Pf Magazine November 2019

SPECIAL EDITION

CSOs & Outsourcing CORPORATE

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“The pharmaceutical industry is ready for CSOs to be more proactive” Page 4 SAVINGS

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The evolution of CSOs Strategic sourcing Pf Award Winners Club PHARMAFIELD.CO.UK

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

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THE STATE OF AFFAIRS 2020 Horizon scanning The Brexit effect

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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.

Pharma trends for 2020

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We are looking for key opinion leaders and influencers in pharma to provide industry intelligence for the Pf Special Edition on The State of Affairs 2020.

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If you would like to contribute an article or expert comment, contact amy@pharmafield.co.uk or call 01462 226128.

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Hello.

elcome to November’s Pf Special Edition, where we explore the theme of CSOs & Outsourcing. Things have changed so much since the days of the blockbuster, as more products come off patent, primary care is replaced by specialty, the NHS landscape continues to evolve, and the resulting challenge of reduced customer access presents companies with the reality of adapting their sales force offering to survive. As our industry experts point out – CSOs are no longer solely contract sales organisations, but are developing out of necessity into contract services organisation with the ability to provide cost effective, flexible solutions. Evolve’s Clive Scragg (Evolutionary shift, page 26), explains: “The traditional ‘one size fits all’ approach is far less relevant in today’s market and companies need to be increasingly nimble and creative in how they interact with their customers.”

Our expert contributors explore how outsourcing has developed over the years, as CSOs have adapted to ensure that they stay relevant and able to provide the right services to their pharmaceutical customers to enable them to stay on top of the challenges that they face in today’s market. As Ashfield’s Mick O’Leary puts it (Terms of Engagement, page 4): “Increasingly, CSOs are playing a major role in helping pharmaceutical companies to adapt to changes in incumbent markets or access new treatment demographics or geographies.”

As the environment shifts, CSOs are increasing their offering “beyond the representative” to become trusted partners able to provide additional teams, remote services, and enhanced technical capabilities.

We also look at the advantages of using an experienced project manager as part of a business process outsourcing engagement; the myths around remote sales solutions, and the advantages of using aggregated patient data to enable better patient outcomes.

We hope you enjoy this Pf Special Edition, and if you’d like to comment on anything you’ve read, or have your own stories to share, get in touch at hello@pharmafield.co.uk, tweet us @Pharmafield, or join us on LinkedIn.

HEAD OF CONTENT

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 SALES & 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

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Contributors

SATHYANARAYANAN KRISHNAMURTHY 

ANDY HOLGATE

GRAHAM MCINTOSH 

Andy is the Director of Business Development for Alveo Solutions. With 15 years’ successful international experience of contract sales organisations (CSOs), Andy has unrivalled experience to help clients. He is responsible for spearheading the client communication of Alveo Solutions’ mission to improve the quality of CSO interactions with customers.

Diversify to survive, page 6.

Formerly Bionical Chief Executive Officer and Regional President at Ashfield, Graham is now Managing Director Commercial & Clinical (Pharma) at Uniphar Group Plc, working to accelerate the Uniphar business and overseeing the development of Uniphar companies including Star, OUTiCO, and Clinical Cube in the UK, and Point of Care in Ireland.

Connectivity matters, page 12.

Sathya is Vice President, Regulatory Operations at Freyr Solutions. He is an artwork and package expert and specialist with over 15 years of experience in the life sciences industry that spans operations management, client servicing and people management for biopharma (innovator and generic) and consumer business.

Valued partner, page 24.

PETE HYDE 

Pete is Managing Director of Alveo Solutions. He spends considerable time helping clients to perfect their value proposition and designing the optimum solution for their specific needs. Pete’s broad experience has been gained from 25 years of delivering results with a wide range of pharmaceutical products in different stages of their lifecycle.

Myth busting, page 22.

In this issue ANNA LUKYANOVA

Anna is Chief Operating Officer of Arriello, a provider of innovative, high-impact market access, regulatory affairs and pharmacovigilance solutions and services for small to mid-sized biotech and speciality pharma firms.

She oversees the company’s pharmacovigilance, regulatory and project management teams, balancing client satisfaction with developing and nurturing Arriello’s growing team.

Running a tight ship, page 10.

EMMA MORRISS

Emma is Head of Content at Pharmafield and E4H. She is an experienced editor and content strategist with a background in health and social care.

Celebrating excellence, commitment and drive, page 16.

INTELLIGENCE

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Terms of engagement: Optimising the CSO’s role in sales strategy development

Better together: Extending the secondary use of patient data

MICK O’LEARY

STEVE BRADLEY

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Running a tight ship: Don’t leave outsourcing outcomes to chance

Evolutionary shift: How are pharma companies adapting to change?

ANNA LUKYANOVA

CLIVE SCRAGG

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Connectivity matters: Disrupting the traditional brand management approach GRAHAM MCINTOSH

MICK O’LEARY

With over 27 years’ experience in the pharmaceutical industry, Mick is responsible for building and executing the strategy for Ashfield’s Commercial and Patient Solutions divisions across the UK, Ireland, Nordics and Belgium. Since 2013, he has been Managing Director of Ashfield Ireland, Representative Director for CMIC Ashfield and Ashfield Healthcare Communications K.K. in Japan and was appointed to his current role in 2019.

Terms of engagement, page 4.

NHS

INSIGHT

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Diversify to survive: How have CSOs diversified and grown?

ANDY HOLGATE

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Myth busting: What’s the reality behind remote sales solutions?

PF AWARDS

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Celebrating excellence, commitment and drive: The Pf Award Winners Club 2019 EMMA MORRISS

THE SECTOR HAS EVOLVED IMMEASURABLY SINCE INCEPTION

PETE HYDE

STEVE BRADLEY

Steve joined Cegedim in 2013 and was appointed to the position of Group Managing Director, Cegedim UK, in January 2018, to lead the combined UK business that encompasses Cegedim Rx, Vision (In Practice Systems Ltd), THIN and Cegedim Health Data.

Better together, page 8.

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Valued partner: The role of regulatory partnering in compliant market access SATHYANARAYANAN KRISHNAMURTHY

Mick O’Leary, page 4

28 Directory

T TERMS OF ENGAGEMENT What are the advantages, challenges and possible future of CSOs, and how can they optimise their role in better sales strategy development?

he pharmaceutical industry is in the midst of unprecedented change, driven mostly by the migration of product portfolios from mass market solutions to highly specialised and/or personalised therapies.

In this environment, reimbursement is becoming more complex and successful commercialisation means targeting multiple, often self-educated, stakeholders before a prescription is even written.

In response, the pharma industry is exploring new sales and marketing models to meet these modern challenges. Traditionally, contract services organisations (CSOs) have provided a flexible, cost-effective way for the pharma industry to adjust the implementation of its strategy by providing sales representatives on-demand. However, given the current state of flux, just how relevant can CSOs be in helping pharma companies manage such major changes in the way they engage their audience?

WORDS BY

Mick O’Leary

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INTELLIGENCE

Increasingly, CSOs are playing a major role in helping pharmaceutical companies adapt to changes in incumbent markets or access new treatment demographics or geographies

ADDRESSING A CHANGING MARKET

Despite the singular challenges the pharmaceutical sector faces, it has sustained growth for decades while adjusting to increasingly stringent regulatory requirements, new customer dynamics and fluxing market pressures.

One area that has more recently seen major change has been pharmaceutical sales.

In short, the number of field representatives has shrunk dramatically over recent years, coinciding with a drop in access to healthcare providers, in addition to the advent and subsequent proliferation of digital communication channels. These challenges have collectively been major drivers in a reliance on CSOs across most pharmaceutical businesses. There has been a huge increase in demand for sales representatives on more flexible contracts and more sophisticated, often digital-led, and integrated sales campaigns.

Providers like Ashfield have broadened their offering beyond the representative and have developed other channels such as medical science liaison (MSL) teams, remote services (including remote key account managers (KAMs) and MSLs) and sophisticated AIdriven patient support capabilities. All can be linked together and are underpinned by sophisticated data analytics, strong recruitment, compliance and an enhanced understanding of the market.

CSOs are playing a major role in helping pharmaceutical companies to adapt to changes in incumbent markets or access new treatment demographics or geographies. This has a number of inherent benefits (flexibility, scalability, access to expertise) but most importantly it enables pharma businesses to rapidly optimise levels of sales resources and mitigate the risks associated with building permanent in-house teams. As pressure on the pharmaceutical industry to operate ever more effectively and efficiently escalates, outsourcing of field sales is certain to increase.

However, CSOs can and should be playing a prominent role in strategic decision making when it comes to sales. In response to the pressures mentioned, pharmaceutical businesses will soon be making longterm commitments to addressing the commercialisation needs of the sector via trusted CSO partners.

STRATEGIC SOURCING

To deliver on short-term projects, contracted commercial providers must get the basic, foundational elements right and establish trust by rapidly deploying and retaining representatives with the appropriate skill set for the engagement. But there is an unmet need for more fundamental change in go-to-market healthcare models, and the pharmaceutical industry is ready for CSOs to be more proactive and collaborative with their strategies. As a result, there is a growing focus on ‘strategic sourcing’ which involves developing partnerships instead of using contract services as a buffer at intermittent points of a campaign.

Strategic sourcing is the outsourcing of a substantial percentage of non-core services, with the aim of enabling a pharmaceutical company to focus internal efforts on business-critical objectives. In the sales department, this means the outsourcing of day-to-day sales activity while the pharmaceutical company pays attention to the development and marketing of its brands.

Moving from commoditised services to strategic partnerships can realise a greater mutual value, but it requires a long-term approach from both CSO and pharmaceutical businesses. Co-determination of marketing, pricing and access strategy would likely be central considerations of any such model, followed by everything from marketing communications to sales force sizing, candidate profiling, targeting methods, call lists, sales training and sales materials. Both parties would need to be

involved in recruitment specifications, training, measurement and reward-system design. A successful roll-out and the ongoing partnership would require buyin and constant engagement from senior stakeholders in both organisations with a focus on day-to-day operational quality.

There is also greater emphasis on CSOs to deliver more than just a commodified service. To be viewed as strategic partners, CSOs need to challenge businesses with new ideas. Drawing on the sector-wide information generated by their business analytic systems, they could position themselves as increasingly proactive by showcasing best practices, identifying new market opportunities or demonstrating added value. Given their focus on sales models, CSOs could also consider advising on new, integrated commercial models and helping their customers to implement them.

There also needs to be some consideration of pricing models, as traditional flat rate arrangements will need to give way to models based on shared risk and reward.

‘FULL’ OUTSOURCING

Outsourcing by the pharmaceutical industry has been changing over the past three decades, becoming more strategic, with little sign that it will slow down any time soon. As contract providers grow, developing their reach and capabilities, and pharmaceutical businesses push for leaner operating costs, it is possible that integration will eventually be replaced by the outsourcing of all commercial and customer-facing functions for a particular brand or franchise.

Everything from clinical trials, research, manufacturing, back office processes and a large proportion of commercialisation activities are already being outsourced, while ideas about what capabilities should remain core are in flux. It is up for discussion as to what cannot be outsourced, with some believing that the purpose of a brand is the only thing that is truly ‘core’. This is already the case for many virtual businesses and there is no reason that this mindset could not be adopted by larger organisations. For contract commercial providers, this means going beyond offering services to becoming true partners – sharing risk and reward, guiding strategy, and forming decade-long relationships. Mick O’ Leary is Regional President - Commercial & Patient Solutions at Ashfield Commercial & Patient Solutions.

Go to www.ashfieldhealthcare.com

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DIVERSIFY TO SURVIVE From humble beginnings, contract sales organisations have diversified and grown to provide a range of essential services.

WORDS BY Andy Holgate

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he days of ‘rent-a-rep’ are long gone, following the remarkable journey taken by contract sales organisations (CSOs).

Remember when armies of recently qualified graduates in syndicated teams diligently delivered key messages almost by rote, through three product details, often on overlapping territories? Remember when joining a CSO was a nursery step toward ‘a real job’ in a manufacturer?

CSOs today in no way resemble those from which they evolved.

CSOs have diversified so much that to many, the term contract SALES organisation is now a misnomer and they have instead attempted to rebrand as contract SERVICES organisations.

The sector is characterised by two types of business; the CSO that is part of a large, diversified corporate entity, such as IQVIA, Syneos, Ashfield and Star Medical, and the independent, arguably more purely sales-focused CSO, such as Alveo Solutions or CHASE. HOW IT ALL BEGAN

The UK CSO sector began with Innovex in the 1980s, who were acquired by Quintiles in 1996. Quintiles itself began as a contract research organisation (CRO), so this was the first sign of the diversification to follow. Quintiles’ merger with IMS in 2016 created a business employing 58,000 people, providing a vast range of services.

CSO is just one part of this empire.

Syneos, Ashfield and Star Medical were also created following many acquisitions and services expansion; Syneos was formed from another CRO:CSO merger, between INC Research and InVentiv, creating a business with 23,000 staff, and services from the laboratory to commercialisation. The CSO business is particularly strong in the US, and currently small in Europe but with expansion ambitions.

After forming in 1997, Ashfield’s sale to UDG in 2000 allowed Ashfield to build an offer encompassing primarily clinical and commercial services, healthcare communications and consultancy.

CSO remains a core offering, and via acquisition of additional CSO businesses, Ashfield built a global footprint to rival that of IQVIA. Star Medical is not alone in beginning as a recruitment agency, then re-positioning to also offer CSO. They were purchased by Uniphar in 2015, and following other acquisitions, can offer a range of clinical and commercial services.

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CHASE is another business which started as a recruitment agency and continues to operate direct-to-headcount recruitment alongside CSO. Founded in 2016, Alveo Solutions is the newest CSO, with a mission to offer services relevant to today’s market; especially more tailored solutions implemented via the optimum channel, that are outcomes focused and have a determination to build prescribers’ trust by delivering value in all interactions with healthcare professionals.

GLOBAL DIFFERENCES

Europe’s CSO market is more saturated than the US’s. Social healthcare systems mean greater price controls. With more stringent labour laws, the need for greater sales force flexibility drove strong CSO market penetration; for example, roughly 30% of all field sales heads in the UK are CSOs. In the blockbuster heyday, the CSO’s main purpose was extra noise, and profits were good, but in these uncertain times, teams are smaller and CSO benefits perhaps centre around employment risk mitigation. In the US, labour dynamics and price controls are very different. Consequently, reasons to use CSOs have been more related to overall employment cost savings, though market access pressures are biting there too, which is increasing the attraction of flexibility.

INSIGHT

As primary care gives way to specialty and access challenges continue, CSOs are feeling the squeeze

CORPORATE OR INDEPENDENT?

Because the number of representatives has declined massively over the past 10 years, as primary care gives way to specialty and access challenges continue, CSOs are feeling the squeeze. To satisfy investors’ demands, and the need to cover significant overheads, evolution via services diversification has been a key drive for the corporates. Provision of nursing services, alongside other high value roles, for example medical science liaisons and key account managers, has helped CSO business. Meanwhile, growth in digital, remote capabilities has added higher margins whilst offering an alternative channel to try to reach customers.

The corporates have attempted to leverage their size and breadth by seeking to contract with clients above country and/or for multiple services. They may even offer financial incentives to do so, in addition to the implied benefit of the convenience of ‘shopping under one roof’. There has been an attempt to reposition themselves as clients’ strategic partners, but ultimately, when the chips are down it’s still a client/supplier relationship, and local trusted relationships still count. Clients still like to be in control of delivery of their contract, and expect to receive timely and dedicated customer service. For corporate CSO business developers, the proposition is certainly more complex to describe and coordinate, and for customers potentially less clear and more onerous to navigate.

However, the value proposition from independent CSOs is more focused, with arguably a tighter relationship between contracting parties. The CSO is not just part of a larger entity. Anderson & Trinkle, in their book, ‘Outsourcing the Sales Function’, stress the purity of purpose offered by sales outsourcing. It begs the question of whether the associated services offered in a ‘one-stop shop’ proposition somehow dilute the overall goal.

The CSO sector aims to mirror CRO, where virtually all clinical trial activity is outsourced. But that hasn’t happened. Undoubtedly, CSO quality can match and supersede that of pharma itself. Speed of deployment is faster, and the benefits of flexibility are clear.

The sector has evolved immeasurably since inception. What is clear is that pharma can choose from a range of businesses that all have incredible strengths. Perhaps it’s the style of relationship that counts as much as the services themselves?

Andy Holgate is Director of Business Development at Alveo Solutions.

Go to www.alveosolutions.com M AG A ZI N E S P EC I A L ED I T I O N | N OV EM B ER 2019 | 7

Better together COMBINING A RICH OBSERVATIONAL DATA SOURCE WITH PRIVATE, PUBLIC SECTOR AND RESEARCH BODIES’ RESOURCES LEADS TO BETTER OUTCOMES. WORDS BY Steve Bradley

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he NHS is being transformed through the digitisation of healthcare services and more insightful use of patient data. Over the last five years, research has shown that data analytics could save the health service anywhere between £16.5 billion and £66 billion annually, while a recent market report valued NHS data at £9.6 billion.

Despite these financial benefits, it can be rightly argued that the true value of healthcare data lies in patient outcomes.

Good data can power better pathways and safer, more effective models of care. It is our ability to harness this traditional information source through technology and sophisticated analytics that will drive better outcomes and more sustainable models of care. ‘Aggregated Patient Data’ could, therefore, be a key component of healthcare transformation.

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DATA DRIVES BETTER HEALTHCARE

The NHS collects an immense amount of data across multiple touchpoints, with the most data-rich being clinical consultation, where around 6 million GP appointments a week and almost 120 million outpatient appointments a year occur in England alone.

This patient-doctor interaction can offer tangible value when the data is anonymised, collected and analysed at scale. Indeed, NHS England’s ‘Next Steps on the NHS Five Year Forward View’ highlights the ‘valuable opportunities’ of ‘longitudinal data’ to drive better healthcare, citing the unique role general practice plays.

Longitudinal data can provide a realworld picture of patient journeys, treatment pathways and health outcomes. It can help NHS organisations – both locally and nationally – measure variation and see how clinical decisions impact public health. And it can inform decision-making in a range of crucial areas from resource planning, pathway design and medicines optimisation to disease management, NHS commissioning and drug development.

The potential for its application is enormous.

Over the years, health stakeholders including clinicians, academics, health economists and the life sciences industry have applied longitudinal patient data to help understand disease, improve diagnosis, and assess pathway and policy effectiveness. Moreover, as technology continues to evolve, opportunities to extend the secondary use of patient data to drive health improvements are increasing.

For example, aggregated patient data is one of the most valuable sources of observational data to determine the real-world impact of new medicines. Real-world observational studies have become fundamental to give

robust and meaningful insight, and measure the clinical and cost effectiveness of new therapies. The shared benefits of utilising these forms of data are profound: patients gain access to life-changing therapies, doctors can give their patients early access to the best treatments, and life sciences companies obtain evidence to secure regulatory approval.

UNLOCKING THE FULL POTENTIAL OF DATA

In addition to longitudinal patient data, new data streams are emerging that are giving new insight – from understanding patient populations, to local variation and unaddressed needs. Deeper and more complex data sets are being created through the combination of information captured in patient registries, biobanks and clinical trials networks with electronic patient records, unlocking clearer definitions of what healthcare ‘value’ looks like in the real world.

The rapid increase of data at macro-level is also transforming the way policymakers and healthcare leaders plan and manage NHS services. Proposals to broaden NICE’s use of data and analytics are, for example, currently at the consultation stage, but they include an ambition to unlock and exploit the ‘full potential of data’ from a range of sources including electronic patient records and primary care datasets.

As clear as the transformative value of this data might be, there are significant considerations over its usage. The aggregation and use of patient data is, rightly, heavily regulated. Patient confidentiality must always be protected, irrespective of the potential opportunities that data sharing creates. But that is not enough. For data to be truly valuable, it must be collected ethically, used responsibly and managed properly.

NHS

Furthermore, just as the foundation of good healthcare is based upon the confidence between doctor and patient, trust in the data collector is necessary for the transformative potential of health data to be realised.

CONFIDENCE IN DATA

Data security and privacy is the key to trust – and without it, data is worthless. First and foremost, longitudinal patient data must be anonymised, structured and coded so that patients and GPs can’t be re-identified at a later stage. The most effective datasets are built and maintained using the right protocols, facilitating reliable and accurate data that yields transformative insights whilst safeguarding privacy at all times.

A practical example of this is The Health Improvement Network (THIN), Cegedim’s proprietary database, which NICE cites as a source of observational research data that can help inform healthcare planning. Databases like THIN give health stakeholders access to depersonalised, non-extrapolated primary care records that can empower healthcare research to unlock more effective models of care.

Combining such a rich data source with the resources of private, public sector and research bodies is key to identifying a better way of addressing current patient pathways, trends and understanding of the wider healthcare economy; from economic modelling and more effective resource planning, to informing the discovery, development and use of high-value medicines. Smart use of data is increasingly being recognised as a fundamental driver of health service improvements and enhanced patient outcomes. However, as healthcare stakeholders seek to redesign services and transform care, the most effective solutions may rely not on new tools of disruption, but on data that’s already routinely captured through everyday NHS services. Aggregated patient data – ethically captured, managed and shared collaboratively amongst all healthcare stakeholders – could just be the key to better care and better patient outcomes.

Steve Bradley is Group Managing Director at Cegedim UK. Go to www.cegedim.com

Opportunities to extend the secondary use of patient data to drive health improvements are increasing

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INTELLIGENCE

Running a tight ship The importance of not leaving outsourcing outcomes to chance.

WORDS BY Anna Lukyanova

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

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hen biotech and pharma organisations outsource activities that are seemingly less ‘critical’ than the running of clinical trials, it’s too easy to neglect the importance of tight project management and stakeholder coordination to keep delivery on track. Whether the processes are around international pharmacovigilance or regulatory information management and filing activities, it is essential to ensure that outsourcing outcomes are not left to chance.

In a clinical trials context, the need for tight project management is selfexplanatory, especially when entrusting the operations to a third-party research organisation. Keeping strict control over quality, process, resourcing, data management, audit trails and cross-party communications is essential to the success and credibility of outcomes, the management of costs, and the containment of risk.

But move outside of clinical research, and biotech and pharma organisations quickly become more lax in their expectations of formal project management.

If they are outsourcing processes such as pharmacovigilance or regulatory submissions management, firms’ chief priorities tend to be buying in particular technical prowess and access to scalable resources, placing all emphasis on the

relevant technical expertise and capacity of the teams they are engaging.

Yet this preoccupation with the technical logistics can come at a price. While it goes without saying that service providers must be expected to field qualified talent with relevant experience of processing the given type of work, these qualities alone do not guarantee an optimum and tightly managed engagement. Trained scientists don’t necessarily make for natural project managers or communicators, so there is always a risk that the ins and outs of successful process coordination could suffer if there isn’t a designated person or team to bring all of the different strands together.

STAYING ACCOUNTABLE

Often the project originator may underestimate what’s involved, as what seems to be a straightforward process is transferred to the outsourced service provider. If the brief is to deliver pharmacovigilance (PV) case reporting for 30 countries, for example, their primary objective will be to identify PV experts in sufficient supply. But by neglecting to vet the surrounding provision for coordinating ongoing communication with internal and external stakeholders (including business development people, technical teams, external vendors, contract/procurement departments, HR and even accounting and finance), any number of issues could emerge which – unchecked – could lead to project scope creep, missed deadlines, exceeded budgets and more.

No matter how well defined an initial project is, requirements and other parameters will frequently change across the delivery lifecycle.

Ideally most of these variables will be planned for upfront as part of a risk assessment, and resources calculated to allow for potential peaks and troughs of demand. But it will be critical to the smooth running of the project that an accountable individual or team has their finger on the pulse, monitoring for changes to the requirements of the service, or any other factors that have influenced throughput and the ability to deliver as expected.

Expecting technical ‘do-ers’ to step up to the project manager role is unrealistic.

This is something that happens routinely, but typically with unwelcome results.

The pressure to coordinate stakeholders, keep everyone in the loop, push forward action plans with individuals, and handle issues wherever these might spring up, can overwhelm someone not primed for this role. In the worst cases it has led to those people leaving their job, at which point stakeholders might finally realise that complex engagements might even need a team of project managers to keep all the strands together.

The importance of the project manager role may be further underestimated further in a regulatory submissions context. Assuming the assignment is ‘simply’ to file documents on time, life sciences firms and their service provider partners might question where the role is for a project manager.

Yet managing the transfer of a remit from the process owner to a third-party service provider, especially if multiple business entities, locations or regulatory jurisdictions are involved, needs to be meticulously organised.

THE HELICOPTER VIEW

A project manager will be primed to think outside of the box, not looking solely at the immediate requirement and the job specified, but at process interdependencies.

If they are doing their job well, they will also be proactively scanning for scope to introduce more efficient ways of working or strategic automation – where it could help to expedite delivery and contain or reduce long-term costs, even when work volumes spiral.

If the immediate project is international regulatory submissions filing, for instance, the broader remit might include staying ahead of evolving updates or additions to regulators’ demands – which can be hard to keep track of

Firms need to be ready for anything as they plan and process their workloads and fulfil their obligations

without a dedicated, coordinated focus.

In a PV context, the expanded role may involve exploring opportunities to streamline and automate translations of international case reports, towards greater efficiency and reporting consistency. Technical experts, focused on the immediate task in hand, wouldn’t necessarily take this broader view.

Among the expected benefits of using an external service provider is not just the ability to draw on superior economies of scale (because the investment of skilled resources and advanced technology aids can be shared between multiple clients); there is also the potential opportunity to access best-practice approaches to delivery. A project manager with a higher-level view of operations, is in an ideal position to distill key learnings from across multiple engagements, so that all clients are better off.

There may be an additional charge for having the advantage of a project manager as part of a business process outsourcing engagement, but typically the value they bring to the table – not least in identifying additional scope for efficiency and service improvements – can pay dividends.

As compliance demands grow and become more bureaucratic, and as regulatory audits and inspections become more commonplace, firms need to be ready for anything as they plan and process their workloads and fulfil their obligations. Sharing ownership of these activities with a trusted provider can bring comforting reassurance that all is as it should be, and nothing has been left to chance, which by no coincidence is the mantra of every good project manager.

Anna Lukyanova is Chief Operating Officer of Arriello. Go to www.arriello.com

We have the vision, the insight, the technology and the confidence to recruit your next superhero and attract the best talent for your team. www.ashfieldhealthcare.com

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T WORDS BY Graham McIntosh

he age of the ‘empowered patient’ is upon us.

With the click of a button, an individual can access a wealth of information about their diagnosis, or they can connect with other patients. As patients become increasingly engaged in treatment decision-making, their needs must be addressed. The rising power of the ‘consumer patient’ is challenging the status quo for all healthcare stakeholders.

The shared vision of many within the healthcare ecosystem is to ‘get the right treatment to the right patient at the right time’. Regardless of whether you work in a biopharma, medtech or healthtech company, we all have a responsibility to work collaboratively with healthcare professionals to provide optimal treatment for patients.

Across the Uniphar Group, we take our role in this ecosystem very seriously. Our vision is to improve patient access to pharmaco-medical products and treatments by developing connectivity between manufacturers and healthcare stakeholders.

A NEW ECOSYSTEM

The traditional era of the ‘blockbuster’, which addressed large patient populations, meant a brand management team could project the product lifecycle and develop a brand strategy based on the broad needs of a large patient population. The ecosystem we operate within today is very different; healthcare organisations are partnering across the ecosystem to develop complex speciality products and ‘next-gen’ therapies that target a patient’s unique genetic profile. The old approach to brand strategy will no longer cut it in such a complex and dynamic environment.

Connectivity matters The traditional brand management approach isn’t working anymore – combining expertise holds the key to success.

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

INTELLIGENCE

Too often, data captured during product development and commercialisation remains an untapped asset

As we move forward, effective brand engagement requires a comprehensive understanding of the needs of patients and an integrated approach to HCP education; an integrated approach that will ensure we effectively meet patients’ needs. We believe the key to this is data. Too often, data captured during product development and commercialisation remains an untapped asset and organisations fail to leverage the wealth of external data that can be used to better understand the needs of patients and HCPs. As a health insights and technology leader, we are challenging the old ‘brand management’ paradigm. The strategic

acquisitions of Star, OUTiCO, Point of Care and Clinical Cube and the subsequent financial investment to integrate all data sources, means we have been able to build a unique and rich customer-centric healthcare database. We can provide holistic and innovative solutions for our clients at all stages of their brand lifecycle.

CONTINUOUS IMPROVEMENT

‘Intelligent Brand Engagement’ is a unique approach to engaging healthcare stakeholders which delivers factual datadriven insight. Significant investment in technology, platforms and experienced resource means we have the ‘real time’

capability to share insights on all aspects of the healthcare ecosystem. Based on this insight, we design tailored client solutions which enable meaningful multi-channel interactions with all healthcare stakeholders.

We then measure the outcome of each interaction and learn to ensure we continue to improve engagement.

Through each ‘Data; Insight; Outcome; Learn’ loop, the brand strategy evolves, and we deliver more intelligent customercentric solutions for our clients. 'Intelligent Brand Engagement' is our backbone and runs through the core of all the services we provide for our clients.

In the sales and marketing space, our pioneering multichannel HCP and patient engagement offering is disrupting the traditional ‘push’ model to a new ‘pull’ model. Combining behavioural science theory, and data from both interactions and research, we can predict the optimal approach to HCP stakeholder engagement; the right channel, the right time and the right purpose to meet their needs. In doing so, we empower our clients to have tailored and impactful interactions with healthcare stakeholders, from the delivery of patient support programmes and managed access programmes, to medical sales representatices engaging with HCPs, to HCPs and nurses engaging with patients.

We also offer clinical and distribution services for our clients which harness the power of data. For example, our innovative distribution models are designed using insights generated through combining internal operational data with external geolocation and weather data to ensure that we get the right medicine to the right location at the right time.

As we continue through this unprecedented era of ‘empowered patients’ and ‘personalised medicines’, healthcare organisations must evolve in order to meet the needs of the patient. We are at the forefront of this change and believe that ‘Intelligent Brand Engagement’ centred around insights will deliver the critical connectivity. A partnership between manufacturers and healthcare stakeholders that will ensure the right treatments get to the right patient at the right time. We are up for the challenge, are you? Graham McIntosh is Managing Director, Commercial & Clinical (Pharma), at Uniphar Group plc.

Go to www.starmedical.co.uk

M AG A ZI N E S P EC I A L ED I T I O N | N OV EM B ER 2019 | 13

Pf Awards 2020 are open for nominations Showcase your talent at the biggest and most prestigious industry awards

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T H U R S DAY 5 M A R C H 2 02 0

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Deadline for entries to Pf Awards 2020

Pf Awards Assessment Day, King Power Stadium, Leicester

Pf Awards Dinner, Royal Lancaster London

Want to enter? Contact the Pf Awards team on team@pfawards.co.uk or 01462 476120

www.pfawards.co.uk #pfawards2020

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PREMIER AWARDS CELEBRATION

2 3

Celebrating

EXCELLENCE, COMMITMENT & DRIVE 1

PF AWARD WINNERS PAST AND PRESENT CONVENED IN LONDON TO CELEBRATE THEIR ACHIEVEMENTS AND NETWORK WITH THEIR PEERS AT THE PF AWARD WINNERS CLUB 2019.

WORDS BY Emma Morriss

I

t is often said that a Pf Award win is career-changing for those pharmaceutical sales and marketing professionals that have had the honour of achieving one. That was evident at the Pf Award Winners Club on 25th September at London’s Living Room in London City Hall.

Situated on the top floor of City Hall, London’s Living Room offers stunning panoramic views over the River Thames and some of London’s most iconic monuments, including Tower Bridge, the Tower of London, the Shard and the Gherkin.

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CELEBRATING EXCELLENCE FOR 20 YEARS Pf Awards celebrates its 20th anniversary in 2020 and Karl Hamer, Publisher of Pf, opened the Pf Award Winners Club by paying testament to the longevity of the Pf Awards.

He expressed his pride over the continuing success of the event, which recognises top performers, celebrates their achievements and reflects on what the industry needs.

Karl said: “I started my career carrying the bag, and if the Pf Awards had been around when I was a sales representative, I would have entered. It’s important to be able to recognise industry in this way.”

Karl then handed over to Melanie Hamer, the driving force behind the Pf Awards.

Melanie has developed, grown and evolved the Pf Awards over the past two decades, ensuring that they continue to raise standards.

Melanie explained: “Pf Awards is all about recognising and celebrating success, and everyone in this room is an example of this.

“Pf Awards is also about raising the standards in the industry and keeping that bar raised; I’m sure you will agree that this is important.

6

1. View of Tower Bridge, London 2. Inside London City Hall 3. Joanne Tordoff, Helen Butters, Janette Benaddi and Bridget Logan 4. Melanie Hamer and David Gleghorn 5. Rob Turnbull, Raheel Mirza, Dave Lampard and Kay Varlas 6. Karl English and Lorna Towndrow 7. Sara Hale, Hayley Smith, David Gleghorn, Sally Vennard, Sadikah Patel, Katrina Walker and Tom Pickles 8. Karl Hamer reflects on Pf Awards 9. Daniel Davies and Richard Johnson

LIFE-CHANGING EXPERIENCE

7 “And it’s why the Pf Awards Assessment Day is designed to challenge you professionally and ensure that only the top candidates are recognised on the big screen and stage.”

Thanking the Pf Award Winners Club sponsors, Melanie added: “Ashfield, CHASE and Star have kindly sponsored this evening for us. They, along with many other commercial sponsors, have been great supporters of Pf Awards over the years and I would like to personally thank them. Without them, this evening would not be possible.”

Melanie then undertook the roll call of Pf Award Winners, inviting them to the stage individually to receive their Pf Award Winners badge. Winners came from as far back as 2000 and as recently as 2019, showcasing the fantastic spectrum of industry and career progression that surrounds Pf Awards.

“ The Pf Award Winners Club reminds us that we’re really good at what we do and it allows us to celebrate”

8

9

Once all of the Pf Award winners had been recognised, Melanie introduced the evening’s inspirational speakers, Yorkshire Rows, by saying: “Tonight is all about success and achievement, something that this evening’s guest speakers know all about.

“Yorkshire Rows is a team of four formidable mums from Yorkshire who are the first women to row across the North Sea and also hold a Guinness World Record for rowing across the Atlantic. These four ladies are not professional sportswomen, they are four ordinary working mums who ‘dared to dream’.”

Taking to the stage, Frances, Helen and Janette apologised for their fourth member Niki’s absence, then went on to enthral and motivate everyone in the room with the story of their journey – from mums who met at the local rowing club every Saturday morning, to World Record holding, ocean-rowing women who took on a life-changing experience.

Janette has a personal connection to the pharmaceutical industry, as she started her career as a medical sales representative, so she was delighted to be at the Pf Award Winners Club helping to celebrate success.

Describing their decision to row the Atlantic and the required training as “challenging”, Frances explained how they had to face their fears and discover strengths that they never knew they had.

A seemingly innocuous conversation between them at the Annual Boat Club Dinner led to that decision to row the Atlantic. Frances explained: “Rowing was my oasis in an otherwise busy week.” And when the conversation turned to entering the Talisker Whisky Atlantic Challenge, Frances added: “I said yes. You have to say yes if an opportunity is offered.” She continued: “There’s an adventure in everybody but you have to choose your own and then be relentlessly dedicated.”

Supported by their partners and children, they set about training. Dubbed ‘Four Mums in a Boat’ by the media, it took three years to get in the best shape to complete the challenge safely.

“We weren’t the normal face of the race,” explained Helen. “We needed a huge amount of effort to get to the start line. We were working mums, we couldn’t train in the gym every day, so we needed to adapt our training around our family.” This included training in the kitchen whilst cooking dinner, supporting the children with their homework and looking after the dog.

M AG A ZI N E S P EC I A L ED I T I O N | N OV EM B ER 2019 | 17

1. Huw Nicholas and Oliver Hardman 2. Kathy Wadhams and Alison Duncan 3. Ian Robinson, Ramesh Majithia and Colin Watson 4. Pf Award Winners 5. Melanie Hamer opens the event 6. Guest speakers Janette Benaddi, Frances Davies and Helen Butters 7. Guest speaker Frances Davies 8. View from City Hall 9. Melanie Hamer and Nicholas Saunders

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THE JOURNEY Having undertaken all the preparation, Janette explained that leaving as the race began was the hardest part of all.

“As skipper, it was hard to leave La Gomera, to let go of the shore and head into the unknown.” She added that their naivety was however an advantage: “We didn’t know what we were facing.”

The challenge wasn’t without drama.

They depleted their battery system on Christmas Day leaving them with no automatic steering or desalinator for clean water; Niki fell over and damaged her coccyx; they sailed through Hurricane Alex, and suffered with blisters and sores. Although Janette added: “We had beautiful moments too, it was amazing to see the dome of stars at night and felt like we were on another planet.

We also saw whales, dolphins and sea turtles; it was a beautiful journey and we were intent on enjoying the experience.”

When they finally reached the finish line they came 22nd out of 26 starters, but more than that, they had achieved something incredible. Janette explained: “It didn’t matter when we arrived, what mattered was that we enjoyed the journey and remained friends. It was incredibly

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6 overwhelming and a tremendous experience.

More people have climbed Everest than have rowed the Atlantic.”

Not only did they row the Atlantic in 67 days, five hours and two minutes, they also broke a World Record for the oldest all-female crew to complete the 3000-mile challenge. They also raised more than £100,000 for charity.

Melanie and Karl then presented Janette with an honorary Pf Award Winners Club badge to mark her past connection to the pharmaceutical industry.

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8

WINNERS SPEAK As the Yorkshire Rows left the stage, Pf spoke to the guests about what brought them to the Pf Award Winners Club.

KATRINA WALKER , winner of the

3

2017 Sales Team Pf Award, said: “I love attending the Pf Award Winners Club.

It keeps my Pf Award win alive and I really feel part of something special.”

RICHARD JOHNSON , Country General

Manager at Kyowa Kirin, added: “We’re delighted to be here tonight.

We’re committed to putting our top talent forward for the Pf Awards 2020.”

MARTYN BEAUCHAMP, 2017

Account Manager Pf Award Winner, explained: “The Pf Awards are tangible recognition of excellence in our industry, from an external body of experts. They recognise the incredible work and talented individuals that I am humbled to work alongside. The Pf Award Winners Club is an excellent networking opportunity.”

DAVID GLEGHORN , winner of the

2017 Sales Team Pf Award said: “The Pf Awards are the jewel in the crown of the pharmaceutical industry.

It’s really nice to be recognised, and the Pf Award Winners Club is always in an amazing setting in keeping with its prestigious reputation.”

It’s been incredible to hear the struggles and challenges of the Yorkshire Rows and what they’ve achieved.”

KAY VARLAS , who won the 2019

Learning and Development Partnership Pf Award, explained: “Winning for learning and development has set an example within our company and I’m encouraging others to enter the Pf Awards 2020.

When I won, it was the first time I’d entered but I was with a seasoned veteran in Raheel Mirza. The Pf Award Winners Club is great and I’m hoping to be able to bring more people from Thornton & Ross to the event in 2020.”

RAHEEL MIRZA , double Pf Award

Winner, who won the Leadership and Development Partnership Pf Award in 2016 and 2019, added: “Thornton & Ross would like to have representation from all levels of the organisation at the Pf Awards next year. We’re aspiring to havestrong candidates in every category.

“The Pf Awards allow people to raise their own profile and the profile of their organisation. Individuals are able to show their full potential. It’s great to have been in the presence of the Yorkshire Rows.”

ROB TURNBULL , winner of the 2017

Regional Manager Pf Award, continued: “It is a spectacular evening. It’s fantastic to be recognised amongst my peers. I’m exceptionally proud to be able to attend the Pf Award Winners Club and see how colleagues, peers, winners and alumni have progressed since their Pf Award win.”

DAVE LAMPARD, who won the 2019

9

Field Manager Pf Award added: “I was promoted two months after my win. I’m now Head of Business Development.

The Pf Award Winners Club has been both inspirational and heart-warming.

ALISON DUNCAN , 2017’s Secondary

Care Specialist Pf Award Winner and Outstanding Performer, concluded by saying: “It’s been a great event to be part of. I enjoy meeting the other Pf Award Winners and entering the Pf Awards is the best thing I’ve done in more than 20 years in the industry.

It offers additional opportunities, raises awareness of industry and helps to deliver amazing patient outcomes.

It’s great to be celebrated. It’s a fantastic event and I’ll be coming back for years; the speakers are exemplary.”

Go to www.pfawards.co.uk

M AG A ZI N E S P EC I A L ED I T I O N | N OV EM B ER 2019 | 19

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A DV ERTO R I A L

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WO R D S BY

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“Remote interactions provide a way to have flexible conversations with HCPs for sales, market access or educational purposes”

THE POWER OF REMOTE PERSONAL INTERACTIONS Digital engagement is essential in today’s tech-driven landscape.

But could life sciences companies be doing better?

E

ngagement between life sciences companies and healthcare professionals (HCPs) has always been about interactions between people, to build trustbased relationships. Traditionally, the interactions have relied on face-to-face meetings with presentations based on printed sales aids and leave-pieces. As time to meet with HCPs comes under increasing pressure, and technology is more widely accepted in day-to-day life, digital approaches are providing additional engagement opportunities for HCPs. Remote interactions provide a way to have flexible conversations with HCPs for sales, market access or educational purposes, without the need to rely on meetings that interrupt an HCP's already demanding day, or can only happen when a representative is in the locality.

Remote meetings in a virtual, compliant, technology-agnostic space offer convenience, security and flexibility to HCPs. Research from IQVIA has shown that HCPs find these meetings useful and informative.

Despite not being widely used as part of promotional or engagement strategies, remote contact is frequently amongst the top three most impactful interactions1.

Find out more about our research on remote interactions in our latest whitepaper ‘The power of remote personal interactions’ 1 available for download at www.IQVIA.com

Y O U R W AY F U R T H E R IQV IA.COM/FURTHER

M AG A ZI N E S P EC I A L ED I T I O N | N OV EM B ER 2019 | 21

MYTH BUSTING There are common myths surrounding remote sales solutions – what’s the reality?

Myth 1

Myth 2

We sometimes encounter customers who don’t believe that remote solutions deliver because they’ve had a negative experience in terms of outcomes; this can be down to the value proposition attractiveness itself, but more often than not, it’s because of the unsuitability of the value proposition for remote engagement. We believe in a channel neutral approach to solution design, i.e. let’s not try to fit a remote solution to everything; we need to build solutions that utilise the right channels at the right time. We call this the opti-channel approach; we urge customers to consider the suitability of the proposition using our opti-channel matrix.

Whether you’re designing a standalone solution, or an element of a multichannel mix, it’s important to identify the optimum channel through which to engage.

The remote accessibility of certain customer groups varies enormously; GPs for example are notoriously difficult to access on the phone, whereas access to other primary care stakeholders is comparatively easier. That said, the idea of channel preference as a standalone concept is essentially flawed; this is because channel preference is proposition dependent. The willingness of a customer to engage through a channel is very much dependent on the complexity of the proposition and in some cases, the attractiveness of the proposition. This is the same as our private lives; in the last week I’ve purchased some items online, some on the phone, and went into a store to buy a new bed – so what does that make my channel preference?

REMOTE SALES SOLUTIONS WORK FOR ALL

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he industry is increasingly adopting remote sales solutions as cost effective methods of interacting with healthcare professionals, either as standalone projects or part of a wider marketing mix. Many companies are keen to engage remotely and embrace the modern digital way of doing business.

Alveo Solutions is often consulted in designing multichannel solutions, a capability that is frequently outsourced.

We've learned from our extensive experience that there are some common misconceptions regarding the approach of remote selling, so we would like to dispel some of the myths.

CHANNEL PREFERENCE DATA

THE WILLINGNESS OF A CUSTOMER TO ENGAGE THROUGH A CHANNEL IS VERY MUCH DEPENDENT ON THE COMPLEXITY OF THE PROPOSITION

WORDS BY Peter Hyde

INSIGHT Figure 1.

REMOTE SOLUTION CASE STUDY This case study demonstrates what can be achieved by building a bespoke opti-channel solution for a client, utilising insight and extensive experience with the appropriate incorporation of digital elements.

TARGET ACCOUNTS 4500

8000

Alveo

7000

3500

6000

3000 5000 2500 4000 2000 3000

1500 1000

Client syndicated solution face-to-face 40 FTE team

Alveo bespoke sales solution remote 4 FTE team

500

2000

Market total – Patient treatment months

Individual product – Patient treatment months

4000

1000

Jul-16 Sept-16 Nov-16 Jan-17

Mar-17 May-17 July-17 Sep-17 Nov-17 Jan-18  Market

Myth 3

REMOTE SALESPEOPLE ARE LOWER CALIBRE SALESPEOPLE

Remote sales can be a cost-effective solution for various reasons, but this doesn’t mean the calibre of those delivering these solutions is any lower than a face-toface salesperson. Some effective faceto-face salespeople are not that effective on the phone and some are actually ‘call reluctant’. We proactively search out high performers in their current roles and put them through a tough selection process to assess their suitability for both remote interactions and face-to-face engagement, depending on the team we are building.

Too often, poor performing ‘nomadic representatives’ see remote job roles as a stepping stone to future roles. This is not a great fit, and it’s our responsibility to ensure those people don’t end up delivering remote solutions for the wrong reason!

 Alveo promoted product

Mar-18 May-18 July-18 Sep-18 Nov-18 Jan-19 Mar-19 May-19

 Competitor 1

 Competitor 2

GETTING IT RIGHT

This is a primary care solution (Figure 1.) delivering a compelling value proposition to practice managers and nurses with a mature brand. These customers, I would suggest, have no automatic pre-disposed channel preference, but are willing to engage remotely because of the proposition suitability.

We worked collaboratively with the client to perfect the value proposition and have engineered the solution through the optimum channel using a small team of high calibre, remote salespeople.

This ongoing project delivered an uplift in excess of £1 million in the first two years; a very different outcome to that delivered by a traditional 40 head syndicated team over the previous 12 months.

This a great example of what happens when you get it right – the right team delivering a perfected value proposition through the right channel.

Peter Hyde is Managing Director, Alveo Solutions. Go to www.alveosolutions.com

THIS IS A PRIMARY CARE SOLUTION DELIVERING A COMPELLING VALUE PROPOSITION TO PRACTICE MANAGERS AND NURSES WITH A MATURE BRAND

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Valued partner Contracting out market access activities frees up life sciences companies to do what they do best.

WORDS BY Sathyanarayanan Krishnamurthy

We pioneer We pioneer by looking beyond today to constantly improve and extend what is possible for the benefit of people living with skin conditions.

Want to know more about LEO Pharma?

Visit www.leo-pharma.co.uk

LEO Pharma, Horizon, Honey Lane, Hurley, Berks, SL6 6 RJ © LEO, LEO Pharma UK October 2019 ALL LEO TRADEMARKS MENTIONED BELONG TO THE LEO GROUP UK/IE/MAT-28930

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he world of life sciences is always evolving; so is the need for medicinal product/ medical device manufacturers to expand their operations globally. Merely inventing a pathbreaking medicine or a device won’t fulfil the purpose of life sciences companies. They must ensure that the drug/device reaches the end-user in the quickest and safest possible way.

They should create real value for patients in need. But what if the patient segments are distributed far and beyond the origin of manufacturing? In such cases, it is essential to access the markets where the potential patient segment exists.

However, market access needs to be carried out with caution to increase the scope of the business and to serve the purpose of life sciences.

To gain a competitive advantage in the target market, companies should focus on well-defined approaches that reflect local needs, not only from the product perspective, but also from the regulatory point of view. The strategy varies from company to company, but with the same underlying goal – successful market access.

In the field of life sciences, the market access strategy must align with that of the target market’s guidelines and regulations for successful product compliance.

There are a few key factors that companies should focus on: • An intelligence-driven regional market approach • Appointing local teams inclusive of qualified persons or authorised representatives • Establishing better contacts with local/ regional health authorities • Analysing product and organisational readiness.

Though a winning market access strategy must focus on all the points mentioned above, it appears to be of viable benefit only when applied to large manufacturers. Small or midsized companies do not, at times, possess sufficient in-house capabilities to access the markets beyond their reach. Even some larger manufacturers feel that they should invest much of their time and effort in new inventions rather than focusing on market access procedural setbacks. Therefore they must opt for third-party support, or in simple terms, contract out their market access activities.

INSIGHT

THE CURRENT SCENARIO

Partnering enables companies to ensure that the product reaches the market on time by lowering overall business risk

OUTSOURCING BENEFITS

In the past, partnering in the field of life sciences was considered a risky approach, given concerns about clinical data safety, patent transparency, and so on. However, the global life sciences industry is evolving at a rapid pace and becoming more dynamic.

The challenges, such as changing regulations and market dynamics, make it difficult for companies to obtain the necessary approvals in time. To ensure that the compliance is taken care of, companies often subcontract their regulatory activities to regional experts/service providers such as regulatory affairs specialists, regulatory intelligence (RI) providers, and life sciences regulatory experts. The benefits of this approach include: • Less time to market: Partnering with regional compliance experts can drastically reduce the go-to-market time for the manufacturers. Regional experts’ knowledge of local regulatory procedures saves time spent on creating, reviewing and submitting the dossiers, leading to increased chances of quick approvals and early entry to market.

• Reduced costs: Partnering with compliance experts provides companies with significant cost advantages. Instead of establishing an exclusive local operational hub and recruiting an in-house team which might require specialised training, companies can choose expert consultants who can handle local operations individually at a considerably lower cost.

• Risk management: Compliance or regulatory partners are highly-skilled experts well-versed in the conditions of the target markets. It is easier for them to mitigate the risks associated with the market access strategy and overcome any unwanted challenges. Partnering enables companies to ensure that the product reaches the market on time by lowering overall business risk.

Regulatory partnering in life sciences is growing fast; many companies partner with third-party compliance experts to ensure optimum results. The global pharmaceutical regulatory affairs partnering industry was valued at USD 5.7 billion in 2018 and is expected to grow at a CAGR of 11.9%1. The practice of regulatory partnering has proved beneficial for life sciences companies as it allows them to focus on key areas of operation, thereby improving efficiency.

REGULATORY PARTNERING

Companies outsourcing at least one function

22%

Companies that are not outsourcing, but have done it in the past

22%

Companies that are not outsourcing and have never outsourced

56%

Source: IQVIA

According to research from IQVIA 2 , most life sciences companies are in favor of regulatory partnering. Almost 56% of pharma companies are partnering with compliance experts for one or other regulatory activities. The majority of the manufacturers and new market enthusiasts say that regulatory partnering streamlines all of their procedural activities and ensures quick market access with lower cost and a managed risk profile. However, caution is needed when choosing the right partnering model.

PARTNERING AND OPERATING MODELS

As health authority guidelines and requirements evolve, the challenges pertaining to market access tend to change. Companies therefore need to choose the correct operational model based on their requirements. Models that companies generally adopt to address the challenges include: 1. Functional Service Provider (FSP) model: The FSP model offers companies the freedom to pick and choose the regulatory functions that they wish to outsource to a third party. The majority of big life sciences companies opt for this model, as it provides the flexibility of resources while reducing cost and maintaining quality.

2. End-to-End model: Since small-sized companies might not have specialised resources to autonomously carry out all functions, they choose the end-to-end subcontract model.

3. Hybrid model: Mid-sized companies often opt for a hybrid model to manage their regulatory activities. They use the FSP model to understand the dynamics of the domestic market, and the end-toend model to ensure successful market entry to international markets.

Regulatory partnering is a beneficial factor for compliant market access. It is time that companies shifted from traditional market access strategies. With the plethora of operating models available, regulatory constraints can easily be overridden, with a special focus on evaluating the right partner. It is important that companies ensure that the prospective partner has the right regulatory talent, intelligence, flexibility, and fits the bill of delivery models and the high-end technical excellence that suits the submission’s needs. Sathyanarayanan Krishnamurthy is Vice President – Regulatory Operations at Freyr Solutions.

Go to www.freyrsolutions.com https://www.grandviewresearch.com/industry-analysis/ biotechnology-pharmaceutical-services-outsourcingmarket | 2https://www.iqvia.com/-/media/quintilesims/ pdfs/seizing-the-potential-of-commercial-outsourcingin-the-pharmaceutical-sector.pdf 1

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EVOLUTIONARY SHIFT As the NHS and access to medicines renders the ‘one size fits all’ approach irrelevant, how are companies adapting to engage their customers?

O

ver the last decade the pharmaceutical industry has seen many of its blockbuster products come off patent in therapy areas such as cardiovascular, diabetes and respiratory.

These products were predominantly promoted within primary care and supported by large sales teams. This has resulted in a marked reduction in the numbers of sales representatives required to support those brands, which were traditionally supplemented with either syndicated or dedicated teams on contract.

These additional support teams have also shrunk and therefore the offering to the industry by means of a contracted field force has needed to adapt and evolve. Whilst this

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WO R D S BY

Clive Scragg

might not be true across the board, there has been a definite shift to the footprint of sales teams right across the industry in both shape and size. This trend will continue as more established products come off patent.

influential customers are all examples of how the environment has changed. This has made it more relevant than ever for us to be able to adapt our CSO offering, in terms of both skills and experience.

WHAT ELSE HAS EFFECTED THIS CHANGE?

WHAT’S CHANGING IN THE NHS AND HOW CAN INDUSTRY REACT?

As I commented in a Pf article earlier this year, the landscape of the NHS and access to medicines has changed and become increasingly difficult; whether that be launching a product or increasing access to an established brand. Consequently, the traditional ‘one size fits all’ approach is far less relevant in today’s market and companies need to be increasingly nimble and creative in how they interact with their customers. Patent expiry, cost pressures, guidelines and reduced access to key

The NHS Long Term Plan has seen the emergence of Primary Care Networks (PCNs) across the UK. A great example of an emerging customer group is in regard to clinical pharmacists. From July 2019, each PCN received recurrent funding to hire a clinical pharmacist. They will be working in partnership with existing healthcare professionals (HCPs) to drive up the standard of care and better support colleagues around medicines use.

From a pharmaceutical company perspective,

A DV ERTO R I A L

it will be important to engage with this emerging customer group, as they may have a direct influence on how a product may be accessed.

HOW HAS EVOLVE ADAPTED?

As this is a new NHS initiative and the concept is not proven, a flexible contract model is likely to be the best approach to engage these customers. At Evolve we have a skilled bank of qualified pharmacists, who are able to have a peer-to-peer interaction with these influential HCPs, complementing the existing field-based sales teams. Evolve are able to partner with pharmaceutical companies to tailor an offering to work with these customers in an educational, promotional or advisory capacity, depending on the need of a particular brand.

HOW HAS YOUR CSO OFFERING CHANGED?

I believe that the best approach is now to look at working in partnership with our clients during the early stages of any outsourcing project. At Evolve, we regard ourselves as a ‘Commercial Solutions Organisation’ rather than a ‘Contract Sales Organisation’.

Our priority lies in establishing a strong working partnership and understanding with our clients.

At the start of any project we sit down to discuss their brand specific needs in order to forge the correct solution for them, rather than simply providing the headcount at the end. By engaging early with the client to discuss what their project's objectives, goals and scope are, we can help to design, build and develop a much more rounded solution, where shared outcomes and KPIs are understood and agreed from the outset. This type of approach results in less confusion and misunderstanding and ultimately creates a solution that provides the required return on investment.

HOW WILL THE CSO OFFERING CHANGE AS PRODUCTS GO OFF PATENT?

The type of products being launched, coupled with the changes to the environment in which we launch into, means that the need to look at different ways of supporting sales; market access or medical science liaison (MSL) teams will need to adapt. Looking at the roles of the MSL for example; as the industry launches products into more specialist disease areas, such as oncology, immunology and rare diseases, the ability to have a contracted field-based medical

“Companies need to be increasingly nimble and creative in how they interact with their customers”

team to support the commercial function and appropriately support off-label and unlicensed indications will also be relevant.

The need for these teams will vary over time as indications may or may not become approved and to have them as a flexible resource could become more appropriate from a commercial viewpoint.

Specialists in Recruitment, Contract Sales Teams and Outsourcing

Market Access Managers

WILL THE WAY WE INTERACT WITH HCPS CHANGE?

I think this has already started to happen, both within the industry and with companies supporting the industry. Individuals working within the NHS, as in life, are constantly looking to digest their information in different ways. As such, we need to offer the capability to interact with those customers in the most effective and appropriate way for them, and not have a one-dimensional view. Not everyone is looking for a traditional face-to-face sales interaction and some individuals would prefer to discuss things on a digital basis. Customers often prefer that interactions take place remotely, where they may share the information online or over the telephone. I think it’s important to offer an alternative to our clients where the technology and ability to interact like this is available, by offering skilled hybrid teams that can evolve with the changing marketplace.

Key Account Managers

Primary Care Reps

MSL Resource

DO YOU THINK A CSO OFFERING IS STILL RELEVANT IN TODAY’S MARKET?

Absolutely, in fact I think it’s probably even more relevant than ever. The fact that the market is more complex and new challenges are always upon us, means that our ability as a company to offer solutions that are ever more creative and flexible becomes increasingly important. I believe the future for CSO is bright, as long as the industry is in the mindset to adapt to change!

Clive Scragg is Director of Commercial Development, Evolve. Go to www.evolvecouk.com

Multi-Channel Account Managers 0113 457 0777 outsource@evolvecouk.com www.evolvecouk.com

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D I R ECTO RY

DIRECTORY ARRIELLO Arriello, based in Europe, has been a leading provider of risk management and compliance services to the life sciences sector since 2008.

These include market consultancy, global regulatory affairs strategy and implementation, full and local pharmacovigilance solutions, clinical drug safety, and quality and compliance auditing. www.arriello.com sales@arriello.com +353 1 293 6755

ASHFIELD Ashfield, part of UDG Healthcare plc, is a global leader in commercialisation services for the healthcare industry.

We partner with our clients to build creative, scalable and tailored health solutions, to deliver positive outcomes for patients and add value to your business. www.ashfieldhealthcare.com web@ashfieldhealthcare.com 0870 850 1234 ALVEO SOLUTIONS Alveo Solutions is the first contract sales organisation to offer a high quality service to clients looking for a more individualised and responsive solution. We provide versatile multichannel solutions that are designed to deliver impressive results whilst building sustainable channels to engage with healthcare professionals. www.alveosolutions.com info@alveosolutions.com 023 8185 0089

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CEGEDIM HEALTH DATA Cegedim Health Data is the trusted partner for real world data and real world evidence. We believe that the application of data, intelligence and reason can vastly improve business, society, patient care and outcomes. www.cegedim-health-data.com samir.dhalla@cegedim.com

IQVIA IQVIA is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry, dedicated to delivering unique and actionable insights. In the UK, we serve pharmaceutical and biotech companies and most of the NHS

0207 501 7000

Trusts to drive innovations and improve patient outcomes. www.iqvia.com

CHASE We are a leading provider of contract and permanent people solutions in the pharmaceutical, healthcare and clinical industries. www.chasepeople.com connect@chasepeople.com 0131 5536644

EVOLVE Market leading recruitment and CSO within the pharmaceutical and healthcare sectors. www.evolvecouk.com support@evolvecouk.com 0113 457 0777

E4H E4H is an industry leader in medical education and partnership working.

We work closely with our clients, healthcare professionals and patients to understand needs and provide the right solutions. www.e4h.co.uk enquiries@e4h.co.uk 01462 226126

PHARMAJOBS Where Pharma Talent Goes.

PharmaJobs supports pharmaceutical professionals who strive for more, whether established thought leaders, or rising stars making their mark in industry. We provide the best roles for you to take the next step in your career. www.pharmajobs.co.uk hello@pharmajobs.co.uk 01462 226130

STAR Star is passionate about helping clients to make a commercial impact through their unique approach to data, insight and unrivalled industry knowledge and experience. Its services are underpinned by selecting the very best talent and placing them in roles they love. www.starmedical.co.uk resourcing@starmedical.co.uk / outsourcing@starmedical.co.uk 01225 336 335

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