Please note that the preliminary program will continue to be updated as details are finalized.
Registration for the pre-conference workshop is in addition to meeting registration. The registration fee is $95.
ISBER Update: Qualification in Biorepository Science
Presented by: Brent Schacter
ISBER and the ASCP have partnered to create a new qualification exam for biobankers. This short presentation will provide the audience with updated information about this qualification program in the field of biorepository science.
Basic Business Planning for Biobanking
Presented by: Marianne Henderson, Daniel Simeon-Dubach, Kirstin Goldring
Successful Biobanking operations begin with accurate and responsible planning. This session will provide guidance on how fulfill your banks mission by formulating a business plan that will satisfy stakeholders through the use of SMART performance metrics and audit points. Discussions will include infrastructure assessments, Funding and cost management as well as SWOT analysis.
Success is the Result of Preparation: Emergency Planning for Biobanks
Presented by: Helen Morrin, Rebecca Pugh
Emergencies can occur everywhere and Biobanks are just as likely as every other industry to suffer the consequences of poor planning. This session will help you build a culture of preparedness to ensure that your assets (specimens, data, infrastructure and staff) can be protected from disasters. Interactive discussions and activities will address risk assessment, crisis management, critical response procedures, planning for natural disasters, as well as data protection and recovery. This workshop will offer the opportunity to discuss the unique emergencies that may affect your operations and offer solutions to help you create your own emergency plans.
Pre-registration required. Registration fee is $5.
Research technologies are transforming our biological knowledge-base in ways that have never been possible. As the stewards of quality biospecimens and associated big data, biobanks are providing pathways to diagnostics and discovery that permeate across the globe with the goal of improvement in prevention, wellness, and healthcare applications. The opening plenary of ISBER 2020 aims to provide high-impact scientific narratives in which biobanks have paved the road towards a better tomorrow. Accomplishments in biomarker discovery, community engagement, and advancements in artificial intelligence will be some of the storylines highlighted by speakers who have utilized biobanks for their research.
KEYNOTE: The Transformative Power of Lifestyle Medicine
Dean Ornish, MD, Preventive Medicine Research Institute, USA
Biodiversity Archives as Databanks of Ecosystems Past
Kyle Van Houtan, PhD, Monterey Bay Aquarium, USA
CIRM – A Global Leader in the Translation of Stem Cell Science into Cell and Gene Therapy Medicines
Abla Creasey, PhD, Californa Institute for Regenerative Medicine, USA
Making Real Advances in Health and Life Sciences
Lester Russell, MD, MBA, FFCI, National Health Service, United Kindgom
Using Data Privacy to Empower Health Research
Dawn Barry, MBA, LunaPBC, USA
This presentation will discuss validation of the groundbreaking MVE Fusion® Series Freezers self-sustaining technology that untethers liquid nitrogen storage from regular supply requirements. The MVE Fusion may be utilized in locations where it is impractical or impossible to use other liquid nitrogen technologies.
Speaker: Dr. Robert Hanner, Associate Professor, College of Biological Science, Department of Integrative Biology, University of Guelph
Advancing personalised medicine will require new and effective biomarkers that will aid in early and better diagnosis and the development of efficient new therapies. The hallmark of such advances lies in successful translational research which utilizes human biospecimens. Breakthrough discoveries will therefore require quality biospecimens for the identification, development and validation of new research findings.
The session represents a review of biobanking of novel human cell systems for a new generation of cellular therapies and personalised diagnostic testing. Speakers will address the new challenges that these systems bring for biobanks in terms of ethics, data management, preservation technology, quality control and characterisation. They will also present potential new technologies and thinking that will be needed to meet these challenges.
Biospecimens to Profile Human Diseases
Ida Biunno, PhD, ISENET Biobanking, Italy
Creation of the CIRM iPSC Collection for Disease Modeling and Drug Screening
Stephen Lin, PhD, California Institute for Regenerative Medicine, USA
Blood Profiling Atlas in Cancer (BloodPAC) Consortium: Raising the Bar for LBx Data in Public Databases
Lauren Leiman, MS, MBA, Blood Profiling Atlas in Cancer (BloodPAC), USA
Jerry Lee, PhD,University of Southern California, USA
The European Bank for Induced Pluripotent Stem Cells (EBiSC)
Heiko Zimmermann, PhD, Fraunhofer Institute for Biomedical Engineering, Germany
The International Stem Cell Banking Initiative: Building Consensus
Meri Firpo, Memphis Meats, USA
Biorepository specimens and data can only fulfill their potential to truly transform health and accelerate scientific discovery if the outcomes are robust and meaningful for all. Biobanks need to be inclusive of all populations, including the underserved and vulnerable communities to address the current lack of diversity and genetic bias, in addition to reducing health disparities. The advent of precision medicine and increased use of genomic tools (including WGS, WES, targeted gene panels, somatic sequencing in cancer, etc.) in both clinical medicine and research has highlighted the urgency to acquire samples from diverse genetic populations and ancestral communities to create meaningful results for all groups. Engagement with these communities face additional challenges, requiring sensitive responses to building trust and partnerships, to meet each community’s needs.
This session will highlight the importance of including underserved and vulnerable communities in biobanking and a roadmap to address the missing communities and populations. Presentations will include an overview of the breadth and need in this field and focus on the engagement and proven methods for recruitment and retention of these communities, along with research outcomes and impacts. A panel discussion featuring experts with further global perspectives and experience concludes this session.
Underserved and Vulnerable Population Biobank Participation: Is it happening?
Paula Kim, TRAC-Translating Research Across Communities, USA
Recruiting Racial & Ethnic Minority Women to the Komen Tissue Bank: A Motivational Roadmap
Kathi Ridley-Merriweather, MA, Susan G. Komen Tissue Bank at the IU Simon Cancer Center, USA
Biobanking – A Southern African Perspective
Himladevi Soodyall, PhD, Academy of Science of South Africa, South Africa
Research at the Service of the Most Vulnerable: How to Team-Up and Ensure Their Inclusion in Advanced Research Processes
Sara Casati, PhD, BBMRI-ERIC, Italy
Pre-registration required. Registration fee: $40
The 8th Annual Fun Run/Walk/Sleep event is scheduled to take place early morning on Thursday, April 16. All proceeds will benefit the ISBER Travel Award which provides complimentary registration and travel support for biobankers from emerging countries to attend the ISBER Annual Meeting. Register for the Fun Run/Walk/Sleep when completing your meeting registration, or at the registration desk on-site and join us for an invigorating Thursday morning!
Biobanks have become key assets to research and clinical care. Biobanks require financial and operational support from organizations, key stakeholders and the community to be sustained. This plenary symposium will highlight scientific success stories that have resulted from the use of fit for purpose biospecimens and data from biobanks to power their findings and translation into practice. Scientific success feeds back to increase the stature and reputation of biobanks as an important infrastructure in discovery research. Lessons learned from this plenary will be specific examples of how scientific success can be leveraged to increase the value/reputation and financial, operational and social sustainability of biobanks.
KEYNOTE: From Human Tumor Biobanking to Human Tumor 3D-Bioprinting: Innovating for Personalized Medicine in Oncology
Nicolas Forraz, PhD, CTI Biotech, France
The Russian Radiobiological Human Tissue Repository of the Southern Urals Biophysics Institute (SUBI)
Christopher Loffredo, PhD, Georgetown University Medical Center, USA
Value of Proactive Participation of Patients for Drug Discovery and Development
Yoshinoro Satomi, PhD, Shionogi & Co., Ltd, Japan
Reef Coral Health Evaluation and Biobanking in an Era of Changing Global Climate
Anderson Mayfield, PhD, NOAA/University of Miami, USA
Biobanking in Latin America: Achievements, Challenges and Perspectives
Antonio Hugo Campos, MD, PhD, Rede D’Or Network Hospitals, Brazil
Corporate Workshop Hosted by Labvantage Solutions Inc.
Corporate Workshop Hosted by Liconic Instruments
Moderator: Steve Broach, Biobanking Specialist, Liconic Instruments
- Dr. Peter He, CSO, VP Origincell, Shanghai China
- Steve Broach, Biobanking Specialist, Liconic Instruments
The storage and retrieval of frozen biological samples sensitive to temperature excursions above the commonly accepted upper limit of the glass transition phase of water (Tg: -137°C) are currently undergoing a significant shift from traditional manually based practices and processes to the incorporation of some level of automation. This migration confers myriad advantages to the primary objective of maintaining sample integrity.
This workshop will provide insights and a discussion forum on improvements in cryogenic sample handling practices as they impact the larger expansion of biological samples’ role in elucidating the biochemical mechanisms of genetic profiles, disease states, and therapeutic modalities.
1:00pm – 1:10pm – Opening Remarks and Historical Perspective on Cryogenic Sample Storage
Presented by Steve Broach
1:10pm – 1:30pm – Stemcell Cell Case Study
Presented by Peter He
1:30pm – 1:40pm – Automation Case Study
1:40pm – 2:00pm – Panel Discussion
Moderated by Steve Broach
Corporate Workshop Hosted by Brooks Life Sciences
Speaker: Marta Castelhano, DVM, MVSc, Director, Cornell Veterinary Biobank
Biobanks play an integral role in research and precision medicine by collecting, processing, storing, and distributing high-quality biological material and associated data. With large commitments from the institutions that support biobanks – the NCI has reported spending over 50 million dollars per year on its biobank infrastructure – and advancements in precision medicine resulting directly from these resources, stakeholders (donors, funders, and users) are more likely to request a value and impact measure for the biobanks they support, along with a long-term sustainability plan that can assure the continuous running of such operations beyond the immediate future.
Biobank sustainability has been defined and characterized to encompass three dimensions (financial, operational, and social), and solutions have been proposed to increase sustainability practices. To address the social dimension of sustainability, the proposed strategies have included two major components – one relating to the acceptability of the biobank’s activities by not only the participants/donors, but also the public at large, and the other a commitment to accept standards of practice with approaches that show the commitment to those practices, such as enrolling in accreditation or certification programs for biobanks.
In January 2019, the American Association of Laboratory Accreditation (A2LA) introduced the ISO 20387 Biobank Accreditation Program. This third party accreditation offered an independent review of an organization’s compliance with ISO 20387 – General Requirements for Biobanking, the first standard released by the International Organization for Standardization (ISO) exclusively for biobanks. In this workshop we will explore how accreditation to ISO 20387 can improve biobank sustainability, by using the case example of the first biobank in the world to receive accreditation to this standard – the Cornell Veterinary Biobank.
- Biobank Sustainability Dimensions
- Biobank Sustainability Practices
- Types of Conformity Assessment and Attestation
- Importance of Biobank Accreditation
- Case Study of Sustainability Improvements through Accreditation
- Aaron J Goldenberg, Case Western University, USA
- Kyle Brothers, University of Louisville, USA
- Jean Cadigan, University of North Carolina, USA
Research in precision medicine aims to identify subsets of patients who share the same biological mechanisms for their disease, and are thus more likely to respond to the same targeted therapies. To achieve this level of personalized health care, researchers need large collections of biospecimens and associated data. While there are a number of large cohorts at individual institutions across the country, individual biobanks and repositories may not provide the diversity and size needed to support further development of precision medicine.
To address this need, many research institutions and smaller biobanks are promoting the networking of multiple biorepositories within or across institutions. This networked biorepository approach permits researchers to access larger, more diverse sets of data and biospecimens through one common interface, while leveraging and preserving the relationships local institutions have built with their communities of donors. However, with these benefits come a number of challenges related to the ethical, regulatory, and governance needs for establishing and maintaining a successful biobank network. For example, each institution that contributes to a networked biorepository likely has its own governance structures and donor needs. For this reason, the networking of cohorts adds a level of complexity to ethical and regulatory considerations, while at the same time introducing a number of novel challenges.
This workshop will explore the unique ethical and governance questions raised by networked biorepositories. We will first discuss data from a study of the perspectives and experiences of stakeholders actively engaged in designing, operating, and governing networked biorepositories. The aim of this project is to characterize the ethical and regulatory challenges created by existing and proposed models for networked biorepositories, and identify policy and practice solutions available for addressing these challenges. This project has included the assessment of experiences from over 25 biobank networks across the US. Participants will be asked to react to our study data and share their own perspectives on the challenges of networked biobanks.
We will then split participants into small groups and provide each group with case studies based on challenges encountered by networks in our study. Participants will have an opportunity to review and discuss their cases, with the goal of identifying and prioritizing possible solutions. These cases will also give participants a chance to discuss the various challenges that could be raised by networking their own collections, including how to address consent, privacy, data security, and data access. Finally, we will utilize the feedback from the workshop and our presented data to collaboratively identify possible best practices for governance and oversight structures best suited for addressing the unique challenges and opportunities in networked biorepositories.
- Marianna Bledsoe, Biopreservation and Biobanking, USA
- Jason Chen, China National GeneBank, China
- William Grizzle, University of Alabama at Birmingham, USA
- Amanda Rush, NSW Health Statewide Biobank, Australia
Further details will be available shortly.
- Stephen J. Wicks, University of Colorado, USA
- Rajeev Singh, Houston Methodist, USA
- Kristy R. Crooks, University of Colorado, USA
- Koh Furuta, CIBER, Japan
- Marianne Henderson, National Cancer Institute, USA
- Yoshinori Satomi, Shionogi & Co., Ltd, Japan
This interactive workshop will concentrate on a couple of data paradigms, seek answers on relative importance of these, and show how biobanking can help in these endeavors.
The workshop will discuss how pharmaceutical companies are seeking citizen participation for collection of individual patient life logs and medical history data, in addition to the genomics and biomarkers analysis, to design new treatments, and how biobanks can play an important role in these pharma-citizen symbiosis. Current data collection models will be reprised.
The workshop will also zero in on the trending hot topic of returning results to biobank participants. The complexities involved, including ELSI issues, will be shared and audience view solicited to try and build a consensus on this debatable topic.
Feasibility and Comparison Study of Fecal Sample Collection Methods in Kidney Transplant Recipients using 16S rRNA and Metagenomics Approaches
Jamie Case, Scripps Center for Organ Transplantation, USA
Establishment of the Prognostic Index of Lung Squamous Cell Carcinoma Based on Immunogenomic Landscape Analysis
Yan Gong, Zhongnan Hospital of Wuhan University, China
Biochemically Tracked Variability of Blood Plasma Thawed-State Exposure Times in a Multisite Collection Study
Chad Borges, Arizona State University, USA
Can Genomic ScreenTapes Be Used to Assess Integrity And Concentration Of DNA Extracted From Formalin-Fixed, Paraffin-Embedded (FFPE) Tissue?
William Mathieson, Integrated Biobank of Luxembourg, Luxembourg
The Relevance of Preclinical Rodent Samples in Omics Method Development and Understanding of Disease Mechanisms
Sam Ansari, Philip Morris International – Science & Innovation, Switzerland
Freezing Tissue Biopsy Samples of Exotic Vertebrates for Future Initiation of Cell Culture
Marlys Houck, San Diego Zoo Global, USA
Aspects of Biobanking Governance: Legal or Ethics?
Henry Jay Silverman, University of Maryland Baltimore, USA
Electronic Consent For Pediatric BioBanking: Do Kids And Parents Understand What They Consent To?
Suzanne Vercauteren, BC Children’s Hospital, Canada
Returning Value to Participants in Biobanking and Research: The Cancer Moonshot(SM) Biobank Patient and Provider Engagement Portal
Esmeralda Casas-Silva, National Cancer Institute, USA
A Roadmap for Developing Uganda National Policy Guidelines for Biobanking
Hellen Nansumba, Uganda National Health Laboratory Services, Uganda
Policy Innovation and Tribal-Federal Partnership: The Alaska Area Specimen Bank
Brenna Simons-Petrusa, Centers for Disease Control and Prevention, USA
Creating and Refining Policy for Sample and Data Sharing in Southern African Biorepositories
Elizabeth Sarah Mayne, University of Witwatersrand, South Africa
- Michael H. Roehrl, Memorial Sloan Kettering Cancer Center, USA
- Pascal Puchois, Trans-Hit Biomarkers, Canada
The following are examples of the topics that the speakers will address:
- What does industry expect from a biobank?
- What are the different source channels that the Pharma-IVD industry uses to get biospecimens needed for research: Vendors, Commercial Biobanks, Web Sources, Market Platforms, Academic Biobanks, Pros and Cons
- What are the different models for cooperation of biobanks with the Pharma-IVD industry at the different stages of drug-biomarker development from fundamental basic research to final FDA filing? Will Biobanks understand what the current and future biospecimen needs are from industry?
- What are the regulatory constraints which, depending on the stages of drug-biomarker development, might prevent genuine scientific collaborations?
- What is the ideal contractual process for both parties? MTA or no MTA?
- What could be the different business models and cooperative networks of biobanks which could help to accelerate scientific discovery of new biomarkers and then translation to the bedside?
In order to maximize impact from this workshop, the participants will hear from all key stakeholders, including the representatives from:
- the R&D department from a diagnostic company
- the biospecimen procurement team from a large pharma or IVD company
- an academic biobank which cooperates with industry within scientific collaboration and also fee for services
- an academic biobank which does not cooperate with industry for different reasons
- a CRO developing interactions between industry and academia
- a commercial biospecimen provider
Presenter: Tatsuaki Tsuruyama, Kyoto University, Japan
In Asia and Oceania, there are many areas where temperature, humidity, etc., are higher than in Europe and the United States. In biobanks, high humidity and temperature seriously damage samples. It has been said that it would be ideal to have enhanced containers and infrastructure in the facilities and to maintain the room temperature and humidity. A hot and humid environment can damage samples, even when they are stored in and out of the storage device.
High humidity causes the breeding of organisms, such as mold, resulting in a deterioration of quality facility standards and the contamination of nucleic acids and proteins. This climatic condition also causes the breeding and entry of small animals, insects, and the like.
In addition to the recent issues caused by heavy rain, typhoons, hurricanes, earthquake, and tsunamis as a result of global warming, the reinforcement of facilities against earthquakes is indispensable. These disasters can frequently occur in the climates of Asia and Oceania. Preparedness to respond to potential fires caused by high temperatures should also be addressed. Disaster control measures are within the scope of this workshop.
It is interesting to review the measures needed to maintain biobank facilities in Asia and Oceania. Therefore, preparations, such as infrastructure maintenance (emergency power supply installation) and staff response manuals, may be required to protect samples before an actual disaster occurs. Further, how is Biobank’s disclaimer set in case of an unavoidable emergency? Sharing such accident experiences in each country is thought to be useful for the preparation of disaster manuals.
- William Grizzle, University of Alabama at Birmingham, USA
- Katherine Sexton, University of Alabama at Birmingham, USA
- Shannon McCall, Duke University School of Medicine, USA
The quality of biospecimens and services provided by bioresources are ensured if the bioresource operations are under the overall purview of a good quality management system (QMS). The components of a QMS typically include standard operating procedures (SOPs) for all activities, training of personnel including in safety, quality control and monitoring of biospecimens, management of investigator requests, periodic evaluations of the bioresource by users, and defined audits. This educational workshop will present the basics of design and operations of a QMS for all types of bioresources. The goal is an update for attendees of the concepts of quality. Specifically, examples of SOPs of bioresource activities in the format of the College of American Pathologists (CAP) will be presented and discussed. Similarly, the basics of the characteristics and requirements of a bioresource training program will be described. The training program discussion will include local, national and international requirements for training programs in safety. A major component of the QMS is quality control (QC) for ensuring that biospecimens and services meet the quality and needs of investigators and their research. The QC approach should require a correct diagnosis of each biospecimen provided to an investigator as well as information as to the extent each biospecimen is involved or not involved by a disease.
- Examples as to QC of biospecimens of malignant and non-malignant diseases will be given.
- The approaches to ensuring the quality of data provided to investigators also will be described.
- The intersection of an investigator’s requests for biospecimens with QC will be described.
- How to set up a program of periodic audits of bioresource operations also will be presented.
Corporate Workshop Hosted by Bruker BioSpin
Further details will be available soon.
Corporate Workshop Hosted by Agilent Technologies.
Join Agilent for a corporate partner workshop about monitoring biobank sample quality.
The DNA and RNA samples that you store in your biobank will be used for important research later. Our workshop will show you how to improve confidence in your sample quality, before and after samples go into storage using different automated electrophoresis platforms. In the workshop, we will have two retrospective analysis of sample storage conditions. Agilent’s nucleic acid QC portfolio streamlines the analysis of both DNA and RNA, including high-molecular weight genomic DNA through 165 kb. Each of Agilent’s automated electrophoresis instruments supply digital data with objective quality metrics that allows for easy data archiving and comparisons. Through the routine use of quality control biobanks can evaluate past and current procedures for continuous improvement while also providing biobank users a detailed understanding of sample quality.
You’ll learn how to:
- Use quality metrics to objectively judge the integrity of your nucleic acid
- Use less of your precious sample for your QC and Accurately size high molecular weight gDNA
- Use Quality metrics for continuous improvements of Biobank processes
10 mins- Objective analysis of DNA and RNA samples with quality metrics, Elisa Viering, MSc Agilent Technologies Waldbronn, Germany
20 mins- Assessment of Standardized Processes – A Retrospective Analysis on Quality of DNA Samples from the Heidelberg CardioBiobank (HCB), Steffi Sandke, Phd, Coordination Office and Scientific Management University Hospital Heidelberg
20 mins- Title (TBD), Monique Albert PhD, Ontario Biobank
10 mins- Q&A
Corporate Workshop Hosted by Freezerworks
- Cheryl Michels, President & System Architect, Dataworks Development, Inc.
- Joe Carrano, Account Manager, Dataworks Development, Inc.
Do you ever wonder if you are asking the right questions when selecting software? Join us for a workshop that will put your mind at ease and your research on the path to success. We’ll cover best practice alignment, key support considerations, and tips on becoming a more informed customer.
Corporate Workshop Hosted by OpenSpecimen
- Srikanth Adiga, CEO, OpenSpecimen
- Poornima Govindrao, Product Manager, OpenSpecimen
OpenSpecimen is a comprehensive biospecimen informatics platform used to track specimens from collection to utilization. Used in 70+ top clinical research centers including Johns Hopkins, UPitt, Emory, UTexas, U of California, etc. It enables biobanks to collect “high quality” data for all types of specimen collections, has a flexible and easy to use user interface and powerful reporting module. It can be integrated Epic, REDCap, Cerner, or any other databases using the REST API.
- Introduction to OpenSpecimen
- Adopters talk about how they use OpenSpecimen
- Online resources to learn and evaluate OpenSpecimen
Corporate Workshop Hosted by PerkinElmer
Speaker: Andrew Brooks, Chief Operating Officer and Director of Technology Development / Chief Scientific Officer RUCDR Infinite Biologics / Brooks Life Sciences
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 solution
- Why preserving sample integrity through automated cold chain sample management is vital for sample viability and throughput efficiency
- High Throughput Nucleic Acid Extraction workflow technology advancements
- Quantification and Nucleic Acid Normalization techniques
- The importance of High Quality nucleic acid extraction
- Example case study workflows of automated sample management and Nucleic Acid Extraction workflows and the importance to future precision medicine treatments
Corporate Workshop Hosted by Thermo Fisher Scientific
Speaker: Erik Steinfelder, Biobanking Market Development Director
Last year, a study performed by the German Biobank Node (GBN) proved again that researchers are in need of high-quality samples that have been processed and stored under reliable conditions. While this might seem obvious, it is easier said than done for many biobankers. What is the best way to prepare and store samples if you are focusing on specific molecular mechanisms of diseases versus investigation of target expression in large patient cohorts when designing a clinical trial? Before samples are actually stored, it is good to have a clear understanding of their potential use i.e. which analytical technologies will be used. In those cases where the analytical end goal is not clear, consensus should be there on which general storage conditions must apply. In the last decade, hundreds of biobanks around the globe were supported by our cold storage solutions, pre-analytical workflows and -omics technologies. What did we see, learn, develop and improve that could help you achieve the requirements of researchers that are desperately looking for samples and associated clinical data? Join us for an industry perspective presented in an interactive manner that could help you to optimize your approach and processes.
- Joseph Kessler, Medpace Reference Labs, USA
- Marianne Henderson, National Cancer Institute, USA
- Tali Johnson, National Cancer Institute, USA
As biospecimens across the world are sitting in freezers, monthly maintenance costs burden the guardians of the collections and their steward organizations. Are the samples in use today? Maybe they are new but must wait for time to use or share? Or are they legacy samples that may not be relevant today?
The presenters are in the end stages of development of a value-based decision-making tool – to support valuation (non-economic) and evaluation of collections in storage from across all biomedical sectors. Specific input from biotech, academic and government biobankers was incorporated into the beta version of the tool. Focused first in human biorepositories, the tool will allow biobankers or researchers a decision-making support to determine if each collection that they have in storage should be saved (investment in continued funding), shared (maybe kept or transferred to others or returned) or destroyed (no value, no ability to use due to lack of consent etc.). The decision tree will be in a user-friendly application that is easy to navigate for a Biobank or PI user and will provide an output in the form of a value score.
The value score will provide applicable information to the custodian of the collection for justifying to stakeholders (funders, operators, community, etc.) that continued investment in storing the collection is a worthwhile investment or not!
The workshop will focus on an overview of the tool and the decision-making interface involved in using it, how the decisions lead to a value score and how those scores could be used practically. The presenters will include a few (2-3) beta testers of the tool, who will present their feedback on its feasibility and utility. The outcomes include user feedback that can be incorporated into the tool development to increase its utility and robustness as a useful mechanism to create a value proposition for collections in your biobank.
- Brent Gali, BC Cancer – Biobanking and Biospecimen Research Services (BBRS), Canada
- Lise Matzke, UBC Office of Biobank Education and Research, Canada
- Tamsin Tarling, UBC Office of Biobank Education and Research, Canada
- Sheila O’Donoghue, BC Cancer Agency Tumour Tissue Repository, Canada
- Suzanne Vercauteren, BC Children’s Hospital Biobank, Canada
- Peter Watson, BC Cancer Agency, Canada
- Amanda Rush, NSW Health Pathology, Austrailia
- Shannon J. McCall, MD, Duke University School of Medicine, USA
Further information will be available soon.
- Clare M. Allocca, National Institute of Standards and Technology, USA
- Monique Albert, Ontario Institute for Cancer Research, USA
- Marianna Bledsoe, Independent Consultant, USA
- Koh Furuta, CIBER, Japan
- Shannon McCall, Duke University School of Medicine, USA
- Brent Schacter, CancerCare Manitoba, Canada
- Daniel Simeon-Dubach, medservice, Switzerland
Background: Biorepository standards and best practices are critical for ensuring that biospecimens are fit for their intended purpose (FIP) 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, including the broad-ranging ISBER Best Practices and a Self-Auditing Tool. Additionally, there are several other resources (e.g. CAP, CTRNet) available to facilitate approaches to FIP in biorepositories. How can these best practices, tools and standards work together to meet individual FIP goals?
Objective: Previous workshops touched upon the principles of combining tools to meet FIP goals. These principles will be summarized briefly to provide a foundation for targeting potential issues to be encountered by new, small and/or specialized biorepositories, and biorepositories in economic regions that will be particularly challenged by the resource requirements of a full FIP program. Topics include:
- Anticipated requirements and concerns for specific countries/economies (experts on specific countries will be sought to participate) and specific areas (human, animal, and environmental biorepositories)
- Use of a combination of tools to take first steps towards FIP
- Analysis of benefits of pursuit of FIP so that biorepositories can make good business decisions as to their own “FIP toolbox”
Approach: There will be 2 sessions: session A is an introduction and panel discussion; session B will divide the audience into groups to discuss scenarios introduced in session A.
Session A will address FIP tools and include a panel to discuss relevant case studies, and will end with development of multiple scenarios, real or hypothetical, by the panel and our participants. Scenarios will each be assigned to a group of participants whose objective will be, with assistance of a mentor/moderator from the organization team, to develop a plan for pursuit of FIP. This plan might consist of questions to explore, combinations of resources to use, potential benefits of different paths, and criteria by which to judge success. In addition to the mentor/moderator, each group will be given summary sheets describing potential applications of the array of tools being discussed.
Session B would begin with a summary of principles and group topics for those unable to participate in session A. Groups will reform and work will continue in interactive groups. A rapporteur from each group will summarize discussions and conclusions.
Conclusion: Trends among all groups will be identified and summarized. Participants will be invited to pose questions to their team mentor/moderator, or to the panel during the summary session.
Analysis of Sample Integrity for Developing a “Value Statement” of Samples and Biobank in China
Charles W. Wang, Shanghai Xinhua Hospital, China
Construction and Development of Clinical Biological Resource Bank for Women and Children
Xiaoqiong Gu, Guangzhou Women and Children’s Medical Center, China
Feasibiility of Assessing Fresh Tumor Quality by Real-Time Remote Digital Viewing Via iPhones: A Study of 195 Cases
Therese J. Bocklage, University of Kentucky COM, USA
Integration of Biobanks into Precision Medicine – A Real Life Example
Anthoula Lazaris, Research Institute of the McGill University Health Centre, Canada
CAP Biorepository Accreditation and ISO 20387: A Gap Analysis
Shannon J. McCall, Duke University, USA
The Women First Clinical Trial Biobank: Participants in Vulnerable and Underserved Populations
Jennifer Kemp, University of Colorado Denver, USA
An Economic Analysis of Cancer Biobanks in New South Wales
Amanda Rush, University of Sydney, Australia
Re-Developing a Human Tissue Retrospective Research Project Request Form
Tiffany H. Shaw, Intermountain Healthcare, USA
New Biobanks Require New Generation of Biobankers: Experience from the Czech Republic
Judita Kinkorova, University Hospital in Pilsen, Czechia
Biobanks Supporting Clinical Study Submission – Clinical Data Interchange Standards Consortium (CDISC) Standards for Biospecimens
Oliver Karch, Merck KGaA, Germany
Data Management Tools in the NIST Biorepository
Jared M. Ragland, National Institute of Standards and Technology, USA
Moving with the Times: The Health Science Alliance Biobank Pathway to Sustainability
Carmel M. Quinn, University of New South Wales, Australia
The round table discussions are an opportunity for delegates to connect and openly discuss various issues in the biobanking industry. This years topics include:
Valuation of Collections Prior to Transfer into an Existing Biobank
Facilitated by Lise Matzke, UBC Office of Biobank Education and Research, Biobanking Biospecimen Research Services, Canada
Artificial Intelligence Applications in Biobanks
Facilitated by Karine Sargsyan, Medical University of Graz, Austria
Establishment of IPSC using Stem Cell Bank Resources
Facilitated by Hongmei Zhou, Shanghai East Hospital affiliated with Tongji University, China
Biobanking Outcomes: Measuring the Impact of Biobanking in Science and Medicine
Facilitated by Lalita Wadhwa, Texas Children’s Hospital, USA
Adoption of Lessons Learned from Failure Stories in Biological Materials Shipment: Why, What and How
Facilitated by Laurent Dollé, Biobanking Wallonia Brussels, Belgium
Biospecimens are collected because they contain the information we require to understand biology, disease and the world we live in. Biobanks have become the ‘librarians’ essential to unlocking the stories associated with each biospecimen. In vision the next generation of biobank having specimens enriched by clinical, molecular and Omics data, will biobanks need to be run as data-driven enterprises? Should they be active in the generation of vast amounts of computer readable information and its interrogation? How are biobanks preparing for a future where biospecimens are integral to an informatics driven discovery process, engaging with the informatics industries as active partners?
Integrative Analysis of Clinical and Genomic Data Reveals Novel Genes Associated with Cardiovascular Traits
Benjamin Glicksberg, PhD, Icahn School of Medicine at Mount Sinai, USA
Integrating EHRs and Biobanks to Support Discovery
Quinn Wells, MD, PharmD, MSCI, MS, Vanderbilt University Medical Center, USA
Large-Scale Inference Across Genomes and Population Cohorts
Manuel Rivas, PhD, Stanford University, USA
Data Integration and Annotation
Michael Neumann, PhD, Interdisciplinary Bank of Biomaterials and Data Würzburg – IBDW, Germany
Biobanks have been portrayed as having the promise to unlock biological processes and promote a better tomorrow. Following the advent of the human genome project, biobanks have become the bedrock to accelerating scientific discoveries. Stemming from the success stories is a blueprint that places the biobank community at the forefront of research infrastructure for many generations to come.
Successful repository operations with a solid base in the implementation of best practices are universal and can be scaled for implementation in any size operation. This session will highlight proven, successful repository operations across the globe. Presentations will demonstrate how repositories stayed relevant and developed coordinated activities to tackle challenges and the changing demands of the scientific communities they serve. Discussions will include utilization of the methods and technology that support acquisition, data annotation, processing, quality control, cryopreservation, and cold-chain logistics.
Multi-Faceted Biobank in Global Medical Research Arena
Shirley Tsang, BioMatrix, USA
Navigating and Optimizing Cryopreservation Protocols and Technology through Global Research and Innovations
Dayong Gao, PhD, University of Washington, USA
CNGB’s Approach for Better Sample/Data Sharing
Yunice Shao, MD, MPH, China National GeneBank, China
Evidence-Based Biobanking in the Interface Between Translational Cancer Research and Cancer Diagnosis
Iman Farahat, MD, PhD, Egyptian National Cancer Institute, Egypt
The availability of large quantities of biospecimens and data for research use has led to major advances in science and medical care. These advances depend upon broad participation from individuals and groups, which is necessary to ensure the benefit of all. Maintaining the trust of research participants, the public and other stakeholders is critical to broad participation in biobanking and biospecimen research. Remaining worthy of public trust requires authentic participant and public engagement; trust is essential for biobank social sustainability.
Discussion at this gathering will focus on what makes a biobank trustworthy. This town hall forum, a first for ISBER, is designed for biobankers, researchers, IRB members, institutional officials, biobank participants and their representatives to discuss the factors that contribute to trustworthy biobanking. It will be an opportunity to identify best practices regarding topics such as consent, privacy, data sharing, and data security to help warrant the trust of research participants, the public, and other stakeholders. It will also be an opportunity to explore what ISBER should be doing to educate and engage the public regarding biobanking activities.