Clinical Trials Support Office (CTSO)
Anna Lok, M.D. is the Alice Lohrman Andrews Research Professor in Hepatology in the Department of Internal Medicine and the Assistant Dean for Clinical Research. Dr. Lok is responsible for leading and implementing the processes of Fast Forward Clinical Trials across the entire UMHS. She provides the overall leadership, management, and oversight of the network of Clinical Trials Support Units and key aspects of the supporting central administrative structure. Dr. Lok completed her medical school and internal medicine residency training at the University of Hong Kong and hepatology fellowship training at the Royal Free Hospital in London. She joined the University of Michigan in 1995 as Professor of Internal Medicine and Director of Clinical Hepatology. She was Associate Chair for Clinical Research in the Department of Internal Medicine between 2008 and March 2016 when she assumed her current position as Assistant Dean. Dr. Lok’s research focuses on viral hepatitis: epidemiology, natural history and treatment. Her research is funded by the NIH, PCORI and industry. She has led many multi-center clinical studies and is currently chair of the NIDDK funded Hepatitis B Research Network steering committee. She has published more than 400 papers and received numerous awards including the 2011 American Association for the Study of Liver Diseases Distinguished Service Award, the 2015 American Liver Foundation Distinguished Scientific Achievement Award, and the 2016 American Gastroenterological Association William Beaumont Prize in Gastroenterology.
After completing her MS at the University of Rochester in Rochester, N. Y. Cyndi began her career with the University of Michigan in 1982. She has held positions in the School of Nursing, Ambulatory Nursing Administration, and as an Advanced Practice Nurse with the Pediatric Bone Marrow Transplant team. She has spent the last 16 years in clinical research administration with MICHR and most recently with the Medical School Office of Research Clinical Trial Transformation as the Director of Clinical Trial Operations . In addition she has also worked with the Senior Associate Dean for Research in the School of Dentistry as an administrative consultant for their Clinical Research Program. As the business and administrative lead for the research mission, Ms. Bower is responsible for the infrastructure, implementation, and operational and fiscal management of the CTSUs. She assists with devising and deploying the associated strategic research initiatives; managing projects; and advising on policy, procedural, and operational issues for the transformation enterprise. She has directed her own research in the areas of participant experience in research and the variables affecting retention, satisfaction and regret. She has published on a business model using mobile research support teams to enhance investigators being able to include vulnerable populations in research. Ms. Bower is an active member of committees at both the local and national level, and preceptor for the IOE students from the College of Engineering.
Mollie has provided project management expertise in various fields, centered around the themes of innovation and cutting-edge research. Prior to joining the clinical trials enterprise, she worked at the Vanderbilt Institute for Clinical & Translational Research, coordinating the eMERGE Network & the PCORI Mid-South CDRN. Previously, she served as an assistant to the MacArthur Foundation Research Network on Law & Neuroscience and as an analyst at a major economic consulting firm. Mollie received a B.A. from Lawrence University (English & History) and a M.A. from University of Wisconsin Milwaukee (History - gender, 18th century pirateology).
Jennifer provides administrative support to the operations team, CTSU Administrators, and assists in the daily operations of the Clinical Trials Support Office. Jennifer started at the University of Michigan in 1997 and has over 18 years executive-level support experience working for the University, Medical School and Healthcare System. Prior to UM, Jennifer spent eight years as an executive assistant for The Mt. Sinai Medical Center/Healthcare System in Cleveland, Ohio. Jennifer holds a Bachelor of Science degree from Western Michigan University.
Acute Critical Care, Surgery, & Transplant
William Barsan is Professor and former Chair of the Department of Emergency Medicine at the University of Michigan Medical School. Dr. Barsan came to the University of Michigan in 1992, as the Section Chief for Emergency Medicine within the Department of Surgery. He led the development of an Emergency Medicine Residency at the University of Michigan and spear-headed the creation of the Department of Emergency Medicine within the medical school in 1999. His academic focus is translational research in stroke and neurological emergencies. Since 2006, he has been the principal investigator of the Clinical Coordinating Center for the Neurological Emergencies Treatment Trials Network (NETT), a large cooperative award from the NIH that conducts clinical trials in neurological emergencies. Dr. Barsan has also been instrumental in promoting the use of adaptive clinical trial designs in confirmatory phase clinical trials and evaluating the advantages and barriers to adaptive design strategies. Dr. Barsan is recipient of numerous awards and has served as president for several academic organizations, including the Society for Academic Emergency Medicine, the American Board of Emergency Medicine and the Association for Academic Chairs of Emergency Medicine. He was elected to membership in the National Academy of Sciences Institute of Medicine in 2003.
Dr. Robert C. Hyzy is a Professor of Medicine, Division of Pulmonary and Critical Care, at the University of Michigan in Ann Arbor. Dr. Hyzy is a graduate of Kenyon College and received his medical degree from New York University School of Medicine in New York City. Dr. Hyzy completed his residency in Internal Medicine and fellowship in Pulmonary and Critical Care Medicine at the University of Michigan. He is Director of the Critical Care Medicine Unit at the University of Michigan Hospital and Co-Chair of the University of Michigan Hospital Critical Care Committee. Dr. Hyzy’s research interests are in the area of critical care medicine, including ARDS, ventilator associated pneumonia, and quality improvement. He was the principal investigator of an NIH funded trial examining the efficacy of GM-CSF in patients with Acute Lung Injury (NCT00201409). He was the site PI for the GRAIL (NCT01335932) and MIND-USA (NCT01211522) trials Presently, he is the site Project Director and Co-Principal Investigator of the NIH Prevention and treatment of acute lung injury (PETAL) network (NCT02509078). Dr. Hyzy has been active in the Michigan Health and Hospital Association Keystone ICU project since its inception in 2003 and presently serves on the Steering Committee of the Keystone ICU Project. He is a Chair of the American College of Chest Physicians Critical Care Network, the Society of Critical Care Medicine Guidelines Management Committee and the American Thoracic Society Quality Improvement and Implementation Committee. Dr. Hyzy has spoken nationally and internationally on several topics related to Critical Care Medicine. He has published multiple articles and chapters in medical journals and textbooks and has been a reviewer for the Annals of Internal Medicine, American Journal of Respiratory and Critical Care Medicine, Chest and Critical Care Medicine.
Dr. John Magee is a Professor of Surgery and Chief of the Section of Transplantation Surgery. Dr. Magee received his undergraduate degree from the University of Pennsylvania and his medical degree from Jefferson Medical College. He completed his General Surgery residency at the University of Michigan in 1996. During his residency, Dr. Magee spent three years as a research fellow in the Department of Surgery at Duke University Medical Center. He also completed the Post-Doctoral Research Training Program at the University of Michigan. Following general surgery training, he completed a two year multi-organ transplant surgery fellowship at the University of Michigan. He joined the faculty in 1998.
Dr. Magee's clinical interests include the care of adults and children requiring kidney, pancreas and liver transplantation, as well as management of immunosuppressive therapy and its complications. Dr Magee is the director of the adult and pediatric kidney transplant program, as well as director of the pediatric liver transplant program.
Dr. Magee's clinical research interests include the treatment of patients with acute liver failure, kidney and liver transplantation in children, and general issues related to solid organ transplantation. He directs several clinical research studies related to immunosuppressive therapy in adult and pediatric transplant recipients. His basic science research interests include the study of endothelial cell biology in inflammation, gene therapy in transplantation, and xenotransplantation. Current research activities are centered on the biology of the immunologically high risk transplant recipient.
Dr. Magee has an active interest in education, both at the medical student and resident level and serves as one of the Assistant Directors of Surgical Education. He leads a weekly seminar series for third year medical students during their Surgery clerkship, and runs the weekly General Surgery Resident journal club. He also serves as co-director of the Surgery ethics seminar series as well as Transplant Grand Rounds.
Dr. Park is a Professor of Surgery in the Division of Acute Care Surgery and Co-Director of the Surgical Intensive Care Unit at the University of Michigan Hospitals. Dr. Park earned her B.S. from the Pennsylvania State University and her medical degree from Jefferson Medical College. She completed her general surgery residency and a vascular research fellowship at the Thomas Jefferson University Hospital. She previously served as Director of the University Surgical Service and Associate Director of the Division of Trauma and Surgical Critical Care Surgery at Thomas Jefferson University. In 2007, Dr. Park joined the faculty at the University of Michigan. Dr. Park has served as a Principal Investigator or Co-Investigator on a number of translational research studies in General, Critical Care and Trauma Surgery, including participation as a member of the Steering Committee of the first NIH/ NHLBI ARDSNetwork. She is a member of several professional societies and is a Fellow of the American College of Surgeons and the American College of Critical Care Medicine. She is board-certified in General Surgery and Surgical Critical Care.
Dr. Scott’s research involvement has focused on clinical trial work in: 1) hyper-acute, thrombolytic, based stroke treatment strategies, 2) efforts to extend stroke treatment via neuronal protection mechanisms (both pharmacologic and hypothermic), 3) the development of mechanical-based clot removal and lysis in stroke, 4) methods to enhance treatment for subarachnoid hemorrhage care via hypothermia, 5) primary stroke prevention via enhanced identification of atrial fibrillation, 6) development of population and systems-based approaches to acute stroke care and research, particularly focusing on community delivery of acute stroke care (second-stage knowledge translation). Dr. Scott leads Michigan StrokeNet, the Regional Coordinating Center for the national NINDS StrokeNet network. This network was established in 2013 to speed the development and conduct of clinical trials in the areas of 1) stroke treatment, 2) stroke prevention, and 3) rehabilitation.
Prior to joining the U-M Clinical Trials team, Barbara served as Director of Clinical Trials Research for Oakwood Healthcare from 2013 to 2016 where she was instrumental in implementing a high-risk lung cancer screening program. She also served as Director of Clinical Trials and Research Compliance at the University of Tennessee from 2004 to 2013 where she coordinated all oncology activities for 13 counties in East Tennessee for the Tennessee Cancer Coalition. Barbara has many years of experience directing clinical trials, co-authoring articles, leading initiatives and delivering research education in the community. She received her Bachelor’s degree in Biological Sciences from the University of Michigan.
Tina Chen, CCRC, is the Clinical Research Project Manager for the Acute, Critical Care, Surgery & Transplant Clinical Trials Support Unit. She is a certified clinical research professional with more than 5 years of experience in the field of medical research and translational clinical studies encompassing multiple therapeutic areas. Tina began her career in academia medical center with the University of Michigan’s Institute of Gerontology in 2010, supporting the CMS Physician Group Practice Demonstration Project with a goal to demonstrate that improving medical care in a proactive and coordinated manner also reduces costs. Since then she has held different positions as a clinical research coordinator, clinical research auditor, and regulatory compliance officer at various institutions including the University of Houston, University of Texas MDAnderson Cancer Center, Baylor College of Medicine Center of Cell and Gene Therapy, and the Texas Children’s Cancer and Hematology Center. She received her Bachelor’s degree in Psychology from the University of Michigan and Master’s degree in Social Service Administration from the University of Chicago.
Jim has been with the University of Michigan for more than 16 years. He received his B.B.A in Management and Finance from The University of Michigan – Dearborn and joined the Financial Operations Payroll office in 2000. As a Pay Analyst Senior he provided payroll and finance support to all departments across campus. In 2010 he joined the Department of Surgery as a Contract & Grant Specialist, providing post award support for clinical trials as well as basic science projects. His past experience has prepared him for his Finance Lead role with the Acute, Critical Care, Surgery & Transplant CTSU where he provides pre and post award support.
Sinan Hanna is a clinical subjects coordinator for Acute, Critical Care, Surgery and Transplant Clinical Trials Support Unit. In 2001 Sinan earned his M.B.Ch.B degree from University of Baghdad, School of Medicine. He practiced medicine as a physician in Baghdad Hospital City and worked with the Italian Red Cross before settling in the United States in 2006. In July 2016, Sinan joined our team as Clinical Coordinator Researcher. He holds an extensive clinical background and is a certified ECFMG (Educational Commission For Foreign Medical Graduate) in the United States.
Dr. Mody is a Professor of Pediatrics in the Division of Pediatric Hematology/Oncology. He joined the Division of Pediatric Hematology/Oncology following completion of his fellowship training in pediatric hematology/oncology at the University of Michigan. He subsequently completed his Masters in Science (MS) in clinical trials design and biostatistics at the school of public health at the University of Michigan. Before coming to Michigan, Dr. Mody completed a pediatric residency and chief residency at the State University of New York, in New York City. Dr. Mody’s primary research interest includes use of precision oncology approach for designing innovative clinical trials for refractory childhood cancers. Dr. Mody is leading a clinical trial investigating the role of next generation sequencing (NGS) in precision oncology for developing novel biomarkers and therapeutic targets against refractory childhood cancers. This effort is being carried out in collaboration with the laboratory of Dr. Arul Chinnaiyan in the Michigan Center of Translational Pathology (MCTP). Dr. Mody’s other research interest includes development of early phase clinical trials against refractory childhood cancers. He is the Principal Investigator of international Phase-II, randomized trial of Chimeric 14.18 or Temsirolimus in combination with Irinotecan/ Temozolomide through Children’s Oncology Group (COG). He is a member of the High Risk Neurobalstoma Committee of COG, institutional performance review committee for COG Phase-I consortium and is the Principle Investigator of the Children's Oncology Group, Phase-I, Phase II-III Consortium studies at C.S. Mott Children's Hospital.
Dr. Moler is Professor of Pediatrics and Communicable Diseases in the Division of Pediatric Critical Care Medicine. He received his MD degree from the University of Michigan Medical School and completed his residency in Pediatrics and fellowship training in Pediatric Critical Care also at the University of Michigan. Upon completing his fellowship training, he remained on faculty at the University of Michigan. Dr. Moler completed a M.S. degree in Clinical Research Design and Statistical Analysis from the University of Michigan School of Public Health. His research interests focus on multicenter clinical research studies related to the field of pediatric emergency and critical care medicine. Areas of current and past expertise include cardiac arrest, therapeutic hypothermia, severe cardiac and respiratory failure requiring rescue therapies, inhaled and intravenous beta 2 agonists, asthma, bronchiolitis and severity of illness outcome modeling. He has been a member of two federally funded pediatric clinical research networks: Pediatric Emergency Care Applied Research Network (PECARN) and Collaborative Pediatric Critical Care Research Network (CPCCRN). Dr. Moler’s current research support is with NHLBI, where he is the lead PI of two multicenter clinical trials (THAPCA) being conducted at 46 sites in the US, Canada and UK. The THAPCA trials are investigating the efficacy of therapeutic hypothermia after pediatric cardiac arrest in the in-hospital (NCT00880087) and out-of-hospital (NCT00878644) settings. He has recent HRSA and NICHD funding and is also a co-investigator on a NHLBI study that is investigating the pharmacokinetics of morphine and midazolam following pediatric cardiac arrest and therapeutic hypothermia.