Nancy Kline Leidy

Nancy Kline Leidy, Ph.D. is the Senior Vice President of Scientific Affairs for United BioSource Corporation (UBC) and a Senior Research Leader for UBC's Health Care Analytics Group in Bethesda, MD. She has over 25 years of experience in clinical and health outcomes research, specializing in instrument development, psychometric testing, and the design and analysis of clinical trials involving clinical, quality of life, and functional outcomes assessment. She has served on the faculties of Michigan State University and the University of Arizona and the research staff of the International Council of Nurses in Geneva, Switzerland. Immediately prior to joining UBC, Dr. Leidy was an intramural scientist at the National Institutes of Health (NIH) where she studied performance variation and structure in people with chronic obstructive pulmonary disease. She currently serves as an Adjunct Faculty Member at Johns Hopkins University.

Dr. Leidy has presented her work at local, national, and international conferences and has over 75 papers published in refereed journals, books and monographs. Her publications have appeared in the American Journal of Respiratory and Critical Care Medicine, Chest, Journal of COPD, European Respiratory Review, PharmacoEconomics, and Quality of Life Research, among others.

She has been the recipient of numerous awards, including the Michigan State University Teacher-Scholar Award and the Wolanin award for excellence in geriatric research and has served as a distinguished lecturer at a number of universities, including Emory University, University of Alabama Birmingham, University of Pittsburgh and the University of Texas. She is an active member of the American Thoracic Society, the International Society for Quality of Life Research and the International Society for Pharmacoeconomics and Outcomes Research, and holds memberships in the European Respiratory Society, American Epilepsy Society, Sigma Theta Tau Honor Society, and the Sigma Xi Scientific Research Society, among others.

Dr. Leidy has worked with the United States Food and Drug Administration (FDA) on issues related to the use of patient reported outcomes (PRO), including symptom evaluation and health-related quality of life in pharmaceutical research. She was the lead author of the seminal paper, "Recommendations for Evaluating the Validity of Quality of Life Claims for Labeling and Promotion" (1999, Value in Health) and served as the ISPOR representative to the Harmonization Project, a multi-organizational effort designed to bring global harmony to regulatory requirements underlying the use of PRO information in labeling and promotion. Dr. Leidy served as one of four team leaders in one of the first Harmonization meetings at the FDA, presenting "The Value of Patient Reported Outcomes." The results of this meeting were published in Value in Health. She is currently the principal investigator of the EXACT-PRO initiative (EXAcerbations of Chronic pulmonary disease Tool), a multi-sponsor instrument development project with the FDA and clinical expertise in chronic bronchitis and chronic obstructive pulmonary disease (COPD).

Dr. Leidy holds a Ph.D. in clinical research with specialties in social psychology and quantitative methods from the University of Michigan. She earned her Bachelor of Science degree from Michigan State University and her Master's degree from the University of Washington.


Nancy Kline Leidy Nancy Kline Leidy, Ph.D. is the Senior Vice President of Scientific Affairs for United BioSource Corporation (UBC) and a Senior Research Leader for UBC's Health Care Analytics Group in Bethesda, MD. She has over 25 years of experience in clinical and health outcomes research, specializing in instrument development, psychometric testing, and the design and analysis of clinical trials involving clinical, quality of life, and functional outcomes assessment. She has served on the faculties of Michigan State University and the University of Arizona and the research staff of the International Council of Nurses in Geneva, Switzerland. Immediately prior to joining UBC, Dr. Leidy was an intramural scientist at the National Institutes of Health (NIH) where she studied performance variation and structure in people with chronic obstructive pulmonary disease. She currently serves as an Adjunct Faculty Member at Johns Hopkins University. Dr. Leidy has presented her work at local, national, and international conferences and has over 75 papers published in refereed journals, books and monographs. Her publications have appeared in the American Journal of Respiratory and Critical Care Medicine, Chest, Journal of COPD, European Respiratory Review, PharmacoEconomics, and Quality of Life Research, among others. She has been the recipient of numerous awards, including the Michigan State University Teacher-Scholar Award and the Wolanin award for excellence in geriatric research and has served as a distinguished lecturer at a number of universities, including Emory University, University of Alabama Birmingham, University of Pittsburgh and the University of Texas. She is an active member of the American Thoracic Society, the International Society for Quality of Life Research and the International Society for Pharmacoeconomics and Outcomes Research, and holds memberships in the European Respiratory Society, American Epilepsy Society, Sigma Theta Tau Honor Society, and the Sigma Xi Scientific Research Society, among others. Dr. Leidy has worked with the United States Food and Drug Administration (FDA) on issues related to the use of patient reported outcomes (PRO), including symptom evaluation and health-related quality of life in pharmaceutical research. She was the lead author of the seminal paper, "Recommendations for Evaluating the Validity of Quality of Life Claims for Labeling and Promotion" (1999, Value in Health) and served as the ISPOR representative to the Harmonization Project, a multi-organizational effort designed to bring global harmony to regulatory requirements underlying the use of PRO information in labeling and promotion. Dr. Leidy served as one of four team leaders in one of the first Harmonization meetings at the FDA, presenting "The Value of Patient Reported Outcomes." The results of this meeting were published in Value in Health. She is currently the principal investigator of the EXACT-PRO initiative (EXAcerbations of Chronic pulmonary disease Tool), a multi-sponsor instrument development project with the FDA and clinical expertise in chronic bronchitis and chronic obstructive pulmonary disease (COPD). Dr. Leidy holds a Ph.D. in clinical research with specialties in social psychology and quantitative methods from the University of Michigan. She earned her Bachelor of Science degree from Michigan State University and her Master's degree from the University of Washington.