What’s in Your Sample?

9:00 Chairperson’s Opening Remarks

Mary Ann Brown, Executive Director, Conferences, Cambridge Healthtech Institute

9:05 Sample Quality – The Key to Success or Failure

Catherine A. Hammett-Stabler, Ph.D., Professor, Department of Pathology and Laboratory Medicine, University of North Carolina

Investigators in biomarker research have focused on analytics and clinical correlations with little attention to the samples being tested.  Sample quality is just as, perhaps more, important.   All too often this critical component is neglected.  This session will discuss the many issues such as collection, processing, and storage that contribute to sample characteristics and dramatically impact results.

9:35 Application of Pattern Recognition Image Analysis for Improved Research-Appropriate Biobanking Specimen QA

R. Mark Simpson, Ph.D., D.V.M., Senior Scientist, Laboratory of Cancer Biology and Genetics; Head, Comparative Molecular Pathology Unit, National Cancer Institute

Recognition of the past inclusion of inappropriate biobanking specimens in biomarker discovery science has become a significant driver of today’s biorepository effort.   Part of biobanking QA includes verification of research objective-appropriate specimen composition, including presence of desired/target tissue types, prior to resource consuming analysis and subsequent validation of extracted macromolecules. Improved precision and throughput enabled by histopathological pattern recognition image analysis helps minimize the inclusion of biorepository specimens that won’t lead, or worse may mislead, investigators to insights on clinically relevant biomarkers and drug targets.

10:05 Selected Poster Presentation: Developing a Research Repository at Texas Tech University Health Sciences Center in El Paso: A Collaborative Endeavor for the Collection, Storage, and Sharing of Biospecimens

Cynthia Camarillo, Ph.D., Senior Director, Texas Tech University Health Sciences Center

10:20 Coffee Break in the Exhibit Hall with Poster Viewing

11:00 Challenges to Successful Sample Procurement

Hannah Maynor, Associate Director, Biorepository, Laboratory Corporation of America

The use of characterized sample sets in research programs can significantly expedite device clearance and streamline drug development. Reference laboratories have access to numerous samples with a wide range of characteristics; however, the success of procuring appropriate samples is affected by factors such as patient consent, specimen integrity and access to clinical information and demographics. This presentation will discuss these challenges to effective sample procurement and strategies for overcoming them.

11:30 Building Assay-Ready Tools for Research and Industry

Belinda J. Wagner, Ph.D., Senior Director, BioCollections and Standards, American Type Culture Collection (ATCC)

With costs of whole genomic sequencing decreasing at a rapid pace, huge amounts of sequence data is being generated from both biomaterial collections and primary isolates. Bioinformatics tools are decreasing the time required to correlate sequence data with clinical or environmental outcomes. However, in order to develop more robust processes and products for applications like personalized medicine, a reliable source of biomaterials with consistently-maintained characteristics that can globally distribute identical reagents to a research or industry consortium is needed. In addition, validating the specificity and sensitivity of these new reagents requires parallel testing of a range of biomaterials with targeted diversity.

12:00 pm Close of Session

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

 

Quality Control

9:00 Chairperson’s Opening Remarks

Belynda D. Hicks, Director, Cancer Genomics Research Laboratory, SAIC-Frederick, Inc., Frederick National Laboratory for Cancer Research

9:05 Quality Control for Sequencing Applications

Belynda D. Hicks, Director, Cancer Genomics Research Laboratory, SAIC-Frederick, Inc., Frederick National Laboratory for Cancer Research

Current genomic technologies demand biospecimens that are well characterized and well qualified for downstream analysis.  Sample requirements will shift as the technology progresses, so it is important to understand the best QC technique that will be predictive of downstream performance.  Formal post-project assessments of metrics versus performance will assist in determining the best QC measurement techniques and sample acceptance criteria.  A robust and predictive quality control process that addresses sample, subject and project level characteristics is a critical component of a quality management system in today’s genomics laboratories.

9:35 The Tissue Quality Index – A Molecular Tool to Monitor Effects of Pre-Analytical Variables on Tissue

Veronique Neumeister, M.D., Senior Associate Research Scientist, Department of Pathology, Yale University

It has been shown that delay in post-surgical tissue processing can affect tissue quality and lead to protein degradation, impacting individualized cancer therapy. Using the AQUA technology, we assessed several proteins and microRNAs on a TMA consisting of 93 breast cancer patients with recorded time to formalin fixation, ranging from 25 to 415 minutes. Integrating the results of these biomarkers, a statistical model was constructed to generate a tissue quality index (TQI). The TQI is designed to predict if time to fixation has been less than one hour for breast cancer and if tissue is still suitable for immunological assessments.

10:05 Selected Poster Presentation: Long-Term Storage of Puregene® Blood Cell Lysates and DNA Extraction Processing in a Developing Nation Setting

Patricia Basta, Ph.D., Facility Director, UNC BioSpecimen Processing Facility, University of North Carolina, Chapel Hill 

10:20 Coffee Break in the Exhibit Hall with Poster Viewing

11:00 Roundtable Discussion - Evolution of Biorepository Accreditation

As set forth early in 2012 the recent advances in NCI best practices for biorepositories and the recent launch of the College of American Pathologists Biorepository Accreditation Program will be reviewed. 

What are the lessons we have learned to date?

• Subject matters from our checklist (CAP BAP) that we want to expand based on feedback from first inspections
• Storage versus research centers/biorepositories
• Informed consent matters
• Role of pathologists in the biorepository industry

Hosts:

Philip A. Branton, M.D., FCAP, Consultant Surgical Pathologist, Office of Biorepositories and Biospecimen Research, National Cancer Institute, NIH

Nancy Yeransian, Senior Manager, Accreditation Programs, College of American Pathologists (CAP)

12:00 pm Close of Session

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