Today, biospecimen collections are used by multiple research groups for varying research aims, from basic research through clinical trials. A well-managed biobank is a critical prerequisite for high-quality biological research. The proper collection, processing, storage and tracking of biospecimens are critical components allowing researchers to better link molecular and clinical information. Thus, by necessity, biobanking is both a science and a business.

Cambridge Healthtech Institute's Seventh International Leaders in Biobanking Congress: Maximizing Your Investment in Biospecimens addresses both the business and science of biobanking, bringing together biomedical and biopharmaceutical researchers, regulators, biorepository managers and practitioners to investigate the best strategies for effective use of biospecimens within today’s cutting-edge biomedical research.

Pre-Conference | Day 1 | Day 2 | Day 3 | Post-Conference | Speaker Biographies

Monday, July 13

1:00 pm Short Course Registration

5:00 Main Conference Registration

Pre-Conference | Day 1 | Day 2 | Day 3 | Post-Conference | Speaker Biographies

Tuesday, July 14

7:30 am Main Conference Registration and Morning Coffee

Keynote Session: It Takes a Village

8:00 Welcome and Chairperson’s Opening Remarks

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

8:15 The Complexity of Pathologist Responsibilities as Custodians of Biospecimens

Sylvia L. Asa, M.D., Ph.D., Laboratory Medicine Program, University Health Network; Senior Scientist, Ontario Cancer Institute; Professor, Laboratory Medicine & Pathobiology, University of Toronto

Pathologists have responsibility for handling patient biospecimens; they implement rigorous quality assurance of processes that determine how specimens are collected, processed, examined, reported and either destroyed, biobanked or retained on file. Pathology is ideally positioned to develop and oversee biobanks and because of its capacity for data generation, generally provides the greatest amount of information for specimen annotation. Pathology also is subject to mandatory requirements for retention of clinical records, including tissue blocks and slides, for legal and accreditation purposes, emphasizing the importance of collecting and documenting biospecimens for research.

9:00 Discovery and Implementation Using EHR-Linked Biobanks: The eMERGE Experience

Rex L. Chisholm, Ph.D., Vice Dean, Scientific Affairs and Graduate Education; Adam and Richard T. Lind Professor, Medical Genetics, Northwestern University Feinberg School of Medicine

Biobanks linked to electronic health records (EHR) provide a unique opportunity to study the association between genetic variation and phenotypes. The eMERGE network, funded by the National Human Genome Research Institute, has not only demonstrated the utility of this approach, but has also begun to develop methods for associating specific genomic variants with EHRs and providing clinical decision support to assist care providers in the use of this information.

9:45 Coffee Break

10:15 Preparing Research Samples for Future Use: Innovative Methods for Assessing Functional Quality Control and Biobanking Best Practices

Andrew Brooks, Ph.D., COO, RUCDR Infinite Biologics; Associate Professor, Genetics, Rutgers University

The presentation focuses on biomarker development and translational research optimization by taking into account how samples are collected, selection of the best technology for sample bioprocessing, global biobanking best practices and how information on each sample should be stored to enhance data sharing throughout the research process. Specific topics to be discussed include:

• Sample bioprocessing and quality control methods that maximize the utility of collected biospecimens for current and future research
• Understanding the power of evolving genomic technologies and how to develop a sample-centric roadmap for future research use
• The role of centralized biobanking and global data integration in real-time data mining and optimization of biospecimen resources
• How to build scientific and operational biomarker development synergies through collaborations to increase research productivity

11:00 Generating Comprehensive Standard Operating Procedures for a Biorepository Network – The CTRNet Experience

Brent Schacter, M.D., FRCPC, Principal Investigator, CTRNet; Professor, Department of Internal Medicine, Section of Hematology/Oncology, College of Medicine, University of Manitoba/CancerCare Manitoba; President-Elect, ISBER 

The Canadian Tissue Repository Network is a consortium of Canadian tumour biorepositories that aims to enhance biobanking capacity and quality through standardization. To minimize the issue of variable biobanking practices, CTRNet has developed and maintained a comprehensive set of standard operating procedures (SOPs). The key elements of the CTRNet SOP development process will be described. Once developed, reviewed and ratified by CTRNet, the SOPs have been published on our website for public access (with over 15,000 downloads in over 60 countries).

11:45 Close of Session

12:00 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

Maintaining a Quality Biobank

2:00 Chairperson’s Remarks

Andrew Brooks, Ph.D., COO, RUCDR Infinite Biologics; Associate Professor, Genetics, Rutgers University

2:05 Development and Implementation of a National Biospecimen Collection Network in a Community Hospital System

Jeffrey Otto, MBA, Ph.D., National Director, Center for Translational Research, Institute for Research and Innovation, Catholic Health Initiatives

Catholic Health Initiatives is the fifth-largest health system in the U.S., with 100+ hospitals spread nationally. Within this community hospital system, the Center for Translational Research (CTR) has built a first-of-its-kind hub-and-spoke biorepository program. Key attributes of this biorepository include: 1) high physical biospecimen quality, 2) EMR-linked patient data, and 3) full chain of custody. This presentation discusses how this program was built.

2:35 Inventory Management; Re-Organization, Consolidation, Quality Assurance and the Cost of Space in the Biorepository

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

Space and organization within the available space are two high-level concerns of the biorepository. We have recently undertaken a multiyear project to reorganize inventory in order to recover lost space and utilize space more efficiently. A cost/benefit analysis of this project contributes to understanding the true costs of space for biorepositories. 

3:05 GenoSpace Biobanking Analytics: A Software Solution for Maximizing the Utilization and Value of Biorepository Resources

Mick Correll, CEO, GenoSpace
Well-annotated biorepositories consisting of archival samples linked to informative clinical, phenotypic, and molecular data offer an invaluable resource for research. Despite the tremendous potential of these resources, effective means of accessing and utilizing the underlying data present particular challenges due to data size, complexity, and heterogeneity. Here we present our experience deploying advanced data analysis and visualization systems that enable the broad use of collected metadata and facilitates more effective use of the samples themselves.

3:35 Refreshment Break in the Exhibit Hall with Poster Viewing

4:00 Is There a Web-Based Solution to the Challenge of Informed Consent and Re-Consent of Legacy Biobank Samples?

Daniel B. Thiel, Public Health Researcher, Health Services Organization and Policy, University of Michigan School of Public Health

Highlighting the results of a pilot web-based informed consent portal for legacy donors to the Michigan BioTrust for Health, this presentation explores practical and ethical challenges raised by informed consent for legacy donors to biobanks. In the case of Michigan’s BioTrust, the legacy samples are residual dried bloodspots derived from state-mandated newborn screening. I also consider this experiment in light of broader implications for biobanks comprising legacy samples.

4:30 Tissue Banking, Bioinformatics and EMRs: The Front-End Requirements for Personalized Medicine

K. Stephen Suh, Ph.D., Director, Genomics and Biomarkers Program, John Theurer Cancer Center, Hackensack University Medical Center

Personalized medicine promises patient-tailored treatments that enhance patient care and decrease overall treatment costs by focusing on genetics and “-omics” data obtained from patient biospecimens and records to guide therapy choices that generate good clinical outcomes. The approach relies on diagnostic and prognostic use of novel biomarkers discovered through combinations of tissue banking, bioinformatics and electronic medical records (EMRs).

5:00 PANEL DISCUSSION: Ensuring Biobank Value through Effective Utilization

Biobanks are necessary and expensive research infrastructures. The ability to demonstrate effective utilization of biobanks is a quality measure that is essential for both financial and social sustainability. This panel discusses approaches for effective utilization of specimens from biobanks, both in the establishment of new biobanks and in the use of legacy collections.

Moderators:

Marianne K. Henderson, MS, CPC, Chief, Division of Cancer Epidemiology & Genetics, Office of Division Operations and Analysis and the Center for Global Health, National Cancer Institute; Chair, Organizing Advisory Committee, ISBER

 

 

 

Marianna J. Bledsoe, MA, Adjunct Assistant Professor, Department of Clinical Research and Leadership, George Washington University School of Medicine and Health Sciences; Co-Chair, Science Policy Committee, ISBER

Panelists:

Rajiv Dhir, M.D., MBA, Chief, Pathology, Shadyside Hospital, University of Pittsburgh Health Systems

Jeffrey Otto, MBA, Ph.D., National Director, Center for Translational Research, Institute for Research and Innovation, Catholic Health Initiatives

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

K. Stephen Suh, Ph.D., Director, Genomics and Biomarkers Program, John Theurer Cancer Center, Hackensack University Medical Center

Daniel B. Thiel, Public Health Researcher, Health Services Organization and Policy, University of Michigan School of Public Health

6:00 Welcome Reception in the Exhibit Hall with Poster Viewing

7:00 Close of Day

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Wednesday, July 15

7:30 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

8:00 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: Quality Systems – The Skeleton on which Everything Else Depends

Mary Kay Belota, MA, MT(ASCP)SBB, CQA(ASQ), Consultant, Consulting Services Division, AABB

• What is a quality system?
• Why is quality important?
• How do you achieve quality?
• Is quality expensive?
• What does it take to reach your quality goal?

Table 2: Academic/Industry Collaborations for Biobanking

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

• Successful examples
• What are bottlenecks? How can we do better?
• Are we talking the same language? How to define the collaboration
• Different models for private versus public universities
• IP and other legal issues

Table 3: Inventory Management and Data Annotation

Rajiv Dhir, M.D., MBA, Chief, Pathology, Shadyside Hospital, University of Pittsburgh Health Systems

• What is inventory management and how do you currently address your needs?
• What are the most common problems you have with inventory management?
• What are the most common data annotation needs seen by you and how do you address them?
• How do you provide data to your clients/investigators? Do you utilize honest brokers?

Table 4: Antibody Validation: On the Vial – in the Vial?

Veronique Neumeister, M.D., Laboratory Director, Specialized Translational Services Lab, Department of Pathology, Yale University School of Medicine

• What is the validity and importance of protein analysis in times of NGS?
• How does tissue quality affect quantitative and qualitative assessment of protein expression?
• The importance of antibody validation and assessment of assay reproducibility – a waste of time or a necessity?
• What is the advantage of implementation of laboratory-developed tests in the clinical setting as opposed to FDA approval of all companion diagnostic testing?

Table 5: Fast, Cheap, Good: Choose Any Two

Jeffrey Otto, MBA, Ph.D., National Director, Center for Translational Research, Institute for Research and Innovation, Catholic Health Initiatives

• Discuss the relationship between speed of acquisition and cost
• Discuss the relationship between a lockdown process and cost
• Discuss the complex relationship between ease, flexibility, process control, speed and cost
• Discuss how these factors impact biorepository sustainability

Table 6: Red Blood Cell Storage in Transfusion Medicine: Questions from an Outsider

Dana Spence, Ph.D., Associate Professor, Department of Chemistry, Michigan State University

• Is it time to rethink the blood collection process?
• Do we even know why we add certain components to collection and storage solutions?
• How much technology is too much technology if the storage process is modified?
• What are acceptable increases in cost to store blood knowing that costs associated with complications will be reduced?
• Who pays for the advances…government or industry?

Table 7: Institutional Biobanks: How to Make Them Work

Suzanne Vercauteren, M.D., Ph.D., FRCPC, Head, Division of Hematopathology, BC Children’s Hospital and Clinical Assistant Professor, Pathology and Laboratory Medicine, University of British Columbia

• What should the governance structure of an institutional biobank look like?
• Can you link all clinical data to your biobank database?
• How feasible is it to reserve (clinical) specimens for research purposes?
• How do you aim to promote the biobank in the scientific community?
• How do you engage patients and the public?

Biosamples, Biomarkers and Clinical Trials

9:15 Chairperson’s Remarks

Jeffrey Otto, MBA, Ph.D., National Director, Center for Translational Research, Institute for Research and Innovation, Catholic Health Initiatives

10:05 Obtaining Biospecimens for Correlative Studies in Multi-Centre Lymphoma Clinical Trials

Koren Mann, Ph.D., Assistant Professor, Oncology, Lady Davis Institute for Medical Research, McGill University

To develop novel agents in lymphoma, we must understand the molecular changes induced by these drugs, particularly in the context of clinical trials. We have developed a series of standard operating procedures (SOPs) to collect quality biospecimens for multiple downstream applications, including immunohistochemistry, exome sequencing, gene expression profiling, metabolomics and circulating tumor DNA. These SOPs were then validated in the context of the Q-CROC2 trial testing the efficacy of the histone deacetylase inhibitor, panobinostat, +/- rituximab in diffuse large B-cell lymphoma.

10:35 Coffee Break in the Exhibit Hall with Poster Viewing

11:15 Case Study: Biospecimen Sciences, Clinical Trials and Precision Medicine: Examples from Our Practice

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

Anthony M. Joshua, MBBS, Ph.D., Staff Oncologist/Affiliate Scientist, Princess Margaret Cancer Centre

We discuss the use of human biospecimens for translational research, in particular molecularly driven clinical trials and our Rapid Autopsy Program. We discuss optimal collection, use and quality of samples, patient enrollment and consent, and integrated clinical and research data collection and annotation.

12:00 pm Close of Session

12:15 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

Tools to Access Biospecimen Quality

2:00 Chairperson’s Remarks

Galen Hostetter, M.D., FCAP, Associate Director, Pathology Core, Van Andel Research Institute

2:05 From Research to Clinic: (Pre-)Analytical Variables and Assay Development

Veronique Neumeister, M.D., Laboratory Director, Specialized Translational Services Lab, Department of Pathology, Yale University School of Medicine

Companion diagnostic tests are critically dependent on tissue quality. However, tissue handling and processing are not always tightly controlled and pre-analytical variables can significantly alter tissue quality. This presentation focuses on the effects of (pre-)analytical variables in the diagnostic and research setting. Methodology and importance of quality control, optimization and standardization of tissue processing, biomarker validation and development of useful laboratory tests for the clinical setting will be discussed.

2:40 Experimental Animal Models to Inform Human Biobanking Practices

Galen Hostetter, M.D., FCAP, Associate Director, Pathology Core, Van Andel Research Institute

Experimental animal models have been widely used to inform veterinary and human pathophysiology with associated improved control of pre-analytic variables to include single marker QC probes or next-generation genomic sequencing of disaggregated tissue samples. We demonstrate animal experiments to combine tissue morphology and expressed protein by IHC, qualitative/quantitative measures of nucleic acids by RIN and Q-ratios, respectively, to assess effect of pre-analytic variables and provide the basis for standardized methods in tissue sample collection and processing.

3:15 Freezing under Pressure: A New Method for Cryopreservation

Nickolas Greer, CSO, Rissali LLC

Chemical cryoprotectants are toxic to live cells, tissues and organs. Cryoprotectant toxicity increases with concentration. Both hydraulic pressure and cryoprotectants increase viscosity of aqueous solutions at the freezing point, inhibit ice crystal growth and induce vitrification of water. By applying pressure during freezing it may be possible to reduce concentration or eliminate cryoprotectants for preservation of viable biological materials, thereby solving the cryoprotectant toxicity problem.

3:50 Refreshment Break in the Exhibit Hall with Poster Viewing

4:30 Microfluidic Evaluation of Red Cells Collected and Stored in Modified Processing Solutions Used in Blood Banking

Dana Spence, Ph.D., Associate Professor, Department of Chemistry, Michigan State University

The collection and storage solutions used to process erythrocytes for storage in transfusion medicine contain levels of glucose that are nearly 10-15x higher than that found in the circulation of a healthy human. Here, data is presented demonstrating that maintenance of normoglycemic levels during the blood storage process helps to maintain certain properties of the stored cells, even beyond five weeks in storage.

5:45 Close of Session

5:45 Short Course Registration

Pre-Conference | Day 1 | Day 2 | Day 3 | Post-Conference | Speaker Biographies

Thursday, July 16

7:30 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee

Specialty Biobanks

8:30 Chairperson’s Remarks

Marianna J. Bledsoe, MA, Adjunct Assistant Professor, Department of Clinical Research and Leadership, George Washington University School of Medicine and Health Sciences; Co-Chair, Science Policy Committee, ISBER

8:35 The Future of iPSCs Biobanking

Jonathan Y.H. Loh, Ph.D., Assistant Professor, Department of Biological Sciences, National University of Singapore, A*STAR Institute of Molecular and Cell Biology

We have developed the technology for efficient derivation of transgene-free hiPSCs from human finger-prick blood. Finger-prick sample collection can be performed on a “do-it-yourself” basis by donors and sent to the hiPSC facility for reprogramming. We show that single-drop volumes of finger-prick samples are sufficient for performing cellular reprogramming, DNA sequencing, and blood serotyping in parallel. Our novel strategy has the potential to facilitate the development of large-scale hiPSC banking worldwide.

9:10 Biobanking to Improve Cardiac Transplant Outcomes

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

A human cardiac transplant biorepository for research on improving cardiac transplantation outcomes has been established. Evidence indicates an association between the levels of cardiac injury biomarkers in the preservation/transportation fluid from the donor heart of transplant cases and the development of inadequate cardiac function post-implant in the recipient. Continued evaluation of the preservation fluid will lead to better understanding of preservation injury and optimization of preservation/transport solutions for cardiac transplant.

9:45 Selected Oral Poster Presentation: Sustaining an Open Scientific Resource: The NHLBI Biorepository

Leslie Carroll, Project Manager, NHLBI BioLINCC Program

The National Heart, Lung, and Blood Institute Biologic Specimen Repository (NHLBI Biorepository) has served as a valuable scientific resource for almost four decades by acquiring quality biospecimen collections and distributing samples to qualified investigators at no fee beyond shipping costs. Sustaining a vibrant and open Biorepository of quality historical and contemporary archival collections is challenging. This presentation reviews the key strategies that are being used to improve biospecimen use, acquire new collections with potential future scientific utility, and optimize collection management.

10:00 Coffee Break in the Exhibit Hall with Poster Viewing


10:45 Planning and Implementing an Institutional Biobank for Children and Women: Ethical and Operational Consideration

Suzanne Vercauteren, M.D., Ph.D., FRCPC, Head, Division of Hematopathology, BC Children’s Hospital and Clinical Assistant Professor, Pathology and Laboratory Medicine, University of British Columbia

The BCCH BioBank’s goal is to ethically collect biospecimens and clinical data from pediatric and adult patients with a range of conditions and store them systematically for future research. Its founding principles include public engagement, long-term sustainability and high-quality specimens. Its planning and implementation was a complex process that involved detailed consideration of the ethical issues concerning the different types of potential participants and careful consideration of the operational structure of the biobank.

11:20 The University Health Network Genito-Urinary (GU) BioBank

Neil Fleshner, M.D., MPH, FRCSC, Chair, Urology, Department of Surgery, University of Toronto; Head, Urology, University Health Network; Director, GU BioBank, Princess Margaret Cancer Centre

The GU (genitourinary) BioBank is a predominantly bio-fluid-based program that follows consenting GU oncology participants over time, obtaining additional specimens and data at predefined intervals and upon any change in clinical state. This capacity for frequent and long-term follow-up has been made possible by integrating the BioBanking process with clinical care at UHN. The GU BioBank has garnered an incredible amount of interest in recent years. We share our experience in setting up and maintaining this patient-centered research program.

11:55 Close of Session

12:15 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

Specialty Biobanks (cont’d)

2:00 Chairperson’s Remarks

Marianne K. Henderson, MS, CPC, Chief, Division of Cancer Epidemiology & Genetics, Office of Division Operations and Analysis and the Center for Global Health, National Cancer Institute; Chair, Organizing Advisory Committee, ISBER

2:05 Give Life Twice – An Overview of Canada’s National Public Cord Blood Bank

Heidi Elmoazzen, Ph.D., Director, National Public Cord Blood Bank

Canadian Blood Services is building a National Public Cord Blood Bank which consists of five collection sites in four cities: Ottawa, Brampton, Edmonton and Vancouver, as well as two manufacturing facilities in Ottawa and Edmonton. An overview of the sources and use of hematopoietic stem cells as well as an overview of cord blood processing, cryopreservation and storage will be provided.

2:35 Toronto Lung Transplant Biobanking Project, What We Are Collecting

Sassan M. Azad, Project Manager, Clinical, Translational & Biobanking Research Office, Toronto Lung Transplant Program, Toronto General Hospital, University Health Network

The Toronto Lung Transplant Program, one of the world’s largest, is supporting clinical research in end-stage lung disease and advancing lung transplantation. Two major areas that limit successful application of lung transplantation are ischemia reperfusion injury (IRI) and bronchiolitis obliterans (BO). Our work explores underlying mechanisms of both these injuries and the development of therapeutic strategies to prevent or reverse them. Our current research focus is on biomarker discovery and gene therapy in lung transplantation.

3:05 Refreshment Break, Last Chance for Exhibit and Poster Viewing

Maintaining a Quality Biobank with IT

3:45 Data Bank and BioRepository for Translational and Basic Research

Annmarie Nowak, Coordinator & Director, Data Bank and Biorepository, Biobanking Systems Integration Cancer Prevention and Population Science, Roswell Park Cancer Institute

The Data Bank and BioRepository (DBBR) at Roswell Park Cancer Institute is a comprehensive data and sample bank, with biospecimens, epidemiologic and clinical information for investigators conducting translational research related to cancer prevention, etiology, detection and treatment. We discuss our recruitment, procurement and processing procedures, the structure and function of LIMS and the integration of clinical, research and biospecimen data.

4:15 Promoting Quality Biobanks and Biobank Quality: The CRIP Toolbox and the Metabiobank p-BioSPRE

Christina Schröder, Ph.D., Head, Metabiobanks CRIP, Fraunhofer Institute for Cell Therapy and Immunology

While biobank registries and catalogs will at best allow queries for specific biobank collections or cohorts, trans-institutional metabiobanks enable parameterized, stratified, though privacy-preserving queries in connected biobanks on a case-by-case and sample-by-sample basis. Building such metabiobanks for a decade, and drawing upon broad expertise in semantic data integration across sectors relevant for translational biomedical research, we have developed the metabiobank software suite “CRIP Toolbox”. We showcase p-BioSPRE, the metabiobank setup for the EU FP 7-funded project p-medicine, as a multipurpose tool to internationally access and promote quality biobanks online.

4:45 Conference Wrap-Up

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

Mary Ann Brown, Executive Director, Conferences, Cambridge Healthtech Institute

Jeffrey Otto, MBA, Ph.D., National Director, Center for Translational Research, Institute for Research and Innovation, Catholic Health Initiatives

5:00 Close of Conference

Pre-Conference | Day 1 | Day 2 | Day 3 | Post-Conference | Speaker Biographies

Pre-Conference | Day 1 | Day 2 | Day 3 | Post-Conference | Speaker Biographies