“Don’t Blot Out Your Results: The Value of Topnotch Science and Quality”

There has been a notable uptick in Warning Letters being issued to universities from the Food & Drug Administration (FDA). An example of this trend occurred when analyses was performed using Western Blot Analysis (WBA) to evaluate clinical trial participants’ blood and cerebrospinal fluid (CSF). However, WBA can only determine relative protein abundance and not absolute protein concentration and is not as rigidly controlled via software controls as other more widely used bioanalytical techniques such as ELISA or mass spectrometry. The FDA conducted a routine study­ specific investigation of the laboratory and it was concluded that there were no documented laboratory procedures to support the study results. Furthermore, the equipment used in the evaluation of the trial samples were not maintained, standardized, or calibrated. The conduct of the overall laboratory and reporting of study results caused this phase of the study to essentially be invalidated by the FDA. Because of the lack of study controls, the university, the Principal Investigator and the Sponsor’s reputations were irrevocably damaged. In fact, this lack of regulation caused a significant loss in the Sponsor’s stock valuation after the FDA issued their findings. It is important to understand how subpar and/or lacking process controls can affect the overall integrity of your study.

This presentation aims to showcase how sound scientific and regulatory practices go hand-in-hand, ultimately helping you and your organization avoid the pitfalls that impacted this clinical trial.