Drugs

Eighth Annual Predictive Safety Testing Consortium (PSTC) / FDA CDER Scientific Workshop

Date:

September 21, 2017

Location:

FDA White Oak Campus
Silver Spring MD

I. BACKGROUND

The FDA and the Critical Path Institute’s Predictive Safety Testing Consortium (PSTC) are engaged in developing biomarkers for predictive safety testing in drug development. The annual meeting brings together the consortia scientists, leading academic experts, interested pharmaceutical companies, regulatory agencies, patient advocacy groups, and non-profit organizations to discuss and share scientific approaches to advance this field.

Goals and Objectives

The purpose of this scientific workshop is to discuss the impact of safety biomarkers on drug development. The workshop will discuss some innovative approaches to biomarker development and qualification, model-based biomarker development, biomarker data repository and data sharing, and global partnerships to advance biomarker development and qualification. The workshop will cover both non-clinical and clinical translation of biomarkers, and the assay validation considerations throughout the qualification process.

Who should attend?

The primary audience includes academia, interested pharmaceutical companies, regulatory scientists, patient advocacy groups, non-profit organizations, scientists including clinicians, clinical pharmacologists, statisticians, pharmacometricians, toxicologists and other researchers who are involved in the development of biomarkers for use in drug development and/or regulatory qualification. The Workshop will be an opportunity to discuss current issues and future direction.

Contact

CDER-PSTC Liaison: Ameeta Parekh – Ameeta.Parekh@fda.hhs.gov

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