KEY INSIGHTS FROM CAMPBELL ALLIANCE S THIRD ANNUAL US MEDICAL AFFAIRS LEADERSHIP SUMMIT

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1 KEY INSIGHTS FROM CAMPBELL ALLIANCE S THIRD ANNUAL US MEDICAL AFFAIRS LEADERSHIP SUMMIT Introduction For the third 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 pharmaceutical companies, helping them tackle their key challenges. Topic No. Operationalizing the Global Medical Affairs Function Our 0 Summit tackled the issue of aligning regional MA affiliates and the broader global organization. Following that thread, in the 0 Summit we wanted to look at how to actually make the global Prior to the meeting, MA leaders had the opportunity to complete surveys on the three following topics: Operationalizing the Global Medical Affairs Function Medical Affairs Launch Excellence How the Affordable Care Act (ACA) Will Drive Priorities 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. MA function operate successfully, given the range of responsibilities at the global, country, and regional level. A tradeoff always exists when achieving global objectives and broader corporate goals while maintaining regional focus and addressing regional needs. Furthermore, does addressing regional needs necessarily mean that country-specific needs are also About the Medical Affairs Leadership Summit Campbell Alliance s Medical Affairs Leadership Summit program comprises three annual, nonprofit 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. 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. Topic No. Summary The need to achieve global objectives and broader corporate goals. while maintaining regional focus and addressing regional needs results in tradeoffs having to be made. Most global MA groups either have no reporting relationship or a dotted line reporting relationship with regional MA teams. Some companies struggle with how to align communications across regions. Defining a process is a critical step to making a global MA group operational, which involves having the appropriate resources to execute the process and holding people accountable. being met? Other key questions are raised about reporting structure, coordinating activities in the various regions, and budgets. For example, if the budget is held globally, should priorities also be set globally? This may work well to maintain a global perspective on strategy, but it may not work when regions have their own priorities and do not necessarily align with the broader set of objectives. So, should budget be maintained on a regional level? This may work to ensure regional needs are met, but on the other hand, regions may not always understand the sensitivities of what else is needed around the world.

2 Figure Reporting Relationship Between Global and Regional Medical Affairs Groups 6 N= % Direct-Line Reporting 6% Dotted-Line Reporting No Reporting N/A - Do Not Have a Glboal MA Organization Q9. What is the reporting relationship between Global and Regional/Country Medical Affairs groups within your organization? % To get a sense of how MA organizations are aligned today, a representative sample of Medical Affairs Leadership Summit participants were asked to characterize the reporting relationship between their global and regional/country MA groups in a pre-summit survey. Of those surveyed organizations that have a global MA group, most either have no reporting relationship or a dotted-line reporting relationship with regional MA teams (Figure ). Most responsibilities are shared by both the regional and global groups, with the exception of Medical Science Liaison (MSL) oversight, MSL strategy and activity planning, Figure Areas of Responsibility of Medical Affairs Group N= MA policies and processes 9 Knowledge management (i.e., centralized library of therapeutic area and product specific medical information) 7 KOL engagement KOL identification 9 MSL oversight MSL strategy and activity planning 0 Continuing medical education (product strategy and implementation) Medical information execution Medical information planning Investigator-initiated trials (strategy, application review, grant approval, and funding) 7 Brand-specific publication plans Brand-specific post-marketing (IIIB/phase IV studies) plan 0 Post-marketing data/evidence generation plan MA launch strategy 0 0 Q7. What are the areas of responsibility of the Global Medical Affairs group and the Regional/Country MA groups? Global Regional Both

3 Campbell Alliance: Strategy. Results. Figure Primary Responsibilities of Dedicated Global Operations Function N=9 Dedicated Global MA Operations Role Track and report overall MA performance (e.g., KPIs, metrics) 9% N= Coordinate interactions and communication between Global MA and Regional/Country MA groups 9% Resource and budget planning and maintenance 6 6% 6% Vendor procurement and oversight Manage discrete Global MA functions (e.g., Med Info, Med Comm) % 6% Other % Yes No Q. Does your Global Medical Affairs group have a dedicated role or function that focuses solely on operations? Qa. What are the primary responsibilities of this dedicated global operations role/function? and continuing medical education. These naturally are more likely to be regional responsibilities (Figure ). The majority of surveyed organizations (6%) have a global MA operations role (Figure ), whose primary responsibilities include tracking and reporting MA performance and coordinating interactions between global and regional leadership. Objectives and Communications Even though some activities may be coordinated between global and regional teams, broader objectives may not be so well aligned. A specialty drug manufacturer represented at the Summit struggles with the fact that objectives are being set at all three different levels global, regional, and country level and every group sees its needs in a different way. More than half of the respondents surveyed (%) felt that global MA has neither the expertise nor resources needed to effectively plan and/or coordinate at the regional/country level (Figure ). An equal number noted inconsistent regional/ country input into the planning phase within their organizations. Other companies struggle not with how to align objectives, but with how to align communications across regions. They reported that boots-on-the-ground teams in each region are not necessarily well connected to one another. So when data come out for example critical phase III data it can be difficult for companies to ensure that the teams in the US, EU, or other markets are in sync with each other in terms of how the data are being messaged. A representative from a top-0 pharmaceutical company participating in the Figure 6 Summit stated that the company s global MA team is responsible for publication plans and corresponding data, while the regional teams are responsible for executing the plans. Therefore, while the broader team is aligned on how data are interpreted, its MSL teams are part of a local organization and may not be aligned on what the data represent or how they are being presented. The company is focusing on fostering more interaction Key Gaps in Operationalizing Activities Led by Global MA % % Global MA group does not have the expertise or resources to effectively develop plans and/or conduct activities at the regional/country level Inconsistent regional/ country input into the planning phase Qb. What are the key gaps your Global MA group has in operationalizing activities led by the Global MA group? % Planning capabilities within organization are insufficient % Other % N= Goals and/or objectives are not aligned between Global MA and Regional/ Country groups during planning/implementation phases

4 between the MSL groups to alleviate this issue. Figure Main Approaches to Global MA Oversight of Regional Activities 6 % N= Another leading pharmaceutical company circumvents this issue by having its global MA team more focused on coordination to make sure a consistent story is being presented and translated correctly. Though each regional team has its own medical plan and execution is left up to these regional teams, the global team reviews the plans to ensure consistency. Defining a Process Defined processes for oversight of Regional/Countryled activities Ad-hoc oversight of Regional/Countryled activities Q. What is your Global MA group s main approach to overseeing activities led by Regional/Country groups? Global MA does not perform oversight of Regional/Country-led activities To begin making the global MA group operational, it is necessary to define a process. This involves having the appropriate resources to execute the process and holding people accountable for the process in multiple regions. Nearly half of survey respondents indicated that they have no defined processes for making global MA-led activities operational. Companies stated that although some processes may exist, the processes do not necessarily work because the MA organization is not fully resourced. Therefore, companies need to focus on processes that have the most value and are executable with the available resources. Another challenge is holding people accountable for execution of a process. For instance, if the process is owned by the global teams, it may be a struggle to gain the cooperation of regional teams to adhere to the process. Regional teams may become too focused on their priorities and fail to consider the global priorities, pushing their needs ahead of the global process. And as seen in Figure, respondents were almost evenly split between having defined processes for overseeing regional/countryled activities () and having no oversight (%). The most common approach to regional oversight is predefined meetings Figure 6 Key Gaps in Operationalizing Activities Led by Regional/Country MA Groups 6 Qc. What are the key gaps your Global MA group has in overseeing activities led by the Regional/Country MA groups? held on a quarterly basis. Among activities led by regional/country MA groups, the most commonly cited issues were a lack of global oversight (6%) and limitations of the reporting structure (%) (Figure 6). Key Takeaways 6% Global MA does not have the appropriate resources for effective oversight % Reporting structure limitations Establishing a true global MA organization that is resourced appropriately, that has the % % % Lack of Poor standardized commumnication processes Other N= Goals and/or objectives are not aligned right talent within the organization, and that has created a well-thought-out blueprint for success is just the first of a multi-part effort. Operationalizing an established global MA function follows closely and presents additional challenges for global MA leadership. The results of our pre-summit survey as well as the insights gathered during the Summit

5 Campbell Alliance: Strategy. Results. Figure 7 In the Last Two Years Number of Commercial Launches In the Next Two Years N= clearly point to the importance of having the right organizational structure in place to operationalize global MA. But leaders of global MA functions also made it clear that, following the approval and acceptance of the boxes, dotted lines, and solid lines, the work is by no means complete. Full attention must then be paid to establishing a process for how the global MA organization plans, communicates, and shares information. These components of global MA operations are difficult to put on paper, but establishing these processes, training personnel on how they work, and pursuing continual improvement are critical to the success of a global MA function. Finally, we noted a clear trend among the well-established global MA functions is a commitment to creating a specialized global MA operations team. While the titles of these groups vary (Operations, Strategy, etc.), their main objective is the same: to establish a broad and inclusive approach that enables the global MA function to run smoothly and make significant contributions to the organization as a whole. Topic No. Medical Affairs Launch Excellence We have seen the MA organization becoming a much more prominent member of launch teams, and given the needs and complexity of today s products, MA will need to continue to play a major role to ensure launch success. As the role of payers continues to expand, it will be important for MA to get involved earlier in launch planning. MA has a major role to play in the data generation process to ensure a broad value proposition is established, requiring improved alignment with Clinical Development. Meanwhile, as sales representatives get less and less access to physicians, MA s role in facilitating scientific exchange with customers around % % 6% Q0. How many commercial launches (product and/ or additional indications) has your MA organization been involved with in the past two years? the data will become increasingly critical. More than % of survey respondents expect MA s role to increase in launch in the next three to five years. While more than half of respondents have supported one or no launches in the last two years, three quarters anticipate supporting two or more commercial launches in the next two years (Figure 7). Additionally, a critical role MA can play in launch is its ability to pull information back into the organization. Given the MA team s ability to have frank discussions with physicians about the data and the theoretical aspects of the disease state, % % Topic No. Summary Q. How many total commercial launches (product and/or additional indications) does your MA organization anticipate supporting in the next two years? they can provide valuable feedback to the organization about what the product may mean to stakeholders, the endpoints that are most important to decision makers, and what additional data they may want to see. Also, keeping a regular check on the questions being asked by stakeholders can provide valuable information to the organization and can help to shape the education provided on specific topics. Budget Challenges Nearly two thirds of survey respondents initiate formal MA launch planning between and months before launch (Figure MA plays an important and growing role in ensuring launch success, including data generation and facilitating scientific exchange with customers. As the role of payers expands, MA will need to get involved earlier in the launch planning process to ensure a broad value proposition is established. Another important role MA plays in launch is its ability to pull information back into the organization around stakeholder attitudes, endpoints of interest, and desired additional data. Securing the necessary budget is the primary challenge for MA in its launch activities.

6 Figure Timing of Launch Planning Initiation N= 6% 9% % % < months - months 9- months + months Q9. How far in advance of launch does MA start formal launch planning? As seen in Figure 9, a cross-functional launch team most commonly handles coordination and management of MA launch activities among survey respondents (%). Coordination of multi-functional activities should be centralized, and it is necessary to participate in frequent, regular meetings to ascertain progress in order to apply more resources to activities that are lagging. All launch planning can be incorporated into cross-functional MA strategy teams to enhance communication and input from all functions and regions. Figure 9 Management and Coordination of MA Launch Activities Coordination and management of MA launch activities is handled by cross-functional launch team Each functional group is responsible for managing their own launch activities % N= Because it is difficult to educate the budget holders on the importance of providing resources to MA early on in the development process, devising well-defined metrics will play a critical role in demonstrating the value and return on investment/engagement that can be found from MA activities. Procurement of external vendor to manage launch preparation activities Dedicated internal function/person to coordinate and manage launch activities MA launch team formed to coordinate and manage launch activities % 9% Q. How does your MA organization coordinate and manage launch activities? ). All participants cited lack of sufficient resources and budget to effectively plan for MA launch as a key issue in launch planning and preparedness. Summit participants trace this to a lack of education of internal stakeholders (leadership) on the importance of MA. Often finance and business partners within the organization fail to appreciate why it is necessary to direct money to a product that is two or more years away from launch. When a company has a broad portfolio, it becomes even more difficult to juggle resources. And when resources do come, they typically go to the commercial side first. Participants in the Summit discussed various techniques to secure not only budget, but also a significant role in launch activities. One technique employed by the MA leader at one specialized pharmaceutical company is to avoid the word planning in resource discussion. A certain connotation exists that a plan does not justify resources. Instead, descriptors are used related to what the planning actually means in terms of deliverables and tactics. Key Takeaways As MA groups strive to demonstrate value and secure resources, it is important to keep in mind the changing landscape when building out teams. Because of changing audiences and the pressure to identify these changing decisions makers, new training models will be needed to create specialized field-based groups. It will also be necessary to proactively define roles and responsibilities of the MA team in order to recruit the right type of people with the right skill sets and experience/knowledge, both from a leadership and field perspective. As MA s involvement in launch planning and execution evolves, new capabilities and skill sets will likely be required, including: Business acumen skills Team-building skills Leadership skills Phase IV trial design Ability to generate, interpret, and communicate different types of data Knowledge of epidemiology, outcomes, value, etc. 6

7 Campbell Alliance: Strategy. Results. Figure 0 Changes Required to Accommodate ACA 7 N= Once an organization comes to an agreement on a set of metrics that defines what a successful launch looks like, MA launch excellence will still rely on finding better ways to learn from the past. Tracking/ establishing best practices from launch to launch and monitoring them over time is a key to determining success. It s not about just understanding what the organization did right in a snapshot in time, but tracking best practices over time from one launch to the next to determine the level of success. MA teams need to be able to think about what they did and how they did it and then critically evaluate whether or not it was effective and what they might change. 6 Change in MA team roles and responsibilities Change in interfacing with external healthcare community 6% 6% New services/ capabilities Additional skill sets % MA Organizational structure % Change in interfacing and coordination with internal stakeholders Being able to communicate that MA did its job, even if the overall launch was less successful than expected, is also a major challenge. Here again, establishing metrics comes into play. It is first necessary to define what a successful launch looks like before being able to measure what any one component of the launch effort may have contributed or taken away. Once a company determines how it can measure success, it can then break it down to look at how individual contributions fed into the overall performance. Topic No. How the Affordable Care Act (ACA) Will Drive Priorities As the healthcare system evolves, it remains critical that MA leaders are on top of current events and trends. Today, there may be no bigger catalyst for change in the healthcare space than the Affordable Care Act. Signed into US law March, 00, the ACA puts in place comprehensive healthcare reforms that focus on three categories: access, cost, and efficiency. In terms of financial implications, the ACA is probably neutral or positive for the pharmaceutical industry. What will have an impact Q9. What changes will be required to accommodate ACA? on the industry, however, is the nature of its customers and the way companies will need to engage. Medical field teams () and evidence generation (%) are the areas survey respondents anticipate to be most impacted by ACA in the next five years. The most common changes to accommodate the ACA are expected to be changes in MA team roles and responsibilities () and changes in interfacing with the external healthcare community () (Figure 0). Topic No. Summary When asked how they would describe the level of knowledge of the ACA within their company as a whole, more than half of survey respondents consider their company to be somewhat knowledgeable about the ACA (). Knowledge of the ACA is most commonly obtained via internal communications and presentations. Formal training on ACA-related topics is limited, but for those that do receive training, the focus is on comparative effectiveness research (CER) and accountable care orga- The Affordable Care Act may be the biggest catalyst for change in the healthcare space today. Medical field teams and evidence generation are expected to be the most impacted by ACA in the next five years. Within MA organizations, formal training on ACA-related topics is limited, but for those that do receive training, the focus is on comparative effectiveness research (CER) and accountable care organizations (ACOs). ACA is expected to lead to changes in the type of customers with which MA will interact in the next five years, such as increasing interactions with large health systems. 7

8 Figure 6 Knowledge of Individual ACA-Related Concepts N= % % % % % CER (Comparative Effectiveness Research) ACOs (Accountable Care Organizations) HIT (Health Information Technology) Patient Centered Medical Home Patient Adherence Quality Measures Value Based Purchasing Continuum of Care Pay for Performance Episodes of Care / Bundled Payments Q9. Please check the three areas (e.g. ACA-related concepts, models) where your company possesses the most knowledge. Figure % % Areas in Which MA Organizations Will Be Leading Healthcare Industry Collaborations in Five Years 9% 9% % % % % % % N= % Quality Measures Continuum of Care CER HIT Patient Adherence Value-Based Purchasing ACOs Patient Centered Medical Home Pay for Performance Other Episodes of Care / Bundled Payments Q6. Looking ahead five years, which areas do you see MA leading both in knowledge and healthcare community collaborations (select top three)?

9 Campbell Alliance: Strategy. Results. Figure Expected Change in Customer Type for MA Organizations Other N= Expected Change in Customer Type for MA Organizations No change % Yes, but only a moderate change 6% Yes, there will be a significant change % N= Q7. Looking ahead five years, do you anticipate the ACA driving a change in the type of customers with which your MA team interacts? Other non-ma internal functions Patient advocacy groups Large health systems Private payers Government payers Mid-level providers (i.e., nurses, nurse practitioners, and physician assistants) Community-level providers Regional KOLs National KOLs No change Decrease level of involvement Increase level of involvement Q7a. What is the change in customer type? (Please indicate changes in the table below by checking the appropriate response: increase, decrease or no change) nizations (ACOs) (Figure ). It follows that confidence in understanding was highest for CER and ACOs. CER and ACOs were also the most commonly cited areas of collaboration with the healthcare community. One leading pharmaceutical manufacturer represented at the Summit is already training its MSLs to go into ACOs. Another company in the oncology space has started a healthsystem MSL team. The challenge becomes finding the right people with the knowledge and skills to build these types of relationships. When it comes to CER, meanwhile, few if any pharmaceutical companies are actively engaged in the US. The concern early on was that the results of CER could have reimbursement repercussions. If a product does not perform well in CER, the fear is that Medicare and Medicaid may decide not to reimburse for the drug. In Europe, meanwhile, companies are facing scrutiny for failing to conduct comparative effectiveness research. Looking ahead five years, however, CER is among the areas % of survey respondents believe MA was most likely to take the lead in both knowledge and healthcare community collaborations (Figure ). Meanwhile, quality measures and continuum of care were both cited by 9% of respondents. Audiences are changing as a result of healthcare reform as well. Most respondents felt ACA will drive at least some change in the type of customers with which MA interacts in the next five years. The most commonly cited increase was in interactions with large health systems (Figure ). In the past year, more US doctors have been employed by a corporation than those independently employed. Physicians are seeking security, and integrated health systems are buying up practices. While it will be necessary to work more closely with those systems in the future, conversations with integrated medical systems can be difficult. Key Takeaways The discussions during the Summit clearly demonstrated that US healthcare reform is on the minds of MA leaders. Each organization, however, views the impact the ACA will have on its function a bit differently. Some MA leaders have gone through the education stage already, i.e., they have an MA team that is well versed on the ACA and the possible impact on the industry. These MA teams are now focused on anticipating the needs of existing and new customers, making evidence a central theme for their MA team and repositioning the services provided by MA to align with the ACA healthcare delivery model. Some aspects of the ACA (e.g., ACOs, CER, quality measures) will emerge as the critical areas for MA. Anticipating how these more critical areas will impact MA and the broader industry should be the responsibility of MA leadership. Historically, MA has played a critical role in managing changes to the healthcare landscape. MA leaders, once again, find themselves at the center of a new and complex shift affecting healthcare delivery. 9

10 Conclusion The importance of medical affairs continues to grow, and the challenges of running a global organization are only going to become more complex. As the healthcare landscape changes and evolves, so too will the needs and responsibilities of MA organizations. Campbell Alliance will continue to provide senior MA leaders with a forum to share and explore best practices through the Medical Affairs Leadership Summit in the US. And recognizing the importance of MA to pharmaceutical manufacturers around the world, we are expanding this program with additional annual, non-profit Medical Affairs Leadership Summits in the EU and Asia. The insights gleaned from all of these events should combine to form a revealing picture of the challenges and opportunities that exist for MA on a global basis. Contact Mike Menta Managing Director Medical Affairs Center of Excellence Campbell Alliance mmenta@campbellalliance.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. Campbell Alliance: Strategy. Results. Headquarters Address 70 Lexington Avenue, Suite 00, New York, NY 007 Telephone: Fax: Toll Free: 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. 0