Adaptive Pharmacogenomics, LLC

In the FDA Critical Path initiative, the use of Pharmacogenomics (PG) was identified as a way to improve the safety and efficacy of medicines and to reduce attrition in clinical development. In addition, the FDA set up a new process for submitting PG data (Voluntary Genomic Data Submissions or “VGDS”) to encourage sharing of PG data and the discussion of results from exploratory PG studies between FDA and sponsors. As a result of the increased interaction between industry researchers and the FDA, it has become clear that many researchers face a common problem with designing a clinical trial that utilizes PG and assessing the feasibility of such a study. As a result, the FDA and Adaptive Pharmacogenomics, LLC (through its predecessor company Zurich Biostatistics, Inc.) developed a software tool to aid the design of clinical trials involving PG. GlaxoSmithKline (GSK) also developed a suite of analysis tools that can be used to assess the potential for integrating PG into clinical development and to help design PG studies in an exploratory setting (i.e., in the early stages of clinical development). The FDA and GSK tools address different stages of drug development and thus focus on different questions. The FDA tool was developed to use already-characterized biomarkers to optimize clinical study design, particularly for late phase 2 and phase 3 studies. GSK developed its tool to assess the utility of specific biomarkers prior to phase 3 of clinical development. The existence of the two tools provides an opportunity for developing a single, general software tool that can help to guide the use of PG throughout clinical development. Such a tool will take account of different study designs and analysis strategies (as typically applied in phases 2 and 3). FDA, GlaxoSmithKline, and Adaptive Pharmacogenomics have entered into a Cooperative Research and Development Agreement (CRADA) to develop such a tool. The CRADA will combine FDA, GSK and Adaptive Pharmacogenomics efforts to develop a general purpose tool with a spreadsheet-like user interface to optimize clinical study design with biomarkers.