Molecular diagnostic tools are becoming the standard of care for treatment of cancer. The availability of new sequencing platforms and biomarker assays will stimulate growth in the field by providing answers to questions regarding cancer diagnosis, prognosis, and best course of treatment. It is of equal importance to identify and resolve existing challenges that impede the effective translation of validated biomarkers from laboratory to clinic in order to see results from these efforts.
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TUESDAY, 11 OCTOBER
9:00 Conference Registration and Morning Coffee
9:30 Chairperson’s Opening Remarks
Dalia Cohen, Ph.D., CSO, Asterand
9:35 Hard Measures of Tissue Quality and Data
Beatrice Knudsen, M.D., Ph.D., Medical Director, Biorepository and Translational Pathology, Cedars-Sinai Medical Center
I will discuss the challenges of designing Q/C measures for specimens in a biorepository that are used to develop predictive biomarkers for targeted therapies. I will also present real life examples of the importance of Q/C for tissue in the realm of personalized medicine.
10:05 Biospecimens Are the Center of the Personalized Medicine Universe
Carolyn C. Compton, M.D., Ph.D., Director, Biorepositories and Biospecimen Research, National Cancer Institute
Human biospecimens are viable and biologically reactive until stabilized (e.g., fixed or frozen) and are subject to acquisition and handling variables that are capable of altering their molecular make-up and/or integrity. It is essential to the development of molecular medicine better to understand the variables in the “life cycle” of biospecimens and how these variables affect the molecular analytical data derived from those specimens.
10:35 Coffee Break - Networking with Sponsors
11:15 Ultra-Rapid BioBanking - Paving the Way for Next-Gen Personalized Health Care
Michael H. A. Roehrl, M.D., Ph.D., Assistant Professor, Pathology and Laboratory Medicine, Boston Medical Center
Highest-quality BioBanking of human specimens is of utmost importance for life science research and the future of personalized health care. We will use several of our ongoing tissue-based proteomic cancer biomarker research projects on human colorectal and lung adenocarcinomas to illustrate the critical steps necessary to make BioBanking a success. We will also present very recent work on colon cancer metabolomics using ultra-fresh tissue procurement and high-field 1H NMR spectroscopy.
11:45 Biobanking Tissue Samples for Medical Research, Possibilities and Impossibilities
Peter Riegman, Ph.D., Head, Erasmus MC Tissue Research Support Unit, Department of Pathology, Josephine Nefkens Institute, Erasmus MC Rotterdam, The Netherlands; Chair, OECI WG European Biobanking; Vice President, ESBB
Innovation of medical care is highly depended on progress in personalized medicine and identification of drug targets and biomarkers. Such studies need access to large numbers of well documented and exchangeable tissue samples of comparable quality. Individual institutes are no longer able to generate the large numbers in time and therefore need to join in multi-center research projects. As a consequence access rules, network infrastructures and quality issues are addressed in the EurocanPlatform and SPIDIA projects, respectively.
Sponsored by
12:15 Translating Pre-Clinical Biomarkers and their Application in Clinical Trials
Austin Tanney, Ph.D., Scientific Liaison Manager, Almac
12:30 Sponsored Presentation (Opportunity Available)
12:45 Lunch for Purchase in Exhibit Hall 9
13:45 Dedicated Poster Viewing in Exhibit Hall 9
14:30 Chairperson’s Remarks
Michael Berndt, Ph.D., Professor, Director, Biomedical Diagnostics Institute
14:35 Companion Diagnostics: Addressing the Challenges to the Pharma Business Model
Ruediger Weseloh, Ph.D., Senior Director, Head Strategic Transactions, Early-Stage Licensing, Merck KGaA
The importance of biomarkers for patient stratification is rapidly increasing. This has implications for the future of the pharma business. For instance, patient stratification requires structured decisions for the alignment of Rx/Dx co-development. In addition, the need for pharma to partner with diagnostics companies is created. This requires pharma to define criteria for the selection of a diagnostics partner.
15:05 Circulating Specific microRNAs Associated with Breast Cancer
Michael Berndt, Ph.D., Professor, Director, Biomedical Diagnostics Institute
The Biomedical Diagnostics Institute is a Science Foundation Ireland funded academic-business-clinical consortia developing integrated point-of-care diagnostic devices for a variety of clinical diseases including cancer. We have defined a whole blood microRNA biosignature in breast cancer with potential as an adjunct in screening and in assessing response to therapy and disease recurrence.
15:35 Refreshment Break - Networking with Sponsors
16:15 Sponsored Presentation (Opportunity Available)
16:45 SOMAmers (Slow Off Rate Modified Aptamers) as Tools to Discover Cancer Biomarkers and Translate them to Diagnostic Products
Stephen A. Williams, M.D., Ph.D., CMO, SomaLogic Inc.
A high-throughput clinical assay will be described that uses a mixture over 1000 SOMAmers as affinity reagents to measure 1034 proteins with CVs of <5%, lower limits of quantitation of ~0.3pM, a dynamic range of 7 logs and a sample volume of <10 microliters. This assay has been used in a series of substantive case-control studies in different cancers (lung, ovarian, pancreas, mesothelioma, melanoma, renal cell) in plasma/serum samples from several thousand subjects. These have revealed individual signatures of cancer as well as proteins common to several cancers which are being translated into diagnostic products.
17:15 Non-Coding RNA - A Whole New World of Potential Diagnostic and Prognostic Biomarkers
Sven Diederichs, Ph.D., Principal Investigator, Molecular RNA Biology & Cancer, German Cancer Research Center
It is now evident that the human genome contains many more functionally important and clinically informative entities: the non-coding RNAs (ncRNA). To assess the expression landscape of these new class of molecules, we have profiled the expression of 17000 non-coding RNAs in three major tumor entities: breast, lung and liver cancer. These studies revealed molecular signatures associated with tumorigenesis (diagnostic), with histological subtypes as well as with the outcome or metastasis development (prognostic). Our research uncovers the functions at the cellular and molecular level of the differentially regulated ncRNAs as well as their clinical importance as diagnostic and prognostic markers.
17:45 The Detection of Cancer Biomarkers on Biosensor Surfaces
Ajit Sadana, Ph.D., Professor, Chemical Engineering, University of Mississippi
This presentation will model the binding and the dissociation of biomarker kinetics using fractals. The fractal dimension provides one with a quantitative measure of the degree of heterogeneity present on the biosensor surface. The predictive equations developed help to manipulate the biosensor performance parameters (such as the binding rate coefficient) in desired directions.
18:15 Interactive Breakout Discussion Groups
TOPIC: Circulating Tumor Cells: Uses, Pitfalls and Challenges
Moderator: Wolfgang Janni, M.D., Ph.D., Professor, Gynecological Clinic, Heinrich-Heine University Hospital Düsseldorf
Solid evidence: CTC in metastastic breast cancer
Early evidence: CTC in primary breast cancer
Urgent Challenge: Phenotyping CTCs
CTC and stem cells: what is the difference?
CTC: which detection method is the best one?
TOPIC: Contamination and Quality Control in Biorepositories
Moderators:
Beatrice Knudsen, M.D., Ph.D., Medical Director, Biorepository and Translational Pathology, Cedars-Sinai Medical Center
Carolyn C. Compton, M.D., Ph.D., Director, Biorepositories and Biospecimen Research, National Cancer Institute
Optimizing prospective tissue collections: How can we reduce the pre-analytical variability?
How to assess the quality of an existing biorepository: How and when should be assess quality?
Biobanking and advanced technologies: Are existing biobanks adequate?
Biobanking in difficult financial times: How can we prioritize the resources?
Can technology development for biobanking overcome present challenges and limitations?
Are we at the point of globaliation of reserach and product development that international standardization should be incentivized/mandated?
TOPIC: Identification and Utilization of Molecular Markers for the Clinic
Moderator: Michael Berndt, Ph.D., Professor, Director, Biomedical Diagnostics Institute
Companion diagnostics and cancer drug development
Importance of novel cancer biomarkers: early detection versus response to therapy
Cancer biomarkers and patient stratification
The role of CTCs in cancer diagnostics
19:15 BIOTECHNICA EVENT NIGHT – Keynote Presentation followed by Networking Reception. Live music and dancing.
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