The Role of Key Opinion Leaders (KOLs) in The Pharmaceutical Industry

By Joseph Gutman, MD, Senior Vice President, Medical Affairs,

DEFINING, IDENTIFYING AND ENHANCING KOLs is an extremely important task. It is clear that the role played by these professionals is of great value to the evolution of pharmaceutical products, way beyond the launching phase. Without their endorsement it is difficult to implement changes in the framework in which individual physicians manage their patients. These individuals (or sometimes organizations or societies) add remarkable worth to the product and extend its life cycle. These also participate in the presentation of clinical and preclinical information in manners that are convincing and easy to understand. Obviously, physicians and scientists in this role must be able to meet with difficult questions posed by others, and most importantly they must exhibit passion for the product, and be excellent and charismatic communicators.

DEVELOPING a KOL program is challenging and it involves identifying experts as well as advocates. A KOL is a top opinion professional that is a well-published researcher, or a very experienced physician, or is the leader of an organization that actively pursues cure or improvement of patients who suffers from specific diseases. Affiliations with universities or well-known Tertiary Care Centers, editorial ranks and previous media exposures are great assets. Each KOL should be evaluated independently, as scientists in less prestigious institutions can be extremely valuable communicators. Thought Leaders are extremely important in teaching treatment modalities for which established guidelines do not exist. They are responsible for bringing state-of-the-art science to the medical community.

Ideally a KOL should have the following characteristics:

A commanding knowledge of the disease(s)
A full understanding of the Product and it's potentials
A full understanding of all competing products or therapeutic modalities
Leadership skills
Peer recognition and respect (or the potential)
A large ground of influence
Passion for his/her ideas
CLASSIFYING KOLs is as well very important. Global KOLs are world-renowned individuals, high-power researchers with an international reputation in their field. They are active in research and have a wide array of publications in their countries and the US peer-reviewed literature. They hold decision-making positions in medical societies and/or are highly influential in their institutions. In most cases they are identified as "Gurus" in their field. National KOLs meet all the criteria of the Global KOLs but lack the international exposure and usually with some help, should achieve global recognition. Regional KOLs are seen more as busy clinicians with a wide area of referrals; they are in most cases high users of the product. This differentiation allows the pharmaceutical company to prioritize and utilize these relationships in a manner that is most efficient and effective. Ideally all KOLs, at all levels should interact with relative frequency to assure constructive discussions as well as a benchmark messages to their medical audiences. These interactions should be encouraged to be free thinking and intuitive in nature.

Effective KOLs pull together research findings, clinical experience and intuition to help physicians in their communities understand new therapeutic modalities and ultimately improve patient outcomes.

KOLs are asked to continually examine current practices as a whole and to define obstacles and limitations to effectively diagnose and treat, analyze outdated methods and identify optimal approaches. In an ideal situation KOLs address issues rather than products, and they provide the context in which a product is used. They help the medical community leave the past and come into the future. Most importantly is the fact that physicians are accustomed to learning form other physicians and will listen to those that aside from being authorities in the field exhibit passion in their beliefs and show good results with their patients.

Traditional medical education has been taking place in relatively small groups lead by an authoritative figure, and the role of Global, National and Regional KOLs should not be different, whether the National KOLs are interacting with Regional KOLs, or the latter with local physicians. This "pyramidal system" elicits the best responses from practitioners.

MANAGING KOLs implies having well defined relationships with experts in the field, and this can only be achieved by defining very well who is a KOL and what is expected of him or her. Usually this relationship starts at phase III trials, but as it is often the case with some products, new indications and uses are developed past the developmental phases, and this is when major KOLs become the carriers of the therapeutic gospel. They will then become the source of great ideas for new uses, more effective uses, and comparative uses. KOLs are uniquely equipped to function at this level. The messages from KOLs should carry answers to at least the following questions: Is this use of the product novel? Does it fill an unmet need? Who is it appropriate for? What are the contraindications? Are there additional indications for this product?
KOLs also provide great contributions in times of controversy about uses and or abuses of the product (a classic example is the use of hormonal replacement therapy after the recent NIH research findings.) KOLs also help the pharmaceutical company with comparisons with competing therapeutic agents/modalities. Frequently, their input becomes "marketing strategy."

GETTING THEM ON BOARD is the next challenge. It must be understood that this is a long-term process. It is not a six or twelve month proposition. At all times the pharmaceutical company must be realistic about what KOLs will and will not do. KOLs must maintain their credibility and integrity in order to have maximum market impact. The idea is to first identify Global and National KOLs, which in turn will be able to teach in a pyramid model the regional KOLs. The initial identification of KOLs is easier during phase III trials done in centers of excellence, but as a product matures and evolves, those that publish the new research finding, and propose the new uses and contribute to the new developments in therapeutic uses become potential KOLs. The broad-front approach is essential: Globally and nationally KOLS must be on board with complete and up-to-date information and a synchronous flow of information is key.

The answer to getting them on board is to give them all the tools they need to become well known communicators, hunger for research and new data, as well as wealth of methods to communicate with each other. The process should be contagious. The approach must be personal, consistent and individual. KOLs must have easy access to one or two specific persons in the company.

OBJECTIVITY and integrity are essential. The credibility of a KOL rides on freethinking and honesty. This will bring extreme value to the relationship with the pharmaceutical company. Ongoing free communication between KOLs maintains objectivity in line. A medical audience will have no difficulty in spotting a commercial program versus an educational program, and it is not difficult to know which one would be more effective. Companies must make sure that KOLs address larger issues than just the product, and in this manner assure education and impartiality, enriching the subject with credibility. Every time a KOL stands in front on an audience their reputation is at stake, and that reputation is what the company banks on to achieve results. The question of honoraria is not an issue in objectivity if KOLs are well chosen. The usual honoraria are never enough to persuade a KOL one way or another. Sometimes a good strategy is to make sure that KOLs are not associated with just one company. KOLs that participate in multiple advisory boards have access to extremely important data from other products. KOLs should not feel disloyal because they participate in activities with other companies.

During meetings positive opinions are validating, but negative opinions always represent great opportunities.

ADVOCATES have a very important role, their objectivity is not as clear as that of the traditional KOL. Advocates are not necessarily physicians or scientist, but often Directors or Presidents of large "Disease Associations" or advocacy groups. Often these individuals play a very important role not only in their obligatory interactions with KOLs, but in their influence over reimbursement issues and Insurance companies policies. Political lobbying very often starts through information brought to the table by these advocates.

The bottom line is that the opinion of key leaders is the ultimate compass.

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