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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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Scientific & Technical Considerations for Developing & Managing Biobanking Protocols Short Course

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The Business of BioBanking - Day 3

Conference Proceeding CD Now Available
  • Speaker Presentations
  • Poster Abstracts
  • and More!

 

Day 1  |  Day 2  |  Day 3  |  Download Brochure 

Wednesday December 8, 2010 

8:30am Morning Coffee

 

BioBank Management: Experience Makes the Difference 

8:45 am Chairperson’s Opening Remarks

8:50 Lessons Learned in Biobanking at the Marshfield Clinic

Cathy McCarty, Ph.D., M.P.H., Senior Research Scientist, Center for Human Genetics, Marshfield Clinic Research Foundation

The Marshfield Clinic Personalized Medicine Research Project, launched in 2002, comprises more than 20,000 participants aged 18 years and older with DNA, plasma, serum samples, questionnaires, and access to comprehensive electronic health records.  More than 20 active studies are underway using the biobank.  Policies and processes are in place to facilitate use of the samples.  Lessons learned in the first 10 years of the biobank will be shared.

9:20 Enabling High-Throughput Pipelines for Basic, Clinical and Translation Research with Cost Effective, Scalable and Sustainable Biobanking Models 

 Lynn Bry, M.D., Ph.D., Director, Crimson Bio-Specimen Core, Partners Healthcare Systems 

9:50 Biobanking and Biospecimen Processing at the Mayo Clinic

W. Edward Highsmith, Jr., Ph.D., Co-Director, Molecular Genetics Laboratory, Mayo Clinic

There are four formal biobanking initiatives currently active at the Mayo Clinic. The largest is the Mayo Community Biobank, which is conducting a pilot study accruing 20,000 adults from the community. In addition, The IRB approved access to participants medical records will make this a valuable prospective cohort for later studies. There are three disease specific biobanks: bipolar disease, cardiovascular disease, and mitochondrial disease. All four biobanks have specimens accessioned, processed, tracked, and stored and prepared for specific studies by the Biospecimens Accessioning and Processing (BAP) laboratory. The BAP facility has developed a suite of QA/QC procedures and technical protocols for the biobanking efforts at the Mayo Clinic. 

10:20 Morning Coffee Break with Exhibit and Poster Viewing

11:00 Business of Biobanking: Perspective from a CRO Central Lab

Barbara E. Glazer, MT(ASCP), Director, Pre-Analytical Services, Global Central Laboratories, Quintiles

This discussion will highlight the unique considerations of biobanking and biospecimen management in support of global clinical trials. As pharmaceutical companies expand and even shift their sites to new countries, the many-layered requirements to support their efforts must be combined. The focus of this presentation will include logistics and customs with an eye on the budget, decisions of where to test and how frequently to test in light of study requirements for inclusion/exclusion criteria or reporting criteria, flexibility in data management and combining data from different laboratories into a unified database.

11:30 The Challenges of Multiuser Repositories for Inherited Disease Research

Jay Tischfield, Ph.D., Professor, Pediatrics & Psychiatry, Robert Wood Johnson Medical School, University of Medicine and Dentistry New Jersey; Genetics, Rutgers University

Large numbers of biosamples and associated clinical data from affected individuals and their relatives, often tens of thousands, are required for association and genetic linkage studies aimed at identifying gene variants that play a role in causation of common diseases (e.g., schizophrenia, diabetes and autism). Collecting, processing, storing and distributing DNA, RNA, cDNA and other derivative products of uniformly high quality and maximum utility for the end user presents unique long-term challenges. We will describe what we have learned after two decades and over 300,000 individual samples.

12:00 pm Close of Morning Session

12:15 Luncheon Presentation (Sponsorship Opportunity Available) or Lunch on Your Own 

 

Closing Case Study Combined Session: BioBankers and BioUser Partnerships 

This session brings together scientists who use biospecimens for research (“biousers”) with operation managers who collect and store the biospecimens (“biobankers”).
Biobankers and biousers elaborate on the characteristics of their working relationship as they address the following issues:

  • How does this partnership work? 
  • What are the bottlenecks? 
  • What does each member bring to the table? 
  • What does each member need from the other? 
  • Ultimately, what are the scientific results? 

1:30 Chairperson’s Opening Remarks

1:35 Yale University Co-Presentation

Alexander Vortmeyer, Ph.D., Director, Fresh and Frozen Tissue Procurement and Distribution, Yale University

Tobias Carling, M.D., Ph.D., Assistant Professor, Surgery; Director, Yale Endocrine Neoplasia Laboratory, Yale University School of Medicine

Diseased and normal control human tissues are an invaluable resource for diagnostic procedures and research. Traditional pathologic procurement techniques cause partial bio-chemical destruction of tissues, while research interests frequently require optimal biochemical preservation. Modifications of traditional procurement techniques are proposed for the benefit of both research analysis and molecular diagnostic evaluation.

2:30 Quintiles Co-Presentation

Barbara E. Glazer, MT(ASCP), Director, Pre-Analytical Services, Global Central Laboratories, Quintiles

Karl Kammerhoff, MBA, Associate Research Scientist, Discovery Medicine & Clinical Pharmacology, Research & Development, Bristol-Myers Squibb

Collaboration is key in developing the partnership between the biobanker and the biouser. This session explores what each party contributes to the relationship and how the
requirements of the individual parties contribute to the end result. Consideration will be given to initial collection of the biospecimen, training of collection sites, anonymization,
data provision, among others. What are the bottlenecks that can occur, and ultimately, how does all of this translate to quality scientific results?

3:35 Refreshment Break – Last Chance for Poster and Exhibit Viewing

4:00 Millennium Presentation
Samples, Assays and Data: Bio-Repository Practices to Maintain Sample Integrity, Enable Genomic Testing, Data Integration and Utility for Translational Medicine

Erik Koenig, Senior Manager, Molecular Technologies, MILLENNIUM: The Takeda Oncology Company

With the increase in outsourcing in the Bio-Pharmaceutical industry, biorepositories are required to coordinate sample tracking, sample testing and retesting within and throughout several laboratories. Biorepository practices, from Millennium: The Takeda Oncology Company, to maintain sample integrity throughout outsourced genomic testing to support translational medicine will be discussed.

4:40 The Broad Institute Co-Presentation

Kristin Ardlie, Ph.D., Director, Biological Samples Program, The Broad Institute of MIT and Harvard

Jordi Barretina, Ph.D., Research Scientist, Cancer Program, The Broad Institute of MIT and Harvard

 

5:20 Conference Wrap-up

5:30 Close of Conference


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