The Clinical Translational Core (CTC) promotes the use of, provides access to, and supports state-of- the art technologies and resources to facilitate translation of research findings into the clinical settings of diagnosis and patient care. Our newly configured Core has expanded to incorporate new technologies and resources in the areas of population health, biomedical research, and biomanufacturing, and serves as a focal point for cost-effective and innovative translational research. The CTC has grown in significant ways to support the increase in interest among our investigators in topics ranging from epidemiology and population health through novel therapeutics and clinical trials. Our collection of registries was dramatically enhanced by the formalized relationship with the Personalized Medicine Research Project (PMRP) of the Marshfield Clinic. We now also provide substantial resources for therapeutics development through Waisman Biomanufacturing, which supports translational investigators by assisting in preparing drug development plans, developing cGMP compliant manufacturing and Quality Control test methods, and providing cGMP manufacturing and testing services for pre-clinical animal studies and early-stage human clinical trials. We propose three specific aims for the next project period.
Aim 1 is to facilitate recruitment of human participants and access to data/specimens for behavioral, biobehavioral, and biomedical research and clinical trials. Registry coordinators, both in Madison and in Marshfield, will facilitate identification and access to unique individuals or populations relevant to studies on IDD. The Madison cohorts include the individuals and families seen in our clinics and the children in our pre-school (one-third of whom have a disability), as well as several distinct registries such as the IDD registry, the fragile X syndrome registry, the infant-toddler registry, and the K-12 registry (the last two especially useful for recruitment of controls). The Marshfield PMRP cohort includes 20,000 people who have consented to share their electronic health records, DNA, and other biosamples for research, and to be re-contacted for future data collections.
Aim 2 is to provide specialized clinical assessments of participants. Core staff will include a clinically certified psychologist and speech-language therapist, who provide standardized psychological and other assessments to supplement the more specialized types of testing needed by the individual projects.
Aim 3 is to provide technologies and consultative services to support development of new behavioral methods and custom applications. The Core provides eye-tracking equipment and behavioral testing suites equipped for remote observation, and the staff have particular expertise in database construction and software development.
Aim 4 is to promote advancement of therapeutics for IDD populations. The Core provides advanced biomanufacturing capability for viruses, plasmids, proteins, and cellular therapeutics, through the Waisman Biomanufacturing facility. Through the interactions with the clinics and access to the registries the Core also fosters participation in several types of therapeutic research.
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