CF Research Translation Center and Research Development Program

Seattle Children’s Hospital and Research Institute
4800 Sandpoint Way NE
Seattle, WA 98105

2001 8th Ave
Seattle, WA 98121

University of Washington
BB1241 Health Sciences Building
Pulmonary and Critical Care, Box 356522
Seattle, WA 98195

Clinical Core People

Bonnie Ramsey, MD

Bonnie Ramsey, MD

Program Director and Director, Clinical Core

Dr. Ramsey has been a clinical investigator in the field of cystic fibrosis (CF) for over 30 years. She is the Co-PI of the Clinical Translational Science Award at the University of Washington, and Vice Chair for Research of the Department of Pediatrics. She is a Professor of Pediatrics holding an Endowed Chair in Cystic Fibrosis Research. She is an elected Fellow of the American Pediatric Society and the American Association of Physicians. Dr. Ramsey along with Dr. E. Peter Greenberg will oversee all administrative and scientific aspects of the center. In addition, Dr. Ramsey is the Director for the Clinical Core of the Seattle CFRTC. She is an internationally recognized leader in clinical research in cystic fibrosis. Her early research was instrumental in moving inhaled tobramycin solution from early translational studies to eventual FDA approval in the United States. She also launched the CFF TDN in conjunction with the CF Foundation in 1998 and has successfully overseen the network’s rapid growth and development.

Christopher H. Goss, MD MSc

Christopher H. Goss, MD MSc

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.

Ronald L. Gibson, MD PhD

Ronald L. Gibson, MD PhD

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.

Moira Aitken, MD, FRCP

Moira Aitken, MD, FRCP

Dr. Aitken is the Associate Director, RDP Clinical Core and Director of the Clinical Connections Program. She is the University of Washington Adult CF Program Director and the Co-investigator of the UW Translational Development Center. She was presented with the Professional of the Year Award from the Cystic Fibrosis Research Institute in 2012 and has mentored six physicians whose careers continue in the CF community, five in the academic setting and one with industry. She is currently mentoring two other physicians/physician scientists who plan to pursue activities in CF translational research. Dr. Aitken will be responsible for developing and implementing the Clinical Connections Program. This program will expose basic science research fellows to expert CF clinicians, clinical scientists, and patients with CF and aims to enhance their understanding of the underlying pathology and clinical manifestations of the disease, to build relationships with CF clinicians and clinical scientists and to develop a better understanding of how their research can improve health and outcomes for people with CF

Sonya Heltshe, PhD

Sonya Heltshe, PhD

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.

KesslerLarry Kessler, PhD

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.