The Rising Value of Medical Affairs – Engagement with External Stakeholders (KOLs, TLs, EEs) by CMK SELECT CMK SELECT CMK SELECT
N. Borinshteyn CMK SELECT CMK SELECT
The ever-evolving relationship between the pharmaceutical industry and its key opinion leaders (KOLs) has been a hot topic for a while, and there are several reasons for that: Recent innovative medicines are so complex that many consumers can’t understand them without expert guidance. Recognizing this, pharmaceutical companies have begun to engage with external experts more
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The Rising Value of Medical Affairs – Engagement with External Stakeholders (KOLs, TLs, EEs)

by N. Borinshteyn / /
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The ever-evolving relationship between the pharmaceutical industry and its key opinion leaders (KOLs) has been a hot topic for a while, and there are several reasons for that:

  • Recent innovative medicines are so complex that many consumers can’t understand them without expert guidance. Recognizing this, pharmaceutical companies have begun to engage with external experts more than ever before.
  • With the federal and PhRMA guidelines, relationships with these physicians are heavily regulated. As a result, there is a need and a requirement to manage the KOL relationships and ensure appropriate reporting systems are in place.
  • Pharma companies need to make sure that coordination efforts between functions and external experts is well coordinated and doesn’t create unnecessary challenges.

Driven by a changing healthcare landscape, and marked by specialized medicines and new stakeholders who demand more complex scientific information across all channels, Medical Affairs teams have found themselves in search of the most effective, efficient ways of managing collaborations with the physicians and other external stakeholders who conduct research, write articles, or speak on their behalf. Managing the relationships and interactions with these stakeholders has ultimately emerged as an individual business discipline within Medical Affairs teams.

What does the term “KOL” mean? Is there a better name for them?

According to Pharma Marketing Network, key opinion leaders, or KOLs, are defined as “physicians who influence their peers’ medical practice, including but not limited to prescribing behavior.” Thought leader (TL), opinion and thought leader (OTL), key influential physician (KIP) and key advocacy influencer (KAI) are all alternate labels for these professionals.

But whatever we call them, that definition doesn’t quite reflect the true nature of the engagement that we, as an industry, have with these stakeholders. For one, not all KOLs are physicians. At various stages of the product lifecycle, we need input and support not only from physicians but also from other allied healthcare professionals (nurses and educators, for example), scientists, caregivers, payers, etc. Thus, addressing these stakeholders as External Experts (EEs), rather than physicians, seems much more appropriate.

How do we best engage with these EEs?

  1. Identify the External Experts you need.

Determining the right EE for your project is critical. An EE with a poor match in expertise or skills may not be able to provide the expected support for a drug development process or affect a drug’s success or effectiveness before it hits the market. On the other hand, the right EE can help you open up opportunities that you were not considering and exceed expectations. And keep in mind, you may need to set different criteria for each group of EEs involved in different projects.

  1. Define and execute a proper engagement strategy.

Most pharma companies are willing to invest resources into EE-related activities; but first, they must figure out how best to collaborate with the proper experts. The more clearly you’re able to define what you need from specific EEs – whether that is attending Advisory Board meetings, facilitating one-on-one consultations, engaging in research collaborations, analyzing data or spearheading educational activities – the more effectively engaged and involved the EEs will be. Having a plan in place that clearly defines your expectations helps to ensure that the experts are available when you need them, and it allows them to prioritize your activities over others, increasing the likelihood that you’ll get their input and participation when it’s most critically needed.

  1. Follow through.

Quite often we get asked by EEs, “How did you use the feedback I provided?” And, often, they do not receive a good answer. While not all of their ideas or recommendations will always be relevant, it is still helpful to follow up with your EEs and summarize what was done or implemented based upon their advice. You may also mention what you decided not to pursue.

  1. Be compliant.

In recent years, companies have been facing a high level of internal and external scrutiny regarding how they engage with EEs as often the programs are intangible and difficult to measure despite a need to maintain compliance with state and federal guidelines. As a result, companies have adopted strategic EE engagement solutions that include both the timely reporting of key metrics and alignment with necessary PhRMA and AdvaMed industry compliance codes and regulations.

What does the future hold for EE engagement?

As pharmaceutical and life-sciences companies continue to realize the tremendous positive impact that EEs have on their businesses, EE engagement will continue to evolve and develop as a critical industry discipline.

By sustaining a process that creates and maintains meaningful and collaborative relationships between EEs and business functions, life-sciences companies can expect to see increased drug development success and accelerated adoptions at the global, national and regional levels.

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