A Key Opinion Leader (KOL) is an individual who has achieved such a significant social or professional status in a certain community.
A Key Opinion Leader (KOL) is an individual who has achieved such a significant social or professional status in a certain community, such as doctors, researchers, lawyers, celebrities, etc., that their recommendations can impact the decision-making process of their peers.
The benefits of engaging KOLs is apparent in almost every industry but has been particularly useful in the world of pharmaceutical drug development.
Pharma and biotech companies typically involve KOLs throughout of the drug development process, enabling them to consult on everything from laboratory procedures to marketing campaigns.
KOLs engaged in pharma are typically characterized as well-respected physicians and clinical researchers of certain specialties.
Although all drugs/medical devices are subject to intense review by the Food and Drug Administration (FDA), certain products and issues may require additional review by a panel of independent experts. Products that fit such criteria are subject to review by an FDA Advisory Committee Meeting (AdComm).
An FDA AdComm is convened for the purpose of evaluating issues related to human and veterinary drugs, vaccines, biological products, medical devices, and food by an independent group of external experts.
An AdComm may be convened to discuss topics, such as first-in-class products for approval, new indications for currently marketed products, safety issues surrounding currently marketed products, and potential future clinical trial designs in specific disease areas.
Key Opinion Leader’s engagement leads to success.
While participating in a live AdComm meeting, product sponsor companies may find it beneficial to enlist the help of KOLs for bolstering their presentations and supporting Q&A sessions. Such engagement can help to facilitate a successful AdComm, as KOLs with strong spheres of influence in disease/treatment areas can put the sponsor’s data into context.
They do this by emphasizing the medical/unmet need for certain products, how a product may impact the current treatment paradigm for disease areas and addressing specific safety concerns associated with products.
Additionally, it is highly beneficial for sponsors to incorporate KOLs into the AdComm preparation process.
Examples of this include: using KOLs to facilitate the generation of effective key messages; support the writing of a concise briefing document and adding valuable knowledge and insight during question and answer rehearsals.
The addition of the right KOLs throughout the preparation process may be the difference between a product achieving a positive or negative vote from panel members on the day of the AdComm.
Innovative Science Solutions (ISS) has developed solutions specifically designed to identify and engage KOLs in the pharma and biotech industries, and to simplify the KOL management process [Link to Kaela’s Blog Post – Managing Relationships: Identifying and Engaging Thought Leaders in Pharma and Biotech].
ISS has almost two decades of experience in KOL management as well as developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact email@example.com
We have summarized decades of experience recruiting expert teams into this easy-to-read, practical guide.
Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more
FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more
One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more
US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more
The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us todayContact us