By Ed Miseta, Chief Editor, Clinical Leader
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The beginning of the year is always a good time to take a look ahead at the trends most likely to impact the industry in the coming months. In January I ran a series of interviews with pharma executives sharing their thoughts on the trends most likely to impact clinical trials. This was an attempt to continue the discussions that were launched with our 2016 industry outlook, which appeared in the December issue of Life Science Leader magazine. One area that is changing quickly, and which promises to impact clinical trials in the coming years, is biopharma. I recently spoke with Jim Esinhart, CEO of Chiltern, about some of these trends.
Prior to joining Chiltern, Esinhart has served as assistant professor of biostatistics at East Carolina university, senior statistician of US-Infectious Diseases Phase II-III Development in Medical Data Sciences at GSK, cofounder and SVP of biostatistics & data management at PharmaResearch Corporation, and VP of global medical data sciences at Charles River Labs. In his current role, he oversees all channels within Chiltern, including biopharma, oncology, medical device & diagnostics and clinical analytics.
Ed Miseta: The entire biopharma industry appears to be poised to continue to make significant gains in 2016. What global macro trends do you think will have significant bearing on biopharma?
Jim Esinhart: One of the things we have seen in recent years is more complex study protocols. I do not see that changing. Increasing study protocol and operational complexity are trends that will continue to impact the industry for a variety of reasons.
Miseta: What is causing this change to occur?
Esinhart: Today, trials are much more complex by virtue of the volume and variety of the data being collected. This is being driven by a variety of factors such as greater regulatory scrutiny for pre- and post-market development and a rise in personalized medicine. There is also a need for diagnostics and access to wearable devices, as well as the rapidly developing use of biomarkers. Add it all up, and what you have is simply much more data. Additionally, the rise of biologics and biosimilar development adds a new level of complexity for everyone. While pharmaceuticals are relatively hearty, biologics often require additional logistics and handling, which leads to a higher level of operational complexity.
Miseta: What trends do you see occurring in other industries that have the potential to cross over and have an impact on the life sciences?
Esinhart: Big data has impacted many industries, and we are already seeing it have an impact on contract research in terms of trial design, feasibility assessments, and recruiting patients for clinical trials. Patients themselves are becoming sources of individualized big data that can be captured and analyzed, not only from the inside, at the cellular level, but also collected from wearable monitors and other kinds of medical and diagnostics devices. Overall, I think the one-size-fits-all model, whether it’s in operational drug development or in the style of customer service provided by CROs, is finished. Personalized medicine and personalized service are the name of the game now.
Miseta: We often see non-traditional companies having an impact in the pharmaceutical industry, especially when it comes to technology. Are there any nontraditional biopharma companies that you think will have a big impact on the life sciences?
Esinhart: That’s a good question, but in reality it is almost impossible to predict where the next technological breakthrough will originate. As a whole, the health care technology sector is young, and there are many companies developing new applications and devices that will impact the industry. Any one of them can have an idea that suddenly gains traction and takes off. We are in an innovation-driven time, and the health care technology industry is poised to have an impact on improving quality, reducing cost and enhancing patient-centricity. As the drive towards more patient-centric trials and approaches continue to gain traction, and as pharma continues to look for ways to make trials more efficient, this will only speed up the adoption of these technologies.
Miseta: Are there any other trends that you think will have a big impact on biopharma in 2016?
Esinhart: One of the things we have seen in the last few years is a lot of merger and acquisition activity. If the trend toward mergers and market consolidation continues, that will certainly have a tremendous impact on the biopharma industry. Another trend I see is the growth in the rate of spending on R&D for small to mid-tier biopharmaceutical companies. Both of these trends create a greater tendency for companies to outsource. We see a rise in the demand for small and mid-sized sponsors to team up with mid-sized CROs to make strides in their R&D objectives on a global level. I also think genomic research will continue to be a big trend in 2016, with a greater focus on oncology and growing interest in neurology worldwide.