Sean X Hu
Global Data, USA
Title: Precision/Personalized Medicine: Encouraging Trend, but Major Challenges Ahead?
Biography
Biography: Sean X Hu
Abstract
Today we are nearly 20 years after the launch of the first poster-child personalized medicine, Herceptin, and more than 13 years after the completion of the Human Genome Project. Driven by both the advancement of biotechnologies and the attraction of the great potential value of personalized / precision medicine, in recent years we have seen solid growth in the number of personalized medicine products. About ten years ago, we predicted that, drastic reduction of costs of emerging genomic technologies was ready to shift the bottleneck of the personalized medicine field from science-centric to business-centric, i.e. from whether or not it would be scientifically and clinically feasible to discover and develop a biomarker / companion diagnostics, to whether or not a pharma / biotech company would be willing to pursue a biomarker for its product and embrace the idea of patient stratification. That prediction was proven true, as, in the past decade, more and more pharma / biotech companies considered biomarker an integral component of their product development and commercialization strategy and delivered a steadily growing personalized medicine pipeline and marketed products.
In parallel, regulatory pathways for personalized medicine have been evolving and maturing. Reimbursement challenges for personalized medicine have also been addressed in key markets in the world. Given those observations, are we now in a “golden age” of personalized medicine? Or, there are other, new major challenges ahead of us? Do many drug development teams still often struggle with a biomarker approach for their drugs? In the high profile example of PD-1/PD L1 immuno oncology products, sharing a similar mechanism of action didn’t result in immuneoncology products with similar biomarkers, or at all. What would those real life examples tell us about the future challenges of personalized / precision medicine? In this presentation, we will review the history and landscape of personalized/precision medicine, and share our views on how the challenges in the field are evolving for the life science industries, and potential solutions.