A new mindset
IMPLEMENTING AGILE IN PHARMA
“Agile enables you to deliver what the customer needs earlier, whilst reducing wasted time, effort and resources” Page 10
Building trust with health Agencies and ABPI Embracing MSLs in industry PHARMAFIELD.CO.UK
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HEAD OF CONTENT
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he August issue of Pf brings you a wide variety of articles ranging from marketing to compliance, MSLs to the NHS, trust and the salesforce, patient engagement and much more. Our cover story explores Agile and how it can help to streamline project management and bring about efficiencies in industry. If you’re not sure what Agile is or how to implement it in your projects, the article sets out what you need to know and is accompanied by a further piece discussing ‘How to implement Agile in pharma’ on our website. We also have a follow-up to our trust survey which found that a third of healthcare professionals didn’t trust industry. The article argues that the sales representative is central to building trust and industry needs to support them to do just that. If you work with MSLs, you’ll know that they’re crucial to industry, but they’re not always supported to maximise their potential. We bring you the results of a survey of more than 200 MSLs which explores their current in-role reality. When it comes to compliance, this month’s ABPI article delves into working with agencies and ensuring they comply with the Code of Practice. We also look at the ABPI’s new guidance for patient engagement. Our NHS article discusses priorities around cardiovascular disease, and community pharmacy focuses on cancer support. We hope that you enjoy this issue of Pf. Don’t forget that you can find regular news and exclusive articles at www.pharmafield.co.uk, new opportunities and job roles on www.pharmajobs.co.uk, we have a new Pf in Conversation coming this month and we’re celebrating 20 years of the Pf Awards, find out more at www.pfawards.co.uk. Next month is our Recruitment and Careers Special Edition and I’ll see you again in October.
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and communications, supporting global pharmaceutical companies and small patient groups with integrated public affairs strategies. DEBORAH EVANS
Deborah Evans FRPharmS FFRPS FRSPH is Managing Director of Pharmacy Complete, a training and consultancy company working with pharmacy and the industry.
Neil Osmond is a technologist and founder of digital agency earthware. He has 20 years’ experience in healthcare and a passion for solving problems for patients and healthcare professionals.
Amy is Special Editions Editor at Pharmafield. She is an experienced journalist and editor of both digital and print content across healthcare, technology and careers.
Amanda is a freelance health and medical education journalist, editor and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, healthcare professionals and the general public.
Dr Rina Newton is Managing Director of CompliMed. CompliMed supports any activity that results in better engagement with the ABPI Code, transparency and consistency in PMCPA case rulings and improvements in self-regulation.
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Claudia is a Director at Decideum, one of the UK’s leading consultancies in healthcare policy and market access. She has over 10 years’ experience in healthcare advocacy
In this issue
Paul is the founder of the customer engagement consultancy Paul Terry Associates. With over 30 years’ experience within the NHS and pharmaceutical industry, he has worked in market access, sales management and marketing.
Sue is Chief Executive of Commissioning Consulting at Wilmington Healthcare, and has a clinical background in nursing, policy and commissioning support. She currently supports the NHS, third sector, pharmaceutical and medtech partners with NHS service redesign and stakeholder engagement.
The essential news from pharma and healthcare
Daring medics to think about rare disease
CouldAgile solve industry’s productivity problem?
Supporting sales representatives to build trust with health
Claudia Rubin looks at Jeremy Hunt's legacy
Exploring HRT and menopause
INSIDE THE NHS
Understanding the role of the MSL in pharma
NHS priorities around cardiovascular disease
Kyowa Kirin on why they value the Pf Awards
New ABPI guidance on patient engagement
The role of community pharmacy in cancer support
Pf speaks to Roche’s Pf Awards 2019 winners
MOVERS & SHAKERS
Ensuring compliance when working with agencies
Who’s moving where in industry?
26 29 FEATURE
Taking the next step in your pharma career
QUICK DOSES TH E N ATI O N A L I N S TIT U TE FO R H E A LTH A N D C A R E E XC E L L E N C E (NICE) recommends A LN Y L A M U K’s ONPATTRO® (patisiran) for the treatment of hereditary transthyretin-mediated amyloidosis. • TH E S COT TI S H M E D I C I N E S CO N S O RTI U M (SMC) has recommended JA N S S E N ’s Darzalex® (daratumumab) plus bortezomib and dexamethasone for treating relapsed multiple myeloma in people who have had only one previous treatment. • A S TR A Z E N E C A will appeal N I C E ’s decision not to recommend Tagrisso (osimertinib) for use within NHS England for untreated locally advanced or metastatic epidermal growth factor receptor mutation-positive non-small cell lung cancer in adults. • TH E E U R O P E A N M E D I C I N E S AG E N CY has recommended two new methods for administering G S K’s Nucala (mepolizumab) to patients with severe eosinophilic asthma. • N I C E recommends N OVA RTI S’ Kisqali (ribociclib) with fulvestrant for hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer who have had previous endocrine therapy. • M U N D I P H A R M A has announced an exclusive distribution agreement with E G I S P H A R M AC E U TI C A L S for Pelmeg®, a pegfilgrastim biosimilar treatment, in Central and Eastern Europe. • S M C has accepted P F I Z E R ’s Ibrance (palbociclib) for the treatment of hormone receptor positive, human epidermal growth factor receptor 2 negative locally advanced or metastatic breast cancer in combination with fulvestrant in women who have received prior endocrine therapy in the advanced breast cancer setting. • A S TR A Z E N E C A’s Forxiga (dapagliflozin) 5mg recommended by N I C E for optimised use within NHS England and Wales for treating adults with Type 1 Diabetes. • N I C E has issued positive final appraisal document for A B BV I E ’s SKYRIZI™(risankizumab) for the treatment of plaque psoriasis in adults.
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or the fourth year running, the Women Count report has found that there has been no progress on gender diversity in senior roles in the FTSE 350. Funded by The Pipeline, the research tracks the number of women in executive positions and on executive committees. When looking at the pharmaceutical industry, it has almost tripled its representation of women on executive committees (now at 26%, up from 9% in 2018). However, the representation across profit and loss (P&L) roles has halved (now 4%, down from 8% last year). There was also a drop in representation of women executive directors on boards (down to 6% from 10% last year). This points to women taking on functional roles on executive committees, not P&L roles or executive director roles, which are key roles to becoming chief executives and possible future chairs of PLCs. In 2019, pharmaceutical companies in the FTSE 350 had: • 26% representation of women on their executive committees • 4% representation of women in P&L roles on their executive committees • 6% representation of women as executive directors on their Boards. Pf View: This is disappointing news, but who is responsible for addressing the gender imbalance? Have your say at email@example.com.
Pf IN NUMBERS
MILLION people visit a pharmacy every day. The role of community pharmacy in cancer, p19
P f N E W S : B R I N G I N G YO U T H I S M O N T H ' S E S S EN T I A L H E A D L I N E S
Graduate drive In May, the PM Society held a free event in London for science students and graduates interested in finding out more about careers in pharmaceutical marketing and healthcare communications. The event highlighted a variety of roles available in industry that combine science with creativity and innovation while also helping people living with disease. Speakers, ranging from pharmaceutical companies to healthcare communications agencies, explored drug discovery, sales and marketing, technology and digital health along with tips when applying for graduate schemes and an interactive panel discussion . They explained the different roles involved in industry, whether in a pharmaceutical company or a supporting agency and how to get into one of these careers. Pf View: If you’re looking for graduates to join your organisation, you can promote your vacancies at www.pharmajobs.co.uk
Menopause affects more than 50% of the population Breaking the taboo, p26
NHS FRAMED T
he NHS Long Term Plan Implementation Framework has been published, setting out further detail on how the Plan will be delivered. Sustainability and Transformation Partnerships and/or Integrated Care Systems are agreeing their five-year strategic plans covering the period 2019/20 to 2023/24. These plans will clearly describe the population needs and case for change in each area, then propose practical actions that the system will take to deliver the commitments set out in the NHS Long Term Plan. The Implementation Framework summarises these commitments alongside further information to help local system leaders refine their planning and prioritisation. This includes detail about where additional funding will be made available to support specific commitments and where activity will be paid for or commissioned nationally. It is intended as an operational document to support health and care systems with their planning, developed and tested with many of the stakeholders involved in developing the NHS Long Term Plan.
Sales incentive GSK has announced changes to its sales representative incentive programme in certain countries. The changes reflect the growing shift in GSK’s portfolio to innovative Specialty Care products, including oncology. GSK says it will allow the company to attract and retain the best salesforce talent, enhancing the quality of dialogue with healthcare professionals (HCPs) and helping them better serve patients. GSK says that the changes uphold its ethical and valuesled approach to HCP engagement, in full compliance with laws and policies, whilst supporting delivery of strong performance. Changes will be made to the incentive programme for pharmaceutical and vaccines sales representatives to better recognise and reward individual effort. They will be applied initially in the US, UK and Canada with a comprehensive training, control and monitoring framework.
NOVEL START New data from Novel START, an open-label trial designed to reflect real-world practice, has demonstrated the effectiveness of Symbicort Turbuhaler (budesonide/formoterol) as a potential anti-inflammatory reliever in mild asthma. The results were published in the New England Journal of Medicine and presented at the American Thoracic Society 2019 International Conference. The trial compared Symbicort Turbuhaler with two commonly used treatment regimens in mild asthma.
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ing’s College Hospital is using the newly approved CAR-T (chimeric antigen receptor T-cell) therapy to treat adult patients with lymphoma. CAR-T therapy is a complex immunotherapy that is personally developed for each individual patient. It involves harvesting T-cells – the immune cells that recognise and kill viruses – from the patient, reprogramming them to recognise cancer cells, and infusing them back into the patient so they attack the cancer. Currently, CAR-T therapy is being used on selected patients at King’s with a recurrence of lymphoma – a cancer that begins in the infection-fighting cells of the immune system. The treatment is effective in around 4050% of cases, including patients who did not respond well to chemotherapy, but it has a unique set of side effects, including neurotoxicity, in the short-term. At King’s, all CAR-T patients are screened for anxiety and depression. Any patient showing symptoms will receive mental health support to cope with the difficult effects of the treatment. Pf View: Having watched the recent BBC Two programme ‘War in the Blood’ on CAR-T Therapy, it’s fantastic that King’s College Hospital is supporting patients’ mental and physical health during this ground-breaking but difficult treatment. If you haven’t seen it, it’s worth a watch.
Mind the gap
SLEEP CONNECTIONS New research presented at the Alzheimer’s Association International Conference (AAIC) 2019 in Los Angeles highlights the relationship between sleep medication and dementia. It examines the use of sleep medicines in mid-life in diverse groups and found surprising differences in their impact on later-life risk of dementia. More frequent use of sleep medications may be associated with higher risk of dementia, especially in older white adults compared to older black adults who experienced reduced risk. Whether the change in risk is due to the medications or sleep problems is not yet known. Men over 65 years of age who used sleep medications were at increased risk of developing Alzheimer’s dementia, as were some women. However, women who used sleep medications but did not have interrupted sleep had a reduced risk.
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Leading dementia experts from universities, pharmaceutical companies and charities have identified six gaps in dementia research that present new opportunities to speed up the search for the first life-changing treatment for the condition. The work, funded by Alzheimer’s Research UK, calls for a fresh focus on how research is conducted, including new approaches to clinical trials and incentives for scientists to increase collaboration to bring about potential treatments faster. The review is published in the journal Alzheimer’s & Dementia. The all-encompassing examination by Alzheimer’s Research UK reviews the barriers that pose a threat to research progress and importantly suggests new ways to accelerate the development of a lifechanging treatment. The opportunities are to: • Investigate the effects of newly-identified genetic risk factors on disease processes. • Improve understanding of why some brain nerve cells are more resilient than others. • Bolster early drug discovery work to identify the most promising new treatment targets. • Ensure the right selection of participants for clinical trials. • Improve ways to measure how effectively drugs are working. • Find ways to begin clinical trials in people decades earlier than we do today. Pf View: This work to accelerate the search for a life-changing treatment for such a devastating disease could have a significant impact on those living with dementia and their families.
P f N E W S : B R I N G I N G YO U T H I S M O N T H ' S E S S EN T I A L H E A D L I N E S
Blood test breakthrough
ew MRC funded research from scientists at the University of Cambridge and the Wellcome Sanger Institute has found that the superbug MRSA may be susceptible to existing antibiotics. Methicillin-resistant Staphylococcus aureus (MRSA) has become a serious problem, forcing doctors to turn to antibiotics other than penicillin or penicillin derivatives, or to different drug cocktails, which are often less effective in treating hospital and community based infections. However, the new research has found that some MRSA infections could be tackled – and by using existing antibiotics. The researchers found that MRSA isolates become susceptible to penicillin in combination with clavulanic acid: a widelyused beta-lactamase inhibitor for the treatment of kidney infections during pregnancy. Using genome sequencing technology, the researchers were then able to identify
which genes make MRSA susceptible to this combination of drugs by identifying several mutations centred around a protein known as a penicillin-binding protein 2a or PBP2a; a protein which enables MRSA strains to keep growing despite the presence of penicillin and other antibiotics derived from penicillin. The team found that two of these mutations reduced the amount of PBP2a produced, while two other mutations increased the ability of penicillin to bind to PBP2a in the presence of clavulanic acid. The team then looked at whole genome sequences of a diverse collection of MRSA strains and found that a significant number of them contained both mutations, suggesting that they too would be sensitive to the combination of drugs. MRSA infections in two model systems, moths and mice, have since been successfully treated using a combination of the two drugs with the team now looking to expand into human trials.
Pf IN NUMBERS
Car-T therapy is effective in around
MDNA Life Sciences has announced that its breakthrough Mitomic® Prostate Test (MPT ™ ) – the world’s most accurate blood test to determine whether a man does or does not have prostate cancer that requires treatment (clinically significant prostate cancer) – is now available for clinical use. The new test takes advantage of the unique characteristics of mutations in mitochondrial DNA as biomarkers which can signify the presence of clinically significant prostate cancer. A clinical study carried out in collaboration with the University of Cambridge shows that the MPT ™ biomarker has a higher than 99% negative predictive value. This means that men with a negative MPT ™ result can safely delay or avoid further diagnostic tests, as they are highly unlikely to have clinically significant prostate cancer. MPT ™ also has a 92% sensitivity, which means that men with a positive MPT ™ result can be referred for immediate medical intervention.
Start CAR-T, p6
Agile 12 principles is based on four statements and
A new mindset, p10
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Time to act The NHS will test the world’s first ‘subscription’ style payment model to incentivise pharmaceutical companies to develop new drugs for resistant infections. The trial will be led by the National Institute for Health and Care Excellence (NICE) and NHS England and NHS Improvement. It will test a ‘subscription’ style model that pays pharmaceutical companies upfront for access to drugs based on their usefulness to the NHS. This is intended to make it more attractive for companies to invest the estimated £1bn it costs to develop a new drug, as they can be reassured that they will still be paid for the drug even though it may be stored for reserves. NICE and NHS England and NHS Improvement are calling for companies to identify products to be considered for the initial phase of the test. The work will be evaluated from the start and findings will be shared with the rest of the world so that other healthcare systems can test similar models. The Association of the British Pharmaceutical Industry (ABPI) has responded by saying that patients “can’t afford to wait”. Dr Sheuli Porkess, Executive Director of Research, Medical and Innovation at the ABPI, said: “Increased resistance to antibiotics is one of the greatest threats to global health we face. [This] announcement is an example of how the UK can lead the world in this fight and hopefully brings us closer to fixing the problems that have hampered investment in antibiotics research for so long. “Patients can’t afford to wait. Our members are ready to get started, and the sooner we get this pilot up and running, the sooner we can apply what we find to other antimicrobials in development.”
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he Royal College of General Practitioners (RCGP) has produced its ‘Fit for the Future’ report, which proposes 15-minute GP appointments as standard, as opposed to the current 10-minute appointment time limit. In response to the proposal, Dr Richard Vautrey, BMA GP Committee Chair, said: “As more and more patients live with a number of complex conditions, GPs are increasingly concerned that short consultations with their patients are rarely conducive with providing the high level of care that people expect and deserve. This unreasonable time pressure also has a major impact on the mental wellbeing of doctors. “No GP wants to rush their time with patients, squeezing it into a 10-minute window when it needs far longer, but they are forced to do so by the sheer volume of workload they are faced with. While it is for practices to determine how long their appointments should be, the BMA wants them to have the necessary resources and workforce capacity to be able to dedicate appropriate time to each patient and set their own safe workload limits. Dr Vautrey went on to say that this “important piece of work” from colleagues at the RCGP mirrors much of what the BMA has been saying for some time about the direction of general practice and what is needed to ensure its future.
Pf IN NUMBERS
There are over
7000 3.5 million
people in the UK live with a rare disease Dare to think rare, p22
P f N E W S : B R I N G I N G YO U T H I S M O N T H ' S E S S EN T I A L H E A D L I N E S
RESPONDED TO A SURVEY ABOUT THEIR CAREER IN-ROLE REALITY Valuable resource, p16
COMPETITION CONCERNS The Competition and Markets Authority (CMA) has accused four pharmaceutical companies of illegal market sharing over anti-nausea tablets. In a statement of objections, the CMA alleges that, between June 2013 and July 2018, Alliance, Focus, Lexon and Medreich agreed not to compete for the supply of prescription only prochlorperazine 3mg dissolvable or ‘buccal’ tablets to the NHS. Prochlorperazine is used to treat nausea and dizziness. Between December 2013 and December 2017, the prices paid by the NHS for prochlorperazine rose by around 700% from £6.49 per pack of 50 tablets to £51.68. From 2014 to 2018, the annual costs incurred by the NHS for prochlorperazine increased from around £2.7m to around £7.5m, even though the number of packs dispensed fell. The CMA has provisionally found that Lexon and Medreich were paid a share of the profits earned by Focus on the supply of the Alliance product and agreed not to compete for the supply of prochlorperazine in the UK.
Parkinson’s UK will invest up to £1m in NRG Therapeutics Ltd to discover and develop a potential drug that could safeguard dopamine cells that are damaged by Parkinson’s and slow down the progression of the condition. Building on discoveries that show a direct link between mitochondrial dysfunction and the loss of dopamine cells, the partnership will develop and translate this pioneering research into a potential therapeutic. The initial investment will support the identification of novel, small, molecules that are likely to enter the brain and protect the mitochondria within dopamine-producing cells. If successful, these molecules will be tested in pre-clinical models of Parkinson’s disease before progressing into small-scale human clinical trials to investigate their safety and potential benefits as a treatment.
MORE THAN JUST PRINT. Each month we publish daily news and exclusive articles on www.pharmafield.co.uk. Here’s a look at some of the exclusive content you may have missed. Want to know the full stories? Find these & the latest news at www.pharmafield.co.uk
THE FIVE LEGAL PITFALLS OF CLINICAL TRIAL AGREEMENTS
ANTIMICROBIAL RESISTANCE: INNOVATION AND AWARENESS
Collaboration between pharmaceutical companies, research organisations and hospital trusts, and the resulting clinical trials of new products and processes, are an essential part of getting new drugs to market. Clinical trials are subject to a high degree of regulation, with multiple parties being involved in their successful execution. It is, therefore, not surprising that the contractual framework surrounding those trials may be complex. Sarah Lynam discusses the five legal pitfalls of clinical trial agreements.
A recent study from researchers at Glasgow Caledonian University warned that Scottish hospitals are at risk of a superbug outbreak – unless attitudes change towards screening. Researchers pointed to concerns over a lack of awareness among health professionals and the public about the threat posed by CPE (carbapenemase producing enterobacteriaceae) and the ways in which it can be stopped. Paul Chapman discusses antimicrobial resistance and how innovation must go hand-in-hand with awareness to combat superbugs.
HOW PHARMA CAN PREPARE FOR BREXIT Brexit is a big issue for many businesses and those in the pharmaceutical sector are probably facing a more uncertain future than many others. Although the pharmaceutical sector will see huge opportunities whatever happens there are some actions that SME companies should be taking to prepare for Brexit. John Leyden shares his basic steps.
AVERTING THE CRISIS IN GENERAL PRACTICE THROUGH COLLABORATION Chris Barker believes a new generation of long-term partnerships could hold the key for GPs looking to retain their GMS contracts, offer their patients the continuity of a local practice and build a sustainable general practice. He explores how to avert the crisis in general practice through collaboration.
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A new mindset
IMPLEMENTING AGILE IN PHARMA
Neil Osmond asks whether the Agile mindset and approach to managing projects could solve the pharmaceutical industry’s productivity problem and discusses the benefits of implementing Agile in pharma.
gile is a mindset made popular by the technology sector, it has the potential to unlock solutions to productivity challenges. But could it solve the pharmaceutical industry’s productivity problem? The first consideration is whether we have a productivity problem in the first place. I believe we are being challenged on two fronts. Firstly, resource efficiency, as a result of declining access to customers through traditional channels, reduced margins, increasing research and development costs and a decrease in overall headcount. Secondly, the growing expectations of our customers and patients for remote consultations, social media, digital solutions and broader service offerings. It seems like we are increasingly required to deliver more, faster, with fewer resources and at reduced costs. If you agree with these statements, I would argue we definitely have a productivity problem! The good news is that we seem to be open to looking to other sectors for solutions and an obvious sector is technology. Big companies such as Google, Spotify and IBM often point to productivity improvements resulting from adopting Agile. However, not everything that works in other sectors works well in a highly regulated sector such as healthcare. The big question is whether a pharmaceutical version of Agile might be the key to unlocking greater productivity.
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C OV ER S TO RY
WORDS BY Neil Osmond
Reflecting on my own journey, I needed a lot of convincing that it was worth the hassle and risk to move from traditional waterfall (Gantt charts etc.) to this new Agile way of working. However, nine years and 150+ projects later, I am 100% convinced that if I had adopted this mindset when I worked in a pharmaceutical company it would have transformed my personal productivity, and also the productivity of the teams I was part of, and which I managed. I am so convinced of its value that the best part of my job is now helping pharmaceutical teams (using Lego) to adopt the Agile mindset and seeing them flourish as a result. However, I am frustrated by some of the myths surrounding Agile. For the record, it’s not new or complex. In fact, it’s not even a methodology. If Agile is anything, I would describe it as a ‘mindset’, of ‘doing more for less’ (who doesn’t want to do that?). At its heart, it enables you to deliver what the customer actually needs earlier, whilst reducing wasted time, effort and resources on the journey. Whilst my company has been using an Agile approach to projects for nearly a decade, until recently it was almost always new to our clients. However, in the last year we have seen a number of clients proactively adopt Agile internally and we have been training business teams on how they can use Agile in their day-to-day work.
Four values of Agile
1. 2. 3. 4.
Individuals & interactions
Responding to change
over contract negotiation
over processes and tools
over following a plan
over full documentation
12 principles of Agile
Reflect and adjust
So, what is Agile and where does it come from? Well the books, of which there are many, will tell you that it is an approach where solutions evolve through collaboration between self-organising, cross-functional teams. It evolved from a conference of technology experts who assembled in Utah in 2001 to discuss how technology projects seemed to be so often late, over budget, to low quality and functionally incomplete. Even when projects were on time, scope, budget and specification, customers seemed to be disappointed anyway. This group of 17 software experts developed four values and 12 principles. You can still see them on the original website www.agilemanifesto.org. That’s it: four values and 12 principles, and what’s more, they aren’t even that new. Their roots are in the lean manufacturing principles developed in the 1940s and 50s in the Toyota Manufacturing Company.
Sources: www.softwaretestingclass.com/agile-manifesto-and-principles www.visual-paradigm.com/scrum/agile-manifesto-and-agile-principles
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Agile helped us create solutions that are aligned with the needs of our customers and patients. It has helped us to get solutions live quicker and respond to user feedback
Kym Jacks-Bryant, Global Digital Marketing Lead, Norgine
Benefits of Agile for pharma
Customer/Patient It enables, even requires, you to bring the voice of the customer, or patient, into the project from the very beginning and throughout.
Visible delivery It focuses a team on shorter term, tangible deliverables over grand plans that rarely realise benefits.
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Harmonising teams It reduces bottlenecks through self-organising teams who take on shared responsibility; they win together and lose together.
Decisions and transparency It encourages decisions to be made at the point the team is wisest, and not before, and brings transparency to projects so risks, progress and delays can be caught and addressed earlier.
Minimises waste It minimises wasted time and effort by encouraging a laser focus on what needs doing next rather than being distracted by lower priority tasks.
C OV ER S TO RY
IMPLEMENTING AGILE IN PHARMA If you’re now excited about ‘the art of the possible’, the next step is where to start your journey with Agile. Here’s some top tips: 1. Jump in together. Train the team and get buy-in before you start. If you succeed as a team and fail as a team then everyone needs to want to ‘have a go’ or it will feel like it was your idea. 2. Start with Agile lite. You can start as simply as using a Kanban board and then build from there. There is no right and wrong way, you will find your ‘right’ way through trial and error. 3. Get your roles right. This is not obvious and took us a while to work out but being clear on who makes the decisions, who manages the tasks getting done, who contributes expertise and who is the voice of the customer makes projects run much more smoothly. 4. Succeed as a team, fail as a team. If you live by this, it makes blame games irrelevant and means that going at the pace of the slowest runner is not an excuse for everyone else. 5. Speed to a Minimum Viable Solution. This can be challenging but can unlock so much value by not committing to work and expenses until you have learned in the real world rather than guessing at the planning stage. 6. Get support functions on board. Get the functions that sign off your tasks to agree to your new way of working. Often signatory and regulatory functions are used as an excuse why Agile would ‘never work here’. However, our experience is the opposite, and once they have the hang of it, medical, legal, IT and compliance can find Agile liberating. If you are still reading then maybe, just maybe, you want to find out more about Scrum, standups, sprints, retrospectives, Scrum Masters and Kanban boards, or maybe even fancy learning Agile in half a day using Lego. If you do, take a look at the ‘How to’ article on Agile that I have written for the Pharmafield website.
CASE STUDIES NICK WILLIAMS – MY JOURNEY WITH AGILE
spent most of my career in the commercial arm of ‘Big Pharma’, with the most recent role being Business Unit Director at MSD UK. MSD started to introduce Agile to support their ambitions with digital; developing, adapting and reinventing content. However, by adopting Agile, I witnessed benefits that went further than simply keeping up with fast-moving digital campaigns. Teams functioned better together, and work was prioritised more clearly, delivered earlier, and with greater confidence that outputs would translate into outcomes for patients and healthcare professionals. I became an Agile advocate and since leaving MSD, I help pharmaceutical teams develop and deliver their strategy by developing their own unique version of Agile. Novartis UK is a great example of a company that has seen the tangible benefits of Agile. The UK Leadership Team was keen to identify ways to support their teams to work through complexity, rationalise workloads and achieve results. We conducted a pilot with a single multi-channel marketing project in one integrated franchise team with a combination of initial training and ongoing support. Agile needed to deliver tangible results for the pilot to have been perceived as a success. They found: • Delivery time – reduced by half compared to internal benchmarks. • Production of materials – 70% reduction in time spent in approval, and costs were 50% lower than expected. • Team satisfaction – rated highly, with confidence to repeat this achievement in future work at +90%. “Our pilot team delivered an outstanding result by adopting an Agile approach and their experience has had a direct influence on our decision to use Agile across more of our business,” said Caitriona Walsh, Business Franchise Head at Novartis UK. “We believe this can play a part in helping us prioritise what’s important and further simplify how we work, which will enable us to have a greater impact for patients.” Nick Williams, Director, Triducive NORGINE – CREATING SOLUTIONS WITH AGILE
s an agency that adopts Agile in every project, we must be careful about how we introduce this to our clients; if we go too fast, they can feel bullied into working our way, but if we go too slow, we risk wasting our client’s resources when we know we could have been more productive. Norgine is a great example of where we have been on a journey from traditional project approaches to fully embracing Agile. “Agile helped us create solutions that are aligned with the needs of our customers and patients. It has helped us to get solutions live quicker and respond to user feedback.” Kym Jacks-Bryant, Global Digital Marketing Lead, Norgine. Neil Osmond is a technologist and founder of digital agency earthware. He has 20 years’ experience in healthcare and a passion for solving problems for patients and healthcare professionals. Go to www.earthware.co.uk/agile
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NHS Neglect Was Hunt’s legacy his downfall? As Jeremy Hunt learned this week, and throughout his career, politicians neglect NHS staff at their peril. Claudia Rubin discusses Hunt’s legacy and how it may have lost him Number 10.
he Conservative Leadership election is over, the decision made, Boris Johnson is Prime Minister and Jeremy Hunt fell short. Had there been any other opponent in the race to be Prime Minister (PM), you might have expected Hunt to be settling into life at Number 10. His career trajectory having gone almost according to plan. From Head Boy to Oxford University, a successful business, MP of a safe seat before he turned 40, quickly into government for a cushy Olympics role, then the longest serving health secretary, and finally foreign secretary. Instead, the gamble of taking on Boris Johnson for party leadership didn’t pay off, and he has reached a rather gritty line in the Westminster sand; his political career plausibly, somewhat prematurely at an end. Only a tiny fraction of the country chose the new PM, and with just one vote for every two secured by Johnson, Hunt just didn’t have the numbers, or the people, behind him. Though portrayed as a somewhat inevitable fulfilment of an overt ambition, Boris Johnson certainly won, in part, because of Hunt’s fundamental failings, set down when he occupied the top job in health.
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HEALTH WASN’T ON HIS SIDE
Neglecting to prioritise the NHS workforce during his time as Health Secretary stands out as perhaps one of Hunt’s chief failings. His failure to see doctors and nurses as the fundamental axis upon which all his policy initiatives would either fly or fall, has been his ultimate undoing. Though few NHS staff are likely to have voted in the leadership contest, many could have championed his candidacy. The lack of Hunt advocates from within the NHS during the leadership campaign, speaks volumes. Especially given the presumed benefit of having someone with immense health policy background in Number 10, (as well as Boris Johnson’s total disinterest in the NHS). More so because in his final act as Health Secretary, Hunt secured widely celebrated funding increases for the NHS, totalling £20.5bn in real terms by 2023. This parting gift, together with a generous reflection of the circumstances of Hunt’s tenure, could have led to vocal support amongst healthcare workers for his campaign. After all, it was during the slowest period of investment in the NHS since its foundation, that Hunt had to meet extraordinary healthcare demand. Health spending had historically risen by about 4% above inflation each year on average, but during his time, it fell to about 1% a year (post-2010). With plentiful Brexit distractions thrown in too, any achievements in health outcomes, patient safety, financial management, and digital reform were impressive. Not least because, with the shambles he inherited after the failed reforms of his predecessor, Hunt had to oversee the unpicking of this complex web into something that better resembles integrated care.
HIS FAILURE TO SEE DOCTORS AND NURSES AS THE FUNDAMENTAL AXIS UPON WHICH ALL HIS POLICY INITIATIVES WOULD EITHER FLY OR FALL, HAS BEEN HIS ULTIMATE UNDOING
WORDS BY Claudia Rubin
LEGACY SPEAKS VOLUMES
However, as many a health, education or home office minister can testify, bringing the workers with you – having the industry body on your side, is key to making a success of your brief. Unfortunately, within two years of taking office, Hunt faced the first strike by health workers in 32 years, when 450,000 NHS staff walked out in October 2014. This was followed in 2016 by the first doctors strike in 40 years, a response to Hunt imposing on them a new contract. Then there’s hitting targets, a long-forgotten luxury. The NHS hasn’t met any of its targets in cancer care, hospital appointments and A&E waiting times since 2015. NHS staff are seemingly under more pressure than ever. Nursing is in particular crisis, and Hunt’s catastrophic decision to abandon the nursing bursary saw applications to study nursing drop two years in a row. There was a record vacancy rate of 41,722 nurses (11.8% of the entire nursing workforce) the month before Hunt departed. The interim NHS People Plan, published in May recognised shortages across a wide range of NHS staff groups noting the most urgent challenge is the current shortage of nurses. Primary care, the backbone upon which the entire NHS operates, is also in a dire situation, and GPs, whose support Hunt would have surely benefited from, was similarly absent in the leadership campaign. Hunt famously called general practice the “jewel in the crown” of the NHS. However, when he left the Department of Health and Social Care in 2018, there were just 162 more GPs in the NHS than there were when he made his 2015 pledge to have “5000 more by 2020”.
Of course, removing political interference from some aspects of NHS policy was a specific goal of the 2012 reforms, but Hunt’s major error was to fail to maintain tough ministerial accountability for staffing the NHS. Responsibility for workforce planning and supply ought to be one of the key political decisions of the Health Secretary. Eleanor Smith MP recently brought a Westminster debate on the subject. Ms Smith, like many others, wishes to see legislation brought forward to further clarify the Secretary of State’s legal duties and powers as regards workforce, for example with the introduction of mandatory minimum safe staffing levels, enforced in law. Never again would the system be able to sidestep workforce planning when setting a 10-year vision for the future of the NHS. This bizarre move threatens to undermine many of the bold ambitions within it. NEGLECT AT YOUR PERIL
Given that the total eligible electorate for the new PM was ten times smaller than the total number of people employed in the NHS, it would be wise for our next Secretary of State for Health and Social Care to be mindful of this important constituency. Do right by them and in turn by the NHS and its patients, and you never know, you might be able to draw upon their support a little way down the road, were you to ever need it. Claudia Rubin is a Director at Decideum. Go to www.decideum.com
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Valuable resource Understanding the role of the MSL Helen Kane surveyed more than 200 medical science liaisons (MSLs) to understand more about their current in-role reality. She gave Pf Magazine exclusive access to the results. WORDS BY Emma Morriss
ccording to IQVIA’s White Paper Medical Science Liaisons: A key to driving patient access to new therapies: ‘Medical Science Liaisons (MSLs) are therapeutic specialists with advanced scientific training. They are experts in communicating complex scientific and medical information to a variety of stakeholders. Their primary role is to build and foster strong relationships with key external experts in their shared therapeutic category. They provide a credible link to external stakeholders,
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helping bridge the communication between clinical development and commercial success. Additionally, MSLs are in a unique position to gather insights that inform business strategy in areas such as product development and market access.’ MSLs work to manage industry reputation through informed, nonpersuasive conversations with healthcare professionals (HCPs). They require a breadth of medical skills and business acumen, plus a good network of contacts, making them a rare breed. This means that for those organisations which are seeking to build a best-in-class MSL function, it is important to support and nurture them.
MSLs IN A CHANGING MARKET
Both industry and the health sector are facing increasing pressures from an ageing population with multi-morbidities, healthcare finance and increased scrutiny from payers and approvers. The doctor/patient relationship is also changing, with patients having a more powerful voice in decisions around their health. Added to this, perceived issues with lack of fair pricing and transparency in industry can affect relationships with HCPs. MSLs are key members of medical affairs who sit between research and development, sales and marketing. This means they need to focus on communication, education and reputation, aligning their activities with the needs of HCPs. To do this, MSLs need to be the right people with solid foundations including proper governance, an embedded scientific engagement model and an aligned strategic direction to the wider business. However, the role is not always clearly defined across industry, as Helen explained: “The MSL function is not necessarily universal. We are aware of at least 28 acronyms for the MSL function, meaning the role of MSLs can be confused amongst HCPs. “What is universal, though, is that MSLs play an important role in a drug’s lifecycle. They are the external face of medical and will have been selected for their scientific and technical expertise, communication skills and business acumen. In pharmaceutical industry language, the MSL is defined as non-promotional.” Although the role of the MSL is one of the fastest growing in industry, it is under scrutiny. Helen added: “To be effective in-role, the MSL needs to have the essential knowledge, skills and behaviours, to be recognised internally and externally as different to sales, as a conduit between the organisation and the healthcare community.” MSLs have an opportunity to engage with HCPs from pre-approval through to post-approval. This is something that commercial and market access teams are unable to do. Helen continued: “MSLs with the right brief, training and direction can be the face of the organisation prior to a drug achieving approval. But they will need to know the company story, understand the vision, philosophy and values. However, according to our survey results, MSLs don’t always rate the need to know that information about their organisations as highly as their scientific knowledge. Both need to be understood.”
F E AT U R E
MSLs play an important role in a drug’s lifecycle
Helen and her team at PIVOT MSL surveyed over 200 MSLs in 2018. Respondents were predominantly field-based or working in hybrid roles. They were split across large, medium and smaller organisations and 25 countries participated. The survey identified some key data about MSLs and their place within organisations: • Interestingly, five out of 10 respondents had been in their role for less than six months to a maximum of three years. • Just over one in 10 didn’t have a job description or weren’t sure of their role, responsibilities, or competencies. • Nearly half reported to an MSL Manager, and a similar number reported to a medical director or medical manager. However, an additional survey identified that nearly six out of 10 MSL managers did not receive any upskilling to support their transition into an MSL management role. • Only 2% of MSLs surveyed said their activities included being a buddy or mentor to new-to-role MSLs. • When it came to career progression, nearly six in 10 respondents said there wasn’t a defined career pathway for MSLs in their organisation. Commenting on these figures, Helen said: “With the continued growth of the MSL function there is a lack of experienced MSLs to satisfy demand. So how do you find potential MSLs? Mainly through academia or healthcare. However, we need to recognise that these individuals are brought into a unique environment and expected to deliver with impact and value. To do so, they need to be supported throughout their professional development journey. However, it’s clear from some of these results that they are not receiving the essential support needed to succeed. Retention of MSLs is an ongoing challenge.”
STRATEGIC, GOVERNANCE & VALUE
As a unique role which can be recruited from outside the industry, initial training is essential to bring the MSL up to speed. The survey found that the key onboarding topics expected by MSLs were: job description; drug scientific data; medical strategy; compliance; ongoing clinical programme; company procedures; therapy area (eg patient journey); competitor data; future clinical strategy; key external customers; key internal stakeholders; healthcare environment; brand strategy; and company story. However, the survey found that less than two-thirds received role-specific onboarding. Added to this, just over half of respondents had a knowledge review prior to going into the field. With nearly one in four not having a review, they had no opportunity to identify where they may have information needs or challenges. Helen added: “Onboarding is critical to building a best-in-class MSL function. Our survey shows that it can range from two days to more than six months of training. MSLs require a huge amount of information and data to be able to do their job properly, I believe there needs to be consistent standards for MSL employment, training, onboarding and management.”
Given the crucial role of the MSL, the survey identified a fairly even split between those MSLs who were involved in the medical strategic plan of their drug (55%) to those who weren’t (45%). The figures improved when it came to a formalised MSL plan which is aligned to the drug strategy, with two-thirds having such a plan. On the subject of governance, threequarters of respondents had MSL Standard Operating Procedures (SOP) or guidance documents. Of those with a SOP, 58% said it had a positive impact on their daily working. As MSLs add value through their key role with HCPs, when it comes to assessing that value, there was a fairly even split of methods used with 30% using quantitative measures, 23% using qualitative measures and for 24% there were no formal metrics. Added to this, the value of MSLs isn’t always recognised company-wide. Nearly half said their value was recognised by medical and commercial leadership, nearly one in four by medical leadership only, and just over one in 10 said it wasn’t recognised at all by leadership in their organisation.
To perform their best, MSLs need specialist skills and the provision of support to teach them. These skills include: managing relationships; engaging and presenting with impact; effective cross functional collaboration; exploring to gather insights; customer identification and profiling; emotional intelligence; planning for impactful customer engagement; planning for field medical success; defining field medical value and impact; supporting launch excellence; self-coaching for personal success; and navigating challenges with confidence. However, the survey identified that one in five respondents said their organisation do not have dedicated MSL training and almost two-thirds received between zero and two coaching visits in 12 months.
WORK TO DO
There is some work to do to ensure that MSLs receive appropriate expert training and in-role guidance in order to be valued and have clear parameters within which to work. However, as an important and trusted link between HCPs and industry, it is essential that MSLs are fully supported to maximise their impact. Helen concluded: “The value of MSLs is in their building of scientific partnerships. They bridge the gap between HCPs, the pharmaceutical industry and clinical research organisations. They are the external face and voice of medical. A good MSL also needs to be a good listener both inside and outside of their organisation, sharing information back and forth for the benefit of all. “A good MSL is a valuable asset. They are bespoke, they need to have specific skills and knowledge that needs to be nurtured. And most of all, in order to retain them they need opportunities for career progression.” Helen Kane is Managing Director of PIVOT MSL. Go to www.pivotmsl.com M AG A ZI N E | AU G U S T 2019 | 17
P F AWA R D S
W STAND UP & BE PROUD Dan Davies shares his company’s motivation for entering and sponsoring the Pf Awards.
HAT IS KYOWA KIRIN?
Kyowa Kirin is a highly successful and rapidly growing Japanbased global specialty pharmaceutical company, engaged in the development and commercialisation of innovative medicines for the treatment of unmet therapeutic needs of patients, their families and healthcare professionals. We use cutting-edge biotechnology centred on antibody engineering techniques to develop these new therapies, with a current focus in oncology and rare diseases. Kyowa Kirin is entering into a phase of unprecedented rapid expansion as it introduces a series of novel treatments. Our business philosophy is underpinned by a commitment to ethical behaviour with key values of integrity, innovation and teamwork. The interests of the patients our products treat will always be at the centre of what we do. WHAT MADE YOU ENTER EMPLOYEES IN THE PF AWARDS 2019? We entered the Pf Awards 2019
in order to showcase the talent we have throughout our organisation. The Pf Awards provides our employees with the opportunity to demonstrate their capabilities outside the organisation. Everyone is so busy these days that we don’t often step back and reflect on our achievements. The Pf Awards gives us a chance to do that and demonstrate and share what makes us so successful. YOU ARE SPONSORING PF AWARDS 2020 AS WELL AS ENTERING CANDIDATES, THIS IS GREAT, WHAT DROVE THIS DECISION? Kyowa Kirin’s profile
has risen in recent years in line with our growth. It’s perhaps fair to say that given our leadership in novel therapy areas and enviable pipeline, our name deserves to be even more widely recognised. Our expansion will create many new opportunities in coming years;
THE PF AWARDS PROVIDE OUR EMPLOYEES WITH THE OPPORTUNITY TO DEMONSTRATE THEIR CAPABILITIES OUTSIDE THE ORGANISATION
sponsorship of the Pf Awards will bring us to the attention of the wider industry which will help us continue to attract the top talent. Being involved with the Pf Awards offers us an industry leading platform to profile our talent and business. I’m proud to take a team of employees to the Pf Awards. IS THERE ANYTHING ELSE YOU WANT TO ACHIEVE?
The Pf Awards showcases the best of industry talent and Kyowa Kirin is incredibly people- and employee-centric. We have an ethos of ‘Commitment to Life’ meaning we want to have an impact on people’s lives, including patients and employees. The Pf Awards gives us a platform to do that outwardly. It allows our people to stand up and be proud to work for Kyowa Kirin. Dan Davies is Business Unit Director for Speciality Care at Kyowa Kirin. Go to www.international.kyowa-kirin.com/uk
R E A D Y F O R A L I F E - C H A N G I N G W I N ? V I S I T W W W. P F A W A R D S . C O . U K T O F I N D O U T M O R E
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The role of community pharmacy in cancer Recent studies have started to involve community pharmacy in cancer prevention, treatment and support. Deborah Evans explores how this can be done.
here are around 363,000 new cancer cases in the UK every year (2014-2016)1 with breast, prostate, lung and bowel cancers together accounting for over half (53%) of all new cancer cases in the UK. With 1.6 million people visiting a pharmacy every day in England 2 , pharmacists and their teams play a significant role in cancer – from prevention through to end of life care. One in every two people in this country will be told they have cancer at some point in their lives and whilst survival rates are improving, more lives can be saved with earlier diagnosis and referral. The NHS Long Term Plan (LTP)3 aims to save thousands more lives each year by dramatically improving how we diagnose and treat cancer – the ambition is that by 2028, an extra 55,000 people each year will survive for five years or more following their cancer diagnosis. To do this, the LTP outlines a number of actions from screening improvements, creating new Rapid Diagnostic Centres, having a new fast diagnosis standard, personalising care and improving access to effective tests and treatments. To achieve this ambition, everyone will need to play their part. COMMUNITY PHARMACY AND CANCER
Community pharmacy can support improved cancer outcomes through: • Prevention. By raising awareness of lifestyle choices that can increase the risk of cancer including running health promotion campaigns on healthy eating, obesity, alcohol, smoking and sun exposure and raising awareness of signs and symptoms of cancer. Smoking cessation, weight management services and alcohol advice and intervention offered in pharmacies can help to lower risk. • Early referral. By raising the importance of national screening programmes such as for cervical and bowel cancers and signposting for further investigation in the case of red flag symptoms e.g. blood when coughing, in urine or faeces, unexpected weight loss, dysphagia (difficulty in swallowing), lumps and changing moles. For example, community pharmacists in Wales will soon be able to refer patients for a chest X-ray as part of a study to help increase the number of people identified with early lung cancer. 4
• Following cancer diagnosis. Pharmacists continue to help individuals with any lifestyle changes required to support their recovery and help manage any side effects or issues with their treatment. For example, a recent study5 explored the impact community pharmacists can have when providing health and wellbeing services to men with prostate cancer to improve their cardiovascular health. Working as part of a multidisciplinary team, pharmacists can also support improved outcomes for patients, particularly in medicines optimisation. • Helping people at the end of their life and during palliative care. This is an important role for pharmacists, particularly in urgent supply of medicines and advising on pain relief titration. Many areas have a locally commissioned or enhanced palliative care service commissioned by NHS England or the local clinical commissioning group to support access to a wide range of specialist medicines for end of life.6 To accelerate improvements in cancer survival, the NHS must look to include community pharmacies in their plans, leveraging our contact with people by formally including us in cancer pathway development. Deborah Evans FRPharmS FFRPS FRSPH is Managing Director of Pharmacy Complete, a training and consultancy company working with pharmacy and the industry. Go to www. pharmacycomplete.org 1 Cancer Research UK https://www.cancerresearchuk.org/health-professional/cancerstatistics-for-the-uk#heading-Zero 2 https://psnc.org.uk/psncs-work/about-community- pharmacy/ 3 https://www.longtermplan.nhs.uk/areas-of-work/ cancer/ 4 http://www.primecentre.wales/plus-study.php 5 https://www.surrey.ac.uk/news/community-pharmacies-make-lifestyle-impact-patientsprostate- cancer 6 https://psnc.org.uk/services-commissioning/services- database/
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What do PMCPA case rulings suggest?
Thorough understanding Rina Newton shares her top tips for ensuring agencies comply with the ABPI Code of Practice.
gencies are engaged by pharmaceutical companies because the expertise they offer may not be available in-house or because there is insufficient resource or time for in-house creation and development. However, engaging agencies brings specific requirements under the ABPI Code of Practice (the Code) that can only be reviewed through a thorough understanding of Prescription Medicines Code of Practice Authority (PMCPA) case rulings. These are often lengthy and difficult to interpret. This article summarises the key requirements of which agencies, and those that engage them, should be mindful. WHAT DOES THE CODE SAY?
Contract staff (representatives, signatories etc) must be ‘fully conversant with the Code and the relevant laws and regulations.’ Although ‘fully conversant’ is poorly defined, the principle has been reinforced in several cases, including: • In 2003, a Lilly contract sales representative heard a quiz on a local radio show asking: ‘Which year was Viagra launched?’. She called and had a conversation with the presenter off-air (which was subsequently broadcast) about the benefits of Lilly’s medicine, Cialis. Lilly admitted responsibility for the representative and for, therefore, breaching the Code by promoting Cialis to the public.
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Cases that involve agencies (which remain unnamed) often state that it is ‘an established principle that pharmaceutical companies are responsible for work undertaken by third parties on their behalf.’ This principle, however, was not actually written into the Code until 2019 (Principle 11). Whilst the types of agencies engaged by industry are very diverse, it is clear that Principle 11 applies to them all. There are cases where the agency was to ‘blame’ and the pharmaceutical company was held responsible, including: • Janssen admitted breaching the Code because its media buying agency and journal publisher used out-of-date prescribing information in an advertisement. This happened despite Janssen informing them of the correct version to use. • Grunenthal was found in breach for one of its products being promoted to the public, when an internal product training video was posted on YouTube. This was done by an actor who was subcontracted by the agency that created the video. • Cephalon was found in breach because the recruitment agency it engaged to recruit a final medical signatory, failed to check whether the medical practitioner was registered (which meant its materials were not certified). There are also cases where pharmaceutical companies themselves failed to apply due diligence or adequate oversight of agencies, including: • Astellas engaged a creative agency which employed nurses to operate a patient support helpline. Astellas failed to keep the nurses updated with product changes because of poor oversight, so were found in breach of the Code. • Celgene breached the Code because of serious compliance failings, which included representatives engaging third parties informally without written agreements. • Gedeon Richter’s events agency sent tweets that promoted its medicine to the public, but the company did not have a contract or brief which set out responsibilities.
Key learning points and top tips
When there is a Code breach, the pharmaceutical company will always be held responsible because it is liable for the acts and omissions of agencies – even if the issues were caused by subcontractors, the agency acted ‘contrary to instructions’ or the pharmaceutical company was ‘badly let down’.
Top tips for working with agencies INITIAL REQUEST FOR PROPOSAL
• Agency staff should know how the Code applies in relation to the project(s). For example, there are immense benefits in discussing promotional campaigns when both sides have a good understanding of Clause 7 (claims, artwork). • If the agency has been involved with previous complaints, these should be discussed to understand learnings and steps to avoid similar breaches. • Agencies should provide evidence they have been trained on the Code. • Agencies should be aware of their clients’ undertakings to the PMCPA, as breaching these could lead to further sanctions.
• It is essential that agencies are fully briefed and trained from the outset, and that this is documented before the project starts. ˚ New staff and/or project updates should be considered. • Agencies should be given core claims documents. ˚ These will help avoid issues with inaccurate substantiation, thus saving time, money and effort. • Agencies should be familiar with company undertakings to the PMCPA. ˚ An undertakings document can also save unnecessary time and money. • Although the initial pitch may have covered how initial Code training is completed and ongoing Code training is covered, the pharmaceutical company should regularly review how agencies are kept abreast of updates, by considering the following: ˚ Include agencies in compliance discussions such as approval meetings. ˚ Invite agencies to attend internal Code training and/or reviews of recent case rulings. ˚ Use regular questionnaires to verify agency Code knowledge is maintained. ˚ Internally assess contract staff involved in the approval of materials. ˚ Check that agency staff are validated on their understanding of company SOPs.
• In addition to the usual checks this should also inform how an agency ensures knowledge of the Code and ongoing training. • It should be clear that the partnership does not rely on only one side having good compliance knowledge. CONTRACTS & SUBCONTRACTORS
• Although contracts should specify the project brief, key deliverables, timelines etc, they should clarify the compliance requirements for both. For example, company to provide agency with updated standard operating procedures and summary of product characteristics, agency to provide evidence of withdrawn material etc. • For some channels of communication, specific Code requirements should be described such as principles for telephone interviews with journalists or social media campaigns to the public. • Subcontractors should be aware of these contractual requirements too.
• Cross-functional kick-off meetings help map out deliverables, set expectation around good documentation and any issues, and also serve to introduce key contacts. • Consider measuring KPIs throughout the project. This can help ensure regular compliance oversight.
When there is a Code breach, the pharmaceutical company will always be held responsible
WORDS BY Rina Newton
• Companies should have a good awareness of what agencies are doing. Oversight need not be reactive, and agencies are encouraged to proactively produce status reports, KPIs stats etc. • Regular oversight should be documented to provide an audit trail. • Debriefs after project completion are recommended so that both parties can understand what worked well and vice versa, so that future projects are optimised.
Working with agencies needn’t be a compliance concern as long as both sides agree and accept responsibility for compliance – from initial briefing and training, to good documentation and regular oversight. Dr Rina Newton is Managing Director of CompliMed. Email firstname.lastname@example.org 1 Case AUTH/3106/10/18 2 Case AUTH/2921/12/16 3 Case AUTH/2409/6/11 4 Case AUTH/2883/10/16 5 Case AUTH/2831/4/16 6 Case AUTH/2612/6/13
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DARE TO THINK RARE Dr Lucy McKay is Chief Executive of Medics4RareDiseases, a UK registered charity which is driving attitude change towards rare diseases in the medical profession and encouraging medical students and doctors in training to ‘Dare to think rare’. INTERVIEW BY Emma Morriss
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hat is Medics4RareDiseases? Medics4RareDiseases (M4RD) is a UK registered charity that is driving an attitude change towards rare diseases amongst medical students and doctors in training. In the rare disease community, we all know that while rare diseases are individually rare, they are collectively common. However, 70% of medical professionals that we have surveyed over the last three years were not aware that rare diseases affect one in 17 people in their lifetime . This is unsurprising as the mantra ‘common things are common’ is rife in medical teaching, while rare disease education can be difficult to cover in a busy curriculum.
In the rare disease community, we all know that while rare diseases are individually rare, they are collectively common
Patient stories demonstrate time and time again that this lack of basic understanding of the relevance of rare diseases in everyday clinical practice contributes to the diagnostic odyssey. M4RD believes that fundamental teaching about rare diseases as a whole is essential for early recognition of rare disease and early instigation of treatment where available. How did it start? The group started as a medical school society founded by five medical students. In 2011, we hosted our first ever evening lecture about Gaucher Disease by Professor Atul Mehta. We invited clinical specialists, patients and advocates to educate our peers about different rare diseases. Other subjects included EhlersDanlos, Retinoblastoma and Battens Disease. In 2013, we attracted the attention of the UK LSD Collaborative who were awarded the PALS Award from Sanofi Genzyme for our joint project ‘If you hear hooves...think zebra’. With this grant, we became Students4RareDiseases and started supporting other medical students throughout the UK to engage with rare disease education. In order to widen our scope, we rebranded to Medics4RareDiseases on Rare Disease Day 2018 and applied to become a UK registered charity. We were entered in the Register of Charities on 20th June 2019. Why rare diseases? As Chief Executive and Founder, I have a personal connection with rare diseases. My eldest brother was affected by MPS II and my mother founded the MPS Society. I grew up alongside the
patient group and when I went to medical school, I was surprised by how little attention rare diseases received. This is an understandable situation because with over 7000 rare diseases it is unlikely a doctor will come across one single disease in their career. However, with 3.5 million people in the UK suffering from rare diseases1, a doctor will be seeing people with rare diseases regularly in practice. Especially as the very nature of rare diseases means those affected are more likely to access healthcare. Therefore, M4RD concentrates on rare diseases as a collective: how common they are, what challenges people face, what support there is out there for clinicians and patients. What are your aims and objectives? The object of M4RD is the relief of sickness and preservation of health of those suffering from rare diseases, throughout the world, by: • advancing the education of medics, associated professionals and the public in rare diseases, genetic and genomic medicine, • promoting research in all areas relating to rare diseases, genetic and genomic medicine and publishing the useful results, • promoting improved care and treatment of those suffering from rare diseases. We want frontline medical professionals to ‘Dare to think rare’ – to be aware of how often rare diseases occur, how to identify signs, have knowledge of the pathway to diagnosis, empower them to think ‘is it a rare disease?’ and to know the next steps. We don’t want them to feel like they’re alone with an unsolved mystery. What do you do and how do you do it? We undertake a number of activities throughout the year. For the past six years, we’ve produced our own annual symposium for medics which we currently hold at The Royal Society of Medicine. We take all of our key messages and pack them into one afternoon. We invite a wide range of experts including patients, advocates, researchers and specialist clinicians. It is important that we all learn from each other. Our aim is to get our key messages grounded into the thinking of the medical professionals in attendance and engage them. Rare diseases are often complex conditions requiring numerous
appointments and on average it takes four years to achieve a diagnosis1. We offer pragmatic tips for medical professionals around understanding, identifying and supporting people with rare diseases. We also help student societies to produce their own professional events and we engage with medical students abroad to help them share messages about rare diseases in their area. Our ambassadorship programme includes a number of doctors who raise awareness of rare diseases through events, articles, or by championing rare diseases in their Trust or teaching group. Alongside this, we develop learning tools, engage in meaningful collaboration with other rare disease organisations, maintain a useful website and active social media presence. You can check out our Instagram Story on Mondays #MysteryDiseaseMonday. We also run specific projects including our Red Flags of Rare Disease Survey and Rare Disease 101 Project. What is the pharmaceutical industry doing to tackle rare diseases? The pharmaceutical industry is hugely important in rare diseases because it is driving progress in treatment. Conditions that were previously devastating and life-limiting, like MPS II and Gaucher, have treatments available. Working together with healthcare providers, patients, researchers and advocates, the pharmaceutical industry is creating new prospects in rare diseases. It also plays an important role in education – the pharmaceutical industry isn’t just about providing treatment but also vital education about holistic management. Who makes your work possible? We are grateful to our industry sponsors who make the work of M4RD possible, and to those who offer non-monetary support such as business support, skills-sharing or mentoring. Our 2019 sponsors are BioMarin, Inventiva and Sobi and we are currently looking for sponsors for 2020 so that we can continue our vital work. We believe that anyone working in rare diseases would benefit by helping us to get our message out to medical professionals. Go to www.m4rd.org 1. www.raredisease.org.uk
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People power Paul Terry explores how the sales representative is best placed to build trust with the health sector, and how industry needs to adapt to support them to do this. WORDS BY Paul Terry
f recently revealed the results of its trust survey, placing a spotlight on an issue that doesn’t seem to be going away any time soon. When asked ‘Overall I trust the Pharmaceutical Industry’, approximately a third agreed, while a third disagreed or strongly disagreed. For many, these results will be a source of sadness; the belief that we make a difference for patients and society is often a core reason for entering the industry. Yet the public and decision makers commonly have a perception that is very different. With this in mind, it is good to see the ABPI launch a ‘Valuing Medicines’ campaign, designed to showcase how industry is critical for the health and wealth of the UK. Issues of trust have major implications for our field-force. In an era of multi-channel engagement, challenging customer access and formulary-driven prescribing, the relevance and purpose of the pharmaceutical sales representative continues to be debated. When faced with a challenging return on investment, it may be tempting to turn to alternative options to engage with customers, particularly if there’s a consideration that sales teams are culpable in helping to sustain a poor reputation.
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According to Maister, Green and Galford trustworthiness is created through credibility, reliability and intimacy (how secure a client feels sharing with the representative) and is undermined by self-orientation.
ourselves how credible industry is as a source of influence and advice? Imagine that you own an expensive sports car. Would you turn to Google to help you learn how to service it? I suspect you’d much rather engage a specialist mechanic, who has unique skills, training and the appropriate diagnostic tools for the job, supplied by the manufacturer. We need HCPs to do the same and turn to industry.
(Credibility + Reliability + Intimacy) UPSKILLING THE SALES TEAM
Considering credibility, what does that look like from our customers’ perspective? The NHS Long Term Plan heralds yet another evolution for the NHS and the demands of ‘more for less’ show no signs of abating. Time is an increasingly precious commodity, so why should customers spend it engaging with sales representatives? Clearly, industry recognises the challenge facing healthcare professionals (HCPs) and is responding, providing options to engage through multi-channel solutions. Yet it’s worth questioning whether we have really got to the root cause of why HCPs may prefer not to engage, before running to a tempting (if incomplete) solution. Perhaps we need to ask
The first step in this is addressing issues of credibility and the ‘Valuing Medicines’ campaign will hopefully be a step towards this. But what are the knowledge and skills that field teams need in order to be recognised as a valuable use of customer time? How prepared are they to answer complex therapeutic questions, which may be subtly nuanced, depending on the patient type or stage along a new integrated pathway? Is the clinical key message that we want to deliver really the thing that is going to add spark to our customers’ flame? The Corporate Executive Board (CEB) offered up an alternative to the transactional sales call. It’s hard to argue against its evidence that in a complex selling environment, the challenger sale, which teaches customers something new and valuable about how to perform better, is the most impactful in changing customer behaviour.
F E AT U R E
An ability to tailor for resonance relies on knowledge of the specific priorities of whomever our representatives are talking to. However, here’s the rub: the NHS labyrinth is complex and very few of our customers have the time for us to have a conversation to explore their needs – they need us to show them something about their own situation that can be improved (that they may have not been aware of) and offer a solution. Maister et al consider self-orientation to have the greatest impact (negatively) on the perception of trustworthiness. The next time we approach a customer, it might be worth considering who we are there for and how well-prepared we are, to help customers see the value in what we offer. ADAPTING INDUSTRY
We then need to look at how we challenge and support our field teams to have value-based conversations; whether the global marketing strategy fits the local situation; what insights the marketing team have that provide an impactful proposition to teach customers. If time is a scarce resource for our customers, how do we treat it in our own organisations? Knowing that the NHS is complex and tailoring for resonance requires exquisite insight (which may be hard to obtain and review), how do we support our teams to build the capability and capacity to work in this way? What do we need to stop doing, in order to start doing this, if we aren’t already?
Digital transformation might help us get messages to our customers, but it is people that build relationships
Organisational readiness and culture are important considerations. Are our training capabilities, coaching capacity, compliance and recognition programmes set up to support our working in this way? Even the most innovative and cost-effective solutions will remain underutilised, unless skilled influencers can help decision-makers understand the relative benefits and positioning along the pathway. BEING RELIABLE
Through all of this, creating trust depends on us being reliable. There are many great examples of our industry supporting ethical ‘beyond the pill’ services, that have benefitted patients. The NHS needs us to innovate not only in our science, but also in the way we are able to navigate our regulatory concerns and process diligently, to provide these solutions. If we can’t resolve our customers’ issues, then we shouldn’t be too surprised if they don’t rely on us. It might be tempting to conclude that the challenge of reframing perceptions of industry trust is insurmountable. But then people rarely give over their trust to institutions, they give it over to people. Steve Radcliffe’s ‘Relationships to Results’ model in ‘Leadership, Plain and Simple’, asserted that in order to create big ideas, that can lead to new opportunities and better results we need to have ‘relationships big enough to get the job done’. Radcliffe believes that failure to invest in relationships leads to poorer results. If we accept that, then perhaps the Pf Trust Survey is a great opportunity for us to consider how we recruit and develop people, to help us navigate to a brighter future. Digital transformation might help us get messages to our customers, but it is people that build relationships. Paul is the Founder of the customer engagement consultancy, Paul Terry Associates. Go to www.paulterryassociates.com Sources: Radcliffe, S. (2012) Leadership Plain and Simple. Financial Times Publishing Maister, Green, and Galford. (2001) The Trusted Advisor. Free Press.
OPPORTUNITIES, PRIORITIES POSSIBILITIES, IDEAS
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Breaking THE TABOO Hormone replacement therapy (HRT) has been battling perceptions of its safety reputation for over 15 years. But for people going through menopause, it can have a significant effect on their symptoms and for most is it considered safe. How can the taboo of HRT and menopause be broken for the benefit of more than 50% of the population?
ike the now debunked link between the MMR vaccine and autism, HRT has been dogged by a bad safety reputation since it was linked to breast cancer in a research study published in 2001. Despite follow-up studies reporting that the benefits of HRT outweigh the risks for most women, the research and subsequent media coverage caused confusion amongst healthcare professionals and members of the public and led to a collapse in confidence in HRT and a dramatic drop in HRT use around the world. WORDS BY Emma Morriss
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enopause is a natural stage of life and is defined as when a person has not had their monthly period for at least 12 months. However, it is a common catch-all term for perimenopause (pre-menopause), and the symptoms associated with changes in hormone levels. Although it is a stage of life experienced by more than 50% of the population, there is a lack of understanding of the significant effect that menopause can have on quality of life. Menopause Doctor, Dr Louise Newson explained: “Symptoms vary tremendously between women. The most common are the vasomotor symptoms (hot flushes and night sweats). Other symptoms include mood changes, memory loss, urogenital atrophy, a lack of interest in sex, sleep disturbances, and joint and muscle stiffness. “These symptoms can be non-existent, last for a few years, or for some women they can last for decades. Around 75% of menopausal women experience
symptoms, with around one third of these experiencing severe symptoms.” Addressing these symptoms should involve lifestyle changes, as Dr Anne Connolly, Chair of the Primary Care Women’s Health Forum explained: “Women expect to spend nearly half their lives post-menopause. They should consider lifestyle changes as well as whether they take HRT at the time of the menopause, protecting their hearts and bones with simple life choices such as smoking cessation, weight management and increased exercise.”
What is HRT?
HRT replaces the hormones that decline around menopause and perimenopause, meaning it can relieve many of the symptoms that impact on quality of life, particularly hot flushes and night sweats. There are two main types of HRT: • Combined HRT (oestrogen and progestogen) – for women who still have their womb. • Oestrogen-only HRT – for women who have had their womb removed in a hysterectomy. Oestrogen-only HRT can be taken as a pill, patch or gel. Progesterone is combined with oestrogen in patches or pills.
MENOPAUSE BY NUMBERS
50% 75% WILL AFFECT MORE THAN
of the population
OF WOMEN WILL EXPERIENCE MENOPAUSAL SYMPTOMS
1/3 of these women will experience
SEVERE SYMPTOMS Source: Primary Care Women’s Health Forum. www.pcwhf.co.uk
HRT safety and guidance
lthough HRT has been available in the UK since the 1960s, much of the reported research into its safety over the years has been conflicting and confusing. This led some women to stop taking HRT and doctors advising patients to come off it. From 2003 to 2007, HRT use more than halved. In 2015, the National Institute for Health and Care Excellence (NICE) produced a good overview of HRT using national experts to review all the evidence available to them at the time. ‘Menopause: diagnosis and management’ clarified that for women around menopausal age, oestrogen‑only HRT causes little or no change in the risk of breast cancer, and HRT that contains oestrogen and progestogen may increase breast cancer risk. This risk may be higher if HRT is taken for longer but falls again when a person stops taking HRT. It also clarifies risks around HRT and blood clots, heart disease, stroke, Type 2 diabetes, osteoporosis, muscle strength and dementia.
There are a few reasons that women can’t take HRT including those who: • have a history of breast cancer, ovarian cancer or womb cancer • have a history of blood clots • have untreated high blood pressure • have liver disease • are pregnant. And for some younger women who have an early menopause, it is important that they take HRT to replace the hormones that they should have and reduce the morbidity and mortality associated with early oestrogen loss. Following the revised NICE guidance on HRT prescribing, work is happening to increase GP and healthcare professionals’ understanding of HRT as well as raise awareness of menopause amongst the general public.
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Rock My Menopause Breaking the menopause taboo
here’s no doubt that research into HRT has created concern and confusion around the treatment. This has led to women not wanting to use it. However, beyond that many people don’t identify their symptoms or know their options for treatment. To tackle this, E4H launched Rock My Menopause, a publicfacing campaign for the Primary Care Women’s Health Forum (PCWHF). Rock My Menopause set out to break the menopause taboo, raise awareness of symptoms and give women the confidence to speak to their primary care clinician and get the best treatment. Rock My Menopause was launched on BBC Breakfast on the first day of #BBCMenopause ‘Wake Up To The Menopause’ week. “Our campaign focus was clear,” explained Hazel Lodge, Commercial Director of E4H, “Working for the PCWHF, they wanted to support women to identify and understand their menopause symptoms, have the confidence to discuss them, break down the taboo and also seek the right treatment, whether or not that included HRT. We also wanted to raise the profile of PCWHF amongst healthcare professionals. “Rock My Menopause started as a closed Facebook Group for women to discuss their symptoms and support each other.” The Facebook group was a great starting point, but key messages needed to be constructed and delivered more widely. “We felt that the taboo around menopause, and that many women didn’t identify their symptoms as perimenopausal, would be the best place to start. By encouraging conversations, we aimed to normalise the subject and enable more people to consider they may be menopausal, and not brush off their symptoms.” In order to do this, E4H created the term ‘Menovist’, defining it as a person who stands up for those going through the menopause; encouraging and engaging in menopause conversations and helping stamp out the taboo.
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Hazel continued: “This was our call to action, to encourage people to sign our #Menovist pledge, share via their social media and champion menopause in daily conversations. “Alongside that, and being backed by the expertise of the PCWHF, our campaign website includes useful information including a symptoms tracker and treatment information. Content is approved by the PCWHF’s primary care clinicians and offers a reliable source of information. “No-one is excluded from Rock My Menopause; we have information on transgender health and menopause, for people with learning disabilities and also menopause and mental health.” The campaign focuses on pelvic floor health, with the social media campaign #PelvicFloorFace. Setting up and launching the campaign in 10 weeks was a great team effort, culminating in its launch on BBC Breakfast. Rock My Menopause Spokesperson and PCWHF Board Member, Jane Davis, discussed the campaign and shared the #Menovist definition. “Information is power; women are better informed and more empowered. We have seen this through the Rock My Menopause campaign; how social media has provided a channel for discussing and sharing information. “The message from BBC Menopause was loud and clear – hormone replacement therapy (HRT) should not be denied to women on the basis of unfounded fears. For those of us who have worked through the HRT scares of the early 2000s, this will have been music to your ears.” The campaign was incredibly wellreceived with the Facebook group growing over 500% in the first week. It also saw increased web and social media traffic, adoption of the #Menovist hashtag, and a spike in healthcare professionals becoming PCWHF Members to continue their professional learning in women’s health. Go to www.rockmymenopause.com
No-one is excluded from Rock My Menopause, we have information on transgender health and menopause, for people with learning disabilities and also focus on menopause and mental health
SOURCES A population-based cohort study of HRT use and breast cancer in southern Sweden, 2001 https://www.ncbi.nlm. nih.gov/pmc/articles/PMC2364137/ Hamoda H, Panay N, Arya R, Savvas M. The British Menopause Society & Women’s Health Concern 2016 recommendations on hormone replacement therapy in menopausal women. Post Reproductive Health 2016;22:165-83 Women’s Health Concern https://www.womens-healthconcern.org/help-and-advice/factsheets/hrt-the-history/ National Institute for Health and Care Excellence [NG23] Menopause: diagnosis and management https://www.nice.org.uk/guidance/ng23/ifp/chapter/ Benefits-and-risks-of-HRT NHS Overview Hormone Replacement Therapy – Who can take HRT? https://www.nhs.uk/conditions/ hormone-replacement-therapy-hrt/
SPOTLIGHT ON CVD Sue Thomas explores how the NHS is prioritising cardiovascular disease. WORDS BY Sue Thomas
ardiovascular disease (CVD), which covers a wide range of conditions, including coronary heart disease, heart valve disease (HVD) and strokes, is responsible for a quarter of all deaths in the UK. It is also the largest cause of premature mortality in deprived areas. Detecting patients at risk of CVD and preventing and treating the disease is a key priority within the NHS Long Term Plan, which has identified CVD as the single biggest area where the NHS can save lives over the next 10 years. In line with this, there will be a big focus on population health management and a bid to drive greater public awareness of CVD. Hence, we will see technology and integrated care organisations being used to identify cohorts of patients who are at risk of CVD, so that timely interventions can be offered. Lifestyle improvements will be key for at-risk patients, particularly weight management, and social prescribing will support this approach. Care will be delivered in line with best practice such as the NHS RightCare toolkit for CVD prevention. CVD PREVENTION
A new national CVD prevention audit will feed into this activity. It will extract routinely recorded but anonymised GP data, making it easier for the new Primary Care Networks (PCNs) and other NHS organisations to improve outcomes for patients and populations. PCNs will play a pivotal role in CVD services and CVD case-finding is one of seven new national services that they will deliver. Many other CVD services will be provided by community teams in PCNs that are likely to include physician associates, clinical pharmacists, specialist heart failure nurses and, possibly, consultants. The use of technology, such as community echocardiograms for HVD detection, will be very important. There will also be a major structural change in stroke services, where hyper acute specialist stroke centres with new clot-busting technology will be replacing existing stroke-receiving units. It will be vital for pharmaceutical and medtech companies to keep abreast of local plans for CVD prevention and management, and to determine how their products can support the NHS in providing more holistic, preventative care that delivers benefits across integrated care pathways. FREE WEBINAR ON CVD IN THE NHS
Wilmington Healthcare will be exploring the NHS Long Term Plan’s vision for CVD in a free webinar on Tuesday 17th September at 2pm. The guest speakers will be Dr Matt Kearney, NHS England’s National Clinical Director for Cardiovascular Disease Prevention, and Wil Woan, Chief Executive of the charity, Heart Valve Voice. To find out more about the webinar and register to attend, visit www.wilmingtonhealthcare.com/cvd. Sue Thomas is Chief Executive Officer of Commissioning Consulting at Wilmington Healthcare. For information on Wilmington Healthcare, go to www.wilmingtonhealthcare.com M AG A ZI N E | AU G U S T 2019 | 2 9
GUIDING LIGHT A new sourcebook from the ABPI is clearing the way to greater patient engagement within the confines of the Code of Practice. WORDS BY Amanda Barrell
mbiguity and confusion over how to compliantly engage with charities has been hampering efforts to embed the patient voice into the heart of the pharmaceutical industry. However, a new document from the Association of the British Pharmaceutical Industry (ABPI) aims to help companies interact with confidence. ‘Working with Patients and Patient Organisations: A Sourcebook for Industry’, published in June, gathers patient engagement advice from across the healthcare sector into one place. Jill Pearcy, Director of Code Engagement at the ABPI, told Pf Magazine: “The objective was to give people more confidence in building partnerships with patients and patient organisations. “These relationships bring significant public health benefits, so we wanted to help companies become more patient centric so they could build those relationships more easily and more successfully.” The document, which was launched at the Pioneering Partnerships event hosted by the ABPI along with the National Institute for Health Research (NIHR) and the Association of Medical Research Charities (AMRC), is aimed at both industry and charities. “The new Code of Practice was launched at the beginning of this year. What came out of the updating process was a real desire to have something that simply stated, in accessible terms, what industry could and couldn’t do when working with patients and patient organisations,” said Jill. “When we looked into that further, we found that patient organisations thought the Code was a good thing to have, but that
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it wasn’t necessarily easy to understand or as accessible as it could be.” Parts of the Code, she went on, were unclear and ambiguous, and that had created something of a roadblock to getting patient-centric projects off the ground. “This kind of uncertainty has perhaps led to a bit of a risk averse attitude in industry, meaning that companies might not necessarily get into these kinds of relationships and joint projects,” she said. “What we want to do with this sourcebook is point out that the ABPI really does believe that it is a good thing for industry to work with patients and patient organisations and we want to support that.” GUIDING PRINCIPLES
The document, which has been developed with input from industry, patient groups and partners including the NIHR and AMRC, offers practical advice, including a checklist for written agreements between partners. “The golden thread running through the whole argument are the principles of clarity, integrity, independence and transparency,” said Jill. “You’ve got to be clear about what you’re doing and why you’re doing it, and what the purpose of the engagement or the relationship is. “The need for integrity goes without saying; if you're not being honest about what you’re doing and why you're doing it, then why do it?” Each party needs to maintain its independence, as well as be open and honest about the purpose of the collaboration “and be able to account publicly for the associated activities and any exchanges of funding”, the sourcebook states. The document covers topics such as research and development, product launches and the rules around medical events.
GOOD QUESTIONS TO ASK WHEN SETTING UP A NEW PARTNERSHIP
WHY DO I WANT TO WORK WITH THIS ORGANISATION?
FAIR MARKET VALUE
“I think some people are quite nervous. They really want to do the right thing and work with patient organisations, but they don't want to inadvertently breach the code or be non-compliant. “If you look at something like meetings, it’s a really tricky area. What do you do if there’s a patient in the room, for example? We wanted to provide something that would just say what the rules actually are and suggest things to think about ahead of time.” The sourcebook recommends that companies think carefully about room layout and access, structure of the agenda, timing of Q&As or closing remarks, and how to signpost clearly which sessions are suitable for which audiences. “It is useful to explain to a patient participant the reasons why certain aspects are not suitable for patients, rather than just saying no,” it says.
Another thorny area is payment, and the sourcebook recognises that greater collaboration will mean people devoting their time and effort to participating in industry activities. It goes on to say they can be paid a ‘fair market value’ or ‘recognised in other ways’ for the value they bring. It is less clear, however, on how to calculate the level of remuneration. The report states: “The ABPI cannot recommend rates due to competition law. It will depend on a number of elements, including the kind of activity being undertaken, the amount of time invested, and the experience and skills of the people involved.” The European Federation of Pharmaceutical Industries and Associations’ Patient Think Tank is currently working on a set of remuneration principles and criteria which could be included in future versions, the sourcebook highlighted.
The sourcebook has been designed to sit alongside, rather than replace the Code
It was important to note, Jill said, that the sourcebook has been designed to sit alongside, rather than replace the Code. “Companies do very much need to make sure they are complying with the Code as well, but hopefully this will help to support people and be a good starting point.” Much like the Code of Conduct itself, she went on, the sourcebook is a resource that will evolve over time. “This is version one, and we hope we will be bringing out a new version that takes account of future changes in the not-too-distant future,” she said, adding that the ABPI was open to feedback on where to take it next. The sourcebook is available to view on the ABPI website. Go to www.abpi.org.uk
HOW WILL PATIENTS ULTIMATELY BENEFIT?
HOW WILL I INVOLVE PATIENTS?
WHAT IS THE BENEFIT TO MY ORGANISATION?
WHO DECIDES ON THE SCOPE OF WORK?
IF EVERYTHING WAS IN THE PUBLIC DOMAIN, WHAT WOULD IT LOOK LIKE?
WHAT MONEY OR BENEFITS ARE INVOLVED?
HOW WILL TRANSPARENCY BE ACHIEVED?
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P f AWA R D S ► From L to R: Julie Van Es, Emma Reynolds and Pf Awards’ host, Hugh Dennis
Pf speaks to Roche’s Pf Awards 2019 winners, Emma Reynolds who won the Secondary Care Specialist Pf Award 2019 and Julie Van Es who won the New Account Manager Pf Award 2019. INTERVIEW BY Emma
When your passion makes an impact Visit www.roche.co.uk/careers to ﬁnd out more.
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ongratulations on your Pf Awards wins. How did you feel when your names were called out? EMMA: I felt completely overwhelmed and surprised, winning the Pf Awards is such a big deal! I’m not sure it really sunk in on the night, as you get taken off for an interview straight away; I still have no idea what I actually said. The next day, I just felt complete pride. JULIE: Yes, surprised and shocked and genuinely proud. Proud that I had managed to convince external experts that I might be doing a decent job. It was just lovely seeing the reaction on our colleagues’ faces as our names were announced.
What made you enter the Pf Awards 2019? How did Roche support you? JULIE: I’d had the privilege of being involved in launching Ocrevus® (ocrelizumab) for Multiple Sclerosis (MS), so there were plenty of personal and team achievements over the last six to seven months to celebrate in the submission. My manager, Jayne, was incredibly supportive, making sure I stayed focused on telling a compelling story. EMMA: I also worked on Ocrevus and had been involved in some really exciting patient work. My manager, Tim, was equally supportive, as was our colleague in HR, Alison, who made sure we were following Pf’s timelines and staying on top of all the paperwork. It was a real team effort. What does it mean to you to win a Pf Award? EMMA: Now that it has sunk in, I feel proud of the achievements which were recognised among my peers, especially those outside Roche. It feels like an important endorsement of the work we are doing day-to-day, which is not always that easy. It’s a confirmation that you are good at your job! JULIE: I completely agree with Emma. This is my 13th year at Roche, a long time to be in one company. Being able to stop and step outside, momentarily, and get external recognition for things which are recognised as examples of best practice, it’s very reassuring. Emma, you won the Secondary Care Specialist Pf Award, tell me about your work and what you think made you stand out. EMMA: I work in the Neuroscience area, specialising in MS, and we are achieving some wonderful things in this therapeutic area. I’ve worked as a Secondary Care Specialist (in Roche, Hospital Sales Specialist (HSS)) for 22 years and always in Roche, so I’m really not sure why I stood out. I know I tried to just be myself at the Assessment Day, spoke very passionately about my work and answered the assessors’ questions honestly. The whole team conveyed a high level of professionalism and confidence. Julie, you won the New Account Manager Pf Award, why do think you won and what do you hope this will do for your career? JULIE: This is a question I would like to ask the assessors, because you always wonder what they take away from these events. Like Emma, I tried to give a genuine representation of myself and was really open and honest about all the achievements and challenges I faced (warts and all). I really embraced the assessors’ questions which drove some really interesting
conversations. I felt this gave me the opportunity to show them what I can really do. What made you choose and stay in the pharmaceutical industry? EMMA: I remember being very excited at a talent fair at university about the prospect of helping patients access medicines. I came to Roche initially as a GP-representative and then became an HSS. I’ve stayed so long because of Roche’s great portfolio. We don’t do ‘me-too’s, and our medicines help you feel you are doing something very special for patients every day. JULIE: I came out of art college and I wasn’t a good enough illustrator! I quickly realised the pharmaceutical industry was the place to be and reflecting on thirteen years with Roche, I’ve had the chance to work on some of Roche’s biggest medicines. Now I’m working in Neuroscience which is exciting all over again; the opportunities just keep coming at Roche. Where would you like your career to go and will winning a Pf Award help? JULIE: Winning has given me a bit more confidence; it definitely gives you a boost to get external recognition. My immediate priority is to develop in-role. I still have a huge amount to learn and my team challenges me every day. Change is happening all the time; I’m staying open-minded about future roles which might emerge and on where I can further develop my skills. EMMA: I think I am where I want to be right now. As Julie said, I think the Pf Awards has given me more confidence that what we are doing is really working. The Pf Awards has given me extra drive to continue to do as much as we can in Neuroscience to help patients. Would you encourage others to enter the Pf Awards? EMMA: I would encourage other people to go for it! Even if you don’t win, at the end of the day it was good fun along the way; just have a go! It was so nice to go there as a team, showcase our achievements and then celebrate at the Pf Awards Dinner; that was very much what that night was about. JULIE: I totally agree! Both of us would just like to say a huge thank you to everyone involved through the whole process. All of us who entered were like a real little team and there have been so many colleagues who have played a part in this all the way along; the camaraderie at the Assessment Day among everyone from Roche was just brilliant. Emma and Julie were Pf Award Winners 2019. To watch their winners’ interviews and find out about Pf Awards 2020 go to www.pfawards.co.uk
“We help millions of people all over the world live longer and better lives every hour of every day.”
AT ROCHE IT’S MORE THAN JUST A JOB
t Roche we believe life is incredibly precious and every day we strive to solve some of the greatest and most complex health challenges facing humanity. We discover, develop and manufacture innovative solutions which detect and treat disease where there is the greatest medical need. Our core diagnostics and biotechnology businesses work collaboratively to deliver personalised healthcare to meet the specific needs of individual patients. We help millions of people all over the world to live longer and better lives every hour of every day. None of this would be possible without our extraordinary employees! Just as we believe that personalised approaches achieve the best outcomes for patients, we offer inspirational opportunities that are as unique as our employees. We have created an inclusive, respectful work environment where people can be authentic and truly invested in their work. Our business environment is constantly changing so we give our people the support and flexibility they need to think big and push boundaries. At Roche, it is more than just a job. It’s a responsibility. A big one. If you really know yourself and are dedicated to making a real impact on the world, come join us on our journey to become the most admired employer in the UK. For more information on careers in Roche, go to www.roche.co.uk/en/careers
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P f TA L E N T
John Nuttall John Nuttall, Chief Executive Officer of Well Pharmacy, has announced his retirement. Nuttall has led the business since 2002 and has played a pivotal role in transforming Well Pharmacy since it was acquired by Bestway Group in 2014.
WHO’S GOING WHERE AND WHY THEY’RE GOING THERE. WORDS BY
Marjorie Norman Cambridge Healthcare Research has appointed former Pfizer Director, Marjorie Norman to its Board. Norman recently retired from the global pharmaceutical giant after 17 years as Director of Worldwide Competitive Intelligence. HEALTHCARE
Dr Matthew Baker
Dr William F. Feehery
NeoPhore has appointed Dr Matthew Baker as Vice President of Immunology. Baker has more than 15 years’ experience developing biologics and is a research expert in B and T cell immunology, including drug immunogenicity. He has held entrepreneurial and leadership positions across the biotechnology industry including Chief Scientific Officer of Abzena.
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Certara appointed William F. Feehery as Chief Executive Officer. Feehery joins Certara from DuPont, where he served as President of DuPont Industrial Biosciences.
Amanda Pritchard has been appointed as the NHS’ Chief Operating Officer. Pritchard was Chief Executive of Guy’s and St Thomas’ NHS Foundation Trust. She will oversee NHS operational performance and delivery, as well as implementation of the service transformation and patient care improvements set out in the NHS Long Term Plan.
Paul Morrissey OPEN Health has appointed Paul Morrissey as Global Business Director.
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Hilary Croft The national charity, Coeliac UK has appointed Hilary Croft as its new Chief Executive Officer. Croft’s senior management career started in marketing with Capgemini, where she worked with a variety of organisations, such as Virgin Atlantic, Sky, Lego and Royal Mail. She said: “I look forward to developing the charity’s strong reputation, bringing fresh ideas and strategic insights.”
From real world data. To real-time analytics. To ah-ha moments for your brand. >> > >>>
John Burt Medherant has appointed John Burt as Chief Executive Officer. Burt was most recently the Chief Executive Officer of Abzena plc.
Paul Hudson Paul Hudson has been announced as the new Chief Executive Office of Sanofi as Olivier Brandicourt announces his retirement. Hudson has been Head of Novartis’ Pharmaceuticals Division since 2016. With nearly 30 years’ industry experience, he has held roles at AstraZeneca and Schering Plough.
Madelaine Allen The Creative Engagement Group (TCEG) has announced that Madelaine Allen will take over as Head of Europe for its scientific engagement and medical training division, Axiom. Allen has been with TCEG for 10 years, most recently as Client Services Director leading account teams for several global healthcare companies.
Y O U R W AY F U R T H E R IQV IA.COM/FURTHER
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PHARMAJOBS WORDS BY Amy Schofield
HOW TO LEVEL UP If you feel that you have gone as far as you can in your current role, it could be time to move up, or move on. Here’s some advice from Pf’s recruitment experts to get you on track for future career success.
CONSIDER YOUR NEEDS
hen was the last time you really felt challenged at work? Are you eyeing up job adverts, dreaming of taking the next step? “No longer feeling challenged with your day-to-day responsibilities, or feeling that you have reached your peak in performance in your current role, are typical signs that it is time to move your career forward,” says Lauren Ward, Support Operations and Graduate Recruitment Manager, Evolve Selection. Joe Grundy, Healthcare / Medical Devices Consultant, Carrot Pharma, recommends keeping your eyes open to new opportunities: “We tend to experience highs and lows of enjoyment in our careers. This can lead us to make conscious decisions to passively explore new opportunities, either internally or externally. By going through this process, should you find a position that offers you that next step and meets your expectations, it’s time to investigate further!”
Lauren advises taking a long hard look at what you really want: “Once you have identified what you are seeking in your next role, you will be able to explore options both internally and externally and select the ones which match your criteria best,” she says. “It is always best to take into account the areas that you feel most comfortable working within when identifying your long-term career goals. Stepping too far outside your comfort zone could be seen as a positive challenge, or alternatively may be seen as a step too far. It is therefore important to be realistic with your expectations when deciding what career move you want to make.” Joe suggests making a list of your key requirements in a new role: “Think broad – salary/ location/work-life balance – these can then be narrowed more specifically based on your needs,” he says. “It’s also common to be led by reputation when researching suitable employers, so try to stay open-minded, allowing yourself to make an independent, informed decision.” DIRECT OR RECRUITER?
Whether you decide to apply to companies directly or to go through a specialist recruiter, adapting your CV to target the specific job is essential. “Your CV should be tailored for every application that you make. Match your strengths, skills and competencies to those required for each position,” says Lauren. “Ensure that you include recent key achievements and successes. These must be specific, measurable and relevant to the vacancy.” “Hiring managers/talent acquisition typically want a CV to tick certain boxes – proven technical skills, experience, key achievements, coupled with tangible evidence to demonstrate you can ‘get the job done’,” advises Joe. “Personal touches can be useful; however, I’d keep them brief.” Working with an expert recruiter can give you extra confidence when searching for your next role. “It can feel overwhelming to consider changing roles but using a specialist recruiter can eliminate some of the apprehensions which come with this,” says Joe. “They have the knowledge to put you forward to companies they believe you’ll be most suitable for. This exchange is also your opportunity to gauge their knowledge of the industry, clients they work with and how they plan to work with you.” Lauren advises choosing a recruiter who fully understands your needs: “If you are working with a market specialist, they should seek to understand what your career goals are and therefore help you achieve them in the best way possible. They should do this by providing expert advice, support and insight to add value to your job search, outside of what you can do yourself.” Go to www.carrotpharma.co.uk and www.evolveselection.co.uk.
I F YO U ’ R E L O O K I N G TO L E V E L U P YO U R C A R E E R , G O TO W W W. P H A R M A J O B S .C O.U K
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