2014 Archived Content
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Tuesday, September 16
7:30 am Breakfast Presentation (Sponsorship Opportunity Available) or Morning Coffee
8:00 Brainstorming Breakfast Discussion Groups
Grab a cup of coffee and join a discussion group. These are moderated discussions with brainstorming and interactive problem solving, allowing conference participants from diverse backgrounds to exchange ideas and experiences and develop future collaborations around a focused topic.
Table 1: Key Hurdles in Biomarker Development
Chad R. Borges, Ph.D., Assistant Professor, Chemistry and Biochemistry, The Biodesign Institute – Center for Personalized Diagnostics, Arizona State University
- How do we improve our approaches to matching clinical needs for cancer markers with analytical scientists and their platforms?
- The biospecimen procurement process: dos and don'ts
- What constitutes acceptable marker validation?
- How do we efficiently transition from discovery platforms to viable clinical platforms? When might transition not be necessary?
Table 2: Historical Samples for Biobanking
Allison Hubel, Ph.D., Professor, Mechanical Engineering and Director, Biopreservation Core Resource, University of Minnesota
- How do we define what a "historical sample" is?
- What are the most common samples that have been in storage > 10 years (tissue, plasma, serum)?
- What percentage of your repository is used for storage and what percentage of the samples are used within 30 days of collection?
- What kind of information would be helpful to have to determine whether or not a sample in storage is useful?
Table 3: Sample Annotation: Investing in the Future and the Value
Michael Liebman, Ph.D., Managing Director, IPQ Analytics, LLC
- What level of patient/sample annotation is critical?
- Can this exist in a linkable database or does it have to be embedded with the sample?
- Anonymization vs. de-identification: Creating value in the biobank and its use
Table 4: Biospecimens and Whole-Genome Sequencing: Are There New Considerations for Privacy and Data Sharing?
Geoffrey P. Lomax, Ph.D., Senior Officer, Standards Working Group, California Institute for Regenerative Medicine
- Is whole genome sequencing appropriate for "historical" samples?
- What access controls, if any (e.g., open access vs. controlled access) should be imposed on "raw" sequencing data to protect donors’ privacy interest?
- Does genomic characterization create substantial new risks to donors, families or groups? Can potential risks be effectively mitigated?
Table 5: Population-Based and Disease-Oriented Biobanking for the Biopreservation of Liquid-Based Gynecological Cell Samples
Nasrin Perskvist, Ph.D., Director and National Coordinator, Cervical Cytology Biobank, Pathology and Cytology, Karolinska Institute and BBMRI.se
- Legal and ethical aspects of a population-based and hospital-integrated biobank: How far are we willing to go?
- The process of moving from a regionally based Cervical Cytology Biobank to a national infrastructure: Is it applicable to the full scope of the population?
- Providing samples to researchers without any risk of leaving insufficient sample volumes for the care of the woman herself: Quality vs. Quantity.
Table 6: Patient-Derived Xenograft (PDX) Models of Human Cancers towards Identifying Tumor-Initiating Cells and Discovery of Patient-Specific Therapeutics
Vinagolu K. Rajasekhar, MSc, MPhil, Ph.D., Senior Research Scientist, Memorial Sloan-Kettering Cancer Center
- Why, to date, have none of the conventional biobanks for patient tumor specimens delivered on our goals for a cancer cure?
- What is the live tumor tissue banking approach and how it can help recreate the original parent tumor heterogeneity and also form a renewable tumor tissue resource?
- How does live biobanking facilitate identification of cancer stem cells and discovery of patient-specific therapeutics?
- Importance of warm autopsies, live tissue bankonomics and sustainability of viable tumor banks
Table 7: Ethical Considerations in Building Future Use Collections
Katheryn Shea, Vice President, Bioservices, Precision for Medicine
- Key considerations in creating informed consent language
- Global challenges and regulatory differences that affect designing your future use collection
- Abstract or Annotate? Generating mineable data sources
Table 8: Pediatric Participants in Biobanks
Suzanne Vercauteren, M.D., Ph.D., FRCPC, Head, Division of Hematopathology, BC Children’s Hospital and Clinical Assistant Professor, Pathology and Laboratory Medicine, University of British Columbia
- Does the opinion of children of non-consenting age matter? At what age?
- Do we need to reconsent at age of majority?
- How do we garner public support for pediatric biobanks?
- How can we improve the quantity and quality of pediatric specimens?
Table 9: Biobanking: How Can Collections Be Maximized without Dedicated Funding?
Wendell G. Yarbrough, M.D., MMHC, FACS, Professor of Surgery, Otolaryngology and Pathology; Section Chief, Otolaryngology; Co-Director, Molecular Virology Research Program; Director, Head and Neck Cancer Program, Smilow Cancer Hospital, Yale University
- Collaborations with researchers who have LN and -80oC
- Engagement of clinicians interested in the disease
- Engagement of pathologists
9:00 Chairperson’s Remarks
Andrew Brooks, Ph.D., COO, RUCDR Infinite Biologics; Associate Professor, Genetics, Rutgers University
9:05 Best Practices in Bioprocessing and Biobanking to Support Biomarker Development
Andrew Brooks, Ph.D., COO, RUCDR Infinite Biologics; Associate Professor, Genetics, Rutgers University
Implementation of biomarkers and pharmacogenomics in routine clinical practice presents significant challenges – especially preservation of DNA and other biomaterials utilized for biomarker identification, assay development and biomarker testing. Their optimum preservation requires implementation of efficient and standardized methods for collection, transport, processing and storage to reduce pre-analytical variability that can degrade sample integrity and impact downstream processing. With the technological advancements for biomarker analysis, ensuring samples collected today will be of sufficient quality for future use is increasingly important.
9:35 Tissue Biobanking for Translational and Basic Research at Genentech: Successes and Challenges
Cary D. Austin, M.D., Ph.D., D.A.B.P., Pathologist, Pathology, gRED, Genentech, Inc.
Genentech’s Human Tissue Laboratory supports a variety of research and development activities, including projects focused on drug and diagnostics development as well as those in basic research in the fields of oncology, immunology, neuroscience and metabolism. Supporting such a diverse set of needs in a rapidly evolving organizational and industrial setting presents challenges that will be discussed.
10:05 Next-Generation Applications for Personalised Genomics: from CARTaGENE to the Clinic
Philip Awadalla, Ph.D., Professor, Faculty of Medicine, University of Montreal; Director, CARTaGENE
CARTaGENE was developed to produce an internationally competitive, cohort-based biobank facilitating the emergence of new and novel research projects. As a result, these investigations will generate new healthcare knowledge for and about Québec, Canada and the international community. By acting as a springboard, scientists can expand their research questions by investigating the genomic, metabolomic, epigenomic and environmental control points of complex chronic disorders and related quantitative traits. My own research program has exploited the deep clinical and phenotypic data collected from over 40,000 participants to discover novel genomic factors associated with disease and quantitative traits.
10:35 Coffee Break in the Exhibit Hall with Poster Viewing
11:15 Viable Biobanking for Personalized Medicine
Wendell G. Yarbrough, M.D., MMHC, FACS, Professor of Surgery, Otolaryngology and Pathology; Section Chief, Otolaryngology; Co-Director, Molecular Virology Research Program; Director, Head and Neck Cancer Program, Smilow Cancer Hospital, Yale University
Viable biobanking of tumors differs from traditional methods by preserving live cells. One advantage of this method is that, based on the tumor’s molecular characteristics, targeted therapies can be tested in vitro to determine effectiveness.
11:45 Next-Generation BioSpecimen Sciences: Moving -Omics to Clinics
Michael H. A. Roehrl, M.D., Ph.D., Director, UHN Program in BioSpecimen Sciences, University Health Network and University of Toronto
The BioSpecimen Sciences Program in Toronto is one of the largest academic research biobanking programs in North America. We show specific examples of next-generation specimen-driven personalized molecular healthcare, such as clinical trials and new kinds of translational and basic sciences that can only thrive with the availability of highest-quality research samples from our patients. We also discuss our IT database and data management infrastructure developments that link various kinds of clinical, research and biospecimen data in real time.
12:15 pm Close of Session
12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
2:00 Chairperson’s Remarks
Shannon Sewards, Associate Director, Human Subjects Division, University of Washington
2:05 Quality Improvement (QI) vs. Research
Shannon Sewards, Associate Director, Human Subjects Division, University of Washington
Navigating the line between quality improvement activities and what meets the definition of regulated research is difficult to discern; they may share similar designs and methodologies and require publication of results. The purpose of this discussion is to highlight the similarities and differences between quality improvement activities and those considered to be regulated research. We will review applicable regulations, examples and case scenarios, and look at tools and guidance that have been developed to assist in this determination.
2:35 Global Biobanking Scenery for Precision, Big Data-Driven Clinical Care
Hoda Elgendy, Ph.D., CSO, BioActive Technologies, Inc.
Biobanking infrastructure must improve rapidly to support personalized medicine. We will discuss biobanking and biobankonomics advances: the establishment of a sustainable business model to form a human tissue biobank infrastructure, crossroads-building between collections, standardization, harmonization, development of special analytical models and tools to optimize the biobanking informatics “Big Data sample bank”, biospecimen quality control and stakeholder engagement. The ethical, legal, policy and social issues raised are challenges, but may lead to transformative solutions and strategic priorities accommodating dynamic global biobanking.
3:05 Selected Oral Poster Presentation: Development of Statistical Process Control Parameters for Tissue Quality in a Pregnancy-Related Biorepository
Donald O. Chaffin, Laboratory Manager, Global Alliance to Prevent Prematurity and Stillbirth (GAPPS), Seattle Children's Hospital
It is vital that specimens obtained though biobanks preserve a level of quality consistent with research needs. Several factors can impede this goal: the heterogeneous nature of starting materials, artifacts introduced by collection, processing and storage and the often destructive nature of test regimes. It is a requisite that specimens are robustly characterized against a set of normative values which can determine suitability for use and that the effects of post-collection events are known and remain “in control” with respect to these values. We present the quality control regimen for placental tissue collected by the GAPPS repository, a pregnancy-related biobank, with a cohort of over 1540 women. This regimen sets the expectation for achievable quality levels with the current protocols and allows evaluation of collection design changes to increase quality and lower variance. The use of statistical process control methods described here assure consistent specimen quality and can drive future improvement in methods of collection.
3:20 Refreshment Break in the Exhibit Hall with Poster Viewing
4:00 Use of Informatics to Accelerate Institutional Biospecimen Procurement
Stephanie Elaine Soares, MS, CCRP, Research Administrator, Urology, University of California Davis
Incorporating informatic approaches to institutional biobanking could lead to improved workflows and increased biospecimen procurement. Use of electronic communications with patients by research institutions could potentially lead to community-based partnerships that may provide a broader donor pool for research biobanking.
4:30 Biobanking Informatics Infrastructure to Support Clinical and Translational Research
Bernard A. LaSalle, Director, Operations, BMIC, Biomedical Informatics, Center for Clinical and Translational Science, University of Utah
Managing biospecimens requires documentation of the nature, quantity and quality of the samples, curated information about the participants who donated them, including clinical and family history, genealogical and demographic information, and consent tracking. It also requires maintenance of links to associated data, including medical and genealogical records, results from molecular analyses and results and conclusions from clinical studies. OpenFurther is an infrastructure which is designed to connect, map and federate the heterogeneous data sources of these data.
5:00 Biobanking: Critical Considerations to Optimize Value
Michael Liebman, Ph.D., Managing Director, IPQ Analytics, LLC
Biobanking has become an increasingly important component of drug development and disease research with most investment focused on the technology of the process of sample collection and management. To enable this expensive activity to achieve its potential value, it is necessary to understand the critical aspects of sample annotation, not just sample management. This presentation will discuss the opportunities and challenges associated with sample annotation and its value proposition.
5:30 Close of Day
5:15-5:45 Dinner Short Course Registration
5:45-9:00 Dinner Short Course: What It Takes to Be a Biobanking Operations Manager: From Patient Interaction to Freezer Inspection More Details >>>
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