MORNING, 9:00 am–12:00 pm
SC1: Technologies, Applications and Commercialization of POC Dx
( ショートコース1：ポイントオブケア診断の技術、応用分野、商業化 )
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.
SC3: Emerging Applications of ctDNA
( ショートコース3：血中循環腫瘍DNA (ctDNA) の新たな応用分野 )
John Simmons, PhD, Vice President, Translational Medicine, Personal Genome Diagnostics
This short course will cover cutting edge applications and clinical trials that use ctDNA for monitoring, minimal residual disease, and plasma tumor mutation burden. The background basics, the technologies, the clinical evidence out there so far, and the highlights of the prospective designs that are underway will be discussed.
AFTERNOON, 2:00–5:00 pm
SC4: Digital Pathology from A to Z for Beginners
( ショートコース4：デジタルパソロジーに関する初学者のための総合的な解説 )
Matthew G. Hanna, MD, Clinical Instructor, Breast and Informatics, Department of Pathology, Memorial Sloan Kettering Cancer Center
Digital pathology is a disruptive technology in the laboratory workflow. It has tremendous potential to change the way pathologists, researchers, and other personnel interact with pathology data. It is an exciting era of potentially practice-changing technology. Although digital pathology comes with significant promise, there are still numerous obstacles that stand in the way of becoming the next standard of care. Aside from clinical practice, digital pathology can be leveraged in the research and education arms of the medical community. This course will cover the nuts and bolts for all related topics in digital pathology for those who are just wondering what all the hype is about, to those who want a little more depth in their understanding of what digital pathology can and will do in the medical community.
SC6: Liquid Biopsies based on Extracellular Vesicles: Prospects, Challenges, and Opportunities
( ショートコース6：細胞外小胞をベースにしたリキッドバイオプシー：展望、課題、可能性 )
Joshua T. 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.
DINNER, 6:45–9:15 pm
SC8: Generating Evidence and Creating a Winning Dossier for Regulatory and Reimbursement Needs
( ショートコース8：規制と償還の要件に対応するエビデンスの生成と成果が見込める関係書類の作成 )
John Sninsky, PhD, Consultant, Translational Sciences
Melina Cimler, PhD, CEO & Founder, PandiaDx
Shivang Doshi, Director, Boston Healthcare Associates, Inc.
Mark Hiatt, MD, Vice President, Guardant Health
Managing the clinical narrative for your diagnostic test requires careful evaluation of the evidentiary requirements of stakeholders. Using those evidentiary requirements to determine your clinical and economic study designs is the cornerstone of effective product development.
SC9: Microfluidics and Lab-on-a-Chip Devices for POCT: Technologies and Commercialization
( ショートコース9：ポイントオブケア検査のためのマイクロ流体デバイスとラボオンチップデバイス：技術と商業化 )
Kris Buchanan, CEO and Founder, Phase Three Product Development
Chris Myatt, Founder & CEO, MBio Diagnostics, Inc.
Richard Spero, PhD, Co-founder, CEO, Redbud LabsEvan F 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.
SC10: Development of Novel Diagnostics for Antimicrobial Resistance
( ショートコース10：抗菌薬耐性に対する新たな診断法の開発 )
Richard Schoske, MA, PhD, MT (ASCP), Chief, Diagnostic & Detection Division, Defense Threat Reduction Agency
Diane L. Dutt, PhD, PMP, Science and Technology Manager, Diagnostics and Detection Division, Defense Threat Reduction Agency
Stephen C. Francesconi, PhD, Diagnostics and Detection Division, Defense Threat Reduction Agency