Pf Magazine May 2017

The

M OST E XC ITI N G MEDICINES

in the

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May 2017 PHARMAFI E LD.CO.U K

th wi 16 w e vie pag r te n in ne o r u zi e o aga e S M Pf

Celebrating 10 years Join us as we celebrate a decade in medical education, building partnerships with pharma and NHS for better patient outcomes.

Keep an eye out for some exciting announcements coming this month.

E V E N T S 4 H E A LT H C A R E . C O M

WELCOME

EDITOR

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

Amy Schofield amy@pharmafield.co.uk ART DIRECTOR

Emma Warfield emma@pharmafield.co.uk COMMERCIAL DIRECTOR

Hazel Lodge hazel@pharmafield.co.uk SALES & MARKETING MANAGER

Rachel Cresswell rachel@pharmafield.co.uk FINANCIAL CONTROLLER

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

Melanie Hamer melanie@events4healthcare.com PUBLISHER

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

Spirella Building Bridge Road Letchworth Garden City Hertfordshire SG6 4ET United Kingdom Cover illustration by Alex Buccheri alexbuccheri.com The content of and information contained in this magazine are the opinions of the contributors and/or the authors of such content and/or information. 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.

I

Letter from the Editor

n many ways, this month’s edition of Pf Magazine is a revelation – it is where the things that matter to you, the pharma community, are revealed.

The Five Year Forward View is – despite its permanently ambiguous title – about half way into its vision. In these pages, we invite a notable frontline expert to look at the plan, and its ‘next steps’, from a commissioner’s point of view.

We also take a magical mystery tour around a drug development lab with Parkinson’s UK, and discover the perilous journey a medicine takes on its route to market. Most of us operate at the ‘finished product’ end of the business, so it’s always important to remember the pioneering science that happens at the beginning. Indeed, it’s another timely reminder that Pf Magazine is produced for each and every person who has an interest in our extraordinary industry.

Our cover story also looks admiringly at some of the treatments that are changing the lives of millions, and even shifting the perception of what certain diseases mean – ‘life’ often emerges, where once there was death. In many ways, this reveals what pharma, at its best, can really do.

Meanwhile, we sit down for a chat with new PM Society Chair, Craig Bradley, host a Q&A with our friends at the ABPI, and report on the current situation with HIV/AIDS and hep C. Our insightful columnists, regular items and a very special Coffee Break complete a formidable line-up.

Keep up the good work,

The Publisher provides the features and advertisements on an ‘as is’ basis, without warranties of any kind, either express or implied, including but not limited to implied warranties of merchantability or fi tness for a particular purpose, other than those warranties that are implied by and capable of exclusion, restriction, or modification under the laws applicable to this agreement.

No copying, distribution, adaptation, extraction, reutilisation or other exploitation (whether in electronic or other format and whether for commercial or non-commercial purposes) may take place except with the express permission of the Publisher and the copyright owner (if other than the Publisher).

The information contained in this magazine and/or any accompanying brochure is intended for sales and marketing professionals within the healthcare industry, and not the medical profession or the general public.

Pf Magazine is published monthly. For a free U.K. subscription visit pharmafield.co.uk/subscribe.

HAVE AN OPINION ON SOMETHING YOU ' VE RE AD IN P f MAGA ZINE? @Pharmafield

M AG A ZI N E | M AY 2017 | 1

CONTENTS N E WS

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

Exciting times for fast moving pharma F E AT U R E

Next steps on 5YFV reviewed F E AT U R E

The complete lifecycle of our drugs COFFEE BREAK

Coffee with the founders of E4H OPINION

Are our NICE days numbered?

OPINION

Pharmacy must have room to flourish F E AT U R E

AIDS/hep C models defy the odds F E AT U R E

You ask the questions, ABPI answers EVENTS & CONFERENCES

Parallel Learning on ACOs F E AT U R E

Astellas and the Fistula Foundation P H A R M ATA L E N T

Who’s moved on and who’s moved up P H A R M ATA L E N T

Interview with new PM Society Chair

03 08 12 14 16 18 20 22 24 28 30 32 34

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MAGAZINE

May RE ADER ’ S VOICE: “It was fantastic to read the April cover story, which shared highlights from the biggest Pf Awards ever. As always, it was a great evening that recognised the very best talent within our industry. I would like to extend my congratulations to the winners of the Awards – all were well-deserved following a rigorous Assessment Day. For Ashfield, it was an eventful night – we celebrated two successful award wins as well as our largest number of finalists ever.

Ashfield is committed to patient services and improving patient outcomes, so I’m incredibly proud of Kathy Wadhams for winning the Clinical Nursing Award.

Neil Lawton’s joint win for the e-Representative Award is equally well deserved and reflects our commitment to excellence in our Contact Centre.”

Colin Watson, Managing Director, Ashfield Commercial and Clinical UK

HAVE YOUR SAY: Is big pharma helping HCPs to understand what they do? Where are the best pharma R&D hubs in the UK and do you work there? Are we winning the battle against diabetes? 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

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

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

ARTIFICIAL INTELLIGENCE

BRIT FUTURE B ritish artificial intelligence company BenevolentAI has partnered with MRC Technology (MRCT) – a medical research charity – to explore drug discovery initiatives in the field of small molecules and antibodies.

The two-year agreement sees BenevolentAI combine the power of its unique technology in the application of AI for drug discovery, with MRCT’s expertise in translating novel biology into lead stage therapeutic assets.

Both organisations will respectively share confidential molecular disease targets and collaborate to develop them into potential new drugs.

Jackie Hunter, CEO of BenevolentBio – a subsidiary of BenevolentAI – said: “I believe that our two organisations’ complementary skills and capabilities will enable the search for, and development of, new medicines to proceed much more quickly.”

A N T I B I OT I C S

Gut feeling Women who take antibiotics over a longterm period during early to mid-life could be at an increased risk of developing abnormal growths associated with bowel cancer.

According to research led by the Solent NHS Trust and Southampton University, those who took antibiotics for two months or more in their 20s and 30s were 36% more likely to be diagnosed with an adenoma.

Colorectal adenomas are abnormal growths in the colon and rectum that precede the development of bowel cancer.

This adds to a growing body of research on how the gut microbiome plays a key role in the development of many diseases, including cancer. It is believed that the use of antibiotics alters the gut microbiome and reduces resistance to hostile organisms.

The study, which included data from 16,642 women, also showed that those who had used antibiotics for two months or more during their 40s and 50s were 69% more likely to be diagnosed with an adenoma.

Pf View: Another unfortunate example of how our insatiable ‘antibiotics culture’ of the ‘90s and 2000s has returned to haunt us.

Big pharma must find solutions quickly.

ZIK A VIRUS.

THEMIS AND US

T

hemis Bioscience has announced the first clinical study worldwide of a live attenuated recombinant Zika vaccine tested in human volunteers.

The specialised biotech company develops prophylactic vaccines against emerging tropical infectious diseases and, after making progress with the development of a prophylactic Chikungunya vaccine, the company have adapted their proprietary vaccine technology for their Zika vaccine program.

Themis’ program is based on a live attenuated recombinant vaccine that promises a fast and effective immune response.

The clinical study at the Medical University of Vienna, Austria, involving up to 48 healthy volunteers, will focus on identifying the most suitable doses of the vaccine candidate in regard to immunogenicity, safety, and tolerability. Results of all groups are expected within the next few months.

Dr Erich Tauber, CEO and founder of Themis, said: “Live attenuated vaccines are regarded as superior as they induce a faster and more complete activation of the immune system leading to durable immunity.”

M AG A ZI N E | M AY 2017 | 3

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

I M M U N O -.

O N C O LO GY.

STRONG FOUNDATION

Vytenis Andriukaitis @V_Andriukaitis

We all have an obligation to support & help those suffering from #parkinsons in their daily tasks whenever we can #UniteForParkinsons

B

ristol-Myers Squibb (BMS) is to utilise ‘FoundationOne’ – Foundation Medicine’s genomic profiling solution, which identifies predictive biomarkers in patients enrolled in clinical trials assessing BMS’s cancer immunotherapies.

Predictive biomarkers to be identified include tumour mutational burden and microsatellite instability. According to Foundation Medicine, they can be measured without the need for wholeexome sequencing through the advanced and algorithms of its FoundationOne® assay. It can also expand treatment options by identifying genomic alterations associated with targeted therapies.

Lilly Trials @LillyTrials

Increased diversity is needed in #clinicalresearch among both participants and researchers Bristol Health @BristolHealthP

@NHSEngland pledges @UHBristolNHS £750k for 24hr psychiatric liaison service in A&E as part of #5yfv Pf Magazine @Pharmafield

Over 2000 women’s lives transformed by Action on Fistula http://buff.ly/2kAFSTG #pharma david3012 @david3012

An extra 35,000 children and young people being treated through NHScommissioned community services next year compared to 2014/15 #5YFV UNAIDS @UNAIDS

C A R E E R S A DV I C E

Ask the experts Ashfield Healthcare Communications, – part of UDG Healthcare – has announced the external launch of its Ask Career Experts (ACE) Panel. This initiative, previously available as an internal service for Ashfield employees, is a series of confidential, virtual career advice clinics for the wider healthcare communications community.

The career clinics are aimed at individuals already working in healthcare communications, but looking to discover more about the different career paths open to them as they progress within industry.

Participants will have access to a panel of experts – via telephone or

There are 36.7 million ppl living w/HIV but only 60% know they are #HIV positive & less than 50% are on #treatment

The AMP Study @AMPStudy

Unprecedented HIV vaccine breakthrough as researchers discover ‘on-off switch’ Science @scienmag

Stanford researchers create deep learning algorithm that could boost drug development Fergus Walsh @BBCFergusWalsh

Brain cell therapy ‘promising’ for Parkinson’s disease

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Skype – who will answer questions and provide advice on pros and cons about the different career options available. Sessions will last 25 minutes and run from 6pm to 8:30pm GMT, on a first-come-firstserved basis.

Viv Adshead, President of Ashfield Healthcare Communications, said: “The Ashfield ACE Panel has already been a huge success internally, so we’re proud to open it up to a wider audience. This is about utilising our position in the industry to help people shape their careers by making initiatives like the Ashfield ACE Panel available to everyone.”

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N H S WA I T I N G T I M E S

DOUBLE TROUBLE

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he number of NHS patients waiting more than 18 weeks for surgery is set to double in the next three years, according to analysis based on official NHS figures.

The NHS Partners Network suggests that the total number of patients waiting for operations on the NHS will increase to almost five million in 2020. This equates to nearly two million more waiting for surgery, compared to 2015.

If current trends continue, that total will include over 800,000

patients waiting more than 18 weeks for treatment. This compares to the 360,000 currently waiting for operations.

David Hare, Chief Executive of the NHS Partners Network, which represents independent providers of NHS care, called for patients to be more assertive. “It is crucial patients are able to exercise their right to choose which provider they are treated by, ensuring they can access the quickest available treatment,” he said.

NUTRITION

Nut cracker Eating more nuts is associated with reduced risk of cardiovascular disease (CVD), cancer and all-cause mortality, according to new research.

An international team, from Norway, the UK and the U.S., analysed 20 studies into nut intake and various diseases.

In the systematic review researchers looked at the association of nut consumption and mortality in adults. Higher nut intake (15-20 g/day or five to six servings/week) was linked with reduced risk of CVD, total cancer and all-cause mortality.

According to the World Health Organization, CVD was the leading cause of noncommunicable disease (NCD) deaths in 2012 and was responsible for 17.5 million deaths (46%) of NCD deaths.

Meanwhile, the results of a clinical trial, published in Metabolic Syndrome and Related Disorders, also found positive benefits associated with eating almonds. The incorporation of almonds in a well-balanced diet was associated with multiple beneficial effects on glycaemic and CVD risk factors, among type–2 diabetes patients.

Pf View: And so, at last, our beloved pub snack makes the move from ‘alternative meds’, into the file marked, ‘scientifically proven’. Rejoice.

Quick doses N O R D I C P H A R M A’s rheumatoid arthritis and psoriasis auto-injector PEN Nordimet® (methotrexate) is now available for UK patients.

TE VA P H A R M AC E U TI C A L I N D U S TR I E S has frozen recruitment, but denied media reports of between 2000 and 6000 job losses.

The E U R O P E A N M E D I C I N E S AG E N CY has granted orphan designation to AstraZeneca’s inebilizumab for the treating of neuromyelitis optica spectrum disorder.

A B BV I E has announced positive phase 2b data demonstrating investigational medicine Elagolix significantly reduced heavy menstrual bleeding in women with uterine fibroids.

New research published by H E I D R I C K & S TR U G G L E S has found that Country Managers and European Heads in UK pharma sector are far more diverse than their French and German counterparts.

The seventh annual P H A R M AC E U TI C A L PAC K AG I N G A N D L A B E L L I N G S U M M I T will take place in Zurich on the 19-21 June 2017.

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A P P R OVA L S .

Brave hearts ONLINE PRESCRIPTION S E RV I C E S

CLICK FATE The Care Quality Commission (CQC) has warned the public of the risks they may be taking when buying medicines online.

This follows the CQC’s action against the irresponsible practices of four websites, which put patients at risk by their failure to apply appropriate safety checks.

One site was found to have taken just 17 seconds to review patient questionnaires before issuing prescriptions. Another prescribed large numbers of asthma inhalers, while failing to follow recommendations.

The CQC also discovered that another site was prescribing a high volume of opioid-based medicines – and failing to follow up patients’ medical or prescribing histories – while a further website did not have a sufficiently robust system in place to verify the identities of patients.

The CQC has suspended the registration of one website, and the others have been given restrictions and told they must make the improvements required by law.

MERGERS &. . AC Q U I S I T I O N S .

LIFE CHANGE

S

cotland has become the first country in the UK to approve the routine use of PrEP – a preventative HIV treatment intended primarily for gay and bisexual men who have unprotected sex.

The Scottish Medicines Consortium (SMC) gave the go ahead to PrEP, which significantly cuts the risk of these groups contracting HIV. Studies suggest that PrEP can reduce the risk of HIV infection by 90% and the drug has been described as a “gamechanger” in the fight against the disease. When used together with safe sex practices, it may help reduce the spread of HIV, however, critics claim that it will encourage promiscuity among gay and bisexual men.

A

stellas Pharma is acquiring private Belgian drug discovery company, Ogeda, in a deal reportedly worth up to $850m.

The deal will give Astellas access to Ogeda’s non-hormonal drug, fezolinetant, which has been shown to reduce menopause-related symptoms, such as hot flushes and night sweats, in phase II trials.

Astellas will pay around $533 million for the company upfront and could also pay Ogeda shareholders another

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The SMC ruling follows NHS England’s unsuccessful bid to deny funding for the drug, where it argued that it was not responsible for providing PrEP to patients.

PrEP – marketed under the brand name Truvada – costs around £450 per month. It is estimated that up to 1900 people in Scotland could benefit from the SMC’s decision.

The Terrence Higgins Trust Scotland said that funding the drug could save the NHS in Scotland £360,000 in treatment costs over a lifetime for every person it prevented from contracting HIV. Pf View: Kudos to Scotland for casting antiquated prejudices about lifestyle into the long grass. If NHS England starts judging how people live their lives, where is the line drawn?

$320 million if the drug reaches certain clinical development and regulatory milestones.

Fezolinetant could become the first medicine of its kind to be used as an alternative to hormone replacement therapies, which have side effects including an increased risk of breast cancer.

Yoshihiko Hatanaka, Astellas’ president and CEO, said: “The transaction fits with our strategy to deliver innovative drugs in therapeutic areas with high unmet medical needs.”

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Phar-OUT deal

Uniphar Group has acquired OUTiCO Limited. Specialist outsourcing organisation OUTiCO will operate as an independent company within Uniphar’s Manufacturer Services division, under the continued leadership of founders Paul Black and Mike Cooper – collaborating with Star as required by customers’ needs.

Uniphar Manufacturer Services’ Managing Director, Padraic Dempsey, said: “The successful acquisition of Star in 2015 enabled us to deliver talented people for outsourced teams and headcount opportunities.

“OUTiCO’s value proposition is very different; the multi-channel account management approach maximises technology to engage with NHS stakeholders in new ways.

This is a new level of flexibility for Uniphar.”

Mike Cooper, Managing Director at OUTiCO, added: “We knew we needed a partner with scale and diversity to realise multi-channel account management’s enormous potential. The cultural and entrepreneurial synergy between ourselves, Uniphar and Star makes this a natural fit.”

COPD

A P P R OVA L S

Scottish independence for Imbruvica The Scottish Medicines Consortium (SMC) has taken the decision to recommend Janssen’s Imbruvica® (ibrutinib) for restricted use, as a treatment option for adults in Scotland with relapsed/refractory chronic lymphocytic leukaemia (CLL) and for whom fludarabine-based regimens are inappropriate.

The SMC decision was based on the results of the pivotal Phase 3 study, RESONATE. It also considered the benefits of Janssen’s Patient Access Scheme (PAS), which supported the cost-effectiveness of ibrutinib.

The decision follows the SMC’s previous advice in August 2016, which recommended the use of ibrutinib as a single agent in CLL patients with 17p deletion or TP53 mutation, who are unsuitable for chemo-immunotherapy.

Dr Mike Leach, Consultant Haematologist at the Beatson West of Scotland Cancer Centre, said: “The approval of ibrutinib for the treatment of CLL patients with relapsed/refractory disease is welcomed by haematologists throughout Scotland.”

Holy TRINITY The Lancet has published the results of the TRINITY study, which demonstrated the superiority of Chiesi’s extrafine ICS/LABA/ LAMA triple fixed dose combination therapy, compared to LAMA tiotropium – a standard treatment for chronic obstructive pulmonary disease (COPD).

The study, led by Jørgen Vestbo – Professor of Respiratory Medicine at the University of Manchester and the University of Southern Denmark – was conducted on 2580 patients over the age of 40 with severe COPD. Patients were assigned to groups – one treated with the triple fixed dose combination (ICS/LABA/LAMA), another with an extemporary triple therapy and a third with the LAMA tiotropium.

Chiesi’s fixed triple combination was found to be superior to the LAMA tiotropium over 52 weeks. The efficacy and safety of the combination was not inferior to those of the extemporary triple combination, and it had the added advantage of using only one device to deliver all drugs.

M AG A ZI N E | M AY 2017 | 7

The

M OST E XCITI N G M E D I CI N E S

in the

WO RLD

Pf rounds up some of the most remarkable treatments to emerge in recent years.

WORDS BY

Amy Schofield

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COVER STORY

Cure for a chronic condition?

MEDICINE: Elbasvir/grazoprevir DEVELOPED BY: MSD USED TO TREAT: Chronic hepatitis C virus

Disarming cancer’s ‘invisibility cloak’ MEDICINE: Atezolizumab DEVELOPED BY: Roche USED TO TREAT: Bladder cancer

Atezolizumab is an investigational monoclonal antibody cancer immunotherapy available in the UK via clinical trials and the first immunotherapy to go through the Early Access to Medicines Scheme for suitable patients with advanced urothelial (bladder) cancers. This PD-L1 inhibitor and works by disarming the cancer of its ‘invisibility cloak’, which allows the immune system – the body’s most effective medicine – to detect and destroy the tumour.

Andrew Ackrill, Principal PD Clinical Development Scientist at Roche Products Ltd, says that it has huge potential in the treatment of cancers: “It’s a very interesting drug.”

Atezolizumab is also being trialled as a treatment for a range of other cancers, alone and in combination, including colorectal (bowel) cancer, breast cancer, renal cell carcinoma (kidney cancer), small cell lung cancer, other solid tumours, diffuse large B-cell lymphoma and paediatric cancers.

“Combining targets gives a synergistic approach,” says Andrew. “It’s a very hot area. We’re very much at the beginning of an exciting time.” Before now, there had been no significant advances in the development of treatments for bladder cancer for 30 years.

Andrew says that it is thanks to Roche’s commitment to oncology, along with the opportunity to share knowledge and expertise with 21 leading centres around

I L L U S T R AT I O N B Y

Alex Buccheri

“ WE ’ RE VE RY M UCH at the B EG I N N I N G of an

E XCITI N G TI M E .”

the world through Immunocore, a worldleading biotechnology company focused on the development of this new class of immunotherapeutic drugs, that the current advances are being made. “Roche has a proud history in oncology and I’ve never seen this level of engagement and activity.

It’s very special.”

Andrew and his team of researchers at Roche have seen complete responses to atezolizumab, but only time will tell if the effects will endure in these patients, who are still being followed. “The durability comes with time,” he explains. “In immunotherapy we’re looking at improved response rates – the ultimate goal is to extend the lives of people. Survival is the ultimate goal.”

Hepatitis C virus (HCV) is a blood-borne virus that predominantly infects the cells of the liver. There are an estimated 150 million people worldwide chronically infected with HCV, which can cause inflammation and significant damage to the liver. Recent research shows that HCV can also affect the digestive system, lymphatic system, immune system and brain.* For 30 years, MSD has been at the forefront of the response to the chronic HCV epidemic.

The licensing of elbasvir/grazoprevir marks the latest innovation in the company’s longstanding investment in finding treatments for chronic HCV infection.

In 1991, MSD’s alfa interferon became one of the earliest licensed treatments for chronic HCV. 20 years later, its HCV protease inhibitor became one of the first direct-acting antiviral medicines against chronic HCV in the EU. With the licensing of elbasvir/grazoprevir in July 2016, MSD introduced a new cure for many patients with genotype 1 (GT1) or genotype 4 (GT4) chronic HCV. Cendrine Banerjee-Quetel, Associate Director, Policy & Communications, External Affairs, MSD, said: “The clinical development program for elbasvir/ grazoprevir was designed to investigate this combination across diverse HCV patient populations, including those with severe renal impairment, on opioid substitution therapy, patients with compensated cirrhosis, or with HCV/HIV-1 co-infection.”

The licensing of elbasvir/grazoprevir was supported by eight clinical trials in approximately 2000 patients. The combination, with or without ribarvirin, is approved for the treatment of chronic HCV in adults with genotype 1 and 4 infection.

MSD is not resting on its laurels, however, and work on HCV carries on: “MSD continues to conduct clinical development work in hepatitis C, across a range of agents and types of patients,” enthused Cendrine.

She adds that patients – aware of the consequences of long-term HCV infection – “are relieved at the opportunity of a cure”. * hepctrust.org.uk

M AG A ZI N E | M AY 2017 | 9

COVER STORY

A Nobel Prize-winning active ingredient MEDICINE: Soolantra 1% ivermectin cream DEVELOPED BY: Galderma USED TO TREAT: Rosacea

Ivermectin, the active ingredient in Soolantra cream, is derived from a single micro-organism found in Japanese soil. It is an antiparasitic, which is also used to treat other conditions, including head lice, scabies and river blindness. In 2015, the scientists who developed ivermectin – William C. Campbell and Satoshi Omura – won a Nobel Prize for the research that led to developing the drug, which has reduced transmission of parasitic tropical diseases.

Commenting on ivermectin, Dr Emma Wedgeworth, Consultant Dermatologist & British Skin Foundation spokesperson, said: “Topical ivermectin has been a very useful addition to the armamentarium of topical treatments in rosacea. It has shown to be effective in the treatment of papulopustular rosacea, and superior to some conventional therapies.”

She added that the precise action of ivermectin is unknown: “It’s unclear how much of ivermectin’s antiparasitic activity is responsible for its effect in rosacea. A small commensal mite known as demodex has long been associated with rosacea, but a causal link has not been proven. Topical ivermectin also has anti-inflammatory effects by decreasing cellular and humoral immune responses. Inflammatory pathways play a pivotal role in the aetiology of rosacea.”

What the experts do know is that however ivermectin works, it is a welcome relief for the sufferers of this distressing condition. “It may be that a combination of its antidemodex and anti-inflammatory effects lead to its efficacy in rosacea,” concluded Dr Wedgeworth.

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

“TO PI CAL IVE RM EC TI N has been a

VE RY US E FU L AD D ITI O N to the ARMAM E NTARI U M of topical treatments in ROSACE A”

A contraceptive for the 21st Century MEDICINE: Sayana Press

(medroxyprogesterone acetate) DEVELOPED BY: Pfizer USED TO: Enable women to self–administer contraception Sayana Press is a revolutionary selfadministered Long-Acting Reversible Contraceptive (LARC) injection, which gives women 13 weeks of effective contraception with no need for daily dosing.

According to Dr Diana Mansour – Consultant in Community Gynaecology and Reproductive Healthcare, New Croft Centre – Sayana Press helps women to stay in control of their contraceptive choices, which is what they want from their contraceptive in the 21st century: “Ideally they want a method that is highly effective, reversible, with non-contraceptive benefits and under their control. Sayana Press, containing 104 mg medroxyprogesterone acetate in a pre-filled, simple injection system, fits the bill.”

Following the commencement of Sayana Press, no pregnancies were reported in two open-label, phase III clinical studies at one year, across 16,023 women-cycles of exposure.

Its efficacy was not affected by weight, meaning that no dose adjustment is needed for women who are overweight or obese.

Normal fertility also returns within 12 months of discontinuing the contraceptive injection.

Sayana Press doesn’t only protect women against pregnancy, it also has other benefits.

“One of the best loved non-contraceptive benefits with progestogen-only injectables is the high rate of amenorrhoea (the absence of periods),” said Dr Mansour. “Over 50% of women using Sayana Press report no

*

periods at the end of the first year. Reducing menstrual bleeding also means a reduction in period pain.”

Another benefit of this contraceptive is that it is licensed to be self-administered by women. “In the past, women needed to visit their GP surgery or sexual health clinic every 12 to 13 weeks to receive their injection,” reflected Dr Mansour. “Now at their first or second consultation they are able to give their own injection, and when confident, be prescribed up to a year’s supply of Sayana Press to self-administer at home.”

This ease of use is backed up by the data. “Research has shown that selfadministration of Sayana Press is ‘easy’ and acceptable with approximately 50% of current users of injectable contraceptives interested in trying this new approach.

There is also the potential to increase treatment compliance over time with selfadministration,” Dr Mansour explained.

Self-administration of Sayana Press also saves the NHS money, reducing clinic attendances for women and allowing more time for other consultations in the GP practice or community contraceptive clinic. “It has been estimated that selfadministration could save the NHS £38.92 per patient each year, if seen in primary care,” Dr Mansour added.

“ S E LFAD M I N I STR ATI O N COU LD SAVE the N H S £3 8 .92 per PATI E NT each YE AR”

For full references, please view the extended article on pharmafield.co.uk.

F E AT U R E WORDS BY

Amy Schofield

Could spider venom be an antidote to stroke-incurred brain damage?

Don’t believe the hype: health headlines dissected TH E S TO RY

TH E R E S U LT S

Most of us would insist on a safe distance from massive poisonous spiders, but not our intrepid scientist friends ‘down under’, who not only got close, but secured their venom as well. In the process, they might have stumbled across a protective therapy for people who have suffered a stroke.

While studying venom from the deadly funnel-web spider, researchers at the University of Queensland (UQ) and Monash University happened upon a compound which they say could protect the cells of the brain from damage, even hours after a stroke.

Not only did administering Hi1a two hours after stroke reduce the extent of brain damage by 80%, but the compound remained effective eight hours after a stroke, reducing the amount of brain damage by around 65% when compared with untreated animals.

The researchers concluded that Hi1a is “a powerful pharmacological tool and a promising lead for the development of therapeutics to protect the brain from ischemic injury”.

TH E R E S E A RC H While sequencing the DNA from three of the lethal arachnids – which were reportedly “milked exhaustively” of their venom – the scientists discovered a protein, Hi1a, that resembled two copies of another chemical known to be capable of protecting brain cells.

Professor Glenn King, Group Leader, Chemistry and Structural Biology Division Investigator at the UQ Institute for Molecular Bioscience– whose research ‘harnesses the chemistry of venoms’ from arthropod predators, such as spiders, scorpions and centipedes, to develop novel pharmaceuticals – said that Hi1a “proved to be even more potent” than the other protective chemical.

In a series of studies on rats, Prof. King and his team demonstrated that a small single dose of the spider venom molecule protected neurons in the brain from strokes.

TH E D E A L “We believe that we have, for the first time, found a way to minimise the effects of brain damage after a stroke,” Prof. King enthused.

The Australian team hope to start human trials of the compound in the next two years, however, further trials must be carried out first. If these trials are successful, treatment of stroke patients could potentially be transformed.

W HAT TH E PR E S S SA I D : “Deadly spider venom could ward off stroke brain damage, say doctors” The Guardian; “Spider venom may offer stroke therapy” BBC News; “Can spider venom protect brain cells after a stroke?” Spectator Health.

SPIDEY

SENSE A BITE FROM AN

AUSTRALIAN

FUNNEL-WEB SPIDER

can kill a human in

15 MINUTES Scientists examined

VENOM

SPIDERS EXTRACTED FROM

FROM QUEENSLAND’S

ORCHID BEACH

STROKE

DEATH IS THE SECOND-LEADING CAUSE OF

WORLDWIDE

M AG A ZI N E | M AY 2017 | 1 1

STEP CHANGE ‘Next Steps on Five Year Forward View’ is here, but what does it mean for commissioners?

T

he Five Year Forward View (5YFV) was Simon Stevens long, imploring, ultimately optimistic love letter to NHS England. That original manifesto, with its neo-healthcare, Atlantic-crossing ideas and crusade against the old order, promised a fresh perspective.

Now that it’s half way towards the original vision – or two and a half years into the five at any rate – the whole country watches and waits for the green shoots of change.

Meanwhile, ‘Next Steps on the Five Year Forward View’ has been duly published, with new targets in some key areas – notably commissioning.

In order to shed some light on what this means we’ve got an expert who could not be closer to the action.

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

J U LI E WO O D NHS Clinical Commissioners Chief Executive

VIEW FROM THE EXPERT:

L

ong before the publication of ‘Next Steps on the Five Year Forward View’ it was clear that the commissioning landscape was evolving. Clinical Commissioning Groups (CCGs) have been playing key roles as architects of this changing landscape and I’m pleased that the Next Steps document has the potential to support the vision that we and our members called for in our ‘future of commissioning’ paper, published last year.

Next Steps recognises just how far clinical commissioning has come since the ‘Five Year Forward View’ (5YFV) was published. Having local clinical leadership at the heart of healthcare commissioning has had immense benefits for patients. While, going forward, we are unlikely to see a single model of commissioning, it is evident that the local clinically-led element must remain, or the NHS will be poorer for it.

FAC I N G U P TO TH E C HA LLE N G E S The delivery plan didn’t ignore the challenges. There was a welcome focus on improving primary care, urgent care, cancer and mental health, all of which are priorities for our members. The willingness to

F E AT U R E

“The NHS provides highquality cost-effective care, but its ability to continue will be restricted if we can’t prioritise areas which get the best outcomes for patients”

relax the 18-week waiting time was an important recognition that the NHS can’t deliver everything that is being asked of it within the resources provided by Government.

That said, the plan won’t solve every problem. The NHS is still being asked to deliver an awful lot with finite funding. CCGs are certainly up for the challenge of working with what they have and creating a sustainable health and care system – but this involves making tough decisions. That means working with those who provide care to establish how best to spend the NHS pounds – they can only be spent once.

E FFE C TI V E PR I O R ITI SATI O N There must be recognition that sustainability needs to involve transformation and doing things differently. The NHS provides highquality cost-effective care, but its ability to continue will be restricted if we can’t prioritise areas which get the best outcomes for patients, while also getting the best value for our limited budget.

Part of this relates to the work that NHSCC are carrying out on medicines spend, referred to in the delivery plan. We’ve worked with our members to produce a list of items that could be considered low priority for NHS funding , either because they offer no or minimal clinical value – because cheaper and equally effective alternatives are available – or are otherwise low priority.

We’re not calling for a blanket ban – there must be flexibility to allow individual patient needs to be met. Through NHSCC our members will work with NHS England, the professions and patient groups on the best way to implement this, ensuring we are taking these needs into account, while making the most effective use of NHS funds.

This work forms only one part of what will be needed to transform the NHS. Clinical commissioners are ready and able to play their part.

They continue to work with partners – through Sustainability and Transformation Partnerships, as well as other local arrangements – to deliver a health and care system fit for the future.

Next Steps has the potential to help and drive forward the transformation agenda. It is vital that we work together across the system to make sure its vision becomes a reality, especially if we are to close the gaps laid out in the 5YFV – not in finance and efficiency but, critically, in health and wellbeing, and care and quality.

THE STEVENS LEGACY WORDS BY

John Pinching

I

n spite of a long cross-party, intercontinental career at the higher echelons of healthcare change management, Simon Stevens remains an enigma – a man on a journey where the destination has not come into sharp focus. Even so, his determination to navigate the chaotic landscape feels very real and there is no doubt that this NHS explorer has gained some very useful traction.

It is perhaps his lack of allegiance to a party (he has worked successfully under Labour and Conservative), and a seemingly stealth-like will to fundamentally and positively change the NHS, which have allowed him to avoid the extremities of political bun fighting. Indeed, Simon Stevens is not an unpopular operator and, when you compare that with Jeremy Hunt’s beleaguered public image, you realise that even a mild approachability in the hostile terrain of public health, is a remarkable achievement.

There have been elements of his conduct which provide clues to his modus operandi. When he told people in Britain to lose weight – he lost weight. He is passionate about reducing sugar from the diets of British citizens, and particularly children – he clearly worries about the same things we do. Furthermore, he hasn’t been afraid to bring elements of what he learnt during his spell in America at United Health, such as Accountable Care Organisations, into an antiquarian NHS. This raises the possibility that the public – contrary to popular belief – don’t reject change to our 1948 institution. We simply respect an honest approach and Stevens has adhered to that.

The targets laid out in the 5YFV and, in particular, his determination to integrate fragmented services – attaching GP surgeries to hospitals – use resources more efficiently and place an emphasis on public responsibility, could represent his lasting legacy.

Ultimately, Simon Stevens’s magic bullet could be a combination of political impartiality, an ‘I’m a user too’ mentality and a ‘Stateside’ perspective, but if the journey ends with an NHS that is both ‘beloved’ and functioning within its means, the appointment of Simon Stevens could just be the greatest decision David Cameron ever made.

M AG A ZI N E | M AY 2017 | 13

The lab

What really goes on at the science end of treatment discovery?

WORDS BY

John Pinching

H IT S E LEC TI O N

H IT TO LE AD

LE AD O P TI M I SATI O N

To develop treatments that can tackle the underlying causes of Parkinson’s we need to change the way brain cells work. The key is finding small molecules that target the process that has gone wrong in the cell.

Up to half a million drug-like molecules are screened, quickly identifying any that may have potential.

To discover more about the chosen molecules, they are tested to identify those with the most promise. Any that fail, or cause problems in other organs, or are known to produce serious side effects, are discarded. Each molecule is tested for strength and it must be soluble in water. Biotech company Oncodesign is currently developing a class of compounds in the Hit to Lead phase that prevent the enzyme LRRK2 from activating. LRRK2 is often found in genes that are associated with Parkinson’s.

Now the group has been whittled down to molecules with genuine promise, it’s time to start developing them into drugs – this step needs skilled scientists who are specialists in drug design. They painstakingly tweak the structure of the remaining molecules to achieve the best possible effects, while minimising any negative reactions. Throughout this process, molecules are refined and then tested repeatedly – this can go on for years.

C LI N I C A L TR I A L S

C LI N I C A L TR I A L S

The new drug is ready for clinical trials on a small number of people, testing for safety, side effects and best dose. Studies involve a small group who may be healthy volunteers or people with the condition.

Two different Parkinson’s vaccines are currently being tested in early stage trials – one developed by US firm Prothena, and the other by Austrian company Affiris.

These studies include a comparison group who receive a placebo, allowing researchers to see whether people who receive the treatment do better than those that ‘imagine’ they have taken it. Exenatide, a drug that is currently used to treat type 2 diabetes, has shown potential for slowing the course of Parkinson’s. A phase 2 trial of the drug is now complete and results are expected in 2017.

PHASE 1

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

PHASE 2

F E AT U R E

A

t the business end of pharma it is all too easy to forget the trials (quite literally) and tribulations of the science that precedes it.

The currency – beyond pounds, dollars and euros – of research and development is what pharma ultimately trades in. It is the gauge with which a company can judge itself and it is the platform upon which employees, stakeholders and, yes, patients can build – whether it is

commercial reputation or improved health.

Having a clear understanding of the exhaustive process involved in bringing a drug to market is essential. While defeat at any stage of the cycle often comes with severe implications, overcoming each hurdle and reaching the mecca of approval has farreaching benefits, often with a global impact.

Here, Claire Bale from Parkinson's UK takes us through each vital step on the journey.

A NEW FRONTIER IN DEVELOPMENT

T

CAN D I DATE N O M I NATI O N

PR EC LI N I CAL S TU D I E S

After all the lab testing, tweaking and modifying, scientists will finally look at the best possible candidates to create a new drug, and select the best contender.

After years of research, if successful, the compound will be taken forward and moved into preclinical drug development.

Before any new experimental treatment can be used on people, it first needs to be rigorously lab-tested. At the preclinical development stage, pharmacologists and toxicologists test the new drug under experimental conditions. Firstly, the scientists will use computer programmes – in silico – before testing the active compounds in test tubes or petri dishes – in vitro. Finally, animal experiments – in vivo – help scientists understand the complex effects of the drug.

C LI N I C A L TR I A L S

PHASE 3

Later clinical trials often take place across many countries, involve hundreds of participants and run for several years.

Apomorphine is already used by many people with Parkinson’s to help control symptoms.

Phase 3 trials are now underway in the US and UK to test a new way of delivering that involves placing a special strip under the tongue.

Results are expected in 2017.

he pathway to creating new drugs is a long, expensive and difficult journey. Each step in the process is vital, and a drug can fail at any stage along the way. For every potential therapy that enters the process, perhaps only one in a thousand will end up being approved for use.

Over the years, investment that would push forward promising early-stage research for Parkinson’s into drug development has gradually dried up – leading to a bottleneck in the drug development pathway and less research making it through to clinical trials.

Now, Parkinson’s UK is embarking on a radical new programme of work to shake-up the drug development process. Funded by a new campaign, ‘We Won’t Wait’, Parkinson’s UK will act as a biotech company to highlight important research and develop it for further investment.

Without building labs, employing teams of scientists or buying expensive equipment, the charity will work ‘virtually’ in partnership with a range of other organisations – companies, universities or other charities – that have the facilities to carry out scientific work. Parkinson’s UK will be able to rapidly invest in promising research projects and make early-stage research more attractive to investors.

While we can’t know exactly what will happen next in terms of treatments, we can be optimistic about ongoing research. We’re confident a cure is there – it just needs to be developed.

Claire Bale is Head of Research Communications at Parkinson’s UK. Go to wewontwait.parkinsons.org.uk

M AG A ZI N E | M AY 2017 | 15

CELEBRATING

10 YEARS

TWO’S COMPANY JP takes coffee and cake with the publishers of Pf Magazine, as Events4Healthcare (E4H) celebrates its 10th anniversary.

INTERVIEW BY

10

John Pinching

10

10

10

01

10 10 10

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

I

’m quite familiar with the husband and wife partnership, Melanie and Karl Hamer, that have successfully run the medical education company E4H for 10 years. After a decade of considerable change – during which time they have become the publishers of Pf Magazine – now seems a good time to reflect.

What are you up to at the moment?

Melanie: Many people are still enjoying the afterglow of the recent Pf Awards Dinner, but I’m already working on the Pf Awards for 2018 and 2019.

Karl: Typically, we develop programmes that raise awareness and confidence in therapy areas. My focus at the moment is on an Atrial Fibrillation partnership programme with Public Health England, NICE and the Academic Health Science Network. It’s a great project, with pharmaceutical company involvement, and will be rolled out later in the year. This is a great example of how we work in partnership across industry and the NHS. What are your reflections on Pf Awards 2017? Melanie: I’m glad we took the decision to change the assessment process – making it tougher. Although it was tough it received very positive feedback as candidates felt they were really challenged. There were more individuals and companies entering, and attendees at the dinner, than ever before and that’s testament to how the awards are perceived. People who reached the Assessment Day should be very proud – it’s a real recognition of excellence.

It’s also been great catching up with previous winners in the magazine, who consider winning an award as a turning point in their career.

How has your first year as owners of Pf Magazine been? Karl: It’s been exciting and challenging. We purchased the magazine as it is the ideal platform to keep the industry updated with knowledge, opinion, NHS updates and what each other is up to. We saw it as a blank canvas and initially met a number of people in industry to get advice on what they needed from a publication that represented their industry.

Melanie: We embarked on a radical rebrand – embracing new audiences, changing the look and feel of the magazine and altering the direction of content. It is now more analytical and opinion-leading, taking on the issues of the day. Also, finding talented people and taking the magazine, and its associated products, forward, has been tremendously exciting.

Why did you start E4H? Karl: We are both from a pharmaceutical background and

COFFEE BRE AK observed a gap in the market. We understood the needs of the pharmaceutical industry and the NHS, therefore we were well placed to use our knowledge to support them by being the link to bring them together.

Melanie: Within six months of starting E4H the demand for new projects was so great that Karl came on board bringing with him his network of NHS and clinical experts.

How has the business evolved?

Melanie: As the business has grown so has our expertise in many more therapy areas. In addition, we have fully embraced the digital era and how healthcare professionals want to consume their education. We have invested in digital platforms, making sure we remain at the forefront of educational advances.

Karl: In the beginning clients would present specific briefs. Now we are engaged earlier in projects, and clients utilise our expertise by telling us what their objectives are. We then jointly develop solutions tailored to their needs and those of their customers.

How has digital impacted on your overall offerings? Karl: The advancement in our digital capability allows us to bring together clinicians and experts in a virtual environment to form webinars, advisory boards, e-learning programmes and forums. Our investment in developing an active network of over 14,000 healthcare professionals has really supported this activity and provides some of our clients with a great opportunity to connect directly with their audience.

Melanie: Although this year we celebrate our 10th anniversary, in some ways we feel like a start-up again; we have acquired a production, technology and creative side to our business in the last two years, meaning we can deliver an end-to-end solution for our clients, which is really exciting.

What have been your most rewarding projects? Melanie: For me it has to be the Pf Awards – they are my third child and I’m passionate about them! We’ve had to move with the industry and the categories have changed – 17 years ago I didn’t even know what e-detailing was. I am motivated by making sure the Pf Awards are always relevant.

Karl: It feels great when customers present us with a challenge, and by working together we develop a solution with real outcomes.

There is nothing more rewarding than a client saying “that was fantastic – it will make a difference to how patients are treated”.

“When you are husband and wife you trust each other; there is no better basis for a relationship and that also applies to business .”

Was it always your intention have a career in pharma/healthcare? Melanie: Initially, I was a dental nurse, but then responded to an advert in the paper and enjoyed a career in pharmaceutical sales, training and management with GSK, Astra and Sanofi.

When I was ‘carrying the bag’, we didn’t have mobile phones, but interacting with people was the same, and that gave me a great foundation for understanding customer needs.

Karl: My background was in accountancy, before moving into sales, marketing and strategic operations. I moved into pharma after a friend’s recommendation and the promise of a company car. I thought I’d do that for 12 months, but remained at AstraZeneca for 15 years!

How did you first meet? Melanie: We met on a presentation skills course at Astra.

Karl: Mel was impressed with my flipchart skills.

What is the key to working successfully as husband and wife? Karl: We talked to another husband and wife partnership – Judy and Chris Philips from CHASE – and they gave us invaluable advice about understanding each other’s strengths. That has always stuck with us – we have defined roles and don’t overlap.

When you are husband and wife, you trust each other implicitly; there is no better basis for a personal relationship and that also applies to business. E4H is a family business made up of a small team but with huge capability for impact.

We feel really lucky to work with some truly talented people on a daily basis.

What record would you choose for the soundtrack of your life?

Melanie: Lionel Richie’s Dancing on the Ceiling.

Karl: Anyone who has worked with me knows I sing a lot, and mostly out of tune. As a family, we love musical theatre and this week I have been singing numbers from ‘Hamilton’.

It’s your last supper, what are you having?

Melanie: We lived in Leicester for seven years – it would have to be Karl’s homemade curry followed by a slice of our 10th anniversary cake.

Sounds delicious. Goodbye.

Bye John. Go to events4healthcare.com

M AG A ZI N E | M AY 2017 | 17

Not so

NICE

NHS England’s muscle flexing could spell end for old regime.

WORDS BY

Alex Ledger

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

T

he tectonic plates upon which the medicines system sits are shifting – in England at least – and the aftermath promises a reformed landscape fundamentally different to any that industry has looked out upon before.

The latest geographical change to which I refer is the establishment of the new Strategic Commercial Unit (SCU) in NHS England and the rapid realignment of control over medicines that is emerging as a result.

There are several aspects of the SCU’s evolution that you ought to be aware of, which will be explored here. Essentially, however, it signifies a single-minded and seemingly successful manoeuvre, from Simon Stevens, to wrestle authority over the medicines spend from those agencies outside of NHS England control.

Moving onto the specifics, your head would have needed to be in the sand over the last month, not to be aware of the announcement from NICE that it would be taking forward three major changes to its processes (which your faithful correspondent wrote about in Autumn last year).

POLITICS

“This marks a fundamental erosion in the role of NICE as supreme arbiter of value and what the NHS should invest in when it comes to medicines.”

Perhaps the most controversial aspect of the changes is the introduction of a new ‘budget impact test’ for medicines assessed

by NICE – a measure that is determined to be cost-effective. Previously, when a medicine was concluded by NICE to be cost-effective, following a rigorous review of its evidence, it would need to receive mandatory funding from the NHS within 90 days. This rule, laid down in statute, meant NICE guidance overrode NHS budgeting decisions and ensured patients gained a ‘right’ (later enshrined in the NHS Constitution) to access NICE approved treatments.

The additional hurdle, that proven costeffective medicines are negotiated under the control of NHS England, can be read as a signal that Stevens has successfully achieved a major land grab over his own budget. It is hard not to be impressed by the achievement. It also marks a fundamental erosion in the role of NICE as supreme arbiter of value and what the NHS should invest in when it comes to medicines.

H E R E ’ S WH E R E TH E STO RY B EG I N S The new budget impact test, now in action since 1 April 2017, removes NICE’s dominance. From now on, when it is forecast that a new medicine will cost the NHS £20 million or more in any one of three years, post-launch, the manufacturer will need to enter into a negotiation. The aim would be either reduce the price to bring it under the threshold, or agree to stagger the entry over a longer period of time, thus managing its cost to the NHS. And who do you think the manufacturer will be negotiating with?

You guessed it, the new NHS England SCU. Understandably you would be forgiven for concluding that £20 million per year is a considerable sum of money. It is, but one must consider that we are talking about the whole of the NHS in England and all eligible patients. A new Alzheimer’s treatment – much-needed we all agree – would easily fall subject to this process, even at a very modest price. As would many breakthrough treatments, such as the wave of hepatitis C therapies that have arrived in recent years.

NICE itself has estimated that around 20% of new medicines per year might be subject to this negotiation. We’re not talking about exceptional circumstances here.

More importantly, however, is the trend being set. What is a £20 million threshold now, might well become a £10 million threshold tomorrow. Indeed, if one examines the details of the recommendations of the Government’s Accelerated Access Review (AAR), it becomes clear that NHS England sees the role of the SCU expanding considerably.

PATR I OT G AM E S What this spells for the future is interesting.

On 28 March, NHS England announced it would be leading a review of “low value prescription items” to deliver savings to the medicines budget in this area.

In total, 10 items have been highlighted so far. Gluten-free foods have garnered the most media coverage, but the list also includes travel vaccines, drugs such as Tadalafil and painkillers. Such ‘decommissioning’ is essential to deliver financial headroom for the NHS at a time of acute financial pressure.

Nonetheless, it indicates another ambition for SCU control – this time at the other end of the medicines life cycle.

There is also the proposed role for the SCU in negotiating new “commercial deals” with industry to consider, again proposed in the AAR. Stevens has indicated that these will include outcomes-based, annuity-based and volume-based pricing deals.

Should these plans go ahead, the SCU will take a lead in reaching previously unforeseen agreements with industry; trading off volumes and outcomes against price. There are significant opportunities here for pharma to deliver major prizes in terms of patient access to new treatments. Industry will need to be equipped to offer what the NHS expects and augurs point towards the SCU driving a hard bargain. Successfully navigating NICE will only be the start of the discussion.

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

“There are significant opportunities here for pharma to deliver major prizes in terms of patient access to new treatments.”

M AG A ZI N E | M AY 2017 | 19

OPINION

W

Stand and deliver Pharmacists working in GP practices – do you understand what they do?

WORDS BY

Deborah Evans

hile the role of the clinical pharmacist in general practice has been developing for some time, it is now an integral part of the transformation in GP services.

Outlined in the ‘GP Forward View’ (April 2016) – to address challenges in GP practices and utilise the vast knowledge of medicines that a pharmacist brings – NHS England has committed to get an additional 1500 pharmacists working in general practice by 2020-21.

This is in addition to a pilot scheme launched in July 2015, which has already seen 491 pharmacists working in around 650 GP practices across the country. A further rollout towards the 1500 target has now been launched, with GP practices applying for funding at the beginning of this year. We should see over 900 new pharmacist positions by March 2018 and over 1300 by March 2019.

Next Steps on the NHS Five Year Forward View further underlines the contribution this role can make to the plethora of NHS woes.

“NHS England has committed to get an additional 1500 pharmacists working in general practice by 2020-21.”

Indeed, pharmacists bring a unique perspective to GP practice; as medicines experts, they help ensure that patients are prescribed the right medicines, are regularly reviewed and adhering correctly.

This includes an operational role; reviewing medicines, ensuring compliance and supporting patient population medication reviews. The innovation also involves working as part of the general practice team to resolve day-to-day medicine issues and treating patients directly.

Many pharmacists are, or will be, independent prescribers running their own clinics, including managing minor ailments, providing extra help to manage long-term conditions and delivering advice for those on multiple medications. The role is pivotal to improving the quality of care, improving patient safety and reducing preventable medicinerelated hospital admissions.

Pharmacists working in GP practices also have an important role to oversee patients’ transfer of care between hospital and the community.

This is where many medicines safety issues occur and, therefore, the pharmacist working in the surgery can be key to ensuring a seamless service for patients, joining up care with hospitals, community pharmacists and other health professionals.

It is the benefits that pharmacists can bring to general practice that have led to such widespread support from GPs. Having a pharmacist in GP practices means GPs can focus their skills on diagnosing and treating patients with complex conditions.

Key supporters to ensuring successful implementation of the programme include NHS England, Health Education England, the Royal College of General Practitioners, the British Medical Association’s GP Committee and the Royal Pharmaceutical Society.

As part of the implementation plan and the wider workforce transformation, Health Education England – in partnership with NHS England – has a requirement to procure approximately 2000 accredited Pharmacist Independent Prescribers places across England.

Aside from the obvious engagement with pharmacists working in GP practice, there is an important role for pharma in facilitating the interface between clinical pharmacists working in hospitals and communities. How engaged are you with pharmacists?

Deborah Evans is Managing Director of Pharmacy Complete, Board Member of Royal Pharmaceutical Society England and practices in a pharmacy within a GP practice.

Go to pharmacycomplete.org or email deborah@pharmacycomplete.org

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

2017 Perception, Motivation and Satisfaction Survey

Have you ever stopped for a moment to consider what it is that really motivates you?

Perhaps you’re striving to build a successful long-term career, or to ensure you and your family are secure?

Or are you simply motivated by the prospect of an increased salary, a better car, or your next promotion?

Or is it – as I suspect – a far more subtle and eclectic mix – one that includes a host of different, but important factors that must combine in an optimal way for you to feel really valued and full of purpose?

If you ever find yourself asking any of the above and wanting greater insight on you, your company, or your peers, now is the time to find out!

Simply take part in the 2017 Perception, Motivation and Satisfaction Survey to get the answers you’re seeking!

Need a company-wide view?

Call George Newall on 0781 000 6472 or Hazel Lodge on 01462 476119 for more details.

And now consider this – does your relationship with your manager and benefits package really stack up? Or is it the cause of some degree of dissatisfaction?

HAVE

YOUR SAY PFPEOPLE .CO.UK

PFPEOPLE .CO.UK

George Newall – Managing Director, Catalyst Project Management Ltd.

REALITY

CHECK

36.7M WORLDWIDE living with HIV/AIDS.

140M

APPROX GLOBAL CASES OF HEPATITIS C.

AT LEAST 350,000 DIE WORLDWIDE FROM HCV COMPLICATIONS EVERY YEAR

IN 2015

1.1 MILLION DIED OF AIDS-RELATED ILLNESSES

PAMELA LIFEGUARD: BAYWATCH STAR

ANDERSON

GIVEN TEN YEARS TO LIVE IN 2002

cured of hepatitis C in 2015 MAGIC TRICK: BASKETBALL LEGEND

EARVIN ‘MAGIC’

JOHNSON has lived with HIV for 26 years.

1980s

Death sentence revoked The last few decades have witnessed remarkable milestones in treating HIV/AIDS and hepatitis C.

N

ot so long ago, being informed you were HIV positive, or had contracted hepatitis C, meant your entire future was thrown into grave doubt – if you had a future at all.

Over the last 35 years, however, AIDS has gone from a virtual death sentence to a perfectly manageable condition.

Indeed, my Uncle, Professor of Immunology, Anthony Pinching, reflected that “the HIV/AIDS model of research had become the standard bearer for other diseases”.

Meanwhile, hepatitis C treatments have reached new highs, with thousands given renewed optimism and even a cure.

Now we hear exclusively from Jane Anderson – a uniquely-placed expert who has been involved in HIV/AIDS for 30 years – and Mykie Leong Chadwick, a Pf Award-winning Service Development Manager, Hepatitis C, from MSD.

4670 HAEMOPHILIACS CONTRACTED HEPATITIS C AND

1200 CONTRACTED HIV FROM INFECTED BLOOD PRODUCTS.

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

WORDS BY

John Pinching

F E AT U R E

CHAN CE O F A LI FE TI M E

JA N E A N D E R S O N Director at the Centre for the Study of Sexual Health and HIV, and Chair of the National AIDS Trust

“As economic constraints deepen we must not allow the phenominal progress of the past 30 years to stall.”

More people than ever before – about 105,000 – are living with HIV in England, as effective therapy increases longevity and new infections continue. For those diagnosed in time and who have lifelong access to antiretroviral medications, HIV has changed from a universally fatal infection into a manageable condition for the long-term, with clinical and virological outcomes that are world leading.

Virological suppression is key, both to avoiding HIV related ill-health and to prevention, as those with completely suppressed viral activity are not infectious to other people. More people with HIV are now living into old age, often with added complications. Late and undiagnosed infection is a major challenge – more advanced infection being associated, not only with increased morbidity and mortality, but also with the risks of unwitting onward transmission.

Estimates suggest that about 17,000 people with HIV are as yet undiagnosed and at least a third of newly-diagnosed people have advanced infection, making expanded HIV testing a crucial intervention.

Despite enormous clinical advances, HIV continues to take a significant toll on people’s lives. For example, quality of life for people with

HIV is below that of the general population, poor mental health is common and HIV-associated stigma and discrimination is unrelenting.

Knowledge and awareness about HIV within the general population is dispiritingly low.

We now have the wherewithal to ensure long life for people with HIV but, as economic constraints deepen we must not allow the phenomenal progress of the past 30 years to stall.

The next few years are crucial in ensuring that treatment evolves to effectively meet the changing needs of an increasing and ageing population.

Measures that improve quality of life in particular, through reducing stigma and discrimination, need to be implemented.

Following the 2012 health reforms, all three commissioning bodies have responsibility for some aspects of the prevention and care pathway.

Ensuring a joined-up approach that delivers seamless care to people is a challenge that must be overcome. Making sure new information is translated into action on the ground, for example, securing access to Pre-Exposure Prophylaxis for all those at high risk of acquiring HIV, must be a key priority.

CU RE I N TH E CO M M U N IT Y

MYK I E LE O N G C HA DW I C K Service Development Manager, Hepatitis C, at MSD

“We believe that each person in the UK living with HCV infection deserves to be cured.”

For the estimated 214,000 people chronically infected with the hepatitis C virus (HCV) in the UK, there are more treatment options available than ever before.

Over the last decade, mortality in the UK – due to hepatitis C-related cirrhosis or liver cancer – has been increasing at an alarming rate; over twice as many people died of HCV-related illnesses in 2014 than in 2005; but, in 2015, there was an 8% reduction in the number of deaths related to HCV compared with the previous year.

In recent years more people are becoming aware of their HCV status and seeking treatment. As HCV is usually asymptomatic, however, it can be a challenge to identify infected people – the number of people in England diagnosed was five times greater in 2015 than in 1996, but half of HCV patients are estimated to be undiagnosed.

Treatments available for HCV have improved dramatically in the last few years, with the introduction of direct-acting antiviral (DAA) treatments. Historically, treatment used to be 48 weeks long, involved injectable and oral dosing, and was effective in only 56% of patients.

DAA treatments can now be taken as a single pill per day, are well tolerated and have cure rates exceeding 90%.

The majority of HCV patients are from marginalised groups in society, including people who inject drugs. Infection, however, could occur through unprotected sex, infected blood transfusions, received before September 1991, or sharing toothbrushes, razors and tattooing or body piercing equipment.

The HCV team at MSD has a vision – achieving a future free of hepatitis C; for patients and the NHS. We believe that each person in the UK living with chronic HCV infection deserves to be cured.

As treatment is only a part of the solution to eliminate HCV, we are also committed to collaborating with organisations to promote awareness and prevention, especially among the populations most at risk for chronic HCV. Curing a patient of HCV is an amazing achievement, but it is also about developing holistic treatment strategies and reducing risk of re-infection that gets me up and ready to go every day. *For further references, please view the extended article at pharmafield.co.uk

M AG A ZI N E | M AY 2017 | 2 3

Regulation questions: Our readers take the opportunity to ask ABPI leaders questions about the industry landscape, the regulatory environment, the future and much more.

WORDS BY

Andreas Knight, Senior Recruitment Consultant, CHASE:

Polly Appleby, Account Manager, Star Medical:

What has most impressed the ABPI about UK pharma’s recent digital initiatives?

With the impending exit from the EU, how does the ABPI think UK pharma will be impacted and are there immediate plans in place?

“We need to continue welcoming highly-skilled talent and maintain access to international scientific networks.”

Rebecca Lumsden, ABPI Head of Science Policy: As part of the UK/EU ‘Life Sciences Transition Programme’, the ABPI is working alongside our members at the BioIndustry Association to engage the life sciences sector and outline the work needed to create a world-leading life sciences environment in the UK, outside the EU. We have welcomed the Government’s commitment to our industry and the broader Life Sciences ecosystem so far. ‘Making the UK the best place for science and innovation’ is one of the Prime Minister’s 12 Brexit negotiation priorities and a core pillar of the new industrial strategy, with new funding made available by the Chancellor for science.

Research and development, however, is a global endeavour. To ensure the UK continues to ‘punch above its weight’ we need to continue welcoming highly-skilled talent and maintain access to international scientific networks. Access to international collaborations, such as the Innovative Medicines Initiative, are highly valuable for both academic and industry researchers.

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

John Pinching

“We are promoting our achievements now, more than ever, by sharing content.”

Aileen Thompson, ABPI Executive Director, Communications: Digital campaigns allow us to celebrate the scientific advances our industry is making and share these with new audiences, including the patients and public.

Earlier this year we launched ‘Only Just Begun’ – a major digital campaign focussing on the value of the pharmaceutical industry in the UK, and the commitment and passion of the people who work within it.

From the £4.2 billion we spend in the UK on R&D, to the £30.7bn contributed to UK GDP in 2015, we are promoting our achievements now, more than ever, by sharing content.

We’re also seeing an uptake in activity and engagement across our social media channels, including Twitter and LinkedIn. It’s great to see the interest growing in our industry through digital platforms.

F E AT U R E

READER’S

R S AY @phar

ma

Lucy Pohling, Account Executive, GCI Health:

John Pinching, Editor, Pf Magazine:

Harriet Lewis, ABPI NHS Engagement Partner (North): Our industry already works in partnership with the NHS, charities and other healthcare organisations for the benefit of patients. This year, we have made the first steps towards a unique new partnership with the NHS in Manchester. The agreement will allow Greater Manchester to explore new ways of paying for medicines based on patient outcomes – enabling the £1 billion spent on medicines in the region to be as beneficial to the local population as possible.

The partnership will also enable companies to work with Greater Manchester Health and Social Care Partnership to improve the utilisation of medicines and the adoption of innovative medicines, using the unique data capabilities of Greater Manchester.

The Salford Lung Study – effectively a real time clinical trial for chronic obstructive pulmonary disorder – is another example of how collaborative joint working is helping develop a new swathe of medicines.

Initiatives like this show that when the NHS embraces innovation, patients benefit, while industry expertise is recognised and welcomed across the country in a growing number of collaborations.

Sam Ogden, ABPI Chief of Staff: The ABPI welcomed seven new innovative, research-based large, medium and small biopharmaceutical members companies in 2016. Together our members provide 80% of branded medicine to the NHS. This is an exciting new era of biosciences in the UK and we are sure that 2017 will be a seminal year for the life sciences sector, and the country as a whole.

Our focus this year is to continue demonstrating the story of our science, innovation and value to healthcare, patients and the economy. This focus is consistent with our priorities, which include enhancing our industry reputation, delivering the current PPRS, improving access and uptake of new medicines and building our relationship with the NHS. We want to continue to identify opportunities and make the UK domestic landscape attractive for clinical development and the manufacturing of medicines. We would say to any prospective new members – come and join us and help to shape this.

How will the ABPI continue to drive joint working, transparency and innovation in the future?

“Collaborative joint working is helping develop a new swathe of medicines.”

f ie

V HA

EY OU

ld

VOICE

The ABPI has had some high-profile gains in terms of members in recent times – what are the organisation’s immediate aims for 2017?

“Our focus this year is to continue demonstrating the story of our science, innovation and value to healthcare, patients and the economy.”

M AG A ZI N E | M AY 2017 | 2 5

F E AT U R E

Hannah O’Neill, Operations Director, Virgo Health:

Julian Given, Chief Officer, Washington Community Health Care:

Karen Borrer, ABPI Head of Reputation: The pharmaceutical industry is on the brink of a golden age of innovation, with some 7000 medicines in the pipeline. As medicines development becomes increasingly complex and we enter an era of ever more personalised medicines, it is critical that we engage with and use the knowledge of patients by involving them at every step.

Industry works with patients through the European Patients’ Academy, for example, which focuses on increasing the capacity and capability of patients to understand and contribute to medicines research and development through education.

We also continue to work on improving the pharmaceutical industry’s reputation.

Disclosure UK makes the transfer of value between the pharmaceutical industry and healthcare professionals more transparent than ever before, with payments or benefits made in kind to health professionals and healthcare organisations in the UK, publicly accessible on a searchable database.

Initiatives like this help us to assure patients and members of the public that we are committed to open-working with colleagues in the NHS and charities. We cannot make the medical advancements needed without working together with patients, health professionals, academics and other experts and we must find ways to do this in a transparent and open way. We have made good progress on this and will continue to look for ways to improve further.

Paul Catchpole, ABPI Value & Access Director: The ABPI is clear – we believe changes, which have now been put in place by NICE/NHS England and will introduce a £20m budget test for innovative new treatments, break the Conservative Party’s 2015 Manifesto promise to speed up the introduction of cost-effective medicines into the NHS. In a recent member survey – when asked about the impact of the Budget Test – 71% of respondents said they believed it meant their companies would prioritise launching new medicines in European countries over the UK; and 89% said they believed it will mean patient access to cost-effective medicines in the UK will decrease.

Thousands of patients may have to wait longer for treatment for conditions like cancer, heart disease and diabetes, while those medicines which will often stand to benefit the most people are caught up in the system. If the NHS became more effective in its planning it could manage the introduction of new medicines in a more coherent way.

Use of new medicines in the UK is already low, with patients seven times more likely to get a newly launched medicine in places like Germany or France. While Scotland and Wales are both making some helpful strides in improving the use of new medicines, English patients appear to be facing more barriers than ever before. As we head towards Brexit, we should be catching up with Europe, not falling further behind.

Ultimately, we would like to see these plans paused while better solutions are found.

Patient groups’ perception of pharma has declined in every area – what does the ABPI make of this and what action must UK pharma take?

“As medicines development becomes increasingly complex, it is critical that we engage with and use the knowledge of patients.”

How do you view the proposal document – published in January – about changing the arrangements for NICE appraisals?

“If the NHS became more effective in its planning it could manage the introduction of new medicines in a more coherent way.”

Go to abpi.org.uk

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

A DVA N C E YO U R T H I N K I N G

Looking to increase your employees’ knowledge of the ever-changing healthcare industry?

Parallel Learning webinars tackle essential NHS topics, from funding flows and devolution in Manchester, to codes of practice and standards.

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WEBINAR REPORT:

Accountable Care Organisations – the future of healthcare?

Parallel Learning’s third webinar looks at the evolution of ACOs and the significant challenges they face.

WORDS BY

Amy Schofield

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

T

he third Parallel Learning webinar was another highly engaging affair. This time, we explored Accountable Care Organisations (ACOs), a number of which are under active development in areas of England.

The speaker was David Thorne – Pf Magazine columnist and Programme Director, York Care Collaborative – and the webinar was, once again, expertly chaired by facilitator and management consultant Michael Sobanja.

“We’re on a burning platform, and we have to do something different.”

Currently, only one licensed ACO exists, in Northumberland. “There are aspirant ones forming, but this is leading edge stuff, and the cement is still very wet,” said David.

ACOs currently remain a concept rather than a concrete structure.

W HAT A R E ACOS? The basic principles of ACOs are about organisations coming together to deliver health, and possibly some social care, in response to growing financial and service pressures. ACOs will be tasked with putting new care models in place that integrate services which were previously provided separately, bringing together a number of providers to take responsibility for the cost and quality of care for a defined population within an agreed budget. The idea for ACOs came about when NHS chief Simon Stevens visited the U.S. and was inspired by examples of how such organisations are working over there.

R A D I C A L C HA N G E David presented the audience with an overview of the current state of the NHS, and how the uncertainty of the present is ushering in significant change for the future of both the health service and the pharma industry. “The NHS is going through radical change and we’re seeing a reversal in policy. The last time we went through this [due to changes under Andrew Lansley], there was a long period of preparation. This is a different kind of time, where we’re seeing change led by the new models of care; by innovation and people pushing the boundaries,” David explained.

E VENTS & CONFERENCES

“I’d be identifying the doctors and the people who’d be leading the change and I’d be all over them.”

He went on to clarify what this means for pharma. “When I meet people from pharma in the field, they’re urgently searching for some kind of organogram of what their future NHS is going to look like,” he said. “I’m afraid that you need to work with uncertainty – but what we are going to see is all kinds of new people, roles, patient pathways and new ways of doing things. This will really affect value proposition in your day–to–day work.”

I NTE G R ATI O N A N D PA RTN E R S H I P NHS and industry know that the health service is not currently integrated. David explained: “There are transaction points, complex pathways; all kinds of strange handovers between different organisations”.

ACOs will be aiming to address this by integrating ‘one team’ principles. “The key thing from all these models is integration and partnership,” he said.

“We’re on a burning platform, and we have to do something different – probably quite radical,” David warned. “The NHS needs to control its supply and demand. The only way it can grasp these nettles is to work in a collaborative and integrative way. There’s is only one direction – integration.”

I M PAC T FO R PHA R MA Speaking as someone who has worked both within the NHS and pharma, David explained the implications of these changes for people in industry. “On a tactical level, the NHS bodies, roles, people and boundaries will change – your customer lists, all the people you target, the functions that will affect your products. There’ll be incredible variation.”

He explained that those in the field are currently being motivated by traditional influences – clinicians – and the end game is clearest to only a few senior managers. The clinicians are largely in the dark, which has implications for pharma. “No matter how senior, clinicians are cut off from the pace of this and the discussions around it.

“The men and women in suits, who are driving these changes, are the ones who know what’s happening on ‘the other side

of the hill’. That’s not a constituency that pharma has traditionally been able to access and have a rapport with.”

He also cautioned that, due to changing priorities, pharma could be caught out: “Pharma hasn’t realised that priorities in practice could change significantly.

When you’re around the clinicians and the things that they want to do in these ACOs, there are some very different ways in which they express priorities, and the pace of this change will surprise many. By the time we get to the autumn, the NHS is going to look very different.”

C HA LLE N G E S FO R TH E FUTU R E ?

David used the example of ‘social prescribing’ – where GPs prescribe things such as friends, socialising and gym memberships for health improvement – to describe how the competition between prescribing and other care is one of the challenges that pharma could face.

“I’m not sure if pharma is ready to regard this area as competition. The clinicians are massive fans of this. There are opportunities, but there are certainly challenges, and the key thing is to be close to the reality on the ground.”

During the Q&A session, chair Michael Sobanja asked David if it was possible for pharma to support and add value to social prescribing. Describing the shift as “a chance for pharma collectively to embrace social prescribing,” David went on to say: “I’m a big champion of pharma and it really gets to me how little pharma is being represented in a positive way. Surely, if someone is depressed, social prescribing can help them, but the anti-depressants can help them too.”

W HAT C A N PHA R MA D O? David emphasised that although there are now “massive” opportunities for pharma, missing them for want of available information was no excuse for not being prepared, and that preparation starts at a local level. “Initially, a lot of this is going to be ‘offline’ to pharma, but gradually the websites, meetings and documents will be coming out – but you’ve got to stay close to

the right people locally.” Rounding off the webinar, Michael asked David: “If you were a pharma sales and marketing manager, what would be the one thing you’d be trying to address, in order to get to grips with the shift that we’ve being describing?”

David had no hesitation in sharing his recommended plan of action: “I’d be identifying the doctors and the people who’d be leading the change, and I’d be all over them. Some companies are working out who will lead the hospital chains,” he revealed.

“I would be all over the people who are actually setting the agenda, and around the NHS everybody knows the organisations who are going to be driving and shaping us.”

As more ACOs are established, the outcome that we all hope for is real benefits for patients. David believes that this is possible with new models, although they will represent radical change within the NHS and in terms of how industry works: “I hope that this will be a tangible change for patients.”

Go to parallellearning.co.uk

DAVID THORNE Originally a mental health nurse, David has occupied senior positions within NHS hospitals and commissioning organisations for over 35 years. He is currently the Managing Director of Blue River Consulting, Chair of Washington Community Healthcare and Non-Executive Director of City and Vale GP Alliance.

Go to blueriverconsulting.co.uk

M AG A ZI N E | M AY 2017 | 2 9

F E AT U R E

WORDS BY

Amy Schofield

Action ON FISTULA

O Astellas is working with the Fistula Foundation to raise money and awareness of a little known but life-shattering childbirth injury.

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

bstetric fistula is a problem that you may not have heard of, but this devastating childbirth injury and the stigma surrounding it ravages the lives of a million women worldwide.

As Kate Grant, CEO of the Fistula Foundation, says: “Fistula is not an issue that most people know or care about – the predominant injury is a hole in the vagina; there’s not many things that are tougher to talk about than that.”

Thanks to Astellas’ involvement in the three-year corporate giving program ‘Action on Fistula’, and the overwhelming generosity of its employees, however, this little known issue is receiving much-needed funding and support – transforming women’s lives in the process.

Kate was first contacted by Astellas three and a half years ago. The company was interested in doing something to address the problem of obstetric fistula in Kenya.

The representative asked Kate and her small team to submit a proposal about how they would tackle it. It was a competitive process, but Astellas chose the Fistula Foundation’s plan, and the Action on Fistula programme kicked off in May 2014.

A LL I N Kate says that working with Astellas hasn’t simply been a case of them providing the cash – there is true engagement on a corporate and employee level. “The Fistula Foundation has what I would truly term a partnership with Astellas – they’ve been with us every step of the way,” reflects Kate. “It wasn’t a situation where they gave us the money and we never heard from them again.

We have the financial and moral support of the company, but Astellas has always been more than a ‘cheque writer’, they’ve been a cheerleader.”

Astellas’ employees also raised money for the Foundation, demonstrating their true commitment to the cause. The company works with a number of charities, and the employees also nominated the Foundation to receive an additional $100,000 of funding. “The employees chose us. That commitment goes to demonstrate the ‘all in’ phenomenon there,” Kate enthused. “The more subtle benefit is that Astellas is getting behind fistula, not only as an issue, but also backing the Fistula Foundation – those things are important too.”

U N LI M ITE D N E E D There are many bigger charities than the Fistula Foundation, but this is one that punches above its weight. Despite its small size, the Foundation raised just over $10m last year – up by a factor of five in the last decade – and did more fistula surgeries than the U.S. Government.

ADVERTORIAL

Together, they get money to over 30 countries. It’s deliberately run by a small team to keep operations as swift and efficient as possible: “We ask, ‘Is that going to help women get treated?’ If the answer is no, we’re not going to do it,” explained Kate. “We try to get eight out of 10 dollars to those who need them.” It’s still a drop in a vast ocean, however, and there is almost an unlimited need for funds.

The Fistula Foundation says that to successfully treat fistula, three elements are needed: a patient, a trained surgeon and a properly equipped facility.

The women suffering from obstetric fistula often feel ashamed and suffer in silence for years, concealing their condition, not knowing that it is treatable.

This makes them hard to find. There are not enough surgeons available to treat the growing numbers of women in need, and some facilities lack even basic equipment.

The statistics show that one million women worldwide, in low–resource countries, suffer from obstetric fistula as a result of giving birth without access to medical help. Out of these, one in 50 get treatment – around 15,000 per year on average* – and thousands more cases develop each year. “It’s relentless,” says Kate. That’s why the committed support of organisations such as Astellas, which is providing funds of €1.5m over three years for the programme in Kenya, is so vitally important. *globalfistulamap.org

INTERNATIONAL AWARENESS The International Day to End Obstetric Fistula, held on 23 May, and approved at the UN four years ago, is an essential tool to leverage awareness of the problem facing so many voiceless women. “There’s a camaraderie around it, even if there aren’t New York Times headlines,” insistes Kate. “We try to leverage opportunities as much as we can, but it’s a challenge.”

Back when Kate was first working on the Action on Fistula plan with Astellas, she identified her dream, which was to get a network of treatment centres, train doctors, create a community of practice, and form a centre of excellence for surgery excellence.

“Astellas bought it,” says Kate. “I thought it could work, but it is gratifying to see how incredibly well it does. It’s exciting.”

“Astellas has always been more than a ‘cheque writer’, they’ve been a cheerleader.”

FISTULA

FACTS 1 MILLION

WOMEN WORLDWIDE SUFFER FROM

UNTREATED

obstetric fistula

60,000 BETWEEN 2010 & 2013, AN ESTIMATED

WOMEN received fistula repair surgery – around

15,000 PER YEAR

50 For every woman treated, at least

ACTION ON FISTULA: TRANSFORMING THE LIVES OF OVER 2300 WOMEN Action on Fistula, launched in May 2014, is an innovative partnership between the charity Fistula Foundation and Astellas Pharma EMEA Limited. Together, they set out to transform

the lives of more than 1200 women in Kenya living with obstetric fistula and to significantly build in-country capacity to deliver ongoing reconstructive surgeries by May 2017.

An obstetric fistula is a hole between the vagina and rectum or bladder, caused by difficult labour, leading to faecal and/or urinary incontinence. Fistula sufferers are often subject to severe social stigma due to constant and humiliating odour, which in many cases drives friends and family away.

Since launch, the campaign has been an unprecedented success, with 2363 women with fistula receiving life-changing reconstructive surgery and a doubling of capacity to conduct fistula surgeries in Kenya. A treatment network has been set up to extend access to services, with six treatment centres enrolled and providing fistula surgeries. A successful outreach programme is also running to reach and identify women for treatment.

Through its collaborative, capacity-building approach, Action on Fistula has changed the treatment landscape in Kenya in enduring ways, ensuring its legacy will continue for many years beyond its three- year duration.

For more information about the campaign, visit: astellas.eu/initiatives/action-on-fistula

GO WITHOUT Source: Fistula Foundation

Go to fistulafoundation.org

M AG A ZI N E | M AY 2017 | 3 1

P H A R M ATA L E N T

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

Rachel Cresswell

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

DANIEL GALLAGHER

PAUL BENNETT

Mylan has appointed Daniel Gallagher as Chief Legal Officer.

Daniel joins Mylan from Patomak Global Partners, where he was president. Gallagher commented: “I am excited to join Mylan’s leadership team at this time in the company’s evolution and am honoured to lead the company’s world-class legal organisation.”

Pharmacist Paul Bennett will become the new Chief Executive of the Royal Pharmaceutical Society in July 2017.

At present he is Chief Officer of the Hampshire and Isle of Wight Local Pharmaceutical Committee.

Paul said: “I am passionate about the advancement of the science and driven to support pharmacists.”

DOMINIC MOORHEAD

Dominic Moorhead has been appointed

by Ferring Pharmaceuticals as Executive Vice President and Chief Financial Officer, effective July 2017. Dominic has 30 years of finance and business experience in the life sciences industry.

Pf’S GRADUATE OF THE MONTH In each edition we feature an outstanding graduate who is making their mark in the industry.

BILL SIBOLD

NAME: Lorna Towndrow

Sanofi has announced the appointment of Bill Sibold as Executive Vice President, Sanofi Genzyme, effective July 2017. He currently serves as head of Sanofi Genzyme’s Global Multiple Sclerosis, Oncology and Immunology organisation.

COMPANY: Ashfield, part of

UDG Healthcare plc ROLE: Digital Sales Representative UNIVERSITY DEGREE: BSc Sport, Physical Activity and Health LORNA SAYS: “I became interested in medicine and the fascinating world of pharmaceutical science while at University, and I realised I wanted to pursue a career in the industry.

At Ashfield, I work in the Commercial Contact Centre in an innovative and fast-paced environment, interacting with healthcare professionals via digital platforms. This allows in-depth conversations around medicine, patient care and disease management, and the opportunity to grow and develop my own career in pharmaceuticals.”

KNOW A RISING STAR WHO DESERVES A MENTION? RACHEL@PHARMAFIELD.CO.UK

CLARE CULPIN

Basildon and Thurrock Hospital has announced the appointment of Clare Culpin as its new Managing Director. Clare joins the hospital from Kettering General Hospital Trust where she worked for more than four years.

She said: “I am delighted to be joining Basildon and Thurrock University Hospitals at what is a challenging but exciting time.”

SIR BRUCE KEOGH

Professor Sir Bruce Keogh has announced that he will be stepping down as NHS England’s National Medical Director at the end of the year, having spent 10 years in the role. He has been appointed as Chair of Birmingham Women’s and Children’s NHS Foundation Trust. Sir Bruce said: “I will have served as National Medical Director for a decade and it has been a huge privilege. I now have the opportunity to focus on improving services for women and children in my home city.

I am really looking forward to it.”

TOM MITCHELL

Ashfield, part of UDG Healthcare plc, has appointed Tom Mitchell as Head of Syndicated Services for the Ashfield Commercial business in the UK. Tom previously held the role of Project Manager, leading a number of syndicated teams. Speaking about his new role, Tom said: “I’m delighted to be focussing on the future strategy and operational excellence for this key area of our business.”

IN BRIEF

Alexion Pharmaceuticals has appointed LUDWIG HANTSON as CEO. Catalent Pharma Solutions has appointed MATTHEW STOBER

to the advisory board of the company’s biologics business.

JOANNE ESTELL will join

Shield Therapeutics as Chief Financial Officer and Board Member.

M AG A ZI N E | M AY 2017 | 3 3

Q Congratulations on getting the role of Chair – are you sitting comfortably?

I’m really excited to become Chair of the PM Society and looking forward to carrying on its mission of promoting marketing excellence throughout the healthcare and life science industries – as it has done for over 40 years. The PM Society is a highlyrespected organisation within the industry, representing the pharma and agency sides, and everything in between. I’m honoured to take the role of Chair from previous coChairs Carwyn and Rachel and, on a personal note, it’s a great opportunity to lead such a prestigious organisation.

New PM Society Chair – Shire Pharmaceuticals’ Craig Bradley – gives his insight into engaging with the changing landscape.

Q How has pharma marketing changed over the last five years? Pharma marketing is constantly progressing, facing up to the challenges of an ever-moving environmental, access, customer and regulatory landscape.

The heart of the role remains the need to communicate a medicine’s value proposition to all relevant stakeholders in relation to pathway optimisation. How this is achieved, however, is always evolving.

From an engagement point of view, there’s been the rise of technology and digital marketing, bringing different channels into the mix, and the change in consumption of information, bringing with it the ongoing need to seek out the next big thing in order to maximise engagement.

Also, as the environment for pricing and reimbursement of treatments has become more challenging – with policy-makers and payors increasingly influencing what prescribers can actually prescribe – the

INTERVIEW BY

Amy Schofield

Flexible training workshops for pharmaceutical & life science professionals

Pharmaceutical Marketing Learn more at pmsociety.org.uk

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

ABPI Code of Practice

Personal Effectiveness

Bespoke Training

P H A R M ATA L E N T

need to develop an effective market access strategy within a brand strategy has become critical. Alongside this there’s the need to ensure patient centricity within all strategies, as they are the end-users of our treatments and should be at the forefront of our thinking – our true customer.

The rise of the internal cross-functional team, with different specialities, means the role of the marketeer is about being the fulcrum for the brand’s activities, as opposed to just delivering on a marketing plan – I often liken my role as Brand Manager at Shire to that of conductor in a talented orchestra!

Q How do you see the role of marketeers changing as digital emerges? The successful marketeer should be anticipating customer preferences and strive to deliver a channel mix, which provides the right information for the audience’s convenience, maximising engagement and outcome.

Digital shouldn’t be a separate facet of the channel mix and should be integrated with traditional channels.

The PM Society has been driving standards in digital pharmaceutical marketing in its broadest sense for nearly a decade through its annual Digital Awards, the Digital Works meeting series and the Digital Interest Group. The Digital Interest Group is committed to highlighting excellence in all the relevant areas and helping PM Society members to improve digital competency.

Q How will marketeers respond to the changes happening in the NHS, for example local care organisations and ACOs? It’s imperative that marketeers don’t just respond to changes, but actively monitor the operating landscape and engage with it. For instance, Sustainability and Transformation Plans should deliver services that are planned by place rather than solely around individual institutions – meaning localisation, and the need to understand what is happening regionally rather than just nationally. There’s a real need to be actively engaging with customers in order to stay in tune with their world.

Also as a Brand Manager with a market access background and responsibility for a rare disease product I believe we should be working with the NHS to actively shape the environment and ensure it is fit for purpose and for the benefit of patients.

“I often liken my role as Brand Manager to that of conductor in a talented orchestra!”

Q How do you see your role in terms of influencing the development of future marketeers? The PM Society has a huge role. Our own PriMe Training workshops have been running for over 10 years, and are continuously updated to reflect the latest industry trends. Aimed at both pharma and agency personnel at all levels, the programme ranges from ‘Pharmaceutical Marketing for non-Marketers’ to ‘Mastering Launch Excellence’. This year we’ve added specific Market Access courses to reflect the needs of the industry. We also have three specific interest groups covering digital, market access and patient engagement.

The PM Society also aims to raise standards in pharmaceutical marketing by presenting awards recognising excellence, as judged by members of the industry and its customers.

Q How can pharma attract high-calibre marketeers from other industries?

I’m not sure that background is all that important. It’s very much about the individual and their desire to lead the brand in delivering creative solutions and strategies to enable appropriate access to treatments for patients. The challenge for someone from another industry moving into pharma will always be working within the ethical framework we have to ensure patient safety, which doesn’t exist in many other industries.

We should, however, welcome all high calibre individuals who want to make a difference to patients’ lives.

Q How do you see the relevance of the PM Society evolving in the future?

There is an ambitious plan and some excellent initiatives being developed to keep the Society relevant to its members, and the industry it represents, in our 2020 vision, including expanding our training courses, educational meetings and activities. I hope to implement this work, put my own stamp on the Society and leave a legacy I can be proud of. Go to pmsociety.org.uk

PM’S POSITION THE SOCIETY promotes marketing

EXCELLENCE

THROUGHOUT THE HEALTHCARE AND LIFE SCIENCE INDUSTRIES

Established for

40 YEARS

230 UK member companies MEMBERS INCLUDE

PR, ADVERTISING,

MEDICAL COMMUNICATIONS & DIGITAL COMPANIES

Works with NHS,

ABPI & HCA CRAIG IS THE FIRST

CHAIRMAN

FROM PHARMA in its history

M AG A ZI N E | M AY 2017 | 3 5

E VENTS & CONFERENCES

Looking for a memorable venue for your next event or conference?

DEAR DIARY

Up-and-coming pharma events for your diary

The Pf Venue Guide 2017 is your guide to selected venues for the healthcare and pharma industry.

Read free online at issuu.com/pfmagazine IN PARTNERSHIP WITH THE MEETINGS INDUSTRY ASSOCIATION

WOULD YOU LIKE TO SEE YOUR VENUE FE ATURED? R ACHEL@PHARMAFIELD.CO.UK

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

16 M AY 2 017

2 2 M AY 2 017

The Pharma Commercial & Sales Conference

Following the money – Funding flows in the NHS, from Parliament to the front-line

A must-attend event for UK & European Pharmaceutical Commercial & Sales Professionals, this one day conference explores strategic commercial and sales strategies of 16 pharmaceutical brands.

WHERE: One America Square, London WHO: Global Insight Conferences INFO: pharmacommercialconference.com CONTACT: 0207 117 1777 or info@pharmacommercialconference.com

18 -19 M AY 2 017

eyeforpharma Latin America Join 200+ industry leaders at Latin America’s number one commercial pharma summit dedicated to commercial innovation, customer centricity and digital innovation. The conference includes four targeted themes, intimate workshops and stakeholder sessions to help direct your journey – don’t miss out!

WHERE: Hotel Hilton Miami Downtown WHO: eyeforpharma INFO: eyeforpharma.com CONTACT: 0207 375 7592 or chernandez@eyeforpharma.com

Julie Wood, Chief Executive of NHSCC, examines where the money for the NHS comes from and how the budget is calculated. Join this Parallel Learning webinar and gain awareness of funding flows, who receives what and how the money is spent.

WHERE: Online webinar WHO: Parallel Learning INFO: parallellearning.co.uk CONTACT: 01462 476120 or enquiries@parallellearning.co.uk

2 7-2 8 J U LY 2 017

International Pharma Regulatory Summit 2017 The International Pharma Regulatory Summit will allow you to effectively interpret complicated regulatory guidelines, to fast track your drug approval process. Register your place today.

WHERE: Singapore WHO: Active Communications International INFO: pharmacommercialconference.com CONTACT: 020 6527 2803 or pwaghmare@acieu.net

For more great events for your diary visit: pharmafield.co.uk/events UPCOMING E VENT WE SHOULD KNOW ABOUT? R ACHEL@PHARMAFIELD.CO.UK

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