COSTA MESA, Calif.,/IReach–PRNewswire/–WCCT Global’s CEO and Founder, Dr. Kenneth T. Kim, presented this past weekend at the 26th Annual KSEA South-Western Regional Conference on the topic “Update on Drug Development in the 21st Century” in Long Beach, CA. The presentation discussed major trends in clinical research for 2016, trends which show promise towards accelerating the drug development process in the global pharmaceutical market. WCCT Global has conducted clinical programs since 1998, evolving from a single research site to a global drug development partner, providing oversight and management in the United States and abroad in Germany, Korea, Singapore, and Taiwan, and thus, the contract research organization is well poised to discuss trends in the industry on a global scale.
The presentation identified six major trends in drug development for 2016, all of which are accelerating development and expediting the approval process. With Asian countries becoming increasingly involved in the development process, Asian sub-populations are being incorporated into “adaptive” clinical trial designs and ethnobridging programs. In a traditional drug development model, INDs would need to be filed in multiple countries, and First-in-Human (FIH), SAD/MAD programs would need to be conducted in all countries involved. However, by including an ethnobridging arm into a Phase I program in the United States, Phase I programs can be bypassed abroad, both reducing costs of conducting the programs and reducing the timelines to NDA. WCCT Global is at the forefront of conducting bridging studies at their Phase I CPU in Cypress, CA, recruiting hundreds of Asian sub-populations and including them into FIH programs.
Additionally, it was made clear that research programs are evolving towards “enriched” clinical trial designs, including personalized medicine (genotypes, biomarkers, etc.), and virtual study design, execution, monitoring, and reporting are becoming more common, causing an evolution in patient inclusion, from “qualified” patients to “characterized” patients. WCCT Global has determined that the best way to recruit these “characterized” patients is through the use of social media, which allow research organizations and clinical sites to identify patients based on age, gender, geography, lifestyle, interests, and personal connections. Unfortunately—WCCT notes—this tool is largely untapped by the majority of the industry when implementing strategies to recruit patients, and it is a lack of patients that is still one of the largest contributing factors to the failure in drug development programs. When asked about his thoughts regarding these trends in 2016, Dr. Kim responded: “WCCT prefers to view these trends as exciting opportunities to grow as a research organization and expand our capabilities, rather than challenges that need to be met in the coming years. Fortunately, we are at the forefront of adaptive clinical trial design, ethnobridging programs, and the use of social media to identify volunteers for research. I believe that these key components of our approach will position us to make some great strides in global drug development in 2016 and beyond.”