Friday, September 10, 2004

8:00-8:30    Morning Coffee

8:30-9:00    Reports from ThinkTank Sessions

BIOMARKER SERIES UPDATE

9:00-9:30    Series Update on Biomarker Discovery and Clinical Biomarkers
Dr. Stephen Naylor, CSBi and Division of Biological Engineering, MIT; and Dept. of Genetics and Genomics, Boston University School of Medicine
Just over a year ago, the first, in a series of CHI Biomarker conferences entitled "Protein Biomarkers-Applications in Diagnostics, Drug Discovery and Toxicoproteomics" was held in Philadelphia (August 25-26th, 2003). The attendees at this meeting discussed the exciting but somewhat nascent and chaotic state of biomarker fundamentals. A subsequent meeting "Biomarker Validation-Bridging Discovery to the Clinic" (Philadelphia, May 3-4th, 2004) discussed biomarker validation and its impact in drug development. Both conferences produced stimulating dialogue and debate. The subject matter covered included biomarker definitions, role of biomarkers in basic and translational research, validation of biomarkers, and impact on improving the drug discovery and development pipeline. As the two conferences highlighted, the paradox remains that whilst biomarker fundamentals are still being vigorously debated, their value in clinical analyses has also been clearly demonstrated. This presentation will provide an update on the state of biomarker fundamentals, as well as current status of biomarkers in clinical development.

10:30-11:00    Coffee Break	Sponsored by:

ASSAY DEVELOPMENT AND VALIDATION

11:00-11:05    Chairperson's Opening Remarks

11:05-11:35    Development and Validation of Assays for Protein/Peptide Biomarkers
Mr. Francois Legay, Head of Marker and Assay Development, Novartis Pharma
The clinical validation of biomarkers is strongly dependent to the robustness and the reproducibility of the analytical methods used to monitor them. In this presentation will be described: The development and validation of ELISA for soluble biomarkers; the validation of flow cytometry assay to monitor intra-blood cell biomarkers.

11:35-12:05    Chips, Panels and Beads: An Array of Alternative Platforms for Designing a Biomarker Strategy for Staging Complex Diseases
Dr. John Bilello, Director of Technology Development, Human Biomarker Center, GlaxoSmithKline 
Complex and chronic diseases are a challenge in drug development due to their multi-component nature and the long-term disease course. Most complex diseases consist of a spectrum of disease states which are often loosely clinically defined. Biomarkers of disease state are seen as one approach to increased definition, stratifying patients for clinical trials and eventually assessing the efficacy of new compounds. A number of new technologies have been developed for measuring levels of multiple biological response modifiers and plasma proteins. Examples of protein biomarker-based strategies for staging complex diseases such as osteoarthritis are to be discussed. 

12:30-2:00 Luncheon Technology Workshop 2D-DIGE: Discover Real Differences in Protein Expression	Sponsored by:
Dr. Christine Rozanzas, Consultant, Applications, GE Healthcare

WHY PROTEIN BIOMARKERS? 
Pros and Cons vs. Genomic and Metabolomic Biomarkers

2:00-2:05    Chairperson's Opening Remarks
Dr. Stephen Naylor, CSBi and Division of Biological Engineering, MIT; and Dept. of Genetics and Genomics, Boston University School of Medicine

2:05-2:35    Integration of Multiple Biomarkers Throughout the Pharma R&D Processes
Dr. Jacky Vonderscher, V.P., Global Head of BioMarker Development, Novartis Institutes for BioMedical Research, Inc.
The use of biomarkers ranges from disease diagnostic markers to drug specific efficacy/safety markers. To achieve the full potential of biomarkers in drug development, an integration of different approaches is required throughout the entire R& D process. Hence, the biomarker strategy will have to be clearly established during the Discovery phase. Biomarkers can then be more precisely defined and validated to provide value during the Development phase. Only when a drug reaching the market clearly benefits or has benefited from the application of biomarkers, will their usefulness be proven.

2:35-3:05    Validation of Biomarkers for Use in Diagnostic Settings
Mr. Thomas Metcalfe, Head of the Roche Biomarker Program, Roche Molecular Systems, Inc. 
Many of the biomarkers used in the development of pharmaceuticals will not be used in clinical settings, but a subset will. These will be used in clinical trials and may be eventually required as companion diagnostics. These biomarkers require more thorough validation than those used in preclinical decision making and have the assays designed to measure these biomarkers have to be able to stand up to the rigors of the clinical diagnostics marketplace.

4:00    Close of the Conference