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Overview

The life sciences innovation model is changing

significantly. Driven by the rise of precision medicine,

increasing reimbursement challenges, and a rapidly

evolving stakeholder landscape, companies have

the opportunity to modernize their business strategy.

Medical affairs is ideally positioned to lead the

transformation, elevating itself from a support-based

department to a core strategic function that

drives the organization to become data-driven and

customer-centric.

“As the industry shifts towards precision medicine, medical affairs must lead the way if life

science organizations are to continue to innovate and grow,” says Robert Groebel, vice

president of medical strategy at Veeva Systems. “European medical affairs leaders are

particularly well suited to lead the way.”

Medical affairs must lead the way if life sciences organizations are to continue to innovate and grow.

– Robert Groebel, Veeva Systems

A Roadmap for Medical Affairs TransformationHow Europe can reinvent the medical affairs model for the precision medicine era

A Veeva Systems white paper

With contributions from:

Allergan

Bristol-Myers Squibb

GlaxoSmithKline

Johnson & Johnson

Incyte

Kyowa Kirin

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Why Europe drives the change

European life sciences companies are powering medical innovation, helping to drive the industry’s future growth. Europe is the source of 1.76 million peer-reviewed publications and 32% of advanced therapy products that were in phase III trials in the past year originated here.

These progressively more sophisticated medicines, coupled with complex treatment protocols, lead to new opportunities in the advancement of care. As more therapies come to market, there will be a greater need for evidence-based scientific engagement with experts.

“Precision medicine compels pharma to innovate rapidly and along multiple paths. Not only do we have new targets and new therapeutic classes, but we are also discovering new indications and new diagnostics that align therapies with specific patient markers,” says Malia Lewin, director of global oncology strategy at Veeva Systems.

European medical affairs organizations have the right experience and perspective to drive the shift towards an increasingly evidence-based model. Simultaneously, they are also faced with a unique set of regulatory and reimbursement challenges that will shape their digital and data-driven stakeholder engagement strategies.

• Complex regulations GDPR has forced a comprehensive compliance overhaul. From stricter data integrity and security mandates to affirmative and specific consent requirements, the life sciences industry is compelled to transform its engagement strategy. Organizations are rethinking everything from data transparency to control and suppression. To cope with the new requirements, companies are shifting towards a digital and data-led scientific engagement model.

• New reimbursement models In recent years, multiple medicines priced in excess of €300,000 have been introduced to European markets, with some even exceeding €1.5 million. While promising great therapeutic benefits, these advanced interventions also bring significant cost pressures on governments with pre-determined annual healthcare budgets. With such high costs for precision medicines, health technology assessments (HTAs) are becoming even more important. The responsibility falls on medical affairs teams to justify these prices using innovative reimbursement models based on scientific evidence, health economic outcomes research, and outcomes-based pricing strategies.

This convergence of factors already compels European medical affairs leaders to evolve their stakeholder engagement strategy. By embracing a digital and data-driven model for engagement, companies also have an opportunity to simultaneously improve the HCP experience.

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1. Modernizing customer engagement

The stakeholder engagement paradigm

Precision medicine is shifting healthcare from the traditional primary care model to a more stakeholder-driven paradigm that includes patients, providers, and payers.

• Patients Patient engagement will need to shift from compliance to understanding needs, experiences, and value. In an environment of more active collaboration between patient and provider, medical affairs needs to employ new strategies to understand the patient experience.

• Providers Decentralized decision-making is shifting power from a single provider to a care team that is subject to institutional boards, advocacy groups, formularies, pathways, and protocols. Additional stakeholders across the healthcare delivery ecosystem are becoming increasingly important as their involvement in patient care rises.

• Payers As progressively more expensive therapeutics are introduced, payers face an increasing cost burden. They will have a greater expectation for real-world evidence and HEOR data to justify the higher prices. At the same time, patients and patient advocacy groups place greater pressure on governments to make more medicines for rare diseases available.

The New Stakeholder Engagement Paradigm

Understanding needs, experience, and value

Patients Providers Payers

Care teams andinstitutional boards

Real-world evidenceand HEOR

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Medical affairs is in a unique position in that it has both the evidence and the scientific expertise to help drive the conversation forward with all these stakeholders.

Account engagement in specialty and rare diseases requires medical affairs to add value through a deeper understanding of the expert and by delivering real-time scientific information. Examples include providing greater support for guidelines and publications, as well as delivering real-world evidence through improved access to Phase IV trials.

Improved stakeholder collaboration requires a multi-pronged approach that drives multi-stakeholder dialogue, centers on scientific value, and creates mutual partnerships. It moves away from the physician preference model and prioritizes ideal pathways and protocols for managing more complex care delivery. One–way “push” conversations are replaced by dynamic, real-time insight exchanges across groups, with a focus on which patients will benefit the most with the fewest side effects.

“There is a real benefit to having wider stakeholder engagement but it’s also a matter of resourcing,” says Fabio Ferfoglia, associate director of European medical affairs operations at Incyte. “You have to justify it by really showing the value.”

Evolving to Scientific Engagement Model

Stakeholder Engagement Drives Impact

From 1:1 Engagement To Care Team Dialogue

From Decision-Based Dialogue To Scientific Value Dialogue

From Launch Readiness To Partnership Across the Lifecycle

From One-Way “Push” Engagement To Dynamic, Real-Time Expert Insights

From Optimal Single Product Use To Right Treatment, Patient, Time

To further adapt to this new paradigm, medical affairs must become increasingly adept at compliantly coordinating with their commercial counterparts, and at structuring their departments in a way that facilitates increased collaboration. Strategically, both should aim to work from the same situation analysis and identify a common set of launch objectives. Tactically, they can identify how to compliantly complement each other, understanding how each is best placed to tackle different challenges.

This type of collaboration requires a close partnership among teams. “An effective approach I have used it to have quarterbacks for sites and KOLs,” comments Michael Smyth, former senior vice president and head of medical affairs at Kyowa Kirin International. “Everyone had to coordinate with the quarterback first. It required real discipline.”

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The evolving physician profile

The European HCP landscape is evolving as more physicians reach retirement. Eurostat’s most current data indicates that 38% of HCPs were 55+ years of age in 2016, up from just 27% a decade earlier. As these physicians retire, they give way to a new generation. At the leading edge of this trend are the UK, the Netherlands, Norway, Ireland, and Romania – countries in which more than 70% of HCPs are under 45 years of age.1

This younger cohort of ‘digital native’ physicians grew up in a world in which Google was the default step in any information search. They are also heavily influenced by the consumer technology experience, using sophisticated smartphones, user-friendly apps, and in-home virtual assistants, all designed to simplify routine tasks or enable new activities. These same experts also expect to use technology in their daily work routines, including in their interactions with the pharma industry.

Starting with countries with the highest number of digitally-primed physicians, medical affairs now has the opportunity to adopt a digital mind set in order to serve the needs of a new generation of scientific experts.

European Countries with Highest Percentage of HCPs Under 45 Years of Age

UnitedKingdom 75%

Ireland 72%

Romania 72%

Netherlands 70%

Norway 70%

1 Eurostat (2019). Healthcare personnel statistics - physicians. Retrieved from https://https://ec.europa.eu/eurostat/statistics-explained/index.php/Healthcare_personnel_statistics_-_physicians

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Modernizing HCP experiences

In the oncology space, scientific experts average approximately seven interactions with life sciences companies per month, and the top 20% indicate having 11-20 monthly interactions.2 These encounters typically last more than 30 minutes, meaning that most experts dedicate 3.5 hours per month to pharmaceutical interactions, and up to 10 hours at the high end.

Adding additional face-to-face time with these highly time-constrained and sought-after experts is unrealistic. Instead, as the industry re-evaluates the nature of the expert-MSL relationship, it can optimize engagement by leveraging the right channels and tools.

Recommendations for a best-in-class HCP experience include:

• Make digital engagement the norm While MSLs clearly have an important role in expert engagement, McKinsey reports that “physicians globally spend at least 1.5 hours each day conducting online research, with at least half of that on social media.”3

Medical affairs can support physician information search by deepening scientific interactions through a holistic, multichannel engagement strategy. From email to virtual meetings, MSLs can compliantly engage physicians throughout specific steps in their scientific journey in a way that was not previously possible.

“If you simply add new processes on top of existing processes, you will just create digital noise without doing anything different,” cautions Andy Williams, head of global medical information and operations at GlaxoSmithKline. “Digital is a new pathway and you have to be smart about how you use it.”

Pharma has also taken a very conservative approach to social media. Even when factually incorrect information is shared by the public online, medical affairs has traditionally not been able to respond. However, some companies recognize the need for change and are even taking small steps towards embracing social media with pre-approved tweets to refute false claims.

Success Story

HCP satisfaction drives remote meeting adoption by MSLs

To test the effectiveness of remote meetings, one large pharma company introduced a limited national pilot in the United Kingdom.

MSLs were initially reluctant to use virtual meeting technology due to concerns that they would become a “call center,” but became convinced of its effectiveness as they quickly saw higher levels of HCP engagement.

One physician had to learn how to click on the hyperlink to join the remote call but found so much value in the experience that he requested a second call only two days later. Previously, the company only interacted with him on a quarterly basis through an in-person meeting. The remote technology enabled home office to immediately demonstrate the scientific value of the initiative.

Ultimately, the company recorded an increase in satisfaction rates among participating physicians. Based on the success of this pilot, remote meeting capabilities are now being expanded to additional countries.

2 Veeva Systems (2019). European oncology expert survey. 3 McKinsey & Company (2018). Medical affairs: key imperatives. Retrieved from https://www.mckinsey.com/industries/pharmaceuticals-and-

medical-products/our-insights/medical-affairs-key-imperatives-for-engaging-and-educating-physicians-in-a-digital-world

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• Optimize for preference Research indicates that younger physicians prefer remote engagement over face-to-face meetings. This is validated by Dr. Enrique Grande, head of oncology at the MD Anderson Cancer Center Madrid, who values the rapid delivery of new scientific resources in a more efficient digital channel: “I can’t afford to see all MSLs every month. Proactive MSLs that send articles and [clinical] resources are extremely useful to me. They are saving me time and making my life a little bit easier. Let’s save time and money. Just send me the email.”

Optimizing for preference can have significant benefits for medical affairs. “In Europe, we understand physicians all the way down to individual preference levels because we are close to them. That’s why the vast majority of our experts are satisfied with their MSL experience,” says Glen Morris, worldwide field medical business solutions lead at Bristol-Myers Squibb.

• Revamp advisory boardsDigital natives compose a growing share of European physicians yet this generation is significantly underrepresented on pharma advisory boards. “Ad boards can be highly biased. Physicians on the verge of retirement tell us that ‘no one wants digital’ but those views do not accurately reflect the priorities of technologically savvy HCPs,” says one senior director of medical excellence at a Top 10 European pharma company. “By expanding and diversifying ad boards, medical can evolve for the future.”

• Get HCP feedbackMedical affairs are also placing a greater emphasis on physician feedback. Some organizations ask HCPs to rate specific MSL interactions and see up to 80% response rates. Others have traditionally conducted one annual feedback survey for face-to-face interactions, but are switching to more frequent data collection as they incorporate remote meetings into a broader multichannel strategy.

Ask Me Anything

?How do you gather feedback from expert interactions?

“ We use our surveys to not only understand the experience we provide, but also to capture KOL needs, to understand how they work, whom they trust, and what their independent views are.”

“The feedback we capture drives our MSL training program.”

“ There is no one global standard for our feedback program. We get high responses if the MSL is there in person though this can lead to biased survey results. But it can also generate new insights. On balance, it’s more valuable as we generate more data.”

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2. Medical affairs guides the HCP journey

Personalizing content along the HCP Journey

Life sciences organizations can use HCP journeys to maximize the impact of scientific engagement. Similarly, content needs to be reflective of both the individual HCP’s preferences as well as their particular stage along the journey.

A new multichannel paradigm for medical affairs (including medical CRM, email, remote meetings, and events) gives companies the opportunity to better collaborate with experts and other stakeholders. Home office can gauge scientific needs and interests by tagging and reporting on the evidence that is consumed, and how it evolves over time.

Strategic insight from HCPs’ consumption of evidence over time and across channels can deepen relationships by guiding decisions on the cadence and focus of engagement. This information spans the full spectrum of the journey, from fundamental disease state education, to management goals, therapeutic choices, therapy-specific outcomes, and future goals.

For instance, engagement with “awareness” level content can indicate a need for education or outreach around safety and efficacy. As engagement continues, the HCP’s scientific journey can be quantified and visualized. The progression along this spectrum maps to the consumer decision journey, from awareness to familiarity, consideration, and finally adoption.

Progression of the Scientific Journey

Scientific Platform

Time

ScientificJourney

DiseaseState

ManagementGoals

TherapeuticChoices

Future/Aspiration

TherapySpecific

Outcomes

Awareness Familiarity Consideration AdoptionChoiceDecisionJourney

Scientific content is effective when it is tailored to specific stages along the physician journey. We need to focus on the needs of the physician at that particular moment.

– Fabio Ferfoglia, Incyte Pharmaceuticals

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Aligning to the HCP journey enables companies to maximize the use of scientific content along the progression from scientific need to advocacy. The value of disease state information may diminish over time and medical teams can focus on delivering outcomes evidence instead.

Aligning Content to the Scientific Journey

Time

Therapeutic outcomes content

Disease state content

Measuring the value of personalized content

Scientific communication is designed to diffuse evidence-based ideas into clinical practice. The rapid, widespread adoption of new ideas requires delivery of the right scientific content at the right time. Medical affairs teams understand that personalizing content is critical to getting expert adoption. “Scientific content is effective when it is tailored to specific stages along the physician journey. We need to focus on the needs of the physician at that particular moment,” says Ferfoglia.

Many organizations choose to delegate this responsibility to their field teams instead of centrally managing the process. On point of agreement is that personalisation works best when left to the MSLs because of the strength of their relationship with the HCP.

Best practices for exceeding expectations with scientific content

• Tailor to the HCP

• Promote high scientific exchange

• Enable data visualisation

• Deliver multichannel access

• Provide non-branded resources

• Embed data

• Focus on patient-centricity

Personalization works when MSLs do it themselves. They know the HCP better than anyone.

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Medical affairs leaders almost universally agree that when it comes to scientific content, quality is much more important than quantity, though most believe that the medium needs to be updated for the digital age. Medical departments still rely heavily on slides for disseminating information. One large pharma company conservatively estimates that each single slide costs in excess of €500 to create, leading to slide decks that cost tens of thousands of euros. Meanwhile, another company’s internal audit indicated that of the hundreds of assets they had developed, MSLs only used 25 specific content pieces. Clearly, there is an opportunity to optimize the process.

Considering the cost and effort required to deliver scientific content, medical affairs leaders need to understand whether their content is valuable to physicians. Albano, et. al. (Pfizer) argue that this can be measured in terms of helping HCPs make better clinical decisions, ultimately leading to improved patient outcomes (such as adverse events avoided, treatment adherence, reduced hospitalization days, quality of life improved, etc.)4 Key metrics in this model include the number of HCP interactions and the percentage of physicians who used the scientific content to make a treatment decision:

Number better decisions made =

(number of HCP interactions) × (% who used information for clinical decisions)

Evolving scientific content for the digital age

Adapting content to digitally minded physicians requires evolving beyond text-based information. “Commercial teams are developing a lot of new visual content while medical affairs everywhere are stuck on the ‘death by PowerPoint’ approach,” comments Morris. “Medical just doesn’t have the same budgets [as commercial] but has to manage the additional protections required by compliance.” James Richards, head of medical information technologies at GlaxoSmithKline adds, “Fortunately, compliance can be built into digital tools and that’s how we are moving towards more graphical content.”

Ask Me Anything

?How does your organization create high-value scientific content?

“When we create patient-friendly information, experts tell us that it is helpful. But ultimately the important thing is to base our content development on scientific insights.”

“ We found that content must be consumable within seconds. That’s why we moved towards infographics. They are attention grabbing but still meet our compliance criteria.”

“ I have seen one company experiment with a joint approach between commercial and medical to share content. Compliance is a partner. It allows them to avoid duplication while identifying high value assets.”

4 Albano, et. al. (2016). A theory on the relativity factors impacting the utilization of medical information services from the pharmaceutical industry. Retrieved from https://journals.sagepub.com/doi/full/10.1177/2168479016640019

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3. Medical moves the organization forward

The critical role of medical insights

Medical insights, real-world evidence, and HEOR data are key ingredients to a medical affairs-led industry transformation. To maximize the value of insights, companies need a structured process to gather, disseminate, analyze, and action insights.

“Decisions need to be made on the basis of the latest available science, with evidence-generation backed by solid processes to gather and disseminate scientific insights,” says Groebel.

Jorge Aguado, director of global medical excellence at Allergan comments, “Across the industry, there are two key challenges to getting medical insights: MSLs should be properly trained to recognize and capture insights, and the insights have to get back to the right people within the organization to shape strategy.”

“Insights provide a complete view of the patient journey over time, covering the spectrum from early disease state education, to management goals, therapeutic choices and therapy-specific outcomes, all the way to future goals,” adds Groebel.

The goal is to identify actionable insights that inform medical strategies, improve interventions, and lead to better patient outcomes. This requires a combination of both human and artificial intelligence (AI) to generate and understand the insights.

Medical affairs leaders can take three steps to make the most out of medical insights:

1. Train MSLs to recognize insights Leaders can help train MSLs to recognize potential insights and to streamline its delivery, creating a “bias for insights” among field teams. By focusing on the most important points of the discussion, MSLs make it easier for home office to process the information. One challenge is that MSLs often do not know where to report the insights back within the company. To make it easier, best in class organizations train field medical teams to consistently use medical CRM systems, helping to ensure that all information becomes accessible by the right people at the home office.

MSLs should be properly trained to recognize and capture insights, and the insights have to get back to the right people within the organization to shape strategy.

– Jorge Aguado, Allergan

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2. Leverage technology In addition to information provided by HCPs, there are potentially thousands of other data sources. “Individual MSLs may not recognize an insight until the home office has them in aggregate,” says Ferfoglia. “So you need a certain volume of data before you start to see the value.” Technology can help capture new insights, as the accompanying case study shows. Once information is tagged and compiled, natural language processing tools can help mine the data for new information. Says Lewin, “AI is an important tool to help identify new information. If you just use business rules, then you are only looking for things you already know.”

3. Provide feedback One common complaint from MSLs is that insights are a ‘black hole’ - they enter information but no one follows up with them. One best practice is to close the communication loop with their field medical teams so they understand what happened with the information they provided and see the value of their efforts. Some companies go even further and also brief the physician(s) with whom the insight originated, letting them know if the information led to an updated label or a new treatment protocol.

“Many companies think about insights too narrowly,” notes Richards. “Having access to insights means you can use them at the granular level with physicians with respect to next-best actions. But on a broader basis, we can also use them to inform and evolve our strategy.”

Success Story

From medical insights to new treatment protocol

Human intuition paired with AI improves patient care

Consistent use of technology, when paired with the right business processes, can help medical teams monitor and improve patient care. One pharma company was able to directly improve its treatment protocol by training its MSLs to consistently record summaries and possible insights in the medical CRM system.

The insights were fed into a machine learning program, surfacing the repeated use of the term “peanut butter”. The medical team decided to investigate further.

After reviewing the cases, the team hypothesised that patients tolerated the drug better when consumed with high fat foods. A small Phase IV study of 50 patients confirmed the theory.

Based on these results, the company changed the drug label with an updated treatment protocol.

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Demonstrating medical affairs’ value

The science-driven shift towards precision medicine affords medical affairs the opportunity to step out of the shadow of the commercial side of the business. This new paradigm requires challenging existing norms and tailoring success metrics to the needs and objectives of the medical organization.

“Medical ROI”

Companies can implement medical-specific KPIs that focus on patient-centricity rather than relying on commercial’s brand-centric goals. For instance, medical affairs has long avoided the term ‘ROI’ due to its association with revenue. But leaders can develop their own framework for ROI by measuring the impact of their efforts on patient outcomes. KPIs can be developed for the clinical impact of scientific content, medical insights, health-economics outcomes research, and real-world evidence.

Framework for Medical Affairs ROI: Measuring the Impact on Patient Outcomes

Impact on Patient Outcomes

ScientificContent

MedicalInsights HEOR RWE

Scientific Share of Voice

To understand scientific share of voice, medical affairs teams should consider the therapeutic landscape and position themselves relative to the behaviors of other therapies. This share of voice is based on a company’s reach and its relationships, both of which can be quantified and benchmarked against similar compounds or companies.

Reach can be quantified in terms of a composite of all core scientific activities: publications, events, and trials. The strength of a relationship with the HCP community can be measured in terms of the number and depth of these collaborations.

Key questions for determining reach and relationships include:

• Who are you collaborating with?

• Who is actively engaging with you in research or attending your events?

• Who are your competitors collaborating with?

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• Are there areas to develop an exclusive relationship?

• Does your level of scientific activity meet industry averages?

While all of this data exists in the public domain, it needs to be structured to surface measures in a manner that is intuitive for decision making. Bringing together engagement data with external stakeholder information is the key to creating a comprehensive understanding of success and opportunity.

Conclusion

As medical science becomes more complex, medical affairs organizations are evolving beyond the traditional scientific engagement model. Sustained MSL-expert relationships, driven by scientific evidence and complemented by personalisation along the journey, is the way forward.

As the industry continues to rethink the profile of the MSL, it will also reevaluate and seek out new competencies, technology solutions, and data sources that better support patient-centric outcomes. Medical affairs leaders are at the forefront of this evolution and newly positioned to rewrite the traditional corporate formula for success.

About Veeva SystemsVeeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva has more than 800 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs. Veeva is headquartered in the San Francisco Bay Area, with offices throughout North America, Europe, Asia, and Latin America. For

more information, visit www.veeva.com/eu.

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