The Role of Key Opinion Leaders (KOLs) in The Pharmaceutical Industry
By Joseph Gutman, MD, Senior Vice President, Medical Affairs,
THUNDER FACTORY, Inc.
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
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
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
Peer recognition and respect
(or the potential)
A large ground of influence
Passion for his/her ideas
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
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
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
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