Bruce Sands, M.D., M.S., is the Dr. Burrill B. Crohn Professor of Medicine at the Icahn School of Medicine at Mount Sinai in New York City. After completing his GI fellowship at the Massachusetts General Hospital (MGH), he joined the faculty of Harvard Medical School and served as the Acting Chief of the Gastrointestinal Unit at MGH before moving to Mount Sinai in 2010 as Chief of the Dr. Henry D. Janowitz Division of Gastroenterology. Dr. Sands is widely recognized for his clinical investigations of new therapeutics for the inflammatory bowel diseases and has published over 275 original manuscripts. He was the lead investigator of the landmark studies including ACCENT 2, UNIFI, and VARSITY which were published in the New England Journal of Medicine, and SEAVUE, published in the Lancet. Dr. Sands was awarded his B.A. and M.D. from Boston University, and trained in internal medicine at the Hospital of the University of Pennsylvania.

Susan Stewart, J.D., has worked for nearly 30 years in biopharmaceutical regulatory affairs, with significant experience devising innovative strategies for novel therapeutics, overseeing regulatory submissions at various stages of product development, and leading interactions with global health authorities. An independent consultant, Ms. Stewart serves as Chief Regulatory Officer for Candel Therapeutics in addition to Chief Regulatory Officer, Regulatory, and Quality for Kaleido Biosciences and Frequency Therapeutics. Prior roles have included Senior Vice President of Regulatory Affairs and Quality at Kaleido Biosciences, Senior Vice President of Regulatory Affairs, Quality, and Compliance at Tokai Pharmaceuticals and Vice President, Regulatory Affairs at Transmolecular. Ms. Stewart also spent 13 years at Genzyme Corporation in regulatory and compliance roles, including serving as Vice President, Regulatory Affairs and began her career with Abbott Laboratories. She is a Fellow of the Regulatory Affairs Professionals Society, a Director of the Board, and holds Regulatory Affairs Certifications for both the United States and Europe. Ms. Stewart received her J.D. from Concord Law School at Purdue University Global and her B.A. from the University of Massachusetts.

Wendy Garrett, M.D., Ph.D., is the Irene Heinz Given Professor of Immunology and Infectious Diseases in the Departments of Immunology and Infectious Diseases and Molecular Metabolism at the Harvard T. H. Chan School of Public Health and a Professor of Medicine at Dana-Farber Cancer Institute and Harvard Medical School. She is also Co-Founder and Co-Director of the Harvard Chan Microbiome in Public Health Center which mission is to expand understanding of the microbiome for improving population health, through basic research, translation, policy, education, and outreach. The Garrett lab focuses on how the gut microbiota influence both innate and adaptive populations and the contribution of these cells to immune homeostasis and disease. Her research team studies the interplay between the gastrointestinal immune system and the gut microbiota in health, inflammatory bowel disease and colorectal cancer. Dr. Garrett practices medical oncology and subspecializes in gastrointestinal malignancies. She received her B.S. and M.S. in Molecular Biophysics and Biochemistry, Ph.D. in Cell Biology, Immunology, and M.D. from Yale University.

Michael Dunne, M.D., is Chief Medical Officer and Head of Development at Bill & Melinda Gates Medical Research Institute. He has held various senior level C-suite roles in connection with the clinical development of numerous infectious disease compounds including Chief Scientific Officer of Iterum Therapeutics where he now serves a Strategic Advisor on the Board of Directors. Dr. Dunne served as Chief Medical Officer of Durata Therapeutics which was acquired by Actavis in 2014. He worked at Pfizer in numerous roles of increasing responsibility including Vice President, Therapeutic Head of Development for Infectious Disease from 2001 to 2009. Dr. Dunne received a B.A. in Economics from Northwestern University and M.D. from the State University of New York Health Sciences Center. He completed his internal medicine residency and fellowships in infectious diseases and pulmonary medicine at Yale University School of Medicine.

Alex Dmitrienko, Ph.D, is Founder and President of Mediana LLC. He has been involved in clinical trial statistics for over 20 years and, prior to founding Mediana, was Vice President, Innovation Unit at Quintiles and Research Advisor, Advanced Analytics at Eli Lilly and Company. Dr. Dmitrienko is actively involved in biostatistical research and has published over 100 papers and five books on key topics in clinical trial statistics, including adaptive designs, multiple comparisons, biomarker analysis, and clinical trial optimization. He has served as an Associate Editor for The American Statistician, Biometrics and Statistics in Medicine, and is a Fellow of the American Statistical Association. Dr. Dmitrienko received a Ph.D. in Statistics from the University of Kentucky.

  1. Balfour Sartor, M.D., is the Midget Distinguished Professor of Medicine, Microbiology, and Immunology, Division of Gastroenterology and Hepatology, Co-Director of the National Institute of Diabetes and Digestive and Kidney Diseases-supported Center for Gastrointestinal Biology and Disease and Founder of the Multidisciplinary Inflammatory Bowel Disease (IBD) Center, University of North Carolina at Chapel Hill School of Medicine. Dr. Sartor’s clinical expertise focuses on managing patients with refractory IBD (Crohn’s disease, ulcerative colitis and pouchitis). His research investigates the ability of specific components of the intestinal microbiota to induce chronic T-cell mediated inflammation in genetically susceptible hosts vs. protective mucosal immune responses in normal hosts. Recently, he has investigated the ability of novel resident bacterial consortia to prevent and treat experimental colitis and their mechanisms of protection. Other recent research has extended microbial-host interaction studies to human samples, including mucosal biopsies and resected tissues from normal, Crohn’s disease and ulcerative colitis patients and to humanized mice. His lifelong contributions to better understand microbial influences in intestinal inflammation and protection have been recognized by the Basic Science Achievement Award from the American Gastroenterological Association and the Career Achievement Award from the Crohn’s and Colitis Foundation. He received a B.S. in Pre-Medicine from Washington-Lee University and a M.D. from Baylor College of Medicine. Fellowship training in Gastroenterology at University of North Carolina (UNC) at Chapel Hill, did his post-doctoral training in host-microbial interactions at UNC-Chapel Hill and advanced research training at the NIH.

Adam S. Cheifetz, M.D., is the Director of the Center for Inflammatory Bowel Disease (IBD) and Medical Director of Infusion Services at Beth Israel Deaconess Medical Center and Professor of Medicine at Harvard Medical School. He is also Director of the Harvard Medical School Gastroenterology Clerkship Elective and Assistant Director of the Advanced Fellowship in IBD at Beth Israel Deaconess Medical Center. Dr. Cheifetz specializes in the treatment of Crohn’s disease, ulcerative colitis, and other inflammatory bowel diseases. In addition to his clinical work, he is involved in multiple IBD research projects and has published over 200 articles and chapters on the subject. Dr. Cheifetz has also published extensively on his current research focus of optimizing biologic utilization through the proactive use of drug concentrations and antibodies. He is a fellow of the American Gastroenterological Association and American College of Gastroenterology. Dr. Cheifetz graduated magna cum laude from Brown University before earning his M.D. from Cornell University Medical College. He completed his internship and residency in Internal Medicine at Yale-New Haven Hospital and his fellowship in Gastroenterology at Yale University before serving as the Present-Levinson Fellow in IBD at the Mount Sinai Medical Center.