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Dr. Bernard is an international expert in ARDS and critical care clinical trials. He will serve as an advisor at the Coordinating Center at Vanderbilt, providing insight on the design and execution of the Phase 2 trials. During his 35-year career in academic medicine, he has conducted NIH-sponsored basic, translational and clinical research, most recently leading large international clinical trials in critical illness, especially in sepsis and ARDS. He has served in leadership roles on many steering committees and advisory councils: NHLBI ARDS Clinical Trials Network Steering Committee (Chair), The International Sepsis Forum (Chair), The American-European Consensus Conference on ARDS (Co-chair), the NHLBI External Board of Advisors, and Program Director of the NIH CTSA Consortium Coordinating Center. He is currently the Executive Vice President for Research at Vanderbilt, where he oversees the entire portfolio of clinical research.
Dr. Kontos is Professor of Medicine in the Division of Cardiology, Professor of Pharmacology and Cancer Biology, and Director of the Medical Scientist Training Program at Duke University Medical Center. He received his BS and MA degrees in Chemistry from the College of William and Mary and his MD from the Medical College of Virginia (MCV) of Virginia Commonwealth University in 1989. He completed Residency and Chief Residency in Internal Medicine at MCV Hospitals in 1993 followed by a fellowship in Cardiology at Duke University Hospital, where he joined the faculty in 1997 after receiving a K08 award from the NHLBI. His laboratory is focused on understanding the molecular mechanisms regulating vascular growth and remodeling with an emphasis on signaling pathways mediated by endothelial receptor tyrosine kinases, including the TIE and VEGF receptors and their regulation of both vascular and skeletal muscle cell growth and differentiation in limb ischemia.
Dr. Kontos is certified by the American Board of Internal Medicine in Cardiovascular Disease, and he is a Fellow of the American College of Cardiology, a Fellow of the American Heart Association’s Council on Arteriosclerosis, Thrombosis, and Vascular Biology, and a Fellow of the American Association for the Advancement of Science. Dr. Kontos served as a chartered member of the NIH Vascular Cell and Molecular Biology (VCMB) Study Section from 2009-2013 and as a member of the American Heart Association's Mid-Atlantic Affiliate Research Committee from 2010-2014. He has been a principal or co-investigator on grants funded by the NIH, the American Heart Association, and industry. He has served as Director of the Duke Medical Scientist Training Program and principal investigator of that program's NIH training grant since 2009.
Dr. Michael Lotze is Professor of Surgery and Bioengineering, University of Pittsburgh; Vice Chair of Research, Department of Surgery, University of Pittsburgh School of Medicine; and Assistant Vice Chancellor Sponsored Training Grants, University of Pittsburgh Schools of the Health Sciences. Dr. Lotze has worked in the field of immunology and clinical medicine for over 35 years and believes that a fundamental understanding of cancer biology and immunology is essential to making progress in oncology. Dr. Lotze’s career has always been predicated on the bench to bedside to bench paradigm in science, starting at the Surgery Branch of the National Cancer Institute (NCI) [1978-1990]. There, he championed the development of novel therapies for patients with melanoma and kidney cancer and the in vivo application of IL-2, IL-4, and IL-7 as cancer therapies. Dr. Lotze developed adoptive transfer of Natural Killer Cells (NKs)/lymphokine-activated killer cells and tumor-infiltrating lymphocyte therapies and launched gene therapy efforts that continued when he moved to the University of Pittsburgh. Since then, he has developed and overseen four separate successful funded Program Project grants on research topics including cytokine gene therapy, dendritic cell (DC) therapy, the tumor microenvironment, and most recently, integration of NKs and DCs in the treatment of cancer patients. For the last 10 years, Dr. Lotze’s team has led the investigative efforts into so-called Damage Associated Molecular Pattern Molecules (DAMPs) and their receptors, specifically focusing on High Mobility Group Box 1 (HMGB1) and the Receptor for Advanced Glycation Endproducts (RAGE). They pioneered this area, organizing the 3rd International Symposium on DAMPs and Alarmins here in Pittsburgh in 2008 (as well as the 6th in New York in September 2013). Dr. Lotze attended the first two International HMGB1 Workshops in Hamburg and organized the event in Pittsburgh in October 2011 and in Honolulu in February 2013. The group’s efforts demonstrated the critical role of HMGB1 in sustaining autophagy. He organized and developed in Pittsburgh the Translational Research in Mitochondria, Aging, and Disease meeting series in 2011, with annual meetings held since then here or at the University of Pennsylvania with Douglas Wallace and next year at Penn State University with Craig Cameron. With Ben Van Houten and others, we created the Mitochondria, Aging and Metabolism Working Group which has been meeting continuously for the last 4½ years. Dr. Lotze received his MD and BMed Sciences from Northwestern University within the Honors Program in Medical Education. He is the co-inventor of 10 patents in dendritic cell vaccines and antigen discovery and serves as associate editor of the Journal of Immunotherapy. He has over 500 publications in peer reviewed journals and book chapters and has edited several texts including three editions of Current Cancer Therapy [with John Kirkwood], the Surgical Treatment of Advanced Cancer [with Joshua Rubin], and Cellular Immunology and the Immunotherapy of Cancer [with Olivera J. Finn]. He developed and edited the 4th Edition of the Cytokine Handbook , the 1st edition of Measuring Immunity , and both editions of Dendritic Cells [1998, 2002], with Dr. Angus Thomson, as well as Cytokines and Cancer  with Michael Caligiuri. Dr. Lotze is past President of the International Society of Biologic Therapy of Cancer and currently heads up the Federation of Clinical Immunology Societies Centers of Excellence, which is located at 49 sites world-wide.
Dr. John Marshall is a Professor of Surgery at the University of Toronto, and a Trauma Surgeon and Intensivist at St. Michael’s Hospital in Toronto, Canada. His academic interests are sepsis, trauma, and the innate immune response. His laboratory studies the cellular mechanisms that prolong neutrophil survival in critical illness by preventing neutrophil programmed cell death, or apoptosis. Professor Marshall has an active clinical research interest in sepsis and Intensive Care Unit-acquired infection, and in the design of clinical trials and outcome measures. He has published 315 manuscripts, and 80 book chapters, and is the editor of 2 books. He is the founding chair of the International Forum of Acute Care Trialists (InFACT) – a global network of investigator-led critical care clinical research groups, Secretary-General of the World Federation of Societies of Intensive and Critical Care Medicine, and vice-chair of the International Severe Acute Respiratory Infections Consortium. He is past-chair of the International Sepsis Forum, past-President of the Surgical Infection Society, and past-chair of the Canadian Critical Care Trials Group. He has given invited lectures at more than 460 meetings around the world, and is a member of the editorial boards of seven journals.
Samir Parikh is Professor of Medicine at Harvard Medical School and a physician in the Division of Nephrology at Beth Israel Deaconess Medical Center. Dr. Parikh graduated magna cum laude from Harvard with a degree in chemistry and received the Founder’s Medal from Vanderbilt University School of Medicine. He completed post-graduate training at Beth Israel Deaconess Medical Center and Harvard Medical School. Dr. Parikh has served as principal investigator on research grants from the National Institutes of Health, American Society of Nephrology, American Heart Association, and American Diabetes Association. His research is focused on the discovery and translation of molecular mechanisms underlying acute kidney injury and sepsis. Ongoing studies are examining the intersection of metabolic and vascular signaling in the kidney and exploring mechanistic links among aging, acute organ dysfunction, and chronic disease. Dr. Parikh has been inducted into the American Society for Clinical Investigation (ASCI). He has received the NIH/NHLBI’s Outstanding Investigator Award.
Dr. Pritzker is Professor of Medicine, Surgery and Biomedical Innovation, Cardiovascular Division, University of Minnesota. Dr. Pritzker received his MD at the University of Minnesota where completed his medical residency and cardiology fellowship including extended training in cardiovascular pathology, electrophysiology and interventional cardiology. His clincial interests are broad and include general cardiology, pulmonary hypertension, and cardiac transplantation. Dr. Pritzker has had a longstanding interest in the role of endothelial modification in cardio-pulmonary and vascular pathophysiology with application in the areas of acute respiratory distress syndrome, sickle cell anemia (in the laboratories of Drs. Vercellotti and Hebbel), cerebral malaria, pulmonary arterial hypertension, and erectile dysfunction. Dr. Prizker is the founder and attending cardiologist at the Minneapolis Heart Institute, Director of the Pulmonary Circulation Center at the University of Minnesota and Medical Director of Heart Transplantation and Mechanical Circulatory Support at the Minneapolis Heart Institute. He was one of the original investigators in the first trials of the Jarvik Artificial Heart as well as one of the first 10 cardiologist to be a “transplant cardiologist” in 1987. He is credited as one of the earliest clinicians to recognition of role of the endothelial and erectile dysfunction as markers of cardiovascular disease. In addition, Dr. Pitzker provided some of the first off label use data to support the repurposing of sildenafil for pulmonary hypertension. Subsequently, his group was the first to use multi-drug therapy for the treatment of pulmonary hypertension (sildenafil and prostacyclin, bosentan and sildenafil).
Dr. Self is an Associate Professor at Vanderbilt University Medical Center, a practicing emergency physician, and clinical trialist who specializes in critical care clinical trials. He will serve as the lead investigator for the Clinical Coordinating Center for the Phase 2 trials of AKB-9778. He will oversee all aspects of the Phase 2 trials, including protocol development, site selection, enrollment, monitoring, data collection, analysis, and dissemination. He leads a team of investigators and study personnel who have successfully led numerous clinical trials during the past decade and are specially trained and motivated to complete clinical trials in ARDS. His prior experience includes serving as the co-principal investigator of the Vanderbilt Clinical Center in the NHBLI-funded Prevention and Early Treatment of Acute Lung Injury (PETAL) Network, which involves enrolling critically ill patients, including those with ARDS, into multiple interventional trials. Within the PETAL Network, he is a Steering Committee member, chair of the Institutional Support Committee (ISC), which is charged with overseeing patient enrollment procedures for all Network trials, and a scientific leader for multiple trials. As chair of the PETAL ISC, he routinely interacts with investigators and coordinators from around the nation to optimize clinical trial enrollment procedures and improve poorly-enrolling sites. He selected each of the enrolling sites for the AKB-9778 program based on their excellent performance in PETAL ARDS trials. Within PETAL, he also leads the Vanderbilt enrolling site, which has enrolled over 250 patients into PETAL trials in the past 4 years, making it the highest enrolling site among 50 participating sites nationally. He has led multiple high impact trials, including the SALT-ED trial (N Engl J Med 2018), the PREVENT trial (N Engl J Med 2019), and the EPIC study (N Engl J Med 2015).