Industry Insights from Paul Meade, M. Sc, MPH
When a biopharmaceutical company introduces a new medicine to the market, it comes after years of research, years of clinical development, and some times even years of regulatory review. With the patent ticking away from the early days of discovery, recovering the cost of such an investment in time and money requires a rapid and successful product launch. Achieving rapid success requires careful planning and a tremendous amount of valuable advice. This sage advice usually comes from respected thought leaders with years of experience in their respective therapeutic areas of expertise.
>From the early discovery phase, key opinion leaders help guide a company’s basic research to ensure unmet medical needs are met in a meaningful and cost-effective way. After moving beyond the proof-of-concept stage and into clinical development, other thought leaders play a critical role in assisting with the design of clinical trials that will be implemented through a network of investigators. Throughout the clinical development phases, thought leaders help guide a company with the most important messages other physicians will hear about the strengths and weaknesses of such a new medicine. And finally, as this new product enters the marketplace and is prescribed by the medical community, thought leaders play an important role in helping those physicians understand which patients can benefit most from this new medicine.
Are these thought leaders all the same ones from the early discovery stage to many years later when the product has reached the market? Occasionally, a thought leader will follow a new product from discovery to launch, but more often than not, there are different thought leaders that offer their expertise and experience based on the evolving needs of this new medicine. Some thought leaders have expertise in the areas of basic research, biomarker discovery, and pathway development, while others have expertise with clinical studies and regulatory issues, and others still have expertise in dealing with the media and patient advocacy groups. The success of a product launch depends on the appropriate consultation of the right thought leader at the right time. Failing to understand the appropriate skills and experiences of the right thought leaders as a new product moves along the research and development stages can result in a less than optimal launch.
With the cost of developing new products escalating with each passing year, timing is everything. Finding the right thought leader with the right expertise at the right time becomes even more critical to defining success for a new product. Each thought leader has a unique set of skills, experiences, and expertise. Knowing how to optimize this expertise at the appropriate time can make all the difference between a mediocre product launch and a tremendously successful one.