Diabetic Kidney Disease: Drug Discovery and Clinical Development Challenges

Speakers

Organizers

Magdalena Alonso-Galicia, PhD

MAG Pharma Consulting LLC

Magdalena Alonso-Galicia, PhD, is a cardiorenal physiologist with 20 years of experience in academic research, drug discovery, licensing – search & evaluation, and preclinical / early clinical development. As the sole owner of MAG Pharma Consulting LLC, she provides a wide range of consulting services to Pharmaceutical, Biotech, and Medical Device companies. In her previous role at Forest Research Institute, Inc., she led scientific reviews of licensing opportunities in the areas of renal, cardiometabolic and respiratory. She also served on multiple respiratory and cardiovascular clinical development teams as preclinical pharmacologist, overseeing inflammation-related biomarker and pharmacology studies. Prior to joining Forest in 2010, she worked in drug discovery at Boehringer Ingelheim and Merck & Co., Inc. in the areas of hypertension, heart failure and chronic kidney diseases. She holds a PhD in Physiology & Biophysics from the University of Mississippi and underwent post-doctoral training at the Medical College of Wisconsin.

Ken Jones, PhD

Allergan

Ken is currently a Principal Medical Writer with Allergan in Bridgewater, NJ, where he is preparing regulatory submission documents for novel biological and chemical entities for their neurology portfolio. He has over 20 years of preclinical drug discovery and clinical development experience in the area of CNS disorders. Ken received his PhD in Physiology at Rutgers University and postdoctoral training at the Harvard Medical School Department of Neurobiology where he developed mammalian primary cell culture techniques to map NMDA and AMPA receptors at synaptic and extrasynaptic sites. His subsequent contributions to research include the deorphanization of several G-protein-coupled receptors, including the elucidation of the dimeric nature of GABAB receptors, and the co-discovery of a non-visual photoreceptor that regulates circadian rhythms. Prior to joining Allergan, Ken was a Senior Clinical Scientist within the Department of Psychiatry at Forest Research Institute.

Scott MacDonnell, PhD

Boehringer-Ingelheim Pharmaceuticals

Dr. Scott MacDonnell obtained his undergraduate and master’s degrees in exercise physiology from the University of Delaware and completed his doctoral work in cardiovascular physiology at Temple University in Philadelphia, PA. He completed a post-doctoral fellowship at Temple University Medical School in the lab of Dr. Steve Houser. His fellowship research focused on identifying mechanisms responsible for the pathogenesis of heart failure. Specifically, his work examined the role of CaMKII in altered contractility, myocytes apoptosis, and transcriptional regulation associated with heart failure progression. This work has been published in Circulation Research and recognized as a best manuscript by the editorial board in 2010. Additionally, Scott was recognized by the International Society for Heart Research and awarded the young investigator of the year in 2008. Scott currently works as a principal scientist at Boehringer Ingelheim within the department of CardioMetabolic Disease Research. His research is focused on identifying novel therapeutic treatment options for chronic kidney disease, heart failure, and fibrosis.

Jennifer Henry, PhD

The New York Academy of Sciences

Speakers

Matthew D. Breyer, MD

Eli Lilly and Company

Matthew D. Breyer received his MD from Harvard and training in Nephrology at Parkland UTHSCD. From 1985–2007 he was Professor of Medicine in the division of Nephrology at Vanderbilt University Medical Center where his work focused on the study of prostaglandin receptor transgenic mouse models to study diabetic kidney disease and hypertension. Dr. Breyer held numerous NIH and VA grants and from 2001–2006 headed the nephropathy sub-group of the NIH Animal Models of Diabetic Complications Consortium (AMDCC). As a result of his interest in developing treatments for diabetic nephropathy he moved to Eli Lilly in 2007 to oversee a program to develop bio-therapeutics for diabetic kidney disease. In 2009 he was appointed to his current position at Eli Lilly as Chief Scientific Officer Lead Generation Biotechnology Discovery Research, where he oversees preclinical target identification and validation of biologics for metabolic, neurologic, oncologic and chronic kidney diseases.

Frank C. Brosius, MD

University of Michigan

Frank C. Brosius' laboratory focuses on molecular and translational kidney research with the goal of developing effective new treatments for diabetic complications. He has studied diabetic kidney disease mechanisms for over 20 years and for the past 12 years has been at the center of animal models research in diabetic nephropathy as one of the principal investigators in the NIH Animal Models of the Diabetic Complications Consortium. More recently, as part of a large team-science approach they have worked to uncover the transcriptomic, proteomic and metabolite profiles of diabetic complications in both humans and mouse models. He is the corresponding PI for 2 large multi-investigator grants in this area and is Director of the NIDDK funded O'Brien Kidney Core Center at the University of Michigan. As part of this process, they discovered that the gene expression of a large number of JAK/STAT genes were increased markedly in kidney tissues of patients with diabetic kidney disease, and that these expression changes correlated with the degree of kidney dysfunction. These findings led to development of a phase 2 clinical trial sponsored by Eli Lilly and Co for which he is a principal investigator. He has been sought out by other pharmaceutical companies for unbiased recommendations about the best animal models to use for preclinical studies of diabetic nephropathy as well as for identification of potential targets in humans.

Benjamin D. Humphreys, MD, PhD

Brigham and Women's Hospital

Dr. Humphreys is Director of the Harvard Stem Cell Institute Kidney Program where he is a Principal Faculty member. He is an Associate Professor of Medicine at Harvard Medical School and directs the Laboratory of Translational Research in Kidney Repair. He received a bachelor's degree from Harvard College and MD and PhD degrees from Case Western Reserve University. He completed a residency in Internal Medicine at Massachusetts General Hospital and a fellowship in Nephrology at Brigham and Women's Hospital in Boston. He is an Established Investigator of the American Heart Association and a member of the American Society of Clinical Investigation. He has published 43 peer-reviewed original publications and 42 review articles or book chapters. A specialist in kidney injury, his laboratory utilizes mouse models to identify new treatments for patients suffering from acute and chronic kidney disease.

Tony Jourdan, PhD

NIH / NIAAA

Dr. Tony Jourdan obtained his master's degree and completed his doctoral work in nutrition and physiology at the INSERM U866 "lipids, Nutrition Cancer" in Dijon, France. He focused on the involvement of the peripheral endocannabinoid system in the pathogenesis of obesity and ore particularly on liver metabolism. He is currently holding a visiting Fellow position within the laboratory of physiologic studies under Dr. George Kunos mentorship (National Institute on Alcohol Abuse and Alcoholism, NIH). His current research focuses on studying the impact of peripheral endocannabinoid system on obesity/diabetes, theirs consequences and the development of an effective drug therapy. His work has resulted in numerous publications in peer review journals such as Diabetes, Nature Medicine or PNAS.

Kathleen Lincoln

Boehringer-Ingelheim Pharmaceuticals

Kathleen Lincoln is a researcher within the department of CardioMetabolic Disease Research at Boehringer-Ingelheim Pharmaceuticals, Ridgefield CT. She received a bachelor’s degree from Mercy College and is currently in the final stages of submission of her master’s thesis final project in Integrative Pharmacology from Michigan State University. Kathleen previously worked as a research associate in the VelociGene program at Regeneron Pharmaceuticals creating transgenic mouse models to study specific gene functions. Her current research focuses on developing and characterizing disease relevant animal models of diabetic nephropathy and designing and executing in vivo studies to evaluate new renal therapeutic drug candidates.

Matthias Meier, MD

F. Hoffmann-La Roche Ltd

Dr. Matthias Meier is a board-certified physician in Germany and Switzerland qualified in Internal Medicine with subspeciality in Diabetology and Nephrology currently serving as Senior Medical Director at F.Hoffmann-La Roche Ltd in Basel/Switzerland. He formerly received medical and scientific training at the Diabetes Research Institute in Munich/Germany, the University of Leicester/UK, the Joslin Diabetes Center/Harvard Medical School in Boston/USA as well as the Hannover Medical School/Germany where today he is an associate professor and faculty member. Furthermore, he has specialized in Pharmaceutical Medicine with outstanding experience in preclinical and clinical drug development in cardiovascular and metabolic disease areas. Dr. Meier is member of various scientific associations including 'Fellow of the American Society of Nephrology (FASN)' and acts as a reviewer of renowned scientific journals in his field of key expertise, mainly diabetes mellitus as well as kidney and associated diseases such as renal anemia.

Shahnaz Shahinfar, MD, FASN

S. Shahinfar Consulting, Inc. and The Children's Hospital of Philadelphia

Dr. Shahnaz Shahinfar received her medical degree from Ferdowsi University School of Medicine in Iran. She completed her Residency in Pediatrics and Fellowship in Pediatric Nephrology at Georgetown University Hospital in Washington, D.C. In 1981, she joined Merck & Co., Inc. and was involved with many clinical trials in the areas of diabetes, hypertension, and kidney disease, including outcome trials. Her primary focus and interest has been progression of chronic kidney disease. While at Merck, she initiated and implemented the RENAAL trial, a landmark outcome study in type II diabetic patients with kidney disease. She also has been involved with clinical trials of cardiovascular and renal outcomes in diabetic nephropathy and cardiovascular morbidity and mortality in hemodialysis patients. She conducted some of the first double-blind, placebo-controlled, clinical trials in hypertensive children with enalapril, lisinopril, and losartan. Shahnaz is an Adjunct Associate Professor of Pediatrics in the Associated Faculty of the School of Medicine at the University of Pennsylvania and the Children’s Hospital of Philadelphia. Currently, she is a research consultant to the pharmaceutical industry on the design and implementation of clinical trials. Her work has resulted in numerous publications in peer review journals.

Katalin Susztak, MD, PhD

University of Pennsylvania

Katalin Susztak MD, PhD is currently an Associate Professor of Medicine at the Renal Electrolyte and Hypertension Division of the University of Pennsylvania Perelman School of Medicine. Dr. Susztak earned her doctorate (MD, PhD) degrees at Semmelweis University School Medicine, Budapest, Hungary in 1997 and she completed residency in Internal Medicine and clinical fellowship in nephrology at the Albert Einstein College of Medicine. She completed her post-doctoral work with Dr. Erwin Bottinger, where she initially worked on genomic studies of diabetic kidney disease and also defined the role of podocytes in diabetic nephropathy development. Dr Susztak is a nephrologist and physician-scientist. Work in her laboratory is aimed towards the understanding of renal fibrosis and chronic kidney disease development. She has performed translational research work to identify novel, genetic, genomic and epigenomic biomarkers of chronic renal disease. She has shown that an integrative analysis of epigenetic and genetic settings in diseased cells can provide a rational basis for more accurately modeling the critical biological pathways involved in mediating the progressive phenotype in individual patients. Her laboratory uses genetic approaches and mice as a model organism to test the role of candidate signaling molecules directly in vivo. Specifically, her work highlighted the role of the Notch and Wnt/beta-catenin pathway in chronic kidney disease development, renal epithelial cell homeostasis, renal stem or progenitor cell function and differentiation. Her recent results have revealed the role of embryonic programs in adult disease development causing alterations in renal epithelial cells and causing kidney fibrosis development. These studies have broad impact and clinical significance, since novel pharmaceuticals can be created around these principles. The work in the laboratory of Dr. Susztak is supported by the National Institute of Health, the American Diabetes Association and Juvenile Diabetes Association. Dr. Susztak is an elected member of the American Society of Clinical Investigation. She was the recipient of the 2011 Young Investigator Award of the American Society of Nephrology and American Heart Association for her groundbreaking research on chronic kidney disease development.

Aliza Thompson, MD

Food and Drug Administration (FDA)

Aliza Thompson is a Medical Officer and Clinical Team Leader in the Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, at the US Food and Drug Administration. Dr. Thompson joined the Division of Cardiovascular and Renal Products in 2007. She received her medical degree from Johns Hopkins and completed her Internal Medicine and Nephrology training at Columbia University/New York-Presbyterian Hospital. She holds a Master of Science in Biostatistics/Patient Oriented Research Track from the Columbia University Mailman School of Public Health.