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Sunday, September 30
5:00 Conference Registration
Pre-Conference Tour*
On-Site Tour of LabCorp’s Center for Molecular Biology & Pathology (CMBP)
5:30 Shuttle Transportation to LabCorp Tour
Complimentary roundtrip shuttle service to and from the Sheraton Chapel Hill will be provided for all conference delegates.
6:00-8:00 On-Site Laboratory Tour and Reception
Join your colleagues for an evening of networking at LabCorp’s Center for Molecular Biology & Pathology (CMBP) in the Research Triangle Park. Enjoy a tour of the facility:
- View state-of-the-art instrumentation
- Visit multiple laboratories focusing on various disciplines, including molecular oncology, infectious disease, cytogenetics, and flow cytometry
- Interact with our key scientists and thought leaders
We will conclude with a lively evening reception featuring cocktails and delicious gourmet hors d'oeuvres.
Click Here for Detailed Agenda
*Complimentary for all registered attendees!
Co-hosted by: 
Monday, October 1
7:15 am Conference Registration and Morning Coffee
Lessons Learned: Clinical Specimens Are Valuable
8:15 Chairperson’s Opening Remarks
Diane Uzarski, Associate Director, Biobanking Program, Duke Translational Research Institute, Duke University
8:30 Biobanking Initiatives at Duke
Helena Ellis, Director, Duke Biobank, Duke Translational Medicine Institute, Duke University
There are many biobanking entities at Duke, each operating independently and within their specific area of expertise. The Duke Biobank, under the auspices of the School of Medicine, the Duke Cancer Institute and the Duke Translational Medicine Institute, is leading an initiative to link these biobanking groups via an informatics system, as well as to provide an easy mechanism for searching for specimens at Duke that may be available for secondary use.
9:05 Challenges and Obstacles in Locating and Obtaining Rare Disease Specimens
Yaffa Rubinstein, Ph.D., Director of Patient Resources for Clinical and Translational Research, Office of Rare Diseases Research, (ORDR), National Center for Advancing Translational Sciences (NCATS)
Presenter: Liz Horn, Ph.D., Director, Genetic Alliance Registry and Biobank, Genetic Alliance
There are about 7,000 rare diseases, which are a clinically heterogeneous group and mostly genetic in origin. Rare diseases are commonly diagnosed during childhood and often have seriously deleterious long term effects. Their cumulative public health cost is quite substantial, effecting millions of people worldwide. Rare disease specimens, to the extent that they are available, are widely dispersed across large geographical regions and among various government or privately supported biorepositories, which are often quite hard to locate. In addition, the lack of common ethical precepts and legal regulations (informed consent, ownership, and patient privacy) interferes with global sharing of these specimens.
9:40 Coffee Break in the Exhibit Hall with Poster Viewing
10:30 Designing and Implementing a Centralized, Publicly Accessible, Linked Sample-Clinical Data Repository
Philip Cooley, Fellow, Bioinformatics and High-Performance Computing, RTI International
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Central Repository makes data and biospecimens from NIDDK-funded research available to the broader scientific community. It thereby facilitates: the testing of new hypotheses without new data or biospecimen collection; pooling data across several studies to increase statistical power; and informative genetic analyses using the Repository’s well-curated phenotypic data. This talk describes the design behind the Repository and the importance of standardized procedures to test the integrity datasets prior to distribution.
11:05 Establishing a Quality Control Program to Optimize the Quality of Tissue Biospecimens for Research
Angen Liu, M.D., Ph.D., Medical Director, Tissue Biospecimen Resource Center; Associate Staff, Anatomic Pathology, Cleveland Clinic
High-quality human biospecimens, tissue, cells, cell derivatives, and associated clinical information, are key elements of a scientific infrastructure that supports identification of both molecular biomarkers and diagnostic agents. Many factors such as ischemia time, storage conditions and biomolecule extraction methods may compromise biomolecule quality and contribute to preanalytical variability. In addition, as most solid tumors are composed of a complex mixture of cells and tissue, tissue histology quality may also contribute to tissue biospecimen variability and effect on research outcomes. We aimed to develop a quality control program to optimize the quality of tissue biospecimen at both histology and biomolecular levels. The detailed quality assurance and quality control methods will be described.
11:40 Improving Sample Quality: New Automated -80°C Storage System Provides Maximum Temperature Stability for Biological Samples Martin Frey, Ph.D., Head of Storage Technology Market Segment, Hamilton Bonaduz AGHamilton Storage Technologies developed a novel automated -80°C storage system to minimize warming effects during sample storage. Test results prove that samples are kept well below -70°C throughout their entire life in the system. Eliminating the unknowns of temperature oscillations results in more uniform sample quality for research projects.
11:55 pm Close of Morning Session - Enjoy Lunch on Own
Drug Discovery and Development
2:00 Chairperson’s Remarks
Amelia Warner, Pharm.D., Head, Clinical Pharmacogenomics and Clinical Specimen Management, Global Clinical Development and Regulatory Affairs, Merck
2:05 Retrospective Analysis: Contribution and Implementation in Drug Development
Amelia Warner, Pharm.D., Head, Clinical Pharmacogenomics and Clinical Specimen Management, Global Clinical Development and Regulatory Affairs, Merck - Download Podcast
Identification of subpopulations of responders in clinical drug development is increasingly more common as our understanding of heterogeneity of disease and the spectrum of response is understood. Collecting specimens for future use has resulted in many landmark scientific findings that have influenced success of drug filings and have impacted drug labels globally. This session will investigate how retrospective analyses from banked specimens continue to impact clinical drug development.
2:35 Novartis Translational Research Initiative: Taking BioBanking to Early Pharmaceutical Research
Dmitri Mikhailov, Ph.D., Associate Director, Translational Medicine, Novartis Institutes for Biomedical Research
Use of high quality, well-annotated human biological material will improve understanding of disease mechanisms, validate biomarkers, and identify novel drug targets. It is also a way to de-risk drug discovery projects by testing early hypotheses in relevant disease context. The Novartis Translational Research Initiative was launched to facilitate access to strategically valuable human biosamples, to support early research projects and translational research studies. This presentation outlines some of the operational, informatics and organizational measures the Novartis team has taken to establish best practices for using human bio-specimens in a multinational pharmaceutical research organization.
3:05 Presentation on “Indivumed’s Patient Tumor Culture Platform – IndivuPTC”Florian Unger, Ph.D., Scientist Drug Testing & Proteomics, Indivumed GmbH, HamburgIndivumed has developed a primary organotypic preclinical culturing system for fresh and intact patient tumor samples, IndivuPTC(Patient-specific Tumor Culture), that closely reflects the in vivo situation and takes the heterogeneity of a patients` tumor into account. The IndivuPTC system is suitable to measure and analyze responses to targeted drugs, large and small molecules and classical chemotherapeutics in a natural tumor microenvironment.
3:20 Refreshment Break in the Exhibit Hall with Poster Viewing
Clinical Trials/Outcomes
4:00 Optimizing PGx Collection in Clinical Trials
Anita Nelsen, Director, R&D Human Sample BioRepository & Genetics Sample Acquisition, GlaxoSmithKline
Clinical trial samples collected for pharmacogenetics research are vital to understanding why some patients respond differently when taking medicines. These samples can be used during the clinical trial or banked for future analysis either later in drug development or post-marketing. To avoid bias these sample sets must be representative of the clinical trial population however many collections are incomplete. This presentation will explore reasons for attrition in PGx sample sets, case studies demonstrating the impact of sample attrition, and strategies to improve sample collection rates.
4:30 Whole-Exome Sequencing of DNA from Peripheral Blood Mononuclear Cells (PBMC) and EBV-Transformed Lymphocytes from the Same Donor
Eric Londin, Ph.D., Fellow, Computational Medicine Center, Thomas Jefferson University
The creation of lymphoblastoid cell lines (LCLs) through Epstein-Barr virus (EBV) transformation of B-lymphocytes can result in a valuable biomaterial for cell biology research and a renewable source of DNA. While LCLs have been used extensively in cellular and genetic studies, the process of cell transformation and expansion during culturing may introduce genomic changes that may impact their use and the interpretation of subsequent genetic findings. To determine such changes, we performed whole exome sequencing on a tetrad family using DNA derived from peripheral blood mononuclear cells (PBMCs) and LCLs from each individual.
5:00 Development of Sample Biorepository for the TRIBE-AKI Consortium
Chirag Parikh, M.D., Ph.D., Director, Translational Research Program, Section of Nephrology, Yale University School of Medicine
There is an urgent need for biomarkers of acute kidney injury. In order to discover and validate biomarkers of acute kidney injury the TRIBE-AKI consortium created a sample biorepository of urine and serum samples from adult and children undergoing cardiac surgery who were at risk for kidney injury. We created a biospecimen data management system (BDMS) that supports TRIBE-AKI and is intended for multi-center collaborative clinical studies that involves shipment of biospecimens between sites. This system works in conjunction with a clinical research information system (CRIS) that stores the clinical data associated with the biospecimens, along with other patient-related parameters.
5:30 Networking Reception in the Exhibit Hall with Poster Viewing
6:30 Close of Day
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