Roundtable Discussions

Expanding Shared BioSample Attributes Libraries and Building Common Data Elements Registries for Biorepository Collaborations

James McNally
University of Michigan

There is a growing interest in the development of Common Data Elements (CDE) across the biomedical sciences. The National Center for Biotechnology Information, U.S. National Library of Medicine, for example, has released a standardized list of 500+ variables as a tool to describe a BioSample using structured attribute name system. The proposed roundtable seeks to discuss efforts to develop CDEs for biospecimen’s and ways that structured nomenclature can be shared across repositories, offering enhanced opportunities for data discovery, information sharing and collaboration.

Early Applications of Viable, Functional Tissue Cryobanking

Jedediah Lewis, JD, Alyssa Ward, PhD
Organ Preservation Alliance

Historically, cryopreservation with post-thaw viability and function has been a process reserved for cells and small tissues. In the last 5 years, it has become a major research priority to scale up cryopreservation in order to bank larger larger tissues and whole organs, with successes in the recent years across e.g. sheep ovaries, rat limbs, rabbit kidneys, and human fingers, cartilage, and ovarian tissue. Biobanks may be some of earliest end users of these technologies, as the technical barriers are relatively modest compared with whole organs; high-yield use cases identified in consensus meetings so far, e.g. at the second global Organ Banking Summit at Harvard Medical School, include viable tumor samples to drive personalized therapies, functional cadaveric organ strips or slices for drug toxicity testing, and functional studies of diseased vs. control (healthy) donor tissue.

Clinical Validation and Biobanks

Suzanne Vercauteren
BC Children’s Hospital BioBank

Many biobanks have biobank certification but are not clinically certified as they are considered to be research based. However situations arise where findings are uncovered through research and these findings need clinical validation. How do/should biobanks position themselves such that they can support this clinical validation.

Most Common CAP Inspection Deficiencies and How to Avoid Them

Shannon J. McCall, MD
Duke University School of Medicine

The Vice Chair of the College of American Pathologists’ Biorepository Accreditation Program will discuss with participants the most common CAP inspection deficiencies identified during the first five years of the program. Participants will discuss practical approaches to meet the relevant standards and avoid citation. A second facilitator, Ms. Helena Ellis (an experienced CAP inspector) will assist with the conversation.

Blood Collection – How much and Why?

Rajeev Singh MD, MBA1, Jeff Rando MBA2
1Houston Methodist Research Institute
2University of Texas System Health Biobank (UTSHB) Consortium

This roundtable proposes to discuss the quantity of blood collected for research purposes across the different subjects, studies, analytical platforms and countries/regions, and the reasons behind the same. Will also discuss the roadblocks facing such collections.

Cell Therapy Starting Material-When the Process Becomes the Product, Best Practices are a Must!

Kimberly Negrin, PhD
HemaCare Corporation

Cell and gene therapies are an exciting new branch of medicine. With novel applications being approved for clinical trials on an almost daily basis, the outlook for patients has never been brighter. It’s important to remember, however, that cells and tissues are parts of intricate biological systems, prone to variability and often challenging to maintain at their optimal efficacy. Cell and gene therapy products are only as good as the biological starting material used to produce them. Researchers considering an apheresis/tissue product supplier for their cell therapy project need to understand the best practices that are most likely to guarantee top-quality starting material.

Join top industry experts with extensive apheresis and process development experience as they examine a number of key topics. Participants are invited to join discussion on best practices in quality control for apheresis/leukapheresis products, donor facility accreditation, and donor network management. The roundtable will also provide insights on such issues as the importance of recallable donors, the need for validated quality assurance criteria, and the advantages of customized cell processing methods. Our experts will provide insider tips on state-of-the-art instrumentation and protocols, choosing the best stem cell mobilization strategies for your project, and more. Join the conversation and get your cell therapy project off to a great start!

The Real Costs of Biobanking – Costs per Sample of Manual vs. Automated Storage

Lindsay Crone
Hamilton Storage

Identify and discuss the leading costs of biobanking storage.

How do we measure the costs of manual storage versus automated storage?:

• Manual freezers—Freezer type (-20°C/-80°C) vs. freezer footprint vs. freezer sample storage capacity
• Utilities—power, CO2, LN2, chilled water
• Labor

How do the costs compare?

How do I identify my Return on Investment?

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