The drug discovery and development process is a complex and challenging landscape, especially for the majority of small biopharmaceutical and medical device companies. It’s truly a survival of the fittest environment, fraught with potential pitfalls and company killers.
For every Kite Pharma (acquired by Gilead for $12 billion), Ignyta (acquired by Roche for $1.7 billion) and Rhythm ($120 million IPO), there are many Coherus BioSciences, Otonomy’s and Regulus’s. Most compounds in development will fail before they see the light of phase 3. While an investigational product’s safety and or efficacy are often the main culprits, there are many under-considered challenges that small firms face. These challenges extend development timelines and drive up burn rates. When combined with the former, the path to extinction can be rapid for small companies.
Despite these challenges, new therapies continue to be carved by brilliant and adventurous scientists, medical experts, and entrepreneurs. And we cannot thank them enough. These pioneers and their efforts are the only reason new drugs make their way through the gauntlet, to emerge on the other side as new products for pickup under prescription at the local pharmacy. It’s an exciting journey for companies emerging from the lab and entering the clinic for the first time.
While there are a variety of potential pitfalls to be navigated, one area is most disruptive to the execution of clinical trials: On-time patient enrollment and strong patient retention. Today, this topic is often holistically described as patient engagement.
As most small development firms are funded through milestone driven investments by private equity, managing clinical trial timelines and efficiency become paramount in achieving success. Statistically, there is no bigger challenge these firms face than on-time enrollment of studies. It is the number one or two cause of study delay in every analysis performed over the past 15 years. With daily operating costs for a pivotal trial running $60,000 and up for most companies, the stakes are high.
There are steps companies can take to better position themselves to avoid these pitfalls and even excel in shortening timelines. These steps are evidence-based, and were developed over 25 years of working with biopharmaceutical companies in planning and executing clinical trial enrollment and retention. Melynda Geurts, Imperial’s vice president of operations and patient engagement specialist, will be sharing useful and actionable advice with small and emerging companies during an upcoming educational session in Houston, Texas. If you would like to attend her session on January 24, please click on the link below to register and learn more. We’ll share more over the next couple of weeks to get your synapse firing over what will be discussed.
