We have assembled a team of leading GI clinicians and researchers as scientific advisors in our target indications.
Inflammatory Bowel Disease
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. 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. 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.
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.
Familial Adenomatous Polyposis
Dr. Burt is professor emeritus at the University of Utah, School of Medicine, where he held Barnes Chair of Medicine until his retirement. He received his medical degree from the University of Utah, did internal medicine training at Barnes Hospital, Washington University in St. Louis, and GI fellowship training at the University of Utah. His career has focused on familial risk and genetics of colon cancer. He was part of the group that discovered the APC gene, the gene responsible for FAP when mutated and also the first gene mutated in over 85% of all colon cancers. Dr. Burt has been a leader in the application of genetic testing to colon cancer syndromes, syndrome phenotype description, syndrome clinical management and syndrome chemoprevention. His CV includes 112 original journal articles, 86 reviews and 49 book chapters and books and numerous abstracts. He has been a reviewer for numerous journals including the New England Journal of Medicine, JAMA and Gastroenterology. He has been associated with the Huntsman Cancer Institute of the University of Utah for more than two decades serving in multiple capacities including senior director of prevention and outreach and senior director of the inherited cancer syndromes clinic. At the national level, he has served as a member of the Board of Directors of the American Gastroenterological Association, and chair of the NCCN colon cancer prevention guidelines committee.
Dr. Erdman is an attending pediatric gastroenterologist at Nationwide Children’s Hospital and Professor of Clinical Pediatrics at The Ohio State University College of Medicine. He also serves as Director of the Pediatric Gastroenterology Fellowship Program and supervises all educational activities for the GI Division. Dr. Erdman served on the Training Committee of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) and contributed to the updated Training Guidelines for pediatric gastroenterology in polyposis and colon cancer.
His clinical and research interests are in the area of hereditary colorectal cancer and the polyposis syndromes in children and adolescents. He has conducted laboratory research using rodent models to understand basic processes in gastroenterology and the pathophysiology of polyposis syndromes. Polyamine metabolism has been of long-standing interest, dating back to his Fellowship at the University of Nebraska and later at The University of Arizona in Tucson. In a collaborative effort, published in Carcinogenesis in 1999, he helped provided the first evidence documenting alterations in intestinal and colonic polyamine metabolism in the ApcMin/+ mouse model of Familial Adenomatous Polyposis (FAP). This study provided early rationale for targeting polyamine metabolism in patients with FAP. In addition, Dr. Erdman participated in the pharmaceutical company trial entitled “Trial in pediatric patients with familial adenomatous polyposis (FAP) (CHIP)” (NCT00585312).
He is a member of the International Society for Gastrointestinal Hereditary Tumors (InSiGHT) and the Collaborative Group of the Americas on Inherited Colorectal Cancer (CGA-ICC). He served on the Executive Council of the CGA-ICC and was elected President of that organization (2009-2010), and presided over the planning and execution of the 14th annual meeting in October 2010 in Dallas TX. The members of InSiGHT and CGA-ICC represent the major international centers of excellence treating patients with FAP and other genetic syndromes associated with colorectal and other GI cancers.
Dr. Lynch is a gastroenterologist and scientist with specific expertise in cancer risk for mismatch repair gene mutation carriers. He is a professor in the Department of Gastroenterology, Hepatology and Nutrition at The University of Texas MD Anderson Cancer Center, where he provides surveillance for patients and families with hereditary colorectal cancers, and is actively involved in the counseling and management of these patients and families. Patrick Lynch has led or collaborated on multiple NIH and industry-funded studies in hereditary colorectal cancers, including basic science, clinical, chemoprevention, and behavioral studies. He is a member on the governing council of the International Society for Gastrointestinal Hereditary Tumors, past president of the Collaborative Group of the Americas on Inherited Colorectal Cancer, chairman of the Subcommittee on Colorectal Cancer of the American Gastroenterological Association, and a member of the International Society for Gastrointestinal Hereditary Tumours where he led the development a proposed staging system and stage-specific interventions for familial adenomatous polyposis.
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.