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1:30 Chairperson's Opening Remarks
Beatrice Knudsen, M.D., Ph.D., Medical Director, Pathology and Laboratory Medicine, Cedars-Sinai Medical Center
1:35 Sample Acquisition and Sample Management: Still an Emerging Market
 Brian Chadwick, Managing Member and Consultant, LookLeft Group LLC
Demand exceeds supply of usable biospecimens to meet research objectives. While the literature suggests there may be a billion biospecimens stored globally, numerous sample collection efforts require prospective clinical trials because commercial sale of samples is a disparate and regulatory-challenged marketplace. Commercial biobanking facilities often have too few acceptable samples "on the shelf," and protocols often require specifically targeted biospecimens, which are less available through commercial channels.
2:05 The Impact of Differing National Regulations and Policies on Multinational Trials Involving Specimen Collection
 Amelia Warner, Pharm.D., President, Gentris Corporation; Founder and CEO, Global Specimen Solutions, Inc.
Complex global regulation and law for human specimen research continue to evolve as policymakers assess what tenets of ethical specimen procedures should be required for future biomedical research. This greatly impacts researchers' ability to collect and study representative specimen sets from global clinical trials. We will address current ongoing issues and discuss potential strategies to address successful global specimen collection.
2:35 Liver Disease Biobank: A Moving Target for Research and Clinical Study Integration
Anthoula Lazaris, Associate Director, HPB Transplant and Research Unit, Surgery,
McGill University Health Centre Research Institute
We are involved in a large-scale FRSQ project to study the cell biology of NAFLD and NASH at the mechanistic level using an innovative Systems Medicine approach that combines quantitative modeling and wet-lab research. We are performing (i) enhanced phenotyping of clinical samples through transcriptomics, proteomics and lipidomics, followed by (ii) high-end bioinformatics and systems analysis to identify disease biomarkers and (iii) biomarker validation through clinical cohorts. This presentation will describe our experiences in the creation of the MUHC-RI Liver Disease Biobank, where high-quality liver specimens are collected.
3:05 Selected Oral Poster Presentation: Cincinnati Children’s Heart Institute BioRepository (HIBR) for Pediatric Heart Disease
Robert B. Hinton, M.D., Associate Professor, Pediatrics; Director, Cardiovascular Genetics; Director, Heart Institute BioRepository, The Heart Institute, Division of Cardiology, Cincinnati Children's Hospital Medical Center
The objective of the Heart Institute BioRepository (HIBR) is to facilitate a broad spectrum of current and future research by combining tissue specimens with deep phenotype information on patients with pediatric heart disease. The HIBR is an ongoing repository using a Human Subjects Research approach. The basic goals of the HIBR are to collect, maintain and govern whole blood, heart tissue and urine, and combine these specimens with a comprehensive phenotype Registry using an Honest Broker system.
3:20 Refreshment Break in the Exhibit Hall with Poster Viewing
4:00 Customized Biobanking in the Era of Precision Medicine – Strategies and Opportunities
Beatrice Knudsen, M.D., Ph.D., Medical Director, Pathology and Laboratory Medicine, Cedars-Sinai Medical Center
We have established an innovative and centralized biobank at Cedars-Sinai Hospital, a 1000-bed tertiary care medical center in Los Angeles. This infrastructure includes a novel approach to consenting patients and a pipeline from tissues to data in a biobank-associated translational research core. The presentation will highlight our strategies, accomplishments and analytical methods development in the endeavor.
4:30 From Many to One: An Initiative to Develop an Institution-Wide Human Specimen Resource at an Academic Medical Center
 Devon D. Kelly, Director, OHSU Knight BioLibrary, Oregon Health & Science
University, Knight Cancer Institute
OHSU has been collecting and storing specimens for decades. Implementation of a standardized model is necessary to best organize and utilize individually maintained repositories. We will describe our efforts to aggregate multiple repositories under a single umbrella, in areas like governance, community engagement, business modeling, process improvements and informatics platforms, plus change process management strategies, current examples of collaborative relationships and uses of the specimens.
5:00 Governance Model for a Pathology-Based Tissue Procurement Core at the Duke Cancer Institute
 Shannon McCall, M.D., Director, Duke Biospecimen Repository and Processing Core, Pathology, Duke University School of Medicine
Duke's Department of Pathology has established a shared resource for tissue procurement: the Biospecimen Repository and Processing Core (BRPC). It operates under one IRB protocol and its "customers" are the DCI's 10 Disease-Specific Working Groups, which each determine priorities for specimen collection and utilization. This governance model reduces not only competition between investigators to enroll patients and collect specimens but also the risk to patients. It supports efficiencies in research expenditures by fostering collaboration, increasing cohort sizes and utilizing biospecimens for multiple downstream analyses.
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1:30 pm Chairperson's Opening Remarks
Jay A. Tischfield, Ph.D., CEO, RUCDR Infinite Biologics, Distinguished Professor, Genetics, Rutgers University
1:35 Preventing "Identity Theft" at a Biobank via Analytical and Functional Quality Control
 Jay A. Tischfield, Ph.D., CEO, RUCDR Infinite Biologics, Distinguished Professor, Genetics, Rutgers University
Nucleic acid quality control is essential for accurate and reproducible genomic analysis in both research and clinical settings. However, most sample processing is decentralized, leading to differential results between laboratories. To this end, standardized functional quality control methods have been developed to qualify nucleic acid quality and, most importantly, provide a metric for comparing samples extracted at different sites. The critical need to develop a quality gold standard for nucleic acid and implement best practices in sample management focusing on integrity, quality and control will be discussed.
2:05 Development of a High-Throughput RNA Extraction and Quality Control Process
 Victoria Kelly, Ph.D., Molecular Biology Group Leader, Molecular Biology, Coriell Institute for Medical Research
RNA from whole blood is a common sample type collected in longitudinal clinical research studies, with many of these studies aiming to discover miRNA biomarkers. Developing high-throughput methods by which to extract whole RNA including miRNA and analyze quality while maintaining integrity from sample accession to distribution is critical for the value of these collections. We will present our process including data collected to optimize and validate methods of extraction and quality control testing.
2:35 The SPIN and SMART Metrics: The New Generation of Biorepository Sample Quality Assessment for Downstream Analysis
 Timothy J. Geddes, Manager, Erb Family Core Molecular Laboratory, Beaumont BioBank, William Beaumont Hospital
We describe the development of two metrics designed to keep up with emerging proteomic and genomic analysis technologies. The first of these is known as SPIN (Sample-specific Protein Integrity Number) and is designed to discover proteins in individual sample types with the goal of establishing an index to assess the integrity of stored specimens for protein-based biomarker studies. The second metric is referred to as SMART (Size Metric Analysis RNA Threshold), which is formulated to determine the usability of highly degraded RNA isolated from archived FFPE blocks.
3:05 Selected Oral Poster Presentation: Long-Term Storage of Dry RNA in a Skin Cancer Biorepository for Next-Generation Molecular Studies
Steven Robinson, Ph.D., Research Manager, Skin Cancer Biorepository, Division of Medical Oncology, University of Colorado
High-quality RNA is required for molecular biology experiments. Novel techniques for desiccating and storing RNA at room temperature have recently been developed. In this presentation, we will look at the comparative quality of desiccated versus frozen RNA stored over long periods for use in next-generation molecular studies, including gene expression assays and whole-transcriptome sequencing.
3:20 Refreshment Break in the Exhibit Hall with Poster Viewing
4:00 What We Know about the Influence of Storage Temperature on Biospecimen Quality
 Allison Hubel, Ph.D., Professor, Mechanical Engineering and Director, Biopreservation Core Resource, University of Minnesota
Selection of a temperature at which to store your biospecimens can be a daunting task. There are scientific principles for the selection of a storage temperature that can help guide selection. A summary of studies on storage temperature will also be described.
4:30 Appropriate Freezing Processes and Optimal Storage Containers for Biological Specimens
 Alexandra Lerch-Gaggl, Ph.D., Scientific Director, Pediatric BioBank & Analytical
Tissue Core, Children's Research Institute and Medical College of Wisconsin
Best sample quality even after long-term storage should be a priority of sample banking. This presentation will discuss advantages and differences between various freezing techniques, introduce the purpose of using cryoprotective agents, demonstrate differences in storage containers and raise the awareness for factors influencing samples integrity related to freezing and thawing after long-term storage.
5:00 CAP Accreditation for Biorepositories: A New Approach to Biospecimen Quality
 Philip Branton, M.D., Consulting Pathologist, Biorepositories and Biospecimens Research Branch, National Cancer Institute, National Institutes of Health
CAP Accreditation offers an opportunity for standardization of practice. Today, there are few resources for biobanks that seek external verification/quality assurance of how they are performing and how they are conforming to benchmark standards of quality. The CAP Biorepository Accreditation Program features a unique peer-based inspector model that integrates education and a sharing of best practices to advance quality.
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