We have assembled a team of leading GI clinicians and researchers as scientific advisors in our target indications.
Dr. Hanauer is an internationally recognized expert on the treatment of inflammatory bowel disease. He currently serves as the medical director of the Digestive Disease Center at Northwestern University Feinberg School of Medicine and as the Clifford Joseph Barborka Professor of Medicine. After earning his medical degree from the University of Illinois, Dr. Hanauer completed his internship and residency in internal medicine followed by a fellowship in gastroenterology at the University of Chicago. There Dr. Hanauer was mentored by one of the great clinicians in American gastroenterology, the legendary Dr. Joseph B. Kirsner. Dr. Hanauer held a Professorship in Medicine at Chicago named for Dr. Kirsner.
As Chairman of the Gastrointestinal Drugs Advisory Committee at the US Food and Drug Administration, Dr. Hanauer authored the FDA’s “Guidelines for Clinical Evaluation of Drugs for Patients with Inflammatory Bowel Disease”. From 2014-2015, he served as president of the American College of Gastroenterology (ACG), where he has been a member of the ACG Board of Trustees since 2006, an officer of the ACG since 2010 and a contributing committee member since 1989. He has represented the ACG at the FDA related to development of end-points for IBD in a series of “GREAT” meetings. He edited Nature Reviews Gastroenterology & Hepatology and chaired the ACG Finance Committee from 2011 to 2012. Dr. Hanauer has also held leadership positions in the American Gastroenterological Association (AGA) as chair of the Sections on Infection, Immunology and Inflammatory Bowel Disease as well as Clinical Practice, and served on the AGA Governing Board as a Counselor for Clinical Research. Internationally, he is a member of the European Crohn’s and Colitis Organization (ECCO) and is a former chairman of the International Organization for IBD (IOIBD).
Dr. Hanauer was awarded the AGA Fiterman Foundation Joseph B. Kirsner Award in Gastroenterology in 2001 and the AGA Janssen Award for Clinical Excellence in GI in 2004. He is currently an Associate Editor for Clinical Gastroenterology and Hepatology. In addition, Dr. Hanauer has worked with the American Board of Internal Medicine serving on the Gastroenterology sub-specialty. He has also held leadership positions within the Crohn’s & Colitis Foundation of American and in 2011 received CCFA’s Scientific Achievement Award for Clinical Research. Over the course of his career, Hanauer has authored or co-authored hundreds of peer-reviewed journal articles, books, book chapters, monographs, and editorials.
Dr. Brian Harvey has extensive industry, regulatory and clinical expertise in GI diseases. He previously was Vice President of U.S. Regulatory Strategy at Pfizer (2012-2015) and Vice President of U.S. Regulatory Policy at Sanofi Aventis (2007-2012). Prior to joining industry, Dr. Harvey worked at the U.S. Food & Drug Administration, most recently as director of FDA’s Division of Gastroenterology Products. Dr. Harvey led the regulatory review for NDA and BLA submissions of major breakthrough drugs for the treatment of IBD in adults and children, including adalimumab (Humira®), infliximab (Remicade®), and mesalamine (Lialda®). Throughout his FDA career, Dr. Harvey remained a practicing clinician at the Anne Arundel Medical Center in Maryland. As Principal Consultant of Brian E Harvey LLC since 2015, he has consulted extensively for large and small companies on regulatory and development issues related to drug, biologic and medical device approvals.
Dr. Harvey graduated with honors from Middlebury College in Vermont. He earned his Ph.D. in biochemistry and M.D. degree at the University of Connecticut. Prior to joining the FDA, he conducted post-doctoral research at Harvard Medical School, followed by his internal medicine internship and residency at Boston’s Beth Israel Hospital and a three-year gastroenterology fellowship at the Johns Hopkins Hospital in Baltimore, MD.
Dr. Hyams is one of the world’s leading experts in pediatric inflammatory bowel disease (IBD) including Crohn’s disease and ulcerative colitis. As Head of the Division of Digestive Diseases, Hepatology, and Nutrition at Connecticut Children’s Medical Center, he has led pivotal clinical trials for therapeutic agents in IBD and directed a long-term natural history registry that has described the course of almost 2000 children newly diagnosed with IBD. Dr. Hyams is the recent recipient of a $10.4M grant from the National Institutes of Health investigating the response of children newly diagnosed with ulcerative colitis to standardized therapies. He has worked with the FDA developing endpoints for pediatric clinical trials, has published more than 250 peer reviewed articles, and is the co-editor of one of the standard pediatric digestive disease textbooks, Pediatric Gastrointestinal and Liver Disease. Dr. Hyams was the first pediatrician to ever receive the prestigious Scientific Achievement in IBD Clinical Research Award from the Crohn’s & Colitis Foundation of America. He graduated from University of Pennsylvania School of Medicine and conducted his residency and fellowship at Boston Children’s Hospital.
Dr. Joshua R. Korzenik, one of the leading IBD researchers and key opinion leaders in the country, is director of the Brigham & Women’s Hospital Crohn’s and Colitis Center and assistant professor at Harvard Medical School. Dr. Korzenik has been involved in IBD research and care of patients for almost 25 years, with his research focusing on 1) translational research in IBD and 2) investigating environmental influences in IBD, with a focus on their common nexus of the intestinal microbiome. Dr. Korzenik is the author of almost 60 peer-reviewed articles and research papers. He speaks frequently at professional meetings and is an active member of many professional committees. Dr. Korzenik has been the principal investigator of over a dozen research projects, ranging from studies of diet and probiotics to international comparisons of IBD. Dr. Korzenik earned his bachelor’s degree from Harvard College in 1980 and his medical degree from Albert Einstein College of Medicine in the Bronx, New York, in 1987. He was a resident at Harvard-affiliated Beth Israel Deaconess Hospital in Boston from 1987 to 1990 and fellow in gastroenterology and clinical epidemiology at Yale University School of Medicine Hospital from 1991 to 1994. He is a longstanding member of the medical advisory committee for the New England chapter of Crohn’s and Colitis Foundation of America.
Dr. Rifat Pamukcu was a Founder, Director and CSO of Cell Pathways, Inc.(CPI), an emerging pharmaceutical company acquired by OSI Pharmaceuticals. He directed the basic science, preclinical drug development, clinical research, regulatory programs, and various aspects of chemical scale-up and manufacturing over the course of decade. While at CPI, he led the development of exisulind, an oral apoptosis modulator and phosphodiesterase inhibitor, for the treatment of Familial Adenomatous Polyposis (FAP). He received his BA in Biology from The Johns Hopkins University and his MD degree from the University of Wisconsin School of Medicine. Dr. Pamukcu has authored over 110 journal articles, book chapters, and abstracts and is an inventor on over 280 issued or pending patents in the areas of drug discovery and development for cancer prevention, cancer treatment, and inflammatory bowel disease.
Dr. Rieder is an investigator at the Department of Pathobiology and an Associate Staff at the Department of Gastroenterology, Hepatology and Nutrition at the Cleveland Clinic, Cleveland. His clinical focus is patients with inflammatory bowel diseases (IBD) with a special emphasis on the field of pathogenesis, prediction and therapy of IBD.
Dr. Rieder has published more than 60 articles and book chapters and has been recognized for his expertise and he serves on multiple committees, speakers’ panels, steering committees and editorial boards. He is a member of the European Crohn’s and Colitis Organization (ECCO), the German Gastroenterology Association, the American Gastroenterology Association, the America Physiological Society, the American College of Physicians, and the Crohn’s and Colitis Foundation. He is the associate editor of Clinical and Translational Gastroenterology, section editor of Annals of Gastroenterology, on the editorial boards of the Journal of Crohn’s and Colitis, Inflammatory Bowel Diseases, BMC Gastroenterology, American Journal of Physiology: Gastrointestinal and Liver Physiology and Gastroenterology and Hepatology Journal. Dr. Rieder is the senior author of the new ECCO guidelines for Ulcerative colitis, the first author of the ECCO consensus on Fibrostenosing IBD and co-author of the new ECCO guidelines in Crohn’s disease.
He received his medical degree from the Ludwig-Maximilians-University Medical School in Germany. He underwent training in Internal Medicine / Gastroenterology at the Klinik und Poliklinik für Innere Medizin I, Universitätsklinikum Regensburg, Germany and a residency in Internal Medicine and fellowship in Gastroenterology, Hepatology and Nutrition at the Cleveland Clinic in Cleveland, Ohio. Dr. Rieder has performed research fellowships at Harvard Medical School and the Cleveland Clinic.