Pf Magazine Spring 2022

SPRING 2022 PF-MEDI A .CO.UK

THE FUTURE OF PHARMA

“

The big question is: now that we’ve built digital relationships, how do we make them sustainable?

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• Sustainability: From buzz word to business-critical

• Keeping compliant in a digital world

• Opportunities & challenges in rare disease

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EDITOR

W

Hello.

elcome to the first Pf Magazine of 2022, which examines what the year could have in store for pharma if opportunities are seized and lessons from the last two years are learned.

As I write this, the Prime Minister, Boris Johnson is announcing an end to all domestic Covid restrictions in England. It’s a big step forward and whilst people may have mixed feelings about this, there is no doubt that the last two years has given industry the skills, and the standing, to transform its reputation, work more collaboratively with the NHS and improve patients’ lives.

Following the Veeva Europe Commercial and Medical Summit at the end of last year, our cover story includes insight from healthcare leaders at Boehringer Ingelheim, LEO Pharma and Merck on the rapid digital shift of the last two years, developing relationships and a modern marketing strategy for this new world we find ourselves in.

There is no doubt that a big consideration for 2022 is sustainability and our feature on page 12 looks at how organisations can turn a buzz word into a business-critical principal. As Per Rehné states in the article: “The pharma sector is razor sharp in terms of testing and scientific profiling; that same expertise can be directed at ‘greener’ manufacturing and supply.”

It is no surprise that clinical trial recruitment boomed during Covid, in fact, compared to 2019/2020, it nearly doubled in 2021 when just short of 1.4 million participants took part in clinical research across England alone1. How can industry maintain this momentum? Meerim Almazbek considers how technology could be the solution to a lack of diversity in clinical trials.

To gain an insight into how one organisation has evolved in the digital landscape, Pf spoke to Federico Fanti, Global Head of Commercial Operations, LEO Pharma.

Read his thoughts on the future of engagement in our interview on page 26.

As our ways of working continue to adapt, it is incredibly important to understand how to keep compliant in the digital world, from websites and social media to webinars and podcasts. Our feature on page 30 offers plenty of practical tips from Rina Newton.

I hope you enjoy reading this issue and if you would like to be involved in the Summer issue of Pf Magazine, drop us a line at hello@pharmafield.co.uk

1 https://www.nihr.ac.uk/about-us/what-we-do/ourresearch-performance/annual-statistics.htm

Emma Cooper emma.cooper@e4h.co.uk HEAD OF MARKETING OPERATIONS

Emma Morriss emma.morriss@e4h.co.uk CREATIVE DIRECTOR

Emma Warfield emma@e4h.co.uk MID WEIGHT DESIGNER

Sigrid Dalland sigrid@e4h.co.uk SENIOR EDITOR E4H

Amy Schofield amy@pharmafield.co.uk COMMERCIAL DIRECTOR

Hazel Lodge hazel@e4h.co.uk FINANCIAL CONTROLLER

Fiona Beard finance@e4h.co.uk PUBLISHER

Karl Hamer karl@e4h.co.uk HEAD OFFICE

3 Waterloo Farm Courtyard, Stotfold Road Arlesey, Bedfordshire SG15 6XP United Kingdom

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M A G A Z IN E | S P R IN G 2 0 2 2 | 1

Spring HAVE YOUR SAY: If you’d like to share an idea for a feature or collaborate with us on a captivating advertorial, please get in touch.

GET IN TOUCH: hello@pharmafield.co.uk

Contributors

@pharmafield

@pharmajobsuk

Pf Magazine

Jeremy Hooper

Jeremy is Health Economics and Intelligence Consultant at Conclusio.

He has worked on the analysis of large and complex data sets in the Defence and Health sectors internationally for over 25 years.

NHS finance and budget impact modelling, page 15 Chris Moore 

Monica Shaw 

President of Veeva Europe, Chris is a 30-year veteran of the life sciences industry who began his career at ICI Pharmaceuticals (now AstraZeneca).

Monica is Executive Vice President and Head of Europe, Canada, and Australia at LEO Pharma. Monica originally trained as a medical doctor, before moving across to the pharma industry 15 years ago. She has launched over 15 products in her career and is passionate about getting great products to patients.

John Leslie

Cover story, page 08

Ben is Global President at Mind+Matter, an Ashfield Health company.

Cover story, page 08 Peter Guenter

Peter is a member of the Executive Board of Merck KGaA and CEO of Healthcare. He joined Merck in January 2021 after serving as CEO of Almirall from 2017–2020.

Per Rehné

Cover story, page 08

Per is Chief Executive Officer at Clasado Biosciences.

Timmo Rousku Andersen

Sustainability in pharma and life sciences, page 12

Timmo is Head of Human Pharma Regions at Boehringer Ingelheim and has the global commercial responsibility for areas including diabetes, oncology, pulmonology, and cardiology.

Cover story, page 08

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Joanna Stephenson

Joanna is Managing Director at PHD Marketing.

Sustainability in pharma and life sciences, page 12

John is NHS Finance Associate at Conclusio and was previously a Chief Officer of a large Clinal Commissioning Group.

NHS finance and budget impact modelling, page 15 Ben Beckley 

Cell and Gene Therapy, page 16

In this issue 04 Meerim Almazbek 

Meerim is Senior Solutions Director, Community Planning& Optimization, Global Team Lead at Within3.

Clinical trials in 2022, page 20 Craig Bradley

Craig is Head of Marketing Immunology & HAE at Takeda and was PM Society Chair 2017–2020.

Rare but relevant, page 22 Emma Morriss

Emma is Head of Marketing Operations at E4H. The brand managers digital toolkit, page 25

INSIGHT

An overview of the best bits recently published on www.pf-media.co.uk

Clinical trials in 2022

06

INDUSTRY ROUND-UP

The latest news, current collaborations and ones to watch in the industry

08

COVER STORY

Commercial innovation and the future of pharma

11

PHARMACY

The state of prescriptions

12

FEATURE

Sustainability: From buzz word to business-critical

15 Federico Fanti 

Federico is Global Head of Commercial Operations at LEO Pharma and has over 10 years’ experience in the pharma industry.

In conversation, page 26 Rina Newton 

20

ICYMI

22

INSIGHT

Rare but relevant: Challenges and opportunities in rare disease

25

INSIGHT

The brand managers digital toolkit

26

IN CONVERSATION

Pf talks to Federico Fanti, Global Head of Commercial Operations, LEO Pharma

30

INSIGHT

Compliance in a digital world

34

NHS

MOVERS AND SHAKERS

Budget impact modelling

Who’s moving where in the industry?

16

36

INSIGHT

CAREERS

Cell and Gene Therapy: Keeping the patient at the heart of treatment

Pf shines the spotlight on OKRA.ai CEO Dr Loubna Bouarfa

Rina is an ABPI Code and healthcare compliance expert.

Compliance in a digital world, page 30

“The organisations that reach the most HCPs in the next two decades will be those that provide relevant information through deliberate, timely interactions at every turn” Cover story, page 08

ICYMI IN CASE YOU MISSED IT

MORE THAN JUST PRINT. In between your quarterly issues of Pf Magazine, you will find daily news, exclusive web articles and thought leadership opinion pieces on www.pf-media.co.uk Take a look at some of the exclusive content you may have missed and the exciting things we’ve got coming up.

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PF-MEDIA.CO.UK HAVE YOUR SAY

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IC Y MI

NEWS

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WEB.EXCLUSIVES

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TECH

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COVID-19

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GLOBAL.PHARMA

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VIDEO

QUICK LOOK HAVE YOU CAUGHT UP ON OUR NEW VIDEO SECTION YET? Featuring educational webinars and exclusive interviews, just scan this code to catch up on all the content you may have missed.

1

2021: Reflections on a year in pharma Following his first full year as Managing Director of Novartis UK, Ireland & Nordics and Country President UK for Novartis Pharmaceuticals, healthcare leader Chinmay Bhatt shares his reflections on 2021 and how industry can build on this for 2022.

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FOUR MUST-READ ARTICLES THIS MONTH

Pitch perfect: Understanding the new value proposition for the NHS The shifting mindset and preferences of the NHS customer means that industry now needs a new way of organising and describing its commercial propositions.

Wilmington Healthcare’s Oli Hudson describes what this new value proposition looks like and what it needs to cover.

3

Employer branding in recruitment Done well, employer branding can help organisations stand out against competitors and gain an edge. Here, Chris Anderson, Operations Director at Evolve, shares his insight into why employer branding is so important for pharmaceutical and healthcare companies in today’s workplace and how to achieve it.

4

Ending access challenges to new combination treatments Combination treatments have the potential to deliver significant clinical benefits to patients across a number of disease areas, but what are the challenges facing them? Dr Emma Roffe, Oncology Head for Takeda UK and Ireland, explores this.

M A G A Z IN E | S P R IN G 2 0 2 2 | 5

Ones to watch Start-ups that have caught our attention

Below: ExSeed Health

EXSEED HEALTH

ExSeed Health is a male fertility start-up which provides a testing kit marrying the powerful camera capabilities of modern smartphones with sophisticated, cloud-based analysis. It provides patients with a live view of their sperm sample directly on the screen and highly accurate quantitative analysis of their sperm concentration and motility in just 3–5 minutes. The results are paired with additional behavioural and diet data to generate a bespoke lifestyle program that helps men improve their sperm quality over a 90-day period. The at-home test does not require users to attend a doctor’s surgery, clinic, or hospital facility. www.exseedhealth.com

MOTILENT

A technology start-up on a mission to change the way we see the gut, Motilent specialises in the assessment of digestive diseases using AI medical image analysis. Focusing on Crohn’s Disease, Irritable Bowel Syndrome and Gastroparesis, the start-up was launched by King’s College London and University College London and is now making its mark in the United States following clearance from The Food and Drug Administration and a national hospital partnership. www.motilent.co.uk

ONCOASSIST

Integrated software platform, ONCOassist, was created to improve cancer care globally. With the aim to streamline the decision-making process for oncology healthcare professionals by including relevant, up-to-date tools and content all in one place, the app saves valuable time, reduces stress and improves the quality of patient care.

It is the only platform to offer adjuvant tools specifically for mobile usage.

NEW AIDS AND HIV ACTION PLAN FOR 2022 TO 2025

YOPPIE

The Department of Health and Social Care has published a policy paper Towards Zero – an action plan towards ending HIV transmission, AIDS and HIV-related deaths in England – 2022 to 2025. The four-year action plan benchmarks its objectives against 2019 statistics which were not affected by Covid-19 related factors.

www.yoppie.com

The new action plan aims to: • Reduce the number of people diagnosed with HIV infection in England from 2,860 in 2019 to under 600 in 2025.

• Reduce the number of people diagnosed with AIDS within three months of HIV diagnosis from 219 in 2019 to under 110 in 2025.

• Reduce deaths from HIV/AIDS in England from 230 in 2019 to under 115 in 2025.

www.oncoassist.com

Female-founded and focused on building the future of menstrual care, Yoppie creates products and services that conveniently fit into busy lifestyles. With a firm belief that menstrual care needs a makeover, Yoppie puts all of its products in packaging that looks good on the shelf and is recyclable, plastic-free and FSC certified.

Offering flexible letterbox subscription services and sustainable, natural period care products, Yoppie also provides a support group for sharing stories and asking questions.

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MERGERS & ACQUISI T IONS

IN D U S T R Y R O U N D - U P

E4H

Brand commercialisation and pharmaceutical marketing agency, E4H, has been acquired

by Uniphar Plc, the trusted global partner to pharma and Medtech manufacturers.

E4H, as a business unit, will sit within the Group’s Commercial & Clinical Pharma (C&C Pharma) division which provides outsourced sales, marketing and distribution solutions to multinational pharmaceutical and medical device manufacturers.

PSYROS DIAGNOSTICS

UK-based Psyros Diagnostics has signed an agreement to be acquired by Swedish company Prolight Diagnostics AB. Psyros Diagnostics’ ground-breaking single-molecule counting Point-Of-Care (POC) technology enables the measurement of biomarkers at extremely low concentrations in approximately 10 minutes or less. The Covid-19 pandemic saw the use of POC testing increase substantially and increased the value of rapid, simple and efficient testing near the patient.

MEDABLE

Medable, the leading software provider for patient-centered clinical trials, has acquired LEO Innovation Lab’s Omhu A/S, a Denmark-based digital health tech company. Omhu was launched in 2020 to develop new ways of supporting patients and doctors when diagnosing, managing, and treating skin conditions. As part of the agreement with LEO Pharma, Medable will take over the Omhu mobile applications and a team of 38 people with significant experience in digital health and artificial intelligence.

RECIPHARM

Recipharm is continuing to build its service offerings in new biologic modalities through the acquisition of Vibalogics, a virotherapy contract development and manufacturing organisation.

The deal will provide Recipharm with capabilities in new biologics modalities, leveraging Vibalogics’ expertise in oncolytic viruses, viral vaccines, and viral vector gene therapies to bring a high degree of diversification across multiple technologies and modalities.

COLLABORATION CORNER TECHNOLOGY

SKIN DISEASE

DRUG DISCOVERY

Cegedim Healthcare Solutions is collaborating with Clarity Informatics (part of the Agilio Software Group), as part of its extended partner programme. The cooperation supports the expansion of Clarity Informatics within the UK, introducing TeamNet to Cegedim customers, a sharing, compliance, and workforce management platform for GP practices and practice groups.

TeamNet has been built specifically for primary care and can be used as both an intranet and a sharing platform that will revolutionise the way practices manage and communicate with their team and external stakeholders.

Almirall and The Institute for Research in Biomedicine Barcelona, an independent, international research centre engaged in fundamental and applied biomedical science, have announced a research collaboration to identify new oral treatments for immune-inflammatory skin diseases with remaining high unmet medical needs using molecular glue degraders, a novel therapeutic modality. These monovalent degraders offer a new avenue to induce the degradation of potentially disease-causing proteins that cannot be targeted with conventional therapeutic agents.

Curve Therapeutics has announced a global research collaboration with MSD, to discover and validate modulators of up to five therapeutic targets using its Microcycle® technology, initially for oncology and neurology indications.

Under the agreement, Curve will perform high throughput mammalian cell-based functional screening, hit characterisation, data-mining and analysis, and Microcycle® optimisation. MSD will be responsible for lead optimisation, clinical development, manufacturing and commercialisation of compounds identified through the collaboration.

M A G A Z IN E | S P R IN G 2 0 2 2 | 7

&

Commercial innovation

the future of pharma

Healthcare leaders from Boehringer Ingelheim, LEO Pharma, and Merck reflect on the rapid digital shift of the last two years, developing relationships and a modern marketing strategy.

WORDS BY Emma Cooper

E

very year, innovators and practitioners from across the biopharma industry gather at the Veeva Europe Commercial and Medical Summit to exchange ideas and set a course for the future of life sciences. At the most recent conference in November 2021, leaders from Boehringer Ingelheim, Merck, and LEO Pharma – amongst others – discussed changing commercial models and how the events of the past two years will shape the next two decades.

Industry leaders reflected on the evolution of relationships between life sciences brands and scientific experts, physicians, and other stakeholders in the pharma ecosystem.

In particular, they explored how their companies must adapt to new challenges in order to maintain strong connections with their customers.

Chris Moore, president of Veeva Europe, offered his observations from working with a broad spectrum of top pharma companies and up-andcoming biotechs, noting: “The pharma industry has achieved amazing 8 | P F - M E DI A .C O.U K

things, especially in the last couple of years. In many cases, it’s had to rely on digital interactions to reach stakeholders during this time. The big question is: now that we’ve built digital relationships, how do we make them sustainable? And most importantly, how do we make them real and relevant?”

The move to digital modes of engagement has certainly accelerated over the past two years. Companies find themselves constantly reassessing how much to return to face-to-face meetings and where to rely on digital platforms for multichannel engagement that healthcare professionals (HCPs) often prefer, and what is the right balance.

SHARPENING PRECISION ENGAGEMENT SKILLS

For LEO Pharma, it all starts with upskilling. The company has found that the skills of today’s representatives need to be dramatically different from the representative of 10 or 15 years ago. In Veeva Summit’s opening keynote, Monica Shaw, Executive Vice President for Europe, Canada, and Australia, shared that representatives

need to be “curious, open minded, and agile.” Digital know-how is now a key asset to rapidly adjust and iterate engagement strategies.

Peter Guenter, CEO of Merck Healthcare and member of the executive board at Merck KGaA, doesn’t believe representatives will ever disappear, especially not in specialty care. “The pandemic is fundamentally changing the way we think about our go-tomarket model,” he said. “I would describe it as a more customer-centric, face-to-face model – augmented by digital solutions.”

At Merck, this means adopting a more precise approach to HCP engagement. Guenter explains: “We’re enhancing direct face-to-face engagement with representatives, by calling in an ‘on duty’ medical science liaison (MSL) to virtually answer specific scientific questions during in-person meetings when needed. This hybrid customer engagement with collaboration between sales and medical actually helped us increase share of voice without increasing our number of representatives or MSLs.”

C O V E R S TO R Y DRIVING PERSONAL CONNECTIONS THROUGH RELEVANCE AND TRUST

Chris Moore

President, Veeva Europe

Timmo Rousku Anderson

Head of Human Pharma Regions, Boehringer Ingelheim

Peter Guenter

CEO, Merck Healthcare

Monica Shaw

Executive Vice President and Head of Europe, Canada and Australia, LEO Pharma

With a focus on digital engagement in recent years, most Veeva Summit participants noted they are also looking to rebuild the human connections that came with meeting HCPs in person.

Physicians increasingly require scheduled appointments times for representative or MSL visits, so there’s less physical mixing in waiting rooms or hallway chats and fewer organic, on-the-fly touchpoints.

Timmo Rousku Andersen, Boehringer Ingelheim’s Head of Human Pharma Regions, noted that, given these limitations, attributes like trust, relevance, speed, proximity – and being digitally empathetic – are even more important to HCPs. “By ensuring easy, fast, and super relevant engagements with our customers, we can still keep that emotional connection,” he said, during the event keynote.

CREATING A 360-DEGREE VIEW

In a healthcare system that’s increasing in complexity, it can be difficult to identify who to build relationships with,

or how best to do so. According to Monica Shaw: “The world has become more complex. There are more stakeholders at every part of the value chain, whether we’re talking about payers, customers, or how we support patients in understanding their disease. So key account management has probably never been more important than it is today.”

Andersen recommends creating a 360-degree view of each customer, which makes it easier for a life sciences organisation to coordinate across multiple medical or commercial teams. “We need to think much more fluently through a continuum of services, offerings, and interactions,” he noted. “Digitalisation allows us and our customers to better record, understand, measure, and demonstrate real value around patients. HCPs don’t care whether our business card says commercial representative, MSL, key account manager, or anything else. They just want us to solve their patients’ issues.”

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Now that we’ve built digital relationships, how do we make them sustainable?

And most importantly, how do we make them real and relevant?

”

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C O V E R S TO R Y FROM SOLO SPORT TO TEAM EFFORT

This approach is changing the role of the representative and forcing field teams to rethink their reliance on personal relationships. Andersen feels that representatives now need to move from the traditional mentality of ‘my’ customer to ‘our’ customer – and from being a ‘friendly face’ to being a ‘relevant face.’

He said: “The representative needs to base each visit on everythingthe company knows about that customer. Then they need to share any insights they gain rather than keeping everything in their head, because that’s the mindset shift that will catapult us forward and make us more relevant.”

MARKETING STRATEGY

The digital evolution also impacts marketing strategists as they work to shorten campaign cycles. Life

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The digital evolution also impacts marketing strategists as they work to shorten campaign cycles

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sciences companies acknowledge that they can no longer take months to build marketing promotions based on sales insights. Instead, organisations need to take those learnings and flip them into compelling new campaign materials in a matter of weeks.

Shaw noted that in addition to timeto-market, LEO Pharma is focused on delivering the right content to its customers. She said: “An interesting learning for us during our recent product launch has been the kind of information that people want. We’ve seen quite a lot of pull for specific content to service evolving HCP needs as they’re engaging with their patients in a digital environment. It’s all about being relevant and adding value to our customers, day-to-day.”

LOOKING AHEAD

The most important takeaway from Veeva’s Summit was that, whether in-person or remote, commercial and medical teams need to challenge the status quo to drive effective customer engagement. The organisations that reach the most HCPs in the next two decades will be those that provide relevant information through deliberate, timely interactions at every turn.

PHARMACY

The state of prescriptions Chemist4U has analysed NHS data on England’s prescription levels in the last five years, the most prescribed drugs in England and the forecast for the future.

WORDS BY Emma Cooper

O

nline pharmacy and NHS healthcare provider Chemist4U has surveyed 2,024 people, revealing over half (53%) of British people think that as a nation, we are prescribed too much medication.

Analysing NHS England digital data, Chemist4U’s State of England’s Prescriptions Report also revealed the considerable increase in prescriptions over the last five years and predicted the number would continue to rise.

HOW DO ELECTRONIC PRESCRIPTIONS COMPARE? According to Pharmdata1, 64.69 million items were dispensed using the electronic prescription service (EPS) from the NHS Dispensing and Services

Estimated number of prescriptions over the next four years: Year

Number of prescriptions

2021

1,123,408,776

2022

1,130,770,066

2023

1,138,131,356

2024

1,145,492,646

2025

1,152,853,936

Summary in England, since February 2020, with 81.07 million items distributed overall, meaning that just under 80% (79.80%) of prescriptions were delivered using this service.

Due to the Covid-19 pandemic, this number has increased since April

2020. Between March and April 2020, there was an 11.46% increase in the items dispensed via EPS, with 92.07% of prescriptions dispensed in this way.

This trend has continued throughout the past 18 months, with just over 96% of all items now dispensed using EPS.

Top five most prescribed items in England in 2021: Rank

Prescription

Medication use

Total number prescribed

1

Atorvastatin

Lowers cholesterol

54,752,135

2

Omeprazole

Treats heartburn and indigestion

33,915,913

3

Levothyroxine sodium

For underactive thyroid

34,333,510

4

Amlodipine

Treats high blood pressure

33,088,928

5

Ramipril

Treats high blood pressure

29,727,745

PUBLIC PERCEPTIONS A recent review suggested that onetenth of items2 dispensed in England by primary care settings are inappropriate or could be changed, with 15% of people in the country also taking five or more medicines per day.

When it comes to paying for private prescriptions from Pharmacist Independent Prescribers, almost two in five (39%) of those surveyed said they would be happy to pay for this service. 15% said they would be happy to pay between £6–£10, including

the current £9.35 NHS prescription cost, with a further 9% willing to pay £11–£15, and 5% willing to pay £16–£20.

Only 0.1% said they’d be willing to pay over £21.00.

1 w ww.pharmdata.co.uk 2 w ww.bbc.co.uk/news/health-58639253

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Sustainability

in pharma & life sciences How can you turn a buzz word into a business-critical principal?

Per Rehné explores the benefits of changing your mindset.

WORDS BY Per Rehné

L

ike many adjacent industries, the life sciences and pharmaceutical sectors are making serious headway in the direction of sustainability.

While the idea isn’t new – all competitive modern businesses are now putting ‘green’ principles at the heart of business – it’s new ground for many in terms of using sustainability performance as a commercial edge.

The health market has almost existed in a bubble when compared to more traditional ‘retail’ industries such as food and beverage and fast-moving consumer goods (FMCG) because the intent is different. Consumers are judging products on different things – when selecting a product such as medicine to meet a particular health need, it’s all about the scientific backing and efficacy, or when more than one comparable alternative

exists, it may then come down to price point or brand equity. Now, of course, sustainability is becoming absolutely central to every business looking to compete. Consumers are making purchase decisions that include the environmental impact of the product, which creates real influence on the bottom line.

At Clasado Biosciences, we sit at a really interesting crossroads in terms of where we fit in the market. Not only do we manufacture the award-winning Bimuno® prebiotic supplement for consumer retail markets including independent pharmacies, high street stores and supermarkets, but alongside we sell Bimuno® as a prebiotic ingredient for other brands to use to power their formulations.

We also have an active healthcare professional programme, engaging with pharmacists, general practitioners and

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Consumers are making purchase decisions that include the environmental impact of the product, which creates real influence on the bottom line

1 2 | P F - M E DI A .C O.U K

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F E AT U R E

dietitians, to spread more knowledge of gut health and its advantages.

This multifaceted business strategy gives us a unique perspective on what consumers are looking for, what the health industry is seeing in terms of demand, how product developers are reacting, and what the main priorities are set to be moving forward in the health industry. Of course, it also helps us to shore up our own market performance and ensure we’re always delivering what the market needs. For us, this means making our business as sustainable as it can be.

One of the most interesting aspects of sustainability as it continues to drive the life science agenda is that a more data-driven approach can be extremely effective at creating lasting,

meaningful change. The pharma sector is razor sharp in terms of testing and scientific profiling; that same expertise can be directed at ‘greener’ manufacturing and supply.

For our part, we aim to make our sustainable efforts transparent and deeply integrated into our company’s DNA. It’s this approach that stops sustainability being an obligation or, at worst, just lip service. To create a real ‘sustainable transformation’, we will mentally deconstruct our complex supply chain to analyse each stage individually. What are our Carbon outputs in scopes 1, 2 and 3? Where can we digitalise to reduce CO2 emissions and how are we making that measurable?

This approach means that our business always understands the wider environmental impact of its activity, from the sourcing of raw materials, the production of our prebiotic ingredient, the manufacturing of our finished consumer supplements and all packaging and labelling. With transparency, it also enables every member of the Clasado team to be invested in the sustainable development of the business.

We all have important sustainable initiatives on the agenda, including global Net Zero goals, the EU Packaging Levy, and for businesses in the UK, the Plastic Packaging Tax and Competition & Market Authority’s Green Claims Code – so there’s never been a better time for life sciences to get better acquainted with a consumer-led and data focused sustainability strategy.

Our key message to our friends and peers in the life sciences and pharma sector, whether that be OTC or otherwise, is that we have to change our mindset when it comes to sustainability. If we view it as a concession or a box ticking exercise, it won’t be meaningful. If it’s embraced as part of company culture and is given real weight in product or brand development, it becomes a very organic process. As the health industry continues to become more like the ‘classic’ retail sectors, how effectively life sciences, biosciences and pharma businesses can create meaningful change will not only protect the long-term future of the sectors but will signpost a new dawn of sustainability.

Per Rehné is CEO at Clasado Biosciences.

Go to www.clasado.com

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F E AT U R E

Making marketing more meaningful How ‘green’ communications in pharma can be sincere but strategic.

WORDS BY Joanna Stephenson

A

cross the diverse and exciting over-the-counter (OTC) pharma landscape, one of the most notable – and almost inevitable – evolutions is that the sector is becoming more closely related to classically ‘commercial’ retail categories.

In essence, shoppers are increasingly judging pharmaceutical businesses by the same standards and qualities as they would in everyday purchase industries such as FMCG, food and beverages. The behavioural gap between pharma and retail is narrowing, particularly when looking at how proactive consumers are getting with managing their own physical and mental health.

Where typically efficacy or price point might be a natural focus for the consumer when looking to purchase OTC pharmaceutical products, there are now many more factors at play.

Naturally, as consumer demand for sustainable products continues to soar, this climbs higher on the priority list for pharmaceutical businesses and their supply chains. As a specialist communications partner to the life sciences and biosciences sectors, at PHD Marketing we are seeing this play out in real time.

How can pharmaceutical businesses – which haven’t necessarily had to focus on sustainability as a commercial edge previously – connect the dots between a sustainable supply chain and retail success?

14 | P F - M E DI A .C O.U K

MAKE EVERY ELEMENT OF THE SUPPLY CHAIN MORE MEASURABLE

Whether ingredient sourcing, packaging, labelling, logistics or otherwise. When sustainability can be measured, it can be analysed, understood and improved.

UNDERSTAND THE GREEN CLAIMS CODE AND ITS IMPACT

In an effort to tackle ‘greenwashing’, where sustainability claims are causing confusion and mistrust in consumers and businesses alike, new guidelines from the UK Government’s Competition and Markets Authority have been introduced1. This means that all externally communicated sustainability claims, such as on-pack, point of sale or on websites: • Must be truthful and accurate • Must be clear and unambiguous • Must not omit or hide important relevant information • Must make comparisons fair and meaningful • Must consider the full life cycle of the product or service • Must be substantiated.

DON’T UNDERESTIMATE THE CONSUMER DECISION-MAKING INFLUENCE

How shoppers engage with sustainable products is the subject of much study; the bottom line is that it influences purchase decisions. As many pharma categories start to overlap and merge,

the shelves are becoming ever more competitive. This means every tangible commercial edge that can be taken, must be taken. Packaging is a great example; new data from the Chartered Institute of Marketing finds that an overwhelming 78% of consumers want large companies to do more concerning sustainable packaging.

“

How shoppers engage with sustainable products is the subject of much study

”

F IND INSPIRATION IN THE FMCG WORLD

The sustainability drive being seen in life sciences and pharma sectors may be relatively new, but it started much earlier in the FMCG sector. This has given brands a great deal more time to use sustainability strategically and weave it deeper into the DNA of the product. While still very different in development, delivery and regulation, pharmaceutical businesses can put sharper focus on how other sectors have turned ‘obligation’ into a true retail competitive edge.

Joanna Stephenson is MD at PHD Marketing.

Go to www.phdmarketing.co.uk 1 w ww.gov.uk/government/publications/ green-claims-code-making-environmental-claims

NHS

NHS finance & budget impact modelling Will 2022 be the year pharma demonstrates it has aligned with NHS ambitions, aims and goals?

WORDS BY Jeremy Hooper & John Leslie

M

any decisions about the design of the financial system at the heart of the NHS are taken at national level. However, as key elements of the future NHS evolve, including integrated care systems (ICSs), new provider collaboratives and new forms of contracting, many of these decisions are also being taken at a more local level with place becoming the key point of intervention and transformational currency.

While plans to restore financial and operational performance have often proved very short-lived, pharma’s support of the NHS through the pandemic signals an opportunity for industry to adapt its approach to partner with the wider NHS to help achieve its broader aims of financial sustainability and tackle disparities in health outcomes.

New financial arrangements, including the dismantling of Payment

by Results (PBR) and the increasing importance of system-wide working, accountability and responsibility makes the management of costs, delivering quality services and the metric on how that is measured everyone’s business.

The focus on cost generation will fall on collective performance, not just where it is generated.

ONE SIZE DOESN’T FIT ALL While common issues abound, ICSs will each face specific challenges in addressing national objectives. Local conditions relating to deprivation, pre-existing inequalities, prevalence of disease and multi-morbidity factors will create particular needs that shape local strategies and service delivery approaches. Understanding the impact of these and being able to tailor the partnership-working offer to suit the specific need will continue to elevate the industry beyond the sum of its products.

What practical steps can pharma take to adapt its approach to the NHS and be clear on its offering?

Go to www.pf-media.co.uk to read the full article.

As ICSs become legal entities, their preoccupation with corporate and clinical governance, operational structures and workforce issues will reduce. However, the pressing needs will remain; that is, to make the new entities work and deliver value-based, quality driven services that improve the experience and health outcomes for local people. The budget for achieving this will always be subject to some level of financial constraint. The way in which budget impact is modelled and articulated is not as limited.

Pharma has the opportunity to imbue its NHS partnership offer and proposals with a multi-year, whole pathway and system-wide approach via a comprehensive model of costs and benefits (both financial and non-financial), as outlined in the HM Treasury Green Book. Other areas of Government have had to follow this approach for decades; the need to address disparities, workforce and other challenges make this approach even more important to the development of sustainable and equitable healthcare in England.

Jeremy Hooper is Health Economics and Intelligence Consultant and John Leslie is NHS Finance Associate at Conclusio.

Go to www.conclusio.co.uk

M A G A Z IN E | S P R IN G 2 0 2 2 | 1 5

Cell & Gene Therapy

KEEPING THE PATIENT AT THE HEART Ben Beckley, Global Lead, EmerGENE, explores how to create a detailed map of a patient’s clinical, behavioural and emotional journey that enables manufacturers to design patient-centric service programs.

WORDS BY Ben Beckley

M

ore so than any other technology, the patient is at the centre of the Cell and Gene Therapy (C&GT) ecosystem.

As such, sector leaders need to assure every stakeholder that patient-centricity is a core mission.

The fact that well over 3,000 C&GTs are in development globally1 is evidence of the industry’s growing awareness of the new therapeutic possibilities opened up by CG&T. However, there remains a gap between the potential of treatment advances and patients’ understanding and experience.

PATIENT EXPERIENCE

Over the past decade, novel C&GTs have cast a wide net with approved treatments for burns, degenerative muscular and skeletal disorders and for several cancers. As the technology advances and more businesses enter the market, further indications – often rare and orphan – will join this list, creating completely distinct patient pools with each new trial and approval.

From the patient’s perspective, the most unique nature of these therapies is in their personalisation and their central role in manufacturing. Patients are now often the source of the raw materials needed to create the treatment – as is the case with ‘autologous’ therapies – where they are the beginning and end point of a circular value chain, and not just receiving a finished product.

16 | P F - M E DI A .C O.U K

For C&GT patients this translates into creating accessible and relevant content, on-demand healthcare access and support, as well as virtual appointments.

Although advances in digitalisation and new communication technologies are positively impacting the patient experience, more nuanced engagement is still needed in the C&GT space.

JOURNEY TO TREATMENT

In short, each C&GT creates a new supply chain and new patient experiences, and they need to be fully comprehended by every party for C&GTs to deliver on their potential.

The patient experience needs to be understood and valued, with appropriate support offered where necessary.

CONTENT IS KING

The industry needs to think differently about strategies to communicate effectively with C&GT patients across four core pillars: • Pricing, reimbursement and support systems with the patient experience in mind.

• Delivery and experience analysis conducted with a focus on creating empathetic and personalised interactions.

• Interactive patient journey maps to record and analyse experiences through early onboarding, cell collection processes, treatment and beyond.

• Patient and clinical education for the treatment and the support, plus options for how and where they can tailor their healthcare.

This can only be achieved through effective dialogue between patients, healthcare professionals (HCPs), manufacturers and their strategic partners combined with the gathering, synthesis and utilisation of data to inform decisions.

Meeting with patients and their families in the early stages enables the creation of patient support solutions that are as personalised as their therapy. Every patient’s healthcare journey is unique.

With C&GTs, they must undergo lengthy treatments, that often include a conditioning regimen followed by cell tissue, bone marrow, or sometimes even a tumour sample collection, and long wait times in between treatment.

This can be an extremely draining experience, particularly during conditioning where long periods of time in isolation are essential to avoid infection. Removing a patient from their support system can also exacerbate social and cultural challenges that all contribute to any negative perception of the journey.

There is also a large financial burden on families due to the often-high cost of treatment in some economies and the inability to return to work for both

“

The patient experience needs to be understood and valued, with appropriate support offered where necessary

”

IN SIG H T

the patient and any caregivers. Most therapies are given through centres of excellence that may require longdistance travel and due to the length of treatment and monitoring, lengthy stays in rented accommodation. Both lead to an increase in the financial burden upon C&GT patients.

TRANSPARENCY IN DIALOGUE

As with many new treatments there can be an element of mistrust that must be overcome for C&GTs to reach their potential. A meta-analysis of published research into patient and public perspectives on C&GTs found that acceptance of these therapies is influenced by gender, age, education, severity of illness and associated risk of death and geography2.

The same study found that: ‘Regardless of their level of knowledge, patients generally expressed a desire for more information and clarity’ and ‘acceptance of cell and gene

therapies varied among patients but generally increased after the provision of information.’

Realistic expectations must be set with patients and their families built on transparent dialogue regarding treatment uncertainties. Translation of clinical benefits and risk are needed as integral parts of patient onboarding and understanding where and how patients want to receive this essential.

THE ROLE OF HEALTHCARE PROVIDERS

Medical communications also have an important role to play in positively impacting HCP knowledge and experience. Providers and patients may be comfortable with their current healthcare management plan and uncertain if C&GT is right for them.

This apprehension and delay in referral for curative treatment can lead to a negative patient experience, with C&GT treatment viewed as a last resort. Both

the industry and centres of excellence need to prioritise communication strategies to bridge any knowledge gaps that lead to hesitancy from HCPs, enabling early life-changing intervention for patients.

THE FUTURE FOR C&GT PATIENTS

Companies are developing frameworks to give the industry a unique advantage in understanding the complexity of the C&GT patient lifecycle. Novel data technology and software can enable a seamless experience for both providers and patients. In creating detailed maps of each patient’s clinical, behavioural and emotional journey, companies can design a long-term support services program for the individual.

Ben Beckley is Global Lead at EmerGENE. Go to www.oneashfield.com/emergenecell-gene-therapy 1 w ww.asgct.org/global/documents/asgct-pharmaintelligence-quarterly-report-q3-2021.aspx 2 w ww.ncbi.nlm.nih.gov/pmc/articles/PMC7722871

M A G A Z IN E | S P R IN G 2 0 2 2 | 1 7

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Smarter, Clinical trial recruitment has boomed during Covid but smarter tech adoption is needed for 2022.

WORDS BY Meerim Almazbek

C

linical trial recruitment in the UK has boomed over the last few years.

Compared to 2019/20, trial recruitment nearly doubled in the following year when just short of 1.4 million participants1 took part in clinical research across England alone.

A combination of factors contributed to this rise, including a rising sense of public responsibility, and a developed understanding of the trial space thanks to Covid-19. But most importantly, the industry has technology to appreciate and leverage.

Widespread adoption of virtual engagement technology meant sponsors could bring the trial to the participants. In doing so, they reduced the burden for participation and made trials more accessible.

So, is the job done? Not at all.

Trials are far from perfect, but the industry – and perhaps more crucially, patients – can benefit from increased recruitment. The answer isn’t just more tech, but smarter tech.

A TRIAL SITE ALTERNATIVE

Consider this question: would you rather participate in a trial from your home, or travel to a site two or three miles away?

Put this simply, you can see why virtual engagement in decentralised trials is being adopted more widely. Naturally, it’s more complicated than that, but these are questions drug developers must ask as they evolve how trials are designed and carried out.

“

BAME participants still only make up 5% of trials, despite being 15% of the population

”

Decentralisation of trials depends on suitability for various endpoints, participants, and outcomes. According to McKinsey2, site activation and patient enrolment are the primary areas where decentralised trials play a role. However, in digital patient engagement and assessment, the use of decentralised trial technology drops by around 10–15% on average.

Clearly, there is room for further innovation. We know that patients are becoming increasingly comfortable with remote technologies, around three times

as much as they were pre-pandemic, across all sectors. For site sponsors, the next step lies in using decentralised trial tech to not just manage sites and identify patients, but to engage in electronic consent, telemedicine, and remote patient monitoring.

THE DIVERSIT Y BOTTLENECK

Over the past few years, many voices in the industry spoke up about diversity in clinical trials. But even as 2021 drew to a close and UK minsters joined forces with pharma to push for more diversity3, the situation was still lacking. Black, Asian and minority ethnic (BAME) participants still only make up 5% of trials, despite being 15% of the population.

So, what is the next step?

Decentralised trials may have lowered the barriers to entry for some groups, including those from less advantaged socio-economic backgrounds, but what about other under-represented groups?

A recent study in The Lancet4 identified language as a prominent factor discouraging people from marginalised backgrounds. Using the example of a trial of type 2 diabetes, the study reports that “language variables were not routinely described, making it difficult to compare

not harder 2 0 | P F - M E DI A .C O.U K

IN SIG H T

characteristics of the recruited sample with the target population.”

The report concludes with the need to establish translation features.

With technology, issues like translation have an easy solution.

In 2022, sponsors and providers need to use technology that offers inbuilt translation across the full scope of engagement. This relatively straightforward solution can eliminate unnecessary and potentially discouraging language barriers.

LISTENING TO PATIENTS

There has been a massive effort with engaging patients in trials. Now, into the new year, pharma companies need to make sure they’re getting the most out of the time patients are giving to them, and that means smarter insights management.

The output of gathering insights – fundamental truths given by a participant through research – is typically presented as long transcripts that are paper-based or even in the form of digital notes. Produced through hours of careful attention to detail and years of education and experience, these notes are valuable – but they also represent huge amounts of costly input, processing, and interpretation.

But this isn’t when teams want to get bogged down in another process.

Translating insights to action can be faster by using technology to collate

information, automatically generate transcripts, and shorten the path to next steps. More importantly, the meaning of what patients say is preserved and prioritised.

FOR 2022

The clinical trial space experienced significant change in 2021. Now, more than ever, people see the benefit of participating in and engaging with trials. It’s a huge boost, but the industry needs to continue building on this.

Recruitment needs to be maintained and the use of the trial technology needs to be further integrated.

The solutions are here, and at Within3 we’re proud to be leading the way in this area. The question for the pharma industry over the next year won’t just be whether or not they’re using tech, but it will be how are they using it? Are they getting the results they need? If they are, then it’s a bright future for clinical trials.

Meerim Almazbek is Senior Solutions Director, Community Planning & Optimization, Global Team Lead, Within3.

Go to www.within3.com

1 w ww.nihr.ac.uk/about-us/what-we-do/our-researchperformance/annual-statistics.htm 2 w ww.mckinsey.com/industries/life-sciences/ our-insights/no-place-like-home-stepping-up-thedecentralization-of-clinical-trials 3 w ww.innovativetrials.com/press-release-ending-thediversity-gap-in-research 4 w ww.thelancet.com/journals/lanpub/article/PIIS24682667(21)00100-6/fulltext

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Rare but relevant A

round one in 17 1 people are likely to be affected by a rare disease at some point in their lives1, which amounts to 3.5 million people in the UK 2 and 30 million people across Europe3. Looking behind the numbers would no doubt reveal a multitude of patient voices, and also their wider support networks of family, friends, and carers who are also greatly affected by rare disease too; in totality rare disease isn’t actually so rare in terms of impact.

Alongside this, the spectrum of rare disease is vast, with current estimates suggesting there are around 7,0002 rare diseases identified and recognised.

the healthcare system. Running through all of this there is a distinct human element, and a patient-centric approach is essential.

CHALLENGING JOURNEY

In order to understand the complexities of rare disease marketing we have to understand the challenging journey a patient with a rare disease faces when seeking diagnosis, treatment or a wider intervention.

When a disease is rare, knowledge of the symptoms, or collection of symptoms, and what that could indicate disease-wise is rare too, and a generalist healthcare professional (HCP) may not be aware of the signs associated with the rare disease – ultimately not realising the disease is present A comprehensive understanding of in a patient. the patient journey and the specific So, obtaining an accurate therapy area ecosystem is required diagnosis of a rare disease can be a lengthy and arduous process2.

Each individual rare disease then, Looking at the approaches marketers by definition, has a small patient can take, traditional methods of population which means the affected pharmaceutical marketing aren’t patients don’t necessarily receive the generally as effective for rare disease attention and support they need from for a number of reasons. The patient

“ ”

2 2 | P F - M E DI A .C O.U K

What are the opportunities and challenges for pharma marketers in the UK rare disease environment?

WORDS BY Craig Bradley

pool for rare disease is considerably smaller, which means finding patients who have been diagnosed with a rare disease can be a complicated process. This also applies to the number of treatment centres and associated expert HCPs. By definition, clinicians specialising in a rare disease are few and far between and any one individual can be responsible for a large patient population. The ecosystem for a rare disease includes not only the HCPs referring to expert centres, but a much wider and diverse group of stakeholders including the multidisciplinary team (MDT), payers and policymakers, plus patient advisory groups who play a vital role in representing the patient voice.

A comprehensive understanding of the patient journey and the specific therapy area ecosystem is required. A thorough mapping of this ecosystem allows us to form a detailed picture of the different stakeholders involved, alongside the individual patient journeys and flows, which ensures interactions can be tailored to meet their needs at each touchpoint. Once this level of understanding is attained there’s a real opportunity to become a real partner to the key stakeholders, with tangible opportunities to improve patient care.

IN SIG H T

Around 1 in 17 1 people are likely to be affected by a rare disease at some point in their lives

3.5 million

This amounts to

people in the UK 2

&

30 million people across Europe3

Current estimates suggest there are around

7,000

rare diseases identified and recognised2

OMNICHANNEL APPROACH

In general terms, Covid-19 has been a catalyst to the pharmaceutical industry embracing more divergent, omnichannel approaches to engagement.

And specifically for rare disease an omnichannel approach to customer marketing can be especially effective in helping us reach our audience because it focuses on ways to engage HCPs in a manner that allows the delivery of on-demand personalised information, obtained through their preferred channels at their preferred time. This approach requires a deep understanding of customers and a shift from a product-centric to customercentric way of thinking, operating and delivering. Some rare diseases are only treated in a tiny number of centres, with a very small number of expert clinicians, and a limited range of MDT members to engage. For the rare disease focused marketer, these are very defined audiences, where closer relationships must be nurtured. It’s less about numbers and overall noise, in contrast to marketing efforts for larger scale therapy areas. Effective rare disease marketing requires an ethical, humancentric approach, with special focus on providing HCPs with the support, resources and information they need to better understand, care for, or treat a rare disease and the patients in their care.

FRAMEWORK

In terms of our operating environment in the UK, the Government has recognised that there are many challenges for rare disease patients and their families, publishing the UK Rare Diseases Framework2,4 in January 2021. This framework aims to ensure the lives of people living with rare diseases continues to improve, building on the commitments made in the UK Strategy for Rare Diseases in 2013 and the work that has been done to date, whilst highlighting the key focus areas of speeding up diagnosis, increasing awareness of rare diseases among HCPs, better co-ordination of care, and improving access to specialist care, treatments and drugs. The evaluation and access to medicines treating rare disease can still pose a challenge for the pharma marketer and their wider cross-functional team.

There are three main obstacles to accessing treatments4: • The use of the medicine being restricted to segmented patient populations.

• Delays in patients accessing the treatment due to health technology assessment (HTA).

• Reimbursement challenges, or the medicine not being reimbursed for use at all.

In working with smaller numbers of patients in rare disease, the Association of the British Pharmaceutical Industry (ABPI) 4 notes there is often uncertainty in supporting data sets for new treatments, which means that obtaining a positive HTA outcome can be challenging. Although a small subset of medicines for very rare conditions meet the strict criteria to follow the Highly Specialised Technology evaluation (HST) process, most orphan medicines are appraised by the National Institute for Health and Care Excellence (NICE) through the Single Technology Appraisal (STA) process.

And as NICE plays the vital role of trying to maximise the value that the NHS can achieve for patients in England, given the limited total NHS budget available, it’s often tough to demonstrate value for individual rare diseases. Even getting to launch for a treatment in a little-known, often neglected condition, is a different proposition than launching in more common therapy area. There does appear to be positive movement on this front with the Innovative Medicines Fund (IMF)5, which looks to support patients with any condition, including those with rare diseases, to get early access to the M A G A Z IN E | S P R IN G 2 0 2 2 | 2 3

IN SIG H T

most clinically promising treatments where further data is needed to support NICE in making final recommendations around their routine use in the NHS. For the marketers and their teams there’s an increased emphasis on wider system value demonstration, plus gathering and usage of real-world evidence to support that.

“

T here’s a real need to ensure engagement is personalised and relevant

”

2 4 | P F - M E DI A .C O.U K

PERSONALISED AND RELEVANT

Overall, to engage key HCPs working in rare disease, and ultimately help ensure patients and the wider ecosystem can access the support and solutions they need, pharma marketers working in rare disease must have a granular understanding of both the met and unmet needs plus the patient journey specific to that therapy area. A move toward an omnichannel approach, even for rare conditions, can also be of benefit for engagement as it enables the small cohort of treating HCPs to be engaged in a way that appeals to them, accessing the information and resources they need when they want via the platform of their choosing. As we’re dealing with such small numbers of key stakeholders there’s a real need to ensure engagement is personalised and relevant, in a way that is different to higher prevalence

therapy areas. It certainly feels that there is currently more momentum than ever around the recognition of rare diseases as a whole in the UK to improve the lives of those living with rare diseases, and industry can definitely play a role in helping fulfil these priorities.

Craig Bradley is Head of Marketing, Immunology & HAE, Takeda UK Limited.

Go to www.takeda.com/en-gb and www.iamnumber17.org.uk 1 W hat is a Rare Disease? www.raredisease.org.uk (accessed 30 January 2022) 2U K Rare Diseases Framework. www.gov.uk/ government/publications/uk-rare-diseasesframework (accessed 30 January 2022) 3E uropean Commission, Rare diseases www.ec.europa. eu/health/non-communicable-diseases/steeringgroup/rare-diseases_en (accessed 30 January 2022) 4 A BPI, Rare Diseases. www.abpi.org.uk/rare-diseases (accessed 30 January 2022) 5N HS England. www.england.nhs.uk/2021/07/nhsengland-announces-new-innovative-medicines-fundto-fast-track-promising-new-drugs/ (accessed 30 January 2022)

Job code: C-ANPROM/GB/IG/0064

Date of preparation: February 2022

IN SIG H T

THE BRAND MANAGER'S DIGITAL TOOLKIT

Supporting your digitally enabled customers face to face

Recruitment.

Sales Outsourcing.

Employer Branding.

Your customers’ expectations have changed; are you ready for your next face to face meeting? Do you have the tools to support your digitally enabled customers?

They’re not going back to the old ways of working.

WORDS BY Emma Morriss

S

hifting interactions need dynamic tools. Since we transitioned from face to face interactions with hard copy leave pieces and some digital to support, to a fully digital environment, all engagements have been virtual, all assets digital, and all events online.

Now, as we shift again into a mix of in-person engagement in clinic or at events where people miss the human interaction, networking with peers and making connections, you need the dynamism of digital.

Healthcare professionals want to be contacted in the most convenient way for them, with the information that is most relevant to who they are, where they sit in the product lifecycle and their priorities.

In the main this is digital-first. But how does that work face to face?

A digital toolkit will equip you with all the tools to ensure your customers have what they need when they need it.

WHY A DIGITAL TOOLKIT?

There are many reasons to invest in creating a digital toolkit.

Firstly, you are maximising your assets. You’ve spent two years developing quality, digital output, but when it’s on a laptop or iPad without Wi-Fi, it’s harder to convey in-person.

With a digital toolkit you can give all clinicians the same level of experience whether meeting in person or virtually.

Be consistent, be confident, be informed.

Digitally share information, capture email addresses, update preferences

and data consents with a simple conversation, whether you’re discussing clinical data or your latest resource.

With a digital toolkit, the ultimate goal is to reach more customers, wherever they are on the lifecycle and capture that all-important data from a single conversation.

There’s no need to leave them with a leaflet or ask them to visit your website when they have 5 minutes to spare. Invite them to receive relevant information for them and their patients using their mobile device.

Want to share your latest video, research, patient case studies? Send it straight across, let them scan a QR code and it’s there on their device for reading now or later – and pop a data capture in front of it and you can gather consents or update preferences.

Any tools you use with customers can be included in your digital toolkit, and if you’re not sure where to start, we can help.

DIGITAL ENGAGEMENT SPECIALISTS

At E4H, we’re digital engagement specialists for healthcare. We will support your brand commercialisation with digital assets for in-person and virtual interactions. We’ll develop your assets, your website, and your communications to keep customers engaged with your brand.

The next time to want to ensure your customer is left with useful tools to help improve their patients’ lives, think E4H and we will deliver. #WeAreE4H. www.e4h.co.uk

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Pf talks to Federico Fanti, Global Head of Commercial Operations, LEO Pharma about customer engagement and evolving in the digital landscape.

WORDS BY Emma Cooper How has your organisation adapted to working remotely for the last two years?

While it may sound controversial, working remotely has brought a lot of breadth to my work relationships. I still miss the connections you get being face-to-face, but there’s something powerful about being able to jump on a call with a colleague in another part of the world and build a relationship from scratch that we weren’t able to do before. As an organisation, I don’t see us shifting fully back to in-person. I do think, however, we are getting to a place where a hybrid mix is going to be what helps us make progress faster and advance relationships further, internally and with our customers.

How is your organisation rebuilding and maintaining connections with healthcare professionals (HCPs)?

Having launched a product in this environment over the last few months, we’ve done a lot of work to better understand the full range of channel preferences HCPs have. There are those who only want to interact remotely and engage in ways that are fully digital. Others prefer getting information in person or embracing a mix of both digital and face-to-face.

But most importantly, we learned about the types of content HCPs want in this on-demand world. Ultimately, it’s about being relevant and adding value to their day-to-day. Instead of a traditional push-only model of communication, we’ve seen HCPs reach out more for the right content. This is helping us become more efficient and enables us to service HCP needs as they evolve in the digital landscape.

How do you decide which HCPs are key to engage with and how do you plan your sales force accordingly?

Given this, how do you balance the differing roles of commercial and medical?

The world is becoming increasingly complex, especially now that we have more stakeholders at every part of the value chain. Whether we’re talking about payers, customers, or how we support patients in understanding their disease, key account management is more important now than ever. When it comes to balancing commercial and medical within this changing framework, there is an opportunity to be even clearer about the pivotal role medical teams will play in the future – especially as engagement preferences evolve and there is a 2 6 | P F - M E DI A .C O.U K

IN CO VE SA I

N ON ER AT N

IN SIG H T

“

Instead of a traditional push-only model of communication, we’ve seen HCPs reach out more for the right content

”

greater focus on better serving the patient. Every expert has a trade-off in terms of how they manage their patients and balance efficacy versus safety. These decisions are very much scientific in nature, leading to conversations medical teams will need to have more and more. We will need to support them in the same way that we support our commercial representatives, both from a capabilities and a platform perspective.

Is increased digital engagement a significant measure of customer success?

The industry often rewards itself on the growing number of digital engagements their sales representatives are driving. But volume and quantity is not sufficient to demonstrate successful engagement, nor does it signify representatives are addressing the full needs of HCPs and patients. Taking examples from other industries, customer-centricity is at the core of every interaction, identifying what is it they want and why every step of the way. Life sciences still has a way to go, but the use of data and analytics is the next step in taking us to a new level of customer-centric engagement. Especially as our company expands into new territories, getting automated insight into customers and their preferences is key to being more effective and bringing engagements to the next level.

Will the future of engagement remain hybrid?

If so, how can companies effectively balance the digital and in-person chasm?

While digital is enabling us to save time and be more efficient in the way we interact with HCPs, these last two years have shown us that technology alone does not guarantee great customer experience. When making an initial connection with an HCP, representatives should start with a personal, face-to-face meeting. They can then maintain that relationship with various digital and in-person touchpoints. These can include exchanging an email between meetings, sharing a website, or sending materials that the physician can use directly in their daily practice. This is what it will mean to truly support each customer’s individual needs, ultimately helping them provide the best treatment for their patients.

Hybrid engagement is here to stay, and this means focusing on developing new skillsets, creating different types of content, and embracing a new on-demand engagement standard.

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IN SIG H T

“

If you want to remain relevant as a representative, be adaptable and be curious

”

The biggest challenge will be to change the mindset of current field forces, which also include medical teams. Many still think that the best way to engage with HCPs is in person and that the traditional face-to-face way of communicating will become the norm again. But now, we are learning that not all HCPs want that. Companies need to be prepared to sustain that shift and push adoption of new strategies across their organisation.

What advice do you have for representatives adjusting to this new landscape?

Companies are looking for different capabilities than they were 10 years ago. With market volatility and increasing complexity, the skillset needed to navigate this new world is different to that of the representative of a decade ago.

If you want to remain relevant as a representative, be adaptable and be curious. Have an open mindset that will help you adapt to the new model and ensure you remain agile so you can pick up new concepts and ideas, of which the use of digital is a pivotal one. Representatives need to be able to understand the customer preference when it comes to contents and channels, rather than mastering one single channel. This can be a big change for some, but it will lead to greater performance outcomes.

What digital tools do you think will be key in implementing for the future?

We have come a long way in using better tools to engage with our customers, but where we can go even further is in harnessing two-way communication and the power of data and analytics. Both will help the industry provide a 360-degree style service to HCPs, meeting them where they are on their timetable, and creating long-lasting relationships.

Veeva CRM Engage Connect is a great example of this, enabling compliant instant messaging between HCPs and representatives and opening a pull channel to enable two-way digital engagement with healthcare providers.

Real-time, in-depth insight into who our customer is, their engagement preferences, and the patients they see, is also important to tailor communications effectively. Data that shows how HCPs reacted to a specific email, website, or text are critical to determining next-best actions in terms of the content representatives need to send or the next call they should make. Veeva is helping the industry close this gap of meeting the customer where they are and providing them with the relevant information they need. Artificial intelligence will also be a game changer in advancing the digital representatives of the future.

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Compliance in a digital world Examining the European Federation of Pharmaceutical Industries and Associations (EFPIA) Code’s Principles for the use of digital channels.

WORDS BY Rina Newton

W

e’ve heard it so many times before – the UK pharma industry and associated agencies asking year after year for some/better digital guidance in relation to the Association of the British Pharmaceutical Industry (ABPI) Code; the Prescription Medicines Code of Practice Authority (PMCPA) agreeing and telling us all it will be “out soon”.

The sad reality is that the PMCPA has archived its Guidance About Digital Communications that relates to the ABPI Code and the ABPI Working Group that was tasked with updating this guidance expected its publication soon after the ABPI Code 2021 became operational (in July 2021).

To date, nothing has appeared.

Dr Felix Jackson, Founder of medDigital, was involved with this digital guidance as part of the ABPI Code Working Group in 2020. Although not an official representative of the ABPI or the Working Group, his opinion on the matter is: “I believe that the ABPI is still very keen to do this and it is still much-needed.” He sympathises with their efforts,

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though, and surmises that: “The delay to its publication is likely to be due to several factors – Covid, Brexit and the implementation of the new ABPI Code in 2021.”

An ABPI spokesperson said: “The ABPI has previously worked closely with members to develop draft guidance on the ABPI Code as it pertains to use of digital communication channels. With the ABPI 2021 Code of Practice now live, this draft digital guidance is being updated with new content, with the aim of publishing later this year.”

The ABPI has also commissioned PwC to create Guidance on the Use of Social Media (which will likely be published in March 2022).

In the meantime, the PMCPA and Appeal Board have both been ruling about cases that involve the use of hashtags, tagged accounts, sponsored social media advertisements, Google indexing and app stores etc. on a case-by-case basis.

Not only does this mean companies have to second-guess what may or may not be acceptable by deciphering very specific (and sometimes confusing) rulings, ‘compliance’ appears to entirely depend on the PMCPA and Appeal Board’s understanding of digital channels, functionality and technology.

Therefore, it’s a useful reminder to revisit the digital guidance contained within Annex 3 of the EFPIA Code. This article describes and interprets advice for ‘member companies’ (MC) on digital principles, content and channels.

IN SIG H T

There are 4 key overarching principles to consider and for each, my key take home message Overarching Principle

Summary

Key take home

COMPLIANCE

The content, audience and use of the platform should be considered to identify relevant laws and regulations.

The UK’s ABPI Code incorporates requirements of the EFPIA Code and the law (except GDPR).

Digital communications fall under the scope of Directive 2001/83/EC and the EFPIA Code of Practice.

All promotional and non-promotional digital communications under the scope of the ABPI Code must therefore be compliant with it – in terms of intent, target audience and method of dissemination.

Material shared either by MC or third parties acting on their part, is the responsibility of MC (includes branding, sponsorships, promotion of Medicinal Products).

All UK pharma companies will be held liable for the actions of their agencies (and subcontractors) if their activity breaches the Code. See Case AUTH/3473/2/212.

Material on social media pages or websites owned by MC is their own responsibility; this responsibility may also apply when connecting with other companies/‌organisations.

They may be held liable if social media is ‘connecting’ (ie. URL links, hashtags or tagged accounts) to other accounts. See Cases 3431/11/20, 3441/12/20 and 3162/2/19.

MC are responsible for content shared by their staff (including private accounts) when they are deemed to be acting on behalf of MC or advocated by MC to disseminate material.

Personal social media is under the scope of the Code if the employee or agency posts/likes/shares about a subject that is of commercial interest to the company.

Company guidelines should guide staff on how to navigate this.

There should be in place clear and specific UK SOPs.

MC should develop guidelines to review and delete unfit comments (within the scope of data protection regulations) on their own digital channels.

Accounts that are under the company’s liability, should have comments disabled or moderated to ensure compliance.

PHARMACOVIGILANCE

MC should establish guidelines for digital channels which may include processes to adhere to pharmacovigilance requirements (recording and reporting adverse effects).

Accounts that are under the company’s liability, where comments are not disabled, should have in place moderation to ensure potential adverse events are reported.

TRANSPARENCY

MC must indicate sponsored content/ communication in accordance with EFPIA Code of Practice.

Pharma companies should be clear about their involvement at the outset – whether it is their activity, sponsored or at arm’s length (eg. disease awareness websites).

Content on digital channels should state involvement of MC whether posted by MC or third party – define content and funding.

Pharma companies should make sure that material published by their agencies on their behalf is clear about pharma involvement at the outset (eg. emails sent by mailing houses).

EFPIA Code of Practice (Chapter 5) requires reporting of “value transfers to HCPs, HCPs and POs”.

Any transfers of value should be disclosed, and certain digital activities may involve these (eg. virtual advisory boards).

Definition of target audience important.

Some activities may be intended for a certain target audience (eg. medical education to HCPs) but may be visible to other audiences (eg. public because open access social media is used).

RESPONSIBILITY

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4

key content considerations affecting all digital communications

1

The MC should determine the correct digital channel and audience in relation to the content in compliance with relevant regulations and laws.

• Eg. Sponsored advertisements on LinkedIn or Twitter using targeting parameters such as geography, age and ‘follower look-alikes,’ can help ensure content targets users with a relevant interest (see Case AUTH/3393/10/20).

Instagram may be better for a younger audience; websites with different content should consider how access is restricted between different groups.

3

Consider a risk assessment as to how suitable the ‘content, access, set-up and maintenance’ is.

• What is the communication aim?

Eg. The intent of the communication should be agreed first at a concept meeting and the approval system should reflect this to aid efficient approval.

• What kind of content is planned?

Material on Medicinal Products?

Disease awareness?

Promotional/non-promotional?

Eg. It is essential to first categorise the material according to context (who will read or use and how) and only then can the correct compliance criteria be used to achieve efficient approval.

• Is MC involvement clearly indicated?

Eg. This should be accurate and prominently displayed at the outset without the user searching to find it.

• Audience – does the audience need to be verified and how?

Eg. Consider promotional emails where prior permission of the recipient is always required vs log-in for websites (not always required).

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2 4

Information should be regularly updated and state most recent date of update on each item or page.

• Eg. Although promotional content on websites should be certified and could be compliantly recertified every two years, it can attract complaints, so it may be better instead to reapprove (and update dates on) websites.

Consider how the channel works in relation to content.

• Is it open access with interaction enabled?

How is information shared? Is it closed group or targeted?

Eg. Open access social media campaigns to encourage more visitors to company websites should not promote prescription- only medicines to the public or disguise promotion, they should be clear who the target audience is and ensure the website itself clarifies this before content is displayed.

• Are there limits to the material content?

Eg. Character size of content on Twitter may prevent the communication aim.

• Are relevant guidelines for users considered?

Eg. Twitter does not allow content that relates to medicines – does this prevent closed groups for promotion to healthcare professionals?

• How is audience data handled?

Eg. If collecting sensitive and personal data (eg. for log-in to certain types of patient support programmes), are the proper permissions in place?

• There must be a method of assessing and approving material.

Once content is appropriately categorised, only then can a decision about route of approval (certification by a medical signatory vs examination by an appropriately qualified person) be made.

IN SIG H T

There are many channels that can be utilised by MC in digital communications (not all can be included thanks to evolving innovation): WEBSITES • Log-in is only required if content is promotional and there is no other information for the public available.

Otherwise, it is acceptable for different content to be clearly signposted for different users.

• Keyword and search engine optimisation can be used to increase ‘traffic’ to website, but this should be used with the audience in mind (ie. public must not be encouraged to access HCP-only content).

• Websites can be created or sponsored by MC and created by a third party. MC involvement should be clearly indicated without a user needing to search for this information.

• MC should be wary of links on websites. If it is not made clear to users that such links may direct them to websites for which the company has no responsibility, then the company may be liable for unacceptable content such as promotion to the public.

SOCIAL MEDIA: • Open access should be approved with the public in mind. Therefore, content such as promotional materials for HCPs or press releases for the media, cannot be shared in this way.

• Closed groups can prove to be useful as tailored content can be delivered in a compliant way eg. video content for patients prescribed a medicine published on a private YouTube group.

BLOGS:

WEBINARS:

• MC may directly own and author their own blog or sponsor/ contract other blog authors.

If open access, neither type may promote to the public.

• MC involvement must be accurateand clearly indicated atthe outset for both.

PODCASTS: • Considering intent and audience, a webcast may be better or a downloadable podcast housed on company website instead.

• Podcast intent and content may render it promotional or non-promotional – this affects approval.

• If the podcast is housed on Spotify (or similar), a process for reapprovals or recalls must be considered.

• These can be live streamed or recorded for later access.

• MC is accountable for content and audience even when using a third party.

DIRECT CHANNELS: • These are usually private channels directed at one or many other channels.

• According to this guidance, MC must obtain permission from target individual to receive messages and they must be able to request to opt out, keeping in mind the need to avoid excessive contact.

• According to the ABPI Code, permission is only needed if promoting via these channels.

DISCUSSION FORUMS: APPLICATIONS: • The MC should first check if the app is regarded as a medical device whereby relevant regulations apply.

• The guidance for websites could be followed but consider how the app is advertised on the Apple/Google AppStore. See Case AUTH/3403/10/20.

• If the app is aimed at a select audience, then only these individuals should have access.

• MC are responsible for moderating forums on their own or third party platforms.

• These should clearly identify the target audience eg. closed group of advisors at a virtual advisory board.

1 EFPIA Code of Practice 2019: Accessed www.efpia.eu/media/636597/211222-efpia-code.pdf 2 All PMCPA rulings mentioned can be found at www.pmcpa.org.uk

Whilst this overview serves to prompt our thinking on all things relating to digital content and channels, it does not replace or override individual company SOPs and policies. In that regard, those creating/approving such documents should consider including how to mitigate the biggest compliance risk to digital activities – prohibiting promotion to the public by defining a promotional claim (which is not included in the EFPIA or ABPI Codes). Rina Newton is an ABPI Code and healthcare compliance expert.

M A G A Z IN E | S P R IN G 2 0 2 2 | 3 3

Movers & Shakers Who’s on the move in the industry?

WORDS BY

Emma Cooper

PH A RM A

PAUL ARCHER

Envision Pharma Group has promoted Paul Archer to Chief Commercial Strategy Officer (CCSO). In his new role, Archer will lead the development of an integrated commercial group strategy to drive continued revenue growth through service synergies and the implementation of new services.

PH ARMA

SUSAN RIENOW

Pfizer has appointed Susan Rienow as UK Managing Director and Country Manager, taking over from Ben Osborn who has been appointed Regional President of Pfizer’s Hospital Business Unit for International Developed Markets.

Susan joined Pfizer over twenty years ago and has been leading the UK Vaccines Business Unit since June 2021, including supporting the UK Vaccines Taskforce and the UK Health Security Agency throughout the 2021-2022 Autumn/Winter booster campaign and launching the paediatric formulation of the Pfizer/BioNTech Covid-19 vaccine.

CON SU LTAN CY

MARK HAMMOND

Equity firm Limerston Capital has appointed Mark Hammond as its Chief Executive Officer, following the acquisition of Gosport-based laboratory Wickham Micro.

Mark joins from PBD Biotech and has held senior roles within both private and public companies, including Melbourn Scientific, Intertek and Aesica Pharmaceuticals. Mark’s people-focused leadership approach and strong track record of commercial development will enable him to drive the expansion of Wickham Micro, reinforcing its reputation as the leading provider of pharmaceutical and medical device testing services.

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M OV ER S & S H A K ER S PH A RMA

ROLAND KREISSIG

Roland Kreissig has been appointed Oncology General Manager, Novartis UK and Ireland.

He joins the UK organisation following a 17-year career within Novartis and will be leading the UK team to finalise an organisational transformation that embraces a move to new external engagement models supported by data and digital.

PH A RMA

AGE NCY

AGE NCY

CARLOS GALLARDO PIQUÉ

KRISTIAN WEBB

REBECCA FERGUSSON

Carlos Gallardo Piqué, current Vice-President of the Board at Almirall has been appointed President of the Board of Directors, following an announcement from Dr. Jorge Gallardo Ballart that he intends to retire. Carlos started his pharmaceutical career at Pfizer prior to joining Almirall, where he held positions of increasing seniority over nearly 10 years.

Since leaving Almirall as General Manager of the UK and Ireland in 2013, Carlos has served as a member of Almirall’s Board of Directors. In addition, he has established a successful career as a venture capitalist investing in digital health.

CON SU LTAN CY

HAROON ALLYBACUS

Nottingham-based contract research organisation (CRO) Cellomatics Biosciences has appointed Haroon Allybacus as Senior Business Development Manager. Haroon began his career in big pharma, before moving into CROs and biotechs.

Commenting on his appointment, Haroon said: “I am truly passionate about the life sciences industry and believe there is nothing more rewarding than supporting companies with the development of new therapies for diseases with unmet treatment needs.”

Page & Page and Partners has

appointed Kristian Webb as its first Scientific Director. The global creative communications agency specialising in health, wellness and lifestyle is continuing its expansion and Kristian will lead the scientific team and work across all areas of the business, including medical education, disease awareness and compelling scientific storytelling.

Anthem PR , part of the Resonant Group, has appointed Rebecca Fergusson as Managing Director.

Rebecca brings more than 20 years of experience in senior leadership roles including MD of Red Health, previously part of Huntsworth, and most recently with Mind+Matter, part of Ashfield Health. Commenting on her appointment, Rebecca said: “Many healthcare agencies have diluted or even lost the skill to develop campaigns that gain traction in earned, not just owned and paid media. With an increasingly rare strength in media and influencer relationships, the team at Anthem is an exception. I believe bringing this editorial mindset to multichannel strategic healthcare communications is essential. So, I’m looking forward to leading this talented team of people to even greater success.”

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CAREERS

Pf shines the spotlight on OKRA.ai CEO Dr Loubna Bouarfa, following her selection as European Young Leader 2022.

WORDS BY Emma Cooper

D

r Loubna Bouarfa has spent the last 15 years researching the field of artificial intelligence (AI) and implementing it across healthcare. In 2007, Loubna applied her research to the operating table, predicting surgical error in real time and alerting surgeons to potential errors in order to prevent them.

With an innate desire to drive the healthcare industry towards a future of personalised medicine, powered by explainable AI, Loubna founded OKRA Technologies in 2015. The goal was to ensure that AI made people more intelligent and empowered them to make better decisions which could ultimately improve lives.

Loubna has been instrumental in building the OKRA Explainability Engine, which empowers users by providing explanations behind the outputs of AI systems. Individuals can choose from a recommended set of pathways, each one fully explained, and the Explainability Engine provides the most intelligent reasons to drive outcomes, based on healthcare professional need.

RECOGNITION

The European Young Leader (EYL40) programme celebrates 40 European leaders, rising stars and change makers that are coming together to help build connections across different fields of 3 6 | P F - M E DI A .C O.U K

work from around the world. The 40 leaders will be tasked with navigating differing political and ideological viewpoints to address key issues such as green energy, digital transformation, relations with neighbouring countries and rising power inequalities.

Speaking to Pf about her recent achievement, Loubna said: “I look forward to collaborating with the most innovative European young leaders and together we will create a more competitive, equal and inclusive Europe.

“Artificial intelligence will bring about a series of transformative shifts, changing every aspect of human activity, with our economy focussing from volume-based to value-based, while creating new exciting opportunities

CAREER CLOSE-UPS

for the human race. AI technology brings impressive speed to activities that normally take months or years, heralding a new era of true automation, where time, our most valuable asset, will be freed up to pursue more interesting quests. Moreover, a tremendous reduction of waste and a better use of resources will also help usher humanity in a new epoch, promising healthier, more creative lives for all.

“We now have the possibility to embrace the future with confidence, with our commonly shared European values as our guiding principles, and reshape the healthcare system.

Combining safety and innovation, we can succeed in our mission to safeguard the uniqueness of each patient across Europe and we can rise up to the challenges of the 21st century.”

Go to www.okra.ai

Interested in more career close-ups?

Head over to www.pf-media.co.uk for our regular feature.

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