Translational Biomarkers

August 19, 2010
11:30 am – 1:00 pm EST

The criteria for acceptable translational biomarkers and the various approaches to their selection will be discussed using real examples. In addition methods and requirements for qualification of translational biomarkers will be reviewed. The following areas will be highlighted:

Pathways downstream of the drug target modulated by pharmacology
Listing candidate biomarkers: human and animal concordance
Biomarker qualification: Technical, practical, acceptable
“Molecularly correct” patient populations
Human models that parallel animal models

Attendees will learn how to select appropriate biomarkers for use in preclinical models that will translate to humans. This will enable the translation of preclinical data into decision criteria for:

project viability In the preclinical phase based on animal model, in vitro and safety data
target validation in preclinical and clinical phases
dose predictions based on PKJ/PD modeling
subject selection and project viability in early clinical development based on biomarker responses and their relationship to preclinical efficacy and safety biomarker responses in early clinical studies

Instructor: Bruce H. Littman, M.D., former VP and Head of Translational Medicine at Pfizer, now President of Translational Medicine Associates, LLC

Who Should Attend:

Safety: target and off-target issues, translatable safety biomarkers, human genetic variants
Biotech and pharma scientists with responsibilities in translational medicine, biology and risk mitigation
Academics wishing to learn about translational medicine in the industry setting
Executives making investment and hiring decisions who need to understand the value of this phase of drug development
Investors who must know the right questions to ask about the data supporting preclinical drug candidates

Instructor Bio

Following post-graduate training as an internist, rheumatologist and immunologist at Tufts New England Medical Center, Harvard's Robert B. Brigham Hospital and the National Cancer Institute, N.I.H. in Bethesda, MD, and 13 years on the faculty of Virginia Commonwealth University’s Medical College of Virginia Bruce joined Pfizer's first Experimental Medicine group in 1989. His main focus became translational pharmacology, biomarker driven development decisions and exploratory clinical development across multiple therapeutic areas. He became the head of the Experimental Medicine group at legacy Pfizer with responsibility for research activities leading to proof of concept and was instrumental in starting Pfizer's Clinical Pharmacogenomics group and Pfizer's first biomarker laboratory. He played a key role in implementing important organizational changes through two major acquisitions. As Vice President, Global Head of Translational Medicine, he established Pfizer's Global Translational Medicine organization with groups in each of eleven therapeutic areas. Translational Medicine worked to improve the translatability of preclinical data into humans and increase Phase 2 survival through biomarker development for early validation of drug targets; demonstration of desired pharmacological activity in humans and development of clinical methods and biomarkers to advance the development of Pfizer products. In addition Bruce had other global development responsibilities including management of a large budget for biomarker qualification activities.

Bruce retired from Pfizer at the end of 2007 and started an independent consulting company, Translational Medicine Associates, LLC. He was also Co-Chair of the Inflammation and Immunity Steering Committee of The Biomarker Consortium (Foundation for the NIH) from 2007-2010 and has remained a member of that committee. He also serves on the Board of Directors of BioFortis, a small bioinformatics company. Over the last 1.5 years he has consulted extensively for large pharmaceutical and small biotech companies, non-profit research organizations and PhRMA.