18 - "The ENRICHMENT in silico Clinical Trial (U.S. FDA Joint Project)"
Host: Steven M. Levine
Sr. Director Dassault Systèmes and Executive Director, Living Heart Project
ABSTRACT: Innovation in medicine has never been faster, yet the hurdles to bring these products to market have never been higher, threatening the sustainability of progress in healthcare. We are at a crossroads and while the regulatory bodies recognize this, they are challenged to safely transition to a new testing and paradigm. Borrowing from other regulated industries faced with similar challenges, they are turning to virtual testing to bend the curve back towards efficiency. The US FDA has taken a leading role in building this pathway, including their participation in the Living Heart Project from the outset in 2014. Following five years of development and testing, the FDA took the next step to launch a Critical Path initiative called the ENRICHMENT Project to transform the Living Heart into a virtual patient population, execute an in silico clinical trial and evaluate how best combine virtual patient data with real patient data to more effectively capture clinical experience from a trial or real world use. The entire process will be published as methodology to reduce cost and risk by creating virtual control arms or forming enrichment strategies. Progress to date will be presented..
BIO: Steven M. Levine, PhD is the Sr. director of virtual human modeling at Dassault Systèmes. Dr. Levine has more than 30 years of experience in the development of computational tools that translate cutting-edge science into product innovations. He is the Founder and Executive Director of the Living Heart Project. Dr. Levine was elected into the College of Fellows in the American Institute for Medical and Biological Engineering (AIMBE) and holds a PhD in Materials Science from Rutgers University. He began is career in health tech at the San Diego based startup Biosym that went public as Accelrys in 2004 and acquired by Dassault Systèmes in 2014.
