M E DS & M I N D F U LN E SS
February 2018 PHARMAFI E LD.CO.U K
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Letter from the Editor
lready we find ourselves hurtling into 2018 and yet, in order to look forward, we should return to our very basic primal instincts – methodically breathing, placing one foot in front of the other and generally finding our neutral space. Indeed, our cover story looks at how the future of prescribing could involve, not only pioneering pharmaceuticals, but exercise sessions, adult colouring and all manner of mindfulness. This month my Coffee Break is with a man who likes to get a move on. His single obsession is to accelerate the often-laborious process of getting life-saving medicines to market and let them get on with saving patients’ lives. On the subject of dynamism, comms departments operating in the pharma space are among the most tenacious groups of people around. Forever being told they can’t do this and they can’t say that, we find out how some of the best exponents in industry communicate vital messages about pharma. Meanwhile, our latest woman in pharma, Janssen’s Hanneke Schuitemaker, shares her inspirational story, as well as some fascinating insights into gender politics and perceptions in our industry. In our marketing section, we take a tour through pharma’s commercial evolution and the forces which have dictated it from the 1980s to the here and now. As Pf Awards season hots up we also catch up with another winner from yesteryear, whose victory changed her life forever. Our columnists in pharmacy, politics and healthcare return with more insights, intrigue and irreverence, TH E while a bevvy of regular features M I N D FU LN E S S make this another unforgettable I S SU E : Pf Magazine. Colouring is a great way to beat stress and anxiety. Have a go Have a superb day, with our special colour-in cover. Send your masterpieces to email@example.com or @pharmafield
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M AG A ZI N E | FEB R UA RY 2018 | 1
CONTENTS Bringing you this month’s essential headlines HIGH FIVES
Five fascinating things about… adherence C OV E R S TO RY
Could mindfulness really be part of the script?
February MAGA ZINE
David Thorne makes some chilling predictions COFFEE BREAK
Mark Samuels is the med access master
HAVE YOUR SAY: What are your memories of the Pf Awards? Do young people want a career in pharma? Should there be access to unapproved meds in certain cases? We’ll be covering these issues in the next Pf Magazine – want to contribute? GET IN TOUCH: firstname.lastname@example.org
Claudia Rubin on healthcare’s AI future
Our industry has changed, and this is how F E AT U R E
Pharma communication in a regulated world
BE IN THE KNOW. R I S E of the D I G I TA L DOCTOR
Is big healthcare data facing judgement day? P H A R M ACY
Deborah takes on the gender imbalance in pharmacy PH AR
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03 07 08 11 14 16 18 20 22 23 24 26 30 34
N E WS
Partnerships between pharma and the NHS
2017 PH AR MA FI FI E LD.C O.U E LD .C O. K
F E AT U R E
The challenge of taking on rare diseases P F AWA R D S
Award Winner Cate Oliver recalls how life changed P H A R M ATA L E N T
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Hanneke Schuitemaker talks women in pharma
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P f N E WS : B R IN G IN G YOU TH I S M O NTH ' S E SS ENTI A L H E A D LIN E S
C O L L A B O R AT I O N S
C ARTIFICIAL INTELLIGENCE
Mind over matter The Pistoia Alliance has called on the pharmaceutical and technology industries to support greater collaboration around artificial intelligence (AI) in pharma R&D. Its survey sought the views of 374 life science professionals on AI, machine learning (ML) and natural language processing (NLP), finding that interest is high, with almost half (44%) of respondents already using or experimenting with AI. A number of hurdles to their widespread application, however, were identified, with technical expertise the most cited barrier for AI (30%) and for ML/NLP (28%). The Alliance believes that collaboration between stakeholders will lead to ‘augmented’ AI that works alongside humans for positive outcomes. In particular, unity over data standards, benchmark sets and data access. Dr Steve Arlington, President of The Pistoia Alliance, said: “We urge those in the pharmaceutical, biotechnology and technology industries to explore ways in which they can collaborate now, to find answers to common problems of the future.” Pf View: As we discover in this issue of Pf Magazine, AI has arrived and the onus is on every individual working in pharma to familiarise themselves with the new landscape. The pressure is also mounting on companies to improve AI functionality, and quickly.
A P P R OVA L S .
ICE has published a Final Appraisal Determination recommending Takeda’s NINLARO (ixazomib) in combination with lenalidomide and dexamethasone (Rd) for the treatment of multiple myeloma patients who have already received two or three therapies. The combination is now available on the Cancer Drugs Fund (CDF), while the landmark decision will also mean multiple myeloma patients in England will have access to a novel medicine prescribed alongside the two-drug current standard of care. A number of trials have shown that patients treated with a novel three-drug combination may live longer without their disease worsening, compared to two-drug combinations.
ancer Research UK has announced the signing of a five-year drugdiscovery collaboration between its subsidiary, Cancer Research Technology (CRT), and Celgene Corporation. Together the organisations will discover, develop and commercialise new anti-cancer treatments. The partnership represents an expansion of CRT’s themebased translational model that now encompasses six industry partnerships. CRT will lead drug discovery R&D activity and can progress clinical candidates through phase one trials. Under the terms of the agreement, Celgene will pay an upfront fee to CRT, and have the option to secure US rights to projects resulting from the collaboration, subject to the payment of additional option fees. Celgene will also have the chance to secure global rights to such projects at the end of phase I clinical trials, subject to the payment of additional option fees. Dr Iain Foulkes, CRT’s CEO, said: “This is our largest drug discovery collaboration to date and represents a major endorsement of the reputation and scale of our expertise in both drug discovery and clinical development.”
Over the past 20 months several novel triplet regimens combined with Rd have been approved by the European Medicines Agency and are becoming the new standard of care in Europe and the US. IRd is the first novel Rd-based triplet, however, to have access in the UK via the CDF. Rosemarie Finley, Chief Executive at Myeloma UK, said: “We are grateful for the commitment shown by Takeda, NICE and NHS England to working together to deliver access. It will make a real positive difference to patients’ lives.”
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I N N OVAT I O N .
DESIGN for life
The NHS has selected 138 entrepreneurs to design and deliver new technological solutions and innovations in healthcare. The Clinical Entrepreneurs Programme, run by NHS England, supports NHS workers to work with and learn from leading health and technology industry experts to develop their own innovative ideas. Within the first year, Clinical Entrepreneurs recruited to the programme have already launched 50 start-ups, leading to the creation of 344 jobs. The initiative also includes the appointment of five healthcare scientists, tackling conditions such as sickle cell disease and allergic reactions. The latest innovations include a voice controlled data collection app for sickle cell patients, which can be worn by patients, and the Allergy Assist App, which helps allergy sufferers to share information and support on their condition. In addition, Sci-connect will provide tailored online support and resources to undergraduates and junior staff in the early stages of their careers.
In total, Clinical Entrepreneurs have been awarded over £3.7million of public sector funding and have raised over £48m of private sector funding. More than 5.6million patients and professionals used the innovations on the programme, ranging from educational training platforms for medics, providing video consultations with GPs, to medical diagnostic devices. Professor Tony Young, National Clinical Lead for Innovation, NHS England, said: “Frontline workers have a unique insight into patients’ experiences, and supporting all our staff to develop and deliver their ideas for better care will mean better outcomes for patients.” Pf View: This is undoubtedly the future of public health – harnessing and encouraging innovation and cementing the UK’s reputation as a global leader in modern healthcare delivery, with radical solutions and technological excellence.
fizer has commented on the successful hearing which saw BESPONSA (inotuzumab ozogamicin) granted reassessment by NICE as a treatment for adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia. The pharma giant’s appeal was upheld late last year. Craig Eagle, Head of Oncology, Pfizer UK, said: “NICE’s decision to uphold
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the appeal and re-assess the evidence for inotuzumab ozogamicin is good news for some of the most vulnerable leukaemia patients in the UK.” The NICE appraisal committee will now re-assess the evidence for the treatment before issuing a second final appraisal determination.
P f N E WS : B R IN G IN G YOU TH I S M O NTH ' S E SS ENTI A L H E A D LIN E S
T JOINT VENTURES.
he Pharmaceutical Information and Pharmacovigilance Association (PIPA) and CompliMed have announced the formation of a joint venture that will provide PIPA members with access to an enhanced Code Forum. The new Code Forum group will be chaired by ex-member of the PMCPA Panel, CompliMed Managing Consultant, Ros Henley, and will continue to meet quarterly to discuss Code compliance matters relevant to their roles and responsibilities.
Typical agenda items will include reviewing recent case rulings by the PMCPA and MHRA, assessment of legislation, and presentations by third party subject matter experts invited to attend. CompliMed will take over the logistical management of the Code Forums. Meetings will take place at their Kings Langley offices in March, June, September and December 2018.
Quick doses ALZHEIMER’S DISEASE
END OF THE LINE Pfizer is ending its neuroscience discovery and early development programme, an area which includes research into possible Alzheimer’s disease medicines. The US-based company expects that 300 jobs will be lost across its programmes in Andover, Cambridge, Massachusetts and Groton, Conneticut. Pfizer will reallocate this funding to ‘those areas where we have strong scientific leadership and that will allow us to provide the greatest impact for patients.’
It will not make any changes to funding for tanezumab – which treats osteoarthritis – fibromyalgia treatment Lyrica, or its rare disease programme. Dr James Pickett, Head of Research at Alzheimer’s Society, said: “With no new drug for dementia in the last 15 years, this will come as a heavy blow to the estimated 46.8 million people currently living with the condition across the globe.” He called on the pharma industry to “unite with us to turn breakthroughs into treatments”.
NICE issues FAD recommending JANSSEN’s Imbruvica (ibrutinib) as option for treating relapsed or refractory mantle cell lymphoma in adults in England and Wales, if they have had one previous therapy. • FDA accepts supplemental New Drug Application for use of A S TR A Z E N E C A’s Tagrisso (osimertinib) in first line treatment of patients with metastatic non-small cell lung cancer whose tumours have EGFR mutations. • TA K E DA and TI G E N I X announce that the CHMP of the EMA, in conjunction with the Committee for Advanced Therapies, has adopted a positive opinion recommending marketing authorisation for Crohn’s disease treatment, darvadstrocel. • R E CO R DATI acquires trio of BAY E R consumer health brands for French market: Transipeg ®, TransipegLib® and Colopeg ®. • S A N O F I and R E G E N E R O N P H A R M AC E U TI C A L S will expand investment for the clinical development of the PD-1 antibody cemiplimab, in oncology, and dupilumab, in Type 2 allergic diseases. • A S TR A Z E N E C A and M E D I M M U N E announce EC approval of Fasenra (benralizumab) as an add-on maintenance treatment in certain adult patients with severe eosinophilic asthma.
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P f N E WS : B R IN G IN G YOU TH I S M O NTH ' S E SS ENTI A L H E A D LIN E S CLINICAL TRIALS
Seeing is believing
I N N OVAT I O N
A sickness surveillance system will help the NHS plan for surges in demand this winter by tracking outbreaks of norovirus, which causes vomiting and diarrhoea, and other illness around the country. Data gathered by Public Health England will be used by NHS England operational monitoring teams to study winter trends and to help give early warning about rising outbreaks of flu, respiratory syncytial virus, norovirus and other acute seasonal illnesses. The findings will allow the NHS to anticipate rises in hospital admissions and produce a planned response. This could include rescheduling planned surgery
in advance, freeing up beds and converting ‘swing’ wards from elective to emergency care for patients with certain conditions. Meanwhile, outpatient appointments can be switched to ‘hot clinics’ that avoid A&E referrals by providing direct access to GPs and staff can be moved from planned activity to support general medicine. Professor Keith Willett, NHS England’s Medical Director for Acute Care, said: “We can plan how to best provide care to a higher number of patients with a specific illness, and to corral patients who are suffering the same illnesses.”
pioneering method of delivering lifesaving drugs using microbubbles is one step closer to being used in patients, thanks to a research project between Medicines Discovery Catapult and the University of Leeds. The technology has the potential to pave the way for patients to access new treatments, in much less time, and cost. Thousands of the bubbles, one thousandth of a millimetre in size, can fit on a grain of sand. They are made, and then burst, by two machines developed by scientists at Leeds. The first, called the Horizon platform, creates the microbubbles and, once they are transported by the bloodstream
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Timely reporting of results from pharma company-sponsored clinical trials for newly approved medicines has reached the highest recorded level. A new study, coupled with assessments of the previous five years, indicates that the disclosure rate of industry-sponsored clinical trials at 12 months has significantly improved year-on-year from 71% in 2009 to 93% in 2014. The ABPI-sponsored study was published in the peer-reviewed journal, Current Medical Research and Opinion. It is the latest in a series covering trials in patients associated with all 142 new medicines approved by the European Medicine Agency over the continuous six-year period 2009-2014. This study is the last to be conducted by Livewire Editorial Communications on behalf of the ABPI and assessed all completed company-sponsored trials in patients related to all 32 new medicines, licenced to 22 different companies and approved by the EMA in 2014. It shows that of the 542 evaluable companysponsored clinical trials that 93% (505) had been disclosed on a registry or in scientific literature within 12 months of first regulatory approval or trial completion, while 96% (518) had results disclosed by the end of the study on 31 July 2016. Dr Sheuli Porkess, ABPI’s Interim Executive Director of Research, Medical and Innovation said: “This final study further demonstrates industry’s commitment to transparency. Our goal now is to bring together the wider clinical research community to ensure trial data is published accessibly for the benefit of patients, clinicians and researchers.”
to the right place in the body, the microbubbles are then burst with a second machine, releasing the drugs. The released drug can act at high concentrations on specific tissues without harming other areas of the body. The three-year research collaboration is the first project to be delivered from the Medicines Discovery Catapult’s new laboratories at Alderley Park, in Cheshire. Professor Stephen Evans from the University of Leeds said: “This will take existing research to the next stage and aims to validate the technology on a range of drug molecules, developing it to a stage suitable for consideration in humans.”
R IC H R E WA R D S Mango Health has created an app that uses gamification to set it apart from other adherence apps on the market. The app reminds patients when it's time to take their meds, records each dose, and automatically alerts users to potentially dangerous interactions between medications and supplements or food and drink. The company’s founders come from gaming backgrounds and have used their experience to create the gaming component. Users are rewarded with points every time they take their medication correctly and maintain healthy habits. These can be used to unlock the chance to win gift cards and charitable donations in weekly raffles.
B A R R I E R S D OW N
A research team from the University of East Anglia, Macquarie University, the University of Leeds, and the University of Amsterdam have developed a questionnaire – the Identification of Medication Adherence Barriers Questionnaire (IMAB-Q) – which aims to help patients and practitioners to identify medication adherence barriers in routine community pharmacy practice. Nine pharmacies in Norfolk were selected to distribute the IMAB-Q to patients prescribed medication for heart disease prevention. Negative emotions and beliefs about consequences were the most frequently reported barriers.
High Fives: Medicine adherence analysed An estimated 50% of patients prescribed medication for chronic conditions do not adhere to the prescribed directions, resulting in increased morbidity and NHS resource wastage*.
C OU N T E R AC T ION
The Centers for Disease Control and Prevention (CDC) has called on pharmacists to improve adherence, suggesting multiple ways in which pharmacists could help. Their recommendations include the use of pillboxes and blister packs to keep medications organised in a straightforward way, and the use of electronic pill monitors to reduce unintentional nonadherence. The CDC’s ‘Morbidity and Mortality Weekly Report’ revealed that of the prescriptions that are actually filled, only half are taken as prescribed: ‘Patients typically struggle to adhere to therapies due to issues with timing, dosage, frequency, and duration,’ the CDC reported.
BE YON D T H E PI L L In November 2017 the US FDA approved Otsuka Pharmaceutical’s new formulation of its ‘digital pill’, aripiprazole, which contains an ingestible sensor that tracks when a pill has been taken. As Otsuka’s antipsychotic and mood stabiliser, Abilify MyCite, dissolves in the stomach, the sensor activates, sending a signal to a patch worn by the patient. This data is sent to an app on the patient’s smartphone and can be transmitted via a web-based portal to doctors and caregivers.
E A SI LY FORG O T T E N The recent REMIND Randomised Clinical Trial, which measured the effect of reminder devices on med adherence, addressed the contribution of forgetfulness when it comes to not taking chronic disease treatments. It compared the effect of low-cost reminder devices – a pill bottle strip, digital timer and standard pillbox – on adherence among patients taking up to three meds to treat chronic conditions. The results showed that devices did not improve adherence and may have been more effective if coupled with interventions to ensure consistent use.
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MEDS & MINDFULNESS As society increasingly embraces a holistic approach to health, industry, HCPs and pharmacists are moving away from treating the symptoms, focussing instead on the whole person.
TH E AB BVI E HAB IT
bbVie has created a series of mindfulness podcasts for blood cancer patients to support people living with these diseases and their partners or carers. Together with mindfulness expert Dr Caroline Hoffman, AbbVie developed a series of podcast recordings with support from the UK’s leading blood cancer charities, including Leukaemia CARE, the Lymphoma Association, CLL Support Association and Bloodwise. They were created in response to the growing body of research which demonstrates the negative psychological impact of blood cancers on patients,
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including depression, concerns about body image, relationships with others, loss of self-esteem, isolation and financial stress. These mindfulness podcasts aim to help alleviate the emotional stress felt by those living with blood cancers and improve their overall well-being. Head of Campaigns and Advocacy at Leukaemia CARE, Zack PembertonWhiteley, said: “The emotional and psychological impact of a leukaemia diagnosis is often overlooked. It’s easy to fixate on an issue and lose sight of the bigger picture of how it’s affecting you, so it is important that anybody affected by a leukaemia diagnosis takes time to reflect
on their wider thoughts. Mindfulness offers a way of doing this.” There are three modules to the podcasts: mindfulness of the breath; mindfulness of the soles of the feet, and mindfulness of the body. “You may have recently been diagnosed with a blood cancer or be waiting to see if or how your condition progresses. You may be undergoing tests or treatments, or perhaps you are in remission,” explains Dr Hoffman. “When you practice mindfulness, you are training your brain into positive habits of coping, and responding to the many stressful events that may be happening in your life.”
Amy Schofield SOCIAL PRESCRIBING
ocial prescribing is an innovative, personalised approach to health that enables GPs and other frontline HCPs to work with patients taking into account their social, emotional and practical needs to find solutions to their health problems, often using services provided by the voluntary and community sector. The growing social prescription movement has clear benefits for individual patients, potentially reducing demand on the NHS, particularly in primary care services. Dr William Bird MBE set up Intelligent Health in February 2010 with the vision of transforming the health of millions across the UK through innovative initiatives to get people moving. As a GP, he set up the Health Walk scheme in
I L L U S T R AT I O N B Y
April 1996, followed by the Green Gym one year later, then the Beat the Street programme, which has encouraged half-a-million people across the world to get moving and improve their health. “Our current healthcare system tackles the rise in long-term conditions such as diabetes, obesity, depression and dementia. We need to move to the cause of these illnesses and tackle the underlying problems of loneliness, disconnection with the natural environment and a lack of purpose,” he says. “In order to transform health and inequalities we are moving to a system where social prescribing becomes a norm. This can save our NHS and help build happier, healthier, more connected communities where we would all want to live.”
H E R E & N OW ovartis’ Here & Now campaign is a pan-European advanced breast cancer (ABC) awareness initiative from Novartis Oncology. The project aims to raise awareness of ABC, uncover new insights into its impact and support those living with the disease across Europe, through ‘a series of creative and thought-provoking activities’. This includes a ‘Mindfulness patient resource’, a guide for ABC patients who suffer from depression and emotional stress resulting from their illness.
G O I N G D I G ITAL
he so-called ‘social network for health’, HealthUnlocked, has created a ‘social prescribing tool’ which harnesses the power of technology to improve patient outcomes beyond the pill. This digital social prescription tool, integrated into the clinical system EMIS Web, allows GPs to prescribe information, services and online support. “Social prescriptions are a new way of approaching the management of chronic health conditions in primary care. By signposting non-medical services and resources we can empower people to engage themselves in their health and lifestyle,” explains HealthUnlocked’s Chief Medical Officer, Dr Matt Jameson Evans. “Using our technology we have been able to incorporate the peer support already improving outcomes in online HealthUnlocked communities, and bring it together with voluntary and CCG services. By doing so we can offer a digital version of social prescription to GPs that they find easy to use during the consultation, and their patients find beneficial.” Initially live in two GP practices, the technology will be rolled out across practices in North East London as part of a partnership between Innovation Test Bed, Care City and HealthUnlocked. “Over the past year we have seen a significant rise in practices looking to implement this and people actively looking for these type of resources,” says Dr Jameson Evans. “Social prescription in this form may be a relatively new concept, but by further enabling and embracing the technology that does it, we have the potential to give people the tools for a better quality of life, reduce reliance on medications, lessen use of GPs and A&E and radically rethink how we manage chronic health conditions.”
Here & Now signed up international mindfulness coach, Greg Burdulis, to develop a mindfulness resource that could psychologically and emotionally support women living with ABC. The mindfulness guide consists of five modules that use mindfulness and motivational messages to develop skills: calm, self-compassion, gratitude, pain management and active imagination. Each exercise along with its introduction lasts 15 to 20 minutes and can be downloaded onto a smartphone or tablet.
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BE MINDFUL Mindfulness helps to: • Lower stress • Reduce worry • Improve focus • Create more positive connections • Find meaning and gratitude.
“Mindfulness means paying attention in a particular way; on purpose, in the present moment and non-judgementally’’
N E E D L E WO R K
IAN RUB EN STEIN
GP at Eagle House Surgery in Enfield since 1984, he uses complementary techniques in addition to modern medicine when treating his patients.
I COMMUNIT Y MINDED
JANE D E VENI SH NHS Standards and Services Pharmacist, Well Pharmacy
ommunity pharmacy also plays a vital role in this more balanced approach to healthcare. Jane Devenish, at Well, says that community pharmacists have the opportunity to have a different relationship with their patients, one that supports the patient to make small changes that can make a big difference to their health. “Person-centred care is one of the GPhC standards, recognising that improving what matters to the patient is the most important health outcome, and
this usually can’t be done by medication alone,” says Jane. It’s the accessible ‘local touch’ that enables community pharmacy to offer more than a prescription service. “Pharmacists and technicians who work in the community have great links with other organisations in their locality, directing people through the complex network of health and social care,” explains Jane. “Increasingly, this includes charity and social care groups, such as choirs, to improve breathing, or groups for people with Parkinson’s disease or dementia.”
CO M P L E TE LY H E A LTH Y Pfizer’s ‘Wellness’ section of its website also advocates the power of the ‘whole person’ approach in improving patient wellbeing, featuring tips and advice on social connectedness. The company offers patients a wealth of information on how to promote complete wellness by adopting a wide-ranging approach to health, including connecting with others, trying new experiences, staying active, tackling insomnia, cultivating healthy sleep habits, eating well and mindfulness techniques.
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taught myself hypnosis at school and my GP trainer taught me acupuncture in 1982. I am trained in counselling and I’ve written about using placebo in medicine. In the 1980s I used hypnosis during my regular consultations and I was also clinical hypnotist for the Whittington Hospital cognitive behavioural therapy pain management programme. As general practice became increasingly busy I found I had less time for hypnosis, so I decided to concentrate on using acupuncture for the relief of pain. This is popular with my patients and colleagues, and forms an important part of my current work. My conventional practice has always been informed by my alternative interests. Sometimes these are extremely unconventional, such as when I sat in with a group of trainee psychic mediums! It all adds to the mix and keeps me engaged with my patients. Modern medicine is very effective, but it has become more technical, less personal and many people have become disenchanted with it. I want to encourage doctors to bring the enchantment back by marrying modern medicine with traditional practices.
Go to wearehereandnow.com Go to abbvie. co.uk/mindfulness. For further reference, check out Dr Rubenstein’s book, ‘Consulting Spirit: A Doctors Experience with Practical Mediumship’, available on Amazon.
The NHS’s original prophecy is under threat and new forces are changing the game at will.
his year is the 70th anniversary of the NHS; that embodiment of the Good Samaritan parable admirably rooted in the Christian socialism of 1940s coal miners. So, what state will our beloved institution find itself in during 2018? Here are some predictions. CO N S O L I DATI O N E V E RY W H E R E We’ll see fewer but considerably larger GP practices and myriad federated groups, while mental health trusts will merge with acute ones and CCGs will cluster towards reinvention. All the NHS morphing will be wrapped in a deliberate fog of undefined acronyms. Legal challenges will open debate about whether we’re heading for a return to the District Health Authorities of the 1980s, or US-type managed care organisations. N H S FU N D I N G W I L L D O M I N ATE In 2018 we’ll see a switch in emphasis from funding levels to prioritising a limited budget. We’ll see public debate of the NHS purpose – and boundaries – with IVF being a preferred battleground of NHS managers. Managed pathways will set explicit limits to patient expectations, towards a national menu of NHS services. Some waiting times will be selected to rise and all of this will intentionally foster self-pay and co-pay. WO R K FO R C E W I L L R I VA L F U N D I N G Brexit, student nurse bursaries, demography and years of absent planning herald a perfect storm. The Agenda for Change renegotiation will see attempts to end automatic increments and introduce performance elements to the pay scales of 70% of NHS staff. Watch for moves to introduce regional pay differentiation disguised as additional levers to recruitment.
THE NHS WILL EXPAND SUB- COS In my July column last year, I signalled NHS trusts which provide other localised facilities. These sub-companies are everywhere but, seriously, who in pharma is really prepared for what this means? It is a massive issue for the NHS that remains invisible to its suppliers. ‘War game’ it through, assessing the potential scenarios properly and you’ll change your current strategy, I promise.
“A ll the NHS morphing will be wrapped in a deliberate fog of undefined acronyms”
P R O C U R E M E NT & CO M P E TITI V E E D G E Device and service suppliers are rightly obsessed with category towers, collaborative procurement partnerships, total solutions frameworks and the other fruit of the Carter Review tree. They are busy catching up with a fragmented NHS starting to act as a co-ordinated block with shared prices, specifications and bulk buying. Now, imagine that facilitated by 50 or so collaborating groups of NHS trusts rather than 200 competing organisations. DE-PRESCRIBING & JUDG EMENTS Sadly, pharma seems to have no answer to being seen as a commodity of marginal value or regarding how to gain a constituency of support for valuing medicines. We’ll soon see increasingly concerted restriction strategies and connected formularies managed by the regional medicines optimisation committees. Over the counter prescribing will be used as a screen to target so-called drugs of limited value and those targeted as high cost. The NHS may even develop its own generic supply. After 70 years of waiting, will 2018 will be the ‘Year of NHS Monopsony’? David Thorne is Chair, Washington Community Healthcare and Non-Executive Director, City and Vale GP Alliance. Go to blueriverconsulting.co.uk
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Entries for the Pf Awards 2018 are in. Who will make it to the Assessment Day? Don’t forget to book your dinner tickets for the Pf Awards Dinner. Join us and comedian Hal Cruttenden as we celebrate excellence in pharmaceutical and medical device sales.
D O N ’ T M I S S TH E I M P O RTA NT DATE S FO R YO U R D IA RY:
Assessment Day, King Power Stadium, Leicester T H U R S DAY 0 8 M A R C H 2 018 : Pf Awards Dinner, Royal Lancaster London
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F E AT U R E
Can eating your greens prevent dementia?
T H E R E SE A RC H Researchers at Rush University Medical Center in Chicago, led by study author Martha Clare Morris, aimed to increase the understanding of biological mechanisms underlying the association between nutrients in green leafy vegetables and cognitive decline. The primary nutrients and bioactives in greens such as spinach, rocket and kale include vitamin K, lutein, nitrate, folate and kaempferol. The participants were divided into five equal groups based on how often they ate leafy green vegetables. For those who ate the most, the rate of decline in scores on thinking and memory tests was slower by 0.05 standardised units per year than the rate for those who ate the least leafy greens – an equivalent difference to being 11 years younger.
Don’t believe the hype: health headlines dissected WORDS BY
T H E R E SU LT S
T H E ST ORY
Research appears to show that eating one or two servings of leafy green vegetables per day could slow the memory decline associated with ageing. The newspapers greeted the study with headlines suggesting that eating your greens could actually stave off dementia. So, does eating a salad a day really keep the doctor away?
This was a prospective study of 960 participants of the Memory and Aging Project. Participants aged 58–99 years – without an existing dementia diagnosis – completed a food frequency questionnaire and had less than two cognitive assessments over a mean period of 4.7 years. The study results, published in the online issue of Neurology, appeared to show a link between consumption of leafy greens and a slowing of cognitive decline. The researchers concluded: ‘Consumption of approximately
HAS BEEN used in salads
SINCE ELIZABETHAN TIMES
one serving per day of green leafy vegetables and foods rich in phylloquinone, lutein, nitrate, folate, α-Tocopherol, and kaempferol may help to slow cognitive decline with aging.’
T H E DE A L The study does build on the body of research that shows a healthy diet could slow memory loss, and proves a fragile link between eating leafy green vegetables and a reduction in cognitive decline and memory loss. As dementia itself wasn’t measured in the study, at this stage it can’t be concluded that the diet could prevent dementia. In addition, some participants were followed-up for the relatively short period of two years, and it can take longer for memory loss and dementia to develop. Morris herself pointed out that the study merely showed an association. Dr James Pickett, Head of Research at Alzheimer’s Society, agreed, but added: “What’s good for the heart is good for the head. A healthy diet rich in essential nutrients, combined with regular exercise and avoiding smoking, can help to reduce your risk of developing dementia.”
W H AT T H E PR E S S SA ID: “A salad a day keeps dementia away, researchers say” LAtimes.com; “Eating salad could help stave off dementia, new research reveals” Express.co.uk; “A salad a day keeps brains 11 YEARS younger” Mail Online.
PEOPLE TAKING BLOOD THINNERS
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outs from university. People throw the word ‘exciting’ about a lot in healthcare, but this really is. From a blank sheet of paper, we are now rapidly building and delivering the Catapult’s programmes of work.
REACHING THE TOP
Mark Samuels is on a mission to get medicines to patients and start dynamic friendships. INTERVIEW BY
here’s a lot of talk in this business about ‘putting the patient first’, but my guest today backs it up by repeatedly putting his neck on the line, to prove he’s doing just that. Chief Business and Strategy Officer at Medicines Discovery Catapult, Mark Samuels, doesn’t like a simple existence and prefers climbing seemingly insurmountable obstacles – metaphorically and literally. Let’s find out why. What is the brilliantly-named Medicines Discovery Catapult? The purpose of the Catapult is to support the life sciences sector and, in particular, small to mediumsized enterprises (SMEs) at the early stage of research. Many of these will be biotech companies, diagnostic companies or spin-
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In what ways can you help these guys? We’ve got some very rare scientific kit which, if you were a small company with a highly promising molecule, you wouldn’t otherwise have access to. For instance, we’ve got the UK’s only solid state nuclear magnetic resonance facility, which is vital for drug target validation. Furthermore, we’ve got a vast breadth of expertise, and often this know-how is as important as lab capabilities. By the end of this year, we aim to have over 100 staff, made up of world-class people with commercial, scientific and informatics experience. They don’t just talk about it, they’ve done it for real. What other ways are there of supercharging the med pathway? We’re driving collaborations, which combine capabilities from all the different organisations involved. Drug discovery in the UK can seem very fragmented – lots of brilliant teaching hospitals, universities and patient charities doing great work, but it isn’t always obvious to an SME how to bring them together. What do patient charities bring to the mix? Many of them are huge powerhouses in their own right, and they know precisely what a patient needs. This is an area where drug discovery can be strengthened, because eventually people in industry will need to submit patient reported outcomes, so it’s better to trigger that process from the start. How do you get people who are protective of their discoveries to share information? I pioneered some of the most complex collaborations in clinical research, when I led the establishment of the Government’s translational research collaborations. These are very large-scale consortia, each involving up to 36 different universities and NHS Trusts, working as one team with industry. So, you can imagine the challenges involved in getting all of them to work together. What great things happen when they break bread? Those partnerships have been running for years now and been responsible for many successful projects, including a trial
COFFEE BRE AK
“I instigated the ongoing HIV collaboration between Oxford, Cambridge and London. Even against all odds, collaboration can happen as a force for good.” of the first new drug in 50 years for chronic cough and the world’s largest clinical trial for preventing rheumatoid arthritis. I instigated the ongoing HIV collaboration between Oxford, Cambridge and London biomedical research centres, which is currently undertaking a first in-human trial for a cure. Even against all odds, collaboration can happen as a force for good. In the vast healthcare landscape, where does the Catapult sit among NICE, the NHS and so on? As a broker and neutral convener. We’re funded by Innovate UK and, therefore, not-for-profit and here to benefit the UK. I probably have an unusual breadth of insight into UK life sciences; for example, I represented the UK’s diagnostic industry in co-chairing the establishment of NICE’s programme to evaluate diagnostics. I also know what the industry’s position on submissions is, from my time on the strategy board of the NHS’ research arm. At the Catapult, we’ve certainly got a wide range of perspectives we can bring together. Did you always plan for a career in life sciences? I studied molecular biology for my first degree, then went to work for Unilever and spent many years in fastmoving consumer goods in the UK, Holland and France. I had a great time and at one point in my career, worked on marketing for Star Wars – a dream job!
On top of a mountain? Come on, Mark, I wasn’t born yesterday! It’s absolutely true. They introduced me to Roche, and that’s how I came into the industry in 2001. I started in a marketing role and eventually become head of business development for Roche’s diagnostics division. After a decade, I left Roche for a role in Government, where I set up the National Institute for Health Research’s Office for Clinical Research Infrastructure, driving collaboration in the research centres it funded. It was such a big task that many of my respected colleagues told me not to take the job. How did it pan out? It had all the challenges of a start-up. At the beginning, we had four members of staff and were operating out of a coffee shop, and yet we were representing the Government, so had all the bureaucracy that comes with that. Within five minutes of starting, Pfizer had announced it was closing Sandwich – but I actually enjoy difficult situations, and things soon improved. We started forming a lot of allies very quickly and built partnerships with many of the foremost scientific leaders in the country. When I started in 2009-10, £30m was coming in through industry investment, and by 2014-15 it was up to £130m. What are your major ambitions for the Catapult in the future? Patient-centred collaborations, and starting with the patient need. After all, we are all patients, and we all need this to work. What record would you choose for the soundtrack of your life? God is a DJ. Naturally. It’s your last supper, what are you having? Pizza and wine, please. Coming up! Goodbye, Mark. Bye John. Go to md.catapult.org.uk
That’s an usual career path, Mark. I definitely come from a different background – I was a serious mountaineer in my 20s and 30s, and took six months off to climb the Alps and Andes. I was on a mountain called Aconcagua, when I ran out of money and realised it was time to get a job. It was sheer serendipity that, while I was there, I bumped into another couple of climbers who happened to be recruitment consultants for the life sciences sector.
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AI is here
Launching ageing healthcare systems and people into the future is not a possibility – it’s a necessity.
ith tales of Victorian era conditions on hospital wards, chronic ambulance queues and surgery delays reminiscent of the NHS’s nadir in the early 1990s, it almost seems delusional to look at the potential for artificial intelligence (AI) in healthcare. But engage we must, as there is no future for healthcare delivery in isolation from increasing technological change. Indeed, the overwhelming need to reduce the burden on health systems here, and in the developing world, makes turning to tech ever more urgent. Fortunately, the hype around AI guarantees plenty of activity in this space, with lots of new research, such as the excellent contribution from think tank, Reform, whose new report ‘Thinking on its own; AI in the NHS’ makes practical recommendations for its adoption. The prize on offer is achieving better outcomes in preventing ill health, for example, through wearables and deploying the data they collect, as well as making faster, more accurate diagnoses and utilising public resources more effectively. Getting better diagnosis is not only good for patient outcomes; it means the right clinical approach is found more quickly, reducing waste and inefficiency.
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L E A P O F FA ITH : T R A N S FO R M I N G T H E N H S TO DAY & TO M O R R OW The effective use of information and technology is fundamental to the NHS transformation envisioned in the ‘Five Year Forward View’ and in Sustainability and Transformation Plans. This is being reflected in the NHS by, for example, the Driving Digital Maturity Programme which aims to ensure the NHS is paper-free at the point of care. It is also found in the establishing of Global Digital Exemplars (GDEs), an internationally recognised NHS provider delivering exceptional care through the use of world-class digital technology and information. NHS England is currently supporting seven digitally advanced mental health trusts, and 16 digitally advanced acute trusts, through funding and international partnership opportunities, to become GDEs. The NHS is also at the forefront of harnessing technology in genomics. With over 41,000 genomes sequenced so far, the 100,000 genome project is well underway. One sequenced genome is equivalent to 200GB of data – the approx memory of a laptop . Multiply that by 100,000 people and that’s a lot of data. This is the issue of fundamental importance to any AI aspirations; the scramble for good, clean data. Currently, NHS patient data is of poor quality, in the wrong format, not collected consistently and massive concerns remain around privacy and access. According to Norman Lamb MP, whose Science & Technology Committee is currently carrying out an inquiry into decision-making algorithms, NHS digital capability is “a million miles away” from unlocking AI’s potential.
— we help people achieve healthy skin
DATA DAY: FUTURE IS NOW “It has been estimated that there are 500 separate AI pilots across the NHS at present ” Another major challenge is trust; the whole digitialisation and AI project relies on carefully nurturing and protecting public trust. Trust of course is the essence of all successful health treatment – a basic level of trust in your physician and in the system is required before anyone will take a prescribed medication. When it comes to use of our personal data, we must tread very carefully. Every scandal plagues progress, from Alder Hey in 1999 to the care.data fiasco a few years back; each one erodes trust and sets us back years. So far the UK’s approach to AI in healthcare is piecemeal; individual projects run by an array of partners using their own technology to demonstrate effectiveness. It has been estimated that there are 500 separate AI pilots across the NHS at present. Moorfields Eye Hospital and DeepMind Health launched a medical research partnership in 2016 using AI technology to better analyse scan data with the aim of changing the way professionals carry out eye tests and leading to earlier detection of eye diseases. A project between Genomics England and Illumina is developing a knowledge base to improve and automate genome interpretation. The tools will operate within the Genomics England secure database to enable researchers and clinicians to access information and reports more readily. Amazon Web Services has partnered with Cerner to help healthcare providers better use their data to make health predictions about patient populations. Cerner’s ‘healthIntent’ is a cloud-based population health management platform which would give the NHS the ability to aggregate, transform and reconcile data across the whole of healthcare. This level of data on a population would enable public health leaders to engage citizens to take an active role, and manage each individual to improve their health. If this data could reach beyond electronic health records (EHRs) and capture GPS data and browsing history too, then one
can imagine how transformative – and possibly alarming – this could be. Put aside even the risks around data breaches and the operational, regulatory and legal concerns to navigate, the public are sceptical of any misuse of their data by corporations. Last year’s autumn budget confirmed the establishment of the world’s first national advisory body for AI, while the Centre for Data Ethics and Innovation will set standards for the use and ethics of AI and data. What’s required now is a clear regulatory framework that enables the private sector to form strong and transparent partnerships with the holders of the data. While some predict that the future lies with tech firms seeking to buy healthcare providers as a way of ensuring collection of clean data, this trajectory must surely be resisted. Power lies with those who hold the data and, therefore, it's advantage NHS. The public sector and academia should be encouraged to engage with the private sector, but where our data is used to develop AI, the current bias towards a profit motive should be removed. Some good investment from the increased R&D spending outlined in the industrial strategy is invaluable, but it needs to be more ambitious so that we see a real national imperative to drive this technology. The trade-off may be slower progress, but the result will be better constrained AI and more effective healthcare. Ultimatey, the NHS must benefit financially from AI opportunities, and they must benefit the patient. If financial benefit falls only to commercial organisations, trust among the public could be jeopardised. To build towards the use of AI across the NHS we need robust data ethics, clever articulation of the rewards at stake and, critically, investment. Only then can we truly arrive in the future of healthcare. Claudia is a Director at Decideum. Go to decideum.com
IT’S NOT ABOUT SKIN CONDITIONS It’s about the people living with them
WE UNDERSTAND … that the more you know the easier it is to take control in challenging situations … and living with a skin condition is no exception. We see the challenges you, your family and your friends face as our own, why? Because at LEO Pharma we have many decades of experience in developing care options and resources for people living with a range of skin conditions. So we understand what it’s like. As a global company dedicated to dermatology, with our UK/Ireland operations based in Berkshire, our mission is to help people achieve healthy skin and this focus stems from listening to people living with skin conditions. Want to know more about us? Visit www.leo-pharma.co.uk
www.leo-pharma.co.uk LEO Pharma, Horizon, Honey Lane, Hurley, Berks, SL6 6RJ © LEO · LEO Pharma · UK · December 2017 ALL LEO TRADEMARKS MENTIONED BELONG TO THE LEO GROUP · UK/IE/MAT-13867
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t is easy to forget that our competitive industry still has 80-90% gross margins and, as a consequence, its traditional commercial model is driven by sales growth, rather than worrying about costs. Under most circumstances, incremental sales drive incremental profit. Within the affiliates this is obvious, and country managers have often resisted attempts by corporate counterparts to take a centralised approach to sales and marketing, claiming their country’s commercial ecosystem is unique and not amenable to meddling. Of course, the modern pharma company will also have to conduct market access, medical education and phase IV studies within its affiliates, but the reality is that most affiliate activity is focused on sales. For large pharma companies the sales and marketing budget usually beats R&D budgets by 1.7 times, and this is becoming increasingly difficult to justify.
R ISE OF PR I M A RY C A R E D OM I NA NC E Throughout the 1980s and 90s the focus on sales-driven growth led to the evolution of some very different ways of working within primary care, from co-promotion and co-marketing with embedded local players, to the ‘petal’ system of multiple salesforces detailing overlapping product ranges. The purpose of these techniques, together with employment of contract sales teams, was a sort of ‘shock and awe’ strategy which swamped the physician with frequent visits about particular products. The competitive response was usually swift and commensurate, resulting in a commercial arms race between players within a hotly contested therapeutic area. This was known as the ‘share of voice’ model, and when applied to large primary care categories, it drove top line growth so successfully that governments and institutional payers were forced to find a response to escalating drug bills around the world.
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NEVER B AC K L A SH F ROM H E A LT H T E C H NOLO G Y
DE A D E N D : PR I M A RY C A R E H I T S A WA L L
This response varied from country to country, but has taken two main forms; the Health Technology Assessment response and the consolidated payer response. Throughout the 1990s and 2000s, in the UK (NICE), much of Europe, Australia and parts of Asia, there has been systematic developing of a process that assesses whether a product represents value for society. Much of the health economics work is shared among countries, and pricing comparisons made between the same product in different countries are routine. The benchmarks for the monetary value of a healthy human being are the subject of debate, but are necessary to make budgetary choices in a system without unlimited resources. The consolidated payer model, operating in the US through pharmacy benefit managers such as Express Scripts, relies on large payers exerting pressure on manufacturers for rebates, with some undifferentiated product portfolios having to rebate as much as 50% of their gross price. The impact of health technology assessments can be seen today, manifesting itself in pricing pressure, therapeutic substitution, a diminution of decisionmaking by physicians and a conscious shift towards products with a confirmed medical need. A decline in R&D productivity, however, has not made this process easy.
Many commentators blame the decline in R&D productivity for the steep fall in product approvals through the 2000s but, in reality, there have been several forces at work. The rise in genomics, together with high-speed screening techniques, led to a belief that chemical libraries could be screened against unprecedented targets and that optimised drug candidates would flood through the discovery phase into phase I trials. The sharp product rise in the early clinical phases then came to a shuddering halt during phase II ‘proof of concept’ studies, when large numbers of clinical failures unveiled the reality – there is no short cut to understanding disease biology. As research cul de sacs were explored, a squeeze on primary care products began in the form of price pressure from above and greater safety demands from below. As a consequence, and aided by the rise in technology, a rapid increase in the proportion of newly-approved, biological in origin drugs commenced. Monoclonal antibodies, vaccines, enzyme replacement therapy and other therapeutic peptides, aided by insatiable demand for insulin, developed strong sales and completely changed the nature of commercial interfacing with physicians.
“T he success of biologicals in terms of both approval and sales has required the industry to change its commercial emphasis”
Recruitment & Outsourcing Specialists in Pharmaceuticals, Healthcare and MedTech
The first chapter of pharmaâ€™s commercial evolution takes us from the insatiable sales-drive of the 1980s to the present, highly complex marketing landscape. WORDS BY
ENDING BIOLO G IC A L S C H A NG E T H E C OM M E RC I A L DY NA M IC The pressure on primary care products, together with the impact of the patent cliff in 2012/13, have combined to drive sales of primary care products into stagnation. Much of industry downsizing, particularly within commercial operations, has been in response to this. Perhaps most merger and acquisition activity within pharma also has its origins in this relentless pressure on primary care sales and the need to reload the pipeline quickly with biologicals and specialties. The success of biologicals and other specialties, such as oral cancer drugs, in terms of both approval and sales, has required the industry to change its commercial emphasis. The huge traditional focus on primary care or family doctors has changed to specialists, and their support workers within a secondary care or hospital environment.
The increased complexity of the specialty sell, sometimes involving multiple decision-makers, formulary approval, health economic arguments, companion diagnostics and performance-related reimbursement, has required a much smaller, but more skilled group of people to interface with the healthcare network. Many companies have yet to find the necessary mix of skills within their workforce and are still working under the old assumptions that spending on promotional activities can remain as high as it used to be under traditional models. They do so at their peril. Check out Part 2 in the next issue, as promotional resources and modern data come under intense scrutinyâ€Ś Stewart Adkins was a Pharmaceutical Analyst at Lehman Brothers for 23 years and is now a Director of Pharmaforensic Limited. Go to pharmaforensic.co.uk
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TALKING YOUR LANGUAGE Like anyone in pharma, comms departments rely on a vast knowledge of regulation.
ll pharma employees are constantly weighing up what they are doing with the welter of regulations that determine what we can and can’t do. Many will have undergone specific ABPI training – I know, because everyone at the company I work for has just gone through it! Indeed, it is a serpent’s nest, but if you know where the danger points are, you can still communicate messages in a way that stimulates and excites. PR and comms departments representing pharma are often the spark that ignites the flame of knowledge about a new medicine discovery, an approval, a breakthrough or how lives could be changed forever. These tenacious information machines also toe a notoriously stringent line; always under the watchful eye of regulators. In many ways, what they produce holds a mirror up to the whole of industry. Let’s hear from two people at pharma’s information highway.
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AI M S We are inspired by a desire to improve the health and lives of people worldwide. Whether it’s raising awareness of health issues or new evidence for a drug’s efficacy, we aim to break down what can be an overwhelming amount of information into accessible stories that resonate with audiences.
C HALLE N G E S We’re well versed in industry regulations and try to avoid seeing them as a barrier to impactful communications. Just as every cloud has a silver lining, with every challenge there’s the opportunity to do something different, to find fresh and thought-provoking ways of engaging our audiences. Ultimately, it’s about looking for innovative solutions within the boundaries set by regulations.
E XC ITE M E NT It isn’t every day you find yourself launching a new therapy that’s set to change the path for generations to come, and it isn’t every day you open the papers to find the story you’ve been working on for months splashed across the front pages. Those are the real highlights that allow us, as communicators, to be part of a collective history that is so much bigger than any one function alone.
F E AT U R E
“It isn’t every day you open the papers to find the story you’ve been working on for months splashed across the front pages”
“We are science companies, while the NHS is full of jargon. As a result, we have become used to language that alienates. Companies must be clearer”
C L AI R E MARTI N
GWE NAN WH ITE
Director at GCI Health
Director of Comms and PR at AbbVie
AI M S
As an industry we’ve been telling the value story of pharma more explicitly in recent times, but we can still be more transparent about what it takes to deliver pharmaceutical innovation. We need to continue to be responsible as an industry, always ensuring the patient is at the centre of every decision and demonstrating our commitment beyond the provision of a single product.
We aim to safeguard our company reputation and advocate for a healthcare system where everyone who falls ill gets the best possible outcomes. This means aiming for partnerships with patient organisations and the NHS in all we do, as everyone is working toward the same goal.
AC H I E VE M E NTS In this industry it’s vital to hold on to expertise and keep people with knowledge of pharma’s unique terrain. Team consistency enables us to build relationships with our clients, allowing both sides to get the best out of the arrangement.
C HAN G E I think the industry is starting to come round to the fact that more authentic communications, with greater scope for character and originality, resonate with audiences far better than the heavilyscripted, polished lines with which healthcare communications has previously been synonymous. Granted, we work in a highly-regulated environment, but communications professionals shouldn’t feel shackled by it. Go to gcihealth.com
C HALLE N G E S Agility can prove a challenge. In the digital age of ever-shorter news cycles it is especially challenging sometimes to manage our obligations in assuring and auditing our external communication, and responding in a timely fashion.
E XC ITE M E NT Healthcare is consistently near the top of public priority and debate in the media. This is because it touches all of us. We are privileged to work in an industry that has the potential to have a transformative impact on people’s lives and there are not many communications professionals who are able to say that.
PHAR MA We aim to be positive and directly engage with the real problems facing the NHS. There is no escaping that an increasingly elderly population – largely driven by past
success at tackling disease – and long-term funding constraints, are putting major pressures on the health service. Through our Sustainable Healthcare Initiative we aim to be practical. More than 85% of healthcare spend is not on medicines, so we try to think holistically about the opportunities the NHS has to maximise what it does.
AC H I E VE M E NT 2017 saw us awarded company of the year by multiple organisations, including the Pf People Survey company of choice. We were also the second highest pharma company on the list of UK Great Places to Work and ranked #1 in the UK Pharma RepTrak survey for the second year running. Our way of working positively and ethically is being recognised as important and we saw these as validations of the culture we have built here.
C HAN G E Tone is where I think the industry has the biggest opportunity to make a change. We are science companies, while the NHS is full of jargon. As a result, we have become used to a language that alienates. Companies need to be clearer in how we communicate. There is no regulatory barrier that stops us doing that – it is entirely cultural. Go to abbvie.co.uk
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We’re just getting used to it, but will healthcare data become federated in the future? WORDS BY
“Pooling and connecting data from different settings makes it richer, but also more attractive to cyber criminals”
n overwhelming trend in 2018 will be increasing restrictions around releasing healthcare data for analysis, just as we begin to connect with it for deeper insights. This has obvious implications for industry. Maintaining timely access to robust healthcare data is vital in demonstrating value and outcomes, as well as forging partnerships with patients. Real world data – observational data, reflective of routine healthcare delivery – is also the key to establishing the holy grail of outcomes-based pricing. So, why the concern about releasing healthcare data? The issues are four-fold. Firstly, pooling data from different settings makes it richer, but also more attractive to cyber criminals. Secondly, citizens aren’t generally in favour of agencies combining their data beyond what is necessary, especially since the care.data fiasco. Thirdly, there is the ongoing apprehension about industry access to patient data. Finally, fear about increased responsibility and fines from breaches of the forthcoming European General Data Protection Regulation isn’t helping. In response, the walls are going up and this has led to researchers conducting analysis in strictly controlled environments, only seeing fake data or not seeing data at all. Ever since Sir Nick Partridge’s 2014 review of data, held by the Health and Social Care Information Centre (HSCIC), the writing has been on the wall. He recommended
‘That the HSCIC actively pursues a technical solution to allow access to data, without the need to release data out of the HSCIC to external organisations’. In short, researchers will be expected to enter a secure ‘sandbox’ environment to analyse data, instead of it being released. Consider also the development of the Simulacrum – a ‘synthetic’ oncology dataset modelled to correspond in distribution to the real thing at Public Health England (PHE). It means researchers query fake data, and only if PHE deems these queries appropriate will it conduct the analysis itself. This has also shaped thinking behind the Digital Healthcare Data Federation. The phrase ‘data federation’ may sound confusing, but the issue is that European data controllers don’t want to breach social contracts with their citizens by transferring data outside their nations. To enable data analysis across Europe, a federation where each constituent nation retains some autonomy, will respond to requests for data queries, but researchers never get to see the raw data. It may appear that we retain the same levels of access through these approaches, but there is a stark difference between having appropriately de-identified data transferred into our hands and this new trend. No one wants sensitive patient data to be mishandled, but a lack of visibility may throttle innovation. Industry’s relationship with healthcare is about to become even more complicated, if that could be possible. Hassan Chaudhury is Chief Commercial Officer at Health iQ Limited. Go to healthiq.co.uk
Care.data doom The NHS had collected vast amounts of patient data since 1989, before launching its care.data information-sharing facility in 2013. The ‘announcement’, however, was botched as the NHS’s leaflet to every household became lost among other junk mail. care.data was closed in 2016 amid concern from the public about confidential medical records getting in the wrong hands.
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’m writing this on a train returning home from London, feeling both overwhelmed by and optimistic about the task ahead. I’ve been at a meeting with likeminded women, hosted at the Royal Pharmaceutical Society (RPS), reflecting on the number of us carrying out senior roles in the profession. Pharmacy has a poor record of women in leading positions. Our profession is predominantly female and the last official data from the General Pharmaceutical Council, in 2013, indicated 61% of pharmacists were female, with an even greater proportion in the pharmacy workforce, but we are not seeing this play out at senior level. In short, those in leadership positions shaping the direction of pharmacy do not reflect those they lead, or represent. Aside from senior leaders within pharmacy, the lack of appropriate diversity within our leadership bodies has been a concern of mine and others for some time. None of the pharmacy organisations has more than 50% female representation at senior level, with many considerably lower. At the top of the leading community pharmacy organisations, there is just one female Chief Executive; due to leave this year. Meanwhile, the National Pharmacy Association Board (NPA) is, and has been for many years, exclusively made up of men. On a more positive note, the RPS English Board, of which I was a member (2014-17), is made up of 50% women. The evidence is unequivocal; boards and executive teams made up of a diverse mix of men and women are more effective. Women bring a distinct set of skills, and with the health service under enormous pressure, a different approach is essential. Pharmacy needs to deliver within contracting budgets; having great leaders and clear decision-making is essential. The good news is that women across the globe are gaining a louder voice. I believe 2018 is the year for the pharmacy profession to address the lack of diversity at senior level. The situation is holding pharmacy back. We need to collectively own the matter and do something about it.
Interests of fairness The majority of pharmacy’s workforce are women, so why do men continue to secure the top jobs?
J US T D O IT Getting to grips with this situation is complex with many causative factors at individual, organisation and systemic level. The first step is to gather data which shines a light on the issue, and also having enough women – and men – who want to encourage a new era. Making meaningful change requires commitment, passion, collaboration and great engagement capabilities – qualities women have in spades. I want to see a strong leadership within pharmacy to help steer the profession through challenging times of change. It is not about making the numbers balance, it’s about getting the right people in senior roles, so they can shape the future. If you want to be part of this movement in pharmacy then please get in contact – 2018 is our year for making change happen. Deborah Evans is Managing Director of Pharmacy Complete, a specialist consultancy and training company working with pharmacy. Go to pharmacycomplete.org email:email@example.com
“T he situation is holding pharmacy back. We need to collectively own the matter and do something about it”
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THE SITUATION E N V I R O N M E NTA L C H A N G E : H E A LT H C A R E D EL I V ERY ’ S M E TA M O R P H O S I S
ast month, in the January issue of Pf Magazine, I discussed evolving accountable care systems and organisations. The key features in these evolving systems are outcome focus, long-term approach, integration of services and delivery at scale. One of the questions I posed, following the piece, was: can both pharma and healthcare providers enter into meaningful yet pragmatic, outcome-based commercial relationships or will it be business as usual? So, let’s deconstruct what outcome-based deals might look like. On first examination, it could be conceded that they are not altogether new; stakeholders have explored the concepts of ‘value based pricing’ and ‘outcome guarantees’ for years. The former is a general term which is used to describe pricing based on specific cost-effectiveness thresholds, rather than arbitrary pricing. The latter provides money back if the product doesn’t perform to an agreed standard. These can operate as separate concepts or could go hand in hand; value-based pricing with an outcome guarantee could be used when benefits are uncertain, due to immature evidence perhaps, and the resulting risks for the payer are high. The NHS has dabbled with this approach through early ‘patient access schemes’, which facilitated cost-effective pricing when
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Firm handshake Can pharma drive innovative relationships in the evolving NHS? WORDS BY
Dr Duncan Jenkins
the NICE TA submissions looked shaky. Initial schemes managed risks associated with uncertainty around parameters, such as initial response rates, duration of treatment or size and number of doses. Indeed, the NHS struggled with completing the onerous paperwork, while companies confused even themselves with the complex deals they created. Patient access schemes have now reverted to simple discounts or rebates as the administrative burden was simply too high. These old schemes are even less likely to work in the new world where there is less interest in whether ‘drug A achieves outcome B in patient C’, and more focus is given to outcomes achieved across
patient populations defined by a specific condition. Successful achievement will be down to the combined efforts of care systems, professionals, patients and their families, as well as broader population health promotion measures. The critical factors that will be addressed include treatment pathways and algorithms, decision support measures, adherence to treatment, self-care and a whole raft of other small, but helpful stuff. The outcomes focus will be driven by quality improvement methods where systems are tweaked to achieve proxy outcomes in the short-term, with the expectation that these will lead to improvements in health status downstream.
“In the new world there is less interest in whether drug A achieves outcome B, and more focus is given to outcomes achieved across patient populations”
THE SOLUTION C U LT U R A L S H I F T S : C H A N G I N G T H E H A B I TS O F A L I FE T I M E
o, back to you! Can you create a commercial opportunity in an environment where your product is not the sole focus? Where the combined efforts of many stakeholders – including you and other commercial partners – achieve the outcomes? Where the financial incentive, or penalty, may be shared across several stakeholders? Where it may take a number of years to achieve these outcomes? What might your role be? It could be education, provision of niche services, such as patient helplines or adherence packages or providing intelligence and wisdom. And what will the contract look like? Medicines with a price based on what the system achieves? Will it specify services alongside, will there be a minimum contribution and how will this be defined in a quality improvement environment?
The other dimension to this is whether the NHS has the capability and maturity to hold the ring in these potentially complex systems. Currently, relationships between NHS and pharma feel like they are in an odd place, perhaps stifled by the focus on conflicts of interest and the whole issue of disclosure. While commercial deals are a different matter, will the NHS be able to welcome familiar stakeholders into an unfamiliar system of mutual benefit? Predictably, there will be concerns to ensure that commercial activities and competition don’t impinge on progress, yet pharma will need to ensure a minimum return through volume of sales, even if the final or total price paid is determined by outcomes. And what compliance arrangements will be needed on the part of pharma, and the
governance and contractual arrangements on the part of the NHS? Putting the two halves of this equation together, we require two or more parties to provide a collective effort towards achieving things outside of each individual’s control, where the outcomes can’t easily be apportioned and in an environment of trust. Sounds like a partnership to me. The remaining question is whether there is sufficient financial headroom in the system to allow such relationships to deliver financial benefits. Stay tuned and we’ll discuss this next time. Dr Duncan Jenkins is a Director at MORPh, specialist training providers for CCG, clinical, practice and GP pharmacists. Go to morphconsultancy.co.uk
MORPh NHS learning sets are back! Book your place now: 01905 612789 | firstname.lastname@example.org 23rd JANUARY 2018, LONDON New Care Models, Tools to segment and track development of NCM and What is the impact on services and Pharma? Dr Duncan Jenkins, Specialist in Pharmaceutical Public Health Dudley CCG Morph Consultancy @MorphCLtd @MorphConsultancy
20th FEBRUARY 2018, LONDON An update on RMOCs and the Wider Medicines Agenda Julie Wood, Chief Executive, NHS Clinical Commissioners
20th MARCH 2018, LONDON NHS Rightcare Carl Marsh, NHS Rightcare Delivery Partner 18th APRIL 2018, LEEDS Sustainability and Transformation Partnerships Helen Liddell, Head of Medicines Optimisation Leeds CCGs www.morphconsultancy.co.uk 01905 612789 | 07976 417312
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Not alone The last day of February every year is Rare Disease Day, but what is being done to help people suffering from these rare conditions? WORDS BY
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n the UK, one in 17 people will be affected by a rare disease at some point in their life. Collectively, rare diseases are actually not uncommon. A rare disease is defined by the European Union as one that affects less than 5 in 10,000 of the general population. According to the charity Rare Disease UK, there are between 6000 and 8000 known rare diseases and around five new rare diseases are described in medical literature every week. In the UK, a single rare disease may affect up to 30,000 people. Some diseases will affect only a handful of people, or a single person in an entire country. Rare diseases are often chronic and life-threatening, and can be single gene, multifactorial, chromosomal or nongenetic. They include rare cancers such as childhood cancers, and conditions such as cystic fibrosis, Huntington’s disease, Duchenne muscular dystrophy and acute myeloid leukaemia. Rare diseases represent such a large and complex group of conditions, and affect a small proportion of the population, therefore substantial investment by pharma in developing new treatments has always been a barrier to innovation in this area. Rare diseases actually affect 3.5 million in the UK, and a total of 27-36 million people in the EU have a rare disease. In the UK, one in 17 people will be affected by a rare disease at some point in their life.
This represents a big opportunity for pharma to meet considerable unmet clinical needs in a market with very limited treatment options, and demonstrates a need to support integration and networking among EU research, patient and healthcare organisations. Research from the University of Liverpool in 2016 found that companies which market ‘orphan’ drugs for rare diseases are five times more profitable and have up to 15% higher market value than other drug companies.
W H AT I S A N O R P H A N D R U G D E S I G N ATI O N? Regulatory authorities such as the European Medicines Agency can grant ‘orphan drug status’ to a potential rare disease treatment. In the EU, this is applied where the potential medicine is for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition that affects not more than five in 10,000 people in the European Union, or where the medicine is unlikely to generate sufficient profit to justify research and development costs. Once authorised, the medicine is given 10 years of market exclusivity.
F E AT U R E
“Patients are being misdiagnosed or dismissed entirely; and many are made to believe they are hypochondriacs, or that they suffer from a mental health disorder.”
Who’s investing? Top pharmaceutical companies by orphan drug revenue worldwide in 2016 (in billion U.S. dollars)
Rebecca Holmes, Edinburgh Area Coordinator for Ehlers Danlos Support UK
Celgene Bristol-Myers Squibb
4 6 8 10 12 Orphan drug revenue in billion U.S. dollars
Source: statista.com. The EU’s FP7 (7th Framework Programme for Research and Technological Development) and Horizon 2020 invested a total of 870 million Euros in rare diseases research between 2007-2015.
ACC E S S I N G TR E ATM E NT A 2016 report from Rare Disease UK, ‘The Rare Reality – an insight into the patient and family experience of rare disease’ surveyed 1203 UK people affected by rare diseases, representing over 450 different rare conditions. The report found that among those surveyed: • For many patients the day-to-day challenges of managing their condition are made worse by the absence of an effective treatment • In the absence of effective licensed medicines, unlicensed or off label medicines are an important route of access to treatment for rare disease patients • Where a treatment has been licensed for a rare condition, patients may struggle to access it due to the complexities of appraisal and commissioning processes • Most patients would participate in research if given the opportunity.
R E A L IT Y C H E C K The UK Strategy for Rare Diseases sets out ‘a shared six-year vision for improving the lives of all those with rare diseases in the UK by 2020’, incorporating 51 commitments that must be achieved by that year. Each UK country is tasked with taking action and developing plans to implement the strategy that best meet their own health and care systems, but will work together where required. There are discrepancies from country to country however. For example, Ehlers-Danlos Syndrome (EDS), a multi-systemic inherited connective tissue disorder, has no specialists in Scotland, but a number in England. Professor Rodney Grahame, one of the world’s leading experts in EDS, said: “No other condition in the history of modern medicine has been neglected in such a way as Ehlers-Danlos Syndrome”. Rebecca Holmes has EDS and campaigns on behalf of sufferers. “There are several different types of EDS and, irrespective of the type, symptoms range from being life-changing, to life-limiting, to-life threatening,” she explains. Rebecca is the Edinburgh Area Coordinator for Ehlers Danlos Support UK, and runs local support groups for those affected by the disease. She also works as part of an action group to lobby for greater awareness of EDS and increased care provision for those who suffer from EDS. “There is a huge lack of awareness of EDS in Scotland, and perhaps even worse, a massive amount of misinformation. There are currently no specialists in the condition in Scotland. Parents whose children are awaiting diagnosis are being accused of abuse or of having Munchausen’s by proxy syndrome,” she says. “Patients are being misdiagnosed or dismissed entirely; and many are made to believe they are hypochondriacs, or that they suffer from a mental health disorder.” Rebecca has called for MSPs to take action by getting involved in the Cross Party Group for Rare Diseases. “We urgently need a patient care pathway for EDS. This would give medical staff the knowledge to put adequate management in place, and improve quality of life and prevent complications. Those with rare diseases are not the majority, but we do exist. And we’re really, really hurting.”
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F E AT U R E
RARE IN NUMBERS
1PEOPLE in 17 OR 7% OF THE POPULATION, WILL BE AFFECTED BY A
RARE DISEASE AT SOME POINT IN THEIR LIVES
This is equal to APPROXIMATELY
3.5 MILLION 30 MILLION PEOPLE IN THE UK AND
80% PEOPLE ACROSS EUROPE
of rare diseases have a
of rare diseases affect
CHILDREN Source: raredisease.org.uk
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PE RSO NAL S TO RY:
Zoe Gale, 24, on living with Cushing’s Disease.
onsiderable weight gain, disruptive menstrual cycle, hair loss, a ‘buffalo hump’, ‘moon face’, stretch marks, a body covered in bruising, loss of muscle mass, insomnia. All of these come together to form the pretty collection of symptoms caused by the rare disease, Cushing’s disease. At 20 I was relatively healthy and finishing my study abroad year in Madrid. Then symptoms started to surface. As I returned to university for my final year I made an effort to work out, however, this didn’t deter the weight gain. When I went to the doctor I was told, “You’re just stressed out from your final year of university”. I knew this wasn’t the case. During my final year, trips to the doctor increased with blood tests after blood tests. Still no answers. I returned home where things didn’t get much better. The doctors had no idea what was going on. A friend mentioned Cushing’s disease, something I’d never heard of, and told me to investigate this with my doctor. I Googled it straight away. It was a rare disease caused by a brain tumour. Surely this wasn’t happening; I was only 22. My doctor told me I didn’t look like someone who had this disease. I showed him a picture of me before my symptoms started. That was when he referred me to a specialist in endocrinology. On my first appointment he was 99% sure I had Cushing’s disease and that this was caused by a brain tumour. There were more blood tests and an MRI scan to confirm it. After two years of numerous trips to see five different doctors I finally had a diagnosis. I should have been scared. But
just knowing what was actually wrong made me feel much better, and the fact that it was treatable – even if it was through brain surgery – was a huge relief. It can take decades for an accurate rare disease diagnosis, so what seemed like a long road was maybe a short and lucky street compared to what other people have to go through. Once diagnosed, I was treated within three months, at St George’s Hospital in London. The surgeon, nurses and staff looked after me with great care on the HDU – they really were incredible. After two months my life returned to some normality. I went back to work, went out with my friends and started to feel like my life was back to how it should be. 18 months after my operation my health has improved dramatically. I still have to take steroids every day, which could be a lifelong thing, but that’s a small price to pay. You don’t know how strong you are until you’re faced with a challenge. This would not have been as easy without my family and friends and for that I am truly grateful. I have moved jobs and now work in the marketing department of an events company that focuses on highlighting the importance of genomics to help patients with cancer and rare diseases. I probably would not have gone for the job interview if I had not been through my experience. ARTICLE REFERENCES: raredisease.org.uk https://ec.europa.eu/research/health/pdf/infographic_ rare_diseases.pdf#view=fit&pagemode=none https://www.geneticalliance.org.uk/news-events/news/ rare-disease-uk-launch-second-patient-experiences-report/
MEDICAL EDUCATION MASTERCLASS:
How to present an engaging webinar for healthcare professionals WORDS BY
D E V E LO P A N E F F E C TI V E WO R K F LOW P R O C E S S
Webinar planning often involves communicating with busy key opinion leaders, while also managing approval processes. So, it’s important to ask: what needs to be done and by when? Build in the appropriate timelines and make sure everybody involved is aware. E4H uses an intuitive project management tool, which allows us to share updates with clients from conception to delivery.
SET CLEAR KPIs A N D G OA L S
E4H clients have set goals that they want to achieve. We always agree on a set of key performance indicators (KPIs) with clients which go beyond registration numbers. For example, how can we use webinar materials post-event? We’ve invested in the latest webinar technology to track KPIs during and post-webinar, incorporating traditional feedback techniques like forms or surveys.
U S E I N -W E B I N A R P O L L S TO M A I NTA I N E N G AG E M E NT
It’s always a good idea to engage with delegates throughout the webinar with polls and resources. What existing knowledge do delegates have of the topic? Has it improved by the end of the webinar? You might also use polls to gauge who your audience is. This enables speakers to position their session effectively and engages delegates from start to finish.
hen you want to connect with several healthcare professionals in various locations, a webinar is the obvious answer: it enables organisations to engage with numerous practitioners in one go, wherever they happen to be, at a time of your choosing. Attendance numbers are important, but it’s not the only factor you should be looking at. If your delegates aren’t engaged, it’s unlikely they’ll have achieved any of the desired learning outcomes. Here are a few essential tips for maximising engagement.
C H O O S E TH E R I G HT DAY A N D TH E R I G HT TI M E
As healthcare professionals are increasingly busy, we ensure our webinars run at a convenient time, allowing for a maximum number of delegates. This may be lunchtime for some sectors, or first thing for others. Either way – do your research. E4H’s experience means we have a comprehensive understanding of our audience, from a group of secondary care specialists, to over 500 GPs. Rachel Cresswell is Sales and Marketing Manager at E4H and Pharmafield. Talk to E4H today about your next webinar project. Call 01462 476 120 or go to e4h.co.uk
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P H A R M ATA L E N T
n a new series we look at how winning a Pf Award transforms every aspect of a winner’s life, not just the professional side…
P ER S O N A L I won the Pf Award two years ago, alongside my Apodi colleague, Melissa O’Reilly. It recognised the vital work we carried out in the areas of atrial fibrillation and stroke prevention, in partnership with Herefordshire CCG, and sponsored by Bayer. This memorable victory, and being a top candidate in the Clinical Nursing Award, were the pinnacles of my career. To say it was a shock is an understatement! The whole process was inspirational, from the incredibly challenging Assessment Day to the tremendous excitement of the Awards Dinner. Also, to be networking among hardworking, motivational and successful peers, was an honour I’ll never forget.
NAME: C AT E O L I V E R AWA R D : NHS RECOGNITION AWA R D 2 0 1 6
P F AWA R D W I N N E R S :
THIS IS YOUR LIFE WORDS BY
P R O FES S I O N A L Professionally, it gave me a huge boost to be recognised by my peers. The programme made an immense impact on patient lives, and it was really important to me that people could see the difference it was making. It also gave me the self-belief and determination to succeed, and proved to me that hard work and drive can make a huge difference. After winning the award I moved on, was promoted to working on an anticoagulation programme with IQVIA and, this month, I started a new chapter of my career as a Clinical Implementation Specialist in Infection Control with Ecolab Ltd.
“Post-award, the changes are enormous. My family spent the first few weeks after I won being told that they were living with an award winner!” R EC R E AT I O N A L Post-award, the changes are enormous. My family spent the first few weeks after I won being told that they were living with an award winner! It gave me an enormous sense of pride, but also more self-confidence, a bigger zest for life and the appetite to take on personal challenges. Since winning the award I have taken up walking, lost four stone in weight and am now fitter and happier. I have even joined cake decorating classes and become more creative. Winning the Pf Award changed my life – the passion and hard work paid off, and my life has new focus.
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 P F AWA R D S . C O . U K T O F I N D O U T M O R E
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For products to succeed across the pharma commercial landscape it’s about what and who you know. WORDS BY
any consider market access as a new component of commercial pharma, but in reality it has always been around in one format or another. The complexities that exist in this vibrant field are constantly evolving, however there are four areas that have remained consistent. 1. Understanding the health benefits and financial implications your product may have on each UK healthcare economy 2. Being at the forefront of change within the market and being prepared for the impact this has on your product 3. Ensuring all non-prescribing – as well as prescribing – stakeholders are involved with your product in each local healthcare environment 4. Communicating the value of your product to the range of customers who influence its performance. This is very different from selling the benefits of a product and requires a more strategic way of working, not to mention patience and gravitas, as customers will be senior decision makers all with challenging agendas. Not only do you need to be able to gain access to them, you’ll need to find a way to show them how you can help their agenda and not just cost them money. Market access is also about packaging data in the right way, for the right customer, at the right time. As the NHS is constantly changing, albeit at a slow pace, the challenge is to keep one step ahead of the overall stakeholder group. This means, when it comes to adopting your product, you need to understand the different agendas of all those involved in local decision making and funding.
INTERESTED PARTIES Market access customers are often referred to as ‘payors’, and could be described as national or local decision-makers, policy makers or budget-holders. Other market access customers you’re likely to work with include: Commissioners, Prescribing Advisors, NICE Implementation Leads, Chief Pharmacists and Hospital Business Managers. There will also likely be more diseasespecific market access customers. For example, in Oncology, these may include Cancer Network Directors, Cancer Network Pharmacists or Tumour Site Specific Leads. Whilst these groups are not able to prescribe a product, the decisions they make play a significant role in the ability of prescribers to use them. Essentially, this means there is no point in trying to persuade a clinician to prescribe your product, if you aren’t able to convince the people who hold the purse strings. GET TING INTO MARKET ACCESS If you’re looking for this type of job within pharma, opportunities should be influenced by existing experience. If you’ve not worked in this field before, but have a strong sales background, you could start to look at a hybrid-type market access/key account management role which will allow you to leverage your sales experience to open doors. If you’re already in the market access space, then of course you could look to secure a more dedicated position. Either way, if you have the right background then we would love to hear from you. Andreas Knight is a Senior Recruitment Consultant at Chase. Go to chasepeople.com
Don’t narrow your options.
With consistently more Sales, Marketing and Market Access vacancies than anyone else*, the smartest way to develop your Pharmaceutical or Healthcare career is with Pf’s CSO of the Year 2017/18. Get in touch today to find your dream Permanent or Contract role.
0131 553 6644 | chasepeople.com email@example.com *www.pharmafield.co.uk/jobs
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115735 CHASE Ad 257x58 Darker v2 RM.indd 1
P H A R M ATA L E N T
MOVERS & SHAKERS
AG E N CY
M A R T Y N DAV I E S Co-founder of Juniper Pharma Services, Martyn Davies, has been awarded a CBE in the Queen’s New Year Honours List for his contribution to the UK science industry and ground-breaking achievements in pharmaceutical research. Now an advisor to the board of Juniper Pharmaceuticals, Martyn is also an Emeritus Professor at the School of Pharmacy at the University of Nottingham.
A L B E R TO M A R TI N E Z The Mundipharma network of independent associated companies has announced Alberto Martinez as President and Chief Executive Officer of Mundipharma International Ltd. Alberto said: “I feel honoured to lead the Mundipharma organisations in Europe in the next chapter of our evolution.”
K I M B E R LY B L AC K W E L L
WHO’S GOING WHERE AND WHY THEY’RE GOING THERE. WORDS BY
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Eli Lilly and Company has announced that Kimberly Blackwell will join Lilly Oncology as Vice President of early phase development and immuno-oncology, effective March 2018. Dr. Blackwell is currently Professor of Medicine and Assistant Professor of Radiation Oncology at Duke University Medical Centre. “We are pleased and honoured to welcome Dr. Blackwell to Lilly,” said Sue Mahony, Ph.D., Senior Vice President and President of Lilly Oncology. “She is highly regarded for her leadership in cancer research, especially metastatic breast cancer, where she has led programmes that resulted in numerous ground-breaking regulatory approvals in the oncology sector.” KNOW A RISING STAR WHO DESERVES A MENTION? RACHEL@PHARMAFIELD.CO.UK
SIR MICHAEL RAKE Sir Michael Rake has joined Great Ormond Street Hospital as Chairman. Sir Michael brings a wealth of leadership experience in business from easyJet and BT. He is also Senior Business Adviser at the Chamber of Commerce and Chatham House, and Vice President of the RNIB. Sir Michael said: “I am honoured to be given this opportunity to serve a wellloved organisation which makes a dramatic difference to the lives of children with rare diseases in the UK and elsewhere.”
GW P H A R M AC E U TI C A L S
Gillian Hales has retired from Eli Lilly and Company after 21 years – she had been in pharma for 32 years. She was most recently a Principal Territory Business Manager.
GW Pharmaceuticals has announced the appointment of three new independent members to its Board of Directors, bringing the total number to eight. Joining are, Catherine Mackey, Alicia Secor and Lord William Waldegrave. “The support and guidance of these accomplished leaders will be valuable as GW embarks on the next stage of its journey,” stated Dr. Geoffrey Guy, GW’s Founder and Chairman of the Board of Directors.
PROFESSOR M A R K DAWS O N UK-based drug discovery group Storm Therapeutics has added Professor Mark Dawson to its scientific advisory board. Professor Dawson has experience in epigenetics having spent several years researching epigenetic regulation of leukaemia stem cells.
M AG A ZI N E | FEB R UA RY 2018 | 33 05/01/2018 16:07
P H A R M ATA L E N T S E R I E S
WOMEN of PHAR MA INTERVIEW BY
Global Head of Viral Vaccine Discovery and Translational Medicine at Janssen on the advantage of quick thinking and curiosity
n a special series of exclusive PharmaTalent interviews we shine a light on the women leading, inspiring and blazing a trail within industry. Pf ’s Political Correspondent, Claudia Rubin, wrote recently about how pharma has a long way to go in offering equal career opportunities to women, citing the fact that among the top 20 pharmaceutical companies, as ranked by sales in 2016, senior female executives represented just 17% of the management team. ‘Pharma knows it must find a way to encourage more women to rise through its ranks’, Claudia wrote. According to the Pf People 2017 Perception, Motivation and Satisfaction Survey Report, the pharma industry is represented by more females than males, at 58% to 42%. Women in pharma also appear to have greater longevity, with the survey finding that more than 15% of female respondents have been working in the pharmaceutical industry between 11 and 20 years.
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Women’s roles are evolving, and pharma is one industry where they can rise through the ranks, as the success stories of the inspirational women featured in our new series show. How did your path to pharma begin and how did you get to where you are today? I had a quite successful career in academia when I was asked to join Crucell (now Janssen Vaccines, part of Johnson & Johnson). It took me quite some time to make up my mind and to prepare myself for the jump to biotech. The new job was quite different from my job in academia where I had a lot of authority and long term experience. In the new job, I had to lead people who were much more knowledgeable on their topic than me at the time. But I rapidly realised that this was a great opportunity, and that I could learn from them while focussing on the higher strategic level. Two weeks after I had started in my
new job, the public announcement was made that Johnson & Johnson was planning to acquire Crucell. This was music to my ears as being part of a larger and more established healthcare company meant that we would be able to work more effectively to actually deliver vaccines to the world and improve people’s health. After the acquisition, I was asked to lead the viral vaccines portfolio in the new organisation. Which character traits and talents have been most instrumental to your success? I consider myself a fast thinker, I can think out of the box. And I am curious, and I ask the right questions that help drive the process. That for sure has helped me to where I am now. On top of that, I can motivate people, motivate teams. And people motivate me. I lead a group of outstanding people that speak up and step up. Perhaps most importantly, I pay a lot of attention to the opinions of the people I trust.
P H A R M ATA L E N T Do women have to work harder to rise through the pharma ranks? I am not sure if it is harder work but I do think that women sometimes feel pressure to act a little bit 'like a man', in order to be seen and taken seriously by senior management. I also think there can be a tendency for men to hire men, and for women to hire women, reflecting their appreciation of what each gender brings to the table. But ultimately, we have learned that we need gender balance and diversity in the workplace. I inherited a quite diverse team and am very happy to experience that. It absolutely is a huge benefit. Is there a ‘glass ceiling’ for women in the pharma industry? Historically, there’s no doubt about that. Today, I do think things are changing, and changing faster than you might think. Even I am pleasantly surprised when I see the numbers. At Johnson & Johnson, 44% of the company’s employees are at manager and director level and 32% of our VPs are women. That marks tremendous progress. That said, this company has always been a trendsetter – in 1886, 14 employees started Johnson & Johnson. Eight of them were women, brought on by James Wood Johnson. Now, as a whole, this industry does have a long way to go. I do see that women are better represented in certain areas compared to others. Leadership teams in pharma R&D consist mainly of men. The good thing is that there is increasing awareness for improving diversity and inclusivity. We just need to ensure that this trend extends to higher level leadership teams. How can the pharma industry attract and retain more senior female executives? To be candid, by hiring and promoting more of us! The only way for the industry to become more female friendly is by installing a greater proportion of female leadership. It’s the same challenge we see in many other industries too. This isn’t unique to pharma and it isn’t 'rocket science'. The solution is pretty simple.
We need people who can think out solutions and translate ideas in actual data that prove we are on the right track. We also need people who can lead, who can assign the right tasks to the right people. We need people who get the most out of their internal teams, and who work well with external contractors. People who understand regulations for testing in humans. Who can find the fastest route without compromising on safety for our volunteers and patients. I could go on forever. There are a lot of different tasks that need to be fulfilled optimally for our enterprise to be successful. And all these disciplines need leaders at the top. And leaders need to think fast, dare to take informed decisions, dare to take strategic decisions, and dare to trust their teams. What’s the best piece of career advice you’ve ever been given? The first one came from my biology teacher in high school who on the evening of my diploma ceremony asked what I was going to do next. I was planning to go to medical school. But I told him that I was mostly interested in medical research, and not so much in direct patient care. He advised me to study medical biology, advice I took immediately and which I have never regretted. The other major piece was the encouragement not to be afraid to give up my academic career and go to pharma. One of my previous bosses said, “don’t worry too much, you will be successful anywhere”. That gave me the faith I needed at that time to make the move.
And although it is extremely hard work, I love every bit of it. I have never regretted that I left academia. Working with Johnson & Johnson is exciting as the company has a great corporate social responsibility. To be allowed to work on an HIV vaccine, after working in academia for 20 years on the pathogenesis of this tough viral infection, is a unique opportunity. And also the commitment that the company made, to develop an Ebola vaccine, the support we received to accelerate this program during the outbreak in 2014… That’s what makes me tick. What does your professional future look like? Of course, I don’t have a crystal ball. But just for starters – I hope to be around at Johnson & Johnson when the efficacy data on our investigational HIV vaccine become available in the not-too-distant future (and I hope those data are positive!). And I am also extremely excited about our other vaccine programs that are planned to deliver efficacy data before and after that time. I would like to be in a position to further guide and support the leaders of the future and share my experiences. My curiosity will always win, along with the strong desire to be part of Johnson & Johnson’s vision to develop potentially life-saving vaccines and improve global health. My ultimate hope is that, working with our incredible partners, we can protect people around the world who are vulnerable to disease. That’s the goal – that’s what I want to see in my future. Go to janssen.com
“This company has always been a trendsetter – in 1886, 14 employees started Johnson & Johnson. Eight of them were women”
How can more young women be encouraged to take more STEM subjects at school and university? By getting rid of the gender stereotypes. We need to emphasise that boys and girls can be equally good in STEM subjects, as I myself can attest to. And we need to get rid of certain stereotypes about STEM subjects themselves – because they can be FUN. What qualities and talents does a woman entering the pharma industry need? As with men, we need a whole range of different talents.
M AG A ZI N E | FEB R UA RY 2018 | 3 5
O N YOU R R A DA R
Approvals and rejections from the FDA and EMA/CHMP
A P P R OVA L S
A P P R OV E D D R U G O F TH E M O NTH :
OGIVRI Mylan. FO R : Patients with breast or metastatic stomach cancer whose tumours overexpress the HER2 gene. As a biosimilar to Genentech’s Herceptin (trastuzumab), it is the first to be approved in the U.S. by the FDA for the treatment of breast or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer. C O M PA N Y:
OZ E M PIC Novo Nordisk. FO R : Type 2 diabetes. The EMA’s CHMP adopted a positive opinion recommending the granting of marketing authorisation for Ozempic (semaglutide), which will be available as a solution for injection. Approved for its clinically relevant effect on glycaemic control when used in combination with other glucose-lowering medicinal products, or on its own when metformin cannot be used. C O M PA N Y:
T O OK A D Steba Biotech. FO R : Prostate cancer. Approved by the CHMP for treating men with low-risk prostate cancer, where the cancer affects only one side of the prostate and patients would normally be expected to survive for at least 10 years. Tookad is a powder for an injectable solution and contains the active substance padeliporfin. C O M PA N Y:
G I A PR E Z A La Jolla Pharmaceutical Co. FO R : Increasing blood pressure (BP) in adults with septic or other distributive shock. This injection for intravenous infusion was approved by the FDA to treat ill hypotensive (abnormally low BP) patients who do not adequately respond to available therapies. Giapreza effectively increased BP when added to conventional treatments. C O M PA N Y:
R E J E C TI O N S
A PL I DI N PharmaMar. FO R : Multiple myeloma. The CHMP adopted a negative opinion recommending the refusal of the marketing authorisation for Aplidin. The data from the main study showed only a modest increase of around one month in the time patients given Aplidin lived without their disease getting worse, compared with those treated with dexamethasone alone. C O M PA N Y:
3 6 | PH A R M A FI EL D.CO.U K
GUT FEELING Findings from the first human trials of a gas-sensing ingestible capsule could revolutionise the way that gut disorders and diseases are prevented and diagnosed. A research team at RMIT University in Melbourne, Australia, discovered previously unseen mechanisms in the human body, including a potentially new immune system. The capsule, which is swallowed, detects and measures the gut gases; hydrogen, carbon dioxides and oxygen in real time, sending the data to a smartphone. The authors say the sensors could offer a potential diagnostic tool for disorders of the gut, from food nutrient malabsorption to colon cancer. HAIR STYLE Researchers at Indiana University School of Medicine have successfully developed a method which shows that hair follicles can be grown in cultures of mouse stem cells. During the study, the team was ‘amazed’ to see hair follicles sprouting from ‘skin organoids’ they had created. First author on the study, Dr Lee, said these findings serve as a blueprint for how to make the entire skin organ from scratch using stem cells, potentially leading to new therapies for human diseases, including alopecia, acne and skin cancers. SURGICAL STEEL Robots will be used to operate on patients at Barts Health NHS trust after being awarded £5.5m of funding from Barts Charity. Using a computer console placed beside the patient, surgeons will operate by moving the Da Vinci robot’s ‘arms’, which hold surgical instruments, by using their own hands and feet. The robots also enable patients to be treated in a minimally invasive manner, making a number of small incisions instead of a single large cut, and allowing for less blood loss and pain, and faster recovery.
SOMETHING THAT SHOULD BE ON OUR R ADAR? R ACHEL@PHARMAFIELD.CO.UK
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