Translational Medicine in Drug Development: Preclinical Phase

June 29, 2010,
11:30 a.m. to 1 p.m. EST

This first of six seminars will provide an overview of translational medicine activities during the preclinical phase of drug development with several in-depth examples to illustrate specific important concepts. This seminar will also introduce the entire series where future seminars will focus on target validation, selection and qualification of translational biomarkers, how to use translational science for setting effective decision criteria and detailed case studies in Oncology and Neuroscience.

Learning Objectives

Drug targets: identification, confidence and indications
Evaluating pharmacology: in vitro, animal models and biomarkers
Efficacy: relation to pharmacology, disease models, genetic variants, translatable efficacy biomarkers

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:

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

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.