Chronic Kidney Disease: Detection and its Association with Cardiovascular Disease in Clinical Care and Clinical Trials
Sponsored by: Covance
Date: 4 June
Days to go: 9
Time: 4PM London/11AM New York
The links between CKD and CVD, and Implications for Managing Patients in Clinical Care and Clinical Trials
Chronic Kidney Disease (CKD) is a global epidemic yet is widely under-recognized. Diabetes, the leading cause of CKD, and the burden of associated cardiovascular disease (CVD), contributes to CKD morbidity and mortality.
Many patients do not receive the proper attention in management of their risk factors, partially due to physicians' under-detection for CKD as well as the somewhat asymptomatic nature of CKD. Often, this delay in timely detection of CKD results in patients requiring dialysis or renal replacement therapy in the form of kidney transplantation.
Managing CKD patients also has several negative implications, which can impact drug development advances for renal therapies.
Since 2007, only eight new molecular entities have been approved by the FDA for CKD patients, a statistic that highlights the opportunity to improve screening and management of CKD patients, as well as a need to ensure patients are involved in more clinical trials that can ultimately facilitate approvals for more novel therapies.
Barbara S. Gillespie, MD MMS FASN,
Vice President & Therapeutic Head of Nephrology, Covance Adjunct Professor, University of North Carolina
Dr. Gillespie supports sponsors on renal drug and device development, serves on the Board of Directors at the Kidney Health Initiative, a public-private partnership between the FDA and American Society of Nephrology and participates in several advisory boards and stakeholder panels.
Prior to Covance, Dr. Gillespie worked at Quintiles for 11 years in several leadership roles, and worked on over 15 indications across both CKD and End-Stage Kidney Disease serving as a consultant to sponsors for Clinical Development Plans, Due Diligence, Regulatory submissions, Commercialization Plans, Health Economics Outcomes Research and Patient Reported Outcomes. Her roles also included executive sponsor on a Strategic Partnership and member on a Steering Committee and a Scientific Ad Board.
She is also an associate medical director at a small local dialysis unit, a fellow of the American Society of Nephrology, and received board certification in Internal Medicine in 2004 and in Nephrology in 2006 and 2015.
Peter A. McCullough, MD, MPH, FACP, FACC, FCCP, FAHA, FNKF, FNLA, FCRSA,
Founder and current president, Cardio Renal Society of America Vice Chief of Medicine, Baylor University Medical Center
Dr. McCullough is an internationally recognized authority on the role of CKD as a cardiovascular-risk state with more than 1000 publications and 500 citations in the National Library of Medicine. His works include the "Interface between Renal Disease and Cardiovascular Illness" in Braunwald's Heart Disease Textbook.
Dr. McCullough has led observational studies and randomized trials of therapies for acute kidney injury, hypertension, acute coronary syndromes, heart failure and cardiorenal syndromes, as well as chaired and participated on 20 data safety monitoring committees for large randomized trials. He advised sponsors and the FDA resulting in approval of 17 new drugs and 3 novel in vitro diagnostic tests used today around the world.
He serves on the editorial boards of multiple specialty journals, made presentations on the advancement of medicine across the world and has been an invited lecturer at the New York Academy of Sciences, the National Institutes of Health, U.S. Food and Drug Administration (FDA), European Medicines Agency, and the U.S. Congressional Oversight Panel.
Key Learning Objectives
- Understand how to effectively screen for CKD.
- Increase detection of CKD and management of associated risk factors, including CVD. Learn about strategies to increase detection of CKD.
- Start to understand the clinical implications of managing CVD in CKD towards clinical trials.
- Hear about the management of associated risk factors, including CVD.
- Medical Affairs
- Project Management
- Regulatory Specialist
- Clinical Operations
- Commercial and Sales
- Chief Medical Officer
- Chief Development Officer
- Medical Director
- Operational Director
- Clinical Development Director
- Clinical Development Manager
- Procurement Manager