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 Services
The specific objectives of the Clinical Core are as follows:
Provide preclinical support for novel therapeutics
The specific aims of the preclinical support services are:
- Develop mechanisms for preclinical review and consulting in order to promote the development and/or commercialization of promising translational research programs, and
- Provide detailed assistance with the development of regulatory strategies and submissions to the Food and Drug Administration (FDA) for clinical development.
Collaborate with translational investigators in the development of clinical research plans to evaluate the safety and efficacy (proof of concept) of new therapies (e.g., biologic, drugs) and provide consultation and personnel for implementation of early clinical trials.
The specific aims of the clinical protocol and implementation support services are:
- Provide detailed assistance with the development of the clinical research plans of promising therapeutics for phase 1 and proof of concept phase 2 human clinical trials that would meet all FDA requirements, and
- Provide detailed assistance with the implementation of these research plans and support investigators in moving promising therapeutics into phase 1 and proof of concept phase 2 human clinical trials that would support an FDA approved clinical development plan and eventual approval for patients with cystic fibrosis.
Work with other biomedical cores to enhance and support bacterial and human specimen repositories
The specific aims of the biorepository support services are to:
- Create a biospecimen discovery portal for identification of CF samples (human and bacterial) that are available for research within the Seattle consortium, and
- Create a specimen requisition process that will permit investigators to request specific specimen types from the repository or for prospective acquisition.
Developmental Research and Training
The specific aims of the developmental research and training support services are to:
- Develop novel outcome measures for translational research and efficient biostatistical approaches to inform translational study designs, and
- Develop a robust clinical research training program for CF translational investigators including dissemination of “tool kits” for study development and implementation.
Supported by a grant from the National Institutes of Health (NIDDK P30 DK 89507). Please reference this grant number on all publications resulting from support provided by this Core Center grant.