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MONDAY, NOVEMBER 16, 2009

7:30 am Conference Registration and Morning Coffee

 

COMPREHENSIVE BIOBANKING:
THE SPECIMEN LIFE CYCLE

8:30 Chairperson’s Remarks

Andrew Brooks, Ph.D., Associate Director, Technology, Rutgers University

KEYNOTE PRESENTATION
8:35 The Biospecimen is the Center of the Molecular Medicine Universe

Carolyn Compton, M.D., Ph.D., Director, Biorepositories and Biospecimen Research, National Cancer Institute

 

COLLECTION

9:20 Challenge of Safeguarding Diagnostic Properties of Tissue Sample While Securing Sufficient Sample for Biopreservation

Renata B. Greenspan, COL. MC (Ret), Director, BioSpecimen Network; Associate Director, U.S. Military Cancer Institute, Walter Reed Army Medical Center

Advances in cancer risk assessment have improved detection rates and allow for earlier removal of suspected lesion. As clinical methods have improved a specimen obtained for diagnostic examination is much smaller than previously encountered. The dilemma of how to obtain sufficient “fit for purpose” tissue sample for biomedical research which retains full diagnostic properties has become a significant challenge for Biobanks and pathologists. Acquisition and procurement techniques available to pathologists in meeting those challenges will be discussed. The presentation will also explore the ethical, legal and regulatory concerns of non-diagnostic collections and the potential for developing a standard of care for such collections.

PROCESSING

9:55 Impacts of Biopreservation on Disparities Between Biospecimens and Their Origins

Aby J. Mathew, Ph.D., Senior Scientist & Senior Director, Strategic Relations, BioLife Solutions, Inc.

The fundamental basis for improving the current techniques for biospecimen acquisition and storage is an understanding that all phases of the biospecimen lifecycle can cause stress and degradation of the specimen, which can potentially affect biomarker integrity. Protein and nucleic acid biomarkers must reliably recapitulate the condition of the source material from which they were isolated in order to accurately diagnose disease and determine effective treatment modalities. The purpose of this talk will be to discuss aspects of the biospecimen lifecycle where stresses occur and present suitable interventions that can help to optimize biopreservation, which can improve biospecimen consistency and utility, and therefore potentially improve diagnostics and patient care.

10:30 Networking Coffee Break Sponsored by Biolife Solutions 

11:00 One Stop Biobanking

David Toke, Ph.D., Associate Managing Director, Rutgers University Cell & DNA Repository

The Rutgers University Cell and DNA Repository (RUCDR) receives a wide variety of human biospecimens, where they are processed into high quality distributable biomaterials. In an effort to meet the ever changing demands of end-user dictated scientific research applications, the RUCDR employs a wide variety of automated platform systems and technologies necessary to remain competitive with the commercial Biobanking marketplace.

11:35 Biological Samples – Unlock the Potential

Diane Leong, Ph.D., Associate Director, Sample Repository, Genentech

12:15 pm Close of Morning Session

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

 

STORAGE

2:00 Chairperson’s Remarks

Lisa Miranda, President, Biobusiness Consulting Inc.; Former Technical Director, TTAB Core Facility, Univ. of Pennsylvania 

2:05 Managing Large Biorepository Collections for Collaborative Translational Research

Johanna L. Goderre, B.A., Assistant Project Director, Epidemiology, Johns Hopkins Bloomberg School of Public Health
Standardized collection, processing, and labeling of biospecimens linked to study subjects’ consent and phenotypic data afford a wide range of novel and rigorous scientific investigation. The presentation will elucidate the logistical management of specimen collection and long-term storage, protocol standardization and compliance, data management, and review of appropriate scientific proposals for a multi-site, NIH-funded collaborative study. Structured collection of data and specimens over time allows researchers the flexibility to quickly respond to innovative research questions. More than 100 WIHS publications in peer-reviewed journals have been supported by biorepository samples. Additionally, WIHS has supported more than 20 P01, R01, K23, R03, and U01 grants by contributing samples from a variety of repository collections.

2:35 The Four Pillars of Good Biorepository Management  Sponsored by Vitro Bio E
Jonathan Horan, B. Sc.  /  Product Manager, Vitro Ltd.
Health and biomedical research organizations that use human material have made huge advances in recent times and maturing biobanks are increasingly sharing their collections in the name of improving scientific research. This progress also brings new ethical obligations, risks and legal implications. The proper registration of biological material donations, tracking their processing, administering their storage and capturing the appropriate associated information needs to be controlled more than ever. Every point, from extraction, processing, and storage, to dispatch to researchers, implies certain controls. We present the four pillars of Security, Traceability, Process Integrity and Material Interchange that form the foundation of a well-managed biorepository.

APPLICATIONS

2:50 Increasing DNA Extraction Capacity – A Technology Overview
Robert Corr, Ph.D., Associate Director, DNA & Biofluids Center, Pfizer Global Research & Development
New protocols, extensive multiplexing, increased sensitivity of detection, and advances in miniaturization and automation have substantially reduced the amount of DNA required for downstream assays and prompted the question: are we banking an appropriate amount of DNA? This presentation describes the process of reviewing the current technology landscape with the intent of increasing daily DNA extraction capacity by ten-fold while maintaining quality and reducing operating cost. The exploration of the technology landscape included the review of chemistry (solid-phase, precipitation, silica, and magnetic bead technologies) and various automation options. Additionally, in-house and outsourcing processing costs were compared.

3:20 Science-Guided Biobanking for Cancer Drug and Biomarker Development

Hartmut Juhl, M.D., Ph.D., CEO of Indivumed GmbH and Inostics GmbH, Adjunct Professor, Georgetown University, Adjunct Professor, University of Hamburg, Indivumed GmbH

Availability and quality of tissues limit application of DNA- and protein-based biomarkers. Indivumed offers solutions to develop and apply biomarkers more effectively by providing high quality biobank and tissue collection procedures conserving protein pattern in tissues. Using science-guided biobanking, the effects of tissue ischemia on target expression in common cancer pathways are controlled, and Indivumed can profile pipeline drugs against viable human tumor tissue for proliferation, viability, apoptosis, IHC and signaling pathway analyses. Tissue-based DNA analyses have been replaced with plasma-based DNA mutation analysis.

3:35 Networking Refreshment Break

4:05 Use of Specimens for Clinical Trials

Leonardo Sahelijo, M.D., Medical Director, Pharmacogenomics, Takeda Global R&D

4:35 Managing Clinical Biobanks: From Current Investments Through Compounding Interests Panel Discussion
Panelists:

Moderator:  Lisa Miranda, President, Biobusiness Consulting Inc.; Former Technical Director, TTAB Core Facility, Univ. of Pennsylvania 
Marielena Mata, Ph.D., Senior Research Science the Biobank Manager, Biomarkers, Centocor

Diane Leong, Ph.D., Associate Director, Sample Repository, Genentech

Robert Corr, Ph.D., Associate Director, DNA & Biofluids Center, Pfizer

5:30 Welcome Reception and Grand Opening of Exhibit Hall

6:30 Close of Day