Research Project
6488611
Description (provided by applicant): The major objectives of the Core Drug Development are by providing a central coordinating site for data management and communication (e-mails, meetings) to support the research Projects and the other by providing this centralized service to the other projects and cores is important in fulfilling the overall goal of developing CV-N as a microbicide. We plan to integrate Biosyn's decision-making and process of product development practices with the conduct of this Program Project. We feel that the product development activities occurring within the Program Project need to be coordinated with activities happening outside of the scope of this Program. A functional decision-making body will streamline the development of CV-N and combinations of CV-N. Since one of the most challenging aspects of CV-N development is the need to reduce production costs of CV-N, the Core will work to aid in the assessment of cost of CV-N along the way. Additionally, the Core will manage two pharmacokinetic/pharmacodynamic Phase I studies: one evaluating three concentrations of CV-N, and the other, three combination products. The safety and acceptability data from these studies will aid in determining the best product to move forward into Phase I traditional studies. We have produced a work plan that lays out assumptions of moving CV-N forward as a microbicide.
