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Friday, March 28

8:30am Chairperson's Remarks
John Russell, Editor, BioIT World

KEYNOTE SPEAKER

8:35 Polymerase Chain Reaction: A Quarter Century of Pioneering Discovery and Promises for the Future Sponsored by Wafergen BioSystems David H. Gelfand, Ph.D., Chief Scientific Officer, Wafergen BioSystems My talk will highlight the advances of PCR, focusing on novel Designer DNA Polymerases and improvements in PCR analytical specificity, which have dramatically improved analytical sensitivity. Future advances in PCR technology will address the need for (1) instrument platforms with increased throughput capability, (2) increasing enzyme extension rate when copying RNA, (3) improvements in specificity in multiplex PCR ・eliminating primer dimer and other unintended, non-specific amplification products and (4) strategies for sensitive detection of rare somatic mutations in periph-eral fluids.

9:05 The Use of Pathway Analysis Tools in Integrative Pharmacogenomics Studies 
Jeff Kiefer, Ph.D., Head of Knowledge Mining and Bioinformatics, Pharmaceutical Genomics Division, TGEN 
Pathway analysis tools have become indispensable aids in the analysis of genomic data. We have developed an integrated pharmacogenomic research platform based on high-throughput RNAi, gene expression and array CGH. Pathway tools play a central role in the synthesis and analysis of these various data sets. Specific examples will be showcased illustrating the utility of pathway analysis tools.

9:35 Integrating High-Throughput Data via Pathway-Centric Analyses 
Joseph D. Szustakowski, Ph.D., Developmental and Molecular Pathways, Novartis Institutes for BioMedical Research 
In this talk we will discuss pathway-centric methods we apply to high throughput, genomics scale experiments. Such analytical methods cast experimental results into a common currency that facilitates data integration across disparate platforms. Using several case studies, we will illustrate how pathway-centric methods allow us to extract insights from multiple experiments that may otherwise be overlooked.

10:05 Pathway Analysis Tools in Understanding Metastasis 
Venkateshwar G. Keshamouni, Ph.D., Research Assistant Professor, Division of Pulmonary and Critical Care Medicine Department of Internal Medicine, University of Michigan Health System 
Metastasis is the primary cause of cancer related mortality. During metastasis cancer cells acquire self-sufficient autocrine growth signals, and become autonomous cellular enti-ties with a capacity to migrate and invade throughout the host from their origin in the primary tumor. Cancer cells acquire such a capacity by undergoing a phenotypic conver-sion known as epithelial-mesenchymal transition (EMT). This talk will describe the use of pathway analysis tools in elucidating the mechanisms involved in EMT and the molecular insights provided in understanding the process of metastasis, which may serve as a basis for future therapeutic interventions.

10:35 Coffee Break in the Foyer

11:00 A Network Biology Framework for Biologics Discovery and Development
Brian D. Harms, Ph.D., Senior Scientist, Computational Biology, Merrimack Pharmaceuticals, Inc.
Receptor-mediated signaling networks are attractive therapeutic targets in oncology. However, the complexity of these networks, characterized by redundancy, cross-talk, and non-linearity, hinders the generation of reliable qualitative insight into how to develop the most effective therapeutic. Merrimack Pharmaceuticals uses quantitative bio-chemical pathway models to yield significant improvements in drug design and decision-making throughout the development of our therapeutics. We will show how insights from our Network Biology approach find application in drug targeting, biomarker identification, and response prediction.

11:30 Pathway Tools in the Interpretation of Genomic Data in VXDS
Federico Goodsaid, Ph.D., Genomics Group, Office of Clinical Pharmacology, Office of Translational Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration 
The reviews of Voluntary eXploratory Data Submissions (VXDS) and of genomic data submitted through INDs, NDAs or BLAs require an accurate description of biological path-ways associated with these data. Biological pathway tools have been applied over the past three years in the review of these data. Tools supported by different databases con-tribute different pathway information to these reviews. The value of these tools is considerably enhanced as reports generated by these tools become integrated into these re-views. We will discuss the impact of these tools leading to a consensus on biological interpretation of genomic data.

12:00 Luncheon Workshop (Sponsorship Available) or Lunch on Your Own

1:00 Chairperson's Remarks

1:05 Management of Drug-Induced Pro-Arrhythmic Toxicity (Torsades De Pointes) Across the Entire Drug Life Cycle
Icilio Cavero, Ph.D., Cardiac Safety Consultant
The regulatory, legal and ethical requirements in safety assessment will be covered. The importance of adopting an efficient management approach from drug concept to post-marketing stages will be stressed. Cardiac toxicity should embrace all aspects of cardiac electrophysiology. Prevention should be the key ap-proach for obtaining a rapid approval. This can be achieved by the use of pre-clinical safety data in designing clinical protocols.

1:35 Formation of an International Effort to Understand the Genetic Basis of Drug Related Serious Adverse Events
Arthur L. Holden, Chairman and CEO, International SAE Consortium, Ltd.
The SAEC Ltd. has been formed to identify and validate DNA-variants useful in predicting and managing the risk of drug induced serious adverse events. It is focused on understanding the genetics and biology of SAEs, which affect drugs both on the market and under development. This presentation will summarize the origins and current status of this novel research initiative; its objectives, organizational structure, re-search plans, and technical approaches being utilized. The SAEC's IP and data release policies will be summarized. 

2:05 Predictive Toxicology - an Integrated Project within the 的nnovative Medicines for Europe・Initiative
Phil Hewitt, Ph.D., UK and Eurotox Registered Toxicologist, Head of Toxicogenomics, Non Clinical Development Toxicology Darmstadt, Merck Serono Research
The PredTox project is an important part of the 的nnoMed・pilot project, the precursor to the European Commission's 的nnovative Medicines Initiative・(IMI). Combining 双mics technologies with traditional toxicology endpoints is a unique strategy for toxicity prediction and mechanistic elucidation. Gene expression and pathway analysis of a proprietary drug development candidate is compared with other 双mics platforms.

2:35 Massively Parallel High-Content Signal Transduction Analysis
John K. Westwick, Ph.D., President and Chief Executive Officer, Odyssey Thera, Inc.
The past decade has seen an enormous increase in our understanding of the individual components of signal transduction pathways and their connections to human disease. However, most assay strategies are reductionist in nature, and fail to exploit the highly ramified nature of cellular networks. We have engineered a panel of hundreds of fluorescence- and luminescence-based high-content signal transduction assays, and routinely run the assays with hundreds of compounds with rapid turn-around. We are using this capability to improve the success rate of drug discovery projects. In addition, the massively parallel nature of the assay panel, combined with the richness of data delivered with high content automated microscopy and diverse chemical and siRNA probes applied to the panel, provide a unique understanding of the geography and mechanics of the signal transduction process.

3:05 Close of Conference