Core C: Biostatistics and Pharmacology (Director: Avital Cnaan; Co-Director: Jeffrey Barrett)
The Biostatistics and Pharmacology Core will be a resource for all projects and cores. The IPCP program involves numerous experiments that examine activity of the neurokinin-1 receptor (NK-1R) antagonists, immunomodulatory effects and their underlying mechanism, understanding the pharmacokinetics of the lead NK-1R antagonist, aprepitant, in both SIV rhesus macaques and HIV+ adults, and examining the therapeutic potential of this NK-1R antagonist in management of HIV. This Core seeks to define linkages between the experiments used to define target molecule activity (Projects 1 and 2), experiments which discriminate pharmacologic agents for advancement into later stage screening, experiments to establish a response pharmacology model (Project 3) and finally experiments to assess human safety and activity (Project 4).
The experiments require expertise in study design and planning, pharmacology and pharmacokinetics, information systems, and statistical analysis to support the scientific approaches of the investigators in the projects and Core B. Therefore, the Cores specific aims are:
Specific Aim 1: To provide expertise and assistance on study design and statistical analysis.
- Aid in the statistical components of the design of the experiments in Projects 1, 2 and Core B;
- Develop statistical analysis plans for Projects 3 and 4;
- Perform statistical analyses, summarize results and participate in dissemination for all 4 projects.
Specific Aim 2: To provide pharmacokinetics (PK) and pharmacodynamic (PD) support
- Develop an allometric model to predicts human exposure based on historical and Project 3 data;
- Perform pharmacokinetic/pharmacodynamic modeling in Projects 3 and 4;
- Create a clinical trial simulation for the subsequent clinical study after Project 4.
Specific Aim 3: To provide information systems and data management support
- Design and maintain a database to accommodate all 4 projects and Core B, with appropriate permissions to enter/review data and allowing access from four geographical sites;
- Upload data as necessary, manage and correct data;
- Provide reports and regulatory support;
- Implement a data sharing plan.