Medical Affairs Leadership Summit, Key APAC Insights - August 2016

Second Annual APAC Medical Affairs Leadership Summit: Key Insights By Keith Morris, Linda Liong, Lynn Okamoto and Sebastian Bather

Second Annual APAC Medical Affairs Leadership Summit: Key Insights

TABLE OF CONTENTS1 Topic No. 1

Defining the Medical Affairs Vision & Mission ..........................................Page 4

2 Topic No. 2Field Medical Team Transformation ........................................................Page 8

3 Topic No. 3 Role of Medical Affairs in Late Stage Development ...............................Page 12

4 Topic No. 4Medical Affairs Launch Readiness ........................................................Page 15

5 Topic No. 5Maximizing Resources While Retaining Talent ........................................Page 17


The Second Annual APAC Medical Affairs Leadership Summit brought together Medical Affairs leaders from a range of pharmaceutical and biotechnology companies in March 2016 to discuss five areas of shared interest:

• Defining the Medical Affairs Vision & Mission• Field Medical Team Transformation• Role of Medical Affairs in Late Stage Development• Medical Affairs Launch Readiness• Maximizing Medical Affairs Resources While Retaining Talent

As in prior years, the Summit provided a forum for Medical Affairs leaders to share perspectives on the most pressing challenges, learn about best practices, and exchange strategies for achieving greater success. Medical Affairs executives are facing a rapidly evolving healthcare landscape that demands more from their teams than ever before. Medical Affairs organizations must reconsider the processes for creating and communicating their vision, becoming more proactive and strategic, and defining their value to the broader organization. And, all of this must be done with limited resources.

This paper shares highlights from the conversations framed within the inVentiv Consulting team’s own broad experience in Medical Affairs. It is intended to prompt a further exchange of ideas to enhance professional Medical Affairs expertise in the year ahead.

ABOUT MEDICAL AFFAIRS LEADERSHIP SUMMITS

InVentiv Health Consulting hosts three Medical Affairs Leadership Summits per year: one each in the United States, Europe and the APAC Region. Each Summit provides a forum for Medical Affairs leaders to share their perspectives on key challenges facing their organizations and to brainstorm potential solutions to these challenges. Prior to each Summit, inVentiv Consulting surveys a broad group of Medical Affairs leaders on key industry topics, with survey findings augmented by the firm’s own research and experience. This serves as a springboard for discussion during the Summit. Over the years, white papers summarizing key learnings from each Summit are shared with industry peers to prompt a further exchange of ideas. This paper summarizes insights from the Second Annual APAC Medical Affairs Leadership Summit held in Singapore in March 2016.

Topic No. 1

Defining the Medical Affairs Vision & Mission

An overall vision for Medical Affairs is important to help define the broader goals and value that the function brings to the larger organization. Historically, Medical Affairs organizations have been perceived as service providers to the larger enterprise. Today, it’s important for Medical Affairs to be proactive, customer-centric and strategically aligned with the Clinical and Commercial functions. In addition, as healthcare systems evolve worldwide to increase the influence of payers, limit access to providers and become more patient-focused, the vision for Medical Affairs must accommodate the changing informational needs of medical customers while reflecting the importance of engaging and partnering with a broader range of key stakeholders (Figure 1).

MEDICAL AFFAIRS VISION

• The Medical Affairs vision should be updated to fit the evolving role of the Medical Affairs organization from supporting role to strategic partner.

• Influence of payers and limited access to providers are key trends that will continue to influence the vision for Medical Affairs.

• An internal communication plan and defined supporting deliverables are instrumental to vision implementation, but lack of time and resources are barriers.

• Being ready and able to provide strong regional insights is one of the most fruitful ways to have influence on global strategy.

• When well executed, the vision articulates a branded value for Medical Affairs that supports staff retention and justifies resource allocation to meet the changing needs of their organizations.

Topic No. 1


Discussion at this year’s Medical Affairs Summit confirmed opinion that a clear vision for the Medical Affairs organization is necessary to drive a shift in mindset that sees Medical Affairs as a key strategic player rather than a passive partner in operational execution. The vision should define specific objectives and the behaviors needed to achieve them. The vast majority agreed that a robust internal communications plan and defined supporting deliverables are instrumental to making the vision real, relevant and actionable (Figure 2). The task of clearly defining the vision for Medical Affairs also requires soliciting and integrating input from Clinical, Commercial and other internal partners. When well executed, the vision articulates a branded value for Medical Affairs that supports staff retention and justifies resource allocation to meet the changing needs of the organization.

Topic No. 1


Summit participants felt that being ready and able to provide strong regional insights is one of the most fruitful ways to have influence on global strategy. As one Summit participant put it, “When there are no strong insights coming from Medical Affairs, we end up being a passive partner.” Identifying opportunities to provide these insights both prior to and post-launch can influence clinical trials and launch strategies. There is, for example, a significant opportunity for Medical Affairs to improve market insights in rare diseases, an area where traditional market research has limitations. But first, a more systematic and structured approach to insight gathering, such as compiling databases of medical inquiries, is necessary for Medical Affairs to have a more proactive, influential voice within the larger organization.

Many Summit participants felt that while regional teams clearly have opportunities to tailor activities to their region, they perceive they have no real influence on overall strategy (Figure 3). What influence they do have is perceived to be determined depending on region or country, therapeutic area and product life cycle.

Topic No. 1


A number of factors were cited as obstacles to achieving and communicating progress on the Medical Affairs vision. A lack of specific skills and an absence of internal buy-in were mentioned, but the single biggest obstacle seemed to be time and headcount constraints (Figure 4). Although these may be limited, effective and consistent execution of the vision is critical to drive buy-in throughout the Medical Affairs organization and with other internal partners.

Topic No. 2

Transforming Field Medical Teams

Today’s field medical teams face unprecedented scrutiny, expectations and challenges. They must build and expand on their traditional scientific expertise to successfully meet the needs of a diverse and growing range of medical customers. For APAC field medical teams today, this range of customers includes:

• Hospital-based providers• Academia• Organized customers • Managed care stakeholders• Community-based providers• Patient advocacy organizations• Patients and/or caregivers

Of these, organized customers and managed care stakeholders are rising in importance, reflecting the increasing emphasis on value-based healthcare worldwide (Figure 5). In turn, the emergence of new customers and the evolving needs of existing medical customers are driving significant changes in field medical team structure and operations (Figure 6).

FIELD MEDICAL TEAM TRANSFORMATION

• Organized customers and managed care stakeholders are rising in importance, reflecting the increasing emphasis on value-based healthcare worldwide.

• The emergence of these new customers, combined with the evolving needs of existing medical customers, is driving significant change in field medical team structure and operations.

• Business acumen and advanced communications skills are the most relevant competencies for future field medical teams.

• Increasing interaction with market access organizations is also an emerging trend, requiring expertise in local reimbursement and healthcare delivery dynamics.

• New, more systematic approaches are needed to measuring field team effectiveness; one of the most important metrics should be how effectively medical insights are shared.

Topic No. 2


For instance, the need for greater interaction with market access organizations and a focus on patient-centric strategies is a clear emerging trend. This means that expertise in local reimbursement and healthcare delivery dynamics will become more important for field medical teams in the future. It can be challenging in the APAC region, however, due to wide variations from country to country (and even within countries, such as China), requiring field teams to be more flexible in how they respond than they’ve had to be in the past.

In this new environment, advanced communication skills are indispensable, both to engage with diverse external stakeholders and to effectively communicate insights to inform the work of commercial, clinical and other teams inside the company. Facilitation skills are critical as well. As one participant noted, “For established products, [field teams] must be experts at facilitating the discussion while for new products, they must be expert at translating the science.” Based on our experiences there is a notable growing trend that in the APAC region, similar to other parts of the world, companies are looking at multiple field medical type roles. Some companies utilize Clinical Trial Liaisons (CTL) and in some cases transition them to the more traditional Medical Science Liaison (MSL) role. Still other organizations within the APAC region look to Clinical/Nurse Educators to fulfill educational needs.

Topic No. 2


The increasing importance of insight-generation is another reason training should focus more on communication skills and less on presentation skills. Skillfully conducted conversations – asking probing questions, understanding open-ended inquiry, conducting follow-up – produce valuable data and insights beyond what has traditionally been expected of field medical teams.

Another important skill – and a relatively new requirement for field medical teams – is business acumen (Figure 7). Although it was noted that field medical teams should not be driving sales and promotional activities or involved in pricing discussions, there is room for teams to add an understanding of marketplace dynamics to their scientific expertise. Teams must be adept at engaging with emerging customers and be well versed in health economics, reimbursement and other topics related to quality and value of care.

Topic No. 2


Organizations frequently lack a systematic approach to defining, collecting and measuring field team effectiveness, and there are currently no industry benchmarks for doing so. However, metrics for field medical teams need to be clearly defined and easily quantifiable. One of the most important metrics of field team effectiveness should be how well medical insights are shared (Figure 8).

Topic No. 3

Role of Medical Affairs in Late Stage Development

Once a drug is approved, it becomes necessary to convince actual prescribers to use it and payers to reimburse for it. Payers want to know, does the drug or intervention work in the real world? Does it provide benefit or value over existing interventions? A great deal of additional “late stage” evidence may be required to answer these questions based on health economics and outcomes research (HEOR) or comparative effectiveness studies, product or disease registries, low-intervention or pragmatic clinical trials, and non-interventional studies. This real world data, when combined with other late-stage insights, is the kind of real-world evidence that payers, governing parties and healthcare providers – all of whom are increasingly influential in self-paid markets – are requesting.

Summit participants agreed it was important to have a Medical organization capable of supporting real-world evidence generation. But the role of Medical Affairs in generating this real-world evidence is still being defined. To begin with, APAC-specific, local data to support real-world evidence is scarce, and the resources and infrastructure with which to generate it are limited (Figure 9). There is also limited experience with the methods and techniques for conducting late stage research, and limited understanding about how the data can be used to support the market access mission of Medical Affairs. Furthermore, regional Medical Affairs organizations cannot always rely on Global expertise in real-world evidence generation because it often requires country-specific knowledge. Consequently, there can be no such thing as “one size fits all” and Medical Affairs must take a country-by-country approach when developing late stage strategy.

ROLE OF MEDICAL AFFAIRS IN LATE STAGE DEVELOPMENT

• Payers, governing parties and healthcare providers are requesting real-world evidence.

• The role of Medical Affairs in generating this real-world evidence is still being defined.

• Post-approval studies in APAC are usually planned much later than in the US or EU, and most are planned on an “as-needed” basis.

• Given the region’s diversity there is no such thing as “one size fits all” and Medical Affairs must take a country-by-country approach when developing late stage strategy.

• The process of getting approval for late stage studies can be long, due to competitive priorities, lack of internal processes and lack of buy-in from internal stakeholders.

Topic No. 3


Multiple functions contribute to the development of post-approval/real-world study plans but there are notable differences from company to company with regard to planning process and strategy. Post-approval studies in APAC are usually planned significantly later – less than two years prior to launch – than in the US or EU, and most are planned on an “as-needed” basis (Figure 10). The process of getting approval for late stage studies can be long, due to competitive priorities, lack of internal processes and lack of buy-in from internal stakeholders.

ROLE OF MEDICAL AFFAIRS IN LATE STAGE DEVELOPMENT

• Opportunities exist for clinical research organizations and other partners with late stage expertise and appropriate APAC experience to provide support.

Topic No. 3


Overall, the lack of expertise and skills within the Medical Affairs organization along with lack of time and headcount resources are the biggest obstacles that make implementing real-world evidence studies in Asia difficult (Figure 11). Opportunities exist for clinical research organizations and other partners with late stage expertise and appropriate APAC experience to provide support.

Topic No. 4

Medical Affairs Launch Readiness

The perceived value of Medical Affairs involvement at launch varies greatly across markets, therapeutic areas and products. To demonstrate value, Medical Affairs organizations in APAC must continue to identify and leverage opportunities to encourage thoughtful and balanced investment in launch-critical Medical Affairs activities.

Because some APAC markets typically represent a smaller contribution to revenue expectations, launch in APAC can be significantly delayed (often by years) compared to US or EU markets. Consequently, launch-funding allocation in APAC (especially compared to the US or EU) may disproportionately favor some functions at the expense of others. Indeed, limited headcount and insufficient planning are considered the key challenges that Medical Affairs faces during launch. With a reduced requirement for field medical team work in advance of launch comes limited flexibility to plan and execute. This may reinforce a tendency among some MSLs to maintain a focus that is too narrow and KOL-centric (Figure 12). MSLs can be encouraged to appropriately prioritize KOL activities and develop engagement plans for a broader audience. A related challenge is that APAC Medical Affairs team must balance how to run consistent launch planning for groupings of smaller, heterogeneous markets, such as Southeast Asia, while attempting to prioritize launch plans for larger, more critical markets, such as Japan and China, often in response to the larger challenges of pricing pressure and a short product life cycle.

MEDICAL AFFAIRS LAUNCH READINESS

• The perceived value of Medical Affairs involvement at launch varies greatly across markets, therapeutic areas and products.

• To demonstrate value, Medical Affairs organizations must continue to identify and leverage opportunities to encourage thoughtful and balanced investment into launch-critical Medical Affairs activities.

• It is important for MSLs to appropriately prioritize KOL activities and develop engagement plans for a broader audience.

• Risk of program failure can be mitigated with earlier involvement of Medical Affairs in program strategy.

• Early involvement may also be relevant for therapeutic areas where geography influences epidemiology, or for highly complex trials.

Topic No. 4

Medical Affairs Launch Readiness

Similar to the situation with regard to late-stage development, for many organizations the role of Medical Affairs at launch is still being defined. In APAC, the majority of Medical Affairs launch readiness activities begin after the start of phase 3 (Figure 13). A strong case can be made for earlier Medical Affairs involvement on several fronts. For instance, the impact of failed programs due to disproportionate allocation of local resource to global initiatives or trials is often magnified in APAC. Such risk can be mitigated with earlier involvement of Medical Affairs in program strategy. Early involvement may also be relevant for therapeutic areas where geography influences epidemiology, or for highly complex trials. In these cases, there may be opportunity to help optimize evidence generation with early scoping during phase 3, to gather insights in advance from a broad set of stakeholder, or to leverage advanced market data to gain traction.

Each of these approaches will help emphasize the important contributions Medical Affairs can make to a successful APAC launch.

MEDICAL AFFAIRS LAUNCH READINESS

• Taking advantage of opportunities to gather insights in advance from a broad range of stakeholders or leverage advanced market data can help emphasize the important contributions Medical Affairs can make to a successful APAC launch.

Topic No. 5

Maximizing Resources While Retaining Talent

As the vision for Medical Affairs evolves to meet the challenges of a rapidly changing healthcare environment, it’s inevitable that a close look is being taken at how best to attract, train, manage and retain talent. As it turns out, finding and retaining qualified Medical Affairs personnel appears to be the most significant “pain point” for Medical Affairs organizations in APAC (Figure 14). The pain is likely compounded when Medical organizations are already under-resourced and “stretched too thin.”

MAXIMIZING RESOURCES WHILE RETAINING TALENT

• Finding and retaining qualified Medical Affairs personnel appears to be the most significant “pain point” for Medical Affairs organizations in APAC.

• Communication skills and an advanced degree are the most sought after skills for Medical Affairs hires.

• The lack of a clearly defined career path and lack of work-life balance are the biggest perceived threats to talent retention.

• Optimizing resource utilization – putting the right person in the right roles with the right motivation – has become key. A robust training and onboarding program can help to accomplish this.

Topic No. 5


But as one participant explained, “Finding qualified talent is not a problem. Retaining talent, however, is a huge issue.” Lack of a defined career path and lack of work-life balance are the biggest perceived threats to talent retention. In some companies, for example, only a select few may be chosen for advanced talent management programs leaving the rest unable to see opportunities to advance. Organizations with “flat” management structures may discourage those who see little or no opportunity for career growth. To address these issues, Medical Affairs teams should look for opportunities to re-think and more clearly define career paths for roles beyond Medical Manager, for example, or reevaluate the position of MSLs within the broader Medical hierarchy.

Consistent with the need for Medical Affairs staff to engage more deeply with a broader range of stakeholders, communication skills (along with an advanced degree) are the most sought after skills for Medical Affairs hires (Figure 15). Emotional intelligence, the ability to fit to team dynamics and learning agility were also mentioned as desired qualities. However, assessing communication skills and emotional intelligence can be challenging. And the ability of Medical Affairs organizations to hire appropriate talent is hampered by the small (and potentially over-paid) talent pool available throughout Asia.

Topic No. 5


High turnover may also result when the desire for “fast track” financial rewards and status come at the expense of pursuing a longer-term development path with the company. There may be opportunities to better align organization and incentive compensation structures to advance value-added roles. In addition, arduous compliance and risk management procedures are a significant source of frustration for field team members. Creating more proactive human resource policies and procedures can have a significant impact on retention.

Given these recruitment and retention challenges, optimizing resource utilization – putting the right person in the right roles with the right motivation – becomes key. As was pointed out at the Summit, although medical knowledge is a requirement for new hires, other skills are “trainable.” A robust training and onboarding program can go far to improve resource utilization and better position Medical Affairs to have a more proactive, strategic and influential voice within the larger organization.


CONCLUSIONMedical Affairs is undergoing a transformation globally and the changes taking place in Asia are similar in some ways – although quite distinct in others – to those discussed at Summits in the United States and Europe. Medical Affairs teams are now required to have greater flexibility in responding to the complex and quickly evolving challenges of the marketplace, regardless of where the changes are taking place. Medical Affairs teams need new and expanded skills and the ability to demonstrate value across the organization through clearly articulated vision and strategic planning. The topics for the APAC Summit addressed these issues and more. Conversations highlighted the need to expand capabilities, engage new stakeholders, be more proactive, develop new skills, and define new career paths. inVentiv Consulting, along with our industry Medical Affairs colleagues, continues to find these meetings a unique, global forum for the open exchange of ideas and best practices, and we look forward to continuing them in the coming year.

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About inVentiv Health ConsultinginVentiv Health Consulting (formerly Campbell Alliance) is an industry-leading consulting firm specializing in the biopharmaceutical industry and part of inVentiv Health. We provide services across a comprehensive range of key areas, including commercial strategy and planning, medical affairs, risk and program management and pricing and market access. Industry focus and depth of functional expertise, combined with strong scientific and market knowledge, uniquely position us to tackle highly complex business and market challenges to develop actionable strategies for our clients.

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Sebastian BatherAPAC Regional Managing DirectorinVentiv [email protected]

Keith Morris, RPh, MBAManaging Director, Practice Area LeaderinVentiv Health [email protected]

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Medical Affairs Leadership Summit, Key APAC Insights - August 2016