Key Insights from Campbell Alliance s Fourth Annual US Medical Affairs Leadership Summit

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1 Key Insights from Campbell Alliance s Fourth Annual US Medical Affairs Leadership Summit By Keith Morris and Mike Menta For the fourth year running, Campbell Alliance brought together Medical Affairs (MA) leaders from a diverse range of pharmaceutical and biotechnology companies to share ideas at the Medical Affairs Leadership Summit. Topics for discussion at this year s summit were based on input from MA leaders regarding the issues they face and on our experience working with dozens of Medical Affairs teams, helping them tackle their key challenges. Prior to the meeting, participants were presented with eight potential topics for the Summit. Three were selected, and the participants completed surveys on the following areas of interest: Global Medical Affairs Structure Metrics/Value Talent Retention/Development The results from each survey served as a starting point for discussion at this year s Summit. This paper shares the key insights that emerged from the survey findings and the thoughts from the broad cross-section of MA leaders who gathered to discuss the data. About the Medical Affairs Leadership Summit Campbell Alliance s Medical Affairs Leadership Summit program comprises three annual, non-profit events held in the US, EU, and Asia. The Summits are designed to give MA leaders a forum for sharing insights about the key challenges they face and provide a mechanism for creating and sharing solutions. As signature events during a year-long cycle of collecting and analyzing data about MA leaders most pressing issues, the Summits provide MA leaders an opportunity to learn about how their peers address key issues, discuss potential solutions, and gain insights from Campbell Alliance s research and expertise.

2 Topic No. 1 Summary: Global Medical Affairs Structure Global Medical Affairs (GMA) teams are often responsible for publications, medical information, research (ISTs, IITs), medical communications, and medical field teams areas where more consistency is needed and more efficiencies can be realized. While medical writing and medical information are the most common areas of outsourcing, many GMA organizations are now taking a more strategic look at outsourcing all types of field medical teams. Contract medical teams are being considered more often and for a broader range of activities than in the past. Only about half of GMA organizations have responsibility for the major regions (i.e., US, EU). The advantages of having a major region within GMA include consistency of communication, centralization of services, and alignment with a global strategy. GMA is a highly dynamic function and must evolve as therapeutic areas of interest change, customers evolve, geographies shift in priority, and business strategies unfold. Topic No. 1 Global Medical Affairs Structure Topics related to Global Medical Affairs (GMA) specifically how to establish and evolve a best-in-class global team have consistently been of interest to Summit participants. This year, the discussion was focused on GMA structure. GMA teams vary in which MA functions are included in their organizations. In general, when more consistency is needed and more efficiencies can be realized, GMA teams find themselves responsible for the function. Examples include publications, medical information, research (ISTs, IITs), and medical communications (Figure 1). In addition to enabling consistency and efficiency, discussions during the Summit addressed the strategic aspect of these critical GMA functions. These functions are all directly related to both the generation and communication of data and evidence, a core strategic element of best-in-class GMA teams. The topic of outsourcing GMA functions continues to be of high interest among MA leaders. To get a sense of how outsourcing is currently viewed by MA leaders, we surveyed the participants on this topic. While medical writing and medical information were the most common areas of outsourcing, the use of contract field medical teams (including medical science liaisons [MSLs]) generated the most discussion during the Summit. Many GMA organizations are now taking a more strategic look at outsourcing all types of field medical teams. Deploying contract medical teams is approached differently by each organization, depending on company size, culture, availability of resources, and previous outsourcing experience. What is clear, however, is that contract medical teams are being considered more often and for a broader range of activities than in the past. From supporting mature products to interfacing with new MA customers (patient advocacy, integrated health systems, etc.), MA leaders are taking a strategic look at contract medical teams to take advantage of opportunities and address some unique GMA challenges (Figure 2). In addition to the scope of responsibility of GMA and the role of outsourcing, we surveyed summit participants on various aspects of GMA structure. Summit participants provided some valuable insights into their experiences, past and present, the importance of having the right GMA structure. As seen in Figure 3, our survey results showed that only about half of GMA organizations have responsibility for the major regions (i.e., US, EU). Having a major geographical region as part of GMA has a significant impact on the GMA organization and brings with it both advantages and challenges. The advantages of having a major region within GMA include consistency of communication, centralization of 2

3 Campbell Alliance: Strategy. Results. Figure 1 Functions within GMA Organization 100% N=18 90% 80% 70% 60% 89% 83% 83% 78% 72% 67% 61% 56% 56% 56% % Respondents 50% 40% 30% 33% 33% 28% 22% 20% 10% 0% Publications Medical information Research (ISTs, IITs) Medical directors Medical communications MA operations MSLs Grants Medical training Research (phase IIIb/IV Medical writing Program management HEOR Other Q3. Which of the following functions are within your GMA organization? services, and alignment with a global strategy. Our survey also addressed some of the challenges with GMA having responsibility for a major region. Those challenges and potential solutions are summarized in Figure 4. The final discussion around GMA structure addressed how often the structure changes. GMA is a highly dynamic function and must evolve as therapeutic areas of interest change, customers evolve, geographies shift in priority, and business strategies unfold. The frequencies of GMA structure change along with a more detailed look at the drivers of change are depicted in Figure 5. Figure 2 % Respondents 70% 60% 50% 40% 30% 20% 10% 0% 12% Medical communications Key Activities Due to GMA Structure Publications 24% Q4. What are key activities that are outsourced due to the GMA structure? 0% IIT submission management Scientific writing 65% 12% MSLs 53% Medical information 18% Other N=17 3

4 Figure 3 GMA Responsibilities for Major Regions N=17 47% 53% 14% 14% 14% 12% 10% 19% Publications Medical information Research (ISTs, IITs) Medical Directors Medical Communications Medical Directors Medical Communications Yes No 17% Q6. Does GMA include responsibilities for major regions (i.e., US or EU)? Figure 4 Challenges Solutions N=15 Don t fully understand the market dynamics, customers, and local needs. This can be addressed by having a universal (global) MA strategy, which the local regions can then implement based on their customers needs. The strain between regional priorities (and pressures from the region to fulfill them) and more global priorities and themes. These are best addressed by having regional priorities part of the GMA plan and providing value regionally from GMA (i.e., with publication planning, ISS evaluation, management, etc.). Bandwidth and full support Outsourcing, consultants The knowledge about local issues/needs/ capabilities is a challenge when GMA makes decisions about a specific local issue. Bringing in local MDs and other functions that can inform the GMA staff. Potential conflict of interest between what is best globally and locally. Management of centralized interests vs local interests and allowing enough flexibility in each approach to not stifle activity. Prioritization of where resources and iniatiatives will be allocated. Q8. What are key challenges of having responsibility for a major region within GMA and how do you address them? 4

5 Campbell Alliance: Strategy. Results. Figure 5 N=17 Frequency of GMA Organization Structure Change 13% Drivers of Change Executive leadership-driven Efficiency and life cycle management 13% 37% Overall organizational changes (growth, refocusing, etc.) Budget and resource realignment 6% Adapting to changing environment with needs for transparency and for consistent processes globally Annually 2-3 years 31% 3-4 years N/A Not within MA, but as part of company reorganization Q8. What are key challenges of having responsibility for a major region within GMA and how do you address them? Poor performance and changes in the reporting structure Addition of new partners with limited experience in the company s key therapeutic structure and too many of them with disparate needs Topic No. 2 Summary: Metrics/Value Value demonstration is being pursued as a top priority for those in MA and is supported by the entire MA organization. The concepts of metrics and value demonstration are linked but should also be evaluated separately, often with different approaches to clearly demonstrate MA contributions to the broader organization. Value demonstration will be advanced by MA routinely telling a story that is clear and concise and that reflects contributions that are unique to MA. When describing MA value demonstration, it is important to consider both internal and external customers of equal importance. With the shift from traditional MA activities such as medical information and phase IV trial support to customer-facing activities, value demonstration efforts and metrics should be focused in these areas as a priority. When considering potential solutions to demonstrating value, it is critical to involve internal stakeholders in the design of a value demonstration initiative. Summit attendees supported the notion of looking outside of the pharmaceutical industry to gain additional ideas to provide guidance in demonstrating value. 5

6 Topic No. 2 Metrics/Value Current State of Metrics and Value Demonstration Our survey results reflect that value demonstration for MA functions continues to be important to MA leaders. Figure 6 shows that value demonstration is currently being pursued as a top priority for those leaders and is supported by the entire MA organization. It is also clear that for MA functions, the concepts of metrics and value demonstration are linked but should also be evaluated separately, often with different approaches to clearly demonstrate MA contributions to the broader organization. While the exact relationship between metrics and value demonstration is often debated, MA leaders feel that value demonstration will be advanced by MA routinely telling a story that is clear and concise and that reflects contributions that are unique to MA. When metrics are described within the context of a broader story, MA can make real progress with demonstrating value. When describing MA value demonstration, it is also important to consider both internal and external customers of equal importance. This balanced approach ensures that the broad impact of MA activities is included in value demonstration. Our survey results and discussions during the Summit reflect that compliance is not a barrier to MA value demonstration. As a best practice, MA leaders see compliance and legal as partners rather than a deterrent to initiatives designed to demonstrate value. Figure 6 Value Demonstration N=17 In general, Medical Affairs members at every level support efforts to demonstrate value Value demonstration is more of a longer term internal PR campaign than a defined set of metrics and measurements The inability to demonstrate value has a tangible, negative impact on the Medical Affairs function at my company (e.g., ability to secure FTEs, expand budget, inclusion in strategic meetings, etc.) Value demonstration for Medical Affairs is a top priority for me and my leadership team Value demonstration, in some form, is currently being pursued for my Medical Affairs organization As long as compliance is shaping Medical Affairs activities, meaningful value demonstration is impossible Value demonstration should be designed around a balance of external and internal customers 4 13 Value demonstration should be designed around internal customers only (commercial, clinical, C-suite) Value demonstration should be designed around external customers only (patients, providers, payers) Q13. To what extent do you agree or disagree with the following statements? Strongly disagree Disagree Neither agree nor disagree Agree Strongly agree 6

7 Campbell Alliance: Strategy. Results. Past Experience with Value Demonstration MA leaders attending the Summit have had a significant amount of experience in the past with surveying both internal and external customers to demonstrate value. Figure 7 reflects that interactions and collaborations with payers and organized customers (integrated health systems, large group practices, etc.) have high potential to demonstrate value for MA. It is also important to note that evidence generation, communication, and the broader concept of scientific exchange was reported as having the highest potential in this area. The shift from more traditional MA activities such as medical information and phase IV trial support to customerfacing activities is clear; value demonstration efforts and metrics should be focused in these areas as a priority. Customer surveys implemented by MA functions vary greatly in their content, but they address topics such as access, scientific concepts, reliability of information provided by MA, and behavior changes. For internal customers, value demonstration is becoming synonymous with medical insight gathering and sharing. MA leaders have had recent experience (and success) with providing unique medical insights about disease states, products, and healthcare delivery in relevant therapeutic areas. Figure 8 demonstrates the importance of medical insights as reflected by our survey data. Figure 7 Potential Solutions Customer Facing Activities That Have the Most Potential to Demonstrate Medical Affairs Value Evidence generation, communication / scientific exchange Payer interactions / collaborations Organized provider (IDNs, health systems, etc.) interactions / collaborations Medical information Supporting clinical trials (phase II and III) Other (phase IV implementation) 1 (Highest potential) Q15. Please rank the customer facing activities that have the most potential to demonstrate Medical Affairs value. When considering potential solutions to demonstrating value, it is critical to involve internal stakeholders in the design of a value demonstration initiative (Figure 9). Individuals on the commercial side specifically provide valuable insights in this area. In attempting to demonstrate value through metrics, creating a story, or customer surveys, internal stakeholders should be a partner in these endeavors. Looking forward to what can be done differently to demonstrate value, MA leaders through both the survey and the discussions during the Summit (Lowest potential) N=15 felt strongly that looking outside of the pharmaceutical industry for additional ideas and guidance would be a worthwhile effort. The breakout sessions during our Summit were designed to do just that; explore some ideas from outside the industry. The Summit participants were prepped for the breakout sessions by first discussing how they define value, identifying a product that provides high value, and, finally, identifying a service (more closely aligned to GMA) that provides high value. Following the value primer, the breakout groups addressed three questions related to innovation, branding, and execution

8 Figure 8 Internal Stakeholder Activities That Have the Most Potential to Demonstrate MA Value N=17 Communication of medical insights outside of the Medical organization (i.e., to Commercial, Market Access, etc.) 88% Contribution to strategic brand planning, life cycle management, and related initiatives 76% Contributions to launch planning 53% Evidence generation 41% Communication of medical insights internally with the Medical organization 24% Training of non-medical Affairs personnel 12% Medical/legal/ regulatory review 6% Q16. Check the top 3 internal stakeholder activities that have the most potential to demonstrate Medical Affairs value (select at least 1, no more than 3 answers) % Respondents Figure 9 Most Important Component in Demonstrating Value Least Important Component in Demonstrating Value Involving internal stakeholders in the design of a value demonstration initiative Constantly and proactively communicating available information on value A broad set of metrics that are measured routinely Support of a few senior leaders among key internal stakeholders N=17 12% 12% 35% 41% 0% 25% 50% 0% 25% 50% % Respondents % Respondents N=16 Q19. Which of the following is the most important component in demonstrating value? Q20. Which of the following is the least important component in demonstrating value? Other Constantly and proactively communicating available information on value Involving internal stakeholders in the design of a value demonstration initiative A broad set of metrics that are measured routinely Support of a few senior leaders among key internal stakeholders 6% 6% 25% 31% 31% 8

9 Campbell Alliance: Strategy. Results. Branding Innovation What parallels can we draw between examples outside pharma and the value proposition of Medical Affairs? Branding How are we going to identify and define our value proposition? Innovation The sessions began by drawing parallels between the MA function and organizations outside of pharma. Participants discussed both the Volvo brand and the Apple Genius Bar in some detail. Medical Affairs is generally perceived simply as an enduringly dependable and stable function within the organization. A number of Summit participants challenged the group to think about whether this is how MA should still be viewed. Exchanging knowledge and gathering information (i.e., medical insights) from customers and helping the broader organization make sense of it all was an example of an opportunity to demonstrate value. Embracing this element of MA would definitely shift how MA is viewed internally. Additionally, being viewed by the customer (internally and externally) as the true expert will also deliver value. Defining and communicating the MA value proposition is central to value demonstration. The key elements in this area, as defined by MA leaders, are timeliness, expertise, and innovation. Other areas, more transformative in nature, were also addressed, including social media patient interactions and packaging knowledge in a more digestible form for broader consumption. While both would have inherent challenges, steps like these could play an important role in value demonstration. Execution Execution What tools and innovative ways can we think of to demonstrate value to internal and external customers? Employing the right tools to demonstrate value is a key challenge in the MA arena. Participants discussed the example of an innovative tool that focuses on timeliness and accuracy of medical insights, for instance, after medical congresses. Providing an easy-to-use tool for internal and external customers would go a long way to brand MA and move toward clear value demonstration. 9

10 Topic No. 3 Summary: Talent Retention/Development Business leadership/acumen and strategic thinking are needed to address the evolving role of MA. Medical directors may find themselves in a position to lead their medical teams as MA takes a more active role in bringing insights from the external stakeholders and distributing them to the rest of the organization. Developing new skills and competencies will require not just training but a cultural change within the organization. The biggest threat to talent retention is lack of a clearly defined career path, which is a particular issue among field team members. Topic No. 3 Talent Retention/Development Skills and Competencies The skill sets and competencies required by MA personnel are changing as the external market environment evolves and as internal stakeholders increase their demands on MA. When asked what general unique skill sets/competencies are needed to address the evolving role of MA, 100% of survey respondents cited cross-functional collaboration. Collaboration is necessary across MA functions in addition to collaboration with groups outside MA, including commercial, marketing, and market access. Business leadership/acumen and strategic thinking were cited by 73% of survey respondents as unique competencies needed to address the evolving role of MA. Only 23% of respondents, however, cited business acumen/mba as a top skill set they generally look for when recruiting people for an MA organization. Rather, an advanced degree along with medical knowledge and previous industry experience were the skills most commonly sought after. As a result, it is no surprise that the people who enter the MA field typically possess strong scientific/medical backgrounds but may lack the skills to lead and manage a team effectively, particularly at the medical director level. As MA takes a more active role in bringing insights from the external stakeholders and distributing them to the rest of the organization, some medical directors will find themselves in a position to lead their medical teams, so business leadership skills will be particularly critical. Development and Retention Developing these new skills and competencies will require not just training but a cultural change within the organization. From the top down, leaders need to support training not only by making it available but also by making it part of a personal development mentoring program. It is all too easy for MA leaders to become so busy doing their day jobs that they forget the important task of spending time coaching, mentoring, and assembling professional development plans for their people. Investing in personnel development not only provides people with the skills they need to excel in the evolving marketplace, it is also an important way of driving talent retention. The biggest threat to talent retention cited by survey respondents is lack of a clearly defined career path (Figure 11). This is a particular issue among field team members. Solving this problem requires an investment of time to understand 10

11 Campbell Alliance: Strategy. Results. a person s strengths and identify opportunities within the organization that can build on those strengths. When asked to consider the three biggest reasons for retaining key MA individuals, 87% of survey respondents cited the allowance of special projects, identified by the employee, to be included in their work (Figure 12). It is important to recognize that some individuals are not a good fit for a leadership position due to many reasons, including a lack of aptitude or lack of passion. Instead, organizations should leverage individuals strengths, identifying areas in which they will excel based on passion and drive and a demonstration of ability to do well in that position. When people feel as though an investment is being made in their career progression and that their involvement and contributions bring value to the organization, they will be more likely to choose to stay. Talent retention goes beyond financial compensation. Offering more money is a shortterm solution. Retaining talent for the long term requires an acknowledgement of an individual s contribution, an investment of time in training and career planning, and providing opportunities to grow and develop in the areas where their passions lie. Figure 11 Lack of a defined career path Threats to Talent Retention 79% N=14 Overwhelming workload, i.e., lack of work/life balance 64% Other Lack of scientific/clinical aspects of the job 36% 36% Lack of interest in pipeline Q23. In considering your talent retention situation, what do you consider the 3 biggest threats to losing key MA individuals? 14% % Respondents Figure 12 Successful Talent Retention Methods N=15 Competitive salary 47% Clearly defined and attainable career path 60% Allowing for the right balance of clinical/scientific activities with busienss/operational activities Allowing for special projects, identified by the employee, to be included in their work 80% 87% Other: work-life balance 7% Q33. In considering the successes you have had in talent retention, what do you consider the three biggest reasons for retaining key MA individuals? 11

12 Conclusion The Medical Affairs function is truly undergoing a transformation. The changes being undertaken by MA leaders clearly point to MA moving from supportive and reactive to a more strategic and proactive function. Demands being put on MA come from many areas, both inside and outside of the organization. With these demands comes the need to evolve. The topics for this year s Medical Affairs Leadership Summit addressed this evolution. The dialogue around global MA structure became a dialogue about new operational models, where flexibility and efficiencies are built in. The metrics discussion expanded to the broader value demonstration concept as Summit participants looked outside of our industry for ideas. Finally, talent retention and development moved to the forefront of key challenges faced by MA leaders. In 2015, Campbell Alliance will hold its fifth US Medical Affairs Leadership Summit. Recently, inaugural Summits have been kicked off in the EU and APAC, making these Campbell Alliance programs truly global in nature, involving more than 50 companies. Campbell Alliance, along with our industry Medical Affairs colleagues, remains committed to providing MA leaders with a forum to engage in this dialogue around Medical Affairs transformation. Contact Keith Morris RPh, MBA Vice President Campbell Alliance keithmorris@inventivhealth.com Mike Menta Chief Operating Officer Campbell Alliance mike.menta@inventivhealth.com Scan here to download an electronic version of this white paper or visit RESULTS. It s a pretty simple word that s used a lot in the business world, but what does it really mean? When you cut through all the clutter, results means performing beyond expectations, eradicating challenges, and achieving your business goals. It means not just dreaming it. But actually doing it. Campbell Alliance is purpose-built to help biopharmaceutical and medical technology companies achieve results. Whether it s seizing the leadership position in a new market, solving seemingly impossible challenges, or developing innovative approaches for success, we don t quit until the desired results are delivered. We offer the insight to help leaders develop powerful strategies, as well as the knowledge to ensure they ll work in the real world. And through our relationship with inventiv Health, we bring the global implementation capabilities needed to put even the most ambitious plans into action. Delivering results is what we do. Let s get to it. Campbell Alliance: Strategy. Results. Headquarters Address 370 Lexington Avenue, Suite 1100 New York, NY Telephone: Fax: Toll Free: Campbell Alliance: Strategy. Results. Campbell Alliance is a leading management consulting firm focused on helping biopharma companies address key strategic business questions, and achieve tangible results. Campbell Alliance is the strategic consulting business line of inventiv Health, a best in class solutions provider of clinical and commercial support and expertise to elevate our clients performance. inventiv Health combines a broad range of deep therapeutic expertise with an unparalleled breadth of commercialization capabilities. 12