For most pharma companies, key opinion leaders (KOLs) have become an increasingly important part of the team, throughout the
entire lifecycle of product development. And at each stage, there are electronic tools to help companies get the most out
of their KOLs. Here's an overview:
Phase II: Advice and Consent
Pre–Phase II, KOLs advise on target product profile. Specifically, they assess competitive products (current and future),
unmet market needs, considerations for product labeling, and avenues for differentiation. In Phase II, they provide guidance
on structuring clinical trial protocols to generate credible, convincing, differentiated data in line with the needs they
believe the product might address.
A key online tool for this stage: collaborative software. Community tools let KOLs add comments to documents in an asynchronous
fashion, eliminating the need to find common meeting times in physicians' overcrowded schedules and enabling easy sharing
of opinions. These tools should be used to manage review requests and document updates in a structured fashion. They can be
configured to prohibit the download of a document already checked out or to automatically reinstate a document after a given
time if the user has not uploaded an updated version.
Phase III: Going Global
As a drug enters Phase III, brand teams typically engage influential physicians from various relevant markets. That increasingly
means international markets. According to Parexel's Bio/Pharmaceutical R&D Statistical Sourcebook 2007/2008, more than 23,000 investigators were working on new FDA-regulated clinical trials. More than 40 percent were located outside
the United States, covering 91 countries.
In this stage, password-protected online forums offer an effective way to increase the global reach of Medical Science Liaisons
(MSLs) while preserving confidentiality and reinforcing the scientific nature of the online discussions.
Internet KOL portals can be used to provide KOLs with training and reference materials and for general project management
of offline KOL activities, such as workshops or symposia. In addition, online forums with MSLs enable the company to collect
information from KOLs, such as their perceptions of safety and efficacy data, regional market conditions, and so forth.
Similar solutions already exist for general physician communications. Industry reports claim that the next generation of the
"e" relationship will expand beyond e-detailing, toward providing a truly integrated online/offline customer-service experience.
Examples of service portals include
Given the regulatory attention to separating disease awareness from product messages, brand teams will want advice from their
company's regulatory affairs, medical group, and clinical group before sharing data with KOLs. Such discussions should typically
begin six months to a year before the end of Phase III.
The therapeutic-area Web site is a place where the brand team can publish concise, transparent, and fair-balance content generated
by KOLs, MSLs, or a medical communications agency. Such content normally outlines the therapeutic gaps in the market and starts
engaging physician audiences. This is a natural online complement to traditional publications. If the drug gets approved and
aligns with one of the highlighted market gaps, adoption and ramp-up in those critical first six months postapproval will
only be stronger. A password-protected section on the same site can also provide MSLs easy access to reference information
when traveling. It can also provide MSLs with a convenient information warehouse, from which they can e-mail documents (approved
by the company's regulatory team) to KOLs and other research physicians they interact with.