[  概要   |   展銷前置會   |   1日目   |   2日目   |   3日目   |   Catalog(PDF)  ]

Wednesday, March 26

7:00am Registration (Open until 5:30pm)

8:00 Plenary Keynote Introduction
Edward G. Heidig, General Counsel and Deputy Secretary, Business, Transportation and Housing Agency

8:10 Risk Diagnosis for Disease Prevention
C. Thomas Caskey, M.D., F.A.C.P., Director and Chief Executive Officer, Brown Foundation Institute of Molecular Medicine, University of Texas Health Science Center 
There are an increasing number of presymtomatic diagnostic options which include: genetic, imaging, and analyte technology. Examples of linking a specific diagnostic to a therapeutic decision and FDA approval have fueled the activity for personalized medicine. It must be appreciated that diagnostic capacity emerges far more rapidly than an approved safe therapeutic. Thus the personalized medicine goal has a bottle neck for broad utility. A strategy of studying approved drugs for maximal efficacy is realistic and reasonable toward that goal since it is estimated that many approved drugs are effective in less than 50% of patients. These approaches will be discussed.

8:55 Disruption of the Pharmaceutical Industry: Moving from Products to Solutions
Theodore J. Torphy, Ph.D., Corporate Vice President & Head, Science & Technology, Johnson & Johnson
The pharmaceutical industry is bracing itself for a period of unprecedented challenges. This new era for our industry is being brought on by the confluence of several environmental factors, both internal and external to the industry, including; 1) non-sustainable increases in healthcare expenditures, 2) spiraling costs and decreasing productivity of R&D, 3) reimbursement driven by medical and economic outcomes, and 4) the proliferation and redistribution of healthcare outcomes information. Although all of these factors threaten to disrupt our industry, it is the evolving transparency in healthcare outcomes information that represents the most unsettling threat to our current business model, as well as the largest opportunity to transform our industry. For this transformation to take place, it is imperative that we change from an industry in which the sole mission is to provide products to one that provides broader, cost-effective solutions to areas of major healthcare needs.

9:40 Grand Opening Refreshment Break in the Exhibit Hall

11:00 Chairperson's Remarks
Michael Liebman, Ph.D., Executive Director, Windber Research Institute

11:10 Translational Medicine: What, Why and How? 
Michael Liebman, Ph.D., Executive Director, Windber Research Institute
We have developed a translational medicine platform that uniquely links the clinician, molecular researcher, informatician and patient into a single, decision-support system. This incorporates a personalized health record, clinical data, genomic and proteomic data with diagnostic, pathologic and molecular images within a unique, patient-centric data repository and supports both clinical and research activities, as well as interfaces into pharma/biotech needs.

11:40 Impact of Translational Methods on Drug Development
Richard Sachse, M.D., Head of Experimental Medicine, Global Exploratory Development, UCB Pharma SA
In order to maximize success of clinical development, increased focus is put on translational medicine by most pharmaceutical companies. With an integrated application of innovative pharmacology and clinical methods and technologies, translational medicine is delivering data, which set the basis for milestone decisions for particular development projects. By demonstrating early proof of principle, confidence in the target is built, allowing discovery research to further work on this particular target. Similarly, adequate proof of pharmacological activity of a particular compound during exploratory studies decreases the failure rate for late stage clinical development. This presentation will review the impact of translational medicine on the overall drug development process, including its impact on discovery research as well as the attrition rate during confirmatory development. Particular focus is put on the use of biomarkers for Go/No-Go decision making.

12:10pm An Ontology Driven Clinical Trials Management System
David Parrish, Executive Director of Informatics, Immune Tolerance Network
We have developed reference ontologies and protocol design tool which has been used to create a knowledge base of clinical studies and support the export of computable representations of each study structure. In this session we will describe the technologies used to create the ontology and a knowledge acquisition tool, as well as demonstrating how this system will; a) configure the workflow rules of transactional system (patient and specimen tracking) supporting better annotation of the result data and b) allow users and third party applications to query the data repository based on concepts defined in the ontology without needing a detailed understanding of the underlying data structures. The future plan for extending the ontology to include assay design will also be described. 

12:40 Technology Spotlight (Sponsorship Available)

1:10 Walk & Talk Luncheon in Exhibit Hall

2:15 Chairperson's Remarks
Sandor Szalma, Ph.D., Director, Discovery Informatics, Centocor R&D, Inc.

2:20 The Winding Path(ways) to Biomarker Discovery 
Sandor Szalma, Ph.D., Director, Discovery Informatics, Centocor R&D, Inc.
The number of molecular platforms enabling translational research for biomarker discovery is steadily increasing. So does the plethora of algorithms and approaches aimed at interpreting the data from these different experimental modalities. We have selected a set of closely related autoimmune disorders - psoriasis, psoriatic arthritis and rheumatoid arthritis - to illustrate the challenges and possible solutions on the path towards biomarker discovery. The strengths and weaknesses of the applied informatics solutions - including statistical as well as integrative biology tools - in pharmaceutical drug discovery settings will be discussed in great depth.

2:50 Predictive Response Biomarkers �ETheory and Practice
Hans Winkler, Ph.D., Senior Director, Oncology, Johnson and Johnson B.I.O.
Targeted cancer medicines have been shown to be highly effective, albeit in a limited percentage of patients in any indication. It is therefore highly desirable to be able to identify patients with high likelihood of clinical benefit from a particular treatment. Two distinct approaches will be discussed: a target expression/activity approach, as exemplified by ErbB1 and ErbB2 therapies as well as novel approaches to discovery and clinical validation of molecular profiles of tumor and blood components. The latter comprises the classification of markers based directly on patients�Ebenefit.

3:20 The Challenges of Biomarker Validation in the Clinical Setting
Stephen M. Hewitt, M.D., Ph.D., Clinical Investigator, and Chief, Tissue Array Research Program, Laboratory of Pathology, Center for Cancer Research, National Cancer Institute
There are a multitude of biomarker discovery platforms, each which produce useful but complex data. Reducing these potential clinically relevant biomarkers to clinical utility remains a bottleneck. The demands of diagnostic pathology and clinical medicine limit the utility of many potential biomarker platforms. The path toward clinical utility requires examination of analyte specification as well as assay performance to generate a useful biomarker. Routinely, assays are ported to new platforms and assays are modified to optimize performance in a clinical sample. 

3:50 Expression of Genes and microRNAs as Biomarkers of Hematopoietic Stem Cell Potency
David Stroncek, M.D., Chief Blood Bank, Department of Transfusion Medicine, National Institutes of Health
CD34+ cell counts are most often used as a measure of the potency of clinical hematopoietic progenitor cell components. However, stem cells make up a small proportion of CD34+ cells and this proportion differs among various sources of hematopoietic progenitor cells. Molecular assays including gene expression profiling and microRNA expression profiling are providing more precise information that may lead to the identification of better stem cell biomarkers. 

4:20 Reception in the Exhibit Hall (Sponsorship Available)