8:45 Opening Remarks From The Chairperson

Lisa B. Miranda
President
Biobusiness Consulting, Inc.

9:00 From Population Genetics To Personalized Genetics

deCODE genetics has carried out population based genetic research in Iceland for over ten years and is currently an undisputed leader in genetic discovery of common diseases. In the past, these genetic discoveries have been used to target specific biological pathways for drug development, diagnostic products and, now more recently, also in a web based personalized genetic services named deCODEme.com.

• Providing the informatics perspective on how deCODE has leveraged its unique population resource in Iceland
• An overview of some of the informatics solutions deCODE has developed to capture and analyze its clinical, genetic and the comprehensive Icelandic genealogical data will be presented
• Describing how deCODE is translating its research findings towards personalized medicine and preventive healthcare

Hakon Gudbjartsson
PhD, VP Informatics
deCODE Genetics Inc. (Iceland)

9:45 International Case Study: Estonian Biobank And Human Genetic Variation

For seven years, the Estonian Genome Project has been collecting blood samples and phenotypic information on the population of this small northern European country. Its goal is to use the resulting tens of thousands of samples in association studies, and to eventually use them in personalized medicine.

• Examining the foundation of the Estonia Biobank
• Understanding legal and ethical basis of the Estonian Genome Project (EGP)
• Exploring scientific basis of the EGP biobank
• Human genetic variation in samples of Italy, Germany and Estonian origin
• Looking into Future prospects of development

Andres Metspalu
M.D., Ph.D., Head of the Department of Biotechnology
University of Tartu (Estonia)

11:00 Bridging The Biospecimen With Biomarker Discovery And Drug Development

• An overview of the evolutional technologies of translational medicine
• Translating the potential of human population genetics research to improve the quality of health
• Understanding why do we need a biobank from the pathology perspective
• Maintaining sample integrity for biomarker discovery and development

Barbara S. Ducatman
M.D., Professor and Chair of Pathology, Associate Dean for Faculty Services, Director, WVU National Center of Excellence in Women's Health
West Virginia University School of Medicine

11:45 Industry Case Study: Cutting Edge Biospecimen Research On Biomarker Discovery

• An overview of oncology biomarker development and diagnostics
• Understanding the importance of the biosample collection and storage from the research perspective
• Optimizing sample collection and distribution processes
• Making biobanks accessible for researchers
• Case study on oncology biomarker development and companion diagnostics

Marielena Mata
Principal Research Scientist
Biomarkers Centocor R&D Inc.

1:30 Case Study: Accelerating Genomic Studies With Well-Structured Clinic Network And Biobank

As a leading genomic research company with programs in 25 common diseases, Genizon BioSciences find that biobanking is playing a critical role in their research efforts. Over 47,000 subjects are stored in the biobank for research purposes and 95% of which have consented to be re-contacted. In this session, a case study of leveraging a well-developed biobank for advanced genome study will be shared.

• Structuring and building of Genizon’s clinical network and biobank
• Explaining the dynamic aspect of Genizon’s biobank and its importance in R&D
• Providing Examples of biobank usage for R&D projects at Genizon

Dr. Majid Belouchi
Vice President and Chief Scientific Officer
Genizon BioSciences Inc.

2:15 The Merck Clinical And Assay Specimen Initiative: Standardizing Global Processes To Ensure Meaningful Use Of Biospecimens

• Working with clinical operations teams (including international subsidiaries) to standardize collection practices and improve collection rates of genomic specimens
• Development of a new IT system (CSMS) to support the entire specimen life cycle: Biomarker planning, trial set up, primary testing, and storage / retrieval
• Execution of a Sigma black belt project to clean up the existing biospecimen collection: Development and application of a comprehensive specimen retention algorithm
• Strategies to integrate specimen, patient, and clinical data and to enable scientists to search for, identify, and readily access specimens of interest
• Developing new governance processes to ensure that access to specimen resources is aligned with franchise scientific objectives
• Outsourcing biorepository operations to an external central lab organization: Operational expectations, integration with Merck CSMS IT system

Ken Wilke
Director, Research Planning & Integration
Merck Research Laboratories

3:30 Exploring Compatibility For Collaboration – Perspectives From BioPharma, Academia And Government Agencies

Pharmaceutical companies and academia operate in very different models and having different approaches. This panel discussion is bringing together representatives from bioPharma industry, academia and government to have a face to face discussion on the compatibilities for collaboration efforts. Hear some of the opening discussions and bring your questions to the session:

• Do we have common data and collection sets?
• Do we have compatible business models?
• Does one-size-fit-all approach apply to all parties?
• Do we have the same research objectives?
• Streamlining the research objectives and biobanking processes

Session Moderator:

Lisa B. Miranda
President
Biobusiness Consulting, Inc.

Panelists:

5:00 Closing Remarks From Chairperson And End Of Conference