Pre-Clinical and Clinical Sciences Workgroup Q3-2015 Update
The PCS-WG is focused on the evidence-based evaluation of translational tools that support the effective decision making to advance new agents from the pre-clinical to clinical development space. These tools represent innovative approaches to address pre-clinical issues, including pre-clinical in vitro and in vivo efficacy, pre-clinical drug safety, and toxicology, pre-clinical PK/PD analyses involving the use of appropriate biomarkers, pre-clinical drug metabolism, drug interaction potential and pharmaceutical profiles. These tools may be submitted to regulatory authorities for regulatory review and/or qualification as appropriate. The PCS-WG also addresses other issues as pharmaceutics, clinical PK/PD analyses of concentration vs. pharmacologic response data from clinical studies.
- A sub-team of the PCS-WG developed a data inventory summary to advance the evidence-based evaluation of the in vivo pharmacology sterilizing mouse model. The statistical analysis plan is in development and will be expanded to include other in vivo pharmacology models. The evidence-based evaluation of the sterilizing mouse model was proposed as an outcome of the CPTR-NIAID in vivo Pharmacology Workshop.
- Proceedings from the CPTR-NIAID in vivo Pharmacology Workshop were submitted to Antimicrobial Agents and Chemotherapy (AAC) in August, 2015.
- The HAS-WG and PCS-WG teams reviewed FDA’s Draft Guidance “Pulmonary Tuberculosis: Developing Drugs for Treatment and Guidance Co-development of Two or More New Investigational Drugs for Use in Combination” to determine if the documents provide a clear roadmap for TB drug regimen development. The FDA is reviewing these comments and proposed recommendations.