Pf Magazine December 2018 by E4H Ltd

December 2018 PHARMAFI E LD.CO.U K

HOW TIME FLIES Reflecting on 2018

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HEAD OF CONTENT

Emma Morriss emma.morriss@pharmafield.co.uk SPECIAL EDITIONS EDITOR

Amy Schofield amy@pharmafield.co.uk C R E AT I V E D I R E C T O R

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Waving goodbye to 2018.

t’s that time of year where we’re all shocked that the months have flown by, there’s a faint sound of Jingle Bells throughout the high street and a mad rush to wrap up work before the festive break. As this year has brought about changes at Pf and across the industry, we thought we’d spend this issue reflecting on 2018, what it has delivered, or not, with a look to what we may expect in 2019. Our cover story revisits January’s predictions and whether they came true whilst considering what came from leftfield. Did you achieve your plans for 2018? Did anything unexpected challenge you? Take a look at what our panel says of their predictions and let us know what you think 2019 will bring. In politics, Claudia delves into the big developments of 2018. Did you see Jeremy Hunt’s departure coming? We certainly didn’t, but Claudia says with hindsight, the signs were there. In pharmacy, we have a review of a community pharmacy pilot which, if rolled out across England, has the potential to release 18 million GP appointments and save over a million A&E attendances each year. Impressive to say the least. For those thinking about 2019, we are exploring what may be the therapy areas of future. Without giving away any spoilers they include Alzheimer’s disease, multiple sclerosis and antibiotics. These are just a few of the features you’ll find in this month’s Pf. We’ve also got men’s health, careers, cystic fibrosis, the top news stories and more. Once you’ve finished with all this, keep a look out for next month’s Pf Special Edition. January’s magazine takes a forward looking approach to 2019, which is perfect for goal setting and horizon scanning as you start the New Year. Thanks for reading. As ever, we hope you enjoy this issue and if you’d like to be involved in a future issue of the magazine, drop us a line at hello@pharmafield.co.uk

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M AG A ZI N E | D ECEM B ER 2018 | 1

CONTENTS 04

N E WS Bringing you the essential headlines

C OV E R S TO RY

Reflecting on our predictions from January

P O L I T I C S

MAGA ZINE

December

Reviewing the big political news of 2018

F E AT U R E

What will be the therapy areas of the future?

HAVE YOUR SAY: If you’d like to share an idea for a feature or collaborate with us on a captivating advertorial, please get in touch. GET IN TOUCH: hello@pharmafield.co.uk @pharmafield

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C O F F E E B R E A K

The future of cystic fibrosis using digital and data

T H E R A PY A R E A

Men’s health matters

F E AT U R E

Unlocking the potential of community pharmacy

P H A R M ATA L E N T

MSD’s Sandy Lindsey loves her job because…

M OV E R S & S H A K E R S

Who’s moving where in the industry?

C A R E E R S

Succeeding as a key account manager

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

Be in the know. To request a FREE print subscription for your workplace, or to sign up to our weekly newsletters for the latest headlines, Jobs of the Week, PharmaTalent and thought-provoking features, visit www.pharmafield.co.uk/subscribe This issue and all past issues of Pf Magazine can be viewed online at www.issuu.com/pfmagazine

CONTRIBUTORS

A M A N DA B A R R E L L

JA M E S R OAC H

C L AU D I A R U B I N

S A L LY S H E P PA R D

Amanda is a freelance health and medical education journalist, editor and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, healthcare professionals and the general public.

James is an experienced NHS director having held roles in hospitals, clinical commissioning groups and in joint roles with social care. James runs Conclusio Limited, developing innovative solutions in health and care systems in UK and China.

Claudia is a Director at Decideum, one of the UK’s leading consultancies in healthcare policy and market access. She has over 10 years’ experience in healthcare advocacy and communications, supporting global pharmaceutical companies and small patient groups with integrated public affairs strategies.

Sally is Team Lead, Women’s and Men’s Health Physiotherapy at Poole Hospital NHS Foundation Trust, and recently became an NHS England Clinical Entrepreneur. She is also a member of The Bowel Interest Group’s steering group, which works to support healthcare professionals caring for patients with bowel conditions.

D EC L A N C A S S E L L S

K AY E M C I N TO S H

AMY SCHOFIELD

S I M O N TOY

Declan has 20 years’ experience in the medical device industry, has led a number of international expansion projects and held many senior management positions in multinational companies including Medtronic, Conor Medsystems, Kinetic Concepts and American Medical Systems.

Kaye is a freelance editor and writer specialising in health and social affairs. She is the former editor of Health Which? and WI Life.

Amy is Special Editions Editor at Pharmafield. She is an experienced journalist and editor of both digital and print content across healthcare, technology and careers.

Simon is Managing Director and Founder of Performance Associates. As MD since 2001, Simon helps turn soft skills into hard results for many blue-chip organisations, specialising in the importance of Emotional Intelligence for leaders, managers and sales professionals.

M AG A ZI N E | D ECEM B ER 2018 | 3

PRESCRIBING

Cannabis on script

NHS

CUTTING TIME

Expert doctors can now legally issue prescriptions for cannabis-based products for medicinal use. Prescribing decisions for medicinal cannabis are restricted to clinicians listed on the Specialist Register of the General Medical Council. This follows the change of law in October which gave specialist clinicians the option to legally issue prescriptions on a case-by-case basis, when the patient has unmet clinical needs. The Department of Health and Social Care and NHS England have issued guidance for doctors on prescribing, monitoring, clinical guidelines and pharmacovigilance. The National Institute for Health and Care Excellence (NICE) is producing a clinical guideline on the prescribing of cannabis-based products for medicinal use in humans. Whilst NICE is preparing the guidance, the British Paediatric Neurology Association is developing clinical advice on the use of cannabis-based products in paediatric patients with certain forms of severe epilepsy. The Royal College of Physicians is also developing additional advice around prescribing for use in intractable chemotherapy-induced nausea and vomiting and chronic pain. In related news, Dragonfly Biosciences Ltd has announced that it will commence the production and distribution of medical cannabis in early 2019, following a joint venture with a leading cGMP pharmaceutical company in Malta.

ANTIMICROBIAL . R E S I S TA N C E .

NOT SO NOVEL

New research shows a decline in novel testing technologies for antimicrobial resistance (AMR). It highlights a downward trend in new point-ofcare technologies being created to diagnose infectious disease and identify pathogens and AMR, amid a lack of innovation and investment. A comprehensive study of patent filings was undertaken by IP firm Marks & Clerk and CPA Global for Nestaâ&#x20AC;&#x2122;s Longitude Prize. The study reveals year-on-year decline in patent filings

ew polling has found that the majority of the public want the promised NHS cash boost to be used to help cut record high waiting lists for elective treatment. The polling, conducted by ComRes, found that seven in 10 British adults believe that meeting the 18-week target for accessing elective NHS treatment, such as hip and knee operations, should be a priority if there is an NHS cash boost from Government, with a similar proportion saying this standard should be met even with the NHS under significant financial pressure (72% and 69% respectively). 2019 marks the 15th anniversary of the introduction of the 18week referral to treatment target. However, this standard has been missed every month for the past two and a half years with the latest NHS figures showing over 530,000 people currently waiting over 18 weeks for treatment following a GP referral. In response to the polling, a coalition of health bodies, including the NHS Partners Network, the Royal College of Surgeons, the Patients Association and the British Orthopaedic Association, have written to the Health and Social Care Secretary Matt Hancock, calling on the Government to prioritise cutting waiting times for non-urgent treatment as part of the forthcoming NHS 10-year plan. Pf View: Itâ&#x20AC;&#x2122;s not surprising that the public wants the NHS to cut waiting lists. However, the fact that the target has been consistently missed for the past 2.5 years is indicative of the ongoing pressures facing the system.

for point-of-care diagnostics to tackle infectious disease and detect pathogens and AMR through 2014 and 2015. Following a dip in innovation as a possible result of the 2008 financial crisis, patent filings reached their highest levels for the past decade in 2014, with 118 patents for point-of-care diagnostics for infectious disease filed globally. By 2015, this figure had dropped significantly to 94 patents. The global market for point-of-care diagnostics remains in its infancy.

4 | R E A D M O R E N E WS O N L I N E AT PH A R M A FI EL D.CO. U K

Most diagnostics are routinely undertaken in a laboratory setting so that the introduction of a new point-of-care diagnostic requires the creation of new markets. New funding has mainly been for early research into new antibiotics. Funds to support diagnostics have been limited. However, the Department of Health and Social Care has announced capital funding for research into AMR.

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

llergan has announced the initiation of two global inflammatory bowel disease (IBD) clinical research programmes for brazikumab, an investigational drug being studied for IBD. The INTREPID (Crohn’s disease) and EXPEDITION (ulcerative colitis) IBD clinical research programmes

will evaluate the safety and efficacy of brazikumab and will investigate the role of biomarkers in determining a predictive response of brazikumab in patients with IBD. They are the first active comparator studies of an IL-23 inhibitor therapy in IBD to evaluate biomarkers as potential predictors of treatment response and the first randomised comparison of an IL-23 inhibitor versus HUMIRA® (adalimumab) in Crohn’s disease and ENTYVIO® (vedolizumab) in ulcerative colitis.

Allergan is initiating the INTREPID and EXPEDITION programmes following a Phase 2 clinical trial that showed higher anti-inflammatory response and remission rates with brazikumab in patients with Crohn’s who had higher levels of a key IBD biomarker compared to those who had lower levels. In July, Allergan announced clinical trial success for abicipar for treatment-naïve patients with neovascular age-related macular degeneration.

CLINICAL TRIALS

INTREPID EXPEDITION

FA L S I F I E D M E D I C I N E S

CLINICAL TRIALS.

SO SOLID

Bristol-Myers Squibb and Compugen will enter into a clinical collaboration to evaluate therapeutic regimen in advanced solid tumours. The clinical trial collaboration will evaluate the safety and tolerability of Compugen’s COM701, an investigational antiPVRIG antibody, in combination with Bristol-Myers Squibb’s programmed death-1 (PD-1) immune checkpoint inhibitor Opdivo (nivolumab), in patients with advanced solid tumours. In conjunction with this collaboration, Bristol-Myers Squibb will make a $12 million equity investment in Compugen. Compugen will sponsor the ongoing two-part Phase 1 trial, which includes the evaluation of the combination of COM701 and Opdivo in four tumour types, including non-small cell lung, ovarian, breast and endometrial cancer. The collaboration is also designed to address potential future combinations, including trials sponsored by Bristol-Myers Squibb to investigate combined inhibition of checkpoint mechanisms, such as PVRIG and TIGIT. The clinical combination of multiple immune checkpoint inhibition is designed to test the biological rationale of the PVRIG pathway and the synergistic activity demonstrated in preclinical models.

Cracking seizure

There has been more than £2 million of fake medicines seized in the UK as part of an international crackdown. The crackdown on falsified medicines and medical devices by the Medicines and Healthcare products Regulatory Agency (MHRA) has netted a haul of more than 1 million doses worth in excess of £2 million. They were seized as part of Interpol’s globally coordinated Operation Pangea initiative involving 116 countries. Between 9 and 17 October, the MHRA and UK partners found falsified and unlicensed medicines and medical devices in the UK including diazepam, modafinil and dermal fillers.

M AG A ZI N E | D ECEM B ER 2018 | 5

H E A LT H C A R E

Prevention is better than cure

ealth and Social Care Secretary, Matt Hancock, has published his vision for how he plans to transform the Government’s approach to prevention, paving the way for a prevention green paper in 2019. Prevention is better than cure shifts the focus to primary and community care services and the value they can bring in offering early support. Prevention will be at the heart of the NHS long-term plan, and will use new approaches like predictive prevention, which will explore how digital technology can be used to offer individuals precise and targeted health advice. Hancock outlined his plans during a keynote speech at the Annual Meeting of the International Association of National Public Health Institutes. The plans include: • consulting next year on measures to encourage employers to support more disabled people into work, and to improve access to occupational health • increasing specialist mental health services to a further 30,000 women during pregnancy and during the first year after they have given birth by 2020 to 2021 • halving childhood obesity by 2030 • reducing loneliness and social isolation, and making social prescribing available in every local area by 2023 • diagnosing 75% of cancers at stages 1 and 2 by 2028 • sequencing 5 million genomes in five years and offering whole-genome sequencing to all seriously ill children and those with cancer by 2019, as well as adults with rare diseases or cancers.

6 | R E A D M O R E N E WS O N L I N E AT PH A R M A FI EL D.CO. U K

I N N OVAT I O N .

AHEAD OF THE GAME

The UK Government has announced a £55m five-year investment in Medicines Discovery Catapult, to allow the UK to continue as a global leader in medicines research and development (R&D). A total of £215 million investment is split across the Medicines Discovery, Digital, Future Cities, and Transport Systems Catapult centres. It builds on the announcement made in August by the Chancellor of the Exchequer, Phillip Hammond, of nearly £1 billion for the Catapult network. Medicines Discovery Catapult is a national centre supporting the UK biotechnology sector by running applied R&D projects which industrialise and drive the adoption of new technologies and improve access to valuable UK R&D resources that help them succeed.

CLINICAL TRIALS

Positive response Janssen has announced new data on STELARA® (ustekinumab) for adults with moderate to severe ulcerative colitis (UC). It shows treatment with a single intravenous (IV) dose of STELARA® induces clinical remission and response in adults with moderate to severe UC who previously experienced an inadequate response or intolerance to conventional or biologic therapies. Results from the induction phase of the Phase 3 UNIFI study show that treatment with a single IV dose, at both doses studied, induced clinical remission in a significantly greater proportion of UC patients at week eight compared with placebo. Major secondary endpoints – including the proportion of patients in clinical response, endoscopic healing, as well as healthrelated quality of life scores – were significantly improved at week eight among patients receiving ustekinumab compared with those receiving placebo.

Quick doses NICE has issued final guidance for K YOWA K I R I N I NTE R N ATI O N A L’s Crysvita (burosumab) within its marketing authorisation, for treating X-linked hypophosphataemia (XLH) in children and young people with growing bones in England and Wales.

R O C H E receives European Commission approval for Venclyxto® plus MabThera for the treatment of adult patients with chronic lymphocytic leukaemia. • M E R C K’s Mavenclad® selected as a Rapid Uptake Product by the Accelerated Access Collaborative.

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

BIOSIMILARS

ovartis has entered into an agreement and plan of merger with Endocyte, a US-based biopharmaceutical company focused on developing targeted therapeutics for cancer treatment. Endocyte uses drug conjugation technology to develop targeted therapies with companion imaging agents, including 177Lu-PSMA-617, a potential first-in-class investigational radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC). 177Lu-PSMA-617 targets the prostate-specific membrane antigen (PSMA) present in the majority of patients with mCRPC, and has shown promising Phase II data. 177Lu-PSMA-617 is currently being investigated in the Phase III global VISION clinical trial in men with mCRPC, a disease with limited treatment options and significant unmet medical need. If completed, the Endocyte acquisition would expand the Novartis RLT platform with both a potential near-term product launch and early-stage clinical development programmes. The deal would also enable Novartis to harness its research and development expertise to investigate the potential development of 177Lu-PSMA-617 for use in earlier lines of prostate cancer therapy.

Same but different

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

ON TARGET

Following the expiry of the EU patent on Humira®, a number of adalimumab biosimilars have been launched in the UK and across Europe. NHS England Chief Executive Simon Stevens has asked doctors to consider biosimilar versions of adalimumab. NHS England said that adalimumab is the single medicine on which hospitals spend the most, at a cost of more than £400 million a year. It added that more than 46,000 patients are prescribed the drug. NHS England issued guidance telling trusts and clinical commissioning groups that nine out of 10 new patients should be started on the best value medicine within three months of a biosimilar launch, adding that at least 80% of existing patients should be switched to the best value biologic within 12 months. A number of adalimumab biosimilars have been launched since the patent expiry. Amgen launched AMGEVITA® across Europe; Sandoz announced that Hyrimoz® is available for patients in the UK, and Samsung Bioepis Co. Ltd announced the European launch of IMRALDI™. Pf View: The raft of adalimumab biosimilars that have been launched as the Humira® patent expired highlights the impact that biosimilars will have on the industry, especially given this NHS England guidance.

D R FA L K P H A R M A U K announces the UK launch of Jorveza, the first globally licensed drug approved for the treatment of the immune mediated, chronic and progressive disease of the oesophagus, Eosinophilic Oesophagitis.

E L I L I L LY A N D CO M PA N Y receives EU approval for Verzenios® (abemaciclib) for the treatment of metastatic breast cancer. The National Institute for Health and Care Excellence (NICE) also published draft guidance on abemaciclib use in the NHS.

NICE has published a Final Appraisal Determination recommending JA Z Z P H A R M AC E U TI C A L S ’ Vyxeos® for routine use on the NHS in England and Wales for acute myeloid leukaemia. NICE also approves P F I Z E R ’s MYLOTARG ® for acute myeloid leukaemia.

R E G E N E U S has received a Notice of Intention to grant a European patent for Progenza. • European Medicines Agency has granted O R C H A R D TH E R A P E U TI C S ’ investigational thalassemia drug OTL-300 Priority Medicines designation.

M AG A ZI N E | D ECEM B ER 2018 | 7

MEDICAL DEVICES

I N N OVAT I O N .

IN THE MIST

The Medicines Discovery Catapult is to collaborate with AstraZeneca to advance the adoption of Acoustic Mist Ionisation Mass Spectrometry (AMI-MS) within drug discovery. For the first time, UK small and medium-sized enterprises will have access to this state-of-the art bioanalytical technology through research partnerships with the Catapult. The collaboration will also enable AstraZeneca to further unlock the potential of AMI-MS by accessing the Medicines Discovery Catapult’s technical expertise. Although a powerful technique used to determine the mass, structure and abundance of molecules, traditional mass spectrometry has limitations

G OV E R N M E N T.

Distorting the evidence

in the rate at which samples can be introduced into the mass detector. The industry has therefore relied on other expensive labelled technologies that increase the duration and cost of early stage drug discovery. AMI-MS delivers a 20-fold improvement in throughput compared to traditional mass spectrometry. Instead of using a needle to inject a liquid sample into the mass detector, AMI technology uses sound energy. A fine mist of charged droplets is ‘lifted’ from the surface of a sample into the mass spectrometer. Contactless and contamination-free, AMI-MS can analyse up to three samples per second, or more than 100,000 samples per day.

The Science and Technology Committee has expressed concern that nearly half of clinical trials fail to publish their results. It is calling for increased transparency. Its report Research integrity: clinical trials transparency highlights the work previously done by campaigners, which shows that 50% of clinical trials do not publish any results, presenting risks to human health and increasing research wastage. The Committee is concerned that selective non-publication – ‘or publication bias’ – of results distorts the published evidence base and is a threat to research integrity. The Health Research Authority (HRA) has been responsible for ‘promoting research transparency’ since 2014, but the Committee concluded that not enough had been done to improve reporting rates. The Committee wants the HRA to produce a strategy for fixing this problem and believes its performance should be measured against progress. A trials tracker website reveals that Public Health England has three overdue trials dating from 2010-2016 relating to meningitis vaccination. Meanwhile, many NHS trusts have high numbers of unreported clinical trials: the Manchester University NHS Foundation Trust has 13 overdue trials, NHS Greater Glasgow and Clyde has 12 that are due to have reported, and both Newcastle upon Tyne Hospitals NHS Foundation Trust and Hull and East Yorkshire Hospitals NHS Trust have 11 outstanding trials. Pf View: It’s interesting that the Committee raised concerns over unreported clinical trials from Public Health England and NHS Trusts. Research transparency is essential from all sides of the industry.

8 | R E A D M O R E N E WS O N L I N E AT PH A R M A FI EL D.CO. U K

Understanding MDR A survey of over 200 regulatory professionals has revealed a lack of understanding of the new Medical Device Regulation (MDR) requirements. The Race to EU MDR Compliance conducted by KPMG and the Regulatory Affairs Professionals Society (RAPS) found regulatory affairs and quality leaders at medical device manufacturers need a better understanding of the new rules that govern the ability to sell products in the EU. The survey found: • 78% of medical device companies do not have a sufficient understanding of EU MDR • 58% of all respondents said they had no strategy in place to remediate gaps in their clinical data or processes for collecting data • 45% of North American and 29% of European respondents were ‘not very confident’ in meeting the regulatory deadline. In 2017, the EU updated regulations governing medical devices and their accessories to ensure unsafe or non-compliant equipment stays off the market. The new rules, which come into effect in May 2020, address postmarket surveillance such as data gathering for medical devices on the market. As well as impacting new devices, legacy devices with valid certifications under the Medical Device Directive must also meet the requirements. The report states that medical device makers should evaluate their products’ clinical evidence to see if there are any gaps and develop a remediation plan; address changes that need to be made in the recertification process for existing products; and build cross functional teams from quality assurance, supply chain management and regulatory compliance.

ICYMI

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

IN CASE YOU MISSED IT

TH E B E N E F IT S O F U S I N G DATA TO P E R S O N A L I S E C A N C E R C A R E In late October, Reform published new research A data-driven approach to personalised cancer care. It found that a more effective use of data could bring about much-needed improvements in cancer care. Report author, Maisie Borrows of Reform gave Pf Magazine exclusive insight into the benefits of using data to personalise cancer care.

B R E X IT A N D TH E U K L I F E S C I E N C E I N D U S TRY With Brexit still filling headlines and each industry in the UK having concerns over their future, Damon Culbert explores Brexit and the life sciences industry. He considers the potential impact of Brexit on regulation, technology, the European Medicines Agency’s move to Amsterdam and the effect Brexit may have on the availability of workers.

“Collecting and analysing data will provide insight that can significantly advance understanding and management of cancer.”

“To leave the EU with no deal would be to raise borders where there were none before, restricting the reach of the science community massively.”

H I G H CO U R T R U L I N G AG A I N S T N OVA RTI S A N D B AY E R : I M P L I C ATI O N S With the High Court ruling against Novartis and Bayer who had challenged the lawfulness of a policy adopted by 12 clinical commissioning groups in the North East, Claudia Rubin and Tom Jaggs look at the implications for pharma.

TH E CO M I N G S TO R M I N TH E P H A R M A S U P P LY C H A I N Hassan Chaudhury and Najib Rehman discuss how the pharmaceutical supply chain is complex and fragmented with too many intermediaries, wide variation in remuneration schemes, structural inefficiencies, and poor access to timely information to allow understanding of what is going on. Read their article to find out more about the coming storm in the pharma supply chain and how there is a genuine need for disruption.

PF MAGAZINE IS MORE THAN JUST PRINT. Each month we publish daily news and exclusive articles on www.pharmafield.co.uk. Here’s a look at some of the exclusive content you may have missed.

DO YOU HAVE AN E XCLUSIVE ARTICLE FOR PHARMAFIELD.CO.UK? GET IN TOUCH hello@pharmafield.co.uk

“Attempting all the hurdles to medicines access for British patients is already a tight commercial decision, and if after all those hurdles are overcome, system-wide local commissioning policy can blow a hole in the whole approval process, that judgement will become even harder.”

“The sector is ripe for disruption and it simply isn’t possible to resolve this without better information.”

M AG A ZI N E | D ECEM B ER 2018 | 9

A YEAR IN PHARMA How did the experts' predictions fare?

WORDS BY

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

Amanda Barrell

COVER STORY

It’s hard to believe, but as quick as a flash it’s December – which seems a fitting time to reflect on a year in pharma. Back in January, we asked industry experts to gaze into their crystal balls and tell us what 2018 had in store for the pharma and healthcare sectors. How did their predictions fare? And where are we now? We found out.

EXPERT PANEL

J E A N - M A R I E AU L N E T TE Vice President of EMEA sales, TraceLink

JA N E D E V E N I S H NHS Standards and Services Pharmacist, Well Pharmacy

C H R I S M O L LOY Chief Executive Officer, Medicines Discovery Catapult

JESS FINE Executive Director, External Affairs, MSD

JA M E S R OAC H Managing Director, Conclusio Limited

M AG A ZI N E | D ECEM B ER 2018 | 1 1

Challenges JEAN-MARIE AULNET TE , Vice President of EMEA sales, TraceLink

THE PREDICTION: “The biggest challenge the pharma industry faces is realising the full complexity and resources needed to meet the requirements of the EU’s Falsified Medicines Directive (FMD).” THE REFLECTION: “While I am extremely pleased to see most of the National Medicine Verification Systems are now live, a year later I believe the challenges remain. Managing product coding, master data, serialisation and compliance data for products in the European market has been, and remains to be, much more complex than it appeared at first glance. “A significant number of the EU’s 2,000plus pharmaceutical companies are yet to complete the European Medicines Verification Organisation’s on-boarding process and

COMMUNITY PHARMACY JANE DEVENISH, Pharmacist, Well Pharmacy THE PREDICTION: “The role and scope of pharmacists is rapidly changing, and the landscape for community pharmacy will continue to change in 2018.” THE REFLECTION: “For pharmacists and their patients, life has been hectic, with further pressure on GP surgeries and other health services meaning our support is needed like never before. “Updated guidance restricting NHS prescribing of some drugs for minor health conditions has meant many more patients have been seeking advice from their local pharmacy. The extension of the NHS Urgent Medicine Supply Advanced Service and Digital Minor Illness Referral Service schemes has seen community pharmacy firmly embedded in the urgent and emergency care pathways, receiving referrals from NHS 111 for provision of urgent medicines or advice on selfcare. “One significant and positive change has been legislation to give a legal defence to pharmacists who have made an inadvertent dispensing error from a registered pharmacy. That has added weight to a major focus on patient safety. Most pharmacies now regularly produce a patient safety report, reflecting on and reviewing previous incidents or near misses to spot trends, and ensure learnings are embedded.”

1 2 | PH A R M A FI EL D.CO.U K

develop their connection to the EU-Hub production environment. “This is a process that could take several months to complete, and it is imperative to compliance. A recent poll from TraceLink revealed that only a very small percentage of pharmaceutical organisations have completed end-to-end testing with at least one National Medicines Verification Organisation. “An additional concern, as the on-boarding deadline of February gets closer, is the question of whether dispensing organisations, hospitals and pharmacies have put systems in place to connect to relevant national systems, as required by the regulation.”

BREXIT JESS FINE , Executive Director, External Affairs, MSD

THE PREDICTION: “We believe this country can be well-placed to lead the world in delivering high-quality care for patients. To meet this ambition, however, it is essential that we address some very real concerns.” THE REFLECTION: “Of course, uncertainty caused by Brexit continues. We continue to plan for all scenarios to ensure patients’ medicines supply is not disrupted post-March 2019. “We sincerely hope the UK and the EU will negotiate a deal that will ensure frictionless trade, encourage scientific research collaboration, enable the industry to employ the best talent from around the world and ensure pharmaceutical regulations are fully aligned between the EU and UK. “For our sector to flourish it is imperative for our industry that 2019 brings greater certainty and clarity.”

CHRIS MOLLOY, Chief Executive Officer, Medicines Discovery Catapult THE PREDICTION: “While the UK will be outside the EU, the industry and the expert opinion remains in the UK, and biology knows no borders. The post-Brexit world does give the UK the potential to carve a distinct role for itself in discovery and early clinical development.” THE REFLECTION: “We see and feel a national community acting with purpose and confidence. We also believe that the UK’s wisdom and capability in this sector is a massive national export opportunity post-Brexit. The need for active research and development, and access to the national infrastructure remains clear.”

“ We’re really pleased to see the Life Sciences Industrial Strategy develop with the creation of a new industry and government forum in the Life Sciences Council”

WHAT’S TRENDING?

COVER STORY

Opportunities for industry JESS FINE , Executive Director, External Affairs, MSD THE PREDICTION: “We welcome the Government’s Industrial Strategy which offers the opportunity to deliver a stable and holistic approach to life sciences that recognises the full value of innovative medicines from early stage research all the way through to adoption.” THE REFLECTION: “We’re really pleased to see the Life Sciences Industrial Strategy develop with the creation of a new industry and government forum in the Life Sciences Council, as well as an implementation board. We are delighted to be involved in both of these and see them as key drivers to delivering a flourishing life sciences sector in the UK. “For our part, MSD continues to forge ahead with plans to open a new stateof- the-art discovery research centre and headquarters in London. It will house 150 of the world’s brightest and best research scientists, as well as 800 existing employees in clinical and support functions. “We have already started to build our new discovery team in London and will be using the London BioScience Innovation Centre as an interim base over the next few years whilst we develop our discovery centre.”

JAMES ROACH, Managing Director, Conclusio Limited INDUSTRY PARTNERSHIP IN THE NHS “The continued roll out of the Memorandum of Understanding between the pharmaceutical industry and the Greater Manchester local authority is good news. “Recent work by Health Innovation Manchester and industry partners has shown what is possible when expertise, energy and enthusiasm is combined under a common purpose. “The continued funding of Academic Health Science Networks is also a positive step forward. “They now need to be freed to broker the wide-scale engagement of pharma into the innovation and transformation challenges that the NHS is facing.”

CHRIS MOLLOY, Chief Executive Officer, Medicines Discovery Catapult THE PREDICTION: “By structuring investment partnerships focused on innovative opportunities, the UK has immense potential to be harnessed through translational centres like the Medicines Discovery Catapult to create national pipelines of new ideas that move into the clinic.” THE REFLECTION: “UK SMEs, international technology companies and academics are now working under our roof to address the application of more patient-relevant pre-clinical models of disease and improving the disease biology we use to test for new medicines. “AstraZeneca and innovative technology companies are working with us to industrialise emerging technologies. We have announced the first of a number of major grants with Optibrium to co-develop new artificial intelligence-driven systems that make sense of complex drug metabolism data. “We are helping match consented patent samples and data with UK innovators and helping biotechnology to access UK public sector capability they did not know was there. At the same time, research charities are engaging with us to develop discovery syndicates. These are new discovery consortia that leverage patient trust, upstream biology and clinical engagement.”

STRUCTUR AL CHANGE AND EMERGING OPPORTUNITIES “The development of integrated care partnerships and integrated care systems creates a platform for pharma to transition from supplier to partner. “This is an excellent opportunity for pharma to deliver services at scale and demonstrate value in terms of therapy optimisation, illness prevention and developing outcomesfocused, efficient services.” AND WHAT DIDN’ T WE SEE COMING? “Well, I didn’t predict a change in health secretary! However, we look forward to working with Matt Hancock in his new role,” concluded Jess Fine.

M AG A ZI N E | D ECEM B ER 2018 | 13

REMEMBERING 2018 1 4 | PH A R M A FI EL D.CO.U K

n the unlikely event of an orderly Brexit occurring with barely a ripple of disruption to the financial sector, agriculture industry, world of academia, international sport, tourism and so forth, one might wish to remember 2018 for how it played out in areas beyond Brexit. If so, a few important issues of interest for the pharmaceutical and med tech industry are worth considering.

On politics The big political (health) story of the year was of course the exit of longest-ever-serving Health Secretary Jeremey Hunt giving way to the surprise appointment of Matt Hancock. Having been given an extra string to his bow (and the renaming of the Department to boot) in the Prime Minister’s New Year Cabinet reshuffle, seeing the NHS through its 70th birthday celebrations and securing the promise of a first-ever 10-year plan, with historic additional funding alongside it, in hindsight it is obvious that 2018 was to be his last at the political helm of the NHS. More surprising, perhaps, was that it was also the last year for the official at the NHS’ helm; Professor Sir Malcolm Grant CBE gives way to Lord David Prior as NHS England Chair. It is, therefore, Hancock and Prior who will steer us through the long-term plan. With their vision firmly in preventive medicine, we can expect to see primary care, community care and a whole host of nanny state, nudgetheory tactics playing a greater role as the NHS desperately looks to bring down costs.

On economics Bringing down costs is essential if the NHS is not to swallow whole the additional £20bn funding it secured in the Budget. The broad public support that this extra funding enjoys would soon disappear in the face of financial mismanagement and a failure to make savings. Half of all hospital trusts will report a deficit in 2018/19 and staff shortages are at critical levels – this year saw a 10% increase in the number of vacancies in just three months. Despite national and international recruitment campaigns, one in 11 posts, or 108,000 jobs, remain unfilled.

POLITICS

On policy You could argue that the reverse has happened with senior management posts. With a requirement for clinical commissioning groups (CCGs) to reduce management costs, the direction of travel this year was for CCGs to create single commissioners at a sustainability and transformation partnership (STP) footprint level. 31% of the population is now managed by just 13 accountable officers who work across 59 CCGs, located in 12 STPs. With further commissioning restructuring likely (and doubtless more confusing acronyms along with it), policy-makers might pay heed to the Commons Select Committee which, in June, urged the Government to do better at communicating its plans for NHS structuring. Some had hoped (even expected) that this year would have stood out for progress in rare disease policy. November marked five years since the publication of the UK rare disease strategy. The sharp-witted will note that as a five-year strategy, we should have been able to mark some of its aims as complete and be in the happy position of embarking upon evermore ambitious next steps in the field. The highly anticipated progress report on the strategy was published in March, setting out where some progress had been made, namely (and, of course, imperfectly) in the roll out of the highly specialised technology appraisal process for ultra-orphan medicines â&#x20AC;&#x201C; but little else of concrete reassurance to industry, or rare disease patients, has materialised, and few people are expecting a new strategy any time soon.

WORDS BY

Claudia Rubin

On innovation and access to medicines At the end of 2017, the Government published the UKâ&#x20AC;&#x2122;s Industrial Strategy followed by a series of sector deals, including for life sciences. Many of us cautioned that the ambitions it set out would amount to little without clear and robust accountability. Well finally, 12 months later, the newly-established Industrial Strategy Council, Chaired by Bank of England Chief Economist Andy Haldane, met to discuss how to hold the Government accountable for progress on commitments made in the strategy. Whether the Government can claim any credit for the deal struck with NHS England on access to CAR-T cell therapy for children with certain blood cancers is questionable, but it has to be hailed as perhaps the most high-profile innovation success of the year. This is in contrast to the overly-hyped Accelerated Access Review, which this year finally got underway, albeit with seven already launched; previously available products will now get a bit of extra help towards uptake. Much expectation for progress in innovation spread throughout the NHS, now rests with the new Pharmaceutical Price Regulation Scheme.

On health outcomes And finally, where it all really matters, is that for all the ups and downs, can we safely conclude that 2018 brought about improvement in health outcomes for people up and down the country? In a word, no. For 2018 was the first year in which UK life expectancy stopped improving since records began in 1982. As it turns out, everyone has perhaps been rather distracted by the incredible challenge posed by Brexit, and next year is sure to be just as bumpy a ride. Claudia is a Director at Decideum. Go to www.decideum.com

THE BIG POLITICAL (HEALTH) STORY OF THE YEAR WAS OF COURSE THE EXIT OF LONGESTEVER-SERVING HEALTH SECRETARY JEREMY HUNT GIVING WAY TO THE SURPRISE APPOINTMENT OF MATT HANCOCK

M AG A ZI N E | D ECEM B ER 2 0 1 8 | 15

THERAPY AREAS of the future

Research into medical treatments has never been more exciting. From personalised medicine and gene editing to immunotherapy, we look at where the next breakthroughs might come.

ALZHEIMER’S D DISEASE

WORDS BY

Kaye McIntosh

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

r James Pickett, Head of Research at the Alzheimer’s Society, shared: “It’s a sad fact there hasn’t been a new treatment for dementia in over 15 years – but all is not lost as since 2013, the number of clinical trials for Alzheimer’s drugs has doubled.” A Phase II trial into BAN 2401, from Eisai and Biogen, showed a reduction of the amyloid plaques in the brain that are a hallmark of the disease, and a slowing of cognitive decline. Dr Pickett says the research “brings genuine hope to drugs targeting amyloid”. Research indicates that people with Type 2 diabetes are more likely to develop Alzheimer’s. A drug used to treat Type 2 diabetes, Liraglutide, has shown promise for the treatment of dementia. In laboratory studies, it improves symptoms and reduces the amount of amyloid plaques. The drug is being studied in a Phase IIb trial led by Dr Paul Edison of Imperial College, London. The trial, due to complete in March 2019, is testing the effects in the early stages of Alzheimer’s. If successful, Liraglutide could be available for dementia in five to 10 years.

F E AT U R E

ntibiotic-resistant infections could kill up to 10 million people a year by 2050, according to the Association of the British Pharmaceutical Industry. Yet the pipeline for new drugs has slowed to a trickle. “ The biggest challenges are economic,” said Kevin Outterson, Executive Director of CARB-X, a non-profit international partnership that funds early-stage and Phase I research into the most dangerous resistant bacteria. In 2013, The World Economic Forum warned antibiotic resistance is “arguably the greatest risk” to human health. “We live in a bacterial world where we will never be able to stay ahead of the mutation curve.” Bacteria constantly evolve to develop defences against medicines, so any new therapies must be reserved for only those patients with the most serious resistant infections. “But success is achievable,” Kevin added, “so long as companies are given the time and money needed to bring products to market.” Public-private partnerships and governments are heavily involved in the drive to develop new antibiotics, as the return on investment in any product that can’t be widely used is too low to make commercial sense. Carb-X has 10 products in development that represent a new class against the most critical multidrug and extensively drugresistant Gram-negative bacteria. “If any one of these succeed, it will be the most important antibiotic innovation in our lifetimes,” said Kevin. One product is Amicidin Beta solution, a protein that acts as a surfactant, used during and after operations to treat heavily contaminated or infected tissues. Produced by Amicrobe, it is heading towards Phase I trials. It could be used to combat periprosthetic joint infection, a devastating complication of hip or knee replacement. Another is a class of therapies based on the human microbiome – attempting to achieve the benefits of faecal transplants in a controlled manner. Vedanta Biosciences is developing VE303, a capsule containing defined, freeze-dried bacteria that colonises the gut and outcompetes C. difficile – a common cause of diarrhoea in older hospital patients. A Phase I study finishes this year. Vedanta Biosciences’ Chief Executive, Dr Bernat Olle said: “Every time antibiotics are used, they will select for resistance.” Instead, he added that using live bacteria “might help to curb resistance” by displacing gut microbes that have developed antibiotic resistance.

“ Immunology will be a real game changer in the next 20 years. We are harnessing the body’s natural ability to deal with a threat”

CANCER

ANTIBIOTICS

he future is exciting,” explained Stuart Farrow, Director of Biology at Cancer Research UK’s Therapeutic Discovery Laboratory. “Immunology will be a real game changer in the next 20 years. We are harnessing the body’s natural ability to deal with a threat.” There are several different approaches, including altering the white blood cells known as T cells and tackling the checkpoint modulators that turn immune responses on and off. In September, NHS England approved a personalised medicine, Kymria, for a form of childhood leukaemia. This CAR-T therapy involves taking T cells from the patient and inserting a gene that targets a protein unique to tumour cells. “Checkpoint inhibitors are another ‘huge focus’, especially in melanoma and small cell lung cancer,” said Stuart. These drugs block proteins that stop the immune system attacking cancer cells, while checkpoint modulators stimulate the immune response. In one study, 40% of advanced melanoma patients receiving a checkpoint modulator were alive three years later. “A lot of the cells we are interested in are involved in disease processes away from cancer, such as rheumatology,” added Stuart. “We are looking at the autoimmune continuum, from conditions where the immune system is over-active, to cancer where it is not reacting.”

M AG A ZI N E | D ECEM B ER 2018 | 17

TYPE 1 DIABETES

DEPRESSION & INFLAMMATION

ne of the most exciting areas of research around Type 1 diabetes is smart insulin – a chemically modified form that rests in the system until glucose hits and activates it. Dr Eleanor Kennedy, Research Manager at the Diabetes Research and Wellness Foundation, said: “It’s an incredibly clever way of people not having to think about what they have just eaten because the smart insulin will be there waiting for you.” It promises that “you will activate the exact amount of insulin that you need” and it could make hypoglycaemia a thing of the past. In August, the largest manufacturer of diabetes medicines, Novo Nordisk, acquired a start-up, Ziylo, which developed synthetic glucose-binding molecules. Eli Lilly bought another start up in 2016, while Sanofi has a collaboration with the Juvenile Diabetes Research Foundation which funds projects including a biochemical switch activated by glucose.

Dr Kennedy said other promising research includes immunomodulation – putting a barrier between the immune system and the beta cells lost in type 1 diabetes. “If you can get in quick with newly diagnosed people who still have around 10% of their beta cells functioning then you will not need to go onto exogenous [external] insulin.” The ADDRESS-2 project, led by Professor Des Johnston of Imperial College London, runs studies including one investigating how much insulin people can make themselves in the first year of type 1 diabetes, while another looks at the safety of a vaccine that stops the immune system from attacking the beta cells that store insulin.

“ One of the most exciting areas of research around Type 1 diabetes is smart insulin, it could make hypoglycaemia a thing of the past”

here have been no major breakthroughs in depression since SSRI antidepressants in the 1990s. However, a new way of looking at the condition may hold the key. “If you’ve got an inflammatory disease like rheumatoid arthritis your chances of being depressed are much higher than a comparator group,” explained Professor Ed Bullmore, Head of the Department of Psychiatry, University of Cambridge and Vice-President of Experimental Medicine for GSK. “The symptoms of depression, brain fog and cognitive impairment could be directly related to your arthritis, rather than the arthritic process being limited to the body and the psychological symptoms resulting from a conscious reflection on what it is to have the disease,” he added. Inflammation can pre-date depression. Hepatitis C patients treated with interferon are exposed to an inflammatory shock and about one in three will then become depressed. High levels of inflammation are also found in people with Alzheimer’s disease. Professor Bullmore leads The Wellcome Trust Consortium for the Neuroimmunology of Mood Disorders and Alzheimer’s Disease, bringing together three pharmaceutical companies, Alzheimer’s Research UK and six universities. A phase IB biomarker validation study is starting this year, while a new molecule that penetrates the central nervous system is moving into Phase II trials for depression. “Inflammation is incredibly important in all areas of medicine,” said Professor Bullmore. “Immunology looks like it is increasingly central to therapeutics across the board.”

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

F E AT U R E

“ There’s been a huge amount of progress in the relapsing-remitting form of multiple sclerosis”

MULTIPLE SCLEROSIS T

here’s been a huge amount of progress in the relapsingremitting form of multiple sclerosis (MS), with 14 diseasemodifying treatments now available. But primary progressive MS is a different story. In June, The National Institute for Health and Care Excellence (NICE) provisionally rejected the first treatment licensed for this condition, Roche’s Ocrelizumab, due to cost, while approving it for the relapsing-remitting type. However, there are promising avenues. In MS, the myelin that surrounds nerve fibres in the brain and spinal cord is damaged. A Phase IIA study on a drug that aims at a target called RXR gamma is due to report next summer. Neuroprotection is another key area – priming the nerve fibres to stay healthy for as long as possible. Phase II trials into high dose simvastatin showed it reduced the rate of brain shrinkage, while patients had better disability scores. A Phase III trial is now recruiting. The anti-inflammatory Ibudilast is a first-in-class small molecule drug that is about to move into Phase III. The FDA has granted it fast-track status, speeding up the review process. Produced by MediciNova, it is believed to protect against cell death. In Phase II trials, it halved the rate of brain shrinkage. Dr Susan Kohlhaas, Director of Research at the MS Society, said: “Ultimately, we need a combination treatment where we target the faulty immune system, prime the body to repair itself and protect the nerve fibres from damage.”

TH E R APY AR E A S O F TH E FUTU R E

While these six areas could well be the ones to watch in 2019 and beyond, with pharma companies focusing on innovative treatments to improve people’s lives, we’re certain others will appear in the running.

KEY FIGURES

MORE THAN

YEARS since a new dementia

TREATMENT

ALMOST

3.7 MILLION

PEOPLE HAVE BEEN DIAGNOSED WITH DIABETES

IN THE UK 10 MILLION COULD DIE FROM

antibiotic-resistant infections by

2050 14 disease modifying treatments for relapsing-remitting MS

MORE THAN

100,000 people live with MS

IN THE UK Sources: www.diabetes.org.uk www.mstrust.org.uk

M AG A ZI N E | D ECEM B ER 2018 | 19

COFFEE BRE AK

In the driving seat Dr Su Madge is the driving force behind a digital platform called CF Future Care, putting people with cystic fibrosis (CF) in the driving seat to monitor their health at home.

INTERVIEW BY

Emma Morriss

2 0 | PH A R M A FI EL D.CO.U K

ell us about what you do. I have several roles; I am a consultant nurse for adults with CF and an associate director for the Adult Cystic Fibrosis Service. I also hold the position of Clinical Chair for Infection and Immunity at the hospital. I started nurse training at University College Hospital, London and after a few years completed the Registered Sick Children's Nurse training at Great Ormond Street Hospital. I was a ward sister on the respiratory high dependency ward for a few years and then developed one of the first CF clinical nurse specialist roles in the UK. I continued in that role at Great Ormond Street Hospital until 2002, when I joined the Royal Brompton Hospital adult CF service as a consultant nurse. During that time, I completed a masters and PhD degree, both in the area of CF. We have a large adult CF multidisciplinary team which works closely together on a daily basis and which I am fortunate to be part of. There is also a paediatric CF service at the Royal Brompton and the two multidisciplinary teams work in partnership on things like transition and research.

What facilities do you have at the Royal Brompton? The Royal Brompton Hospital is one of the largest CF centres in Europe. We have a large number of adults with CF, this is historical as we were the first adult CF service in the UK, however there are now many more spread around the country. We have more or less the same facilities as all CF centres as we all have to meet national guidelines. These include single, en-suite rooms and space for outpatient segregation. What is the current situation with supporting people with CF? The current national CF problem is the increase in adult numbers, our paediatric colleagues are very good at looking after children with CF. Consequently, there are few childhood deaths. Nationally resources have not developed to meet this increasing need and there are now many adult centres in the UK with almost as many patients as the Royal Brompton. How many people do you support? We care for almost 600 adults with CF. What are you doing to help people with CF to access healthcare? People with CF are informed, by their clinical teams, from an early age that maintenance and awareness of their lung function is important to maximise their life expectancy (CF Trust, 2011). As a result, people with CF are expected to attend clinics at their specialist CF centre regularly to monitor their lung disease and prevent or halt disease progression (CF Trust, 2011). People with CF report that attending

“ By putting data in the patients’ hands, there is hope it will start to equalise the power dynamic that exists between patient and the healthcare team who currently hold much of the data used for clinical decision making”

clinic so frequently for monitoring is significantly impacting on their quality of life. They must take time off work, arrange childcare and find the significant cost of travel into central London. In addition to this, CF outpatient services are busy and frequently overbooked. A growing concern given that research in this area has predicted an increase in the numbers of adults with CF by 75% due to advances in medical care and associated increased life expectancy (Burgel et al, 2015). A recently published guideline in CF has urged healthcare teams to consider providing telehealth as an option for routine monitoring with benefits recognised both to the patient experience and in allocating hospital resources (NICE, 2017). Tell us about CF Future Care. This innovation project, Back in the Driving Seat, aims to address these challenges by empowering the person with CF to monitor their own CF health from home through a digital platform called CF Future Care. By providing self-assessment equipment and a technology platform to share that data with the healthcare team, this in turn unlocks the CF team’s ability to provide remote, virtual consultations and advice. It will allow people with CF to gain a greater awareness of their CF health and to see the impact of lifestyle changes or new medicines. Why is it important to give people with CF more control? By putting data in their hands, there is hope it will start to

equalise the power dynamic that exists between the individual with CF and the healthcare team who currently hold much of the data used for clinical decision making. For the CF centre, it offers the opportunity to reduce the number of in-hospital clinic appointments and consider how to allocate resources better in view of the growing CF population. How are you developing the platform? We are being generously supported by the Royal Brompton & Harefield Hospitals Charity, who are raising £500,000 towards the project through their Back in the Driving Seat campaign. The project involves sourcing and providing self-assessment equipment for people with CF, designing and building a technology solution for sharing of health data, and the provision of remote clinical review over video link. We have been scoping potential technology companies to build the data sharing platform and using additional self-assessment kits such as weighing scales and glucose monitoring. Individuals are continuing to test home spirometry and we have been holding remote consultations in order to obtain feedback from all users. This helps us get baseline survey data on how the clinical service can evolve and what functionality would be a priority in a technology solution. How are you getting on? The project is in part-implementation stage. So far, the following has been achieved: • Home spirometry kit and video-link technology tested • Home spirometry sourced and in use with 40 adults with CF • Remote clinical review over video-link tested • A nimation created for people with CF on the purpose of health monitoring and sharing data • Co-design virtual workshops completed with 10 service users and 12 staff • Funding established from a combination of pharmaceutical and charity funds. What’s the aim for the future? The adult multidisciplinary CF team at the Royal Brompton and I want to help people see that those with CF and their families are part of the team and should be involved in decision making around treatment and care. We hope that this project will not only transform the future of CF care for our patients, but for patients across the UK. Go to www.rbhcharity.org/cfappeal

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M AG A ZI N E | D ECEM B ER 2018 | 21 15/01/2018 13:32

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Men’s health matters Why do men find it hard to get help for their health worries? “ Many men only make an appointment once they fear they have a serious medical condition” WORDS BY

Amy Schofield

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

hether it’s because they’re embarrassed, don’t want to bother anyone, or think that their doctor won’t take them seriously, men are often the ones who ignore their physical or mental health symptoms, hoping they’ll go away. But with statistics showing that one man in five dies before he reaches 65*, it’s clear that men’s reluctance to seek help for their health worries is causing half of the population unnecessary suffering. The facts are stark – life expectancy in the UK for males is 78.2 years and for females 82.3 years – in other words, men live two hours fewer per day (Reference: BMJ). According to statistics on mortality compiled by Men’s Health Forum, men are more likely than women to die prematurely. In England and Wales, 19% of all male deaths were aged under 65 (compared to 12% for women) and 38% of all male deaths were aged under 75 (compared to 26% for women). Males are more likely than females to die in all age groups under 85 years. With statistics like these, surely it’s time for men to face the fact that things need to change. But how?

YO U ’ R E N OT A LO N E Dr Zubair Ahmed, GP from MedicSpot, says that men find it difficult to admit when something is wrong: “Our analysis of NHS data shows that men go to their GP 27% less than women do. Men can sometimes find it hard to admit that they need help,” he explains. “During my 11 years of experience as a GP, I found that many men only make an appointment once they fear they have a serious medical condition. But we need to understand that this expectation of men to deal with health problems on their own is putting lives at risk.” Dr Andrew Thornber, Chief Medical Officer at Now Patient, says that ignorance is far from bliss: “Sadly, far too many men don’t go to their GP when they feel unwell or discover something that doesn’t feel quite right in their bodies,” he says. “Many men think they’re not going to get ill and/ or by ignoring the problem, it’ll simply go away.” Dr Ahmed cautions men to keep up with routine health checks, even if they don’t feel that anything is wrong. “Feeling fine is not the same as being healthy. Men should be getting regular check-ups to help stay on top of their health and find potential health issues before they become a problem,” he says. “Diseases such as high blood pressure and heart problems are more common in men and early detection allows men to have the best chance of getting the right treatment more quickly.”

* menshealthforum.org.uk ** Martin-Merino, E., Ruigomez, A., Wallander, M., Johansson, S. and GarciaRodriguez, L. (2009). Prevalence, incidence, morbidity and treatment patterns in a cohort of patients diagnosed with anxiety in UK primary care. Family Practice, 27(1), pp.9-16.

F E AT U R E

KEEP IN MIND

f men have issues with seeking help for physical health concerns, when it comes to mental health, the situation is even worse. “Instead of bottling these things up, men should be talking to their GPs and discussing any problems they might have with those close to them – this includes mental health as well as physical health,” says Dr Ahmed. Research shows that women are more likely than men to have a common mental health problem, and almost twice as likely to be diagnosed with anxiety disorders.** However, women are generally more willing to discuss their emotional experience than men. Dr Mark Winwood, Director of Psychological Services at AXA PPP healthcare, says that this unwillingness by men to open up about mental health is ingrained, and has devastating results. “Stigma still surrounds men’s mental health that prevents many from seeking help. This drives an alarmingly high number to take drastic action – 75% of all suicides in England are male and it’s the biggest killer of men under 50,” says Dr Winwood. “From a young age, boys are taught to be ‘brave’. Men therefore bottle up emotions which can trigger negative thoughts, distress and anxiety. If left untreated, this can escalate into total lack of self-worth and suicidal tendency,” he adds. “Demonstrating emotions should be seen as a sign of strength and willingness to get help. You would never say to someone with a broken leg ‘just walk on it’. Just because we can’t see poor mental health, doesn’t mean they aren’t suffering.”

MAN’S TALK Source: www.menshealthforum.org.uk

A N OTH E R WAY If men find it hard to talk to their GP, could there be an alternative? The role of community pharmacies, as well as online pharmacies, is growing. People can now pop in to their local pharmacy for all manner of advice, without needing an appointment, or seek help online. According to Laura Jones, Clinical Lead at Assured Pharmacy, it might be the ‘ad hoc’ and more anonymous nature of the pharmacy that could enable men to more readily seek advice. “According to research, men feel that it needs to be serious to trouble the doctor and so the pharmacy feels like an easier first step in getting treatment. Not needing an appointment and knowing they can come in when things take a turn for the worse makes the pharmacy the perfect place for men to go, rather than the GP, as they can receive quick help and advice,” she says. Laura says that men also find it easier to seek help from an online pharmacy: “My current job revolves around talking to men about their health conditions and helping get them the best advice and treatment. Being online they feel very confident calling and discussing their health concerns with us,” she explains. “It’s very important to keep asking important questions to patients in every medical interaction as you never know when they may take your advice/help.”

Men are twice as likely as women to have inadequate health literacy. Men are less likely than women to acknowledge illness or to seek help when sick. The biggest single cause of death in men is cancer, the second is circulatory diseases.

M AG A ZI N E | D ECEM B ER 2018 | 2 3

F E AT U R E

DR ANDRE W THORNBER ’ S H E ALTH MANAG E M E NT TI PS FO R M E N

DON’T RELY ON ‘DR SEARCH’ When it comes to health, there can be a lot of information and advice on Google that can be misleading. A symptom can mean something completely different from patient to patient. Don’t spend ages trawling the internet but instead seek professional medical advice, as quickly as you can.

BE PREPARED It is always useful to write down your concerns/symptoms before you talk to your GP, so you don’t miss anything out. That way, you won’t forget anything and the GP can correctly diagnosis or provide the right health advice.

DON’T IGNORE IT The quicker the problem gets sorted and treated, the quicker you can get back to normal. Leaving a health problem, no matter how insignificant you think it might be, could make things worse, so don’t delay making an appointment to see your GP.

DON’T BE EMBARRASSED GPs aren’t embarrassed, so don’t be embarrassed by your health problem, as your GP will usually have seen it all before. Your doctor is a highlytrained medical professional, used to examining people and talking about uncomfortable or sensitive issues all the time.

Go to www.medicspot.co.uk/dr-zubair-ahmed; www.nowpatient.com; www.assuredpharmacy.co.uk; www.axappphealthcare.co.uk/health-information/mental-health

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

SPEAK TO A VIRTUAL GP Digital health is revolutionising the UK healthcare system, helping to ease the burden on the NHS. You can now get GP appointments via mobile technology at a convenient time and place, putting the care of each patient’s health into their own hands, and helping those who find GP appointments uncomfortable to feel less stressed.

M I N D M AT TE R S

SUICIDE is the biggest cause

35 76%

OF DEATH FOR MEN UNDER

JUST OVER THREE OUT OF FOUR SUICIDES, OR

are by men Source: ONS

ADVERTORIAL

IS YOUR ORGANISATION 2019 READY? WORDS BY

s 2018 winds to an end, many of us will start to ponder exactly what our focus should be for 2019, if we haven’t done so already. At Performance Associates, we are regularly asked what are the hot topics and/or concerns that we hear about from our clients. This year is no different, so we thought it might be of interest to share with you the most common challenge we are asked about and consider what approaches you might think about to address it.

Simon Toy

G A I N I N G CO M M ITM E NT With key stakeholders at all levels of the NHS becoming harder to see, it is more important than ever that we maximise the impact we have with them when we do see them. Unfortunately, a common theme within the pharmaceutical sales environment, which is revealed in just about every audit ever completed in the industry, is that sales people (at whatever level) simply do not ask for a commitment. This reluctance to ‘a call to action’ seems particularly foolhardy when one considers that, along with pre-call planning, it has the strongest correlation with sales success. Given that most sales professionals have completed more courses on closing for commitment than they’ve had hot dinners, the question is ‘why is it still a problem?’. The answer nearly always centres on the sales person’s belief systems. This often reveals itself with comments such as: ‘The HCP will see me as pushy and it will be harder to make appointments in the future’. This fear will act as a barrier to closing for commitment and the only way to address this problem is to tackle the limiting belief causing it. In any walk of life, individuals fail to fulfil their potential not because of a lack of knowledge or skill, but because of the limiting nature of their belief systems. Many organisations tell us that ‘we’ve addressed beliefs in a workshop’ as if that is ‘job done’, ‘box ticked’. Unfortunately, if beliefs have been ‘addressed’ in a workshop but the negative behaviour still manifests itself, guess what, the belief has not been ‘addressed’. Remember, a belief is learnt in the past, acts in the present and predicts the future.

Coaching, including self-coaching, has long been seen as a powerful tool for unleashing potential in people. However, many coaching approaches fall short of achieving this aim due to their transactional approach. Only an effective transformational coaching approach that considers the way the coachee thinks and feels as well as what they do, will lead to long term change. Our psychologists’ research demonstrates that a questioning framework based on transformational rather than transactional coaching is 31% more likely to deliver corporate goals. What’s more, the coaching has to be focused on sound Emotional Intelligence principles linked to the factors known to drive sales effectiveness. In a nutshell, the best way to overcome a reluctance to ‘asking for the business’, ‘closing the sale’, delivering a ‘call to action’ or any of the other euphemisms to describe gaining commitment from our customers, is to educate the sales force in how to self-coach their limiting beliefs, develop a transformational coaching approach within your first and second line managers, and ideally, support this with world-class Emotionally Intelligent sales coaches to embed the entire process and help transfer the responsibility to your management community. Simon Toy is Managing Director, Performance Associates. If you would like to know more about this article, please contact us on info@performanceassociates.org. Go to www.performanceassociates.co.uk

M AG A ZI N E | D ECEM B ER 2018 | 2 5

HEALTHCARE ON THE HIGH STREET

Figure 1. C H A L L E N G E S FAC I N G TH E H E A LTH C A R E SYS TE M

Lack of investment

Insufficient workforce

TH E P R O B L E M S

WORDS BY

James Roach

orking with the National Pharmacy Association; Jaunty Springs, an innovative GP practice; and Basegreen Pharmacy, a community pharmacy in Sheffield, I evaluated an integrated primary care service delivery model which has significant potential if scaled up and offers pharma a role as a catalyst for change.

Unfunded work and rising demand in bureaucracy

TH E O P P O RT U N IT Y I S R E A L Although there are many challenges facing healthcare, there are opportunities for community pharmacy and the pharmaceutical industry. As NHS England’s own data demonstrates, there are 30 million consultations in general practices that could be delivered in a different setting, see figure 2.

Figure 2. B R E A K D OW N O F G P CO N S U LTATI O N S

P H A R M ACY K E Y FAC T S There are around 11,500 community pharmacies in England • Each pharmacy serves approximately 5000 people • 1.6 million people walk into a pharmacy every day which equates to each pharmacy seeing 136 patients without an appointment every single day • In almost all cases, access to a pharmacy will be far easier than a GP. C H A L L E N G E S TO TH E H E A LTH C A R E SYS TE M Work in primary care is becoming more complex and intense due to: • The ageing population • Increasing numbers of people with chronic long-term conditions • Decreasing numbers of people who want to self care • Increased numbers of initiatives redirecting work from hospital settings to community and primary care settings • Rising public expectations • Significant workforce challenges in relation to recruitment and retention in primary care. These challenges are summarised in figure 1.

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

Inadequate infrastructure

12m Potentially avoidable GP consultations

15m

164m U N AVO I DA B L E

Source: NHS England

Unavoidable   Other in practice Self care/Pharmacy   Outpatients

 Sick notes/appeals  Other  Care navigation  Organisation in practice

F E AT U R E PA R TN E R S H I P WO R K I N G This leads us onto the integrated primary care service delivery model which is partnership working between the National Pharmacy Association, Jaunty Springs GP practice and Basegreen Pharmacy in Sheffield. The core ethos of the model is that any patient who could be managed in a community pharmacy should be referred there to reduce practice workload, improve the patient experience and encourage positive patient behaviours towards self care and care management. The community pharmacy accesses the GP practice’s SystmOne from the pharmacy consultation room, utilising the existing N3 connection for virtual review, booking of patients and updating of the patient record in real time. Patients are given the choice of healthcare professional in either the practice or through undertaking a consultation with the community pharmacist in their consulting room. Community pharmacy is able to undertake direct consultations with patients in the pharmacy or for older patients in their place of residence. In-depth medicines data analysis is also led by the community pharmacist. Patients have access to the full community pharmacy team which consists of two community pharmacists, one full time equivalent (FTE), one of whom was an independent prescriber, two dispensers, 1.5 whole time equivalent (WTE) accuracy checking technician and medicines counter assistant. This team, working in tandem with the general practice team, generates a high-quality, seamless integrated care service for the patients.

K E Y B E N E F IT S TO TH E H E A LTH SYS TE M Upon evaluation of the model there were clear benefits for the health system. It offers the opportunity to create more capacity in primary care through a highly scalable model. It has the potential to reduce average waiting times in primary care settings which reduces pressure on the whole GP team. As a result, average waiting times at the GP practice are lower than the local and national average. The community pharmacy team supports patients in taking their medicines, enhancing adherence and supporting quality and safety of prescribing within the practice. This in turn eliminates prescribing errors at source and in real time by allowing the community pharmacist to access the full GP record and make changes. It creates a critical change in patient behaviour, making pharmacy the first port of call for a range of conditions and there is also increased support for frail older patients in their own home, and those registered individuals residing in residential care. The model also brings the additional benefits of utilising existing patient and professional relationships and breaking down silos within the health system, which have led to improved trust and confidence in the clinical input of the community pharmacy team. Q UA NTITATI V E B E N E F IT S TO TH E H E A LTH SYS TE M Under the model, more than 1000 interventions were carried out by the community pharmacist over a nine-month period. From the pilot, it was demonstrated that every four minutes of pharmacist time saves approximately two minutes of GP time, whilst also improving quality. For every day of dedicated community pharmacist support for general practice, one whole session of GP clinical time is created, meaning an additional 25 patients can see their GP every week.

Figure 3. R E A DY R E C KO N E R : I M PAC T O F O N E DAY ( E I G HT H O U R S) O F D E D I C ATE D CO M M U N IT Y P H A R M ACY S U P P O R T FO R G E N E R A L P R AC TI C E E AC H W E E K

P I LOT

ENGLAND

Interventions per • 3 062 interventions could annum (per day of be undertaken by the community pharmacy community pharmacy team support/ week)

• 3 5.2m interventions per annum based on one day of community pharmacy support per week (11,500 pharmacies)

GP capacity released

• 0.178 WTE GPs/practice

• 1213 WTE GPs • 9 .45% of GP appointment capacity across England • 18 million appointments per annum

A&E attendances

• Down 7.5%

• 1.154m attendances saved annually

“ There are currently 11,500 community pharmacists and this evaluation demonstrates that if every pharmacy was to provide just one day of clinical support to general practice each week, it would release in excess of 18 million GP appointments per year” M AG A ZI N E | D ECEM B ER 2018 | 2 7

F E AT U R E

KEY CONCLUSIONS SMALL STEPS CAN MAKE A BIG DIFFERENCE Operational integration between community pharmacy and general practice can be delivered through existing IT capabilities, supported by a template Memorandum of Understanding to govern data sharing between practices and pharmacies and a shared care arrangement. This is possible without the need for legal or structural integration. The evaluation of the pilot established that: • Read-write access to GP clinical systems is already feasible within a community pharmacy setting, and adds significant value • There is real potential in using community pharmacy differently – to explicitly support general practice, and to provide better and more integrated care for patients • The availability of routine access to the GP clinical system is the key enabler to unlocking the potential of community pharmacy to deliver more advanced and holistic clinical care in a different setting.

INTEGRATING PRIMARY CARE UNDER A SINGLE PURPOSE The evaluation details no service specifications, because there are none. The modus operandi is integrated care because ultimately an holistic approach is the best for the patient and, in the long term, for the health service. Through alignment of priorities, sharing of information and respect for the skills and clinical competence of the community pharmacy team, there is a real opportunity for primary care to come together almost as a single organisation with a single purpose. CHANGING PATIENT BEHAVIOURS A notable feature of the Jaunty Springs integrated care model is that the vast majority of the interventions were made from the community pharmacy consultation room, rather than on the premises of the GP practice, with patients being booked directly to see the community pharmacist in the community pharmacy. For the GPs and community pharmacists involved that has been key in changing patient behaviours in terms of how they access core services. Above all, it’s been great for patients in the area, who have benefited from the improved access to medicines support. We have adopted the successful principle that any patient that could be well managed by the community pharmacist should be referred there to reduce practice workload, improve the patient experience and encourage positive patient attitudes towards self-care. WHERE COULD PHARMA PLAY A PART? Given that such a programme is critical for the future sustainability for the NHS, industry partners could work with their existing contacts in primary care and community settings to enable a different type of service model in this space.

Figure 4. P OTE NTIAL J O I NT WO R K I N G O F F E R I N TH E I NTE G R ATE D PR I MARY C AR E S PAC E

CLINICAL

C O R P O R AT E

COMMERCIAL

 Enabling self-activation  Therapies optimisation  Case finding and cohorting Enabling real world  evidence and research across whole systems  Developing core and extended clinical skills  Developing an integrated clinical model based on local need

 Media and engagement  Developing a new workforce model  Maximising efficiency through pathway and service mapping  Data integration and exchange  Governance and process  Business case and proposals

 Outcomes-based contracting  Pump priming of technology and new innovations  Delivery partnerships  Cost frameworks  Developing risk and gain share models  Enabling business to business relationships across the primary care interface

T R A N S FO R M

ENABLE

T R A N S AC T

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

This is a credible area where industry could act as the catalyst for change in health economies and transition from a supplier of a product to an innovation and service development partner. This is critical for the sustainability of the NHS, and pharma can play a real part in impacting on it as well as helping to sustain key parts of their existing supply chain (general practice and community pharmacy) and unite under the common purpose of sustainability. James Roach is Director of Conclusio Limited. Email jamesprroach@yahoo.co.uk

ADVERTORIAL

“We have noted that 60 to 70% of symptoms will improve when simple measures are addressed”

WORDS BY

Sally Sheppard

BOWEL MANAGEMENT – HOW TO HELP: Biofeedback may be helpful if first line measures have not worked

here are two broad categories of bowel symptoms, once red flags have been excluded; not going (constipation or obstructive defaecation) and not being able to stop going (faecal incontinence). First line conservative care can be offered by any health care professional (HCP), from primary care practice nurse, GP, or pharmacist, to specialist teams comprising colorectal surgeons, gastroenterologists, bowel nurses and pelvic floor physiotherapists. Essential first responses often include possible medication or diet causes, contributing mobility or pre-existing bowel habits, previous surgery or life changes. We have noted that 60 to 70% of symptoms will improve when simple measures such as diet, fluids, and technique and position for evacuation are addressed. This is often the stage at which proper laxative use can be guided, or loperamide use (to slow down rather than stop) can be outlined depending on whether constipation or incontinence is an issue. These first line measures are very cost effective when delivered by the first clinician the patient sought help from.

SPE C I A L IST C A R E Once onward referral is indicated and the patient attends for specialist care – for example with a specialist physiotherapist or nurse – management may include: • Use of a bowel diary • Assessment of obstetric trauma • Pelvic floor power and strengthening exercises • Splinting options for a rectocele • Handheld rectal irrigation • Consideration of possible internal rectal prolapse and concurrent bladder symptoms addressed. For a small group of patients, bio-feedback may be offered as a specialist management.

BIO - F E E DB AC K The phrase bio-feedback is used very broadly – a careful rectal examination that encourages correct functional use of the muscles both for contracting and relaxing during strain is actually a form of bio-feedback. The patient will be actively engaged and through language, verbal feedback, repetition and communication this can re-train and re-educate. The shared goal would be for the patient to put

into practice what they have learned and begin to see symptom improvement. Sometimes the muscles that need retraining are inherently over active and it is a harder challenge to teach the process of ‘letting go’. Specialist therapists and nurses may offer a handheld device to indicate the muscle activity visually and facilitate the process of learning to let go. This may be through an electromyography unit or pressure sensitive manometry. Other techniques may include training awareness of the whole zone around the pelvis and practising letting go via diaphragm, deep core muscles and pelvic floor. This harnesses the patient’s own awareness and does not require an external machine to illustrate the result. There may be a need to reduce the sensitivity within the rectum and allow it to fill without great urgency. This usually requires use of the pelvic floor muscles to trigger a delay, or a holding on sensation. This technique can be adopted by the patient during real bowel urgency at home and sometimes it is practised in the form of rectal balloon catheters with or without visual feedback. There are some centres that offer a series of repeated sessions using balloon catheters to help to re-educate release work of the muscles during expulsion and hold ability during filling. Generally, any management option should be patient-centred and the effect reviewed regularly. Clinical experience shows us that for some patients, improvement is rapid, patient goals are met quickly and self-management achieved early. For others, repetition is needed and if progress is not achieved a review of the approach or escalation into a multidisciplinary team case review is indicated. Sally Sheppard is Team Lead Women’s and Men’s Health Physiotherapy Service, Poole Hospital NHS Foundation Trust. Go to www.bowelinterestgroup.co.uk

M AG A ZI N E | D ECEM B ER 2018 | 2 9

P H A R M ATA L E N T

I LOVE MY JOB BECAUSE … INTERVIEW BY

Amy Schofield

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

Sandy Lindsey, National Implementation Lead Manager, Vaccines, MSD, joint winner of the Account Project Pf Award 2018, on how her role is really all about the people.

“I NEVER GET BORED AND THERE ARE ALWAYS NEW CHALLENGES!”

… E V E RY DAY I S V E RY DI F F E R E N T , from helping shape our future strategies, engaging with our key stakeholders, meeting with my team and everything in between. This is why I do this job, as I never get bored and there are always new challenges! I’m pretty sure there is no job with a typical day, and if there is keep it away from me!

… I T ’ S A L L A B OU T T H E PE OPL E . …IT H AS TO BE S OM E T H I NG I B E L I E V E I N, T H AT MO T I VAT E S M E A N D I A L S O E NJOY, O T H E RW I SE W H Y D O I T ? Working within a franchise that focuses on prevention of diseases and public health through our vaccines (in the UK alone, last year we reached over two million people through our vaccines) and the provision of women’s health products, our goal is to help shape population health in the UK and to support the NHS to help every child, woman and man to have a healthier future. This is achieved through a variety of programmes and initiatives that helps ensure that those that are eligible to receive a vaccine can make an informed choice on vaccinations. In this respect we are truly ‘Inventing for Life’.

Not only about the people I work with (who are awesome) but all of the people, the UK population.

… I T ’ S I M P OR TA N T T O M E T O D O W H AT I D O. My job is about population health, and it’s my job to make sure that prevention is as important as treatment when it comes to healthcare – as they say prevention is better than cure, it really is.

… I F E E L E X T R E M E LY PROU D T O H AV E WON T H E AC COU N T PROJ E C T AWA R D AT PF AWA R D S 2 018 . I’m especially proud of my team member Priyanka Trehan, who was central to the success of the work presented as part of the Pf Awards. We definitely had smiles on our faces.

… M SD OF F E R S M A N Y OPP OR T U N I T I E S T H ROUG H C A R E E R PRO G R E S SION, S O CI A L A N D O T H E R N E T WOR K S . For professional development this includes mentoring, stretch assignments, secondment opportunities, leadership and manager acceleration programmes. We also have many different networks as part of our Global Diversity and Inclusion Centre of Excellence, including the newly set up Next Generation Network, The Women’s Network and many more. MSD is a global company so there are also opportunities to live and work abroad.

… I L OV E T O V I SI T DIFFERENT PLACES, INSIDE A N D OU T SI DE T H E U K . I love all seasons of the year, so I am a keen snowboarder during the winter and love to go on sunshine holidays during the summer. I am also a regular at the gym which helps keep my energy levels up and also allows me to enjoy my food.

“PREVENTION IS AS IMPORTANT AS TREATMENT WHEN IT COMES TO HEALTHCARE”

Specialists in Bespoke Contract Sales Teams and Outsourcing

…T H E E XCI T I NG T H I NG A B OU T M Y C A R E E R I S T H AT YOU N E V E R K NOW W H AT ’ S J US T A ROU N D T H E COR N E R . I regularly get asked “What do you want to be (when you grow up)?” but I find this a hard question to answer as the landscape of healthcare is so fluid. I am particularly excited about digital transformation and what part that will play for pharma, the healthcare industry and population health.

MSD’s ‘What gets me out of bed in the morning?’ campaign can be found at msd-uk.com @MSDintheUK Sandy’s winner’s interview at the Pf Awards 2018 is available online. Go to www.pfawards.co.uk /winners-interviews-2018

M AG A ZI N E | D ECEM B ER 2018 | 3 1

A connected career

Declan Cassells is Managing Director of Renew Health. He shares his insights on the changing healthcare landscape, technological innovations and connected health.

hat do you do, and how did your career path lead you to where you are today? Ireland is known as one of the key medtech hubs globally and so, as an engineering graduate, it was a logical place to start my career. I found it a dynamic and challenging environment, which I thoroughly enjoyed, so I decided to continue my career within this industry. Over the last 20 years, I have led a series of international expansion projects setting-up new manufacturing operations, engineering

facilities, research and development and distribution channels for multinational companies including Medtronic, Conor Medsystems, Kinetic Concepts and American Medical Systems. Since 2014, I have been the Managing Director of Renew Health, responsible for overseeing operations, distribution, marketing, sales and the strategic commercial direction of the business. What I really enjoy is the variety of work my role offers. It is also heartening that we make products that have a hugely positive benefit to people’s lives – be that a product to detect and diagnose a medical issue or a device that can treat an otherwise debilitating condition. How do you meet the challenges of today’s shifting healthcare landscape? While we work in a highly regulated industry, I believe

Renew Health Limited – the connected health medtech company committed to delivering exciting medical technologies to patients and communities worldwide. www.renewhealthlimited.com | +353 90 646 5460

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

ADVERTORIAL

“The crossover between lifestyle and medicine is becoming more unified and connected health is the driving force that I believe will change the healthcare system from being reactive to proactive”

it is important to create a very agile company environment that can respond quickly to changes within the industry and importantly, our customers’ needs. Our founder has a motto and one that I try and live by: ‘Think Big, Keep it Simple and Make it Happen’. Tell us more about the innovations that you’re developing, particularly Renew ECP Therapy, and how it benefits patients. Renew Health is committed to improving the quality of life of individuals with cardiovascular disease, especially those suffering from angina. We have an impressive portfolio of products and one of the most exciting ones is Renew External Counterpulsation (ECP) Therapy. Cardiovascular disease is a system-wide chronic illness that results in a weakened circulation, with damaged arteries and blood vessels inhibiting effective blood flow to the brain, heart and organs in the body. Renew ECP Therapy is a non-invasive treatment that improves blood circulation, resulting in better cardiovascular health, and improved overall health, as good circulation aids the body’s delivery of oxygen, nutrients, and other materials that cells need to support, repair and protect the body. We are currently investing in a global research programme examining the impact of ECP on wider health benefits including sports recovery and preventative healthcare. Plus, we have the Zensor™ device. What does ‘connected health’ mean to you? The crossover between lifestyle and medicine is becoming more unified and connected health is the driving force that I believe will change the healthcare system from being reactive to proactive. Connected

health not only helps health organisations run more efficiently but it can improve patient outcomes through developing technology that can diagnose, manage and connect with patients with long-term conditions, and even prevent people from getting these conditions in the first place. The real benefit of connected health is about empowering people to take an active role in their own healthcare while being offered the best possible services available. Renew Health has recently launched innovative connected health products aimed at the cardiology sector. Both these products, Zensor™ and UltraLinq, have been designed to reduce healthcare costs, streamline workflow and improve patients’ outcomes. What have been your key milestones and achievements? I am most proud of the business I have helped build with the great support of the team at Renew Health. When I joined in 2014, there were only four people in the European office. Now we have almost 100 staff across Europe and the US and four products in the market. I am very fortunate to have a team that strives every day to make a difference to people’s lives. I am particularly proud of the fact that the team is so open to change. In a business that is growing and developing so quickly, being able to facilitate and thrive in an environment that continually moves and changes is vital. What motivates you? No two days are the same at Renew Health. With such a demanding schedule and extensive international travel, it is easy to pay less attention to the team around you. I am motivated by developing the team I have around me and I set aside time regularly to help make sure that the right resources are dedicated to the right tasks, and in prioritising the most important projects. What does the future hold for you, and Renew Health? Renew Health has already demonstrated substantial growth in a relatively short time and we expect this rate of growth to continue in the future. It will predominantly focus on developing sales channels throughout Europe combined with expanding our healthcare portfolio. This planned growth will bring many challenges to the organisation and I am confident the team will work together and embrace them. Go to www.renewhealthlimited.com

ZENSOR™ FOR CARDIAC ARRYTHMIAS With Renew Health’s acquisition of the Intelesens business, the award winning medtech company acquired a unique product, the Zensor™ device, an intelligent, wireless device for patient cardiac monitoring. Since its inception in 2014, Renew Health has rapidly evolved, fully establishing itself as a connected health company with a diverse portfolio, ranging from its enhanced blood circulation device, Renew ECP Therapy, through to its cloud-based reporting and exam management system, UltraLinq. One of the most recent products to be launched in the Renew Health portfolio is the Zensor™ device, which is the world’s first Wi-Fi enabled, three-lead, 14-day continuous ECG and remote event monitor for the detection of cardiac arrhythmias, including atrial fibrillation (AF).1 The Zensor™ device is built on a robust technology platform that incorporates proprietary world-class high sensitivity arrhythmia and respiratory algorithms and software developed in collaboration with research and clinical partners. This type of technology is increasingly used to improve patient care, streamline staff workflow, and help deliver significant longterm healthcare savings. Full regulatory approval for the Zensor™ device has been achieved in both the EU and USA. 1 Wyndham CRC. Atrial fibrillation. The most common arrhythmia. Tex Heart Inst J. 2000;27:257–267

M AG A ZI N E | D ECEM B ER 2018 | 3 3

P H A R M ATA L E N T

MOVERS & SHAKERS

H E A LT H C A R E

TO M H E Y M A N Tom Heyman will join the International Biomedical Research Alliance’s Board of Directors. Heyman is currently the President of the Johnson & Johnson Development Corporation and leads the J&J Venture Capital Group.

WORDS BY

Hannah Alderton

3 4 | PH A R M A FI EL D.CO.U K

JA S O N M C K E N N A STEM Healthcare has welcomed Jason McKenna as its new Chief Executive Officer. Jason has been with STEM since 2010, he previously worked at AstraZeneca. Rob Wood, President of Advisory Services said: “Jason founded STEM in the US and Brazil and has been a Board Member for the last six years. He’ll bring continuity to our business, so clients can be confident that STEM will go from strength to strength.”

H E A LT H C A R E

K ATE L A N C A S TE R The Royal College of Obstetricians and Gynaecologists (RCOG) welcomes a new chief executive. Kate Lancaster is the Director of Strategy for an NHS trust in Hertfordshire where she oversees development of strategy across four hospitals. RCOG President, Professor Lesley Regan said: “We are stepping up our focus on developing women’s health strategy and Kate will be a lynchpin in driving forward major change.”

AG E N CY

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

AG E N CY

H E A LT H C A R E

NICK BRUCE

J E A N E T TE K U S E L

MAP BioPharma has brought on Nick Bruce to enhance its market access capabilities. Nick Bruce was the Director of Value Access and Policy at Amgen UK. Nick will oversee MAP’s general market access consulting offering and will work closely with the health economics and outcomes research team.

Jeanette Kusel has been appointed as the Director for NICE Scientific Advice at the National Institute for Health and Care Excellence (NICE). She brings with her 10 years of consultancy experience in the health technology evaluation field and a firm knowledge of the life sciences industry.

PHARMA .

M A R I A E K L I N D - C E RV E N K A Maria Eklind-Cervenka is Inceptua’s new Chief Medical Officer. Maria has experience steering international teams from her previous roles at Sobi, AstraZeneca and BoehringerIngelheim. Maria specialises in cardiology and internal medicine. Her role will focus on supporting Inceptua’s Commercial Products unit as it expands into new markets and therapy areas.

PHARMA

A N D R E W W R I G HT Andrew Wright has been appointed as Financial Controller and Company Secretary of Hemogenyx. Andrew is also an Executive Director at Trayned Insight Ltd, a data science company serving the healthcare and pharmaceutical industries.

When curiosity takes precedence at school, it’s not just lessons that get more exciting. At Bayer we support young people in discovering the joys of research – and maybe developing a passion for applying science to tackle the societal challenges of our day and age. Just as Bayer employees are doing worldwide. That’s why we sponsor innovative scientific projects all over the world through the Baylab school laboratories in various countries, the Bayer School Support Program and the “Making Science Make Sense” initiative. www.bayer.co.uk

PHARMA

P H I L I P P E BA S TI D E Phillippe Bastide brings his 25 years of experience in the pharma industry with him to Mundipharma as its new Head of Biosimilars. Phillippe’s career consists of over five years of biosimilar experience with both Amgen and Shire, in both European and Global commercial roles.

Curiosity

PHARMA

CRAIG BRADLEY Shire has appointed Craig Bradley as Product & Business Lead for Internal Medicine across the UK and Ireland. He was previously Brand Manager within Internal Medicine. Bradley, the only Chair from a pharmaceutical company in the PM Society’s history, is now responsible for Shire’s Internal Medicine portfolio, which consists of both launch and mature brands.

AG E N CY

JEZ MOULDING As Pharmaspectra takes a new direction to drive growth it has appointed Jez Moulding to be its new Chief Executive. Jez is a former Sanofi employee and was the Executive Vice President of Ashfield. He brings to the role 25 years of experience in the pharma industry.

PP-OTH-UK-0026-1 October 2018

M AG A ZI N E | D ECEM B ER 2018 | 3 5

P H A R M ATA L E N T

WORDS BY

Amy Schofield

H OW T O S U C C E E D A S A

KEY ACCOUNT MANAGER Pf asked two consultants from top pharma recruitment consultancies for their views on what it takes to be a successful key account manager. A N DY B OY D| Senior Recruitment Consultant, Evolve

ROL E & R E SP ONSI BI L I T I E S The responsibilities of a key account manager (KAM) vary widely, depending on the structure of an organisation. However, in all cases, the focus lies in building relationships with key customers who will influence the prescribing or use of a particular product. This requires a tailored approach to suit the type of customer. KAMs are ultimately responsible for building trust with all influential customers and in turn, increasing profitability and revenue for a product.

W H AT R E C RU I T E R S LO OK FOR There are various factors that recruiters look for when sourcing KAM level candidates. Having experience and examples of partnering with a range of NHS customers, that can be accessed easily, will stand out against the competition. Along with this, examples of specific key successes in previous KAM roles are essential to ensure a successful application. Key account managers need to be exceptional relationship builders and have the ability to manage relationships on an ongoing basis.

DE SI R A BL E PE R SONA L I T Y T R A I T S Having the ability to work autonomously is an essential factor when applying for KAM opportunities. The ability to think laterally and outside of the box is important to identify opportunities within accounts, as well as having a driven mentality to achieve required results. The best KAMs are able to build, manage and maintain relationships with key stakeholders.

3 6 | PH A R M A FI EL D.CO.U K

Time management and strong communication skills are imperative to effectively manage accounts and to ensure that the correct brand-specific message is being portrayed to the right customers.

STAR’S TOP 5 SKILLS FOR BEING A SUCCESSFUL KAM

M A R I E E N T W IST L E | Northern Business Unit Manager, Star

Solutions-focused

T H E K A M ’ S ROL E The role of a KAM is to develop and implement business plans that deliver the sales and uptake of a drug, or portfolio of drugs, across a designated group of key accounts or regions – with a bit of brand management, advocate development and budget management thrown in! They also need to be experts in their local NHS area and, of course, comply with the ABPI Code of Practice.

Sales ability/ influencing skills

SK I L L S & E X PE R I E NC E The very best KAMs are committed, driven to succeed, naturally intuitive, proud of what they do, patient-focused, and will have a healthy dose of competitiveness in them to be able to perform at their peak in what can be a testing environment. As healthcare continues to evolve, top KAMs also need to be able to see the bigger picture, be great networkers, and think strategically to make a real impact. When it comes to finding that perfect candidate, we at Star look for people who can sell, are able to manage an account at all levels, have a real understanding of their customers’ challenges and can find ways to overcome barriers, and who have a real interest in their therapy area. Go to www.evolveselection.co.uk Go to www.starmedical.co.uk

Commercial awareness

Business planning

Relationship building

Mylan is dedicated to creating better health for a better world. One person at a time. Providing medicine to you and your family isn’t our job. It’s our mission. Learn more at mylan.co.uk

NON-2018-0854 – DOP: June 2018

Flexible recruitment solutions Whether you’re looking for brand exposure, or to post multiple roles – we’ve got the package for you. Getting up and running is easy – get in touch on 01462 476119 or hello@pharmafield.co.uk to discuss your online recruitment strategy.

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