Applying Advanced Informatics to Accelerate Drug Development in Diabetic Nephropathy

Biomarkers, Drug Discovery and Development, Life Sciences, Pharmaceutical, Pharmaceutical Regulation ,
  • May 06, 2016 | 10am BST (UK) / 11am CEST (EU-Central) / 5am EDT (NA)
  • 0 min

Diabetes and hypertension frequently coexist and account for much of the increased global burden of kidney disease. There are multiple drugs in development to reduce progression of diabetic nephropathy, but there are well-recognized challenges associated with conduct of later phase clinical trials in diabetic patients with kidney disease.

To optimize clinical trial performance and maintain patient safety, sponsors are increasingly taking advantage of advanced informatics tools. Join this webinar and consider the potential of collaborative partnerships between academicians, clinical investigators and contract research organizations in delivering new therapies for patients with diabetic nephropathy.

Speakers

George L. Bakris , MD, Hon. DSc, F.A.S.H, F.A.S.N., F.A.H.A., Professor of Medicine, Director, ASH Comprehensive Hypertension Center, The University of Chicago Medicine, Chicago, IL

Dr. Bakris received his medical degree from the Rosalind Franklin School of Medicine and completed residency in Internal Medicine at the Mayo Graduate School of Medicine where he also completed a research fellowship in Physiology and Biophysics. He then completed fellowships in Nephrology and Clinical Pharmacology at the University of Chicago. From 1988 to 1991, he served as Director of Renal Research at the Ochsner Clinic and had faculty appointments in the Departments of Medicine and Physiology at Tulane University School of Medicine. He later was Professor and Vice Chairman of Preventive Medicine and Director of the Rush University Hypertension Center in Chicago from 1993 until 2006. Currently, he is a Professor of Medicine and Director of the ASH Comprehensive Hypertension Center in the Department of Medicine at the University of Chicago Medicine.

Dr. Bakris has published over 700 peer-reviewed articles and book chapters in the areas of diabetic kidney disease, hypertension and progression of nephropathy. He is the Editor or Co-Editor of 20 books, in the areas of Kidney Disease Progression and Diabetes as well as the new edition of Hypertension: A Companion to Braunwald’s The Heart. Additionally, he is an Associate Editor of the International Textbook of Cardiology. He was a member of the NIH National High Blood Pressure Education Program Working Group on Hypertension and Renal Disease (1994). He also serves as a special government expert to the Cardio-renal Advisory Board of the FDA and to CMS. He was a co-principal investigator on the NIH Clinical Research training grant for clinical research (K30) (1999-2004). He chaired the first National Kidney Foundation Consensus report on blood pressure and impact on renal disease progression (2000). He has also served on many national guideline committees including: The Joint National Committee Writing Groups VI & 7 (1997, 2003), the JNC 7 executive committee (2003), the American Diabetes Association Clinical Practice Guideline Committee (2002-2004), the National Kidney Foundation (K-DOQI) Blood Pressure Guideline committee (2002-2004 & 2013) and (K-DOQI) Diabetes Guideline committee (2003-2005 & 2014). Dr. Bakris is the past-president of the American College of Clinical Pharmacology (2000-2002) and the American Society of Hypertension (ASH). He is the current Editor-in-Chief, Am J Nephrology, Editor-in-Chief- Up-to-Date, Nephrology section, Hypertension Section Editor Up-to-Date and Assoc. Ed of Diabetes Care. He serves on more than 18 editorial boards including Nephrology, Dialysis & Transplant, Hypertension, J Hypertension and J American Soc. Hypertension.

Michael D. Cressman, D.O., Senior Medical Director, Covance

Michael Cressman is a board certified nephrologist who has over 30 years of experience in clinical trials of treatment of hypertension, dyslipidemia, diabetes and cardiovascular disease prevention. He is a former member of the professional staff of the Cleveland Clinic, Associate Professor of Medicine in the Center for Clinical Pharmacology at the University of Pittsburgh Medical Center, global medical leader in the rosuvastatin clinical development program and chair of the Renal Safety Knowledge Group at AstraZeneca. His prior experience includes numerous interactions with FDA and other regulatory agencies on a wide range of efficacy or safety issues that are relevant to the clinical development process. Dr. Cressman joined Covance as a Senior Medical Director in 2012.

Jennifer Ennis, MD, Medical Director, Litholink Corporation, A LabCorp Company

Dr. Ennis joined LabCorp (Litholink) as a Medical Director in 2009. She oversees the medical and clinical aspects of Labcorp’s clinical decision support tools for management of chronic kidney disease, cardiovascular disease, and diabetes. She completed residency and fellowship at the University of Chicago, and is board certified in internal medicine and nephrology. Dr. Ennis is also a Clinical Assistant Professor of Medicine in the Section of Nephrology at the University of Illinois at Chicago. In addition to her clinical and teaching responsibilities, she performs clinical research in chronic kidney disease and has authored several abstracts and peer-reviewed publications.

Who Should Attend?

Chief Medical Officers, Chief Scientific Officers, plus senior level professionals involved in:

  • Clinical development program management
  • Clinical development project management
  • Medical affairs
  • Regulatory affairs
  • Regulatory strategy
  • Translational Medicine
  • Personalized Medicine
  • Biomarker Development
  • Companion Diagnostic Strategy
  • Diagnostics
  • Preclinical or Clinical Outsourcing

Xtalks Partners

Covance

Covance, the drug development business of Laboratory Corporation of America Holdings (LabCorp), is the world’s most comprehensive drug development company, dedicated to advancing healthcare and delivering Solutions Made Real ®.

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