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TDN Consulting Group

The Therapeutics Development Network (TDN) Consulting Group includes physician investigators and scientists from the CF Therapeutics Development Centers and TDN National Resource Centers, as well as TDN Coordinating Center (TDNCC) faculty and staff.

Through the TDN’s Consulting Services Program, these individuals — many of them international leaders in the field — are available to collaborate with sponsors and investigators on CF clinical research development and planning.

TDN - Frank Accurso, M.D.
Frank Accurso, M.D.
CF Biomarkers, Airway Inflammation, Clinical Trial Design

Dr. Accurso is a Professor of Pediatrics at the University of Colorado Denver and the CF Center Director at Children’s Hospital Colorado. His research interests are in early diagnosis of CF through newborn screening and biomarkers of disease in CF.

He holds grants from the NIH and the CF Foundation to explore outcome measures in CF. Dr. Accurso directs the TDN Center for Biochemical Markers and the TDN Center of Sweat Analysis and also has consulted for more than two dozen companies interested in CF.

TDN - Moira Aitken, M.D.
Moira Aitken, M.D.
CF Outcome Measures, Clinical Trial Design

Dr. Aitken is a Professor in the Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Washington School of Medicine.

She has been with the TDN since its inception in 1998. Her research has focused on understanding the mechanisms of airway inflammation and infection in CF, development of new outcome measurements in CF and CF clinical trial design.

TDN - Gail Anderson, Ph.D.
Gail Anderson, Ph.D.
Pharmacokinetics and Drug Metabolism

Dr. Anderson is a Professor in the School of Pharmacy at the University of Washington in Seattle. She obtained her Ph.D. in Pharmacokinetics from the University of Washington in 1987.

She is an author on more than 100 publications in pharmacokinetics and drug metabolism and has more than 25 years of research experience, including clinical and in vitro drug interaction studies with antimicrobial agents.

TDN - Alan Brody, M.D.
Alan Brody, M.D.
Imaging, Clinical Trial Design

Dr. Brody is a Professor of Radiology and Pediatrics at the University of Cincinnati College of Medicine, Chief of Thoracic Imaging at Cincinnati Children’s Hospital and Medical Center and Co-Director of the TDN Center for Diagnostic Imaging.

His research focuses on improving our understanding of CF and other diffuse lung disease in children. Dr. Brody has authored multiple manuscripts on the use of computed tomography of the lungs in patients with CF and has led the imaging arm of several trials using computed tomography as an endpoint for CF lung disease.

TDN - Jane L. Burns, M.D.
Jane L. Burns, M.D.
Microbiology

Dr. Burns is a Professor of Pediatrics in the Division of Infectious Diseases at the University of Washington and Clinical Director for Infectious Diseases at Seattle Children’s Hospital.

For the past decade she has directed the TDN Core Laboratory for CF Microbiology, which performs centralized quantitative microbiology for CF studies. Her research interests for the past 20 years have been CF microbiology and antimicrobial resistance.

TDN - John P. Clancy, M.D.
John P. Clancy, M.D.
CF Biomarkers, CFTR Functional Assays, Clinical Trial Design

Dr. Clancy is a Professor in the University of Cincinnati Department of Pediatrics and the Director and Tom Boat Endowed Chair, CF Translational Research for Cincinnati Children’s Hospital Medical Center.

His research is focused on defining mechanisms to maximize the function of CFTR mutations, coupled with biomarker development for therapeutic trials. Dr. Clancy also investigates protease dysregulation in acute and chronic neutrophilic lung diseases, including CF. His research has generated more than 100 manuscripts, chapters, education monographs and abstract publications in high-impact journals.

TDN - Stephanie Davis, M.D.
Stephanie Davis, M.D.
Pulmonary Function Testing in Infants and Young Children, Clinical Trial Design

Dr. Davis is Director of the Section of Pediatric Pulmonology and Allergy at Riley Children’s Hospital (Indiana University) and Director of the TDN Center for Pediatric Lung Function.

She served as Co-Chair of the American Thoracic Society/European Respiratory Society Working Group that standardized guidelines for infant and preschool lung function testing, and has served as PI or Co-PI on several CFFT-sponsored multicenter studies.

TDN - Scott Donaldson, M.D.
Scott Donaldson, M.D.
Ion Transport, Mucociliary Clearance, Clinical Trial Design

Dr. Donaldson is an Associate Professor of Medicine in the Pulmonary and Critical Care Division at the University of North Carolina at Chapel Hill, where he serves as Co-Director of the Therapeutics Development Center and Associate Director of the Adult CF Center.

Dr. Donaldson also is the chair of the TDN Translational Advisory Group. His research has focused on the study of abnormal ion transport and mucociliary clearance in CF and the development of therapies that address these issues. Over the last 15 years he has led a large number of both investigator-initiated and industry-sponsored studies.

TDN - Ronald L. Gibson, M.D., Ph.D.
Ronald L. Gibson, M.D., Ph.D.
Airway Infection, Clinical Trial Design

Dr. Gibson is a Professor of Pediatrics at the University of Washington School of Medicine. At Seattle Children’s Hospital, he is an attending physician and serves as Director of the CF Care Center, Co-Director of the CF Therapeutics Development Center and Director of the Pediatric Pulmonary Fellowship program.

His primary research focus is on early events in the pathogenesis of lung disease in CF, including the risk factors for and the treatment of Pseudomonas aeruginosa airway infections in young children with CF. Dr. Gibson has been a lead or co-investigator for several Phase 1 to Phase 3 clinical trials involving novel antimicrobial agents, anti-inflammatory compounds and modulators of ion transport.

TDN - Chris Goss, M.D., M.Sc.
Chris Goss, M.D., M.Sc.
Pulmonary Function Testing, Patient-Related Outcome Measures, Clinical Trial Design

Dr. Goss is a Professor in the Division of Pulmonary and Critical Care Medicine, Department of Medicine, University of Washington School of Medicine. He received his M.Sc. in Epidemiology from the University of Washington in 2000.

He has been with the TDNCC since 2000, where he serves as Co-Director and manages the medical monitoring program for both industry and non-industry studies. His research focuses on the development of patient-reported outcome measures for use in CF clinical trials.

TDN - Nicole Mayer Hamblett, Ph.D.
Nicole Mayer Hamblett, Ph.D.
Biostatistics, CF Outcome Measures

Dr. Hamblett is an Associate Professor in the Department of Pediatrics at the University of Washington School of Medicine, Director of the Seattle Children’s Center for Biomedical Statistics and Co-Director of the TDNCC.

As a biostatistician, her research interests include the design and analysis of clinical trials with emphasis in the pediatric and orphan disease setting. She is involved in the development of new clinical outcome measures for CF and, in particular, the validation of biomarkers to enable early evaluation of new therapies.

TDN - Sonya Heltshe, Ph.D.
Sonya Heltshe, Ph.D.
Biostatistics, CF Outcome Measures

Dr. Heltshe is a Research Assistant Professor in Pediatrics at the University of Washington and a Senior Biostatistician at the TDNCC. Her research interests include statistical methods in the design and analysis of clinical trials, and bias estimation for screening and diagnostic tools.

She is involved in epidemiologic studies to assess utility of nutritional, inflammatory, microbiologic and metabolic outcome measures in CF. Dr. Heltshe was at the University of Colorado and the NIH prior to joining the TDNCC and has contributed to CF research for more than 10 years.

TDN - James Heubi, M.D.
James Heubi, M.D.
Gastrointestinal Disorders, Clinical Trial Design

Dr. Heubi is Associate Dean for Clinical and Translational Research and Associate Chair of Pediatrics for Clinical Investigation at the University of Cincinnati College of Medicine.

His medical practice focuses on the treatment of childhood disorders related to the GI and hepatobiliary tract and nutrition. Dr. Heubi’s research interests include cholestatic liver disease in childhood, inborn errors of bile acid metabolism, bone disease in gastrointestinal and hepatobiliary disorders, fat absorption and cholesterol absorption and metabolism. He also has been actively involved in direction and coordination of regulatory programs related to human subject research.

TDN - Susan Jacob, Pharm.D.
Susan Jacob, Pharm.D.
Investigational Drug Systems

Dr. Jacob is the Manager of the Investigational Drug Service at Seattle Children’s Hospital and is on the clinical faculty at University of Washington School of Pharmacy.

She has collaborated with the TDN since 2006, consulting on protocol design and providing expertise in areas such as drug distribution, identifying and developing placebos, developing and implementing blinding systems and packaging and labeling study drugs for multicenter clinical trials. Dr. Jacob also serves on the Seattle Children’s Institutional Review Board and Scientific Advisory Committee.

TDN - Denny Liggitt, D.V.M., Ph.D.
Denny Liggitt, D.V.M., Ph.D.
Preclinical Animal Toxicology and Model Development

Dr. Liggitt is a Professor and Chairman of the Department of Comparative Medicine at the University of Washington School of Medicine. He is a board-certified veterinary pathologist (ACVP) with extensive experience in animal model development and characterization and in the preclinical development process.

He previously served as Associate Director of Pharmacology and Head of the Pathology Unit at Genentech, Inc., where he established the preclinical pathology group and served as the principal pathologist. Since his return to academia, he has consulted with a variety of biotechnology companies in regard to preclinical model development and drug safety.

TDN - Bonnie Ramsey, M.D.
Bonnie Ramsey, M.D.
Outcome Measures, Clinical Trial Design

Dr. Ramsey, TDNCC Executive Director, has been involved in CF research for more than 20 years and is internationally recognized as a leading clinical investigator in CF. She was the principal investigator for the Phase 3 trials of two groundbreaking CF therapies, tobramycin inhalation solution and ivacaftor.

Dr. Ramsey launched the TDN in conjunction with the CF Foundation in 1998 and has successfully overseen the network’s rapid growth and development. She is a Professor and Vice Chair for Research in the Department of Pediatrics, University of Washington School of Medicine, and the Director of the Center for Clinical and Translational Research at Seattle Children’s Research Institute.

TDN - George Retsch-Bogart, M.D.
George Retsch-Bogart, M.D.
Clinical Trial Design, Outcome Measures

Dr. Retsch-Bogart is the Division Chief of Pulmonology in the Department of Pediatrics at the University of North Carolina at Chapel Hill. A Professor of Pediatrics, he also has leadership roles in the Child Health Core and the Clinical and Translational Research Center.

As Co-Director of the CF Therapeutics Development Center at UNC since 1998, he has extensive experience in the conduct of clinical trials. He also chaired the TDN Steering Committee from 2006-2010 during a period of substantial network expansion. He has served as lead PI on several national and international clinical trials and has regularly consulted on issues of study design and drug development. 

TDN - Margaret Rosenfeld, M.D., M.P.H.
Margaret Rosenfeld, M.D., M.P.H.
Outcome Measures in Infants and Toddlers, Patient-Reported Outcomes, Clinical Trial Design

Dr. Rosenfeld is a Professor in the Pediatric Pulmonary and Sleep Division at the University of Washington School of Medicine and Co-Chair of the ATS/ERS Working Group on Infant and Preschool Lung Function Testing.

Her research program focuses on the assessment and treatment of CF lung disease in young children, including the development of appropriate outcome measures such as infant and preschool lung function tests, definition of pulmonary exacerbation and patient-reported outcomes. She is the PI of the EPIC Observational Study (a large-scale investigation of risk factors for early acquisition of Pseudomonas aeruginosa) as well as a series of clinical trials of hypertonic saline in infants.

TDN - Steven Rowe, M.D., M.S.P.H.
Steven Rowe, M.D., M.S.P.H.
CFTR Functional Assays, Clinical Trial Design

Dr. Rowe is an Associate Professor of Pulmonary, Allergy, and Critical Care Medicine; Pediatric Pulmonology; and Physiology and Biophysics at the University of Alabama at Birmingham (UAB), where he co-directs the Therapeutics Development Center and directs the TDN Center for CFTR Detection.

He has over 10 years experience in the design and conduct of clinical trials testing new therapeutic agents to correct the ion transport defect in CF, including the use of electrophysiologic and other outcome measures to estimate CFTR activity.

TDN - Arnold Smith, M.D.
Arnold Smith, M.D.
Microbiology, Drug Development

Dr. Smith is a Professor of Pediatrics and Microbiology at the University of Washington School of Medicine. He has been involved in antibiotic research for over 30 years, conducting clinical efficacy trials and defining pharmacokinetics in children and adults.

Dr. Smith has conducted studies examining the oral, intravenous and aerosol routes of administration and has over 60 peer-reviewed manuscripts published in these areas. He has experience in contemporary molecular biology, clinical trial design and drug development. He has served on FDA and NIH review panels.

TDN - Jill Van Dalfsen, B.S., M.T.
Jill Van Dalfsen, B.S., M.T.
Microbiology, Clinical Trial Design

Ms. Van Dalfsen is the Director of Network and Clinical Trial Operations at the TDNCC. Her background includes 10 years as a clinical microbiology medical technologist and two years of teaching medical laboratory science before moving to the pharmaceutical industry.

She worked in pharmaceutical lead discovery, clinical development and global medical affairs for PathoGenesis and Chiron for more than 14 years before joining the TDNCC and has consulted on clinical trial design for multiple companies.

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Updated: 5/5/14

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