Pf Magazine January 2019 by E4H Ltd

SPECIAL EDITION

The state of affairs 2019 JANUARY 2019

Horizon scanning The Brexit effect “Brexit-related change will define the European pharmaceutical and healthcare sector” Page 06

Gender imbalance at the top PHARMAFIELD.CO.UK

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

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

PARTNERSHIP WORKING COV E R I N G :

Pharma/NHS partnerships What are partnerships really about? Showcasing best practice Partnership working in action Therapy areas Geographical differences Sales & marketing R&D

M A K E YO U R VO I C E HEARD

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

We are looking for key opinion leaders and influencers in the pharma sphere to provide industry intelligence for the next Special Edition, covering Partnerships in pharma and healthcare.

If you would like to contribute an article or expert comment, contact amy@pharmafield.co.uk or call 01462 476119.

HEAD OF CONTENT

Hello.

s we accelerate into 2019, it seems as if the fluctuating state of the world shows no sign of stabilising. Political upheaval and uncertainty surround us still, and at the time of going to press, progress on Brexit was stalling and the UK Government was in chaos. But if there’s one thing that the pharmaceutical industry does well, it’s building on its formidable reputation to plan for the future, constantly innovating and striving for better outcomes, despite the insecurities we face. In this Pf Special Edition, we look ahead to what’s on the agenda for pharma and healthcare throughout 2019, and beyond. We cover the most exciting developments in technology, including how the power of artificial intelligence is enhancing diagnosis and medicines discovery, and how augmented intelligence – a combination of human and artificial intelligence – is making the most of the latest technologies to extract the most relevant data to enable more meaningful customer engagement. Our expert analysts also look at issues including the impact that Brexit could have on the regulatory and marketing landscape in 2019; industry’s readiness for the Falsified Medicines Directive; trends in patient engagement; pharma’s preparedness for the future of NHS commissioning, and the gender imbalances within both NHS and pharma leadership. We also find out how despite fierce competition from the U.S. and China, the UK’s strong history as a leading centre for the pharma industry and its position as the thriving home to a growing number of entrepreneurial technology companies, combined with excellent drug discovery expertise, presents major opportunities for a successful future. Enjoy this Special Edition, and if you would like to have your say on anything you’ve read, get in touch with us at hello@pharmafield.co.uk. And from the team at Pf, we wish you a very happy, healthy and prosperous New Year.

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

Amy Schofield amy@pharmafield.co.uk CREATIVE DIRECTOR

Emma Warfield emma@pharmafield.co.uk GRAPHIC DESIGNER

Olivia Cummins olivia@pharmafield.co.uk COMMERCIAL DIRECTOR

Hazel Lodge hazel@pharmafield.co.uk DIGITAL MARKETING EXECUTIVE

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

Hannah Alderton newsdesk@pharmafield.co.uk FINANCIAL CONTROLLER

Fiona Beard finance@e4h.co.uk Pf AWARDS

Melanie Hamer melanie@e4h.co.uk PUBLISHER

Karl Hamer karl@e4h.co.uk HEAD OFFICE

Spirella Building, Bridge Road Letchworth Garden City, Hertfordshire SG6 4ET United Kingdom

@pharmafield @pharmajobsuk

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

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M AG A ZI N E S PECI A L ED IT I O N | JA N UA RY 2019 | 1

Contributors JEAN-MARIE AULNETTE Jean-Marie Aulnette is the Vice President of Europe, the Middle East and Africa (EMEA) Sales at TraceLink. With over 20 years’ experience in international sales, his main focus at TraceLink is to deliver track and trace solutions across EMEA pharmaceutical markets to ensure visibility, traceability, and compliance throughout the supply chain. Is the market ready for FMD? Page 18.

AMANDA BARRELL Amanda is a freelance health and medical education journalist, editor and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, healthcare professionals and the general public. Future planning, page 4. CRAIG BRADLEY Craig is Product & Business Lead (Associate Director) at Shire. Craig has worked for Shire since July 2006 within a variety of sales, marketing and market access roles. He has over 15 years’ experience within the pharmaceutical industry and has been the PM Society Market Access Interest Group Lead since May 2016 and PM Society Chair since February 2017 – making him the society’s first chair from a pharmaceutical firm. Terms of engagement, page 32. PAUL BROOKS Paul is Executive Director of RAPS. He has over 25 years’ experience within the medical device regulatory affairs environment during his 35-year career with the British Standards Institution (BSI), as well as being head of the medical device EU Notified Body responsible for review and clearance of medical devices against European regulations. The Brexit effect, page 6.

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SEB BURCHELL Seb Burchell is PR & SEO Outreach Manager for the Assured Pharmacy group. In the balance, page 25. ORHAN CAGLAYAN Orhan is the Brand Director at CPhI Worldwide and bioLIVE – two events examining the intersections between business and biotech/pharma. 2019 – a strong year for global pharma? Page 13.

EMMA CLAYTON Emma is a Marketing and Market Access Consultant for Pharma and the NHS, whilst holding roles as an Ambassador to the APPG for Diabetes, the Founder of ‘NHS Women Leaders’ Programme and as a local government councillor. Mind the gap, page 30. MATT HODGSKISS Matt is Lead Data Scientist at the Medicines Discovery Catapult. He studied Natural Sciences at Durham University (BSc) and then Physics and Computing in Medicine and Biology (MSc) at University of Manchester. Matt has worked in software development for over 10 years as a software developer and data scientist. AI & the future of medicine, page 16. ROB HODGSON Rob Hodgson is a Supply Chain and Warehouse Management System Specialist at Access Group – which develops integrated business software for the pharmaceuticals and medical supplies industry. The firm also works in sectors such as aerospace, engineering and food and drink. Let’s get digital, page 20. SANTOKE NAAL Santoke (BSc Hons Dip IoD) is Head of Market Access at IQVIA, responsible for the strategy and direction for market access across IQVIA UK & Ireland. He has worked within large and small pharma and biotech organisations in various commercial roles for 27 years. Previously, Santoke held the position of Managing Director at Pierre Fabre Ltd for the UK. His areas of expertise are the UK landscape and market access, pharmaceutical structures and resource management, strategy and leadership. Horizon scanning, page 8.

DAVID THORNE Originally a nurse, David has occupied senior positions within hospitals and commissioning organisations as well as pharma and medtech. He is the Managing Director of Blue River Consulting. Future imperfect, page 38. ANDREW PANNIFER Andrew is Lead Cheminformatics Data Scientist at the Medicines Discovery Catapult. Before joining the MDC, he was Head of Medicinal Technologies at the European Screening Centre (Newhouse), responsible for leading the development of a HTS triage application for the IMI European Lead Factory consortium and responsible for project cheminformatics. AI & the future of medicine, page 16. CLIVE SCRAGG Clive is Director of Commercial Development at Evolve. Over 30 years pharmaceutical sales, marketing, market access and senior business leadership experience in pharma. Redefining CSO, page 37.

PAUL SIMPSON Paul is the Head of Contract Sales and Medical Solutions at IQVIA. He has extensive pan-European and US experience of pharma/biotech commercialisation and has held senior roles in marketing, sales and general management. Horizon scanning, page 8. ROGER STURE Roger has 35 years’ successful experience in pharma and Commercial Director experience of Cat C branded generic launches. He now runs Visual Numbers, specialising in simplifying prescription data cost-effectively, for pharma to intelligently target. Out of the box, page 10. DANIEL TEDHAM Daniel is Managing Director at Wasdell Manufacturing, overseeing operations at the Wasdell Group’s facility in Newcastle upon Tyne. He is responsible for the development of its growth strategy, its structure and the overall business performance of the company’s manufacturing arm. He holds a BA (Hons) in Marketing and Psychology and has several industry specific qualifications. Is the market ready for FMD? Page 18.

PIETER VERCRUYSSE Pieter is the Commercial Director at Tjoapack and holds a master’s degree in Pharmaceutical Sciences. He joined Tjoapack in 2009 and has had several roles within the company, including QA/QP, Innovation Manager and Director Operations. Pieter is responsible for key account management, implementation of new products and processes, artwork/data management and customer services. Is the market ready for FMD? Page 18. MARK WARD Operations Director at Star, Mark puts positive and rewarding client relationships at the forefront of everything he does. He recognises that people and their development are at the core of what makes Star unique and works to harness this talent every day. How to future-proof your career, page 29. TIM WARREN Tim is Director at Triducive, a health and payer communications consultancy which understands the concerns and aspirations that drive payer behaviour at every stage of the decision-making process. Triducive engages, educates and empowers healthcare payers to make informed decisions that improve patients’ lives and ensure commercial success. Payer insights, page 34.

HELEN WESTROPP Helen leads corporate branding and engagement projects at Coley Porter Bell, and is passionate about helping brands create greater value, especially in the financial services and B2B sectors. Culturally aware, page 26. STAFFAN WIDENGREN Staffan, Director Corporate Projects at Recipharm, is programme manager for the Recipharm global serialisation project and part of a global steering committee that is working closely with Recipharm’s clients to ensure they plan and implement changes that comply with pending regulatory requirements for drug serialisation. Is the market ready for FMD? Page 18.

In this issue INTELLIGENCE

DIGITAL

Future planning: The industry view of the year ahead AMANDA BARRELL

The Brexit effect: What could be the impact on the regulatory landscape? PAUL BROOKS

Horizon scanning: What’s ahead for pharma and healthcare? PAUL SIMPSON & SANTOKE NA AL

The year ahead: Will 2019 be a strong year for pharma? ORHAN CAG L AYAN

Are you FMD ready? Industry experts offer their advice DANIEL TEDHAM , JE AN - MARIE AULNE T TE , PIE TER VERCRUYSSE & STAFFAN WIDENG REN

Out of the box: Augmented intelligence for better future insights ROG ER STURE

AI & the future of medicine: Transforming diagnosis and discovery ANDRE W PANNIFER & MAT T HODGSKISS

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This legion of female workers is a source of untapped talent who could be playing a pivotal role in building the health service of the future

”

Emma Clayton Mind the gap, page 30.

NHS

Let’s get digital: Moving towards a digital pharma supply chain

Terms of engagement: Patient engagement trends for 2019

ROB HODGSON

CR AIG BR ADLE Y

DIVERSITY

Payer insights: Defining payer types to stay ahead of the curve

SEB BURCHELL

Future imperfect: Is pharma prepared for future NHS commissioning?

TIM WARREN

In the balance: The truth about gender diversity in pharma leadership

DAVID THORNE

Culturally aware: The importance of brand and culture in M&As

Mind the gap: The gender gap lurking at the heart of the NHS

HELEN WE STROPP

EMMA CL AY TON

40 Directory

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FUTURE Continuing funding shortages, Brexit uncertainty, regulator moves and regulation reforms: there is no shortage of change facing the sector in 2019. WORDS BY

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

Amanda Barrell

e asked the industry’s trade associations about the biggest challenges to tackle and most exciting opportunities to embrace in the year ahead. What does 2019 have in store for pharma and healthcare? U TI L I S E TE C H N O LO GY Managing the health problems associated with an ageing population on an evertightening NHS budget will continue to challenge the sector in 2019. But according to the Association of British HealthTech Industries (ABHI), the health service can rise to the occasion by utilising technology. Jonathan Evans, Communications Manager at the organisation, said: “Treatment for the likes of cancer and stroke is now quicker and more targeted, supporting improved survival rates and life expectancy. “Yet with this demographic shift comes a rise in chronic conditions, including increased rates of diabetes and obesity, which are now the primary drivers of stress on what is already an over-stretched healthcare system.” While the cash boost the NHS received in 2018 was “wholly welcome”, it was lower than what many analysts had called for, Jonathan said, adding that many trusts were now operating under “significant strain”. Identifying, diagnosing and treating people as early as possible to manage or halt disease progression is key. “Digitally-enabled solutions and data driven products, that make the most of the NHS’ rich information pool, could be the answer we sorely need,” said Jonathan, adding that the adoption of new systems should be solution-based. “The procurement environment needs to be able to recognise the true value of technology, based on quality, and not simply based on securing the lowest possible price.”

INTELLIGENCE

PLANNING CHALLENGE AND OPPORTUNIT Y Pharma faces “myriad issues” in 2019, and the challenges are accumulating at a “considerable pace”. Leslie Galloway, Chairman of the Ethical Medicines Industry Group (EMIG), said it could be the “most significant year for change that many of us will experience in our lifetime”. In 2019, the National Institute for Health and Care Excellence (NICE) will start charging for technology appraisals and the “significant costs” of the Falsified Medicines Directive will be felt across industry. The UK sector will also need to cope with the negative economic impact of losing the European Medicines Agency (EMA) headquarters to mainland Europe after Brexit. However, by focusing on developing ground-breaking medicines, the pharmaceutical industry can turn these challenges into opportunities, Leslie said, adding that EMIG was committed to facilitating the joint working that would secure success. “We need to improve our data so our clinical evidence meets the requirements of NICE and we are working to ensure our members can benefit early from all the assistance the organisation has to offer,” he said. “We also need to develop a better relationship with NHS England, and I believe the opportunity to do that is on the horizon.”

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E M B R AC E A N D A DA P T UK biotech had a great 2018, raising more money on both private and public markets than the year before and producing worldleading innovative science. Building on that success in 2019 relies on access to long-term investment, or patient capital, according to Steve Bates, Chief Executive of the BioIndustry Association (BIA). He said: “The UK continues to produce fantastic science across a range of scientific areas including genomics, antimicrobial resistance, cell and gene therapy and engineering biology. UK companies are producing therapies that have the capabilities to change and save lives. “To build on this success, it’s vital that UK biotech companies can access long-term patient capital to give them the funds that they need to grow and scale here in the UK.” The challenges of 2019 are global, but so are the opportunities. Steve explained: “There are challenges from the Trump administration on medicines pricing and the ongoing trade issues between the US and China, which are expected to have an impact across a range of industrial sectors. “But UK life sciences companies are accustomed to adapting to changes in the ecosystem and the UK has the strong fundamentals of great science and robust financing.” The BIA’s China Special Interest Group has been set up to help UK companies make the most of opportunities to work with counterparts in the Far East, he added. “Collaborations are already starting to pay off and we are likely to see this trend continue in 2019.”

UK life sciences companies are accustomed to adapting to changes in the ecosystem and the UK has the strong fundamentals of great science and robust financing

W H AT A B O U T B R E X IT ? There’s no getting away from the ‘B’ word, and the future of the UK’s place on the European stage continues to concern the whole sector. The biggest challenge facing the pharmaceutical and healthcare industry is uncertainty, and the actual costs of preparing for a possible ‘hard Brexit’ have already been considerable. “Uncertainty is one of the most costly factors in terms of investment decisions that have been postponed. That uncertainty will continue until we have a clear picture of our future relationship and that could take a further two years,” said Leslie. The two most critical issues for the health tech sector, said Jonathan, were the timely supply of goods from the EU into the healthcare system and regulatory alignment. “We have campaigned for regulatory alignment and for ensuring products used in healthcare are exempt from any new customs tariff or VAT arrangements, afforded pre-shipping clearance and fasttrack access across any new areas,” he said. “But given the ambiguity of Brexit, we are also working on scenarios where the UK does not remain aligned to the regulatory framework and European trading area.” While news of an initial withdrawal agreement between the EU and UK was largely welcomed by industry, at the time of going to press it was far from final and the prospect of ‘no deal’ was still on the table. There are also concerns that a political declaration on the future relationship between the two parties did not prioritise patient needs. “All sides need to ensure public health and patient safety are not negatively affected by Brexit. There remains a long way to go for certainty on Brexit for life sciences businesses but the initial agreement on the deal is a key step on that journey,” said Steve.

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“

It is unclear how full alignment of UK and EU regulations and regulatory processes for pharmaceuticals and medical devices can be managed without daylight opening up

”

B WORDS BY

Paul Brooks

rexit-related change will define the European pharmaceutical and healthcare sector in 2019, both in terms of how drug products are regulated and how they are marketed. But, while Brexit is certain to impact the development, manufacture and sale of drugs, the ongoing lack of clarity on the future relationship between the UK and EU makes gauging the precise impact very difficult. The following predictions for 2019 are based on those certainties that are available at the time of going to press.

The BREXIT EFFECT

What impact could Brexit have on the regulatory and marketing landscape in 2019? 6 | PH A R M A FI EL D.CO.U K

E M A R E LO C ATI O N One certain impact of Brexit is that the European Medicines Agency (EMA), the EU agency tasked with regulating pharmaceutical, medical devices and veterinary medicines, is moving from London to Amsterdam. The agency 1 has started preparing and is on track to have moved into a temporary headquarters in the Sloterdijk area of Amsterdam before the UK officially withdraws from the EU on 29 March 2019. It is due to complete its final move to its tailor-made premises in the city’s Zuidas district next November. The move will impact regulation of the pharmaceutical industry. In August 2 , EMA predicted it will lose 30% of its workforce and said it will need to temporarily suspend non-core activities, including non-essential guideline development and some aspects of international collaboration. Likewise, it is not clear what impact EMA’s departure will have on its interaction with the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in areas like policy development. Previously, the UK regulator has been very visible in Europe, providing input and perspective that supported EU regulatory developments that have been pragmatic, positive to innovation and forward-looking while protecting patient interests. R E G U L ATO RY A L I G N M E NT It is unclear how full alignment of UK and EU regulations and regulatory processes for pharmaceuticals and medical devices can be managed without daylight opening up, and whether fully reciprocal acceptance by all EU Member States can be achieved. There are still key questions regarding pharmacovigilance activities, which must take place in an EU member state or EEA territory, manufacturing facility inspections and batch release and certification. What impact these issues will have on drug supplies in the UK is unclear. Earlier this year, the UK Government called on pharmaceutical manufacturers and medical device companies to develop contingency plans to ensure patients will continue to have access to medicines after Brexit. UK Health and Social Care Secretary, Matt Hancock asked3 manufacturers to stockpile six additional weeks of supplies to try to prevent shortages. He also said that, even if no trade deal is struck with the EU before withdrawal, the UK will continue to accept products that have been batch tested and released in accordance with EU rules. ‘This means there will be no requirement for any further manufacturer-led batch testing and release of medicines in the UK,’ Hancock wrote4 .

INTELLIGENCE

C L I N I C A L TR I A L S The regulation of clinical trials is another area where some detailed information on the post-Brexit landscape is available. In August5 ,MHRA issued guidance on the expected impact of the EU’s new Clinical Trials Regulation (CTR), which is likely to be implemented during the transition period. It wrote: ‘If the new regulation does not come into force during the implementation period, the Government has confirmed that UK law will remain aligned with parts of the EU’s CTR legislation that are within the UK’s control, so that researchers conducting clinical trials can plan with greater certainty.’ And in September6, the European Commission issued its advice on the likely impact of Brexit on clinical trials, based on the assumption the UK becomes a ‘third country’ after withdrawing from the EU. It said sponsors wishing to import trial supplies from a third country need a qualified person (QP) ‘permanently and continuously at his disposal’ in the EU to ensure the medicine was made in accordance with good manufacturing practices (GMP). The Commission also pointed out that after the UK leaves the EU, sponsors will no longer have to file UK-specific clinical trial information to EudraCT. The exception being if the country is the only location in a study that is part of an agreed paediatric investigation plan.

F M D ‘ S A F E T Y F E AT U R E ’ PAC K AG I N G R U L E Another certainty is that EU rules on drug safety features that come into force next year will apply to products made in the UK after Brexit. From February, the Falsified Medicines Directive (FMD) calls for two distinct safety features to be added to saleable units: a unique identifier (UI) and a tamper-evident device. According to MHRA7: ‘The UK will still be a Member State in February 2019 and will therefore implement the FMD Delegated Regulation in line with our existing obligations. ‘When the UK exits the EU, the Withdrawal Act will convert existing EU law into UK law and preserve the laws we have made in the UK to implement our EU obligations. This means that the duties of the FMD would continue to apply, unless specifically revoked.’ UK ROLE IN EU P H A R M AC E U TI C A L S E C TO R The UK plays a key role in the development, manufacture and supply of medicines in the EU. In addition, MHRA is a major part of the EU’s regulatory apparatus. According to EMA, a third (427/1165) of centrally authorised products on the EU market are made by UK drug companies. Likewise, a quarter of centrally authorised drugs have a UK-based QP for pharmacovigilance. With this in mind, in January 8 the agency set out to assess how drug industry preparations for Brexit were progressing. The results, which were released in July 9, were mixed. EMA wrote9 that 58% of marketing authorisation holders (MAHs) for the 694 centrally authorised products that have an

important step in their regulatory processes in the UK, are on track to maintain their authorisations after Brexit. However, it also raised ‘serious concerns’ about the ability of companies behind 108 UKmade, centrally authorised products to make the necessary changes to be in compliance with regulations before 29 March next year. TH E R O L E O F R E G U L ATO RY PROFESSIONALS Regulatory professionals are accustomed to leading and establishing predictability in activities where the outcomes are inherently unpredictable, and it is part of their role to mitigate the risk. The outcomes and consequences of Brexit are still far from certain, but as a regulatory professional, their role is critically important to be able to make the transition with minimal disruption. The main objective is that access to the most effective, affordable, safe and innovative healthcare products is maintained for all Europeans. RAPS is closely monitoring this period of uncertainty and transition and is committed to informing regulatory professionals of the latest news and insights as they develop. Paul Brooks is Executive Director, RAPS. Go to www.raps.org 1 https://www.ema.europa.eu/en/news/new-tracking-tool-emasrelocation-amsterdam 2 https://www.ema.europa.eu/en/news/brexit-preparedness-emafurther-temporarily-scale-back-suspend-activities 3 https://www.gov.uk/government/news/dhsc-publishes-brexit-guidancefor-pharmaceutical-industry-and-suppliers-of-medical-devices 4 https://assets.publishing.service.gov.uk/government/uploads/system/ uploads/attachment_data/file/735745/brexit-medicines-letter.pdf 5 https://www.gov.uk/government/news/clinical-trials-regulation 6 https://ec.europa.eu/info/sites/info/files/notice_to_stakeholders_ brexit_clinical_trials_final.pdf 7 https://www.gov.uk/guidance/technical-information-on-what-theimplementation-period-means-for-the-life-science-sector 8 https://www.ema.europa.eu/en/news/ema-surveys-pharmacompanies-their-preparedness-brexit 9 https://www.ema.europa.eu/en/news/ema-identifies-gapsindustry-preparedness-brexit

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Horizon scanning Whatâ&#x20AC;&#x2122;s on the agenda for healthcare in 2019 and what does this mean for pharma? 8 | PH A R M A FI EL D.CO.U K

WHAT CAN PHARMA DO?

N H S FO RWA R D V I E W As we enter into a new world post Brexit, our 70-year-old NHS continues to evolve and thrive to become a world class service by adapting to the external environment. The New NHS 10-Year Plan promises to deliver next generation efficiencies with a new structure of governance and financial controls in place within seven distinct areas and NHS England working in tandem with NHS Improvement. Integrated care will become the model of care throughout localities with a focus on local leadership and governance to ensure services are joined up with an aim to treat neighbourhoods and create a model for population health. The continuing focus on spend and affordability will remain a key focus as medicine optimisation models of care drive some of the inefficiencies in the system. New models and approaches by the National Institute for Health and Care Excellence will play a key role in speciality, rare and ultra rare conditions as assessments become more fitting, as well as commercial arrangement on managed access. The role of digital will play a key role, as the new funding made available begins to re-shape the priority centres and digital exemplars to ensure better sharing of data.

PRESSURES ON INDUSTRY

INTELLIGENCE

here is a clear call for pharma to change the way it interacts with the NHS to reflect an understanding of the changing structure and its need. This comes at a time when it is becoming increasingly difficult to generate the positive return on investment that the industry needs to fund ongoing research and development in the continued search for life improving treatments. Cost and time to commercialisation is increasing, the time left to commercialise within patent protection is decreasing, specific labelling is reducing the population to be served, and there is persistent downward pressure on pricing. In effect, the industry is being asked to deliver results with less and innovate at the same time: the new models of care and integrated approach means pharma is required to adapt and ensure alignment, not just for new product launches, but any commercialised product in the changing and challenging UK market. Market access is not an event that is followed in serial fashion by traditional promotion; market access and continued access to medication is an integral part of the product life cycle that needs to be intertwined with local promotional support. However, areas should inform each other reciprocally if industry and the NHS are to work together to truly deliver on population outcomes. Just like in any good business plan, working with an NHS partner requires insights, planning, delivery and feedback to inform the next cycle of planning and execution.

s the environment continues to change structurally in the NHS, with extra pressure on affordability and medicine optimisation, pharma is feeling the pinch. As well as the extra charges for the health technology assessment process and the newly-announced pharmaceutical price regulation scheme payments, it is not surprising that global pharma colleagues are questioning the viability of the UK. The backdrop of Brexit has added extra pressure and resource to ensure ‘no deal’ scenarios are played out and costed out with little support from the Government. However, the UK remains one of the early launch countries as well as holding its position as one of the leading research centres in the world. The new £700m Francis Crick Institute in London is testament to that *, as well as the UK being home to four of the world’s top 10 leading universities**. As treatments become better and life expectancy increases, novel ways to co-create solutions with the NHS in a collaborative way will become necessary in terms of pricing and value add. The introduction of therapies, such as the CAR-Ts, has meant a re-think on costs over and above just drug costs, ensuring the *Ref: Nature 522, 406-408; 2015 **Ref: QS World University Rankings ® 2019

In understanding how to adapt, we first need to identify the population need we are trying to answer. Collaboration with key stakeholders across these integrated models of care is critical; taking time to uncover how our different biopharma offerings align with their goals. Whilst at first sight it may seem counterintuitive in a challenging economic market to invest more in good market research upfront – not just on marketing messages and core claims but critically investing in the ‘what’ and ‘how’ of delivery – it can be the best means of optimising the use of the valuable resources available and help to reduce wasted effort. • Key account managers, healthcare team and medical science liaisons need to operate as one team and align to local priorities for any given geography. • Additional value-added services to these local teams are vital to ensure integration of primary and secondary care support. • Marketing, medical and patient access teams should also align objectives internally with the ability to flex at local level. • Relationships with the academic community via bodies like academic health science networks are critical to drive the innovations needed, as highlighted in Sir John Bell’s Life Science Sector Deal.

decision is made collectively across different stakeholders, including pharma. Whether it is effective launch planning and delivery or optimising the availability of currently available medicines in a volatile environment – for example through the phenomenon of Brexit or more generally the inexorable increasing pressure on costs – we need to build our plans on partnership, insight, joined up tailored delivery and above all else the ability to remain flexible. Paul Simpson is Head of Contract Sales and Medical Solutions, IQVIA. Santoke Naal is Head of Market Access, IQVIA. Go to www.iqvia.com

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Industry is being asked to deliver results with less and innovate at the same time

” WORDS BY

Paul Simpson & Santoke Naal

The Sector Deal The second Life Sciences Sector Deal announced in Dec 2018 highlights how industry continues to show confidence in the UK’s R&D strengths, building on UK’s world leading research and data assets and AI leadership, with £1.2 billion of new inward investment announced as part of the deal • Supporting the UK Government, NHS and life sciences in achieving better treatment value and greater access to medicines, IQVIA has committed a transformative investment package, opening a fourth UK clinical research Prime Site facilitated by the National Institute for Health Research, and announcing a significant partnership with Genomics England.

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Will 2019 be the year in which pharma sales and marketing teams use augmented intelligence to successfully exploit infinite data? WORDS BY Roger Sture

Out of the box

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uzz Lightyear made his first appearance in 1995 at a time when pharma companies were first exploring Windows-based CRM systems. You’d get Buzz ‘out of his box’ and in your imagination he could fly and make all the right noises, but the reality was that he really couldn’t fly and still can’t. Similarly, while CRM has made some identifiable progress, pharma business managers and key account managers (KAMs) are still manually entering ‘Clinical Commissioning Group Medicines Formulary Status’ and similar information into CRM systems. In 2019 however, pharma sales and marketing could finally combine the latest technologies and software ‘outof-the box’ to realise infinitely more joined-up data at our fingertips: highly focused, actionable insights would result, transforming the way in which pharma utilises infinite data. DATA T Y P E S Where do we start? Gartner research indicates that by 2020, 85% of chief information officers (CIOs) will be piloting artificial intelligence (AI) programs through a combination of buy, build and outsource efforts. Data is ‘the world’s most valuable resource’ (The Economist May 6th 2017). It will continue to grow exponentially and with the advent of faster, more efficient technologies, become easier to obtain. However, having ‘data mountains’ doesn’t lead to success; it will be how we utilise the data skilfully and efficiently to create actionable insights that will ensure success. Forrester analysts predict that data-driven companies who make the most of insights will favourably separate themselves from the herd.

D I G I TA L

“

L E T ’ S LO O K AT TH E T WO T Y P E S O F DATA , ‘ S T R U C T U R ED’ A N D ‘ U N S T R U C T U R ED’

We are wasting valuable time on information searching, gathering and assimilating data, rather than being in front of customers selling

S T R U C T U R ED DATA (i.e. available in a database-like format such as row column or similar form) accounts for only 20% of data available. Figure 1 below shows an example of how pharma currently merges different datasets into dashboards to enable business managers, KAMs and sales representatives to see effort vs results more clearly. Sales, market share, sales growth and customer contacts are all ‘structured data’, easily displayed into such a dashboard using the latest business intelligence tools such as Tableau and Alteryx. The CCG Formulary Status information however, is ‘unstructured data’ mainly gathered by business managers and KAMs spending significant time searching NHS websites for up-to-date information on Formulary Status, or following customer feedback. A McKinsey report noted that employees spend on average 1.8 hours every day searching and gathering information: this is simply too long. It’s certain that it’s true in pharma; we are wasting valuable time on information searching, gathering and assimilating data, rather than being in front of customers selling, presenting a constant challenge to business managers and KAMs as they juggle time.

”

Figure 1. CO M PA R I N G P R O D U C T G R OW TH , SA L E S , M A R K E T P OTE NTI A L A N D TOTA L CO NTAC T S W ITH FO R M U L A RY S TAT U S DATA

CCG / HB / LCG CODE

FORMULARY STATUS

AFK CCG UJA CCG VJF HB MXE HB VVB CCG TNL CCG RPB CCG NWR HB KOD LCG WGJ CCG DTE HB YSL CCG XUG CCG XTS CCG LCZ CCG ECJ CCG BUO CCG TWF CCG KHU CCG EYB CCG

1st line 2nd line Joint None 2nd line Joint None 1st line None 2nd line Joint 1st line None None 2nd line None None Joint None None

PRODUCT A GROWTH

PRODUCT A SALES

£116,115

58%

£112,730 £98,748 £86,891 £47,246 £31,293 £23,298 £15,326 £14,098 £9462

13 45% 76%

£0

77 65

75% 63% 54% 36% 95% 52% 67% 68% 12% 69% 56% 7% 10% 60% 22% 69% 56%

-£1030 -£1586 -£2190 -£2286 -£3032 -£9083 -£15,910 -£55,638 -£67,267 £10o,000

TOTAL CONTACT

£10o,000

HB: Health Board LCG: Local Commissioning Group

£0

£500,000

212 42 95 106 23 231 25 42 78 91 262 41 35 84 59 13 24 £1,00o,000

 Market sales  Product A sales

100 150

200 250 300

M AG A ZI N E S PECI A L ED IT I O N | JA N UA RY 2019 | 1 1

D I G I TA L

“

For best results pharma needs to look at whole solutions which couple human intelligence with AI

” U N S T R U C T U R ED DATA accounts for 80% of all available data, and while found in CRM systems’ in call notes, customer interactions, emails and so on, it is predominantly found in webpages, documents, videos, audio files, presentations and social media platforms. There are individual tools to capture certain unstructured datasets, but for best results pharma needs to look at whole solutions which couple human intelligence with AI. This is where augmented intelligence comes into play, which is best defined as a combination of human and artificial intelligence. It makes the most of the latest technologies to extract data from the internet and process it to ensure that the most relevant information is highlighted for action. This is an example of humans making the most of AI rather than being replaced by it. In the financial services and insurance sectors, companies are already successfully deploying out-of-the box augmented intelligence solutions to have all the necessary insights at their fingertips, enabling more relevant and meaningful customer engagement and consequently, more success. Technology companies such as Squirro already offer augmented intelligence solutions, which use the latest machine learning, predictive analytics and AI solutions finely tuned to business needs. All key information is gathered and analysed, then smart recommendations are made and visualised in dashboards (even inside CRM systems such as Salesforce) enabling users to utilise their time making much better informed decisions, rather than wasting significant time searching the internet.

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TE C H N O LO GY

ugmented intelligence solutions (such as Squirro) truly join up all pertinent structured and unstructured data with a single out-of-the-box service and really could deliver for pharma in ways both infinite and exciting. Business managers and KAMs would have 360-degree views of their customers, not only from all multichannels within an organisation linked together, but also from relevant internet feeds, highlighting all key information around that customer. Augmented intelligence would draw new data pools of knowledge from right across the internet, leading to more real-time wisdom on customers, competitors and market factors. Deeper and greater data insights will be drawn from available data in ways not seen before and greatest opportunities will be identified to make recommendations on best next actions. Will augmented intelligence really take pharma to infinity and beyond – in 2019 and beyond? We will see… Roger Sture is Owner, Founder and Company Director at Visual Numbers Ltd. Go to www.visualnumbers.co.uk

INTELLIGENCE WORDS BY

Orhan Caglayan

2019

A strong year for global pharma? Is pharma entering a new age of innovation and productivity, and where does the UK stand in the global market?

he strength of global pharma has been growing over the past year, according to the annual survey conducted for CPhI Worldwide. This extensive survey of international pharmaceutical companies and executives ranks the most prominent pharma countries’ reputations, evaluating country specific performance when it comes to active pharmaceutical ingredient (API) production, innovation, market competitiveness, growth potential and finished dosage formulations. Eight out of 10 top nations improved their overall score across all categories – with tabletopping nations the U.S. and Germany the only countries not to improve. For the second year running Germany, Japan and the U.S. emerged as the top-ranked, tier-one nations for pharmaceutical quality and overall score – with India and China making dramatic strides in raising their overall reputations. This is possibly a reflection of China’s sizeable efforts to improve quality over the last year. In fact, according to CPhI Annual Report Expert Bikash Chatterjee, we will see poorer quality manufacturers drop out of the market over the next couple of years, resulting in China’s manufacturers competing in international markets as well as domestic markets. However, most promising, was the improvement in growth potential industrywide, as eight out of 10 countries’ scores rose.

manufacturer by Germany, The Netherlands and Belgium within the next couple of years. These assessments are backed up by poll data provided by GlobalData where the majority of respondents predict a negative result of Brexit for the UK healthcare industry – and the number of respondents predicting a negative result has dramatically increased between the second and third quarter of this year.

THE BREXIT EFFECT

Fiona Barry, Associate Editor at PharmSource, a GlobalData product, believes that within Europe, a disproportionate number of advanced therapy medicinal products (ATMPs) are manufactured in the UK and depending on how Brexit is resolved, the trend may well change. Barry believes that the UK may be usurped as the leading ATMP

Figure 1. TH E P E R C E NTAG E A N N UA L C H A N G E I N OV E R A L L R E P U TATI O N R A N K O F E AC H CO U NTRY

Germany USA Japan UK France Spain Korea Italy China India -2

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GROWTH POTENTIAL

India (7.16), the U.S. (7.04) and China (6.81) are again the countries highlighted as having the fastest growth potential. Respondents cited their high growth domestic markets and expanding manufacturing exports as the key drivers. The U.S., which has seen a resurgence in the past year, was understandably strong, while Germany was seen as Europe’s key growth market. The biggest movers in terms of growth potential in comparison to last year were the UK, boosting its score by 12.72%, followed by Italy (+10.94%), the U.S. (+10.63%) and Japan (+9.56%).

Figure 2. THE R ANKING OF COUNTRIES ACCORDING TO THEIR PREDICTED PHARMA MARKET GROW TH

Italy UK France Spain Korea Germany Japan China USA India 0 1 Growth potential score

“

The biggest movers in terms of growth potential in comparison to last year were the UK, followed by Italy, the U.S. and Japan

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INNOVATION

Innovation activities are vital for new medicines and the U.S. (7.93) is again the highest-ranking country in this sector. Japan (7.49) comes in second, owing to its historic patent-centric drugs market, excellent reimbursement, and a large number of innovative pharma companies. Germany and the UK also scored extremely well. Spain was the big mover with a 16.38% increase in comparison to last year. The continuing evolution of the biotech industry in Madrid and Barcelona seems likely to be having positive effects and will continue to have these effects going into 2019. Italy (+10.80%), India (+10.02%) and France (+8.12%) completed the top four sector movers. Mirroring 2017, Germany (8.07), the U.S. (8.01) and Japan (7.95) are again above all

other major pharma economies in terms of the quality of finished formulations driven by the strong standing of their manufacturers and regulators. The second tier includes the UK, France, and Italy, while India and China were regarded as having lower-quality finished products. The latter’s comparable status to India is somewhat surprising given India’s more substantial finished product industry. India leads the way in growth improving by 14.72%, but it was closely followed by China, which saw its score increase by 13.74%. Italy (11.90%) and Korea (8.88%) complete the top four movers. These findings indicate a wider trend of perceptions around quality gradually harmonising as India and China climb to western standards.

China Italy Korea Spain India France UK Germany Japan USA 0 1 2 Innovativeness score

Ahead of Pharmapack Europe which launches next month, we also have insights from the soon-to-be launched Pharmapack Europe drug devices report. This report will include pharmaceutical packaging and drug delivery device expert insights regarding what is in store for the next few years. The report predicts that a number of new innovation hubs with a more diverse mixture of smaller, highly agile companies will become established in the next few years across

A strong year for global pharma?

Figure 3. TH E R A N K I N G O F CO U NTR I E S ACCO R D I N G TO TH E I R I N N OVATI V E N E S S I N TH E P H A R M A I N D U S TRY

2019

INTELLIGENCE

France, the UK, Switzerland and Germany. As a result, what we will likely see is the larger drug delivery manufacturers and pharma companies scouring these new innovation hubs for licensing partners and acquisitions. Ultimately, these new combinations of small and large companies should help accelerate and enable these new, ground-breaking technologies to reach the patient without becoming slowed by scale-up challenges or regulatory approvals.

WHATâ&#x20AC;&#x2122;S NEXT?

Figure 4. TH E R A N K I N G O F CO U NTR I E S ACCO R D I N G TO TH E Q UA L IT Y O F F I N I S H E D P R O D U C T M A N U FAC T U R I N G

China India Korea Italy Spain France UK Japan USA Germany 0 1 2 3 Quality of finished product score

What is most exciting about all of these changes is that there is an increasing diversification of the types of companies, types of professionals, and collaborations in the industry driving innovation forward outside of the traditional hubs. Potential factors slowing innovation, particularly in the UK, will be the long-term implications of any trade deals negotiated between the UK and the EU. Overall, we may be entering a new age of productivity and innovation and there is renewed confidence globally with all but one market improving their outlooks for 2019. Orhan Caglayan is the Brand Director at CPhI Worldwide and bioLIVE. Go to www.cphi.com/europe/ and www.bio.live

M AG A ZI N E S PECI A L ED IT I O N | JA N UA RY 2019 | 15

AI & the future of medicine How is the power of artificial intelligence helping to enhance diagnosis and discovery?

“

Using nothing more than a database of existing molecules, AI algorithms can learn some of the rules of chemistry and create entirely new virtual molecules”

” WORDS BY

Andrew Pannifer & Matt Hodgskiss

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

edical advances, better drugs, healthier lifestyles and safer workplaces have resulted in us living longer lives. However, late diagnosis of otherwise treatable illnesses is now one of the biggest causes of avoidable deaths. In addition, longer lives and larger elderly populations are inevitably associated with complex and chronic health conditions with limited treatment options. Artificial intelligence (AI) algorithms were first explored in the 1960s, however they have only entered widespread use over the last decade. This is due to the increasing volume and availability of data and the exponential advances in computing power. Today, AI now has the power to not only improve early diagnosis but also to support the discovery of vital new medicines.

E A R LY D I AG N O S I S Early diagnosis of disease is vital to increase both the length and quality of patients’ lives. Although significant progress has been made in diagnosing many forms of cancer, little progress has been made where symptoms do not present until a late stage, for example in pancreatic cancer. The application of AI to early diagnosis presents significant opportunities for both earlier intervention and improved efficiency. Established AI image processing models are being adapted to interpret medical scans with comparable performance to expert clinicians. There has also been an increase in app-based symptom checkers, which use AI to interpret symptoms from users to give a suggested diagnosis. The increasing uptake of wearables and home monitoring devices will also generate additional data to further improve diagnosis and management of chronic conditions. However, AI systems are not infallible and will inevitably make errors, raising issues around accountability and ethics. As adoption of patient-facing AI increases, there will be a key role for clinical professional bodies, healthcare regulators, for example the National Institute for Health and Care Excellence (NICE), and the Medicines and Healthcare products Regulatory Agency (MHRA) in ensuring public safety.

D I G I TA L

Medicines discovery

R E C E NT D E V E LO P M E NT S Machine learning is well established in the drug discovery industry and is used from the very early stages in a project to select molecules for progression, through to application in later preclinical stages to minimise the risk of toxic or metabolically unstable molecules reaching clinical trials. Until recently, these learning approaches have largely been restricted to working with well-defined problems with data that can easily be transformed, or ‘featurised’, into a structured format that the learning algorithm can then process. They have also been used in a relatively passive mode – filtering or scoring ideas proposed by humans but unable to generate novelty themselves. Recent developments in AI, however, are extending the power of machine learning beyond these boundaries and enabling more complex, fuzzy and less-defined questions to be addressed effectively. A key advance in the recent ‘deep learning’ approaches over previous learning methods is that they themselves can extract the relevant features from the data without prior reduction to simple features, extending the data sources that can be used, reducing bias and ultimately enabling the data to ‘speak for itself’. AI is also able to generate novelty. Using nothing more than a database of existing molecules, AI algorithms can learn some of the rules of chemistry and create entirely new virtual molecules with the ability to steer generation towards those with desired properties. We are also seeing methods to plan chemical syntheses; a difficult multistep problem where AI must decide which of a multitude of branches to pursue.

F U T U R E P E R S P E C TI V E S AI is already having an impact on the drug discovery industry, but short-term hype about the power of AI needs to be kept in perspective. The very high level of inventive abstraction that humans are capable of without prior experience, to bring distant concepts together remains problematic for a machine (a human can easily imagine a dog in a lounge suit dreaming about a white Christmas, while a computer will struggle). We should also be wary of unrealistic criteria for success. Where AI has been used in image recognition or driverless cars, performance near that of a human is a major success. Suggesting that AI will be successful only when the gene name of a therapeutic target is input, and a drug emerges from the other end, is to set an extraordinarily high bar. This would require spectacular outperformance over our existing discovery system, where most projects end in failure. Well before that distant ‘Drug Machine’ vision, AI will impact where we work with it as a tool. We can anticipate increasingly sophisticated text-mining algorithms aiding biologists to keep track of the >800 thousand biomedical articles published annually and identify linkages between diseases and underlying biological processes. Unearthing new datasets with these methods will also help feed the data-hungry machine learning algorithms. Increasingly accurate predictions of a potential drug activity towards biological targets that may induce side-effects, will reduce the number of compounds that need to be synthesised and tested, enabling go/no-go project decisions to be made more quickly and with more confidence. Engaging human creativity and imagination to develop learning approaches that increase the effectiveness of AI is critical; for example, methods to capture increasingly sophisticated and accurate descriptions of protein-drug interaction are being developed. The UK is well-placed to take advantage of these developments, via

a growing sector of small and medium sized enterprises (see below for some examples). Coupling these developments with the UK’s long-standing position as a leading centre for the pharmaceutical industry with the intricate knowledge of how to develop a drug in practice holds the potential for a high growth industry. The field is competitive with major investments taking place in China and the US, but the UK ecosystem of entrepreneurial technology companies and practical drug discovery expertise presents a major opportunity. Andrew Pannifer is Lead Cheminformatics Data Scientist at Medicines Discovery Catapult. Matt Hodgskiss is Lead Data Scientist at Medicines Discovery Catapult. Go to www.md.catapult.org.uk/ UK Companies working in AI Babylon Health | www.babylonhealth.com Ask Babylon – an AI symptom checker Skin Analytics | www. skin-analytics.com Novel AI models to identify skin cancer GTN | www. gtn.ai Pushing the boundaries of describing how drugs react with their targets ExScientia | www.exscientia.co.uk At the forefront of objective decisionmaking and compound design NextMove | www. nextmovesoftware.com Cutting-edge software to automatically identify and extract key data in scientific documents Intelligens | www. intelligens.ai Methods to enable machine learning algorithms to process ‘sparse’ data Optibrium | www. optibrium.com Working to incorporate sparse data algorithms into software applications for drug discovery

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Is the market ready for the Falsified Medicines Directive (FMD)? IN YOUR VIEW, HOW FAR DID INDUSTRY PROGRESS IN 2018 IN TERMS OF READINESS FOR FMD?

WHAT HAVE THE GREATEST CHALLENGES BEEN IN MEETING THE FMD REQUIREMENTS?

WHAT’S YOUR ADVICE TO MARKETING AUTHORISATION HOLDERS UNPREPARED FOR THE REQUIREMENTS?

JEAN-MARIE AULNETTE: The European Medicines Verification Organisation (EMVO) provides an update on the readiness of the pharma industry in Europe – and still, less than three months out, not all pharmaceutical companies have completed the EMVO on-boarding process and developed their connection to the EU Hub production environment. This process can take up to six months and any businesses that aren’t well underway face a significant risk of not being ready in time.

DANIEL TEDHAM: For contract manufacturers and packagers, one of the main challenges of implementing serialisation was installing and validating the sophisticated coding and detection equipment required. It was also vital to ensure that the software systems put in place are capable of supporting multiple client and country serialisation coding requirements. Companies have also had to consider a number of necessary changes to packaging components. Artwork templates had to be reworked and redesigned to incorporate these requirements, which added a layer of cost and complexity that some businesses hadn’t factored into their preparations.

DANIEL TEDHAM: Any company that is not close to validating a solution must look to outsource serialisation requirements to third-party contract partners. Some manufacturers that do not count packaging as a core competency took this route at an early stage to offset some of the costs of buying and installing new hardware, as well as ensuring the right IT infrastructure was in place and training staff. Ultimately, this has allowed them to negate the production downtime required to equip lines. These factors make the outsourcing approach an appealing option, and as the deadline looms, this is likely to become more prevalent.

STAFFAN WIDENGREN: The reality is that there are still some companies that will not meet the regulatory deadline. This is particularly the case for smaller organisations that were unable to invest the necessary time and resources into preparing for the FMD. For these companies, outsourcing their serialisation requirements will be the only option.

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PIETER VERCRUYSSE: The most obvious FMD challenge is the varying market demands that one solution must cater for. Many companies supply products to a global marketplace and each country’s legislation differs slightly. There is not a one-size-fits-all solution to serialisation requirements, so companies have had to develop adaptable solutions that can be customised when necessary. Cost has also been a barrier for some companies. The upfront investment required to equip lines and to introduce the necessary IT infrastructure to manage and exchange the data that will be generated is huge. This, added to the cost of training staff and the time required to adequately try and test lines, means for many small and midsized players, implementing a solution inhouse has simply not been a viable option.

PIETER VERCRUYSSE: For those companies that are further away from finalising a solution, the sensible decision at this stage is to look to third party providers who can support them with a compliant solution. However, the onboarding process also takes time, so the sooner companies approach contract providers the better.

“

The end goal for the industry should be the implementation of full track and trace systems that work collaboratively across the global marketplace

”

INTELLIGENCE

Pf asked four industry experts for their views.

DANIEL TEDHAM Managing Director, Wasdell Manufacturing, a division of the Wasdell Group

JEAN-MARIE AULNETTE Vice President EMEA Sales, TraceLink

PIETER VERCRUYSSE Commercial Director, Tjoapack

STAFFAN WIDENGREN Director Corporate Projects, Recipharm

WHAT DOES THE FUTURE HOLD FOR SERIALISATION IN THE EU?

HOW HAS BREXIT AFFECTED PREPARATIONS?

JEAN-MARIE AULNETTE: Once a compliant solution is in place, businesses should begin thinking about how to leverage the new information created by serialisation and the master data produced to achieve greater business value. This, combined with the ability to seamlessly exchange information with direct and indirect trade partners through a digital network platform, is what is driving the digitalisation of the pharmaceutical supply chain. Processes that will transform because of this include product recalls, the enablement of secure, distributed product verification for supply chain partners, and the launch of patient-centric programs that enable the ultimate consumers of medicines to interact with real-time product information based on the uniquely identifiable products.

DANIEL TEDHAM: While the Brexit negotiations muddied the waters and little clarity was offered as to how the UK pharma industry would countinue its operations within Europe, the UKâ&#x20AC;&#x2122;s regulatory bodies have always been committed to the implementation of the FMD regulations. Companies have adopted different approaches to create contingency plans that would ensure continuous operations in Europe. Some have developed joint ventures and co-location of premises in the EU. At Wasdell, we have invested in a new facility and legal entity in Ireland to provide continuity for our customers and maintain access to global markets.

PIETER VERCRUYSSE: It is likely that we will see regulations continue to evolve, which will ideally result in a degree of standardisation across the global market. For example, although aggregation is not a legislative requirement in Europe, it can enable more efficient passage of drugs through the supply chain, resulting in cost and resource savings. As these benefits are recognised, aggregation will likely become a more standard requirement. The end goal for the industry should be the implementation of full track and trace systems that work collaboratively across the global marketplace. This will not only help to eradicate counterfeit medicines but also help companies realise the operational and logistical efficiencies offered by increased visibility and access to legacy data.

STAFFAN WIDENGREN: Theoretically, Brexit should have little impact on preparation for serialisation. However, analysis and release activity may be impacted by Brexit. If we have a hard Brexit, for example, all pharmaceutical products that are manufactured, packed, analysed and released in the UK will need to be retested in an EU country before release to this market. Unfortunately, this will have a significant impact on the supply chain because it will restrict timings and resources.

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Let’s get digital What is the importance of data-driven processes in pharmaceuticals manufacturing, storage and distribution?

or an industry with R&D at its core, it’s no surprise that pharmaceutical companies are harnessing the power of data to improve the efficiency and success of clinical trials, and the approvals process. Clinicians have long been able to access vast databases of molecular structures, alongside existing research and trial results – yet there were obvious limitations because clinical trial environments tended to be ‘traditional [and] tightly-controlled’.1 As with almost every other industry, the widescale adoption of big data has transformed pharmaceuticals almost beyond recognition. Its scope is enormous but in recent years, we’ve seen it being used to optimise workflows, promote shared learning, develop new and more complex treatments faster, comply with regulations, meet commercial targets and, ultimately, improve patient outcomes. Now we are on the cusp of discovering how powerful artificial intelligence (AI), virtual reality (VR) and augmented reality (AR) might become in aiding research. Janssen Research & Development, for instance, is working with

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

university experts to develop algorithms that would help clinicians predict how different cells will react to the same compound, so new studies can get off the ground quicker. 2 Another leader in the field is Pfizer, which has joined forces with pharmaceutical tech company XtalPi to create what has been described as ‘a hybrid physics and AI-powered software platform for accurate molecular modelling of drug-like small molecules.’3 But the excitement surrounding new technologies such as these is somewhat tempered by the fact that pockets of the pharmaceutical industry have yet to realise the full potential of digital technology. TH E C H A N G I N G FAC E O F P H A R M A S U P P LY C H A I N S One such area is supply chain management, where manual processes, legacy IT systems and a lack of integration make it difficult for manufacturing and distribution companies to drive efficiencies, prove traceability and compliance, and reduce time-to-market. It certainly seems absurd that so much money is invested in speeding up R&D, only for operational inefficiencies further along the supply chain to delay release, increase wastage and/or push up costs. That’s not to say that the majority of pharmaceutical manufacturers and distribution specialists are completely without tech; indeed, when we start working with them, they are often on their third or fourth piece of software. The problem is they tend to adopt what I term ‘vanilla ERP’ solutions – essentially, a glorified accounting and inventory management system that provides limited actionable insights. Some also rely on users updating information retrospectively, rather than it being readilyavailable at the start of every task.

D I G I TA L

In pharmaceutical warehousing, for example, real-time data contained in warehouse management systems (WMS) gives managers full visibility over every process, enabling them to prioritise tasks, monitor progress and identify SLOB (slowmoving and obsolete) stock. It’s about driving action, rather than simply reporting. Achieving all this is important for businesses in all sectors, though it is especially critical in pharmaceuticals where treatments have expiry dates and/or must be kept in a temperature-controlled environment. It might be possible, albeit difficult, to shift dead stock if you sell clothes or books – but not when the effectiveness and safety of medical treatments are compromised. A WMS is also extremely valuable if an issue, such as a temperature fluctuation, occurs in the warehouse because it shows the precise location of stock at the time. Using data from other systems, managers can therefore identify any affected batches and write them off. What’s more, since tasks are driven by customer demand, linked to sales orders, teams are able to pick several items off the shelves at once, rather than responding to them one-by-one. Real-time data can also be used to track stock as it moves through the warehouse to alert teams when it is reaching its expiry date, putting it on hold so it can be destroyed safely and securely. When you consider the potential for human error when performing such tasks, there is a compelling case for automating them. Without a standardised WMS, it is also near-impossible to prove compliance and traceability from production to end-user and no company – whether manufacturer, distributor or retailer – can afford to be the ‘weak link’ that compromises the integrity of a treatment. The prevalence, and inherent risks, of counterfeit drugs and medical devices, for example, has placed fresh demands on manufacturers and distributors. Under the EU Falsified Medicines Directive, the final part of which comes into force in February, every batch must ‘display a 2D data matrix code and human readable information’ capable of being scanned at different stages of the supply chain. 4 Barcode scanning, for instance, is a feature of any good WMS and helps to ensure accuracy and compliance. Rather than manually keying in information when goods arrive on site, and risking error, workers scan them, with data stored in a central location that can be accessed at any time.

I M P R OV I N G P R O D U C TI O N PROCESSES Logistics is, of course, just one part of the pharmaceutical supply chain; another is mission-critical planning and scheduling in pharmaceuticals production. Our team worked on a project involving a major US pharma company, which had been tasked with proving that a planned facility could deliver an influenza vaccine for half the US population should a pandemic break out. Using production data from previous batch runs, the team was able to develop a capacity model for an entirely new plant. Simply feeding this information into a spreadsheet would not have delivered the detailed results – and confidence – stakeholders needed for the facility to get the go-ahead. As an example, the software enabled those working on the project to identify a bottleneck in the bioreactor and solve the issue. Once production had begun, employees at the facility used the software to ensure resources are used optimally to keep every task on track. Furthermore, different tiers within the company are able to access data to support better decision-making, from those using shop floor data capture to manage day-to-day production, to senior managers working at a strategic level. The pharmaceuticals sector is characterised by its commitment to new technologies, but it’s worth remembering that, for some companies at least, this doesn’t mean VR headsets or robotics. A good warehouse management system and/or scheduling system will even integrate with legacy software, so companies don’t need to go through the upheaval of replacing everything.

“

Pockets of the pharmaceutical industry have still yet to realise the full potential of digital technology

”

WORDS BY

Rob Hodgson

As we have seen, platforms that use data and present it in a way that drives the right behaviour in manufacturing and distribution are just as important as the ones being developed within cutting-edge research teams. Rob Hodgson is Warehouse Management and Supply Chain Specialist at the Access Group. Go to www.theaccessgroup. com/supply-chain-management 1w ww.hbr.org/2016/11/the-promise-and-challengeof-big-data-for-pharma 2 w ww.jnj.com/latest-news/how-artificial-intelligenceis-helping-janssen-discover-new-drugs 3 w ww.prnewswire.com/news-releases/ xtalpi-inc-announces-strategic-researchcollaboration-with-pfizer-inc-to-developartificial-intelligence-powered-molecular-modelingtechnology-for-drug-discovery-300644351 4 w ww.gov.uk/guidance/implementing-the-falsifiedmedicines-directive-safety-features

M AG A ZI N E S PECI A L ED IT I O N | JA N UA RY 2019 | 2 1

Have you got what it takes? Time to prove it! Only the best in the industry will share the stage with Hugh Dennis at the Pf Awards Dinner this March. Book your tables now at www.pfawards.co.uk

D O N â&#x20AC;&#x2122; T M I SS TH E I M P O RTANT DATE S FO R YOU R D IARY

M O N DAY 21 JA N UA RY 2 019

Deadline for entries to Pf Awards 2019 TH U R S DAY 7 M A RC H 2 019

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In the balance When it comes to gender diversity in pharma leadership, research has found that the pharmaceutical industry is lagging far behind. Whatâ&#x20AC;&#x2122;s being done to get more women into senior roles?

WORDS BY

Seb Burchell

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

DIVERSITY

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Only 34 women sit on the boards of directors of the biggest pharmaceutical companies in the world, compared to 82 male directors

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ender diversity remains one of the biggest challenges in employment leadership today. Men taking up the majority of senior roles is a common theme in the working world. In 2018, the share of female chief executives in the Fortune 500 had declined to 24, after reaching an all-time high of 32 in 2017. In total, this equates to a 5% share of the available leadership positions. In this article, we’ll take a look at the number of women in leadership roles, specifically in the commercial pharmaceutical industry. Gender disparity is ripe within the pharmaceutical industry, particularly in the commercial world. In 2018, an online pharmacy investigated the gender makeup of the leadership teams (both the executive committees and the boards of directors) from the 10 biggest pharmaceutical companies by revenue in the world. The research by Assured Pharmacy found that in these companies, the number of men greatly exceeds the number of women in senior leadership roles, in both the executive committees and board of directors. Within these 10 pharmaceutical companies, only 34 of the 133 positions on the executive committees are held by females. Johnson & Johnson and Pfizer lead the way with 40% of women holding roles.

CO NTI N U I N G PAT TE R N When our attention turns to big pharma’s boards of directors, the pattern of gender disparity continues. Similarly to the executive committees, only 34 women sit on the boards of directors of the biggest pharmaceutical companies in the world, compared to 82 male directors. The companies with the most diverse boards are GlaxoSmithKline and Sanofi, in which women make up at least 40% of their boards of directors. Why is this the case, particularly when there’s a strong representation of women in much of the pharmaceutical sector? It has been suggested that the gender disparity in leadership roles in commercial pharma can partially be attributed to women getting the ‘wrong’ degrees. One article highlights that, although the number of women studying sciences outweighs men, more men study degrees such as business and economics that are arguably more suitable for the corporate pharmaceutical world. In addition, research outlined on Pharmaceutical Online states that as seniority of the degree increases, the number of men achieving these qualifications greatly exceeds the women doing so – which is a recurring theme of progression. Despite academia generally laying the foundations for people’s career paths, a large proportion of university graduates go on to work in an industry unrelated to their degree topic. Moreover, businesses looking to employ staff generally look at experience as well as academic qualifications, thereby making the argument that women aren’t studying the right degrees to become leaders in pharma questionable.

C U LT U R E C H A N G E Other sources suggest that companies’ recruitment and retention process may partially be to blame for the lack of female representation at leadership level. A report commissioned by Massachusetts Biotechnology Council highlighted that 61% of women thought their previous companies’ recruitment process was gender biased. Despite this evidence against diversity in the senior pharma workplace, there seems to be some light at the end of the tunnel for women wanting to work in the senior roles at the biggest pharmaceutical companies. Specific organisations, such as Lilly, have recognised this disparity and have made particular efforts to improve diversity in leadership. After digging deeper into why gender disparity exists in business leadership roles, Lilly has made a concerted effort to get more women into leadership positions. By creating intervention schemes and changing their company culture, Lilly saw a rise of women leaders from 38% to 41% last year. In addition, women made up 61% of promotions in 2017, while the amount of women directly reporting to their chief executive increased from 31% to 43%. Consequently, can we say that gender diversity in leadership positions within the commercial pharmaceutical world is improving? If you look back to 30 years ago, the answer is a resounding yes. However, one would expect diversity to improve from a time where much of society’s view of women was archaic and old-fashioned. It appears that the right steps are being made to achieve fair gender representation in senior roles, however, there is still a long way to go, evidenced by several of the biggest companies in the world. Seb Burchell is PR & SEO Outreach Manager for the Assured Pharmacy group. Go to www.assuredpharmacy.co.uk

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Culturally aware UNDERSTANDING THE VALUE OF ‘SOFT FACTORS’ SUCH AS PEOPLE, BRAND AND CULTURE IS KEY TO LONG-TERM M&A SUCCESS.

WORDS BY

Helen Westropp

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

ens of millions of pounds are wasted in mergers and acquisitions (M&A) every year when acquirers fail to understand the value in the brand and culture of the business they are buying. This is particularly the case in pharmaceutical and biotechnology businesses. Close to 90% of all M&A deals never get off the ground. And seven out of 10 fail to create long-term shareholder value, according to KPMG. This is often because there is a concentration during M&A deals on the hard factors – extensive due diligence and attention to market considerations, financial calculations, cost-saving opportunities, balance sheet and legal issues – while brand and brand strategy is often overlooked or only evaluated post M&A. The ideal time to consider the real worth of soft factors, such as brand, culture and people is during due diligence or even better when the target has been formally selected and vetted, rather than later.

INTELLIGENCE

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92% of business executives surveyed admitted their deal would have ‘substantially benefitted’ from a better cultural understanding prior to the merger

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P H A R M A M & A I N 2 0 19 2018 has been the strongest year in a decade for pharma M&A according to the Financial Times. This is for myriad reasons – from drugs coming off patent to pharma companies’ perennial search for the next generation of market-leading medicines, from technological innovation to greater consumer centricity and a recent trend of consolidation among contract development and manufacturing organisations (CDMOs). Cambrex is acquiring Avista Pharma solutions in a step to maintain its place as a leading CDMO, as was the case for Thermo Fischer Science’s acquisition of Patheon and Catalent of Juniper Pharmaceuticals. 2018 started with Celgene paying $9bn for Juno. This was around twice the value of its stock in the week before the announcement. In August, Novo Nordisk purchased Ziylo, a small UK biotech company spun out of the University of Bristol, in an unusual deal that both parties said could eventually be worth more than $800m if a series of milestones are met. These are striking examples of a trend that seems set to grow – namely, high-stakes partnerships between stalwart incumbents and disruptive minnows. The market seems to be bullish about M&A deals in 2019. According to E&Y’s Geln Giovannetti: “Biotech is awash with capital right now”. Added to this is the ongoing search by pharma companies to counteract slow growth by adding clinical programmes and innovative treatments. Several biopharmas are the subject of speculation by analysts – Clovis Oncology seems to be near the top of the list. Most M&A in pharma and biotech is about expertise, pipeline, portfolio synergies, portfolio expansion or market share, with competitive service providers within the same fields looking to gain more market share and benefit from the synergies inherent in a partnership or merger. While large and midsize pharmaceutical companies, on the other hand, constantly faced with the pressure to refill their drug pipeline, are continually relying on acquisitions or in-licensing from smaller biotech companies to gain access to new innovation in general, and more innovative drug candidates in particular. But it’s worth noting that historically, a high percentage of M&A deals never get done and most that are completed do not result in long-term shareholder value. This is in part due to acquirers failing to understand the value in the brand and culture of the business they are buying.

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The market seems to be bullish about M&A deals in 2019

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VA LU E O F B R A N D A N D C U LT U R E The approach of looking at brand and culture later in the process is flawed. While pharma and biotech companies work toward the same basic objectives – they are very different in nature. Biotechs are often smaller and more flexible than pharmaceutical companies and their most coveted assets tend to be their scientific minds and proprietary technology. Pharmaceutical companies’ contributions to partnerships are more often based on regulatory, sales and marketing expertise. The ideal time to consider the real worth of soft factors as well, such as brand, culture and people, is during the due diligence process or ideally during the initial conversation. Waiting until the target has been formally selected and vetted will ultimately be too late. According to KPMG research The Morning After; Driving for Post Deal Success, 92% of business executives surveyed admitted their deal would have ‘substantially benefitted’ from a better cultural understanding prior to the merger. This means focusing on elements such as organisational structures and ways of working; the type of culture in the companies involved: • is it fast or slow? • does it focus on long-term sustainability versus short-term profit (one of the most common reasons for failed mergers)? • is it top down, hierarchical and formal versus informal? • is it ‘corporate’ versus progressive? • how do we ensure staff won’t feel distrustful, disillusioned or disenfranchised during the M&A process? The recently approved Takeda/ Shire deal will be an interesting case in point. The two companies have very distinctly different types of culture.

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SECTION HE AD

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We have seen brands that were the very reason for the acquisition weakened or destroyed because of a lack of understanding of what the brand stood for

” PA R TN E R S H I P B L I S S To achieve partnership ‘bliss’, before finalising the deal, each party must truly understand the other’s business, the value proposition each brings to the table, and, importantly, the subtle nuances, such as corporate culture, that can ultimately make or break a deal. That way it will provide a better idea of the challenges that will be faced during the integration process and whether or how those differences are surmountable. It also means focusing on answering early on the critical questions: • ‘What are the inherent brand equities of what we are acquiring?’ • ‘When we own this asset, what are all the ways we can create value with it?’ • ‘What are the untapped growth opportunities of the acquired brand or the combined brands to provide long-term benefit?’ So often in M&As, we have seen brands that were the very reason for the acquisition weakened or destroyed because of a lack of understanding of what the brand stood for rather than just its financial worth. They end up destroying the very things the brand was bought for in the first place.

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

TH E FU T U R E I S B R I G HT However, despite the current failure rate for M&As, the outlook needn’t be so grim. Brand strategists can help decision-makers have the right conversations and ask the right questions at crucial, and often difficult, moments of the M&A process. The key is to bring the brand into business strategy discussions in advance of the deal and carry it forward well past the transaction itself, into genuine integration. Incorporating brand at all phases of a merger, from discussions to implementation to integration, undoubtedly forces difficult discussions and decisions, but it ensures that people act in direct response to their business strategy and their unique position in the market. Companies that are willing to spend the additional time and effort addressing organisational culture and brand and thinking about how they will integrate these prior to and during due diligence, are more likely to achieve the sort of growth and efficiencies they are seeking through mergers and acquisitions. With some forethought and planning, there are ways to avoid costly mistakes and retain the assets that made the target so attractive in the first place. Helen Westropp is Managing Partner at Coley Porter Bell. Go to www.coleyporterbell.com

ADVERTORIAL

eople are the lifeblood of our business at Star. Whether they are candidates looking for Star support to secure roles within pharma, devices or healthcare, or Star employees working with specific clients, we must continue to provide the very best talent to drive desired outcomes. The demands on these people in industry evolves as the landscape and environment changes to meet the needs of an ever-changing patient population. Chronic disease is increasing – sales representatives of the future will need to keep these patients at the forefront of their minds at all times. Representatives are no longer only tasked with selling Product A versus Product B for the commercial gains of the pharma organisation, but to be the trusted partner to the NHS, to be agile and adaptable and truly speak the language and understand the needs of the customer at-hand. What does this mean for the representative of the future and the key skills that must be developed and harnessed?

“The individuals that are winning out there are those that are comfortable engaging with payers, providers and clinicians on a range of topics”

Data-driven – There is a wealth of data and insight readily available that must be digested, understood and utilised in accordance with local, regional and national agendas. The industry provides data as a matter of course, but the most effective individuals will use the freely available data and insight to shape both their own knowledge and thinking linked to the brand value proposition. The closer the individual can get to this data and use it appropriately, the more value they can add both now and in the future. Digitally-enabled – Customers want to be engaged using their channel preference. Face-to-face calling is only one element. There is a need to ensure representatives of the future can communicate effectively via telephone, email, and screenshare, and further understand which part of this mix to use at the appropriate time. Developing IT skills and capability to maximise the multichannel mix will be a critical development for future success. Flexible approach – Navigating complexity and demonstrating flexibility are essential skills. Companies want representatives to be able to flex and respond to commercial opportunities more fluidly. The historic model where representatives have a set territory doesn’t always meet company needs over time. Geographic flexibility coupled with the ability to work across different complex customer groups is now essential. While relationship-building with NHS customers will always be important, the ability to articulate a strong value proposition to diverse stakeholders has become increasingly key. The individuals that are winning out there are those that are comfortable engaging with payers, providers and clinicians on a range of topics. These are individuals that can transition between market access, promotional and service development activities. Identifying and continuing to develop these rare individuals should be a critical part of any company’s sales strategy.

It isn’t just down to the individual to develop these core skills needed. The onus is on the pharmaceutical and CSO industry to provide the tools and environment to build the capability to thrive in the modern environment. Investment in appropriate data sources, technology as well as investment in individuals, will ensure a sales function is ready to meet the demands of 2020 and beyond. Mark Ward is Operations Director at Star. To find out more about Star’s innovative outsourcing and resourcing solutions, please email outsourcing@starmedical. co.uk or resourcing@starmedical.co.uk. If you’re on the hunt for a new role, or just curious what’s out there, email your CV to candidates@starmedical.co.uk, or call 01225 336 335 to speak to a member of our team.

WO R D S BY

Mark Ward

HOW TO FUTURE-PROOF YOUR CAREER

Mark Ward, Operations Director at Star, on the key skills that sales representatives need to develop to stay ahead of the curve.

M AG A ZI N E S PECI A L ED IT I O N | JA N UA RY 2019 | 2 9

MIND THE From patient to pharma, everyone involved in the health service stands to benefit from closing the NHS leadership gender gap – and there has never been a better time to act. WORDS BY

Emma Clayton

he NHS is powered by women. They make up the overwhelming majority of those working on the frontline of the country’s health: but go a little further up the ranks and it’s a different story. According to NHS Employers, while 77% of the NHS workforce are women, just 45% work at senior management level. In 2015, a report from the Health Service Journal painted a woeful picture, finding that just 36% of chief executives, 26% of finance directors and 24% of medical directors are female. This is quite simply bonkers – and it needs to change. We live in a country that prides itself on equality, diversity and parity, yet this massive gender gap exists at the heart of our biggest, most beloved institution.

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TH E C A S E FO R C H A N G E The under-representation of women in NHS leadership has significant implications for the quality of services. This legion of female workers is a source of untapped talent who could be playing a pivotal role in building the health service of the future. It’s not just GPs and hospitals any more. Integrated care systems are needed if we are to meet the challenges of delivering sustainable, quality care to an ageing population that’s living with more long-term conditions. To do that we need people who can build consensus across healthcare, social care, mental health and beyond: women have a huge range of skills in this area and they are skills that are desperately needed. We all want the NHS to be a better institution, led by people who make the right decisions to improve patient care. That means we need more talent, opinions and experiences around the table when those decisions are being made

DIVERSITY

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This legion of female workers is a source of untapped talent who could be playing a pivotal role in building the health service of the future

M OV I N G TOWA R D S A S O LU TI O N As part of a team looking at the economic impact of Government policy, I conducted a survey of women in the NHS – and one thing that struck me was many women were struggling to attain leadership roles. There is a huge need to empower women, so I personally decided to use my own skills and do something about it; I set up the NHS Women Leaders network. The initiative aims to help current female leaders support each other as well as inspire others, by building a community of mutual support and an online repository of tools and resources. In the coming weeks and months, we will be interviewing a wide range of female NHS leaders about their experiences. We will find out how they got to where they are today and how they overcame the barriers that so obviously exist. These profiles, which will offer motivation, inspiration and practical advice, will be published on a dedicated website and pushed out through various publications, social media and digital channels. The interest and support we have received so far, including a promise to launch the first interview from Caroline Dinenage MP, a Minister at the Department of Health and Social Care, shows there is a real need. What we are finding is that women want to be involved in empowering each other and they want to profile the work they are doing. With NHS Women Leaders, we want to drive the conversation and build a community. It would be great if at the same time we can inspire some joint working across the health and pharma sectors. Because ultimately, we all want the same thing – better patient outcomes.

I N D U S TRY A N D J O I NT WO R K I N G As an industry, we are always talking about changing patients’ lives, so why aren’t we utilising all the tools at our disposal? I have worked alongside the NHS, in the pharmaceutical industry, for more than 20 years. These companies already have huge personal development programmes through which employees are upskilled, developed and prepared in order to move on with their careers. But we are not sharing these basic leadership skills with our customers and where the critical need is. Industry could and should be playing a pivotal role in upskilling the women of the NHS. They know how it’s done, and they already have the best practices of how to build leaders. We should be providing free-to-access leadership programmes, skills development, competencies and core education. That would be more of an investment in our customers and in our patients than a detail aid or an exhibition stand could ever be. Everyone in the healthcare sector, including pharmaceutical and life sciences companies, has made a commitment to improve patient outcomes. We should now look to give the people delivering those outcomes the skills they need to do it competently.

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TH E TI M E I S R I P E Experience in the private sector shows us that diversity at leadership level is critical to success, and the NHS needs to follow that example. And this is well recognised. When Matt Hancock took on the role of health secretary earlier this year, he said that upskilling and developing the workforce was one of his top priorities. “Only when the whole workforce has the chance to fulfil their potential can the health and care system operate at its best,” he said. Nationally, we are starting to see a shift in the conversation regarding equality and diversity, and the Government has committed to improving leadership in the NHS. We have started the momentum and now is the perfect time to come together to create a more diverse health service. Because closing the gender gap will help us all achieve our goal of greater patient care. Emma Clayton is Managing Director, Grey Bear Consultancy. Go to www.nhswomenleaders.org or contact Emma on emma@greybearconsultancy.co.uk LinkedIn – NHS Women Leaders Twitter @NHSWomen

GAP

M AG A ZI N E S PECI A L ED IT I O N | JA N UA RY 2019 | 3 1

I WORDS BY

Craig Bradley

t is notoriously difficult to predict how patient engagement trends within healthcare and the related policy landscape will evolve to shape the future of healthcare. However, the engaged and empowered patient has been increasingly discussed in the policy landscape for the last decade at least 1,2 – and this is a trend which is only going to continue growing as technology continues to advance, offering the pharmaceutical industry opportunities to engage. To begin with it is worth considering the definition of patient engagement, of which there are many. However, all share these underlying themes: the facilitation and strengthening of the role of those using services as co-producers of health, and healthcare policy and practice 3,4 .

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For 2019, the trend of patient engagement is only likely to become more important with the continued desire for the patient to be involved in their own care

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Terms of engagement The trend for true patient engagement can only be good news for pharma and for patient outcomes. 3 2 | PH A R M A FI EL D.CO.U K

AC TI V E PA RTN E R As we consider the trends for 2019 and beyond, it should be noted that the engaged and empowered patient is not a new concept. A wealth of information on treatments is available on the internet from various sources, including the pharmaceutical industry, and via social media, meaning that patients have increasingly been seeking to be treated as partners when it comes to decisions about the services/treatments relevant to their condition. As technology continues to rapidly advance, the way people interact with both healthcare services and their own treatment in order to manage their condition is changing. We now firmly live in a digital age, where people manage much of their lives through their smartphones – a trend that both the pharmaceutical industry and NHS are keen to harness. Looking from the pharmaceutical industry side, there is definitely now a two-way street of industrypatient dialogue. The last few years have seen a genuine move toward patient centricity as the industry has realised the benefit of the informed, educated and motivated patient. There’s a real opportunity for a future of patient-centricity where the patient is empowered and is an active partner in their healthcare through the digital medium. In 2018, a PM Society Patient Engagement Interest Group Report5 highlighted how the empowered patient can improve outcomes: ‘Through patient engagement, our industry needs a more holistic approach that makes the great science we do more relevant for people living in our society today. If not a patient today, we all will become one in the future: patient empowerment will help us to manage our illness more effectively, adhere to our medicine and improve our outcomes.’

NHS TE C H S U P P O R T From a provider perspective over its 70-year existence, the NHS has been transformative in tackling widespread diseases and pioneering advances in surgery, screening and gene therapy, amongst other notable successes. As it seeks to modernise, one of its key current strategies is around utilising technology to drive innovation, as digital health can help it to better track, manage and improve patients’ health, empowering them to live more independently and productively. Digitally-enabled monitoring and targeted outreach will also free up healthcare capacity for face-to-face care where it’s most needed. For example, a recent Kings Fund report on technology highlights how patients are embracing new technology and increasingly expect their care to be supported by it6. As an example, the majority of people say they would use video consultations to consult their GP about minor ailments and ongoing conditions, which would radically alter the face of healthcare provision in the UK.

CO L L A B O R ATI V E C A R E The engaged patient also means that the traditional ‘one-size-fits-all’ approach we’ve had to healthcare needs to evolve, with personalised and targeted interventions that meet the needs of the individuals likely to become increasingly common. Technologysupported self-management can help to empower patients to better manage and understand their condition, supporting improved behavioural and clinical outcomes. Alongside all this there are opportunities for better and more efficient use of data in the UK via the engaged patient utilising technology, from data reporting, evaluating treatment outcomes, and increasingly creating targeted approaches to treatment. There is also great potential for the generation of effective value-based realworld evidence. All these themes offer great collaborative opportunities for the industry, NHS and the empowered patient! For 2019, the trend of patient engagement is only likely to become more important with the continued desire for the patient to be involved in their own care, the need for the industry to continue to engage and demonstrate value, and the NHS to create efficiencies. This should lead to increased opportunities for engagement across these groups.

At the PM Society we have a range of Interest Groups, run by experts in their field, related to the issues highlighted, aiming to advance knowledge, share best practice, and recognise excellence in the industry – including Digital, Market Access and Patient Engagement itself; check out the PM Society website to get involved and join the conversation yourself! Craig Bradley is Product & Business Lead (Associate Director) at Shire Pharmaceuticals and Chair of the PM Society. 1 Coulter A. and Collins A. Making shared decision-making a reality: No decision about me, without me. The Kings Fund 2011. Available at: https://www.kingsfund.org.uk/ publications/making-shared-decision-making-reality (accessed on 07 December 2018). 2 Department of Health (2012). Liberating the NHS: No decision about me, without me. [online] Available at: https://www.gov.uk/government/publications/ government-response-to-the-consultation-on-proposalsfor-greater-patient-involvement-and-more-choice (accessed on 07 December 2018). 3 Patient Engagement: Technical Series on Safer Primary Care. Geneva: World Health Organization; 2016. Licence: CC BY-NC-SA 3.0 IGO. 4 Carman KL, Dardess P, Maurer M, Sofaer S, Adams K, Bechtel C, et al. Patient and family engagement: a framework for understanding the elements and developing interventions and policies. Health Aff. 2013;32(2):223-31. 5 PM Society. 2018. PM Society Patient Engagement Interest Group: Empowered patients improve outcomes. Available at: https://pmsociety.org.uk/article/empowered-patientsimprove-outcomes [accessed on 07 December 2018]. 6C astle-Clarke, S (2018). The NHS at 70: What will new technology mean for the NHS and its patients?. London: The King’s Fund. Available at: https://www.kingsfund.org. uk/publications/nhs-70-what-will-new-technology-meannhs-and-its-patients (accessed on 07 December 2018).

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INTEGRATION

WORDS BY

Tim Warren

Payer INSIGHTS How well pharma companies engage with payers within a morphing NHS landscape will determine whether brands succeed or fail.

019 promises to be a year of action for the NHS where key policy themes such as ‘prevention rather than cure’ may be given real teeth, and newly formed Integrated Care Systems (ICSs) will start to make some traction. Staying ahead of the curve will be challenging. But by segmenting payers into groups with similar definable drivers, and providing added-value services that support the NHS’s prevention policy, forward-thinking pharma companies can foster mutually beneficial relationships with the NHS that will last far beyond 2019. P R E V E NTI O N ‘Prevention rather than cure’ was the overriding message from Health Secretary Matt Hancock as he set out his long-term vision for the NHS in November 2018. The NHS’s goal to give people “five more years of healthy, independent life by 2035” will be achieved through “joinedup care that is centred around individuals”, he said. Tackling health inequalities, increasing personal responsibility and improving early intervention will be key in delivering this pledge – and we have been promised more meat-on-the-bones in a Green Paper due in early 2019.

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Throughout 2019, ICSs will forge closer links between NHS organisations and local authorities, giving greater emphasis to prevention and population health as well as the integration of health and social care. ICS metrics will also have a heavier focus on prevention. Furthermore, the move towards one bottom line within ICSs (The System Control Budget), with everybody working towards achieving the best outcomes for patients through more efficient spending, should, in theory, enable more early intervention and preventative care services. For pharma, the ‘holy grail’ in 2019 is to show a reduction in disease prevalence and NHS service demand, and clearly highlight how primary care services can be supported to deliver. While this might not always be possible, here’s how forwardthinking pharma companies can tailor their offerings in 2019 and provide value-added services that align to the newly emerging NHS agenda:

1. 2. 3.

Provide added-value with supportive healthy behaviour education packages and complementary wellness programmes. These extra services will help to foster a longer-term relationship as the ICSs seek to fulfil the prevention agenda. Emphasise preventative elements of therapies in business cases and how they can support people to live healthier lives and avoid expensive secondary care. Ensure your value propositions complement a wider package of care. Typically, commissioners see the costs of care as falling into three categories: consumables (including the medicine budget); location of care costs; and staff costs. The opportunity here is to define the optimum patient journey that ensures all the appropriate steps are taken and effectively implemented, while reducing unnecessary staff or location costs objectively and defensibly. Develop Integrated Care Pathways (ICPs) to reflect the new structure. Show how a robust care pathway can help prevent illhealth and help the NHS shift care to the lowest intensity setting to reduce costs.

NHS

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For pharma, the ‘holy grail’ in 2019 is to show a reduction in disease prevalence and NHS service demand

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PERSONALISATION With the diverse structures that ICSs bring, it’s clear that a one-size-fits-all approach doesn’t work for the payer audience. However, as pharma companies seek to understand the new drivers and priorities for payers in 2019, we must not overlook the power of segmentation. Taking a ‘back to basics’ approach and segmenting the payer audience into groups with similar motivations can help with brand positioning and ensure that messages resonate.

Payer types At Triducive, we have defined some payer types that enable: • communication in a consistent language that resonates with different payer needs • the creation of payer engagement strategies and narratives that speak to individual emotional drivers • an understanding of the evidence needed to provide each type of payer with a reason-to-believe.

THE INNOVATOR PAYER

Driven by the desire to be innovative across budget management and project delivery. Evidence required: Past examples of innovative working with other healthcare partners. THE PATIENT PAYER

Driven primarily by the desire to demonstrate the best possible patient outcomes and experience. Evidence required: Patient experience; Patient reported outcomes (PROMs). THE COSTEFFECTIVENESS PAYER

Driven by comparing the value for improved outcomes – either within a therapy area or across therapy areas. Evidence required: Comparative effectiveness data (including PROM and observational data to inform pharmaco-economic models and cost-effectiveness analyses); Cost per qualityadjusted life year (QALY); Head-to-head randomised controlled trials data; threshold levels of confidence.

THE BUDGET MA XIMISER PAYER

Driven by ensuring the budget is optimised across the care pathway. This includes location and staff costs. Evidence required: Medicine wastage; Medicines optimisation; Service capacity; Preventing unplanned hospital admissions; Secondary Uses Service data. THE BIG THINKER PAYER

Driven by the ambition to strategically move forward and to leave a personal legacy. Evidence required: Resource allocation model; Service specifications; Medicines optimisation; Joint working with industry; Models of care; ICS. THE PROCESS FOLLOWER PAYER

Driven by a need to show a rational business case to their line manager. This type of payer looks for a ‘package’ that can be easily implemented, with minimal effort. Evidence required: Integrated Care Pathway; Health Technology Assessment guidance; Consensus views.

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NHS

Increasing success

It is important to remember that payers are often a mixture of more than one ‘type’ and so payer engagement should always be aligned accordingly. Profiling and targeting payers in accordance with brand planning - such as defining helpers vs. hinderers and mapping according to the adoption curve to segment early adopters vs. laggards – is also helpful.

Opportunity to shorten this line

WIDE ADOPTION

MA XIMISING LOE

Make relevant messages stick to activate payers

Remove blocks by educating payers so they value what’s in it for them

Activate payers by demonstrating value by making implementation easy

PRE-APPROVAL APPROVAL PAYER ENGAGEMENT

TIME PAYER EDUC ATION

PAYER EMPOWERMENT Ref: Based on typical brand lifestyle

THE FUTURE FOR PHARMA 2019 will undoubtedly be a year of uncertainty for pharma. We look forward to the NHS providing more detail in its long-term strategy on how it plans to embed its policy agenda – including answering the all-important funding question. Taking a ‘back-to-basics’ approach that re-examines payer motivations can help navigate through the new integrated commissioning landscape, and shape your payer engagement strategies, in order to successfully differentiate your brand and ensure cut-through for your value proposition. Tim Warren is Managing Director at Triducive, a health and payer communications consultancy. Go to www.triducive.co.uk

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

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2019 will undoubtedly be a year of uncertainty for pharma.

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that status quo and build outsourced solutions that are grounded in data, insights and collaboration. We have shifted our model to become a Commercial Solutions Organisation, as opposed to a traditional Contract Sales Organisation. BUILDING BETTER SOLUTIONS

REDEFINING CSO

Clive Scragg on how Evolve are challenging the traditional paradigm of the CSO.

aving worked with various CSO ‘suppliers’ over the last 25 years and having experienced the client/ provider relationship from a client’s perspective, I believe I have a particular insight into what makes that relationship effective and productive. In considering how this relationship can be more productive and enduring; the traditional paradigm of the CSO being simply viewed as a ‘supplier’ needs to change and evolve. Rather than being the implementors of a fixed strategy; the best outcomes happen through a partnership of mutual trust and respect, where both parties are involved at an early stage to help shape and build the solution.

“I believe we now have a unique opportunity to change that status quo and build outsourced solutions that are grounded in data, insights and collaboration”

CHALLENGING THE CSO STATUS QUO

In my opinion, now is the time to challenge that traditional paradigm of the CSO. With the changing landscape of the NHS, access to companies’ medicines has become increasingly difficult; whether that is gaining market access for newly launched products or increasing access to more established existing brands. In joining Evolve, I believe we now have a unique opportunity to change

WO R D S BY

Clive Scragg

Understanding our clients’ needs is core to this approach. Whether that be simply supplying vacancy management, or conversely working together to help build a service or offering to evaluate a new commercial model, while mitigating and managing risk. The premise that our approach is data-led and insights-driven allows us to build a better solution for our clients. The solution will of course vary dependent on the opportunity, but it is also vitally important that the goals and objectives of both parties are clearly defined and understood from the start. Sales and market access teams will continue to be a highly effective way of interacting with virtually all stakeholder groups. As the role of the representative evolves and access remains a challenge, maximising the performance and impact of your field teams becomes more critical than ever before. For example, deploying differential resourcing across different geographies, dependant on market access, will become even more relevant. Future teams and individuals will need the skills and knowledge to operate across a much more diverse customer base, becoming solutionsorientated as opposed to transactional. JOIN THE EVOLUTION

The notion that one size fits all has gone. This will also involve using differing tools and channels in interacting and communicating with customers in order to deliver the best brand-specific solution; be that face-to-face, e-detailing, telesales or hybrid roles. Building on Evolve’s strong recruitment heritage in providing highly-skilled and motivated people and complementing that with our data and insights-led solution, please join me in this exciting evolution and partner with us to produce outstanding results for your brands. Clive Scragg is Director of Commercial Development at Evolve. Call 0113 457 0777 www.evolveselection.co.uk

M AG A ZI N E S PECI A L ED IT I O N | JA N UA RY 2019 | 3 7

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Pharma seems to be ill-prepared despite the opportunities presented by integrated patient pathways and the demise of PbR to product value propositions

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Future imperfect? What’s the future for NHS commissioning and is pharma prepared? 3 8 | PH A R M A FI EL D.CO.U K

WORDS BY

David Thorne

NHS

he NHS has had commissioning since 1991 but it has definitely failed to thrive and, as clinical commissioning groups (CCGs) prepare to wither away, it is still reasonable to wonder what commissioning actually is. So, let’s imagine a world where NHS organisations across a recognised area work together to plan long-term achievement of a strategy based upon national priorities and specific needs of local people. They do that collaborating with obvious partners like local authorities (councils) and bodies like MIND and Macmillan. This might be across a recognised system patch of two to five million people. This plan is then delivered by NHS organisations with expertise on acute care, mental health, ambulance, and so on, working as a virtual team. Some people then sit slightly apart from the focus on daily delivery to plan longer term, check progress and ensure consistent quality of service. The delivering bodies have one, united, agreement with those doing the planning and checking that sets out the funding and KPI achievement. That agreement is managed in partnership across maybe three or four areas within the larger integrated system. Then GPs, community nurses and social care staff might work together as a formal team at 30-50,000 population level on smaller-scale local projects that apply to a town, group of villages or large city estate. They could plan and deliver together with useful amounts of flexible funding. What we have above is the vision; a Sustainability and Transformation Partnership (STP) becoming an Integrated Care System with organisations moving towards being an Integrated Care Partnership (ICP). One Team NHS to work with social care via new aligned incentive contracts that replace Payment by Results (PbR). Then Primary Care Networks emerging from GP federations to supply local creativity and bring primary care properly into the NHS and away from independent contractor separation. Sounds good doesn’t it? Well, that’s been the Plan A for three years now since STPs were set up; but the problem is that it is a concept not

a plan. There is no real road map for getting there and how can the NHS manage the massive cultural and system change required whilst handling intense daily operational pressure in the here and now? So, what we’re seeing is extreme variation in the progress of health economies in moving forward. One key factor is the ability of local NHS leaders to work together as future teams whilst still being performance managed in the current system. That tends to correlate to areas in relative financial strength and KPI achievement. But, those further ahead are also first to find the bear traps of tricky transition, which is why tangible progress on integration seems so rare. Let’s focus on what is certain. NHS England and NHS Improvement are merging and setting up seven regional management teams. In no way is this, apparently, a return to Strategic Health Authorities or Regional Offices! The NHS internal market is going already, to be replaced by integration and consolidation. That means an end to PbR, competition between NHS providers and adversarial contracting relationships. It means new types of NHS contracts and increased teamwork with local authorities. CCGs will continue to consolidate through shared management teams to resemble the primary care trust clusters we used to have. Such super-CCGs will then be ready to morph into the ICPs once there is some kind of local agreement about how on earth they will work. Primary care is set for major change in 2019. Practices are set to be incentivised to form primary care networks that will eventually be the base unit of the integrated local NHS architecture. These networks will follow the primary care home idea and the aim is to reproduce the energy of practice-based commissioning and GP fundholding while connecting practices into the mainstream NHS structure. Therefore, what we’ll see in 2019 is the continuation of longer-term trends that I described in an equivalent article last Christmas and all that has really changed is the lexicon and some detail of the architecture. None of this should be a surprise, but pharma seems to be ill-prepared despite the opportunities presented by integrated patient pathways and the demise of PbR to product value propositions.

Pharma faces aggressive de-prescribing plans because the NHS perceives medicine as a simple source of cost-saving, rather than a vital component of treatment. This is linked to the work directed through NHS clinical commissioners that has prepared the public for self-pay, co-pay and limits to the scope of NHS service. IVF and vasectomies have joined a set of surgical procedures and medicines that are now semi-detached from the NHS menu. I frequently hear the frustrations of account managers prevented by company stricture from seeing people who are key to their product but deemed not to be ealthcare professionals. I also see the inability of sales and marketing strategies to cope with changes like the move from PbR or social prescribing increasingly acting as a competitor. Pharma is struggling to get ahead of change and to even engage in the argument. The response has to start with a united campaign to champion medicines aimed at NHS staff who do not have a clinical background. David Thorne is Chair, Washington Community Health Care and Non-Executive Director, City and Vale GP Alliance. Go to www.blueriverconsulting.co.uk

M AG A ZI N E S PECIAL EDITION | JA N UA RY 2019 | 3 9