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. Priorities identified included the need for improved modeling and simulation tools, further emphasized in FDA’s 2011 Strategic Plan for Regulatory Science. In an effort to support and advance model-informed medical-product development (MIMPD), the Critical Path Institute (C-Path), FDA, and International Society of Pharmacometrics 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.

Author(s): Klaus Romero, Vikram Sinha, Sandra Allerheiligen, Meindert Danhof, Jose Pinheiro, Naomi Kruhlak, Yaning Wang, Sue-Jane Wang, John-Michael Sauer, Jean-Francois Marier, Brian Corrigan, James Rogers, H. J. Lambers Heerspink, Tawanda Gumbo, Peter Vis, Paul Watkins, Tina Morrison, William Gillespie, Mark Forrest Gordon, Diane Stephenson, Debra Hanna, Marc Pfister, Richard Lalonde, Thomas Colatsky

Year: December 1, 2014