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Leaders in Biobanking Congress 2013 - Day 2

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Tuesday, November 5

7:30 am Morning Coffee

8:15 Biobanking Brainstorming Breakfast Discussion Groups

Grab a cup of coffee and join a discussion group. These are moderated discussions with brainstorming and interactive problem solving, allowing conference participants from diverse backgrounds to exchange ideas and experiences and develop future collaborations around a focused topic.

Table 1: International Harmony

Pedro Rondot RadíoPedro Rondot Radío, M.D., Executive Director, Public Oncologic Serum Biobank, Institute of Oncology "Angel H. Roffo," Research Área, University of Buenos Aires

• Why and how do we need to harmonize in biobanking?
• Which are the most debated and recognized ELSI challenges related to this issue?
• Do we need to use the same e-infrastructure (ontology resource) for a proper and secure interchange of personal and biological information in "International Harmonization"?
• e-BRAIN (Biobanking Resources American Infrastructures Network): Exploring the potential for a harmonized North and South American approach to the networking of human biobanks. Is it possible to think about this, as the EU did?

Table 2: Using Business Strategy to Maintain and Build Biospecimen Collections

Dawn E. BowlesDawn E. Bowles, Ph.D., Assistant Professor, Department of Surgery, Division of Surgical Sciences and Co-Director, Duke Human Heart Repository

• How can we garner institutional support for our biospecimen collections?
• How do we develop a cost model to monetize biospecimens?
• How do we create a market-driven biobanking enterprise to drive science?

Table 3: Development of Patient-Derived Xenograft (PDX) Tumor Models for Clinical Translational Studies: A Live Biobanking Approach

Vinagolu RajasekharVinagolu K. Rajasekhar, MSc, MPhil, Ph.D., Senior Research Scientist, Memorial Sloan-Kettering Cancer Center

• Why, to date, have none of the conventional biobanks for patient tumor specimens delivered on our goals for a cancer cure?
• What is the live biobanking approach and its novel features, such as recreating parent-like tumor heterogeneity and forming a renewable tumor tissue resource?
• How is live biobanking advantageous over conventional biobanking in the discovery of clinically relevant biomarkers and in developing patient-specific therapeutics?

Table 4: Innovations in Biospecimen Acquisition

Brian ChadwickBrian Chadwick, Managing Member and Consultant, LookLeft Group LLC

• Prospective targeted sample collection clinical trials
• Commercial acquisition of biospecimens
• Sample pricing/sample costs
• Relationships between biopharmaceutical and diagnostic companies with academic medical centers for ongoing biospecimen collection
• Online biospecimen buy/sell/exchange systems
• Regulatory/IRB issues

Table 5: Logistics and Utility of Induced Pluripotent Stem Cell Banks

Jay TischfieldJay A. Tischfield, Ph.D., CEO, RUCDR Infinite Biologics, Distinguished Professor, Genetics, Rutgers University

• Is there a "best" source cell type for iPSCs?
• What are the early candidate diseases for drug screening with iPSCs?
• How many iPSC lines need to be banked?
• What characterization of banked iPSCs is required?
• What are the prospects for using iPSCs for autologous cell therapy?

Table 6: Cryopreservation of Biospecimens: Myths and Realities

Allison HubelAllison Hubel, Ph.D., Professor, Mechanical Engineering and Director, Biopreservation Core Resource, University of Minnesota

• What do we know about the cryopreservation process and the effect that it has on biospecimen quality, and what do we need to investigate?
• What resources are available to improve my preservation when my organization or I have problems with our biospecimen quality?
• Cost and workflow issues are important in biobanking. What needs to exist to reduce cost of preserving and improve biospecimen quality?



Biospecimens and Translational Science 

9:00 Chairperson’s Opening Remarks

Sherilyn Sawyer, Ph.D., Scientific Director, BWH/Harvard Cohorts Biorepository, Channing Division of Network Medicine, Brigham and Women’s Hospital

9:05 Developing and Using the Duke Human Heart Repository (DHHR) for Basic and Translational Research

Dawn E. BowlesDawn E. Bowles, Ph.D., Assistant Professor, Department of Surgery, Division of Surgical Sciences and Co-Director, Duke Human Heart Repository

Few human heart tissue repositories exist in the United States. At Duke, we have created a readily accessible, well-curated, clinically relevant human heart tissue repository. From our well-established collaborations with Duke Surgery and local organ procurement organizations, we have acquired and banked 36,000 specimens from 374 diseased as well as non-failing human hearts over the last four years. In addition to banking tissues, the DHHR provides derivatives such as primary human cardiomyocytes, cardiac fibroblasts and cardiac progenitor cells as well as expertise in assessment of cardiac function and physiology at the cellular, tissue and whole-organ level.

9:35 Employing Quantitative PK/PD Approaches for Bench-to-Bedside Translation of Antibody Drug Conjugates

Dhaval K. ShahDhaval K. Shah, Ph.D., Assistant Professor, Pharmaceutical Sciences, The State University of New York, University at Buffalo

The presentation will highlight how to integrate data from tumor biomeasure studies, in vitro and in vivo ADC ADME studies and biodistribution studies, using quantitative PK/PD approaches. Tumor biomeasures were obtained from cancer cell lines and PDX xenograft models for preclinical work, and from patient samples for the clinical translation. Use of an integrated PK/PD model to guide the discovery of ADC and precision medicine efforts will be discussed.

10:05 Selected Oral Poster Presentation: Partners in Progress: Changing Clinical Practice through Biomarker Research

Diane Uzarski, MPH, RN, Associate Director, Biobanking, Duke Translational Research Institute, Duke University

Duke has developed an innovative systems approach to translational biomarker research, covering all aspects of drug and diagnostic development, and integrating experience and expertise of an array of internal and external organizations and industry partners. Duke continues to develop and refine this system and has fostered translational breakthroughs by bridging basic and clinical researchers with these research partners. An overview of Duke’s systems approach to the integration of clinical and translational research will be presented, highlighting real-world applications including Duke’s premier biospecimen repositories and recent biospecimen informatics advances.

10:20 Coffee Break in the Exhibit Hall with Poster Viewing

11:00 Bioinformatics Support for Clinical Genomic Testing: A Tale of One City

Gail H. Vance, M.D., Professor, Medical & Molecular Genetics; Professor, Pathology & Lab Medicine; Director, Division Diagnostic Genomics; Director, Indiana Familial Cancer Program, Indiana University School of Medicine

Biorepository specimens are a rich resource of genomic information for clinical and research investigation. This presentation will highlight the journey of one clinical molecular laboratory’s efforts to establish next-generation sequencing as a clinical service and the hurdles encountered to acquire clinical bioinformatic support.

11:30 Fit-for-Purpose Biospecimens: Ensuring Effective Use of Legacy Collections

Sherilyn Sawyer, Ph.D., Scientific Director, BWH/Harvard Cohorts Biorepository, Channing Division of Network Medicine, Brigham and Women’s Hospital

One of the greatest challenges faced by legacy biobanks is the age and rarity of their biospecimens. The decision to commit rare specimens to research studies without insight into how specimens will perform with different analytic platforms, or with biomarkers of interest, can result in a waste of resources. With biospecimens in continuous use for the last 40 years, the BWH/Harvard Cohorts Biorepository uses a rigorous profile of pilot experiments and assay quality controls (QCs) that are traceable over time to assure fit-for-purpose use of specimens. The Cohorts Biorepository monitors biospecimen performance over time, assesses the impact of specimen age and processing/collection method on analytic outcomes and measures the stability of biomarkers over time within cohort participants.

12:00 pm Enjoy Lunch on Your Own


Case Studies: Biobanker/Biouser Partnerships
(Sponsorship Opportunities Available)

1:30 Chairperson’s Opening Remarks

Lori Ball, COO, BioStorage Technologies, Inc.

BioStorage1:35 Case Study #1: Future Use of Clinical Specimens: Ensuring Adherence to the Informed Consent

Lynn WetherwaxLynn Wetherwax, Senior Manager, Research Operations Clinical Immunology & BSM, Amgen



Catherine WeaverCatherine Weaver, Global Head of Solution Design, BioStorage Technologies, Inc.

As custodians for patient specimens, we must ensure sample management practices demonstrate compliance to the informed consent and protection of patient privacy on behalf of the investigator. This presentation will focus on planning for ethical and compliant use of human specimens for future research, optimizing specimen collection and monitoring strategies, and managing for compliant and efficient use and destruction of human specimens.

Precision Bioservices2:20 Case Study #2: Building a Quality Biological Collection – The Practical Application of Best Practices

Katheryn Shea, Vice President, Precision Bioservices and Past President, ISBER

Eric M. Eastman, Ph.D., CSO, DioGenix, Inc.

Building quality biological collections begins with the incorporation of best practices into each aspect of the collection. Multiple best practice guidelines are available, such as the third edition of ISBER’s “Best Practices for Repositories,” which was published in 2012. The practical application of these best practices depends on the intended use of the specimens, as the goal is to ensure the preserved specimen is fit for the purpose intended. This case study will show how these best practices were implemented for a study being conducted by DioGenix for the development of a unique test for the early diagnosis of multiple sclerosis (MS). This assay, MSPrecise™, measures codon replacement frequencies in the variable region of immunoglobulin (Ig) heavy chain (IGHV) genes in B cells isolated from cerebrospinal fluid (CSF) and peripheral blood B cells. Standardized processing and QC have been a critical component in the execution of this study.

3:05 Refreshment Break in the Exhibit Hall with Poster Viewing

Sequenom3:30 Case Study #3: Accurate, Rapid, High-Throughput DNA Sample Identification and Quality Control for BioBanking

Neelam_DivyaDivya Neelam, Senior Scientist, Applications & Technology, Field Sales, Sequenom®, Inc

Thibodeau_BryanBryan Thibodeau, Ph.D., Research Associate, Beaumont BioBank, Beaumont Health System

World-wide biobanking is on the rise with ongoing efforts at these biorepositories to standardize sample collection, quality and sharing practices in order to provide broader access to samples. The Beaumont BioBank is a comprehensive biorepository and core molecular facility that has selected Sequenom’s iPLEX® Pro Sample ID Panel to relate multiple sample types from each donor, generate a DNA fingerprint and assess the quality of samples prior to downstream analysis due to its high discriminatory power.

4:15 Case Study #4: Biobanking Across the Portfolio: A Pharma Approach and Case Study to Enable Decision-Making

Donna FarleyDonna Farley, Associate Consultant, Eli Lilly and Company



Dennis A. LaskaDennis A. Laska, Consultant Biologist, Tailored Therapeutics, Eli Lilly and Company



Mary ZunigaMary Zuniga, Clinical Diagnostic Services Consultant and Clinical Trial Sample Coordinator, Eli Lilly and Company

High-quality biospecimens are necessary to meet the research needs of scientists and enable decision-making. Discovery and Clinical Operational groups at Lilly are working collaboratively to help scientists meet those needs. Biobanking perspectives from sample management experts working in Discovery and Clinical Operations will be shared. The case study entitled, “Discovery and Tailoring Therapeutics through Human Biobank-Facilitated Biomarker Development” will be presented by a Lilly scientist in the Tailored Therapeutics group.



5:00 Closing Panel Discussion

5:30 Close of Conference


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