CLI 8561 Translational Neuroscience
This course will provide students the knowledge, skills and perspectives on pre-clinical and clinical drug/biologics development with an emphasis on interventional clinical trials in Neuroscience. Major topics include understanding basic mechanisms of neurologic diseases, identification of targetable neurologic disorders, generation of informative cell lines and animal models for preclinical testing, pharmacokinetics and pharmacokinetic modeling in the pediatric and adult populations, clinical trial readiness, identification of primary outcomes and endpoints in a rare disease population, clinical trial design, biomarkers, statistical analysis considerations, unique GCP and ethical aspects of drug discovery in neurologic disorders, and regulatory aspects of human subjects research for small molecule and biologic investigational products.