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2014 Archived Content

Cambridge Healthtech Institute’s Inaugural

Biospecimen Science and Sample Prep

Enabling Sample-Centered Precision Medicine

February 10-12, 2014 | Moscone North Convention Center | San Francisco, CA


Personalized medicine is based on the analysis of inter-patient differences at the molecular level through the measurement of biomarkers. Biomarkers are detected in human biospecimens, which represent samples for particular molecular tests. A systematic approach is necessary to ensure the availability and quality of biospecimens, as well as for their appropriate pre-analytical processing both in research and in the clinical laboratory. Cambridge Healthtech Institute’s Inaugural Biospecimen Science and Sample Prep conference is designed to bring together leading industry, academic and government experts in biospecimen science and molecular diagnostics to discuss major challenges and the latest advances in biospecimen management and quality assurance, and pre-analytical processing, sample preparation and target enrichment.

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Monday, February 10

10:30 am Conference Program Registration


11:50 Chairperson’s Opening Remarks
David L. Rimm, M.D., Ph.D., Professor, Pathology; Executive Director, Translational Pathology; Director, Yale Pathology Tissue Services, Yale University  

12:00 pm BioSpecimen Sciences: Pioneering Sample-Centered Precision Medicine

Michael H.A. Roehrl, M.D., Ph.D., Director, UHN Program in BioSpecimen Sciences, University of Toronto

In the age of personalized molecular medicine, BioSpecimen Sciences and BioBanking are rapidly becoming the key drivers of success. We will explore important considerations related to patient sample quality, procurement, and database annotation for use in deep omic personalized molecular profiling for individualized therapy guidance, biomarker surveillance, and drug discovery. We will show examples of how BioSpecimen Sciences done right will enable a new generation of molecularly-driven clinical trials for drug development.

12:30 Genentech’s Human Tissue Laboratory: Supporting Innovation in Translational and Basic Research within a Large and Rapidly Evolving R&D Setting

Cary D. Austin, M.D., Ph.D., Pathologist, Department of Pathology, Genentech, Inc.

Genentech’s Human Tissue Laboratory supports a variety of research and development activities, including projects focused on drug and diagnostics development as well as those in basic research in the fields of oncology, immunology, neuroscience, and metabolism. Supporting such a diverse set of needs in a rapidly evolving organizational and industrial setting presents challenges that will be discussed.

1:00 Session Break

1:15 Luncheon Presentation - Optimize Use: Increase Biospecimen Utility with Real-Time Annotation & Data Reconciliation of Clinical, Specimen and Ethical Attributes

Katheryn Shea, Vice President, Bioservices, Precision Bioservices
The foremost concern in specimen utilization is the reliability of the data associated with the specimens. Careful documentation of all use parameters including medical history, clinical manifestations, permitted and restricted sample uses per the informed consent, and physical attributes of the specimens are needed to determine if samples will be fit for purpose.  Real-time, traceable data reconciliation processes ensure the quality of the data and usability of the specimens.   

1:45 Luncheon Presentation II (Sponsorship Opportunity Available) 

2:15 Session Break


2:30 Chairperson’s Remarks
Katheryn Shea, Vice President, Bioservices, Precision Bioservices, Inc.  


2:35 General Pre-Analytical Issues in Clinical Diagnostics and Molecular Pathology

Gianni Bussolati, M.D., Professor, Department of Medical Science, University of Torino

Cold ischemia time, transfer and temperature and time to and of fixation constitute critical and potentially detrimental conditions for tissue preservation. Standardization of such variables will be approached with implementation of new technology and multidisciplinary expertises.

3:05 The Tissue Quality Index: A Denominator for Immunohistochemistry

David L. Rimm, M.D., Ph.D., Professor, Pathology; Executive Director, Translational Pathology; Director, Yale Pathology Tissue Services, Yale University

Standardization of immunohistochemistry (IHC) has been challenging, to the point that some scientists consider the assay inherently non-quantitative. In comparison, RNA measurements can be quantitative by using a series of housekeeping genes as a normalization factor that adjusts for the myriad and undefinable pre-analytic variables. Here we introduce the first steps toward providing a similar “denominator” for IHC. While not yet a true normalization factor, the tissue quality index has the potential to provide information on tissue integrity for biomarker assessment.

3:35 High Content Single-Cell Diagnostics in Oncology

Peter Kuhn, Ph.D., Associate Professor of Cell Biology, The Scripps Research Institute

Tumor heterogeneity is the result of both genomic instabilities and mircoenvironmental adaptations under both natural evolution of the disease and treatment pressures. Heterogeneity is mostly evaluated at the cellular level considering the individual cell as the biological unit. We have established a framework of single cell analyses that can integrated high content data at the phenotypic and genotypic level. The number of biological units/single cells analyzed provides the measure of resolution of the quantified heterogeneity. The high-content analysis utilizes the high-definition circulating tumor cell (HD-CTC) assay, which provides for an enrichment-free approach to identify and characterize CTCs. We utilized the HD-CTC assay to study protein biomarker expression combined with single-nucleus sequencing for genome-wide analysis of copy number variation (CNV) in fluid and solid biopsies with sequential sampling over the course of disease evolution. Standardized sample preparation methods that enables quantitative comparisons of multiple specimen types both intra- and inter-patient as well as along the timeline of cancer evolution. This presentation will focus on both pre-analytical validation and research results in multiple cancer types.

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4:05 Improving Upstream Sample Management and Downstream Bioprocessing 
Kristina Robson, Ph.D., Senior Director, Comprehensive Solutions, BioStorage Technologies 

Robust sample inventory and bioinformatics systems are fundamental to optimizing the value of biological sample collections. This session will cover our BioProcessing Solutions integration of a streamlined process for sample management and downstream bioprocessing.

 4:20 Orthogonal PCR: Sample to Actionable Results Using Coupled qPCR and High Multiplex Endpoint Detection

Richard A. Montagna, Ph.D., Senior Vice President, Scientific Affairs, Rheonix, Inc.

The limitations of current real time PCR systems (qPCR) for multiplexing have been overcome by combining four color qPCR with simultaneous detection of 50 additional targets on a DNA array.  The orthogonal system allows raw specimens to be introduced and automatically processed through sample preparation, analysis and readout without any user intervention.  

4:35 Refreshment Break and Transition to Plenary Keynote 

5:00 Plenary Keynote Session (Click Here For More Details)  

6:15 Grand Opening Reception in the Exhibit Hall with Poster Viewing

7:45 Close of Day

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