Before I (CWR) came to Bausch + Lomb, I was a cataract surgeon in New York City. As a key opinion leader (KOL), I represented the Iolab division of Johnson & Johnson, Novartis Ophthalmics, and Allergan, Inc. I enjoyed working with industry for several reasons:

• It allowed me to share knowledge I had acquired about techniques and best practices, thereby helping colleagues as well as the next generation of surgeons to become familiar with treatment options.
• Doing so gave me an opportunity to be at the forefront of new technology and innovation.
• It was a break from my own practice that permitted me not only to teach but also to learn from my colleagues.
• I was compensated for my time.

Having been an “insider” at Bausch + Lomb for 3 years, I better understand the value of KOLs to industry and can share my insight with you.

WHY DOES INDUSTRY NEED KOLs?

KOLs are one of the most effective ways for industry leaders to communicate with physicians directly in private meetings, at conferences, or even through the media. Why? Practicing physicians are able to speak about a company’s treatment portfolio in a powerful and authoritative way, because they are doing so based on firsthand experience. Moreover, doctors are far more likely to listen to their peers.

Practicing physicians also have a unique perspective on unmet clinical needs and are able to recommend treatment options and/or solutions to fill those gaps. What is more, KOLs represent a trusted pool of investigators that industry can turn to for research and clinical trials.

KEY CHANGES IN RELATIONSHIPS BETWEEN KOLs AND INDUSTRY

Being a KOL today for a company is not the same as it was even 5 years ago. Key regulatory and compliance changes have dramatically altered the relationship between industry and KOLs.

Industry has moved away from consulting agreements based on monthly/quarterly retainer fees to a fee-for-service model in which each activity is billed and paid for separately under a predetermined fee schedule. Many companies have made this transition to better document their costs to financial and regulatory agencies. The Physician Payments Sunshine Act comes into play here; this legislation requires the manufacturers of pharmaceuticals and devices to report payments to physicians to the Centers for Medicare & Medicaid Services.

Companies take important steps to ensure that they are not influencing any faculty or continuing medical education programs. The goal is to prevent regulatory agencies from erroneously concluding that a company is engaged in off-label promotion via an educational program. What constitutes a proper or improper form of promotion has also come under increased scrutiny.

Another change is a shift to a more nationalistic approach. Physicians want more than anything to hear from KOLs in their own markets. Unless they are global KOLs who possess early expertise in the use of products, it is important for doctors in Germany to hear from KOLs practicing in Germany, doctors in Japan to hear from KOLs practicing in Japan, etc.

WHAT DOES INDUSTRY WANT FROM KOLs?

In a continually evolving landscape, three qualities make a good KOL for any company.

Trustworthiness. With their colleagues, good KOLs are forthright about their knowledge, openly recognize any biases they may have, and give opinions that are both logical and well conceived. With industry, they maintain all confidentialities at all times and are forthcoming about their relationships with competitors. Billing time spent is appropriate to the effort, and they spend the company’s money as if it were their own.

Credibility. Good KOLs never say anything that they do not independently know is true, and they never present data that cannot be verified. They always identify and distinguish their opinions from those of their sponsor.

Authority. Good KOLs have extensive experience with both the treatment option and the product they are discussing. They have experience designing and executing high-quality research. Finally, they possess excellent communication skills, and they respect their colleagues.

WHAT MAKES A GREAT KOL?

Certain qualities separate solid from outstanding KOLs. The latter are proactive, always presenting fresh ideas and opportunities to industry to develop new treatments and improve existing ones. Part of this proactive behavior is a willingness to embrace their sponsors at every level of the company. That means partnering with the medical affairs teams, regulatory teams, and sales representatives. Great KOLs also perform research not sponsored by industry.

Most important, industry embraces the great KOLs with whom it has long-standing relationships that deliver consistent results. The longevity demonstrates these physicians’ commitment not only to their profession but also to improving the company’s evolving portfolio, ultimately to the benefit of patients.

ADVICE

I (CWR) have three pieces of advice for readers who are KOLs or who wish to step into that role.

The first tip is to be selective about the companies with which you choose to partner. Do not feel obligated to jump at every opportunity that presents itself. I become hesitant when KOLs are working with too many of my competitors.

Second, be selective about the products you endorse. Keep in mind that, if a product about which you spoke glowingly turns out to be unsuccessful for any reason, it can affect your reputation.

Finally, remember that how you are perceived by industry and colleagues is as important to your success as what you are actually doing. This means engaging those whom you trust to tell you honestly how others see you.

Paul Misiti is director, medical office operations, for Bausch + Lomb. Mr. Misiti may be reached at (585) 338- 5923; paul.misiti@bausch.com.

Calvin W. Roberts, MD, is senior vice president and chief medical officer of eye care for Bausch + Lomb. Dr. Roberts may be reached at (585) 338-6633; calvin.w.roberts@bausch.com .