Clinical Core People

Multi-PI/Program Director, Director, Clinical Core

Dr. Goss is a Professor of Medicine in the Division of Pulmonary and Critical Care Medicine and an Adjunct Professor of Pediatrics. He will serve as the Co-Director of the Clinical Translational Core of the P30. He is the Director and Chief Medical Officer of the CFF funded Cystic Fibrosis Therapeutics Development Network, a clinical trials network composed of 77 research sites throughout the US, and has over 15 years of experience in clinical trials in CF. He received his MSc in Epidemiology from the University of Washington in 2000 and is an expert in clinical trial design and clinical trial outcome measures with an emphasis on patient reported outcomes. He has served as Chair of the Cystic Fibrosis Foundation Registry Committee for the last 10 years. He is co-director of the Clinical Research Training Track for the Pulmonary Division at the University of Washington.

Co-Director

Dr. Gibson is a Professor of Pediatrics in the Division of Pulmonary Medicine. Dr. Gibson’s current clinical research focuses on risk factors for and treatment of early Pseudomonas aeruginosa airway infection in CF. He is the co-PI for a large-scale investigation of risk factors for early and chronic infection with Pseudomonas aeruginosa, and a co-investigator on a prior NIH- and current CFF-funded study to evaluate genetic modifiers of early CF lung disease, airway infection, and nutritional outcomes. Dr. Gibson is the Director of the Clinical Core of the UW CF Research Development Program. He is also the co-PI of the CFF TDN Center at the UW, the CF Center Director at Seattle Children’s Hospital (SCH), member of the Steering Committee for the Center for Clinical and Translational Research at SCH and the CFF Translational Advisory Group. He will be the Associate Director of the Pilot & Feasibility program within the institutional P30 award; Dr. Gibson will work with Dr. Singh on recruitment of pilot study applications, review and selection of the pilot studies, and consultation regarding protocol development for the funded clinical and translational projects. He will work closely with the Research Coordinators on IRB submissions and will serve as the proxy PI for IRB applications at SCH for projects in which the PI does not have an appointment at SCH but requires specimens from patients.

Co-Director

Dr. Kapnadak is a cystic fibrosis and transplant pulmonologist at the University of Washington. He has been on faculty at UW since 2014 after having done advanced training in CF and lung transplantation at the University of Pittsburgh Medical Center. My current academic interests center on advanced CF lung disease, including issues pertaining to access to lung transplant, candidacy for transplant, and optimizing care to improve quality of life and other outcomes. Dr. Kapnadak is co-chair and first author of the CF Foundation’s consensus guidelines for the care of individuals with advanced CF lung disease, which provided detailed recommendations on medical management of advanced disease, common psychosocial issues, and preparation for lung transplant. Dr. Kapnadak also collaborated on several other projects related to optimizing care and improving access to transplant in advanced CF.

Consultant

Dr. Ramsey has been a clinical investigator in the field of cystic fibrosis (CF) for over 30 years. Dr. Ramsey has been acknowledged for her contributions to CF including the Paul D’ Sant Agnese Award (1998), the Lifetime Achievement Award (2013) and the Richard C. Talamo Award (2022) from the Cystic Fibrosis Foundation, the Lifetime Achievement Award from the American Thoracic Society (2014), elected to the National Academy of Medicine in 2015, and received the Warren Alpert Foundation Prize (2018). In addition to serving as Multi-PI of the CF Research Translation Center from 2010-2022, Dr. Ramsey was the Co-PI of the Clinical Translational Science Award at the University of Washington, the Vice Chair for Research of the Department of Pediatrics and an Endowed Chair in Cystic Fibrosis Research. In 2023, Dr. Ramsey became an Emeritus Professor of Pediatrics. Dr. Ramsey’s initial focus of research was treatment of P aeruginosa (Pa) infections in Cystic Fibrosis and understanding the natural history of Pa infections in CF. Her work led to the development of inhaled tobramycin (TOBI) as an FDA approved therapy for patients with CF. I then established the CFF Therapeutics Development Network (CF TDN) which I led from 1998- 2015. Through this network Dr. Ramsey was a key leader in the development of multiple CFTR modulators such as ivacaftor.

Biostatistician

Dr. Heltshe received her PhD in biostatistics from the University of Colorado School of Public Health in 2007. She worked as a statistician with Children’s Hospital Colorado Cystic Fibrosis Center from 2002 through 2007 while completing her doctoral work. There, she collaborated on research of CF lung function, microbial diversity, proteomics, and inflammatory markers. Dr. Heltshe received a training fellowship through the National Cancer Institute in 2007 and completed a year long post-doc with the Biometrics Branch of the Division of Cancer Epidemiology and Genetics. In 2009 she came to the CF Foundation’s Therapeutic Development Network (TDN) Coordinating Center in Seattle, WA as a senior biostatistician. She has devoted an extensive effort to CF newborn growth endpoints and standards with a continued commitment to biomarkers and nutritional facets in the CF population. She is currently an Assistant Professor in the Department of Pediatrics at University of Washington and the Director of Statistical Research for the Therapeutic Development Network Coordinating Center at Seattle Children’s Research Institute.

Co-Investigator

Dr. Kessler is Professor and Chair of the Department of Health Services in the School of Public Health. He has over 30 years of experience in health services research. He came to the University of Washington from the U.S. Food and Drug Administration (FDA) where he served as the director of the Office of Science and Engineering Laboratories at the Center for Devices and Radiological Health. His work in cancer surveillance with the Applied Research Branch at NCI substantially changed the way in which cancer surveillance is performed, with the addition of the Cancer supplements to the National Health Interview Survey, the SEER-Medicare data system, and the Breast Cancer Screening Consortium and the Breast Cancer Surveillance Consortium. He has an extensive research record in applied health services research with special work in cancer, in cancer surveillance research, and regulatory knowledge of medical products. His recent research has broadened this into related fields of comparative effectiveness, patient centered and outcomes research. Some of his recent work has been on CER with respect to diagnostics and on use of technologies in back pain. His extensive experience at the FDA along with his recent CER efforts will be of great use to the translational nature of the UW CFRTC P30 projects.