Event Date/Time: Feb 08, 2005
End Date/Time: Feb 09, 2005
The major concern in the pharmaceutical industry is that the increased investment in discovery R&D, in part driven by the implementation of various “omic” technologies”, has led to the increased number of drug targets and the number of compounds entering development, however has failed to result in an increased number on NCEs. A major contributing factor to this paradigm is the costly late-stage attrition that often results from drug candidates transitioning into clinical trials without sufficient information about safety, efficacy, or pharmacology. Translational Research focuses on implementing bi-directional plans to enable better decision making at the pre-clinical/clinical interface through more informed lead selection and terminating high-risk projects earlier. The Inaugural Translational Research meeting will outline strategies for implementing decision making models for go/no-go decisions, establishing the advancement criteria for lead candidates, effective risk management and “fail early” strategies, and implementing effective translation plans for lead candidates and biomarkers. Since the key emerging tool in Translational Research is biomarkers, the meeting is paired with the Second Annual Biomarker Validation meeting, which will address issues of biomarker translation and clinical validation, as well as the role of biomarkers in candidate advancement.