Wednesday 23 May 2012- stream two

• › Dr Estelle Marrer, Biomarker Expert, Novartis

Identifying stable gene lists for diagnosis, prognosis prediction, and treatment guidance of tumors remains a major challenge in cancer research. Microarrays measuring differential gene expression are widely used and should be versatile predictors of disease and other phenotypic data. However, gene expression profile studies and predictive biomarkers are often of low power, requiring numerous samples for a sound statistic, or vary between studies. Given the inconsistency of results across similar studies, methods that identify robust biomarkers from microarray data are needed to relay true biological information. Here a method will be discussed to demonstrate that gene list stability and predictive power depends not only on the size of studies, but mainly on the clinical phenotype. Both stability and accuracy can be predicted by means of the expression profiles which are available from standard microarray data sets.

• › Andreas Schuppert, Director, Applied Sciences, Bayer Technology Services GmbH

• › Michael Boettcher, Global Clinical Project Leader at the Department of Clinical Pharmacology, Bayer Schering Pharma AG

• › Dr Robert M. Miller, Chief Consultancy Physician, Aptiv solutions

• Why modify conventional Phase 1 trial design?
• Key elements of early diagnostic development
- Biomarker integration processes
- Informed consent issues
• Phase 2 deliverables in the era of targeted agents
 

• › Richard Buller, Vice President, Translational Oncology, Pfizer

- the principles of biomarkers for both safety and efficacy in regulatory toxicology studies for both small and large molecules to support FIH studies.
- the importance of pharmacodynamic biomarkers used in toxicology studies to support FIH studies.
- brief overview of classical and emerging biomarkers used in regulatory toxicology studies to support FIH studies.
 

• › Nicholas Buss, Toxicology Project Leader, MedImmune

• The promise of emerging safety biomarkers is to facilitate detection and monitoring of safety liabilities of drug candidates across preclinical species and human patients.  This will ultimately lead to better risk management of safety issues including understanding of human relevance of preclinical safety findings and full utilization of therapeutic index in target patient populations.
• The development of emerging safety biomarkers and their qualification has been a subject of extensive research efforts in industry, academia and regulatory agencies including variety of  consortia in US and Europe. 
• The presentation will discuss current status and case studies of application of emerging biomarkers of liver and kidney injury in preclinical and clinical drug development pointing out gaps that needs to be addressed to fully utilize their potential.

• › Jiri Aubrecht, Senior Director and Group Lead of Safety Biomarker Laboratories, Pfizer

• › Anthony Gee, Professor of PET and Radiochemistry, Division of Imaging Sciences, Kings College London & Director of PET and Tracer Development, GlaxoSmithKline

• › Mary Savage, Senior Research Fellow, Merck