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Developing Global Quality Controls and Standards

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Transitioning a Biobanking Effort with Scientific and Fiscal Responsibility

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The Business of BioBanking - Day 2

Conference Proceeding CD Now Available
  • Speaker Presentations
  • Poster Abstracts
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Day 1  |  Day 2  |  Day 3  |  Download Brochure 

Tuesday, December 7, 2010 

 

8:15 BioBanking Brainstorming Breakthroughs  

Grab a cup of coffee and join a table discussion. These focused groups are designed for conference attendees to discuss important and interesting topics related to biospecimens from procurement, preservation, biomolecular extraction, and biomarkers. These are moderated discussions with brainstorming and interactive problem solving, allowing conference participants from diverse areas to exchange ideas, experiences, and develop future collaborations around a focused topic. 

Investing in the Future – Quality Products 

9:15 Chairperson’s Opening Remarks 

9:20 The Benefits of Biospecimen Banking Standardization and Regulation for Cellular Therapy

Daniel Powell, Ph.D., Research Assistant, Professor, Pathology, Laboratory Medicine, Obstetrics and Gynecology, University of Pennsylvania

9:50 Global Quality Control: Best Practices in Standardization Efforts

Andrew Brooks, Ph.D., Director of Operations, Rutgers University Cell and DNA Repository; Associate Professor, Genetics, Rutgers University

Best practices efforts and global standard operating procedure deployment are helping the biorepository community achieve a level of performance and reproducibility previously unattainable. With that said, the standardization of sample collection procedures and processing guidelines is only one part of a much larger issue: sample quality control. This session will look at technologies, procedures and collaborative efforts to develop global, application-specific metrics allowing for the more direct comparison of samples across studies, and most importantly, across biorepositories.

10:20 Drug Rescue and the Value of BiobankingSponsored by
Gentris web

L. Scott Clark, Ph.D., Chief Scientific Officer, Gentris Corporation

For every 5,000 drug candidates that enter pre-clinical testing, only one will receive FDA approval. Pharmaceutical organizations are under pressure to reduce costs and address key reasons for drug failure – adverse drug reactions, lack of efficacy, and unfavorable pharmacokinetics/drug metabolism properties. Banking a consented pharmacogenomic sample becomes invaluable for any of the above scenarios. Analysis or re-analysis of stored samples can rescue a failed drug by eliminating re-recruiting, re-consenting, and re-enrolling patients.

10:35 Morning Coffee Break with Exhibit and Poster Viewing

 

11:15 Best Practices for Biological Resource Centers (BRCs)
Yvonne A. Reid, Ph.D., Manager, Scientist, Cell Biology Program, American Type Culture CollectionThere are several Biological Resource Centers (BRCs) throughout the world, yet there are very few that adhere to the Best Practices for BRCs as defined by the best practice guidelines, a consensus document published by the Organization for Economic Co-Operation and Development (OECD) in 2007.  The best practices guidelines ensure that biological materials are of the highest standard and are authentic; the preservation techniques used retain important functional biological characteristics ensuring consistency among centers supply them; ensure protection of the health of laboratory personnel, the public and the environment.  These topics will be discuses in context of current activities at ATCC, a BRC. 

11:45 Panel Discussion: Navigating the Road of Regulations

Selected speakers discuss the challenges, best practices, and future developments for navigating regulations, standardizations, and quality control.
 

12:15 pm Close of Morning Session

12:30 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own

 

Investing in the Future – Biopreservation 

2:00 Chairperson’s Opening Remarks

2:05 Biopreservation: Entering the Post-Genomic Era

John G. Baust, Ph.D., UNESCO Chair & Professor; Director, Institute of Biomedical Technology, Binghamton University; Editor-in-Chief, Biopreservation & Biobanking

Until very recently, efforts to “optimize” preservation protocols were constrained by a biophysical paradigm which assumes that cells are essentially “biologically” but not structurally passive” to the freeze-thaw process. It is now recognized, to the contrary, that the management of the cell’s molecular-based stress responses is paramount to functional preservation and post-banking utility. Key elements necessary to establish post-genomic functionality in cryopreserved samples will be reviewed.

2:35 Droplet-Based High-Throughput Cryopreservation of Clinical Samples

Utkan Demirci, Ph.D., Assistant Professor, Medicine, Brigham and Women’s Hospital; Harvard-MIT Health Sciences and Technology; Harvard Medical School

Blood shortages present a major global health problem. The long term cryopreservation of red blood cells provides a supplementary inventory to help meet demand during such shortages. We introduce a new ultra-rapid vitrification method using RBC encapsulating droplets that can be performed at high throughput. This method could also be designed to entail minimal labor, making it attractive for routine clinical use. Our novel approach could also be applied to storage of samples through automated methods in small scale volumes.

3:05 Advances in Biopreservation of Biofluid Biospecimens

Allison Hubel, Ph.D., Professor and Director, Biopreservation Core Resource, University of Minnesota
Biofluid biospecimens (plasma, serum, urine, bronchial lavage fluid, tear fluid, seminal fluid, and ascites fluid) contain not only cells but also proteins, enzymes, lipids, metabolites and peptides, which can be utilized as biomarkers of health and disease. Currently, millions of biofluid biospecimens are stored by freezing without following any preservation protocol and in the absence of any stabilizing agents. We will describe best practices on preservation of biofluid specimen in order to optimize quality and therefore value of the biofluid biospecimen.

3:35 Refreshment Break with Exhibit and Poster Viewing

 

Investing in the Future - Data Management 

4:00 Why Are Prospective Clinicopathological Data as Important as Specimens?

Iman Osman, M.D., Director, Interdisciplinary Melanoma Cooperative Group; Associate Professor, Dermatology and Oncology, New York University Langone Medical Center

We describe our experience in developing a prospective clinicopathological and biospecimen database. Biospecimens, clinicopathological data, and followup information are collected using developed protocols. Information pertaining to biospecimens is recorded in 35 fields, and clinicopathological information is recorded in 371 fields. Investigators conducting research utilizing the IMCG biospecimen resource are blind to clinicopathological information, and molecular data generated using biospecimens are linked independently with clinicopathological data by biostatistics investigators. The presentation will focus on the importance of linking the specimens to prospective well annotated clinicopathological information.

4:30 Contemporary Access to Historical Biospecimen Collections

Leslie Carroll, Senior Systems Analyst, NHLBI Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC) Information Management Services, Inc.

Legacy biospecimen studies are notoriously hard to utilize for modern day research; however, a wealth of information resides in these historical biospecimens and associated longitudinal data. This discussion will focus on the methods and key concepts used by the NHLBI BioLINCC team to streamline biospecimen collections and make them available through a website to the wider scientific community.

5:00 The International Serious Adverse Events Consortium

Arthur L. Holden, Chairman and CEO, iSAEC

The iSAEC was formed in 2007 with the singular goal to identify and validate DNA-variants useful in predicting the risk of drug induced serious adverse events [SAEs].   It is an international nonprofit organization comprised of leading international pharmaceutical companies, the Wellcome Trust, research networks from around the world, and the U.S. Food and Drug Administration (FDA).  After successfully completing its initial pilot studies into the genetics of drug induced liver injury and serious skin reactions (2007-2009), the iSAEC has recently funded and is launching the second phase of research into the genetics of drug induced SAEs.  This presentation will summarize the current status of this novel banking and research initiative, its results to date, and its research plans for its second phase.  Specifically, the presentation will focus the development and international expansion of our SAE research cohorts sourced from academic networks, member pharmacos, and innovative new provider partnerships which leverage EMRs. 

5:30 Dedicated Poster Viewing with Wine & Cheese Reception In Exhibit Hall

6:00 Close of Day


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