What Every Sponsor Should Know Before Planning Dialysis Trials: Insight From a PI and Dialysis Organizations

Barbara Gillespie, MD, MMS, FASN, VP and Therapeutic Head of Nephrology, Labcorp; Adjunct Professor, Division of Nephrology and Hypertension, University of North Carolina School of Medicine

Barbara Gillespie, MD, MMS, FASN, a board-certified nephrologist, advises sponsors on renal clinical development and serves on the board of directors at the Kidney Health Initiative, a public-private partnership between the FDA and American Society of Nephrology. She serves on several advisory boards and stakeholder panels, including the NKF Patient Network Steering Committee.

Laura M. Dember, MD, Professor, University of Pennsylvania

Laura M. Dember, MD, is a professor of medicine and epidemiology at the University of Pennsylvania Perelman School of Medicine where she is a faculty member in the renal-electrolyte and hypertension division and a senior scholar for the Center for Clinical Epidemiology and Biostatistics. Dr. Dember has been a practicing nephrologist for the past 25 years and is a clinical investigator with a major focus on interventions to improve outcomes in end-stage kidney disease. She has held leadership roles in NIH-funded multicenter clinical trials in hemodialysis, including the Dialysis Access Consortium trials, the Hemodialysis Novel Therapies Consortium, the HiLo trial, and the HOPE trial.

She was the principal investigator for the Time to Reduce Mortality in End-Stage Renal Disease (TiME) trial, a large, cluster-randomized pragmatic trial that was fully embedded in clinical care delivery and conducted in partnership with two large dialysis provider organizations as one of the initial trials of the NIH Health Care Systems Research Collaboratory. Dr. Dember has also served on steering committees and data monitoring committees for industry-sponsored clinical trials in dialysis.

Amy Young, VP and General Manager, DaVita Clinical Research

Amy Young has been a vital part of DaVita Clinical Research (DCR), bringing deep experience in the execution of research required to bring new therapies to market. Amy has direct experience in the care of chronically ill patients and brings essential knowledge in developing and delivering trials in specialty patient populations. After receiving a BA in biology with a minor in chemistry from Augsburg University, cum laude, she joined DCR holding posts with increasing responsibilities. Mrs. Young has experience in the areas of strategy, leadership, operations, clinical trial conduct, renal patient populations and clinical services.

She holds a CCRC from the Association of Clinical Research Professionals.

Hans-Juergen Arens, PhD, VP, International Clinical Research Services, Global Medical Office, Frenova Renal Research

Dr. Arens, PhD, has nearly three decades of experience in the pharma and medtech industries. He held various positions in drug clinical research and development at Takeda, Merck KGaA and Abbott/AbbVie with responsibility for global clinical development teams bringing major blockbuster drugs to life. He also worked on strategic development of companion diagnostic and biomarker approaches connecting diagnostics and pharma in the field of personalized medicine.