Building a Translational Safety Strategy
Tuesday, November 18, 2014
2:00 p.m.-3:00 p.m.
FDA-White Oak Bldg. 2 Room 2047E
Building a Translational Safety Strategy: An Overview of Nonclinical and Clinical Biomarker Qualification Efforts in the Predictive Safety Testing Consortium
John-Michael Sauer, Ph.D. Executive Director, Predictive Safety Testing Consortium (PSTC)
Critical Path Institute, Tucson, Arizona
Dr. John Michael Sauer is a toxicologist by training with over 15 years of experience in drug discovery and development. He has been responsible for leading multiple functional areas across several pharmaceutical companies. He is dedicated to bringing quantitative translational science approaches to safety assessment, as well as transforming the way we use nonclinical safety data to drive clinical study design and data interpretation.
John Michael has over 100 scientific publications in the areas of toxicology, drug metabolism, clinical pharmacology, pharmacokinetics, and pharmacology.
John Michael is currently the Executive Director of the Predictive Safety Testing Consortium (PSTC) at the Critical Path Institute (C-Path). He is responsible for leading a consortium of 19 pharmaceutical companies in partnership with the FDA, EMA and PMDA. The primary goal of the PSTC is the qualification of nonclinical and clinical safety biomarkers for use as drug development tools. My role requires close interaction with both industry members and regulatory partners. The PSTC has played a significant role in shaping the qualification process, as well as defining the evidentiary standards required for biomarker qualification.
Prior to joining C-Path in 2013, John Michael had the opportunity to play an individual contributor role at Eli Lilly where he participated in the development, registration, and commercialization of Strattera for the treatment of ADHD in children and adults, as well as supported many other discovery and development teams. He also played a pivotal leadership role in the transformation of Elan Pharmaceutical’s discovery and development strategies including the incorporation of several quantitative translational science approaches. John Michael also gained operational and management experience in the Contract Research Organization (CRO) environment as the Site Scientific Head for the Covance Chandler site in Arizona.
John Michael received his undergraduate and Master’s degree in Biomedical Sciences at Western Michigan University and his Doctorate degree in Pharmacology and Toxicology from The University of Arizona.
The Predictive Safety Testing Consortium (PSTC) is a unique public private partnership that brings together pharmaceutical companies to share and validate each other’s safety testing methods in cooperation with the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). PSTC is currently focused on the qualification of translational safety biomarkers. This common goal is shared by six working groups: Cardiac Hypertrophy, Hepatotoxicity, Nephrotoxicity, Skeletal Myopathy, Testicular Toxicity, and Vascular Injury. All of these research programs have a strong translational focus in order to select new safety drug development tools that are applicable across the drug development spectrum and advance a comprehensive safety strategy. In order to reach goals, PSTC has established collaborations with the FNIH Biomarker Consortium and the Innovative Medicines Initiative (IMI) SAFE-T consortium.
The objective of this presentation is to review the PSTC’s current approach to translational safety biomarker qualification. Specific examples will be presented on research program design across several working groups. The implementation of current regulatory approaches (Letter of Support and a progressive approach to safety biomarker qualification) will also be discussed. Finally a discussion on the scientific expectations (evidentiary standards for analytical validation, statistical analysis, nonclinical expectations, etc.) for biomarker qualification will be presented.