Clinical Research and Regulatory Affairs Service
Kira A. Dies, ScM, CGC, and Stephanie Jo Brewster, MS, CGC, Co-Directors
This service facilitates the mission of the Translational Neuroscience Center, providing coordination among studies, communications, resource development and implementation of new or ongoing pre-clinical and clinical studies. The service is led by experts in protocol development and launching of new studies. The directors are available to guide TNC researchers in designing human studies, including the preparation of Institutional Review Board (IRB) and FDA submissions. Additionally, staff of the Clinical Research and Regulatory Affairs Service will help researchers with recruitment plans, budget development, supervision of study coordinators, study monitoring and audit preparation. A dedicated administrative assistant, Lea Florentino, coordinates TNC meetings and communications. The TNC leaders plan to provide translational neuroscience researchers with dedicated resources for data analysis and biostatistics, as well as additional study coordinators. This service will complement existing efforts in the Boston Children’s Clinical Research Center and Translational Research Program
The Neurophysiology Service aims to become a leader in the facilitation of acquisition and processing of high quality human neurophysiological data reflecting underlying pathophysiology, and of potential use as surrogate biomarker, in neurologic disease and developmental disorders. Through routine and timely delivery of the highest quality neurophysiological data, including EEG data, and strict adherence to ethical research standards, we aim to accelerate translational research and clinical trials and allow for next generation interventions for neurological disorders. The Core provides consultation regarding trial design, rationale for a neurophysiology measure relevant to target disorder or developmental process, assessment of data-acquisition needs including contextual review of the literature and current competitive efforts elsewhere, identification of research collaborators, and recommended software or platform for processing.
Pharmacometrics Research Core and Pharmacology Service
Robin Kleiman, PhD, and Luis Pereira, PhD, Co-Directors
The Pharmacometrics Research Core provides analytical services for assaying drugs/metabolites in biological matrices (e.g. plasma, serum, blood, urine, CSF, saliva, tissues). The Core provides pharmacokinetic and pharmacodynamic analyses for current and future clinical trials and research projects (including contract services). It conducts stability and potency studies for pediatric formulations compounded at BCH as per recent demand from FDA and CMS. Finally, the Core fosters grant applications and research collaborations, both intra and extramural. The TNC can additionally provide investigators with consultation in the identification of resources for pharmacodynamic assay development and contract research organizations able to provide bioanalysis of pre-clinical samples needed to support animal clinical trials.
MRI/Radiology Imaging Core
This core represents a collaboration between the Translational Neuroscience Center and the Department of Radiology at Boston Children’s Hospital. Dr. Warfield is Director of research and Director of the Computational Radiology Laboratory in Radiology. Topics of special interest include brain development and newborn MRI, pediatric epilepsy surgical planning, image-guided therapy and autism.