Medical Affairs Team Structure: Centralized or Decentralized?

A medical affairs team’s structure is contingent on a number of determining factors.  The growing complexity of the compliance requirements that pharmaceutical and biotechnology companies must adhere to has greatly impacted their organizational structures, particularly in medical affairs.  But companies must also weigh their portfolio needs in their decisions about how to structure teams.  Furthermore, how the medical affairs team interacts with other parts of the organization impacts reporting relationships and group responsibilities. Continue reading

Global Pharmas in Disagreement about Medical Education Budgets

By Natalie DeMasi,
Research Analyst

Medical education has been and continues to be a critical segment of a medical affairs team’s mission.  However, the jury is still out in regard to how much time and money a company should devote to it.

In the global medical affairs arena, the number of medical education FTEs ranges from 0 to 5, with no consistent pattern among Top 20, medium-sized and small companies (Figure 1 ).  Among surveyed small companies, one dedicates 5 FTEs to medical education, the highest number for those surveyed.  Another small company has Continue reading

Companies Increasingly Position Health Economics Teams within Medical Affairs

By Yanis Saradjian,
Director of Consulting

Blockbuster patent expirations are impacting pharmaceutical companies throughout the industry.  Remarkable shifts in corporate earnings send budgetary shock waves through nearly every department of a pharmaceutical or device manufacturer.  Even at some of the largest companies, medical affairs teams — seemingly insulated from spending cuts during the economic crisis in the late 2000s — have been issued a challenging mandate: Do more with less.  Although serving the medical community is an important corporate responsibility, life science companies cannot spend outside their means to do so.  Now medical affairs groups must not only manage their core responsibilities — to generate, package and disseminate medical and clinical information — but they also have been asked to take the lead on other important activities such as health economics and pharmacovigilance. Continue reading

Regulatory and Compliance Functions Within Medical Affairs Teams

Over the past several years, we have seen a slow shift among regulatory affairs and compliance groups in the pharmaceutical industry as these groups move under medical affairs oversight. This hasn’t been a surprise among many industry observers, but it hasn’t been a complete shift either. Fewer than 40% of surveyed companies in a recent Cutting Edge Information study put compliance functions under the medical affairs department’s supervision. Continue reading

Product Launch: A Busy Time for Medical Affairs Teams

Marketing and commercial teams get a lot of the credit for a successful product launch, but medical affairs teams are typically buzzing with activity in the months (sometimes even years) preceding drug approval.  As the official communication channel between a pharmaceutical company and the scientific community, the medical affairs department plays a critical role in successful product launches.  Each of the medical affairs subfunctions plays its own unique part to play to properly support a new drug. Continue reading

Driving KOL Engagement Efficiency through Physician-Interaction Databases

Cutting Edge Information recently conducted research among pharmaceutical medical affairs groups that looked at physician-interaction database ownership.  The research revealed that ownership of these databases varies among the surveyed companies.  Global groups at 60% of companies report responsibility for these internal databases.  Companies that do not report global groups’ responsibility for an internal database (40%) may consider their use of Excel spreadsheets or Outlook to track physician interactions as internal database.  Other global medical affairs teams allow country-level groups to document physician interactions according to local regulations.  Still other companies may be in the process of either developing a new database platform or transitioning from an existing one. Continue reading

Product Development Stage Dictates Medical Affairs Spending Patterns

Although marketing and market access functions may not support a developing drug until Phase 2 or even later, companies need to coordinate between several different teams as products move through different development stages beginning in the pre-clinical stage. Understanding the science behind the product is increasingly important for market access functions as payers increasingly require comparative effectiveness research and health outcomes data. Continue reading

Technology’s Role in Enhancing and Expanding Medical Information Teams’ Capabilities

Within companies’ medical affairs groups, medical information subfunctions disseminate information quickly across consumer and healthcare practitioner audiences alike.  However, US companies rely on different-sized medical information teams to fulfill these roles.  Figure 1 shows the disparity across surveyed US companies’ medical information staffing teams.  Groups range from less than a single FTE up to 20 FTEs at one surveyed large pharmaceutical company. Continue reading

Asia and the Medical Affairs Function

Regardless of company size, establishing operations to support expansions in new territories has a big impact on existing organizational structures.  The question often rests on how the subsidiary will be connected to the headquarters. Will it be a centralized or decentralized operation? How independent does this operation need to be based on distance, time zone, cultural aspects, size and/or budget? Mix these factors, in addition to regional capabilities, and headaches will result for even the most experienced executives. Continue reading