Manal F. Abdelmalek, MD, MPH is Director of Hepatology and institutional lead for investigator-initiated and industry-sponsored multicenter clinical studies at Mayo Clinic, USA. Until recently, she was tenured Professor of Medicine in the Division of Gastroenterology and Hepatology at Duke University and Director of the NAFLD Clinical Research Program at Duke University.

Since first reporting NASH as a case of cryptogenic cirrhosis over 20 years ago, her research area of interest has focused on risk factors for NAFLD acquisition, fibrosis progression, and discovery of new and novel therapeutic interventions. She has expertise in the design and conduct of investigator-initiated, industry sponsored and NIH-funded clinical studies evaluating new therapies and biomarkers for NAFLD. Her expertise includes transitioning new compounds to first-in-man early phase studies and the translation of clinic-to-bench and bench-to-clinic research to define pathogenic mechanisms underlying NAFLD acquisition and progression.

Dr. Barnes is a Board-certified General Surgeon, Surgical Oncologist in Houston, Texas and is affiliated with United Memorial Medical Care-Houston. He received his medical degree from University of Michigan Medical School and has been in practice for more than 20 years.

He is also an attorney licensed in Texas, New Mexico, and Montana. He participates in International medical charity work and is a national and international speaker on health care and health care law.

Cardiologist
University of Mississippi Medical Center, Jackson, MS, USA

Dr. Javed Butler is the Patrick H Lehan Chair of Cardiovascular Research, Chairman of the Department of Medicine, and Professor of Medicine and Physiology at the University of Mississippi. Prior to joining the University of Mississippi, he was Charles A Gargano Professor, Director of the Division of Cardiovascular Medicine, and co-Director of the Stony Brook University Heart Institute, NY, USA. Dr Butler served as Director for Heart Failure Research at Emory University, Atlanta, GA, USA, and prior to this served as the director of the heart and heart-lung transplant programs at Vanderbilt University, Nashville, TN, USA. Dr Butler received his medical degree from Aga Khan University, Karachi, Pakistan, and then completed his residency training at Yale University, New Haven, CT, USA. Dr Butler’s research interests focus on clinical trials in patients with heart failure. He is board-certified in cardiovascular medicine, advanced heart failure, and transplant medicine.

Gastroenterologist, Transplant Hepatologist
Director, MGH Fatty Liver Clinic, MGH Gastrointestinal Unit

Kathleen E Corey, MD, MPH, MMSc is an Assistant Professor of Medicine at Harvard Medical School and Director of the MGH Fatty Liver Clinic in the MGH Gastrointestinal Unit.
Dr. Corey’s clinical interests include all areas of hepatology including non-alcoholic fatty liver disease (NAFLD), viral hepatitis including hepatitis B, C and D infection, autoimmune hepatitis, cholestatic liver disease including primary biliary cirrhosis and primary sclerosing cholangitis. In addition, Dr. Corey treats patients with hereditary forms of liver disease including hemochromatosis and alpha-1-antitrypsin disease.
Dr. Corey’s research focuses on non-alcoholic fatty liver disease and the development of non-invasive biomarkers for the diagnosis and monitoring of NAFLD. Dr. Corey has lectured regionally and nationally on NAFLD.

Professor of Medicine
Florence McAlister Distinguished Professor of Medicine
Member of the Duke Cancer Institute
Affiliate of the Duke Regeneration Center

Dr. Diehl is a leading researcher in the field of nonalcoholic fatty liver disease (NAFLD) with a long standing interest in liver injury and repair. She is currently the Director of the Duke Liver Center and the Florence McAlister Professor of Medicine at the Duke University School of Medicine. Dr. Diehl has conducted seminal research in many areas, including liver regeneration, the role of cytokines in liver disease, and hepatocellular cancer. In addition, she has conducted the definitive work in understanding the important role of Hedgehog signaling proteins in liver pathobiology, from liver regeneration, to hepatic fibrosis, to activation of stellate cells, growth of progenitor cells, and development of cirrhosis. She received her M.D. from Georgetown University, followed by residency and a fellowship in gastroenterology at Johns Hopkins University.

Alternate CHMP member at Medical Products Agency Läkemedelsverket

Kristina Dunder is a doctor specializing in internal medicine and endocrinology. After working in a hospital for 17 years and writing a thesis, she felt it was time to try a different way of practicing medicine. Kristina Dunder started working at the Medical Products Agency in 2005 as a clinical investigator and since then I have been increasingly involved in EU-wide approval procedures. She has been the Swedish delegate to the CHMP since 2012.

Professor, Radiology

The research objective of Richard L. Ehman, M.D., is to expand the range of tissue, organ and system characteristics that can be noninvasively evaluated with MRI techniques. Dr. Ehman is best known for his groundbreaking work in medical imaging, specifically in nuclear magnetic resonance and its use in diagnosing a variety of conditions. He is also credited with developing magnetic resonance elastography, which allows physicians to determine the stiffness of internal organs without invasive procedures. His research program is focused on developing new imaging technologies. Dr. Ehman holds more than 40 patents, and many of these inventions are widely used in medical care. His research has been supported by competitive grants from the National Cancer Institute, National Institute of Biomedical Imaging and Bioengineering, and the National Institute of Aging.

Director, Biomedical Engineering and Imaging Institute
Professor | Diagnostic, Molecular and Interventional Radiology
Professor | Medicine, Cardiology

Dr. Fayad serves as professor of Radiology and Medicine (Cardiology) at the Icahn School of Medicine at Mount Sinai and holds the Lucy G. Moses Professorship in Medical Imaging and Bioengineering. He is the founding Director of the Biomedical Engineering and Imaging Institute; Vice chair for Research, Department of Radiology at the Icahn School of Medicine at Mount Sinai. Dr. Fayad’s interdisciplinary and discipline bridging research – from engineering to biology and from pre-clinical to clinical investigations – has been dedicated to the detection and prevention of cardiovascular disease with many seminal contributions in the field of multimodality biomedical imaging (MR, CT, PET and PET/MR) and nanomedicine. His work has recently expanded in understanding the effect of stress on the immune system and cardiovascular disease.

Gastroenterology Consultants of San Antonio

Dr. Stephen A. Harrison is the Medical Director of Pinnacle Clinical Research. He earned his medical degree from the University Of Mississippi School Of Medicine. He completed his Internal Medicine residency and Gastroenterology fellowship at Brooke Army Medical Center and a 4th-year advanced liver disease fellowship at Saint Louis University. He is board-certified in both Internal Medicine and Gastroenterology. Dr. Harrison served as a Professor of Medicine at the Uniformed Services University of the Health Sciences and is currently a Visiting Professor of Hepatology at the Radcliffe College of Medicine, University of Oxford. He is currently an Associate Editor for Alimentary Pharmacology and Therapeutics. He is a peer-reviewer for over 20 medical journals and internationally known for studies in hepatitis C and non-alcoholic fatty liver disease.

Co-Director, Better Treatments Program

Hiddo J. Lambers Heerspink is a Professor of Clinical Trials and Personalized Medicine and a clinical pharmacologist/trialist at the Department of Clinical Pharmacy and Pharmacology at the University Medical Center Groningen. Professor Lambers Heerspink’s research interests focus on optimizing current treatment strategies and finding new therapeutic approaches to halt the progression of renal and cardiovascular diseases in patients with diabetes. He is active in clinical trials focused on renal and cardiovascular complications of type 2 diabetes. He served as a member of the Work Group that developed the KDIGO 2020 Clinical Practice Guideline for Diabetes Management in Chronic Kidney Diseases. He is an editorial board member of the Clinical Journal of the American Society of Nephrology.

Cardio-Oncology
Cardiology

Dr. William Gregory Hundley is a proud alumnus of VCU School of Medicine and the first director of the Pauley Heart Center. His expertise in preventive heart care and his research in cardio-oncology will build on our strengths in the Pauley Heart Center and VCU Massey Cancer Center. His research focuses on preventive heart care for patients undergoing chemotherapy, which has been found to increase the risk of heart attack and other cardiovascular issues a decade or more after treatment. He was the first in the world to use MRI to visualize and measure blood flow in coronary arteries and the first to demonstrate that MRI stress testing can identify those at risk of heart attack.

Associate Professor, Gastroenterology

Michelle T. Long, MD, MSc is a physician-scientist with an expertise in Nonalcoholic fatty liver disease (NAFLD), and an Associate Professor of Medicine at Boston University. She completed her clinical training at Massachusetts General Hospital and Boston Medical Center. Dr. Long is the Director of the NAFLD Research Center and the Director of Clinical Research for the Section of Gastroenterology and Hepatology. Her clinical and research interests center on the relationship between NAFLD and cardiovascular disease.
Dr. Long is primarily interested in patient-oriented research investigating fibrosis and inflammation in patients with NAFLD and in imaging and risk stratification strategies for hepatic fibrosis.

Department of Endocrinology,
Diabetes and Metabolism

Executive Director Forum for Collaborative Research

Veronica Miller is the Director of the Forum for Collaborative Research (the Forum), a public/private partnership addressing cutting edge science and policy issues through a process of stakeholder engagement and deliberation. Dr. Miller has extensive experience in working with all major global and U.S. organizations and agencies involved in HIV research and policy. She is a leading expert in the process of engaging stakeholders from both sides of the Atlantic to resolve significant health policy and public health issues. Under her leadership the Forum’s deliberative process to advance regulatory science applied successfully to HIV was extended to drug development for hepatitis C infection in 2007, and starting in 2014, to the treatment of liver diseases (NASH and fibrosis), and human cytomegalovirus disease in solid organ and stem cell transplant patients.

Associate Dean for Global Affairs
Professor Medicine, Cardiology
Professor Population Health Science and Policy
Professor Diagnostic, Molecular and Interventional Radiology

Jagat Narula, MD, PhD, MACC is Professor of Medicine and Philip J. and Harriet L. Goodhart Chair in Cardiology, and the Director of Cardiovascular Imaging Program in Mount Sinai’s Zena and Michael A. Wiener Cardiovascular Institute and the Marie-Josée and Henry R. Kravis Center for Cardiovascular Health. He is the Associate Dean for Global Health at the Icahn School of Medicine at Mount Sinai.
In 1989, upon finishing his cardiology fellowship training and PhD (Cardiovascular Immunology) from the All India Institute of Medical Sciences – Delhi, Dr. Narula relocated to Massachusetts General Hospital (MGH) and Harvard Medical School. At MGH, he completed cardiology, heart failure & transplantation, and nuclear cardiology fellowships and then joined the cardiology faculty.

Professor at Sorbonne University and Hospital Pitie Salpetriere

Vlad Ratziu is a Professor of Hepatology at Sorbonne University, and performs his hospital work at the Pitié-Salpêtrière Hospital in Paris, France. Professor Ratziu received his medical training at Paris Descartes University; he then completed a 2-year postdoctoral fellowship at the Liver Center at the University of California, San Francisco, CA, USA, and went on to earn a doctoral degree from Paris Diderot University for his work on the pathophysiology of viral and metabolic liver fibrosis.

Senior Physician, Brigham and Women’s Hospital
Eugene Braunwald Professor of Medicine, Harvard Medical School

Formally trained in cardiovascular medicine and epidemiology, Dr. Paul M Ridker is the Eugene Braunwald Professor of Medicine at the Harvard Medical School and directs the Center for Cardiovascular Disease Prevention, a translational research unit at the Brigham and Women’s Hospital in Boston. Dr. Ridker’s research focuses on the design and conduct of multi-national randomized trials, the development of inflammatory biomarkers for clinical and research use, the molecular and genetic epidemiology of cardiovascular diseases, and on novel strategies for cardiovascular disease detection and prevention. Currently, Dr. Ridker serves as Trial Chairman and Principal Investigator of two multi-national, randomized, placebo-controlled clinical trials designed to address whether reducing inflammation can reduce cardiovascular event rates.

Professor
Department of Internal Medicine
Division of Gastroenterology, Hepatology and Nutrition

Prof. Arun J. Sanyal was recently appointed as Interim-Chair of the Division of Gastroenterology, Hepatology and Nutrition at VCU/VCUHealth. Dr. Sanyal is a Professor of Medicine, Physiology and Molecular Pathology. Dr. Sanyal also serves as Chair of the NIH NASH Clinical Research Network, the NIMBLE consortium and the Liver Forum for NASH and fibrosis. His research interests include all aspects of NAFLD and NASH as well as complications of cirrhosis and end stage liver disease. He was recently ranked in top 0.01% of medical scientists based on their impact on the field (PlosBio 2019).

Director, Institute for Augmented Intelligence in Medicine
– Center for Deep Phenotyping and Precision Therapeutics

Sanjiv J. Shah, MD is the Stone Endowed Professor; Director of Research for the Bluhm Cardiovascular Institute; Director, Center for Deep Phenotyping and Precision Medicine in the Institute for Augmented Intelligence in Medicine; and Director of the Heart Failure with Preserved Ejection Fraction (HFpEF) Program at Northwestern University Feinberg School of Medicine. Dr. Shah’s clinical expertise and research program are focused on HFpEF, which is one of the most prevalent cardiovascular diseases and for which there are few proven treatments

Deputy director of the Division of Diabetes, Lipid Disorders and Obesity in the FDA’s Center for Drug Evaluation and Research

John Michael Sharretts is a health care provider primarily located in Washington, DC, with other offices in Philadelphia, PA and SILVER SPRING, MD. Dr. Sharretts graduated from the Virginia Commonwealth University School of Medicine in 1994. He has 28 years of experience. His specialties include Cardiovascular Disease, Endocrinology, Diabetes & Metabolism and Internal Medicine.

Dr. Shulman is the George R. Cowgill Professor of Medicine and Cellular & Molecular Physiology at Yale. He is also Co-Director of the Yale Diabetes Research Center.

Dr. Shulman has pioneered the use of magnetic resonance spectroscopy combined with mass spectrometry to non-invasively examine intracellular glucose and fat metabolism in humans and transgenic rodent models that have led to several paradigm shifts in our understanding of type 2 diabetes (T2D), including the molecular mechanisms by which ectopic lipid promotes liver and muscle insulin resistance, as well as developing new drugs for the treatment of T2D, nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH).

Radiology
Abdominal Imaging

Dr. Claude B. Sirlin is a radiologist in San Diego, California and is affiliated with multiple hospitals in the area, including UC San Diego Health-La Jolla and Hillcrest Hospitals and VA San Diego Healthcare System. He received his medical degree from University of California (San Francisco) School of Medicine and has been in practice for more than 20 years.

Director Division of Cardiology and Nephrology in FDA’s Center for Drug Evaluation and Research

Norman Stockbridge, MD, PhD received his MD in 1978 and PhD in Physiology in 1981 from Duke University. He received post-doctoral training at Duke and New York Medical College. Dr. Stockbridge was a Staff Fellow at the NIH National Eye Institute. In 1985 he joined the faculty of the Department of Surgery at University of Alberta doing basic cellular electrophysiology research. Dr. Stockbridge joined FDA’s Division of Cardio-Renal Drug Products in 1991, serving a medical officer, medical team leader, and deputy division director, prior to becoming the division director. He is currently the Director of the Division of Cardiovascular and Renal Products within the FDA Center for Drug Evaluation and Research.

Deputy Director of the Division of Cardiology and Nephrology, at the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA)

Aliza Thompson is a Clinical Team Leader in the Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research (CDER), at the U.S. Food and Drug Administration (FDA). Dr. Thompson joined the FDA in 2007; her team focuses on products being developed to treat renal-related indications. Dr. Thompson has served on several CDER biomarker qualification review teams and has been involved in larger efforts to define an evidentiary framework for CDER biomarker qualification. She received her medical degree from Johns Hopkins Medical School 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.

Internist

Dr. Joseph G. Toerner is an internist in Gaithersburg, Maryland. He received his medical degree from Case Western Reserve University School of Medicine and has been in practice for more than 20 years. Dr. Joseph Toerner, MD is a infectious disease specialist in Washington, DC. Dr. Toerner completed a residency at University Hospitals of Cleveland. Dr. Toerner is board certified in Infectious Disease.

Associate Professor, Division of Cardiology, Department of Medicine
Cardiologist, Hamilton Health Sciences

Dr. Van Spall is a full-time cardiologist in the Department of Medicine. Her clinical focus is in Heart Failure, Echocardiography, and Acute Care Cardiology. She is actively involved in the clinical education of medical students, residents, and clinical fellows. Dr. Van Spaal obtained Bachelor of Science and Doctor of Medicine degrees, and completed postgraduate training at the University of Toronto. She then obtained a Master of Public Health degree at the Harvard School of Public Health. She is a fellow of the Royal College of Physicians and Surgeons of Canada, with certification in Internal Medicine, Cardiology, and Level III Echocardiography.

Professor of Medicine
Charles Johnson, Professor of Medicine
Chief of Nephrology
Professor in Population Health Sciences
Member of the Duke Clinical Research Institute

Myles Wolf, MD, MMSc, is the Charles Johnson, MD, Professor of Medicine and Chief of the Division of Nephrology at the Duke University School of Medicine. He received his MD from the State University of New York–Downstate, completed Internal Medicine and Nephrology training at the Massachusetts General Hospital, and obtained a Master of Medical Sciences degree in Clinical and Physiological Investigation from Harvard Medical School. After serving on the Harvard faculty for 6 years, Dr. Wolf moved to the University of Miami Miller School of Medicine, where he eventually served as Chief of the Division of Nephrology and Hypertension, Director of the Clinical Research Center, and Assistant Dean for Translational and Clinical Research.

Dr. Younossi earned his medical degree from the University of Rochester School of Medicine and Dentistry in Rochester, New York (Alpha Omega Alpha, 1989)

Dr. Younossi completed his residency in internal medicine as well as a fellowship in gastroenterology and hepatology at Scripps Clinic and Research Foundation in La Jolla, California. During his residency and fellowship, he earned his master of public health degree from San Diego State University (SDSU) School of Public Health in San Diego, California, being awarded both the Hanlon Award and Outstanding Student Award for SDSU. He then served as the Staff Hepatologist and Senior Researcher at the Cleveland Clinic Foundation, Cleveland, Ohio (1995– 2000).

Professor of Therapeutics-Cardiology at the University of Lorraine. Doctor in Medicine, Doctor in Human Biology (PhD), Clinical Pharmacology (University of Lyon and Oxford).

Prof. Faiez Zannad is a cardiologist and an internationally recognised heart failure (HF) specialist. He is a Eugene Braunwald Scholar and a visiting Professor at Brigham & Women’s hospital, Harvard Medical School. He has pioneered and made significant contributions to research and care in HF. He is the founder of the Global CardioVascular Clinical Trialists (CVCT) Forum and Workshop, the annual international think tank dedicated to the science of clinical trials.