CCSA is pleased to announce that we have been selected by the National Center for Advancing Translational Sciences Division of Preclinical Innovation (NCATS DPI) to perform regulatory support activities for lead gene therapy candidates. We are proud to be supporting the development and implementation of regulatory strategies, creation and submission of pre-IND briefing and meeting requests, and preparation and maintenance of INDs on behalf of NCATS DPI. NCATS DPI conducts translational research in human therapeutics development. NCATS, in collaboration with National Human Genome Research Institute (NHGRI) and National Institute of Neurological Disorders and Stroke (NINDS), has initiated the Platform Vector Gene Therapy (PaVe-GT) project. PaVe-GT includes development of gene therapy treatments for congenital myasthenic syndromes (CMS) and organic acidemias (OA). Under our new contract, CCSA is also responsible for providing pre-IND meeting support with the FDA, post-IND filings, preparation and submission of expedited program applications, and drafting of clinical and non-clinical protocols, as well as providing other ongoing support activities to help advance NCATS DPI’s product development pipeline.
