Pf Magazine January 2017 by E4H Ltd

Crystal Ball: HEALTHCARE PREDICTIONS â&#x20AC;&#x2DC;17

January 2017 PHARMAFI E LD.CO.U K

35%

HAVE BELIEF in present products

Iâ&#x20AC;&#x2122;M LOOKING

for a PROMOTION

24% ARE SATISFIED with their company culture

26%

LOOKING TO change company in

2017

Pf People is the only dedicated annual survey in the UK pharma industry. The Perception, Motivation and Satisfaction Survey 2017 provides employers with a powerful understanding of their employees and a vital insight into the industry. To enter your personnel into the 2017 Pf People Survey and to view the 2016 results, please call the sales team on 01462 476119 or email hello@pfpeople.co.uk.

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WELCOME

EDITOR

John Pinching john@pharmafield.co.uk A S S I S TA N T E D I T O R

Amy Schofield amy@pharmafield.co.uk ART DIRECTOR

Emma Warfield emma@pharmafield.co.uk COMMERCIAL DIRECTOR

Hazel Lodge hazel@pharmafield.co.uk FINANCIAL CONTROLLER

Fiona Beard finance@events4healthcare.com P f AWA R D S

Melanie Hamer melanie@events4healthcare.com PUBLISHER

Karl Hamer karl@events4healthcare.com pharmafield.co.uk events4healthcare.com @pharmafield @pharmajobsuk HEAD OFFICE

Spirella Building Bridge Road Letchworth Garden City Hertfordshire SG6 4ET United Kingdom Cover illustration by Alex Buccheri alexbuccheri.com

The content of and information contained in this magazine are the opinions of the contributors and/or the authors of such content and/or information. Events 4 Healthcare accepts no responsibility or liability for any loss, cost, claim or expense arising from any reliance on such content or information. Users should independently verify such content or information before relying on it. The Publisher (Events 4 Healthcare) and its Directors shall not be responsible for any errors, omissions or inaccuracies within the publication, or within other sources that are referred to within the magazine. The Publisher provides the features and advertisements on an ‘as is’ basis, without warranties of any kind, either express or implied, including but not limited to implied warranties of merchantability or fi tness for a particular purpose, other than those warranties that are implied by and capable of exclusion, restriction, or modification under the laws applicable to this agreement.

Letter from the Editor

t some point during the last 12 months it became fashionable to regard 2016 as the single worst set of 365 days in recorded history. Curiously enough, I have never sensed any lingering gloom from within our industry. Indeed, quite the opposite. Perhaps, from our vantage point, we can be uniquely philosophical – after all, there have been significant milestones in almost every major disease area. Rejoice – we’re all going to live longer, folks! Furthermore, companies are excited about UK pharma and still regard it as the standard-bearer for research and development. With this considered, pharma is starting to look forward to 2017 with considerable optimism, while also recognising that there are some almighty challenges ahead. In the first Pf Magazine of the year, we encourage industry luminaries to gaze into the sacred crystal ball and share their findings. In addition, we gather some fascinating predictions regarding the NHS, ABPI and healthcare politics. As we venture further into the jungle of 2017, we will also recognise the rise of a different and impressive animal – the modern Medical Scientific Liaison. With an increasing emphasis on cross-sector alliances, data sharing and meaningful communication, could it be the year of the MSL? Also in this edition, we report on a growing phenomenon, which will continue to influence and inspire – the patient. No longer a reticent species; they are informed, they want to get involved and they want to make a difference. Make no mistake, the patient voice is getting louder and we will hear much more of it in the near future. These are exciting times. From everyone at Pf, we hope you have a year to remember,

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IN THE NE X T ISSUE: We ask healthcare professionals working in industry how they navigate the moral maze. Also, ‘antimicrobial resistance panic’ and pharma working with NHS – an enduring love story...

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M AG A ZI N E | JA N UA RY 2017 | 1

MAGAZINE

Contents “The UK has decided to leave one of the biggest global markets for pharma. The UK, at 3% of the global market, may be suddenly perceived as a minnow.” Leslie Galloway, Chairman, EMIG. Cover story, page 8

3 N E WS

COFFEE BREAK

It may be a New Year but, reassuringly, this is still the most exciting industry in the world

JP raises his coffee cup to industry legend and former ABPI President Chris Brinsmead

Worrying about stuff can have a negative impact on your wellbeing – it’s official!

F E AT U R E

Our experts are lined up beside the crystal ball and poised to provide their predictions

13 OPINION

With so much change across the NHS, David Thorne wonders what a hospital really is

14 POLITICS

Alex enters the NHS labyrinth as it heads for the most complicated year in its history

2 | PH A R M A FI EL D.CO. U K

F E AT U R E

P H A R M ATA L E N T

The doctors’ long healthcare reign may be ending – the patient will see you now

Raheel Mirza’s magic moment was only last year but already it’s transformed his life

20 F E AT U R E

Pharma’s new leading lights come in from the cold and they want to talk about science

26 F E AT U R E

Once a new therapy has arrived, for some patients, the journey to access has just begun

OPINION

P H A R M ATA L E N T

Pharmacy’s most passionate voice returns and she’s full of praise for a brave new pilot

Galderma’s Alexandra Tretiakova wants to be part of the skincare solution

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C O L L A B O R AT I O N S

ALTOGETHER NOW QuintilesIMS has announced that it will lead a collaborative initiative, which aims to provide clearer and more proactive insight into how anti-cancer treatments are used in a real-world setting across key European markets. The project will also involve founding partners Bristol-Myers Squibb, Eli Lilly and Company, Merck KGaA, Darmstadt, Germany and Pfizer. There are currently gaps and inconsistencies in knowledge about the use of oncology products across Europe. Additional information about how they are used by patients – including which types of patients are using them and in

T R A N S PA R E N CY

Good pharma

what sequences – is vital in the drive to improve oncology patient care. Current information on treatment use is typically based on historical data, which only provides a past view. The new initiative is intended to provide more timely, consistent and comprehensive data resources. Ultimately, this would allow patients to make better informed decisions, while respecting their privacy. Cancer is a leading cause of death in Europe, with more than 1.7 million deaths and three million new cases each year.

Pf View: This is a victory on two fronts – not only is the patient benefitting, but it is a clear indication that pharma companies are unifying and sharing knowledge for the greater good. This simply wouldn’t have happened 10 years ago.

harmaceutical companies are showing a ‘significant trend’ towards increased clinical trial transparency, according to a new ABPI study. It shows that 90% of clinical trial results – on all 34 new medicines approved by the European Medicines Agency (EMA) in 2013 – were disclosed within a 12-month timeframe. ‘Clinical trial transparency of recently approved medicines’ was published in the peer-review journal Current Medical Research and Opinion, and is the latest in a series that spans a five-year period. Together with results from two earlier studies, the research, conducted by Livewire Editorial Communications, on behalf of the ABPI, indicates that the disclosure rate of industry-sponsored clinical trials at 12 months has steadily improved, year-on-year, from 71% in 2009 to 90% in 2013. The research revealed that, of the 539 evaluable company-sponsored clinical trials related to 34 new medicines, 484 (90%) had been disclosed on a registry or in scientific literature within 12 months, 500 (93%) had results disclosed by the end of the study on 31 July 2015, while larger phase III trials reached disclosure rates of 93% within 12 months, and 95% by 31 July 2015. Dr Jacintha Sivarajah, Head of Medical Affairs at the ABPI, said: “These findings reaffirm the industry’s commitment to greater transparency across all its relationships and activities.”

M AG A ZI N E | JA N UA RY 2017 | 3

BAC K T WE ET THE WORD ON CYBER STREET SOMETHING TO SAY? @Pharmafield

GP Survival @cgps_gp

T EC H N O LO GY.

‘APP-Y DAYS

Almost 700 GPs sign letter to @Telegraph saying they have no confidence in Govt’s STP plans for NHS. Pfizer Inc. @pfizer

Antimicrobial resistant infections cause over 50,000 deaths annually in Europe & the US #AMR #ValueOfMeds

A health app has been clinically proven to be an accurate predictor of disease. Quealth – a free app from UK digital health company ROADTOHEALTH – allows users to assess their risk of developing the six most common lifestyle-driven diseases. These are: dementia, cardiovascular disease, type 2 diabetes, chronic obstructive pulmonary disease and six forms of cancer. The app is governed by an ongoing programme of formal clinical validation, led by Paul Nash, Quealth’s Head of Clinical Governance. It is delivered in collaboration with the company’s clinical advisor, Dr Stephen Weng, an Applied Epidemiologist at the University of Nottingham's School of Medicine.

AstraZeneca @AstraZeneca

We’ve helped develop NiCoLA-B the world’s first ‘collaborative’ and most advanced drug discovery #robot Janssen EMEA @JanssenEMEA

We ranked #2 in 2016 Access2Medicines Index. We’re committed to make innovations accessible to all in need Emma Baars @emmajbaars

NHS moving towards self care, patient activation and expert patient programmes, empowering people with the knowledge and tools to be well ABPI @ABPI_UK

#Flu is serious for those in at-risk categories and schemes like #jabathon @NHSflufighter are encouraging conversations about vaccination Bruce Warner @BruceWarner

Patients’ Association survey shows 70% of patients felt that they did not need to see their GP after speaking to their practice pharmacist.

4 | PH A R M A FI EL D.CO. U K

A P P R OVA L S .

NICE ONE

he National Institute for Health and Care Excellence (NICE) has published its Final Appraisal Determination (FAD) recommending Janssen’s Imbruvica®(ibrutinib), as a treatment option for adults with chronic lymphocytic leukaemia (CLL). Ibrutinib is the first in a new class of medicines known as ‘Bruton’s tyrosine kinase (BTK) inhibitors’. It has been designed to specifically to block the BTK protein from causing malignant B cells to multiply. The FAD recommendation was based on the results of multiple trials and is suitable for certain patients, including those who have been through one prior therapy. NICE concluded that ibrutinib represents a clinically and cost-effective treatment and, therefore, the UK joins 39 countries in making ibrutinib routinely available. Jennifer Lee, Director of Health Economics, Market Access & Reimbursement at Janssen UK, said: “Janssen is dedicated to ensuring that patients with blood cancer have access to the most effective therapies.”

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M E R G E R S & AC Q U I S I T I O N S

Allergan wins Chase A

llergan has completed the acquisition of Chase Pharmaceuticals, enabling the Dublin-headquartered company to add a new Phase III– ready programme for Alzheimer’s disease to its portfolio. Chase – a clinical-stage biopharmaceutical company – has been focussed on the development of improved treatments for neurodegenerative disorders, including Alzheimer’s disease, and has been aquired for an upfront payment of $125 million. This total is subject to certain adjustments and additional regulatory and sales milestone payments. Under the terms of the agreement, potential milestones of up to $875 million will be due to Chase shareholders. California-based Chase’s lead compound, CPC-201, is a patent-protected combination of the most commonly prescribed acetylcholinesterase inhibitor (AChEI), donepezil, and the peripherally acting cholinergic blocker, solifenacin. AChEIs have been shown to improve cognition in Alzheimer’s disease patients. David Nicholson, Chief Research and Development Officer of Allergan, said: “This acquisition builds on our commitment to develop innovative approaches to improve the lives of millions of patients suffering from this devastating illness.”

Quick doses G FC D I AG N O S TI C S has been awarded one of the three Longitude Prize Discovery Awards for its ground-breaking development of a test which successfully detects antibiotic resistant bacteria. The US FDA has accepted the first Biologics License Application for M E D I M M U N E ’s durvalumab, a PD-L1 human monoclonal antibody (mAb), for the treatment of metastatic urothelial carcinoma. The O B E S IT Y H E A LTH A L L I A N C E has stated: “We must take bold action now, bringing in measures like the Soft Drinks Industry Levy and restricting junk food marketing to children” The European Commission has granted conditional marketing approval to A B BV I E ’s VENCLYXTO™ (venetoclax) for patients with difficult-to-treat chronic lymphocytic leukaemia. G R Ü N E NTH A L , B O E H R I N G E R I N G E L H E I M , E L I L I L LY, A S TR A Z E N E C A and JA N S S E N C I L AG have been named following breaches of the ABPI Code of Practice for the Pharmaceutical Industry. N OVO N O R D I S K’s type 2 diabetes treatment, Xultophy ® (IDegLira), has achieved its objectives in a new phase 3b trial.

P R O S TAT E C A N C E R

SCOTLAND the BRAVE

anofi Genzyme has announced that the Scottish Medicines Consortium (SMC) has accepted Jevtana® (cabazitaxel), for the treatment of metastatic hormone-refractory prostate cancer (mHRPC), across NHS Scotland. In Scotland, nearly one in two men will be affected by prostate disease at some stage of their lives, and approximately one in 11 are likely to develop prostate cancer. In time, most prostate cancers become resistant to hormone therapy and continue to grow despite treatment. Jevtana is the only remaining chemotherapy option available on the NHS that is not responsive to hormone therapies, following initial chemotherapy. The SMC announcement comes after Sanofi Genzyme provided an updated submission following its initial application in June. Jevtana is already available in England, Wales and Northern Ireland. Roger Wotton, Chairman at prostate cancer patients’ charity TACKLE, said: “Any extension of time that a man with prostate cancer is able to get back with family and friends is highly important.”

M AG A ZI N E | JA N UA RY 2017 | 5

ZIK A VIRUS

Missing link discovered

CANCER

ORAL EXAM Rates of mouth cancer have risen by 68% in the UK over the last 20 years, according to new analysis from Cancer Research UK. Released as part of the awarenessraising activities of Mouth Cancer Action Month, the figures reveal that mouth cancer is on the rise for men and women – going from eight to 13 cases per 100,000 people, over the last two decades. For men under 50, the rate has risen by 67% in the last 20 years, up from 340 cases to 640 cases each year. For men aged 50 and over, rates have increased by 59% – climbing from 2100 cases, to 4400 cases every year. In women under 50 rates have risen by 71% in the last 20 years, with annual cases rising from 160 to 300. Meanwhile, rates among women over 50 have gone up by 71%, with cases increasing from 1100 to 2200. Oral cancers include cancer of the lips, tongue, mouth (gums and palate), tonsils and the middle part of the throat (oropharynx). Around nine in 10 cases of oral cancer are linked to lifestyle and other risk factors. Smoking is the biggest avoidable risk factor, while other risks include alcohol, diets low in fruit and vegetables and Human Papilloma Virus (HPV) infections. Jessica Kirby, Cancer Research UK’s senior health information manager, said: “It’s important to know your body and spot the disease as early as possible.”

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he Zika virus can cause glaucoma in infants who are exposed to the virus during gestation, according to a new report from researchers based in Brazil, and at the Yale School of Public Health. In the early stages of the microcephaly epidemic, the researchers also reported that Zika causes severe lesions in the retina. Meanwhile, It is already known that exposure to the virus during pregnancy causes birth defects, including microcephaly. Dr. Albert Icksang Ko, professor at the Yale School of Public Health and co-author of the study published

TB.

IT WAS MEANT TB

in the journal Ophthalmology, said: “We identified the first case where Zika appears to have affected the development of the anterior chamber, or front portion of the eye, during gestation, causing glaucoma after birth.” Further research is now needed to determine if glaucoma in infants with Zika is caused by indirect or direct exposure, either during pregnancy or following a birth. Pf View: Industry is reacting impressively. There are several trials unfolding for Zika therapies and 2017 represents a pivotal year in the fight against this global threat.

anssen Pharmaceuticals Inc has been awarded the prestigious International Prix Galien for its multi-drug MDR-TB treatment. The award – presented every two years to a medicine that has previously won a National Prix Galien – recognises excellence in scientific innovation to improve human health. It is the first time that a treatment for a neglected disease, such as tuberculosis, has been recognised by the awards. The development of Johnson & Johnson’s treatment for MDRTB marks a significant step towards addressing the global threat of antimicrobial resistance. TB is the world’s leading infectious disease killer, affecting an estimated 10.4 million people around the world every year.

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A P P R OVA L S .

DERM TIME

he European Medicines Agency will review the marketing authorisation application (MAA) for Sanofi and Regeneron Pharmaceuticals’ Dupixent® (dupilumab). The treatment is aimed at adults with moderate-to-severe atopic dermatitis (AD), who are candidates for systemic therapy. The MAA contained data from three Phase 3 pivotal studies in the global LIBERTY AD program, which included more than 2500 patients. Dupixent is currently under clinical development and its safety and efficacy have not been fully evaluated by any regulatory authority. In addition to AD in adults, it is also being studied in paediatric AD, asthma, nasal polyposis and eosinophilic oesophagitis.

A P P R OVA L S

Myeloma med marketing mission The European Commission has granted conditional marketing authorisation for Takeda’s NINLARO® (ixazomib) capsules, indicated in combination with lenalidomide and dexamethasone. The therapy is for adult patients with multiple myeloma who have received at least one prior therapy. The decision to approve ixazomib as the first oral proteasome inhibitor to treat multiple myeloma follows a positive opinion by the European Medicines Agency Committee for Medicinal Products (CHMP) for Human Use, in September 2016.

The European Commission matched the CHMP’s recommendation to approve ixazomib, based on data from the pivotal Phase 3 TOURMALINEMM1 trial, which demonstrated that ixazomib plus lenalidomide and dexamethasone increased the length of progression-free survival by approximately six months. Bob Munro, a patient representative from Myeloma UK, said: “I applaud the European Commission for recognising the additional benefit that ixazomib will bring to patients.” Follow-up analyses for overall survival are planned for 2017.

CANCER RESEARCH

Friends with benefits AbbVie and the Johns Hopkins University School of Medicine have announced a five-year collaboration agreement, with the goal of advancing medical oncology research and discovery. The pact will focus on several areas of oncology research, which could include lung, colorectal, breast, prostate and haematological cancer. It will also allow Johns Hopkins Medicine physicians and scientists to explore new therapies, developed by AbbVie, for use in pre-clinical research, funded by the collaboration. In addition, the relationship provides the opportunity for both organisations to work closely and promote scientific knowledge exchange. AbbVie also gains the option of an exclusive license to certain Johns Hopkins Medicine discoveries made under the agreement.

ALZHEIMER’S DISEASE

Head ache for Eli Lilly Eli Lilly’s much-anticipated Alzheimer’s therapy, Solanezumab, has not demonstrated any benefits for people with mild Alzheimer’s. The treatment – an antibody against amyloid; the protein that clumps together in the brains of people with Alzheimer’s disease – failed to slow cognitive decline. Had development of the drug been successful, it would have been the first new treatment for dementia since 2003, and the first to slow the progression of Alzheimer’s. Jeremy Hughes, Chief Executive of Alzheimer’s Society, responded by saying: “It’s extremely disappointing to learn that it hasn’t delivered a meaningful change for people living with dementia, when the need is clearly so great. We must and will redouble our efforts and investment into dementia research.” Pf View: This is a bitter pill to swallow for Eli Lilly and many millions of patients. As Alzheimer’s awareness gains traction and diagnosis levels increase, industry is under considerable pressure to deliver some tangible solutions.

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Crystal Ball: HEALTHCARE PREDICTIONS â&#x20AC;&#x2DC;17

2016 was a year of seismic shifts, but what does 2017 have in store for pharma and healthcare?

8 | PH A R M A FI EL D.CO.U K

aving reflected on a tumultuous 2016 in the last issue, Pf has assembled a team of luminaries from across the NHS, industry and politics. They have been tasked with gazing into the 2017 healthcare crystal ball and sharing their predictions. Will we be dancing in the streets or hiding behind the sofa? Let’s find out...

COVER STORY

Dr Charles Alessi, Senior Advisor, Public Health England

“2017 will be a year of turmoil for health and care in England. This will act as the spur for long awaited changes to implement a more locallybased delivery of care where local government and health are the important players and the person – not the patient – takes centre stage.”

THERAPY AREAS AND R&D Chris Molloy, CEO Medicines Discovery Catapult

P Ryan Wooller, Business Development Director, Star

“2017 will be the year of pharma understanding the gamechanging nature of sustainability and transformation plans (STPs). Implications could pose both a threat and an opportunity for the pharma commercial model. Pharma supporting pathways of care could rise up the customer agenda.”

atient charities hold the ‘long-term’ view, and that has helped fund continuing research into cancer, heart disease, Parkinson’s, Alzheimer’s and many others. We are building a new model for discovery: disease–based syndicates, with patient research groups as the cornerstone. Engagement with their communities is critical to target selection, validation and proof of concept. In an industry which takes over 10 years to bring products to market we should resist the temptation to continually refocus our R&D from one disease to another. Long-term global efforts in cancer have been needed to reach the current success in product flow and survival rates. Quite rightly there has been a societal and scientific focus on dementia, helped by the excellent leadership and research focus of Alzheimer’s UK. Rates, however, may already be at a high watermark. On a scientific level, if we are to take on the complexity of most non-orphan diseases we must look past the one-gene, one target, one medicine approach of old. We remain horribly weak in the war on microbial disease. If the world does not invest, the UN foresees a $100 trillion impact on the global economy in the next 50 years – we are all at risk. There are economic barriers to overcome, but more worrying is the loss of expertise in the sector. A recent survey indicated the number of active, card-carrying experts worldwide may now be less than 2000. An agreement at G20 on re-entry incentives will spark a renaissance in long-term funding, and the influx of money from the US will be a major step forward in 2017.

M AG A ZI N E | JA N UA RY 2017 | 9

Leslie Galloway, Chairman, Ethical Medicines Industry Group (EMIG)

EU DEPARTURE Chris Molloy, CEO Medicines Discovery Catapult

ost-Brexit, 2017 will not offer the certainty that industry needs in terms of regulation or people movement. We should accept that situation and focus on things we can do – ensuring the UK remains a fertile place to discover and improve new medicines. The UK has considerable public assets across academia and the NHS, and a financing hub that provides 30% of all European investment in biotech. It also has a strong, high-quality CRO community that can thrive in the modern ‘virtual’ discovery model. Combining these capabilities is key to our industrial strategy in medicines and the significant increase in recent funding for InnovateUK. The £100M refilling of the Biomedical Catalyst provides the fuel.

2 H E ALTH AN D SOCIAL CARE Helen McKenna, Senior Policy Advisor, The King’s Fund

e mustn’t judge the Government’s performance on a daily or weekly basis. Much of what is really happening will be behind closed doors and many compromises will be reached. The messages that we need Government to receive are: 52% of people may have voted to leave the EU but many more, if asked, would have voted for a stronger economy that will support healthcare, education, law and order and living standards. Having a vibrant economy is vital for any political party and the pharma industry should be at the forefront of any industrial strategy, because we don’t just deliver prosperity to the UK, we help deliver some of the best healthcare in the world. We should retain as many of the benefits of EU membership as we can – the single market and access to the right people. We also need to focus on the opportunities that we can exploit with the Medicines and Healthcare Products Regulatory Agency and how we can become a global centre for research. We have the opportunity to drop Corporation Tax to 10%, to attract international investment. If global companies are to invest in UK healthcare we need an NHS that is properly funded and a New Medicines Fund which delivers our new medicines to patients. The UK – at 3% of the global market – may suddenly be perceived as a minnow and, if we have to develop a separate regulatory approval system, it could drop us down the ‘ladder’ of global pharma priorities.

017 promises to be a pivotal year for health and social care. NHS finances will continue to be a major concern – the Autumn Statement confirmed the NHS settlement set out in the last Spending Review, which means that 2017 will usher in three years of very little growth in the health budget. Health leaders will be expected to get NHS performance back on track in 2017 – but this will be tough. At the same time that budgets are squeezed, many NHS services are struggling to maintain their operational performance. The latest NHS statistics show that services are under huge pressure and often failing to meet key targets, including the four–hour A&E and 18–week referral-to-treatment targets. Demand for services keeps rising – the number of A&E attendances and emergency admissions to hospital are increasing rapidly. This increases the

10 | PH A R M A FI EL D.CO.U K

Karen Bell, Business Development Director, Ashfield Healthcare

“2017 will be a year of setting a new bar for best–in–class representatives. We’ll see increased demand for individuals who are highly skilled at communicating with a wide range of stakeholders, and people who excel at engaging with customers remotely. The trend for ‘hybrid’ roles will also continue to gather pace. Those who can adapt to different customers and technologies will really shine in 2017!”

strain on services, with almost 11% of patients now spending more than four hours waiting in emergency departments. General practice, mental health and community services also remain under huge pressure. There will be continuing calls on the government to identify a long–term solutions to social care funding. The social care sector is in a critical state – fewer people are able to access the care they need, delayed discharges from hospital are at record levels and there are deeply worrying warnings about the fragility of some large care providers. To find extra money, there will be a need to put social care funding on a sustainable footing for the future. Although 2017 offers plenty of challenges, there are also some important opportunities. The new models of care being developed, in response to the NHS Five Year Forward View, along with the work being undertaken to deliver Sustainability and Transformation Plans, offer significant potential.

COVER STORY

Robert Taylor, Head of Europe, Commercial Solutions, Quintiles IMS

TH E POLITI CAL S PH E RE

“2017 will be a year of broadening the use of technology to support the sales process and the on–going emergence of the multichannel sales model. While the ‘human channel’ remains the cornerstone, interest in digital and remote engagement continues to grow, and demand for efficient commercial solutions which leverage different channels is increasing.”

Alex Ledger, Deputy Managing Director at Decideum

017 offers one unique opportunity for pharma – the chance for industry to work with Government to develop a new industrial strategy for Britain. It goes without saying that Brexit has changed everything. The stakes have never been higher. The health of the UK economy is intrinsically linked to the success of its highly-skilled industry sectors and life sciences is the cornerstone of this, employing around 175,000 people, and with a £51bn turnover in 2015. The UK wants to go toe-to-toe with the big US life sciences hubs in Boston and the Bay area on the West Coast. To do this – in a world unfettered by the regulations of the European Union – it must convince the global pharmaceutical industry that, in spite of potential barriers to accessing the European market, the UK offers unparalleled attractions, a world class research infrastructure and an innovationopen NHS, worthy of investment. Q1 of 2017 will see a hive of activity on this strategy – coordinated jointly by the Secretaries of State for Health and for Business, and via the Office for Life Sciences. Indeed, some of this work is already underway and life sciences has been earmarked as one of the subjects which will form the Government’s overall post-Brexit plan. Pharma has a rare chance to join together as an industry, look beyond marketplace competitiveness and provide the UK with the best prospect of competing independently on the global stage.

PRIMARY CARE Dr Anne Connolly, GP and Chair, Primary Care Women’s Health Forum

T Peter Rutherford, Vice President Integrated Market Access, EMEA and Emerging Markets, Quintiles IMS

“2017 will be a year of increased focus on patient access requirements, as the need for scientific communications throughout the product lifecycle, and the numbers of complex new products requiring integrated patient support programs, continues to grow.”

he main challenges will be coping with the fall out of local authority (LA) funding cuts. Delayed discharges, cancelled operations, higher emergency admissions and poorer community care are happening because of cuts in community placements, social support and staff in LA commissioned services, such as health visitors, school nurses and youth workers. Other challenges include increasing demand and the poorer health of the population. Ageing and chronic long-term frailty problems, obesity and the link with metabolic syndrome, cardiovascular disease and cancers, mean that the self-care agenda will need to be prominent. There will be a push from GPs for patients to buy their own over-the-counter medicines and use online resources, pharmacists and other allied healthcare professionals before going to their GP or A&E. All clinical commissioning groups are having to make cost efficiency savings, so more will want to make decisions about QIPP (Quality, Innovation, Productivity and Prevention) savings. As GP practices develop into federations there will be a push for care closer to home, some care delivered by AQP (Any Qualified Provider) and better use of technology. The extended hours developments will need GP practices to work closer together to make sure that care can be delivered by primary care for longer hours. Hospitals are under increasing pressure to reduce planned admissions and surgery as they struggle to cope with the extra unplanned and emergency work.

M AG A ZI N E | JA N UA RY 2017 | 1 1

COVER STORY

Nick Lavery, Co–Founder & Managing Director, Republic M!

“2017 will be a year of growth for healthcare with continued market access pressure and greater competition. Return on investment will become increasingly important and the industry will accelerate adoption of innovative promotional and educational channels. This multi-channel approach will be integrated across the promotional mix to drive profitability.”

TH E D I G ITAL RE VOLUTI ON Dr Farzad Entikabi, GP and founder of Doctor Care Anywhere

he NHS is one of the most clinically advanced health services in the world, but the sector needs to implement innovation to find opportunities for improvement, as it faces the pressures of reduced budgets, rising demand and an ageing population. Primary healthcare is one of the most strained areas of the NHS, with 60 million more consultations a year required compared to five years ago, and waiting times predicted to rise next year, from just under two weeks, to 17 days. Our recent research with YouGov found that due to the barriers of accessing a GP, 3.3million people have missed or put off seeing a GP, risking their longer–term health, and potentially costing the NHS more. It is becoming clear that our primary healthcare services are stretched to breaking point and that, along with appropriate funding, innovation is also needed. Technology – and specifically telehealth – is already offering solutions to these concerns, not only in terms of the diagnosis, monitoring and treatment of illnesses, but also in the way patients access healthcare. Indeed, 70% of GP appointments can be conducted via video or phone, and the next few years will see a significant change in how we access primary healthcare, with virtual GPs providing a quick, reliable and flexible healthcare service to a greater number of people. Digital innovation is fuelling extraordinary developments in healthcare and will be a critical force in ensuring that existing health issues do not escalate into more significant problems.

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CLINICAL DEVELOPMENT Divya Chadha Manek, Head of Business Development (Commercial), National Institute for Health Research (NIHR)

he NIHR Clinical Research Network predicts that the strapline for clinical development in 2017 will be ‘collaborate, collaborate, collaborate’. 2016 was a year dominated by mergers and acquisitions within the life sciences Industry. M&As are not a new thing within the sector, however, it is becoming apparent that for a company to be successful, there needs to be a shift in its approach to developing medicines for ‘tomorrow’s world’. This move towards more open ways of working through strategic partnerships – spanning healthcare, academia, life sciences industry, the charitable sector and patient organisations – is gathering momentum. Mirroring the growing trend for outsourcing drug discovery, new and innovative collaborative models are emerging with the aim of accelerating medicines development. Collaborations take many forms and bring many benefits. We are now seeing charities collaborating with the life sciences industry on multiple

levels, allowing them to work in new ways and bring benefits to patients. Lab–based scientists and academics are coming together with clinical researchers, enabling them to share ideas and resources, driving forward drug discovery. Similarly, life science companies are forming alliances with research delivery organisations and the NHS to optimise early phase testing of potential pharmaceutical products to expand their research and development programme. Universities are joining forces to harness big data and find ways to support the safe use of patient data for medical research, while patient organisations are promoting initiatives to help finance generic drug trials for rare diseases. The NIHR Clinical Research Network predicts more exciting collaborations. We often use the catch line: ‘The NHS is open for business’, but perhaps it’s time to say – ‘we are not just open for business, we are open for innovative approaches on how we do business.”

OPINION

When is a hospital not a hospital? A mind-boggling question enters the healthcare conciousness WORDS BY

David Thorne

ustainable Transformation Plans (STPs) are encroaching on already demanding terrain. Around 70% of the NHS spend, for example, is in acute hospitals. My local STP has a £600m gap to bridge – the annual running cost of two typical District General Hospitals (DGHs). Do we shut them down? Those two DGHs are full of patients, so we need some unprecedented reduction of demand, as well as a restructuring of supply in order to hit the balance. Every STP boils down to that challenge. OK, STPs may not be achievable in full, but that won’t stop the attempt to make them work, because the acute hospital consolidation they foretell is their rationale – even partial achievement will be seen as success. Those leading the change may even turn out to be managers and senior clinicians within local trusts; redesigning the system and controlling other neighbouring trusts. In reality, though, we’re probably heading for hospital ‘chains’ grouped around tertiaries. These ‘hot hubs’ will be linked to ‘cold satellite sites’. All STPs suggest similar models in varying states of detail. Hot sites might have emergency medicine, consultant-led obstetrics, paeds, full diagnostics and theatres capable of emergency surgery. Cold sites, in contrast, will have support services. The public may even accept that a hospital, while technically still existing in their town, might be marketed as part of a vibrant university hospital group. It’s just possible! Then there’s the stuff going on outside hospitals, in terms of premises and roles. Minor surgery in health centres, new kinds of cottage hospitals, step up and step down beds, new types of care homes, outreach by specialists, physician’s assistants, GPs employed in dual roles and teams of nurses managing patients across a pathway, working on both wards and in “As the NHS moves to patients’ homes. What is a hospital, or a GP surgery, or even ‘a community’? Old labels are toast. innovative organisation The NHS is redefining care along pathways systems, pharma needs of effective touch points, but pharma too often to mirror that new world.” sees boxes in which things like ‘community’ and ‘hospital’ are duly placed. As the NHS moves to innovative organisation systems, pharma needs to mirror that new world. A much-needed rethink is required by companies – and not just about roles. You disagree? Well what if one unified NHS drug budget was created across the health economy? Maybe they could break the drug budget up and allocate it to, say, a diabetes pathway programme budget, so that a clinical team might consider its drug spend alongside staffing, premises and other costs. It’s time to catch up with the pace of change. David Thorne is Chair, Washington Community Healthcare and Non-Executive Director, City and Vale GP Alliance. Go to blueriverconsulting.co.uk

M AG A ZI N E | JA N UA RY 2017 | 13

WORDS BY

Alex Ledger

Rude awakenings Politicians, patients and professionals must face up to the daunting reality of 2017.

n September 2016, the King’s Fund reported that “Relentless demand for services is driving up waiting times and exacerbating financial pressures in the NHS.” Demand is going up, finances are not and NHS services are on the brink of collapse. Such reports have become part of our daily language when discussing the NHS – it is easy to become desensitised. Understandably, we ask – what can we do? One initiative attempting to cut through the core of the problem and examine the relative merits of ‘solutions’ – both proposed or already underway – is being led by the House of Lords Select Committee on the Long-term Sustainability of the NHS. It is chaired by Lord Patel, a leading consultant obstetrician and life-long employee of the NHS. The Committee is midway through its inquiry and aims to report to the House with recommendations by 31 March 2017. This report will ultimately receive a response from the UK Government and will be debated in the House. The ‘long-term’ approach of the NHS is crucial because this is something that has been lost amid the focus on central strategy decision-making in the ‘Five-Year Forward View’. Five years might seem a sizeable

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timeframe but, in the context of resolving the sustainability of the country’s most important public services, it is a relatively short period. In contrast, Patel’s committee is looking at a 15-20 year horizon. This is a good thing.

“Key institutions governing the health system are not aligned with addressing challenges over the longterm – even at top level.” One major problem to date has been that key institutions governing the health system are not aligned with addressing challenges over the long-term – even at top level. Chris Wormald, head of the civil service within the Department of Health, stated during his evidence session to the Committee, that the Department does not focus work on the long-term sustainability of the healthcare system, with its priority being on delivering shorter term aims and the ‘Five-Year Forward View’. We should expect that one of the recommendations of the Committee’s report is that such an approach should be changed.

CYRIL AND THE STATS

SIR CYRIL CHANTLER – CHAIR OF GREAT ORMOND STREET HOSPITAL FOR CHILDREN NHS TRUST – SAID:

“Medicine has changed, and the demography of the country has changed, but the NHS hasn’t changed to reflect that.”

51%

Sir Cyril is not wrong. According to the Patel Committee’s own papers it is estimated that in 2030 there will be

MORE PEOPLE

AGED 65+ IN ENGLAND, COMPARED TO 2010

101% MORE

PEOPLE IN ENGLAND WILL BE AGED 85 AND OVER IN 2030

COMPARED TO 2010. PEOPLE WITH THREE OR MORE LONG-TERM CONDITIONS IN ENGLAND WILL INCREASE BY

OVER 50% BY 2018, COMPARED TO 2008.

POLITICS

s n o i t u l o s e R r New Yea

eased – there is an incr and – natu ra lly r de e ol e tim ar a us at , of S serv ices opor tion mands more N H of us, a greater pr e de or fa r. ch m hi so e t w ar en of e l er nm Al Th G over itions. le long-ter m cond the response from is tip e ul er m H . of r re be su m es nu ented pr e under unpreced when finances ar nt statements is clea r from rece Never theless, it d the notable Gover nment – an e th by e ad m M e LO C A L I S N HS fu nd in g e N HS su stai nabl any reference to th e of e ak m nc e to se al ab os ement – that ther The latest prop the Autu m n Stat ai nabi lit y and st in s Su se of ea cr l rm in fo ve e le e the ha s ar isen in th for the N HS abov is ke y is no ne w money Plans (STPs). Th d View. ar rw Fo of r e ea Tr ansfor mat ion us in g better by the Five-Y ev hi ed ac itt at m m ed co m ai g mai ns the N HS’s intervention is d decision-mak in in your mea ns’ re se ith ba w eg in ac iv pl h ‘L ug resources th ro ty. r feasible or not. dget responsibili mantr a – whet he rt and reform in g bu so of the ca re de volution Fu ll-scale health N r is, howe ver, te es ch I N T E G R AT I O Greater Man oader we are seei ng in ence to nt need for the br id ge ev ur r an he g as d rin ile Du . ha ed ng at Lo pe re g – y to deliver in on un likely to be ness Cavend ish re sy stem and ke ro ca Ba r , th al ee he itt m m the ca ll for greate y the Lords Co nabi lit y, ha s been e M in ister ’s Polic ai im st Pr su e S th H e N of th d ea At re. the former H d on loca l alth and social ca integr at ion of he ew that STPs relie financial re ve se r de Un it – gave the vi ify in g as they cial ca re is un so un t ns en ive ia ic om in m cl d heav ily to ex pens polit ic ia ns an d is cont ribut in g but that Greater r, an te re es su ch es an pr M er have in Great in tr usts. s would not S bed-blocki ng w ith t of ci rc umstance rected via the N H Manchester’s se models of ca re’, di ew ‘n y e. e er wa l Th wh ca se iti el cr gged as a be repl icated sites, has been fla r cont rol over to s te rd ea is, ua gr as ng ph nd va ha em e to Some of th The polic y rhead loca llyg sustainabilit y. ea in er sp h liv ic m de wh fro of n s, ie io tit STP geog raph lost, due to compe ist ic. Fa ili ng ches, is more real however, has been as d, ving their futu re ul or ientated approa s-al l polic ies wo , such as STPs, lea fit ies elic siz po eon d, t. ub cent ra lly-le format ion’ in do nisms, wh ich ‘vehicles for tra ns ay to loca l mecha at ion w ill gr te ith in w at therefore, give w th up es and come ely, it is likely ng at le tim al Ul ch t is n ow r a ne w settlemen identif y thei them. out of reach until e n lv ai so m re divide re to ic an or st pl e hi a workable na l le vel, and th s is ag reed at a natio em st sy cial ca re the health and so n ee tw ca l lo be e G gl N I sin FU N D et and a w ith a sin gle budg al l on health than ed er ac ov pl ire ss re qu le re ds d en ul The U K sp ch as serv ices. Th is wo pean countr ies su com m issioner of Ac t of w ne a d an compa rable Eu ro g in ant rest ruct ur e Net herla nds. fic th d ni an sig t ha s ce an nm Fr that Gover en Ger many, ent – somet hi ng endi ng on social am sp rli ic Pa bl pu e, n. or rtai Fu rt herm GDP t w ill in g to ente to less than 1% of indicated it is no ca re w ill fa ll back ent. cu rrent pa rliam by the end of the ility ha s sib on sp dget Re The O ffice for Bu di ng w ill er al l health spen pred ic ted that ov of GDP – – as a propor tion need to increa se , the plan to demand. Clea rly in order to meet cy out the st drop of efficien squeez e ever y la enou gh. N HS may not be

Alex Ledger is Deputy Managing Director at Decideum – the views expressed here are entirely his own. Go to decideum.com

M AG A ZI N E | JA N UA RY 2017 | 15

MAN FOR ALL SEASONS JP is in the company of industry legend and former ABPI man Chris Brinsmead

t’s the first americano of 2017 and – by way of celebration – I’m having a chat with one of the most experienced and wise campaigners of them all. He’s been there, done that and is still wearing pharma’s heart on his sleeve. What interesting things are you up to at the moment, Chris? I work as a Non-executive Director for a number of companies including UDG plc, The Wesleyan Assurance Society and Cambian Group plc. In addition, I chair Bamburgh Capital and – perhaps of most interest – Proveca Ltd; a company focussed on developing medicines for children in Europe. I am also on the council at Imperial College. Blimey! What have been your professional highlights of 2016? Proveca received a licence, across Europe, for Sialanar. It’s the first medicine to be licensed

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INTERVIEW BY

John Pinching

for the treatment of chronic drooling in children. Personally speaking, my proudest moment was completing the ‘Coast to Coast’ walk in September – it was great fun and I met some wonderful people. How do you think industry has handled NHS turbulence and, indeed, the EU exit? I think industry has been steady in seeking to be an effective partner to the NHS and government. Clearly there are some uncertainties as we enter the era of a separation from Europe, but the UK still has some outstanding strengths in discovery, development and research. It also enjoys strong talent bases, including some of the best universities in the world. Which challenges have been the most significant for pharma recently? On a UK basis, dealing with the NHS and seeking to describe the value of our medicines in ways which really make sense. Globally, we must continue to strive for the discovery of new

medicines, while working in a commercial environment that is more focussed on value. On a personal level, was it always your intention to embark on a career in pharma or was it – as is the case with most people – a complete accident? It was something of an accident, but a very happy one, as I have enjoyed working with many talented people throughout the world – all focussed on improving health outcomes. Where did you study? The universities of Nottingham and Manchester, although my professional career experiences have probably provided most of my learning. What was your big break in pharma? I have had many, including working overseas at an early point in my career, joining a company which was growing very fast and being lucky enough to work on global launches for three major cancer medicines during the nineties.

COFFEE BRE AK

“Clearly there are some uncertainties as we enter the era of a separation from Europe, but the UK still has some outstanding strengths in discovery, development and research.” What were your early memories of the industry? A place where people worked hard, had great relationships with customers and where the attitude was nearly always ‘can do’. How has pharma changed in the ensuing years? Pharma has become more complex, more regulated and more challenging, but industry has also become more responsible, which is a good thing. Is the general perception of pharma in the mainstream media inaccurate? Sometimes the media reports good news, but all too often the ‘negative’ stories create the impression that industry only does bad things. This is a shame when you consider that many healthcare gains have come from the introduction of innovative medicines, which have generally been developed in partnership with healthcare professionals. Is industry working more effectively with the NHS these days? I think that it is. It felt as if there was a low point in the UK, about 10 years ago, but I think most companies now try to work in a collaborative manner with the NHS.

Do you think pharma is more focussed on patients than it was, say, 20 years ago? Pharma has always been focussed on the patient, although we may have learned better ways to incorporate the patient voice in discovery, development and in the commercialisation of medicines. Tell me about your time with the ABPI? I served on the board of the ABPI for around five years, before becoming President. At that time we needed to focus on building trust, innovating and doing a better job of describing value. The folk at the ABPI and many industry people worked really hard to understand how these challenges could be addressed and we made some great strides. It represented a turning point for industry, customers and government. Has the industry’s regulator evolved? There have been many improvements and some strong partnerships. The increase in regulation has not always been helpful and the plethora of bodies in the UK represent a huge amount of duplication. We shall have to see what happens in the next year or so, but it will be important for the UK sector to hold on to the many strengths we have developed in working with our European partners.

Does industry need to worry about Donald J. Trump? We need to listen and understand – a new President will create opportunities and challenges. Those who recognise and act on these will ultimately be the winners. What has been the most important lesson in your career? To always listen to differing viewpoints and find the common ground – it’s always there, but we do not always work hard enough to uncover it. What are you looking forward to in 2017? Helping Proveca become a fullyfledged children’s medicine company, spending time with family and friends and witnessing my local football team shrug off their current miasma. If you could choose one record for the soundtrack of your life what would it be? Hakuna Matata. It’s your last supper, Chris – what are you having? Pie, chips and mushy peas! Lovely stuff. Happy New Year, Chris. You too, John.

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WORDS BY

John Pinching

Patients please The ‘missing link’ between industry and healthcare provision has arrived (and they mean business).

ot so long ago your GP was the all-seeing, allknowing, god-like figure, with your healthcare record in their filing cabinet. Patients would live for decades with a condition they knew nothing whatsoever about – their life and, indeed, death had been obediently handed over to the healthcare profession. A lack of input from patients – the very people for whom pharma and the NHS exist – has, over several decades, created a power vacuum and it has taken an entire digital revolution for ‘the patient’ to occupy that void. Recognising that there has been cultural shift, a few buzz terms – designed to create solidarity between industry and the patient community – have emerged, such as ‘patient centricity’ and,

the utterly vacuous, ‘focussing on the end user’. This was wellmeaning enough, but, until relatively recently, patient presence at healthcare-driven events has been practically non-existent and, for those patients willing to provide personal data and assist with research, experiences have been mixed. Meanwhile, the online patient voice has grown in decibels – to the extent that it can no longer be ignored. The rise has developed through shared experience, support networks and, above all, challenging the medical profession. This, in turn, has seeped offline and into society – the patient has come in from the cold. People want to know about their condition, people want to manage their illnesses and they want better therapies and apps to enable them to do it. The patient voice is here and it’s getting much louder.

TOP TALK

Memorable quotes from the ABPI’s inaugural Patients First conference

“Once you’ve invited us to the party, don’t exclude us, and talk to us in a language we understand.”

“Patient research must be in the community – empower people by explaining research outcomes.”

“Patient data is at the core of innovation; experience of living with a condition shapes new treatments.”

“Research must be demystified. Take away the white coat and test tubes, and change the language.”

Jane Taylor, Chair of Patient Insight Group, Arthritis Research UK

Dr Doug Brown, Director of Research and Development, Alzheimer’s Society

Nicola Blackwood MP, Parliamentary Under Secretary of State for Public Health and Innovation

Angela King, Patient Advocacy Lead, Novartis

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E VENTS & CONFERENCES

VIEW FROM THE EXPERT

H E R E ’ S TO YO U, N I C K RO B I N SO N The BBC’s former Political Editor, Nick Robinson – a self-confessed workaholic – was diagnosed with a rare form of lung cancer in 2015. At the ABPI’s Patient’s First conference he appeared as the de facto ‘celebrity patient’ and was brilliantly candid about his experiences. “It’s been a curious public journey”, he confessed. “And, yes, being in the public eye, you do get more attention and support.” He was brutally honest about the reality of illness and the fragility of life itself. “You’re not in control, your body is – but we can control how we react. We head straight for the internet, and it’s almost always alarming. Shut the page!” Nick went on to talk about how it wasn’t death that worried him, but the fear that someone might know something that they weren’t telling him. He said that he was far happier when he discovered that the doctor didn’t know the outcome. When he realised that Nick was fine with that, the doctor was “much more open about uncertainty.” He urged us, as patients, to use our voices. After a wretched first stage of chemo, Nick told the nurse it had been dreadful, and was given a different cocktail next time. He also set himself a personal goal – to return to his television duties on election night. “That was my Mount Everest,” he said. And return he did. “You can never put patients first enough,” he concluded. Nick Robinson has recovered and currently hosts Radio 4’s Today programme.

“Conditions affect society – not just one person. It’s about changing mindsets and improving quality of life.” Keith Wilson, Patient Research Ambassador

“Before starting chemo, I was told you could travel on the tube afterwards – you can’t! Patients are the experts.” Professor Trisha Greenhalgh, Professor of Primary Care Health Services, University of Oxford

ver the last few years, the patient voice has become more confident, more educated and more important. The digital revolution has led to increased access to information, and a brave new world of healthcare has emerged. Discussion forums, Twitter, Facebook, Instagram and many others provide patients with a platform to openly discuss health concerns, research their condition and share thoughts about their day-to-day lives. This has resulted in the growth of more engaged patients – and those providing healthcare have had to listen to what they’re saying. The increasing volume of the patient voice has also coincided with the squeeze on NHS services. Four years ago the Department of Health published ‘Liberating the NHS: No Decision About Me Without Me’. It specifically targeted healthcare professionals, with the aim of providing patients with better choices and more control over their health. Drawing on years of running product trials, and cohort patient trackers through talkhealth, feedback suggests that if patients are informed and feel more in control, commitment to their healthcare routine is higher, with better compliance. Some 17 years ago, my own GP – who I think was ahead of his time – admitted he had run out of treatment ideas and acknowledged that I knew more about my daughter’s condition than he did! This experience repeats itself across health forums, as those battling with health issues become 'professional patients'. In his book, The Patient Will See You Now, Eric Topol said: “We’ve learned in general that doctors don’t like smart patients. But this sort of attitude will do little to hold back a new generation of increasingly smarter patients and more supportive and smarter doctors.” With rapid advances in technology it will be fascinating to witness the further progress of patient empowerment over the next decade. Deborah Wyatt is Founding Director of talkhealth Partnership Ltd. Go to talkhealthpartnership.com

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Knowing me, knowing you

MSL IN PROFILE

In the ranks of pharma and the NHS there are people that speak the same language WORDS BY

John Pinching

n the curious ‘no man’s land’ that exists between industry and the NHS, Medical Scientific Liaisons (MSLs) break bread with healthcare professionals; conversing in a common vernacular, and maybe sharing the odd science-based joke. This is a language that only they understand. Indeed, increasingly, industry views MSLs as the key to engendering trust and delivering on the promise of transparency. No longer simply a loyal foot soldier – the MSL is leading the charge. A few pioneering pharma companies are instigating this remarkable rise – harnessing a passion for science and utilising an ability to communicate vital messages about life-changing products. Motivated only by medical research, exciting therapy development and making a difference, MSLs are, perhaps, the future of pharma itself.

TH E R O L E As part of the Medical Affairs team, MSLs are the bridge between the pharmaceutical company and healthcare professionals – facilitating the exchange of unbiased medical and scientific information. We work throughout a product’s lifecycle, and pre-licence activities can include advanced budgetary notification to payors, medical educational meetings and advisory boards. We can also assist in formulary applications and investigator’s initiated trials. The primary objective of the MSL is to establish and sustain peer-to-peer relationships with therapy area experts at major hospitals and academic institutions. TH E D I F F E R E N C E At Chugai Pharma UK we all have the patients’ interests at heart and are regularly reminded of why we do what we do. We believe that continual innovation, investment in research and partnerships, are the key drivers in targeting difficult-to-treat conditions and improving quality of life. As MSLs, we are at the forefront of sharing the clinical trial data, ensuring that clinicians have the information they need in order to make the right prescribing decision. TH E R E WA R D Medical educational meetings are one of the most rewarding parts of the role. I truly enjoy presenting and engaging on a relevant disease area and providing up-to-date information and support. We are currently working on delivering a series of meetings in the area of cancer cachexia, which is a very challenging and mostly undiagnosed condition. TH E C H A N G E The pharmaceutical market is changing to accommodate the increase in personalised medicine, immunotherapy and fluctuating NHS budgets. There is great competition in the biopharma industry and, consequently, we need to be working in compliant collaboration with our internal partners, and to the highest of standards. TH E FU T U R E My personal ambition is to keep developing as an MSL – there’s always room to learn and develop. Aiming to be the best I can be at my job means that I’ll be delivering an improved service to my customers. I’m looking forward to being part of my first product launch as an MSL next year. Chugai Pharma UK has an exciting pipeline and 2017 promises to be a memorable year for all of us. Go to chugai.co.uk

Camila Marotta, Chugai Pharma UK

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F E AT U R E

“MSLs are the bridge between the pharmaceutical company and healthcare professionals – facilitating the exchange of unbiased medical and scientific information.” THE ROLE At Janssen UK, the MSL function represents the medical department of the company. As an MSL, I interact peer-to-peer with healthcare professionals; supporting education and facilitating the exchange of up-to-date scientific knowledge on new and current Janssen products, ensuring the best outcomes for patients.

Camila Marotta

THE DIFFERENCE As an MSL, I have a deep-seated responsibility to healthcare professionals, and the patients who come under their care. By ensuring that we build strong, ethical relationships with clinicians and provide the highest quality of education and service, we are in the best position to make a positive difference to the lives of patients. We support initiatives such as investigator-initiated studies and real world evidence data collection, and this research has the potential to enhance how treatments work, improve clinical decision making and, ultimately, transform patient care. TH E R E WA R D Peer-to-peer conversations with clinicians are really fulfilling – taking time to engage with them and understand their interests and thinking. The quality of these interactions – together with the information and education provided by Janssen – has resulted in increased engagement and a strong belief among clinicians in the value we offer. Being able to further support the clinicians I work with in their ongoing education, or within their appraisals, is also very rewarding.

“By recognising our strengths and demonstrating that we are willing to listen, the role develops in line with the needs of people we serve.” Steve Patmore

TH E C H A N G E The MSL role is changing – expectation is no longer just on data delivery. I have become more heavily involved in projects which gather insights from internal and external partners, enhancing the quality of interactions with healthcare professionals. By recognising our strengths and demonstrating that we are willing to listen, the role develops in line with the needs of people we serve. From a clinician’s perspective, I believe they are looking for more from pharma companies – they value the clinical conversations that go beyond mere translation of data, and are interested in the evaluation of real world evidence and health outcomes. TH E F U T U R E As the lead on customer feedback projects within Janssen diabetes, I am looking forward to evaluating responses. This will be the first time we have had the opportunity to know what our customers think and this supports us in realising our aspiration of being the best. In terms of my own education I am looking to completing a virtual diabetes course at the University of Copenhagen. My other interest is in ‘critical thinking’ and I’ll be looking to develop this in 2017. Go to janssen.com

Steve Patmore, Janssen

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OPINION

“The General Pharmaceutical Council are introducing the system so that members of the public are reassured that health professionals are safe and effective beyond their initial registration.”

T Judgement days Niamh reflects on a trustworthy pilot that really seems to fly WORDS BY

Niamh McMillan

he end of 2016 marked the conclusion of the General Pharmaceutical Council’s (GPhC) eightmonth pilot of ‘Continuing Fitness to Practice’ (CFtP). This is the proposed new arrangement, which provides further assurance to the wider community that pharmacists meet certain professional standards. Indeed, I have personally taken part in the pilot, which involved recording four CPD (continuing professional development) entries, in a simplified recording format, and carrying out a peer discussion. An additional element required the production of a case study documenting a change to the practice that benefitted patients or service users. The GPhC are introducing the system so that members of the public are reassured that health professionals – including pharmacists – are safe and effective beyond their initial registration. After considerable research it concluded that encouraging a more ‘reflective practice’ would be the most compelling way to do this. CFtP will reaffirm that registrants meet the code of standards, ethics and performance, while accounting for the full range of roles and settings in which registrants practice. As a result, it will be based upon common standards, flexible processes and evidence-based requirements. In addition, registrants will be required to receive declarations from external sources related to the individual’s current context of practice. This will mean that the processes to record and review evidence must be flexible in regard to the diversity of roles and settings within pharmacy practice. The GPhC are currently collating feedback on the pilot which, in my opinion, has been great! I’ve loved the new recording format, which is so much easier to use. I’m also delighted that it took on previous feedback, which indicated that – while we do generally enjoy CPD – we didn’t appreciate the ‘old’ system, which was somewhat laborious. The new version allows for increased self-reflection, by the introduction of peer interactivity, and that’s a much more dynamic and personal way of carrying it out. The evaluation began in mid-December 2016 and will continue into 2017. It will be followed by consultation and preparation for an official launch in 2018. I genuinely enjoy learning and developing, and believe this is the case with the majority of pharmacy professionals. Providing us with user-friendly platforms to do this can only be a good thing. Niamh is Clinical Development Manager at Superdrug. Please note, these are Niamh’s personal views and do not necessarily reflect those of the Superdrug business.

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F E AT U R E WORDS BY

Amy Schofield

Can you really worry yourself sick?

I TOLD YOU I WAS ILL

Don’t believe the hype: health headlines dissected TH E S TO RY Do you constantly worry that a mysterious nagging pain could be the thing that kills you? Does the receptionist in your local GP surgery recognise you by your voice when you call for an appointment? According to new research, hypochondria – agonising that something is wrong, when the evidence suggests otherwise – really could be ruining your health. Also known as the ‘worried well’, people who constantly stress out about phantom illnesses are more likely to develop heart disease than those who are confident that they remain in rude health.

TH E R E S E A RC H Researchers at the University of Bergen in Norway examined health data from more than 7000 people born in Norway in the 1950s. The anxiety levels of participants were measured using a standard questionnaire, while their heart health was tracked using national data on hospital treatment for heart conditions. The purpose of the study wasn’t to establish whether anxiety over health caused heart disease later in life but, rather, if there was a correlation between the two. The study was published in the BMJ Open.

TH E R E S U LT S The researchers found that during the 10– year follow-up period, twice the number of people who scored highly on the anxiety tests went on to develop heart disease (6.1%), compared to those who weren’t anxious about their health (3%), even when other risk factors – such as diet and smoking – were taken into account. Once the results were adjusted for risk factors, analysis showed

that those with health anxiety at the start of the study were found to be 73% more likely to develop heart disease than those who weren’t. Curiously, the effect was also found to be more evident in men than women.

TH E D E A L Although the results of the study showed that there was a link between health anxiety and heart disease, the researchers could not establish exactly why. This was because those with anxiety were likely to have other mental health issues, which could also contribute to coronary heart disease. The study authors said: “This finding corroborates and extends the understanding of anxiety in various forms as a risk factor for heart disease.” So, although health anxiety wasn’t found to be the single cause of heart disease, you clearly can worry yourself sick.

W HAT TH E PR E S S SA I D : ‘”Worried well” make themselves sick’ The Telegraph; ‘Hypochondriacs more likely to develop heart disease, study finds’ The Independent; ‘Why it’s no surprise that hypochondriacs get more heart disease’ Spectator.co.uk

HYPOCHONDRIAC

COMES FROM THE GREEK WORD HYPOKHONDRIA,

which literally means ‘UNDER THE CARTILAGE (OF THE BREASTBONE)’

FAMOUS hypochondriacs include CHARLES

DARWIN,

FLORENCE NIGHTINGALE & ANDY WARHOL

AFTER A PERFORMANCE OF HIS PLAY, ‘THE HYPOCHONDRIAC’,

MOLIÈRE

DIED passed out on stage and

A FEW DAYS LATER

M AG A ZI N E | JA N UA RY 2017 | 2 3

P H A R M ATA L E N T

AWA R D W I N N E R S :

Where are they now? JP talks to Raheel Mirza who is still walking on sunshine after his team’s magnificent victory in March 2016

ho were you working for at the time? Ashfield Insight & Performance – a leading global training, skills benchmarking and consultancy agency that provides tailored solutions for its clients. It currently provides training and consultancy to a wide variety of top 20 pharma and healthcare companies at a local, regional and global level.

to be involved in this field – in some shape or form – for the foreseeable future.

What award did you win? The 2016 Pf Award for the Learning & Development Initiative – we delivered a business simulation workshop for a blue chip pharmaceutical company.

Would you recommend entering the Pf Awards? 100%! It’s a brilliant opportunity to challenge yourself and test your skills and achievements against other people in the industry. It’s also a great benchmark to measure yourself against.

What are your recollections of that evening? It was extremely exciting, nerveracking and tense! There was a real buzz around the room and, as the winners were being announced, everyone got even more excited as they anticipated the possibility of us winning. And we did. How did you celebrate? I celebrated the success with my colleagues, who had all inputted into the simulation workshop – it was a real team effort. Lots of congratulatory messages were shared on Twitter, email and text. It was great for our organisation and a recognition of our hard work. Once the champagne had settled, how did you change? It was an opportunity to reflect on the campaign. What followed was a realisation that what we do is recognised across the industry by our peers. Were you more ambitious? It definitely encouraged me to talk more about how successful we have been and engage with our clients even more enthusiastically. How did it impact on your career? Very positively! The acknowledgement from peers within the organisation was great and it provided me with the opportunity to talk more about what we do and how we have achieved the success of winning the award.

INTERVIEW BY

John Pinching

2 4 | PH A R M A FI EL D.CO.U K

What was your next position? It is only nine months since I won! I am still in the same role and enjoying what I am doing. L&D is a great place to be and I intend

Do you think winning an award was a trigger for your further success? Absolutely! We have started working with more clients and securing new business as a result of the win. More clients want to know what we did and how we can help them to achieve similar successes.

Do you still look back fondly on your win? Yes. It was a brilliant night, a great achievement and it will live long in the memory! Go to pfawards.co.uk

Alright on the night: Raheel picks up his award from TV’s Gethin Jones. Raheel has been thriving since his victory last year.

Will you be a winner in 2017? Only the best in the industry will share the stage with presenter Marcus Brigstocke in March. Enter today and change the course of your career forever. For more information visit

or contact the events team on 01462 476120

# PFAWA R D S2 017

MON DAY 2 3 JA N UA RY 2 017

TH U R S DAY 2 M A RCH 2 017

TH U R S DAY 9 M A RCH 2 017

Deadline for entries into 2017 Pf Awards

Assessment Day, King Power Stadium, Leicester

Pf Awards Dinner, Lancaster London Hotel

S I LV E R S P O N S O R S

SPONSORS

PFAWA R D S .CO.U K

INCREDIBLE JOURNEYS While plotting their way to our medicine cabinets new drugs won’t always use the most obvious map WORDS BY

Robert Donnell

he path of a new drug – from research to licensing – is a familiar one to companies seeking to take their products to market. There are still, however, potential stalling points, before the treatment reaches the patient. Even when the data on the drug’s Phase I – III trials has been announced, and published, in peer-reviewed journals, there is still the hurdle of gaining licensing from the appropriate regulatory authority. And even when it has been licensed, it may not be available in certain countries, due to an absence of sales infrastructure, or because it is not commercially viable to launch. Take Europe, for instance. The European Medicines Agency will grant marketing authorisation for a drug in 28 countries, but a pharma company may not launch in all those separate countries simultaneously. Certain larger markets – including the UK, Germany and France – take precedence. Due to internal capacity, commercial return or reimbursement issues, there may be a delay of months – or even years – before the product is launched in all countries. In circumstances where a drug has not yet been commercialised and made available through the normal supply chain, Managed Access Programmes (MAPs) can provide a valuable way of helping a patient with unmet medical needs. Indeed, MAPs represent a realistic, boundary-resilient way of providing patients or physicians – who know a drug exists somewhere else in the world – with a realistic opportunity of accessing the treatment.

2 6 | PH A R M A FI EL D.CO.U K

MAP is a collective name for the different regulatory compliant programmes that countries have devised to help the patient with an unmet clinical need. These programmes vary in name, and some people may be more familiar with other terms, such as Named Patient Programmes, Early Access and Compassionate Use Programmes. With the appropriate MAP, an unregistered drug can be supplied to a patient with a physician-assessed unmet clinical need, before the drug is available in the respective country. Although this process and concept is counter-intuitive to many people in the industry, MAPs are becoming more common. The timing of a MAP may vary, and the therapy could surface when the drug is licensed in other countries, but not the patient’s country. Furthermore, it could materialise when the drug is licensed in the patient’s country – but unavailable due to the pharma company not having launched it there – or before the drug has been licensed anywhere. As you would imagine, MAPs are not easy to execute, requiring highly-specialised regulatory customer service and operational expertise in order to deal with distribution issues that exist outside the usual industry processes. Factors such as patient criteria, regulations and importation protocols – all of which vary from country to country – need to be taken into account. For the pharmaceutical industry, MAPs can be understandably unfamiliar terrain, but this is where their role in facilitating patient access to drugs comes into sharp focus.

OPINION

I N S I C K N E S S A N D I N S TE A LTH PAT I EN T S A R E FO L LOW I N G M A P S I N I N C R E A S I N G N U M B ER S

ltimately – whatever the stage – a regulatory compliant programme is required to get the drug to the patient who needs it, outside of the usual regulatory and supply chain framework that the pharma industry operates within. Counter-intuitive, yes, but also crucial. Without the MAP, the patient would have to wait months or years to gain access to a drug that could ease their suffering or even save their life.

“Without the MAP, the patient would have to wait months or years to gain access to a drug that could ease their suffering or even save their life.” MAPs are also used to help deal with orphan diseases – conditions that affect fewer than 200,000 people nationwide. There are between 6000-8000 orphan diseases, many of which affect only a few hundred patients. On these occasions, it is not feasible for a pharmaceutical company to set up supply chains across all regions in which patients are suffering from a particular orphan disease, or even have the drugs registered in each of those countries. Here again, a MAP can provide treatment options that would otherwise be out of reach. With such an array of uses, then, it is unsurprising that MAPs – despite being so different to the rest of the industry – are not uncommon. They can be found across the world, whether it’s the Temporary Authorisations for Use programme in France, the European-wide compassionate use programme, or with different countries’ individual patient programmes. And although some in the industry approach the world of MAPs with uncertainty – and others are still unaware of their existence – awareness is increasing rapidly. This is not just limited to within the industry either – these days, patients around the world with the same diseases can connect and share information online. Robert Donnell is Head of Business Development at Durbin. Go to durbinglobal.com

E D ITO R ’ S V I E W ccess to medicine is an emotive subject, which brings with it a complex moral and regulatory maze – it’s exceptionally difficult to navigate for both patient and healthcare professional. One only has to reflect on the Cancer Drug Fund narrative to emphasise how carefully these processes have to be handled. The truth that dare not speak its name is that desperate patients don’t care whether something has been approved, or whether all the boxes have been ticked. If they’ve only got six months to live – they’ll take anything. Without access to real or perceived life-saving treatments, patients can very easily be tempted into the unscrupulous recesses of alternative medicine or even attempt to source therapies on the black market. This is well demonstrated by Ron Woodroof’s pursuit, during the 1980s, of HIV/AIDS drugs in the film, Dallas Buyers Club. After being denied therapies in his own country – even when they have been approved for another condition – Ron smuggles drugs from Mexico and bribes healthcare professionals (as you do). This is extreme, but it serves to remind us that, in pursuit of life, humans will do almost anything. With this considered, legitimate alternatives must be encouraged.

M AG A ZI N E | JA N UA RY 2017 | 2 7

P H A R M ATA L E N T

MOVERS & SHAKERS

LISA ANSON

DR JOHN REX

AstraZeneca’s Lisa Anson is the new President of the ABPI. She joined the ABPI Board in 2012, and helped implement PPRS. She will take up the role from John Kearney in April 2017. “I am honoured and delighted,” she said.

Dr John Rex is new Chief Medical Officer at antifungal company, F2G. He joins from AstraZeneca and has also been a F2G Nonexecutive Director. Ian Nicholson, Chief Executive Officer, F2G, said: “We are delighted that John is able to increase his commitment.”

COLIN GODDARD

Mission Therapeutics, a drug discovery and development company focussed on selectively targeting deubiquitylating enzymes to treat cancer, neurodegenerative and other diseases, has welcomed Dr Colin Goddard as Non-executive Chairman. Prior to joining Mission Therapeutics, Dr Goddard was Chief Executive Officer of OSI Pharmaceuticals and a Director at Human Genome Sciences.

NAGORE FERNANDEZ

WHO’S GOING WHERE AND WHY THEY’RE GOING THERE. WORDS BY

Amy Schofield

2 8 | PH A R M A FI EL D.CO.U K

Ashfield – part of UDG Healthcare plc – has announced the appointment of Nagore Fernandez as Head of Clinical Services, Europe. Nagore is a Clinical Pharmacist and holds a Masters in Clinical Research. After joining Boots UK, in the Quality and Compliance department, she moved into senior management roles within the Walgreens Boots Alliance. She will now be responsible for developing Ashfield’s clinical services strategy.

ADVERTORIAL

NEW YEAR NEW VIEW?

ED OWEN

The Medicines Discovery Catapult (MDC) has announced the appointment of Ed Owen as Head of Engagement and Communications for the charity sector. He will be responsible for the MDC’s wider strategic, engagement and communications work. Owen said: “I am passionate about the power of people to make change, and excited to be part of this venture.”

You could be walking on air with PharmaJobs.

NADIA WHITTLEY

Arquer Diagnostics has appointed Nadia Whittley as CEO. With over 25 years’ experience in the life sciences sector, Nadia has a leadership record of growing revenues and motivating teams, spanning several therapeutic areas and different geographies. Her focus at Arquer will be to execute the commercial launch of the company’s MCM5-ELISA diagnostic test, and expansion of the technology into a wider range of cancers.

HELEN GORDON

Helen Gordon is to leave her post as the Royal Pharmaceutical Society’s (RPS) Chief Executive Officer – which she has held since 2010 – to become the Chief Executive of The Royal Society of Medicine, in March 2017. She said: “I would like to pay credit to all the elected members, staff and presidents, past and present, who work tirelessly to support the pharmacy profession.”

All the best jobs and recruiters in one place. Find your next role, get career advice and gain industry insights. Get airborne!

DR J MICHAEL RYAN

Asceneuron has announced the appointment of Dr J. Michael Ryan as Chief Medical Officer. He has over 15 years of central nervous system clinical research experience and extensive drug development expertise. He joins the company from Novartis Pharmaceuticals, where he worked on the clinical development strategy. He will be responsible for advancing Asceneuron’s pipeline of innovative small molecules and progressing tau modifiers, through the clinic.

PHARMA JOBS.CO.UK

W H E R E TA L E N T G R O W S

M AG A ZI N E | JA N UA RY 2017 | 2 9

P H A R M ATA L E N T

Q What do you do? I am the UK and Ireland Managing Director for the Galderma corporation – a subsidiary of Nestlé Skin Health (Nestlé Group). Galderma is a global dermatology and skincare company specialising in medical, aesthetic and consumer solutions for different skin conditions – from highly sophisticated Rx products, to injectables and consumer brands, like Cetaphil.

understand, however, that I wanted to be a part of the solution in terms of what healthcare companies provide to HCPs and society – I was very excited about helping Russian patients access new technologies. I made my way from a sales representative role in the 1990s, to country/general management positions later in the 2000s. It has been an exciting journey, with different organisations – commercial, non-commercial, and service providers.

Q How long have you been in pharma? I was born in St. Petersburg, Russia, and got my first job in a pharma company in 1995. It was the very beginning of the pharma business over there, and I didn’t know much about the healthcare industry at the time. I quickly came to

Q What are your career highs and milestones? I have a degree in foreign languages from the State University of St. Petersburg, which helped me to understand other people, while building the right communication between the customers and providers, and different cultures.

Galderma’s MD for UK and Ireland, Alexandra Tretiakova, shares her advice on navigating the challenges of an ever-changing industry. INTERVIEW BY

3 0 | PH A R M A FI EL D.CO.U K

Amy Schofield

In 1995 I joined Alcon Pharmaceuticals’ representative office as an assistant and – after two years – decided to try a sales role, and became a surgical disposables representative for the entire Russian Federation. Following that, I spent two years travelling across 11 time zones. I was also given the opportunity to go to the Ukraine and set up a new business for Alcon. I had four exciting years in Kiev, starting from scratch in a country where brands were not even heard about, and growing it to a solid $20+ million USD business. I then spent eight years in the General Manager role for Alcon in Moscow, and helped to drive the business 5x. Q What happened next? In 2010 I took a completely different challenge, becoming the Executive Director of International Medical Device Manufacturers Association (IMEDA), representing the voice of global medical devices companies, in front of the government and regulators in Russia. It was a very interesting experience, which allowed me to take my understanding of the markets, global and regional trends, and different stakeholders’ positions to the next level. After IMEDA I also had the opportunity to work for Diaverum, a health service provider managing a chain of private clinics specialising in nephrology. My most recent experience is with Galderma – firstly in Switzerland and now in the UK. Q What drives you? The opportunity to make a difference, create new ways of doing things for the benefit of patients and the business, and bring the technologies we have in Galderma closer to every person who has a skin condition. It is exciting to know how much we can do to change people’s lives for the better and I believe we should not lose this opportunity!

Q What’s the best piece of careers advice you’ve ever been given? Only do jobs that you feel excited about as they are the only ones you believe in. I need to believe in what I am doing, I need to know my work has a value and makes the world better. I truly enjoy being part of the solution. Q How do you turn the challenges into opportunities? A business environment full of challenges is – in a way – quite easy. Challenges indicate the direction of travel. It would be much more complicated to set up a strategy, if we didn’t have challenges! How would we know where the gaps are and for which issues we need solutions? I take challenges as my guiding lights! Q What is the current state of the pharma industry? The pharmaceutical industry is going through major changes – roles and responsibilities are changing. We cannot just stay in our isolated medical/ pharmaceutical world and rely on R&D to bring us new solutions. We need to become real partners and solution-providers to many more stakeholders: payers, governments, patients, media. Yes, we need to keep the highest level of compliance and quality, as we are engaged with the most precious resource known to humankind – people’s life and people’s health. Q How can pharma continue to make a difference? The industry has already accumulated a great amount of knowledge, data, tools and technologies that can be used for many positive purposes – notably, education, support for HCPs, tools for payers to make the right decisions and advice to governments when it comes to long-term strategies. Pharma needs to be a part of the solution – not only bringing new technologies to the NHS and other healthcare systems, but also supporting

“I need to believe in what I am doing, I need to know my work has a value and makes the world better.”

innovative projects in communication, health economy, IT, and data management. There are so many great things we can develop – together with other stakeholders – if we build partnerships and add value to everything we do. Q Where would you like to be five years from now? I started my new assignment with Galderma in July 2016, so I have a lot to do here. I like London and still need to learn a lot about the country. I also need to identify opportunities to further develop healthy, sustainable and profitable business for Galderma, in both the UK and Republic of Ireland. Many things can change in five years, but I am sure I will be looking for opportunities to make a change and bring my knowledge to a bigger regional role. Q What advice would you give to a person entering the pharma sales industry now? Surf the change! We exist in an industry where courageous and flexible leaders will be most needed in the years to come! Q What does the future hold for Galderma? Great opportunities! Everybody has a skin! It is our interface with the world: as we live longer, we will take greater care of our skin. We all deserve the best of our skin and Galderma’s mission is to give this chance to everyone. Go to galderma.co.uk

M AG A ZI N E | JA N UA RY 2017 | 3 1

E VENTS & CONFERENCES

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3 2 | PH A R M A FI EL D.CO.U K

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