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MONDAY, AUGUST 24
MORNING, 9:00 am–12:00 pm
SC1: Technologies, Applications and Commercialization of POC Dx
Holger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH
This short course will provide an overview on the technological aspects of POC system developments. It will introduce current technologies such as microfluidics, sensors, paper- and smartphone-based approaches and discuss their trends and limitations. The course will discuss a variety of POC systems in different stages of their development, from early stage to established diagnostic systems in the clinical routine. Market aspects of POC systems as well as practical examples of commercialization for molecular diagnostic, immunological and clinical tests will be presented.
SC2: Global Companion Diagnostic Commercialization Bootcamp
Charles Mathews, Principal, ClearView Healthcare Partners
Successful development and launch of companion diagnostics require careful consideration of an array of success factors. All too often there are difficult transitions between development, regulatory approval, and assay commercialization. In this short course, you will hear about global companion diagnostic commercialization from industry experts with both diagnostic and pharma perspectives. Attendees will learn from the successes and failures of various companion diagnostic launches and will be able to take away best practices that can be aligned to their own projects/programs. The course will conclude with a deep-dive examination of a particularly interesting example, the launch of one of the first next-generation sequencing-based companion diagnostics, the Thermo Fisher’s Oncomine™ Dx Target test.
AFTERNOON, 2:00–5:00 pm
SC3: Liquid Biopsies Based on Extracellular Vesicles: Prospects, Challenges, and Opportunities
Joshua Smith, PhD, Research Staff Member, Translational Systems Biology and Nanobiotechnology, IBM T.J. Watson Research Center
Hakho Lee, PhD, Associate Professor and Hostetter MGH Scholar, Center for Systems Biology, Massachusetts General Hospital
Extracellular vesicles (EVs) exhibit a number of properties that make them attractive as a rich source of biomarkers for disease diagnosis, treatment monitoring, and therapeutics, including their abundance in a wide breadth of bodily fluids, nucleic acid and protein content, and protective lipid membrane that preserves this cargo from degradation. This course reviews key discoveries in EV research, describes current efforts to exploit their properties to capture market value, and takes a look at exploratory and emerging technologies aimed at accelerating their study and use. Existing gaps in understanding, along with current efforts to address these unknowns, will also be elucidated.
SC4: Accessing Point-of-Care Markets in the US, Europe, and China
Lawrence Worden, Founder, Principal, IVD Logix
Lucy Hattingh, MBA, Principal, Lucy Hattingh Consulting
Nathaniel Whitney, President, Whitney Research
SC5: Regulatory, Reimbursement & Quality Issues in Advanced Diagnostics
Melina Cimler, PhD, CEO & Founder, PandiaDx
Hilary Ann Baldwin, Regulatory Director, Regulatory, Caris Life Sciences
Danielle Scelfo, Senior Director, Health Policy and Reimbursement, Hologic, Inc.
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WEDNESDAY, AUGUST 26
dinner, 7:00-9:30 pm
SC6: Microfluidics and Lab-on-a-Chip Devices for POCT: Technologies and Commercialization
Evan Cromwell, President & CEO, Protein Fluidics
This short course will provide an overview of microfluidic techniques, including valved and valve-less devices, pumped systems, and capillary flow approaches. Practical examples will keep the discussion grounded in the realization of commercializable devices. We will discuss engineering approaches to enhance the advantages and minimize the challenges. Throughout, the science will be linked to the commercial case for these devices, including a full discussion of a recent success story of a centrifugal microfluidic molecular assay system.
SC7: Early Cancer Detection
Nicholas Dracopoli, PhD, CSO, DELFI Diagnostics
There is a growing need for new diagnostic tests to detect early stages of cancer. This need is driven by the better treatment response and prolonged survival of patients whose cancer is detected in early stages. These cancers are small, localized, and genetically more homogeneous than late-stage tumors that are larger, more heterogeneous, and have spread to distant organs. Early cancers are hard to detect because they do not have necrotic cores and may not yet be recognized by the immune system, so few of their cells are dying and releasing their contents into circulation. This course will discuss several different approaches to look for canonical cancer mutations, or downstream consequences of these mutations, to identify pre-symptomatic, non-metastatic cancers and to develop novel tests with high sensitivity and specificity for the detection of early-stage disease.
SC8: The COVID-19 Case Study: Accelerated Development of Diagnostics for Novel Infectious Disease Threats
Helen Roberts, Ph., President, Seegene Technologies
Lawrence J. Worden, Founder, Principal, IVD Logix
Fritz Eibel, Senior Vice President, Global Sales, Active Motif