The design, planning and conduct of trials with dialysis patients require an understanding of how dialysis is delivered daily so that protocols can avoid disrupting the workflow of the clinical dialysis staff. This webinar will review some key medical and operational considerations and lessons learned to position future dialysis trials and protocols for success.
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.
Dr. Gillespie’s previous roles include working as an associate medical director at a small local dialysis unit and being a fellow of the American Society of Nephrology. She received board certification in internal medicine in 2004 and in nephrology in 2006 and 2015. She completed her internal medicine residency at the University of North Carolina and nephrology fellowship at Duke University.
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.Message Presenter
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.Message Presenter
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.
Dr. Arens uses his expertise to involve himself and his team in directing services around conducting international clinical trials and performing analytics on Fresenius’ own worldwide proprietary database, supporting clients with medical and operational leadership, as well as consulting services. As head of Frenova International, he has developed a service portfolio dedicated to supporting external sponsor companies in the planning, preparation and execution of clinical trials at center networks throughout Europe, the Middle East, Africa, Latin America and Asia/the Pacific.
He received his PhD in pharmacology/toxicology from Johannes Gutenberg University Mainz, Germany.
Who Should Attend?
- Sponsors (Medical and Devices)
- Patient Groups
- Dialysis Organizations
- Other Stakeholders (American Society of Nephrology [ASN], Kidney Health Initiative [KHI], National Kidney Foundation [NKF])
- Chief Medical Officer
- Chief Executive Officer
- Senior Medical Director
- Medical Director
- Clinical Development Director
- Research and Development Director
- Operational Director
- Senior Operational Director
- Clinical Director
- Senior Clinical Director
- Research Director
- Health Economic and Outcomes Research Director
- Principal Investigator
- Site Coordinator
What You Will Learn
- Protocols must be patient-centric and dialysis-centric: briefly review the daily practice of dialysis and the importance of minimizing disruption to care delivery for patients and the routine workflow of dialysis staff
- Share lessons learned on protocol design, including but not limited to: reasonable entry criteria, sensible endpoints, practical schedule of assessments, shorter Informed Consent Forms (ICFs), etc.
- Provide insight on dialysis trial execution: collaborating with dialysis organizations and independent units, data collection (efficacy and safety), etc.
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