The ISBER Education & Training Committee is pleased to announce the following Educational Workshops taking place at the ISBER 2018 Annual Meeting.
Please note, the workshops are open to all registered delegates at no additional cost.
Pre-registration is now open! Click the title of the workshop to register.
Please note that pre-registration does not guarantee your seat at the Educational Workshops. As space is limited, we recommend arriving 5-10 minutes early to secure your seat.
Tuesday, May 22, 2018 – 3:00 pm – 4:00 pm
Educational Workshop 1: Returning Individual Genetic Research Results: Challenges and Responsibilities
Helena Ellis (USA), Sarah Dry (USA), Nazneen Aziz (USA), Audrey Fan (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.
Sheila O’Donoghue (Canada), Cathy Seiler (USA), Daniel Simeon-Dubach (Switzerland)
This workshop will focuses on the rationale for updating and the process associated with updating the ISBER Best Practices Guidelines, a summary of the changes made between the third and fourth edition, and the dissemination of the Best Practices world-wide.
Educational Workshop 3: Accessing Human Samples to Deliver New Medicines for Patients: An Industry Perspective
Clive Greene (United Kingdom)
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.
Wednesday, May 23, 2018 – 11:30 am – 12:45 pm
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 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.
Educational Workshop 5: The Revised Common Rule: Practical Implementation Challenges for Biorepositories and Strategies for Addressing Them
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.
Wednesday, May 23, 2018 – 1:45 pm – 3:30 pm
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 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.
Educational Workshop 7: Animals, Plants, Environments, and Humans – How to Leverage Cross-Sector Collaborations to Increase your Biobank Sustainability
Piper Mullins (USA)
Collaborations enhance biobanks, and interdisciplinary collaborations provide exciting opportunities for biobanks looking to increase research output and sample utilization. This interactive workshop will employ case studies and group discussions on how biobanks can work more efficiently together through intra-organizational and external collaborations, especially across different areas like animal and human biomedical. We will focus on sample use in biobanks and demonstrate how organizations can go outside their organization or sector to find other customers and different collaboration types.
Biobanks each offer a unique set of samples, collections, and varying services, and there is a need to increase communication between different biobanks. 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 veterinary biobank to develop, test, and refine SOPs.
Attendees will learn and discuss how to collaborate with other biobank disciplines or areas to increase biobank usage and therefore sustainability. These “outside the box” collaborations can provide funding and/or value statements that a bank’s samples are desirable, which can be used to explain to funders why to support them, and increase scientific value. All biobanks have to make a plan for use and users, and costs associated. Attendees will gain tools to find collaborations and ways to think outside of their own sectors and gain new users and funds.
Anyone seeking ways to increase their biobank’s sample utilization and value statement is encouraged to attend, both experienced collaborators and those just getting started.
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.
Thursday, May 24, 2018 – 1:15 pm – 2:15 pm
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.