MICHAEL D. WATERS, Ph D, is an independent consultant with over 40 years of toxicology and toxicogenomics research experience at the EPA, at NIH/NIEHS and in the private sector. He has held adjunct professorships in toxicology and pharmacology at both the University of North Carolina and Duke University. CLAUDE L. HUGHES, MD, Ph D, is an Executive Director in the Therapeutic Science and Strategy Unit at Quintiles IMS. He is also an Adjunct Professor at North Carolina State University, and Wake Forest University as well as a Consulting Professor at Duke University Medical Center.