Pf Magazine April 2020

LIFESAVING MEDICINES REPUTATION VACCINES CONTROL LIVING LONGER, HEALTHIER LIVES TIGHT REGULATION COMMITMENT TO HIGH STANDARDS AND STRICT PARAMETERS IN WHICH INDUSTRY HAS TO WORK APRIL 2020

Medicines and Medical Devices Bill

“ Repairing reputations needs to start at home” Page 12

2019 ABPI Code complaints

Drug pricing and reimbursement PHARMAFIELD.CO.UK

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HEAD OF CONTENT

W

Hello.

e are in difficult times; the global pandemic of coronavirus is impacting on all aspects of life.

As countries, communities and companies go into lockdown, it seems trivial to be writing this letter, but it’s important that we keep going, looking after ourselves and each other. And looking out for others is a key element of why we all work in our industry.

Whatever the wider perception of pharma, we are trying to make a difference to people’s lives. Our colleagues are currently trying to develop a vaccine for COVID-19, others are ensuring that the NHS has the medications and medical devices it needs to look after our most vulnerable. We are pulling together to do our bit.

Reflecting on the cover story of this month’s Pf Magazine, we wanted to look at industry’s reputation and what needs to be done to counteract the negative headlines. As with anything, bad news sells, but pharma does so much good that it’s time to shout about our successes, including our colleagues working around the clock to develop a coronavirus vaccine.

The pharma industry is one of the most highly regulated in the UK, but the public aren’t necessarily aware of this. This understanding could help to change perceptions. But in our ABPI article, Dr Rina Newton asks whether self-regulation is working. She analyses PMCPA complaints about industry in 2019 and how issues could be resolved to ensure timely implementation of learning from code breaches.

Rebecca Lanning looks at the role of NICE in drug reimbursement and whether others are now playing a key role in decisions. Claudia Rubin discusses the Medicines and Medical Devices Bill and what’s required to get it right. Oli Hudson explores clinical commissioning group mergers and what that means for pharma, and industry’s partnership working with the NHS is the subject of James Roach and Johnny Skillicorn-Aston’s article.

We also look at Parkinson’s, clinical trials, key account excellence, transfers of care around medicines, the evolution of pharma recruitment and finally, logical reasoning tests.

I hope you find this issue of Pf Magazine interesting. Don’t forget you can keep up-to-date with the latest industry developments online at www.pharmafield.co.uk. Next month we will be publishing our Pf Awards 2020 Post Awards Brochure. In the meantime, stay safe.

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

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M AG A ZI N E | A PR I L 2020 | 1

April 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

REBECCA LANNING

DR RINA NEWTON

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.

Getting it right for all, page 14.

Rebecca is a Senior Consultant at Lexington Communications.

A health policy specialist, she has significant experience delivering Global and European pharmaceutical programmes.

When it comes to reimbursement, NICE no longer holds the cards, p26.

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.

Is self-regulation working? page 16

JAMES ROACH

AMANDA BARRELL

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

What’s the point…of difference, page 20.

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

Reputation control, page 10.

DEBORAH EVANS

Deborah is Managing Director of Pharmacy Complete, a training and consultancy company working with pharmacy and the industry.

On hand: Pharmacy’s role in discharge medicines, page 23.

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. CCG mergers drive integrated care agenda, page 13.

JOHNNY SKILLICORN-ASTON

Johnny is Engagement and Communications Director at Conclusio Limited. 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.

What’s the point…of difference, page 20.

SARAH TAYLOR

Sarah is Commercial Capability Lead at Rubica Change & Analytics. She has a wealth of experience in the pharmaceutical sector, having held a number of key roles in national and global organisations. She applies that experience and her expertise to the challenge of organisational change, supporting pharmaceutical clients to achieve excellence in customer relationships.

The missing piece, page 28.

NIKKI PHAM

Nikki is currently studying an MA in Creative Enterprise in Cardiff. She works as a copywriter, particularly in the space of higher education, early career and business. She is also developing her own creative startup using her skills in social media, communication, illustration, and design.

Logical reasoning tests, page 36.

In this issue 04 NEWS

IN CONVERSATION

24

Bringing you the essential headlines

Clinical trial patient recruitment and engagement

COVER STORY

10

26

It’s time to shout about pharma’s high standards and success

Who has control of drug reimbursement?

INSIDE NHS

13

28

The impact of CCG mergers on pharma

A reasoned approach to key account excellence

POLITICS

14

30

How do we get the Medicines and Medical Devices Bill right for all?

Looking for a breakthrough in Parkinson’s

16 ABPI

ADVERTORIAL

Is industry self-regulation working?

Evolving to meet pharma’s recruitment needs

20 FEATURE

MOVERS & SHAKERS

It’s time for pharma to build on its differences with the NHS

Who’s moving where in the industry?

PHARMACY

23

36

Pharmacy’s role in discharge medicines to prevent readmission

Logical reasoning tests

FEATURE

FEATURE

THERAPY

33

34 CAREERS

QUICK DOSES The N ATI O N A L I N S TIT U TE FO R H E A LTH A N D C A R E E XC E L LE N C E ( N I C E ) has published final draft guidance recommending D OVA P H A R M AC E U TI C A L S ’ avatrombopag for treating thrombocytopenia in people with chronic liver disease needing surgery.

• N I C E published final draft guidance recommending TE VA’ S A J OV Y ® (fremanezumab) for preventing chronic migraine.

• The European Commission has approved A B BV I E ’ S Venclyxto® (venetoclax) in combination with R O C H E ’ S Gazyvaro® (obinutuzumab) for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia.

• The C H M P of the European Medicines Agency issued a positive opinion recommending the approval of S H I O N O G I ’ S FETCROJA® (cefiderocol), a new antibiotic for the treatment of infections due to aerobic Gram-negative bacteria in adult patients with limited treatment options.

• N I C E has published draft guidance that does not recommend Roche’s Polivy (polatuzumab vedotin) in combination with rituximab and bendamustine.

• N OVA RTI S announced that both the FDA and EMA have accepted its Supplemental Biologics License Application and Marketing Authorization Application, respectively, for ofatumumab (OMB157) for the treatment of relapsing forms of multiple sclerosis in adults.

• K YOWA K I R I N I NTE R N ATI O N A L announced that the SMC has enabled access to Crysvita® (burosumab) in the NHS in Scotland to treat X-linked hypophosphataemia, in children with radiographic evidence of bone disease, one year and older and adolescents with growing skeletons.

• N I C E has not recommended Janssen’s Stelara (ustekinumab), for treating moderately to severely active ulcerative colitis in adults.

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

ARTIFICIAL INTELLIGENCE

WORLD FIRST

A

world first breakthrough in artificial intelligence (AI) drug discovery has been announced as a new drug candidate created using AI begins clinical study. A phase I clinical study of DSP-1181 has been initiated in Japan for the treatment of obsessive-compulsive disorder as an initial indication. DSP-1181 was created through the joint research

by Sumitomo Dainippon Pharma and Exscientia, with Sumitomo Dainippon Pharma providing its experience and knowledge in monoamine GPCR drug discovery and Exscientia applying its Centaur Chemist™ Artificial Intelligence platform for drug discovery.

This project required less than 12 months to complete the exploratory research phase, just a fraction of the typical average of 4.5 years using conventional research techniques.

Pf View: AI is proving its worth in many applications to the benefit of industry and patients.

Pf IN NUMBERS

74 CCGs

P f N E W S : B R I N G I N G YO U T H I S M O N T H ' S E S S EN T I A L H E A D L I N E S

SKILLS STRATEGY

More people required The Science Industry Partnership has published the Life Sciences 2030 Skills Strategy in collaboration with the Association of the British Pharmaceutical Industry and the BioIndustry Association, with support from the Office for Life Sciences. It sets out how the UK Life Sciences sector will attract, retain, train and develop the research, manufacturing and technical skills required by a dynamic and diverse UK sector.

The Skills Strategy forecasts the sector’s demand for 133,000 skilled scientific staff through to 2030, all in highly specialised roles across the sector which embraces biopharmaceuticals, medical technologies and the services and supply chain.

Each of the functional areas of the workforce are anticipated to require up to: • 19,300 jobs in Biopharma R&D and 6400 in Biopharma manufacturing • 8000 jobs in MedTech R&D and 46,500 in MedTech manufacturing • 52,400 Service and Supply jobs.

WILL MERGE IN APRIL 2020 CCG mergers, p13

PF AWARDS

Winners announced

T

he Pf Awards 2020 Winners were announced on 12 March, in an event that was live streamed from the Royal Lancaster in London.

The 600 guests, sponsors and candidates were invited to join the Pf Awards online, following the difficult decision to cancel the live event.

In an unprecedented situation for Founding Director of E4H and of Pf Awards – Melanie Hamer – the winners and top finalists were still able to hear their names announced and celebrate their success from the comfort of the own homes and offices.

Candidates, sponsors and guests joined in the celebrations with office parties, virtual meetings and by tuning in at home with their families. Social media engagement was high as everyone shared photos, videos and comments as the Pf Awards Ceremony progressed.

The full list of winners can be found on pages 18 and 19 and the Pf Awards Post Awards Brochure will be published next month.

CORPORATE

Large API Sanofi is to create the world’s second largest API company. It plans to create a new European company dedicated to the production and marketing to third parties of active pharmaceutical ingredients (API).

The project will create a standalone company combing Sanofi’s API commercial and development activities with six of its European API production sites.

The new company would rank as the world’s second largest API company with approximately €1bn in sales by 2022. It is likely to include 3100 skilled employees and to be headquartered in France.

A planned IPO on Euronext Paris would be evaluated with a decision expected by 2022, subject to market conditions.

HIV

PARTNERSHIP RENEWAL ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, and the University of North Carolina at Chapel Hill, a leading global public research university with significant expertise in HIV basic and clinical research, have announced the $20m renewal of their unique, publicprivate research partnership solely focused on discovering a cure for HIV. Pf View: What fantastic news that this partnership to find a cure for HIV will continue.

M AG A ZI N E | A P R I L 2020 | 5

PHARMA.

APPG FOR LIFE SCIENCES

T

he All-Party Parliamentary Group (APPG) for Life Sciences has been relaunched.

Chaired by Daniel Zeichner MP, the APPG will raise awareness of UK life sciences among parliamentarians and explore the challenges and opportunities facing the sector.

At its first meeting since the General Election, the APPG considered how parliamentarians, government and industry can work together to ensure that patients and the economy continue to benefit from innovation in the UK life sciences sector. Leading industry experts from biotech SME Theolytics, the Association of the British Pharmaceutical Industry (ABPI) and Sysmex UK spoke at the meeting, which was attended by MPs and members of the House of Lords.

COMPETITION LAW

SIGNIFICANT FINES Following an investigation, the Competition and Markets Authority (CMA) has found that four pharmaceutical companies broke competition law. The probe by the CMA into the supply of nortriptyline, a drug relied on by thousands of patients every day to relieve symptoms of depression, has resulted in fines totalling more than £3.4m, and a payment of £1m directly to the NHS. It has also led to the disqualification of a company director. The investigation exposed two breaches of competition law: market sharing and information exchange.

Pf View: Given the focus of this issue of Pf Magazine is on the reputation of industry, companies breaking the law in this way give weight to the public’s negative perception of pharma.

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

LIFE SCIENCES

Land of opportunity The Office for Life Sciences has announced six new locations that have been awarded the prestigious status of Life Science Opportunity Zone, helping raise their profile at a national and international level. These zones will be able to attract investment from national and international businesses linking research and business expertise.

They highlight opportunities such as vacant lab space, land to build new facilities, or links with higher education. Their special designation will help them attract investment and deliver jobs, drive economic growth and deliver improved health based on the UK’s expertise in life sciences.

The new Life Science Opportunity Zones are: • Stevenage Advanced Therapies Campus, Hertfordshire • Birmingham Life Sciences Park, West Midlands • Harwell Science and Innovation Campus, Oxfordshire • Cambridge Biomedical Campus, Cambridgeshire • Porton Science Park, Wiltshire • Discovery Park, Sandwich, Kent.

P f N E W S : B R I N G I N G YO U T H I S M O N T H ' S E S S EN T I A L H E A D L I N E S

BREAST CANCER

Screening breakthrough

HIV

FUNDED PREP

T

he Department of Health and Social Care has announced that HIV drug PrEP is to be made available across England. Local authorities will receive £16m in 2020 to 2021 to deliver the preventative HIV treatment. The funding from the Department of Health and Social Care will ensure anyone who is at a high risk of contracting HIV will receive PrEP from their local sexual health clinic to reduce their risk of getting the virus. When taken daily, PrEP is highly effective at preventing HIV transmission from sex or injection drug use. Studies have shown that PrEP reduces the risk of getting HIV from sex by about 99% when taken daily.

NICE

GENERAL PRACTICE

CORONARY GUIDELINE

New package

NICE has published a draft updated guideline on acute coronary syndromes to improve survival and quality of life for people who have a heart attack or unstable angina.

It brings together recommendations from existing guidelines and partially updates: • Unstable angina and NSTEMI: early management (CG94).

• Myocardial infarction: cardiac rehabilitation and prevention of further cardiovascular disease (CG172).

• Myocardial infarction with ST-segment elevation: acute management (CG167).

• Hyperglycaemia in acute coronary syndromes: management (CG130).

The BMA GP England committee has agreed the new GP contract package with a focus on recruitment and retention of the workforce. The committee voted to accept the package of changes to the GP contract for 2020-21, which includes funding to attract more doctors to take up partnership roles and expand the practice team seeing patients in surgeries.

The agreement, which builds on the five-year deal announced last year, is the result of months of negotiations between the BMA and NHS England and NHS Improvement.

It also covers risk assessment, drug treatment, invasive management, cardiac rehabilitation and planning for discharge.

Harnessing photonics, European scientists have created a new mammographic imaging system that determines benign or malignant breast lesions, spelling an end for unnecessary biopsies for millions of women.

Scientists from the Horizon2020 project SOLUS have developed a non-invasive, multimodal imaging system that uses ultrasound and light technologies to easily differentiate between benign or malignant lesions – without having to perform a biopsy.

Similar to a pregnancy ultrasound appointment, a clinician scans the breast with a handheld ‘smart optode’ pen probe that combines light and sound to collate blood parameters and tissue constituents.

Using diffuse optical imaging scientists can monitor changes in concentrations of oxygenated and deoxygenated haemoglobin, collagen, lipids and water present in a suspected tumour against a preprogrammed set of results.

M AG A ZI N E | A P R I L 2020 | 7

Pf IN NUMBERS

Coronavirus guidelines The International Pharmaceutical Federation (FIP) has issued international coronavirus guidelines for pharmacists covering how they should deal with the latest coronavirus outbreak.

Produced by pharmacists and a virologist, ‘Coronavirus 2019-nCoV outbreak: Information and interim guidelines for pharmacists and the pharmacy workforce’, is downloadable in the six official United Nations languages along with other resources on the FIP website.

57% Four in five

JUST

PHARMACY

OF PEOPLE IN THE UK HAD FAITH IN THE PHARMACEUTICAL SECTOR

Reputation control, p10

CLINICAL TRIAL SPONSORS SAY FINDING ELIGIBLE PATIENTS IS A SIGNIFICANT BARRIER In Conversation, p24

145,000 people in the UK are living with Parkinson’s Looking for a breakthrough in Parkinson’s, p30

RESEARCH

Full access Elsevier has given full access to its research and data content on its COVID-19 Information Center for PubMed Central and other public health databases such as the WHO COVID database, for as long as needed while the public health emergency is ongoing. This additional access allows researchers to use artificial intelligence to keep up with the rapidly growing body of literature and identify trends as countries around the world address this global health crisis.

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

PHARMA.

Vaccine candidate Clover Biopharmaceuticals, a China based global clinical-stage biotechnology company focused on developing novel and transformative biologic therapies, entered into a research collaboration with GSK for its protein-based coronavirus vaccine candidate (COVID-19 S-Trimer).

GSK provided Clover with its pandemic adjuvant system for further evaluation of S-Trimer in preclinical studies.

P f N E W S : B R I N G I N G YO U T H I S M O N T H ' S E S S EN T I A L H E A D L I N E S

Mitigating impact To mitigate against the impact of coronavirus (COVID-19) on pharmacy businesses, the National Pharmacy Association is asking the Government to consider a series of urgent contingency measures.

It has requested contingency funding for pharmacies that are required to close due to staff shortages caused

by COVID-19. Many pharmacies are small businesses with existing cash flow problems.

Coronavirus could exacerbate this situation, so an NHS scheme may be necessary to bring forward payments to pharmacy businesses and cover shortfalls.

PHARMA

Fast track Roche’s cobas SARSCoV-2 Test to detect novel coronavirus has received FDA Emergency Use Authorization and is available in markets accepting the CE mark.

PF IN NUMBERS

IN 2019, PMCPA PUBLISHED

74 CASES Is self-regulation working? p16

ICYMI

PHARMACY

ARE VIRTUAL MEETINGS PART OF YOUR CORONAVIRUS CONTINGENCY PLANS? Coronavirus has created worrying times around the world. As businesses set their coronavirus contingency plans, there are ways to ensure that pharma carries on its business as usual by moving from face-to-face interactions to virtual meetings.

E4H shares the benefits of virtual meetings and its capability in running events from ad boards to a live-streamed awards ceremony, for industry and healthcare audiences.

RESEARCH

GOVERNMENT INVESTMENT Government has pledged £20m to develop a new coronavirus vaccine and other new vaccines to combat the world’s deadliest diseases, amid the worldwide coronavirus outbreak.

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.

REDUCING ANIMAL USE IN BIOPHARMACEUTICALS EU directives and animal welfare initiatives keep challenging scientists and industry leaders to change conventional practices. Far from hindering scientific and technological progress, this urge for change has fostered innovation in the biotech industry on a global scale. ProteoGenix share how these directives continue to support the development of integrated solutions to reduce animal use in biopharmaceuticals.

M AG A ZI N E | A P R I L 2020 | 9

REPUTATION CONTROL Why pharma needs to shout about high standards and success

WORDS BY

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

Amanda Barrell

C OV ER S TO RY

TIME TO SHINE

Pharma is hiding its light under a bushel – giving negative headlines free reign to shape the industry’s reputation among the general public.

T

hey say there’s no such thing as bad publicity, but, as the pharma industry is acutely aware, that isn’t always the case.

The 2019 Edelman Trust Barometer found just 57% of people in the UK had faith in the sector. While this figure constituted a two-point increase on 2018, it still ranked the industry markedly lower than its hospital and clinic colleagues, who scored 71% on the same survey.

Part of the problem, say many experts, is a disproportionate number of negative headlines in the mainstream press.

Rina Newton, Managing Director at CompliMed, said: “I don’t think pharma has a particularly good reputation among the general public, purely down to the fact that the amount of bad press far outweighs the amount of good.

“The Association of the British Pharmaceutical Industry (ABPI) does try to get good news stories out there, mainly by its social media channels, but they do not seem to get picked up by journalists in the same way as the more negative ones.”

Recent Competitions and Marketing Authority (CMA) investigations into collusion over prices and wrangles over market access for expensive new drugs, particularly in the rare disease space, have led to scathing coverage, for example.

Such headlines lead to a perception that pharma is “all about profit”, said Sue Farringdon, who is Chief Executive of Scleroderma and Raynaud's UK (SRUK) and Chair of the Patient Information Forum.

“Reports in the press about pharmaceutical companies being investigated over ‘unacceptable and unethical’ price hikes, do cause real concern among the public,” she told Pf. “When patients read that pharmaceutical companies have reportedly increased their prices, and that the NHS is now paying tens of millions of pounds more than they were five years ago, this deepens the level of distrust.”

Ethical Medicines Industry Group (EMIG) Chairman Leslie Galloway agreed that the general public’s image of industry was based, predominantly, on what they read in the tabloids.

“The focus of such articles will, most commonly, be patient access issues linked to pricing or untoward side effects. Sadly, this focus detracts from much of the good that pharma delivers to patients and research,” he added.

The problem isn’t only a matter of journalists only liking a bad news story. The industry also has a traditional conservatism that can stop it from “shouting about its successes”.

“Take the coronavirus, for example,” said Rina. “There is so much work going on, with scientists working 24 hours a day to find vaccines, but we don’t hear about that in the press. Those stories are just not getting out there.

“There’s this view that they can’t talk to the public directly because of the Code of Practice, but that’s an absolute myth.”

Continuing with the example of coronavirus, she said that publicising efforts to find a vaccine would not constitute promotion to the public, as prohibited by the Code.

“We could just say that the pharma industry is putting a lot of money and effort into quickly finding a vaccine – a vaccine that does not even exist yet, so it’s not promotion of a medicine to the public.

It’s just a good news story,” she added.

CONSISTENT COMPLIANCE

This rigid attitude to code compliance can also impact on how healthcare professionals (HCPs) react to industry, which has a knock-on effect on patients.

“The way pharma works with HCPs is so varied. One company will say we need your speaker slides eight weeks before the meeting and will make extensive changes, whereas another will say we need them two weeks before and will only make minor edits. What is the HCP supposed to take from that?”

A survey carried out by this publication last year found that just one third of HCPs trusted pharma, agreeing with the statement: “Overall, I trust the pharmaceutical industry”.

It also revealed that some companies were more trusted than others, with 25% saying their personal experience was a large contributing factor.

BADGE OF HONOUR

Industry’s less-than-flattering reputation, however, is completely at odds with the fact that it is among the most regulated sectors in the UK. Said Leslie: “It is probably fair to say that industry is obsessed with being compliant with regulation. The Medicines and Healthcare products Regulatory Agency (MHRA) ensures that companies are compliant through their thorough industry inspections and we also have the Code of Practice that sets very high standards.”

The general public are less aware of the restrictions, however, which can contribute to the perception of ‘Big Pharma’ as a faceless, corporate entity, shared Sue. “I don’t think the public is aware of the wide reaching and strict regulations that pharma is subject to and an understanding of the environment in which they have to operate might be helpful,” she said.

“Pharma could do more to be transparent about the way it works, and the challenges and risks involved in drug discovery, to better educate people about the operating environment and the constraints that exist in bringing therapies to market.”

Asked if self-regulation worked in this regard, Jill Pearcy, Director of Code Engagement at the ABPI, pointed to the support the current system enjoyed from the MHRA and Government alike.

“If they didn’t think it was working, they wouldn’t support it in the way that they do,” she said.

M AG A ZI N E | A P R I L 2020 | 11

C OV ER S TO RY

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

But repairing reputations needs to start at home, said Rina, who feels companies shouldn’t be scared to share their successes.

“We need to stop using the Code as a stick to beat ourselves with but use it to demonstrate our commitment to high standards,” she went on.

“There are so many companies doing amazing things around compliance, but if you Google them, all you find is the negative headlines. We haven’t really paraded ourselves as upholding the high standards that we’re proud to adhere to.”

Sue agreed, explaining that while patients generally didn’t think the pharma industry “was on their side”, positive work was changing opinions.

“Some organisations have invested in adopting a more patient-centric approach, fostering meaningful engagement and involvement, and there is a greater sense of being in it together to create patient benefit,” she added.

According to Leslie, the best approach for industry wanting to repair reputations is transparency and to focus on what it does best – delivering high value technologies that address patient need.

1 2

Only 57% of people in the UK have faith in pharma.

Good news stories don’t make it through to the public.

3 4 5

The public isn’t aware of the level of regulation in industry.

TAKEAWAYS

The best approach for industry wanting to repair reputations is transparency and to focus on what it does best – delivering high value technologies that address patient need

GRASP THE NETTLE

TOP 5

“We have done research in this area, and the Code of Practice is seen as the right thing to have in place by HCPs and patient organisations.”

She pointed to the huge amount of work companies put into schemes such as Disclosure UK but said there was always more that companies could do to be more transparent.

“I think language is an issue,” she said, “We all come from a very scientific background and people tend to speak in quite technical terms.

“I think we have to be mindful of how we explain what we do. We need to go to people in their language rather than using ours and expecting people to have to translate what we’re doing.”

Robert Smith, the ABPI’s Senior Media Executive, added that pharma had some amazing stories to tell – but that needed to be done in a way that resonated with the audience.

“It is very much the ABPI’s role to help our companies to do that, because what they're doing is truly incredible. We're doing that both in the media, but also across social and digital media,” he said.

The Association’s #ValuingMedicine campaign, which was launched at the start of 2019, aims to make the detail of the UK’s medicines system more accessible, for example.

“Through simple videos and infographics, we try to lift the lid on things like the new Voluntary Scheme and breakdown how the National Institute for Health and Care Excellence works. In the autumn we also launched a second phase covering the research and science aspect of what companies do, telling the development story of a medicine,” explained Robert.

Industry can do more to be transparent.

Pharma needs to focus on what it does best – delivering high value technologies that address patient need.

NHS

CCG mergers drive integrated care agenda What does the latest tranche of CCG mergers mean for pharma? WORDS BY Oli Hudson

P

harma’s stakeholder map is set to change once again, bringing new territory planning challenges, following NHS England’s decision to allow 74 clinical commissioning groups (CCGs) to merge in April to establish 18 new ones.

The new mergers will see the total number of these organisations fall from 191 to 135, with significant variation in the number of CCGs involved in different mergers and the population sizes they will cover.

For example, Kent and Medway Sustainability and Transformation Partnership is merging all of its eight CCGs into one with a population of 1,846,478; while the new Northamptonshire CCG will be formed by merging just two CCGs and will have a population of 730,650.

INTEGRATED CARE AND PHARMA

The latest tranche of CCG mergers is a significant milestone in the journey towards integrated care, as the NHS moves decisively towards the NHS Long Term Plan’s vision of ‘typically’ just one CCG per Integrated Care System (ICS) area.

This collaborative approach will help to deliver a 20% reduction in operational costs, including administration, enabling savings to be ploughed back into frontline services.

Pharma’s account planners will have to consider the needs of a wider population within a CCG area and the NHS’s move towards managing healthcare at a system level, with pooled budgets and collaborative working practices.

This requires a holistic, whole system approach from pharma as CCGs come under pressure to help make savings across whole patient pathways.

NEW ROLES AND RESPONSIBILITIES

Historically, CCGs have been responsible for planning and purchasing healthcare locally. However, as they reduce in number, but become larger in size, they will take on a more strategic role.

In line with this, they will be instrumental in helping the NHS to introduce place-based care and to ensure that providers are doing the right thing for their local population.

They are also expected to formally take on other roles and work from NHS England, which could include specialised commissioning.

The extent to which formularies will be affected by the mergers is unclear.

For example, all the Lincolnshire CCGs are merging but they already use one formulary. However, it will be important for pharma to track variation between CCGs. As the NHS moves towards larger CCGs with pooled resources and budgets, it will be vital for pharma to determine how money flows within these organisations and where it will be spent. This will also demand a tailored approach as there will be considerable variation between different localities as new territories emerge with new budgets and new decision-making units.

Ultimately, pharma is working with a very different type of health economy now and this is being set in stone by CCG mergers, which will be key to delivering many aspects of integrated care.

Oli Hudson is Content Director at Wilmington Healthcare. For information on Wilmington Healthcare visit www.wilmingtonhealthcare.com M AG A ZI N E | A P R I L 2020 | 13

GETTING IT RIGHT FOR ALL With the Medicines and Medical Devices Bill heading through Parliament, what is required to get this legislation right?

WORDS BY

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

Claudia Rubin

POLITICS

T

he Government would like us to view the Medicines and Medical Devices (MMD) Bill, which had its second reading in parliament in March, through the lens of boosting Britain’s long-term prospects outside the EU. While Brexit has made some new legislation in this area essential, this Bill is also a much-needed opportunity to shape the access environment for healthcare innovation.

Broadly welcomed by industry and by members across the House of Commons, the intentions behind the Bill are good. It is in how it will be applied and whether it is bold enough, that we are most interested.

What exactly does it mean when it aims to maintain alignment with EU marketing authorisations, for example? How will it prevent rare disease patients in this country from being excluded from participating in pan-European clinical trials? How comprehensive will the data stored in the proposed new medical devices registry be?

The intention is that the Bill enables the Government to legislate to create a comprehensive statutory register of medical devices in the UK

DETAILED SCRUTINY

MPs recognise the Bill’s importance, not least as a requirement of Brexit, but also because they are keen to protect the pharmaceutical industry. As the single largest private sector investor in UK research and development and a provider of many jobs across the country, it is good to see politicians acknowledging what is at stake.

So, despite broad cross-party support for the Bill, it will attract detailed interest, particularly from those MPs who, judging by their informed contribution to the second reading debate, have a strong sense of the opportunities and pitfalls ahead. This in turn makes it particularly worthwhile for industry to delve carefully into the detail and assist in the Bill’s scrutiny to ensure optimum legislation emerges.

PATIENT SAFETY

Politicians are concerned to see a robust regulatory framework for medical devices. MPs know all too well the NHS’s uncomfortable history of poor regard for patient safety. If publication hadn’t been delayed due to the COVID-19 outbreak, they would have been keenly reading the report from the Independent Medicines and Medical Devices Safety Review (the ‘Cumberlege Review’) which was due to be published in March, and no doubt ensuring the Bill encapsulates the lessons learned from it.

Indeed, better capturing the benefits of innovation without compromising patient safety is one of the four key aims of the Bill, according to the Secretary of State for Health and Social Care. This is certainly a fine line to tread.

There are some welcome examples of where the Bill helps to bring us up to date with innovation, such as in the law relating to manufacturing processes. In the era of personalised medicines, this Bill recognises that hospitals must be able to assemble treatments like gene therapies or 3D printed tablets at the bedside of a named patient.

The Bill also grapples with patient safety. One of the most interesting exchanges so far is around the requirement that the Secretary of State must have regard to the i) safety of MMDs, ii) availability of MMDs and iii) attractiveness of the UK as a market for them. However, as shadow health secretary Jon Ashworth pointed out, will these criteria be of equal value? Given that the Bill confers an extensive range of powers on the Government, enabling it to enact significant change through secondary legislation, further clarity on this aspect is essential.

Giving the Government power to make regulatory changes when necessary, without the need for primary legislation, will allow the UK regulatory environment to be more conducive to rapidly evolving healthcare technology. But it is clear that if the regard for safety is over-emphasised, it will be to the detriment of the second and third priorities. Getting the balance right will be essential and further definitions are required.

DEVICES REGISTER

In devices, the right balance is most keenly going to be needed in the proposed new devices register. The intention is that the Bill enables the Government to legislate to create a comprehensive statutory register of medical devices in the UK. It is suggested that such a register could be held by the MHRA, and that it would be compulsory to register a device with them.

Registries are generally welcomed by industry, who have long argued for better use of the data they generate. Further clarification on the MHRA’s role in the registry, what additional funding will be in place for MHRA’s extra workload, and crucially what the scope of the registry will be, is needed.

With an eye on safety, the Chair of the Access to Medicines and Medical Devices All Party Parliamentary Group, Anne Marie Morris MP, has called for the registry to facilitate following the journey of a device after it is implanted in a patient, in order, for example, to be able to recall faulty units or to evaluate longer-term benefits.

The potential scope and function of a registry is fundamental, given that medical devices do not lend themselves well to randomised controlled trials enabling them to demonstrate in-year savings.

Devices’ value instead often lies in longer term health outcomes and data registry could be pivotal for NICE approval. Seizing the opportunity that a well thought-through registry offers the MedTech landscape is indicative of the need for industry to help ensure we get this piece of legislation just right. Claudia Rubin is a Director at Decideum. Go to www.decideum.com M AG A ZI N E | A P R I L 2020 | 15

It is difficult to conclude clearly why the industry appears to increasingly attract complaints; it is likely that many factors play a part in the overall perception of non-compliance

WORDS BY Dr Rina Newton

C

ompliMed are experts on the Association of the British Pharmaceutical Industry (ABPI) Code of Practice. We consider it highly constructive to provide healthy challenges of Prescription Medicines Code of Practice Authority (PMCPA) processes and decisions in order to help the wider pharmaceutical industry improve its understanding of, and therefore its adherence to, the Code. Fundamentally, the PMCPA administers the Code; the ABPI, and therefore the industry, owns it.

ARE COMPLAINTS INCREASING?

The Code is only enforced on a complaints basis; ‘no complaints’ for a particular company does not necessarily equate to that company ‘being compliant’. Therefore, the volume of complaints received by the PMCPA does not necessarily reflect ‘compliance’ of the whole industry, but it does help indicate who is complaining and about what.

Last year was significant in terms of the volume of complaints processed by the PMCPA. In 2019 they published 74 cases – an increase of 68% compared to 2018.

Although a better statistic to consider is the number of complaints that the PMCPA received, this is unknown for 2019 because the 2019 PMCPA annual report has not been published or even the 2018 report (though we know 87 complaints were received in 2018).

The PMCPA annual report tends to be published many months after the end of the preceding year. A timely report with detailed information on types of complaint, may help the industry identify the aforementioned trends.

In 2019, the biggest group of complainants were healthcare professionals (responsible for nearly half of all complaints received).

In addition, 18 complainants were specified by the PMCPA as being non-contactable.

However, half of these were described as health professionals, potentially increasing the figures further.

Alarmingly, this demonstrates that increasingly the industry’s own key stakeholder is compelled to complain about the industry’s conduct.

Insight could be gathered on what specifically healthcare professionals complain about, whether they initially approach companies directly and whether their complaints amount to eventual Code breaches.

Is self-regulation working?

Is self-regulation still working? Analysis of the PMCPA’s management of complaints about the industry and how issues could be resolved.

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

ABPI

Such outputs may help the industry understand how direct complaints are handled by companies, if customer-facing teams need better training etc. The question remains though, who should gather such intelligence for the industry? The ABPI or PMCPA? The Code of Practice Panel themselves noted in a case report for Biogen (Case AUTH/2965/8/17, no longer available on their website for unknown reasons), that it is “not for the Panel to issue guidance”.

Trends could be addressed by the ABPI through training and support, but its available expertise and resources would need to be enhanced.

The conclusion that can be drawn from a rise in complaints is that, on the face of it, the industry is attracting criticism and companies are failing in their efforts to self-regulate.

WHY IS THE CODE HARD TO ADHERE TO?

Even expert users struggle at times to navigate and interpret the complexities of the Code. Whilst at times content is longwinded, gaps also exist e.g. there is no clause dedicated to patients and in fact, no definition of a patient. It is, therefore, unsurprising that the ‘average’ user may choose not to refer to the Code at all, which does not bode well for engagement.

We have suggested in the past that the use of colour, tables and flow diagrams would help users, in much the same way a company may create engaging standard operating procedures.

The ABPI Code Working Group has also suggested the adoption of a European Federation of Pharmaceutical Industries and Associationslike structure for the Code to aid usability.

Although the ABPI’s active ownership of the Code has risen sharply through their recruitment of a Code Engagement Director and the implementation of the ABPI Compliance Network, more work is required to establish them as the resource on Code advice. In January, the ABPI held a review day following the completion of the Code Working Group’s work. Their outputs will be announced shortly and are expected to include simplification and streamlining.

WHY IS THE INDUSTRY NOT LEARNING FROM PUBLISHED CASES?

Cases published on the PMCPA website provide a valuable means of understanding how principles are applied in practice and provide one of the best opportunities for the industry to quickly and easily digest key learning points and implement improvements in self-regulation.

They are often more useful than simply reading the Code but currently, cases fail the industry on many levels; a ruling can take several hours for an average user to read and digest due to their length, language used and repetition; a case summary only includes the complaint and the ruling, therefore, the average user may not even review important aspects included in a company’s response.

Increasingly, the PMCPA is taking many months to provide rulings to the respondent company, let alone the wider industry, so it can be difficult to implement learnings in a timely manner.

Whilst the earliest published cases were only one to two pages long, rulings are now much lengthier. This could be due to a number of factors: • complaints may be lengthier • company responses can be extremely detailed • the ruling sometimes extends to the Panel’s concerns about unalleged matters • summary sections are not succinct • rulings are appealed.

We have suggested a more structured template for case reports that encourages the Panel to link rulings to the reasons for such decisions, so that the average reader can understand what went wrong and why.

There are many other issues that are not covered in this article – corrections of previous rulings embedded in other cases, mistakes made by the case preparation manager, the allowance of spurious complaints with little or no evidence provided by (often anonymous) complainants, lack of transparency in the complaints process etc.

It is difficult to conclude clearly why the industry appears to increasingly attract complaints; it is likely that many factors play a part in the overall perception of ‘non-compliance’. However, a fundamental part of self-regulation is to continuously reassess and challenge the status quo whilst striving to improve.

For now, providing the industry with clear case rulings, should go a long way in allowing companies to improve their understanding of key principles and how to comply with the Code. Dr Rina Newton is Managing Director of CompliMed. Go to www.complimed.co.uk

TOP 5 TAKEAWAYS 1 It is difficult to know right now exactly how many complaints were received in 2019.

2 Healthcare professionals appear to be the largest group of complainants.

3 The Code can be difficult to navigate and interpret.

4 Delays in providing rulings can prevent timely implementation of learnings.

5 Many factors play a part in the perception of non-compliance.

M AG A ZI N E | A P R I L 2020 | 17

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What’s the point… of difference?

Pharma and the NHS Barriers to partnership working are breaking, it’s time for pharma to build on its differences to be more than a supplier.

WORDS BY James Roach and Johnny Skillicorn-Aston

I

t might be argued that 2020 could be one of those milestone years, which occur every now and then, when two agents of change realise they can walk side by side, speak multiintelligible languages and have more to gain than fear in developing an ever-closer relationship.

Pharma and the NHS are, in the simplest of terms, co-dependent entities. Pharma has a market in the NHS and the NHS has a supplier in pharma, however, it is a relationship that goes beyond the basic supply and demand dynamic.

Through technical, device and drug innovation, the pharmaceutical industry has made a major contribution to disease eradication, cure, management and modification of symptoms. By creating a climate and framework for the development and uptake of the most innovative and life-changing medicines, the NHS has set theground for collaboration and cooperation. Unfortunately, the relationship has all too often run along conventional lines of purchaser/supplier.

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F E AT U R E

THE PARTNERSHIP PIVOT

Across the purchaser/supplier landscape, there have been some oases of change.

Yet, while pharma and the NHS have been gathered around the same watering holes for many years, each has watched the other drink but has often taken flight when the other raises its head or makes a move.

That is changing; conversations are being had more freely about opportunities that once would not have been contemplated.

One word has been the pivot for this; partnership, a hackneyed phrase but one that resonates now with more than the buzz of management-speak.

Both NHS and pharma alike are getting to grips with redefining their relationship.

Factors illustrating this in the NHS include the expanded remit of the Accelerated Access Collaborative (AAC); the 2018 relicencing of the Academic Health Science Networks as the key NHS transformation arm and the creation of NHS England’s Commercial Medicines Directorate.

Likewise, pharma is making its moves and recalibrating its relationship with the NHS through collaboration on risk-sharing and co-production of solutions in partnership with both competitors and the NHS. At the same time, it is focusing on resetting the thinking of NHS staff and patients toward viewing the industry as a contributing partner to, rather than a contractor within, a sustainable world-class health system.

PARTNERSHIP WORKING BREAKTHROUGH

A breakthrough example of this can be found in the 2017 Memorandum of Understanding 1 between pharma and the Greater Manchester Health and Social Care Strategic Partnership Board, which created a partnership that would seek to: • Transform the health, wellbeing and wealth of the people of Greater Manchester • Optimise care • Develop and adopt innovation at pace and scale • Create an environment for flexibility and opportunity to develop outcomes-based pricing methods.

Playing into the changing NHS landscape, its aims neatly connect what once might have been viewed as separate agenda: • Health and wealth • Optimal care and innovation through commercially focused, financial modelling.

A package that includes both a return on investment (RoI) and a social return on investment (SRoI).

Health commissioners are accountable for effective patient outcomes and experience through delivering sustainable and affordable service pathways that give a good RoI. With the advent of Integrated Care Systems, there has been a shift to including a SRoI factor in the commissioning dynamics.

PHARMA’S ROLE IN SUPPORTING THE NHS

There is no question over the place of pharma in providing the chemical and organic inputs to the NHS that deliver remedy, nor the scale of its operations in so doing. A quick look at the facts shows: • In 2017, pharmaceuticals contributed £12.6bn to the UK economy • UK is a major centre, and key player, in the production of pharmaceuticals2 • 41% of the sector’s demand is generated from overseas sales, making the sector the third most export intensive in UK manufacturing 3 .

However, the pharma industry’s place in the hearts and minds of patients and the NHS workforce is less certain. Increasing its approval rating as a trustworthy partner means strengthening how it demonstrates its significant contribution to patient wellbeing through prevention, disease modification and cure, and measuring value beyond what can be captured in financial terms.

Resetting the concept of value by measuring the wellbeing, social, environmental and economic outcomes of a therapy, drug or device is an ideal place from which to build a new partnership model between pharma and NHS commissioners and providers.

STAKEHOLDER APPROACH TO PARTNERSHIP

Taking a stakeholder approach and engaging with all those who might experience change, whether positive or negative, will help those who wish to work in partnership to arrive at a set of common values. This helps with the transition from the conventional purchaser/ supplier model, largely because this approach focuses on what social value has been created rather than the financial return for the investor (health commissioner).

The relationship is less characterised by ‘He who pays the piper’ and more by ‘Share and share alike’.

Marking out a point of difference is no longer about the what, it is now about the how and the what else

Manchester’s example reflects that approach and now dovetails into the ambitions of the NHS Long Term Plan. It is also a model that can be easily embedded within an Integrated Care System and supports measures aimed at addressing the wider determinants of health.

Returning to the AAC, it serves to localise its aims and objectives by: • unlocking the potential that rests in strength of local system relationships and partnerships • drawing on the widest base of experience, knowledge, research and data to develop a cutting-edge pop-health model – analysing from the bottom up to identify where impacts can have greatest effect • evidencing cure – the rate at which morbidity and disability are reduced or constrained.

Moreover, it places pharma at the centre of the patient experience. It makes it an equal partner in a common endeavour to translate innovation and transformation into benefits that can be felt by local people; fires up the entire supply chain by putting patients at its start, not just at its end, and faces up to the significant challenges posed by demographic, procurement and workforce factors.

M AG A ZI N E | A P R I L 2020 | 21

F E AT U R E

Top 5

INFLUENCING CHANGE

Influencing change in how services are planned and delivered; collaborating in developing optimal therapies that modify disease, manage symptoms and help patients normalise their lives, is a role that pharma can embrace now more fully than ever before. This opportunity demands more than being able to demonstrate clinical efficacy, that is a given, the old-fashioned approach of ‘marking out’ is the key. Demonstrating the point of difference pharma makes rests in assimilating the new doctrines in healthcare, adjusting to its demands and focusing on the wider benefits associated with the product.

But in order to achieve this, pharma needs to ask itself: • Does it support a more integrated, value-based, patient-centric and integrated model of care?

• Is it a good fit with the nascent delegated specialised commissioning and transfer of responsibility to sustainability and transformation partnership level?

• Does it provide an innovative medicine to patients at the point of need?

• Can it demonstrate delivery of the national AAC ambition at a local level?

• Is it an opportunity to provide specialist care in community settings and/or in the patient’s own home?

• Does it improve clinical workforce capacity through the use of an innovative medicine, reducing the need for in-patient/clinic and specialist healthcare professional time?

• Does it come with lower monitoring and administration requirements?

• Does it satisfy the ‘asks’ of the NHS Long Term Plan?

- O ut-of-hospital model - P reventative health and opportunities to reduce inequality - Improves quality - Enabling workforce to operate at the top of their licence - Digital applications - Sustainable, affordable and tangible RoI and SroI - Reduce unwarranted variation - Reduce demand - Support ‘Getting it Right First Time’ and ‘RightCare’.

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Takeaways

1

Pharma’s relationship with the NHS goes beyond supply and demand.

The point is not to supply more for less, it is to be more than a supplier; that is the difference

Marking out a point of difference is no longer about the what, it is now about the how and the what else. What, besides the therapeutic target, can be achieved through the take-up of a drug or device within a mixed economy healthcare partnership that delivers national health ambitions for local people? The point is not to supply more for less, it is to be more than a supplier; that is the difference.

James Roach is Managing Director and Johnny Skillicorn-Aston is Communications and Engagement Director at Conclusio Ltd. Go to www.conclusio.org.uk References 1 Greater Manchester Health and Social Care Strategic Partnership Board www.gmhsc.org.uk/wp-content/ uploads/2018/05/05-Pharma-Industry-MoU-CoverSheet-FINAL.pdf | 2 HM Government: Invest in Great www.great.gov.uk/international/invest | 3 The Manufacturers Organisation: Pharmaceutical Sector Bulletin www.makeuk.org/-/media/eef/files/reports/ industry-reports/sector-bulletin-pharmaceutical.pdf

2

Partnership working requires a redefining of the relationship.

3

Pharma needs to take a stakeholder approach and engage with partners.

4

Pharma should sit at the centre of the patient experience.

5

Ultimately, pharma should be more than a supplier.

PHARMACY

ON HAND: PHARMACY’S ROLE IN DISCHARGE MEDICINES Community pharmacy will support newly discharged patients with medication concerns, preventing readmission. WORDS BY Deborah Evans

A

n older patient, recently diagnosed with atrial fibrillation, phoned on a Saturday morning to say she had been discharged from hospital and was very confused about her medicines. I asked her to bring all her medicines into the pharmacy and together we could work out what she was on, ensure she knew how to take her medicines and allow her to return anything that was no longer needed.

We had received a secure digital notification from the hospital through the local discharge referral scheme called Transfers of Care Around Medicines (TCAM) which listed her new medicines and advised which medicines needed to be withdrawn. This referral from the hospital enabled me to confidently support the patient and reduce any harm that may arise from her continuing to take the wrong medicines, or not start those that would help her.

The transfer of care process between secondary and primary care is associated with an increased risk of adverse events, with 30% to 70% of patients experiencing unintentional changes to their treatment or an error being made due to miscommunication.

Patients discharged from hospital frequently need extra support, confused about any changes that might have been made. It’s not unusual for changes to be missed in the repeat prescribing process with patients reverted to the medicines that might have taken them into hospital in the first place.

My patient was unsure about which one of the two anticoagulants she needed to take, and which one needed to be stopped.

She was continuing to take three other medicines that had been discontinued and had chosen to stop a medicine for diabetes believing that it was contributing to her heart failure. She was on 15 different medicines but had 19 in her possession; it was no wonder she was confused.

The consultation left her much clearer about what, when and how to take her medicines and she returned those that she no longer required. Importantly, I ensured that her repeat medicines would be prescribed correctly in future, an important step to avoid the problem repeating itself.

TRANSFERS OF CARE AROUND MEDICINES

TCAM is a local scheme, supported by the Academic Health Science Network and Local Pharmaceutical Committee, and from July 2020, a hospital discharge referral service will be available across the country. Hospitals will be able to digitally refer patients who would benefit from extra guidance around new prescribed medicines to their community pharmacy.

The NHS Discharge Medicines Service is part of a number of measures being introduced as part of the second year of the five-year Community Pharmacy Contractual Framework, and will have a fee attached to it, the details of which are currently under negotiation.

This new service is a further example of how community pharmacy is transforming to be more integrated into the healthcare system whilst improving medicines safety and supporting patients to stay out of hospital. 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

The transfer of care process between secondary and primary care is associated with an increased risk of adverse events

KEY STATS AROUND DISCHARGE

79% OF PATIENTS ARE PRESCRIBED AT LEAST ONE NEW MEDICATION AFTER BEING DISCHARGED FROM HOSPITAL. PATIENTS WHO SEE THEIR

COMMUNITY PHARMACIST AFTER THEY’VE BEEN IN HOSPITAL ARE LESS LIKELY TO BE READMITTED NATIONALLY, SAVINGS OF

£28.8m ARE PROJECTED FROM TCAM SCHEMES, BASED ON A REDUCTION IN LENGTH OF STAY OF 113,406 DAYS AND

2007 FEWER READMISSIONS.

M AG A ZI N E | A P R I L 2020 | 2 3

RECRUITMENT, ENGAGEMENT & DIVERSITY Kate Shaw, Chief Executive of Innovative Trials, discusses the need to be patient-centred in clinical trials. INTERVIEW BY Emma Morriss

T

ell me about yourself and your career history?

Clinical research is a fascinating field. Prior to co-founding Innovative Trials 10 years ago, I worked for a number of large global pharmaceutical companies and at one time was the only patient recruitment specialist for Roche. I established Innovative Trials due to a consistent and growing need for specialist patient recruitment support by pharmaceutical companies and others.

What does Innovative Trials do? Innovative Trials is a clinical trial patient engagement company. We work globally alongside pharmaceutical clients and clinical research organisations (CROs) to address their patient recruitment and retention needs.

Our approach is patient-centred: we go directly to patients, focus on their needs, communicate with them in ways that truly engage, and make sure they are fully informed. Our core team comes from a pharma background and have run trials themselves, which means we also understand the perspective, and challenges, of our clients.

Which therapy areas do you work in? At Innovative Trials we work across all therapy areas and support trials for potential treatments and vaccines, particularly those that are more complex and, therefore, more difficult to recruit to. Projects have involved trials relating to oncology, paediatric arthritis and women’s health.

How can industry improve access to clinical trials? Clinical trials have the potential to make a significant impact on patient care as those participating are likely to receive closer monitoring and best practice care. Despite this, clinical trial recruitment has always been a challenge.

Around four in five clinical trial sponsors say finding eligible patients is a significant barrier 1. If trials miss their recruitment target dates, this can prove extremely costly and inevitably lead to delays in treatments coming to market, if at all.

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

Industry needs to work together to tackle misconceptions; research should be seen as something positive and not something to be afraid of

One challenge is how and when industry considers the needs of patients.

Trial investigators and sponsors primarily focus on trial design and protocol to ensure research achieves its endpoints and gathers the right data to bring a treatment to market. While this is certainly important, little consideration is traditionally given to patient experience. This can often be overcome by building it into the trial design.

Industry needs to ensure all communication avenues are explored: most clinicians do not always know about open clinical trials, so cannot inform their patients. This subsequently limits recruitment opportunities.

Location can also be a barrier. Traditionally, clinical trials have taken place at large sites and hospitals with patients expected to travel regularly for treatment. If we are to improve access, industry needs to take a more localised approach and involve more community-based hospitals.

How can patients be encouraged to participate? For patients, the main challenge remains that many still don’t know what clinical research is or what it involves. We often only hear about it in the media when something goes wrong. Industry needs to work together to tackle misconceptions; research should be seen as something positive and not something to be afraid of. Only by educating people about clinical research will it open them up to the possibility of clinical trial participation.

I N C O N V E R S AT I O N

And of course we, as a whole, need to ensure that any patient materials are produced in the most engaging way for that particular audience and answers their most pertinent questions. This doesn’t always happen.

How can industry encourage diversity in clinical trials? Patient recruitment is not just about finding more people, it’s about finding the right people for the right clinical trial.

Patient diversity is key and yet is something the sector as a whole struggles to achieve.

Relationships are vital in encouraging more patients of all ethnicities to participate in clinical trials. Many people are introduced to trials through their physician, so strong links with them are necessary. The industry also needs to look at how it is engaging with more locally-based community and patient advocacy groups.

Which groups are currently underrepresented? As an industry we must do more to encourage more people from black, Asian and minority ethnic (BAME) communities to participate in research.

Currently, most patients involved with clinical trials are white and middle-class.

We know that not all patients will respond to medical treatments in the same way, which means a lack of diversity limits opportunities to test the safety and effectiveness of new treatments in the widest range of patients.

everyone will want to wear a device or wants a device like Google or Alexa in their home. Industry needs to ensure there are a variety of communication options available that are appropriate for the patient population in question.

How can trials ensure patient retention?

Recruiting enough suitable – and ideally diverse – patients into a clinical trial is only one part of the process. Keeping people engaged so that they do not drop out is equally vital. Without enough patients to report meaningful results, trials may fail.

This in turn puts medicines at risk.

Despite this, patient retention, like recruitment, is often overlooked. The entire patient experience should be considered from the outset: recruiting patients and keeping them engaged means thinking about the type of information they want and how they want to consume it; how they are spoken to; the way they are looked after during the trial and how their family is looked after and treated. Go to www.innovativetrials.co.uk Reference 1 Clinical Trials Transformation Initiative. Moving Recruitment Planning Upstream to Reduce Barriers to Participation: Recommendations from the CTTI Recruitment Planning Project. Presented at SCOPE Summit, 2017

Top 5 takeaways 1 There is a growing need for patient recruitment support in clinical trials.

2 Finding eligible patients is a barrier.

3 Lack of patient diversity limits opportunities to test drug safety and effectiveness.

4 Patient retention is just as important as recruitment.

5 The entire patient experience should be considered.

What’s the future for clinical trials? Clinical trials are becoming more complex, especially with the development of precision medicines for disease subgroups, so increasing patient diversity and addressing issues around patient recruitment will get more pertinent.

Protocols are becoming more demanding for the investigator sites as well as the patients taking part, so study sites will need support to balance priorities. This could be training and coaching staff in patient engagement best practice, helping sites to optimise their performance, or providing practical support to find eligible patients at a local level.

What role can technology play? We are starting to see technology such as voice-powered and wearable devices being used to capture and track trial data. There is certainly a place for these products in making some processes easier, but not M AG A Z I N E | A P R I L 2020 | 2 5

When it comes to reimbursement, NICE no longer holds the cards The upcoming NICE Methods Review begs the question: at what price does a drug represent value for money to the NHS?

T

o date, the National Institute for Health and Care Excellence (NICE) has been unwavering in its response but Kim Darroch, former British ambassador to Washington, claims the US will lobby to hike up drug prices in a UK-US trade deal. So, should we expect a change to how NICE assesses drugs in postBrexit Britain, and does it matter anyway?

Well, Mr Darroch isn’t wrong in his assessment. The US has been forthright in its approach. President Donald Trump may see the UK as a ‘freeloader’1, enjoying the benefit of higher US drug prices subsidising European markets. For instance, the recent furore over Orkambi led to NICE rejecting a 40% discount on the price paid by the US2 .

President Trump is said to be actively taking advice on how the NHS can pay more for US medicines3 and NICE’s price cap – usually beyond the reach of political interference – has been identified as a key target for US negotiators 4 .

However, as long as negotiators focus on the inflexibility of NICE’s cost-effectiveness threshold5 , the threat to the NHS budget in a future trade deal is minimised. As the eventual approval of Orkambi – or the accelerated appraisal of Trikafta – shows, the role of NICE is changing but it isn’t due to Brexit or the demands of a foreign president.

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When it comes to drug pricing and reimbursement NICE has not been the sole arbiter for a number of years

WORDS BY Rebecca Lanning

INFLEXIBILITY

In theory, NICE decides what drugs should be used on the NHS by drawing on evidence of clinical benefits and cost-effectiveness.

It calculates how much it costs for a new drug to produce a ‘quality adjusted life year’ (QALY), or an extra year of good quality life.

If a new drug improves outcomes but is more expensive than the current standard of care, NICE calculates the increase in health and divides this by the increase in cost to determine an incremental cost effectiveness ratio (ICER). NICE’s threshold for acceptable ICERs – between £20,000 to £30,000 – is commonly known as its threshold range.

To put this into context, prior to final negotiations with NHS England, the ICER for Orkambi ranged between £218,000 to £349,000 per QALY gained6.

NICE’s approach led Jeffrey Leiden, Chief Executive of Vertex, to publicly criticise the very basis of its decision-making. He also argued the

appraisal should take into account the potential savings conferred to society and the NHS by new and innovative treatments, such as a reduction in sick leave or fewer hospitalisations. Indeed, this critique is not without precedent and also forms a critical part of the submission from the Pharmaceutical Research and Manufacturers of America7 (PhrMa), the trade group representing US pharmaceutical companies, to the government agency developing the US’ negotiating objectives.

But NICE has not shied away from these limitations. It is acknowledged that the QALY perpetuates health inequalities and spill over effects on productivity. Wider economic returns and social value are ignored in calculations; but NICE rarely rejects a drug on grounds of cost-effectiveness alone8. In reality, the threshold plays a far less important role in appraisal than people think because NICE often approves new drugs far above its stated range at a cost of around £45,000 per QALY9, 10.

F E AT U R E

DRUG PRICING AND REIMBURSEMENT

In fact, when it comes to drug pricing and reimbursement NICE has not been the sole arbiter for a number of years. NHS England has been incrementally implementing a series of mechanisms which signal a sea change in responsibility for affordability and, by extension, the assessment of highpriced drugs. From the creation of the Commercial Medicines Unit, taking over responsibility for Patient Access Schemes and agreeing outcomes-based pricing agreements, it could be said that NICE is becoming sidelined. Indeed, NHS England went one step further with the introduction of the budget impact threshold by effectively making a high budgetary impact the reason for manufacturers to reduce their price, either directly or indirectly, by lowering the cost-effectiveness threshold11.

While this greater oversight allows the NHS to exert more downward pressure on drug prices and negotiate pricing that it deems affordable, reimbursement decisions are still vulnerable to other external pressures.

Herceptin and the Cancer Drugs Fund aside, political intervention in pricing and access has been exceptional over the years.

But Matt Hancock’s intervention in Trikafta in February – not long after reports of a planned No 10 power grab for the NHS12 – is an indication that even NICE’s independence could be under threat.

While the US may want to redesign the NICE process as part of a US-UK trade deal, NHS England has been taking steps to effectively bypass NICE when appraising innovative medicines. This has created a situation where NHS England has a role in affordability so – threshold or not – will it continue to play a key role in applying pressure on drug prices irrespective of a trade deal? Rebecca Lanning is a Senior Consultant at Lexington Communications.

Go to www.lexcomm.co.uk

making your brand

NHS England has been taking steps to effectively bypass NICE when appraising innovative medicines

1

The US may lobby to increase drug prices in a UK-US trade deal.

2

NICE’s approach to decisionmaking has been publicly criticised.

3

References 1 www.ft.com/content/5ec2c642-54b0-11e8-b3ee41e0209208ec | 2 www.decisionresourcesgroup.com/blog/ kalydeco-sailed-vertexs-orkambi-faces-strong-headwindseurope | 3 www.telegraph.co.uk/news/2018/05/15/trumpthreatens-use-us-trade-talks-force-nhs-pay-drugs | 4 www.phrma.org/-/media/Project/PhRMA/PhRMA-Org/ PhRMA-Org/PDF/P-R/PhRMA-Comments-on-USUK-Trade-Agreement.pdf | 5 www.phrma.org/-/media/ Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/ PhRMA-Comments-on-US-UK-Trade-Agreement.pdf | 6 www.nice.org.uk/guidance/ta398/documents/appraisalconsultation-document | 7 www.phrma.org/-/media/ Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/ PhRMA-Comments-on-US-UK-Trade-Agreement.pdf | 8 www. doi.org/10.1007/s40273-014-0158-6 | 9 www. doi. org/10.1002/hec.3086 | 10 www.doi.org/10.1002/hec.864 | 11 www. doi.org/10.1007/s10198-017-0933-3 | 12 www. thetimes.co.uk/article/no-10-power-grab-for-nhs-sparksbacklash-over-turf-war-wf bdn8f3m

more relevant to healthcare systems

NICE rarely rejects a drug on costeffectiveness alone.

4

NHS England has been playing an increasing role in drug pricing.

5

Political intervention in pricing and access could increase.

triducive.co.uk

M AG A ZI N E | A P R I L 2020 | 27

F E AT U R E

THE MISSING PIECE Making the case for a reasoned approach to key account excellence.

Key account excellence requires a change in behaviour and change can encounter resistance

T

he current health provider landscape offers huge opportunities for pharmaceutical companies that are willing to adapt and evolve.

Key account excellence, with its focus on the customer and their priorities, has long been seen as the way to make the most of those opportunities. However, many companies have found it challenging to implement this way of doing business.

We have five practical and proven principles for achieving key account excellence. The first of these is the prioritisation of accounts – an analytical process that enables teams to identify accounts that are ripe for a much closer, mutually-beneficial relationship. It can also pinpoint areas in which you can work with them more productively, where, for example, there’s a match between your products and their patients’ needs. The choice of a key account should always be one that benefits your company, your customer and their patients.

Of course, you shouldn’t look to change the way you work with every customer, even if you could. You may have active and valuable accounts that can be maintained and improved without radical changes. At least, for the moment.

THE MISSING PIECE

Despite its importance, our research has identified a key challenge when it comes to the prioritisation of accounts: establishing a clear understanding of why an account has been prioritised, ie a clear rationale.

• 36% of the companies surveyed were not agreed on the key factors that indicate a customer’s readiness for a changed relationship.

• 33% were not confident that their account teams were focused on the right accounts.

• 15% of individuals felt a clear rationale would improve the way they prioritised their time and effort in key accounts.

Source: Rubica Change & Analytics

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WORDS BY Sarah Taylor

THE VALUE OF A CLEAR RATIONALE

A clear rationale is imperative for three main reasons: 1. Changing customer relationships involves a serious investment of time, energy and resources. You can’t afford to do it for every account, so you need to be sure of focusing on the accounts that present the greatest opportunities.

2. Key account excellence demands cross-functional team support.

Engagement and commitment at every level are essential and a convincingly argued case will help you to persuade everyone to play their part.

The breaking down of silos matters. For example, we recently worked with a customer facing team where an internal medical professional was better placed to develop the relationship. They were able to correct a misunderstanding of the clinical data which was concerning the customer. Someone in a more commercial role could not have had that conversation.

3. A clear rationale will support practical decisions about a key account – identifying needs and opportunities that are currently unmet and setting a direction for future activity.

Recently, one customer facing team, after reviewing their business plan, recognised the need to scale down their ambitions for a key account and settle on a more achievable goal. A solid rationale enabled them to assign the required team roles and responsibilities and set clear action points. With everyone clear about what was required of them, they could move the account in the right direction.

WINNING HEARTS AND MINDS

This way of working focuses on getting closer to the needs and ambitions of key healthcare professionals. But what about your internal stakeholders? They are the people who are going to make it happen and it’s vital that you do everything necessary to gain their enthusiastic support.

Key account excellence requires a change in behaviour and change can encounter resistance. Historically, those who work directly with customers have been given the marketing strategy, segments and accounts and told where to concentrate their efforts. Now they need to adopt a whole new mindset and way of working.

In implementing a major change like key account excellence, it can be tempting to adopt a top-down directive and simply impose the new way of working. The response, however, is likely to be halfhearted at best, when you really need engagement and commitment.

interrogate the proposals. Include a semi-formal mechanism to gather feedback, positive or negative, from the cross-functional or local team. Also signpost it clearly, so that they know where to leave comments.

Your team’s investment of time and energy in the changes will encourage a more positive and engaged way of working. Greater understanding will help them to notice when things are going well and, if they are not, to raise concerns or suggest changes. Finally, remaining flexible is a key element of maintaining key account excellence.

Sarah Taylor is Commercial Capability Lead at Rubica Change & Analytics.

Go to www.rubica.co.uk

Ashfield

See the world in a new light...

INSPIRE CONFIDENCE AND CHANGE BEHAVIOUR

To win everyone’s confidence and support, you have to convince them of the necessity for change and get them involved, exploring, clarifying and passing comment.

Be precise. A generalised commercial ambition is not good enough. “We want more doctors to trial our products!” Yes, but why these accounts and why change the way you service them?

Paint a picture of key accounts that’s information-rich and grounded in reality, not assumptions. Explain the outcomes you expect from evolving relationships.

Articulating and sharing your rationale will prepare people to change their ways of working. It will help them to move away from a reliance on traditional success metrics and tactics and focus on different outcomes.

It can also fundamentally shape beliefs and self-belief. And that matters. They need to see the potential for real change and feel they can make a difference, even if they have worked on the same account for years.

Make it a conversation. Encourage a wider and deeper engagement with the proposed changes. Make it clear that you value honest opinions and listen to what they say. Open dialogue is part of the change process, not just a briefing.

Local workshops are a good platform for exploring intended changes. Critical thinking exercises allow people to

Top 5 takeaways 1 Key account excellence involves getting closer to the needs and ambitions of key healthcare professionals.

2 Prioritisation of accounts is the first principle to employ.

3 You need a clear rationale for prioritising certain accounts.

4 Key account excellence requires behaviour change which can encounter resistance.

Ashfield is a vibrant and exciting recruitment agency Field, office and home based roles Pharma | Biotech | Medical Find your perfect role today www.ashfieldhealthcare.com

5 Remaining flexible is important in maintaining key account excellence.

M AG A ZI N E | A P R I L 2020 | 2 9

LOOKING FOR A BREAKTHROUGH IN PARKINSON’S Will recent investments and developments offer hope for people living with Parkinson’s?

WORDS BY Emma Morriss

W

HAT IS PARKINSON’S? Parkinson’s is the fastest growing neurological condition in the world. It causes ongoing damage to the brain and affects the brain cells which produce dopamine. As the cells stop working it affects the movement of the body.

According to the NHS: • Parkinson’s is caused by a loss of nerve cells in the substantia nigra area of the brain leading to a reduction in dopamine.

• The dopamine reduction is responsible for many of the symptoms of Parkinson’s.

• It is unclear exactly what causes the loss of nerve cells.

There is currently no cure for Parkinson’s and according to Parkinson’s UK around 145,000 people in the UK are living with the condition.

This is predicted to rise to more than 172,000 people by 2030. 18,000 people are diagnosed every year: two people an hour.

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THERAPY AREA

Although it is a progressive condition, people can live well with Parkinson’s on the correct treatment KEY STATS

1 in 37

PEOPLE ALIVE TODAY WILL BE DIAGNOSED WITH PARKINSON’S IN THEIR LIFETIME.

Ultimately, more than one million people are likely to be affected by the condition in the UK, as it includes the impact the condition can have on friends, family members and colleagues, as well as the person living with Parkinson’s.

Parkinson’s can affect anyone, however it is more prevalent in men aged 50 to 89. It is unclear why men are more likely to develop the condition than women. It could be down to a combination of biological and lifestyle factors.

WHAT ARE THE MAIN SYMPTOMS?

There are more than 40 symptoms of Parkinson’s and each person living with the condition can experience symptoms differently. Symptoms can be categorised as motor and non-motor, and people may also experience mental health issues.

Those symptoms most associated with Parkinson’s are tremor, rigidity and slowness of movement, though there is no ‘typical’ experience of Parkinson’s.

Other motor symptoms include falls and dizziness; freezing (feeling stuck to the ground); muscle cramps and dystonia (unexpected contraction of muscles).

Other non-motor symptoms include fatigue; low blood pressure; bladder and bowel problems; restless legs; sleep issues; eating, swallowing and saliva control problems; speech and communication problems; and eye problems.

Mental health issues include mild memory and thinking problems; anxiety, dementia; depression; hallucinations and delusions.

WHAT TREATMENT OPTIONS ARE AVAILABLE?

Although it is a progressive condition, people can live well with Parkinson’s on the correct treatment. Advances in treatments mean that people now have a normal or near-normal life expectancy.

Treatments can include physical therapy, medication, and for some people, surgery.

As every person experiences Parkinson’s differently, treatment will be tailored to the individual. Many people find a combination of treatments work well for them and this can take time to get right.

However, upon diagnosis most people are prescribed levodopa, dopamine agonist or a MAO-B inhibitor depending on their age, lifestyle and symptoms.

Parkinson’s treatments generally work to increase dopamine in the brain, act as a dopamine substitute or block enzymes that break down dopamine.

The main Parkinson’s drugs are: • Levodopa (Co-beneldopa and Co-careldopa) • Dopamine agonists (pramipexole, ropinirole) • MAO-B inhibitors (rasagiline, selegiline, safinamide) • COMT inhibitors (entacapone, opicapone) • Amantadine • Anticholinergics (Procyclidine, Trihexyphenidyl) • Apomorphine • Rotigotine skin patch (Neupro).

AROUND

145,000 PEOPLE IN THE UK ARE LIVING WITH THE CONDITION. TWO PEOPLE ARE DIAGNOSED WITH PARKINSON’S

EVERY HOUR

40 THERE ARE MORE THAN

SYMPTOMS OF PARKINSON’S Source: Parkinson’s UK

M AG A ZI N E | A P R I L 2020 | 31

THERAPY AREA

RESEARCH DEVELOPMENTS

There are a number of research developments which could change the future of treatments for people living with the condition.

VIRTUAL BIOTECH

Each year Parkinson’s UK, its supporters and partners invest more than £4m into the Parkinson’s Virtual Biotech to rapidly develop and test the most promising research findings with the aim of turning them into treatments.

In 2019, the charity partnered with NRG Therapeutics Ltd to discover and develop a potential drug that could safeguard dopamine cells that are damaged by Parkinson’s and slow down the progression of the condition. Building on discoveries that show a direct link between mitochondrial dysfunction and the loss of dopamine cells, Parkinson’s UK invested up to £1m in NRG Therapeutics to develop and translate this pioneering research into a potential therapeutic.

The charity then invested up to £100,000 in research at the University of Sheffield’s Institute of Translational Neuroscience.

The two organisations are working to modify two compounds that boost mitochondrial function in dopamine-producing brain cells and potentially reduce nerve cell death.

The Parkinson’s Foundation in the US granted the charity £200,000 to help support a project seeking to discover new ways that may prevent brain cell death by stabilising the source of energy essential to cell survival.

Results from a recent study, carried out by Neurolixis with funding from the Virtual Biotech programme, looking at an experimental drug (NLX-112) to tackle the debilitating side effect of dyskinesia (involuntary movements) may have potential as a future treatment.

NLX-112 targets serotonin cells inside the brain which are believed to contribute to the development of dyskinesia, by releasing dopamine in an erratic manner. It aims to reduce dyskinesia by decreasing the amount of dopamine released. The results showed that NLX-112 successfully reduced dyskinesia.

EARLIER DIAGNOSIS

Lundbeck has received a grant from The Michael J. Fox Foundation for Parkinson’s Research to find a validated method to diagnose Parkinson’s. Based on a biomarker, the method can potentially lead to earlier diagnosis.

GUT HEALTH AND PARKINSON’S

A new study found that gut bacteria could guard against Parkinson’s. Building on previous research linking brain function to gut bacteria, the study in a Parkinson’s model of roundworms identified a probiotic which prevents the formation of toxic clumps that starve the brain of dopamine.

Researchers from the Universities of Edinburgh and Dundee used roundworms altered to produce the human version of alphasynuclein that forms clumps. They fed these worms with different types of over-the-counter probiotics to see if bacteria in them could affect the formation of toxic clumps. Bacillus subtilis was found to have a remarkable protective effect against the build-up of this protein and also cleared some of the already formed protein clumps.

This improved movement symptoms in the roundworms.

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TREATMENT FOR IRREGULAR SLEEP WAKE RHYTHM

Biogen is acquiring from Pfizer a novel clinical stage asset with application in Alzheimer’s and Parkinson’s. PF-05251749 is a novel CNS-penetrant small molecule inhibitor of casein kinase 1. Biogen plans to develop the Phase 1 asset for the treatment of sundowning in Alzheimer’s and irregular sleep wake rhythm disorder in Parkinson’s.

We desperately need more research to ultimately find a cure for this condition

KAREN’S STORY

M

anaging symptoms with Deep Brain Stimulation Karen, a passionate motorcyclist, was diagnosed with Parkinson’s in 2013, aged 47. Karen describes herself as a ‘fighter’ and has always been determined not to let Parkinson’s get in the way of her living her life.

“There is currently no cure for Parkinson’s, so I firmly believe research into better treatments and therapies is so important. After I was diagnosed, I decided to take part in an 18-month clinical trial, but once the trial had finished, I realised that my condition had deteriorated significantly, and it was very difficult.

“Before my diagnosis, I initially noticed a tremor and weakness in my left leg and problems with my sight but my main symptom after I was diagnosed was dystonia, which is awful muscle cramps, and at its worst I was taking up to 21 tablets a day and 10 injections to control my symptoms. But even this wasn’t enough to always keep the dystonia at bay and I could experience up to 12 attacks a day.

“In 2017 I had Deep Brain Stimulation (DBS), which has been incredibly successful in managing my symptoms. Without the operation, I think I would have ended up needing a wheelchair within a year. It’s been life changing.

“Now I don’t need to take any medication and I am back to 95% normal functionality, an increase on the 70% my consultant told me I could expect.

“I would recommend anyone considering DBS to do your research and speak to the Parkinson’s UK helpline, as not everyone with Parkinson’s will qualify. This has been really successful for me and enabled me to live well with Parkinson’s, but you never know what is around the corner and we desperately need more research to ultimately find a cure for this condition.”

Sources www.parkinsons.org.uk/information-and-support/what-parkinsons | www.parkinsons. org.uk/information-and-support/how-does-parkinsons-progress | www.parkinsons.org. uk/information-and-support/parkinsons-and-mental-health | www.parkinsons.org.uk/ information-and-support/parkinsons-drugs | www.nhs.uk/conditions/parkinsons- disease | www.nhs.uk/conditions/parkinsons-disease/treatment

A DV ERTO R I A L

“Working on international vacancies has really broadened our horizons and allowed us to support long-standing and new clients with a greater breadth of talent for their businesses”

I

t seems hard to believe that almost 13 years have passed since we opened the doors to Evolve in October 2007. We started the business with the focus of becoming a leading UK recruitment and CSO provider within the Pharmaceutical and Healthcare sectors.

Over the past few years working in Evolve; we’ve seen changes within our market.

Initially, our growth was focused mainly within the sales and marketing sectors. Like all companies and markets, we’ve had to adapt our model in line with industry fluctuations to aid the continued success of the business.

EVOLVING WITH PHARMA

WORDS BY

Chris and Andy Anderson

The last three years in particular have been an exciting challenge. We’ve developed our model and expanded to work in sectors that we hadn’t covered previously, driven by both market change and demand from our established client base. A substantial addition to our UK business, was the move to working internationally, particularly across Europe and the US. Whilst initially unknown territory for the business; working on international vacancies has really broadened our horizons and allowed us to support long-standing and new clients with a greater breadth of talent for their businesses.

EVOLVING OFFERING

Another addition to our service portfolio was the establishment of our Executive Search function. Moving into new sectors of the market led to a rise in senior management and C-Suite level vacancies for the business. We felt the requirement was there to dedicate a specialist team of highly-experienced recruiters to partner with our candidates and clients to support demand at this level.

EVOLVING FOR YOU

In conclusion, we feel that there is a healthy future for the industry and we’re really pleased to be in the position to help support the growth and change for our customers. We’re sure there will always be a plethora of new unforeseen challenges ahead and our business is in a strong position to adapt to any changes and move with the times. Establishing long-term partnerships with our clients and candidates, to deliver first-class customer service, will always be our number one priority and remains at the core of all we’re able to offer as a business.

To find out more about Evolve, visit www.evolvecouk.com

WORKING WITH AN EVOLVING NHS

EVOLVING TO MEET PHARMA’S RECRUITMENT NEEDS Brothers Chris and Andy Anderson from Evolve share what their business has to offer in a changing pharma market.

We’re all aware of how the NHS has changed and how Pharma has needed to adapt commercial models in line with these changes. Similarly, as a specialist recruiter and CSO provider, we have done the same.

Whereas previously our specialities were focused around Key Account Management, Market Access and Sales Management; the rise of more clinically-focused positions within the market has led us to also diversify into areas such as Medical, Regulatory, Health Economics and Outcomes Research (HEOR), Clinical, Pharmacy and Medical Engineering.

Over the last two to three years, we’ve seen significant growth for our business in these sectors and have developed trust and respect with our clients, both by resourcing the best talent as a recruitment supplier and delivering highly successful projects as a CSO.

“We’re really pleased to

be in the position to help support the growth and change for our customers”

M AG A ZI N E | A P R I L 2020 | 3 3

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

Hannah Alderton

AGENCY

Kevin Kiely

PHARMA

Mark Bridgewater

PHARMA

PHARMA

Dr Andrew Ellis

Dr William van’t Hoff

The British Biosimilars Association (BBA), the trade body representing the interests of biosimilar manufacturers, has welcomed Dr Andrew Ellis as its new Chair.

Andrew, Director of Secondary Care at Teva UK, is an existing member of the BBA’s steering group and will succeed Kavya Gopal, from Sandoz, as its new Chair.

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Dr William van’t Hoff has been appointed as the next Chief Executive of the National Institute for Health Research Clinical Research Network.

Vectura has appointed Mark Bridgewater as Chief Commercial Officer. The new role will further strengthen the leadership team to drive business development and growth to transform it into a successful contract development and manufacturing organisation.

Medilink UK, the representative body for the UK health technology sector, has appointed Kevin Kiely as Chief Executive Officer. Kevin was co-founder of the Medilink model, which brought together in a formal regional association the health technology and related life science industry, the NHS and universities, to drive innovation across the sector.

PHARMA

Samantha Pearce Industry executive Samantha Pearce has joined Jazz as Senior Vice President, Europe/Rest of World. She joins Jazz at a time of significant company growth, including its expansion into new therapeutic areas in Europe and Rest of World markets.

MOVERS & SHAKERS

CHARITY

Celean Camp FRAME, the medical research charity committed to reducing the number of animals used in scientific testing, has appointed its first Chief Executive Officer. Celean Camp (left) has joined FRAME from the Association of Child Protection Professionals, where she was Director.

PHARMA

Patrick Lansky

PHARMA

Tim Flanagan Applied Photophysics Limited has appointed Tim Flanagan as Chief Executive Officer and member of the Board of Directors effective immediately.

Yposkesi has welcomed Patrick Lansky as Vice President of US sales and marketing.

With 20 years’ biotechnology experience including a decade in contract development and manufacturing organisation cell and gene therapy, Patrick is charged with forging bioprocessing partnerships with US biopharmaceuticals developers.

PHARMA

Tom Keith-Roach AstraZeneca has appointed Tom Keith-Roach as President of AstraZeneca UK. Tom is a 17-year veteran of AstraZeneca who joins the UK team following multiple senior in-country, above-country and global Therapy Area leadership positions.

M AG A ZI N E | A P R I L 2020 | 35

CAREERS

LOGICAL REASONING TESTS What you need to know

Logical reasoning tests are a cornerstone of aptitude tests. They comprise the foundation for many job interviews on assessment days.

But what can you expect from them? WORDS BY Nikki Pham

W

hile it is probably not the hardest type of assessment, logical reasoning tests allow you to demonstrate your logical aptitude. Developed logical skills are an asset as they represent the advanced thinking capacity of a potential team member. Logic allows us to analyse the world around us, draw conclusions and accumulate the necessary data for making informed decisions.

We use logical reasoning to handle day-to-day routines and spontaneous events and employers want to be sure that their employees are able to undertake their direct duties and creative problem-solving. That is why logical reasoning tests are so popular.

WHAT ARE LOGICAL REASONING TESTS?

Logical reasoning tests are very similar to IQ-tests. In general, to solve them you don’t need any specific skills. The majority of tasks use shapes, sequences, and patterns and can also be called diagrammatic reasoning or spatial reasoning tests. Your task will be to manipulate these shapes and patterns using logic and draw conclusions for choosing the correct answer. Some logical reasoning tests assess a more specific part of your logical thinking so may feature abstract, inductive or deductive reasoning.

WHAT DO LOGICAL REASONING TESTS SHOW?

Logical reasoning tests evaluate a person’s capacity to analyse given data and draw logical conclusions. A deeper inquiry can reveal versatile character traits that can demonstrate if you’re good at problem-solving or flexible thinking. Different tests target different logical thinking skills.

• Inductive reasoning is an ability to come to conclusions relying on the patterns and sequences to assess the situation as a complex whole. Inductive reasoning is used every day for basic planning such as time management and task setting. Inductive reasoning abilities can demonstrate how good you will be with business routines.

• Deductive reasoning involves coming to specific conclusions about a situation or an object using general information. For example, Michelangelo is your friend’s tortoise, all tortoises eat fruit, therefore Michelangelo will eat an apple. Deductive reasoning plays a crucial role in creative problem-solving as it involves finding solutions on limited information.

• Abstract reasoning is also called conceptual reasoning as it also uses conceptual thinking. Abstract reasoning is used to identify trends, logical rules, or differences in patterns. The levels of abstract reasoning ability show the flexibility of your intellectual abilities and determine how well you handle new skills and your potential for career growth.

HOW TO PASS LOGICAL REASONING TESTS

Solving logical reasoning tests doesn’t require specific knowledge or skills, they evaluate your way of thinking, so your main objective is to keep calm and take the tasks one at a time.

Don’t overthink them. Read the description and choose a suitable answer, no matter how easy it may sound.

Don’t rush, but don’t spend too much time on a question you can’t figure out; skip it and return to it later. Giving a hard task a second look might help you spot a sequence or pattern you didn’t notice first time around.

Be prepared. The best way to avoid rookie mistakes is to practise. This familiarity will help you to plan your time and build your potential for success with logical reasoning tests.

Go to www.practiceaptitudetests.com

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MEDICAL EDUCATION EXPERTS

#WeAreE4H Looking to reach healthcare professionals?

Let E4H do the promotion for you.

• Create and send engaging mailers • Comprehensive mailing list of healthcare professionals • Segment by location or speciality

To discuss how E4H can help you share your key messages, call Karl Hamer, 01462 226126 or email karl@e4h.co.uk | www.e4h.co.uk

PHARMA JOBS .CO.UK W H E R E P H A R M A TA L E N T G O E S

W H E R E P H A R M A TA L E N T G O E S