Pf Magazine October 2017 by E4H Ltd

October 2017 PHARMAFI E LD.CO.U K

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EDITOR

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

Amy Schofield amy@pharmafield.co.uk ART DIRECTOR

Emma Warfield emma@pharmafield.co.uk COMMERCIAL DIRECTOR

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Rachel Cresswell rachel@pharmafield.co.uk FINANCIAL CONTROLLER

Fiona Beard finance@e4h.co.uk P f AWA R D S

Melanie Hamer melanie@e4h.co.uk PUBLISHER

Karl Hamer karl@e4h.co.uk pharmafield.co.uk e4h.co.uk @pharmafield @pharmajobsuk HEAD OFFICE

Spirella Building Bridge Road Letchworth Garden City Hertfordshire SG6 4ET United Kingdom Cover illustration by Alex Buccheri alexbuccheri.com The content of and information contained in this magazine are the opinions of the contributors and/or the authors of such content and/or information. Events4Healthcare accepts no responsibility or liability for any loss, cost, claim or expense arising from any reliance on such content or information. Users should independently verify such content or information before relying on it. The Publisher (Events4Healthcare) and its Directors shall not be responsible for any errors, omissions or inaccuracies within the publication, or within other sources that are referred to within the magazine. The Publisher provides the features and advertisements on an ‘as is’ basis, without warranties of any kind, either express or implied, including but not limited to implied warranties of merchantability or fi tness for a particular purpose, other than those warranties that are implied by and capable of exclusion, restriction, or modification under the laws applicable to this agreement.

Letter from the Editor

o operate in the pharma industry is to operate on the edge. Fine lines separate success and failure; elation and disappointment. This is particularly prevalent when, after years of research, development and faith in a product, the time comes for NICE to cast its judgement. In our cover story, we look at what happens when a treatment receives the thumbs up, while also discovering what unfolds when the authorities say, ‘sorry, not this time’. During a remarkable Coffee Break I have a chat with the magnificent Kris Hallenga – an icon of self-care who has waged war against breast cancer and, in the process, inspired legions of young people. In addition, we have a feature which focuses on breast cancer; examining the legacy, reporting on the current situation and pondering the future. We also examine the dynamic partnerships occurring between industry and the third sector. The perception is that charities and pharma have completely different motivations but, in reality, there are many common denominators, not least improving the lives of patients and taking on killer diseases. Combining their different skills in these arenas is already making a significant difference. In contrast, our piece on counterfeit medicines uncovers the negative impact that illicit treatments have on industry, patients and wider society, while examining how organisations are fighting back, exposing fakery and protecting patients from deadly products. Once again, our compelling columnists navigate the complex NHS, pharmacy and political terrain, and a host of regulars, including ‘Don’t believe the hype’, ‘Marketing Focus’ and ‘On Your Radar’ complete a captivating line-up. Have an unforgettable day, folks,

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M AG A ZI N E | O C TO B ER 2017 | 1

CONTENTS

03 08 11 12 13 14 16 18 20 23 24 26 30 34

MAGAZINE

N E WS

Bringing you this month’s essential headlines C OV E R S TO RY

A NICE tale of rejection and recommendation

October READER’S VOICE:

OPINION

While reading September’s Pf Magazine, it was great to see how pharma and healthcare organisations are increasingly incorporating virtual and digital technologies into their business. Evolve has recently ventured into this space and has a growing number of clients utilising or seeking to apply virtual interviewing technologies to their recruitment practices. Although this is sometimes daunting for potential users, it’s clear they will play a vital role, ensuring cost savings for companies, and enabling access to a wider pool of candidate applicants. Feedback gained so far regarding our technologies has been extremely positive, despite some initial cynicism due to a shift forward in the recruitment process. Ultimately, digital technologies will enable the pharma and healthcare sector to embrace a new era of recruitment and position themselves as forerunners in an ever-more competitive employment marketplace. Chris Anderson is Director at Evolve Selection.

David Thorne on getting personal with prescribers F E AT U R E

Can Marmite really prevent birth defects? REVIEW

The PM Society Digital Awards in high-res MARKETING

Demystifying market access with Samir Paul OPINION

The Life Sciences Industrial Strategy analysed COFFEE BREAK

Uplifting chat with breast cancer champ F E AT U R E

Pharma and charity in colourful collaborations OPINION

Deborah Evans on why NICE is so underrated

HAVE YOUR SAY: Have you used a digital doctor service? What unusual jobs have you done outside pharma? What are your memories of past Pf Awards Dinners? We’ll be covering these issues in the next Pf Magazine – want to contribute? GET IN TOUCH: hello@pharmafield.co.uk @pharmafield

@pharmajobsuk

Pf Magazine

F E AT U R E

Report on the menace of counterfeit medicines F E AT U R E

Treating breast cancer has come a long way P H A R M ATA L E N T

Learn to fly in the Clinical Nurse category P H A R M ATA L E N T

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

Sage advice from QuintilesIMS’s Tim Mills

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P f N E WS : B R IN G IN G YOU TH I S M O NTH ' S E SS ENTI A L H E A D LIN E S

A PLEASURE M A N U FAC T U R I N G .

& PAIGNTON

£26million pharmaceutical manufacturing unit has been opened in Paignton, Devon. The project has delivered a brand new, 78,000 sq ft manufacturing unit that has all the latest technology and equipment required to provide a modern, class-leading pharmaceutical facility. As the largest NHS manufacturer of sterile products in the UK, the new pharmaceutical unit’s sterile environment enables the research and development of new and innovative medicinal products.

Torbay Pharmaceuticals employs more than 170 people. The unit develops and manufactures a wide range of medicinal products, which are then sold to and used by NHS hospitals across the UK, and healthcare organisations around the world. Proceeds of income generated by the pharmaceuticals unit are ploughed back into local healthcare in Torbay and South Devon, which provides a multi-million pound cash injection for the local population’s needs each year. Sir Richard Ibbotson, Chairman of Torbay and South Devon NHS Foundation Trust, said: “These fabulous new facilities offer a modern, class-leading environment, enabling Torbay Pharmaceuticals to further grow and flourish.” Pf View: A great tonic for the life sciences, job creation and Devon, as a vibrant place on the pharma map. Furthermore, a defiant message to those who thought Brexit meant doom, gloom and the end of civilisation.

N A N OT EC H N O LO GY.

Micromachines

or the first time, nanoengineers have used micromotors to demonstrate the treating of a bacterial infection in the stomach. The tiny vehicles, each about half the width of a human hair, swim quickly through the stomach, neutralising gastric acid, before releasing their load of antibiotics at the desired pH. Nanoengineers at the University of California San Diego demonstrated the micromotor-enabled delivery approach in mice, as a promising new method for treating stomach and gastrointestinal tract diseases with acid-sensitive drugs.

The work is a collaboration between the research groups of nanoengineering professors, Joseph Wang and Liangfang Zhang, at the UC San Diego Jacobs School of Engineering. Wang and Zhang pioneered research on the in vivo operation of micromotors and this study represents the first example of drug-delivering micromotors for treating bacterial infection. The procedure is notable for not using proton pump inhibitors, which can cause adverse side-effects including headaches, diarrhoea and fatigue when taken over long periods of time.

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SKIN CANCER.

SEA CHANGE

LIFE SCIENCES.

GATES OPEN

Walsall-based emollient brand, AproDerm, part of Fontus Health, is sponsoring a huge fundraising challenge to help the fight against skin cancer. The company has committed £15,000 to support ‘Ocean Brothers’ Greg Bailey, 26, and Jude Massey, 18, as they prepare to row the Atlantic Ocean in January 2018. The stepbrothers aim to raise £100,000 for the British Skin Foundation in memory of their father Peter Massey. Peter passed away in August 2015 after an arduous 16-year battle with skin

group of specialist life sciences providers has announced an alliance, the Health Science Business Gateway (HSBG), which will provide comprehensive support for overseas companies looking to establish business operations in the UK. The members of the HSBG include BG Healthcare, Clinical Professionals, Illingworth Research Group, Roboleo & Co and TRAC Services. The new venture will see them working more closely together, and with affiliated organisations, to ‘unlock access’ to the UK life science environment, helping to promote inward investment to the UK in the process. The HSBG will also provide a point of contact to access a comprehensive network of businesses for specialist advice and support in key areas such as regulation, R&D, market development, technology assessment, NHS access, talent landscape and business law. Yvette Cleland, CEO of Clinical Professionals, said: “It is essential that we offer a complementary service that acts as a nationwide gateway for investors wishing to investigate the UK as a destination of choice for their expanding life sciences business.”

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cancer. One year on, the brothers made the decision to cross the second largest ocean in the world to raise as much money as possible for research into the disease. Greg and Jude said: “After seeing Peter suffer for such a long time, we really want to make a difference by funding skin cancer research, so other families don’t have the same sad experience we did. The money that AproDerm are donating goes a long way to helping us achieve that goal.” More information can be a found at oceanbrothers.co.uk

PA R T N E R S H I P S

On Trak

The Cell and Gene Therapy (CGT) Catapult has announced a partnership with UKheadquartered company TrakCel. The agreement involves incorporating TrakCel’s needle-to-needle supply chain management platform into the CGT Catapult’s large-scale cell and gene therapy manufacturing centre. The 7200m 2 structure provides state-ofthe-art facilities and a support infrastructure, enabling collaborators to carry out large-scale manufacturing of cell and gene therapies as they progress towards commercial supply. The partnership will also allow CGT Catapult collaborators to benefit from an established software solution which is able to track cell therapies across the whole supply chain. TrakCel technology will also help establish the Stevenage Bioscience Catalyst, where the services are located, as an emerging global cell and gene therapy cluster.

P f N E WS : B R IN G IN G YOU TH I S M O NTH ' S E SS ENTI A L H E A D LIN E S

SOCIAL CARE

C O M PA N Y N E WS

Counter sale Merck has announced that it is preparing strategic options for its Consumer Health business, including a potential full or partial sale of the business, as well as forming partnerships. The Consumer Health business features a number of leading products in over-thecounter categories. The business focuses on consumer-centric solutions, driven by global megatrends and achieved net sales of €860 million in 2016. Its portfolio includes several brands and products such as Bion, Femibion, Nasivin, Neurobion and Seven Seas. Any possible proceeds from a potential transaction would be used to deliver on the company’s overall financial targets. Belén Garijo, Member of the Executive Board of Merck and CEO Healthcare, said: “We expect increasing internal constraints to fund the business to reach the required scale. Fully anticipating this, we are preparing strategic options.”

Pattern emerges

he Director of Policy at Alzheimer’s Society has called on the Government to act over “poor quality home care”. Rob Burley was responding to a report from Healthwatch England into home care services that has identified four common themes in need of improvement. The report analyses the experiences of 3415 home care users, their families and front-line staff across 52 local areas, between August 2015 and June 2017. Over 400,000 people with dementia currently use home care services. Most of those surveyed were positive about their home care, however, Healthwatch discovered four themes across its research to help commissioners provide and regulate social care services: • Staff members were unfamiliar with their clients’ care plans and on first time visits insufficient time was allowed to enable them to read the care plan. • Some staff members lacked experience and basic skills, such as being able to wash someone or make them breakfast. • Staff members arrived at different times and even missed appointments, which did not meet the needs of the service user. • Providers must look at making greater and more regular use of feedback to address problems early and prevent minor issues turning into complaints. Rob Burley said: “This is yet another warning signal that the crumbling social care system is laying intolerable stress on both staff and people with dementia, leaving homecare workers with their hands tied.”

Quick doses Phase III trial data shows treatment with A S TR A Z E N E C A’s Brilinta reduces risk of death in patients with history of heart attacks. • N I C E recommends treatment with alendronic acid, ibandronic acid and risedronate sodium for preventing bone fractures.

JA N S S E N announces decision to discontinue development of the investigational hepatitis C treatment regimen JNJ-4178. • S A N O F I completes acquisition of Protein Sciences, allowing S A N O F I PA S TE U R to acquire Flublok influenza vaccine for its portfolio.

B I A L and E I S A I announce data confirming effectiveness of Zebinix for treatment of partial-onset epilepsy in adults. • TA K E DA and Japanese biotechnology company N O I L E - I M M U N E B I OTE C H will collaborate to develop chimeric antigen receptor T cell therapies.

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A N T I M I C R O B I A L R E S I S TA N C E

Gon but not forgotten

esearchers from Imperial College London and the London School of Hygiene & Tropical Medicine have tested a new antibiotic, closthioamide, for the first time on gonorrhoea samples in the laboratory. It is hoped that the drug, originally discovered in 2010, could eventually offer an alternative for current antibiotics that are becoming less effective against gonorrhoea. The researchers tested 149 samples of N. gonorrhoeae from hospital patients with infections in the throat, urethra, cervix and rectum. They discovered that at very low amounts, closthioamide was effective against 146 of 149 samples taken from patients, and against all of the samples provided by the World Health Organisation (WHO), which were known to be resistant to other antibiotics. The bacteria which produce closthioamide only make tiny amounts, not enough to test or use, so researchers chemically manufactured it by mimicking the natural structure. Although closthioamide has still to be tested on animals and humans, the scientists say in a paper, published in the journal Antimicrobial Agents and Chemotherapy, that it could be an exciting new step in the fight against the disease. Dr John Heap, lead author from Imperial’s Department of Life Sciences, said: “This new finding might help us take the lead in the race against antimicrobial resistance.” Pf View: This is a rather brilliant ‘roundabout’ way of getting to a successful end point. Creating imaginative alternatives to increasingly useless antibiotics is not a very sexy area, but results like this could prove critical over the ensuing decades.

M E N TA L H E A LT H

HALF A WORLD AWAY Mental health experts have called on health ministers across the Commonwealth to prioritise mental health, as research shows that only 48% of Commonwealth countries have a mental health policy. The research of laws and policies in 52 countries of the Commonwealth, funded by the World Psychiatric Association (WPA), also reveals that lowincome countries are more likely to have mental health policies than high income nations. For those countries with a mental health policy, the research showed that 16% refer to equity of resources between physical and mental illness, while 56% of the policies do not explicitly promote deinstitutionalisation.

Also, almost half (44%) of policies do not explicitly promote the integration of mental health services into general health services. The findings have led the WPA to urge national health ministers throughout the Commonwealth to either introduce new mental health policy or review current policies to ensure those with mental health problems receive help, care and treatment. Dinesh Bhugra, President of the World Psychiatric Association, said: “We call for mental health and mental health discrimination across the Commonwealth countries to be discussed as a priority during the Commonwealth Summit in London in April 2018.”

Pf View: Again, the huge inconsistencies in global mental health provision are exposed. Nearly half of commonwealth countries don’t recognise it in policy form, which reminds us that the journey is only just beginning.

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N E WS FO CUS Looking at a notable story in sharp focus

Hunt’s proposals to cut supervision of technicians by qualified pharmacists branded “bad for pharmacies and patients”

ealth Secretary Jeremy Hunt is reportedly looking at proposals allowing pharmacy technicians to conduct assessments and hand out prescribed drugs unsupervised. Julie Cooper, Labour’s Shadow Minister for Community Care, says that internal Department of Health documents show “they’re drawing up ways to staff pharmacies on the cheap”. The plans, which could cut out the supervisory role of licensed pharmacists in all community pharmacies, say that technicians should be allowed to conduct clinical assessments alone without the supervision of qualified pharmacists.

E X P E R T A N A LYS I S

P f N E WS : B R IN G IN G YOU TH I S M O NTH ' S E SS ENTI A L H E A D LIN E S

TH O R R U N G OV I N D Community Pharmacist Mr Hunt had previously stated that there were no plans to remove pharmacist supervision of medicines supply. The Health Secretary is also proposing abandoning rules which state that a licensed pharmacist should be on site at all times in the pharmacy to make clinical interventions if necessary. The Government cut the community pharmacy budget by 4% in 2016/17 to £2.687bn. Cooper said: “At the heart of each and every community pharmacy is a highly-qualified community pharmacist. Removing the requirement to have such a pharmacist on site is a backward step that will impact on the levels of service provided and lead to an inferior service for patients. “Jeremy Hunt urgently needs to make clear why he’s telling MPs one thing and his Department are saying another. This ongoing uncertainty is bad for pharmacies and it’s bad for patients too.” Ian Strachan, National Pharmacist Association chairman, said: “Medicines have the power to harm as well as heal and it’s irresponsible to even contemplate downgrading safety procedures in pharmacies.” A Department of Health spokesperson said: “We want to make the best use of every member of staff’s skills in pharmacies.”

Pharmacists lead the pharmacy team to ensure the best outcome for patients. The disgraceful attempt to take away the protection afforded by a pharmacist supervising the dispensing process and protecting the public is the latest assault on patient safety. This latest issue is on top of a raft of measures that will have a seismic impact on the way patients receive their medicines. As a pharmacist I have worked with very able technicians as part of a team, however the training that pharmacists receive compared to technicians is not comparable. A five-year rigorous training course to Masters level cannot be substituted, but this seems to be a Government intent on getting healthcare on the cheap at the expense of patients. The plan completely dismisses the important work of pharmacists as they consistently prevent unnecessary admissions to GPs and A&E. Providing NHS flu vaccinations, conducting medicine use reviews and counselling patients are just some of the vital services that pharmacists are capable of providing as Masters-trained medicines experts. I believe this is part of a much bigger process intent on destroying the community pharmacy service now on offer, and replacing it with a dangerous experiment. Last winter nearly 500 ambulances were turned away by A&E departments around the country. With a flu epidemic forecast this winter, it is not the time to be replacing a highly-trained, accessible healthcare professional on the high street who can help to relieve pressure on the NHS.

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NICE

recommendations & rejections report WORDS BY

Amy Schofield

How do medicines make it to market and what is NICE’s role in the process? TE C H N O LO GY A P P R A I SA L S : W H ER E P OT EN T I A L C A N FLO U R I S H Technology appraisals are recommendations by NICE on the use of new and existing medicines and treatments within the NHS. They are either: • Single technology appraisal (STA): Used to assess new technologies; a single drug or treatment, usually new pharmaceutical products or license extensions for existing products. NICE also uses STA for reviews of some published appraisals. This process enables NICE to produce guidance soon after the technology is introduced in the UK. • Multiple technology appraisal (MTA): Used to assess several drugs or treatments for one condition. • Fast track appraisal (FTA): In April this year, the FTA process was introduced to speed up access to the most cost-effective new treatments. Appraisals assess medicines, medical devices, diagnostic techniques, surgical procedures and health promotion activities. NICE bases its recommendations on a review of clinical and economic evidence. Clinical evidence shows how well the medicine or treatment works and economic evidence demonstrates how well the medicine or treatment works in relation to how much it costs the NHS, and whether it represents value for money. Each appraisal can receive one or more recommendation, and can comprise more than one type of recommendation.

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COVER STORY

M A K I N G IT TO M A R K E T In Europe the European Medicines Agency (EMA) carries out the role of granting marketing authorisations, which allow the manufacturer to sell and promote the new medicine for the indication(s) that the regulatory agencies have assessed and approved. Many UK assessments are carried out by the Medicines and Healthcare Products Regulatory Agency (MHRA). Each medicine is assessed to determine if it does what it claims to do. In addition, judgement is made on ‘benefit to harm’ balance.

DECISIONS DECISIONS N I C E H A S FI V E D EC I S I O N T Y P E S : 1 R EC O M M E N D E D

The drug or treatment is recommended for use: • In line with marketing authorisation from the European Medicines Agency (EMA) or Medicines and Healthcare Products Regulatory Agency (MHRA), or • In line with how it is used in clinical practice in the NHS (or both). 2 OPTIMISED

The technology is recommended for a smaller subset of patients than originally stated by the marketing authorisation. 3 O N LY I N R E S E A R C H

The drug or treatment is recommended for use only in the context of a research study, for example a clinical trial. This sometimes happens for new technologies when there isn’t yet enough clinical evidence to make a recommendation for use in the NHS. 4 N OT R EC O M M E N D E D

The treatment is not recommended when there is a lack of evidence for the clinical effectiveness of the technology, or if it’s not considered to be a cost-effective use of NHS resources compared with current NHS practice. 5 R EC O M M E N D E D F O R U S E I N T H E C D F

If there is early evidence that a drug has clinical benefits for cancer patients, but still needs more evidence to prove its cost effectiveness, then it can be recommended for use within the Cancer Drugs Fund, which means that new cancer drugs can be made available to patients much more quickly than before. Source: nice.org.uk

A D C E TR I S ( B R E N T U X I M A B V E D OT I N ) At the end of August 2017, Takeda’s Adcetris was recommended as an option to treat systemic anaplastic large cell lymphoma (sALCL), a very rare and aggressive cancer of the lymphatic system, on the NHS in England and Wales. In June this year NICE decided not to recommend routine funding for the drug, asking Takeda for a revised cost-effectiveness analysis. The drug has been available on the NHS in England via the CDF since April 2013. The final appraisal, however, recommended Adcetris as an option for treating relapsed or refractory sALCL, but only if patients have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and the company provides the drug as per the terms of a commercial access agreement with NHS England. Although “pleased” with NICE’s decision, Takeda professed to be “disappointed” with the restriction. Adam Zaeske, Takeda UK General Manager, said at the time: “It is disappointing that NICE has added a last minute ECOG restriction that could result in a small number of patients no longer having access to the medicine and being left with limited options.” N E X AVA R ( S O R A F E N I B ) NICE recommended Bayer’s sorafenib for use on NHS England for the treatment of patients with advanced hepatocellular carcinoma (HCC) who have a Child-Pugh grade A liver impairment and have failed or are unsuitable for surgical or loco-regional therapies. Bayer agreed a commercial access agreement with NHS England that provides the drug – the only approved pharmacological option for patients with HCC – at an undisclosed discounted price. Sorafenib works by stopping the proteins on the surface of cells, inhibiting tumour growth. It is estimated that it extends life by at least three months. Previously, treatments for patients with advanced liver cancer were limited. Andrew Langford, Chief Executive of the British Liver Trust, said at the time: “Evidence shows that outcomes for people with advanced liver cancer are particularly poor, so any increase in length of life is very important.”

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COVER STORY

“The positive decision followed a four year campaign to secure routine access to Kadcyla”

CA S E STU DY: VO LTE FACE

he decision not to recommend a drug or treatment need not spell the end of hope for patients in need of it. In June 2017, NICE performed a U-turn that was welcomed by breast cancer sufferers, patient groups, charities and clinicians, as the regulator reversed its provisional decision not to recommend Roche’s Kadcyla® (trastuzumab emtansine) for incurable HER2-positive advanced breast cancer in England. The positive decision followed a fouryear campaign to secure routine access to Kadcyla, a treatment already available for access in Scotland and 15 other European countries. The decision reversed the previous draft guidance issued in December 2016, which rejected Kadcyla’s use on the NHS in England. Close collaboration between Roche, NHS England and NICE resulted in NICE recommending Kadcyla as a cost effective treatment. The decision is expected to benefit nearly 1000 women across the UK each year. In the pivotal EMILIA study on 991 women, Kadcyla was shown to increase the median overall survival in women with advanced HER2–positive breast cancer, previously treated with Herceptin and a taxane, by 5.8 months compared with lapatinib and capecitabine. In response to the positive decision, Dr Andreas Makris, Consultant Clinical Oncologist, Mount Vernon Cancer Centre, Middlesex, commented: “Kadcyla is an important treatment option, able to extend life for an average of six months, giving women the invaluable time to spend with their loved ones that they deserve.” Richard Erwin, General Manager of Roche, called it, “a positive example of how solutions can be reached when all parties show flexibility”.

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I N D US TRY I N S I D E R VI E W: JAM E S RE AD Director, Policy & Communications External Affairs, MSD UK

SD has achieved a number of successful recommendations from NICE in recent years, including a series of cancer indications for pembrolizumab. Industry and NICE, however, will need to overcome some important challenges if we are to ensure that UK patients can promptly access new medicines that might be able to help them. The Government’s recently published Life Sciences Industrial Strategy recognises many of the issues and proposes that new medicines be appraised through a single, value-led process, managed by NICE. It will include opportunities for a range of flexible funding and reimbursement vehicles, alongside the ‘NHS Adoption Plan’ for the individual medicine. In the coming years, companies will be seeking many more recommendations for innovative medicines. That will include a range of treatments across many different cancers often in combination with other therapies, supported by a wide variety of clinical evidence. We are confident that together we will find ways to make sure patients can access important new treatments, helping the NHS to keep advancing outcomes for people affected by serious illness across the UK.

WI N N E RS & LOS E RS R ECO M M EN D ED Name: Ibrutinib alone For: Previously treated chronic lymphocytic leukaemia and untreated chronic lymphocytic leukaemia with 17p deletion or TP53 mutation. Name: Pomalidomide, in combination with low‑dose dexamethasone For: Multiple myeloma previously treated with lenalidomide and bortezomib. Name: Everolimus For: Advanced renal cell carcinoma after previous treatment. N OT R ECO M M EN D ED Name: Pegylated liposomal irinotecan in combination with 5‑fluorouracil and leucovorin For: Pancreatic cancer after gemcitabine. Name: High-dose imatinib For: Treating imatinib-resistant or intolerant chronic myeloid leukaemia.

CAN C E R D RU G S

Since 2000, NICE has published 253 individual recommendations on cancer drugs in 194 technology appraisals.

OPINION

“I see companies which are more familiar with NICE than what happens when a prescriber whacks Acmemed 10mg into their computer”

Screen time Do pharma people know what happens to their products at the end of the line?

I WORDS BY

David Thorne

M E AN I N G WHAT ?:

Mind-boggling abbreviations solved FP10 Prescriptions purchased by NHS organisations, such as hospital trusts, and distributed free to medical and nonmedical prescribers. APC Area Prescribing Committees oversee the development of prescribing and medicines management in specific regions. QOF The Quality and Outcomes Framework is a voluntary annual reward and incentive programme for all GP surgeries in England. SMC Scottish Medicines Consortium provides advice to NHS Boards and their Area Drug and Therapeutics Committees.

joined pharma after 14 years in the NHS and was immediately fascinated by sales tactics, account working and the practical detail of prescribing. Fortunately, I had a legendary old-school sales manager to guide me. He constantly emphasised the importance of “the last three feet” in front of a customer. My colleague introduced me to a community pharmacist, which led to revelatory discussions around the practicalities of FP10s, formularies and the early impact of IT systems. Subsequently, as I worked through a dozen launches, this became invaluable. With each new product, I put a line of sticky notes along the wall, working through the challenges we needed to overcome in order to be successful. I worked backwards, starting with the moment a patient walking into the chemist with a prescription. Over the next 10 years I saw the line get longer, as NICE emerged and GP practice IT systems developed. Additional sticky notes kept coming – APCs on the left, QOF in the middle and the workings of online prescribing and dispensing on the right. It strikes me that pharma has become increasingly fascinated with the things furthest away from the endpoint; NICE, SMC, formularies and highlevel reimbursement. These are clearly

important, but the immediate risk is that companies have sometimes assumed that NICE endorsement or formulary acceptance translates to scripts. Companies are becoming less familiar with the things that matter around the point of prescribing exacerbates the problem. In general, I see companies which are more familiar with NICE than what happens when a prescriber whacks Acmemed 10mg into their computer. It is rare to meet someone who has seen what unfolds when their product is entered into the a main practice’s IT systems, or who understands how those systems are set up and edited. Then you have the ‘advisory’ prescribing management systems to comprehend, diagnostic ordering to understand and, especially, the impact of templates that guide HCPs as they move through on-screen algorithms during consultations. Templates are fundamental to primary care, so ask a GP or nurse to show you one and, I promise, you’ll be amazed. Any product manager, sales person or clinical advisor needs to understand how such systems guide HCPs. It is no longer ‘the last three feet’ that can decide your business, but the last three screens. David Thorne is Chair, Washington Community Healthcare and Non-Executive Director, City and Vale GP Alliance. Go to blueriverconsulting.co.uk

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REVIEW Feeling great: Saatchi & Saatchi Wellness team pick up their award from Russell Kane

D I G ITAL LOVE Winners from 2017 PM Society Digital Awards

Yes PM!: The EarthWorks team were thrilled to take two awards home

P R O M OT I O N A L P R O G R A M M E S

Oi Ltd, The Bayer IMCM Lighthouse Project H C P E D U C AT I O N & S U P P O R T

“A bespoke algorithm turned emotional data into unique individual emoscapes”

The Health Hive Group, VR simulation training experience H E A LT H C A R E PA R T N E R S H I P S

The EarthWorks, My PAH PAT I E N T I N I T I AT I V E S

90TEN, Prime – Making HIV history M A R K E T AC C E S S

RFA Advertising & Marketing, Noxafil budget impact model C O N G R E S S/ M E E T I N G S

ebee Health, ERS – GSK respiratory M U LT I C H A N N E L C A M PA I G N

90TEN, Prime – Making HIV history C O R P O R AT E C O M M U N I C AT I O N S

Sandoz International, Sandoz HACk – Healthcare Access Challenge AG E N CY S E L F - P R O M OT I O N

Saatchi & Saatchi Wellness, Saatchi & Saatchi Wellness Rebrand F I L M Health Unlimited, Small steps – COPD life is calling A N I M AT I O N

HealthCircle Advertising, It’s hard to see when CAC starts I N N OVAT I O N : N E W T E C H N O LO GY

The Health Hive Group Ltd, VR simulation training experience I N N OVAT I O N : N OV E L T H I N K I N G

Sudler Milan, Escape Room I N S P I R AT I O N AWA R D

Health iQ, Ground-breaking approach to MPS1 The EarthWorks, MyAsthma app D I G I TA L AC C O U N T M A N AG E R

Doctors.net (Alice Carter) D I G I TA L T E A M

Four Health Media

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MARKET LEADERS: Pharma marketing has at last embraced digital.

lthough it was the eighth PM Society Digital Awards, this occasion seemed to score its signature in the virtual sand more emphatically than ever before. For so long our industry has been a polite bystander, as the rest of the universe leapt on the digital super-highway, but in recent years pharma has seized the zeitgeist and invited it to stay on a long-term basis. Fortunately, PM Society’s Rachel Farrow recognised that this era would come, and created an occasion that specifically celebrated digital wizardry in the brave new pharma marketing world. Thus, the great, the good and the edgy convened at The Brewery, in London. Not least comedian Russell Kane whose observations of the British character and its relationship with alcohol were chillingly familiar, as the raucous laughter would testify. As the awards were distributed by Russell and the disembodied tones of Lotto legend, Alan Dedicoat, we witnessed the sizzling innovation, stunning visuals, incredible apps and inspiring patient engagement that has dragged pharma kicking and screaming into the 21st Century.

Jamie Thompson, Associate Creative Director at Saatchi & Saatchi Wellness, reflected on his team’s victory in the Agency Self-Promotion category: “The rebrand involved the whole agency. And to win for something so personal to our people and their feelings is truly special. “We believe that empathy leads to creativity. That’s why we created the first ever corporate identity that responds to feelings. We captured the emotions of our people using EEG headsets and a bespoke algorithm that turned emotional data into unique individual emoscapes,” he added. Kosha Vyas, Account Manager at The EarthWorks, which scooped the Healthcare Partnerships title, said: “Our strategy, to be an agency exclusively focused on patient engagement, continues to reap rewards for the patients who benefit from the tailored solutions we develop in partnership with our clients. “As we have seen from winning this award, our end-to-end capabilities, from strategic consultancy and research, to the development of world-leading health technology, allows us to provide real world value to patients and their HCPs.”

F E AT U R E

Can eating Marmite prevent miscarriages and birth defects? Don’t believe the hype: health headlines dissected. W O R D S TH E S TO RY ‘Cure’ isn’t a word very often bandied around in clinical research. Results from a study by Australian scientists, however, have apparently shown that Vitamin B3 (found in Marmite) can cure deficiencies which cause miscarriages and birth defects. What are the facts behind the hype?

TH E R E S E A RC H Researchers at Sydney’s Victor Chang Cardiac Research Institute, led by Professor Sally Dunwoodie, discovered that deficiency in a vital molecule, nicotinamide adenine dinucleotide (NAD), prevents a baby’s organs from correctly developing in the womb. Researchers took four families that each had a child with multiple birth defects, and carried out genetic sequencing. After discovering gene mutations that affected production of NAD, they looked at similar disease-causing mutations in mice and the effect that increasing vitamin B3 in the diet had on preventing malformations in developing embryos. Vitamin B3, also found in meat and green vegetables, is needed by the body to make NAD. Previous studies showed

WISE

that despite pregnant women taking vitamin supplements, at least a third have insufficient levels of B3 during the critical first trimester of embryonic development. The new findings indicated that pregnant women may need more of the vitamin.

TH E R E S U LT S The researchers studied the effect of vitamin B3 on developing mouse model embryos, with what they called ‘astounding’ results. Before vitamin B3 was introduced into the mother’s diet, embryos were either lost through miscarriage, or offspring were born with severe birth defects. After the supplements were given, both miscarriages and birth defects were completely prevented, with all offspring born healthy.

TH E D E A L

Amy Schofield

Miscarriages and birth defects happen for a range of reasons, not because of one rare genetic mutation. In addition, three of the four children included in the study were the offspring of parents related by blood, which could indicate that the type of genetic mutations studied are more specific to the children of parents who are related. Clearly, the effect of increases in vitamin B3 consumption would still need to be tested in humans and, love it or hate it, we should conclude that these headlines are hyping.

W HAT TH E PR E S S SA I D : “Why Marmite could prevent miscarriages and birth defects” Telegraph.co.uk “Why MARMITE could be the secret to a healthy pregnancy” Mirror.co.uk “Vitamin B3 could prevent birth defects, miscarriages, scientists say” Foxnews.com

The results could indicate that the benefits of vitamin B3 are more broadly applicable to the wider population and are not limited to a rare genetic condition, however, the research does not necessarily translate to reducing miscarriages in human females, as pregnancy outcomes in women were not studied.

THE NAME MARMITE derives from a

TYPE OF FRENCH

COOKING POT

115 36%

MARMITE’S RECIPE HAS REMAINED UNCHANGED IN

YEARS

A single serving

CONTAINS OF THE RECOMMENDED DAILY ALLOWANCE OF B3

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MARKET ACCESS:

What’s the plan? BUILDING A CULTURE OF PERFORMANCE Inicio works with pharmaceutical and life sciences organisations to optimise their sales through a more intelligent approach to data. We enable our clients to make better use of their commercial data, gain better insight, make better decisions, and drive more sales.

QUALITY INTREGRITY COLLABORATION COMMITMENT

Over time market access has become increasingly important to the pharma industry. W O R D S B Y Samir Paul

ith different roles interpreting market access in different ways, the need to define what it means and develop a robust plan of attack, alongside the need to evaluate the success of the market access plan, means it is now as critical as ever to plan effectively for future success. Inicio Consulting’s Samir Paul shares his expert insight.

TH E M E AN I N G The phrase market access can be interpreted in many different ways, and has in times gone by been a bit of a mystery to some, if not many. In a complex NHS and healthcare environment, with clinical and non-clinical stakeholders under increasing pressure to deliver value healthcare solutions to patients, it is time for industry to better understand and align with our customers in order to deliver high quality care through high quality products and services. In our view, market access is about delivering a package of care to patients, with demonstrable clinical value and cost benefit with an integrated and clear value proposition.

TH I N K LO CAL +44(0)7595 821220 info@inicio.consulting www.inicio.consulting

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Market access is no longer about delivering the single same message to every payer-type customer on a target list. Localised strategies are key to ensuring that your market access plan can be implemented successfully. The tailoring of value propositions with appropriate

messaging and channel use is critical to ensure that as an industry, we are closely aligned to both local and national healthcare agendas, while meeting the needs of customers working in differing healthcare environments.

C ROS S - FU N C TI O NALIT Y In terms of developing and implementing market access strategies, as an industry we have often worked in silos – marketing develops the brand strategy; market access develop their strategy; medical will likely have their own objectives and so on. What is critical, however, is not thinking of market access as a separate deliverable. Successful market access strategies require all functions of an organisation to work closely together, bringing their own experience and expertise to the table in order to develop one robust, clear and integrated plan. We all talk about our passion to deliver innovative and ground-breaking medicines to patients, and if this is the case, I genuinely believe that if our industry worked in a more integrated cross-functional manner, we would deliver more value.

MARKETING

WH O AR E YO U R CUS TO M E RS? Who are market access customers? Broadly speaking, anyone involved in the decisionmaking process. We have tended to place customers into segments, namely those who are ‘market access’, and those who are not. Historically, we have worked with the notion that key opinion leaders or external experts; Commissioners, Formulary Pharmacists, Medicines Management, Public Health and so on, are the ‘market access’ segment and those that fall outside are not. I would argue that although these customer groups could be imperative to brand adoption, it is critical to think in a more integrated way; in that there are other clinical and non-clinical stakeholders who have a part

to play in the decision-making process. Let’s not only think of those who govern policy and funding as our only market access customers; it is essentially anyone who can play a role in driving the success of your brand and delivering positive outcomes for patients.

E VALUATI N G TH E I M PAC T In terms of how we evaluate the success of what we do, we subconsciously look to sales performance, what our customerfacing personnel are delivering in terms of quantity and quality, and we are always trying to understand if the ‘message’ has been delivered. I have to challenge thinking as to whether this is enough? Do we really have a clear grasp as to whether the NHS understands our proposition, do our customers believe it and, subsequently, will they act upon it? We measure a lot of the ‘what’ without necessarily understanding ‘why’ stakeholders believe what they do and how our stakeholders behave. Should we dig deeper into insights that genuinely inform us about whether our ‘package’ of care is delivering value to our patients and the NHS? Samir Paul is Founder and Director of Inicio Consulting.

SUMMARY

Market access is about delivering a package of care to patients

Demonstrating clinical value and cost benefit are critical

Think local, while aligning to national strategies where relevant

Cross-functional working ensures delivery of value

Consider segmenting and targeting customers/ stakeholders based more broadly on who participates in the decision-making process “Market access is no longer about delivering the single same message to every payer-type customer on a target list”

When evaluating the success of market access strategies, think more closely about the ‘why’ behind the ‘what’. Inicio provides a range of Insights, Analytics & Performance services to help pharmaceutical companies evaluate the impact of their market access strategies. For further details, please contact samir.paul@inicio.consulting, call 07595 821220 or go to inicio.consulting

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POLITICS

ith expectations of the Brexit-befuddled minority Government low, the mere publication of a policy document is considered an achievement. Whether the policy recommendations contained within are implemented, is another matter. The newly published Life Sciences Industrial Strategy (LSIS), is a result of the Government asking Lord Bell to bring the life science industry together, and thus lay out the sector’s vision of how the UK might exploit its existing strength and increase the pace of economic growth. Life sciences is already one of the dominant economic sectors in the UK and, according to one analysis, it generates a £64 billion turnover, employing more than 233,000 scientists and staff. The opportunity is significant and potential rewards even more so. Its economic significance assured, a further political point is that the sector is widely distributed across the UK and brings significant growth to virtually every region, further solidifying its position and potential clout. Life sciences give credibility to the Prime Minister’s otherwise less tangible attempts to talk up her Government’s industrial strategy.

For whom Lord Bell tolls An old friend returns and she has the Life Sciences Industrial Strategy in her sights.

THEME AND US: Claudia analyses the LSIS The LSIS has five key themes – science, growth, NHS, data and skills. SCIENCE

Establish a coalition of funders to introduce the Health Advanced Research Programme and undertake large research infrastructure projects. CR: Though an opportunity for industry to be a substantive partner to Government, it places the burden of risk on the coalition of funders – namely the pharmaceutical industry.

G R OW T H

Create four UK companies valued at above £20 billion in the next ten years. CR: Using nationally and regionally available incentives makes this appealing, but the focus on larger companies suggests that growth among smaller companies will not be as visible or rewarded equally.

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NHS

All new medicines appraised through a NICE-managed process – with opportunity for reimbursement, contractual arrangements, and value assessment beyond QALY. CR: Though this would seem that a key long-term battle has been won, it comes in stark contrast to the recent changes to NICE’s Technology Appraisal (TA) and Highly Specialised Technologies (HST) programmes.

DATA

E-prescribing mandatory for hospitals and national registries of therapy-area-specific data created and aligned with relevant charity. CR: With benefits aplenty, an e-prescribing system may also introduce much more rigorous criteria for prescribing, including high-cost drugs. Data generation is contingent on the NHS being able to process patient information much more ably than it is currently.

SKILLS

Establish a migration system that allows the UK to recruit the best international talent. CR: Given current controversy over immigration, the vagueness is unsurprising. Free movement is a wellknown concern for the life sciences sector, but other than a welcome NHS-wide action plan based on the skills gap within science, the report suggests others will need clever ideas to make their case.

With the NHS consistently topping polls of policy areas people care most about, it is peculiar that the life sciences sector, so intertwined with healthcare delivery, attracts such little attention. If only one message endures from this report, it should be that the LSIS agenda is central to ensuring and improving the NHS. Furthermore, many of the steps outlined in it are opportunities uniquely available to the NHS and could not be realised in many insurance-based healthcare systems. The strategy also notes the exciting opportunity to better utilise NHS data. Though Lord Bell emphasised that the strategy is an ‘Industry View’, his message that a relationship of trust and collaboration between NHS and industry, where the former harnesses innovation, driving growth of the sector and transforming itself in the meantime, is fundamental. In acknowledging the hard time industry has had in the past few years, Lord Bell’s report calls upon all of us to support the NHS, while recognising there is a unique chance for life science in the UK to deliver economic growth, reward for the NHS and a sustainable return for industry.

“Life sciences give credibility to the Prime Minister’s otherwise less tangible attempts to talk up her Government’s industrial strategy”

WORDS BY

Claudia Rubin

FINAL ANALYSIS With so much content to digest, what next in terms of action? Industry has certainly had its day in terms of developing this plan, so does its role stop there? Does it sit back, relax and let the implementation good-times roll in? Probably not. Although initially set in motion by the Government, the report is most certainly being framed as Lord Bell’s independent review. Current understanding suggests there will not be a commitment to implementing the LSIS, however, the Government has indicated that a ‘sector deal’ will follow, which will provide a framework for implementation. Realistically, it is highly unlikely that all recommendations within the report will be put into effect, and Bell has privately recognised as much. The strategy needs to be seen over a five-year period, requiring careful oversight. Straddling as it does two Government departments – Health, and the new Business Energy and Industrial Strategy Department, could make this job harder. Meanwhile, The Lords Science & Technology Committee inquiry into the LSIS will hear oral evidence during October. One key question the Committee seeks to address is ‘Who should take responsibility for implementation’, begging the additional question of whether there should again be a life sciences minster; a job ably carried out by George Freeman, under David Cameron, but curiously absent from Theresa May’s line-up. In conclusion, the next steps are negotiations with the Government to establish sector deals, and it is up to industry, and those of us who value its work, to make best use of this document for all its worth. Claudia is a Director at Decideum. Decideum has produced a detailed analysis briefing on the LSIS. Get in touch with Claudia if you would like a copy. Go to decideum.com or call 020 7368 1611

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Girl power When her life changed dramatically Kris Hallenga used her experience to change the world forever. INTERVIEW BY

John Pinching

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COFFEE BRE AK

ris discovered she had breast cancer when she was only 22. Through her pioneering campaign charity CoppaFeel! she has brought confidence, hope and inspiration to countless people across the world. She epitomises the modern patient and, following her own challenging prognosis, has given others the strength to take control. I had the pleasure of chatting to her and this is her remarkable story. What initiatives is CoppaFeel! driving this summer? It’s funny you should mention driving, we have a big van called Belinda, the ‘boob-mobile’, which goes around festivals. It’s a brilliant education hub, where we give young people temporary tattoos and, as our volunteers are applying them, open up a conversation about boob health. We can also get a bit of data, and they can spread info about breast cancer and CoppaFeel! across social media. We’ve been doing this for years, but it is the first time we’ve had our own vehicle, which is really cool. Those five-minute conversations we’re having in a field are potentially life-saving. Uniquely, the CoppaFeel! website takes something very serious and approaches it in a fun way. It helps that a bunch of young people started it – we knew how we wanted to be spoken to. Although I am 31 now, I am surrounded by students in the office, so I appreciate the vibe among teenagers and people in their twenties. When we first went into schools we were surprised by how much kids wanted to know. Most people have had an experience, in their family or social group, of cancer. They’re resilient and up for learning new things. You’ve also got some familiar faces on your website. It’s great to have celebrity endorsements from the likes of Dermot O’Leary and Fearne Cotton, but we’re now moving towards online influencers and ‘youtubers’. Although many of us have not heard of them, young people are watching their output day in, day out.

Your messages seem to be about handing control back to patients. We should never entirely rely on other people when it comes to our own health. Even if our healthcare providers picked up every cancer, we still need to know our own bodies. After my experience, it seems absurd that you would rock up to a GP, let them examine you once and accept the verdict. Knowing your own body and when you need to act on something, gives you a sense of control which is very empowering. If you confidently say that, after 10 years of checking, there is something different about your boobs, they have to refer you. What had your experience with HCPs been? I was let down badly by two GPs, but had I known myself that the changes happening to my boobs were bad, things could have been very different. People ask me why I didn’t sue, but getting two GPs struck off wasn’t going to make a massive impact. Educating people and promoting better conversations about breast cancer with GPs could. Ultimately, the GPs that ignored my symptoms would have seen my story in the press and I like to think they would not make the same mistakes again. How did you get through the initial period after diagnosis? I started immediately with a secondary diagnosis and, knowing that it was a disease I was unlikely to get rid of, had to navigate my own route through it. There were days when I was crying a lot, but I had a treatment plan and was focussed on getting better. Waiting to see the impact of my first treatment was most difficult. When did you regroup and decide to do something positive? Two months after my diagnosis and 10 days before my hair fell out, I was at my mum’s house with some friends and my sisters. I told them there wasn’t really any provision for young people to find out about breast cancer, and asked if they wanted to help me create something. Despite not having any experience they all wanted to give their time. How quickly did you realise you had a hit? During the first festival we went to, we were positioned beside the mainstage. It was all very amateur; just a gazebo and some stickers! I was going through chemo and injecting myself to ensure my white blood cells were at an acceptable level. We just blagged it, by painting people’s faces, as an

excuse to talk about boobs. The tent was full the entire time and we realised right then that if we could convince students, we could be on to something. Following that I had my mastectomy, we got charity status and I won a Pride of Britain Award. What treatments have you been on? I’m on palbociclib, which was developed by Pfizer, and is doing wonders at the moment. I’m also taking exemestane, the hormone blockers, and monthly injections of denosumab. This is another example of taking control. Oncologists don’t know everything and I did my own research about which drugs were right for me. Is there life before and after cancer diagnosis? I had been living in Beijing and found out my diagnosis when I returned home for Christmas. When I think about the girl before cancer, I was very different. I was 22, didn’t really have a clue about life and had been through a couple of bad relationships. I wasn’t sure what my purpose was but, oddly enough, when I found out I had cancer, the purpose became clear.

“We should never entirely rely on other people when it comes to our own health. Even if our healthcare providers picked up every cancer, we still need to know our own bodies.” What are your plans now? Somehow eight years have passed since I started CoppaFeel!. At the beginning of last year, I took a step back from being CEO. I stay involved in the campaigns and continue doing the things I love, but now I also have a life in Cornwall. Thoroughly deserved. What is your perfect day? Discovering a new café that does a delicious brunch, and paddle-boarding on a calm lake. Naturally. What hit record says most about you? ‘Power’ by Little Mix. I’ll check them out. Goodbye Kris. Bye John. Go to coppafeel.org

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Opposites ATTRACT Pharma and the third sector may have more similarities than you think. WORDS BY

John Pinching

eople generally see industry and specific disease charities as being poles apart; strategically, motivationally and even ethically. In reality, common denominators between the two apparently alien factions are manifest. Indeed, even their differences; industryâ&#x20AC;&#x2122;s expertise in development and manufacturing, in contrast to the skills charities possess in the arena of awareness-raising and patient engagement, make them compelling allies, rather than foreign entities. Evidence of this co-existence and cooperation comes in the form of several dynamic pharma-charity partnerships. Here are some of the most impressive.

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F E AT U R E

ancer Research UK’s record of developing novel treatments is comparable to any pharmaceutical company. Industry partnerships have proved hugely valuable in achieving this; they enable us to translate our world-class research into effective treatments for patients. Commercial partnerships are at the heart of how we interact with industry. Our team works with pharmaceutical companies, who bring the skills, materials and funding necessary to convert promising scientific discoveries into industrial propositions. Through Cancer Research UK’s Therapeutic Discovery Laboratory, we bring together the best minds in academic cancer research, with the drive of industry. Multiproject alliances include partnerships with AstraZeneca, Merck and Forma. Our Centre for Drug Development (CDD) has taken over 120 potential cancer drugs into clinical trials and six have made it to market, with others in development. Through our Clinical Development Partnerships scheme, the centre works with leading pharma companies, on a shared ‘riskreward’ basis, giving promising new drugs the best chance of making it.

Once clinical data is gathered, companies retain intellectual property rights, or transfer them to Cancer Research UK for a share of revenues. Thanks to our network of Experimental Cancer Medicine Centres we have the specialist infrastructure to bring innovative treatments to patients through clinical trials. The Combinations Alliance is a unique scheme, run through these centres, where we test novel drug combinations using assets from different companies, with a view to improving standard treatments. Cancer Research UK’s industry interactions have been proven to benefit patients. The first PARP inhibitor, rucaparib (Rubraca), was discovered by our scientists at the Northern Institute for Cancer Research, in collaboration with Agouron and Pfizer. With the help of the CDD, rucaparib entered trials and stimulated interest in PARP inhibitors from other companies. Last year, in the US, the drug was designated a ‘breakthrough therapy’ by the FDA, for patients with advanced ovarian cancer. We will continue to work closely with industry to accelerate the development of potentially life-saving treatments and beat cancer sooner. Go to cancerresearchuk.org

H E ART S TR I N G S PROFESSOR JEREMY PEARSON Associate Medical Director at the British Heart Foundation

“The BHF funds academic-led projects that involve pharma where there is clear potential for patient benefit”

he British Heart Foundation’s (BHF) vision is a world where people do not suffer or die prematurely from heart disease. A crucial objective of our strategy is to enhance the translation of cardiovascular research into improved patient care. This goal requires strong relationships; academics can bring scientific know-how and years of experience, while pharma provides drug development and commercial expertise, including access to compound libraries and regulatory advice. To achieve its mission, the BHF funds academic-led projects that involve pharma, where there is clear potential for patient benefit. For example, The Heart Protection Study, led by the University of Oxford, was jointly funded by the BHF, Medical Research Council, Merck and Roche Vitamins Ltd. This was a 20,000-patient study that showed the benefits of simvastatin in lowering cholesterol, ultimately leading to a reduction in coronary heart disease risk. We have a clear policy outlining the terms of these collaborations, ensuring that universities have intellectual property rights and that if findings result in commercial success, the university and BHF are recognised. This

B I G - C H IT TE RS DR NIGEL BL ACK BUR N Cancer Research UK’s Director of Drug Development

“We bring together the best minds in academic cancer research with the rigour and drive of industry”

allows revenue to be re-invested into research. The BHF has a dedicated funding scheme to accelerate the translation of cardiovascular research. The Translational Award provides funding to de-risk promising innovations, enabling them to secure further investment. The committee assessing opportunities has a range of members with differing backgrounds including medicinal chemistry, drug development and venture capital investment expertise. They help academics translate their work and attract pharma interest by providing advice, identifying commercial hurdles and shaping project design. The BHF takes an active role in connecting academics with pharma to further stimulate knowledge exchange. Last year, we held a workshop which included speakers from pharma, investment and regulatory organisations, allowing academics to discover exactly what experts look for when assessing potential projects. Pharma is keen to learn from academia and we play a role in initiating university visits where industry can find out about specific projects and form mutually beneficial collaborations. Go to bhf.org.uk

M AG A ZI N E | O C TO B ER 2017 | 2 1

F E AT U R E

B R E ATH I N G S PAC E

JA SON CATER Director of Fundraising at the British Lung Foundation

positive, lasting impact on the lives of respiratory patients is an essential shared value for any pharmaceutical partnering with the British Lung Foundation. The relationship must be grounded in the charity’s goals of improving the lives of people living with or affected by a lung condition. An example of such a partnership is a project calling for improved access to treatment for idiopathic pulmonary fibrosis (IPF) patients. IPF is a condition that causes continuous scarring of the lungs. The scar tissue stops the lungs doing their job of drawing oxygen from the air and passing it into the blood. For those living with the condition, it means breathing gets increasingly difficult. IPF has no known cure or cause, and affects adults of all ages. Roche was one of two pharmaceutical companies that funded the dissemination of a report by the charity, which made recommendations to improve outcomes for IPF patients. These included establishing the Taskforce for Lung Health in order to produce a five-year strategy for tackling lung disease and improving access to personalised treatments, diagnosis and support.

FO RC E I S S TRO N G

PROFESSOR DAV ID DEXTER Deputy Director of Research at Parkinson’s UK

“People with Parkinson’s have waited long enough for better treatments, so we decided to make clinical trials faster”

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hroughout my years of working in Parkinson’s research, a major barrier to the development of new drugs has been the design of clinical trials. Trials are also, of course, an essential part of discovering safe treatments and, ultimately, a cure for the condition. The most commonly used drug for Parkinson’s, Sinemet, was developed more than 50 years ago. People with Parkinson’s have waited long enough for better treatments, so Parkinson’s UK decided to make clinical trials smarter and faster. In 2015, we took the bold step of founding the Critical Path for Parkinson’s (CPP) Consortium, in partnership with the Critical Path Institute. Nine major pharmaceutical companies joined the project in its first year, alongside government agencies, academic organisations and other Parkinson’s charities. Through the consortium, these members work together to garner support from global regulatory agencies for new ways of designing and carrying out clinical trials. Using clinical data from around 8000 people, recently diagnosed with

“Roche funded the dissemination of a report by the charity, which made recommendations to improve outcomes”

The project held a half-day seminar with patients, carers and healthcare professionals, to hear directly what they thought the issues are and what, in an ideal world, the care pathway for IPF should look like. This helped identify key principles for good IPF care, including being centred on the patient and their wishes, making all possible treatment options available and ensuring people in all parts of the country access the same standards of care. The British Lung Foundation then carried out its own research, identifying areas of best practice and finding policy solutions, which would lead to the changes patients want to see. Roche and other pharmaceutical expertise was essential to the project and its aims. Go to blf.org.uk

Parkinson’s, the CPP Consortium developed a clinical trials simulation platform. Clinicians can use the platform to determine the optimum length and size of a trial, as well as predicting the likelihood of success. This will lead to more efficiently designed trials, cutting the cost of drug development – historically, a huge obstacle to making progress. One of the CPP Consortium’s biggest achievements was in 2016 when the European Medicines Agency issued a public letter of support, backing our campaign for the use of a brain scan that identifies the loss of dopamine brain cells, a symptom of Parkinson’s. This can be used as a selection tool to identify Parkinson’s patients more accurately, ensuring we have the most suitable participants for trials. Having worked in Parkinson’s research for 32 years, I thought I’d seen it all and had started to lose hope that the old process was the best we could find. I joined Parkinson’s UK earlier this year because they knew we could do things differently by joining forces with pharmaceutical companies to find better treatments and a cure. Go to parkinsons.org.uk

OPINION

RMOC EXPLAINED

WORDS BY

The function of RMOCs has been codeveloped by NHS England and NHS Clinical Commissioners on behalf of CCGs, in partnership with NHS hospital representatives, NICE and representative bodies of the branded and generic pharmaceutical industry. RMOCs bring together decision makers and clinicians across the four regions of England to share best practice, understand the evidence base, coordinate action in order to reduce variation, improve outcomes and maximise value from medicines.

Deborah Evans

NICE to be wanted Deborah upholds a much-maligned organisation with a vital future

he sexy NICE headlines tend to be when a drug has been blocked or access is restricted. Indeed, how your company’s medicine is positioned within specific guidance could influence your view of NICE. I believe, however, that this organisation has a very positive impact across our health services. It raises standards, achieves consistency and ensures evidence underpins what we do. NICE looks at drugs where availability varies; this could be due to different local prescribing, funding policies or indecision over value. NICE standardises access to healthcare and this has to be good. Variation only leads to poor care. It also does much more that influences our daily practice; providing confidenceboosting guidance on managing specific conditions, improving health, providing social care, services and interventions that flow into communities.

NICE Technology Appraisals (TA) go further, and when NICE recommends a treatment as an option, the NHS must make sure it is available within three months. Therefore, if a patient has a condition and their doctor thinks the therapy is right, it should be ready for use, thereby standardising care across the country. Despite the wealth of guidance, an ‘industry’ has existed in local NHS organisations across the country where teams of people, usually led by pharmacists, review the evidence and come up with local guidance themselves, even when NICE has published in the area. This is largely driven by budget constraints and a real or perceived need for localism. There has to be a more efficient way. NHS England has also been concerned that new medicines, not evaluated by the TA programme, are instead being assessed multiple times across the NHS. This has

“It is clear that NICE guidance and standards can be a solid foundation for encouraging behaviour change and improving evidence-based practice”

C be NI o t ow

resulted in the establishment of four Regional Medicines Optimisation Committees, who evaluate new medicines which are not on the TA programme, and share recommendations across the four regions. This will enable pharmacists and CCG colleagues to focus on the implementation of recommendations to achieve greater consistency in local medicines and prescribing practice. My hope is that this work complements the recommendations made by NICE and does not duplicate their activity. Coordination is key. Aside from the known-about guidance, we’re increasingly seeing the impact of NICE Quality Standards in a number of disease areas, ranging from standards in acute coronary syndromes to varicose veins. These set out the priority areas for improvement in health and social care; essential reading for commissioners and providers who want to give the best care to patients. What is clear is that NICE guidance and standards can be a solid foundation for encouraging behaviour change and improving evidence-based practice within a range of healthcare settings. When I work in practice or when developing pharmacy services, I want to be confident that I am doing the best for patients and that care is underpinned by research and evidence. I will always turn to NICE. Thank you to Dr Mahendra G Patel, NICE Principal Enterprise Fellow in Pharmacy Practice, for his help in compiling this piece. Deborah Evans is Managing Director of Pharmacy Complete, a specialist consultancy and training company enabling a healthier future for pharmacy. Go to pharmacycomplete.org

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F E AT U R E

750 MILLION SINCE 2012,

STACKED UP:

Counterfeit meds worldwide

ILLICIT DRUGS INTERCEPTED AT AFRICA’S PORTS*.

30% WHO ESTIMATES

of MEDICINES SOLD IN ASIA, AFRICA & LATIN AMERICA ARE COUNTERFEIT.

ESTIMATED SIZE OF MARKET RANGES

$200 from $75 billion to

BILLION

THE ANNUAL

DEATH TOLL FROM COUNTERFEIT DRUGS LEVELS OUT AT AROUND ONE MILLION.

THE LARGEST DEATH TOLL IS IN AFRICA, WHERE AROUND

200,000 people die each year DUE TO FAKE ANTIMALARIAL DRUGS.

FAKE NEWS Medicines access provider Inceptua on the scourge of counterfeit medicines

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DURING 10 DAYS IN 2016,

113 MILLION

ANTIMALARIAL, ANTIBIOTIC & ANTI-INFLAMMATORY TABLETS IN 16 COUNTRIES SEIZED.

97%

hazy definition of counterfeit medicine, varying degrees of regulation, rising online availability and lenient punishments for traders has led to increased levels of counterfeit drugs. More recently, there have been more sophisticated counterfeit drugs appearing. Fake versions of Xepilon, a schizophrenia treatment, and Votrient, a cancer therapy, have both been found in Germany, while an imitation of Ominitrope, a human growth hormone, surfaced in France, Denmark and Mexico. One expert estimates that a $1000 investment in counterfeit drugs can result in a $30,000 return; 10 times the profit of trafficking heroin. Another source reported that selling counterfeit Sildenafil “can be as much as 2000 times more profitable” than selling cocaine. Note: The dollar currencies used within the text refer to USD.

from China & India*

“A $1000 investment in counterfeit prescription drugs can result in a $30,000 return, 10 times the profit rate of trafficking heroin” The risk of being caught is actually lower because detection is so difficult, and penalties are less serious due to a focus on intellectual property rights, rather than human consequences. The WHO estimates that 30% of the world’s national regulatory agencies can’t function and, in Africa, there are 54 regulatory bodies, many of which are under-resourced. Every country has issues with counterfeit drugs, and while there are countries with robust measures, global harmonisation is lacking.

CO PY CATS: COU NTERFEIT M ED I CI N E E XPL AI N ED A counterfeit medicine is one which is deliberately mislabelled with respect to identity and/or source. Products may include correct ingredients or incorrect ingredients, or be without active ingredients, or with insufficient/ inadequate quantities of ingredients or with fake packaging. The WHO recently redefined them as 'substandard and falsified medical products'. This is intended to move the focus away from intellectual property rights rather than the destructive nature of the products.

D R WH O? The proliferation of websites has led to easy access to what patients believe are real pharmaceuticals. What purported to be a Canadian pharmacy, for example, was actually 51 websites spread across several countries including China, Malaysia, Taiwan, Russia and Indonesia. Analysing the IPs of the websites uncovered a further 1005 active domains, 70% hosted in Russia and the remainder in France. In 14 days, 86,276 unique sites worldwide were traced. When the National Association of Boards of Pharmacy in the US reviewed 11,299 websites offering prescriptions for sale, it discovered that '10,823 (95.8%) were operating out of compliance with state and federal laws'. Staggeringly 4932 global sites selling illicit pharmaceuticals were suspended during an Interpol Operation, Pangea, in 2016. The Drug Supply Chain Security Act, in the States, came into force in 2015, covering manufacturers, re-packagers and wholesale distributors. Even in the UK, where regulation and medicine tracking is stringent, The Pharmaceutical Security Institute found that between 2011 and 2015 the global incidence of drug counterfeiting increased by 51%. European Council, meanwhile, have released a Falsified Medicines Directive, which aims to improve patient safety by mandating that marketing authorisation holders and manufacturers have a system to prevent falsified medicines from entering the legal supply chain.

In practice, pharmaceutical manufacturers will need to apply a unique identifier and tamper verification feature to the outer package of medicinal products. By February 2019, a European Medicines Verification System will guarantee the verification of medicines throughout the supply chain and at the time of delivery to the patient. Not only will this allow government bodies to trace the product, but patients will be able to verify their own medication using an app. In 2015, Pedigree had 500 million drug packets coded, and was instrumental in combating a counterfeit antimalarial drug putting thousands of Africans at risk. The risks are clear; healthcare professionals may be unfamiliar with original products, which could have travelled through several importing markets, increasing risk at every step.

Medicines Access

Transforming Access to Medicines Powered by understandingÂ Delivered with compassionÂ

E XPLI C IT CO NTE NT The WHO estimates that 16% of counterfeit drugs contain the wrong ingredients. Some contain hazardous elements such as rat poison, boric acid and antifreeze, while others include household items such as floor wax, brick dust, paint and paint thinner. 17% contain the wrong levels of essential ingredients and more than 30% donâ&#x20AC;&#x2122;t contain any active ingredients. Inceptua Medicines Access prevents falsifed medicines entering the supply chain through its own rigorous quality checks. Go to inceptua.com. For a complete list of references relating to the article please go to the online version of the magazine at pharmafield.co.uk

*Operations carried out by World Customs Organisation, with the Institute of Research against Counterfeit Medicine.

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Pathway to promise It’s international Breast Cancer Awareness Month and the UK’s biggest killer needs attention. W O R D S B Y Amy Schofield

reast cancer has been the most common cancer in the UK since 1997 *, and 1 in 8 women in the UK will develop breast cancer in their lifetime. During Breast Cancer Awareness Month, around 5000 people will be diagnosed with the disease, with one person diagnosed every 10 minutes. Things are improving, however – in the UK, breast cancer survival has doubled in the last 40 years, while almost 9 in 10 women survive breast cancer for five years or more. Despite this, around 11,400 people die from breast cancer in the UK every year.

55,000

THE FACTS

IN THE UK, AROUND

WOMEN ARE DIAGNOSED

with breast cancer each year

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85% OF WOMEN DIAGNOSED WITH ADVANCED BREAST CANCER WILL

not live longer than five years

F E AT U R E

TR E ATM E NT D E VE LO PM E NTS N OVA RT I S : At the time of going to press, Novartis was waiting for NICE’s decision on whether Kisqali (ribociclib) will be funded by the NHS. Following the drug’s authorisation from the European Commission in August for the treatment of advanced breast cancer, ribociclib is now licensed for use in Europe as a first-line treatment in combination with an aromatase inhibitor in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/ HER2-) locally advanced or metastatic breast cancer.

R O C H E : After suffering the setback of provisional rejection by NICE in December 2016, Roche’s Kadcyla (trastuzumab emtansine) was the subject of what was dubbed a ‘monumental U-turn’ by the media earlier this year, as the manufacturer agreed a deal with NHS England to make the drug available to around 1200 women per year with advanced aggressive cancer.

PFIZER : In February this year, NICE made the provisional decision that Ibrance (palbociclib) should not be routinely funded on the NHS in England. Its final appraisal was paused for Pfizer to present further clinical data. Then in May, Pfizer made the unexpected announcement that it would give out palbociclib for free until NICE makes its decision on whether it should be available on the NHS. At the time of going to press, palbociclib was still being given to women with incurable metastatic breast cancer at no cost.

A S T R A ZEN EC A : Promising trial results for the PARP inhibitor Lynparza (olaparib) were recently revealed. Results from the Phase III OlympiAD trial found a 42% reduction in the risk of the disease spreading in patients taking Lynparza, compared to those undergoing chemotherapy.

E X PE RT VI E W Professor Arnie Purushotham, Cancer Research UK’s senior clinical adviser

ecent technological developments have enabled the study of cancer’s molecular and genetic characteristics in unprecedented detail, shifting the view of breast cancer as, not one disease, but a collection of unique diseases with their own challenges. This has ushered in a wave of exciting research into tailoring treatments to each person’s individual cancer, so patients get treatments that are right for their disease. Coupled with this progress has been finding less invasive techniques to take a detailed snapshot of each person’s tumour, which could help guide therapeutic decisions. Liquid biopsies, blood tests that fish out fragments of tumours for analysis, are increasingly occupying this role. In the future, these innovative methods may have a role in diagnosing the disease earlier.

But just as it’s crucial to ensure patients get treatments that are best for them, it’s essential to prevent harm from giving people treatments that they don’t need. One of Cancer Research UK’s Grand Challenges seeks to address this issue by determining how to distinguish between those who do need treatment and those who don’t in women with a condition called ductal carcinoma in situ (DCIS), which can sometimes develop into breast cancer. This work could spare thousands of women unnecessary treatment.

“Innovative methods may have a role in diagnosing the disease earlier”

D O E S IT AD D U P? Breast Cancer UK’s ‘You Do the Maths’ campaign shines a light on the relatively small amounts currently spent on understanding and preventing the causes of cancers, and asks whether more can be invested to help prevent breast cancer. • 75% of breast cancer cases thought to be attributable to environmental and lifestyle causes • 1% of research funding spent on environmental and lifestyle causes of cancer in 2014 • It is estimated that 20-30% of cases are due to genetic mutations. Of these, 2-3% are associated with BRCA mutations • £51m is the estimated annual cost savings if the incidence rate for breast cancer was reduced by 10%.

*Cancer Research UK

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F E AT U R E

Making an impact What difference have breast cancer campaigns made? PE RSO NAL S TO RY Katy English, 24

“

t looks like you’ve got cancer,” said the registrar, without warning, or sensitivity. I instantly went numb and completely shut down. My mum, panicking, asked questions: “How are you going to treat it, you’ll be able to sort it out won’t you?” “What, you want me to go through all the treatment options now?” he said with disdain. We were led away by a breast care nurse, who came to be an invaluable guide throughout. Luckily that first registrar was the only detestable character who played a part in my care; the oncologist, surgeon, chemo nurses and breast care nurses (all women) were outstanding. At 24-years-old, being told I had cancer was unbelievable, devastating, horrifying. Until then I was a ‘normal’ twentysomething; recently graduated, proud to have moved out of my parents and in with my boyfriend and best friends from school, and even prouder to have just been offered a place to start a PGCE. I hadn’t been worried when I felt a lump in my breast, they often felt a bit lumpy or bumpy at different times of the month, but I made a doctor’s appointment when I noticed the bottom of one breast looked flatter than the other when I raised my arms. The GP immediately referred me for

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

R AC E FO R LI FE Over the past 20 years, over 8 million women have taken part in Cancer Research UK’s events, from 5k runs to muddy obstacle courses, raising over £547 million to fund research.

WE AR IT PI N K DAY

“My whole world turned upside down” tests. That was when my whole world turned upside down. They decided that as the lump was large and my lymph nodes tested positive, I would have six rounds of chemo, to hopefully shrink the lump before surgery to lose less of the breast. Chemo was hard. My family and boyfriend were by my side through everything, I couldn’t have done it without their infinite love and patience. I wanted a double mastectomy and my surgeon and I both had to appeal for it to be approved, after initially being rejected, but it went ahead on the 22nd of December. I was discharged on Christmas Eve. I then had three weeks of radiotherapy every day, and now I have to take oestrogen blocking tablets for 10 years, which give me hot flushes and achy joints and muscles, but I have gradually regained energy. I recently swam 25km in a month and raised £3500 for Bart’s Charity Breast Cancer Research Fund, and I am due to start my PGCE. The last year has been an enormous challenge, but I feel stronger than ever and pray that it never comes back.

Rock a pink cowboy hat in the boardroom, wear a pink feather boa to walk the dog – it doesn’t matter, as long as you do it in support of Breast Cancer Now on Friday 20 October. The campaign has raised £30.1 million to date for breast cancer research.

CO PPAFE E L! In a mission to educate us that young people get breast cancer too, the charity, headed by the inspirational Kris Hallenga, has launched many campaigns encouraging women (and men) under 30 to regularly check their boobs. These include Check ‘em Tuesday, the Bra Hijack, the Coppafeel! Boob Tour, and #GetItOff YourChest. Read Kris’s remarkable story on p18.

M E N G E T B R E A S T CAN C E R TO O

Breast cancer is not an exclusively female disease – although it is rare, male breast cancer accounts for 1 in every 100,000 males. According to Cancer Research UK, data shows that male breast cancer mortality is strongly related to age, with the highest mortality rates being in older males. In the UK in 2012-2014, on average each year around 6 in 10 (55%) of deaths were in males aged 75 and over. If you are concerned about breast cancer, need advice or would like to talk to someone, call 0808 800 6000 or go to breastcancercare.org.uk

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