 Micro- and Nanofluidics in Diagnostics and Life Sciences: Technologies, Applications and Markets
This course is designed for scientists, managers, technicians and engineers who would like to acquire a comprehensive overview of the field of microfluidics. Starting with the underlying physical principles of miniaturization, the course includes an introduction into microfabrication technologies for microfluidic devices covering a wide range of existing materials (glass, silicon, polymers) and manufacturing technologies and describes the complete development cycle of a microfluidic device from the design to the ready-to-use device.
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 Applications of Detection Theory in Diagnostics
This course defines false positives, false negatives and dichotomous test as well as sensitivity, specificity, limit-of-detection, and response time. Attendees will understand and analyze a dose-response curve, construct and analyze a Receiver Operating Characteristic (ROC) curve from raw data, define Positive Predictive Value (PPV) and Negative Predictive Value (NPV), and interpret detector performance trade-offs using a ROC curve.
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 Roadmap for Accelerating Commercialization of Molecular DiagnosticsThis course is focused on the development of molecular diagnostics as they make their way from biomarker discovery and initial proof of clinical performance through to commercial launch and market development. The course emphasizes identification of critical hurdles that when addressed early, can materially accelerate progress. Vital areas that are covered include reimbursement strategies, regulatory path decisions, physician education and key opinion leader development.
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 Future of Point-of-Care Platforms
This course looks at POCT markets and technologies from the point of view of senior executives making strategic choices about priorities and market directions. The discussion focuses on the changes in healthcare markets overall and the implications for POCT companies, especially as affected by molecular medicine. The multiple paths to market and potential barriers for POCT firms in the changing healthcare environment are also covered, along with a range of potential strategies for success. This course is intended for decision-makers from POCT firms and investors, as well as diagnostic firms and scientists seeking a broader business view of point-of-care.
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 Circulating Tumor Cells As Surrogate Endpoints In Clinical Trials
Recent trials using an FDA-cleared assay show that CTC number is a biomarker of prognosis and more predictive than posttherapy changes in PSA, raising the possibility that posttherapy changes in CTCs might represent an intermediate endpoint of treatment efficacy. The question of whether CTC counts are potential surrogates for survival is currently being addressed in the context of a phase 3 registration trial. Also under study are biologic profi ling of these tumors to explore the relationship between specific alterations in androgen receptor signaling and the response to novel agents targeting these alterations.
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 Reality Check On Companion Diagnostics
About the Course:
- Landscape of the companion diagnostic space today
- Types of companion diagnostics tests
- Clinical areas for companion diagnostic tests
- Potential new companion diagnostic tests that will impact the market
- Three fundamental steps in companion diagnostics
- Impact on healthcare improvement and healthcare cost reduction
- Where is the revenue coming from?
- Who are the key players?
- Where are the gaps?
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