Marilyn Martinez Food and Drug Administration

Marilyn is a Senior Biomedical Research Scientist for the US FDA, CVM. She is also a CLSI voting member, chaired the development of a VICH bioequivalence guidance, is an adjunct professor in the College of Veterinary Medicine, NCSU, and is a Federal Liaison to OrBITO. Marilyn is on the Editorial Board of the JVPT and is an Associated Editor of the AAPS Journal. She received the 2015 Lloyd Davis Lifetime Achievement Award from the AAVPT and is a Fellow of the AAPS and the Controlled Release Society. Marilyn is the FDA PI on a Cooperative Research and Development Agreement with Simcyp for the purpose of expanding the utility of the canine in silico physiologically based pharmacokinetic models and for the development of breed-specific in silico populations. The latter will be invaluable for exploring sources of pharmacokinetic variability in dogs and for supporting the use of the dog as a preclinical species in human drug development. Currently, much of Marilyn's research focuses on the use of in vitro methods for predicting in vivo product performance, extrapolating pharmacokinetic information between dogs and humans, and the use of in silico models for predicting in vivo product performance.