Medical Affairs Management (PH214)

Igniting Innovative Global Strategy
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Published 2015
476 Pages
500+ Metrics
380+ Charts and Diagrams

Innovating Global Medical Affairs Strategy and Processes for Deeper Impact

As healthcare stakeholders become more focused on clinical data and scientific discussions, the importance of a global medical affairs strategy 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.

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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 global medical affairs strategy development. 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. Use this report to implement best practices for developing a consistent global medical affairs strategy.

Medical Affairs Management includes the following highlights:

  • Insights from top medical affairs leaders highlighting medical affairs’ most exciting and most concerning trends
  • Best practices for establishing fluid yet compliant internal firewalls
  • Detailed benchmarks exploring how companies staff and budget 15 key medical affairs subfunctions
  • Data showing 2015 budget per supported product and per FTE
  • Data showing the number of outsourced medical affairs FTEs
  • Budget allocations per year (2014–16) for total medical affairs budget
  • Stage of start and peak activity levels for 15 medical affairs subfunctions
  • Profiles showing 12 medical affairs teams’ budget and staffing data

 

Questions This Study Answers about Global Medical Affairs

  1. Does my medical affairs function have enough resources — people, money and tools — to carry out our responsibilities?
  2. What are some innovative ways that my team can demonstrate value to the internal organization?
  3. How can our team use key performance indicators (KPIs) and other measures to prove medical affairs’ value?
  4. How can my company structure medical affairs teams to improve cross-team communication?
  5. How can we ensure appropriate, compliant interaction between our medical and commercial groups despite industry-mandated firewalls?
  6. What are the most exciting — and most concerning — trends facing medical affairs today? Is my team well-equipped to handle any and all upcoming changes?
  7. How should my team allocate its resources to different medical affairs subfunctions?
  8. Should my medical affairs team house expanding functions like HEOR and Phase 4 studies?

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Top Reasons to Read This Report

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.

Medical Affairs Metrics

Chapter 1: Establishing Structure to Facilitate Internal Coordination

Major Takeaways

  • Learn how to establish effective firewalls between commercial and medical affairs that do not hinder necessary communication.
  • Identify the best structure and communication methods for your medical affairs team.
  • Determine which subfunctions your medical affairs team should support.

Chapter Data

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

  • Functional oversight of medical affairs, by team region and company size
  • Diagrams of medical affairs structures across company sizes (top 10, top 50, and device)
  • Medical affairs structure, by team region and company size (e.g., centralized into one department, decentralized by business unit or therapeutic area, decentralized by brand)
  • Title of medical affairs head, by team region and company size
  • Percentage of medical affairs teams responsible for specific subfunctions (e.g., medical education, MSL teams, HEOR), by team region
  • Range and average number of products medical affairs teams support, by team region
  • Number of marketed and investigational products medical affairs teams support

 

Chapter 2: Benchmarking Medical Affairs Budgets and Staffing

Major Takeaways

  • Right-size medical affairs budgets on a per-product basis.
  • Determine medical affairs staffing levels.
  • Identify subfunctions for which to outsource budget and FTEs.

Chapter Data

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

  • Average budget and FTEs per subfunction
  • Average budget allocations to specific medical affairs subfunctions, by team region
  • Range and average of total medical affairs budget, by year (2014–2016), by team region
  • Total medical affairs budget for 2014, 2015, and 2016, by team region
  • Medical affairs 2015 budget per supported product, by company, for US teams and global teams
  • Medical affairs 2015 budget per FTE (excluding field-based personnel), by team region

 Medical Affairs Staffing

  • Range and average of medical affairs staffing for 2015 and 2016 (excluding field-based personnel)
  • Medical affairs staffing for 2015 and 2016 (excluding field-based personnel), by company

Medical Affairs Outsourcing

  • Percentage of teams that outsource budgets for one or more medical affairs subfunctions, by team region
  • Percentage of global, US and country-level teams outsourcing budget for specific medical affairs subfunctions
  • Range and average number of outsourced medical affairs FTEs, by team region
  • Number of outsourced medical affairs FTEs, by company and by team region

 

Chapter 3: The Transformation of Medical Affairs: Exciting and Concerning Trends

Major Takeaways

  • Develop a more robust global medical affairs strategy
  • Identify emerging trends in new medical affairs capabilities.
  • Learn innovative methods to prove medical affairs value.
  • Identify potential concerns for medical affairs leaders and methods for mitigating these concerns.

 Chapter Data

11 charts detailing exciting and challenging trends in medical affairs, as described by surveyed medical affairs executives.

  • Diagrams showing exciting and concerning trends in medical affairs
  • Direct quotes from surveyed medical affairs executives identifying exciting trends:
    • Medical affairs’ increasing role in corporate strategy
    • Increased emphasis on scientific exchanges with healthcare professionals
    • Emphasis on new types of data and evidence
    • Use of new technology to facilitate interactions with patients and HCPs
  • Direct quotes from surveyed medical affairs executives describing concerning trends:
    • Misconceptions about medical affairs being commercial
    • Misuse of scientific data
    • Compliance and overregulation
    • Difficulty interacting with KOLs because of compliance
  • Type of database teams use to track physician interactions

 

Chapter 4: Cultivating Thought Leader Engagement and Meeting Physician Needs

Major Takeaways

  • Identify budget, staffing and resource trends for thought leader development, MSLs and speaker programs.
  • Learn the best time to begin and peak subfunction activities during a product’s lifecycle.
  • Keep up with emerging trends in thought leader development, MSLs and speaker programs.

 Chapter Data

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.

  • Average ranking of factors used to determine a physician’s scope of influence

MSL Resources

  • Percentage of medical affairs teams with responsibility over MSL teams
  • Percentage of medical affairs budget allocated to MSL teams, by company
  • MSL team 2015 budget, by company
  • MSL team budget change from 2015 to 2016
  • MSL team budget outsourcing
  • Number of FTEs dedicated to MSL teams in 2015, by company
  • Change in staffing for MSL teams from 2015 to 2016
  • Development stage of MSL activity start, by team region
  • Development stage of peak MSL activity, by team region
  • Activity start and peak for MSL teams, by company

Thought Leader Development

  • Percentage of medical affairs teams with responsibility over thought leader development
  • Percentage of medical affairs budget allocated to thought leader development, by company
  • Thought leader development 2015 budget, by company
  • Thought leader development budget change from 2015 to 2016
  • Thought leader development budget outsourcing
  • Number of FTEs dedicated to thought leader development in 2015, by company
  • Change in staffing for thought leader development from 2015 to 2016
  • Development stage of thought leader development activity start
  • Development stage of thought leader development peak activity
  • Activity start and peak for thought leader development, by company

Speaker Programs

  • Percentage of medical affairs teams with responsibility over speaker programs
  • Percentage of medical affairs budget allocated to speaker programs, by company
  • Speaker programs 2015 budget, by company
  • Speaker programs budget change from 2015 to 2016
  • Speaker programs budget outsourcing
  • Number of FTEs dedicated to speaker programs in 2015, by company
  • Change in staffing for speaker programs from 2015 to 2016
  • Development stage of speaker program activity start
  • Development stage of speaker program peak activity
  • Activity start and peak for speaker programs, by company

 

Chapter 5: Accomplish Medical Communications Objectives through Strategic Budget and Staffing Allocations

Major Takeaways

  • Identify budget, staffing and resource trends for medical information, medical publications and medical education.
  • Learn the best time to begin and peak subfunction activities during a product’s lifecycle.
  • Keep up with emerging trends in medical information, medical publications and medical education.

Chapter Data

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.

  • Survey participants’ perception of how technology is affecting medical communication

Medical Information

  • Percentage of medical affairs teams with responsibility over medical information
  • Percentage of medical affairs budget allocated to medical information, by company
  • Medical information 2015 budget, by company
  • Medical information budget change from 2015 to 2016
  • Medical information budget outsourcing
  • Number of FTEs dedicated to medical information in 2015, by company
  • Change in staffing for medical information from 2015 to 2016
  • Development stage of medical information activity start
  • Development stage of medical information peak activity
  • Activity start and peak for medical information, by company

Medical Publications

  • Percentage of medical affairs teams with responsibility over medical publications
  • Percentage of medical affairs budget allocated to medical publications, by company
  • Medical publications 2015 budget, by company
  • Medical publications budget change from 2015 to 2016
  • Medical publications budget outsourcing
  • Number of FTEs dedicated to medical publications in 2015, by company
  • Change in staffing for medical publications from 2015 to 2016
  • Development stage of medical publications activity start
  • Development stage of peak medical publications activity
  • Activity start and peak for medical publications, by company

Medical Education

  • Percentage of medical affairs teams with responsibility over medical education
  • Percentage of medical affairs budget allocated to medical education, by company
  • Medical education 2015 budget, by company
  • Medical education budget change from 2015 to 2016
  • Medical education budget outsourcing
  • Number of FTEs dedicated to medical education in 2015, by company
  • Change in staffing for medical education from 2015 to 2016
  • Development stage of medical education activity start
  • Development stage of medical education peak activity
  • Activity start and peak for medical education, by company

 

Chapter 6: IITs, Medical Grants and Phase 4 Trials: Promoting Research and Corporate Goodwill

Major Takeaways

  • Identify budget, staffing and resource trends for IITs, medical grants and Phase 4 trials.
  • Learn the best time to begin and peak subfunction activities during a product’s lifecycle.
  • Keep up with emerging trends in IITs, medical grants and Phase 4 trials.

Chapter Data

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.

  • Average percentage of Phase 4 trials and IITs containing certain research aspects

Investigator-Initiated Trials

  • Percentage of medical affairs teams with responsibility over IITs
  • Percentage of medical affairs budget allocated to IITs, by company
  • IITs 2015 budget, by company
  • IITs budget change from 2015 to 2016
  • IITs budget outsourcing
  • Number of FTEs dedicated to IITs in 2015, by company
  • Change in staffing for IITs from 2015 to 2016
  • Development stage of IIT activity start
  • Development stage of peak IIT activity
  • Activity start and peak for IITs, by company

Medical Grants

  • Percentage of medical affairs teams with responsibility over medical grants
  • Percentage of medical affairs budget allocated to medical grants, by company
  • Medical grants 2015 budget, by company
  • Medical grants budget change from 2015 to 2016
  • Medical grants budget outsourcing
  • Number of FTEs dedicated to medical grants in 2015, by company
  • Change in staffing for medical grants from 2015 to 2016
  • Development stage of medical grants activity start
  • Development stage of peak medical grants activity
  • Activity start and peak for medical grants, by company

Phase 4 Trials

  • Survey respondents’ perception of where Phase 4 trials belong within an organization
  • Percentage of medical affairs teams with responsibility over Phase 4 trials
  • Percentage of medical affairs budget allocated to Phase 4 trials, by company
  • Phase 4 trials 2015 budget, by company
  • Phase 4 trials budget change from 2015 to 2016
  • Phase 4 trials budget outsourcing
  • Number of FTEs dedicated to Phase 4 trials in 2015, by company
  • Change in staffing for Phase 4 trials from 2015 to 2016
  • Development stage of Phase 4 activity start
  • Development stage of peak Phase 4 activity
  • Activity start and peak for Phase 4 trials, by company

 

Chapter 7: HEOR and Managed Care: Coordinating Medical Affairs and Market Access Personnel

Major Takeaways

  • Identify budget, staffing and resource trends for HEOR, HOLs and MCLs.
  • Learn the best time to begin and peak subfunction activities during a product’s lifecycle.
  • Keep up with emerging trends in HEOR, HOLs and MCLs.

Chapter Data

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.

HEOR

  • Perception of where HEOR belongs within an organization
  • Percentage of medical affairs teams with responsibility over HEOR
  • Percentage of medical affairs budget allocated to HEOR, by company
  • HEOR 2015 budget, by company
  • HEOR budget change from 2015 to 2016
  • HEOR budget outsourcing
  • Number of FTEs dedicated to HEOR in 2015, by company
  • Change in staffing for HEOR from 2015 to 2016
  • Development stage of HEOR activity start
  • Development stage of peak HEOR activity
  • Activity start and peak for HEOR, by company

 Managed Care Liaisons (MCLs)

  • Percentage of medical affairs teams with responsibility over MCLs
  • Percentage of medical affairs budget allocated to MCL teams, by company
  • MCL team 2015 budgets, by company
  • MCL team budget change from 2015 to 2016
  • MCL team budget outsourcing
  • Number of FTEs dedicated to MCL teams in 2015, by company
  • Change in staffing for MCL teams from 2015 to 2016
  • Development stage of MCL activity start
  • Development stage of MCL team peak activity
  • Activity start and peak for MCL teams, by company

 Health Outcomes Liaisons (HOLs)

  • Percentage of medical affairs teams with responsibility over HOLs
  • Percentage of medical affairs budget allocated to HOL teams, by company
  • HOL team 2015 budget, by company
  • HOL team budget change from 2015 to 2016
  • HOL team budget outsourcing
  • Number of FTEs dedicated to HOL teams in 2015, by company
  • Change in staffing for HOL teams from 2015 to 2016
  • Development stage of HOL activity start
  • Development stage of peak HOL activity
  • Activity start and peak for HOL teams, by company

 

Chapter 8: Drug Safety, Compliance and Regulatory Affairs: Diverse Perspectives Bolster Medical Affairs Strategy

Major Takeaways

  • Identify budget, staffing and resource trends for drug safety, compliance and regulatory affairs.
  • Learn the best time to begin and peak subfunction activities during a product’s lifecycle.
  • Keep up with emerging trends in drug safety, compliance and regulatory affairs.

Chapter Data

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.

Drug Safety

  • Perception of where drug safety belongs within an organization
  • Percentage of medical affairs teams with responsibility over drug safety
  • Percentage of medical affairs budget allocated to drug safety, by company
  • Drug safety 2015 budget, by company
  • Drug safety budget change from 2015 to 2016
  • Drug safety outsourcing
  • Number of FTEs dedicated to drug safety in 2015
  • Change in staffing for drug safety teams from 2015 to 2016
  • Development stage of drug safety activity start
  • Development stage of peak drug safety activity
  • Activity start and peak for drug safety, by company

Compliance

  • Perception of where compliance belongs in an organization
  • Percentage of medical affairs teams with responsibility over compliance
  • Percentage of medical affairs budget allocated to compliance, by company
  • Compliance 2015 budget, by company
  • Compliance budget change from 2015 to 2016
  • Compliance budget outsourcing
  • Number of FTEs dedicated to compliance in 2015, by company
  • Change in staffing for compliance from 2015 to 2016
  • Development stage of compliance activity start
  • Development stage of peak compliance activity
  • Activity start and peak for compliance, by company

 Regulatory Affairs

  • Perception of where regulatory affairs belongs in an organization
  • Percentage of medical affairs teams with responsibility over regulatory affairs
  • Percentage of medical affairs budget allocated to regulatory affairs, by company
  • Regulatory affairs 2015 budget, by company
  • Regulatory affairs budget change from 2015 to 2016
  • Regulatory affairs budget outsourcing
  • Number of FTEs dedicated to regulatory affairs in 2015
  • Change in staffing for regulatory affairs from 2015 to 2016
  • Development stage of regulatory affairs activity start
  • Development stage of peak regulatory affairs activity
  • Activity start and peak for regulatory affairs, by company

Chapter 9: Medical Affairs Team Profiles

Major Takeaways

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.

Structure

The first two pages of each profile describe the team’s structure, such as:

  • Company size and team scope
  • Number of investigational and marketing products the team supports
  • Geographic region the team oversees
  • Function to which the team reports
  • Subfunctions for which the team is responsible
  • Number of in-house and outsourced FTEs dedicated to each subfunction

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:

  • Percentage of subfunction budget the team outsources
  • Percentage budget change from 2015 to 2016

SAMPLE CONTENT FROM MEDICAL AFFAIRS MANAGEMENT

 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.

  • Thought leader development is the most common subfunction for surveyed global medical affairs teams.
  • MSL teams are the most common for surveyed US teams.
  • Meanwhile, most surveyed country-level teams are involved in medical education.

These trends underscore the role of medical affairs teams at different regional levels.

Excerpt from Medical Affairs Report

 

The following excerpt is a key finding from the full report's executive summary.

Encourage Better Cross-Functional Communication through Medical Affairs Structure

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.