Michael D. Roth, MD, is a professor of pulmonary & critical care medicine and molecular toxicology at the David Geffen School of Medicine/UCLA and directs a combination of basic and translational research on understanding the lung and immunologic effects associated with marijuana and tobacco use, the development of immunologic therapies for cancer and more. He is also the vice chair for research compliance in the Department of Medicine. Dr. Roth has participated in all three of the Scleroderma Lung Studies and currently acts as the lead principal investigator/sponsor for Scleroderma Lung Study III.
Donald P. Tashkin, MD, is emeritus professor of medicine in the Division of Pulmonary and Critical Care Medicine at the David Geffen School of Medicine/UCLA. He served as director of the Clinical Pulmonary Function Laboratory at the UCLA Medical Center for approximately 30 years and as interim chief of his division. His research interests include the evaluation and treatment of SSc-ILD, as well as the pathophysiology, prevention and treatment of COPD, the pathophysiology and clinical pharmacology of asthma, the pulmonary effects of abuse of smoked substances (including marijuana, crack cocaine and tobacco) and of community air pollution.
Cathie Spino, ScD, is a research professor and director of statistical analysis of biomedical and educational research (SABER) in the Department of Biostatistics. She collaborates with investigators on the design and analysis of multi-center clinical trials and provides infrastructure oversight. She joined the department in September 2007, after spending 10 years in the pharmaceutical industry as a statistician and statistical manager. She began her career in academia as an assistant professor in the Department of Biostatistics at the Harvard School of Public Health.
Dinesh Khanna, MD, MSc, is the Frederick G.L. Huetwell Professor of Medicine and director, University of Michigan Scleroderma Program. Dr Khanna has published over 350 peer-reviewed articles and book chapters. His current research is focused on validating outcome measures, trial design and understanding the mechanism of action(s) of novel targets in the context of scleroderma clinical trials. He led the development of the ACR Combined Response Index in Systemic Sclerosis (ACR CRISS). Dr. Khanna is a recipient of the Henry Kunkel Young Investigator Award from the ACR.
This report describes an investigator-initiated and sponsored clinical trial supported in part by a funding contract from Genentech Inc. to the University of California, Los Angeles. Dr. Volkmann reports receiving consulting fees from Boehringer Ingelheim. Dr. Spino is a statistical consultant for Elcos.
Dr. Khanna is currently funded by the National Institutes of Health with grants from NIAMS and NIAID (as part of Clinical Autoimmunity Center of Excellence). He is the coordinating PI for ongoing and recently completed NIH and industry-funded trials of abatacept, brentuximab, pirfenidone, riociguat, tofacitinib and tocilizumab in scleroderma.