ceutical Research and Manufacturers of America Clinical Pharmacology Technical Group, chair of the adiponectin workgroup for the Biomarkers Consortium, and member of the board of directors for the American Society for Clinical Pharmacology and Therapeutics. His publications are in the areas of biomarkers and surrogate endpoints, experimental medicine, pharmacokinetics, pharmacodynamics, and drug–drug interactions across a variety of therapeutic disciplines. Dr. Wagner was coauthor on an influential perspective in Nature Reviews Drug Discovery, entitled “A cost-effectiveness approach to the qualification and acceptance of biomarkers” and a paper in Clinical Pharmacology and Therapeutics on “Biomarkers and surrogate end points for fit-for-purpose development and regulatory evaluation of new drugs.”

Elizabeth A. Yetley, Ph.D., who served as the consultant to the committee, is a retired government scientist. Her career spans more than 28 years of government service, including 24 years at the FDA, culminating with her appointment as lead scientist for nutrition. From 2004 until her retirement, she was a senior nutrition research scientist with the NIH Office of Dietary Supplements. Her leadership activities in the field of nutrition public health policy have had a considerable impact. She has been responsible for nutrition labeling (particularly for the development of the health claims paradigm), national food fortification programs, use of national nutrition monitoring and surveillance systems to support nutrition and food safety health policies, infant formula and medical food reviews and regulatory oversight, dietary supplement regulation, and the use of nutrient-related reference values in public health policy formulation. She has received more than 75 honors, commendations, and letters of recognition for her service and has served as a scientific representative for the government to more than 50 associations, panels, and committees. She has authored or coauthored approximately 100 scientific and peer-reviewed publications. Dr. Yetley received her Ph.D. in nutrition, with a minor in biochemistry and physiology, from Iowa State University.

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