Next Generation Dx Summit brings together more than 800 international diagnostic professionals working in the field and offers unparalleled insight from the comprehensive programming and networking with key opinion leaders in the industry. The event is unique in the marketplace. This year the coverage spans cell- and cell-free biopsies, commercialization, reimbursement, biomarkers and companion diagnostics for immunotherapy, point-of-care testing, infectious disease, microfluidics and precision medicine. Now in its twelfth year, Next Generation Dx Summit is a must-attend event with complete coverage of the most timely and important issues for the industry.
Cambridge Healthtech Institute's fourth annual Clinical Trial Oversight Summit will feature four co-located conferences covering best practices and recent trends relevant to clinical research monitoring, auditing, clinical quality assurance, site management, and vendor oversight. This four-day summit will include presentations from experts, case studies, interactive breakout discussion groups, workshops, and networking opportunities. Themes throughout will include risk-based approaches to clinical trial management, implementing quality systems-based approaches to GCP compliance, ensuring reliable study data, responding to the evolving regulatory landscape, and preparing sites and clinical research partners for inspection-readiness.
The document discusses HIV self-testing in South Africa. It notes that from 2005-2015 there was a sharp increase in HIV diagnoses in Africa, and from 2010-2014 over 600 million people received HIV testing services in low- and middle-income countries, nearly half of all tests in Africa. However, there remains a testing gap as only 45% of people living with HIV know their status. HIV self-testing is proposed as an innovative way to help close this gap and reach key populations by making testing more accessible and private. The document outlines several HIV self-testing implementation and research programs currently underway in South Africa, and barriers to introducing HIV self-testing in the country such as regulatory issues.
Purpose of the call:
To learn about:
•successful strategies and approaches to engage patients and caregivers in MedRec,
•how teams effectively dialogue with patients and their caregivers on the benefits of having an accurate medication list, and
•the development of paper and electronic tools and resources created for patients and their caregivers to create and maintain their medication lists.
Watch the webinar http://bit.ly/1fnE61V
CHI's Next Generation Dx Summit 2022 | August 22-24, 2022 | Washington, D.C.James Prudhomme
Advancing Diagnostics Together
We are proud to host Cambridge Healthtech Institute's Fourteenth Annual Next Generation Dx Summit which will take place in-person at the Grand Hyatt Washington, D.C. on August 22-24. The Next Generation Dx Summit is the nexus for key opinion leaders across the world to share recent progress in diagnostic advancement and technology innovation. The event provides a valuable window on how point-of-care, infectious disease, liquid biopsy and companion diagnostics are changing the standard of care. Now in its fourteenth year, the Next Generation Dx Summit is a must-attend event with complete coverage of the most timely and important topics for the industry.
CHI's 10th Annual Next Generation Dx Summit, August 20-24, 2018, Washington, DCJames Prudhomme
The document is a program for the Next Generation Dx Summit, which will take place from August 20-24, 2018 in Washington DC. The summit will include 14 conference streams covering topics like molecular biopsy, immuno-oncology, rapid testing, precision medicine and business. It will feature over 1000 scientific and technology presentations, 250 industry sponsors and exhibitors, and 90 conference programs. The summit celebrates 10 years of the diagnostics community coming together to advance developments in areas like rapid and non-invasive testing, cancer detection, and clinical sequencing.
Overcome Operational Challenges in Biomarker-driven Clinical TrialsJames Prudhomme
Cambridge Healthtech Institute offers two back-to-back symposia on the operational aspects of precision medicine trials and the improvement of infrastructure to better support those trials. The 2nd Annual Managing Precision Medicine Trials Symposium (January 24-25, 2017) focuses on strategizing design for biomarker driven trials and novel clinical trial design. The Inaugural Sample, Lab and Diagnostics Services in Clinical Trials Symposium (January 25-26, 2017) focuses on clinical sample management and sourcing and diagnostics services.
This document provides information about the 10th Annual Immunogenicity & Bioassay Summit taking place from October 22-25, 2018 in Washington, DC. It will include conferences on immunogenicity assessment and clinical relevance, immunogenicity prediction and control, and optimizing bioassays for biologics. There will also be a symposium on immunology for biotherapeutics and a training seminar on design of experiments. The summit brings together industry, academia, and regulatory authorities to discuss challenges in the field. It provides opportunities for networking, learning about new expectations, and hearing from thought leaders and regulators.
This document provides information on two pre-conference workshops at the "Superbugs & Superdrugs" conference on combating antimicrobial resistance.
The first workshop discusses rapid diagnostic tools for infectious diseases, focusing on tracking emerging infections, state-of-the-art diagnostic methods, mobile applications, and challenges in diagnosis.
The second workshop examines how antimicrobial copper touch surfaces can improve patient outcomes and reduce costs by lowering healthcare-associated infections and antimicrobial resistance. It will evaluate the evidence supporting copper's use and discuss cost-benefit analysis and practical implementation.
Cambridge Healthtech Institute's fourth annual Clinical Trial Oversight Summit will feature four co-located conferences covering best practices and recent trends relevant to clinical research monitoring, auditing, clinical quality assurance, site management, and vendor oversight. This four-day summit will include presentations from experts, case studies, interactive breakout discussion groups, workshops, and networking opportunities. Themes throughout will include risk-based approaches to clinical trial management, implementing quality systems-based approaches to GCP compliance, ensuring reliable study data, responding to the evolving regulatory landscape, and preparing sites and clinical research partners for inspection-readiness.
The document discusses HIV self-testing in South Africa. It notes that from 2005-2015 there was a sharp increase in HIV diagnoses in Africa, and from 2010-2014 over 600 million people received HIV testing services in low- and middle-income countries, nearly half of all tests in Africa. However, there remains a testing gap as only 45% of people living with HIV know their status. HIV self-testing is proposed as an innovative way to help close this gap and reach key populations by making testing more accessible and private. The document outlines several HIV self-testing implementation and research programs currently underway in South Africa, and barriers to introducing HIV self-testing in the country such as regulatory issues.
Purpose of the call:
To learn about:
•successful strategies and approaches to engage patients and caregivers in MedRec,
•how teams effectively dialogue with patients and their caregivers on the benefits of having an accurate medication list, and
•the development of paper and electronic tools and resources created for patients and their caregivers to create and maintain their medication lists.
Watch the webinar http://bit.ly/1fnE61V
CHI's Next Generation Dx Summit 2022 | August 22-24, 2022 | Washington, D.C.James Prudhomme
Advancing Diagnostics Together
We are proud to host Cambridge Healthtech Institute's Fourteenth Annual Next Generation Dx Summit which will take place in-person at the Grand Hyatt Washington, D.C. on August 22-24. The Next Generation Dx Summit is the nexus for key opinion leaders across the world to share recent progress in diagnostic advancement and technology innovation. The event provides a valuable window on how point-of-care, infectious disease, liquid biopsy and companion diagnostics are changing the standard of care. Now in its fourteenth year, the Next Generation Dx Summit is a must-attend event with complete coverage of the most timely and important topics for the industry.
CHI's 10th Annual Next Generation Dx Summit, August 20-24, 2018, Washington, DCJames Prudhomme
The document is a program for the Next Generation Dx Summit, which will take place from August 20-24, 2018 in Washington DC. The summit will include 14 conference streams covering topics like molecular biopsy, immuno-oncology, rapid testing, precision medicine and business. It will feature over 1000 scientific and technology presentations, 250 industry sponsors and exhibitors, and 90 conference programs. The summit celebrates 10 years of the diagnostics community coming together to advance developments in areas like rapid and non-invasive testing, cancer detection, and clinical sequencing.
Overcome Operational Challenges in Biomarker-driven Clinical TrialsJames Prudhomme
Cambridge Healthtech Institute offers two back-to-back symposia on the operational aspects of precision medicine trials and the improvement of infrastructure to better support those trials. The 2nd Annual Managing Precision Medicine Trials Symposium (January 24-25, 2017) focuses on strategizing design for biomarker driven trials and novel clinical trial design. The Inaugural Sample, Lab and Diagnostics Services in Clinical Trials Symposium (January 25-26, 2017) focuses on clinical sample management and sourcing and diagnostics services.
This document provides information about the 10th Annual Immunogenicity & Bioassay Summit taking place from October 22-25, 2018 in Washington, DC. It will include conferences on immunogenicity assessment and clinical relevance, immunogenicity prediction and control, and optimizing bioassays for biologics. There will also be a symposium on immunology for biotherapeutics and a training seminar on design of experiments. The summit brings together industry, academia, and regulatory authorities to discuss challenges in the field. It provides opportunities for networking, learning about new expectations, and hearing from thought leaders and regulators.
This document provides information on two pre-conference workshops at the "Superbugs & Superdrugs" conference on combating antimicrobial resistance.
The first workshop discusses rapid diagnostic tools for infectious diseases, focusing on tracking emerging infections, state-of-the-art diagnostic methods, mobile applications, and challenges in diagnosis.
The second workshop examines how antimicrobial copper touch surfaces can improve patient outcomes and reduce costs by lowering healthcare-associated infections and antimicrobial resistance. It will evaluate the evidence supporting copper's use and discuss cost-benefit analysis and practical implementation.
This document provides information on two pre-conference workshops at the "Superbugs & Superdrugs" conference on combating antimicrobial resistance.
The first workshop discusses rapid diagnostic tools for infectious diseases, focusing on tracking emerging infections, state-of-the-art diagnostic methods, mobile applications, and challenges in diagnosis.
The second workshop examines making materials like copper touch surfaces in healthcare settings to improve patient outcomes and reduce costs by lowering infection rates and antimicrobial resistance. It will evaluate the evidence for copper's antimicrobial efficacy and cost-benefit analysis.
World ADC Frankfurt 2015 - sample brochureWorld ADC
The World ADC Frankfurt meeting has been established with the simple mission of speeding up the development of more potent and safe antibody drug conjugates.
Learn not only how to make an ADC, but how to make a great one. With insights on numerous novel payload technologies, robust strategies for preclinical evaluation and emerging clinical data, there is no better opportunity to accelerate your research.
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
Global Engage is pleased to announce the 2018 Precision Medicine & Biomarkers Leaders Summit USA taking place on May 7-8th in Boston, MA. The event is part of our highly successful Drug Discovery Series which includes conferences on Biologics, Medicinal Chemistry, NASH, Pharmaceutical R&D IT and the Human Microbiome amongst others. It is also the sister meeting of the European Precision Medicine Summit which has run successfully since 2013.
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
Tracks focus on R&D strategies, Biomarker development, Immuno-oncology, CDx development, AI and Big data analysis and approaches – Attending this Summit will provide you with the opportunity to mix and interact with experts working in all facets of Precision Medicine through the individual, panel and roundtable discussions on offer.
Make Plans to Attend the Number 1 Immunogenicity and Bioassay Event Bringing Together Industry,
Academia and Regulatory Authorities. Featuring 8 FDA Presenters!
SMi Group's Injectable Drug Delivery 2018 conferenceDale Butler
This document provides information about two half-day pre-conference workshops on injectable drug delivery taking place on May 15, 2018 in London. Workshop A from 8:30-12:30 will focus on creating a human factors and usability engineering file in accordance with FDA and IEC62366-1 standards. Workshop B from 13:30-17:30 will examine wearable injectors and their ability to meet clinical needs while reducing healthcare costs. Both workshops aim to equip attendees with practical knowledge and strategies for developing safer and more user-friendly drug delivery devices and technologies.
- Discover new methods for managing clinical next-gen data with insights from Pfizer, Boston Children’s Hospital and AstraZeneca
- Uncover and critique the latest technologies out there for you to use in clinical trials. Mayo Clinic, Merck and Harvard Medical School let you into their trade secrets
- Hear the genomics strategies that Roche, Millennium and Regeneron are using for discovery and validation of clinically actionable biomarkers
-Bristol-Myers Squibb, Takeda and Partners Healthcare the role that NGS can play when implementing an effective strategy in the lab to speed up CDx development
- Learn how to integrate molecular details into medical decision making, with fresh data from Washington University School of Medicine and Genzyme
12th Annual Molecular Diagnostics Conference Part of TRI-CON 2015Nicole Proulx
CHI's flagship diagnostics event, "Molecular Diagnostics: Executive Strategies for Success" taking place February 16-18, 2015 in San Francisco, CA. In its twelfth year this is the leading event for the industry featuring experts on business strategy, platform development, regulation and reimbursement who will outline the steps needed to take to achieve commercial success in the current environment.
(2286) World Orphan Drug Congress USA 2016 A4 32 Page Brochure 1.5 SCREEN SPREADPinky Fadullon
This document provides information about the 6th Annual Global Orphan Drug Conference and Expo taking place April 21-22, 2016 in Washington D.C. The conference will bring together stakeholders in the orphan drug industry including pharmaceutical companies, patient advocacy groups, regulators, payers, and investors. It will include keynote sessions, workshops on topics like market forecasting and commercialization, and networking opportunities. A pre-conference day of workshops is scheduled for April 20th.
CHI's Immunogenicity and Bioassay Summit 2015James Prudhomme
This document summarizes an upcoming conference on immunogenicity assessment and clinical relevance for biopharmaceutical products. The conference will take place November 17-18, 2015 in Baltimore, MD and will include keynote speakers from the FDA and industry. It will feature sessions on regulatory expectations, preclinical studies and risk assessment, different assay formats and technologies, and challenges with immunogenicity assessment. Short courses on related topics will also be offered. The document provides an agenda with session topics, speaker names and affiliations, and descriptions of presentation topics.
SMi Group's Inaugural Big Data in Pharma conferenceDale Butler
This document provides information about a conference on big data in the pharmaceutical industry, including an agenda, speaker details, and workshop information. The two-day conference will focus on how big data can be leveraged to enhance research and development, clinical trials, and real-world evidence generation. Highlights include sessions on personalized medicine, predictive analytics, and social media strategies. Post-conference workshops will discuss the legal aspects of cloud computing and designing studies using big data to support drug development and marketing. The event aims to help pharmaceutical companies exploit big data's potential to create better medicines and new revenue streams.
Improving the development of diagnostics testsMarilia Costa
1) Rapid diagnostic tests have great potential to improve healthcare in low- and middle-income countries by enabling accurate and timely treatment, but many barriers currently limit their development and deployment.
2) Key barriers include insufficient prioritization of diagnostics, financial challenges, demanding technical requirements, shortcomings in evaluation methods, complex regulatory systems, lack of quality assurance, and inadequate involvement of private healthcare providers.
3) Potential solutions involve prioritizing diagnostics development globally and nationally, using economic incentives, promoting locally-driven design, strengthening regulatory frameworks and quality assurance, engaging private providers, and developing flexible tools to support surveillance and differential diagnosis.
Customized Oncology Development Solutions: Clinical Trials Designed Around You®Covance
Covance provides customized clinical trial solutions and services for oncology drug development. Their services include utilizing patient lab data to assess trial feasibility and identify eligible patients, scientific consultation in precision medicine areas, and selecting investigator sites with the right patients and experience. Covance aims to help clients accelerate development timelines, improve the probability of success, and deliver trials on budget.
The Hub – Solutions Distinctly for Nimble Biotechs Brochure Covance
Welcome to a unique experience - one that's Designed Around You®. Where you control your journey from start to finish. Regardless of where you are and how far you aspire to go, choose the options that make the most of your endeavor. Learn more about the innovations you can tap at any stage of the drug development process.
This document provides information about the Cell & Gene Therapy conference taking place on October 10-11, 2018 in London. It includes details about the agenda, speakers, workshops, and registration information. The two-day conference will focus on topics related to manufacturing, regulation, and translational research of cell and gene therapies. There will be presentations from industry experts on developing stem cell and gene therapies, as well as workshops on practical development issues and competitive intelligence in the cell and gene therapy field.
SMi Group's Adaptive Designs in Clinical Trials conferenceDale Butler
This document summarizes an upcoming conference on adaptive designs in clinical trials taking place from April 20-21, 2015 in London. The conference will focus on topics such as Bayesian adaptive designs, subgroup selection in clinical trials, integrating real-world patient data into adaptive trials, and designing biomarker-driven multi-arm multi-stage cancer trials. Speakers will discuss challenges with adaptive designs and their use in different therapeutic areas like neurodegenerative diseases. Participants can also register for optional half-day workshops on April 22nd focusing on Bayesian clinical trial designs and navigating international regulatory landscapes for adaptive trials.
Clinical Genomics & Informatics Europe - ProgramJaime Hodges
Bio-IT World and Cambridge Healthtech Institute's Fifth International Clinical Genomics & Informatics Europe Conference will feature four main tracks on Clinical Exome Sequencing, High-Scale Computing, RNA Sequencing and Genome Informatics. In addition, two pre-conference Symposia on Clinical Epigenetics and Digital Detection Techniques and Applications will be provided. View the full program and details at http://www.clinicalgenomicsinformatics.com
Precision Medicine & Biomarkers Leaders Summit - Boston USA - 7th & 8th MayTony Couch
This expanding series attracts the leading authorities worldwide working in companion diagnostics, biomarkers, immuno-oncology, liquid biopsies, AI and other facets of precision medicine. It has been praised for its stimulating, interactive and engaging environment where it brings together a multi-disciplined community of researchers, leaders and innovators whose aim is to develop groundbreaking and impactful treatments for patients.
Attracting over 3,300 drug discovery and development professionals from over 40 countries in 2015, the Tri-Conference has grown into a diverse event, focusing on Molecular Medicine, specifically on Discovery, Genomics, Diagnostics and Information Technology.
With a 23 year history, this year’s expanded coverage includes additional programs on Molecular Diagnostics for Infectious Disease, Precision Medicine and Cancer Immunotherapy, as well as two new symposia on Companion Diagnostics and the Commercialization of Molecular Diagnostics.
CHI's Targeting Stromal Cells in Cancer and Inflammatory Diseases Conference ...James Prudhomme
This virtual meeting will highlight cutting-edge science and provide insight into recent developments towards therapeutic stromal cell targeting in cancer and chronic inflammatory diseases. View full details and register: https://www.healthtech.com/stroma-conference
CHI's Bioassays for Immuno-Oncology Symposium, Oct. 23, 2017 in Washington, DCJames Prudhomme
Biological assays demonstrating drug characteristics such as potency, mechanism-of-action, and stability, are one of the most critical components of an FDA biologic submission. However, with more complex mechanisms-of-action, immunotherapies add a layer of difficulty to bioassay selection and development. At Cambridge Healthtech Institute's Inaugural Bioassays for Immuno-Oncology symposium, experts in bioassays for immuno-oncology therapies will discuss selection, development, and standards for bioassays and immunoassays. Special attention will be given to understanding the mechanism-of-action for immunotherapies, whether they be antibody- or cell-based. Overall, this one-day immersive symposium will outline a product life cycle approach for developing and implementing biological assays from preclinical studies to clinical development. This symposium is part of the Immunogenicity & Bioassay Summit.
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This document provides information on two pre-conference workshops at the "Superbugs & Superdrugs" conference on combating antimicrobial resistance.
The first workshop discusses rapid diagnostic tools for infectious diseases, focusing on tracking emerging infections, state-of-the-art diagnostic methods, mobile applications, and challenges in diagnosis.
The second workshop examines making materials like copper touch surfaces in healthcare settings to improve patient outcomes and reduce costs by lowering infection rates and antimicrobial resistance. It will evaluate the evidence for copper's antimicrobial efficacy and cost-benefit analysis.
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- Discover new methods for managing clinical next-gen data with insights from Pfizer, Boston Children’s Hospital and AstraZeneca
- Uncover and critique the latest technologies out there for you to use in clinical trials. Mayo Clinic, Merck and Harvard Medical School let you into their trade secrets
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12th Annual Molecular Diagnostics Conference Part of TRI-CON 2015Nicole Proulx
CHI's flagship diagnostics event, "Molecular Diagnostics: Executive Strategies for Success" taking place February 16-18, 2015 in San Francisco, CA. In its twelfth year this is the leading event for the industry featuring experts on business strategy, platform development, regulation and reimbursement who will outline the steps needed to take to achieve commercial success in the current environment.
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This document provides information about the 6th Annual Global Orphan Drug Conference and Expo taking place April 21-22, 2016 in Washington D.C. The conference will bring together stakeholders in the orphan drug industry including pharmaceutical companies, patient advocacy groups, regulators, payers, and investors. It will include keynote sessions, workshops on topics like market forecasting and commercialization, and networking opportunities. A pre-conference day of workshops is scheduled for April 20th.
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1) Rapid diagnostic tests have great potential to improve healthcare in low- and middle-income countries by enabling accurate and timely treatment, but many barriers currently limit their development and deployment.
2) Key barriers include insufficient prioritization of diagnostics, financial challenges, demanding technical requirements, shortcomings in evaluation methods, complex regulatory systems, lack of quality assurance, and inadequate involvement of private healthcare providers.
3) Potential solutions involve prioritizing diagnostics development globally and nationally, using economic incentives, promoting locally-driven design, strengthening regulatory frameworks and quality assurance, engaging private providers, and developing flexible tools to support surveillance and differential diagnosis.
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Covance provides customized clinical trial solutions and services for oncology drug development. Their services include utilizing patient lab data to assess trial feasibility and identify eligible patients, scientific consultation in precision medicine areas, and selecting investigator sites with the right patients and experience. Covance aims to help clients accelerate development timelines, improve the probability of success, and deliver trials on budget.
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Welcome to a unique experience - one that's Designed Around You®. Where you control your journey from start to finish. Regardless of where you are and how far you aspire to go, choose the options that make the most of your endeavor. Learn more about the innovations you can tap at any stage of the drug development process.
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Biological assays demonstrating drug characteristics such as potency, mechanism-of-action, and stability, are one of the most critical components of an FDA biologic submission. However, with more complex mechanisms-of-action, immunotherapies add a layer of difficulty to bioassay selection and development. At Cambridge Healthtech Institute's Inaugural Bioassays for Immuno-Oncology symposium, experts in bioassays for immuno-oncology therapies will discuss selection, development, and standards for bioassays and immunoassays. Special attention will be given to understanding the mechanism-of-action for immunotherapies, whether they be antibody- or cell-based. Overall, this one-day immersive symposium will outline a product life cycle approach for developing and implementing biological assays from preclinical studies to clinical development. This symposium is part of the Immunogenicity & Bioassay Summit.
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Cambridge Healthtech Institute (CHI) is pleased to announce the Third Annual FAST: Functional Analysis and Screening Technologies Congress. Now in its third year, the FAST Congress brings you the latest technologies and research in cellular screening.
The Third Annual Phenotypic Drug Discovery meeting will return with new updates and case studies in phenotypic screening, high-content analysis, physiologically-relevant cellular models, chemical genomics and chemical proteomics. The rapidly evolving area of 3D cellular models will be addressed by two back-to-back meetings, with the Inaugural 3D Cell Culture: Organoid, Spheroid, and Organ-on-a-Chip Models meeting focusing on the new predictive cellular models for drug discovery and toxicity assessment. It will review the use of primary and stem cells, complex co-culture cell models, tumor spheroid models, novel organ-on-a-chip models for efficacy and safety screening, functional analysis, and compound profiling. The Third Annual Screening and Functional Analysis of 3D Models meeting will follow with case studies of phenotypic and high-content screening of complex 3D cellular systems for compound and target selection.
The 2014 Congress attracted more than 250 senior delegates, representing over 160 companies from 20 countries. With half of the attendees from big pharma and biotech and a third from academia and government, the FAST Congress offers exclusive networking opportunities with diverse international attendance. Please join our focused Screening event and learn from 60+ scientific presentations, an assortment of educational courses, 20+ exhibitors and your fellow expert delegates. We look forward to seeing you at the event.
Next Generation Dx Summit 2015 - Moving Assays to the ClinicJames Prudhomme
The Next Generation Dx Summit, entering its seventh year, brings together more than 800 diagnostics professionals from across the world, providing comprehensive programming and valuable networking opportunities. Spanning from clinical diagnostics to business strategy, this year’s expanded program encompasses predictive cancer biomarkers, companion diagnostics, infectious disease, point-of-care, pharmacy-based diagnostics, cell-free DNA, commercialization, cancer immunotherapy, and reimbursement. With widespread coverage of all the most relevant diagnostics topics, the Next Generation Dx Summit promises to be a must-attend event to hear the latest announcements and developments in this rapidly evolving field.
Call for Posters: Functional Analysis & Screening TechnologiesJames Prudhomme
Cambridge Healthtech Institute is accepting scientific posters for their 2nd Annual FAST Congress on improving drug screening methods using 3D models and phenotypic screening. The deadline to submit an abstract for a poster is October 10, 2014. Posters on topics related to 3D cellular models, phenotypic screening, organ-specific testing, and developing assays for live tissue models are welcome. Presenters will have their abstracts published in the conference proceedings and be entered to win a cash prize.
Join us in Boston this coming Fall to attend Cambridge Healthtech Institute's (CHI) 2nd Annual FAST: Functional Analysis & Screening Technologies Congress on November 17-19, 2014 and meet with a community of 250+ biologists, screening managers, assay developers, engineers and pharmacologists dedicated to improving in vitro cell models and phenotypic screening to advance drug discovery and development at 6 conferences: Phenotypic Drug Discovery (Part I & II), Engineering Functional 3D Models, Screening and Functional Analysis of 3D Models, Organotypic Culture Models for Toxicology and Physiologically-Relevant Cellular Tumor Models for Drug Discovery. Delegates have the opportunity to share insights in interactive panel discussions and connect during networking breaks. View innovative technologies and scientific research revolutionizing early-stage drug discovery in the exhibit/poster hall.
Short Courses at CHI's Immunogenicity and Bioassay Summit 2014James Prudhomme
Cambridge Healthtech Institute (CHI) will once again offer comprehensive training at the Sixth Annual Immunogenicity and Bioassay Summit 2014. The following courses are led by well-respected professionals in the pharmaceutical industry who have much experience in helping investigators overcome their difficulties with these challenging assays and with risk assessment. Delegates will enjoy an intimate setting with their peers and instructors and have the opportunity to ask questions and exchange experiences.
Course: Development of High-Dose Biologics Dosage FormsJames Prudhomme
Course: Development of High Dose Biologics Dosage Forms will be held on May 6, 2014 in Boston, MA - part of the Biologics Formulation & Delivery Summit.
Course: Challenges and Opportunities in Protein and Peptide Drug DeliveryJames Prudhomme
When: May 4, 2014
Where: Seaport World Trade Center, Boston, MA
Proteins and peptides represent a significant segment of the therapeutics spectrum with many promising candidates under early development or in late-stage clinical trials. Several of these molecules are poised to make a substantial impact, especially in the under-represented or unrepresented categories such as neurological disorders and neurodegenerative diseases. A key challenge to be overcome with protein and peptide based biologics, however, is their effective delivery to the target site while achieving the optimum balance of stability, safety, bioavailability, and patient compliance. This short course will provide a broad overview of the opportunities and challenges in the development of the next generation of protein and peptide therapeutic delivery systems.
PK/PD and Immunogenicity Conferences, May 2014, Boston, MA - part of PEGSJames Prudhomme
The Safety Stream at PEGS will guide attendees through the process of developing a comprehensive immunogenicity and PK/PD strategy to ensure successful biologics. With a focus on novel constructs, high level science and expert advice will examine assay strategies, management of product immunogenicity, and modeling PK/PD to improve drug performance. Risk assessment and regulatory guidance to ensure clinical success and a competitive advantage will also be addressed.
PEGS - the essential protein & antibody engineering summitJames Prudhomme
Over 1,600 participants will gather in Boston’s historic Seaport District for open forum discussions and collaboration in the areas of protein & antibody engineering, oncology, expression, analytical, safety, and - new this year- bioprocessing and therapeutics programming.
Structure-Based Drug Design Facts & Figures InfographicJames Prudhomme
Among 32 pharma and biotech companies surveyed, structure-based drug design is the most prevalent activity with the most players emphasizing the fragment-based variation.
CHI’s Inaugural Biologics Formulation and Delivery Summit will provide a forum for focused discussions on current challenges and opportunities in delivery of biotherapeutics. This 2-part summit will discuss various formulation and device-based approaches for designing physiologically relevant, patient friendly, targeted biologics products.
Part 1: Formulation Strategies for Improved Delivery of Biologics (May 5-6)
Part 2: New Technologies for Biologics Delivery and Targeting (May 6-7)
Podcast: Reducing and Monitoring Bioassay VariabilityJames Prudhomme
Discussing the biggest challenges to managing bioassay variability, new tools, and strategies that researchers are using to combat it, and how procedural variation can have unwanted repercussions.
Structure-Based Drug Design for Epigenetic Targets CourseJames Prudhomme
This document announces a short course on structure-based drug design for epigenetic targets to be held on June 19, 2013 at the Revere Hotel in Boston prior to a larger conference. The course will review how structural biology has contributed to the discovery of small molecule modulators of epigenetic targets. It will focus on emerging targets such as bromodomains, methyltransferases, and lysine demethylases. Attendees can register online, by phone, or via email.
Biomarkers & Diagnostics World Congress 2013 - May 6-8, 2013, Philadelphia, PAJames Prudhomme
This document provides information about the Biomarkers & Diagnostics World Congress 2013 conference, including the date, location, and overview. The conference will take place from May 6-8, 2013 at the Loews Philadelphia Hotel in Philadelphia, PA, and will focus on biomarkers and diagnostics research and implementation. The document lists the conference program tracks and schedule, as well as featured speakers and faculty. Registering by March 29th can save up to $250 on the conference fee.
The ability to recreate computational results with minimal effort and actionable metrics provides a solid foundation for scientific research and software development. When people can replicate an analysis at the touch of a button using open-source software, open data, and methods to assess and compare proposals, it significantly eases verification of results, engagement with a diverse range of contributors, and progress. However, we have yet to fully achieve this; there are still many sociotechnical frictions.
Inspired by David Donoho's vision, this talk aims to revisit the three crucial pillars of frictionless reproducibility (data sharing, code sharing, and competitive challenges) with the perspective of deep software variability.
Our observation is that multiple layers — hardware, operating systems, third-party libraries, software versions, input data, compile-time options, and parameters — are subject to variability that exacerbates frictions but is also essential for achieving robust, generalizable results and fostering innovation. I will first review the literature, providing evidence of how the complex variability interactions across these layers affect qualitative and quantitative software properties, thereby complicating the reproduction and replication of scientific studies in various fields.
I will then present some software engineering and AI techniques that can support the strategic exploration of variability spaces. These include the use of abstractions and models (e.g., feature models), sampling strategies (e.g., uniform, random), cost-effective measurements (e.g., incremental build of software configurations), and dimensionality reduction methods (e.g., transfer learning, feature selection, software debloating).
I will finally argue that deep variability is both the problem and solution of frictionless reproducibility, calling the software science community to develop new methods and tools to manage variability and foster reproducibility in software systems.
Exposé invité Journées Nationales du GDR GPL 2024
ESPP presentation to EU Waste Water Network, 4th June 2024 “EU policies driving nutrient removal and recycling
and the revised UWWTD (Urban Waste Water Treatment Directive)”
Immersive Learning That Works: Research Grounding and Paths ForwardLeonel Morgado
We will metaverse into the essence of immersive learning, into its three dimensions and conceptual models. This approach encompasses elements from teaching methodologies to social involvement, through organizational concerns and technologies. Challenging the perception of learning as knowledge transfer, we introduce a 'Uses, Practices & Strategies' model operationalized by the 'Immersive Learning Brain' and ‘Immersion Cube’ frameworks. This approach offers a comprehensive guide through the intricacies of immersive educational experiences and spotlighting research frontiers, along the immersion dimensions of system, narrative, and agency. Our discourse extends to stakeholders beyond the academic sphere, addressing the interests of technologists, instructional designers, and policymakers. We span various contexts, from formal education to organizational transformation to the new horizon of an AI-pervasive society. This keynote aims to unite the iLRN community in a collaborative journey towards a future where immersive learning research and practice coalesce, paving the way for innovative educational research and practice landscapes.
Travis Hills' Endeavors in Minnesota: Fostering Environmental and Economic Pr...Travis Hills MN
Travis Hills of Minnesota developed a method to convert waste into high-value dry fertilizer, significantly enriching soil quality. By providing farmers with a valuable resource derived from waste, Travis Hills helps enhance farm profitability while promoting environmental stewardship. Travis Hills' sustainable practices lead to cost savings and increased revenue for farmers by improving resource efficiency and reducing waste.
Remote Sensing and Computational, Evolutionary, Supercomputing, and Intellige...University of Maribor
Slides from talk:
Aleš Zamuda: Remote Sensing and Computational, Evolutionary, Supercomputing, and Intelligent Systems.
11th International Conference on Electrical, Electronics and Computer Engineering (IcETRAN), Niš, 3-6 June 2024
Inter-Society Networking Panel GRSS/MTT-S/CIS Panel Session: Promoting Connection and Cooperation
https://www.etran.rs/2024/en/home-english/
The binding of cosmological structures by massless topological defectsSérgio Sacani
Assuming spherical symmetry and weak field, it is shown that if one solves the Poisson equation or the Einstein field
equations sourced by a topological defect, i.e. a singularity of a very specific form, the result is a localized gravitational
field capable of driving flat rotation (i.e. Keplerian circular orbits at a constant speed for all radii) of test masses on a thin
spherical shell without any underlying mass. Moreover, a large-scale structure which exploits this solution by assembling
concentrically a number of such topological defects can establish a flat stellar or galactic rotation curve, and can also deflect
light in the same manner as an equipotential (isothermal) sphere. Thus, the need for dark matter or modified gravity theory is
mitigated, at least in part.
ESR spectroscopy in liquid food and beverages.pptxPRIYANKA PATEL
With increasing population, people need to rely on packaged food stuffs. Packaging of food materials requires the preservation of food. There are various methods for the treatment of food to preserve them and irradiation treatment of food is one of them. It is the most common and the most harmless method for the food preservation as it does not alter the necessary micronutrients of food materials. Although irradiated food doesn’t cause any harm to the human health but still the quality assessment of food is required to provide consumers with necessary information about the food. ESR spectroscopy is the most sophisticated way to investigate the quality of the food and the free radicals induced during the processing of the food. ESR spin trapping technique is useful for the detection of highly unstable radicals in the food. The antioxidant capability of liquid food and beverages in mainly performed by spin trapping technique.
hematic appreciation test is a psychological assessment tool used to measure an individual's appreciation and understanding of specific themes or topics. This test helps to evaluate an individual's ability to connect different ideas and concepts within a given theme, as well as their overall comprehension and interpretation skills. The results of the test can provide valuable insights into an individual's cognitive abilities, creativity, and critical thinking skills
The debris of the ‘last major merger’ is dynamically youngSérgio Sacani
The Milky Way’s (MW) inner stellar halo contains an [Fe/H]-rich component with highly eccentric orbits, often referred to as the
‘last major merger.’ Hypotheses for the origin of this component include Gaia-Sausage/Enceladus (GSE), where the progenitor
collided with the MW proto-disc 8–11 Gyr ago, and the Virgo Radial Merger (VRM), where the progenitor collided with the
MW disc within the last 3 Gyr. These two scenarios make different predictions about observable structure in local phase space,
because the morphology of debris depends on how long it has had to phase mix. The recently identified phase-space folds in Gaia
DR3 have positive caustic velocities, making them fundamentally different than the phase-mixed chevrons found in simulations
at late times. Roughly 20 per cent of the stars in the prograde local stellar halo are associated with the observed caustics. Based
on a simple phase-mixing model, the observed number of caustics are consistent with a merger that occurred 1–2 Gyr ago.
We also compare the observed phase-space distribution to FIRE-2 Latte simulations of GSE-like mergers, using a quantitative
measurement of phase mixing (2D causticality). The observed local phase-space distribution best matches the simulated data
1–2 Gyr after collision, and certainly not later than 3 Gyr. This is further evidence that the progenitor of the ‘last major merger’
did not collide with the MW proto-disc at early times, as is thought for the GSE, but instead collided with the MW disc within
the last few Gyr, consistent with the body of work surrounding the VRM.
CHI's Next Generation Dx Summit | August 25-27, 2020 | Washington, DC
1. TABLE OF CONTENTS
Register Early for
Maximum Savings!
TABLE OF
CONTENTS#NGDx20
P R E M I E R S P O N S O R
Organized by
800+
Diagnostics
Professionals
58%of Attendees from
IVD & Pharma
42%
C-Suite &
Directors
60+Industry Leading
Sponsors &
Exhibitors
n Enabling Point-of-Care Diagnostics
n Point-of-Care Technologies
POCT TECHNOLOGIES
AND STRATEGY
n Enabling Point-of-Care Diagnostics
n Advanced Diagnostics for
Infectious Disease
POCT AND
INFECTIOUS DISEASE
n Enabling Technologies for
Liquid Biopsy
n Early Detection of Disease
LIQUID BIOPSY/
EARLY DETECTION
n Drug-Diagnostics Co-Development
& Companion Dx
n Immuno-Oncology Biomarkers
and Diagnostics
COMPANION DX AND
IO BIOMARKERS
n Coverage and Reimbursement
n Commercialization
BUSINESS
n Your NGS Lab: Relevant Issues
n NGS Advances and Multimodality
Assays
NGS ADVANCES
2020 CONFERENCE
PROGRAMS
NextGenerationDx.com
12th Annual
Advancing Diagnostics Together
AUGUST 25-27
WASHINGTON, DC
GRAND HYATT WASHINGTON
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TABLE OF CONTENTS
VIEW Enabling Point-of-Care Diagnostics
VIEW Point-of-Care Technologies
POCT TECHNOLOGIES AND STRATEGY STREAM
VIEW Enabling Technologies for Liquid Biopsy
VIEW Early Detection of Disease
LIQUID BIOPSY/EARLY DETECTION STREAM
VIEW Drug-Diagnostics Co-Development
& Companion Dx
VIEW Immuno-Oncology Biomarkers and Diagnostics
COMPANION DX AND IO BIOMARKERS STREAM
2020 CONFERENCE PROGRAMS
VIEW Enabling Point-of-Care Diagnostics
VIEW Advanced Diagnostics for Infectious Disease
POCT AND INFECTIOUS DISEASE STREAM
VIEW Coverage & Reimbursement
VIEW Commercialization of Diagnostic Tests
BUSINESS STREAM
Table of Contents
VIEW Your NGS Lab: Relevant Issues
VIEW NGS Advances and Multimodality Assays
NGS ADVANCES STREAM
VIEW ABOUT THE SUMMIT
VIEW CONFERENCE AT-A-GLANCE
VIEW PLENARY KEYNOTE PRESENTERS
VIEW SHORT COURSES
VIEW TRAINING SEMINAR
VIEW POSTERS
VIEW HOTEL & TRAVEL
VIEW 2020 SPONSORS
VIEW MEDIA PARTNERS
VIEW SPONSOR & EXHIBIT INFORMATION
VIEW REGISTRATION INFORMATION
BACK TO COVER
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TABLE OF CONTENTS
T
For more than a decade, 800 industry professionals
have considered the Next Generation Dx Summit in
Washington, DC a nexus for key decision and policy-
makers, academic and industry leaders to learn the
latest technologies, assays, sample prep and detection
methods, analysis and machine-learning approaches
that drive innovation. Regulatory and reimbursement
solutions will be featured that are critical to the
implementation of value-based care.
Non-invasive, rapid diagnostics tests are advancing to help manage outbreaks
and emerging pathogens. Immunotherapy biomarkers and companion
diagnostics are vital tools for the pharma and biotech industries, and the
implementation of these tests will ensure the safety and viabilities of these
essential therapies.
TABLE OF CONTENTS
Welcome
PRE-CONFERENCE
SHORT COURSES
August 24
Monday
DINNER SHORT
COURSES
August 26
Wednesday PM
August 25 - 26 | Tuesday - Wednesday AM | PART A CONFERENCES
STREAM
Enabling Point-of-Care Diagnostics Point-of-Care Technologies
WTM
August 26 - 27 | Wednesday PM - Thursday | PART B CONFERENCES
Conference At-A-Glance
#NGDx20
SHORT
COURSES
Enabling Technologies for Liquid Biopsy
LIQUID
BIOPSY/EARLY
DETECTION
Early Detection of Disease
Your NGS Lab: Relevant Issues (Training Seminar)
NGS
ADVANCES
Enabling Point-of-Care Diagnostics Advanced Diagnostics for Infectious Disease
Drug-Diagnostics Co-Development & Companion Dx
COMPANION
DX AND IO
BIOMARKERS
Immuno-Oncology Biomarkers and Diagnostics
POCT AND
INFECTIOUS
DISEASE
Coverage and ReimbursementBUSINESS Commercialization of Diagnostic Tests
POCT
TECHNOLOGIES
AND STRATEGY
NGS Advances and Multimodality Assays
SHARED
PROGRAMS
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TABLE OF CONTENTS
11:30 am
Chairperson’s Remarks
11:35
Diagnostic Technologies that Will Shape
Precision Medicine in 2020 and Beyond
David Walt, PhD, Hansjörg Wyss Professor, Biologically Inspired Engineering, Harvard Medical
School; Professor, Department of Pathology, Brigham and Women’s Hospital; Core Faculty, Wyss
Institute for Bioinspired Engineering, Harvard University, HHMI Professor
Precision medicine is being driven by the ability to measure biomarkers at an unprecedented
scale. New technologies that enable the measurement of proteomic and genomic signatures,
engineered nanomaterials for diagnostics and imaging, smart watches, and new imaging
modalities provide personalized profiling that can be used to guide therapies. In order for these
technologies to have the greatest benefit, there will need to be profound changes in the entire
diagnostics ecosystem.
12:05 pm
PANEL DISCUSSION:
What Technologies Will Shape
Precision Medicine in 2020?
Moderator: Susan Hsiao, MD, PhD, Assistant Professor, Pathology and Cell Biology, Columbia
University Medical Center
Panelists: Jonathan Nowak, MD, PhD, Assistant Professor, Pathology, Harvard Medical School;
Associate Pathologist, Brigham and Women’s Hospital
David Walt, PhD, Hansjörg Wyss Professor, Biologically Inspired Engineering, Harvard Medical
School; Professor, Department of Pathology, Brigham and Women’s Hospital; Core Faculty, Wyss
Institute for Bioinspired Engineering, Harvard University, HHMI Professor
What is the clinical impact of some of the following technologies and what are the current
bottlenecks and challenges that need to be surmounted? Examples of each will be given:
• RNA sequencing
• Single-cell sequencing and analysis
• AI and machine learning
• Tumor mutational burden measurement
• Emerging uses of NGS
• Tumor microenvironment
• Multi-modality and transcriptomics
• Microbiome
12:35
Plenary Keynote Introduction
Charles Mathews, Principal, ClearView Healthcare Partners
12:45-1:15
Fireside Chat
Moderator: Charles Mathews, Principal, ClearView Healthcare Partners
Sara Brenner, MD, MPH, Associate Director for Medical Affairs; CMO, In Vitro Diagnostics, Office
of In Vitro Diagnostics & Radiological Health (OIR), Office of Product Evaluation & Quality (OPEQ),
Center for Devices & Radiological Health (CDRH), U.S. Food & Drug Administration
The value per minute
per day was just
off the charts.
VP Marketing, Click Diagnostics
“ “
WEDNESDAY, AUGUST 26
Plenary Keynote Session
Co-Organized by
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TABLE OF CONTENTS
Sponsors
PREMIER SPONSORS
CORPORATE SPONSORS
CORPORATE SUPPORT SPONSORS
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TABLE OF CONTENTS
VIEW EXHIBIT FLOORPLAN
DOWNLOAD EXHIBITOR PROSPECTUS
invitation-only vip dinner/hospitality suite
Sponsors will select their top prospects from the conference
preregistration list for an evening of networking at the hotel or at a choice
local venue. CHI will extend invitations and deliver prospects, helping
you to make the most out of this invaluable opportunity. Evening will be
customized according to sponsor’s objectives. (i.e.: Purely social, Focus
group, Reception style, Plated dinner with specific conversation focus)
exhibit
Exhibitors will enjoy facilitated networking opportunities with qualified
delates. Speak face-to-face with prospectus clients and showcase your
latest product, service, or solution.
additional branding & promotional opportunities include:
• Footprint Trails
• Conference Tote Bags
• Literature Distribution (Tote Bag
Insert or Chair Drop)
• Badge Lanyards
• Padfolios
• Mobile App Advertisement
• Meter boards
• Water bottles
• Notepads
Looking for additional ways to drive leads to your sales team?
CHI’s Lead Generation Programs will help you obtain more targeted, quality
leads throughout the year. We will mine our database of 800,000+ life
science professionals to your specific needs. We guarantee a minimum of
100 leads per program! Opportunities include:
• Live Webinars
• White Papers
• Market Surveys
• Podcasts and More!
podium presentations — Available within Main Agenda!
Showcase your solutions to a guaranteed, targeted audience
through a 15- or 30-minute presentation during a specific
conference program, breakfast, lunch, or separate from the
main agenda within a pre-conference workshop. Package
includes exhibit space, onsite branding, and access to
cooperative marketing efforts by CHI. For the luncheon
option, lunches are delivered to attendees who are already
seated in the main session room. Presentations will sell out
quickly, so sign on early to secure your talk!
one-on-one meetings
Select your top prospects from
the pre-conference registration
list. CHI will reach out to your
prospects and arrange the
meeting for you. A minimum
number of meetings will be
guaranteed, depending on your
marketing objectives and needs.
A very limited number of these
packages will be sold.
Sponsor Opportunities
Comprehensive sponsorship packages allow you to achieve your objectives
before, during, and long after the event. Signing on earlier will allow you to
maximize exposure to hard-to-reach decision-makers.
ATTENDEES BY GEOGRAPHIC LOCATION
REST OF
WORLD: 2%
USA:
89%
EUROPE:
6%
ASIA:
3%
2019 ATTENDEE DEMOGRAPHICS
n IVD & Pharma................. 57%
n Academic Labs............... 12%
n Healthcare Provider...........9%
n Healthcare.........................8%
n Government.......................6%
n Services..............................4%
n Societies............................3%
n Other...................................1%
COMPANY
TYPE
n Executive & Director.......41%
n Manager..........................11%
n Professor........................10%
n Scientist/
Technologist...................18%
n Sales & Marketing..........17%
n Other..................................3%
DELEGATE
TITLE
For more information regarding sponsorship
and exhibit opportunities, please contact
COMPANIES A-K
Jon Stroup | Sr Business Development Manager
781-972-5483 | jstroup@cambridgeinnovationinstitute.com
COMPANIES L-Z
Ashley Harvey | Business Development Manager
781-247-6292 | aharvey@cambridgeinnovationinstitute.com
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TABLE OF CONTENTS
Short Courses*
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.
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
*Separate registration required
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CONFERENCE STREAMS
POCT Technologies
and Strategy Stream
AUGUST 25-26
AGENDA Enabling Point-of-Care Diagnostics
AUGUST 26-27
AGENDA
Point-of-Care Technologies
2020 POCT TECHNOLOGIES AND STRATEGY CONFERENCES
POCT TECHNOLOGIES AND STRATEGY
POCT AND INFECTIOUS DISEASE
LIQUID BIOPSY/EARLY DETECTION
COMPANION DX AND IO BIOMARKERS
BUSINESS
NGS ADVANCES
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TABLE OF CONTENTS
Recommended Short Courses*
SC1: Technologies, Applications and Commercialization
of POC Dx
SC4: Accessing Point-of-Care Markets in the US,
Europe, and China
*Separate registration required, click here for details
TUESDAY, AUGUST 25
7:30 am Registration and Morning Coffee
REDUCING ERRORS AT THE POINT-OF-CARE
8:30 Chairperson’s Opening Remarks
James Nichols, PhD, DABCC, FACB, Professor, Pathology,
Microbiology and Immunology; Medical Director, Clinical Chemistry;
Medical Director, POCT, Vanderbilt University School of Medicine
8:40 Real-World Issues Encountered with POCT
Valerie Ng, MD, PhD, Chair, Department of Laboratory Medicine &
Pathology; Laboratory Director, and Director, Transfusion Services,
Clinical Laboratories, Alameda Health System
Caregivers expect point-of-care testing (POCT) to be fast and
accurate. And, while manufacturers design their POCTs with these
goals in mind, real-world testing often defeats the purpose of the
best designed POCT system or device. This talk will present real-
world vignettes of POCT, highlighting the impact of non-laboratory
test personnel, patient care time pressures, and less than orderly
environments on POCT devices, their performance, and quality of
test results. Suggestions for improved POCT design based on these
known real-world pitfalls will be presented.
9:10 Challenges and Practical Solutions in Implementing
Point-of-Care Testing
Joseph Wiencek, PhD, Assistant Professor, Department of Pathology;
Medical Director, Point-of-Care Testing; Associate Medical Director,
Clinical Chemistry; Co-Director, Clinical Chemistry Fellowship,
University of Virginia School of Medicine
Point-of-care testing (POCT) is universal in modern healthcare.
New and innovative technologies permit diagnostic tests to leave
the confines of the centralized laboratory and migrate to the site
of patient care. Unfortunately, the excitement of this technology
is often lost due to an assortment of practical obstacles. Many of
these challenges will be discussed and practical solutions will be
offered.
9:40 Risk Management for Point-of-Care Testing
James Nichols, PhD, DABCC, FACB, Professor, Pathology,
Microbiology and Immunology; Medical Director, Clinical Chemistry;
Medical Director, POCT, Vanderbilt University School of Medicine
Point-of-care testing is laboratory testing conducted close to the site
of patient care. As tests migrate out of the laboratory, devices are
subject to environmental extremes and operator variation that can
impact patient results. Errors with point-of-care testing can come
from a number of sources, including the instrument, the operator,
the reagent, and the environment. Staff need to be cognizant of the
probability for error and take actions to prevent and detect errors
before they affect results and patient care. Risk management steps
through the testing process detecting potential sources for error,
then acts through training, maintenance, or the addition of control
processes to minimize the potential for errors. This presentation
will discuss the common sources of POCT error, describe how
manufacturers are engineering their products to prevent errors, and
will identify ways that institutions can design their quality control
programs to minimize error.
10:10 Coffee Break in the Exhibit Hall with Poster Viewing
10:55 Chairperson’s Remarks
James Nichols, PhD, DABCC, FACB, Professor, Pathology,
Microbiology and Immunology; Medical Director, Clinical Chemistry;
Medical Director, POCT, Vanderbilt University School of Medicine
11:00 Let’s Talk about Quality Control & Individualized
Quality Control Plans
Jelani Sanaa, MS, MLS (ASCP) CMSBBCM, SHCM, Clinical Laboratory
Scientist, Centers for Medicare and Medicaid Services (CMS);
Centers for Clinical Standards and Quality (CCSQ); Quality, Safety and
Oversight Group (QSOG); Division of Clinical Laboratory Improvement
and Quality (DCLIQ)
IQCP provides laboratories with flexibility in customizing quality
control (QC) policies and procedures for non-waived testing,
based on the test systems in use and the unique aspects of each
laboratory. IQCP is voluntary. Laboratories can achieve compliance
by following manufacturer’s guidelines and all CLIA QC regulations
as written. If those guidelines are less stringent than CLIA, or if
the manufacturer does not provide guidelines, the laboratory must
implement an IQCP.
11:30 Talk Title to be Announced
Corinne Fantz, PhD, Director, Scientific Affairs, Roche
12:00 pm Talk Title to be Announced
Chris Myatt, PhD, CEO, MBio Diagnostics, Inc.
12:15 Rapid POC Solutions for SARS CoV-2
and Associated Respiratory Pathogens
Claire Huguet, Head, Biomarker Services, Randox Biosciences
Randox is committed to developing infectious syndromic panels to
provide precise diagnostics. In collaboration with Bosch, Randox
has now released several IVD-quality tests on the POC Vivalytic
platform. The latest extended coronavirus 10-plex viral panel detects
the SARS-CoV-2 target, MERS, SARS, and 7 other respiratory viruses
resulting in similar clinical presentation.
12:30 Luncheon Presentation (Sponsorship Opportunity
Available) or Enjoy Lunch on Your Own
1:00 Refreshment Break in the Exhibit Hall with Poster
Viewing
PREPARING FOR THE NEXT WAVE OF POC
DIAGNOSTICS: OVERCOMING CHALLENGES WITH
CONSUMER TESTING
1:30 Chairperson’s Remarks
Lawrence Worden, Founder, Principal, IVD Logix
1:35 Encouraging Innovation: BARDA’s Division of Research,
Innovation and Ventures (DRIVe)
Šeila Selimović, PhD, Program Manager, Early Notification to Act,
Control, and Treat (ENACT), Division of Research, Innovation, and
Ventures (DRIVe), Biomedical Advanced Research and Development
Authority (BARDA), Office of Assistant Secretary for Preparedness and
Response (ASPR), U.S. Department of Health and Human Services
(HHS)
The Early Notification to Act, Control and Treat Program within
BARDA/DRIVe aims to protect Americans and save lives via
pre-symptomatic technology. ENACT seeks pathogen and insult
agnostic technologies to identify, characterize, and adapt signatures
(biological, biometric, behavioral, and physiological) that can inform
on health security threats or exposures prior to symptom onset to
facilitate treatment and prevent subsequent cascading effects where
possible. We are exploring discovery and validation of biomarkers
suitable for non-invasive or minimally invasive collection and other
health signatures and tools, empowering individuals to take initial
steps to determine health changes that assist clinician care by
determining appropriateness of antibiotic vs. antiviral treatment and
CBCs from remote settings, including the home.
CHI’S 14TH ANNUAL | AUGUST 25-26, 2020
Enabling Point-of-Care Diagnostics
IMPLEMENTATION AND BUSINESS STRATEGIES
POCT TECHNOLOGIES AND STRATEGY
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TABLE OF CONTENTS
POCT TECHNOLOGIES AND STRATEGY
ENABLING POINT-OF-CARE DIAGNOSTICS, continued
2:05 Overcoming Regulatory Challenges for Home-Use Tests
Elliot Cowan, PhD, Principal, Partners in Diagnostics
Home-use tests can increase access to testing, safeguard privacy,
empower individuals to take control of their healthcare decisions,
and protect public health. However, these benefits come with
significant risks and challenges, including how to demonstrate
that the benefits outweigh the risks, how to address the need for
infectious disease reporting, and post-market surveillance. This talk
will describe how regulators deal with such issues to bring home-use
tests to market.
2:35 Innovative Approaches to At-Home Collection for STI
Testing
Charlotte Gaydos, MS, MPH, DrPH, Professor, Division of Infectious
Diseases, Johns Hopkins University
The iwantthekit (IWTK) program offers internet-requested kits for
home collection for screening of common STI. Other programs
exist. We will discuss innovation programs and acceptability for
home collection, and we will review published programs. Many
studies reported use of and willingness to use home collection when
available. There was willingness to pay an average of $10-30. User
satisfaction was high for home collection.
3:05 Sponsored Presentation (Opportunity Available)
3:35 Refreshment Break in the Exhibit Hall with Poster
Viewing
PREPARING FOR THE NEXT WAVE OF POC
DIAGNOSTICS: OVERCOMING CHALLENGES WITH
CONSUMER TESTING (CONT.)
4:25 Chairperson’s Remarks
Lawrence Worden, Founder & Principal, IVD Logix
4:30 Professional Concerns with At-Home Testing
Jeanne Mumford, MT(ASCP), Manager, Point-of-Care Testing, Johns
Hopkins University
Currently at-home testing is available in many formats including
glucose, urine pregnancy, drug screens, HIV, STI’s and Strep A
testing. There are manufacturers who provide the consumer with
access to physician care for positive tests and some may even
benefit surveillance studies by reporting to local health departments.
The ability to give access to testing for those patient populations
that may be underserved or underinsured also weigh heavily in the
debate of OTC self-testing. Though many arguments support the use
of consumer OTC self-testing, there are still some concerns from a
quality assurance perspective from the medical technologist who
currently oversee point of care testing in the health care setting. In
this session, we will discuss some of those concerns from the point
of care coordinator’s point of view.
5:00 PANEL DISCUSSION: Overcoming Challenges with
Consumer Testing
Moderator: Lawrence Worden, Founder & Principal, IVD Logix
Panelists: Elliot Cowan, PhD, Principal, Partners in Diagnostics
Charlotte Gaydos, MS, MPH, DrPH, Professor, Division of Infectious
Diseases, Johns Hopkins University
Jeanne Mumford, MT(ASCP), Manager, Point-of-Care Testing, Johns
Hopkins University
Šeila Selimović, PhD, Program Manager, Early Notification to Act,
Control, and Treat (ENACT), Division of Research, Innovation, and
Ventures (DRIVe), Biomedical Advanced Research and Development
Authority (BARDA), Office of Assistant Secretary for Preparedness and
Response (ASPR), U.S. Department of Health and Human Services
(HHS)
5:30 Sponsored Presentation (Opportunity Available)
6:00 Welcome Reception in the Exhibit Hall with Poster
Viewing
7:00 Close of Day
WEDNESDAY, AUGUST 26
7:15 am Registration
7:30 Problem Solving Breakout Discussions with Continental
Breakfast
DEPLOYING POINT-OF-CARE TESTING TO
MANAGE DISEASE OUTBREAKS
8:25 Chairperson’s Remarks
Gerald Kost, MD, PhD, MS, FAACC, Director, Point-of-Care Testing
Center for Teaching and Research (POCT•CTR); Emeritus Professor,
School of Medicine, University of California, Davis
8:30 Geospatial “Hot Spots” Need Rapid Point-of-Care
Diagnostics to Stop Highly Infectious Threats and
Antimicrobial Resistance
Gerald Kost, MD, PhD, MS, FAACC, Director, Point-of-Care Testing
Center for Teaching and Research (POCT•CTR); Emeritus Professor,
School of Medicine, University of California, Davis
Increasingly, we observe the adverse personal, societal, economic,
and cultural impact of outbreaks, antimicrobial resistance, and
disasters. Nations are not prepared! POC strategies can mitigate
risk, reduce harm, and improve crisis standards of care. Global
solutions integrate national POCT policy and guidelines, and
distribute financial burden and reasonable business models.
9:00 Rapid Development of Diagnostic Tests for New
Threats: 2019 Novel Coronavirus Pneumonia (COVID-19)
and Other Pathogens
Timothy Minogue, Diagnostic Systems Division, United States Army
Medical Research Institute of Infectious Diseases
To bridge the gap between rapid point-of-care diagnostics and
sequencing, we developed a highly multiplexed assay designed
to detect 164 different viruses, bacteria, and parasites using the
NanoString nCounter platform. Included in this assay were high-
consequence pathogens, such as Ebola virus, highly endemic
organisms including several Plasmodium species, and a large
number of less prevalent pathogens to ensure a broad coverage of
potential human pathogens.
9:30 Point-of-Care Molecular Diagnostics for Disease
Outbreak Settings: The Path to the Future
Rachel Spurbeck, PhD, Principal Research Scientist, Health Outcomes
and Biotechnology Solutions, Battelle Memorial Institute
Rapid, accurate, and affordable point-of-care (POC) diagnostics
are key to detecting and subsequently mitigating the impact of
disease outbreaks, particularly for emerging pathogens. Molecular
approaches to detection offer speed, sensitivity, and specificity, but
can introduce complexity and expense, making it difficult to achieve
a POC diagnostic suitable for use outside a clinical setting. This
talk will review the current state of the art for molecular diagnostics
and examine the path forward to deployable POC diagnostics
for outbreak settings, including some of the challenges being
undertaken today.
10:00 Presentation to be Announced
10:30 Coffee Break in the Exhibit Hall with
Poster Viewing
11:30 Plenary Keynote Session
Please click here for details
1:15 pm Luncheon Presentation (Sponsorship Opportunity
Available) or Enjoy Lunch on Your Own
1:45 End of Enabling Point-of-Care Diagnostics
Recommended Dinner Short Course*
SC8: The COVID-19 Case Study: Accelerated
Development of Diagnostics for Novel Infectious
Disease Threats
*Separate registration required, click here for details
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TABLE OF CONTENTS
WEDNESDAY, AUGUST 26
10:30 am Registration
11:30 Plenary Keynote Session
Please click here for details
1:15 pm Luncheon Presentation (Sponsorship Opportunity
Available) or Enjoy Lunch on Your Own
1:45 Refreshment Break in the Exhibit Hall with Poster
Viewing
INNOVATING THE NEXT GENERATION OF POC
2:15 Chairperson’s Opening Remarks
Nardev Ramanathan, PhD, Global Lead Analyst, Digital Transformation,
Lux Research, Inc.
2:20 AI-Linked Precision Lesion Diagnostics
John McDevitt, PhD, Chair, Department Biomaterials, New York
University College of Dentistry
2:50 The Next Generation of Continuous Diagnostic Sensors:
A Case Study on the Breakthroughs for Sweat Biosensing
Jason Heikenfeld, PhD, Vice President, Operations, Office of
Innovation; Professor and Director, Novel Device Laboratory, University
of Cincinnati
Continuous biosensing promises to bring the lab into a wearable
format that measures anything from cardiac health to pre-
symptomatic viral detection. The reality of this promise is
that success continues to be limited to glucose monitoring
or conventional, decades-old optical or electrical non-specific
measures. We present the real challenges the field faces, along with
first-ever breakthroughs that have resulted in non-invasive wearables
that can provide continuous blood-correlated chemical data. Our
case study is sweat biosensing, but learnings apply to all other forms
of biofluid access (saliva, tears, urine, interstial fluid).
3:30 Developing Next-Generation Diagnostics to Meet
Clinical Needs
Ping Wang, PhD, DABCC, Chief, Clinical Chemistry; Director, Core
Laboratory Hospital, University of Pennsylvania
The field of point-of-care technologies has witnessed strong
growth, as evidenced by new clinical or consumer products or
research and development directions. Only when combined with
appropriate strategies for clinical needs assessment, validation and
implementation, these technologies may significantly impact care
delivery and associated outcomes and costs. In this presentation, I
will discuss clinical needs, validation and implementation strategies
for novel point-of-care technologies from two perspectives: as a
practicing clinical laboratory director and as a technology researcher
and developer.
3:50 Fluorescence-Based Detection Platform
for Immunoassays: Manufacturing Challenges
Violeta Tacheva, Lifecycle Manager, STRATEC Consumables GmbH
The social importance of the market approved point-of-care
products remained uncontroversial. Stratec Consumables GmbH
will present some manufacturing possibilities and the challenges
during developing of scalable high quality, reproducible and reliable
products. As example, we will present a fluorescence-based
detection platform for immunoassays.
4:05 Presentation to be Announced
4:20 Refreshment Break in the Exhibit Hall with
Poster Viewing
REDEFINING POC IN THE DIGITAL ERA
5:05 Chairperson’s Remarks
Sharief Taraman, MD, CMO, Cognoa; Division Chief, CHOC Children’s
Hospital
5:10 Fast, Accurate, and Actionable: How Digital Tools in
Femtech Unlock a $50 Billion Market
Danielle Bradnan, MS, Research Associate, Digital Health and
Wellness, Lux Research
Current diagnostic paradigms often leave women’s health as a
secondary or niche consideration, which has led to considerable
struggles for over half of the global population in terms of getting a
rapid, accurate, and actionable diagnosis. However, with the advent
of digital tools such as apps, wearables, and AI, healthcare startups
are rapidly developing solutions to close the gap between symptoms
and diagnosis. We will explore the current solution landscape in this
talk and highlight the opportunities that diagnostic tools offer.
5:40 Advancing Care with Digital Therapeutics
Sharief Taraman, MD, CMO, Cognoa; Division Chief, CHOC Children’s
Hospital
Early intervention of autism is proven to impact a child’s lifelong
outcomes, but today’s system misses the critical window when
treatment has its greatest impact. This session explains how a
clinically validated, AI-powered prescription diagnostic, designed
for use by pediatricians, can streamline and scale early diagnosis
and fast-track access to care. Audiences will understand how digital
therapeutics can enable equitable health outcomes for children with
behavioral health conditions.
6:10 Development of a Smartphone App for Non-Invasive
Detection of Anemia Using Only Patient-Sourced Photos
Wilbur Lam, MD, PhD, W. Paul Bowers Research Chair, Associate
Professor, Department of Pediatrics, Wallace H. Coulter Department
of Biomedical Engineering, Aflac Cancer and Blood Disorders Center
of Children’s Healthcare of Atlanta; Chief Innovation Officer, Pediatric
Technology Center, Emory University and Georgia Institute of Technology
We introduce a paradigm of non-invasive, on-demand diagnostics
for hematologic diseases using only a smartphone app and photos.
We initially targeted anemia, characterized by low blood hemoglobin
levels, which afflicts >2 billion people. Our app estimates
hemoglobin levels by analyzing color and metadata of fingernail
smartphone photos and screens for anemia (hemoglobin levels
<12.5 g/dL) with a 97% sensitivity (n = 100 subjects). Moreover, with
personalized calibration, this system achieves an accuracy of ±0.92
g/dL compared to gold standard hemoglobin levels (n = 16 subjects),
empowering chronic anemia patients to serially monitor their
hemoglobin levels instantaneously and non-invasively.
6:40 Close of Day
6:40 Dinner Short Course Registration*
7:00 - 9:30 Dinner Short Course*
Recommended Dinner Short Course*
SC6: Microfluidics and Lab-on-a-Chip Devices for POCT:
Technologies and Commercialization
*Separate registration required, click here for details
THURSDAY, AUGUST 27
7:15 am Registration
7:30 Problem Solving Breakout Discussions with Continental
Breakfast
IMPROVING POC
8:25 Chairperson’s Remarks
Holger Becker, PhD, Founder & CSO, microfluidic ChipShop GmbH
8:30 Novel Techniques for POC Disease Monitoring Utilizing
Programmable Molecular Velcro
Kaylyn Oshaben, PhD, Synthetic Biology Specialist, Altratech Limited
Altratech is interested in moving disease monitoring to the point-of-
care and beyond. Common barriers to implementing point-of-care
CHI’S 2ND ANNUAL | AUGUST 26-27, 2020
Point-of-Care Technologies
EXPLORING MICROFLUIDICS, SENSORS & DIGITAL TOOLS
POCT TECHNOLOGIES AND STRATEGY
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TABLE OF CONTENTS
POINT-OF-CARE TECHNOLOGIES, continued
or home nucleic acid disease monitoring systems revolve around
sample prep, reagent storage and user expertise. To overcome some
of these barriers, we are developing new techniques that utilize
peptide nucleic acids (PNA) as both enrichment and capture agents
that simplify sample prep, reagents and detection technology.
9:00 Application of Intelligent Quality Management at Point-
of-Care
Sohrab Mansouri, PhD, Staff Scientist, Advance Development,
Instrumentation Laboratory
This presentation describes an integrated QC method based on
identifying error patterns for a given measurement system and
devising a method for rapid detection and targeted corrective action
with no user involvement.
9:30 Presentation to be Announced
9:45 Sponsored Presentation (Opportunity
Available)
10:00 Coffee Break in the Exhibit Hall with Poster Viewing
FEATURED SESSION: NUCLEIC ACID DETECTION
11:00 Chairperson’s Remarks
Shawn Mulvaney, PhD, Section Head, Surface Nanoscience and
Sensor Technology Section, Chemistry, US Naval Research Laboratory
11:05 Global Considerations with Nucleic Acid at POC
Nardev Ramanathan, PhD, Global Lead Analyst, Digital Transformation,
Lux Research, Inc.
Nucleic acid amplification technologies (NAATs) are high-
performance tools for rapidly and accurately identifying pathological
changes, be it in the patient’s DNA or in the RNA/DNA of pathogens
in the case of infectious diseases. Traditionally, these diagnostic
tests take time, and require centralized labs with highly skilled and
trained staff, appropriate infrastructure, quality assurance protocols
and controlled environments to house complex equipment and
cold chain-dependent reagents. However, access to this becomes
challenging for decentralized settings with large and complex
geographies and/or low- and middle-income countries with
large burdens of infectious disease and challenged by extreme
environments, poor infrastructure, few trained staff and limited
financial resources. Point-of-care (POC) capabilities for nucleic acid
testing offer huge opportunities here to tackle this unmet need.
Many recent advances are bringing us closer to this reality, mostly
around microfluidics and miniaturization of biosensors. However,
there are still other considerations to be had, around population
and sociodemographic differences that will impact how these
technologies will be implemented and deployed. This talk will tackle
the global considerations for nucleic acid POC using case studies of
currently deployed medical technologies as examples.
11:35 Engineering Biology for Diagnostic Solutions
William Blake, PhD, CTO, Sherlock Bioscience
SHERLOCK is a method for single molecule detection of nucleic
acid targets and stands for Specific High Sensitivity Enzymatic
Reporter unLOCKing. It works by amplifying genetic sequences
and programming a CRISPR molecule to detect the presence of a
specific genetic signature in a sample, which can also be quantified.
When it finds those signatures, the CRISPR enzyme is activated and
releases a robust signal. This signal can be adapted to work on a
simple paper strip test, in laboratory equipment, or to provide an
electrochemical readout that can be read with a mobile phone.
12:05 pm Instrument-Free Paper-Based POC Pathogen
Diagnostics for the Clinic and the Home
Paul Yager, PhD, Professor, Bioengineering, University of Washington
Instruments ranging from the venerable GeneXpert to ones just
coming on the market allow fairly rapid NAAT pathogen detection,
but they are based on disposable cartridges and a permanent
(and relatively expensive) instrument. Our lab has been developing
instrument-free disposable NAAT devices that retain the advantages
of the instrumented systems, but free the user from the need for
purchasing a permanent instrument (and the up-front cost that
incurs).
12:35 Sponsored Presentation (Opportunity Available)
1:05 Luncheon Presentation (Sponsorship Opportunity
Available) or Enjoy Lunch on Your Own
1:35 Refreshment Break in the Exhibit Hall with Poster
Viewing
SUCCESSFUL CASE STUDIES
2:15 Chairperson’s Remarks
Richard Chasen Spero, PhD, CEO, Redbud Labs, Inc.
2:20 CASE STUDY: From AIDS to Ebola, Commercializing
Rapid Tests for Infectious Disease
Stephen Tang, PhD, President & CEO, OraSure Technologies, Inc.
OraSure CEO Stephen S. Tang, PhD will discuss OraSure’s
experiences developing and commercializing industry-leading
diagnostics to power public health. Dr. Tang will share OraSure’s
experience commercializing its trailblazing rapid point of care tests
for HIV and HCV and its FDA-cleared rapid antigen test for Ebola.
2:40 CASE STUDY: eRAPID Technology – A Universal
Electrochemical Sensor Platform
Pawan Jolly, PhD, Senior Scientist, Wyss Institute, Harvard University
A case of developing a sensitive and robust biosensor for early
detection of allergies as part of Project ABBIE will be presented. I will
also share my journey of how to transition from a university research
project to a diagnostic start up.
3:00 CASE STUDY: Federal Resources for Early Stage
Diagnostic Start Up
Tiffani Lash, PhD, Program Director, National Institutes of Health
I will discuss the federal resources for early stage companies that
fall into the research portfolios of biosensors, platform technologies,
and mHealth programs at NIH. NIBIB Point-of-Care Technologies
Research Network will be explained, consisting of three centers
charged with developing point-of-care diagnostic technologies
through collaborative efforts that merge scientific and technological
capabilities with clinical need.
3:20 PANEL DISCUSSION: Commercializing Point-of-Care
Tests
Moderator: Richard Chasen Spero, PhD, CEO, Redbud Labs, Inc.
Panelists: Stephen Tang, PhD, President & CEO, OraSure Technologies,
Inc.
Pawan Jolly, PhD, Senior Scientist, Wyss Institute, Harvard University
Tiffani Lash, PhD, Program Director, National Institutes of Health
• Platforms that are used for testing
• Why are these formats important?
• What’s the driver for growth?
• How did they build their companies?
• Where the industry is and where it is headed
4:20 End of Summit
POCT TECHNOLOGIES AND STRATEGY
13. TABLE OF CONTENTS
POCT and Infectious
Disease Stream
AUGUST 25-26
AGENDA Enabling Point-of-Care Diagnostics
AUGUST 26-27
AGENDA
Advanced Diagnostics for Infectious Disease
2020 POCT AND INFECTIOUS DISEASE CONFERENCES
CONFERENCE STREAMS
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POCT TECHNOLOGIES AND STRATEGY
POCT AND INFECTIOUS DISEASE
LIQUID BIOPSY/EARLY DETECTION
COMPANION DX AND IO BIOMARKERS
BUSINESS
NGS ADVANCES
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TABLE OF CONTENTS
POCT AND INFECTIOUS DISEASE
Recommended Short Courses*
SC1: Technologies, Applications and Commercialization
of POC Dx
SC4: Accessing Point-of-Care Markets in the US,
Europe, and China
*Separate registration required, click here for details
TUESDAY, AUGUST 25
7:30 am Registration and Morning Coffee
REDUCING ERRORS AT THE POINT-OF-CARE
8:30 Chairperson’s Opening Remarks
James Nichols, PhD, DABCC, FACB, Professor, Pathology,
Microbiology and Immunology; Medical Director, Clinical Chemistry;
Medical Director, POCT, Vanderbilt University School of Medicine
8:40 Real-World Issues Encountered with POCT
Valerie Ng, MD, PhD, Chair, Department of Laboratory Medicine &
Pathology, Laboratory Director, and Director, Transfusion Services,
Clinical Laboratories, Alameda Health System
Caregivers expect Point-of-Care Testing (POCT) to be fast and
accurate. And, while manufacturers design their POCTs with these
goals in mind, real-world testing often defeats the purpose of the
best designed POCT system or device. This talk will present real-
world vignettes of POCT, highlighting the impact of non-laboratory
test personnel, patient care time pressures, and less than orderly
environments on POCT devices, their performance, and quality of
test results. Suggestions for improved POCT design based on these
known real-world pitfalls will be presented.
9:10 Challenges and Practical Solutions in Implementing
Point-of-Care Testing
Joseph Wiencek, PhD, Assistant Professor, Department of Pathology;
Medical Director, Point-of-Care Testing; Associate Medical Director,
Clinical Chemistry; Co-Director, Clinical Chemistry Fellowship,
University of Virginia School of Medicine
Point-of-care testing (POCT) is universal in modern healthcare.
New and innovative technologies permit diagnostic tests to leave
the confines of the centralized laboratory and migrate to the site
of patient care. Unfortunately, the excitement of this technology
is often lost due to an assortment of practical obstacles. Many of
these challenges will be discussed and practical solutions will be
offered.
9:40 Risk Management for Point-of-Care Testing
James Nichols, PhD, DABCC, FACB, Professor, Pathology,
Microbiology and Immunology; Medical Director, Clinical Chemistry;
Medical Director, POCT, Vanderbilt University School of Medicine
Point-of-care testing is laboratory testing conducted close to the site
of patient care. As tests migrate out of the laboratory, devices are
subject to environmental extremes and operator variation that can
impact patient results. Errors with point-of-care testing can come
from a number of sources, including the instrument, the operator,
the reagent, and the environment. Staff need to be cognizant of the
probability for error and take actions to prevent and detect errors
before they affect results and patient care. Risk management steps
through the testing process detecting potential sources for error,
then acts through training, maintenance, or the addition of control
processes to minimize the potential for errors. This presentation
will discuss the common sources of POCT error, describe how
manufacturers are engineering their products to prevent errors, and
will identify ways that institutions can design their quality control
programs to minimize error.
10:10 Coffee Break in the Exhibit Hall with Poster Viewing
10:55 Chairperson’s Remarks
James Nichols, PhD, DABCC, FACB, Professor, Pathology,
Microbiology and Immunology; Medical Director, Clinical Chemistry;
Medical Director, POCT, Vanderbilt University School of Medicine
11:00 Let’s Talk about Quality Control & Individualized
Quality Control Plans
Jelani Sanaa, MS, MLS (ASCP) CMSBBCM, SHCM, Clinical Laboratory
Scientist, Centers for Medicare and Medicaid Services (CMS);
Centers for Clinical Standards and Quality (CCSQ); Quality, Safety and
Oversight Group (QSOG); Division of Clinical Laboratory Improvement
and Quality (DCLIQ)
IQCP provides laboratories with flexibility in customizing Quality
Control (QC) policies and procedures for non-waived testing,
based on the test systems in use and the unique aspects of each
laboratory. IQCP is voluntary. Laboratories can achieve compliance
by following manufacturer’s guidelines and all CLIA QC regulations
as written. If those guidelines are less stringent than CLIA, or if
the manufacturer does not provide guidelines, the laboratory must
implement an IQCP.
11:30 Talk Title to be Announced
Corinne Fantz, PhD, Director, Scientific Affairs, Roche
12:00 pm Talk Title to be Announced
Chris Myatt, PhD, CEO, MBio Diagnostics, Inc.
12:15 Rapid POC Solutions for SARS CoV-2
and Associated Respiratory Pathogens
Claire Huguet, Head, Biomarker Services, Randox Biosciences
Randox is committed to developing infectious syndromic panels to
provide precise diagnostics. In collaboration with Bosch, Randox
has now released several IVD-quality tests on the POC Vivalytic
platform. The latest extended coronavirus 10-plex viral panel detects
the SARS-CoV-2 target, MERS, SARS, and 7 other respiratory viruses
resulting in similar clinical presentation.
12:30 Luncheon Presentation (Sponsorship Opportunity
Available) or Enjoy Lunch on Your Own
1:00 Refreshment Break in the Exhibit Hall with Poster
Viewing
PREPARING FOR THE NEXT WAVE OF POC
DIAGNOSTICS: OVERCOMING CHALLENGES WITH
CONSUMER TESTING
1:30 Chairperson’s Remarks
Lawrence Worden, Founder, Principal, IVD Logix
1:35 Encouraging Innovation: BARDA’s Division of Research,
Innovation and Ventures (DRIVe)
Šeila Selimović, PhD, Program Manager, Early Notification to Act,
Control, and Treat (ENACT), Division of Research, Innovation, and
Ventures (DRIVe), Biomedical Advanced Research and Development
Authority (BARDA), Office of Assistant Secretary for Preparedness and
Response (ASPR), U.S. Department of Health and Human Services
(HHS)
The Early Notification to Act, Control and Treat Program within
BARDA/DRIVe aims to protect Americans and save lives via
pre-symptomatic technology. ENACT seeks pathogen and insult
agnostic technologies to identify, characterize, and adapt signatures
(biological, biometric, behavioral, and physiological) that can inform
on health security threats or exposures prior to symptom onset to
facilitate treatment and prevent subsequent cascading effects where
possible. We are exploring discovery and validation of biomarkers
suitable for non-invasive or minimally invasive collection and other
health signatures and tools, empowering individuals to take initial
steps to determine health changes that assist clinician care by
determining appropriateness of antibiotic vs. antiviral treatment and
CBCs from remote settings, including the home.
CHI’S 14TH ANNUAL | AUGUST 25-26, 2020
Enabling Point-of-Care Diagnostics
IMPLEMENTATION AND BUSINESS STRATEGIES
15. 15 | NextGenerationDx.com REGISTER EARLY & SAVE!
TABLE OF CONTENTS
POCT AND INFECTIOUS DISEASE
ENABLING POINT-OF-CARE DIAGNOSTICS, continued
2:05 Overcoming Regulatory Challenges for Home-Use Tests
Elliot Cowan, PhD, Principal, Partners in Diagnostics
Home-use tests can increase access to testing, safeguard privacy,
empower individuals to take control of their healthcare decisions, and
protect public health. However, these benefits come with significant
risks and challenges, including how to demonstrate that the benefits
outweigh the risks, how to address the need for infectious disease
reporting, and post-market surveillance. This talk will describe how
regulators deal with such issues to bring home-use tests to market.
2:35 Innovative Approaches to At-Home Collection for STI
Testing
Charlotte Gaydos, MS, MPH, DrPH, Professor, Division of Infectious
Diseases, Johns Hopkins University
The iwantthekit (IWTK) program offers internet-requested kits for
home collection for screening of common STI. Other programs
exist. We will discuss innovation programs and acceptability for
home collection, and we will review published programs. Many
studies reported use of and willingness to use home collection when
available. There was willingness to pay an average of $10-30. User
satisfaction was high for home collection.
3:05 Sponsored Presentation (Opportunity Available)
3:35 Refreshment Break in the Exhibit Hall with Poster
Viewing
PREPARING FOR THE NEXT WAVE OF POC
DIAGNOSTICS: -OVERCOMING CHALLENGES
WITH CONSUMER TESTING (CONT.)
4:25 Chairperson’s Remarks
Lawrence Worden, Founder & Principal, IVD Logix
4:30 Professional Concerns with At-Home Testing
Jeanne Mumford, MT(ASCP), Manager, Point-of-Care Testing, Johns
Hopkins University
Currently at-home testing is available in many formats including
glucose, urine pregnancy, drug screens, HIV, STI’s and Strep A
testing. There are manufacturers who provide the consumer with
access to physician care for positive tests and some may even
benefit surveillance studies by reporting to local health departments.
The ability to give access to testing for those patient populations
that may be underserved or underinsured also weigh heavily in the
debate of OTC self-testing. Though many arguments support the use
of consumer OTC self-testing, there are still some concerns from a
quality assurance perspective from the medical technologist who
currently oversee point of care testing in the health care setting. In
this session, we will discuss some of those concerns from the point
of care coordinator’s point of view.
5:00 PANEL DISCUSSION: Overcoming Challenges with
Consumer Testing
Moderator: Lawrence Worden, Founder & Principal, IVD Logix
Panelists: Elliot Cowan, PhD, Principal, Partners in Diagnostics
Charlotte Gaydos, MS, MPH, DrPH, Professor, Division of Infectious
Diseases, Johns Hopkins University
Jeanne Mumford, MT(ASCP), Manager, Point-of-Care Testing, Johns
Hopkins University
Šeila Selimović, PhD, Program Manager, Early Notification to Act, Control,
and Treat (ENACT), Division of Research, Innovation, and Ventures
(DRIVe), Biomedical Advanced Research and Development Authority
(BARDA), Office of Assistant Secretary for Preparedness and Response
(ASPR), U.S. Department of Health and Human Services (HHS)
5:30 Sponsored Presentation (Opportunity Available)
6:00 Welcome Reception in the Exhibit Hall with Poster
Viewing
7:00 Close of Day
WEDNESDAY, AUGUST 26
7:15 am Registration
7:30 Problem Solving Breakout Discussions with Continental
Breakfast
DEPLOYING POINT-OF-CARE TESTING TO
MANAGE DISEASE OUTBREAKS
8:25 Chairperson’s Remarks
Gerald Kost, MD, PhD, MS, FAACC, Director, Point-of-Care Testing
Center for Teaching and Research (POCT•CTR); Emeritus Professor,
School of Medicine, University of California, Davis
8:30 Geospatial “Hot Spots” Need Rapid Point-Of-
Care Diagnostics to Stop Highly Infectious Threats and
Antimicrobial Resistance
Gerald Kost, MD, PhD, MS, FAACC, Director, Point-of-Care Testing
Center for Teaching and Research (POCT•CTR); Emeritus Professor,
School of Medicine, University of California, Davis
Increasingly, we observe the adverse personal, societal, economic,
and cultural impact of outbreaks, antimicrobial resistance, and
disasters. Nations are not prepared! POC strategies can mitigate
risk, reduce harm, and improve crisis standards of care. Global
solutions integrate national POCT policy and guidelines, and
distribute financial burden and reasonable business models.
9:00 Rapid Development of Diagnostic Tests for New
Threats: 2019 Novel Coronavirus Pneumonia (COVID-19)
and Other Pathogens
Timothy Minogue, Diagnostic Systems Division, United States Army
Medical Research Institute of Infectious Diseases
To bridge the gap between rapid point-of-care diagnostics and
sequencing, we developed a highly multiplexed assay designed
to detect 164 different viruses, bacteria, and parasites using the
NanoString nCounter platform. Included in this assay were high-
consequence pathogens, such as Ebola virus, highly endemic
organisms including several Plasmodium species, and a large
number of less prevalent pathogens to ensure a broad coverage of
potential human pathogens.
9:30 Point-of-Care Molecular Diagnostics for Disease
Outbreak Settings: The Path to the Future
Rachel Spurbeck, PhD, Principal Research Scientist, Health Outcomes
and Biotechnology Solutions, Battelle Memorial Institute
Rapid, accurate, and affordable point-of-care (POC) diagnostics
are key to detecting and subsequently mitigating the impact of
disease outbreaks, particularly for emerging pathogens. Molecular
approaches to detection offer speed, sensitivity, and specificity, but
can introduce complexity and expense, making it difficult to achieve
a POC diagnostic suitable for use outside a clinical setting. This
talk will review the current state of the art for molecular diagnostics
and examine the path forward to deployable POC diagnostics
for outbreak settings, including some of the challenges being
undertaken today.
10:00 Presentation to be Announced
10:15 Sponsored Presentation (Opportunity
Available)
10:30 Coffee Break in the Exhibit Hall with Poster Viewing
11:30 Plenary Keynote Session
Please click here for details
1:15 pm Luncheon Presentation (Sponsorship Opportunity
Available) or Enjoy Lunch on Your Own
1:45 End of Enabling Point-of-Care Diagnostics
Recommended Dinner Short Course*
SC8: The COVID-19 Case Study: Accelerated
Development of Diagnostics for Novel Infectious
Disease Threats
*Separate registration required, click here for details
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TABLE OF CONTENTS
POCT AND INFECTIOUS DISEASE
WEDNESDAY, AUGUST 26
11:30 Plenary Keynote Session
Please click here for details
1:15 pm Luncheon Presentation (Sponsorship Opportunity
Available) or Enjoy Lunch on Your Own
1:45 Refreshment Break in the Exhibit Hall with Poster
Viewing
DEVELOPING AND SHOWING CLINICAL IMPACT
OF RAPID DIAGNOSTICS
2:15 Chairperson’s Opening Remarks
Jennifer Dien Bard, PhD, D(ABMM), Director, Microbiology and
Virology, Children’s Hospital Los Angeles; Associate Professor,
Pathology and Laboratory Medicine, Keck School of Medicine,
University of Southern California
2:20 Clinical Impact of Rapid Molecular Blood Culture Test
at a Tertiary Cancer Care Center
Esther Babady, PhD, Medical Director, Clinical Microbiology Service,
Memorial Sloan Kettering Cancer Center
Sepsis remains a significant cause of morbidity and mortality in
hospitalized patients. Cancer patients and other immunocompromised
hosts are particularly at increased risk of sepsis. Novel molecular
methods for rapid diagnosis directly from blood samples are now
available for identification of pathogens and select resistance markers.
This presentation will review the clinical impact of rapid molecular tests
on patient outcomes at a tertiary cancer care center.
2:50 What’s New in the Molecular Detection of Bloodstream
Infections?
Kimberly Hanson, MD, MHS, Director, Transplant Infectious
Diseases and Immunocompromised Host Service; Director, Medical
Microbiology Fellowship Program, Section Head, Clinical Microbiology,
University of Utah, ARUP Laboratories
Delayed diagnosis of bloodstream infections (BSI) is associated
with poor clinical outcomes. This session will review the current
landscape of BSI molecular diagnostic testing, including rapid
pathogen identification, antimicrobial drug resistance detection, and
the potential utility of host response signatures.
3:20 DOD’s Pursuit of Pre-Symptomatic Non-Invasive
Diagnostics
Edward Argenta, Science & Technology Manager, Biological &
Chemical Technologies, Defense Threat Reduction Agency
The Department of Defense, Chemical and Biological Technologies
Department is managing a disruptive portfolio developing algorithms
utilizing artificial intelligence approaches to deliver warning of an
acute exposure to a pathogen or toxic chemical prior to overt signs
and symptoms using non-invasive biomarkers. The portfolio has
shown successes in both animal and human exposure studies,
and will continue to pursue advancing the research to provide early
identification of exposure.
3:50 Presentation to be Announced
4:05 Presentation to be Announced
4:20 Refreshment Break in the Exhibit Hall with
Poster Viewing
MULTIPLEX PANELS
5:05 Chairperson’s Remarks
Esther Babady, PhD, Medical Director, Clinical Microbiology Service,
Memorial Sloan Kettering Cancer Center
5:10 Head-to-Head Comparison: Nanopore Sequencing
and Microarray Resequencing for Multiplex Pathogen
Identification
Robert Duncan, PhD, Principal Investigator, Office of Blood Research
and Review, Center for Biologics Evaluation and Research (CBER), FDA
GeneChip Resequencing microarrays have been advanced for
infectious disease agent detection and identification from Ebola to
Zika. Next-generation sequencing with the highly mobile and cost-
effective nanopore sequencing device is challenging the supremacy
of the microarray in rapid point-of-need pathogen detection. This
talk will present results of side-by-side application of these two
platforms for detection in pathogen-spiked blood samples and
compare their performance.
5:30 Syndromic Testing for Meningitis/Encephalitis: Saga of
the Love-Hate Relationship
Jennifer Dien Bard, PhD, D(ABMM), Director, Microbiology and
Virology, Children’s Hospital Los Angeles; Associate Professor,
Pathology and Laboratory Medicine, Keck School of Medicine,
University of Southern California
As part of the Multiplex Panel session, this talk will focus on multiplex
testing for the laboratory diagnosis of meningitis and encephalitis
as compared to standard-of-care testing. The potential benefits
and limitations of panel testing for meningitis and encephalitis
compared to standard-of-care testing will be discussed. The potential
approaches to maximize testing yield will also be discussed.
5:50 The Biofire Pneumonia Panel: Does It Relate to
Microbiological and Clinical Variables?
Kenneth Rand, MD, Medical Director, Clinical Microbiology Laboratory;
Professor, Pathology and Medicine, University of Florida
The BioFire FilmArray Pneumonia Panel (PP) detects 15 common
bacterial pathogens semi-quantitatively (copy # from 104 to 107),
3 atypical pneumonia bacteria, 8 viruses, and 7 antimicrobial
resistance markers by multiplex PCR in about 1 hour in the
laboratory. Results of our 396-patient study suggest PP detects
more bacterial isolates than conventional microbiology, and the
copy number correlates with outcome variables, such as ICU length
of stay, temperature, and white cells in the BAL. Results reported
in a 3–4 h timeframe after a BAL could potentially improve both
antibiotic choice and de-escalation in critically ill intubated patients.
6:10 PANEL DISCUSSION: Advancing Multiplex Panels for
Clinical Diagnostics
Moderator: Esther Babady, PhD, Medical Director, Clinical Microbiology
Service, Memorial Sloan Kettering Cancer Center
Panelists: Robert Duncan, PhD, Principal Investigator, Office of Blood
Research and Review, Center for Biologics Evaluation and Research
(CBER), FDA
Jennifer Dien Bard, PhD, D(ABMM), Director, Microbiology and
Virology, Children’s Hospital Los Angeles; Associate Professor,
Pathology and Laboratory Medicine, Keck School of Medicine,
University of Southern California
Kenneth Rand, MD, Medical Director, Clinical Microbiology Laboratory;
Professor, Pathology and Medicine, University of Florida
Tim Blauwkamp, PhD, CSO, Karius
• Comparison of multiplex platforms
• Reimbursement considerations
• Proving clinical utility of multiplex diagnostic tests
6:40 Close of Day
6:40 Dinner Short Course Registration*
7:00 - 9:30 Dinner Short Course*
Recommended Dinner Short Course*
SC8: The COVID-19 Case Study: Accelerated
Development of Diagnostics for Novel Infectious
Disease Threats
*Separate registration required, click here for details
CHI’S 12TH ANNUAL | AUGUST 26-27, 2020
Advanced Diagnostics for Infectious Disease
IMPROVING CLINICAL OUTCOMES THROUGH NOVEL TECHNOLOGY AND MOLECULAR TESTING
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TABLE OF CONTENTS
THURSDAY, AUGUST 27
7:15 am Registration
7:30 Problem Solving Breakout Discussions with Continental
Breakfast
CONSIDERATIONS FOR AMR DIAGNOSTICS
8:25 Chairperson’s Remarks
Chairperson to be Announced, MeMed
8:30 I Don’t Watch Reality TV, I Live It – Reimbursement
Challenges under PAMA
Ester Stein, MBA, Director, Corporate Reimbursement, Government
Affairs, Abbott
This talk will focus on the reimbursement challenges under PAMA
for the more commonly performed diagnostic tests. The talk will
focus primarily on coding and payment issues, and will provide
policy updates.
8:45 Don’t Take That Antibiotic! You Might Get...Fat? The
Science of the Microbiome
Norman Moore, PhD, Director, Scientific Affairs, Abbott
Even though the global threat of antibiotic-resistant microorganisms
is significant, many patients demand antibiotics and doctors are
far too willing to provide them. This talk shows that the relationship
between us and our bacteria is more important than previously
thought. Disrupting that balance can cause a host of medical issues.
Sponsored by9:30 Serum Epitope Repertoire Analysis (SERA):
A Novel Serology Platform Enabling Multiplex
Diagnostics and Sero-Surveillance
Kathy Kamath, PhD, Director, Discovery, Research & Development,
Serimmune Inc.
SERA incorporates bacterial display peptide libraries, NGS, and
custom bioinformatics to profile antibody repertoires and map them
to infectious and other diseases. The platform enables parallel
testing of an unlimited number of biomarkers in a single, universal
assay, and quantitative longitudinal monitoring of that response as it
evolves over time.
9:45 Sponsored Presentation (Opportunity Available)
10:00 Coffee Break in the Exhibit Hall with Poster Viewing
Co-Organized withDIAGNOSTIC STEWARDSHIP
11:00 Chairperson’s Remarks
Joseph Campos, PhD, D(ABMM), F(AAM), Director,
Microbiology Laboratory, Infectious Disease
Molecular Diagnostics Laboratory, Laboratory Informatics, Children’s
National Medical Center; Strategic Alliances Liaison and Former
Secretary, ASM
11:05 Diagnostic Stewardship: Because You Can’t Do
Everything for Everyone All the Time
Christopher Doern, PhD, D(ABMM), Associate Director, Microbiology,
Virginia Commonwealth University Medical Center, Medical College of
Virginia Campus; Co-Chair, ASM’s Clinical Micro Open
11:25 The Role of Diagnostic Stewardship in Improving
Patient Care and Reducing Overall Healthcare Costs
Matthew Binnicker, PhD, Consultant, Division of Clinical Microbiology,
Department of Laboratory Medicine and Pathology; Vice Chair of
Supply Chain Management, Department of Laboratory Medicine and
Pathology; Vice Chair of Practice, Department of Laboratory Medicine/
Pathology, Mayo Clinic; Chair, ASM’s Professional Development
Subcommittee
Healthcare is transitioning from a fee-for-service model to one
focused on value-based care. As a key component of patient
care and the value-based equation, clinical laboratories will need
to be an active participant in the development of diagnostic
stewardship programs, so that healthcare providers are guided
towards the “right test, for the right patient, at the right time.” This
presentation will provide an overview of establishing an effective
diagnostic stewardship program, and provide examples of how
healthcare providers can be guided towards appropriate testing
and result interpretation. Specific case scenarios will be reviewed
to demonstrate how diagnostic stewardship can lead to increased
efficiency, reduced cost, and improved patient care.
11:55 A Laboratory Medicine Best Practices Systematic
Review and Meta-Analysis for the Laboratory Diagnosis of C.
Difficile
Colleen Kraft, MD, Associate Chief Medical Officer, Associate
Professor, Pathology/Laboratory Medicine, Medicine/Division of
Infectious Diseases, Emory University Hospital; Chair, ASM’s Evidence-
Based Laboratory Medicine Practice Guidelines
12:05 pm PANEL DISCUSSION: Extended Q&A with Session
Speakers
Moderator: Joseph Campos, PhD, D(ABMM), F(AAM), Director,
Microbiology Laboratory, Infectious Disease Molecular Diagnostics
Laboratory, Laboratory Informatics, Children’s National Medical
Center; Strategic Alliances Liaison and Former Secretary, ASM
Panelists: Speakers of the Session
12:35 Presentation to be Announced
1:05 Luncheon Presentation (Sponsorship
Opportunity Available) or Enjoy Lunch on Your Own
1:35 Refreshment Break in the Exhibit Hall with Poster
Viewing
CLINICAL METAGENOMIC SEQUENCING
2:15 Chairperson’s Remarks
Norman Moore, PhD, Director, Scientific Affairs, Abbott
2:20 Clinical Metagenomic Sequencing and Human Host
Response: Changing the Diagnostic Paradigm?
Charles Chiu, MD, PhD, Professor, Laboratory Medicine and Medicine/
Infectious Diseases, Director, UCSF-Abbott Viral Diagnostics and
Discovery Center, Associate Director, UCSF Clinical Microbiology
Laboratory, UCSF School of Medicine
Metagenomic next-generation sequencing (mNGS) is a
transformative technology for infectious disease diagnosis as
it enables detection of nearly all pathogens – viruses, bacteria,
fungi, and parasites – in a single assay. Here we will discuss the
integration of multiple approaches to enhance the clinical utility of
body fluid mNGS, including nanopore sequencing, CRISPR-Cas12-
based pathogen detection, complementary host response analyses,
and simultaneous diagnosis of cancer.
2:50 Mycobacterial Infections in Immunocompromised
Patients, the Perfect Fit for Metagenomic Solutions
Nathan Ledeboer, PhD, Professor and Vice Chair, Pathology and
Medical Director, Medical College of Wisconsin
DETECTION OF RESISTANCE
3:20 Applying Next-Generation Sequencing for Detection of
Antimicrobial Resistance
Patricia Simner, PhD, D(ABMM), Associate Professor, Pathology;
Director, Bacteriology, Division of Medical Microbiology, The Johns
Hopkins University School of Medicine
3:50 FLASH: A Next-Generation CRISPR Diagnostic
for Multiplexed Detection of Antimicrobial Resistance
Sequences
Emily Crawford, PhD, Scientist II, Infectious Disease Initiative, Chan
Zuckerberg Biohub
4:20 End of Summit
POCT AND INFECTIOUS DISEASE
ADVANCED DIAGNOSTICS FOR INFECTIOUS DISEASE, continued
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TABLE OF CONTENTS
CONFERENCE STREAMS
Liquid Biopsy/
Early Detection Stream
AUGUST 25-26
AGENDA Enabling Technologies for Liquid Biopsy
AUGUST 26-27
AGENDA
Early Detection of Disease
2020 LIQUID BIOPSY/EARLY DETECTION CONFERENCES
POCT TECHNOLOGIES AND STRATEGY
LIQUID BIOPSY/EARLY DETECTION
POCT AND INFECTIOUS DISEASE
COMPANION DX AND IO BIOMARKERS
BUSINESS
NGS ADVANCES
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TABLE OF CONTENTS
LIQUID BIOPSY/EARLY DETECTION
CHI’S 5TH ANNUAL | AUGUST 26-27, 2020
Enabling Technologies for Liquid Biopsy
ADVANCING TECHNOLOGIES FOR CLINICAL UTILITIES
Recommended Short Courses*
SC1: Technologies, Applications and Commercialization
of POC Dx
SC3: Liquid Biopsies Based on Extracellular Vesicles:
Prospects, Challenges, and Opportunities
*Separate registration required, click here for details
TUESDAY, AUGUST 25
7:30 am Registration and Morning Coffee
EXOSOMES AND CIRCULATING TUMOR CELLS IN
CANCER LIQUID BIOPSY
8:30 Chairperson’s Opening Remarks
Hakho Lee, PhD, Associate Professor and Hostetter MGH Scholar,
Center for Systems Biology, Massachusetts General Hospital
8:40 The Wide World of Liquid Biopsy Biomarker Platforms
for Cancer Screening
Sam Hanash, MD, PhD, Director, Red & Charline McCombs Institute;
Evelyn & Sol Rubenstein Distinguished Chair, Cancer Prevention;
Professor, Clinical Cancer Prevention-Research, Translational
Molecular Pathology, University of Texas MD Anderson Cancer Center
There is currently intense interest in developing liquid biopsy
applications for cancer screening with a multitude of platforms
being implemented to this effect. The contribution and merits of
biomarkers types for lung cancer screening will be presented.
9:10 Clinical Platform for Molecular Analyses of
Extracellular Vesicles
Hakho Lee, PhD, Associate Professor and Hostetter MGH Scholar,
Center for Systems Biology, Massachusetts General Hospital
This presentation will discuss our key advances towards clinical
analyses of extracellular vesicles (EVs): i) development of a
high-throughput assay strategy, HiMEX (high-throughput magneto-
electrochemical exosome), and ii) assessment of EVs as potent
biomarkers for cancer management.
9:40 Chasing the Exosome Dream: Developing an Exosome-
Based Platform for the Screening and Monitoring of Lung
Cancer
Lydia Sohn, PhD, Chancellor’s Professor, Mechanical Engineering;
Faculty Assistant to the Vice Chancellor for Research, UC Berkeley
Although the standard of care for non-small cell lung cancer includes
surgery and many options for therapeutics, the response is highly
variable and patient specific. Detecting early-stage recurrence would
allow clinicians to adapt or change therapy within a curative window,
greatly improving outcomes and mortality rates. We are developing
a sensitive, simple-to-use, platform based on exogenous labeling
that could detect tumor-derived extracellular vesicles in blood and
saliva for patient monitoring.
10:10 Coffee Break in the Exhibit Hall with Poster Viewing
10:55 Chairperson’s Remarks
Hakho Lee, PhD, Associate Professor and Hostetter MGH Scholar,
Center for Systems Biology, Massachusetts General Hospital
11:00 Making Ultrasensitive Digital Droplet Assays Mobile
David Issadore, PhD, Assistant Professor, Bioengineering & Electrical
& Systems Engineering, University of Pennsylvania
We have developed a mobile phone-based imaging technique that
is >100× faster than conventional microfluidic droplet detection,
does not require expensive optics, is invariant to flow rate, and
can simultaneously measure multiple fluorescent dyes in droplets.
By using this time domain modulation with cloud computing,
we overcome the low frame rate of digital imaging, and achieve
throughputs as high as 1 million droplets per second. We integrate
on-chip delay lines and a microbead processing unit, resulting
in a robust device, suitable for low-cost implementation, with
ultrasensitive measurement capabilities. Additionally, I will present
unpublished data showing how this approach can be used for high-
throughput single extracellular vesicle analysis.
11:30 High-Throughput Label-Free Isolation of
Heterogeneous Circulating Tumor Cells and CTC Clusters
from Non-Small-Cell Lung Cancer Patients
Sunitha Nagrath, PhD, Associate Professor, Chemical Engineering,
University of Michigan
We applied an inertial microfluidic Labyrinth device for high-
throughput, biomarker-independent, size-based isolation of CTCs/
CTC clusters from patients with metastatic non-small-cell lung
cancer (NSCLC). The Labyrinth device recovered heterogeneous
CTCs in 100% and CTC clusters in 96% of patients with metastatic
NSCLC. The majority of recovered CTCs/clusters were EpCAM,
suggesting that these would have been missed using traditional
antibody-based capture methods.
12:00 pm Presentation to be Announced
12:15 Sponsored Presentation (Opportunity
Available)
12:30 LUNCHEON PRESENTATION:
Driving Clinical Confidence in Assay Development: The
Importance of Blood Sample Preservation
Speaker to be Announced
1:00 Refreshment Break in the Exhibit Hall with Poster
Viewing
ADVANCES IN DETECTING CELL-FREE DNA
1:30 Chairperson’s Remarks
G. Mike Makrigiorgos, PhD, Professor, Radiation Oncology, Dana-
Farber Cancer Institute and Harvard Medical School
1:35 FNIH Biomarkers Consortium Development of Quality
Control Materials for ctDNA Assays
Dana Connors, MSc, PMP, Senior Scientific Project Manager, Cancer,
Foundation for the National Institutes of Health
ctDNA shows great promise for cancer patient management but
there is a need for standardization in its use. A public private
partnership was initiated through the Biomarkers Consortium at the
FNIH to address this unmet need. This presentation will describe
how a pre-competitive alliance came together to better understand
the need and acceptable performance characteristics of quality
control materials, and provide an update on the intended use and
outcomes of the FNIH ctDNA Quality Control Materials project.
2:05 New Technologies for Low-Cost and Efficient Targeted
Re-Sequencing for Liquid Biopsy Applications
G. Mike Makrigiorgos, PhD, Professor, Radiation Oncology, Dana-
Farber Cancer Institute and Harvard Medical School
As the potential of liquid biopsies for prognostic, predictive or
early cancer detection applications grows, so does the demand
for technical advances to accompany the burgeoning range of
applications. We present new developments that enable targeted
re-sequencing for liquid biopsy applications at a fraction of the
current cost, while retaining or increasing sensitivity and specificity.
Examples for detecting low-level mutations in circulating DNA will be
presented.
2:35 Exploiting ctDNA Biology and Personalized Sequencing
for Sensitive Detection of Low Burden Disease
Christopher Smith, PhD, Research Associate, CRUK Cambridge
Institute, University of Cambridge (Nitzan Rosenfeld’s Laboratory)
Cell-free tumor derived DNA (ctDNA) analysis offers the potential
for minimally invasive detection of early stage disease as well as
minimal residual disease after treatment. However, the utility of
ctDNA is currently limited when the tumor burden is low. Here, I
will describe novel approaches that leverage knowledge of ctDNA
biology and personalized sequencing for sensitive detection even in
these challenging settings.
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TABLE OF CONTENTS
LIQUID BIOPSY/EARLY DETECTION
ENABLING TECHNOLOGIES FOR LIQUID BIOPSY, continued
3:05 Nu.Q™ Capture – Isolation and Profiling
of Tumour-Derived Circulating Cell-Free
Nucleosomes
Mark Eccleston, Business Development Director, Volition
This talk focuses on the development of an efficient approach to
immunocapture of cell-free circulating nucleosomes, including the
enrichment of tumour-derived, circulating cell-free nucleosomes and
associated DNA from background nucleosomes of haematopoietic
origin. Clinical applications for mass spectrometry, immunoassay
and sequencing-based analysis of cell-free, circulating tumour
nucleosome will also be discussed.
3:20 Sponsored Presentation (Opportunity Available)
3:35 Refreshment Break in the Exhibit Hall with Poster
Viewing
ADVANCES IN DETECTING CELL-FREE DNA
(CONT.)
4:25 Chairperson’s Remarks
G. Mike Makrigiorgos, PhD, Professor of Radiation Oncology, Dana
Farber Cancer Institute and Harvard Medical School
4:30 Targeted Digital Sequencing of Circulating Tumor DNA
for Minimal Residual Disease Detection and Treatment
Monitoring
Bradon McDonald, PhD, Computational Scientist II, Center for
Noninvasive Diagnostics, Translational Genomics Research Institute,
Phoenix ArizonaTARDIS (Muhammed Murtaza’s Laboratory)
Longitudinal analysis of circulating tumor DNA has shown promise
for monitoring treatment response. However, most current methods
lack adequate sensitivity for residual disease detection during or
after completion of treatment in patients with nonmetastatic cancer.
To address this gap, we have developed targeted digital sequencing
(TARDIS) for multiplexed analysis of patient-specific cancer
mutations. In this talk, I will share results of TARDIS benchmarking
and analysis of plasma samples from early-stage breast cancer
patients treated with neoadjuvant therapy.
5:00 PANEL DISCUSSION: Circulating Tumor DNA – Current
State and Future Development for Liquid Biopsy
Moderator: Sam Hanash, MD, PhD, Director, Red & Charline
McCombs Institute; Evelyn & Sol Rubenstein Distinguished Chair,
Cancer Prevention; Professor, Clinical Cancer Prevention-Research,
Translational Molecular Pathology, University of Texas MD Anderson
Cancer Center
Panelists: Dana Connors, MSc, PMP, Senior Scientific Project Manager,
Cancer, Foundation for the National Institutes of Health
G. Mike Makrigiorgos, PhD, Professor, Radiation Oncology, Dana-
Farber Cancer Institute and Harvard Medical School
Christopher Smith, PhD, Research Associate, CRUK Cambridge
Institute, University of Cambridge (Nitzan Rosenfeld’s Laboratory)
Bradon McDonald, PhD, Computational Scientist II, Center for
Noninvasive Diagnostics, Translational Genomics Research Institute,
Phoenix Arizona TARDIS (Muhammed Murtaza’s Laboratory)
5:30 Sponsored Presentation (Opportunity Available)
6:00 Welcome Reception in the Exhibit Hall with Poster
Viewing
7:00 Close of Day
WEDNESDAY, AUGUST 26
7:15 am Registration
7:30 Problem Solving Breakout Discussions with Continental
Breakfast
EMERGING TECHNOLOGIES FOR EARLY
DETECTION AND RECURRENCE
8:25 Chairperson’s Remarks
Lynn Sorbara, PhD, Program Director, Cancer Biomarkers Research
Group, National Cancer Institute (NCI), NIH
8:30 Detection of Exosomal Protein and MicroRNA
Combined Biomarkers via Exo-PROS Assay for Cancer Early
Detection
Yun (Sunny) Wu, PhD, Associate Professor, Biomedical Engineering,
University at Buffalo, The State University of New York
Exosomal proteins and microRNAs are promising biomarkers
for cancer liquid biopsy. We have developed an exosome protein
microRNA one stop (Exo-PROS) liquid biopsy assay, which enables
one-stop capture of tumor-derived exosomes (TEX) and sensitive
quantitation of TEX surface proteins and intra-vesicular microRNAs
on a single device. The Exo-PROS assay has shown superior sensing
performance than ELISA and qRT-PCR. The potential application
of Exo-PROS assay has been demonstrated in lung cancer early
detection.
9:00 Direct Kinetic Fingerprinting and Digital Counting of
Single Cancer Biomarker Molecules in Human Biofluids and
Single Cells
Nils Walter, PhD, Francis S. Collins Collegiate Professor of Chemistry,
Biophysics & Biological Chemistry; Founding Director, Single Molecule
Analysis in Real-Time (SMART) Center; Founding Co-Director of the
Center for RNA Biomedicine; Chemistry, University of Michigan
The sensitive and accurate quantification of specific cancer
biomarkers plays important roles in medical diagnostics and
research. We have developed a kinetic fingerprinting approach with
dynamically binding probes for the direct, digital, hyper-accurate
detection and counting of diverse single biomarker molecules in
complex biofluids, including blood serum, urine and in situ, with
femtomolar to attomolar limits of detection (LODs). We are currently
working to commercialize our technology, termed SiMREPS (single-
molecule recognition through equilibrium Poisson sampling).
9:30 Third-Generation Liquid Biopsy: A Comprehensive
Characterization of Circulating Analytes for Patient-Centered
Cancer Research
Peter Kuhn, PhD, Director, USC Michelson CSI-Cancer; Dean’s
Professor of Biological Sciences; Professor of Biological Sciences,
Medicine, Biomedical Engineering, and Aerospace and Mechanical
Engineering, University of Southern California
As cancer care is transitioning to personalized therapies with
necessary complementary or companion biomarkers, there is
significant interest in determining to what extent non-invasive liquid
biopsies reflect the gold standard solid biopsy. We have established
an approach for measuring patient-specific circulating and solid
cell concordance by introducing tumor touch preparations to the
high-definition single-cell analysis workflow for high-resolution
cytomorphometric characterization. Patient-specific level of
concordance can readily be measured to establish the utility of
circulating cells as biomarkers and define biosignatures for liquid
biopsy assays.
10:00 Sponsored Presentation (Opportunity Available)
10:30 Coffee Break in the Exhibit Hall with Poster Viewing
11:30 Plenary Keynote Session
Please click here for details
1:15 pm Luncheon Presentation (Sponsorship Opportunity
Available) or Enjoy Lunch on Your Own
1:45 End of Enabling Technologies for Liquid Biopsy
Recommended Dinner Short Course*
SC7: Early Cancer Detection
*Separate registration required, click here for details
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TABLE OF CONTENTS
LIQUID BIOPSY/EARLY DETECTION
CHI’S INAUGURAL | AUGUST 26-27, 2020
Early Detection of Disease
ASSESSING OPPORTUNITY AND OVERCOMING CHALLENGES
WEDNESDAY, AUGUST 26
10:30 am Registration
11:30 Plenary Keynote Session
Please click here for details
1:15 pm Luncheon Presentation (Sponsorship Opportunity
Available) or Enjoy Lunch on Your Own
1:45 Refreshment Break in the Exhibit Hall with Poster
Viewing
OVERVIEW
2:15 Overcoming the Challenges to Realize the
Opportunities of Early Disease Detection
John Sninsky, PhD, Independent Consultant, Translational Medicine
and Science
Diagnosis early in the natural history of disease promises to lead to
improved health management. However, over diagnosis needs to be
avoided. Valuable lessons learned from cancer will be instructive
for other chronic diseases. The integration of Information from
multiple disparate biological compartments to generate informative
probabilistic models will be paramount. How the healthcare system
determines applicable evidence level and rewards value with
reimbursement will be critical.
DATA AND ECONOMIC ANALYSIS
2:50 JAMA Users’ Guides to the Medical Literature: How to
Read Articles That Use Machine Learning
Yun Liu, PhD, Senior Research Scientist, Google Health
Many recent clinical diagnostic tools have been developed using
machine learning and must be evaluated using a 3-step process
of deriving, validating, and establishing the clinical effectiveness
of the tool. Several key considerations are appropriate machine
learning methods used for the type and size of data, proper tuning
of prespecified settings (called hyperparameters) on a dataset
independent of the final validation set, and a rigorous reference
standard.
3:20 Technology Valuation in the Era of Value-Based
Incentives for Physician Services
John Hornberger, MD, MS, Adjunct Clinical Professor of Medicine,
Stanford University
The U.S. has the highest per capita healthcare costs, with substantial
financial and clinical variability due to over- and under-use of
mispriced technologies (“moral hazard”). Physician-led professional
societies are creating/owning quality metrics for assessing
performance. Under MACRA, performance also is assessed based
on costs for an episode of care. To succeed under these new
incentives, physicians will need risk-based algorithms assessing
technology quality and costs; representative examples to be
presented.
3:50 Sponsored Presentation (Opportunity Available)
4:20 Refreshment Break in the Exhibit Hall with Poster
Viewing
REIMBURSEMENT
5:05 Chairperson’s Remarks
John Sninsky, PhD, Independent Consultant, Translational Medicine
and Science
5:10 Medicare: Adapting Prevention Policy for a New
Molecular Era
Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates LLC
Medicare has historically been far behind the curve in providing
coverage for preventive services, especially novel diagnostic tests.
Medicare’s approach is so slow, it risks actually discouraging
investing because of the long and slow policy pipeline. Medicare
can adopt new preventive benefits for diagnostics if they are
directly legislated by Congress. In addition, Medicare can adopt new
diagnostics through the year-long National Coverage Determination
(NCD) process, if they have been previously endorsed by the U.S.
Preventive Services Task Force. These serial steps can add many
years to the adoption of new technology and depend on irregular
multi-year timelines in the case of USPSTF. We will discuss the pros
and cons of the status quo, best practices, and case studies for
coping with the status quo, and the outlook for new policy that would
better encourage much-needed innovations.
5:40 Lessons Learned and Challenges of Reimbursement for
Early Detection of Disease
Paul Gerrard, MD, CMO & MolDX Director of Clinical Science, MolDx
Palmetto
6:10 Presentation to be Announced
6:40 Close of Day
6:40 Dinner Short Course Registration*
7:00 - 9:30 Dinner Short Course*
Recommended Dinner Short Course*
SC7: Early Cancer Detection
*Separate registration required, click here for details
THURSDAY, AUGUST 27
7:15 am Registration
7:30 Problem Solving Breakout Discussions with Continental
Breakfast
OPPORTUNITIES AND CHALLENGES OF EARLY
DIAGNOSIS OF DISEASE
8:25 Chairperson’s Remarks
John Sninsky, PhD, Independent Consultant, Translational Medicine
and Science
8:30 KEYNOTE PRESENTATION: Overdiagnosis and
Premature Treatment Challenge of Early Disease
Detection
Laura Esserman, MD, MBA, Professor, Surgery, University of
California San Francisco Medical Center
9:00 Multi-Modal Approaches to Early Disease Detection and
Population-Based Screening
Drew Watson, MBA, PhD, Biostatistics and Clinical Development Advisor
For many diseases, population screening is essential to improving
patient survival. Despite the promise of blood-based “liquid
biopsies”, progress has been limited necessitating new multi-omics
approaches incorporating multiple technologies. We discuss new
approaches to biomarker discovery, algorithm development, and
clinical validation using mechanistic, statistical, and machine
learning approaches for handling of multi-omics data. We further
discuss the need to improve clinical decision support systems to
facilitate clinical decision making.
9:30 Epigenetic Genomic Modifiers as Proxies of Gene
Expression for Cancer
Alex Aravanis, MD, PhD, CSO, Head, R&D; Co-Founder, GRAIL
10:00 Coffee Break in the Exhibit Hall with Poster Viewing
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TABLE OF CONTENTS
LIQUID BIOPSY/EARLY DETECTION
EARLY DETECTION OF DISEASE, continued
OPPORTUNITIES AND CHALLENGES OF EARLY
DIAGNOSIS OF DISEASE (CONT.)
11:00 Chairperson’s Remarks
John Sninsky, PhD, Independent Consultant, Translational Medicine
and Science
11:10 Opportunity for Pre-Competitive Multi-Stakeholder
Collaboration for NAFLD Detection and Intervention
Veronica Miller, PhD, Executive Director, Forum for Collaborative
Research; Professor (Adjunct), UC Berkeley SPH
Non-alcoholic fatty liver disease (NAFLD) affects approximately
25% of adults and 10% of children in the U.S. and is associated with
obesity, type 2 diabetes mellitus, dyslipidemia and hypertension.
Severe clinical outcomes include decompensated cirrhosis and
hepatocellular carcinoma. The current diagnostic standard for
non-alcoholic steatohepatitis (NASH), the more advanced form of
NAFLD, is based on liver biopsies. Early diagnosis of the higher risk
individuals is paramount. Representation and active engagement of
scientific experts from all stakeholder groups in a non-competitive
environment increases clarity and standardization while decreasing
uncertainty. Lessons learned will be summarized.
11:25 Breast Cancer Overdiagnosis and the Precancer
Problem
Alexander Borowsky, PhD, Associate Professor, Department of
Pathology and Laboratory Medicine, University of California, Davis
Breast cancer screening by mammography, which began in the
U.S. about 40 years ago, has led to significant increases in the
incidence of early-stage breast cancers, including ductal carcinoma
in situ (DCIS), also called precancer or stage 0 disease. However,
the expected reciprocal decrease in subsequent late-stage breast
cancers was not found. It is now clear that some screen-detected
breast “cancers” are indolent lesions without significant malignant
potential.
11:40 Challenges of CT Lung Screening Implementation
Andrea McKee, MD, President, Rescue Lung, Rescue Life Society;
Chairman, Radiation Oncology, Lahey Hospital & Medical Center
Discussion of challenges and lessons learned from implementation
of one of the largest clinical and biomarker research-integrated
CT lung screening programs in the United States. Review of
infrastructure required for local implementation success. Exploration
of cultural and societal transformation necessary for widespread
lung screening adoption.
11:55 PANEL DISCUSSION: Opportunities and Challenges of
Early Diagnosis of Disease
Moderator: John Sninsky, PhD, Independent Consultant, Translational
Medicine and Science
Panelists:
Alexander Borowsky, PhD, Associate Professor, Department of
Pathology and Laboratory Medicine, University of California, Davis
Andrea McKee, MD, President, Rescue Lung, Rescue Life Society;
Chairman, Radiation Oncology, Lahey Hospital & Medical Center
Veronica Miller, PhD, Executive Director, Forum for Collaborative
Research; Professor (Adjunct), UC Berkeley SPH
12:35 pm Sponsored Presentation (Opportunity Available)
1:05 Luncheon Presentation (Sponsorship Opportunity
Available) or Enjoy Lunch on Your Own
1:35 Refreshment Break in the Exhibit Hall with Poster
Viewing
EARLY DETECTION OF CANCER AND BEYOND
2:15 Chairperson’s Remarks
Abhijit Patel, MD, PhD, Associate Professor, Yale University School of
Medicine
2:20 Saliva Liquid Biopsy
David Wong, DMD, DMSc, Associate Dean of Research, Felix & Mildred
Yip Endowed Distinguished Professor, UCLA School of Dentistry
Saliva is a bodily fluid that we produce ~600ml per day and harbors
multiple omics constituents that can be harnessed non-invasively
and painlessly for personalized and precision medicine, making it
ideal for liquid biopsy applications. Yet, PCR-based technologies
cannot detect ctDNA in saliva samples, whereas an emerging liquid
biopsy platform “Electric Field Induced Release and Measurement
(EFIRM)” can consistently detect ctDNA from NSCLC patients with
actionable mutations in plasma and saliva with concordance of
95%+ with tissue/biopsy-based genotyping, including early stage
lesions.
2:50 Plasma-Based Liquid Biopsies for Early Detection of
Cancer
Nickolas Papadopoulos, PhD, Professor, Oncology and Pathology,
Director of Translational Genetics, Ludwig Center for Cancer Genetics
& Therapeutics, Sidney Kimmel Comprehensive Cancer Center, The
Johns Hopkins Institutions
Early detection of cancer has the potential to significantly reduce
cancer deaths. Liquid biopsies provide an opportunity to develop
tests for the detection of multiple-types of cancer in a single test. We
will discuss the opportunities and the challenges of developing and
utilizing such test.
EARLY DETECTION OF CANCER AND BEYOND
(CONT.)
Chairperson’s Remarks
Cesar Martin Castro, MD, Director, Cancer Program; MGH Center for
Systems Biology, Massachusetts General Hospital/Harvard Medical
School
3:20 The Advantages and Challenges of Liquid Biopsies for
Early Cancer Detection and Screening
Lynn Sorbara, PhD, Program Director, Cancer Biomarkers Research
Group, National Cancer Institute (NCI), NIH
Clinical decisions are increasingly being guided by diagnostic
workups, including imaging and tissue biopsies. Although tissue
biopsy remains the mainstay of diagnostics, there are continuing
efforts to develop non-invasive tests that could be adopted for
samples acquired with minimum discomfort to patients. Liquid
biopsies may be of great importance, particularly when organs
of interest may not be accessible, or the patient may have other
health conditions that prevent them from undergoing the procedure.
These non-invasive or minimally invasive procedures may afford an
opportunity to detect lesions in cases where tissue biopsy may be
difficult or impossible. To date, the use of liquid biopsy in cancer risk
assessment and early detection has remained at the periphery. Most
of the research on liquid biopsies use blood and blood products;
however, other biofluids, such as urine, sputum, saliva, stool, and
cervical-vaginal fluids are being investigated. Despite all of the
advantages of liquid biopsy assays, there are many challenges
to overcome for successful validation and widespread use in the
setting of early detection and screening.
3:50 Leveraging Novel Exosome Nanosensors for Earlier
Pancreatic Cancer Detection
Cesar Martin Castro, MD, Director, Cancer Program; MGH Center for
Systems Biology, Massachusetts General Hospital/Harvard Medical
School
Exosomes reflect promising cancer biomarkers due to their
abundance in biofluids, protein, and RNA contents reflecting parental
cells, and stability in circulation. Pancreatic ductal adenocarcinomas
(PDAC) represent highly lethal cancers often presenting at advanced
stages. Integrating exosomes into monitoring programs for PDAC
could improve clinical outcomes. This talk will discuss novel
nanosensors we developed to analyze exosomes in blood and recent
translational strategies to position them into clinical workflows.
4:20 End of Summit
23. TABLE OF CONTENTS
CONFERENCE STREAMS
AUGUST 25-26
AGENDA Drug-Diagnostics Co-Development
& Companion Dx
AUGUST 26-27
AGENDA
Immuno-Oncology Biomarkers
and Diagnostics
2020 COMPANION DX & IO BIOMARKERS CONFERENCES
Companion DX &
IO Biomarkers Stream
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COMPANION DX AND IO BIOMARKERS
POCT TECHNOLOGIES AND STRATEGY
LIQUID BIOPSY/EARLY DETECTION
POCT AND INFECTIOUS DISEASE
BUSINESS
NGS ADVANCES