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November 2019 • www.pmlive.com

PME PHARMACEUTICAL MARKET EUROPE

Combining hard technology with human skills

Interview with GSK’s Steve Yancey p18 Innovation in the Asia Pacific region p26 Drug prices and competition

Clinical trials

Digital health trends

AI and healthcare

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COMMENT

THE TEAM Editorial: Group Managing editor Iona Everson Reporter Lucy Parsons Studio: Executive director Karl Equi Middleweight graphic designer Helen Penfold Sales: Business director Tara Lovegrove Production: Production director Keith Shilson Production manager Samuel Hamilton

EDITORIAL ADVISORY BOARD Philip Atkinson Founder of Hive-Logic, Lifescience Transformation Uday Bose Corporate vice president, head of global marketing oncology, Boehringer Ingelheim Dr Luc Hermans VP commercial planning and operations Europe, Asia, Middle East, Gilead Sciences Stefan Janssens President EMEA, Cegedim Dendrite John Morris Partner, KPMG Paul Pay Chief business development officer, Norgine Mark Rothera Chief executive officer, Orchard Therapeutics Ian Talmage Senior vice president, global marketing, general medicine, Bayer Pharmaceuticals

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Patience and persistence Welcome to the November issue of PME. In our cover article, Chris Ross explores why pharma’s multichannel maturity isn’t just about hard technology. Looking at the Across Health Multichannel Maturometer 2019 study, the results reveal that 87% of respondents think their companies are still some distance from being ideal organisations in terms of their ability to use digital to improve customer engagement and business impact. The key to success depends on ‘human’ enablers such as skills and organisational culture to capture customers’ hearts and minds. In this issue we also have an in-depth interview with Steve Yancey, vice president and medicines development leader at GSK. While patience and persistence are the prime disciplines of drug development, knowing when to keep the fuse burning or simply walk away takes a confounding blend of science and emotion. Steve talks about how challenging drug

Pharmaceutical Market Europe November 2019

development is and finding ways to overcome the bumps in the road by improving the probability of success. While politicians continue to disagree in parliament and the country tries to make some sense of what is happening with Brexit, new analysis by the Royal Society shows that uncertainty around Brexit has already significantly affected scientific research and its workforce in the UK. As the first December general election in almost a century looms, all eyes are on each party’s election manifesto, and it will be a tough fight to the finish to see who has the best plan for the UK in 2020 and beyond.

Iona Everson Group Managing Editor www.pmlive.com

2 0 1 9 Recognising excellence in improving patient outcomes

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FIND OUT WHO WINS BOOK YOUR TICKETS NOW Wednesday 27 November 2019, Royal Lancaster London PMEA Keynote Speaker – Mark Ormrod Mark Ormrod served for ten years as a Royal Marine. While on manoeuvres in Helmand Province he was caught in a landmine explosion and lost both legs and one arm. In an extraordinary demonstration that life can go on even after tragedy, he’s since completed feats ranging from skydiving to running across America to representing Britain at the Invictus Games. Mark proudly describes his journey and that, whatever the setbacks, the human spirit is an unbreakable thing. Book online at www.pmlive.com/pmea/bookaseat or contact Debbie Tuesley on +44 (0)1372 414243 or dtuesley@pmlive.com For sponsorship opportunities please contact sales@pmlive.com SPONSORS

UPTAKE STRATEGIES P L A N N I N G

C A P A B I L I T Y

L A U N C H

CONTENTS

NOVEMBER 2019 NEWS

BIOGEN AND EISAI IN SHOCK TURNAROUND

COMBINING HARD TECHNOLOGY WITH HUMAN SKILLS

6-8. Agreement reached for Orkambi; Biogen and Eisai in shock turnaround

26-29. A first-of-its-kind study paints a vivid picture of the APAC region’s future

RETHINKING TRIALS

10. UK AI partnership seeks to support people living with chronic conditions: QiC Diabetes Awards 2019

BREXIT NEWS

11. Another day, another Brexit delay

30-31. The pros and cons of protocol amendments

A SNAPSHOT OF… MICROBIOTICA

FREIGHT UNCERTAINTY AMID BREXIT DELAY

32. PME talks to CEO Mike Romanos

12-13. Uncertainty surrounding Brexit is harming UK science; Brexit delay makes freight contracts uncertain

COMBINING HARD TECHNOLOGY WITH HUMAN SKILLS

34-36. Why pharma’s multichannel maturity isn’t just about hard technology

DARWIN’S MEDICINE

14. The end of pharma – a very different world

THE UNHAPPINESS PROJECT

PRICES AND 20 DRUG COMPETITION

IN THE 26 INNOVATION ASIA PACIFIC REGION

38 DIGITAL HEALTH TRENDS

15. How come I can’t find anyone who is ‘happy’ with healthcare?

DIGITAL HEALTH TRENDS 38-39. Why AI is set to transform the nature of healthcare

AI: OPPORTUNITIES AND BARRIERS TO IMPROVING HEALTHCARE

PHARMA BRAND PLANNERS’ BLOG

40-41. How AI is shaping the future of healthcare

16. Setting the right metrics and KPIs in your brand plan

GSK’S LONG AND WINDING ROAD TO ASTHMA BREAKTHROUGHS

INNOVATION IN THE ASIA PACIFIC REGION

STEVE YANCEY, GSK

40 AI AND HEALTHCARE

18-19. PME talks to Steve Yancey, the company’s vice president and medicines development leader

DRUG PRICES AND COMPETITION

20-22. How the CMA is tackling high prices for essential drugs

Pharmaceutical Market Europe November 2019

HEALTHCARE COMMS 45. McCann Worldgroup named European Agency Network of the Year; ONEHEALTH acquires Bartlett Davis; BioMarin opens new Dublin offices

PEOPLE

46. Q&A with Vicky Bramham

46 VICKY BRAMHAM

APPOINTMENTS

42. Changes at Eli Lilly, Gilead, Smtih+Nephew, Amgen and Vertex

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TOP TEN NEWS STORIES 1. Vertex, NHS England and NICE finally reach agreement for Orkambi Vertex and NHS England have finally reached an access agreement for cystic fibrosis drug Orkambi, as well as its other CF treatments Smykevi and Kalydeco. The news will be long overdue for CF patients; after campaigning for access to Orkambi, they will now able to access the drug within 30 days. The drawn-out agreement has been met with criticism, the majority of which has been aimed at Vertex for its apparent inflexibility on pricing and a reluctance to comply with the NICE appraisal process. The definitive agreement means that around 5,000 eligible NHS patients in England will now have full access to the medicines. The negotiation has been finalised because Vertex finally agreed to the ‘confidential commercial terms’ of the agreement – and importantly, it also agreed to submit its drugs for a full NICE appraisal. The agreement also extends to all future licence extensions of the drugs as well as the current licensed indications. NICE, who initially rejected Orkambi because of its cost, has been able to support the agreement, due to a binding condition of the deal that Vertex will have to submit its full portfolio, including its new triple therapy, for a full NICE appraisal in due course. The triple therapy, which has just received approval from the FDA in the US, is thought to be effective in up to 90% of CF patients. The agreement provides hope that the lengthy agreement process will not be repeated for Vertex’s future CF therapies, which could be groundbreaking for those suffering with the debilitating genetic disease.

3. Roche inches towards approval of Spark takeover The Federal Trade Commission is poised to approve Roche’s $4.3bn takeover of gene therapy specialist Spark Therapeutics, according to press reports. Roche has had to delay the expected date for completing the transaction as the FTC and UK’s Competition and Markets Authority (CMA) probe antitrust issues raised by the deal. It is thought that the regulators have been scrutinising the deal because Roche’s antibody drug Hemlibra (emicizumab) has been growing at a phenomenal rate since its launch last year, and is firmly on course to become a blockbuster this year with sales of $925m in the first nine months. Adding Spark’s SPK-8011 and earlier-stage follow-up SPK-8016 would give Roche a strong position in the market, although analysts at Jefferies previously suggested that with a number of other companies developing gene

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2. Biogen and Eisai revive abandoned aducanumab in shock turnaround In a surprising twist, Biogen has said that it plans to ﬁle its experimental therapy aducanumab for Alzheimer’s disease, months after abandoning the drug in phase 3. The Eisai-partnered drug was scrapped in phase 3 earlier this year following advice from an independent data monitoring committee to halt trials. The news was a huge blow for the field of Alzheimer’s research, which has suffered sustained late-stage failures in drug research. It also hit Biogen hard, with its share price plunging 25%. The initial failure of the drug also fuelled the sentiment that the ‘amyloid hypothesis’ of targeting beta amyloid had finally been exhausted. However, that theory has now been revived thanks to Biogen’s announcement that it plans to go ahead with regulatory filings for aducanumab after all. According to Biogen, the results from a subset of patients in the phase 3 ENGAGE study of the drug warrant taking it forward. It said that patients who received sufficient exposure to high doses of the drug experienced significant benefits on measures of cognition and function, including memory, orientation and language. The decision to file aducanumab with the FDA is based on this new analysis, conducted by Biogen in consultation with the FDA. If Biogen does receive approval for the drug, it can expect billions of dollars in annual revenues. However, if the drug is rejected by the FDA, the ‘amyloid hypothesis’ will most likely be well and truly tossed to the side, and Biogen will face the consequences of reviving hope only for it to be dashed again.

therapies – including BioMarin, Sangamo and UniQure – that should not be considered overly dominant. The CMA has set a deadline of mid-December for a decision on the first phase of its review of the acquisition, which could be the end of the process if it decides there is no need to investigate further. If it decides to continue the probe, a lengthier second phase would kick off, making an end of 2019 completion date unlikely. On 29 October, Roche once again extended its tender offer to Spark shareholders, with a new deadline of 25 November, citing a need to give regulators more time to review the proposed $4.3bn merger.

Pharmaceutical Market Europe November 2019

NEWS

4. Ohio opioid trial averted by last-minute settlement The ﬁrst federal trial in the US litigation over the opioid epidemic was prevented by last-ditch negotiations which reached a $260m settlement.

US District Judge Dan Polster was due to start hearing the trial in Cleveland, Ohio in the US and was pushing for an out-of-court settlement to save all parties the hefty cost of litigation. Polster had been busy handling meetings between state attorneys general, lawyers for local authorities and top executives of the US’ largest three wholesalers – AmerisourceBergen, Cardinal Health and McKesson – as well as drugmaker Teva and pharmacy group Walgreen Boots Alliance. The last-minute deal will see McKesson, Cardinal Health and AmerisourceBergen pay $215m to the Ohio counties of Summit and Cuyahoga. Teva is also due to pay $45m in cash and addiction treatments. Polster is presiding over thousands of lawsuits alleging that companies fuelled

5. Merck KGaA launches €13m seed fund for Chinese start-ups Merck KGaA has announced a new RMB 100m (€13m) seed fund to foster startups in China – with an aim at identifying innovations in health and life sciences. The investment will be made through M Ventures, Merck KGaA’s corporate strategic venture arm, with intended investments to be made in Chinese seed-stage companies with individual investments ranging between €500,000 and €1m. The initiative focuses on early innovations developed within the Chinese ecosystem, that are focused on healthcare, life sciences, performance materials or new businesses. “Our seed fund initiative aims to deliver strategic returns so as to underscore our position as an

Pharmaceutical Market Europe November 2019

innovator in China and to strengthen our ties to the dynamic Chinese innovation ecosystem,” said Stefan Oschmann, CEO and chairman of the executive board of Merck. Merck has also opened its new innovation hub in Shanghai, where it will invite start-ups, academic institutions and other industry players to become involved in joint innovation projects. Six start-ups from China and other Asian countries have successfully taken part in the first phase of the Merck Accelerator in China. This programme helps Chinese start-ups to connect with global innovation networks and further develop research. Merck also announced plans for a second innovation hub in Guangdong in Southern China in late 2018.

a healthcare crisis responsible for roughly 400,000 US deaths from 1999 to 2017, according to US government statistics. However, the last-minute deal does not resolve the additional nationwide litigation. The details of a wider settlement on the table differs depending on the source, but is thought to include roughly $22bn in cash and $29bn in products and distribution intended to help tackle the epidemic of opioid addiction that affects every US state. The three wholesalers are offering $18bn over 18 years, with Johnson & Johnson adding another $4bn to the tally. Teva is in the midst of a challenging time financially at the moment so is trying to avoid a cash settlement, opting instead to provide $15bn worth of drugs and some distribution services.

6. AZ reports growth again in Q3, driven by oncology and China sales

AstraZeneca has raised its full-year sales prediction again, with product sales rising for the ﬁfth successive quarter following a growth of 18% at constant exchange rates to an impressive $6.1bn in Q3. This was driven by a strong growth of AZ’s oncology medicines, which saw an overall 48% growth to $2.3bn. Sales growth in 2019 for this area to date has reached 54%, driven by Tagrisso, Imfinzi and Lynparza. Its Merck & Co-partnered PARP inhibitor Lynparza, which AZ recently flaunted at ESMO 2019, has reported an impressive growth of 98% to $847m, driven by an 86% increase in the US and a 227% increase in emerging markets. Its cardiovascular, renal and metabolism (CVRM) franchise was also up 11% to $1.1bn, with growth in sales of Brilinta and Farxiga paving the way. AZ’s respiratory franchise also grew 18% to $1.3bn – although the company saw a 4% decline in sales of Symbicort, this was offset by the growth of Pulmicort and Fasenra, and also a growth of these medicines in emerging markets. The London-listed drugmaker also reported strong growth in emerging markets, especially China, where it saw a sales growth of 40% to $1.2bn. In China, AZ reported oncology sales growth of 67% to $1bn and new CVRM growth of 88% to $359m. It also reported a return to growth of its Europe sales, which were up 1% to $1.1bn. The company has now forecast its product sales to increase by a low- to mid-teens percentage, up from a low double-digit percentage increase.

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NEWS

TOP TEN NEWS STORIES 7. Novartis grows in Q3 thanks to stellar performance of key drugs Novartis has raised its full-year guidance thanks to the growth of a number of its key medicines and its generics unit Sandoz. The Swiss pharma reported net sales of $12.2bn, a growth of 13%, and a core net income of $3.2bn. This is well above the consensus revenue estimate of $11.68bn. Leading the way with $937m in sales was psoriasis drug Cosentyx (secukinumab), which grew 27% over the quarter. Following Consentyx is heart failure drug Entresto (sacubitril/valsartan), which grew 61% to bring in $430m sales in the quarter. Sales of the drug have been growing rapidly, but a recent blow in a trial of patients with

preserved ejection fraction (HFpEF) has created doubt over potentially billions of dollars of revenue. The third highest sales growth was of SMA gene therapy Zolgensma (onasemnogene abeparvovec), which brought in $160m in sales in the third quarter, following its launch earlier this year. The therapy is currently under regulatory review in Europe and Japan, with decisions expected in 2020. Following the growth of these products, Novartis has now revised its net sales, with expected growth now in the high single-digit percentage rate, up from the mid to high single-digit range predicted in the last quarter.

8. GSK takes new-class antibiotic into phase 3 for serious infections GlaxoSmithKline has started two phase 3 trials of the ﬁrst drug in a completely new class of antibiotic that could provide a much-needed option for severe, resistant infections. The new drug, called gepotidacin, is being developed initially to treat uncomplicated urinary tract infection (UTI) and urogenital gonorrhoea. The EAGLE-1 trial will enrol 600 patients with gonorrhoea, while EAGLE-2 has a target population of 1,200 people with UTIs which are confined to the lower urinary tract. Gonorrhoea is the second most common sexually transmitted infection (STI) around the world, and fears are rising of a so-called super-gonorrhoea that is resistant to the recommended first-choice treatment – a combination of azithromycin and ceftriaxone.

10. Astellas stays ahead of FLT3 rivals with EU nod for Xospata

If gepotidacin is shown to be effective in the phase 3 programme, a big question is how it will be used commercially. Pharma companies have exited antibiotic research in droves, put off by the paradox that lies at the heart of antimicrobial drug development: the newest, most effective drugs are typically kept in reserve for infections that don’t respond to older agents. That means they are used the least, delivering little payback for the cost of their development.

9. Merck CFO: we’re not only about Keytruda Merck & Co’s Keytruda topped $3.1bn in sales in the third-quarter – almost a quarter of group revenues – but management insists there is more to the company than the cancer blockbuster. Predictably, discussion of Keytruda’s massive clinical trials programme dominated Merck’s third-quarter results call. However, chief financial officer Rob Davis stressed that “while Keytruda is truly a foundational product, we are a lot more than just Keytruda”. He said the performance of other cancer drugs like Lenvima (lenvatinib) and Lynparza (olaparib), revenue from which doubled in the quarter – as well as the vaccine portfolio headed by cervical cancer vaccine Gardasil and HIV franchise – is evidence there is “a lot internally…to be excited about”. There’s no denying that Keytruda is the story of the moment however, with its 62% sales increase helping Merck post a 15% rise in group revenues to $12.39bn and shrug off a 12% decline for diabetes treatment Januvia (sitagliptin) on pricing pressure. Turning to its other products, Gardasil grew 26% in the quarter to $1.3bn, while chickenpox vaccine Varivax rose 19% to $623m. Alliance revenues from Eisai-partnered Lenvima and AZ-partnered Lynparza reached $109m and $123m respectively.

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Japan’s Astellas Pharma has won EU approval for Xospata, a drug to treat acute myeloid leukaemia associated with a mutation in the FLT3 gene, keeping it ahead of rival Daiichi Sankyo. The approval comes after an accelerated review of Xospata (gilteritinib) as a monotherapy for relapsed/refractory FLT3positive AML, and just a few days after the EMA’s main advisory committee rejected Daiichi Sankyo’s marketing application for quizartinib in the same indication. The EU regulator has given a green light for the use of Xospata in patients with two of the most common FLT3 mutations – internal tandem duplication (ITD) and tyrosine kinase domain (TKD). All told, 20-30% of people with AML have FLT3 mutations, which are associated with poorer outcomes, including a higher relapse rate, faster progression and shorter overall survival times. Xospata has already been approved for this indication in Japan and the US, based on the results of the ADMIRAL study that compared Xospata to salvage chemotherapy. The results of that study showed Xospata extended overall survival (OS) to 9.3 months from 5.6 months in the control group. After one year, 37% of patients taking Astellas’ drug were still alive, versus 17% of those in the chemotherapy arm.

Pharmaceutical Market Europe November 2019

When the big dog wants a big idea.

...IS THE DOGâ&#x20AC;&#x2122;S

Altogether more magic.

NEWS

The best in the UK UK AI partnership seeks to support people living with chronic conditions healthcare system Reason Digital has teamed up with four UK health charities on a project which aims to develop artiﬁcial intelligence (AI) as a coaching tool to support people living with long-term health conditions. The digital social enterprise has partnered with Parkinson’s UK, the Stroke Association, Muscular Dystrophy UK and the MS Society on the project. These organisations will seek to transform the way medical advice and information is delivered to approximately half a million people in the UK living with chronic conditions. This will be achieved through the development of the Digital Health Assistant (DHA), which will use machine learning to develop an understanding of the person to be supported, and will continually adapt to an individual’s needs based on interactions over time.

“Diagnosis of a serious health condition such as Parkinson’s, Muscular Dystrophy or multiple sclerosis, or experiencing a stroke, naturally generates an abundance of questions for the person receiving the news,” said Reason Digital co-founder Matt Haworth. “Online research so often results in unanswered questions and out of date, generic information which just adds to the stress and anxiety of an individual’s situation. What people want is curated information and updates from a trusted source,” he added. The DHA tool is designed to help tackle commons issues that people with chronic conditions in the UK experience – including a lack of tailored and up-to-date information for those who have been recently diagnosed with a long-term health condition, and healthcare staff shortages.

McCann Health New York launches Parkinson’s awareness campaign McCann Health New York has launched a new campaign to raise awareness and increase early diagnosis of Parkinson’s disease. The campaign, named Parkinscents, was created with a focus on tackling Parkinson’s via early detection.

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The company highlighted the fact that many people with the neurodegenerative disease start with treatable symptoms which can go undiagnosed for years. It also brings attention to and encourages the early diagnosis of Parkinson’s, which can in turn lead to earlier treatment and improved health outcomes for patient. The Parkinscents campaign focuses on one of the earliest signs of Parkinson’s – the loss of the sense of smell. This particularly affects certain scents, including peppermint, anise and coffee. For National Coffee Day in the US, McCann partnered with coffee shops across the country to increase awareness with informative coffee sleeves, lids, posters, tent cards, coasters and an interactive website. Through these tools, people could learn more about the early signs of Parkinson’s and when symptoms should prompt a visit to a healthcare professional. The activation of this campaign followed a successful pilot programme at the World Parkinson’s congress in Japan, which targeted both consumers and healthcare professionals.

celebrated at QiC Diabetes awards 2019 The programme recognised the best initiatives and professionals leading practice in diabetes management, education and patient care across the UK. “QiC Diabetes provides a great opportunity to celebrate, and learn from, new ways of working to drive up quality of care. I’m impressed and inspired by the class and breadth of the award winners and ﬁnalists,” said Professor Jonathan Valabhji, national clinical director for obesity and diabetes, NHS England. The awards ceremony opened with a talk from keynote speaker Dr Sam Rice, Consultant Physician and Endocrinology, on empowerment for people living with diabetes. Dr Rice went on to win a surprise NHS Wales Outstanding Contribution Award for Services in Diabetes, for developing a research and innovations portfolio focused on patient support on education. Another recipient of an award for excellence was Dr Lalantha Leelarathna, who won the NHS England Outstanding Contribution Award for Services in Diabetes for his work to improve diabetes care and research in diabetes technology. The People’s Award, supported by Diabetes UK, recognises an individual who has supported or cared for people with diabetes in 2018. Winning this special award was Stefan Haest (pictured above), a champion for peer support who was diagnosed with type 1 diabetes at the age of 11. Since then, he has been committed to helping other children and young people with the condition. The awards also celebrated the hard work of NHS teams working to promote hypo awareness, with the Hypo Awareness Week 2019 Excellence Award. The winner of this coveted award was Cambridge University Hospitals NHS Foundation Trust. Elsewhere, North West Anglia NHS Foundation Trust won the Insulin Safety Week 2019 Excellence Award, demonstrating its hard work and dedication to improving safety in diabetes care. Winning the coveted Diabetes Team of the Year award was West Green Surgery, for its Personalised SMS Care Plan for Diabetes.

Pharmaceutical Market Europe November 2019

BREXIT

Another day, another Brexit delay What happens now? n Westminster, the Brexit uncertainty continues, and despite vehement assurances to the contrary, the UK did not leave the EU on 31 October, either with or without a deal. The EU met on 28 October to consider a Brexit extension until 31 January 2020, with an option for the UK to leave earlier if a deal is ratiﬁed. This ‘ﬂextension’ would allow the UK to leave before the new deadline if a deal is approved by Parliament. There was talk that EU27 leaders favoured a short technical extension, to allow Prime Minister Boris Johnson more time to win support for his withdrawal agreement, over a lengthier delay that might have given the UK time to unlock the impasse in the Commons. However, on 28 October, European Council president Donald Tusk announced that the European Council has agreed to a Brexit delay until 31 January 2020.

What happens now? This ‘ﬂextension’ allows time for a snap election – Johnson’s favoured option given the Conservative’s lead in the polls over Labour. Former PM Tony Blair had suggested a simultaneous general election and a second referendum, saying there was nothing to stop both being organised at the same time.

Parliament, then given support in principle, only to be effectively placed on hold by a subsequent rejection of his proposed three-day timetable for it to be debated in the house.

Election battle Following a motion to debate and vote on a general election in December, MPs have backed a general election on Prime Minister Boris Johnson’s preferred 12 December election date, rather than the alternative 9 December date that Labour and the Liberal Democrats had been pushing for. This means that the UK is now facing its first December election in almost a century. It will be a fierce fight between the two main party leaders, with Conservative’s Boris Johnson and Labour’s Jeremy Corbyn set to battle it out as they begin their respective campaigns. The smaller political parties may look to strike deals with each other – Deputy Lib Dem leader Ed Davey said that the party is in talks with both Plaid Cyrmu and the Green Party, according to the BBC. There can be no definitive answer as to what will appear on the election manifestos, but it is likely that Brexit will be at the forefront as each party attempts to win over voters ahead of the new 31 January 2020 deadline.

The outlook for pharma In a series of votes last month, Johnson’s revised withdrawal agreement was voted down by

Pharmaceutical Market Europe November 2019

Agency (MHRA) would be excluded from the EU regulatory network, it would still have access to EU databases. The future relationship would be negotiated as part of the Free Trade Agreement negotiations. Health Secretary Matt Hancock told the Bioscience Forum in October that the intention is for regulatory collaboration with the EMA to continue, including mutual recognition of products produced in the UK and the EU, according to a BioIndustry Association (BIA) Brexit webcast on 25 October.

A new Northern Ireland problem?

The new version of the withdrawal agreement retains the transition period in Theresa May’s version of the deal in which medicines and devices regulations would stay aligned with the EU. That means, for example, that companies could continue to carry out batch release testing in the UK and manufacturing and distribution licences would continue to be recognised until the end of 2020. There would no longer be UK participation in EU institutions like the EMA and while the Medicines and Healthcare products Regulatory

From a pharma perspective, the new withdrawal agreement, which aims to tackle the issue of the Northern Ireland backstop, raises an important consideration. If no trade deal is agreed before the transition period comes to a close, medicines regulation in Northern Ireland would be aligned to the EU, which might mean the MHRA would have to enforce EU legislation there, but with possibly divergent UK rules on the mainland, said BIA chief executive Steve Bates. Meanwhile, no-deal preparations continue as the country prepares for a general election, with the only certainty being that a Brexit deal that can be agreed upon and voted for by the necessary majority has once again not been achieved.

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BREXIT

Uncertainty surrounding Brexit is harming UK science, says new report UK’s annual share of EU research funding has fallen by nearly a third since 2015 ew analysis by the Royal Society has demonstrated that uncertainty around Brexit has already significantly affected scientific research and its workforce in the UK. According to the analysis, the UK’s annual share of EU research funding has fallen by almost a third since 2015. Figures also suggest that the UK has become a less attractive place for top international science talent, reflected in a 35% drop in scientists coming to the UK via the EU’s Marie Sklodowska Curie Fellowships (MSCA). “We have seen a dramatic drop in the number of leading researchers who want to come to the UK. People do not want to gamble with their careers, when they have no sense of whether the UK will be willing and able to maintain its global scientific

leadership,” said Venki Ramakrishnan, president of the Royal Society. “UK science has also missed out on around €0.5bn a year because of the uncertainty around Brexit. The potential paralysis of a no-deal Brexit and the current state of chaos are hurting UK science and that is hurting the national interest,” he added. Traditionally, the UK has performed well above other EU nations in attracting scientists through the MSCA programme – since the Brexit referendum, this has been signiﬁcantly affected. In 2015, before the referendum, 515 individuals took up the MSCA Individual Fellowships in UK institutions. By 2018, this had fallen to 336 individuals.

Horizon 2020 is an EU Research and Innovation programme which has nearly £70bn of funding available between 2014 and 2020. UK researchers have reported that soon after the referendum, they were frozen out of new Horizon 2020 grant applications, which prompted then Chancellor Philip Hammond to underwrite EU grants to counteract the uncertainty around Brexit. However, the new analysis demonstrates that this did not have its desired effect – ﬁgures from EU databases show that the UK’s share of Horizon 2020 funding fell from 16% in 2015 before the referendum, to a little over 11% in 2018. The number of UK applications to Horizon 2020 also fell from 18,127 to 11,746 – a drop of around 40%.

UK life sciences industry has suffered ‘a lost decade’ Brexit uncertainty could exacerbate the stagnation in the industry The life sciences sector has often been the focus of the UK government – this is unsurprising given the fact that, according to IPPR analysis, it employs almost 200,000 people and supports 482,000 jobs. The new analysis shows that even before the Brexit referendum in 2016, the UK life sciences industry had faced a sustained period of stagnation. According to IPPR, in 2011 the UK attracted over 10% of all life sciences R&D spend globally – so, ‘for every £10 spent on life science research,

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£1 was spent in the UK’. Pharmaceuticals also captured 10% of the gross value added by the UK manufacturing industry overall. For both, the trend has been toward stagnation since 2010/2011 – this reﬂects a ‘missed opportunity to deliver progress against a backdrop of scientiﬁc advance’. For example, R&D spending in the UK suffered a loss of £15bn between 2011-2016. This is particularly alarming, given the fact that the US’

share of the global market has risen from just over 50% to almost 60% in the same time. The analysis also highlights that Brexit presents a ‘cliff edge’, which without intervention strategies could cause a difficult recovery from the ‘decade of stagnation’, or even cause further decline in R&D funding. According to the IPPR, Brexit has impacted life sciences most significantly because it has created uncertainty in the UK market. It highlights the freedom of movement, access to research funding, cross-border collaboration and common regulations as attractive features for potential investors. With the UK leaving the EU, these could change and make the UK a less attractive place for investment. The government has also been unclear as to whether it will uphold those benefits post-Brexit, says the IPPR. This makes it even harder to justify long-term investment in the UK. ‘Should Brexit happen, particularly in a no-deal form, our economy will need to rely on strength industries like life sciences to stabilise. If the government moves to mitigate Brexit, implement the life sciences industrial strategy with more urgency, and make the NHS a more active partner in innovation, these gains are as possible as they are important,’ states the report. Pharmaceutical Market Europe November 2019

BREXIT

UK rations AZ’s paediatric ﬂu vaccine after delivery delays Supplies may be limited as ﬂu season begins

Status of government freight contracts uncertain following Brexit delay Unclear whether ferries will be kept on hold t the beginning of October, the UK government signed freight capacity contracts with a number of freight companies as a contingency to ensure the continuation of the vital medicine ﬂow to the UK in the event of no-deal Brexit. The EU has announced it will approve a Brexit extension until 31 January 2020, after Prime Minister Boris Johnson was required to request an extension after Parliament could not reach an agreement on a Brexit deal. The Department of Transport may now have to change its plans for the contracts, which are in place for six months and collectively worth up to £86.6m. The contracts were awarded to Brittany Ferries, DFDS, P&O and Stena Line. According to the government, the framework will be in place for the next four years and will

continue to be used to help quickly deliver any future procurement if necessary. Currently, the status of the contract remains unchanged, and it is not clear whether the ferries will be kept on hold while Parliament agrees a deal or holds a general election. According to The Financial Times, the contract has a cancellation fee of £11.5m. It is uncertain as to whether the ferries will be kept on hold for the duration of the Brexit extension. In response to the initial freight capacity announcement, the Association of the British Pharmaceutical Industry’s chief executive Mike Thompson said: “Industry will continue to do everything it can to make sure people get their medicines in all Brexit scenarios, as we have been doing for many months.”

Delays in the release of some batches of AstraZeneca’s paediatric flu vaccine – Fluenz Tetra – means supplies may be limited as the 2019-2020 flu season gets underway. The delay means available stocks of the live, attenuated influenza vaccine (LAIV) will have to be reserved for vulnerable children with underlying medical conditions. AZ says the delays have been caused by routine testing on some of its Fluenz Tetra production batches that will have to be repeated – it doesn’t think the efficacy or safety of the vaccine is at risk. It’s hoping to deliver the affected batches in November, but further delay could threaten Public Health England’s plan to make the nasal spray vaccine available free of charge to all primary school children for the first time this year. The new policy has added another 600,000 children to the 25 million people eligible for free flu vaccines in England, as part of a strategy to ‘help keep people well and ease pressure on urgent care services over the colder months’, according to PHE. Both Scotland and Wales have also announced plans to prioritise children with eligible health conditions, as well as the two- to five-year-old programme, in response to the delay. In August, NHS leaders warned that a no-deal Brexit could make delays in the flu vaccine supply this year more likely, and there has been a rush for all producers of the vaccines to make sure sufficient supplies are in stock for the winter months.

UK bans some drug exports to preserve NHS stocks Insists the move is not related to Brexit The UK has published a list of medicines that must not be exported because of shortages in the NHS, but insists the move is not related to Brexit. The ban applies to the so-called ‘parallel trade’ of medicines – the buying and selling of products between countries in order to profit from price differentials. It applies mainly to hormone replacement therapies but also includes adrenaline pens, hepatitis B vaccines and the influenza drug oseltamivir, sold by Roche as Tamiflu, among others. The Association of the British Pharmaceutical Industry (ABPI) has welcomed the news, saying it will “stop some medicine wholesalers from taking advantage of the present circumstances by parallel exporting”. Pharmaceutical Market Europe November 2019

The list isn’t new and is regularly updated by the Medicines and Healthcare products Regulatory Agency (MHRA) as medicine shortages occur in the NHS. The ABPI has previously called for a temporary restriction on parallel exports in the run up to Brexit as currency ﬂuctuations such as a fall in the value of the pound could make exporting medicines to the EU more proﬁtable. The trade body said the Department of Health and Social Care (DHSC) has also invited ABPI members to identify when parallel export could lead or contribute to supply problems in the UK. Traders who ignore the ban and export a medicine on the restricted list could have their wholesale dealer licence revoked by the MHRA.

“I know how distressing medicine shortages can be for those who rely on drugs like HRT and it’s absolutely crucial patients can always access safe and effective treatments through the NHS,” said Health Secretary Matt Hancock. www.pmlive.com

BRIAN D SMITH DARWIN’S MEDICINE THE END OF PHARMA Some parts of our industry may go the way of the kitchen display cabinet and the word processor

lthough most of my time is taken up with research and writing, about a third of it is spent applying Darwinian science to help companies evolve. It provides very practical solutions but it often demands a level of thinking beyond the typical strategic planning charades. As usual in this column, allow me to reach my practical conclusion via a little amble into the science.

Environment selection A big, sometimes contentious, debate among evolutionary scientists is about where evolution happens. The question debated is this: since evolution is a process of selection by the environment, what exactly is it that is selected?

‘Using multi-level selection, it becomes obvious that the market of the future will not choose drugs or devices, it will choose systems’ At one extreme of this debate stands the great Richard Dawkins, who sees ‘the selﬁsh gene’ as the unit of selection. At the other end stand scientists like David Sloan Wilson, who think that selection occurs at multiple levels, from the gene to the organism to the group. Its not an esoteric debate: Wilson’s work, for example, helps to explain why and how we humans developed our altruistic habits. Simply put, altruism or, more broadly, prosocial behaviour makes more sense when you see it as favouring the survival of the group, rather than the individual. For a Darwinian geek like me, these ideas are wonderful tools for understanding how the world changes.

Higher-level selection Here are two examples of multi-level selection that might seem mundane, but they serve to make a point. When I began my working life, my secretary used a word processor – a typewriter with a tiny screen that showed one sentence at a time. And when I was young, my mother bought a kitchen display cabinet, a free-standing piece of furniture. Both items were highly desirable in their time and they

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have not been superseded by direct replacements. Yet I’ve never bought either, and nor have I used either for many years. That is because they have both been replaced by higher level things. The word processor has been replaced by the computer with an all-purpose office suite of software. And the last time we renewed our kitchen we bought an entire fitted room, complete with cupboards and appliances. In both cases, the function of the smaller, lower-level entity was absorbed by a higher-level entity. And why did this happen? Because the selection pressures form the market environment, which included both functional and economic factors, selected in favour of the higher-level entity. The market liked PCs and fitted kitchens so much, it was less concerned with their parts. This is an example of higher-level selection, just as much as the Palaeolithic environment favouring tribes of altruistic humans.

Multi-level selection So, how is the concept of multi-level selection useful in the life sciences market? Well, twice in recent weeks I’ve worked with companies in chronic diseases – diabetes and asthma. Both began their thinking worrying about how to evolve their product – in the first case a continuous blood sugar monitor, in the second an asthma drug. In both cases, it is difficult to see how to adapt to the market’s dominant selection pressure, which favours lower costs and therefore commoditisation. Difficult that is until one reframes the problem as one of multi-level selection. Using that perspective, it becomes obvious that the market of the future will not choose drugs or devices, it will choose systems. This is directly analogous to the market no longer choosing kitchen cabinets but choosing kitchens instead. Through the lens of multi-level selection, the question becomes how to evolve the system, rather than the product. And that lens also allows us to make sense of what we see happening around us. Various respiratory companies are developing smart inhalers as part of their offer. Glucose monitoring companies cooperate with diabetes pharma companies. In the market for medical technology, companies

like Philips, Siemens and GE Healthcare sell integrated systems that optimise health economic outcomes. Rivals who try to compete with stand-alone products rarely succeed, other than when they construct tiny, defended niches.

A different world When one uses multi-level selection to look at the future of the industry, rather than a single business, it predicts a very different world. Our market might follow the path of word processors, kitchen cabinets or, easier to imagine, medical technology; companies in some market sectors like respiratory or diabetes will cease to be pharma companies in our current understanding of the term. They will develop, provide and maintain disease management systems that incorporate pharmaceuticals but also diagnostic and delivery devices and, probably, patient-ﬂow management systems. Looking back from the future, companies that marketed, say, insulin or LAMA/LABA drugs will seems like strange historical artefacts from another age. So, yet again, I argue that a Darwinian view of the life sciences market is not only intellectually rigorous but also practically useful. It is only surprising, in a sciencebased industry, that we don’t make more use of Darwin’s wonderful ideas. Professor Brian D Smith works at SDA Bocconi and the University of Hertfordshire. He is a world-recognised authority on the evolution of the life sciences industry and welcomes questions at brian.smith@pragmedic.com

Pharmaceutical Market Europe November 2019

HEALTHCARE

ROHIT KHANNA THE UNHAPPINESS PROJECT How come I can’t ﬁnd anyone who is ‘happy’ with healthcare?

appiness, or subjective well-being as some refer to it, has long been associated, on some level, with beneficial health outcomes at the individual level. There are a multitude of studies that have shown a relationship between an individual’s subjective wellbeing and some measure of improvement in overall morbidity or mortality. Simply put, we know that happier people have been reported to be healthier people. But, then, why is everyone in healthcare so miserable? I mean, patients are unhappy with the whole thing – prices, access, quality of care. I cannot recall a single chronic patient that I have ever met who has raved about the health system and how efficiently it operates. Occasionally, one will meet a patient who went through an acute scenario and was pleasantly surprised at how it turned out. Caregivers are exhausted and equally disconsolate with the never-ending red tape of insurance paperwork and lengthy wait times as they shuttle their loved ones to and from appointments. Doctors are burnt out and despondent with a system that is nothing like they imagined. Ditto for nurses and pharmacists. Politicians are exasperated with spiralling costs and voter backlash at every turn. Insurance companies and pharmacy benefits managers are crestfallen at the venom directed their way as they are blamed for the egregious costs being imposed on the system. Patient advocacy groups, while doing incredibly important work, often struggle for funding and to find a clear voice that resonates and can move the needle on meaningful policy change on behalf of their membership. And manufacturers – both medical device and pharmaceutical – are no less miserable as they face a barrage of questions from lawmakers about their costs and pricing practices, and a slew of disapproving looks from the general public about their perceived greed and callous approach to patients’ lives. In 2018, See and Yen published a paper showing that happier nations have better health system performance as measured by efficiency. They used the ‘happiness index’, which is a comprehensive indicator that includes several important components, such as caring, freedom, generosity, honesty, health, income and good governance. And they measured efficiency as a function of life expectancy and inverse mortality rates. The findings show that

Pharmaceutical Market Europe November 2019

WORLD HAPPINESS REPORT 2017 happiness is one of the factors that contributes to the efficiency of a country’s health system. Others have also published similar results on the topic of happiness and health. And then there’s the United Nations 2017 World Happiness Report (see chart), which shows that among the top 20 happiest nations on the planet, a healthy life expectancy matters in the overall ‘happiness equation’ but accounts for less of a nation’s overall happiness than, perhaps, we think. This doesn’t necessarily contradict any of the peer-reviewed work out there, as the empirical data is very clear that happiness is only one of the factors associated with health and health system efficiency. What the UN World Happiness Report reinforces is that the impact of happiness might be even less than we think. Of course, there are methodological issues with all these papers and reports. How do we measure happiness? And how do we measure both health and health system efficiency? Is there an inherent selection bias in our data? Or other biases that we are not aware of? But it is all confusing, isn’t it? If happiness is important at an individual level and a societal

level in contributing to population-level health as well as overall health system efficiency, why are so many people so unhappy with the state of healthcare. And if so many people are unhappy with the state of healthcare, how is it that we are producing this efficiency in certain countries? Maybe, the answer is that other variables related to happiness (like income, education, housing, good government, security, religious freedom, etc) mask or overwhelm the low numbers associated with happiness from healthcare. Or maybe there is some reverse causality happening – it’s not entirely that happiness leads to a healthier life and a more efficient health system but that a healthier life and a more efficient health system lead to happiness. Regardless of these important nuances, I have not been able to find any stakeholder group that is truly ‘happy’ with the state of healthcare today. I’m betting you haven’t either.

Rohit Khanna is the Managing Director of Catalytic Health, a healthcare communication, advertising & strategy agency. He can be reached at: rohit@catalytichealth.com

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HEALTHCARE

STEPHANIE HALL PHARMA BRAND PLANNERS’ BLOG Part 6: Setting the right metrics and KPIs in your brand plan

his month we tackle one of the most important and most frequently neglected parts of the brand plan: the metrics and KPIs that give you valuable, regular feedback on your progress towards your brand plan goals and the operational effectiveness of your tactics. In my marketing excellence work across the industry over the years, KPIs and measurement repeatedly come up as one of the most important topics for training or support. Some marketers just run out of time when it comes to this final section of the brand plan, others shy away from giving numbers and targets from a lack of confidence in setting the right target or being seen to fail. But with a bit of time and practice, the measurement section of your brand plan can take on a clear shape and structure, and then be used for some quality operational brand team reviews. There is a clear disconnect between accepted marketing measurement theory and the definition and use of KPIs and metrics in practice. In a recent audit of ten brand plans (global and local) across ten different pharma/biotech companies from 2015-2018, I found the following: • Only one out of the ten brand plans had SMART objectives linked to their KPIs • Only four out of the ten brand plans contained KPIs, and only one of these brand plans contained KPIs with a clear timeline and target • Only three out of the ten brand plans included a budget for market research, measurement and tracking. So let’s start with a couple of definitions: what is a metric and what is a KPI? Essentially a metric is any measure that we can define to give us feedback on our brand plan’s effectiveness, while a KPI is just that; they are the few key metrics that we define as being the most important to focus on. You may have many metrics within your plan but only eight to ten KPIs that will form the basis of your research, tracking and reporting as a cross-functional brand team. The starting point for creating a good measurement section in your brand plan rests with the quality of your commercial, financial and marketing objectives earlier in your plan. Many brand planning frameworks don’t actually stipulate the need to create oneto three-year SMART (specific, measurable, achievable, relevant, time-bound) objectives. If you haven’t already done so, I would strongly recommend that you create some

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clear objectives to include: number of patients treated, number and frequency of prescribers by segment where possible, desired attitude and behaviour change, access levels, sales, market share, advocacy levels and patient/prescriber experience objectives, to name but a few. Once you have a clear set of objectives, you can then create a set of strategic KPIs aligned to each objective, to give you feedback over time on how you are progressing. There are three key elements of a strategic KPI: • Use a variety of sources of information • Set targets at various time points during the year • Ensure the KPIs have a clear target that will ultimately align with the year-end objective. Some teams find Kaplan’s balanced scorecard useful to organise and present the strategic KPIs across four quadrants: customer/patient, financial, competition, organisational learning/processes. Next you will need to define your operational KPIs: the metrics and KPIs for your major programmes and tactics to give you important feedback on whether your programmes are being implemented effectively, engaging your target audience(s) and contributing to a change in attitude and behaviour. Select five to six of your biggest programmes and create three to four metrics for each programme to give you valuable feedback on that programme’s effectiveness, including specific pieces of content, channels and types of tactic or activity.

How do you know if you have created a strong KPI/measurement section in your brand plan and have incorporated measurement into your brand team’s practice? If you can answer yes to these ﬁve questions, you are in good shape! 1. Are your KPIs directly aligned to SMART commercial, ﬁnancial and marketing objectives? 2. Do your KPIs have clear targets and different sources of information and will they be reading out at different points in the year to help with course-correction decisions? 3. Do you have budget in place and a clear owner for research, tracking and reporting against your KPIs? 4. Have you assigned owners for each KPI as a clear leader to monitor progress and any decisions needed during the course of the year? 5. Have you set up regular KPI and performance review reporting processes and meetings with your cross-functional brand team on a monthly or quarterly basis to take proactive decisions to optimise your brand’s performance through the course of the year? For more, see Measure What Matters in Pharma/ Biotech at www.uptakestrategies.com Next time, we’ll be looking at how to manage change, uncertainty and risk within your brand plan.

Stephanie Hall is MD of the award-winning brand planning healthcare consultancy Uptake Strategies

Pharmaceutical Market Europe November 2019

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The long and winding road to asthma breakthroughs Respiratory biologics are booming thanks to scientists who refused to be derailed by early research setbacks By Danny Buckland

atience and persistence are the prime disciplines of drug development, but knowing when to keep the fuse burning or simply walk away takes a confounding blend of science and emotion. The raw balance sheet imperatives are often the final arbiter but playing a long game, and funding it, does bring rewards as Steve Yancey, GSK’s vice president and medicines development leader, knows so well. The company’s severe eosinophilic asthma biologic Nucala (mepoluzimab), an Interleukin-5 inhibitor, has been buoyed by a real-world evidence study – presented at the recent European Respiratory Society’s International Congress in Madrid – which reported a 69% reduction in the annual rate of clinically significant exacerbations. Nucala, which has the market boost of being licensed for home administration via selfadministered auto-injector and prefilled syringe, is running smoothly with approval for the rare disease EGPA in several countries. GSK is also anticipating data in hyper-eosinophilic syndrome and nasal polyposis which could lead to commercial approvals in both by the end of 2020. Its sales-ringing performance chimes with GSK R&D chief Hal Baron’s strategy to concentrate on the immune system and genetics – Nucala was cited as a prime example of the company’s reinvigorated approach when it was unveiled last year.

Biologics are exquisite For Yancey and his development team, the spotlight comes after a long and, at times, dispiriting journey stretching over 20 years. Early research in biologics for respiratory diseases did not fare well, with disappointing clinical trials and a danger that the promise would run out of steam. “Biologics are exquisite in what they can do,” he said. “But it wasn’t that obvious 20 years ago. We were using the dogma and paradigms of one-size-ﬁts-all and that is where we failed.

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The early clinical studies with mepoluzimab were unsuccessful, which was disappointing but there were signals in the data that indicated to both the GSK scientists and the wider scientiﬁc community that we were beginning to understand more about subtypes, phenotypes and endotypes, which gave us the encouragement to have a long, backward look at our data.

‘A third of patients with severe asthma are hospitalised at least once a year, more than half have at least one urgent care episode annually, while 25% may have had at least one near fatal experience’ “We spent a lot of hours reviewing our data and the data the academic community was providing and that allowed us to reassess the medicine and understand that we needed to focus on specific populations such as those with serious eosinophilic inflammation. This was the turning point for the development programme.” The late nights interrogating the science and unpicking data sets prompted the switch from a drug for the broad asthma community to a therapy targeted at a subtype representing around 10% of the asthma population. Nucala had the springboard and the splashdown target. If the drug’s birth was slow and difficult, its ascent to maturity has been fast-tracked – keeping pace with the wider biologics discovery field – and full of firsts, according to Yancey.

Gold standard “The development programme pulled through efficacy and safety but we also blazed some new trails, being the first to use patient-reported outcomes to measure the quality of life in these patients where traditional QALY instruments did not work,” said Yancey, who is based at GSK’s Research Triangle in North Carolina, USA. “We also developed specific protocols to spare oral corticosteroids for those who use them daily, which has become a gold standard study followed by others. “We have studied more than 3,000 patients in 21 clinical trials and 60,000 patients have received Nucala since it was licensed.” Severe eosinophilic asthma (SEA) impacts between 5-10% of the population but they, and other severe asthma subtypes, represent 50% of the cost of asthma care expenditure. A third of them are hospitalised at least once a year, more than half have at least one urgent care episode annually, while 25% may have had at least one near fatal experience. “These figures make us get out of bed every morning,” Yancey says. “Knowing that I am helping patients in some small way to breathe better and to live every breath makes coming to work pretty easy for me.” The high unmet need was reinforced by a report issued in October by the European Federation of Allergy and Airways Diseases’ Patients’ Associations (EFA), which revealed there were 30 million children and adults under the age of 45 living with asthma in Europe and approximately 10% of those adults suffer severe and lifethreatening symptoms. It also voiced patient concern that asthma and Chronic Obstructive Pulmonary Disease were not getting enough attention compared to other chronic diseases and that patients should play a larger role in medical research.

Pharmaceutical Market Europe November 2019

GSK’S STEVE YANCEY

‘Severe eosinophilic asthma impacts between 5-10% of the population but they, and other severe asthma sub-types, represent 50% of the cost of asthma care expenditure’

“We are slightly on a pedestal in that we were the first to approach eosinophilic inflammation in patients with SEA, which allowed us to have the largest breadth of data – five years of safety data,” Yancey added.

Rapid acceleration Advances in respiratory biologics have opened the door for a move from daily inhaled steroids to monthly injections, delivering greater relief and reducing the condition burden on everyday life – unsurprisingly, studies have shown that 96% of patients prefer self-dosing at home. But GSK is not alone in the IL-5 inhibitor arena. AstraZeneca’s Fasenra is making waves with its eight-week dosing schedule and $296m in ﬁrst-half sales – a 244% increase over the same period in 2018. Respiratory biologics is a bustling market.

Pharmaceutical Market Europe November 2019

“There has been a tremendous amount of progress in target respiratory biologics over the last 20 years, but really it has been in the last ten where we have seen the most rapid acceleration, and this has been driven by an evolution in how we think about asthma,” said Yancey. “Back in the days of small molecules, we thought about large populations and homogenous conditions but, as we move to think about stratiﬁed or targeted medicine, we have also come to move the science forward. We recognise that asthma is really a complex heterogeneous disease and it really consists of a number of subtypes and, depending on your sub-type and your expression of the disease, how you will respond to a medicine will vary. This is really the story about biologics; how to understand to target to get the right medicines to the right patient.”

Yancey is full of positivity and pragmatism as Nucala branches out into new applications and the company extends its collaboration sphere. “I always expect bumps on the road – drug development is an incredibly challenging space. Our aim is to overcome them by ﬁnding ways of improving our probability of success. “Our biggest challenge is to be more efﬁcient in picking the winner and not moving as many products or programmes through progression by having a very early look at how we do that. “One of the strengths of GSK is that we are keen to target genetic links to the disease and mechanism.”

Danny Buckland is a journalist specialising in the healthcare industry

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Strengthening business competition and reducing anti-competitive practices How the CMA is tackling high prices for essential drugs By Jonathan Tickner and Hannah Howlett

he Competition and Markets Authority (CMA) is tasked with strengthening business competition and reducing anti-competitive practices for the benefit of consumers both domestically and internationally. Since its inception on 1 October 2013 (as the successor to the Office of Fair Trading), the CMA has opened 2,028 investigations and inquiries, including into a number of household names. For example, earlier this summer Amazon’s potential merger with Deliveroo was put on hold while the CMA investigates the deal. JD Sports, Abellio, Viagogo, Sainsburys, Asda, Rentokil, Visa and Paypal have also been subject to CMA investigations/inquiries in recent years. The pharmaceutical sector is far from immune to scrutiny. In recent years, the CMA has been inundated with a steady and increasing influx of pharmaceutical-related cases. Presently, the CMA has 75 open cases, 12 of these (or just over 16%) involve the pharmaceutical sector and this number only looks set to increase. The investigations cover a myriad of allegations including excessive and unfair pricing, anticompetitive agreements and abusive conduct. In a July 2018 statement regarding its investigations into the pharmaceutical sector, the CMA said: ‘The weight of work we are undertaking in this area demonstrates the priority we are giving to tackling high prices for essential drugs in order to protect the NHS and taxpayers from being exploited.’

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These investigations have yielded results. On 23 May 2019, the CMA provisionally found that between June 2013 and July 2018, Alliance Pharmaceuticals, Focus, Lexon and Medreich agreed not to compete for the supply of prescription-only Prochlorperazine 3mg dissolvable or ‘buccal’ tablets to the NHS. More recently, in August 2019, drug company Aspen offered to pay the NHS £8m as part of a wider package to resolve competition concerns following an investigation into suspected anticompetitive arrangements regarding the supply of ﬂudrocortisone acetate 0.1 mg tablets.

A firm pharma focus The CMA’s focus on the pharmaceutical industry is not surprising. This appears to be a global trend, not least (from a European perspective) since the European Commission (EC) published its final report in its pharmaceutical sector inquiry in July 2009. Sparked by the Commission’s concern that the market entry of generic drugs was being delayed and that fewer innovative products were reaching the market, the inquiry was launched to gain a holistic insight into the pharmaceutical industry and identify the sector-specific problems that were hampering healthy competition. The report focused on targeting practices used by companies to impede or block entry of generic products or the development of competing originator products. The most prolific practices included: the use of settlement agreements between originator companies and generic companies to block

market entry; interventions in national marketing authorisations regarding the approval of generics (which on average delayed market entry for generic drugs by four months); and attempts to discredit and disrupt the supply of generics by endeavouring to influence wholesalers or manufacturers. As a result, the Commission resolved to find a workable solution to curtail such practices. One of the main suggestions required all member states to promote stronger coordination between different national agencies to avoid differing applications of the legal framework. National authorities were also pushed to take firmer action in the aftermath of discovering a competition infringement.

‘Since its inception on 1 October 2013 (as the successor to the Office of Fair Trading), the CMA has opened 2,028 investigations and inquiries’ And it seems to have worked. In the ten years following the publication of the report, national authorities across the EU have imposed fines amounting to over €1bn. In addition to disputes where fines or penalties have been imposed, national authorities have investigated over 100 other cases and reviewed over 80 merger transactions, ultimately flagging 19 of these transactions for anti-competitive concerns.

Pharmaceutical Market Europe November 2019

COMPETITION AND DRUG PRICING

Settling the score While the level of financial penalties imposed by the CMA has not reached the levels imposed by the EC, they have nevertheless been substantial. One of the largest was the £84.2m fine against Pfizer in 2016 for its 2,600% price increase on an anti-epilepsy drug supplied to the NHS. Consistent with section 36(7A) of the Competition Act 1998, the twin objectives of the CMA’s policy on financial penalties are: (i) to impose penalties on undertakings which reflect the seriousness of the infringement; and (ii) to ensure that the threat of penalties will deter both the infringing undertakings and other undertakings that may be considered anticompetitive activities from engaging in them.

Pharmaceutical Market Europe November 2019

With this in mind, the CMA’s stated intention is, where appropriate, to impose financial penalties, in particular in respect of agreements between undertakings which fix prices or share markets, other cartel activities and serious abuses of a dominant position, which the CMA categorises as ‘among the most serious infringements of competition law’. This is, of course, subject to the statutory restriction that the financial penalty may not in any event exceed the maximum penalty of 10% of the worldwide turnover of the undertaking.

Set against this backdrop, the CMA encourages companies to come forward, for example, with information relating to any cartel activity in which they are involved, and will, where appropriate, give lenient treatment to such companies. All of this means that Aspen’s recent offer to pay £8m to the NHS as part of a wider package may be a sign of things to come.

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COMPETITION AND DRUG PRICING

According to the CMA’s August 2019 press statement, the inquiry relates to arrangements made by Aspen in 2016, to two rival firms, based on the allegation that Aspen had paid these competitors to not enter the market. As a result, Aspen is alleged to have been the sole and unchallenged supplier of Fludrocortisone (a drug used to treat Addison’s disease) to the NHS. In a landmark move, and as the direct product of the investigation, Aspen approached the CMA with an unprecedented settlement offer. As part of a broader package, Aspen has been required to admit that it was party to an illegal, anticompetitive arrangement, alongside committing to making a payment of £8m to the NHS. The CMA has reacted positively to Aspen’s approach. Chief executive of the CMA, Andrea Conscelli, stated that it ‘welcome[d] Aspen approaching us to find a new way of addressing the CMA’s concerns. We believe this resolution will benefit the NHS, patients and taxpayers’.

It is little wonder, therefore, that the CMA and Aspen have taken this innovative approach to seek to reach agreement swiftly and practically. Court proceedings, investigations and inquiries are typically drawn out and expensive for all the parties involved.

‘Settlement deals such as the one struck by Aspen are likely to be not just a one-off, but an option worthy of serious consideration moving forward’ It makes business sense to move with the tide of practical change, mitigating the impact of excessive expenditure of both time and money. The ﬁscally prudent and reputationally attractive option of an early settlement allows all parties to move on at pace. On that basis, settlement deals such as the one struck by Aspen are likely to be not just a oneoff, but an option worthy of serious consideration moving forward.

Time is money There are some real and considerable commercial benefits to pharma companies in reaching a settlement with the CMA (and potentially the NHS) at an early stage: 1. Cost: both in terms of reduced fines (settling companies can and commonly do achieve a maximum discount on potential penalty of 20%) and saving/better utilising resources (settling with the CMA means committing to a streamlined administrative process rather than protracted and complex proceedings, which will significantly reduce the costs associated with facing a CMA investigation). 2. Brand image: settlement can be the best way to preserve brand image and market confidence through: a. Saving time: by dealing with the problem quickly it minimises the amount of time that the public is aware of the issue. b. Affording some degree of privacy: settlement discussions in commercial litigation are typically confidential. While the position is slightly different in respect of the CMA, settling at an early stage minimises the amount of information that makes it into the public arena (through a statement of objections in the case of the CMA, and the particulars of the claim in respect of civil proceedings). 3. Increased certainty and stability going forward: settlement allows a company to plan its way through this difficult time with greater certainty, both as to its financial exposure, but also more generally. Of course, settlement does not bring finality (as an infringement decision will be published regardless, which is the basis for follow-on damages action in the CAT or High Court). However, it does allow the company to have a clearer idea of its maximum exposure to a final penalty throughout the process. 4. Future public procurement work: a less considered benefit, settlement may dissuade relevant entities from excluding the company from future public contracts. Under EU law, the public authorities responsible for granting public contracts have a discretion to exclude from procurement procedures any company ‘where the contracting authority has sufficiently plausible indications to conclude that the economic operator has entered into agreements with other economic operators aimed at distorting competition’.

Jonathan Tickner is a Partner and Hannah Howlett is an Associate, both at Peters & Peters Solicitors LLP (and assisted by Amalia Neenan, Legal Researcher)

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Pharmaceutical Market Europe November 2019

IN ASSOCIATION WITH

We’ll need more than a spoonful of sugar to counter vaccine hesitancy By Satinder Phull

‘The need for effective solutions that achieve increased immunisation rates is vital, as is the need for individuals and communities to understand the beneﬁts and risks of immunisation’

ews that the United Kingdom, along with Albania, the Czech Republic and Greece, have lost their measles-free status is deeply troubling, but not surprising. Trust in and uptake of vaccines in Europe has been declining for some time, making disease outbreaks inevitable. But what is the reason for this distrust and how can this be turned around? In the UK, in 2017-18, uptake of the MMR vaccine decreased for the fourth year in a row. It now stands at 91.2%, the lowest level since 2011-12. In the US, uptake of the MMR vaccine among children aged 19-35 months also decreased in 2017. In some communities, coverage is very low (eg, 60% among ultraOrthodox Jews in New York State where a measles outbreak was reported in February). This trend in lower uptake of MMR vaccine has been observed worldwide, along with a 30% increase in measles cases globally, and the sequelae of this infection – deaths, pneumonia and encephalitis. It is, therefore, critical that action is taken to stop the re-emergence of dangerous infectious diseases. This is a serious public health issue and it is time for everyone to work together to counteract the rising distrust in vaccines. And more importantly, to develop and implement evidence-based strategies that rebuild trust and increase immunisation rates.

Vaccine hesitancy A delay in the acceptance or a refusal of vaccines despite availability of vaccination services (vaccine hesitancy) is a crucial element in the rise of vaccine refusal. While this hesitancy may be due to a loss of trust in the effectiveness and safety of vaccines, it could also be due to loss of trust in healthcare systems and those who deliver medical services.

Pharmaceutical Market Europe November 2019

Last year’s report by the London School of Hygiene and Tropical Medicine’s Vaccine Confidence Project found that countries in which GPs had a higher confidence in vaccines, tend to have a larger proportion of the public expressing positive vaccination beliefs. Other studies exploring levels of trust in institutions, such as governments and science in general, also show that the higher the levels of trust, the higher the rates of vaccine uptake. As high confidence in vaccination programmes is crucial in maintaining high coverage rates, the need for effective solutions that achieve increased immunisation rates is vital. One way to overcome hesitancy is to address the vast amounts of misinformation on social media. The wide-reaching and instantaneous nature of the medium means that anti-vaccination messages are accessible to a much wider audience than ever before. In some parts of rural India, for example, there have been reports of sophisticated anti-vaccinations campaigns shared via WhatsApp, targeted according to language and location of the recipients.

Anti-vaccination messages Some platforms have changed their guidelines and are limiting access to channels that promote anti-vaccination messages. Facebook is rejecting adverts with misinformation about vaccines, as well as down-ranking anti-vaccination content. Twitter launched a new tool that directs users searching for vaccine-related keywords to trustworthy public health sources. Instagram will not show or recommend content with misinformation about vaccinations in Instagram’s Explore, hashtag and search pages, while YouTube has removed the ability to advertise anti-vaccination content. This is a good start but promoting vaccination-positive messages and demoting anti-vaccination messages will not be enough.

Trust will need to be at the heart of any turnaround. In different communities, those who are trusted will vary, and building trust will be a complex interplay of sharing evidence and personal experiences. Trust in government, healthcare institutions and professionals, as well as trust in the views of parents, are all important factors in rebuilding trust.

Rebuilding trust A powerful example of rebuilding trust comes from Italy, where a lone parent sparked a campaign that reached thousands. Miriam Maurantonio, fearful for her son’s well-being and concerned about low vaccination coverage and the growing visibility of anti-vaccination movements, used social media to mobilise other parents to post selfies on social media with the hashtag #iovaccino (#Ivaccinate). Maurantonio’s single-handed campaign to encourage vaccine uptake shows the power of social media, but these platforms are not the only influencers. A multistakeholder approach from governments to the pharmaceutical industry to frontline primary care providers to educators and academics and scientists is needed to ensure that individuals and communities understand the benefits and risks of immunisation and view it as both their right and responsibility. There isn’t a one-size-fits-all answer and effectiveness of approaches will vary from person to person and community to community, but one thing is certain, we all have an important role to play in rebuilding trust in vaccines.

Satinder Phull is Director of JPA Health Communications

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Patient journey mapping: exploring the clinical and the emotional journey By Richard Jones, Sumira Riaz, Neil Rees and Melanie Liautard

‘Overlaying the clinical journey with the emotional journey will provide brand teams with a truly holistic view of the patient journey’

hile we can all agree that the value of developing a patient journey map cannot be underestimated when exploring the care pathway for a patient, there appear to be inconsistencies within the same pharmaceutical organisations as to how patient journey mapping is defined. There can often be a dichotomy in scope, content and delivery; for some, mapping the patient journey is to determine the clinical transactional pathway, while for others, the focus is to define the psychological experience of the emotional journey of patients and caregivers from diagnosis and beyond. The adoption of one approach over another is entirely dependent on the needs of the stakeholders and the business requirements within the organisation. However, by considering both rational and emotional parameters, creating a patient journey map that fuses the clinical and psychological experience of the patient and relevant influencers can provide the organisation with a basis for a blueprint to enhance the journey with appropriate interventions. As a starting point, understanding how patients proceed through the healthcare delivery system, using validated real-world data is essential. The production of a clinical pathway can be achieved by analysing Hospital Episode Statistics (HES) data: a records-based system that covers all NHS Trusts in England. While all data is pseudonymised to ensure patient confidentiality, the data collected follows patients’ clinical touchpoints during their time under the care of a physician based in the NHS. The data collected in HES includes, but is not limited to: • Patient details – age, sex, ethnicity and location • Clinical details – diagnoses, investigations/tests, operative procedures, consultant and specialty

Pharmaceutical Market Europe November 2019

• Administrative details – NHS Trust, GP, admission/discharge date and method and referrer. Mapping patients along the entirety of a pathway, from initial referral through further diagnostics to first definitive treatment, enables an understanding of the efficiency of care delivery and where opportunities exist for improvement. There are various aspects of the patient journey elicited from HES data that can shape any subsequent exploration into the psychological experience, such as: • The approximate time between the first and last step? - from first appointment to diagnosis to first treatment • Where are the longest delays? • The approximate time between each step? • How many steps are there? Identifying aspects such as time to diagnosis and time to initiation of treatment can shape how you approach developing a picture of the psychological journey of the patient. The clinical pathway can highlight the HCP types involved in the journey, gathering their perception along with patients, carers and PAGs to help to identify and define the variety of emotions experienced at each touchpoint, thereby providing the psychological dimension. A starting point to build the emotional perspective of the journey is to collate available information. Immersing yourself in existing information, such as previous market research or exploring the disease area on social media platforms supports an initial data immersion exercise that can feed into a bespoke qualitative research approach. Using tailored methodologies and projective techniques to elicit deep-rooted feelings throughout the journey will help us understand the lived experience of the patient and specifically the psychological impact of clinical milestones previously identified. Furthermore, it can be

extended to include the emotional response of caregivers at each key milestone, thereby permitting a further layer of insight beyond that of the patient and the healthcare professional. In addition to mapping clinical patient pathways, the use of HES data can support the development of innovative solutions and service improvement, track outcomes and provide realworld evidence. These data sets are used for the purposes of providing supporting information for business cases, epidemiological research, burden of disease analysis, health economic research, predictive analytical modelling, NICE submissions and quality & outcome analysis. The aim is to improve patient care and support enhanced access to services and innovative solutions, which is additionally supported through an understanding of the patient’s emotional well-being. The data immersion and bespoke market research used to better understand the psychological journey can aid identification of unmet needs, leverage key information points and assist in facilitating tactical solutions around services to improve patient care and support healthcare professional education. Overlaying the clinical journey with the emotional journey will provide brand teams with a truly holistic view of the patient journey. Understanding the unmet needs, drivers and barriers for change along the journey will enable brand teams to develop interventions, for patients, healthcare professionals or other relevant stakeholders. Such support can improve the journey for the patient, leading to improved patient outcomes.

Richard Jones is Patient Engagement Managing Director, Sumira Riaz is a health psychologist, Neil Rees is Head of Research and Melanie Liautard is a Senior Account Manager, all at Open Health

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Pharmaceutical innovation in the APAC region A ﬁrst-of-its-kind study paints a vivid picture of the APAC region’s future By Jamie Munro

he Asia Paciﬁc (APAC) region has been a strong contributor to the pharmaceutical industry’s global market growth for several years. Can such growth be sustained? And to what extent will it be driven by innovation? While various studies have examined innovation more broadly – at the global level and/or with a methodology applicable to multiple industries – none has been sufﬁciently focused to paint a vivid picture of the APAC region’s future. The following fresh perspective on innovation in the APAC pharma market is excerpted from a data-driven analysis that ranked companies on their degree of innovation, using a methodology expressly developed for less mature markets. The full report is free to download and is available from Clarivate Analytics.

A quantitative approach

A mixed macro environment

As the goal was to measure innovation at the company-level, the ﬁrst challenge was to determine the parameters that would best measure innovation in less mature markets. The resulting quantitative measures were primarily related to pre-development conditions and decisions (see sidebar: A multifaceted approach to measuring innovation). The extensive analyses applied a customised scoring mechanism to rank-order a cohort of 929 companies out of a universe of 46,509. The analysis was conﬁned to pharmaceutical and biopharmaceutical products, with innovation in drug delivery, devices and diagnostics considered as out of scope.

The degree of innovation in a country is necessarily inﬂuenced by a variety of social, economic and regulatory factors – some that encourage innovation and others that inhibit it. We examined these factors for Mainland China, Japan and South Korea, concluding, very broadly:

A multi-faceted approach to measuring innovation There is no agreed-upon definition of what constitutes innovation in the pharmaceutical industry and there is no accepted surrogate marker for it. Even the most general definition of innovation (the creation of a new good or service that generates value) is not easily applied. How is ‘newness’ defined? How is the value of a therapy measured? We therefore developed a bespoke methodology based on a set of largely quantitative parameters that encompassed a company’s broad innovation ecosystem. These included factors ranging from academic alliances to the degree to which R&D is translated into actual drug pipeline. We then grouped the individual data parameters into three major indices: early-stage partnering, drug development and maturity.

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• In Mainland China, innovation is spurred by several conditions: the sheer size of the population, an increase in lifestyle diseases, the shift away from state-ownership of enterprises, and the government’s investment in healthcare and regulatory reviews. Tempering this, the country relies almost exclusively on generics, is still overcoming counterfeiting issues, regulates prices heavily and lags behind other countries in the percentage of GDP spent on healthcare.

The study used data collected until the ﬁrst quarter of 2019 to understand the following when looking at 14 APAC countries/regions: • Which countries are most conducive to innovation? • Which companies are leading the way? • Which companies are on the cusp of seizing growth fueled by innovation? • How does a company’s innovation proﬁle affect its success?

Pharmaceutical Market Europe November 2019

INNOVATION IN APAC REGION

• Japan is the scene of opposing incentives for innovation. On the one hand, the government aims to accelerate R&D and is funding projects that make use of artiﬁcial intelligence (AI), is reviving the research-based industry and is promoting drugs of Japanese origin in global markets. At the same time, the economy is facing challenges, the population is ageing, punitive pricing schemes are impacting smaller, domestic companies and the government has set a target of 80% generic substitution by 2020. • South Korea is an innovation-friendly environment, as the government is driving growth in the pharmaceutical and medical instrument sector and is pushing for an expanded presence in the global biotech market. The government provides policy loans and tax incentives for innovation and is striving to reduce approval times and increase its share of the global market, while the Korea Pharmaceutical and Bio-pharma Manufacturers Association (KPBMA) is investing in an AI platform for drug development.

Pharmaceutical Market Europe November 2019

Strong regional pipeline Pharmaceutical companies are proliﬁc in the APAC region. At the time of our analysis, there were 5,547 drugs in active development in the region and 1,509 that have been launched. Of all countries we studied, Japan has the highest number of drugs in active development (nearly 2,000), which is not surprising given the country’s market maturity. Less predictable is the large number of drugs in development in both Mainland China (1,598) and South Korea (1,088). As Figure 1 shows, Japan earned the highest score on a country/region level, having achieved high scores in all three innovation indices. South Korea is a strong challenger to Japan’s dominance, lagging

Map not true to size

behind only slightly in terms of drug development and early-stage partnering. The country’s low maturity innovation score indicates that it has yet to deliver on its potential. The other APAC countries/regions, while relatively strong in drug development, are weaker in early-stage partnering. Within our data set, Mainland China has by far the largest number of pharmaceutical company headquarters (325), followed distantly by South Korea (151), Japan (140) and Australia (130).

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Figure 1: Ranking by country/region Company-level results We separated the larger, more established companies – for our purposes, deﬁned as those that have launched ten or more products (this included many multinational companies). We labelled this grouping as ‘top-tier’ companies and ranked them by their overall innovation score, (the upper quartile of this list appears in Table 1).

‘The APAC region is a rich source of innovation and collaboration opportunities abound for APAC-based and Western companies to accelerate innovation’

Source: Cortellis Competitive Intelligence, Derwent World Patents Index, Derwent Patent Citation Index, Web of Science The three major innovation indices are indicated here: drug development on the horizontal axis, early-stage partnering on the vertical axis and maturity in the size of each bubble. ‘Other’ includes Hong Kong, Indonesia, Malaysia, New Zealand, The Philippines, Singapore, Taiwan, Thailand and Vietnam.

All of the top-tier companies garnered high marks across all three innovation indices. These companies scored the weakest on early-stage partnering, which suggests there is still an opportunity for them to increase the number of their partnerships with academic institutions. Three observations were immediately apparent from the list of top-tier companies:

Table 1: Top-tier company rankings, upper quartile Rank Company

Country/region

Early-stage partnering

Drug development

Maturity

Total score

Daiichi Sankyo Co Ltd

Japan

410

320

135

865

Takeda Pharmaceutical Co Ltd

Japan

395

320

135

850

Eisai Co Ltd

Japan

350

320

135

805

Astellas Pharma Inc

Japan

345

320

135

800

Otsuka Holdings Co Ltd

Japan

325

315

135

775

Shionogi & Co Ltd

Japan

320

315

125

760

CSL Ltd

Australia

345

310

105

760

Ono Pharmaceutical Co Ltd

Japan

320

310

125

755

Mitsubishi Chemical Holdings Corp

Japan

300

315

125

740

Kirin Holdings Co Ltd

Japan

315

300

125

740

Source: Cortellis Competitive Intelligence, Derwent World Patents Index, Derwent Patent Citation Index, Web of Science

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Pharmaceutical Market Europe November 2019

INNOVATION IN APAC REGION

• There is a link between innovation scores and revenue. All of the companies in the upper quartile fall within the top 50 global companies in terms of revenue. • Japanese companies dominate. Nine out of the top ten are headquartered in Japan, as are more than half of all companies on the list. • Mainland China is underrepresented – for now. Only one company headquartered in Mainland China is among the top 40 innovative companies in APAC, even though there were more companies from Mainland China in the sample than from any other country. Those companies with fewer than ten marketed products were considered ‘small and mediumsized enterprises’ (SMEs) (the top ten from the list of 100 appears in Table 2). Given the rank-ordered list of the top 100 SMEs, we noted that: • The correlation between each of the three indices is less pronounced in this tier (many on the list have yet to bring a product to market or expand internationally). • Companies in Mainland China ﬁgure most prominently with more than a quarter of the entrants.

• The top-ranked SMEs score especially high on early-stage partnering, suggesting that this element is integral to their success. • All of the top ten SMEs earned high scores on drug development. • The top ten SMEs show much greater variability between their maturity and composite scores than on other measures.

stage partnering and drug development. Cancer will remain a growth market, although Japan is currently experiencing price containment pressures that other countries will also ultimately face. The outlook for innovation in South Korea is largely positive, thanks to government incentives to encourage foreign investment. For the country to raise its Maturity score, it will need to carry more drugs successfully through to commercialisation, a goal that should be helped by the government’s growth targets and support for investment in AI systems.

Innovation outlook As the macro-environment within the region changes, the scores for the parameters measured in this study will likely shift. Although there will be continued pressure on healthcare spending in Mainland China, the future looks promising overall for R&D there, and the number of innovative drugs introduced is likely to increase. In particular, Mainland China’s heavy investment in cancer therapies should pay dividends in terms of new product launches and government regulatory reforms should speed new drug approvals. In Japan, we expect that ranking scores for companies will differ more widely by company size, with market pressures affecting SMEs more dramatically than top-tier companies. There may be a drop in the country’s scores for early-

Conclusion The APAC region is a rich source of innovation, but in most countries/regions – Japan being the exception – this is not translating into a strong global footprint. Currently, the world as well as local entities are not beneﬁting fully from companies’ innovative activities. However, collaboration opportunities abound for APAC-based and Western companies to reverse this trend and accelerate innovation.

Jamie Munro is Executive Director at the Centre for Innovation in Regulatory Science (CIRS) and the Centre for Medicines Research (CMR)

Table 2: Highest-ranked SME companies, top ten Rank Company

Country/region

Early-stage partnering

Drug development

Maturity

Total score

Lee’s Pharmaceutical Holdings Ltd

Hong Kong

295

270

115

680

Takara Holdings Inc

Japan

325

250

665

Jiangsu Hengrui Medicine Co Ltd

Mainland China

215

300

110

625

BeiGene Co Ltd

Mainland China

210

255

110

575

Nitto Denko Corp

Japan

260

215

565

Glenmark Pharmaceuticals Ltd

India

205

260

100

565

Betta Pharma Inc

Mainland China

200

265

555

CanSino Biologics Inc

Mainland China

215

235

100

550

JCR Pharmaceuticals Co Ltd

Japan

180

250

110

540

10.

Genexine Co Ltd

South Korea

215

240

535

Source: Cortellis Competitive Intelligence, Derwent World Patents Index, Derwent Patent Citation Index, Web of Science

Pharmaceutical Market Europe November 2019

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Rethinking trials: the pros and cons of protocol amendments Protocol amendments occur often and can be beneficial, but the steps involved can be complex By Gareth Macdonald rotocol amendments make it more likely that trials will complete successfully, but they can be risky, burdensome and expensive. Understanding why and when to make a modification is vital, say experts. A protocol change can work wonders – just ask AstraZeneca. In August, AstraZeneca’s systemic lupus erythematosus candidate anifrolumab achieved the primary efficacy endpoint in an amended trial called Tulip-2. Originally Tulip-2 was the same endpoint as a prior study called Tulip-1. However, when anifrolumab fell short in the earlier trial, the firm opted to rejig the protocol with a new endpoint, BICLA. AstraZeneca spokesman Matthew Kent said: “The BICLA was chosen as the primary endpoint for TULIP 2, following a full evaluation of the previous phase e trial TULIP 1, which did not meet its primary endpoint of SRI4. “Systemic lupus erythematosus is a complex, heterogenous disease with many unanswered questions about what drives disease activity, and both the SRI and the BICLA are widely used for assessing disease activity. “An analysis of anifrolumab data supported the BICLA as a more appropriate measure to assess the potential of anifrolumab in TULIP 2,” Kent said.

All change? Most clinical trial protocols are changed at some point. Analysis by the Tufts Center for the Study of Drug Development (Tufts CSDD) indicates nearly 60% of studies are subject to amendments. AstraZeneca’s motivation for amending was obvious, but there are many reasons to make a change. In some cases, patient eligibility criteria are modiﬁed to speed recruitment. In other instances, evolving standards of care prompt amendments.

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The nature and number of protocol revisions usually depends on the study phase, said Chris Learn, Senior Therapeutic Strategy Lead Director, Therapeutic Science and Strategy unit at IQVIA. “Earlier phase studies, such as phase 1 a/b, ﬁrst-in-human or dose escalations with or without combination, typically require fewer amendments than trials in later phases of development,” Learn said, explaining that this is mainly by design. Late phase clinical trials are more complex and involve more patients, which makes amendments – including relating to patient safety – more likely, Learn continued.

‘Analysis by the Tufts Center for the Study of Drug Development (Tufts CSDD) indicates nearly 60% of studies are subject to amendments’ “The patient sampling size increases, as well, increasing the degrees of freedom within phase 2 and 3 trial parameters that may need to be better controlled and or accounted for in terms of safety, efﬁcacy and beyond.”

Trials in children Protocol amendments are also common in trials involving children. The European Medicines Agency is not responsible for approving or overseeing the conduct of clinical trials, and therefore is not involved in clinical trial protocol amendments. However, when it comes to paediatric trials, the agency does get involved, according to spokesman Henry Fitt.

Flitt said: “Sponsors of paediatric implementation plans (PIPs) need to contact EMA’s Paediatric Committee (PDCO) in case changes are foreseen for a study included in a PIP for which they would then possibly have to submit a modification of an agreed PIP and apply for a change in protocol through the national clinical trial authorisation procedures. “These modifications occur regularly,” he continued, adding that in 2018, the PDCO dealt with 223 requests for such a modification.

Challenges So protocol amendments occur often and can be beneﬁcial. However, the steps involved in making such a change are complex, according to Kenneth Getz, recently appointed Deputy Director at Tufts CSDD. “There are many challenges associated with substantial amendments, including suspending the trial and all external service support, modifying the protocol, resubmitting it to the ethical review committee, re-consenting study volunteers and re-engaging investigative site and contract service staff.” All these processes take time and cost money. According to research by FDAMap, a protocol amendment can cost between $72,000 and $500,000. These ﬁgures are roughly in keeping with Tufts’ analysis, according to Getz, who said: “Our 2016 study of nearly one thousand protocols found that two-thirds of phase 3 protocols and 77% of phase 2 protocols have at least one amendment with 2.3 (phase 3 protocols) and 2.2 (phase 2 protocols) amendments on average. “Each phase 2 amendment costs $141,000 on average in direct costs to implement, and $535,000 on average in direct costs to implement a phase 3 amendment.”

Pharmaceutical Market Europe November 2019

PROTOCOL AMENDMENTS

Product complexity The drug industry’s evolution from a provider of chemical-based medicine into a developer of larger molecule drugs and cell and gene therapies is likely to result in an increase in protocol amendments. Trials of such products are usually more complex than trials of small molecule drugs and, according to Kenneth Getz, more complex protocols are associated with a higher incidence of amendments. “We typically see more amendments in oncology and CNS. We also see a higher incidence and average number of amendments in later stage phase 2 and 3 studies. He added: “There are many factors that contribute to complexity, including more targeted and stratified patient populations, emerging safety issues, crowded drug classes and even the duration of time that multiple functions can provide design input.” This view is shared by Chris Learn, who said immunotherapy studies are more prone to amendments than other types of research.

Pharmaceutical Market Europe November 2019

‘The drug industry’s evolution from a provider of chemicalbased medicine into a developer of larger molecule drugs and cell and gene therapies is likely to result in an increase in protocol amendments’

“In comparison to other therapeutic platforms, my observation has been that these trials experience more amendments due to the unknown, unexpected impacts that the host’s immune system brings into play, in addition to those resulting purely from the drug and or drug product alone.”

Flexibility Protocol amendments provide drug developers with the flexibility needed to conduct scientifically robust research, said Jenny Fam, Associate Director, Global Regulatory Affairs, IQVIA. Fam said: “Innovation in drug research does come with new challenges. All stakeholders (clinicians, patients, regulators, etc, not just sponsors, should be prepared for unexpected outcomes and build contingencies.” Fam also said the ability to amend protocols is particularly important in emerging areas of research. “For example, in the case of a failing lot of autologous cell therapy, sponsors need to ensure reserve samples are available, clinicians need to ensure patients are not at risk for missing a dose and regulators need to allow for flexibility in treatment protocols to ensure risk-benefit measures are implemented under such challenges.” Gareth Macdonald is a journalist specialising in the life sciences industry

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MICROBIOTICA

A snapshot of…

MICROBIOTICA n this month’s issue of PME, we take an in-depth look at Microbiotica and talk to CEO Mike Romanos about the company’s technologies and the obstacles it faces in the biotech sector. Cambridge, UK-based Microbiotica is part of a new wave of pioneering ﬁrms focused on developing novel therapeutics based on the microbiome – the bacteria which live in the human body and whose role in regulating health is only now becoming better understood.

What is the central focus of Microbiotica’s research? We are focused on the microbiome, which are trillions of resident microbes, mainly bacteria, in our gut. It is clear that many diseases in every part of our body, not just the gut, are caused by an imbalance in a healthy microbiome and can be corrected by readjusting the microbial balance to a healthy one. An area of high interest is the discovery that responses to cancer immunotherapy are dependent on gut bacteria. This represents a new branch of biology that will revolutionise medicine. How is Microbiotica advancing life sciences with its technology? Microbiotica is a leading expert in the microbiome and is using its technology to identify the good and bad microbiomes in patients. The company can then use this information to produce oral medication that contains live bacteria. This approach has the potential to deliver novel medications that can address the underlying cause of disease with few or no side effects. What makes the company’s technologies stand out in a crowded field? Microbiotica’s capability is founded on groundbreaking research from ten years of investment in the microbiome at the Wellcome Sanger Institute. Trevor Lawley, our chief scientific officer, led the group which addressed several fundamental barriers to exploring this field, including being able to isolate all the bacteria and thus being able to create a database of reference genomes. These technologies have been enhanced and industrialised by Microbiotica, which now has the world’s leading capabilities in these areas. These capabilities attract collaborations with leading groups from around the world to provide the clinical data and samples to feed the process, including a University of Adelaide ulcerative colitis FMT study. There is also a $534m collaboration with Roche’s Genentech and an investment from Paris-based microbiome specialist VC Seventure. 32

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Why will Microbiotica make it in the high-risk, highly competitive biotech ﬁeld? The company has a combination of leading science and platform and highly experienced biotech/ pharma management. Our platform and products are highly differentiated. What are the R&D obstacles that the company is currently facing? The biggest R&D obstacle is in manufacturing the products. In the ﬁrst instance we will use contract manufacturers rather than establishing our own facility, and there is a limited number of CMOs in the world who can do this work, with none in the UK. What are the practical business issues the company is facing? The biggest recent issue for us has been space. In two-and-a-half years we have built an organisation of over 35 people with all the key disciplines and have outgrown our space at the Wellcome Genome

Campus. Lab space in Cambridge is at a premium and we have been constrained as we grow. What impact will Brexit have on the business? A very large proportion of our staff are continental EU citizens and it has been a major recruitment source. As a result, our ability to hire key talent from Northern Europe has been affected. Of greater concern is the university sector – the UK biotech sector is what it is because of the increasing excellence of the university sector over the last 20 years. At Cambridge University, 25% of its staff are continental EU citizens. The UK’s pre-eminent scientiﬁc position is due in large part to the single market and free movement. We know this has had an impact.

Microbiotica has generated therapeutic products comprising multiple isolated gut bacteria as treatment for C difﬁcile, ulcerative colitis and cancer. These products are undergoing testing and are set to be in the clinic in the next few years. Pharmaceutical Market Europe November 2019

MARKETING & COMMS 34 COMBINING HARD TECHNOLOGY WITH HUMAN SKILLS Why pharma’s multichannel maturity isn’t just about hard technology

38 DIGITAL HEALTH TRENDS

Why AI is set to transform the nature of healthcare

46 PEOPLE

Q&A with Vicky Bramham

Pharmaceutical Market Europe November 2019

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Combining hard technology with human skills Chris Ross explores why pharma’s multichannel maturity isn’t just about hard technology – success depends on ‘human’ enablers like skills and organisational culture to capture customers’ hearts and minds harma’s road to omnichannel engagement excellence is paved with opportunity and risk. Current progress is variable, with leaders making impressive strides but laggards – incredibly – only just beginning to dip their toes in the water. In the crowded middle ground between them, many organisations are experimenting with new technologies and attempting multichannel campaigns. However, their use of digital innovation is too often driven not by coherent strategy, but by the fear of missing out. It’s the wrong motivation. The potential for digital to transform the customer experience is signiﬁcant – but suboptimal practices, piecemeal tactics and channel-ﬁrst thinking means that many companies are at risk of squandering the opportunity. There’s still a long way to go.

The need to master omnichannel engagement is pressing. Consumer expectations have been redeﬁned by digital disruption, dramatically reshaping the buyer’s journey and forcing businesses to reimagine their commercial model. Research suggests that the average B2B buyers are now two-thirds of the way through their purchasing journey before they talk to sales, highlighting the importance of high quality digital engagement earlier in the buying cycle to usher prospects through the ‘funnel’. But digital marketing isn’t simply a factory for marketers to generate leads then pass the baton on to sales. Customers need support at every touchpoint along – and beyond – the buying journey, with online channels permanently on hand to deliver timely and relevant content. The challenge is to deliver a seamless experience as customers move between channels.

That’s the deﬁnition of omnichannel excellence – and it’s the holy grail in B2B. Naturally, pharma’s engagement with its customers has its own unique complexities – but the basic principles of modern-day communication naturally transcend all sectors. Traditionally, pharma’s dialogue with prescribers has started with the sales rep and been driven by a ‘share of voice’ model. However, a widespread shift in customer behaviours is forcing companies to extend the operational role of marketing to bolster engagement at every touchpoint of the buyer journey. With the clinical market now dominated by digital native healthcare professionals (HCPs) – and with access to traditional customers reducing – it’s clear that the effective and co-ordinated use of personal and non-personal (digital) channels is key to commercial success. So how is pharma getting on?

Figure 1: Digital allocation in marketing budgets If you oversee a product or marketing budget, which percentage of the marketing budget is allocated to digital initiatives this year?

Source: Across Health Multichannel Maturometer 2019

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Pharmaceutical Market Europe November 2019

TECHNOLOGY AND HUMAN SKILLS

Multichannel maturity 2019

Investment in digital

According to the Across Health Multichannel Maturometer 2019 study, the pace of digital transformation across pharma is as slow now as it was in 2015. Moreover, while 90% of the industry believes pharma will be disrupted by digital technologies, well under half think their companies are preparing adequately for the inevitable. It’s a perception that provides powerful context for the multifaceted multichannel challenges facing pharma in Europe. The Maturometer study, now in its 11th year, allows companies to benchmark their own multichannel performance against their peers in four core areas: people, strategy & organisation; business processes and technology; measurement; multichannel integration. The 2019 results reveal that 87% of respondents think their companies are still some distance from being ideal organisations in terms of their ability to use digital to improve customer engagement and business impact. Furthermore, satisfaction with digital is simply not increasing; little more than 10% are satisﬁed with their company’s digital/multichannel activities, mirroring satisfaction levels reported in 2010. However, despite the apparent failure to gain ground, pharma’s investment in multichannel has reduced in the past 12 months. After three consecutive years of robust growth, digital marketing budgets have fallen to 2017 levels – with 57% allocating less than 15% of their marketing budget on digital. The average allocation – 19.1% – is lower than in 2018 (Figure 1). But the law of averages disguises a digital dichotomy: there are lots of laggard beginners with small budgets being hidden by the more advanced companies that are spending a lot.

So where is that investment going? The ‘multichannel rep’ is growing in strength, with reps increasingly equipped with digital tools like tablet e-Detailing and approved email. However, remote detailing and eRep capabilities continue to lag. On the marketing side, product/disease websites and eNewsletters are the most popular tactics (Figure 2), while web banners on third party media remain a prominent approach. Patient websites and HCP self-service portals are already standard practice in almost half of companies, while the number of pilots in these areas suggests penetration is likely to increase further.

‘The leaders of tomorrow will be those who align their businesses around the customer to deliver personalised journeys and omnichannel experiences that are ﬁt for the 21st century’ In terms of the adoption of digital technologies, content management systems are by far the most widely used, while marketing automation tools are rising fast. However, health tech solutions like AI, chatbots, wearables and predictive analytics are only just on pharma’s radar. The use of technologies to help personalise content – a key area for pharma as customers reject ‘noise’ and look for more targeted content – is standard practice in less than a ﬁfth of organisations.

If pharma is to reap the beneﬁts of personalisation and harness the opportunities of marketing automation, companies need to strengthen their customer insight capabilities and build a 360 degree view of the customer through better integration of marketing and sales.

Strategy and skills However, to focus on investment in channels and technologies is to start in the wrong place. Companies need to think customer-first not channel-first, and this should be reflected in a clearly defined upfront strategy. “Some organisations still make the mistake of starting with tactics,” said Fonny Schenck, CEO, Across Health. “However, best practice begins with defining strategic imperatives then identifying the proxies that will translate them into something actionable. For example, what are the behavioural objectives, leverage points and associated messages needed to generate the greatest impact? Then it’s a matter of determining how you will achieve conversion; which content or services will drive the action/change you want? It’s only once you’ve been through these three steps that you can begin to consider tactics and channels. Unfortunately, many companies start in the wrong place.” The 2019 Maturometer backs this up. When asked about their priorities, digital teams believe their companies should focus much more on strategy than on enablers like technology, tactical content and campaign development. Suboptimal strategy is highlighted as one of the biggest barriers to digital transformation in pharma; managers believe that the absence of a clear

Figure 2: Marketing tactics/channels How often did you use the following multichannel marketing tools today?

Source: Across Health Multichannel Maturometer 2019

Pharmaceutical Market Europe November 2019

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TECHNOLOGY AND HUMAN SKILLS

strategy is a real obstacle, while the perceived lack of internal knowledge around digital is another cause for concern. The strategy void is even stronger in ‘emerging’ digital functions like medical and sales, where ‘lack of strategy’ and ‘no clear business case’ for digital are the top two bottlenecks. The digital skills gap is a long-standing problem. Less than a quarter of respondents (23%) believe their companies have strong digital/multichannel teams (with board support), while only 7% completely agree that their staff are well trained in digital skills. “In order to deﬁne and execute a solid strategy, you of course need motivated and skilled people who know the business and how technology can galvanize and transform it,” said Fonny. “This key condition for success remains elusive in pharma: in 2019, less than 10% of the business functions – marketers (9%), medical (8%) and sales (6%) – feel they are digital experts. For digital/multichannel teams the picture is – perhaps surprisingly – only marginally better (15%).” Remarkably, almost two thirds of marketing (63%) don’t believe they have sufﬁcient knowledge of digital opportunities (Figure 3). One of the biggest areas of perceived weakness is the ability to make decisions around ‘channel mix’; just 8% fully believe that this challenge has no secrets for them. This clearly illustrates the need to reinforce capabilities in this vital area. However, while digital teams increasingly believe that they’re well integrated within their business, more than half (52%)

don’t think they’ve got robust processes in place to help them deﬁne the right channel mix. And less than a ﬁfth think their company has robust technology (17%) and strong SOPs (15%) to enable its digital strategy.

The key to digital transformation So what does all this mean? The Across Health study once again reveals huge variation in digital maturity across the industry. A surprisingly high number of companies are still not doing digital activities at scale, preferring to invest in third-party media or isolated activities that suffer through a lack of integration. Others have progressed further, adopting approaches ranging from single-channel pilots or cross-channel campaigns to the use of multiple sales and marketing channels in glorious isolation. The most advanced have created a platform for more coordinated sales and marketing activity, marking a shift from ‘share of voice’ model to a ‘quality of voice’ approach based on a 360 degree view of the customer. This is the gateway to omnichannel excellence. However, technology alone is not enough. “Success is about focusing on the ‘hard and the heart’,” said Fonny. “Many of the ‘hard’ enablers are already in place; multichannel rep technology is omnipresent and most basic channels are commonplace; sizeable digital teams exist at both international and local level, and even marketing automation is beginning to rise through the ranks. However, the missing enablers are the human ones; the skills, culture and organisational capability that help to win hearts and minds.”

Fundamentally, says Fonny, there are four key components that must be in place to ensure a successful digital transformation. “Primarily, you need a robust, quantified business case – a ‘burning platform’. Secondly, this must be underpinned by a solid strategy, roadmap and vision. Thirdly, you need a coherent set of technological, organisational and skills enablers – the ‘hard’ and the ‘heart’. Often companies believe that if they invest in the tech, the rest will follow. It won’t. You have to invest in both. And finally, you have to work out where you’re going to start. This crucial aspect is often overlooked. Companies want to see quick wins, so it’s important to plan ‘multiple shots at the goal’ and short time-toimpact first steps. The most successful companies embrace agility; they experiment, learn, grow and adapt, and empower their teams with the hard and soft enablers to make change happen.” The 2019 Multichannel Maturometer confirms that pharma still has work to do in all four areas – not least the all-important component of capabilitybuilding at all levels. The digital dichotomy at the budget level shows that the market is moving at two speeds, with leaders going from strength to strength and laggards failing to move forward. The leaders of tomorrow will be those who align their businesses around the customer to deliver personalised journeys and omnichannel experiences that are fit for the 21st century.

Chris Ross is a freelance writer specialising in the pharmaceutical and healthcare industries

Figure 3: The digital knowledge gap Do you feel that you have sufﬁcient knowledge of all the opportunites offered by the internet for your business activities?

Source: Across Health Multichannel Maturometer 2019

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Pharmaceutical Market Europe November 2019

T40

TOP FORTY CREATIVE HEALTHCARE AGENCIES UK

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Creative companions

PMLiVE’s T40 list aims to identify the creative agencies which have had the most impact on advertising, branding, creative and design projects in the UK healthcare sector in 2018.* Visit www.pmlive.com/t40 to inspect the pedigree of those creative agencies leading the way in the UK healthcare sector. Using data veriﬁed by the agencies that took part, you can compare on a number of different metrics and view Top 10 lists for smaller agencies, independent agencies, young agencies, UK focused agencies and agencies with the waggiest tail**

Creativity comes in all shapes and sizes, so whether you’re looking for your new best friend or checking on your current creative companion - it’s worthwhile sniffing out this year’s T40. You can also ﬁnd out online how the list was put together, what metrics were used and how the agencies submitted their data.

*PMLiVE does not recommend or approve any of the agencies on the T40 list and does not guarantee the validity of any of the data shown. The T40 is not a comprehensive list of all agencies working in this sector. Agencies not shown may be outside of the top 40, may have declined to participate or provide any data and there may be some agencies PMLiVE were not aware of when generating the initial shortlst. **Waggiest tail, glossiest coat, most adorable eyes and cutest smile top 10 lists will not be released to the public.

Four digital health trends set to reinvent and re-energise pharma Why AI is set to transform the nature of healthcare By Amanda Glasgow

hen British Secretary of State for Health and Social Care Matt Hancock addressed the Public Health England annual conference in September, his speech provided valuable backing for the prediction that AI is set to transform the nature of health provision. His observation that ‘personalised prevention’ enabled by the ‘data-crunching power of AI’ will become the guiding principle of public health in the 2020s, and the increasing dominance of digital health in general, presents huge opportunities for pharma companies, and not just in terms of cost savings. It has the potential to help pharma ﬁrms transform their relationships with the end users of their products, aiding the creation of more meaningful connections with consumers. So how will this happen? There are four initiatives that pharma companies can adopt to beneﬁt from the digital technologies reinventing consumer health:

Use voice recognition to power consumer connections Voice recognition technology is now a critical dimension of device design. Leading analyst Emarketer predicts that over a third of Americans will be using a voice assistant like Siri or Alexa this year, up 9.5% from 2018. As such, it offers a multiplicity of possibilities for improving patient care. Removing the need to read a screen or type on a keyboard is clearly of huge physical beneﬁt to older people and those who are unwell. So, for pharma companies, a big opportunity is to programme AI assistants to act like a virtual health companion, using voice to remind users to take medication or attend medical appointments. This is particularly appealing for chronic conditions like diabetes, where patients need to undertake numerous steps. But it is also a potent tool for people affected by memory issues. On a purely product-related level, voice-enabled

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interaction with patients offers the chance for better success rates for drugs if outpatients can be helped to take them consistently. However, thinking more broadly, people suffering unexpected new symptoms (eg shortness of breath or sharp bouts of pain) could use voice to record their nature and frequency. Voice is so simple that people could build an accurate pattern of their condition before making their doctor appointment. And there are other possibilities. Changes in an individual’s mental health, for example, could be monitored, as some early research has shown potential for detecting depression via speech.

‘Becoming visible, active partners in consumers’ management of their health might feel like an ambitious target at the moment, but tech evolves fast – in just a few years, the early health tech-adopting pharma companies may have earned the right to sit beside consumers in their homes’ All the above are opportunities for pharma companies to forge an authentic, proactive relationship with people long before they are waiting in line to pick up their prescription. Rather than just being a provider of drugs, enlightened pharma ﬁrms can create a holistic relationship with patients based around helping them take responsibility for their long-term health. Given that the pharma industry is prevented from advertising directly to consumers in most countries, voice is potentially a revolutionary communication channel.

Implicit in all this is that pharma companies can develop a distinctive personality, making them relatable to end users and driving brand trust/loyalty. For pharma, the risk of not harnessing voice is that others will. One of the ﬁrst in-home voicecontrolled health assistants has already been launched this year by US ﬁrm Stanley Black & Decker. Its Pria system – a physical device that is linked to an app – can schedule up to 28 medication doses, provide reminder alerts, dispense the correct medication at the correct time, track caregiver visits and provide 24/7 customer service. This is a space pharma needs to become involved in.

Harness IoT to create real-time interactive relationships The monitoring and management of health conditions is moving forward with the help of AI. Apps in conjunction with physical devices – either worn by the user or sited within the home – can create a comprehensive system for tracking patients’ movements and behaviour, feeding back data to medical professionals and/or friends and family. On an immediate level this allows for better patient support as the dynamic analysis of this data could allow for instant adjustments to care. For example, Abilify MyCite is the ﬁrst ‘digital medicine’ approved by the FDA in the US. It’s a combination of antipsychotic drug aripiprazole and an ingestible sensor made by Proteus Digital Health. When patients swallow the drug, the sensor sends a message to a patch worn on their skin, recording the date, time and physiological information. This is then fed to an app on the patient’s mobile. Although much of the development of AI health products so far has been by tech or hardware specialists, pharma companies are waking up to the possibilities offered by the ‘Internet of Medical Things’. Pﬁzer appears to be the furthest ahead, putting the company in pole position to both enhance patient care and strengthen its connection with end users.

Pharmaceutical Market Europe November 2019

DIGITAL HEALTH TRENDS

The US ﬁrm is collaborating with IBM on a fascinating project (BlueSky) that has equipped a house with masses of sensors on everything from kitchen cupboards to fridge handles. It has been designed to track disease progression in Parkinson’s sufferers. They are invited to spend time in the house and the data collected helps physicians understand their condition via their patterns of movement.

Personalise and improve products through big data Alongside the benefits of real-time tracking outlined above, another key benefit of projects like Pfizer’s BlueSky is the vast amount of rich and relevant data generated. Once this data has been analysed and fed back into the drug production process, it allows the company to fine-tune treatments for patients in the house by showing how medication affects physiological changes. This is a fine illustration of the new era of personalised medicine – and the advantages aren’t just for the small number of patients in the pilot project house. Once the data is aggregated, this will enhance the creation of all Pfizer’s medications for Parkinson’s. Right now, there are three main challenges for drug firms like Pfizer operating at this cutting edge. Firstly, the significant cost of investing in and experimenting with IOMT projects to discover how best to use the technology. Secondly, the issue of patient data privacy. Decisions over how to ask for consent to use data and the limits of what the data is used for will take time to evolve.

Pharmaceutical Market Europe November 2019

Meanwhile, companies must ensure that even where legislation hasn’t yet kept up with developments, they remain on the right side of the ethical line without incurring unnecessary costs.

Shift mindset/culture from pill pusher to life partner

No longer just manufacturers and suppliers of pills, these digital health trends will enable pharma to develop a service-based model and take an active role in patient education and holistic care on a daily basis. In the same way, fintech companies are using technology to shift from offering banking to becoming partners in their customers’ financial management, pharma firms – either alone or in partnership – can become service providers (with all of the new revenue streams that potentially unlocks). Becoming visible, active partners in consumers’ management of their health might feel like an ambitious target at the moment, but tech evolves fast. In just a few years, the early health techadopting pharma companies may have earned the right to sit beside consumers in their homes. Investing in emerging technologies isn’t without risk. And for pharma firms in particular there are regulatory considerations: firms will need to ensure they are not breaching strict UK regulations when adopting AI-powered technologies such as voice, IoT and data. But this is not a reason to hold back from experimentation and careful implementation. As Pfizer’s leadership has recognised, sometimes it’s important to get involved early to reap the benefits.

What seems to be evident from each of these trends is that they give pharma companies an unprecedented opportunity to connect with consumers in a completely new way.

Amanda Glasgow is Head of Experience, EMEA, at digital consultancy Appnovation

‘The increasing dominance of digital health presents huge opportunities for pharma companies, with the potential to help them transform their relationships with end users’ Finally, pharma companies aren’t the only ones with amazing data. The company that owns Fitbit, for example, now has nine billion nights of sleep data available to analyse. But the Pﬁzer example is an indication of the prize available for pharma companies that can harvest in health data, either through bespoke, value-add experiments or apps/ devices that capture the public imagination.

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AI: opportunities and barriers to improving healthcare How AI is shaping the future of healthcare By Kath Mackay

he advancement of AI and machine learning in providing better healthcare is already on the rise across the UK. Increasingly clinicians are conscious that machine or automation-based healthcare enable a host of benefits due to the many innovative projects that are underway. The NHS’ long-term plan has ambitions to drive its digital transformation to maximise the very practical benefits AI can provide. Currently, the main barriers to progress are the difficulties that some innovators encounter when negotiating unfamiliar regulations, lack of clinical safety and efficacy evidence, data curation standards, talent and skills, fear of change and concerns about the impact of working practices and relationships with patients. Despite this, perception is increasingly changing. As wider society embraces new technologies, such as Amazon’s Alexa, there is a noticeable shift in attitude. Smart speakers are a brilliant example of an innovative piece of tech that although they haven’t been designed with healthy ageing in mind, will develop and support us as we get older. From predicting risks in illness to streamlining resources, through our work at UKRI, we support innovators from a range of different fields, including fintech and engineering as they turn their attention to finding solutions to ease the pressure on our national health service. Some of these solutions are already making an impact in the field. Freeing up clinician resource, E-Observations (eObs) allow doctors to observe patients digitally through hand-held devices and send them automatic alerts when patients are identified as being ‘at risk’. Similarly, to increase efficiency, Gendius is developing apps and artificial intelligence to measure and improve outcomes for patients with diabetes. The app, which is already available on Apple and Android, uses machine learning to predict disease progression and then help manage risk.

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Both of these innovations, of course, lessen the burden on clinicians, but they could also contribute to far earlier diagnosis, meaning better and faster care, and fewer long-term health complications. Similarly, AI can deliver exceptionally tailored treatment plans that will have the same effect. Snoozeal has developed a device to treat obstructive sleep apnoea, which contracts muscle at the rear of the tongue, through the use of a 20-minute daily toning regime of mild electric pulses. The device aims to be connected to an intelligent platform to collect biosensor data of tongue tone, which will be classiﬁed by machine learning, and AI-based to deliver personalised treatment regimes.

‘AI should be viewed as a tool to drive efﬁciency and accuracy in the healthcare system by enhancing decision-making, and not as a replacement for human interactions between medical staff and patients’ One of the most exciting developments is within one of the biggest challenges of our generation, dementia. In less than 20 years, the number of people aged 65 and over in the UK will increase by more than 40%. One in four of the population will be in this age bracket, and the rate of dementia sufferers will increase with it, testing the structure of our health service, but technology can help in the battle against the disease, and it already is. Mind over Matter MedTech is improving early diagnosis in dementia by trialling novel, low-cost and portable brain imaging technology. This tests patients’ personalised risk for developing the condition at least a decade before any clinical

symptoms would appear, potentially reducing the chance of a cycle of irreversible neuronal death. Importantly, all of these innovations free up time, allowing practitioners to concentrate tight resources on the most serious cases. Introducing more innovation into the ‘problem’ of providing healthcare to our ageing society isn’t just an opportunity to provide a more efficient and cost-effective service to the end user, but also an opportunity for tech companies to fulfil an everincreasing need. However, to ramp up the support for AI, we do need to address the very natural human hesitancy to adopting artificial intelligence. There are a range of concerns, many of which are justified, including the issue of data and privacy, as the new partnership between the NHS and Amazon’s Alexa exemplified. Naturally, data security needs to be addressed when handing our private information online and people are reluctant for AI to have too much information about what our profiles look like. Given the importance of data security, guidance has been developed and a code of conduct for data-driven health and care technology has been drawn up by the NHS. The diminished number of human touchpoints is also a concern for many. The practice of medicine aims to be an exact science, but lived experience tells us there is an art in diagnosis, because human bodies rarely follow a rule book. For older patients, the potential lack of face-toface interaction could have serious consequences – with isolated individuals already experiencing loneliness, this could take away an important lifeline. What AI can do, however, is give medical staff more time to concentrate on the more human elements of their roles, as complicated, boundarybreaking cases are as important as taking the time to talk. AI, therefore, should be viewed as a tool to drive efficiency and accuracy in the healthcare system by enhancing decision-making, and not as a replacement for human interactions between medical staff and patients.

Pharmaceutical Market Europe November 2019

AI AND HEALTHCARE

The possibilities of what we can achieve could expand with AI. The potential that AI promises for early detection of disease and helping people before symptoms appear means the speed and efficiency with which results can be delivered is increased. This ultimately means patients can be moved out of a hospital setting and treated in the community, addressing the wider goals of lowering costs and increasing efficiency in the NHS, while also leading to a longer, healthier life. The Government is increasingly backing the need for innovation in the future of healthcare. The formation of NHSx, a new joint organisation for digital, data and technology progression and the £250 million funding that the Prime Minister recently pledged to an artificial intelligence laboratory to boost dementia research shows the growing interest in the area. In addition, the £98m Industrial Strategy Challenge Fund (ISCF) Healthy Ageing Challenge has just launched its first funding competitions, looking for innovative solutions for healthier, happier and more independent lives as we age. Both of these funding opportunities give an insight into the growing national interest in AI, opening a door for the UK to potentially be a world leader in both its use and application. To achieve this, it is important that we have experts on board from a wide range of industries

Pharmaceutical Market Europe November 2019

who have the opportunity to be ambitious in developing products which meet forward-thinking but necessary requirements. Specialists such as doctors, business leaders and academics will be key to reaching our full potential.

‘Understanding and embracing the enormous potential of digital technologies and AI is fundamental to creating a healthcare system suitable for 21st century demands’ There is also a large opportunity for businesses and investors who have vital knowledge to offer expertise on the practical side of bringing AI products to market. There are now hubs in the UK that are driving forward technological advancements in healthcare. We have ﬁve new centres of excellence for digital pathology and imaging, including radiology, which use AI medical advances; they have already been established in Leeds, Oxford, Coventry, Glasgow and London – each with partners across many parts of the UK. The centres will develop more

intelligent analysis of medical imaging, leading to better and more efﬁcient clinical decisions for patients, and therefore giving more staff time for direct patient care in the NHS. Each of the new centres can enable companies, in particular small- and medium-sized enterprises, to develop rapidly, and trial and implement products and tools through the NHS, for example, testing the use of AI to highlight potential disease in a chest x-ray. Through the centres, businesses will work with academics, doctors, patients and health economists, who can provide their experience in the industry to support new treatments and medicines that can save and sustain lives. Understanding and embracing the enormous potential of digital technologies and AI is fundamental to creating a healthcare system suitable for 21st century demands. As our ageing population continues to grow, it’s important we keep innovating and seeking opportunities to improve. By doing so, we can develop the new tools our doctors and clinicians need to deliver excellent standards of patient care and sustain the UK as a global leader in healthcare innovation.

Kath Mackay is Director of Ageing Society, Health and Nutrition at Innovate UK

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APPOINTMENTS

Eli Lilly

MIKE MASON M

ike Mason is set to take on the role of senior vice president of Lilly and president of Lilly Diabetes and Lilly USA. He will succeed Enrique Conterno, who will retire from the role at the end of the year. Mason is a 30-year Lilly veteran, and has experience across the company,

Gilead

Smith+Nephew

enhance insulin delivery and improve user experience. He also steered Lilly’s efforts to improve insulin affordability, including the creating the Lilly Diabetes Solution Center, which supports people in need of less expensive alternatives to their insulin, which will continue under his leadership.

Zosano

MERDAD PARSEY

ANDREW DICKINSON

ROLAND DIGGELMANN

STEVEN LO

Gilead has appointed Merdad Parsey as chief medical officer. He will take responsibility for the company’s global clinical development and medical affairs organisations. Parsey joins from Roche Group’s Genentech, where he held the position of senior vice president, early clinical development in the Genentech Research and Early Development group. Prior to Genentech, he served as president and CEO of 3-V Biosciences.

Also joining the senior leadership team at Gilead is Andrew Dickinson, who has been appointed as chief financial officer. Before being promoted to CFO, Dickinson served as Gilead’s executive vice president, corporate development and strategy. Prior to joining Gilead in 2016, Dickinson worked at Lazard Frères & Co. for almost a decade, and served as global co-head of healthcare investment banking.

Smith+Nephew has appointed Roland Diggelmann as the company’s new chief executive officer. Diggelmann joined Smith+Nephew’s board as a non-executive director in March 2018, after departing from his position as chief executive officer of Roche Diagnostics. Prior to his time there, he spent 12 years in the orthopaedics sector, serving in strategy and leadership roles at Sulzer Orthopaedics and Zimmer.

Zosano has appointed Steven Lo as its new president and chief executive officer. He was most recently the chief commercial officer at Puma Biotechnology, and previously worked as senior vice president and chief commercial officer at Corcept Therapeutics. Earlier in his career, Lo spent 13 years at Roche Group’s Genentech, and started his career in the pharma industry at AstraZeneca.

Sirtex Medical

Gilead

with significant expertise in its diabetes business. He currently serves as senior vice president, connected care & insulins, and began his career as an engineer making insulin. During his time at Lilly, Mason has led its connected care business, which leverages technology to

Vertex

Amgen

Achilles Therapeutics

KEVIN SMITH

CARMEN BOZIC

PETER GRIFFITH

BEVERLEY CARR

Sirtex Medical has appointed Kevin Smith as chief executive officer, based on his proven leadership and expertise in the healthcare and pharmaceutical sectors. Prior to becoming the interim CEO of Sirtex, Smith served as executive vice president, sales and marketing for the Americas at the company. Before Sirtex, he served as executive vice president of business development at Gel-e.

Vertex has promoted Carmen Bozic to executive vice president, global medicines development and medical affairs, and also as its new chief medical officer, effective 1 April 2020. Bozic has been leading the clinical development of the company’s cystic fibrosis and alpha-1 antitrypsin deficiency programmes. Prior to joining Vertex, she spent 20 years at Biogen.

Peter Griffith has been appointed as executive vice president, finance and chief financial officer of Amgen, succeeding current CFO David Meline on 1 Jan 2020. He joins Amgen from Sherwood Canyon Group, a private equity and advisory firm, where he served as president. Previously, he retired from EY following a distinguished career, including almost 22 years as a partner.

Beverley Carr has been appointed as chief business officer of Achilles Therapeutics, a UK-based biopharmaceutical company. She brings over 20 years of business development experience in global pharma and biotechnology companies. Prior to joining Achilles, she served as vice president, business development for the immuno-inflammation therapy area at GlaxoSmithKline.

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Pharmaceutical Market Europe November 2019

APPOINTMENTS

Sensydia

NBE-Therapeutics

BioMarin

Lyra Therapeutics

ANTHONY ARNOLD

STEFFEN HEEGER

LON CARDON

DANA WASHBURN

Sensydia Corporation has appointed Anthony Arnold as president and chief executive officer, and to the company’s board of directors. Arnold has expertise in bioelectronic medicine and surgical navigation, and has more than 20 years’ experience from a number of medical technology companies, including SetPoint Medical, Smith+Nephew, Medtronic and Boston Scientific.

Swiss biopharma company NBE-Therapeutics has appointed Steffen Heeger as chief medical officer. He will lead the clinical development of the company’s first lead programme. Heeger has over 15 years' industry experience in the clinical development of targeted cancer therapies. He has held senior medical positions at Merck-Serono, MorphoSys and most recently served as CMO at Selvita.

BioMarin Pharmaceutical has promoted Lon Cardon to chief scientific strategy officer, a newly created role aimed at enriching the company’s pipeline. Prior to joining BioMarin, Cardon was senior vice president of alternative discovery and development, and head of target sciences at Glaxo SmithKline. Previously, he was a professor and Wellcome Trust principal fellow at the University of Oxford.

Dana Washburn joins Lyra Therapeutics as its new chief medical officer. Washburn has almost 20 years' experience in the pharmaceutical and medical device industries and has expertise in leading teams to achieve clinical trial milestones. Most recently, Washburn held the role of corporate vice president and head of global medical services for Paraxel International.

Kintai Therapeutics

Alexion

Metabolon

Mundipharma

FRANCESCA BARONE

TANISHA CARINO

KARL BRADSHAW

MATTHEW HOMENT

Kintai Therapeutics has appointed Francesca Barone as its new head of experimental medicine. Over the past six years, Barone has worked across academia and industry to establish collaborative partnerships to accelerate drug development. Prior to joining Kintai, Barone was a reader and academic head of business engagement for the College of Medical and Dental Science at the University of Birmingham, US.

Alexion Pharmaceuticals has appointed Tanisha Carino as executive vice president and its first chief corporate affairs officer. Prior to joining Alexion, Carino served as the executive director of FasterCures – a centre of the Milken Institute. Before taking the lead there, she was an executive at GlaxoSmithKline, where she led the US policy function, and previously spent over a decade with Avalere Health.

Karl Bradshaw has been appointed as Metabolon’s vice president of biopharma strategy and partnering. He joins from AstraZeneca, where he most recently served as senior director of corporate strategy and development. Bradshaw had various roles during his time at AZ, including head of competitive intelligence for infection, neuroscience and GI. Prior to this he worked as vice president of equity research at Morgan Stanley.

Mundipharma, a global network of privately owned independent companies focused on medicine development, has appointed Matthew Homent as Ireland Country Manager. He joins from Napp Pharmaceuticals, where he served as director of commercial operations. Homent has been with the Mundipharma network for over 20 years, moving to Napp in 2003, where he progressed through a number of roles.

BiomX

Akouos

Abzena

Magenta Therapeutics

MERAV BASSAN

RABIA GURSES OZDEN

KIMBALL HALL

JAN PINKAS

BiomX has appointed Merav Bassan as chief development officer. She has extensive experience in developing therapeutics from early discovery stages through to clinical trials and marketing, and will oversee BiomX’s pre-clinical and clinical development. Bassan was vice president head of translational sciences at Teva Pharmaceuticals, where she managed projects in multiple therapeutic areas.

Akouos has appointed Rabia Gurses Ozden as its chief development officer. She brings over 15 years’ clinical development operations and medical affairs experience with novel therapeutics and medical devices. She served as chief medical officer at Nightstar Therapeutics, which was acquired by Biogen this year. Prior to this, she held leadership positions at Applied Genetic Technologies Corporation and GlaxoSmithKline.

Kimball Hall has been appointed as chief operating officer at Abzena. She joins Abzena from Genentech, where she served for four years as SVP and global head of drug substance. Hall worked for 16 years at Amgen in a number of roles of increasing responsibility. She has held various board and advisory positions, including being a member of the Genentech Executive Committee.

Magenta Therapeutics has appointed Jan Pinkas as senior vice president, translational sciences. Pinkas has expertise in leading drug development programmes. He was head of translational research and development at Immunogen, where he led non-clinical and translational research and development related activities for all programmes in discovery through to late-stage clinical development.

Pharmaceutical Market Europe November 2019

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APPOINTMENTS

Life Healthcare Communications

Unilabs

Ashfield

CAITLIN MCMASTER

JILL BEENE

ALISTAIR HAMMOND

RICHARD CLARKE

Strengthening the team at Life is Caitlin McMaster, who has been appointed to the role of associate copywriter. McMaster initially joined Life as an account executive, so brings client services experience to her new role. She also brings a wealth of creativity and scientific knowledge, having graduated with a Masters in Chemistry with Forensic Analysis from the University of Reading.

McCann Health has appointed Jill Beene as president of McCann Health Echo. Most recently, Beene led H4B Catapult, part of Havas Health and You, and held senior strategy and account planning roles at CDM Princeton and New York. She previously worked at Y&R and BBDO, among others. She will become a member of McCann Health North America’s executive leadership team.

Unilabs has appointed Alistair Hammond as director of communications, making him responsible for all internal and external comminations, including public affairs, executive communications and public relations. Previously he was global director of media relations and PR at CWT. Hammond has over 20 years of experience in media and communication.

Richard Clarke has been appointed as commercial and patient solutions business development director at Ashfield. He has over 30 years of experience in the pharmaceutical industry, having held various national and global roles at GSK and AstraZeneca, including head of global SFE and UK head of commercial learning and development.

Sudler London

Springer Healthcare

Red Consultancy

FAISAL AHMED

ANNA BARTUS

SIMON MITCHELSON

AVRIL LEE

Faisal Ahmed has joined Sudler London as director of innovation and business transformation. In this role, he will oversee innovation and business transformation at the company, and will be responsible for accelerating innovation in health communications. Ahmed’s career includes a decade of experience in health communications, and was also one of the founding members of the Amazon UK start-up team.

Joining Springer Healthcare is Anna Bartus, who has been appointed as associate medical director, where she will strengthen the scientific knowledge and creativity of the services team. She is a fully qualified medical doctor, with over six years of experience working with the pharmaceutical industry, medical communications agencies and the National Health Service. She will be based at the Springer Healthcare offices in London.

Also joining the team at Springer Healthcare is Simon Mitchelson, who has been appointed as a senior business development manager. In this role, he will consult with industry clients across medical education, medical communication, sales force training and MSL support. He has over 15 years’ experience in the pharmaceutical and healthcare industry, and has worked for MSD, Langland and Havas Lynx.

Red Consultancy has appointed Avril Lee as a managing director of its healthcare team – Red Health. She will look after the day-to-day leadership of the health comms division while its managing director Rebecca Ferguson is on maternity leave. Lee has over 20 years of global and UK healthcare experience, in corporate and brand communications, for a range of pharma, biotech, diagnostic and health companies.

Wilmington Healthcare

McCann Health

Wilmington Healthcare

ROGER TOMLINS

SARAH SHIELD

Wilmington Healthcare has appointed Roger Tomlins as a senior consultant. He has worked in healthcare for over 16 years, in both the pharmaceutical industry and the NHS. He joined Wilmington Healthcare from Bristol-Myers Squibb, where he was senior regional access manager. Prior to that, Tomlins worked for Pfizer Essential Health as a clinical effectiveness consultant.

Also joining Wilmington Healthcare as a senior consultant is Sarah Shield. She has worked in the pharmaceutical industry for 14 years, and has experience of providing consultancy on market access, strategic partnerships and government affairs. Previously Shield was national policy and partnership lead for AstraZeneca UK’s cardiovascular and renal franchise.

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Prime Global

Swordfish Advertising

SUE O’LEARY AND REBECCA MASSEY

SARAH RUSH AND SARAH VICKERY

Prime Global has appointed Sue O’Leary as the leader of its market access practice. She will support the business across the group’s six medical communications agencies. Rebecca Massey joins as senior director, global market access & HEOR. Both O’Leary and Massey have experience of delivering evidence-based pricing and market access communications.

Swordfish Advertising has promoted two senior members of its client services team. Sarah Rush has been appointed as client services director, and has over ten years’ experience in healthcare communications. Sarah Vickery has been appointed as group account director. She has over ten years’ experience in the healthcare sector and has successfully managed a number of accounts for the agency.

Pharmaceutical Market Europe November 2019

HEALTHCARE COMMS

McCann Worldgroup named European Agency Network of the Year at 2019 Euro Effie Awards

cCann Worldgroup has been named European Agency Network of the Year for the first time in ten years at the 2019 European Effie Awards, which took place in Brussels last month. The Effie Awards are known globally by advertisers and agencies for recognising all forms of marketing communications that contribute to a brand’s success. It celebrates effectiveness worldwide with the Global Effie, regional Asia Pacific, Euro, Latin American, North American and Middle East/North Africa Effie programmes. The Europe Effie Awards seek to promote and recognise excellence in marketing communications among campaigns that have run in at least two European countries and can prove effectiveness in those countries. The award follows McCann Worldgroup being number one in the European Effie Index for three consecutive years. Winning entries with multi-market campaigns that originated from the UK, Spain, France, Germany, Russia and Greece helped shape McCann Worldgroup’s performance in the region.

“This is a phenomenal achievement. Not only have we gained the number one position, but we have done so with an unprecedented number of markets across our region contributing to this recordbreaking performance. This is a huge tribute to our client partnerships and our strategic leadership in the region,” said Pablo Walker, president of Europe, McCann Worldgroup. “We are thrilled with this result which is shaped by work from so many markets, each proving success in at least two different European countries,” said Harjot Singh, chief strategy officer, McCann Worldgroup Europe and UK. “Victories like these not only cement our shared mission to be individually brilliant and unbeatable as one; they are living proof of our

collective passion to win on behalf of our clients with work that works,” he added. McCann Worldgroup is a global marketing solutions network, and has over 20,000 employees across more than 100 countries. It comprises McCann, MRM//McCann, Momentum Worldwide, McCann Health, CRAFT, Weber Shandwick and FutureBrand.

BioMarin opens new Dublin offices to support growth ONEHealth bolstered by Bartlett Davis acquisition

NEHealth, a healthcare marketing agency, has acquired media specialist Bartlett Davis Communications. The acquisition comes on the heels of the development of ONEHealth’s services and strategy and comes at a pivotal time for both companies, following the launch of the NHS Long Term Plan earlier this year. “This deal will create an extraordinary opportunity for both us and our clients. We now have an enviable pool of specialist talent to tap into, which will not only serve us today, but also create a strong foundation for the integrated future of the healthcare landscape,” said Veronique Cotrel, managing director of ONEHealth Communications. “Bartlett Davis is an established company with a great reputation, and the acquisition will add an invaluable dimension to the ONEHealth offering,” she added. ONEHealth’s North East England office has also moved to Newcastle, with resources and facilities to match its London office. “One of the things clients regularly say about working with both Bartlett Davis and ONEHealth is that they know they can trust us. This trust comes about from years of experience, a solid understanding of the needs of the individual and the priorities and challenges of the companies they represent,” said Andrew Davis, co-founder of Bartlett Davis.

Pharmaceutical Market Europe November 2019

ioMarin, a global biopharmaceutical company, has opened new ofﬁces in Dublin, Ireland to provide a hub for its growing operations across Europe, the Middle East and Africa (EUMEA). The new offices, located in Earlsfort Terrace, further strengthens BioMarin’s presence in Ireland. Last year, BioMarin also announced a €38m expansion of its manufacturing facility in Cork, which is also currently in progress. The offices were officially opened by AnTánaiste, Minister for Foreign Affairs & Trade, Simon Coveney, at an event that brought together members of BioMarin’s global executive team. This included president of global

manufacturing, Robert Baffi, employees, members of the medical and life sciences communities, public representatives and patient representative groups, including Avril Daly, chairperson of Rare Diseases Ireland. “BioMarin has grown to a workforce of close to 500 – Irish-based staff now represent almost 20% of their employees globally, making Ireland its most significant location outside of the US,” said Coveney. “Ireland is a major location for BioMarin and we’re excited to be growing our business here. BioMarin is investing in our future operations in Ireland to support rising demand for our rare disease therapies,” added Jim Lennertz, SVP of EUMEA commercial operations at BioMarin.

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PEOPLE

Q&A What gets you out of bed in the morning?

Which person, living or dead, do you admire the most and why?

My alarm clock! I get up early, around 5:30am, so I can enjoy some peace, a cup of tea and plan my working day before my three children get up!

Nelson Mandela – need I say more!

Who’s your healthcare comms hero? What’s the best thing about working in healthcare comms? Every day is different and the work so incredibly diverse. I sometimes don’t appreciate the true signiﬁcance of what we are doing until I speak to a friend and tell them what I have been up to that day. Being able to tell someone that the communications you are doing is helping bring access to patients for a new cancer treatment reminds you of the importance of the work we do.

What’s the worst thing about working in healthcare comms? That sometimes our rules and regulations can stand in the way of how we may want to communicate a story. But that’s our job – to work out a way of telling that story and adding the right amount of colour that will create impact in a way that doesn’t break the rules!

What’s your favourite bar or eatery?

Eric Low, the former Chief Executive of Myeloma UK. Eric is a tireless and passionate advocate for the improved care of myeloma patients and integral in driving innovative approaches to how new treatments are made available on the NHS.

Vicky Bramham Which book/ﬁlm would you recommend above all others and why? I am enjoying reading The Heartland by Nathan Filer. The author is a mental health nurse and examines schizophrenia to look at various issues within mental health and its treatment. It’s written from his own experience and through interviews with patients and experts. It’s moving and enlightening. I can’t put it down.

Anywhere lively with good, unfussy food and great cocktails! I recently went to Mel e Pere in Soho and really enjoyed it.

What has been your career highlight to date? Joining OPEN Health Patient & Brand Communications and working in such a multidisciplinary environment. I’ve learnt so many new perspectives in a matter of months working closely alongside colleagues in advertising, patient engagement and insights with one common goal.

What’s your golden rule/piece of advice for someone starting a career in healthcare comms?

Which buzzwords/ofﬁce-jargon get on your nerves? Blue-sky thinking, touch base, thinking outside the box, low-hanging fruit, joined-up thinking... I could go on.

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Work as a team, roll your sleeves up and above all be ﬂexible and resilient – you need to be prepared to take the occasional negatives with the many positives.

Vicky Bramham is Managing Director, PR at OPEN Health Patient & Brand Communications

Pharmaceutical Market Europe November 2019

Top job this month Group Account Director/Client Services Director London, ÂŁ70,000 to ÂŁ80,000 This is a great opportunity for a senior account director/group account director looking for a new role. The successful applicant will be working directly with the founding partners, and will be handling a variety of small and large pharma and non-pharma/healthcare clients. In this role, the successful applicant will need to be able to design and deliver digital marketing solutions to support business and marketing objectives. Applicants must have a minimum of six yearsâ&#x20AC;&#x2122; agency experience, preferably in healthcare communications. The successful applicant will work as part of a highly motivated and experienced team. Call Kate on 07557 256508 or email kate@chemistrysearch.co.uk for more information.

November highlights* Group Account Director London, ÂŁ60,000 to ÂŁ75,000

Editorial Team Leader â&#x20AC;&#x201C; Med comms London, ÂŁ50,000 to ÂŁ60,000

Senior Account Manager London/Cheshire, ÂŁ45,000 to ÂŁ60,000

Applicants need to have experience in a healthcare/ pharma advertising agency to at least senior account manager level. Call Gavin on 07506 050019 or email gavin.oneill@media-contacts.co.uk for more information.

An international healthcare consultancy is looking for an editorial team leader to oversee its writing team. Applicants must have a life sciences degree, preferably a PhD. Call Sabine on 01932 797963 or email sabine.willms@id-ss.com for more information.

A global healthcare comms agency is seeking a senior account manager. Applicants must be an established account manager in a healthcare communications agency. Call Jon on 01932 797996 or email jon.gawley@id-ss.com for more information.

Stakeholder and Engagement Manager Cambridge, Salary negotiable

5EKGNÄ&#x203A;KÄ&#x201A; E #FUKSOR London, ÂŁ45,000 to ÂŁ60,000

Senior Medical Writer .ONFON Â VKÄ&#x203A;J DGNGÄ&#x201A; Ä&#x203A;S

Applicants must have ďŹ ve yearsâ&#x20AC;&#x2122; experience in developing and implementing strategies that have driven change in a multi-stakeholder environment. Call Emma on 01293 850800 or email emma@thorpassociates.com for more information.

Applicants must have line management experience. Editorial experience in med comms working with pharmaceutical groups is desirable. Call Julia on 02073 598244 or email julia.walton@media-contacts.co.uk for more information.

Applicants must have a PhD and medical education agency experience, ideally working on both UK and global accounts. Call Richard on 0208 866 2418 or email richard@chemistrysearch.co.uk for more information.

Senior Medical Writer Surrey, Salary negotiable

Principle Communications Advisor Cambridge, Salary negotiable

Medical Writer/Medical Editor London, Salary negotiable

Applicants must have a life sciences degree, and a minimum of two to four yearsâ&#x20AC;&#x2122; experience as a medical writer or senior medical writer in a healthcare comms agency. Email Lauren at lgripton@pararecruit.com for more information.

Applicants should have at least ten yearsâ&#x20AC;&#x2122; strategic communications experience in the health and pharma sectors. Call Emma on 01293 850800 or email emma@thorpassociates.com for more information.

A healthcare communications agency is looking for a medical writer/editor. Applicants must have a life sciences degree and one to two yearsâ&#x20AC;&#x2122; experience in a med comms agency. Email Lauren at lgripton@pararecruit.com for more information.

*100s

of live vacancies with more added daily

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Pharmaceutical

Healthcare advertising

Medical writing

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jobs.pmlive.com *Job numbers were correct as of 29/10/19 *Featured jobs were live as of 29/10/19

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