Defining the Components to Drug Development Tool (DDT) Qualification
In October and November, the Critical Path Institute will host a webinar series titled “Approaches to Statistical Analysis for Biomarker Qualification: Defining the Components to Drug Development Tool (DDT) Qualification” with the following leading biostatisticians Robin Mogg, Ph.D. (Merck and Co.), Xavier Benain, MS (Sanofi), Suzanne Hendrix, Ph.D. (Pentara Corporation), and Matthew Schipper, Ph.D. (University of Michigan). The objective of these webinars is to engage stakeholders to align the approaches for statistical analysis and validation of biomarker panels.
In January 2014, the Critical Path Institute’s Predictive Safety Testing Consortium (PSTC) co-sponsored a scientific workshop with the FDA and convened a breakout session that discussed assessing panels of biomarkers as part of a DDT Qualification Submission. The discussion at the scientific workshop and subsequent interactions between PSTC and regulatory authorities (EMA and FDA) indicated the need to better define approaches to the statistical analysis of biomarker performance when submitting for qualification.
The first webinar was held on October 30th, 2014 with the following sessions occurring once a week until November 20th. The webinars are available here to the public, for those unable to attend the sessions live.
Webinar Session Recordings
Can adaptive study design and sharpened statistical methods improve the efficiency of qualifying biomarker panels?
Robin Mogg, Ph.D., Merck and Co.
Special statistical topics about biomarker qualification
Xavier Benain, M.S., Sanofi
Convergence of symptoms around a latent variable as a gold standard for continuous disease processes
Suzanne Hendrix, Ph.D., Pentara Corporation
Statistical issues associated with biomarker qualification
Matthew Schipper, Ph.D., University of Michigan