Meeting Program

/Meeting Program
Meeting Program2019-09-19T03:49:21+00:00

2019-11-03
2019-11-03
2019-11-04
2019-11-04
2019-11-05
2019-11-05
13:00 - 17:00
Biobanking 101 Workshop

*Registration for this pre-conference workshop is in addition to general meeting registration and is priced at $95.

 

1:00pm – 1:05pm : Introductions

 

1:05pm – 1:20pm: ISBER Tools – International Repository Locator
Presented by Joanne Demchok, NCI

 

The availability of a searchable (online) repository locator, is crucial to research infrastructure. To maximize the value of a specimen or collection, a researcher must be able to locate it. In addition, to generate data that contains statistical rigor, researchers may need to locate and access specimens from multiple repositories. An international repository locator (IRL), containing multiple repositories, would increase accessibility of repositories among key stakeholders including ISBER members, researchers, funding bodies, governments, and private industry.

 

The Working Group currently includes ISBER members from nine countries: Australia, France, Germany, Italy, the Netherlands, Qatar, Switzerland, the United Kingdom and the United States of America, with collective expertise in informatics, repository management, database management, and online locators.

 

1:20pm – 2:30pm: How to Write an Informed Consent Document
Presented by Helena Ellis, Biobanking Without Borders

 

All too often consent forms are written in language that is difficult to understand, with lots of legalese to fulfill regulatory requirements but without significant attention as to whether or not the form actually imparts key information to participants in an understandable manner. In the US the average person reads at the 7th or 8th grade level, so how can we make documents and the risks of genetic tests understandable? It takes an interest and time to review and revise the typical consent form, but the payoffs are substantial. There are many published guides and tools to help researchers write a comprehensible, reasonable length consent form, with simple words and conversational language. This workshop will provide easy to implement, step by step instructions for to write clear biobanking consent forms based on published health literacy principles.

 

2:30pm – 2:45pm: Coffee Break

 

2:45pm – 3:55pm: Cold Chain Management
Presented by Kathi Shea, Brooks Life Sciences

 

Time and temperature are two variables known to impact sample integrity. In this course we will focus on the approaches for managing the cold chain throughout the lifecycle of a sample. Various methods and tools that can be used for selection and qualification of shipping containers, work stations and storage units will be discussed, along with approaches that can be used for measuring and monitoring of temperature during sample acquisition, processing, handling, storage and distribution.

 

4:00pm – 5:00pm: Breakout Discussion

 

17:30 - 18:30
Roundtable Discussions

Blood for Collection (B4C) Workgroup: A Multicenter Collaboration Investigating Blood Collection Volumes in Human Research
Facilitator: Hanluen Kuo, The University of Kansas Cancer Center

 

Biosamples Open Governance Using Blockchain
Facilitator: Daniel Uribe, Genebank.io

 

Sample Reconciliation – Challenges and Solutions
Facilitator: Cathy Seiler, Kaleido Biosciences

 

Living Biobank Special Interest Group – Goals and Directions
Facilitator: Jedediah Lewis, Organ Preservation Alliance

18:30 - 20:00
Welcome Reception

Join us for refreshments and hors d’oeuvres in the exhibit hall while networking with colleagues, exhibitors, and poster presenters.

08:00 - 09:45
Symposium 1: Bringing it Back… to the Community: Banking on Diversity & Sharing /All of Us Spotlight

Chairs: Allison Hubel, Rita Lawlor, Billy Schleif

 

Prevention and precision medicine for all relies on biobanks and research studies that include specimens from diverse populations to answer questions that are generalizable and specific for certain populations. Inclusion of diverse, underserved and specialized populations in research requires special attention to governance structures and active approaches to community engagement. Attention to privacy and trust relationships is a significant element of success. This symposium will discuss the opportunities and challenges in precision medicine and prevention for all, community engagement, IRB governance with a highlight on the activities of All of Us Cohort and other large studies that impact communities.


Keynote Presentation:
Increasing Precision in Medicine: Accessing the Most Genetically Diverse Continent
Abasi Ene-Obong, PhD, 54gene

 

The Networked Approach to Biorepository Science: Big Opportunities and Big Challenges
Aaron Goldenberg, PhD, MPH, Case Western Reserve University
Kyle Brothers, MD, PhD, University of Louisville

 

Every Specimen has a Story: Engaging with Biobanking Community Advisory Boards
Karen Meagher, PhD, Mayo Clinic
David Kotsonas, Community Advisory Board
Betty Smith, Community Advisory Board

09:45 - 10:15
Networking Break
10:15 - 11:45
Symposium 2: All Along the Watch Tower: Wearable Data Tracking and Direct to Consumer Genetics Data

Chairs: Helena Ellis, Rita Lawlor

 

The digital health industry has sprung up quickly in recent years. Easy access to direct to consumer genetics for ancestry and health risk analysis, personal digital health trackers to monitor constantly vital statistics, and lifestyle have contributed significantly to this growth. In 2018, it was predicted that venture capitalists and health systems would invest in the region of $7 billion in digital health solutions including wearables and biosensors like Fitbits, precision medicine and genomics, mobile diagnostics, and clinical decision support via telemedicine. Whilst the FDA regulates medical devices, it does not regulate all genetic services or wearable devices.

 

Wearable data tracking and direct to consumer genetics data have many elements in common. They enable the individual to produce vast amounts of health-related data that are an incredible source of data for research and public health, they raise privacy concerns, and they open a market for individual selling of personal data. In this session, we will discuss the implications of such bio-voyeurism, whether (and how) such data should be shared and banked for future research use and the challenges to be overcome to facilitate such sharing. We will address potential policy gaps and self-regulation recommendations required to ameliorate privacy concerns and other ethics and governance issues related to big data banking.

 

Title TBD
Azar Alizadeh, GE

 

Digitizing the Patient: Objective Data that Complements Biobanks
Jorge Nieva, MD, USC/Norris Cancer Center

 

Direct-to-Consumer Genetic Testing: Promise, Pitfalls & Perils
Ellen Matloff, MS, CGC, My Gene Counsel, LLC

 

12:00 - 13:00
Corporate Workshop: OpenSpecimen – World’s Most Widely Used Open Source Biospecimen Management Software

Presenter: Srikanth Adiga, OpenSpecimen

 

Attend this session to learn how OpenSpecimen is used in leading research centers like Johns Hopkins, UPitt, UPenn, UMass, Emory, UC Davis, Washington University, etc to manage different kinds of biospecimen collections. E.g. prospective biobanking, longitudinal (clinical study/trial), animal, etc.

 

Learning Objectives:

  1. Real-world case studies of OpenSpecimen usage in different centers
  2. Integration with REDCap, EPIC, etc.
  3. Collecting specimen annotations and Reporting (i.e. finding specimens of interest)
  4. How your center can adopt OpenSpecimen?
12:00 - 13:00
Corporate Workshop: The Importance of Sample Management in Precision Medicine: A High-throughput Biobanking Workflow Solution

Presenters:

Andrew Brooks, Chief Operating Officer and Director of Technology Development of RUCDR Infinite Biologics, Chief Scientific Officer Brooks Life Sciences,

Mark Dupal, Director of Market Development, PerkinElmer Applied Genomics

 

The increased acceptance and implementation of precision medicine, direct to consumer genomics and applications such as regenerative medicine have driven the need and adoption for the storage of primary samples and the isolation and storage of high quality, high molecular weight nucleic acid. One reason for primary sample and nucleic acid storage is the value of the information held within the sample.

 

The application of sequencing technologies to research and clinical settings has increased dramatically, generating vast amounts of data about variations in our genomes that could explain some differences in disease susceptibility, progression and how patients react to drugs. The move towards precision medicine and immune modulation therapy development both requiring sequencing in the treatment workflow drive the demand for faster processing, storage and data sample management techniques.

 

Efficient and effective storage ensuring sample integrity is of the utmost importance; retention of sample information with the associated phenotypic insight can provide a wealth of genetic and environmental information that can be unlocked in an attempt to better understand disease and health. In this workshop we explore industry collaborations to provide a solution to the increased need for efficient sample management and nucleic acid extraction that meet todays increased requirement for higher throughput full workflow solutions.

 

Learning Objectives:

  1. Why preserving sample integrity through automated cold chain sample management is vital for sample viability and throughput efficiency
  2. High Throughput Nucleic Acid Extraction workflow technology advancements
  3. Quantification and Nucleic Acid Normalization techniques
  4. The importance of High Quality nucleic acid extraction
  5. Example case study workflows of automated sample management and Nucleic Acid Extraction workflows and the importance to future precision medicine treatments
13:00 - 13:30
Lunch with Exhibits
13:30 - 14:30
Corporate Workshop: Advantages of SOP-Based NMR Diagnostics for the Quality and Future-Proofing of Biobank Samples

Presenter: Eduardo Nascimento, PhD, Field Application Scientist – AIC (Applied, Industrial & Clinical MR Market Division), Bruker BioSpin Corp.

 

NMR QC-Biobank Solution is a fully standardized 600 MHz IVDr platform. This includes SOPs for sample preparation and qualification of plasma, serum, urine, CSF and Contains extracts of body fluids, cells and tissues. The customer can share this NMR-date around the world. The user benefits from the WISYWYG solution with NMR diagnostics with highest reproducibility and transferability.

13:30 - 14:30
Corporate Workshop: Can You Justify Automating Your Storage?

Presenters: Issa Isaac, Sales Manager – Midwest, TTP Labtech, Paul Lomax, Product Manager, TTP Labtech

 

Any investment in automation usually requires a sound business plan to justify the cost of installation and on-going running costs. This workshop considers the factors determining whether automation is viable for a biobank and will provide attendees with a framework to evaluate current manual workflows against automated solutions on a cost per sample basis. This will help to determine whether automation is viable based on the use case and help to build a business case to justify it. The workshop will also consider fully and partially automated approaches to storage, demonstrating that automation can be relevant in a range of settings and not just the largest biobanks.

 

Learning objectives:

  1. Fully appreciate the real costs of manual storage practices
  2. Identify the key factors in considering the benefits of automation in any organisation large or small
  3. Be able to fully quantify the cost per sample of automated storage vs manual
  4. Consider the potential wider benefits of automation vs manual storage
  5. Consider other factors such as environmental policies
  6. Plan flexible short and long term strategies
14:45 - 16:15
Symposium 3: Don’t think twice, it’s alright! There Are Many Roads to Sustainability

Chair: Marianne Henderson

 

Sustainability is a complex and ongoing challenge for most biobanks around the world. A biobank’s mission, sample types, numbers and types of stakeholders served and source(s) of funding, impacts the importance of sustainability in a biobank’s business plan. Furthermore, sustainability issues encompass all financial, social and operations aspects of a biobank. This session will be an interactive moderated discussion with representatives of four different Minnesota biobanks across biobanking sectors, including human, non-human and environmental samples that have achieved sustainability. Each speaker will clearly describe their biobank’s mission, essential elements, sample and stakeholder statistics and operating principles. The moderator will engage with all speakers in a ‘talk show style’ to elicit information of how they define successful sustainability and the challenges and lessons learned in achieving it. Audience participation will be encouraged.

 

Panelists:

 

Keith Barker, PhD, Bell Museum of Natural History

 

Mine Çiçek, PhD, Mayo Clinic Bioservices

 

Cole Drifka, PhD, Biorepository and Laboratory Services, University of Minnesota

 

Bharat Thyagarajan, MBBS, PhD, MPH, Advanced Research and Diagnostics Laboratory, University of Minnesota

16:15 - 16:45
Networking Break
16:45 - 18:30
Symposium 4B: “All I really want to do”… is share data with you: Regulations for Data Sharing and International Collaborations

Chairs: Marianna Bledsoe,  Amanda Moors

 

Recent regulatory changes both in the US and abroad contain requirements that may hinder data sharing and impede international research collaborations. Differences among the various regulations may cause conflicts in requirements for data handling once shared, due to the content and scope of the applicable regulations. As relating to human specimen research, the EU-General Data Protection Regulations recently implemented on May 25, 2018, has broad territorial reach outside of the EU and is significantly affecting multinational studies involving personal data from EU citizens or held by EU entities. While the regulations allow data sharing with countries such as the US when there is appropriate legal basis, many of these approaches have considerable challenges. Furthermore, significant differences among the EU-GDPR, Common Rule and Health Insurance Portability and Accountability Act (HIPAA) are also creating implementation challenges for those wishing to share to data internationally. The Nagoya Protocol contains requirements for movement of data and environmental and biological samples across international borders, as well as provisions for benefit back consideration for source locations of biological specimens. The implementation and the challenges to this regulatory framework will be presented. This session will provide an overview of these challenges and discuss attempts at resolutions. In addition, case studies in international collaborations will be discussed as well as proposed approaches to address the challenges in an interactive panel session.

 

“I ain’t lookin’ to block you up”: International Collaboration and Data Flow Under the EU GDPR
Heidi Beate Bentzen, LLM, University of Oslo

 

Impact of US Privacy Law and GDPR on Data Sharing for Research Purposes
David Peloquin, JD, Ropes & Gray LLP

 

Title TBD
Scott Miller, Smithsonian Institute

16:45 - 18:30
Symposium 4A: Tangled up in Trypan Blue: Living Biobanks

Chairs: Allison Hubel, Xuefeng Liu

 

Tissues, gametes and isolated cells from humans, plants, and animals may be preserved in a manner as to preserve viability and function. Retaining viability and function for a biospecimen presents specific challenges for biobankers. This session is designed to address unique challenges of preserving specific high-value biospecimens, as well as overall challenges with workflow, quality assessment, and downstream uses of specimens from living biobanks.

 

PDX Mouse Models Integrated Into a Precision Medicine Initiative for Ovarian Cancer
Tim Starr, PhD, University of Minnesota

 

Genome Resource Banking of Genetically Modified Rodents and Current Challenges
Yuksel Agca, DVM, PhD, University of Missouri

 

Developing an Off-the-Shelf Living Tissue Supply
Jedediah Lewis, JD, Organ Preservation Alliance

 

Cryopreservation of Cells and Spores by Encapsulation
Alptekin Aksan, PhD, University of Minnesota

 

18:30 - 20:00
Networking Reception and Poster Session

Join us for refreshments and hors d’oeuvres in the exhibit hall while networking with colleagues, exhibitors, and poster presenters.

08:00 - 09:30
Symposium 5: Forever Young? Biospecimen Quality to Ensure Longevity

Chairs: David Lewandowski, Amanda Riffel

 

Biobanks are only as relevant as the specimens that are housed within them. Preanalytical variables have the power to change specimen quality and integrity, which can alter downstream data. This session will review why quality measures are relevant, highlight some of the current standards, and provide state-of-the-science preanalytical quality measures. Attendees should expect to learn how and why to formulate and implement a quality management program for their own repositories.

 

Defining Quality In Tissue Biospecimens
Stephen Hewitt, MD, PhD, National Cancer Institute

 

What Is the Role of Pre-Analytical Variables on Thrombosis Biomarkers in a Diverse Population of Cancer Patients?
Elizabeth Duffy, MA, Boston Medical Center

 

Delta-S-Cys-Albumin: A Lab Test that Quantifies Cumulative Exposure of Archived Human Blood Plasma and Serum Samples to Thawed Conditions
Chad Borges, PhD, Arizona State University

08:00 - 09:30
Educational Workshop: Consent for Future Use of Biospecimens Under the Revised Common Rule

Presenters: Marianna Bledsoe, Independent Consultant, William Grizzle, University of Alabama at Birmingham, David Peloquin, Ropes & Gray LLP

 

In January of 2017, the US federal government issued the first major revision to the Federal Policy for the Protection of Human Subjects in Research (the Common Rule) to address changes in the ethical and scientific landscape since the policy was first published in 1991. The revised Common Rule includes changes that significantly affect biobanking. The general compliance date for most of the Common Rule’s provisions was January 21, 2019.

 

Among the most significant changes related to biobanking in the revised Common Rule is a new provision for broad consent for the storage, maintenance, and research use of identifiable information and biospecimens for future research [45 CFR 46.116(d)]. This broad consent allows participants to consent to future research on their biospecimens and associated data using a consent form that differs from the standard informed consent. The use of the broad consent allows secondary research using the biospecimens to meet an exemption that relies on a limited IRB review if certain conditions are met.

 

The new broad consent provision has a significant limitation. If a participant refuses to provide broad consent, an IRB can never subsequently waive informed consent for the use of the participant’s biospecimens and associated data. This restriction requires significant tracking capability within an institution and, in some cases, even across institutions.

 

In this workshop, presenters and attendees will discuss the interpretation of this provision of the revised Common Rule, various strategies for implementing informed consent for future use of biospecimens under the revised Common Rule, and potential alternatives that exist under the revised Common Rule. Case examples will be used to illustrate various approaches that may be used under the Rule.

 

The format for the workshop will include several short introductory presentations, followed by an extensive, interactive discussion in which attendees will share their experiences and successful approaches to implement consent for future research on biospecimens and associated data under the revised Common Rule.

09:30 - 10:00
Networking Break
10:00 - 11:30
Contributed Paper Session 2: Modern Times – Data and Science

Chairs: Ping Guan, Diane McGarvey

 

Innovative Devices for Community-based Development of Germplasm Repositories
Yue Liu, Louisiana State University

 

BRoTHER – A Regional Biobank Network in Europe
Judita Kinkorova, University Hospital Pilsen

 

NASA Institutional Scientific Collection (ISC) at Ames Research Center
Ryan Scott, NASA, Wyle Labs

 

Human Lung Development from Canalicular Through Alveolar Stages Made Accessible by a Novel Pediatric Biorepository
Gloria Pryhuber, University of Rochester Medical Center

 

Moffitt Cancer Center’s Biospecimen Pilot Project Process: Improving Access to Biospecimens
Edward R. Seijo, H. Lee Moffitt Cancer Center

 

Standardizing Pre-analytical Workflows for Deriving Cell Free DNA from Venous Whole Blood
Jordan Lee Plieskatt, The George Washington University

10:00 - 11:30
Contributed Paper Session 1: Gotta Serve Somebody – Ethics and Standards

Chairs: Debra Garcia, Cheryl Michels

 

Giving Patients, the Public, and Health-Care Providers a Voice in Pediatric Mental Health Biobanking
James Shih, BC Children’s Hospital BioBank

 

ISO TR 22758 Implementation Guide for ISO 20387–Deciphering the ISO 20387 Biobanking Standard
Clare M. Allocca, National Institute of Standards & Technology

 

Service Delivery Through ISO9001 Quality Management System: National Health Laboratory Service Biobank Perspective
Mantombi Maseme, National Institute for Occupational Health

 

The Cost of Utilizing a Permission to Contact (PTC) Platform to Support Research: A Retrospective Access Example
Karlene Carvalho, BC Cancer Agency

 

Analysis of Three Internationally Recognized Biobanking Standards
Tamsin Tarling, University of British Columbia

 

Patients Enhancing Research Collaborations at Holden: The Consolidation of Disparate Biorepository Enrollment Procedures
Laura Jacobus, The University of Iowa

 

Policy Innovation and Tribal-Federal Partnership: The Alaska Area Specimen Bank
Brenna Simons-Petrusa, Centers for Disease Control and Prevention

11:45 - 13:15
Corporate Lunch Symposium: Is Your Cell-free DNA Sample Fit for Purpose? Biobank Samples QC from Agilent

Agilent’s New Automated Electrophoresis Solutions
Elisa Viering, Agilent Technologies

 

Cell-Free DNA Quality and Quantity Assessment ─ A Method Comparison
Thorsten Voss, PreAnalytiX GmbH

 

Automated Low Input Pulsed-Field Analysis of Genomic DNA
Kyle Luttgeharm, Agilent Technologies

 

Join us for a corporate partner workshop about biobank sample quality control (QC). The DNA and RNA samples that you store in your biobank will be used for critical research later. Our workshop will show you how to improve confidence in your QC analysis—before and after samples go into storage using different automated Electrophoresis platforms.

 

You’ll learn how to:

  1. Streamline your QC workflow with the new Cell-free DNA assay.
  2. Make informed decisions with reliable qualification of cell-free DNA.
  3. Use less of your precious sample for your QC and Accurately size high molecular weight gDNA
13:30 - 15:15
Symposium 6B: Integrating Digital Biospecimens – Don’t Leave Them “Blowin’ in the Wind”

Chairs: Stephen Hewitt, Cheryl Michels

 

Digital pathology, along with digital radiology imaging systems is becoming the new norm within clinical digital imaging. They are an incredible resource for immediate review of disease status and tissue samples. The session will focus on digital imaging from radiology and pathology and its potential as a biobanking and research resource to not only catalogue disease but additionally its use as a diagnostic tool and a tool to track the progression of disease and /or recovery. The session will also explore the innovative area of digital imaging as a learning tool to develop artificial intelligent (AI) systems and the potential use of AI systems to provide quality control, analysis of sample composition and computer assisted evaluation of disease.

 

Advancing Digital Biobanking: Impact of Digital Pathology and Computational Pathology Tools
Anil Parwani, MD, PhD, MBA, The Ohio State University

 

Title TBD
Michael Feldman, MD, PhD, University of Pennsylvania Healthcare System

 

Diagnostic Consensus through Image Search – Lessons Learned from Searching in TCGA Repository of Whole Slide Images
Hamid Tizhoosh, PhD, Kimia Lab, University of Waterloo

 

The Cancer Digital Slide Archive: An Open-Source Toolkit for Web-Based Management, Analysis and Visualization of Histology Data
David Gutman, Emory University

13:30 - 15:15
Symposium 6A: Shelter from the Storm – Keeping Biospecimens Alive

Chairs: Daniel Simeon-Dubach, Amy Skubitz

 

Keeping heterogeneous systems alive is a particular challenge for living biobanks. Speakers in this session will expand upon the challenges outlined in Symposium 4A: “Tangled up in Trypan Blue: Living Biobanks” to include challenges of preserving heterogeneous systems such as microbiome, human tumors, and other biospecimens containing numerous cell types.

 

The RAMS Registery/Repository: Biobanking for Microbiome Research in Women’s Reproductive Health and Pregnancy
Gregory Buck, PhD, Virginia Commonwealth University

 

Biobanks in LMIC: Global Efforts needed to foster Pediatric Research
Rania Labib, PhD, Children’s Cancer Hospital-57357-Egypt

 

Conditionally Reprogrammed Normal and Tumor Cells -Living Biobanks- for Personalized Medicine
Xuefeng Liu, MD, Lombardi Comprehensive Cancer Center, Georgetown University

15:15 - 15:45
Networking Break
15:45 - 17:15
Educational Workshop: Pitching Biobanking

Presenters: Suzanne Vercauteren, BC Children’s Hospital Biobank, Daniel Catchpoole, The Tumour Bank – CCRU

 

Over the last decade recognition of the practice of biobanking has dramatically increased and in many academic centres biobanking has become routine. However, stakeholder engagement for biobanks is often limited and challenging. Many stakeholders in the biobanking process including patients, the general public, hospital administration, industry but also researchers and clinicians have no or little concept about the role and function of biobanks to advance research. This results in underuse and underfunding of biobanks. There is an obvious need to engage and educate stakeholders to increase the operational and financial viability of biobanks. However, many biobanks struggle with how and when to present the importance of biobanking to key players. An elevator pitch is a brief, persuasive speech that can be used to spark interest in a topic such as biobanking. We propose to develop elevator pitches for stakeholders in biobanking so that all biobankers have tools to persuade key stakeholders. Key stakeholders for which elevator pitches will be created include the public, patients, researchers, clinicians and nurses, administration of hospital or academic institution, industry, advocacy groups.

 

The objective of the workshop is to have attendees develop elevator pitches for a target audience to raise awareness and use of biobanks. This elevator pitch should contain key messages for the specific target group and should be no longer than 30 seconds.

 

Attendees of this workshop will be divided into working groups. Following a brief introduction to the purpose of the session, the groups will be given a target audience for which to develop a 30 second elevator pitch. The elevator pitch should describe key messages for the specific target group. Each working group will present their elevator pitch to the whole group with a discussion after each pitch.

 

All members will receive a written version of the elevator pitches presented at the workshop with permission of the presenters.

 

This interactive workshop will allow conference attendees to create effective messages for stakeholder groups in biobanking. Attendees will leave the workshop with ideas on how to pitch biobanking to stakeholder groups and key messages and draft documents to refine and adapt for local efforts. The created elevator pitches will be available in paper format and if suitable videos may be created to be posted on the ISBER website.

15:45 - 17:15
Educational Workshop: If it’s Fitness-for-Purpose You’re Chasin’… The Tools, They are a Changin’: Leveraging Standards, ISBER Tools and Other Resources

Presenters: Clare Allocca, National Institute of Standards & Technology, Marianna Bledsoe, Independent Consultant, Koh Furuta, Council for Industrial Use of Biological and Environmental Repositories (CIBER)

 

Biobanking standards and best practices are critical for ensuring that biospecimens are fit for purpose and that the results of studies using biospecimens from biobanks are meaningful and reproducible. Multiple standards and tools are available or under development, with a general goal of maximizing fitness-for-purpose of biological materials and associated data (BMaD)—included among these tools are standards falling under the umbrella of ISO 20387 General requirements for biobanks. ISBER also offers a number of tools, the most broad-ranging of which is the ISBER Best Practices (4th Edition + Addendum). Additionally, there are several other resources (e.g. CAP, CTRNet) available to facilitate other approaches to fitness-for-purpose in biobanks. How can biobanks use these best practices, tools and standards together to meet their individual goals and achieve fitness-for-purpose for their biobank?

 

In this workshop, a mapping of the ISBER Best Practices 4th Edition against ISO 20387 will be presented. The differing goals of these and other tools will be examined, and paths of simultaneous implementation discussed in the context of multiple biobank scenarios/goals. Presenters will discuss how these tools can be used to meet specific requirements of ISO 20387 as well as the general pursuit of fitness-for-purpose. Among the tools to be introduced are the ISBER Self-Assessment Tool (SAT) and ISBER Self Auditing Tool.

 

A panel will discuss the application of this integrated map, with several case studies to demonstrate the considerations that come into play, and examine potential outcomes. The panel discussion will be followed by an audience question and answer session and interactive dialogue on the stand-alone and complementary application of standards, best practices, and other resources, including those apart from ISBER (e.g. CAP and CTRNet) to achieve fitness-for-purpose through quality biobanking processes and products.

 

A significant number of biobanks may find that their pursuit of ISBER tools and other instruments will have taken them a significant distance towards implementation of the ISO20387 standard. This workshop will build upon concepts described during previous ISBER workshops and will serve to help participants understand how biobanking standards, taken together with the broad spectrum of tools now available, can help to improve quality in biobanking.

 

Attendees will learn how to:

  • Access, understand, and implement ISO standards such as ISO 20387 and ISO 22758
  • Differentiate a number of quality-related tools to achieve fitness for purpose for their biobank
  • Identify considerations for the choice and use of tools to achieve fitness for purpose for their biobank
  • Use ISO 22758 Implementation guide for ISO 20387 to assist with ISO 20387.
15:45 - 17:15
Educational Workshop: Irreproducible Research Based on Human Biospecimens: Can New Models of Bioresources Ameliorate This Problem?

Presenters: William Grizzle, University of Alabama at Birmingham, Shannon McCall, Duke University School of Medicine

 

Perceived irreproducibility in research results using human tissue may be due to experimental design, exclusion of data, analytical approaches, and statistics, or may be secondary to bias associated with biospecimens including preanalytical variability, bioresource operations, and biospecimens that are suboptimal. This workshop focuses on tissue variables that may impact research with human biospecimens. Problems can be exacerbated when new models such as reproducible biospecimens are developed or added to an existing bioresource. Irreproducibility increases if investigators and bioresource personnel are not adequately educated as to its causes. Personnel should be trained in new bioresource models before their adoption, e.g., living biobank.

 

Specific areas that will be addressed are the following:

  • Pre-analytical variables that affect the usefulness of human tissues in research include donor variables, changes secondary to initial diagnosis, warm and cold ischemia, tissue damage during surgery, and limitations and errors imposed by collection, processing, storage, and/or distribution of biospecimens and variables of renewable biospecimens and their optimal use
  • Quality assurance including quality control
  • Sources of bias associated with the use of biospecimens in research including patient-derived renewable biospecimens
  • Biospecimen features necessary to support research based on specific technologies and preparations that may require macro/microdissection
  • Storage parameters and distribution approaches affecting biospecimens including renewable biospecimens
  • Tissue utilization of biospecimens including renewable biospecimens • Challenges in meeting future research needs

Drs. McCall and Grizzle are experienced diagnostic and research pathologists with knowledge of bioresources, translational research, biorepository sciences, and bioresource modifications needed for renewable biospecimens. A ten-minute discussion period will allow questions from participants and sharing of ideas.

 

At the end of the workshop, participants will have an introduction or understanding of:

  • Irreproducibility of research results
  • Experimental bias related to irreproducible results
  • Pre-analytical variables and how they cause bias
  • Limitations of research with human tissue
  • Problems with renewable biospecimens and associated changes in typical biobanking operations
  • New skills and training needed for renewable biospecimens.
17:15 - 17:30
Closing Ceremony
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