Kidney disease is often called a “silent killer” as it often develops unrecognized and
gradually progresses into chronic kidney disease. Earlier detection to identify kidney disease and slow its progression has relied on measuring changes in two key biomarkers – glomerular filtration rate (GFR) and albuminuria.
Dr. Barbara Gillespie, vice president and therapeutic head of nephrology at Covance, was recently asked to attend an invite-only workshop on March 15-16, 2018 sponsored by the National Kidney Foundation (NFK), U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
As the only representative from a CRO invited to this unique meeting, Dr. Gillespie will offer valuable insights from the perspective of clinical research. She also serves on the NFK regional medical advisory board and is the only CRO member of the NFK scientific advisory board for chronic kidney disease (CKD) registry.
“This collaboration across multiple stakeholders is critical because researchers need a better understanding of how to assess changes in albuminuria and GFR and apply these as endpoints in clinical trials,” said Gillespie.
“The goal of this scientific collaboration will be to discuss these biomarkers in depth and evaluate the current limitations and strengths of candidate surrogate endpoints. Ultimately, we hope to help develop proposals to improve how we detect early stages of chronic kidney disease and make a difference for patients.”
Barbara S. Gillespie, MD, MMS, FASN
Vice President & Global Therapeutic Area Head of Nephrology
Dr. Gillespie is a board-certified nephrologist and has over 12 years of experience in clinical research and development. She is an Adjunct Professor at the University of North Carolina, Division of Nephrology and Hypertension; and she also serves on the Board of Directors at the Kidney Health Initiative, a public-private partnership between the FDA, American Society of Nephrology, academia and industry.
Her vast experience includes 11 years at Quintiles as Global Nephrology Lead where she led CKD and ESRD trials from protocol design to trial execution, and served as a consultant to sponsors for Clinical Development Plans, Due Diligence, Regulatory submissions, Commercialization Plans, Health Economics Outcomes Research and Patient Reported Outcomes. There she was also a past Head of the North American Internal Medicine Medical Team, and most recently reported directly to the Chief Medical and Scientific Officer to support issues related to strategy, science, ethics and governance.
She serves on several Advisory Boards and Stakeholder Panels including the FDA/EMA/NKF Workshop on Renal Endpoints, National Kidney Foundation CKD Registry, UNC’s PCORI Workshop, and the global Standardized Outcomes for Nephrology (SONG) Initiative.