Medical Affairs (PH184)

Resource Allocation for the Global Marketplace
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  • Real-World Case Studies of Pharmaceutical Medical Affairs Teams

    Cutting Edge Information’s latest medical affairs operations report is the premier benchmarking tool for medical affairs teams around the world.  Global and country-level medical teams have used this data to bolster medical affairs structure, staffing and support within their companies.

    Today’s medical affairs groups’ responsibilities encompass a growing list of new tasks, such as health economics and outcomes research (HEOR) and drug safety and pharmacovigilance.  This report successfully guides medical affairs executives’ decisions for prioritizing new and existing responsibilities while empowering their teams though adequate budget and staffing resources.

    This report examines medical affairs departments across more than 60 US, global and country-level organizations. The data specify the staffing levels and budgets necessary to support activities for 12 medical affairs subfunctions.  Additional department profiles provide a comprehensive overview of real-world medical affairs teams.

     

    Key Questions that This Study Answers 

    1. What is the ideal medical affairs organizational structure to encompass both traditional departments and new responsibilities, such as health economics and drug safety?
    2. How many FTEs does my company need to establish an efficient medical affairs group?
    3. What should the medical affairs budget be, and how should it be allocated?
    4. How are changing regulations affecting medical affairs teams?
    5. What aspects of the medical affairs structure encourage better cross-functional communication?

     

    Top Reasons to Review This Report

    Build strong networks to increase inter-team communication: Learn how top-performing companies create optimal medical affairs networks based on their organizational structure and individual countries’ regulatory requirements. Then, support these structures by defining roles to facilitate groups across multiple geographies.  The best practices contained in this report will show you how top medical affairs teams define and communicate roles and responsibilities to connect groups across multiple geographies.

    Maximize resources to empower teams: Expanding responsibilities requires medical affairs groups to prioritize their resources. Analyze four years of budgets and staffing levels for the medical affairs team, including detailed resource allocation breakdowns for dedicated subfunctions. See how changes in product portfolios impact staffing, and identify which subfunctions typically need the most support.

    Position medical affairs as the intersection of clinical and commercial information: The incorporation of health economics and outcomes research (HEOR) teams into existing structures is just one of a growing number of trends impacting medical affairs teams.  Embrace the importance of HEOR, regulatory affairs, drug safety and compliance groups under the medical affairs umbrella.  Use the data in this study to plan for growth within field-based teams, as well as within corporate-level medical affairs departments.  

     

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  • Medical Affairs Metrics

     

    Chapter 1: Medical Affairs Structure and Cross-Functional Communication

    Chapter Benefits

    • Create a medical affairs network and implement best practices to optimize communication between corporate and country-level teams.
    • Establish suitable reporting relationships both within the medical affairs organization and between functions at the county level to improve cross-functional communication.
    • Coordinate KOL activities with marketing teams to avoid overtaxing individual thought leaders.
    • Increase coordination between medical affairs and health economics and outcomes research teams.

     

    Chapter Data

    10 charts detailing medical affairs organization, oversight and reporting structure.

    • Percentage breakdown of surveyed medical affairs structures (centralized, decentralized by country, decentralized by business unit or therapeutic area, decentralized by brand or product franchise)
    • Oversight of medical affairs in 2011 and 2013, by percentage (autonomous groups, R&D/clinical, commercial operations, other)
    • 3 companies’ real-world team structures:
    • Decentralized medical affairs team structure
    • Medical affairs team decentralized by business unit
    • Global centralized medical affairs team organized under R&D
    • Percentage breakdown of positions leading medical affairs (chief medical officers, vice president, senior/executive director, director, senior manager)
    • Percentage of US groups responsible for specific medical affairs subfunctions
    • Percentage of global groups responsible for specific medical affairs subfunctions
    • Percentage of country-level groups responsible for specific medical affairs subfunctions
    • One (1) real-world example of a global legal review process

     

    Chapter 2: Medical Affairs Resourcing and Budgets

    Chapter Benefits

    • Dedicate medical affairs resources to match product portfolio needs.
    • Compare staffing and outsourcing levels for three types of medical affairs groups:
    • Track four years of budget analysis, including existing budgets from 2011–2013 and budget projections for 2014.
    • Trace the impact of geography and therapeutic area on medical affairs resources.
    • Prepare teams for increased responsibilities during product launch.
      • US
      • Global
      • Country-Level

     

    Chapter Data

    27 charts detailing medical affairs staffing, budgets and outsourcing. Data are provided for each US, global and country-level medical affairs department.

    • Medical affairs staffing in 2013 (excluding field-based personnel)
    • Percentage of medical affairs groups that outsource one or more subfunctions
    • Percentage of US (global, country-level) groups outsourcing medical affairs subfunctions
    • Medical affairs budgets from 2011 to 2013 and projected 2014 budget
    • Percentage change in medical affairs budgets from 2012 to 2013 and projected change from 2013 to 2014

     

    Chapter 3: Thought Leader Engagement and Documentation

    Chapter Benefits

    • Understand MSL teams’ prevalence in the US and their growing importance in other markets.
    • Expand the MSL teams’ role to support thought leader development groups by leveraging MSLs’ existing peer relationships with KOLs.
    • Realign medical and commercial FTEs to support companies’ growing MSL needs.
    • Use a mix of internal and external resources to support thought leader engagement groups’ responsibilities.
    • Use physician-interaction databases to coordinate marketing and medical affairs efforts.
    • Measure the impact of new technology — including social media, mHealth applications and email — on medical affairs efforts.

     

    Chapter Data

    41 charts detailing medical science liaison (MSL) and thought leader development subfunctions — including staffing and budget considerations. Data are provided for key technologies used in medical affairs, as well as US and regional MSL subfunctions. Other metrics are provided for thought leader development functions at US, global and country-level departments.

    • Percentage of medical affairs groups with responsibility over medical science liaisons
    • Number of FTEs dedicated to medical science liaison groups in 2013 and 2014 (US and regional groups)
    • Changes in medical science liaison staffing from 2013 to 2014 (US and regional groups)
    • Percentage of medical affairs budget dedicated to medical science liaisons (US and regional groups)
    • 2013 budget for medical science liaisons (US and regional groups)
    • Change in medical science liaisons budget from 2013–2014 (US and regional groups)
    • Percentage of medical affairs groups with responsibility over thought leader development
    • Number of FTEs dedicated to thought leader development in 2013 and 2014 (US, global and country-level groups)
    • Changes in thought leader development staffing from 2013 to 2014 (US, global and country-level groups)
    • Percentage of medical affairs budget dedicated to thought leader development (US, global and country-level groups)
    • 2013 budget for thought leader development (US, global and country-level groups)
    • Change in thought leader development budget from 2013–2014 (US, global and country-level groups)
    • Percentage of medical groups with responsibility over physician-interaction databases (US, global and country-level groups)
    • Type of physician database used by medical affairs groups (US, global and country-level groups)
    • Access granted to physician-interaction database at medical affairs groups (US, global and country-level groups)
    • Length of time medical affairs groups have used newer technology (US, global and country-level groups)
    • Age of physician-interaction database used by medical affairs groups (US, global and country-level groups)

     

    Chapter 4: Medical Communications

    Chapter Benefits

    • Increase medical information and medical publications teams’ contributions to support products’ pre- and post-launch activities.
    • Develop standard response databases to prevent multiple country-level teams from creating responses to repeated medical inquiries.
    • Expand the role of medical information teams to ensure the accuracy of information and maintain the company’s voice when communicating with customers.
    • Leverage centralized, global teams to prepare medical information and publication materials for country-level affiliates.
    • Make the most of internal resources by outsourcing execution of select activities in medical information and publication.

     

    Chapter Data

    32 charts detailing medical information and medical publications teams — including staffing and budget considerations. Data are provided for these groups at US, global and country-level departments.

    • Percentage of medical affairs groups with responsibility over medical information
    • Number of FTEs dedicated to medical information in 2013 and 2014 (US, global and country-level groups)
    • Changes in medical information staffing from 2013 to 2014 (US, global and country-level groups)
    • Percentage of medical affairs budget dedicated to medical information (US, global and country-level groups)
    • 2013 budget for medical information (US, global and country-level groups)
    • Change in medical information budget from 2013–2014 (US, global and country-level groups)
    • Percentage of medical affairs groups with responsibility over medical publications
    • Number of FTEs dedicated to medical publications in 2013 and 2014 (US, global and country-level groups)
    • Changes in medical publications staffing from 2013 to 2014 (US, global and country-level groups)
    • Percentage of medical affairs budget dedicated to medical publications (US, global and country-level groups)
    • 2013 budget for medical publications (US, global and country-level groups)
    • Change in medical publications budget from 2013–2014 (US, global and country-level groups)

     

    Chapter 5: IITs and Medical Grants

    Chapter Benefits

    • Dedicate the right staffing resources to drive program success and outreach for both IIT and medical grants.
    • Empower medical affairs teams to supervise IITs — a key feature of post-approval market support.
    • Approve IIT requests that align with and further corporate goals.
    • Centralize IIT approval with global groups to prevent repetitive trials.
    • Prepare teams to recognize which product types are best fits for IITs.
    • Vary medical affairs teams’ emphasis on IITs to match the pool of potential investigators within the market.
    • Pair medical grants teams with an easily accessible compliance unit to ensure success.
    • Create partnerships between commercial groups and medical affairs to foster successful medical grants efforts.

     

    Chapter Data

    32 graphics detailing investigator initiated trials and medical grants subfunctions — including staffing and budget considerations. Data are provided for functions at US, global and country-level departments.

    • Percentage of medical affairs groups with responsibility over investigator initiated trials
    • Number of FTEs dedicated to investigator initiated trials in 2013 and 2014 (US, global and country-level groups)
    • Change in investigator initiated trials staffing from 2013 to 2014 (US, global and country-level groups)
    • Percentage of medical affairs budget dedicated to investigator initiated trials (US, global and country-level groups)
    • 2013 budget for investigator initiated trials (US, global and country-level groups)
    • Change in investigator initiated trials budget from 2013 to 2014 (US, global and country-level groups)
    • Percentage of medical affairs groups with responsibility over medical grants
    • Number of FTEs dedicated to medical grants in 2013 and 2014 (US, global and country-level groups)
    • Change in medical grants staffing from 2013 to 2014 (US, global and country-level groups)
    • Percentage of medical affairs budget dedicated to medical grants (US, global and country-level groups)
    • 2013 budget for medical grants (US, global and country-level groups)
    • Change in medical grants budget from 2013 to 2014 (US, global and country-level groups)

     

    Chapter 6: Medical Education and Speaker Programs

    Chapter Benefits

    • Provide necessary support to medical education and speaker program subfunctions to advance new product efforts.
    • Position these subfunctions to work with market access and commercial groups to ensure a successful product launch.
    • Shift resources to adjust to medical affairs’ changing role in medical education and speaker programs.
    • Prepare for growing medical education teams now that the Sunshine Act and regulatory uncertainty have passed, despite smaller budgets and staffing levels.
    • Prepare speaker program teams to begin reporting event funding per the Sunshine Act in 2014.
    • Accredited CME programs are not required to disclose funding, though all other programs must disclose this information to CMS.

     

    Chapter Data

    32 graphics detailing medical education and speaker program subfunctions — including staffing and budget considerations. Data are provided for functions at US, global and country-level departments.

    • Percentage of medical affairs groups with responsibility over medical education
    • Number of FTEs dedicated to medical education in 2013 and 2014 (US, global and country-level groups)
    • Change in medical education staffing from 2013 to 2014 (US, global and country-level groups)
    • Percentage of medical affairs budget dedicated to medical education (US, global and country-level groups)
    • 2013 budget for medical education (US, global and country-level groups)
    • Change in medical education budget from 2013 to 2014 (US, global and country-level groups)
    • Percentage of medical affairs groups with responsibility over speaker programs
    • Number of FTEs dedicated to speaker programs in 2013 and 2014 (US, global and country-level groups)
    • Change in speaker programs staffing from 2013 to 2014 (US, global and country-level groups)
    • Percentage of medical affairs budget dedicated to speaker programs (US, global and country-level groups)
    • 2013 budget for speaker programs (US, global and country-level groups)
    • Change in speaker programs budget from 2013 to 2014 (US, global and country-level groups)

     

    Chapter 7: Expanding Responsibilities In Medical Affairs

    Chapter Benefits

    • Leverage medical affairs’ position as the intersection of information for many cross-functional teams that thrive with access to clinical and marketing data.
    • Embrace the growing importance of health economics and position this subfunction to best access important clinical and market access data.
    • Adjust medical affairs resources to meet health economics needs which fluctuate with upcoming product launches.
    • Position drug safety and pharmacovigilance groups to interact with key medical affairs subfunctions, including compliance and medical information.
    • Align dedicated compliance and regulatory affairs groups to oversee medical affairs operations.

     

    Chapter Data

    16 charts detailing the following emerging medical affairs subfunctions: health economics, drug safety and pharmacovigilance, compliance and regulatory affairs. Charts show staffing and budget data.

    • Percentage of medical affairs groups with responsibility over health economics
    • Number of FTEs dedicated to health economics in 2013 and 2014 at all companies
    • Change in health economics staffing from 2013 to 2014 at all companies
    • Percentage of medical affairs budget dedicated to health economics at all companies
    • Change in health economics budget from 2013 to 2014 at all companies
    • Percentage of medical affairs groups with responsibility over pharmacovigilance/drug safety
    • Number of FTEs dedicated to drug safety in 2013 and 2014 at all companies
    • Change in drug safety staffing from 2013 to 2014 at all companies
    • Percentage of medical affairs budget dedicated to drug safety at all companies
    • Change in drug safety budget from 2013 to 2014 at all companies
    • Percentage of medical affairs groups with responsibility over regulatory affairs
    • Percentage of medical affairs groups with responsibility over compliance
    • Number of FTEs dedicated to regulatory affairs in 2013 and 2014 at all companies
    • Percentage of medical affairs budgets dedicated to regulatory affairs at all companies
    • Number of FTEs dedicated to compliance in 2013 and 2014 at all companies
    • Percentage of medical affairs budgets dedicated to compliance at all companies

     

    Chapter 8: Thought Leader Engagement and Documentation

    Chapter Benefits

    • Get a complete picture of resource allocation across medical affairs groups and subfunctions.
    • Benchmark medical affairs teams against departments with similar structures and size.
    • Identify medical subfunctions receiving increased resources in 2014
    • Review profiles across company sizes:
    • Examine medical affairs structures across different geographic levels:
      • Six (6) Top 20 pharma
      • Four (4) Small pharma/biotech
      • One (1) Medical device companies
      • Three (3) US-level
      • Three (3) Global
      • Five (5) Country-level

     

    Chapter Data

    11 profiles of real-world medical affairs organizations detailing:

    • Company background and medical affairs structures
    • Medical affairs budgets and allocations
    • Medical affairs staffing
    • Medical affairs technology use and access

     

     

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  • 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.

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