Thursday, October 15, 2015

Day 2 Summary for the "Biorepositories and Sample Management Summit"

Biobanks are diverse processing and storage facilities that maintain biospecimens. These stored biological materials can be used for drug development and discovery efforts, precision medicine studies, biomarker-based preclinical research, and more. Increasingly, biobanks are also storing stem cell lines, such as induced pluripotent stem cell lines that are being derived from both healthy and diseased donors. Biobanks can also contain cord blood units collected from newborns, as well as associated tissues that may contain stem cell and progenitor cells, such as umbilical cord blood tissue or placental tissue.

The goal of biobanking is to preserve biological samples for potential use at a future point in time. As the range of tissues being stored for future use has increased, the potential research and therapeutic applications have also expanded, driving growth of the global biobanking market. While this growth is generally positive for the industry, there have also been “growing pains” associated with this industry expansion. To explore these issues and opportunities, the “Biorepositories and Sample Management Summit” was held over the past few days at the Hilton Hotel in Boston, Massachusetts.

Recap of Day 2 of the “Biorepositories and Sample Management Summit” 

Delivering a jam-packed day of content, Day 2 of the “Biorepositories and Sample Management Summit” kicked off bright and early today with the morning sessions that emphasized information management strategies to support biobanking for drug development. The afternoon sessions centered on strategies for sample quality assurance and control. Finally, the conference concluded by highlighting the importance of sustainable biobanking business practices and techniques for establishing predictable cash flow through biospecimen provision to commercial partners.

The opening talk of the day was presented by Dr. Ty Hoover from the MD Anderson Cancer Center, who spoke about American College of Medical Genetics and Genomics (ACMG) informed consent guidelines for biobanking of patient samples. As he emphasized, “these are guidelines, not laws backed by government or a regulatory body.” While the ACMG guidelines can inform policy decisions, Dr. Hoover stated, “ACMG policy guidelines are just that, guidelines; they are not the Standard of Care (SoC).” Nonetheless, he recommended a thorough understanding of these guidelines and brought attention to the key points they contain. He also re-introduced the faand controversial topic of whether primary data should be returned to patients. This was also a hot-topic for discussion on Day 1 of the event, as the concept was previously introduced for discussion by Dr. Stephen Abel of Abbive who suggested that Ethics Committees (EC) are more and more often asking after this topic. 

The next talk was given by Drs. Lesch and Nepochatov of OHSU, who shared their internal strategies for migrating specimen inventory within the OHSU Biobank. Importantly, Dr. Nepochatov highlighted the four aspects of data migration, which are the:
1) Data Environment;
2) Data Cleaning;
3) Staging Database;
4) Migration Scripts.

This talk was followed by Dr. Eric Hall of Duke University, who presented a case study of “Duke’s Implementation of an In-House Informatics Overhaul.” In this presentation, he honestly and humorously revealed the difficulty of implementing an enterprise-wide system for biobanking specimen management. He shared that his group’s cost for the effort has been $3M, allocated over a five-year period. As other conference participants shared their costs for similar enterprise-wide efforts, the results ranged from figures as low as $1M and to as high as $20M.

Next, Dr. Lokesh Agrawal of the of the NIH/National Cancer Institute presented on techniques for assessing biomarkers to determine biospecimen quality. Specifically, he highlighted the importance of creating highly-specific quality assessment resources, tools, and guidelines for human blood-derived biospecimens. He also presented methods to assess the quality of DNA and RNA isolation protocols, and introduced the concept of an RNA Integrity Number (“RIN”).

Dr. Karen Pitt, also from the NIH/National Cancer Institute, then spoke on strategies for cost reduction, using her organization’s biobank as a model system. She spoke about the “Lean Six Sigma” (LSS) approach to biobanking, which is a principle-based management philosophy focused on high consumer value, planned elimination, and waste reduction.

In the final talk before lunch, Dr. Nicole Perfito of Science Exchange addressed the importance of increasing accuracy and reproducibility of preclinical research results. She opened with the shocking statistic that only about 50% of cancer biology studies are reproducibly by outside groups, usually for reasons such as insufficient method reporting, pressure to withhold negative findings, vendor reagent variability, and more. Using her group’s experience in managing a “Reproducibility Project” focused on cancer biology studies, she shared lessons that included the importance of building tools to help capture research workflow and data, the value of uniquely identifying commercial reagents, and the benefits of establishing an open-line of communication with the original study authors. 

After lunch, Dr. Cicek of the Mayo clinic addressed how to optimize procedures to deliver high quality specimens, noting that “everything at the Mayo Clinic from physician care to biobanking is focused on the patient experience.” She highlighted that in biobanking, “Optimization and Standardization” goes hand-in-hand throughout the life cycle process. One enhances the other, and vice versa.

Finally, in my favorite presentation of the day, Dr. George Wilson of the Biobank at William Beaumont Hospital concluded by highlighting methods for creating a sustainable biobanking business model. In particular, he emphasized that biobanks need to create predictable cash flow streams to be sustainable. Interestingly, Dr. Wilson’s Beaumont Biobank was formed in 2007 due to a $2M gift, but subsequently went $6M in debt due to operational costs that were incurred from 2007 to present. Now in 2015, the biobank finally has revenue streams that will make it sustainable into the future. Specifically, he advised that biobanks establish links with commercial partners to provide biospecimens, thereby establishing a “value chain.” He also emphasized the importance of creating a two-pronged cash flow strategy that involves:
1) “Financial Revenue” (money derived from the sale of biospecimens and services);
2) “Academic Revenue” (money derived from academic grants and scientific output).

Sustainability of biobanks was arguably the most discussed topic at this year’s event, which made Dr. Wilson’s talk an exceptional platform with which to conclude the event.

Summary of the “Biorepositories and Sample Management Summit” 

In summary, the “Biorepositories and Sample Management Summit” has been the ultimate biobanking experience of 2015, because it highlighted the most important topics of interest to industry participants. This year, these topics included the:
•    Science and technology of biobanking
•    Business strategies
•    Information management systems and software
•    Regulatory requirements and recently updated policy guidelines
•    Ethics conversations
•    Emerging market segments

Did you enjoy this recap of Day 2 of the “Biorepositories and Sample Management Summit”? View the Day 1 recap here or search the hashtag #biorep2015 to view the live updates that were posted during the event.  

Author: This post was written by Cade Hildreth, President/CEO of BioInformant Worldwide, LLC, a market research firm specializing in the stem cell industry. For more conference updates, follow Cade on Twitter (@StemCellMarket) or LinkedIn.

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