Pf Magazine August 2020 by E4H Ltd

Pharma on the

FRONTLINE “ I was back on the frontline, along with doctors and nurses from all around the hospital who had been redeployed to the ICU”

Page 10

AUGUST 2020 COVID-19 & clinical research ABPI & promotional emails Coronavirus & customer engagement PHARMAFIELD.CO.UK

CO M I N G U P I N TH E N E X T

PF MAG A Z I N E S PECIAL E D ITI O N:

RECRUITMENT & CAREERS Shaping your career now and into the future

M A K E YO U R VO I C E H E A R D

Our Pf Magazine Special Editions cover the issues at the heart of the pharmaceutical environment, including expert comment and analysis from industry insiders.

Our next issue will be the Pf Special Edition on recruitment and careers. If you would like to be involved, submit a thought leadership, share a case study, or promote to our readers, contact hello@pharmafield.co.uk.

HEAD OF CONTENT

Hello.

elcome to the August issue of Pf. COVID-19 is still changing the world in ways we could never imagine six months ago. We wanted to acknowledge the role of the pharmaceutical industry in the coronavirus pandemic response. We know that industry has a lot to offer at this critical time and are delighted to be able to showcase some great examples of industry stepping up for the NHS, society and the world. Our cover story, COVID-19: Pharma on the frontline, shines a light on some of this work. This is just a selection of the great work that is happening, there is so much more that industry is doing, we could’ve filled the whole magazine, which is a wonderful testament to pharma. Obviously COVID-19 still dominates the news, and our features reflect that, too. In regulars, our NHS column focuses on the impact of coronavirus on NHS customer engagement. Politics explores the impact of the pandemic on health technology assessments and what the future may bring. Our ABPI column considers the ABPI Code of Practice and promotional emails, and Pharmacy discusses how COVID has accelerated electronic prescribing. Our features offer a mix of topics. Dr Matthew Hallsworth from the National Institute for Health Research explains how COVID-19 has brought about rapid change of clinical research and what needs to be done to embed some of those developments into future ways of working. Mehrnaz Campbell sets out her six steps to customer stakeholder mapping with practical tips to apply when developing your stakeholder maps. For those involved in brand planning, Mike Williams shares his top tips for reviewing a brand plan to reduce risk and improve performance. Johnny Skillicorn-Aston and Jeremy Hooper then look at the lasting effects of COVID-19 on the population and health systems. We also have psoriasis therapy, engaging with healthcare professionals, a Pf Awards winner interview, and how COVID-19 is changing pharma careers. I hope you enjoy this issue. On a separate note, this will be my last issue of Pf as I am moving into a role with our parent company, E4H. This is an exciting time for Pf. The team we will be making some changes as the year progresses, ready to see in 2021 with a bang. Thank you for making these last two years incredibly enjoyable. Stay safe.

Emma Morriss emma.morriss@pharmafield.co.uk SENIOR EDITOR

Amy Schofield amy@pharmafield.co.uk CREATIVE DIRECTOR

Emma Warfield emma@pharmafield.co.uk GRAPHIC DESIGNER

Olivia Cummins olivia@pharmafield.co.uk COMMERCIAL DIRECTOR

Hazel Lodge hazel@pharmafield.co.uk ACCOUNT MANAGER

Emma Hedges emma.hedges@pharmafield.co.uk NEWS DESK

Hannah Alderton newsdesk@pharmafield.co.uk FINANCIAL CONTROLLER

Fiona Beard finance@e4h.co.uk Pf AWARDS

Melanie Hamer melanie@e4h.co.uk PUBLISHER

Karl Hamer karl@e4h.co.uk HEAD OFFICE

3 Waterloo Farm Courtyard, Stotfold Road Arlesey, Bedfordshire SG15 6XP United Kingdom www.pharmafield.co.uk www.e4h.co.uk ADVERTISING

The content of and information contained in this magazine are the opinions of the contributors and/or the authors of such content and/or information. Events4Healthcare accepts no responsibility or liability for any loss, cost, claim or expense arising from any reliance on such content or information. Users should independently verify such content or information before relying on it. The Publisher (Events4Healthcare) and its Directors shall not be responsible for any errors, omissions or inaccuracies within the publication, or within other sources that are referred to within the magazine. The Publisher provides the features and advertisements on an ‘as is’ basis, without warranties of any kind, either express or implied, including but not limited to implied warranties of merchantability or fi tness for a particular purpose, other than those warranties that are implied by and capable of exclusion, restriction, or modification under the laws applicable to this agreement. No copying, distribution, adaptation, extraction, reutilisation or other exploitation (whether in electronic or other format and whether for commercial or non-commercial purposes) may take place except with the express permission of the Publisher and the copyright owner (if other than the Publisher). The information contained in this magazine and/or any accompanying brochure is intended for sales and marketing professionals within the healthcare industry, and not the medical profession or the general public.

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M AG A ZI N E | AU G U S T 2020 | 1

August 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

Contributors

@pharmafield

@pharmajobsuk

Pf Magazine

CLAUDIA RUBIN

MICK O’LEARY

MIKE WILLIAMS

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. Health Technology Assessment Post-COVID, page 16.

Mick is Regional President for Ashfield Commercial and Patient Solutions across North Europe. He is responsible for building and executing the strategy for Ashfield’s Commercial and Patient Solutions divisions across the UK, Ireland, Nordics and Benelux. Engaging with HCPs, page 24.

Mike has been reviewing pharmaceutical brand plans for almost 20 years. His company, MiraVeta, offers brand plan audits with industry benchmarks. How to review a brand plan, page 26.

DR RINA NEWTON

Johnny is Engagement and Communications Director at Conclusio Ltd. He has nearly a quarter of a century of experience of developing and delivering communication strategies within the public and private sectors and within civil society organisations. Lasting effects of COVID-19, page 28.

DEBORAH EVANS

Deborah is Managing Director of Pharmacy Complete, a training and consultancy company working with pharmacy and the industry. Accelerating electronic prescribing through COVID-19, page 25.

Rina is Managing Director of CompliMed, experts on the ABPI Code. CompliMed supports any activity that results in better engagement with the ABPI Code, transparency and consistency in PMCPA case rulings and improvements in self-regulation. ABPI Code and promotional emails, page 18.

JOHNNY SKILLICORN-ASTON

In this issue

JEREMY HOOPER

Jeremy is Health Economics and Intelligence Consultant at Conclusio Ltd. He has worked on the analysis of large and complex data sets in the defence and health sectors for over 25 years. Jeremy has supported evaluation and performance reporting helping public sector organisations to understand their performance and how that can be used to improve outcomes for the organisation and patients. Lasting effects of COVID-19, page 28. OLI HUDSON

Oli is Content Director for Wilmington Healthcare. He oversees material for training and education, consultancy services, network meetings, thought leadership, events and webinars. In previous roles at the company, he has worked with the NHS and industry on a wide range of training, access, collaboration and partnership projects. Once in a generation opportunity, page 15. MEHRNAZ CAMPBELL

Mehrnaz is Founding Director of Cheemia. She has extensive experience in customer engagement, developing joint working partnership with NHS and securing National Commercial Agreements. She has a hands-on approach in conducting market analysis believing that the gold nuggets found during the analysis are the key elements for developing winning strategies. Six steps to customer stakeholder mapping, page 22. DR MATTHEW HALLSWORTH

Matthew is Head of External Relations at the NIHR’s Office for Clinical Research Infrastructure and leads on external stakeholder relations, including engagement with the pharmaceutical industry. Rapid change: COVID-19 and UK clinical research, page 20.

NEWS

ADVERTORIAL

Bringing you the essential headlines

Engaging with HCPs

COVER STORY

PHARMACY

COVID-19: Pharma on the frontline

Accelerating electronic prescribing through COVID-19

INSIDE NHS

FEATURE

Coronavirus and NHS customer engagement

How to review a brand plan

POLITICS

FEATURE

Health Technology Assessment Post-COVID

Lasting effects of COVID-19

ABPI

THERAPY

ABPI Code and promotional emails

Getting under the skin of psoriasis

FEATURE

PF AWARDS

COVID-19 and UK clinical research

Pf Award Winner, Jo Kemp, is driven to win

FEATURE

MOVERS & SHAKERS

Six steps to customer stakeholder mapping

Who’s moving where in the industry?

“After a short local induction, I was back on the frontline”

CAREERS

George Godfrey, page 10

COVID-19: changing the pharma workforce

QUICK DOSES JOHNSON & JOHNSON has announced that the European Commission (EC) has granted Marketing Authorisation for JA N S S E N ’ S preventive Ebola vaccine. This marks the first major regulatory approval of a vaccine developed by JA N S S E N . • N I C E has issued draft guidance for public consultation which does not recommend N OVA RTI S ’ Mayzent (siponimod) for treating secondary progressive MS. • Entrectinib, R O C H E ’ S Rozlytrek®, a revolutionary treatment for a range of cancers, is the second histology independent drug to be recommended by N I C E for use on the Cancer Drugs Fund. The final draft decision is set to benefit adults and children 12 years and older, with advanced NTRK fusion-positive solid tumours, who have no satisfactory treatment options. • K ITE has received approval to implement a variation to the Yescarta® (axicabtagene ciloleucel) Marketing Authorisation from the European Medicines Agency for end-to-end manufacturing. • The E C has given regulatory approval for the first adjuvanted quadrivalent influenza vaccine to become available across Europe. The new adjuvanted quadrivalent vaccine will be manufactured by S E Q I R U S. • SA N O F I has announced that the E C has authorised Sarclisa® (isatuximab) for use in combination with existing standard of care treatment (pomalidomide and low-dose dexamethasone, or pom-dex) in adults with relapsed/ refractory multiple myeloma.

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NHS

MICROSOFT DEAL

n agreement struck between NHSX, NHS Digital and Microsoft will enable all eligible organisations in England to access Microsoft 365 digital tools. The agreement will improve productivity, enhance collaboration and strengthen cyber security across healthcare services. As part of the agreement, Microsoft 365 will be deployed to as many as 1.2 million staff across NHS organisations, including Trusts, clinical commissioning groups and health informatics services. GPs, consultants, nurses, therapists, paramedics and support staff will have access to services within Microsoft 365, ensuring they are able to use tools such as Microsoft Teams, which will enable staff to collaborate more effectively through instant messaging, audio and video calls. Pf View: With healthcare professionals less likely to hold face to face meetings in a COVID/post-COVID world, the roll out of Microsoft 365 tools across the NHS should help to facilitate digital communications in the new normal.

Pf IN NUMBERS

£25,000

P f N E W S : B R I N G I N G YO U T H E E S S EN T I A L H E A D L I N E S

HIV

Health inequalities A new online tool has been launched which pinpoints HIV health inequalities in England. It is hoped it will improve prevention and planning. The rate of late HIV diagnosis, which is associated with a tenfold increase in mortality, varies from 25% to 69% across England. The new, webbased interactive tool, using the latest HIV surveillance data from Public Health England, has been launched by HIV information charity NAM aidsmap, in partnership with Watipa and Gilead Sciences Ltd. The charity hopes that the tool, HIV Lens, will lead to improved HIV outcomes for all communities and populations in England and help put an end to health inequalities within HIV. HIV Lens has been developed to help maintain the progress made against HIV in England. It visualises the impact of the HIV epidemic on communities, in a bid to help improve prevention programmes and to focus commissioning efforts.

HAS BEEN RAISED BY KIT4CARERS FOR SOCIAL CARE PPE COVID-19: Pharma on the frontline, p10

CANCER

Sensitive blood test

new cancer blood test to analyse patients’ blood for evidence of the disease could be up to ten times more sensitive than previous methods, according to new research funded by Cancer Research UK and published in Science Translational Medicine. In the coming years this method, and others based on this approach, could lead to tests that more accurately determine if a patient is likely to relapse after having treatment and could pave the way for the development of pinprick home blood tests to monitor patients. The technique uses personalised genetic testing of a patient’s tumour to search blood samples for hundreds of different genetic mutations in circulating tumour DNA (ctDNA); DNA released by cancer cells into the bloodstream. Combined with new methods to analyse this data to remove background noise and enhance the signal, the team were able to reach a level of sensitivity that in some cases could find one mutant DNA molecule amongst a million pieces of DNA – approximately ten times more sensitive than previous methods.

CLINICAL TRIALS

PATIENT RECRUITMENT NHS patients will benefit from easier access to clinical research opportunities, following a £7m government investment to launch five new regional Patient Recruitment Centres across England. The centres are distributed across the country to provide opportunities for patients in regions across England who may not previously have been able to take part in clinical studies. During the ongoing coronavirus pandemic, the new centres will also increase opportunities for patients to access trials assessing the latest potential treatments against COVID-19; in addition to trials across all other healthcare specialties. The centres will be managed by the National Institute for Health Research and run by NHS trusts. They will provide dedicated space, purpose-designed facilities and medical expertise to deliver clinical research within NHS hospital sites, with the aim of increasing the number of studies being run across England.

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COVID-19.

RECOVERY PARTNERSHIP

elltrion Healthcare is partnering with the University of Oxford and University Hospitals Birmingham to study the use of CT-P13 (biosimilar infliximab) to accelerate COVID-19 recovery. CT-P13 is being trialled to understand if it could accelerate the recovery of people with COVID-19 symptoms. Severe COVID-19 is associated with a major immune inflammatory response and therefore therapies that have the potential to target this could be used as a treatment for COVID-19. Infliximab is an anti-TNF therapy that is designed to attach to TNF, a protein important in inflammation, and is currently used as a treatment for other inflammatory conditions.

HEALTH

First do no harm The Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege, has published its report. Titled First Do No Harm, it comes after a two-year review of harrowing patient testimony and a large volume of other evidence concerning three medical interventions: Primodos, sodium valproate and pelvic mesh. First Do No Harm sets out nine major recommendations to bring muchneeded help and support to those who have suffered as a result of these interventions, and to reduce the risk of avoidable harm from medicines and medical devices in the future. Pf View: This important report draws on the testimony of over 700 people, mostly women, who have had their lives impacted by these three medical interventions. We hope that the learning and key recommendations will be adopted to improve people’s lives and ensure that the healthcare system is safe for all who access it.

Pf IN NUMBERS ALZHEIMER’S DISEASE

PATHOGEN RECOGNITION Researchers have found a way to design an antibody that can recognise Alzheimer’s disease pathogens. It can identify the toxic particles that destroy healthy brain cells making it a potential advance in the fight against Alzheimer’s disease. Their method is able to recognise these toxic particles, known as amyloid-beta oligomers, which are the hallmark of the disease, leading to hope that new diagnostic methods can be developed for Alzheimer’s disease and other forms of dementia. The team, from the University of Cambridge, University College London and Lund University, designed an antibody which is highly accurate at detecting toxic oligomers and quantifying their numbers. The results of their research on the antibody designed to recognise Alzheimer’s disease pathogens are reported in the Proceedings of the National Academy of Sciences.

PSORIASIS AFFECTS

APPROXIMATELY

1.8 MILLION PEOPLE IN THE UK Under the skin, p30

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P f N E W S : B R I N G I N G YO U T H E E S S EN T I A L H E A D L I N E S

COVID-19

Improved survival

COVID-19

LONG TERM EFFECTS

he Health and Social Care Secretary has announced the launch of a major £8.4m research study into the long-term health effects of COVID-19 on hospitalised patients, which has been funded by the NIHR and UK Research and Innovation. The researchers hope their findings will support the search for treatments for COVID-19 and the development of care pathways that will help patients recover as fully as possible after having experienced the disease. The Post-Hospitalisation COVID-19 Study (PHOSP-COVID), led by the NIHR Leicester Biomedical Research Centre, will draw on expertise from a consortium of leading researchers and doctors from across the UK to assess the impact of COVID-19 on patient health and recovery. This includes looking at possible ways to help improve the mental health of patients hospitalised with coronavirus, and how individual characteristics influence recovery, such as gender or ethnicity. Pf View: As so little is known about the impact of COVID-19 and we are learning all the time, this study is welcome news for understanding the health issues experienced by people who have been hospitalised with the disease.

COVID-19

FINANCIAL BACKING Medical research charity, LifeArc is providing £10m for clinical trials to find effective COVID-19 therapies. All 15 projects – involving nearly 30 different organisations – were selected for their ability to rapidly start trials in patients and the likelihood of success. The trials involve medicines that are approved for use in other indications or those in late-stage development with known mechanism of action. This re-purposing approach, where the drug is known to have a target that could be relevant to COVID-19 patients, has a high chance of identifying a treatment in a shorter time than it would take to develop either vaccines or new medicines.

Vaccine development

AXON Neuroscience has announced it has a promising peptide vaccine against COVID-19 in development. Axon has announced its development of COVIDAX with a unique approach based on 20 years of its team’s research in Alzheimer’s disease. Axon used its established peptide-based vaccine platform to produce a novel prophylactic COVID-19 vaccine, intended to protect healthy individuals from infection. Axon’s vaccine contains only selected epitopes capable of inducing desirable T cell and B cell mediated immune responses to prevent interaction of the virus Spike (S) glycoprotein with its target human cells, thus preventing the virus from entering the cells and spreading.

Low-cost dexamethasone has been shown to improve COVID-19 survival by reducing death by up to one third in hospitalised patients with severe respiratory complications of COVID-19. In March 2020, the RECOVERY (Randomised Evaluation of COVid-19 thERapY) trial was established as a randomised clinical trial to test a range of potential treatments for COVID-19, including low-dose dexamethasone (a steroid treatment). Over 11,500 patients have been enrolled from over 175 NHS hospitals in the UK. On 8 June, recruitment to the dexamethasone arm was halted since, in the view of the trial Steering Committee, sufficient patients had been enrolled to establish whether or not the drug had a meaningful benefit. A total of 2104 patients were randomised to receive dexamethasone 6mg once per day for 10 days and were compared with 4321 patients randomised to usual care alone. Among the patients who received usual care alone, 28day mortality was highest in those who required ventilation (41%), intermediate in those patients who required oxygen only (25%), and lowest among those who did not require any respiratory intervention (13%). Dexamethasone reduced deaths by one third in ventilated patients and by one fifth in other patients receiving oxygen only. There was no benefit among those patients who did not require respiratory support.

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Pf IN NUMBERS

12,000

PEOPLE HAVE BEEN RECRUITED TO THE COVID-19 RECOVERY TRIAL Rapid change, p20

CANCER

NHS

Road to recovery

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New research has been published that explores the immunogenic effect of chemotherapy in relation to ovarian cancer. The study, published in Nature Genetics, uncovers the potential benefit of neoadjuvant chemotherapy to increase the level of specific immune cells in and around tumour sites of people with high-grade serous ovarian cancer (HGSOC). The researchers investigated how chemotherapy affects immune cells that are present in and around ovarian tumours. Overall, these results are very important as they reveal why ovarian tumours that appear similar respond differently to the same treatment. These findings open up new avenues of research to improve current treatments and explore new ones. Furthermore, the findings suggest that by combining immunotherapy with chemotherapy, which activates the body’s immune cells surrounding the tumour, we may be able to improve patients’ response to treatment in a disease that so far remains largely incurable at late stages.

Pf IN NUMBERS

The NHS faces a slow road to recovery and the Government must manage expectations to retain public confidence according to the NHS Confederation. It warns that the health service in England faces an uphill battle as it continues to manage thousands of very sick and recovering COVID-19 patients, maintain social distancing and restart services to treat cancer, stroke and heart care. This challenge will be made harder as healthcare services will be operating with much reduced capacity – possibly around 60% of normal because of the need for infection control measures, including the need to adhere to social distancing measures for patients and staff. Among the key challenges will be dealing with the backlog of treatment, with the waiting list for routine procedures already at more than 4 million. Analysis shared with the NHS Confederation suggests that the NHS waiting list could reach 10 million by the end of the year, possibly higher if there is a second wave of COVID-19 and a lack of treatment or a vaccine. The NHS Confederation warns that it will not be possible to simply ‘switch on’ NHS services immediately.

Immunogenic effect

OF ALL PRESCRIPTIONS IN PRIMARY CARE WERE PRESCRIBED ELECTRONICALLY IN APRIL. Fast forward, p25

COVID-19 .

Ibuprofen trial A trial of a unique formulation of ibuprofen treatment for treating severe acute respiratory distress syndrome (ARDS), a complication of COVID-19, has launched in south London. The LIBERATE trial is a collaboration between London’s Guy’s & St Thomas’ NHS Foundation Trust, King’s College London and the pharmaceutical organisation, the SEEK Group. The study aims to reduce respiratory failure with COVID-19, which may decrease the need for more aggressive intervention such as ventilation and decrease the length of hospital stay. The leaders of the study say that this trial will help to refine treatment for COVID-19, as an approach distinct from either vaccines or anti-viral drugs being researched by other groups. The drug is a unique formulation of ibuprofen, that is already licensed for use in the UK, and is widely used for other conditions. The drug differs from standard ibuprofen. In lab-based experiments performed by the SEEK Group the drug was shown to be more effective than standard ibuprofen for treating ARDS.

ABPI

Consultation open The ABPI is launching a public consultation on the proposed 2021 ABPI Code of Practice for the pharmaceutical industry. Pharmaceutical companies, patient organisations, NHS bodies, those who work in healthcare and others will be asked for their views on a new look, more user-friendly ABPI Code of Practice. The changes being consulted on update the ABPI Code in line with the 2019 European Code of Practice, which is required to be implemented by member associations. They also help clarify the Code, and make sure it is as accessible as possible. The language of the Code has also been updated, reflecting the drive to ‘futureproof’ the Code. One key change is that the proposed new Code will be arranged into six themed sections according to the activity or audience. • Overarching Requirements. • Promotion of Medicines to Health Professionals and Other Relevant Decision Makers. • Interactions with Health Professionals, Other Relevant Decision Makers and Health Care Organisations. • Interactions with Health Professionals, Other Relevant Decision Makers and Health Care Organisations, Patient Organisations and the Public including Patients, Journalists. • Interactions with the Public including Patients, Journalists etc and Patient Organisations. • Annual Disclosure Requirements.

ICYMI

P f N E W S : B R I N G I N G YO U T H E E S S EN T I A L H E A D L I N E S

COVID-19 FORCES RADICAL CHANGES IN NHS FINANCE Oli Hudson of Wilmington Healthcare discusses how COVID-19 is forcing radical changes in NHS finance and gives an overview of the latest developments which are fully explained in a newlyupdated course, How does finance work in the NHS?, run by the company’s Digital Learning Academy.

APM STUDY REVEALS THE CONTRIBUTION OF PROJECT MANAGEMENT IN PHARMA AND LIFE SCIENCE Rebecca Fox at the Association for Project Management (APM) provides an insight into APM’s latest report The Golden Thread, which explores the contribution of project management in the health, pharmaceutical and life sciences sectors, as well as challenges and future expectations for the profession.

CRISIS OR CROSSROADS? KEY ACCOUNT MANAGEMENT POST-COVID Miranda Wheatley Price from Rubica calls for a dynamic response to the current challenge as she explores the future for key account management post-COVID.

GUIDE TO PHARMA E-DETAILING As the COVID-19 pandemic has moved a large proportion of the world online, Mehrnaz Campbell and Lindsey Brookes share their guide to pharma e-detailing.

BECOMING A LEADING PHARMA COMPANY IN THE NEW NORMAL

MORE THAN JUST PRINT. We publish daily news and exclusive articles online at www.pharmafield.co.uk. Here’s a look at some of the exclusive content you may have missed.

The pharma supply chain has been stress tested to breaking point in the past few months. Many life sciences companies have transitioned to entirely new product lines. Change is now the only certainty and pharmaceutical suppliers must be flexible and agile to address the challenges head on. Kallik Chief Executive Officer, Gurdip Singh offers some pointers for pharma companies to become leaders in the new normal.

INNOVATIVE TECHNOLOGY IN THE MEDICAL DEVICES MARKET Bernard Ross explores innovative technology in the medical devices market especially relating to venous thromboembolism (VTE). M AG A ZI N E | AU G U S T 2020 | 9

COVID-19

PHARMA ON THE FRONTLINE Pharma stepped up to support the NHS, the country and the World during the COVID-19 pandemic. Emma Morriss WORDS BY

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C OV ER S TO RY

I WAS WORRIED THERE MAY NOT BE ENOUGH PERSONAL PROTECTIVE EQUIPMENT, WHETHER I WOULD BE ACCEPTED BY MY NEW COLLEAGUES, AND EVEN IF I WOULD SURVIVE SHOULD I SUCCUMB TO THE VIRUS

ON THE FRONTLINE – MEDICAL AFFAIRS TO ICU DOCTOR GEORGE GODFREY, ASTRAZENECA UK

George Godfrey, AstraZeneca UK

uring the coronavirus pandemic, AstraZeneca offered medical colleagues the option to take a month’s leave to volunteer with the NHS. George Godfrey, Head of Cardiology, Medical Affairs at AstraZeneca UK decided to go back to the NHS as an intensive care unit (ICU) doctor with his local London hospital. “I had been out of clinical medicine for a couple of years but felt a calling to return to help my local area cope with the additional burden presented by this pandemic. I was worried there may not be enough Personal Protective Equipment (PPE), whether I would be accepted by my new colleagues, and even if I would survive should I succumb to the virus. “The environment I encountered wasn’t what I expected. COVID-19 generated huge amounts of demand in the ICU and acute wards, but the rest of the hospital had effectively shut down. After a short local induction, I was back on the frontline, along with doctors and nurses from all around the hospital who had been redeployed to the ICU. Each day in the ICU is filled with difficult, sometimes emotional decisions – often made even more acute when demand is as high as it is in the COVID-19 crisis. The commitment and compassion of frontline staff is overwhelming. What comes next, now restrictions are lifting? Only time will tell, but one thing is certain, there is no shortage of humanity on the wards and ICUs of the UK and I was proud to be able to stand alongside them in a time of need.”

VACCINE DEVELOPMENT ASTRAZENECA

traZeneca has worked closely with the UK Government and the NHS to support the national response to the COVID-19 pandemic, including the provision of testing, sourcing medical supplies, volunteer efforts from staff and in the development of a potential COVID-19 vaccine. As the race to find a vaccine increased, AstraZeneca announced a collaboration with the University of Oxford for the global development, manufacturing, and distribution of the University’s potential recombinant adenovirus vaccine. Formerly ChAdOx1 nCoV-19 and now known as AZD1222, AstraZeneca has currently secured global supply capacity of more than two billion doses, following agreements with the UK, US, Europe’s Inclusive Vaccines Alliance, the Coalition for Epidemic Preparedness Innovations and Gavi the Vaccine Alliance, as well as a licence with the Serum Institute of India for low-and-middle-income countries.

SUPPORTING MENTAL HEALTH PAUL SAUNDERS, JOHNSON & JOHNSON UK

OVID-19 has put an enormous strain on people’s mental health. Over the last three months, almost half a million people turned to Mental Health UK and its partner charities for support. In response, Johnson & Johnson has made additional funding available to help stabilise and grow this critical resource. The Mental Health UK helplines support 10,000 people a year, providing information and advice on what local support is available, and how to access it. The funding is an extension of a three-year partnership between Johnson & Johnson and Mental Health UK. Johnson & Johnson’s pharmaceutical arm, Janssen, has a strong heritage in mental health. Paul Saunders, Business Unit Director, Immunology and Neuroscience and CSR Lead, Janssen UK, explained: “Mental Health UK has seen an exponential increase in requests for help since COVID-19, and we hope our funding will help ensure people have continued access to the support they need. There has never been a more important time to look after our own mental health, and to offer our support to those who need it most.” M AG A ZI N E | AU G U S T 2020 | 11

ON THE FRONTLINE – PHARMACY JILL MULLEN, BRISTOL MYERS SQUIBB

SUPPORTING THE VULNERABLE CATHERINE BRANT, NOVO NORDISK UK

PPE FOR SOCIAL CARE KIT4CARERS

IPADS TO ICUS ORIGIN

uring the COVID-19 pandemic, Bristol Myers Squibb (BMS) supported employees as they responded to the call for volunteers to return to the frontline and support healthcare colleagues. Jill Mullen, a BMS sales representative in the north coast of Ireland, with a background as a pharmacist, returned to practice helping her local community pharmacists. Jill explained: “Very early into the pandemic, pharmacies were faced with staff sickness and shortages and had to reduce their opening hours to maintain safe services. I know the pharmacists in my small town very well and they quickly reached out to ask for my support to maintain a safe service for their patients. It was obviously a difficult decision because I didn’t want to put my family at risk, but after discussing it with them and making sure they were happy, and with the full backing of BMS, I now volunteer one day a week in one of two local pharmacies. “Pharmacies are under severe pressure and I will continue to volunteer to help my community, ensuring the safe provision of pharmaceutical services. I believe I did the right thing and will continue to play my part in these strange times.” Rachael Smith, Pharmacy Manager of Bradleys Pharmacy, Portstewart added: “Our pharmacy was struggling to keep up with the massive and unexpected surge in workload. With staff needing to isolate, the help Jill provided was invaluable. She helped us catch up on the backlog and was vital in preventing us becoming overwhelmed again. We are so grateful.”

he social care sector has been hit particularly hard by the coronavirus pandemic where care workers have been supporting older and vulnerable people without always having access to adequate PPE. At the height of the pandemic, Dr Pramod Prabhakaran, an NHS Consultant, Hassan Chaudhury, International Trade Expert and ex-social worker, Omar Butt, Innovation Leader from Vita Healthcare Solutions and Angus Robertson, Managing Partner at Curzon Private Office set up Kit4Carers. The initiative, working with the CareTech Charitable Foundation, has currently raised more than £25,000 and aims to raise £100,000 to provide free PPE to social care workers in the UK and developing nations. Anyone wishing to donate to the fund can do so at www.virginmoneygiving.com/fund/Kit4Carers.

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atherine Brant is a Senior External Relations Manager at Novo Nordisk UK. Prior to this, Catherine worked as a Novo Nordisk Diabetes Education Nurse Facilitator (DENF), teaching and mentoring GPs and practice nurses to support their clinical work in diabetes. At the start of the COVID-19 pandemic, NHS England and Diabetes UK launched The NHS Diabetes Clinical Advice Helpline. All 18 of Novo Nordisk UK’s diabetes specialist nurses volunteered to support the Helpline. Catherine shared: “From the start of my career I’ve focused on helping people with diabetes, whether that’s as a nurse working in the NHS for 18 years, as a DENF at Novo Nordisk or in my current role in the Public Affairs team, so I jumped at the opportunity to be able to support people living with diabetes directly, through volunteering on the Helpline. My team has been so supportive; they have really helped me balance my time between my ‘usual’ job and supporting the Helpline. “As people with diabetes are classed as vulnerable to coronavirus, many are avoiding visiting their GP, nurse or specialist team. Most callers I’ve spoken to need information and reassurance about how to manage their diabetes. It’s very rewarding, and I was so proud when a caller said: ‘I’ve learnt more from you in this half hour than I ever have before’ which really shows the value of the Helpline.”

harma packaging company, Origin, donated 22 iPads to two NHS ICU departments, Hull Royal Infirmary and Castle Hill Hospital. The donation allowed patients to use voice or video calling to keep in touch, with some able to say their final farewells. According to the Trust’s Critical Care Family Support and Liaison Team, the virtual visits had a positive outcome for, not only the patients and their relatives, but also ICU staff. Rich Quelch, Global Head of Marketing at Origin commented: “Often patients spend weeks and weeks on an ICU ward and the suspension of visiting has had a huge effect on their mental wellbeing. It has also been an extremely distressing time for the families of patients who are unable to see and support them. By donating these tablet devices, Origin hopes the experience of staff, ICU patients and their families has been made a little easier at this very difficult time.”

C OV ER S TO RY

I FEEL HONOURED TO BE PART OF THE SURVEY WHICH IS OF SUCH NATIONAL IMPORTANCE IN THE FIGHT AGAINST COVID-19

IQVIA and Star

DIAGNOSTICS ROCHE

oche reacted quickly to COVID-19 with emergency response teams working to bring its cobas® SARS-CoV-2 Test to patients. It received FDA Emergency Use Authorization in mid-March and was also made available in markets accepting the CE mark for patients with signs and symptoms of COVID-19 disease and living in affected areas where the SARS-CoV-2 virus was known to be present. In mid-April, Roche announced the development and upcoming launch of a COVID-19 antibody test, its Elecsys® Anti-SARS-CoV-2 serology test.

GOVERNMENT-INDUSTRY PARTNERSHIP IQVIA AND STAR

he Office for National Statistics (ONS) COVID Infection Survey has been delivered in partnership with the Department for Health and Social Care (DHSC), the University of Oxford, the UK Biocentre and IQVIA. IQVIA was approached by DHSC to provide a UK-wide team of healthcare workers (HCWs) who could be mobilised to conduct blood and swab tests, initially across 1000 households. Within two days, the Government asked for 10,000 households to be tested within the first month. In just over a week, working with the ONS leadership, IQVIA set up and organised processes and logistics for household registration and was building and training the team of HCWs. Within 10 days of the initial approach, a pan-industry COVID-19 tester team of 250 HCWs was built, trained and mobilised to commence household testing, deployed through a new and unique partnership with 11 outsourced HCW companies: Star, Apodi, Bionical, SquareHealth, Bluecrest, TNS, ONS, NatCen, Ipsos MORI, Kantar. The field tester team has expanded to 863 people conducting household tests every day for eight weeks. The scale of delivery is: • 17,523 households registered with >37,000 participants in the study • >127,000 tests in >59,000 household visits in eight weeks. Star Healthcare Worker, Lesley Jarvis commented: “I feel honoured to be part of the survey which is of such national importance in the fight against COVID-19, with the households I have visited being so grateful and friendly.”

MEDICINES PREDICTION AND SUPPLY ACCORD

t the outset of the pandemic, Accord developed a forecasting model to predict which medicines would be in demand and when. This enabled it to ship active pharmaceutical ingredients (API) before export bans and step up production to match the surge in requirements across the EU. This model proved crucial to how Accord responded to key challenges: • Accord anticipated the medicines that would be most vital and ensured continuity of supply working with governments and regulatory bodies to ensure patients have access when needed whilst maintaining prices at pre-COVID-19 levels. • Accord could respond to a supply disruption alert from the DHSC outlining ‘limited supplies’ of all strengths of the neuromuscular blocking agents atracurium and cisatracurium, owing to a ‘recent increase in demand’. These first line medicines for COVID-19 patients are potent muscle relaxants used during surgery and in patients that are ventilated in critical care. Accord had predicted the surge in demand and taken steps to fill the gap. • Accord proactively identified anti-inflammatory, anti-malarial, hydroxychloroquine as a medicine that would be in short supply. The company shipped the API from Asia before the export bans hit. Within 22 days, Accord had successfully manufactured approved hydroxychloroquine (within its existing marketing authorisation) in the EU. As part of its commitment to supporting frontline health workers, Accord donated an initial supply of two million tablets to help support additional clinical research. M AG A ZI N E | AU G U S T 2020 | 13

C OV ER S TO RY

IT'S A PRIVILEGE TO BE ABLE TO BE THERE FOR THEM, DURING SUCH A DIFFICULT TIME

Leanne Jones, Bristol Myers Squibb

SUPPORT ACROSS THE SPECTRUM UCB

CB has launched a community health fund to support the most vulnerable in the community. Veronique Toully, Global Head of Sustainability at UCB explained: “Those who are vulnerable, whether physically, socioeconomically or psychologically have undoubtedly been those most impacted by the pandemic. At UCB, we have been exploring ways to help reduce the burden and support in building resilience for the future. As part of this, we are incredibly proud to have recently launched the UCB Community Health Fund. Managed by the King Baudouin Foundation, the Fund aims to address health disparities amongst vulnerable populations.” As COVID-19 took hold, UCB also partnered with Diamond Light Source and the University of Oxford to design inhibitors of SARSCoV-2’s main protease for treatment of COVID-19 patients; and are collaborating with the University on the development of a vaccine. In the US, UCB colleagues are actively working with the Seattle Structural Genomics Center for Infectious Disease to identify crystal structures of SARS-CoV-2 proteins. Dhaval Patel, Executive Vice President and Chief Scientific Officer at UCB added: “I am incredibly proud we are offering our support, and particularly of those individuals who put the needs of patients first during what is undoubtedly a challenging time.” Alongside its research partnership programmes and long-term commitments to scientific advances in the fight against COVID-19, UCB’s major manufacturing sites have been adapted to support the production of hydro-alcoholic solution, used in hand sanitiser, and made significant donations to healthcare authorities in Belgium and Switzerland. Iris Loew-Friedrich, Executive Vice President and Chief Medical Officer at UCB said: “Knowing that we are making a direct impact and are part of the huge effort to stop the spread of the virus has been incredibly rewarding and testament to the agility of our business and the commitment and dedication of my colleagues.”

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BEREAVEMENT SUPPORT LEANNE JONES, BRISTOL MYERS SQUIBB

eanne Jones works for BMS in the Midlands and has a part time role as a bereavement counsellor, on placement with her university course. During COVID-19, Leanne has been volunteering more of her time to support those in need. She explained: “The bereavement charity I work for, Cruse Bereavement Care, are expecting and preparing for an increase in demand for their services. During this crisis, people who are dealing with an already tragic loss in their lives are having to face the increased trauma of being cut off from some of their usual support network.” “When Bristol Myers Squibb encouraged us to volunteer during the pandemic, I asked to increase my counselling time to during working hours, to offer Cruse some much needed support. I have also lost someone during this crisis and wanted to use my counselling skills where they are desperately needed.” “Bereavement counselling and support can be such a light of hope in troubling times. I have a number of clients who I speak to on a weekly basis, not only those who are grieving for friends and family lost to COVID-19, but also those people who were grieving before lockdown and have lost their support network. It’s a privilege to be able to be there for them, during such a difficult time.”

These are just a few examples of pharma’s support of the coronavirus pandemic. Pf expresses its thanks to industry as well as key workers who stepped up when we needed them most. With thanks to all contributors including the Association of the British Pharmaceutical Industry www.abpi.org.uk and VWV www.vwv.co.uk.

NHS

A once in a generation opportunity The impact of coronavirus on NHS customer engagement. WORDS BY

Oli Hudson

s the first wave of COVID-19 subsides in the UK, pharma has a unique opportunity to transform its relationship with the NHS and realise the true potential of partnership working – that was the overriding message of a recent Wilmington Healthcare webinar which explored the impact of coronavirus on customer engagement. However, Leslie Galloway, Chair of the Ethical Medicines Industry Group (EMIG) and guest speaker, warned that pharma must tread carefully post-pandemic as NHS customers have been “through the mill” and “may not be in a great place”. NEW APPROACH

Speaking at the webinar Impact, engagement, potential: a COVID-19 return to work guide for industry, he said: “Our customers have been looking after us for many years. How can we now look after them and change the relationship permanently?” To capitalise on the opportunity to transform its relationship with the NHS, Leslie explained that pharma must understand the challenges the NHS faces post-pandemic and help to find solutions. Industry should also be mindful that the NHS’ original objectives of reducing demand, improving outcomes and patient safety must still be achieved. He explained: “There is a critical opportunity for industry, and we need to take it. But we must be careful in our approach. If pharma goes in with the intention of selling, the NHS will sense it. Industry needs to think about how its products fit with NHS objectives. How we can help rather than just be there to sell a product.”

Industry should be mindful that the NHS’ original objectives of reducing demand, improving outcomes and patient safety must still be achieved

DIGITAL ENGAGEMENT

As coronavirus has forced the pace of digital transformation in the NHS, Leslie questioned the future of face-to-face engagement for pharma sales representatives, and suggested that if it did resume, meetings might take place away from the GP surgery or NHS trust. However, on the whole, he believed that “digital is the future” and his view was backed up by the findings of a recent PM Society survey which showed that 26% of GPs expected regular face-to-face contact before the pandemic, compared to 12% afterwards. Furthermore, 59% of GPs would have expected regular contact from pharma via the internet before the pandemic, but that figure has since risen to 67%. There was also a marked change among secondary care doctors with considerable variation between specialties. TURNING POINT

The NHS faces a difficult road ahead with fresh challenges to be overcome, and original objectives still to be met. Now is the time for pharma to take a step back and seek to understand how it can help. By taking this approach, pharma could grasp the unique partnership opportunities that are arising post-pandemic and support the NHS through these unprecedented times. In essence, it could realise what we believe is a once in a generation opportunity. To register to listen to the webinar ondemand, visit https://tinyurl.com/y7q8d74v Oli Hudson is Content Director at Wilmington Healthcare. Go to www.wilmingtonhealthcare.com M AG A ZI N E | AU G U S T 2020 | 15

HEALTH TECHNOLOGY ASSESSMENT POST-COVID What will Health Technology Assessment look like post-COVID?

s England and the devolved nations emerge from COVID-19 lockdown at varying rates, so too their respective health technology assessment (HTA) bodies are taking a similarly varied approach to returning to business as usual. While some normal business is resuming across the medicines landscape, many are now looking at how we can create a new normal – being more ambitious than before in how we make HTA work better for patients and for the system. The Scottish Medicines Consortium (SMC) has, for example, already acknowledged that a business-as-usual approach will not satisfy their intention of reducing their backlog as quickly as possible. CHALLENGES

Prior to the emergence of the pandemic, there were already challenges facing the UK’s HTA bodies. The SMC was struggling with capacity issues, leading to a backlog in dealing with submissions. The National Institute of Health and Care Excellence (NICE), which was due to take on all new indications by April 2020, (including those that would have been covered by NHS England), needed to boost capacity in an already overstretched programme. As the pandemic unfolded, NICE, SMC and the All Wales Medicines Strategy Group (AWMSG) set out their programmes of suspended operations due to COVID-19.

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NICE prioritised its activities to focus on therapeutically critical topics (including ‘appraisals involving a cancer medicine’) and guidance addressing COVID-19 diagnostic or therapeutic interventions. The SMC ‘suspended all meetings with immediate effect’ and AWMSG, meanwhile, opted to ‘suspend normal business’. Meanwhile, NHS England Specialised Commissioning Clinical Priorities Advisory Group (CPAG) delayed its May 2020 round until late July, in further evidence that NICE is not yet ready to absorb CPAG’s activities as planned, by April 2020. As of 1 June, of the 89 NICE technology appraisals with a final scope produced since October 2018, 66% were still in progress, 28% had been suspended due to COVID-19 and 6% were suspended for other reasons. Cancer medicines, as promised, have been nominally unaffected by the restrictions (excluding those under Cancer Drugs Fund review) though the actual impact of say remote committee hearings, is yet to be borne out. Very little information was made public on the prioritisation process of topics, making it difficult to establish accountability for these decisions. While NICE has now started publishing guidance not related to COVID-19, moving closer towards ‘business as usual’, recent NICE Board papers suggest that prioritisation of some sort will have to continue. It is crucial that justification for prioritised topic selection is made transparent.

POLITICS

BACKLOG

The most clear and present challenge HTA bodies will face following the resumption of operations is a backlog in appraisals – this may lead to decision outcome delays, further hindering patient access to latest treatments. Increasing internal capacity could allow HTA bodies to ramp up operations while maintaining gold-standard appraisals. This would require more financial backing though and whether there is the appetite for this additional investment from budget-holders remains to be seen. Perhaps more likely, this autumn NICE will review the fee charged to companies for technology appraisals, barely a year after it was first introduced. Should this cost be increased to cover the burden of additional capacity, for example, this could have a range of implications for industry and patients. These include concerns over affordability for SMEs and reducing the attractiveness of the UK as a market for investment (of particular importance in the context of the UK exiting the EU), ultimately further limiting or delaying patient access. Despite NHS England repeatedly stating intentions to disband CPAG’s operations, the backlog in NICE appraisals may instead require CPAG to continue to serve as an important silo for reviewing a small group of medicines. The relatively fast turnaround of CPAG funding decisions, could also mean that more ‘interim’ funding decisions are sought, filling the gap while the backlog at NICE is addressed. Will companies look to the AWMSG as a quicker route to market in Wales if they perceive NICE and SMC to be overloaded by their respective backlogs? This could lead to the AWMSG, which has limited capacity, seeing a rise in their usually low number of submissions, deepening the backlog and creating further unexpected inequality of access across the four nations of the UK. RAPID-C19

The introduction of RAPID-C19 (Research to Access Pathway to Investigational Drugs – COVID 19), a new collaboration between NICE, National Institute for Health Research, Medicines and Healthcare products Regulatory Agency and NHS England to triage, coordinate, and fast-track potential COVID-19 therapies, demonstrates that when there is a drive to speed up access to treatments, it can be achieved.

The most clear and present challenge HTA bodies will face following the resumption of operations is a backlog in appraisals

WORDS BY

Claudia Rubin

It will be hoped that the progress made by RAPID-C19, which appears to mimic the structure of the Accelerated Access Collaborative, will be built upon and repurposed for other areas of medicine. It would be a missed opportunity not to learn lessons through collaborations of this sort to improve access to medicines in future. THE FUTURE

COVID-19 has brought some uncertainty about the direction of the HTA space in the UK, as it has with the majority of sectors. Will an overburdened NICE lead to more innovative commercial deals being carved out at NHS England? Might this lay a precedent for a novel twist in the relationship between pharma and payers? Furthermore, if NICE maintains a level of prioritisation in its topic selection post-COVID, to what extent will the impact on treatments for ‘deprioritised’ conditions be acceptable? Claudia Rubin is Director at Decideum. Go to www.decideum.com M AG A ZI N E | AU G U S T 2020 | 17

n the June issue of Pf, I wrote a short article on virtual promotional meetings and aspects to consider when it comes to ensuring their compliance with the ABPI Code. I also included a compliance checklist. CompliMed has received an overwhelming number of enquiries on this highly topical subject, as more and more NHS customers return to interacting with pharma and attending educational events. This article, therefore, continues our ABPI Code series on Digital Promotion and addresses the subject of promotional emails. Back in 2016, Healthlink Dimensions surveyed how physicians preferred to receive information from pharma and email was noted to “win hands down” (68% preference compared to only 11% for direct mail and 11% for representatives). The preference for emails grew over time and although overall promotion to hospital health professionals decreased with the advent of lockdown (by 57% according to research conducted by Brand Impact and Tracking Evaluation, June 2020), promotional emails remain an important digital marketing tool.

COMMERCIAL AND COMPLIANCE CONSIDERATIONS

n Healthlink Dimensions’ 2020 HCP Communications Survey, the top three things healthcare professionals want from marketers is: • Time – They don’t have enough to read critical information. • Respect – Don’t condescend or waste their time. • Quality – They want useful and practical insights. Whilst this article does not address email execution strategies (such as mobile optimisation, meaningful content, creative subject lines and linked content), these are nevertheless essential factors to consider before deciding on whether email really is the most suitable vehicle of communication for the campaign intent and the target audience. In addition, these factors themselves must stand fast against compliance checks and changes.

For example, if the intent of a promotional email is to encourage a reader to visit a promotional website, then a reviewer/ approver asking that all email links be removed may support compliance but not necessarily the business need. Therefore, compliance considerations should always factor in whether the activity (pre- and postapproval) is in line with business strategy. In June 2020, the ABPI noted that many companies were deliberating when to resume face-to-face engagement with healthcare professionals, and they set out a number of considerations to help members, noting that they were not able to recommend what individual companies should do regarding promotional activities. Given the continued uncertainty, it reinforces the place of promotional emails as important digital marketing tools – therefore, it is prudent to consider the compliance dos and don’ts as illustrated by the key principles.

ABPI CODE

and promotional emails Considerations relating to the ABPI Code of Practice and promotional emails. WORDS BY

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Dr Rina Newton

ABPI

CHECKLIST FOR PROMOTIONAL EMAILS SOME OF THE ASSOCIATED DOS AND DON’TS HAVE BEEN INCLUDED AS EXAMPLES – THIS IS NOT THE FULL COMPLIANCE CHECKLIST.

Promotional emails promote the administration, consumption, prescription, purchase, recommendation, sale or supply of a medicine.

Don’t panic and think all emails are promotional just because they are sent by a sales representative or if they relate to a promotional activity – that’s just not true and it prevents many organisations from making the most of opportunities.

Target audience must be relevant.

Do be as specific as possible about tailoring content to those who have an interest in it.

Recipients must give their permission to receive promotional emails.

Do keep a record of permissions sought, gained and refused; brief your representatives carefully about not causing “inconvenience or offence” on this point.

Recipients should be able to unsubscribe from promotional emails.

Don’t be too slow actioning such requests and make sure your systems support you in this regard.

Promotional emails must not disguise promotion.

Do ensure the whole organisation knows what ‘promotion’ actually is through giving them illustrative examples e.g. “If the representative’s email signature contains a medicine name and the body of the email contains that medicine’s indication, this will render it a promotional email.”

Content should comply with general principles for promotion.

Don’t mislead, exaggerate, disparage, promote off-label etc.

Prescribing information (PI) and other obligatory information should be provided.

Don’t embed PI in an email when a single, direct click to the PI is suffice (but make sure the link works and the PI is correct).

Promotional emails should be certified.

Do ensure final signatories have certified the final proof to which no further amendments are made – especially important if the email is to be sent by a third party.

There are many considerations for promotional emails sent by third parties – relating mainly to due diligence and oversight – and there are, of course, many more considerations for each principle.

Promotional emails remain an important digital marketing tool

PMPCA CASE RULINGS, SOPS AND SIGNATORIES

s with all compliance checklists, insight is gleaned from relevant PMCPA case rulings to develop meaningful and comprehensive checks. In their absence, utilising clear and unambiguous company Standard Operating Procedures and discussing planned promotional campaigns with modern and constructive final signatories play an important part in achieving not just compliant promotional emails, but ones that are read by customers, meet their needs and are commercially impactful. Dr Rina Newton is Managing Director of CompliMed. Go to complimed.co.uk

M AG A ZI N E | AU G U S T 2020 | 19

RAPID CHANGE

COVID-19 & UK clinical research

COVID-19 has brought about rapid change of clinical research; can these be embedded into future ways of working? WORDS BY Dr Matthew Hallsworth

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K health research during the coronavirus pandemic has changed in ways which would have seemed impossible only six months ago. It is vital that we now take the opportunity to understand and embed some of our learnings from COVID-19 clinical research and make impactful changes to the landscape going forward. Since the onset of the pandemic, the UK research community mobilised with unprecedented speed to develop multi-agency collaborative systems that enabled accelerated setup and rapid delivery of high priority research. This approach required government bodies, clinical academic research experts, regulators and the life science industry all working together in extraordinary ways. The National Institute for Health Research (NIHR) has played a critical role in all of this. Through a collaborative process led by NIHR, COVID-19 studies assessed as having the highest potential to deliver evidence with the greatest impact within 12 months have been prioritised as urgent public health research. These studies are fast-tracked for delivery across the NHS through the NIHR, with its Clinical Research Network supporting the site set up and recruitment of patients across the country.

F E AT U R E

GROUND-BREAKING TRIALS

Early in the pandemic, the NIHR and UK Research and Innovation (UKRI) established a joint funding programme for COVID-19 research, investing £24.6m in 27 priority research projects as part of two initial rounds of funding, in addition to further investment as part of a rolling funding call. As a direct result of the NIHR’s response, a variety of ground-breaking clinical trials have been established right here in the UK, resulting in numerous global firsts and potentially life-saving breakthroughs being identified and evidenced. Two of the six initial NIHR and UKRI funded projects have already shown their merits as world-leading and potentially game-changing research against coronavirus: the RECOVERY Trial and the Oxford COVID-19 vaccine trial. The RECOVERY (Randomised Evaluation of COVid-19 thERapY) Phase III trial is testing a range of new and existing drugs to determine if they could be beneficial to hospitalised patients with COVID-19. With NIHR delivery support, in just three months the RECOVERY trial has been able to release results on dexamethasone, providing evidence of the first life-saving treatment for the most seriously ill patients with COVID-19. This cheap and widely available drug has been shown to reduce mortality for those severely ill with COVID-19. The preprint paper states that the drug cuts deaths in ventilated patients by one third, and deaths in other admitted patients receiving oxygen by one fifth. One of the UK’s main strengths showcased in the RECOVERY trial, is the culture of collaboration between industry, the Government and the public sector. The trial has demonstrated the UK’s exceptional capabilities for delivering clinical trials at pace and scale across the NHS. With NIHR support, the trial was set up in record time. The first participant was recruited just 16 days after receiving the funding award, 1000 participants were recruited within the first two weeks, and around 12,000 participants have now been recruited to the study in just three months – from over 175 hospitals across the UK. RECOVERY is now the world’s largest trial of potential COVID-19 treatments. This is in contrast to some other countries where there appears to have been less coordination of trials across research centres.

Not having those collaborative structures across networks of hospitals, which thanks to the NIHR and partners have been established within the UK over the last decade, has resulted in many global clinical COVID-19 trials struggling to recruit sufficient participants and, ultimately, being underpowered as a result. The RECOVERY trial uses an adaptive trial design. This means that it can evaluate multiple treatments at the same time, and as data is monitored continually, drugs which are not showing promising results for COVID-19 can be dropped in favour of other drugs that may have potential benefit. This ability to be able to obtain an early positive, or negative, signal of efficacy has been critical during the pandemic. The NIHR has been supporting the delivery of these types of complex trials for a number of years in the UK, and they will continue to be an increasingly important part of how we carry out clinical research. FLAGSHIP COVID-19 VACCINE TRIAL

The UK’s unrivalled research capability, expertise and infrastructure is again highlighted by the Oxford vaccine trial of ChAdOx1 nCoV-19, funded by NIHR and UKRI as part of the first rapid response call in March 2020. This flagship vaccine trial initiated the first human trials in Europe for a potential COVID-19 vaccine. Three key members of the NIHR Oxford Biomedical Research Centre are leading the trial: Professors Sarah Gilbert and Adrian Hill of the University of Oxford’s Jenner Institute and Professor Andrew Pollard of the University’s Oxford Vaccine Group. In a recent statement, they said: “Although it seems like a very long time since the work started, in reality it is less than four months since we first heard of an outbreak of severe pneumonia cases, and began to plan a response.” This again highlights the unprecedented speed at which the UK coronavirus response occurred. FAST-TRACK APPROVALS

Throughout the pandemic, the UK’s researchers, health authorities and regulators have also been working in extraordinary ways. The NHS Health Research Authority (HRA) implemented a fast-track approval process for COVID-19 studies, enabling their Research Ethics Committee and approval specialists to complete a full review of a study into

If we can embed even a proportion of what has been achieved, then the UK has the potential to be the go-to country for clinical research

a vaccine or immune response, or into COVID-19 prevalence or transmission, in 72 hours or less. Other UK regulators, including the Medicines and Healthcare products Regulatory Agency (MHRA), have also proved adaptable and forward thinking, quickly supporting the setup of clinical studies in a matter of weeks, rather than months, whilst still maintaining the necessary regulatory and ethical standards. FUTURE FOR CLINICAL TRIALS

The UK’s COVID response has collectively demonstrated our ability to accelerate study setup and delivery and has opened the potential to embed this across all future clinical trials. It will now be important to adopt some of the extraordinary ways of working from COVID-19 in a sustainable way to become part of our ‘business as usual’ approach to clinical research. If we can embed even a proportion of what has been achieved, then the UK has the potential to be the go-to country for clinical research. This not only benefits researchers and life sciences companies, but also patients in the UK, who will then be among the first in the world to benefit from cutting-edge treatments and technologies. The NIHR will be working with partners, including the life sciences industry, to try to achieve this and ensure that when a researcher or life sciences company wants to carry out their clinical research, the UK can offer the best experience in the world. Dr Matthew Hallsworth is Head of External Relations at the National Institute for Health Research. Go to www.nihr.ac.uk M AG A ZI N E | AU G U S T 2020 | 21

STEPS TO CUSTOMER STAKEHOLDER MAPPING Fundamental steps of map development and practical tips to quickly develop stakeholder maps.

ustomer stakeholder mapping can be one of the most daunting aspects of business planning. You know what you need to do, but the complexity of the task can lead to procrastination and delay. However, it can be a straightforward process, and often people develop a draft plan in their head without formally writing it down. Here we will focus on developing the map. How to use the stakeholder map will be the subject of a future article including alignment with the stakeholder to drive your business agenda. WHAT ARE STAKEHOLDERS?

The stakeholder map helps you to identify the most influential customers and how they potentially impact your desired outcomes either positively or negatively. So instead of diluting your efforts and trying to influence everyone, you focus your time, energy and resources on those who can make a bigger difference to your business objective. Remember that stakeholders and key opinion leaders (KOLs) are not necessarily the same thing. Stakeholders are specific individuals who influence your objective. The KOLs are thought leaders, subject matter experts in their specific field. That said, a Stakeholder may also be a KOL; however, a KOL is not always a Stakeholder and may not influence your objective. For example, if you have an international cardiovascular opinion leader located in your territory and you want to get a cardiovascular brand on the formulary, the international KOL may not be involved in process of local formulary inclusion. Although they are an opinion leader in the field, if they do not influence the path to formulary adoption of your product, they do not qualify as a Stakeholder in this scenario.

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SIX STEPS TO CUSTOMER STAKEHOLDER MAPPING

THE FIRST STEP IN STARTING CUSTOMER STAKEHOLDER MAPPING IS TO DEFINE YOUR OVERALL OBJECTIVES

This is the most important step because you want to specifically define the stakeholders that influence the achievement of your objective. For example, if you are trying to get your product on the formulary in an account, the key stakeholder may include the formulary pharmacist, the clinical lead for the specialty that relates to your product and the person responsible for completion and submission of the formulary form. In contrast, if you are trying to increase usage and adoption in primary care for a brand that is already on the formulary, the key stakeholders would be completely different and may include specialist GPs, the medicine management pharmacists and the practice pharmacists.

LIST THE KEY CUSTOMERS WHO YOU BELIEVE WOULD INFLUENCE THE PATH TO ACHIEVING YOUR OBJECTIVE .

Think about people who would potentially help achieve this goal, and those who may block your path to success. If you are new to a territory, or unsure about how to identify the relevant stakeholders, asking these questions may help you find them. Let us assume you have a respiratory product and inclusion of your brand on the joint formulary is essential for your product to be used in primary care. Your overarching objective in this scenario is to gain formulary inclusion. Use these questions to help you identify the relevant stakeholders. • What is the normal process for formulary submission in the account? • Who sits on the formulary committee? • Do you require clinical support for submission? If yes, is this a group or individual decision? • Who are the clinical decision makers? • Who is responsible for completing the submission form? • Who is the formulary pharmacist and what role do they play? Additional tips: If you want to identify the stakeholders in a new account or therapy area, looking at the formulary bulletin or formulary documents may help you identify the key people involved in the process. Also look at local strategy documents, guidelines and treatment protocols to see who has written these documents. Often the organisation website provides a list of staff, their credentials and indicate their area of interest.

F E AT U R E

DEFINE THE LEVEL OF INFLUENCE OF THE CUSTOMERS IDENTIFIED IN STEP 2.

NOW PLOT YOUR LISTED STAKEHOLDERS ON A FOUR-BOX GRID.

I suggest using a scale of one to five to define their influence. Give a score of five to those with high level of influence and one to those with low influence. Remember the level of influence of your stakeholders is relative to one another. This is more of an art than an absolute science, so don’t get too hung up about getting it right the first time. Start with drafting this ranking and if you are unsure, talk to other team members and seek their input to validate your assumptions.

Use a vertical line to represent the level of influence with five being high at the top and one at the bottom. Use the horizontal line to represent their level of advocacy for the brand with five on the right as highly supportive and one on the left as actively against the brand. The top right segment of the axis is for influencers with positive advocacy. The bottom right is for customers that are positive advocates but have lower influence. The top left section shows customers with high influence who have a negative attitude towards your product or service, and the bottom left shows those who are neither influencers nor advocates for your product or service.

DEFINE THE STAKEHOLDER’S ATTITUDE TO YOUR BRAND.

Consider if they are supportive of your brand and would advocate it or whether they would actively advise against it. Do not ignore the stakeholders who are against your brand. If they are influential and could have a negative impact on your objective, you need to find a way to better understand their perspective and address their objection either directly or indirectly. Use a scale of one to five to define each stakeholder’s attitude to your brand. 1. Actively against your brand 2. Q uietly against your brand 3. Sit on the fence 4. Q uiet supporter 5. Active advocate proactively shouts about it.

Do not ignore the stakeholders who are against your brand

WORDS BY

Mehrnaz Campbell

LOOK AT THE INTERRELATIONSHIP BETWEEN THE STAKEHOLDERS.

Influence goes in both directions so use arrows to show relationships between people. The influence and interrelationship are based on your understanding of who listens to whom and how individuals influence each other. Defining the relationship is key to help you identify the best strategy to influence your stakeholders indirectly. START CREATING

The stakeholder map gives you a snapshot of the individuals who have a positive or negative impact on your objective and their attitude towards your brand. The map helps you to see this very clearly and helps you develop a relevant plan to achieve your objective. You could use different axes to segment your key stakeholders depending on your objectives. It is important to keep it simple and do not get stuck on technological/graphical tools excessively as the value is in your thinking and assessment of your stakeholders and their influence on your desired outcome. Make a first draft of your stakeholders on paper as this helps to encourage creativity and engage your right and left brain to work together creating a more practical stakeholder map. Still unsure about developing your map? Want to see a video to show you how you can get it done quickly? Sign up to our free video course to do exactly that. Go to www.succeedpharma.com/mapping Mehrnaz Campbell is Founding Director of Cheemia. Go to www.cheemia.co.uk M AG A ZI N E | AU G U S T 2020 | 2 3

A DV ERTO R I A L

W H I T E PA P E R

Ashfield

How to engage HCPs in the post COVID-19 landscape How the pharmaceutical industry can create a vision for the “new normal” and embrace change after the COVID-19 pandemic.

Download the whitepaper by visiting: www.ashfieldhealthcare.com

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

ENGAGING WITH HCPS How the pharmaceutical industry can create a vision for the ‘new normal’ and embrace change after the COVID-19 pandemic.

he pharmaceutical industry is in the midst of a challenging yet fascinating period, as we see an accelerated increase in remote engagement with healthcare professionals (HCPs), driven by the COVID-19 pandemic. Throughout the pandemic, business, healthcare and society as a whole have faced unprecedented challenges. Yet we have also seen great agility, determination and innovation displayed by the pharma industry as it has continued to meet the needs of HCPs and their patients. Although remote interactions have played their part for some time now, the pandemic has demonstrated just how beneficial they are to all involved. As lockdown restrictions in the UK begin to ease and we adjust to what’s frequently called the ‘new normal’, the pharma industry is faced with an enormous opportunity to embrace advances in data analysis and technology, reshaping the way they engage with HCPs and their patients. We see the role of the traditional sales representative becoming elevated, as they evolve into the navigator of an omnichannel model – one that places HCPs firmly at the centre of communication campaigns, delivering the messages they need, in the format they need, in the way that’s most convenient to them. There should be a similar approach in both events and scientific engagement. TRANSITION TO OMNICHANNEL

The transition to a customercentric, omnichannel model is not a straightforward one. It can only work if you truly understand your customers and their interpretation of what value looks like. For that, companies need to be able to respond with speed and agility to insights gleaned from accurate, robust data.

“A cultural shift will be required, embracing integration between functions, as well as brand new metrics and agile ways of working that are constantly evolving to meet changing customer needs.”

WORDS BY

Mick O’Leary

Pharma companies also need the right technology and new content to fit these new channels, and they will have to invest in recruitment, retention and retraining. A cultural shift will be required, embracing integration between functions, as well as brand new metrics and agile ways of working that are constantly evolving to meet changing customer needs. It’s a tall order, but achievable with genuine expertise and support. Get it right and the results will mean stronger, more valued relationships that benefit the company, HCPs, their patients and our society as a whole. The onus is now on all of us to make it happen. For more information, please visit www.ashfieldhealthcare.com to download a copy of our new whitepaper, Reimaging HCP Engagement, which looks at research and draws upon the experience of our colleagues to reimagine what omnichannel engagement will look like as we enter a whole ‘new normal'. Mick O’Leary is Regional President of Ashfield Commercial and Patient Solutions.

PHARMACY

Fast forward The instruction to stay at home, GP surgeries closing their doors and consumers rethinking how they shop has accelerated the use of electronic prescribing. WORDS BY Deborah Evans

he Electronic Prescription Service (EPS) allows prescribers to send prescriptions electronically to a pharmacy of an individual’s choice, flagged by a patient nomination. Whilst the potential for electronic prescription transmission has long been recognised, the development and deployment of EPS as a national system has taken over 16 years. By September 2019, 70% of all prescriptions in primary care were prescribed electronically, stubbornly short of the goal to transfer almost all items this way. Fast forward to earlier this year and the proportion jumped from 79% in February to 85% in April 2020. It is anticipated that the latest stage of roll-out (phase 4), which allows electronic prescribing without a patient nomination, will increase electronic prescribing to over 95%. The green ‘FP10’ will be consigned to the past. EPS as a more efficient prescribing and dispensing process, brings many benefits for NHS, patients, GPs and pharmacy. One benefit is that the patient does not need to be physically present at either surgery or pharmacy as part of the process. This has been critical during the pandemic, particularly for shielding vulnerable patients. Medicines can be ordered online, authorised by the doctor, ‘pulled down’ from the NHS spine by a nominated pharmacy and delivered directly via the Pandemic Delivery Service (due to end on 31 July). The patient does not need to leave their house. As part of EPS and in response to the pandemic, NHS England is hastening the adoption of electronic repeat dispensing (eRD). This allows the prescriber to authorise and issue a batch of repeatable prescriptions for up to 12 months with just one digital signature. All issues of eRD prescriptions are held securely on the NHS spine and automatically downloaded by the patient’s nominated community pharmacy at intervals set by the prescriber. Patients are also driving change. The pharmacies ‘nominated’ by patients for their prescriptions provides an indication of this trend. In just three months post-lockdown, nominations by patients had increased by 12.1%. INTERNET PHARMACIES

Patients are also looking at online options for dispensing their prescriptions. The nominations to Distance-Selling Pharmacies (DSPs) or ‘internet pharmacies’ have grown by 44.5% since December 2019 and 29.7% since lockdown. Whilst DSPs have seen their market share increase during lockdown, these items still represent a small

Amazon’s designs on the pharmacy industry in the UK have recently taken another step forward after the company’s trademark application was approved for the next stage of the registration process

proportion (3.2%) of the one billion items dispensed by community pharmacy each year. Latest data shows that the largest of the DSPs, Pharmacy2U has seen a growth of 116,000 nominations since March, now dispensing over three-quarters of a million items every month. Together with ECHO (part of McKesson), and Well Pharmacy, these three companies have over two-thirds of the DSP market and dispense over a million items monthly. AT RISK

Should this trend continue then bricks and mortar community pharmacies will see a reduction in prescription items, and associated revenue. Add in the recent reduction of funding into the sector and a number of businesses are at risk unless they change their health service model. A game-changer could be the launch of Amazon Pharmacy. Amazon’s designs on the pharmacy industry in the UK have recently taken another step forward after the company’s trademark application was approved for the next stage of the registration process. There is no doubt that the coronavirus pandemic has focused minds and accelerated change which may otherwise have taken months if not years to achieve. The supply chain for medicines is changing; what will be the implications for the industry and how will it respond? Deborah Evans FFRPS FRPharmS FRSPH is Managing Director of Pharmacy Complete, a training and consultancy company working with pharmacy, the NHS and industry Go to www.pharmacycomplete.org M AG A ZI N E | AU G U S T 2020 | 2 5

How to review a

BRAND PLAN How to review a brand plan in four easy steps. WORDS BY

Mike Williams

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

eviewing a brand plan can mean different things depending on who you are and why you’re reviewing it. At a very high level, leaders may just want the summary Life Cycle strategy, the key financials and the ability to compare with other brands so that they can make a portfolio resourcing decision over the next five to 10 years. A global marketing team might be reviewing the brand plan for a specific country to either check alignment to a central strategy or to learn insights that can feed into global decision-making. For the purpose of this article, we’re going to focus on the basics of reviewing a plan to construct a checklist which you might use as a member of a cross functional brand team, or where you are new to the marketing function. Before you start you should give yourself some time in your diary, make sure you have the brand plan in whatever format works best for you (digital or paper ready for scrawled notes) and find a quiet place to focus. Make sure you have a separate place to take notes as we’re going to be going forwards and backwards through the plan. On your notepaper you need to mark out the key elements of the planning process as titles so that you can pull out the relevant information for each section. Most companies have a defined planning process which you can use as a guide, but we’re going to keep it really basic here and use the generic titles ‘Situation’, ‘Strategy’, ‘Tactics’ and ‘Measures’.

F E AT U R E

STEP 1

How will we know if we need a new plan or if we need to improve execution of the current one?

IS THE SITUATION SPECIFIC AND ACCURATE?

The first section of any planning process should include a description of the market situation including the key drivers of customer/consumer behaviour. In our industry, you should expect to see a patient flow describing how the end-users move through the healthcare system and where your product and associated diagnostic tests fit. You should also see a competitor analysis which includes any upcoming launches. You can see the first part of our checklist is already here to make sure all the elements are captured, but there are two specific factors. First, make sure everything is quantified, including the patient flow. If you see the words ‘lots’, ‘many’, ‘few’, ‘often’ then mark them out and make sure you get a specific number for each. We need to decide on our strategy from this data so a simple statement such as ‘The majority of customers complete diagnostic test A’ could mean 51% to 99% of customers. The specific answer may change your strategy or tactic investment. Secondly, try to look at the market through the eyes of your customers, not your company. It can be easy for the excitement for a brand to override reality. For example, you might see in a SWOT analysis that ‘Efficacy’ comes up under ‘Strengths’, however if your customers do not perceive any difference between you and your competitors, then this is not a strength. It can be rephrased as ‘Parity efficacy perception’ and you might well choose to improve the efficacy perception of your brand.

STEP 3 ARE YOUR TACTICS ALIGNED?

If I asked you to write a tactical plan without telling you the product, the therapy area or even if it was launched, you might say this is impossible, but you could probably assume that you’ll use sales representatives, interact with key external experts/ key opinion leaders, have some sort of medical education programme etc. Write down a rough generic set of tactics. Now look at the tactical section of the brand plan and if the lists of tactics are identical then you need to prompt for a more differentiated approach. Look at your ‘What not to do list’ and see if any activities have been added in that do not follow the strategy. Finally, go back to the notes you made on the first part of the plan, review and see if the tactics are scaled large enough to really impact the key drivers in the market. If the budget is spread too evenly, cut some tactics, and focus on a core set which you can invest in at scale.

STEP 4 ARE THESE THE RIGHT MEASURES?

STEP 2 OBJECTIVE, STRATEGY, CSFS AND POSITIONING

This is a big section to cover in one go and with more space we would break this down into individual components, but for the purposes of this checklist we first need to spot that the ‘Objective’ is defined, the ‘Strategy’ is clear and shows that a choice has been made; that the ‘Critical Success Factors’ (CSFs) match the market situation/ drivers and finally that the positioning statement can only apply to your brand. If your statement could apply to any other product, then you’re probably not differentiated enough. This part of the plan should be specific to your company/product/ market so it’s almost impossible to give you a way of assessing if it’s the right way to go, however, a good plan should have made some choices on where to focus. To test this, I would recommend you write a ‘What we’re not going to do list’ and write down which opportunities the plan will not chase, which customer segments they will not follow, which brand attributes they will not promote etc. This simple test can help to ensure that choices and prioritisation have been made in the planning process. Keep hold of this list to make sure there is no drift back towards these areas in the tactics.

Marketers are very good at measuring ‘Stuff’ and our industry has more information available than many others, which can often result in a set of 100 metrics being used to measure the performance of a brand or portfolio. My personal view is that more data points mean more opportunities to spot trends and associations, but if you want to manage a brand you need to identify the most important lead/lag indicators. To review the core measures, ask yourself ‘How will we know if we need a new plan or if we need to improve execution of the current one?’. This should prompt you to consider, what lead indicators show that the plan is working and what would indicate a reason to change. If you can’t see these clearly in the measures, then recommend that a subset is created. Remember, one of the first indicators that you have changed behaviour might be as simple as certain words or phrases appearing in Google searches. REDUCE RISK, IMPROVE PERFORMANCE

Hopefully, this article will give you more confidence to review a brand plan as a member of the cross functional team. While this approach may appear simple, your feedback can help reduce business risk and improve performance so make sure it’s heard. Mike Williams is Managing Director of MiraVeta Consulting. Go to www.miraveta.com M AG A ZI N E | AU G U S T 2020 | 27

F E AT U R E

A Lasting effects Addressing the long-term effects and preventing a negative legacy of COVID-19 amongst the population. WORDS BY

Johnny Skillicorn-Aston and Jeremy Hooper

ddressing the long-term impacts on sickness and disease as a consequence of the COVID-19 pandemic, both causal and additive, will be a continuing challenge for the healthcare sector as it moves through the recovery and restoration agenda. We might understand the epidemiology of the Coronavirus more widely now, but we are less certain on its legacy. One thing is clear; smarter, quicker and larger-scale interventions and more acute models of scrutiny will be critical in lessening the enduring consequences of the pandemic for the nation’s health. Unprecedented in the NHS’ history, it has raised the need to address some key issues. It is for others to determine hierarchy of approach but chief among the varied issues sits the correlation between economic status and poor health, health inequalities and the extra burden the pandemic has placed on this register, and concerns about what should be done to tackle both unmet and rising need. Available data supports the view that people have largely behaved in accordance with the advice given and stayed at home; A&E attendances show a downturn of 50% on last year, while GP appointments show a similar decrease. It could be assumed that patients with symptoms of a minor illness nature might have chosen to just live with them, however, the figures for excess deaths illustrate that this was also the case for other conditions. It is unclear whether this group of people, had they engaged with healthcare professionals, would have had the same outcome. Figure 1. UK PROVISIONAL WEEKLY DEATHS 25000

20000

Deaths no Covid Deaths with Covid Avg. Deaths (2015-19)

15000 10000

Wk. 1 Wk. 2 Wk. 3 Wk. 4 Wk. 5 Wk. 6 Wk. 7 Wk. 8 Wk. 9 Wk. 10 Wk. 11 Wk. 12 Wk. 13 Wk. 14 Wk. 15 Wk. 16 Wk. 17 Wk. 18 Wk. 19 Wk. 20 Wk. 21 Wk. 22 Wk. 23 Wk. 24 Wk. 25

5000

Source: Trend in Weekly Deaths 2020, ONS Weekly Mortality Data

MANAGING EFFECTIVE POPULATION HEALTH

An additional concern is the effect on the 2.2m patients asked to shield from wider society; around 20% have experienced a worsening of their condition and around 30% have been unable to access care. Getting services back on track is not an exact science, new practices in deep cleansing, establishing robust PPE practice and other infection control measures enlarge the challenge. The resumption of effective long-term condition management will help to reduce excess mortality in the coming winter. Dr Anant Jani, Oxford Martin Fellow at the Oxford Martin School, University of Oxford, and population health specialist emphasises an approach that reflects the wider determinants in managing effective population health approaches.

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

The key element is urgency to ensure that the longer-term impacts of the pandemic are not equally sustained

“It is well established that social determinants of health (eg housing, education, transportation, access to jobs, nutritious food, clean air, clean water, support to prevent/recover from substance abuse, etc.) determine 70 to 80% of health outcomes. In the COVID-19 aftermath, we are going to see these factors become even more important and we will need to address them if we hope to maintain the health of our populations.

% of population that gets sick

Figure 2. POPULATION HEALTH

Population approach

Risk reduction approach

Low risk

Medium risk

High risk

Source: Rose, G. A., Khaw, K.-T., & Marmot, M. G. (2008). Rose's strategy of preventive medicine: The complete original text. Oxford, UK: Oxford University Press.

“To promote population health, we must focus on shifting the population risk profile to the left to keep our populations healthy and also decrease the amount of avoidable spend on healthcare. Shifting the population risk profile to the left is even more important in light of the COVID-19 aftermath because many of our citizens will actively transition to states of poor health and once they are in poor health, the level of intervention needed for those individuals to bring them back to a healthy state will be much higher than if we intervened at a population level to control the incidence of their particular morbidity.” URGENCY

This signals a clarion call for earlier interventions that wrap a value-based approach within a population health methodology. Supporting mechanisms to address these factors, individually and collectively, will go far in preventing and/or reducing suffering among our citizens. It will also contribute to lowering the level of resource to address their needs now and in the future. Sustaining innovation within integrated health and care systems will restore services, however, the key element is urgency to ensure that the longer-term impacts of the pandemic are not equally sustained. Johnny Skillicorn-Aston is Communications Specialist, and Jeremy Hooper is Health Economist at Conclusio. Go to www.conclusio.org.uk References Trend in Weekly Deaths 2020, ONS Weekly Mortality Data | Hood CM, Gennuso KP, Swain GR, Catlin BB. County Health Rankings: Relationships Between Determinant Factors and Health Outcomes. American Journal of Preventive Medicine. 2016 02; 50(2): 129-135 | Rose G. Sick individuals and sick populations. Int J Epidemiol 1985; 14: 32–38 | Rose, G. A., Khaw, K.-T., & Marmot, M. G. (2008). Rose's strategy of preventive medicine: The complete original text. Oxford, UK: Oxford University Press | WHO. Social Determinants of Health: The Solid Facts, 2nd edn. Geneva: WHO, 2003.

Hassle-free Pharma, Nurse, Graduate, Healthcare and Medical Device jobs. For more information and our latest jobs, please visit: chasepeople.com

M AG A ZI N E | AU G U S T 2020 | 2 9

Getting under the skin of psoriasis Psoriasis affects around 2% of the population. Although seen as a skin condition, itÂ is an immune condition which can have a physical and psychological impact.

FIND THE BEST SOLUTION WITH CYCLE VALIDATION www.cyclevalidation.com | T: 07708 403102 | info@cyclevalidation.com

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

THERAPY

soriasis is an immune condition which affects the skin, and sometimes the joints. It causes the skin replacement process to accelerate meaning that the usual process of skin replacement, which typically takes three to four weeks, can happen in just a few days. This acceleration results in an excess build-up of skin which usually presents as flaky or scaly patches that can be red, dark, sore, or itchy. Anyone can experience psoriasis. It affects approximately 1.8 million people in the UK and can occur at any age, although the Psoriasis Association says that there are two ‘peaks’ from late teens to early 30s and between 50 and 60. PATTERNS OF PSORIASIS

IT IS BELIEVED THAT PSORIASIS BEGINS IN THE IMMUNE SYSTEM WHEN T CELLS ARE TRIGGERED AND BECOME OVERACTIVE

WORDS BY

Emma Morriss

According to the British Skin Foundation, there are several ‘patterns of psoriasis’. These are: • Chronic plaque psoriasis, the most common form of psoriasis. Plaques usually present on the knees, elbows, trunk, scalp, behind ears and between the buttocks, although they can occur elsewhere, too. • Guttate psoriasis consisting of small spots scattered over the trunk and limbs. The spots can be pink or red on fair skin types and darker on darker skin types. It can be caused by streptococcus. • Palmoplantar psoriasis which affects the palms of the hands and soles of the feet. It may appear at other parts of the body, too. • Pustular psoriasis, a rare form of psoriasis where tiny, yellow, pus-filled spots (pustules) appear on top of very red or darkened skin. Pustular psoriasis can be localised or generalised and can flare up rapidly. Flare ups can lead to hospitalisation for treatment. • Erythrodermic psoriasis is an aggressive and rare type of psoriasis. It affects nearly all of the skin and, in some cases, can also require hospital admission for treatment. • Nail psoriasis can also present in up to half of people with psoriasis. It can cause nail indentations, areas of discolouration, separation of the nail from the bed, thickening of the nails or destruction of nails. Some people may also experience psoriatic arthritis which, as the name suggests, is a type of inflammatory arthritis that affects some people who have psoriasis. It can make joints stiff, swollen and painful.

KEY STATS

1.8 PSORIASIS AFFECTS APPROXIMATELY

MILLION PEOPLE IN THE UK. THERE ARE

TWO PEAKS

30s LATE TEENS TO EARLY

AND 50s TO 60s. SKIN TYPICALLY RENEWS IN

THREE TO FOUR WEEKS WITH PSORIASIS,

it can take A FEW DAYS. M AG A ZI N E | AU G U S T 2020 | 31

THERAPY

WHAT CAUSES PSORIASIS?

PSORIASIS TREATMENTS

RECENT DEVELOPMENTS IN PSORIASIS

It is believed that psoriasis begins in the immune system when T cells are triggered and become overactive, although the exact trigger is still unknown. According to the Psoriasis Association, new research has found that T cells act as if they were fighting an infection or healing a wound. They produce inflammatory chemicals which can lead to rapid skin cell growth causing plaques to form. Psoriasis can, but doesn’t always, run in families, leading some to believe it has its basis in genetics. It is not contagious.

Treatment will depend on the type of psoriasis, the severity of the condition and what works for the individual. It can be a trial and error process to get treatment right, leading to frustration for those living with the condition. Initially individuals should contact their GP to discuss treatments, they may then be referred to a dermatologist in more severe cases. UK charity, the Psoriasis and Psoriatic Arthritis Alliance (papaa) lists the different types of treatments as: • Emollients • Antifungals • Antihistamine • Coal Tar • Steroids • Retinoids • Dithranol • Immunosuppressant therapies • Phosphodiesterase 4 inhibitors • Biologic Agents.

Celltrion Healthcare announced in June that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended expanding the existing marketing authorisation for the subcutaneous (SC) formulation of Remsima® (CT-P13) in an additional five indications including for the treatment of patients with psoriatic arthritis and psoriasis. The subcutaneous formulation can be administered by patients giving flexibility and control. In early June, the Janssen Pharmaceutical Companies of Johnson & Johnson announced new data from two Phase 3 clinical trials, DISCOVER-1 and DISCOVER-2, which showed that TREMFYA® (guselkumab) demonstrated improvements in multiple clinical outcomes including joint symptoms, skin symptoms, soft tissue inflammation, physical function and reduction in radiographic progression at week 52 in adult patients with active psoriatic arthritis (PsA). Guselkumab is currently not licensed for the treatment of PsA and is undergoing evaluation for this use by the European Medicines Agency.

PSORIASIS TRIGGERS

Psoriasis flare-ups can be caused by a range of factors from environment to health. Understanding what triggers a flare up can help people to manage their condition. Common triggers are: • Excessive amount of alcohol • Smoking • Stress • Injury to the skin including cuts and scrapes • Sunburn • Hormonal changes, particularly in women • Medication, including some anti-inflammatories, antimalarial medicines, and ACE inhibitors • Throat infection, such as streptococcal throat infection can cause guttate psoriasis to develop, usually in children and young adults • Other immune disorders, including HIV. Source: NHS.UK

The National Institute for Health and Care Excellence recommends topical therapy as first-line treatment with follow-up review to evaluate effectiveness. Vitamin D may also be prescribed in specific circumstances. If topical treatments do not offer adequate control of the condition, a referral to a specialist is recommended where phototherapy or systemic therapy can be considered. Phototherapy involves exposing the skin to specific types of ultraviolet light, either narrowband ultraviolet B or psoralen with local ultraviolet A (PUVA). Systemic therapy is divided into biological and non-biological therapy. Treatments for psoriatic arthritis include: • Topical analgesics • Non-steroidal anti-inflammatory drugs (NSAIDS) • Corticosteroids • Disease modifying anti-rheumatic drugs (DMARD) • Biologics.

The National Institute for Health and Care Excellence recommends topical therapy as first-line treatment with follow-up review to evaluate effectiveness

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KEY PLAYERS

The key players operating in the psoriasis treatment market are: • Amgen Inc. • Sun Pharmaceutical Industries Ltd. • MSD. • Eli Lilly and Company. • UCB S.A. • Novartis AG. • LEO Pharma A/S. • Celgene. • AbbVie Inc. • Johnson & Johnson Services, Inc. • Pfizer Inc. Source: Fortune Business Insights™

With thanks to the Psoriasis Association.

Sources: Psoriasis Association https://tinyurl.com/yd9eyh5c NHS.UK https://tinyurl.com/yc4o8ln4 | https://tinyurl. com/ya445noq | Leo Pharma https://tinyurl.com/y769nqg9 Capon, F. The Genetic Basis of Psoriasis, International Journal of Molecular Sciences https://tinyurl.com/ y8cxc8m2 | British Skin Foundation https://tinyurl. com/ycmwcwpp The Psoriasis and Psoriatic Arthritis Alliance | https://tinyurl.com/y7ffwu7m | NICE, Psoriasis: Assessment and Management https://tinyurl.com/y97y7krp Fortune Business Insights https://tinyurl.com/ya8wss4z

DRIVEN TO WIN Jo Kemp is Payer Engagement and Outstanding Performer Pf Awards 2020 Winner, here she shares her reaction to winning. INTERVIEW BY

Emma Morriss

id you watch the Pf Awards Ceremony? Yes, I watched it remotely with all my Novartis colleagues who had been to the Pf Awards Assessment Day cross franchise, which was great as we rarely get to support each other at external events such as this. We used Microsoft Teams to dial in and then used your link to watch it live. I watched it in my home office to make sure the WiFi worked! How did you feel when your name was announced? I was taken aback because I didn’t expect the Payer Engagement Award winner announcement to be up first, then to get shortlisted and then to hear my name being called was a shock really – it didn’t seem real! What was lovely though was that my phone started to ping with messages from other Novartis colleagues who hadn’t entered the Pf Awards, but were following on Twitter, which was unexpected support and hugely appreciated. I was even more shocked to discover my name being called out for the winner of the Outstanding Performer Award at the end, as I had not realised this was a category! It feels like a great achievement and I feel very proud to work for Novartis.

I am a very driven individual who puts all my energy into completing projects which are usually bespoke to match the needs of the NHS

Were you expecting it? No, definitely not! Winning once then twice was a total shock! Why do you think you won? It’s always difficult to know how well you come across at events like these. I would like to think the piece of work I did was acknowledged as a challenge but something worthwhile across a system level. I am a very driven individual who puts all my energy into completing projects which are usually bespoke to match the needs of the NHS. What I love about working for Novartis is that they listen to new ideas and help you develop these into fruition. They are not afraid of taking balanced risks with you to try something new. This is a very refreshing way to work and means we earn the respect of our NHS customers early on and develop long-term relationships.

What are you hoping the win will do for you? I hope it gives me, and others at Novartis, the courage to challenge ourselves to do something different in our jobs. Having the confidence and faith to deliver a project whilst overcoming complex challenges, which took eight months to deliver, has been hugely rewarding. I would like to continue to develop bespoke projects that help match the needs of the NHS specifically in the franchise where I work, which is Ophthalmology.

How was the Pf Awards Assessment Day? It was a whistle-stop tour! I was in the middle of training and had been in London the day before and Manchester the day after. There was a major accident on the M1 and at one point I didn’t think I would make my slot! The judges were all very friendly and made me feel relaxed in the room itself, and it’s a fantastic venue overlooking Leicester City football ground.

Would you recommend others enter the Pf Awards in the future? Definitely, it’s a great opportunity to see how others from industry and cross industry see you and your work, which is why it is so valuable to have this positive feedback. Just taking part is a hugely rewarding experience and one not to be feared! Keep up to date on Pf Awards 2021 at www.pfawards.co.uk

Where will you keep your trophy? My trophy will be kept in my office to remind me of what I have achieved in my career.

M AG A ZI N E | AU G U S T 2020 | 3 3

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

Emma Morriss

PHARMA

Chris Dodd

AGENCY

Tom Richards

CONSULTANCY

Andy Holgate CONSULTANCY

Mike Proctor Leading health transformation consultancy, Conclusio, is pleased to announce the appointment of Mike Proctor as its first non-executive chairman. Mike joins Conclusio from his most recent role as Interim Chief Operating Officer at North Cumbria Trust following retirement from his role as Chief Executive of York Foundation Trust. He brings 45 years’ experience gained within the NHS.

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

Andy Holgate has been appointed International Senior Vice President Business Development of neoNavitas Group Holdings Ltd. Andy will be responsible for leading and coordinating business development.

21GRAMS, one of W2O’s operating firms, has appointed Tom Richards as Co-Global Chief Creative Officer. Tom will serve as a creative partner to US-based Frank Mazzola, one of the company’s founding members. Tom joins 21GRAMS from Havas Lynx, where he served as Chief Creative Officer.

Panthera Biopartners appoints Chris Dodd as Executive Vice President of Business Development – Oncology and CNS. Chris joins Panthera from Accelerated Enrolment Solutions (AES) and will specialise in the development of Panthera’s CNS and Oncology Expertise. Prior to joining AES Chris held senior management positions at Medtronic, Beckton Dickinson and Bracket Global now part of Signant Health.

PHARMA

Chris Bath Norgine B.V. has appointed Christopher Bath as Chief Operating Officer. Chris, who has been Norgine’s Chief Financial Officer since 2014, will report to Peter Stein, Norgine’s Chairman and Chief Executive Officer. He will be responsible for all global operations.

MOVERS & SHAKERS

PHARMA

Marc Princen Marc Princen has been appointed the new Global Chief Executive Officer of the Mundipharma network of independently associated companies. In his new role, Marc will be responsible for all Mundipharma strategic and operational matters globally, focusing on seamless execution of the 20202023 Business Plan.

PHARMA

Karen Pulley Consilient Health has announced the internal appointment of Karen Pulley as Sustainability Champion. Karen has been working in the pharmaceutical industry for over 30 years and the focus of her role is to drive Consilient Health’s new ‘Sustainable Business’ strategy.

CONSULTANCY CONSULTANCY

Simon Doyle Simon Doyle is the new Chief Operating Officer of neoNavitas Group Holdings Ltd. He was previously the President of Global Client Relations at STEM Healthcare. Simon will be responsible for accelerating the international expansion of the group beyond the European/US footprint it has currently.

Mark Pringle Mark Pringle has taken up the position of Senior Vice President Capability Development for neoNavitas Group Holdings Ltd. Mark will continue to manage his existing clients through MORExcellent which will become a wholly owned subsidiary of neoNavitas Group Holdings Ltd. Mark will consult with clients and design bespoke offerings which KAMClinic.com now has the capability to deliver.

M AG A ZI N E | AU G U S T 2020 | 35

PHARMAJOBS

COVID-19: CHANGING THE PHARMA WORKFORCE There’s no denying the COVID-19 has changed the world, but will it have a lasting effect on the pharma workforce? WORDS BY Emma Morriss

Recruiting companies will likely be looking to assess virtual engagement skillsets

GRAHAM HAWTHORN MANAGING DIRECTOR, CHASE

t is too early to tell for sure what permanent changes will result from COVID-19, but, for field-based sales staff wanting to stay relevant post-COVID, being able to communicate effectively with customers in person, by video platform or by phone will certainly be key. Healthcare professionals will be doing many more remote consultations with patients, and some will want this to apply to their industry interactions too. To be successful, this will require sales teams to understand that one size does not fit all. Being able to flex approach and adapt to each type of interaction will be crucial. Secondly, since lockdown began, we have witnessed a significant increase in applicants looking to get into pharma. One of the main reasons for this is the industry gaining a higher positive media profile driven by the race to find a coronavirus vaccine. If this interest is sustained post-COVID, it will mean that more talented pharmacists, nurses, graduates etc, will be hired which will raise the industry talent bar even higher. Go to www.chasepeople.com

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

ANDY ANDERSON DIRECTOR, EVOLVE SELECTION

MARK WARD OPERATIONS DIRECTOR, STAR

Since the onset of COVID-19, the sales and marketing aspect of pharmaceuticals and healthcare have changed dramatically and have seen significant impact in terms of being able to engage with NHS customers due to obvious restriction on the ability to interact face-to-face. It’s still early days in many respects with pharma and healthcare companies still trying to understand when and how they will be able to reengage fully with the customers both at primary and secondary care level. Whilst most recruitment was initially put on hold due to COVID-19, we have had many conversations with clients and industry to assess how the future will look from a commercial customer engagement perspective. It’s clear that most organisations are, at least in the short-term, considering a shift towards a full virtual engagement model, but most commonly a hybrid model of face-to-face and virtual engagements. The impact of this means recruiting companies will likely be looking to assess virtual engagement skillsets alongside the traditional face-to-face customer skillsets previously required. We have worked closely with clients at these early stages to understand exactly what these models will look like moving forward. They may indeed vary from market to market according to the needs of the customer and their ability to engage with industry. Go to www.evolvecouk.com

If the NHS witnessed ‘10 years of change in one week’ then pharma had to evolve to remain both relevant and accessible to its customers. There will be a place for faceto-face engagement when time and safety permit, but it won’t be the only channel. Industry has, to varying degrees of success, been utilising multiple channels, but now it’s an essential part of the strategy. We have supported and driven rapid remote enablement of multiple teams across multiple disciplines, delivered digital skills courses, enhanced our digital in-call quality offering, supported clients to increase skills quickly, and engaged organisations on brand value propositions to help ensure digital capability can be put to best use with NHS clinicians. The end user experience has been positive, the NHS has wanted to keep communication channels, and slowly but respectfully, the ‘doors’ are beginning to open. Most pleasing is the way representatives have embraced the new way of working. A desire to practice, a determination to remain compliant, and an understanding that this new world presents the only way to continue communicating with NHS customers. Customer-facing individuals are also commenting how productive a day can be. The desire to learn new skills, and the tools and training that support these, means the future looks bright for the industry and those who engage with it. Go to www.starmedical.co.uk

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