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As healthcare stakeholders become more focused on clinical data and scientific discussions, the strategic importance of medical affairs increases. Science is progressing too quickly for many busy physicians to keep up, and — with the ease of the Internet — many patients are becoming educated consumers. Medical affairs activities are crucial for satiating these stakeholders’ thirst for knowledge.
Medical Affairs Management provides executives with insights and benchmarks about medical affairs teams’ overall structure and resources, as well as 15 different subfunctions. It also explores internal and external trends affecting medical affairs. The report’s data were compiled from global, US and country-level teams for Top 10, Top 50, small and device companies. Armed with these data, medical affairs leaders will continue to innovate and prove the strategic value and overall necessity of medical affairs.
Medical Affairs Management includes the following highlights:
Benchmark resources for medical affairs as a whole — and for 15 vital subfunctions: As the strategic influence of medical affairs grows, ensuring proper resource support is essential. This report showcases medical affairs structure, budget & outsourcing and staffing metrics for medical affairs teams — across company type and team scope (global, US and country-level) — as a whole. Six of this study’s nine chapters also delve into these resource benchmarks for individual subfunctions. The breadth and depth of Medical Affairs Management make this study a one-stop source for medical affairs resource allocation and trends.
Stay ahead of, and prepare for, the latest medical affairs trends: Today’s life sciences landscape calls for an ever-increasing need for medical and scientific information. Gain insight into how the medical affairs function is evolving to meet new opportunities and challenges. This report pinpoints the most exciting and concerning trends facing medical affairs today and compiles direct feedback from leading executives on how they are innovating to better serve healthcare stakeholders, patients and the internal organization.
Establish balanced firewalls to encourage medical affairs’ involvement in corporate strategy: Medical affairs is essentially the keeper of scientific information. These data color just about everything the company does — from sales rep conversations to marketing to portfolio planning and beyond. Despite the benefits of medical affairs’ involvement, a large factor in the function’s ability to impact company strategies is the severity of internal firewalls and the level of communication medical affairs has with other departments. This report discusses how to establish firewalls between commercial teams and medical affairs that enable communication while remaining compliant; how to identify the best structure and communication methods for your medical affairs team; and how to determine which subfunctions your medical affairs team should support.
19 charts showing overall medical affairs team structure and reporting lines. Data are compiled from global, US and country-level teams for Top 10, Top 50, small and device companies.
Medical Affairs Team Structure
35 charts showing medical affairs budget and staffing benchmarks. Data are compiled from global, US and country-level teams for Top 10, Top 50, small and device companies.
Medical Affairs Budgets
Medical Affairs Staffing
Medical Affairs Outsourcing
11 charts detailing exciting and challenging trends in medical affairs, as described by surveyed medical affairs executives.
64 charts detailing resource allocation for thought leader development, MSL teams and speaker programs. Data are compiled from global, US and country-level teams for Top 10, Top 50, small and device companies.
Thought Leader Development
70 charts detailing resource allocation for medical communication teams. Data are compiled from global, US and country-level teams for Top 10, Top 50, small and device companies.
67 charts detailing resource allocation for IITs, medical grants and Phase 4 trials. Data are compiled from global, US and country-level teams for Top 10, Top 50, small and device companies.
Phase 4 Trials
43 charts detailing resource allocation for HEOR, health outcomes liaisons and managed care liaison teams. Data are compiled from global, US and country-level teams for Top 10, Top 50, small and device companies.
Managed Care Liaisons (MCLs)
Health Outcomes Liaisons (HOLs)
37 charts detailing resource allocation for drug safety, compliance and regulatory affairs teams. Data are compiled from global, US and country-level teams for Top 10, Top 50, small and device companies.
This chapter presents profiles for 12 surveyed medical affairs teams. The profiles include global, US and country-level teams for Top 10, Top 50, small and device companies.
The first two pages of each profile describe the team’s structure, such as:
Total Medical Affairs Budget
The next section of the profile provides the team’s overall medical affairs budget for 2014, 2015 and 2016 as well as the percentage budget change from 2015 to 2016.
Allocated and Outsourced Subfunction Budgets
This section of the profiles lists the percentage of the team’s overall medical affairs budget that it allocates to its involved subfunctions. It also includes:
The following excerpt is from Chapter 1, Establishing Structures to Facilitate Internal Coordination.
Medical affairs structures are highly variable and have been in flux at many of the companies included in this report. Regulations from the past decade have forced medical affairs to separate itself from commercial operations, both structurally and communication-wise at many companies. In fact, over half of all surveyed medical affairs teams are autonomous business functions, and another 29% report to R&D/ clinical. The resulting firewall between commercial and medical affairs has mitigated compliance concerns and given medical affairs more autonomy. But some believe these firewalls have effectively isolated medical affairs to the detriment of the company. In this chapter, interviewed executives offer case studies on challenges and best practices for overcoming internal firewalls.
For the medical affairs team itself, companies may choose to centralize the structure and decision making or to decentralize teams based on therapeutic area or country. Centralization — the structure utilized by 42% of surveyed teams — helps companies to align medical affairs strategies throughout their organizations. However, decentralizing also has its benefits. Medical affairs information is specific to the product’s disease area, so dividing responsibilities by therapeutic area helps teams to specialize. Similarly, many medical affairs materials need to be translated into local languages and customs, so regional-level teams can easily facilitate these changes.
Regardless if medical affairs is decentralized or centralized, coordination between different medical affairs teams is crucial to having cohesive operations. Interviewed executives present examples for how to successfully coordinate multiple medical affairs teams at a company.
Medical affairs teams do not only vary by organizational structure. They also vary by the subfunctions for which they are responsible, and team region is a huge factor for subfunction involvement.
These trends underscore the role of medical affairs teams at different regional levels.
The following excerpt is a key finding from the full report's executive summary.
An organization structure as complex as a medical affairs function can judge its success based on its communication abilities. Efficient medical affairs teams are able to communicate through various layers, across multiple subteams and beyond geographical boundaries. As long as information flows back and forth through the medical affairs structure, then the team can uphold its responsibility to respond to medical inquiries and disseminate medical evidence. When those communication processes break down due to a failure of the established reporting relationships, drug companies should examine their organizational structure.
Drug and device companies consider several key components when setting up their medical affairs organizational structures. The most important factor involves separating medical and commercial teams to avoid compliance issues. These compliance concerns include instances in which the company appears engaged in providing off-label information through promotional messaging. In addition to implementing this firewall between medical affairs and commercial operations, companies should develop strong and clear standard operating procedures that outline the approval process for utilizing medical data in communications with medical professionals.
The most important communications for medical affairs teams are between its internal subteams and cross-functional groups, such as marketing and clinical teams. As the medical affairs function has expanded over time, its need to coordinate across the company at a strategic level has only increased. Company C, for example, has established a strong relationship between its medical and clinical marketing teams by including the medical affairs function on strategic planning throughout its products’ lifecycles. As early as Phase 2, the medical affairs team works with clinical teams to identify where investigational products fill the biggest gaps in unmet market needs. As the drug moves closer to launch, the medical affairs team interacts more with the marketing team to prepare the brand team for launch. By helping the brand identify the best data to use when communicating to physicians, the medical affairs teams begins to form a stronger relationship with the marketing function. Following launch, medical affairs assist brand teams on speaker event preparation, as well as identify investigator initiated trial opportunities.
Aside from erecting a structural firewall between medical and marketing teams, there is no true best practice for configuring the actual medical affairs team’s structure. Companies’ medical affairs team structures vary widely. Some pharmas implement fully centralized medical affairs organizations in which global teams are responsible for executing strategy. Others operate fully decentralized functions in which country-level teams develop their own plans to support local market needs. Other options include a hybrid between centralized and decentralized teams to maximize the benefits of both structures. So long as teams up and down the organizational chain can maintain communication with each other in both directions, then companies should design a structure that fits in best with the additional parts of the corporation.