Translational biomarkers for accelerating drug development: From preclinical to clinical - AAPS Workshop.

摘要

The American Association of Pharmaceutical Sciences (AAPS) Workshop on Translational Biomarkers for Accelerating Drug Development: From Preclinical to Clinical was attended by scientists from the pharmaceutical industry, academia and government agencies. The conference focused on new discoveries in disease- and therapeutics-related biomarkers, and the current and future regulatory structures that will help new discoveries to enter clinical trials and practice. In his opening remarks, Lawrence Lesko (FDA) introduced themes that were echoed throughout the conference, including concerns about the attrition of NDAs, the high failure rates of new drugs during clinical trials (the productivity problem) and how new biomarkers could improve the probability for success during drug development. Dr Lesko described how the FDA is working to enable more efficient drug development by developing public-private partnerships to identify biomarkers,