By Gerald L. Messerschmidt, MD, FACP, Chief Medical Officer at Precision for Medicine, Oncology and Rare Disease
Approximately four years ago, several innovators wishing to decrease the product development timeline for cancer products were brought together by Dr. Patrick Soon-Shiong to form the Moonshot 20/20 program. This ambitious multi-functional plan resulted in a meeting between the Moonshot innovators, Vice President Joe Biden, the National Institutes of Health (NIH), and the US Food and Drug Administration (FDA) in December 2015. The next month, President Barack Obama announced the official government Moonshot program initiative headed by Joe Biden. The rest is history.
However, few seem to know the significant commitment the FDA management and experts have made to moving experimental products like cancer biologics and drugs rapidly to approval. Since that time in early 2016, the FDA has approved several new breakthrough products with care, speed, and fanfare.
Recently, KNect365 Life Sciences published the results of a survey to understand the hype in clinical trial innovation (download it here). The takeaway from their survey is that many see change coming and know they need to alter their course, but few have done so or know what to do next. Whether in pharma, biotech, a CRO or other health delivery organization, amazing science, new technologies, robotic and artificial intelligence entities, and efficient clinical trial designs are being recognized; however, how they fit together is daunting to many if not most.
Patient-specific, small population therapies with common treatment targets is clearly hyped today. These can often demonstrate higher efficacy because the population is restricted to those who are targeted to respond. Mobile apps monitoring in real-time are being introduced almost daily. These assist physicians, nurses, and other healthcare providers to understand their patients on a constant basis, which help to assist with the development of new biologics and drugs. Electronic medical/health records (EMR/EHR) are improving the collection of data that are needed to improve health.
Privacy is a major personal issue among patients, families, and professionals. The general data protection regulation (GDPR) appears to have swung the pendulum in favor of protectionism. Medical care and clinical trial privacy have always been ahead of social media and continue to be able to weather this privacy storm today.
However, old organizations change slowly. Many Titanics are going to be unable to turn their ships and avoid the obvious tip of the iceberg visible today. New and more efficient clinical trial designs, time-saving technologies, and analysis interventions are well known to a few of us who have embraced the future of Precision Medicine. Others see but are not acting; they need additional experienced expert brains along with technologies.
In tomorrow’s world, clinical trials are as scientifically and medically sophisticated as the science that bring the products forward. Mistakes in design and arrogance in attitude will cost pharma and biotech millions of dollars, but more importantly, precious time delays to launch a new product and benefit more patients. What’s needed is the understanding, knowledge, experience and innovation to design product development programs that fit more comfortably into a sponsors budget and timeline. More brains, more experts, and more thinking are essential to the efficient application of clinical trials now and tomorrow.