Developing a Fit-for-Purpose Quality Strategy for Biomarker Development

The Association for GXP Excellence (AGXPE) is pleased to announce our upcoming 60-minute webinar entitled, "Developing a Fit-for-Purpose Quality Strategy for Biomarker Development" hosted by Blake Beehler, Head of Non-Clinical Quality at Bristol Myers Squibb.

Please join us on November 2, 2022 for an interactive 60-minute virtual session. The webinar description is below.

Biomarkers are increasingly used in research and clinical practice as a way to diagnose disease, forecast the likely course of a disease, predict what medicines may be beneficial to treat patients, and monitor treatment safety or effectiveness. The GCP regulations are vague when it comes to defining the standards to be applied in the analysis of human clinical trial biospecimens and the GLP regulations apply only to nonclinical studies.  GCLPs bridge GCP and GLP by providing a set of guiding Quality principles applicable to the clinical laboratory setting.  A Fit-for-Purpose Quality approach to biomarker development meets evolving global health authority expectations around patient safety, data integrity, and reproducibility of biomarker analysis while maintaining balance with innovative science and speed-to-patient.

About the Presenter

Blake Beehler is an Executive Director in R&D Quality and the Head of Nonclinical Quality at Bristol Myers Squibb (BMS).  He and his team are responsible for the quality strategy, governance, and evaluation of nonclinical related process from the earliest discovery of a new molecular entity through early development.  Blake started his career at BMS in 1990 as a Drug Discovery Scientist before moving into Clinical Development in 2003.  During his time in R&D, Blake authored 17 peer-reviewed research articles.  In 2005, Blake joined the BMS Global Quality and Regulatory Compliance organization and filled roles of increasing responsibility leading up to his current role as Head of Nonclinical Quality.  Blake earned a Bachelor of Science degree in Biology and a Master of Science degree in Natural Sciences from the State University of New York at Buffalo.