Cambridge Healthtech Instituteの第12回年次会議

At-Home & Point-of-Care Diagnostics
(在宅診断・ポイントオブケア(POC)診断)

ポイントオブケア(POC)検査のイノベーション

2023年3月6 - 7日、PST(米国太平洋標準時)

 

ポイントオブケア(POC)診断市場は、COVID-19診断の波に煽られる前から、着実に成長を続けています。Cambridge Healthtech Instituteの第12回「在宅診断・ポイントオブケア(POC)診断」年次会議では、マイクロ流体、ナノセンサー、小型デバイスなどの最新の技術的進歩や、病院、薬局、救命医療・在宅医療、モバイル環境、限られたリソース環境におけるPOCTの統合も含め、レビューします。

3月6日(月)

Registration and Morning Coffee7:00 am

PLENARY KEYNOTE SESSION: Rx/Dx COLLABORATIONS: STRATEGIES FOR BRINGING TARGETED THERAPIES TO MARKET
基調講演・プレナリーセッション:Rx/Dxのコラボレーション:標的療法の市場投入戦略

8:00 am

Chairperson's Remarks

Edward Abrahams, PhD, President, Personalized Medicine Coalition

8:05 am Plenary Keynote IntroductionPlenary Keynote Introduction

Paul Beresford, PhD, Vice President and General Manager, CDx, Diagnostics and Genomics Group, Agilent Technologies

8:15 am KEYNOTE PRESENTATION:

Precision Medicine, What's So Difficult? The Interplay & Complexities of Pharmaceutical & Diagnostic Partnerships to Deliver the Promise of Precision Medicine

Sarah Hersey, MS, MBA, RAC, Vice President, Precision Medicine, Bristol Myers Squibb Co.

Numerous dynamic intricacies exist between pharmaceutical and diagnostic industries which require careful consideration when deploying precision medicine solutions. This, coupled with technological advances and an evolving regulatory landscape, results in significant complexity. From the push to try to incorporate precision medicine earlier in drug development, through commercialization, what are the potential opportunities as well as hurdles to overcome to enable more effective collaborations to deliver targeted therapies?

8:45 am PANEL DISCUSSION:

Rx/Dx Collaborations: Strategies for Bringing Targeted Therapies to Market

PANEL MODERATOR:

Edward Abrahams, PhD, President, Personalized Medicine Coalition

This session will explore challenges and strategies to discover and develop personalized medicines from the points of view of both the diagnostic and pharmaceutical industries.

PANELISTS:

Christopher Conn, PhD, Director, Diagnostics Strategy, Amgen

Marielena Mata, PhD, Senior Director and Diagnostic Lead, Oncology Program, Pfizer Inc.

David Fabrizio, Vice President, Translational Strategy, Foundation Medicine

Sarah Hersey, MS, MBA, RAC, Vice President, Precision Medicine, Bristol Myers Squibb Co.

Networking Refreshment Break9:30 am

ADVANCES IN POINT-OF-CARE TESTING
ポイントオブケア(POC)検査の進歩

9:45 am

Chairperson's Remarks

Hoi-Ying Elsie Yu, PhD, System and Core Laboratory Director, Chemistry, Toxicology and Point-of-Care Testing, Geisinger Health System

9:50 am

Point-of-Care Testing in the Face of Health Human Resource Challenges

Julie Shaw, PhD, Clinical Biochemist & Director for POCT, EORLA, Ottawa Hospital

Clinical laboratories face severe shortages of medical laboratory technologists (MLT). Point-of-care testing (POCT) can be useful to provide testing when MLTs are not available. However, given clinical staff shortages, the added burden of POCT can be a barrier. Here, I describe a model implemented in our region whereby medical laboratory assistants (MLA) have been trained to perform POCT. The MLAs are supervised by MLTs working off-site. Oversight of POCT by the laboratory ensures quality assurance practices are in place. MLAs are trained in specimen collection and processing, removing many of the pre-analytical errors often associated with POCT. 

10:20 am

Point-of-Care in the Pharmacy and in Critical Care

Kenneth C. Hohmeier, PharmD, Associate Professor, Director of Community Affairs, PGY-1 Community-Based Pharmacy Residency Program, The University of Tennessee Health Science Center

The COVID-19 pandemic has accelerated the pace at which point-of-care (POC) testing is being adopted in the community pharmacy setting. Increasing numbers of community pharmacies are interested in developing their POC test-and-treat programs, including large pharmacy chains, as the US increasingly looks to this setting as a public health destination. After two years of the pandemic, the question is not if community pharmacies will adopt, but how.

10:50 am

Molecular Diagnostics with CRISPR

Jesus Ching, PhD, Vice President, R&D, Mammoth Biosciences

Molecular diagnostics has evolved rapidly over the last several years. Many products reaching the market have focused on decentralized testing, whether at the doctor’s office or at home. The SARS-CoV-2 pandemic only fueled the need for more accurate, lower cost, rapid, and readily available molecular tests. PCR-based testing platforms have dominated molecular diagnostics in sensitivity and specificity. In recent times, CRISPR-based assays have started to demonstrate improved capabilities for diagnostics. The ability to program certain Cas enzymes with gRNAs to detect specific nucleic acid sequences with high sensitivity and specificity makes CRISPR a highly desired platform for molecular diagnostics.

11:20 am Qorvo Biotechnologies Omnia- POC COVID Testing and Beyond

Bryan Bothwell, Senior Director, Strategy, Business Development, Commercialization, Biotechnologies, Qorvo

The point-of-care (POC) diagnostics landscape has been significantly impacted by the COVID-19 pandemic. Programs such as RADx and ITAP ushered in new testing platforms that emphasize innovation and differentiation. As viral dynamics shifted, the status quo of POC testing was challenged. The Qorvo Biotechnologies Omnia platform is the orthogonal solution for the future of onsite testing, not only for COVID testing but for other disease states going forward.

Session Break11:50 am

11:55 am LUNCHEON PRESENTATION:Co-Dx PCR Home Platform

Dwight Egan, CEO, Co-Diagnostics, Inc. (Co-Dx)

12:25 pm LUNCHEON PRESENTATION:Luncheon Presentation to be Announced

Krista Ewing, PhD, Senior Global Product Manager, Porex, Filtration Group

Session Break12:55 pm

CONNECTED DIAGNOSTICS AND DIRECT ACCESS TESTING
コネクテッド診断と直接アクセス検査

1:10 pm

Chairperson's Remarks

Hoi-Ying Elsie Yu, PhD, System and Core Laboratory Director, Chemistry, Toxicology and Point-of-Care Testing, Geisinger Health System

1:15 pm

Access, Connect, and Engage (A.C.E.) - Keys to Future Success of Home Testing

Hoi-Ying Elsie Yu, PhD, System and Core Laboratory Director, Chemistry, Toxicology and Point-of-Care Testing, Geisinger Health System

At-home testing can improve disease management and promote wellness. However, to successfully bridge the gap between home testing and patient management, clinical care teams must develop protocol to engage the target patient group. In this presentation, we will explore the use of home testing in the healthcare setting, and strategies that allow for growth. To promote access and increase efficiency, integration into digital health will be important for home testing.

1:45 pm

Direct Access Testing

James Nichols, PhD, DABCC, FACB, Professor of Pathology, Microbiology and Immunology, Medical Director, Clinical Chemistry and POCT, Vanderbilt University School of Medicine

A variety of clinical laboratory diagnostics are being marketed to consumers. This direct access testing allows the public to obtain laboratory testing without seeing a physician. This presentation will present the benefits and risks of direct access testing.

2:15 pm

A Revolution in At-Home Diagnostics Will Enable Better Virtual First Care

Michael J. Mina, MD, PhD, CSO, eMed

2:45 pm Talk Title to be Announced

Speaker to be Announced

3:15 pm Talk Title to be Announced

Speaker to be Announced

Networking Refreshment Break3:30 pm

30th ANNIVERSARY OF TRI-CON PLENARY KEYNOTE SESSION: GENOMICS INNOVATION
30周年記念TRI-CON基調講演・プレナリーセッション:ゲノムイノベーション

3:40 pm

Chairperson's Remarks

Kevin Davies, PhD, Executive Editor, The CRISPR Journal; Author, Editing Humanity: The CRISPR Revolution and the New Era of Genome Editing

3:45 pm FIRESIDE CHAT:

Sequences, SynBio, and Sailing: Three Decades of Adventure with J. Craig Venter

Kevin Davies, PhD, Executive Editor, The CRISPR Journal; Author, Editing Humanity: The CRISPR Revolution and the New Era of Genome Editing

J. Craig Venter, PhD, Founder, Chairman, and CEO, J. Craig Venter Institute

Since his riveting publication on expressed sequence tags in 1991, which galvanized a revolution in genomics, J. Craig Venter has been a dominant figure in the world of genomics and biotechnology. As the first human to have his personal genome completely sequenced, and as the co-founder of Synthetic Genomics and Human Longevity, he is routinely one step ahead of his peers. As we celebrate 30 years of TRI-CON, we’re thrilled to host Dr. Venter who will discuss his life, his many accomplishments, and his vision for the future of precision medicine and the biotech industry.

4:15 pm PANEL DISCUSSION:

30 Years of Genomics Innovation and the Future of Precision Medicine

PANEL MODERATOR:

Kevin Davies, PhD, Executive Editor, The CRISPR Journal; Author, Editing Humanity: The CRISPR Revolution and the New Era of Genome Editing

Over the past three decades, genomic medicine has been transformed from a distant dream to a clinical reality. With patients suffering genetic diseases and cancer now cured thanks to advances in genomics, cell therapy, genome editing, and computing, the future is bright - but by no means assured. In this TRI-CON keynote panel, we discuss the scientific highlights of an extraordinary journey for practitioners of precision medicine and anticipate where the field is headed.

PANELISTS:

Euan Ashley, PhD, Professor, Genomics & Precision Health, Stanford School of Medicine

J. Craig Venter, PhD, Founder, Chairman, and CEO, J. Craig Venter Institute

Molly He, PhD, CEO & Co Founder, Element Biosciences

Alex Aravanis, MD, PhD, CTO, Senior Vice President, Head of Research and Product Development, Illumina

Welcome Reception in the Exhibit Hall with Poster Viewing5:00 pm

Close of Day6:00 pm

3月7日(火)

Registration and Morning Coffee7:30 am

30th ANNIVERSARY OF TRI-CON PLENARY KEYNOTE SESSION: DIAGNOSTIC INDUSTRY TRENDS
30周年記念TRI-CON基調講演・プレナリーセッション:診断業界の動向

8:00 am

Chairperson's Remarks

Mara G. Aspinall, Managing Director, BlueStone Venture Partners; Professor of Practice, Arizona State University; Advisor, The Rockefeller Foundation

8:05 am PANEL DISCUSSION:

Big Diagnostics: 30 Years of Impact

PANEL MODERATOR:

Mara G. Aspinall, Managing Director, BlueStone Venture Partners; Professor of Practice, Arizona State University; Advisor, The Rockefeller Foundation

Healthcare depends on diagnostics. We all know that diagnostics is the glue that holds the healthcare together and that 70% of medical decisions are informed by a diagnostic - but does that say enough? More than 3.5 million people work in diagnostic industry. The number of companies is at an all-time high. COVID showed the world how valuable a test can be. But with all the changes of the last few years - there have been constants - the industry’s largest players. From the labs to manufacturers, from services to products, there are a few companies that have seen it all. In this panel, we talk to them about the good and bad, challenges and opportunities and most importantly, the impact of the last 30 years.

PANELISTS:

Dave Persing, MD, PhD, Executive Vice President, CSO, Cepheid; CSO, Danaher Diagnostics Platform

Jay Wohlgemuth, MD, CMO and Senior Vice President, R&D, Medical and Population Health, Quest Diagnostics

William G. Morice II, MD, PhD, President & CEO, Mayo Clinic Laboratories; Professor & Past Chair, Mayo Clinic Department of Laboratory Medicine and Pathology; Chair, American Clinical Laboratory Association Board of Directors

Robert J. Bujarski, President and COO, QuidelOrtho Corporation

Cindy Perettie, Head, Roche Molecular Labs

Transition to Sessions9:00 am

AT-HOME TESTING IN THE POST-PANDEMIC ERA
ポストパンデミック時代における在宅検査

9:05 am

Chairperson's Remarks

David Cavanaugh, Founding Partner, DeciBio Consulting LLC

9:10 am

RADx Initiative: Bioengineering for COVID-19 at Unprecedented Speed and Scale

Bruce J. Tromberg, PhD, Director, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health; Lead, NIH’s Rapid Acceleration of Diagnostic Technologies (RADx Tech) Program

The NIH Rapid Acceleration of Diagnostic Technologies (RADx Tech) initiative was launched on April 29, 2020 to urgently expand SARS-CoV2 diagnostics. The initiative is a public-private partnership with unique resources for accelerating innovation, validation, and authorization of test platforms. In 2.5 years, RADx Tech supported companies received 46 EUAs and increased U.S. capacity by more than 5 billion tests, helping drive a paradigm shift to predominantly OTC and point-of-care COVID testing.

9:40 am

Development of a Home-Based Platform for Health Maintenance and Disease Diagnosis

Paul Yager, PhD, Professor, Department of Bioengineering, University of Washington

The Yager laboratory has been working for over a decade to develop technologies to allow low-cost home (or low resource setting) testing for disease states based on multi-dimensional paper microfluidics. During the pandemic, we extended a DARPA-funded project to perform rapid isothermal NAAT multiplexed testing of panels of viruses and bacteria. Lately we developed a common platform for also performing extremely sensitive assays for biomarkers of wellness and chronic diseases.

10:10 am Innovative Tools for the Development of Ultra-Fast Molecular Point-of-Care Tests

Michele Amasio Amasio, Senior Manager, R&D, Meridian Bioscience

The need for high sensitivity, ease-of-use and fast time to result are key challenges in designing and developing a molecular Point-of-care test (POCT). During this session, you will discover Meridian’s unique solutions to reduce development time, shorten workflows and simplify storage and handling of the POC test, whether it is with PCR or LAMP technologies. New innovative approaches to assay optimization will be discussed with examples of applications.

Coffee Break in the Exhibit Hall with Poster Viewing10:40 am

11:25 am

Will Home-Based Molecular Diagnostic Testing Survive Post-COVID Pandemic?

David Cavanaugh, Founding Partner, DeciBio Consulting LLC

Access to molecular diagnostic testing within the home grew significantly during the pandemic as patients purchased platforms, such as Cue Health and Lucira. Additionally, many patients opted to use self-collection devices from commercial reference laboratories coupled with telehealth services for not only COVID-19 testing but also other disease areas, including sexual health and women's health. The drivers of adoption were convenience, the ability to access testing without the risk of catching COVID, anonymity, and improved reimbursement. As we enter the post-COVID pandemic phase, what happens to home-based molecular diagnostics? Do patients return to pre-pandemic testing channels (e.g., primary care, urgent care) or will they expand the use of molecular diagnostics to other indications (e.g., flu, sexual health)?

11:55 am PANEL DISCUSSION:

At-Home Testing in the Post-Pandemic Era

PANEL MODERATOR:

David Cavanaugh, Founding Partner, DeciBio Consulting LLC

The expert panel will discuss at-home testing dynamics following the recent COVID-19 pandemic, including infectious disease, sexual health, women’s health, and the creation and adoption of new at-home diagnostics platforms.

PANELISTS:

Jennifer Dien Bard, PhD, D(ABMM), Director, Microbiology and Virology, Children’s Hospital Los Angeles; Professor, Pathology and Laboratory Medicine, Keck School of Medicine, University of Southern California

Elizabeth M. Marlowe, PhD, D(ABMM) Senior Scientific Director, Head R&D Infectious Diseases & Immunology, Quest Diagnostics Nichols Institute

Bruce J. Tromberg, PhD, Director, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health; Lead, NIH’s Rapid Acceleration of Diagnostic Technologies (RADx Tech) Program

Paul Yager, PhD, Professor, Department of Bioengineering, University of Washington

Michael J. Mina, MD, PhD, CSO, eMed

12:25 pm At-Home Next-Generation Molecular Detection with All-Synthetic PNA and CMOS

Tara Dalton, PhD, CEO, Altratech Ltd

We are developing 'UbiHealth', an alternative to PCR for the detection and quantification of DNA, RNA, and antibodies, in a home respiratory syndromic saliva self-test for Flu/RSV/COVID, with variant identification. There are no enzymes, the assay instead has bead and electronic amplification. Unlimited shelf life and stockpiling for future pandemics will be facilitated by its fully synthetic PNA peptide probes, bio-orthogonal linkers (codeveloped with NIH) and CMOS semiconductor detection.

Session Break12:55 pm

1:00 pm LUNCHEON PRESENTATION:From Inception to Engineering - How to Develop a Lateral Flow Assay with an External Partner

Jacqueline Davis, Senior Commercial Project Manager, LFADS, Life Science | DxRM, MilliporeSigma

You have an idea for a point-of-care assay that can help customers and patients; all that’s left is developing a product! Through a real-life case-study, we will illustrate the typical processes involved in developing a lateral flow test with an external partner. From ideation to commercialization, we will discuss key steps that can shorten time to market and reduce costs while delivering robust results.   

Refreshment Break in the Exhibit Hall with Poster Viewing1:30 pm

Close of Conference2:00 pm

* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。

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カンファレンスプログラム

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