The use of biomarkers in pharmaceutical development and early-phase clinical trials has increased dramatically since the sequencing of the human genome, but particularly over the last few years, with a growing consensus that biomarkers have the potential to speed and improve drug development.
In fact, last spring, the Biotechnology Innovation Organization, in partnership with Biomedtracker and Amplion, released the largest study ever of clinical development success rates that, for the first time, quantified the benefit of using selection biomarkers in drug development — the findings showed that the likelihood of approval from Phase I increased to one in four with the use of selection biomarkers compared to less than one in 10 without. This real data, impressive on its own, makes a clear statement about where the future of drug development is headed and how it could transform the precision medicine landscape.
This panel will address, among other topics:
Mark Frasier, PhD, Senior Vice President, Research Programs, The Michael J. Fox Foundation for Parkinson's Research
Pamela Garzone, PhD, Vice President, Early Oncology Development and Clinical Research, Pfizer
Sally A. Howard, JD, Head of Regulatory Affairs and Policy, Human Longevity, Inc.
David Litwack, PhD, Personalized Medicine Staff, Center for Devices and Radiological Health, FDA
MODERATOR: Christine Meda, Chief Business Officer, IncellDx