February 14….A romantic and possibly complicated time, isn’t it?
You want to form or solidify a relationship with a special someone… with the hope the interest is shared. So you do your best to make an impression that will persuade while still being true to yourself and your best ideals. You’re hoping for a true and honest connection – a relationship where everyone benefits.
For professionals in the pharmaceutical industry, this sounds like an oddly familiar scenario (minus the romance and gifts). You want to find and build a long lasting professional relationship with a key opinion leader, or KOL.
Building long-term relationships with KOLs is a major priority in the journey of a drug’s development – from early clinical trials, through final approval and marketing. And when the relationships are strong, everyone wins. The company benefits because they now have a great thought leader/ambassador who can communicate their progress. The same goes for the KOL, who has the opportunity to be involved with a new investigational therapy to treat patients.
It surprised me when I learned how early on in the process KOLs become part of drug’s journey to market and how important these relationships are. Once a product candidate advances from lab to clinic, the importance of a KOL’s solid support is crucial. They influence and pave the way for market research, understanding the patient journey and current standards of treatment. Additionally, they provide guidance on protocols for clinical trials.
Here are 6 ways I’ve worked with KOLs on behalf of my clients, from the clinic to the market:
Market Research – before your company invests the substantial resources required for clinical study, you need information to understand how patients are treated in practice, versus what is published. What are the current treatments? Do patients respond well? Do we understand the patient journey?
When I work with clients on orphan drug designation applications, these are the kinds of questions I present to KOLs. Their feedback is instrumental for design and approach.
Clinical Trials – working with KOLs is vital for trial design and feasibility. When dealing with a rare disease, are there enough patients in a geography to support a trial? What are the diagnostic criteria used in practice versus the literature? Based on this disease, what is the suggested study duration? Is this KOL interested in being an investigator, and can they help recruit patients?
In planning for upcoming proof-of-concept studies with clients, addressing these questions with KOLs is very useful for protocol design. You’d be surprised how different things are in practice versus the published guidelines.
Investigator Engagement – Clinical trials are the most costly yet critical part of drug development. They are fraught with challenges, from design, to recruitment, and reporting. The figure quoted for late-stage trial success is anywhere from 25-50%, with many earlier stage trials failing prematurely. One of the biggest challenges in clinical trials is patient recruitment. What is the biggest factor in patient recruitment? Engaged investigators. Investigators who are passionate about the science and current on the latest data in a drug’s development become the best recruiters for their studies. Bringing a KOL in to present data to a group of investigators is a powerful way to engage.
I’ve helped trial enrollment increase after facilitating discussions between a leading KOL/investigator and other investigators to share the latest therapeutic updates.
Data Publication – Presence at key congresses is central for healthcare professional engagement. Investors and other stakeholders want to follow the outcomes of various trials. Having leading KOLs who are also investigators present data regularly is a way to capture global attention in a busy marketplace.
Medical Education – As a company advances in clinical development and has NDA filing plans in place, it is time to educate the market about the disease. If it is a rare disease, doctors need to know how to diagnose it, what the current treatment paradigm is, and if there is a need for a better treatment. For a specialty disorder, one group of physicians may refer patients to another group to better communicate their needs.
Physicians, nurse practitioners, and physician assistants all have to understand the psychosocial needs of the patient and their caregiver. An established KOL’s authority will ensure these education parameters are relevant, valued, and sought by all relevant healthcare professionals.
Marketing – Once a drug is approved, KOLs are engaged to appear at traditional speaker programs and congress presentations. They are also brought in to speak to advisory boards and to payers. These regular interactions are critical once a product is approved and in its launch years.
I have retained incredible KOLs who are excellent presenters, know the science well, and care about the patients. One in particular will always be memorable. This KOL started as an adviser at an advisory board, but cared so deeply about the disease state, patients, and caregivers, and expressed a true interest to help educate. This KOL went on to help the client/company with medical education, payer engagement and ongoing marketing after approval.
After years of shepherding this process, I can tell you that drug development is a long journey, and there are no shortcuts.
Building good relationships with KOLs based on trust, honesty, passion for the disease state and the science behind the product is vital for long-term success.
The best relationships are those where everyone wins.
Happy Valentine’s Day.
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About the Author: Sharoni Billik is the Founder and CEO of Sharoni Billik Healthcare Communications, and works with pharmaceutical, biotech, healthcare, and academic institutions and medical societies on medical communications and medical affairs initiatives.