Adaptive Pharmacogenomics, LLC

In 2005, Adaptive Pharmacogenomics, LLC scientists and software engineers began working with the United States Food and Drug Administration (FDA) to develop a pharmacogenomic clinical study design (PCSD) software tool. The first version of that software was delivered to FDA in 2005 and an enhanced version was delivered and evaluated at FDA the following year. Earlier, at the beginning of FDA's Critical Path initiative, pharmacogenomics (PG) was identified as a way to improve the safety and efficacy of medicines and to reduce attrition in clinical development. FDA's sponsorship of the software tool's development demonstrated their commitment to translating advances in basic biomedical research into new drug and biologic products to improve the health and well-being of Americans. In 2008, FDA signed a Cooperative Research and Development Agreement (CRADA) with Adaptive Pharmacogenomics, LLC and GlaxoSmithKline (GSK). The objective of the CRADA is to enhance the PCSD tool with technology developed by GSK and Adaptive Pharmacogenomics and to web-enable the tool. FDA's Federico Goodsaid, GSK's Aiden Flynn, and Adaptive Pharmacogenomics' Michael Palmer made public presentations on the PCSD tool at the 2008 Drug Information Association Annual Meeting in Boston.

Adaptive Pharmacogenomics, LLC offers the insights and expertise gained in developing the PCSD tool to industry. For inquiries, please see the Contact page on our website.