Modeling and simulation for medical product development and evaluation: highlights from the FDA-C-Path-ISOP 2013 workshop

Medical-product development has become increasingly challenging and resource-intensive. In 2004, the Food and Drug Administration (FDA) described critical challenges facing medical-product development by establishing the critical path initiative [ 1 ]. Priorities identified included the need for improved modeling and simulation tools, further emphasized in FDA’s 2011 Strategic Plan for Regulatory Science [Appendix]. In an effort to support and advance model-informed medical-product development (MIMPD), the Critical Path Institute (C-Path) [ www.c-path.org ], FDA, and International Society of Pharmacometrics [ www.go-isop.org ] co-sponsored a workshop in Washington, D.C. on September 26, 2013, to examine integrated approaches to developing and applying model- MIMPD. The workshop brought together an international group of scientists from industry, academia, FDA, and the European Medicines Agency to discuss MIMPD strategies and their applications. A commentary on the proceedings of that workshop is presented here.