title: Strategic applications of toxicogenomics in early drug discovery.
abstract: Productivity issues facing the pharmaceutical industry are numerous, and the current challenges come in the face of an aging population and a demand for new and better medications. These challenges call for improvement in the drug discovery and development process, which paradoxically comes on the heels of remarkable scientific advances and in an era of great opportunity in medical science. Despite these advances, the pharmaceutical industry has yet to translate breakthroughs in new technologies, including genomics, into new drug therapies for unmet medical needs. The strategic application of toxicogenomics to the earliest stages of a drug discovery program offers a valuable opportunity to identify potential safety hurdles earlier than is the norm today. We propose that using genomics predictively (in vitro to predict outcomes in vivo and short-term studies in vivo to predict safety issues in longer studies) can assist in reducing inefficiency in the current paradigm, which is still heavily weighted on traditional endpoints from lengthy in vivo studies. Implementation of these strategies will assist in solving the current pharmaceutical pipeline productivity dilemma of long cycle times and unacceptable attrition rates in the preclinical drug discovery process.
authors.affiliation: Integrative Biology, Lilly Research Laboratories, A Division of Eli Lilly & Co., PO Box 708, Greenfield, IN 46140, USA. timryan@lilly.com
authors.forename: Timothy P
authors.initials: TP
authors.lastname: Ryan
authors.forename: James L
authors.initials: JL
authors.lastname: Stevens
authors.forename: Craig E
authors.initials: CE
authors.lastname: Thomas