Nancy Kline Leidy, PhD, Sr. VP, Sr. Research Leader, Scientific Affairs, Patient-Centered Research at Evidera.

Nancy Kline Leidy

PhD, Senior Vice President, Scientific Affairs and Patient-Centered Outcomes Research

Nancy has over 25 years of experience in clinical and health outcomes research, specializing in instrument selection, development and testing, and the design and analysis of clinical trials involving clinical, patient-reported, and functional outcomes assessment. Prior to joining Evidera, she served on the faculties of Michigan State University and the University of Arizona and as an intramural scientist at the National Institutes of Health (NIH).

Nancy has presented her work at local, national, and international conferences and has over 140 papers published in refereed journals, books, and monographs. In addition to many other research activities, she is director and principal investigator of the EXACT-PRO Initiative (EXAcerbations of Chronic pulmonary disease Tool), the first patient-reported outcome (PRO) instrument development consortia. This multi-sponsor initiative brought together experts in instrument development, clinical research, and regulatory issues to develop and validate the EXACT and a derivative measure, the EXACT-RS (E-RS), for measuring outcomes in chronic obstructive pulmonary disease (COPD) trials. These PRO instruments were the first to undergo qualification review by the U.S. Food and Drug Administration (FDA), with EXACT the first PRO instrument qualified for use in drug development programs (January 10, 2014). The E-RS was the second (March 8, 2016).  Both measures have also been reviewed under the European Medicines Agency (EMA) qualification of novel methodologies.

Nancy is an active member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and American Thoracic Society (ATS) and holds memberships in numerous other organizations. She has served on ISPOR task forces on regulatory requirements for the use of PRO information in labeling (Value in Health, 2003) and good research practices to ensure content validity of PRO instruments for this purpose (Value in Health, 2009, 2011). She was also an adviser to the European Innovative Medicines Initiative (IMI) PRO-ACTIVE Initiative to develop physical activity measures for COPD trials.

Nancy holds a PhD from the University of Michigan, an MS from the University of Washington, and a BS from Michigan State University.