Adding Value to Drug Development – Biomarkers, Precision Medicine, and CDx Development Programs
Friday, February 17, 2017 from 9:00 AM to 4:00 PM (PST)
San Francisco, California
London, United Kingdom
In this UCSF-Stanford CERSI mini-course, we will introduce definitions and examples of biomarkers; discuss how they are qualified and validated, and how they are used in drug development both as pharmacodynamic endpoints and as tools for patient selection and “precision medicine” approaches to therapy. We will discuss issues and challenges inherent in bioassays and the measurement of biomarkers in the lab and in the clinic, including the setting of cut-off values and the interpretation of assay data. Finally, we will discuss in vitro diagnostics and their regulation – including the co-development of drugs and associated companion and complementary diagnostics. Using case studies and examples, attendees will be exposed to the myriad ways that biomarkers are used in modern drug development, regulatory science and clinical practice.
- Understand how biomarkers are used in clinical drug development to assess drug target coverage and toxicities, inform dose selection and select appropriate patients.
- Recognize the many considerations around the assessment of physiologic, metabolic and genetic biomarkers including sensitivity, specificity, and precision that influence how biomarker assays are made “fit for purpose.”
- Understand the regulatory requirements around biomarker qualification and assay validation, and the pathways for incorporating biomarkers into drug labels as companion or complementary diagnostics.
- Recognize the scientific, logistical and regulatory challenges and opportunities associated with drug/diagnostic co-development from laboratory, clinical trial and clinical practice/commercialization perspectives.
Dr. Catherine E. Lofton-Day, Director, Medical Sciences and Head of In vitro Diagnostics, Amgen, Inc.
Dr. Dominic G. Spinella, Translational Medicine Partners, Inc.
When & Where
UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI)
Center of Excellence in Regulatory Science and Innovation is a partnership between University of California San Francisco (UCSF), Stanford University and U.S. Food and Drug Administration (FDA).