Specialties are generally organized by subspecialty: Neurological disorders are, for instance, motor or cognitive in nature.
Connective-tissue diseases are a subset of autoimmune disorders, which in turn fall under the general immunity category. Many
subspecialty disease areas may have as many as 500 thought-leading physicians who, through their research, expertise, or leadership,
wield great influence over research, drug development, and medical practice in their field. Some 100 usually stand out as
movers and shakers—the ones who head academic departments, serve on national associations, even advise federal agencies like
FDA. These are the physicians who define the standard of care.
As fate and the free market would have it, perhaps 80 out of these 100 have not already been tied down by commitments to other
companies. A specialist-focused strategy requires that a company develop a plan for building relationships with each one.
While the most sought-after KOLs are often older, well-established physicians, companies should also be aware of the rising
stars. Younger, up-and-coming specialists who are beginning to publish are often more open to experimental approaches and
current with the latest "-omics" technologies. They also may be hungrier—and more interested in opportunities to lead clinical
trials or serve on scientific advisory boards.
Building relationships with both established and emerging KOLs enables a company to approach another party with intellectual-property
rights to a new molecule. If the compound promises to meet an important patient need, these specialists are likely to be highly
motivated to participate in the clinical stage of drug development—by offering advice about end point selection, trial design,
and patient enrollment. Often they will want to be in charge of Phase III trial sites in order to give as many of their patients
as possible a shot at the new treatment. If they are pleased with the drug's performance, they will be among its most powerful
boosters, raising awareness among colleagues, payers, investors, and patient associations.
Of course, it goes without saying that nothing gets the attention of KOL physicians like having the best-in-class molecule—they
will welcome the chance to get it to their patients.
Meanwhile, the medical staff of the drug company is working with the specialists to line up speakers' bureau engagements,
publication in peer-reviewed journals, and a range of services and opportunities to generate a referral flow to their practice.
At its best, this relationship is a mutually supportive model between the KOL and the drug developer.
The type of specialist on whom interaction is focused changes throughout the drug-development cycle. The most influential—the
academic "super-specialists"—are most valuable in the early stages of discovery and preclinical development when a company
is pressure-testing a mechanism of action, say, or grappling with cellular pathways and optimal targets. But as the product
nears launch, the high-prescribing opinion-leading specialists with more clinical experience rise in importance because they
can generate business. Postlaunch, some specialists are valued because of their regional influence. Transitioning to the right
KOLs at the right time in the development cycle requires smart deployment of resources.
When recruiting specialists for clinical-trials research, companies often do a poor job of balancing the investigator selection
needs of the medical and marketing groups. The clinical-development team typically wants doctors who have a track record in
conducting GCP (good clinical practice) trials and enrolling patients. Marketing tends to want to bring in the KOLs who can
attract attention, network, and use their influence to boost enrollment or get trial results published in prestigious journals.
Once a therapeutic area manager has determined how the KOLs define success—be it professional standing, business opportunities,
or contributions to society—he or she is ready to incentivize the system (see "What Pharma Can Do for Specialists"). Once
these specialist relationships are in place, franchise managers have a core physician base awaiting their product's launch.
Moreover, that base will ignite awareness and high regard among the wider specialist prescribing base. The same formula can
be replicated in Europe, Asia, and other markets.
Market forces are aligned to favor the ascendency of specialists and of specialty medicine. The skyrocketing sales and use
of specialty products have become a cliché. The institutional changes hinted at here will come in fits and starts, but they
will come. All that remains to be seen is which industry giants will adapt their traditions and overcome their biases to succeed
in making the most of this historic opportunity.