Sandra Allerheiligen, Ph.D. (LCC-drug disposition), obtained a bachelor's degree in biology from Trinity University in San Antonio, Texas. She received a doctorate in pharmaceutics from the University of Texas in Austin in 1985 and completed postdoctoral fellowships at the University of Texas Health Center in San Antonio in 1986 and was a clinical assistant professor from 1986 through 1990. Dr. Allerheiligen joined Lilly as a senior pharmacokineticist in 1990. She was promoted to research scientist in 1994; to senior research scientist in 1998; to Head Drug Disposition 1998; to director, global pharmacokinetics/ pharmacodynamics (PK/PD) in 2000; and to director, drug disposition, ADME, and global PK/PD, in 2005. In 2007 she was promoted to Distinguished Research Fellow and Chief Scientific Officer for Quantitative Pharmacology. Dr. Allerheiligen has lectured on clinical pharmacology at the University of Cincinnati College of Pharmacy, Purdue University College of Pharmacy, and Indiana University Medical School among others. Best known for her work in population PK/PD modeling, Dr. Allerheiligen's work on PK/PD modeling and trial simulation provided a foundation for Lilly's quantitative pharmacology initiative. Through her involvement in the American Association of Pharmaceutical Scientists (AAPS) and other organizations, she has worked to expand the use of PK/PD modeling and QP methodologies in academia and across the industry. Dr. Allerheiligen also championed physiologically based modeling, which involves metabolism, protein binding, and physiological parameters to provide a more accurate projection of human exposure to drugs. As the scientific leader of the PK/PD/trial simulation group, Dr. Allerheiligen has built a global modeling and simulation group that is recognized throughout the industry. She expanded the group's focus from primarily registration phase to discovery and translational medicine, developed databases and standard operating procedures, and created training courses. Dr. Allerheiligen has pioneered study designs that leverage sparse sampling techniques. For instance, she evaluated population PK/PD models using visualization tools and mathematical methodologies. Along with her colleagues in PK/PD, Dr. Allerheiligen has developed and implemented a neural network to allow more complete assessment of potential covariates and increase productivity. They were invited to demonstrate the neural network to the U.S. Food and Drug Administration. In addition to her leadership roles at Lilly and within AAPS, Dr. Allerheiligen has made more than 40 presentations on modeling, simulation, and QP. She is a co-founder of two modeling societies. Dr. Allerheiligen was selected as an AAPS fellow in 2005 and a fellow in the American College of Clinical Pharmacology in 2007. In 2008, she will give the keynote address at the U.S. Modeling and Simulation meeting. Because of Dr. Allerheiligen leadership roles within AAPS, leaders at the U.S. Food and Drug Administration (FDA) invited Lilly to a discussion of the agency's Critical Path Initiative. Lilly was one of only three companies asked to participate. QP represents the next evolution of model-based drug development described in the FDA's Critical Path Initiative. In 2007, Lilly was invited to present its QP strategy and drug-disease models to FDA pharmacometricians, clinical pharmacology reviewers, and statisticians. An enthusiastic and committed mentor to statisticians, toxicologists, and ADME and PK/PD scientists, Dr. Allerheiligen also has trained more than 20 scientists in population PK-PD modeling approaches and helped train two graduate students and a postdoctoral fellow. She has sponsored several Six Sigma teams and is completing green belt training.