and everything in between. Whether you’re a high school football player, in the NFL, a soldier in the battlefield, or unfortunate enough to be injured in an auto accident – we hope that this technology will give first responders a better way to determine if you have a life-threatening brain injury and allow faster and more accurate triage and treatment. By improving access and response times, these types of solutions have the potential to really impact patient outcomes.”

ghp October 2015 | 17

Healthcare recruiters: Are you audit-prepared?

18 | ghp October 2015

regulation & policy The relationship between healthcare recruiters, the NHS, Government and public has never been more fragile. There have been a number of public scandals linking to agency staff getting paid seemingly high fees for emergency shifts. This has led to scrutiny of healthcare recruiters and the NHS. A number of healthcare recruitment companies have come under fire because of these numerous scandals because they have not all have been prepared.

This article will example the common areas healthcare recruiter businesses have gone wrong when it comes to accreditation, spot-check audits and the right PR to manage criticism. It will provide a best practice guide to surviving audits and the issues around this.

Healthcare recruitment compliance expert, Duncan Kennedy, of Audit Ready explains: Introduction NHS organisations have always needed to have a flexible workforce to manage fluctuations in activity and to cover vacancies and short term absences. Cover has traditionally been provided by in-house banks or commercial recruitment agencies.

As reported the Government and senior leaders of the NHS are having to address a budget requiring £22bn in efficiency savings and a predicted funding shortfall of £8bn. In 2014/15 NHS providers spent £3.3bn on temporary staff. It clear to understand why the amount spent on agencies is high profile.

In the early noughties there was significant concern about the over reliance on agencies, the amount spent and the impact on the quality of care. One of the strategies for managing agencies was the introduction of framework agreements for nursing. Since that time frameworks have evolved covering all staff groups: the difference then was the use of frameworks was advised rather than mandatory.

Following the Francis Report there has been a heightened sense of priority across the whole service to ensure safe staffing levels are achieved and maintained; which for some Trusts has made it very hard to avoid increased agency use. As such a seismic shift has taken place in the Governments attitude towards controlling costs and raising quality. In September, Monitor and the TDA published mandatory rules for using agency nurses form “approved” framework agreements; subsequently a further announcement has confirmed a new hourly price cap will now be introduced for all types of agency staff.

Framework Agreements A framework agreement is an ‘umbrella agreement’ that sets out the terms (particularly in relation to price,

quality and quantity) under which individual contracts (call-offs) can be made throughout the period of the agreement.

For the NHS, the framework agreements for the supply of temporary healthcare workers were introduced to manage cost and to ensure NHS quality standards relating to pre-employment checks and personnel vetting were performed by awarded agencies.

There are several health framework agreements in place across the country, which are managed by a number of different procurement organisations, the main ones being, the Crown Commercial Service (CCS), Healthtrust Europe (HTE), the London Procurement Partnership (LPP) and NHS Commercial Alliance.

Compliance NHS organisations are required to demonstrate they are compliant with the checks outlined within the NHS Employment Check Standards, as failure to comply could potentially put the safety, and even the lives, of patients, staff and public at risk. When NHS organisation use agencies they are obliged to demonstrate that agencies are performing the required pre-employment screening checks, therefore the requirement to demonstrate compliance is also embedded within the framework agreements and audits are performed by the framework owners to ensure compliance with the NHS quality standards.

Where have agencies gone wrong?

Recently the focus has been on agencies charging “extortionate, excessive and unreasonable” prices to the NHS for the supply of temporary workers i.e. holding the NHS to ransom. These agencies would argue it is a case of simple economics – supply and demand. However, I would argue corporate ambition has been chosen over corporate responsibility. They have decided to take the pound for short term gain rather than work as a responsible supplier, providing a service that is valued rather than despised. Although a relatively small number of agencies, the reputational damage to the sector has been significant and has contributed majorly to the Governments hardened attitude.

ghp October 2015 | 19

20 | ghp October 2015

regulation & policy More importantly, the knowledge across the recruitment sector in ensuring agency workers are compliant with the required recruitment standards and that clinical workers are fit to practise is variable. The differences in the capability of individuals being supplied through agencies can be high. This can be attributed to a number of factors, such as a high number workers from overseas, lack of focus during the recruitment process on assessing clinical skills and experience, lack of continuing professional development. All of these have an impact on the quality of care being provided.

Typically risks are always associated with sourcing workers from a third party and the following reasons may go some way to demonstrate why an assurance programme is required to educate and promote compliance.

Current demand for suitably qualified and experienced staff outstrips the number of workers available and competition across the recruitment sector to recruit workers is fierce.

Pressures from clients to fill an assignment may force individuals to deliberately circumvent requirements, because: • timescales for recruiting agency workers can often be tight resulting in pressure to overlook some pre-employment screening measures; • income from agency work can be irregular, which can be a motive for financial gain; • an agency worker’s loyalty may not necessarily be to the employing organisation and their commitment to following recruitment standards may be diminished; • an agency worker may work for a number of competitor agencies; • assignments can be renewed or extended to the point where a contractor can work in an organisation for many years, often with little or no re-screening.

What do agencies need to do?

All parties involved in drafting policies and implementing procedures need to have an understanding of the NHS standards required.

Embedding a culture of compliance where the reasons for performing NHS checks are fully understood and respected.

Develop robust systems where recruiters cannot circumvent NHS employment check standards.

Invest in supporting agency workers to access training and professional development opportunities and perform good quality appraisals.

Work with framework managers to provide a sustainable temporary staffing solutions.

The perception that all agencies are the same within the NHS is strong. An agency that can demonstrate it is rigidly following the NHS standards will be held in higher regard than an agency that does not.

Duncan Kennedy is director of Audit Ready which is a specialist advisory and training service for healthcare recruitment companies across the UK. Duncan supports organisations to achieve compliance with the many employment checks required by their clients. www.auditready.co.uk

ghp October 2015 | 21

Good Laboratory Standards Developed for Dealing with Infectious Diseases 22 | ghp October 2015

public health Public Health England is in the final stages of creating UK SMI Q 7, which is designed to provide advice on good laboratory practice when undertaking serology assays for infectious diseases.

Public Health England (PHE) acts as custodian of SMIs and review the documents which are in use every three to five years. They are currently in the consulting stages of developing a guide to good laboratory practice when undertaking serology assays for infectious diseases.

SMIs are algorithms and procedures for clinical microbiology, developed through consultation. Patients, public and partner organisations can comment on any open consultations, allowing them the chance to make suggestions on how the standards could be improved.

SMI Q 7: Good laboratory practice in serology assays for infectious diseases describes the essential components of a good microbial serology service. A broad definition of serology is used in this document to include both antibody and antigen tests that are performed, usually on blood samples, to detect infection or immunity.

Conventionally, microbiology and virology laboratories perform microbial serology assays. In an increasing number of laboratories some tests are performed using analysers on automated blood sciences tracks. It is important to recognise those critical pre-analytical, analytical and post-analytical steps and procedures which are essential to the delivery of a high quality service.

The principles described in this new document are also relevant to nucleic acid amplification tests (NAATs) performed on blood samples, especially where microbial serology and NAATs are available for the same infection and may be listed together in order entry systems. In these circumstances there should be an experienced assessment of the appropriateness of performing serology tests or NAATs as part of a unified process that may include changing the request from a NAAT to a serology test, or vice versa.

Good laboratory practice, which is what this SMI documents outline within the field of serology assays for infectious diseases, is referred to as “a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported and archived”. The aim of good laboratory practice is to promote the development of quality test data as well as to provide a tool to ensure a sound approach to the management of laboratory testing, including conduct, reporting and archiving.

Public Health England develop these standards together with partner organisations, Public Health Wales, representatives from Scotland and Northern Ireland, NHS and the Royal College of Pathologists which display their logos on the SMIs. An organisation’s logo in an SMI indicates the society participated in equal partnership and support for the objectives and process of preparing SMIs. Nominees of professional societies are members of the steering committee and working groups that develop SMIs. The nominees participate in the

development of the SMIs although their views cannot be rigorously representative of the members of the partner organisation nor the corporate view of the organisation, with nominees also acting as conduits for two way reporting and dialogue.

Each of the devolved administrations endorses SMIs. Public Health Wales bases its own All-Wales SOPs on the SMIs. The Welsh Microbiological Association, the Scottish Microbiology and Virology Network, the Scottish Microbiology Association and the Northern Ireland Microbiology Forum and Audit Group also endorse the standards.

UK Standards for Microbiology Investigations include: • syndromic algorithms, that are the overarching framework that connect other SMIs, and describe the investigations chosen at the pre-analytical (clinical syndrome) stage • recommended investigations for microbiology • minimum testing algorithms for virology (analytical and post analytical) • clinical guidance that covers the clinical background, differential diagnosis, and appropriate investigation of particular clinical conditions • quality guidance that describes laboratory methodologies to ensure quality, like assay validation, quality assurance and understanding uncertainty of measurement.

There are three groups of users who find SMIs relevant to their work, the first being practicing laboratory medicine professionals in the UK who use the SMIs as a general resource.

Additionally, clinicians use SMIs to learn about the standard of laboratory services they can expect for their patients. SMIs can help them order the appropriate tests electronically from hospital wards.

The final principal user of SMIs is commissioners of healthcare services, who use SMIs to find the standard of microbiology investigations they can seek as part of the clinical and public health care package for their population.

Within the consulting process for SMIs, members of any of these three groups are able to add their views on the document and how it could be improved. All SMIs are developed, reviewed and updated through this consultation process.

The standards unit updates and reviews SMIs by consultation using the opinions of many other stakeholders, including members of the public, partners and specialist groups. This includes microbiology professionals and doctors. The resulting documents reflect the majority view of contributors, which insures that the document is democratically produced and reflects the needs of everyone who will be affected by the document.

The full consultation, which is open until 2nd November 2015, is available to view here.

ghp October 2015 | 23

Third Quarter Results Show NHS in Need of Funding Certainty

24 | ghp October 2015

funding & investment Quarterly Results published by Monitor and the NHS Trust Development Agency show serious financial pressures on NHS Foundation Trusts.

The report showcases Monitor’s findings from a review of the Q1 2015/16 performance of the 151 NHS licensed foundation trusts (NHSFTs) operating during this period, which includes one newly licensed foundation trust (Bradford District Care NHS Foundation Trust).

The results show that sustained financial and operational pressures led NHSFTs to expect that this financial year would be one of the toughest they had faced. During Q1 2015/16 they continued to miss key waiting-time targets, and the sector’s financial performance deteriorated rapidly. NHSFTs ended the first three months of the financial year with a net deficit (before impairments and gains or losses on transfers) of £445m and an aggregate earnings before interest, tax, depreciation and amortisation (EBITDA) (earnings before interest, tax, depreciation and amortisation) margin of only 0.9%. Acute NHSFTs in aggregate reported an unprecedented negative EBITDA of -0.3%.

This indicates that the current level of deficit is not affordable. Monitor is working with its national partners to provide intensive support to mitigate risks that NHSFTs face, with one package of interventions already announced jointly with the NHS Trust Development Authority (NHS TDA) in June. In addition to this they have also written to all NHSFTs in August encouraging them to take a critical look at their plans and explore any further options to reduce their deficits and announced details of controls on agency spending on 1 September 2015.

The financial pressures trusts are under has affected their performances, with NHSFTs continuing to underperform against the 95% target for accident and emergency (A&E) four hour waits in Q1 2015/16.

During the quarter, 2.86m patients attended NHSFT A&E departments, which treated or admitted 94.5% of them within 4 hours. Although attendance in Q1 2015/16 was 4.6% higher than Q1 last year, the growth was mainly due to new NHSFTs and mergers and acquisitions. With these excluded, the like-for-like comparison suggested a 1.0% reduction, a further indication that there is no strong correlation between attendances and target performance.

NHSFTs attributed the underperformance to the sustained high level of emergency admissions. In Q1 2015/16, 560,000 patients (26.1%) attending a major NHSFT A&E unit needed further inpatient treatment, a similar level to previous winter months (Q4 2014/15).

However, bed availability continued to affect patient flow, with high bed-occupancy rates and delayed transfers of care resulted in over 29,000 trolley waits during the quarter, 35% higher than Q1 2014/15.

Overall financial performance over the quarter has been poor, with NHSFTs in aggregate reporting a year-to-date deficit, before impairments and transfers, of £445m at Q1 2015/16, which was £90m worse than plan and £96m more than the full-year deficit for 2014/15. This rapid decline in NHSFTs’ financial

performance saw 118 NHSFTs in deficit this quarter, with a total gross deficit of £485m. This was offset by just £40m gross surplus at 33 trusts.

The severe deterioration in the margin was largely due to higher pay costs (0.8% over plan) while revenues were on plan. NHSFTs were unable to recruit as many permanent staff as planned, resulting in trusts hiring extra agency staff to fill vacancies and maintain safe staffing levels. The extra costs of agency staff (£192m) and bank shifts (£76m) outweighed the £213m savings from vacancies. This had a knock-on impact on NHSFTs’ planned cost improvement programmes (CIPs), as 65% of the £64m shortfall in CIPs during the quarter was pay-related.

Overall Monitor indicated that their interventions in this area, which include implementing new rules on procuring agency staff, would potentially not be enough to secure the financial future for NHSFTs. “Performance in the first quarter of the financial year is usually worse than the rest of the year. In addition, Monitor’s package of interventions announced on 2 June would not have had a significant impact on the Q1 position as it was still in the early stage of implementation. Reflecting their financial pressures, NHSFTs are projecting a full year deficit of £1.01bn, which is £80m worse than the plan of £931m for the year.”

Paul Healy, Senior Economics Advisor, NHS Confederation commented on the report, arguing that funding needed to be secured in the spending review.

“The billion pound NHS deficit now forecasted for Foundation Trusts is a symptom of problems across the entire health and social care system and we agree with Monitor that radical change must happen.

“Unfortunately financial planning in the NHS leaves the health service navigating in the dark without knowledge of how much funding will be available in six months’ time. Eighty-seven percent of our members want to see a long-term financial commitment from the Government on health and social care so that we can plan changes and become more sustainable.

We also want to see £4bn of Government’s £8bn funding commitment available to the NHS within the next two years.

“Hospitals and other frontline NHS organisations have all-but exhausted their options for becoming more efficient. They are also increasingly affected by cuts in social care, local GP shortfall and a host of other challenges.

“We need an end to the short-term approach to finances which is causing financial instability in the NHS and acting as a hindrance to transforming patient care.”

The full report from Monitor can be viewed here.

ghp October 2015 | 25

26 | ghp October 2015

research & development

Genzyme Introduces “vs.MS,” a Global Initiative Aimed at Uncovering the Often Unspoken Challenges of MS to Drive Better Informed Care Initial Findings from Global Survey of People Living with Relapsing Multiple Sclerosis (RMS) and Care Partners to be Shared at ECTRIMS. Genzyme, a Sanofi company, has announced a new global initiative, vs.MS, that is designed to raise awareness of the often unspoken emotional and physical burden of relapsing multiple sclerosis (RMS) on people living with the disease and their care partners.

To better understand the full burden associated with RMS, Genzyme, which has been pioneering the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years, fielded a global survey among more than 1,500 people living with RMS and their care partners across seven countries. An initial set of data from the vs.MS global survey has been shared for the first time at the 31st Congress of the European Committee on the Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain, October 7-10.

“As part of our ongoing commitment to help improve the lives of people living with MS, we are proud to introduce this new global initiative in collaboration with patients and caregivers,” said Darlene Jody, Head of MS Medical Affairs at Genzyme. “At Genzyme, we believe that when we know more, we can do more. The experiences uncovered through the vs.MS survey will help shed light on the physical and emotional toll RMS can have, and we look forward to developing a program that may help drive a more open exchange for better informed care.”

While at ECTRIMS, Genzyme is bringing together thought leaders from across the MS Community representing people living with MS, healthcare providers specializing in the disease, and advocacy groups to review the full vs.MS survey findings and begin developing a program that will be rolled out to the community.

To unveil the initial vs.MS survey results at ECTRIMS, Genzyme is hosting an interactive digital experience at their booth, as well as sharing the findings via the @ GenzymeCorp Twitter handle. For each individual who participates in the interactive digital experience and for every retweet that includes the campaign hashtag #vsMS, Genzyme will donate 5 Euros to the Multiple Sclerosis International Federation (MSIF) in support of the organization’s research efforts.

Data from the vs.MS global survey will provide a glimpse into the impact the disease may have on various aspects of day-to-day life for people living with RMS. For example, half of respondents feel their ability to progress in their career has changed for the worse since they were diagnosed with RMS, and 40 percent are concerned about being able to keep their job.

The vs.MS survey also reveals the effect of RMS on the emotional well-being of those living with the disease and their care partners. For example, more than half of respondents living with RMS feel lonely or isolated because of their MS, while more than half of care partners do not discuss their fear of MS progressing to avoid upsetting the person they care for.

“The results of this global survey offer a unique look into the realities of relapsing MS, including the challenges that people living with MS and their care partners deal with on a daily basis,” said Dr. Barry Singer, MD, Director of The MS Center for Innovations in Care at Missouri Baptist Medical Center in St. Louis, MO, and a vs.MS steering committee member. “We are hopeful that insight into the daily struggles of those living with MS will result in better disease management.”

The vs.MS survey was fielded among more than 1,500 people across seven countries, including people living with RMS and RMS care partners. Developed with input and guidance from a steering committee of leading global neurologists specializing in MS, the online survey addressed topics such as progression and disability; cognitive challenges; relationship and intimacy issues; emotional burden; fatigue and sensitivity; bladder and bowel challenges; and impact of MS on careers.

In the coming months, Genzyme will reveal the full vs.MS data set and partner with the MS Community to encourage behavior and attitude shifts in an effort to drive better outcomes for those affected by the disease.

ghp October 2015 | 27

My thanks to Mr Colin Walker for his time and courtesy allowing me to discover what real-time wireless monitoring in a departmental setting means at first-hand.

28 | ghp October 2015

research & developmen

Investigating Wireless Monitoring and Data Recording Technology in Pathology – Richard McCann meets Queen Alexandra Hospital’s Colin Walker.

Colin Walker manages the Department of Clinical Microbiology at Queen Alexandra Hospital, Portsmouth. The department occupies a section of the hospital’s state-of-the-art Pathology Centre and provides a comprehensive range of diagnostic and clinical microbiology services including bacteriology, mycology, parasitology, TB diagnostic service, diagnostic and screening serology and a range of molecular techniques for diagnosis of bacterial and viral infections. in addition, the department provides clinical advice on diagnosis, interpretation of results, infection and outbreak control management and public health investigations and education and training on all aspects of microbiology.

“We’ve been using the IceSpy temperature monitoring system - from a British firm called The IMC Group - in Clinical Microbiology for more than 12 years,” explains Colin, “and in Sept 2007 we had the opportunity to expand the system across Pathology when all the disciplines relocated to new purpose-build pathology premises at the hospital. So the expansion of IceSpy out of microbiology into blood sciences and into cellular pathology was based on the experiences of its value in microbiology during the previous five years.”

That experience-based decision took the department from manual record-keeping to an entirely automated monitored and recorded system: “Before we had automated wireless monitoring of temperature-related equipment, somebody would be tasked with going round and filling in the sheets for each piece of equipment to record the temperature,” says Colin.

“And because we have a large number of pieces of equipment that lost us an hour out of each day!”

The wireless monitoring removed the need for busy staff to go around with a chart and manually record the equipment temperatures each day. But there were other advantages: “We were manually recording temperatures only once a day whereas the wireless monitoring gave us the advantage of recording on an

hourly basis. So we then had a ‘real time’ idea of how the equipment was performing, such that if there was a fault or the temperature fell outside the minimum and maximum parameters that we’d set up, then the system would give us an alarm, warning that there was a problem.”

Portsmouth Pathology has four Base units - two in Blood Sciences, one of which is in Transfusion, another one in Microbiology and one in Cellular Pathology.

And across pathology there are 134 temperature probes.

“We monitor a range of equipment from refrigerators and freezers (with a range between -20 and -80°C) through to incubators (range +30 to +42°C). We use some of our probes to record both the equipment and the room temperature – that’s important in store areas where we keep consumables. We have the ability to set minimum and maximum temperatures at which individual scout probes will trigger the alarm and we use a visual strobe alarm such that if a piece of equipment falls outside its designated temperature range the strobe will illuminate so everybody in the laboratory can immediately see that there’s a problem.

In order to turn the alarm off we have to actively go and do something about it!”

ghp October 2015 | 29

30 | ghp October 2015

research & development All the various probes within microbiology transmit back to what’s called a BasePlus unit with a visual display that highlights which piece of equipment is out of its parameters, so staff can actively visit that unit and rectify the problem. Quite often that’s something as simple as somebody not quite closing the door, “but a worst-case scenario is that there’s a technical problem. And then armed with that information the software is such that we can record what that problem is and what we’ve done about it, so we have a full auditable trail of the temperature on that piece of equipment,” explains Mr Walker.

“The software itself provides us with a graphical display of each unit probe showing the history going back over a pre-defined period. We archive the database periodically so it doesn’t get too big and we benefit from having all those records going back over a number of years.”

The Pathology Department rates the IceSpy system’s installation as a success. “We started with modest goals,” says Mr Walker,” to save the man hours we were wasting monitoring the equipment and to start collecting some electronic auditable data which we could go back to if we needed to. But the system has conferred additional advantages. For example, we’ve set IceSpy to perform automatic hourly temperature recording in place of a single daily manual record but if we were, say, in a pharmacy and we wanted more data we could select more frequent testing, such as every ten minutes. That’s our choice. The system also has the advantage of ‘out-of-hours’ alarms. Although all our pathology departments run a 24 hours a day service, we can set the system up to send SMS text or email alarms if we ever need to.”

The wireless IceSpy system was originally purchased across some four clinical microbiology units and Queen Alexandra Hospital was an early pioneer of the technology. “To anyone not using wireless monitoring, alarms and data recording yet I’d say the obvious pluses are that it’s easy to set up the probes and the software is intuitive,” advises Mr Walker. “It frees up all the time we used to waste checking manually. And the alerts mean we reduce the chances of damage or loss of the stored items, so temperature sensitive reagents or clinical samples will have maintained their integrity, so we cut wastage.

“Let’s not forget that as well as ensuring all our equipment is working within its correct parameters, a big benefit of the IceSpy technology is to provide an audit trail,” adds Mr Walker. “That helps us meet our accreditation standards. Over the years this has been Clinical Pathology Accreditation (CPA) but that’s now changing to United Kingdom Accreditation Service (UKAS) to ISO15189. And if the visiting inspectors were to ask us ‘How did you know that piece of equipment was working on any particular date?’ or ‘What temperature was it at a certain time?’ we can simply say ‘Here’s all the data!’”

IceSpy offers multi-parameter solutions across many varied applications, so the Pathology Team still has ideas on their ‘wish list’: “The system is extendable and has other capabilities we don’t use at present. It can record humidity, it can record gases. When I have the budget I’d like it to monitor CO2 concentration in our incubators. That’s something I’d look at in the future,” concludes Mr Walker.

ghp October 2015 | 31

32 | ghp October 2015

funding & investment

Trends in Healthcare Investments and Exits – a UK Outlook Nooman Haque, Director of Healthcare & Life Sciences, Silicon Valley Bank UK Branch As we move through the final quarter of the year, 2015 is shaping up to be a pivotal year in the life science investment market. Volatility seems to have returned with a vengeance and this, coupled with the normal uncertainties surrounding the 2016 US presidential election, means it’s worth contemplating what the future may hold.

The first half of the year seemed to go according to the script: a healthy pipeline of crossover funded IPO candidates that indeed went public and continued to have positive price performance. The financial performance was in turn supported by some important clinical milestones particularly in oncology such as Novartis’ data on its CTL019 study in non-Hodgkin lymphoma and multiple myeloma. It’s this kind of positive research news that continues to excite investors.

The importance of crossover investors has been clear for some time. Silicon Valley Bank’s 2014 summary concluded that businesses attracting these investors enjoy higher valuations, quicker listings and superior post-IPO price performance. Bagging a crossover syndicate has, in the last few years, been almost a mark of approval and an inflection point in itself.

The availability of crossover money and its importance in driving capital markets interest has also helped sustain fundraising at the VC level. Limited partners, who invest in VC funds, need to be sure the investment partners can engineer a good exit or listing so that capital can be returned to them. Proving that the old adage, a return of capital is as important as return on capital, is true. Positive VC fundraising activity in 2014, up a staggering 56% on the previous year, means these firms have plenty of dry powder to deploy on new deals. The strong IPO market has also helped fuel the M&A market with upfront payments creeping up and again providing liquidity to the investors.

That pattern continued into the first half of 2015 as five of the six US biopharma IPOs that raised more than $100 million were backed by crossover investors. Overall, nearly half of the 24 biopharma IPOs in the first half of 2015 had crossover interest. Furthermore, this optionality of allowing businesses to go public encouraged the M&A market, particularly for early stage assets. Of the 11 deals struck in the first half of the year, six were pre-clinical or phase 1. In comparison, around 40% of the IPO biopharma candidates were pre-clinical.

Medical device businesses, notable for their absence in the IPO scene, have also returned with the added bonus that two of the seven device IPOs in the first half of 2015 featured crossover investors. Overall, 2015 should top 2014’s 10 device IPOs. As a further benefit to the sector Medtronic, hampered earlier in the year by its merger with Covidien, returned as a buyer and concluded two deals.

If further proof were needed that positivity knows no bounds, Europe’s capital markets seem to have responded, albeit with more caution. Direct comparisons are harder because Europe’s more fragmented capital markets can be a weakness and a strength. It certainly appears to limit the scale of large biopharma IPOs which need specialist investment coverage. However, smaller businesses can find a happy home if they have a good story and willing investors. In the first half of 2015, 14 European businesses went public with 11 making their primary listing on a European exchange, compared to seven in the first half of 2014; although the total amount raised by the 11 businesses was slightly down at €400 million with an average raise of €36 million. In the pipeline for a London listing are two late stage biopharma businesses, Acacia and Shield, who are looking to raise enough money to propel them towards commercialisation.

That’s a good point to pick up the story now. Both Acacia and Shield made their announcements towards the end of Q3 and the financial markets were undergoing turmoil with negative news on China, ambiguous data from the US economy and to cap it all off biotech had its own focus of attention with Turing Pharmaceuticals making the headlines for all the wrong reasons.

When Turing Pharmaceuticals announced it was raising the price of Daraprim – a treatment for toxoplamosis – by 5,000% it drew the ire of the industry.

More importantly, in an environment when presidential candidates are working hard to connect with a somewhat sceptical constituency, it was kept in the news by Hilary Clinton and nightly news pundits. This brought into sharp relief the economic and moral issues around expensive treatments and called into question their necessity and the process of how drugs are brought to market. The ensuing volatility has seen the NASDAQ biotech dip 25% from its peak and has seemingly caused consternation amongst potential IPO candidates. More so, when one considers that the shares of big pharma have not responded in the same way.

ghp October 2015 | 33

34 | ghp October 2015

funding & investment Few doubt that genuinely innovative treatments should command prices to reflect their innovation and risk – at least within the patent system we have now – and there is little to think why the valuations of many biotech businesses who are involved in cutting edge areas should be affected by a business whose only drug came off-patent decades ago. That would be the rational response, but markets do not always respond rationally. In the face of potentially value-impacting measures like price controls, one would expect the valuation of narrow-focused biotech businesses with long development timescales to differ wildly from a diversified and mature big pharma business.

Whilst pre-election threats of impending price controls are likely to be hot air in the long run, the general turmoil has certainly caused some investors to retreat from the market and that is likely a good thing.

Momentum should not drive valuation and volatility reminds everyone that risk does and should scare away investors who, on reflection, don’t understand what they’re getting into and whose investment approach is predicated on nothing more than a greater fool investment strategy. Sensible prices are required for a sustainable capital markets and wild optimism is as bad as pervasive negativity.

It’s encouraging that, as of yet, the crossover investors who have come to anchor the market in recent years show little sign of abandoning the sector. Whilst paper valuation gains certainly help their NAV calculations and thus the fees they obtain from managing money, many crossover investors understand the longer term potential of these businesses and are buying accordingly. Thus being a leading indicator on the ability of a business to attract funding.

The corollary is that if crossover investors do start to withdraw, it will likely herald a reversal in the market and make it more difficult for many businesses to go public. This will place pressure on VC investors to play more of the traditional anchoring role in supporting an IPO and in turn this is likely to impact valuations at private and IPO rounds. Many VCs have continued to raise funds which they can deploy and use as leverage to drive favourable valuations and these experienced investors know how to get businesses onto the market or sold. In short, even in the absence of crossover investors one shouldn’t expect a dramatic tightening, but instead a more discerning and lower priced market. If this undermines the ability of VC funds to raise money then it could become a serious problem while, on the other hand, if not enough businesses are able to raise public money there appears to be little downside should the market got a touch more selective.

Nooman Haque, Director of Healthcare & Life Sciences, Silicon Valley Bank UK Branch Nooman Haque is the Director of Healthcare & Life Sciences with Silicon Valley Bank’s UK Branch. He leads a team dedicated to supporting early, growthstage and established businesses in all sectors of life sciences. Nooman is responsible for developing new relationships, identifying lending opportunities and working with the global life sciences team to support companies with all aspects of their business. He is actively involved within the sector, sitting on the BIA’s Finance and Tax Committee and is a frequent participant on panel and seminars.

ghp October 2015 | 35

36 | ghp October 2015

60 second interview

Our Company in 60 Seconds

What does your business do?

Glossa are an independent speech and language therapy practice for adults with communication or swallowing difficulties.

What’s the aim for your business?

To continue to provide support to clients and their families.

What’s your company’s biggest challenge?

Covering a large geographical area.

Who are your clients?

Adults with acquired difficulties as a result of neurological illness or injury e.g stroke or head injury. We also support those with voice difficulties or a stammer.

What makes you unique?

We provide functional, relevant therapy that is client-led.

Name: Lucy Lowson Company: Glossa Ltd Email: contact@therapyfor.co.uk Web Address: www.therapyfor.co.uk Address: Unit 1 Greystones Court, York YO32 9ST Telephone: 07764999873

What’s your biggest challenge facing you at present?

Trying to provide services to clients where NHS support is lacking and people cannot self-fund.

ghp October 2015 | 37