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Recommended Pre-Conference Short Courses *
(SC2) Roadmap for Accelerating Commercialization of Molecular Diagnostics (9am-12pm)
(SC7) Future of Point-of-Care Platforms (2pm-5pm)
(SC8) Smarter Studies: Designing Efficient and Rigorous Molecular Diagnostics and Biomarker Studies (2pm-5pm)
*Separate Registration Required.
7:00 am Registration and Morning Coffee
8:00 Plenary Keynotes - Details
9:40 Grand Opening Refreshment Break in the Exhibit Hall
11:00 Chairperson’s Opening Remarks
11:10 Massively Parallel Sequencing in Clinical Diagnostics
Wayne W. Grody, M.D., Ph.D., Professor, Divisions of Medical Genetics and Molecular Pathology, Departments of Pathology & Laboratory Medicine, Pediatrics, and Human Genetics, UCLA School of Medicine
The advent of massively parallel or “next generation” DNA sequencing has finally brought into reach the long-anticipated “Thousand Dollar Genome”, or the ability to sequence an individual’s entire genome at reasonable cost. Many are predicting that this achievement will supplant the single-gene genetic testing that largely comprises molecular medicine today. But if so, how will we handle the massive amounts of data produced, distinguish benign variants from pathologic mutations, and convey their clinical implications to doctors and patients? This presentation will review the many considerations that must be faced in developing, validating, performing and reporting these new genome-wide tests. Also considered will be the ethical dilemmas raised by this new technology, including genetic discrimination and privacy, level of government oversight, gene patent restrictions, and direct-to-consumer testing.
11:40 AdvaMed Dx: An Ally in Your Molecular Diagnostics Company’s Future
Andrew Fish, J.D., Executive Director, AdvaMed Dx
AdvaMed Dx is an advocacy organization focused on issues facing in vitro diagnostic (IVD) companies. The membership developed a strategic plan that encompasses global policy initiatives. This talk will cover the highlights of the policy initiatives for all of IVDs and those particularly important to the field of molecular diagnostics.
12:10pm Genome-Era Pathology, Precision Diagnostics and Preemptive Care
Jeffrey E. Saffitz, M.D., Ph.D., Mallinckrodt Professor of Pathology, Harvard Medical School; Chairman, Department of Pathology, Beth Israel Deaconess Medical Center
“Medical sequencing” will revolutionize clinical laboratory diagnostics as the foundation for the new era of personalized medicine. However, the medical profession lags far behind the technology and business communities in recognizing and preparing for this change. Applications of genomic technologies in medical practice must be developed and standardized through CAP-accredited, CLIA-certified clinical laboratories. As a critical first step, we have established a first-in-the-nation pathology training curriculum in genomics and personalized medicine, and we have challenged all ACGME-accredited pathology residency programs in North America to implement a similar program by 2012. We are also leading a discussion among pathology organizations, private insurance companies, government regulators and policymakers, and the technology community to develop a national plan to incorporate and pay for standardized genomic diagnostics in the practice of medicine.
12:40 Luncheon Presentation
Miniaturized and High Sensitivity Protein Detection Assays Using High Density Multiplex NanoarraysSponsored by
Haris Jamil, Ph.D., Vice President, Business Development, Nano BioDiscovery
NanoInk has developed a multiplex protein array technology for the detection and quantification of low abundance biomarkers using small sample volumes. NanoInk’s nanoarrays enable assay miniaturization with improved sensitivity. These protein nanoarrays exhibit improved detection levels over conventional assay technologies with sensitivities for target biomarkers down to the femtograms/ml range.
1:10 Luncheon PresentationSponsored by
Scientific Knowledge or Information? – An Opportunity for Life Science Research Organizations
Colin Williams Director, Product Strategy, Healthcare and Science, Thomson ReutersThe evolution of high throughput technologies means scientists involved in pharmaceutical and biotechnology research are drowning in information, often creating a barrier to progress. The rate of information generation, through technologies such as next generation sequencing, will continue to grow rapidly. The effective management and utility of information creates an opportunity for Life Science organizations to increase innovation and productivity. Using examples from solutions such as Thomson Reuters Integrity this session will show how tools which link expansive and diverse scientific information create knowledge which can support better decision making and create a competitive advantage in research projects for the organizations which employ them
1:45 Dessert in the Exhibit Hall
2:15 Chairperson’s Remarks
Josip Blonder, M.D., SAIC-Frederick, NCI-Frederick
2:20 Solid Tumor Heterogeneity: From Tissue Proteomics to Personalized Medicine
Donald J. Johann, Jr., M.D., Associate Investigator, Center for Cancer Research, National Cancer Institute, National Institutes of Health
Solid tumor heterogeneity is a perplexing scientific and clinical problem. Tissue based proteomic approaches utilizing identity-based mass spectrometry and laser capture microdissection, may serve as a platform allowing enhanced molecular profiling, and the revealing of subtle solid tumor phenotypes.
2:50 Proteomic Profiling of Clinical Specimens in the Context of Cancer Biomarker Discovery and Validation
Josip Blonder, M.D., Senior Research Scientist, Head, Clinical Proteomics, Laboratory of Proteomics and Analytical Technologies, SAIC-Frederick, Inc., NCI-Frederick
Solid tumors undergo tremendous change due to improved understanding of their biology as well as an abundance of new therapeutic agents (i.e., small molecules and monoclonal antibodies) recently approved by FDA. Certainly, clinical proteomics based cancer biomarker discovery could assist tremendously for individual-based treatment assignments, as well as toxicity monitoring. This presentation will highlight a variety of technological approaches utilized in clinical proteomics of renal cell carcinoma (RCC) and summarize respective biological findings in the context of RCC biomarker discovery and validation.
3:20 Clinical Application of Tumor Genotyping to Drive Clinical Trials and Translational Research
Leif Ellisen, M.D., Ph.D., Co-Executive Director, Massachusetts General Hospital Cancer Center, Translational Research Laboratory; Associate Professor of Medicine, Harvard Medical School
Analysis of tumor somatic genetic abnormalities has provided key insights into cancer pathogenesis, signaling, and oncogene dependence. We describe the development and validation of a prospective (pre-treatment), broad-based solid tumor mutation detection platform and its application for clinical decision making, clinical trial enrollment and translational research.
3:50 “So Many Markers, So Little Tissue”: The Layered IHC Solution for Personalized MedicineMichael S. Lebowitz, Ph.D., Director of R & D, 20/20 GeneSystems, Inc.L-IHC detects multiple biomarkers in histological (FFPE) samples. From one 5μm tissue section >10 protein biomarkers can be probed enabling pathway profiling in limiting samples (e.g. core needle biopsies) supporting the development of new diagnostic tests.
4:35 Reception in the Exhibit Hall
5:20 Breakout Discussions in the Exhibit Hall
Concurrent Problem Solving Break-Out Sessions are interactive, problem solving discussions hosted by a moderator to discuss a topic in depth. The discussions are open to all attendees, sponsors, exhibitors, and speakers and provide a forum for discussing key issues and meeting potential partners. Please pick a topic of your choice and join in.
Personalized Medicine Partnerships: Emerging Industry Models
Moderator: Mollie Roth, Esq.; Chief Operating Officer, Diaceutics
- The current disconnect between the business models in the pharmaceutical and diagnostic industries
- Why does PM require a new business model?
- What changes are required to move from the current supplier/buyer paradigm into a true partnership?
- What does a truly effective partnership in the PM space look like?
- An overview of the emerging models
Project Management in the Development of an in vitro Diagnostic in a Changing Global Environment
Moderators: Diane Ward, Ph.D., Senior Director and David Kern, M.B.A., Senior Director, Myraqa, Inc.
It's not just the science, the process matters
Managing a system
Where project management can add value in an IVD environment
Alliance management and strategic partnerships
Introducing New Technologies to the FDA
Moderators: Mya Thomae, RAC, CQA, Founder and CEO, and Lianne McLean, Senior Director, Myraqa, Inc.
Is it too early to meet with the FDA to discuss our new technology?
Intended use statements
Regulatory strategies: 510(k) vs. PMA?
Removing the barriers to commercial success
Proteomic Profiling of Clinical Specimens
Moderator: Josip Blonder, M.D., Senior Research Scientist, Head, Clinical Proteomics, Laboratory of Proteomics and Analytical Technologies, SAIC-Frederick, Inc., NCI-Frederick
Selection, evaluation, and translation of proteomic technologies for cancer biomarker discovery using analysis of clinical specimens.
Future prospects of analyzing tissues and body fluids using proteomics: complementing and enhancing MS-based proteomic assays to conventional molecular diagnostics.
What improvements would facilitate translation of proteomic technologies into the clinical laboratory for quantitative assaying of clinical specimens?
microRNAs for Cancer Treatment Decision Making
Moderator: Glen Weiss, M.D., Director, Thoracic Oncology, VGPCC, Scottsdale Healthcare; Co-Head, Lung Cancer Unit, TGen
What are the first clinical applications that microRNAs will be used for?
What barriers need to be overcome to more widely implement microRNAs for cancer treatment decision making?
Can biofluids supplant tumor tissue derived microRNAs for treatment decision making?
Could microRNAs be used for both cancer treatment decision making and treatment?
Screening for Mutations in Genes to Predict Age of Onset for Genetic Disorders
Moderator: Qing Zheng, M.D., Associate Professor, Genetics, Department of Otolaryngology-HNS, Case Western Reserve University
Can anyone give an example of a genetic mutation that if known, can predict when the disease may happen during the life of that individual?
There are many factors that influence onset of disease. How do we calibrate these in light of the genetics?
Complexity and limitations of predictive medicine: complex traits, genetic modifiers –gene interactions, gene-environmental interactions
Pharmacogenomics, prenatal diagnosis and screening, carrier testing, preconception testing, ethics and law
Emerging Stakeholders in Personalized Diagnostics
Moderator: Harry Glorikian, Managing Partner, Scientia Advisors
Personalized medicine is becoming a critical component of healthcare delivery
Current stakeholders are increasingly active and interested in the benefits offered by personalized medicine
Emerging stakeholders are creating value-driven services that will impact the future direction of personalized medicine
6:20 Close of Day
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