Preliminary Program

08:00 - 17:00
Exhibit Installation

Custom Builds (by request): 8:00am – 5:00pm

Exhibit Installation: 12:00pm – 5:00pm

08:30 - 17:30
ISBER Board Meeting (Invitation Only)
13:00 - 17:30
Marble Arch Meeting – Invite Only
13:00 - 17:00
Technician Workshop

*Pre-registration for this session is required and will be available shortly.

Biobanking has grown in the last twenty years and the fruits of the collective labor have started to emerge. Standard core activities exist in general (biological and environmental) biorepository operations such as accessioning, storage, processing, and shipping of samples. As the demand for high-quality samples for research, medical, and industrial application become more necessary; the need for standard biobanking techniques becomes critical for success.

This workshop shall examine the activities of sample collection, processing, storage, and shipping operations; while providing information on the use of standard methods to assist in maintaining high-quality samples for downstream application. What are the keys to a quality-focused accessioning system? What are the best methods for inventory organization within cold storage units? What considerations should be taken for successful maintenance of the sample supply cold chain? What tools are available to the technician for processing samples? What are the new technologies and innovations harmonizing approaches to evolving challenges in biological and environmental repositories? These are some of the questions to be addressed within this workshop. In addition, small group discussions, led by industry professionals, shall conduct deep dives of how these activities are executed within their respected space and provide practical insight to the challenges faced by technicians today.

16:00 - 19:00
Registration Open
17:30 - 19:00
BIO Editorial Meeting (Invitation Only)
06:30 - 18:30
Registration Open
06:45 - 08:45
Coffee & Pastries
07:00 - 17:00
Speaker Services Open
07:00 - 08:00
Committee Meetings
08:00 - 09:00
Getting to Know ISBER

Find out more about ISBER and get the chance to interact with new members. All meeting participants are welcome and encouraged to attend.

09:00 - 16:00
Exhibitor Installation
09:15 - 12:15
Symposium 1: Creating Global Impact through Big Ideas and Biobanking: Finding Common Ground in Diversity

Chairpersons: Nicole Sieffert (USA), Marianne Henderson (USA)

Session Description:
Big ideas can have global impact by building bridges between stakeholder communities and biobanking sectors. The most successful big ideas leverage knowledge and resources for broad benefit rather than a single scientific discovery or a specific application. This session will illustrate how big ideas intended for targeted benefit can create global impact across sectors with quality biobanking as an essential element.


9:15am – 9:30am
ISBER Welcome and Opening Remarks
Zisis Kozlakidis, ISBER President

Keynote Lecture: Longitudinal Profiling of Biospecimens and Development of Predictive Biomarkers for Therapies – MD Anderson APOLLO program
Ignacio I. Wistuba (USA)

10:15am – 10:45am: Coffee Break

10:45am – 11:15am
Animal/Agriculture/Museum: Giant Panda Conservation
Hou Rong (China)

11:15am – 11:45am
From Prediction to Prevention, Personalized
Sarah Laskey (USA)

11:45am – 12:15pm
An App a Day? Ethico-legal Considerations for mHealth Apps
Ma’n Zawati (Canada)

12:15 - 13:30
Corporate Lunch Symposium
13:30 - 16:00
Symposium 2A: Advocacy in Biobanking

Chairpersons: Daniel Catchpoole (Australia), Billy Schleif (USA)

Session Description:
Advocates for specific diseases, population groups or environmental causes are entering the biobank-driven research domain. As research shifts from specific hypothesis-driven, investigator-initiated studies to broad data-driven collaborations, there is increasing reliance on systematic biobanking who interact with individual donors to enable the supply of biospecimens required for these big studies. The goal of advocates is to ensure that the voices of individual donors are heard and their concerns are addressed. This session will explore the role of advocacy within biobanking in both the human (biomedical) and animal/environmental domains. Key questions to be addressed include the role advocates have in guiding biobank establishment and operations, directing research and ensuring its impact, and determining governance policies involving biospecimens. How should biobanks partner with advocates and what is the key to strengthening these relationships – empowerment or education?


1:30pm – 1:55pm
Community Approaches to Biobanking
Natasha Bonhomme (USA)

1:55pm – 2:20pm
Advocacy in Biobanking: A Pediatric Oncology Advocate’s Perspective
Vickie Buenger (USA)

2:20pm – 2:45pm
A Framework for Indigenous Biobanking
Ngaire Brown (Australia)

2:45pm – 3:05pm: Coffee Break

3:05pm – 3:30pm
Coral Cryopreservation – Can Biobanks Help Save Coral Reefs?
Mary Hagedorn (USA)

3:30pm – 4:00pm
Panel Discussion

13:30 - 16:00
Symposium 2B: Data Today and Tomorrow: How Biobanks can Prepare for Translational Medicine

Chairpersons: Amelia Warner (USA), Cheryl Michels (USA)

Session Description:
Biorepositories are important sources for building large datasets that fundamentally escalate understanding of disease mechanism and treatment efficacy. Building the underlying data structure, governance model, and data sharing policies are critical to allow growth and evolution for today’s biorepositories. This session aims to target items for consideration to make biorepositories of 2018 part of the Big Data Analytics of the future.


1:30pm- 2:00pm
Commercial Biobank Data Issues and Considerations for the Future
Deb Reinhard (USA)

2:00pm – 2:30pm
Data-Driven Research and Decision Making in Agribusiness
Hans van Leeuwen (Belgium)

2:30pm – 3:00pm: Coffee Break

3:00pm – 3:30pm
Building Biorepositories to Fit into Big Data Structures of the Future
Peter Tearle (USA)

3:30pm – 4:00pm
Translation of Biobanked Specimens into Meaningful Datasets
Angela Christiano (USA)

16:00 - 17:00
Poster Installation (Session 1)
16:00 - 20:00
Exhibit Hall Open
16:00 - 17:00
Working Group Meetings
17:30 - 20:00
Welcome Reception
06:00 - 07:30
5K Fun Run/Walk/Sleep

All proceeds from the 5K Fun Run/Walk/Sleep will be used to benefit the ISBER Travel Award, which provides complimentary registration and travel support for biobankers from low and middle-income countries to attend the ISBER Annual Meeting. Register for the Fun Run/Walk/Sleep while registering for the meeting and join us for an invigorating start to Tuesday.

07:00 - 18:00
Registration Open
07:00 - 07:45
Coffee & Pastries
07:00 - 17:00
Speaker Services Open
07:45 - 08:45
Corporate Workshops
09:00 - 12:00
Symposium 3A: Big Innovations in Biospecimen Science: Unlocking a New World of Biobanking Capabilities Through Advances in Biopreservation Sciences and Biospecimen Pre-Analytics

Chairpersons: Jason Acker (Canada), Stella Somiari (USA)

Session Description:
Collaborative efforts are underway between public, private, and industry partners to advance biospecimen research in a variety of fields. These efforts include data exchange, data harmonization and improvement of research protocols. Current advances in biomedical science, conservation, biodiversity, cryobiology and the systematic investigation into the impacts of pre-analytical variables will guide research and set new standards for future sample collection, processing, and storage.


9:00am – 9:30am
BloodPAC: Establishing Standards to Accelerate Development and Approval of Liquid Biopsy Technology
Jerry Lee (USA), Lauren Leiman (USA)

9:30am – 10:00am

Preserving Urine Simply and Economically for the Next Generation Biomarker Discovery
Youhe Gao (China)

10:00am – 10:30am
Rationally Designed Ice Recrystallization Inhibitors – Overcoming the Limitations of Cryopreservation
Robert Ben (Canada)

10:30am – 11:00am: Coffee Break

11:00am – 11:30am
Conservation of Aquatic Resources: The Long Road to Fish Embryo Cryopreservation Using Infrared Laser Warming
Mary Hagedorn (USA)

11:30am – 12:00pm
Panel Discussion

09:00 - 12:00
Symposium 3B: Sustainability in Motion: Biobanking Takes Strategic Dialogue and Innovation

Chairpersons: Marianne Henderson (USA), Daniel Simeon-Dubach (Switzerland) and Kirstin Goldring (UK)

Session Description:
Sustainability in biobanking requires innovative business strategies for organizations of all sizes. A successful sustainability plan is a living, breathing framework that needs to be discussed, reviewed, perhaps revised and re-envisioned to meet the goals for growth and scientific direction of the organization and all of its stakeholders (biobank staff, researchers, leadership, funders, industry, community, and others). The session will highlight innovative ways that the biobanks being presented have met the challenges to their biobank’s sustainability.


9:00am – 9:10am
Introduction to Sustainability in Motion – Partnerships/Collaborations/Innovations

9:10am – 9:35am
Leveraging Technology and Innovation Platforms to Drive Discovery of Novel Biological Crop Protection
Laura Lampa (USA)

9:35am – 10:00am
Academic-Pharma Collaboration and Sustainability
Hiroyuki Kobayashi (Japan)

10:00am – 10:25am
Development of an Academic Research Biobank in Indonesia: How to Keep Going
Jajah Fachiroh (Indonesia)

10:25am – 10:30am: Opening of Interactive Survey on Sustainability

10:30am – 11:00am: Coffee Break

11:00am – 11:25am
Venture Capital Perspective: Biobanks as a Starting Point for Business Ecosystems
Tanja Dowe (Switzerland)

11:25am – 12:00pm
Panel Discussion



09:30 - 19:30
Exhibit Hall Open
12:15 - 13:30
Corporate Lunch Symposium
13:30 - 14:30
Innovative Technologies
14:30 - 15:00
Coffee Break
15:00 - 16:00
Workshop 2: ISBER Best Practices: Recommendations for Repositories 4th Edition Update

Presenter: Sheila O’Donoghue (Canada)

More information will be available shortly.

15:00 - 16:00
Workshop 3: Accessing Human Samples to Deliver New Medicines for Patients: An Industry Perspective

Presenter: Clive Greene (UK)

Adequate and timely provision of appropriate quality, normal and diseased human tissue, accompanied by relevant associated data, is essential for experimental biomedical research to help pharma and biotech companies develop new healthcare interventions and diagnostics. Making human tissues widely available for approved and scientifically valid research is therefore in the public interest. Many companies have spent considerable resource building internal capabilities for utilizing human tissues from internal clinical trials and establishing or partnering a diverse, often global network of approved commercial and academic sources. This multi-modal supply approach is essential in securing samples appropriate to the field of scientific research and in such number that the experiments carry statistical significance to enable critical decision-making; ranging from starting a new drug project on a novel disease target to modifying a patients’ treatment regime.

Not all of the human tissues available to the drug discovery industry have appropriate characteristics to deliver impact from scientific research. Industry ascribes value to samples that are appropriately consented for exploratory science, are of sufficient quality to generate meaningful scientific results, have associated clinical meta-data to derive knowledge on disease and patient populations, and can be supplied quickly to enable agility in experimental design and response to clinical findings. Additional practical considerations need to be given to the procurement of suitable human tissues and how they must be provided to the drug discovery scientists. For example, establishing the appropriate source and format (surgical, post-mortem, tissue size, fresh, fixed, frozen), meeting the experiment or study criteria (post-mortem delay, warm or cold ischemic time, donor characteristics) and defining how and who will be responsible for transportation.

In general, industry experiences a strong track record in the supply of high-value human tissues from our internal clinical trials, commercial sources and specific academic collaborations; the latter of which are often cultivated over many years. Supply from these sources can be trusted to conform with the critical parameters for consent, quality, associated data, speed and simplicity that enable scientific innovation on a timeframe that meets requirements for patients and business. Industry recognizes that a far larger number of human tissues are collected across the broader academic setting. Whilst these samples potentially offer a much needed additional resource to advance drug discovery, there is growing awareness that without the creation of simple mechanisms to share samples and associated data, these collections will lie dormant; becoming increasingly wasteful of both the patient donations and the healthcare resources.

In this workshop, the ISBER Pharma Working Group will share and debate with workshop attendees: 1) the use of human samples in drug discovery and development, 2) a perspective on the challenges that exist for the drug discovery industry in accessing human tissues from Academic biobanks, and 3) steps that could be taken to increase the number of sample collections that have a positive impact on new medicine development and patients’ lives.

15:00 - 16:00
Workshop 1: Returning Individual Genetic Research Results: Challenges and Responsibilities

Presenters: Helena Ellis (USA), Sarah Dry (USA), Nazneen Aziz (USA)

Helena Ellis (Managing Director of Biobanking Without Borders, LLC) will discuss the key legal, ethical and social issues that must be considered when returning individual genetic results to a participant in a biobank. Issues include clinical validity, clinical utility, actionability, responsibility of the researcher, timing of enrollment in the biobank vs. timing of testing, whether the researcher is required to return results to the biobank, maintaining relationships with participants, and objective and subjective factors that influence a participant’s choice and the notion of return of results vs. return of value.

Sarah Dry, MD (Pathologist and Biobank director at UCLA) will present the feedback from UCLA’s community advisory board regarding returning individual genetic results, and present data from a survey of UCLA patients as well as provide insight from her unique perspective as a clinical pathologist as well as the director of a research biobank. Dr. Dry will discuss how these important and complex issues are foremost in the activities and goals for UCLA’s Precision Medicine program.

Nazneen Aziz, PhD (Executive Director of Kaiser Permanente Research Biobank-KPBR) will discuss the advantages of integrated health systems that serve patients both as their healthcare provider as well as the payer of services and how this type of system is well positioned to lead precision medicine efforts. Integrated health care systems such as Kaiser can bridge the gap between genomic research findings and clinical decision making. The KPRB is establishing a Translational Research Core that will “hand-off” genetic findings from biobank participants to their clinical team where the appropriate support and follow up will be provided to the patient. KPRB is conducting a large survey of patients and providers to determine their understanding of genomics, attitudes towards receiving results, readiness and expectations, and the infrastructure and resources needed. Dr. Aziz will discuss how these important and complex issues are a priority for Kaiser’s Precision Medicine Initiative.

Genetic Counselor- TBC- Genetic results are complicated, and may affect both the individual and their family. It may influence a person’s decision to have kids, additional family members may need testing, and participants may lack health insurance. This presentation will describe the services that a genetic counselor provides to patients and their families, such as the influence of family history, identification of risk factors, the risk and benefits of receiving genetic results, GINA, the effect on life insurance, applicable state laws, family member involvement, etc. This presentation will address the potential benefits and challenges in providing counseling in the context of different clinical situations (e.g. patients who present with a chronic illness may have a different reaction than a healthy individual discovering new, disturbing information). This presentation will compare the differences between the thoroughness of education and consent about genetic findings in the clinical setting vs. the research setting, and discuss the ethics and practicality of such issues as which healthcare provider is in the best position to have the first discussion with the patient.

16:15 - 17:30
Contributed Paper Sessions 1 & 2
17:30 - 19:30
Exhibitor and Poster Networking Evening
07:00 - 17:30
Registration Open
07:00 - 17:00
Speaker Services Open
07:30 - 08:15
Coffee & Pastries
08:15 - 09:15
Corporate Workshops
09:30 - 11:30
Contributed Papers Sessions 3 & 4
09:30 - 16:00
Exhibit Hall Open
10:45 - 11:45
Poster Take-down (Session 1)
11:30 - 12:45
Workshop 4: Designing and Maintaining a Human Tissue Repository, Part 1

Presenters: Kathy Sexton (USA), Bill Grizzle (USA)

The design and planning of a human tissue biobank or biorepository requires much preparation and forethought. This workshop will be presented in two parts:

Part 1:

Part 1 will discuss the different repository models that are available, the many issues that should be considered and the various types of services your repository might want to provide, leading the audience through questions they should ask and answer when considering the establishment of a human tissue biorepository at their institution. The answers to the questions will help them design the biorepository that is right for their needs.

11:30 - 12:45
Workshop 5: The Revised Common Rule: Practical Implementation Challenges for Biorepositories and Strategies for Addressing Them

Presenters: Mark Barnes (USA), Marianna Bledsoe (USA)

In January 2017, the US federal government issued revisions to the Federal Policy for the Protection of Human Subjects, commonly referred to as the Common Rule. These regulations involve a number of new changes that pertain to human biospecimen research and biorepository operations. These include changes to the definition of “human subject”, the option of using broad consent and limited Institutional Review Board (IRB) review for secondary research of human biospecimens and/or data, two new exemptions, additional criteria for a waiver of informed consent, and new consent requirements. These changes present new practical implementation issues and challenges for biorepositories. This workshop will provide an overview of the changes to the Common Rule as they pertain to human specimen research and biorepository operations. In addition, presenters and workshop attendees will discuss the practical implementation issues and challenges of these changes and strategies for addressing them.

11:30 - 12:45
Spotlight on the ISBER Biospecimen Research Symposium: Quality Matters

Chairpersons: William Mathieson (Luxembourg), Kathi Shea (USA)

Session Description: In February 2018, ISBER held a two-day symposium in Luxembourg that focussed on biospecimen science. Invited speakers of international repute presented work in three plenary sessions based on biospecimen type: human liquid biospecimens, human tissue biospecimens and environmental biospecimens. For the benefit of Dallas delegates who could not attend the Luxembourg symposium, each of the three sessions will be summarised by a speaker from Luxembourg 2018.


11:30am – 11:50am
Biospecimen Research on Clinical Fluid Specimens: The Best from Luxembourg
Fay Betsou (Luxembourg)

11:50am – 12:10pm
Biospecimen Research on Formalin-Fixed Paraffin-Embedded Clinical Tissue Biospecimens: The Best from Luxembourg
Geraldine Thomas (UK)

12:10pm – 12:30pm
Biospecimen Research on Environmental Specimens: The Best of Luxembourg
Marcos Castellanos (UK)

12:30pm – 1:00pm
Panel Discussion

11:45 - 12:45
Poster Installation (Session 2)
12:45 - 13:45
General Lunch in Exhibit Hall
13:45 - 15:30
Workshop 7: Animals, Plants, Environments, and Humans – How to Leverage Cross-Sector Collaborations to Increase Your Biobank Sustainability

Presenter: Piper Mullins (USA)

Dogs can help humans understand types of cancer. The One Health Initiative has created a framework to share data across human, animal, and environmental biobanks and projects to improve the health of all three. Two intra-organizational biobanks with different sample types successfully test each other’s protocols. Collaborations enhance biobanks, and cross-sector collaborations provide exciting opportunities for biobanks looking to increase research output. This interactive workshop will focus on case studies, examples, and discussions on how biobanks work more efficiently together through intra-organizational and external collaborations, especially across different sectors like animal and human biomedical.

Biobanks each offer a unique set of samples, collections, and varying services, and there is a need to increase communication between different biobanks, such as animal and human biomedical. Animal, plant, environmental, and human biobank collaborations bring together different sample types and services that complement both partners. For example, the Cornell oncology biobank collaborates with the Cornell vet biobank to develop, test, and refine SOPs.

Speakers will highlight the ways in which different sector biobanks can identify needs for a complementary partner and other biobanks to collaboratively address them. There will be a Q&A panel discussion following the case studies where attendees can ask a group of experts and share ideas among the group for discussion.

This workshop is designed for all biobanks looking to improve biobank sustainability. It will highlight how intra-organization or external collaborators increase biobank research scope and usage, thereby illustrating the biobank’s value to their organizational administrations. Attendees will have the opportunity to see different cross-sector collaborations, and to ask and discuss how to implement collaborations at their institution. Workshop outcomes will include a white paper on the methods discussed.

13:45 - 15:30
Workshop 8: Guidelines for Choosing a Biobank Informatics System

Presenter: Kevin Meagher (USA)

The ISBER Informatics Working Group (IWG) will cover the considerations when choosing the system(s) necessary to support their biobank’s activities. Just as biobanks differ in their processes and workflows, their informatics requirements also differ. Inventory systems have gone beyond tracking solely sample information, and many now offer a comprehensive suite or modules of functionality, including consent management, inventory management, survey data, tests results, clinical data management, instrument integration and cohort identification. The presentation will cover components to consider, evaluation criteria, a model decision tree, and practical advice. Participants will learn how to prioritize their own requirements and identify those that are critical, in line with the ISBER Best Practices.

Anyone considering a change in their biobanking informatics system, infrastructure, or environment should attend.

13:45 - 15:30
Workshop 6: Designing and Maintaining a Human Tissue Repository, Part 2

Presenters: Bill Grizzle (USA), Kathy Sexton (USA)

The design and planning of a human tissue biobank or biorepository requires much preparation and forethought. This workshop is organized into two parts:

Part 2:

Part 2 will be devoted to an in-depth discussion of the daily operations of maintaining a biorepository and will include discussions of the importance of quality control and safety. The workshop will provide useful information for anyone thinking about or planning to establish a repository as well as those who have recently begun repositories. Time will be devoted to questions and audience discussion.

16:00 - 17:00
ISBER Annual Business Meeting

Members – join us to learn more about ISBER’s activities, financials, strategic plan and leadership!

16:15 - 20:00
Exhibitor Takedown
17:15 - 18:00
Platinum Partner Meeting with the BOD
19:00 - 23:00
ISBER Networking Evening

Join us for an exciting evening at Eddie Dean’s Ranch! Enjoy a reception and dinner while you mingle with your biobanking colleagues from around the world!

Separate ticket required.

07:00 - 16:00
Registration Open
07:00 - 08:00
Working Group Meetings
07:00 - 13:30
Speaker Services Open
07:00 - 08:00
Vendor Meeting
07:45 - 08:15
Coffee & Pastries
08:00 - 09:00
Corporate Workshops
09:15 - 12:15
Symposium 4B: Collaboration: Getting Set-up in the Land of BIG Opportunity!

Chairpersons: Zisis Kozlakidis (UK), Jajah Fachiroh (Indonesia)

Session Description:
Significant scientific advances and consortia supporting large-scale projects are now well-established as an approach to provide solutions to complex problems. These collaborations are formed by a constellation of different stakeholders sharing their outputs, experiences and resources: from established institutions with integrated facilities to start-up biotechnology companies, from multi-national pharmaceutical companies to highly specialized operators. In this session, the participants will provide details on the type of approaches they have used in initiating, maintaining and generating further collaborations with biobanks in their efforts to facilitate sample collection and utilization. They will also identify the biobanking parameters that they consider when looking for future or sustainable, long-term collaborations.


Title TBC

William Dalton (USA)

The Simplest and Fastest Novel HPV Screening Technology
Youxiang Wang (USA)


Building Collaboration and Networks and Accelerating Research at BBMRI-ERIC
Francesco Florindi (Belgium)

11:20am – 11:55am
Title TBC

Xun Xu (China)

09:15 - 12:15
Symposium 4A: Small Steps in Quality Management Lead to BIG Results

Chairpersons: Piper Mullins (USA), Tatsuaki Tsuruyama (Japan)

Session Description: This session is designed for all participants interested in sample quality, including why quality measures are important, how to implement them, and the current trends. Biobankers from all collection types (human, animal, plant, etc.) will learn why it is important to have high-quality samples, why it is important to maintain compatible sample quality across collaborations, and how organizations have created their quality management systems. In addition, this session will update participants on the current progress, future harmonization, and standardization between ISO norms and ISBER Best Practices.


Using Population Metrics to Aid in Quality Management Processes
Joseph Roberts (Canada)

Tuna Meat Preservation
Tomoaki Hagiwara (Japan)

Standardized Improved Pre-analytical Workflows: The Key for Reliable Diagnostics, Research and Biobanking
Uwe Oelmueller (Germany)

Standards and Best Practice for Quality
Daniel Simeon-Dubach (Switzerland), Koh Furuta (Japan)

11:45am – 12:15pm
Panel Discussion

12:15 - 13:15
General Lunch
12:15 - 13:15
Roundtable Discussions

The roundtable discussions are an opportunity to discuss various hot topics relevant to biobanking. We would like to invite you to propose a topic and facilitate a discussion at the meeting!

*Please note that it is required that a proposed facilitator confirm their willingness and availability to facilitate prior to submitting a proposal.

If you are interested, please submit a proposal at the following link:

Please note that these discussions are intended for peers to share biobanking knowledge relating to the topic in discussion and should not be used for commercial means or product advertisement.

If you have any questions, please don’t hesitate to contact us at

13:15 - 14:30
Poster Takedown (Session 2)
13:15 - 14:15
Special Topic Workshop: ISO and ISBER and CAP, Oh my!

Presenters: Clare Allocca (USA), Marianna Bledsoe (USA), Helena Ellis (USA), Koh Furuta (Japan), Shannon McCall (USA), Cheryl Michels (USA), Nilsa Ramirez (USA), Melissa Rawley-Payne (USA), Brent Schacter (Canada), Daniel Simeon-Dubach (Switzerland)

One of the largest drivers for biobanking is the goal to efficiently achieve quality specimens that are fit for purpose. The assortment of tools to assist in achieving this goal has been increasing in both type and complexity. These tools will be described and their potential interactions, synergies, and differences will be examined. A panel of experts will compare options for varied mechanisms.

Standardization encompasses concepts such as quality management, explicitly defined requirements, and conformity assessment (demonstration that specified requirements relating to a product, process, system, person, or body are fulfilled). Biobanks may benefit from adopting relevant standards in whole or in part, and applying them to processes ranging from minor operational guidance to critical quality management systems. Standardization may also become a pathway to accreditation (e.g. by working with an accreditation body such as CAP) or certification (e.g. by use of certification products provided by entities such as CTRNet). What do all these terms really mean? What do all these acronyms stand for? Where should a biobank begin? How does a biobank determine how to best use standardization to obtain value for their organization? These issues, as well as considerations and challenges for implementation of standards, will be addressed.

Also available to biobanks are best practices documents, including the 2018 revision of ISBER’s Best Practices document, 4th edition. How do best practices documents relate to standards, and how can they be used in concert with standardization to serve biobanking needs? How do I navigate the large number of guidance documents that are currently available? Does one need to choose among these approaches or can they be used together?

Once the components of this “toolbox” have been discussed and several paths to fitness-for-purpose of biospecimens have been examined, we will facilitate an interactive discussion on biobanking standards-related needs. The workshop will solicit input to develop a white paper, as well as to design and plan a focused biobanking standardization workshop in late 2018. Questions for consideration and discussion may include:

  • What information is still needed to make current standardization practices “accessible” to the diversity of biobanks?
  • When evaluating operations that target the quality of your biospecimens, what tools do you find to be lacking?
  • ISO 20387, General Requirements for Quality and Competence of Biobanks, should be available by early 2019. With the release of this umbrella document, what types/applications of biobanking would most benefit by the development of specific standards under this umbrella?
  • Should Biobanking standardization and best practices be harmonized?
  • How does the size, available resources, location (including developing countries) and/or type of biobank affect needs for standardization and best practices?
  • How do I calculate both the resource needs and potential benefits that can accrue to my biobank through standardization and best practices approaches?

The results of these discussions will be recorded and a white paper will be developed to describe the findings.

14:30 - 15:30
Working Group Meetings
15:30 - 16:30
Committee Meetings
Select date to see events.

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