Cambridge Healthtech Instituteの第8回年次会議

Infectious Disease Diagnostics
(感染症診断)

ポストパンデミック時代における新興技術

2023年3月7 - 8日、PST(米国太平洋標準時)

 

COVID-19のパンデミックは、感染症診断向け先端技術における爆発的なイノベーションと投資に拍車をかけています。Cambridge Healthtech Instituteの第8回「感染症診断」年次会議では、クリニック、コミュニティによる監視、薬局、限られたリソース環境、在宅診断での応用まで網羅します。技術革新には、感染症の迅速診断とコミュニティによる監視、多重検査と変異型の検出、抗菌薬耐性、NGSとメタゲノム、宿主応答などが含まれます。最後に、ポストパンデミック時代における先端診断向け投資、規制、償還、市場参入戦略について紹介します。

3月7日(火)

HOST RESPONSE DIAGNOSTICS FOR INFECTIOUS DISEASES
感染症向け宿主応答診断

2:00 pm

Chairperson's Remarks

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

2:05 pm

How Host Response Testing Could Transform Early Testing Workflows for Acute Infections and Sepsis

Timothy Sweeney, PhD, Co-Founder & CEO, Inflammatix, Inc.

This session will cover novel technologies that leverage the host immune response to infection and will discuss how host response tests could change diagnostic and treatment workflows for patients with suspected acute infections and sepsis.

2:35 pm

Host Response Diagnostics for Infectious Diseases: Moving toward Clinical Utility

Christopher W. Woods, MD, MPH, Professor, Medicine, Global Health & Pathology, Duke University

For over two decades, numerous investigative groups and industry partners have pursued the development and implementation of multi-analyte, host response-based, infectious disease diagnostics. Propelled by the recent pandemic of COVID-19 and the ongoing fight against antimicrobial resistance, regulatory agencies, payors, and end-users are gearing up for this revolution in diagnostics. Dr. Woods will review the current landscape and what the future may hold.

3:05 pm PANEL DISCUSSION:

Host Response-Based Diagnostics for Infectious Disease

PANEL MODERATOR:

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

Diagnostic testing based on the patient’s host response represents a paradigm shift in how we diagnose infectious diseases. We will discuss the promise, potential, and challenges in implementation of host response-based testing as an alternative or complementary method for diagnosing acute infections in hospitalized patients. We will also discuss applications of host response-based diagnostics in public health, including severity classification and outbreak surveillance of pathogens such as influenza and SARS-CoV-2.

PANELISTS:

Timothy Sweeney, PhD, Co-Founder & CEO, Inflammatix, Inc.

Christopher W. Woods, MD, MPH, Professor, Medicine, Global Health & Pathology, Duke University

Ephraim L. Tsalik, MD, MHS, PhD, FIDSA, Vice President & CSO, Infectious Disease, Danaher Corp.

3:35 pm Talk Title to be Announced

Mark Eccleston, Dr, Chief Technology Officer, Products, Volition

Refreshment Break in the Exhibit Hall with Poster Viewing4:05 pm

PLENARY KEYNOTE SESSION: MULTI-CANCER EARLY DETECTION
基調講演・プレナリーセッション:多重がんの早期発見

4:45 pm

Chairperson's Remarks

Larry Kessler, ScD, Professor, Health Systems and Population Health, University of Washington; Deputy Chair, MCED Consortium

Sponsored Presentation (Opportunity Available)4:50 pm

5:00 pm PANEL DISCUSSION:

Evaluation and Implementation of Multi-Cancer Early Detection Tests

PANEL MODERATOR:

Larry Kessler, ScD, Professor, Health Systems and Population Health, University of Washington; Deputy Chair, MCED Consortium

Multi-cancer early detection promises to improve cancer diagnosis, treatment and patient care. However, introducing MCED technologies into clinical care requires evaluation and assessment of benefits and risks, potential outcomes, costs, and value. The multi-stakeholder expert panel will address how MCED will impact clinical care, outstanding challenges in evidence generation, test reimbursement, market adoption, and equitable patient access.

PANELISTS:

Philip E. Castle, PhD, Director, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health

Tomasz Beer, MD, CMO, Multi-Cancer Early Detection, Exact Sciences

Omar Perez, PhD, Head, Medical Diagnostics, AstraZeneca

Megan P. Hall, PhD, Vice President, Medical Affairs, GRAIL LLC

Hakan Sakul, PhD, Vice President and Head, Diagnostics, Pfizer, Inc.

Close of Day5:45 pm

3月8日(水)

Registration and Morning Coffee7:30 am

30th ANNIVERSARY OF TRI-CON PLENARY KEYNOTE SESSION: DIAGNOSTICS INNOVATION AND INVESTMENT TRENDS
30周年記念TRI-CON基調講演・プレナリーセッション:診断イノベーションと投資動向

8:00 am

Chairperson's Remarks

Tom Miller, Founder & Managing Partner, GreyBird Ventures, LLC

8:15 am KEYNOTE PRESENTATION:

Failure: The Best Way to Learn

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

The thought of failure creates fear. The reality of failure creates opportunity. We must embrace failure and all it can teach. As Arianna Huffington said: “Failure is not the opposite of success - it’s part of success.” We will discuss how to think differently about failing - how to motivate yourself and your teams.

8:30 am PANEL DISCUSSION:

Diagnostics Innovation and Investment Trends

PANEL MODERATOR:

Tom Miller, Founder & Managing Partner, GreyBird Ventures, LLC

Diagnostics investing experts will review what is hot and what is not in the field. Technological trends and white spaces will be identified, and entrepreneurs will be given best practices to maximize chances for successful financing. The panel will also provide guidance to founders to optimize operational success post-financing and what to do in the event of a stumble, the dreaded pivot, or in dealing with failure.

PANELISTS:

Ajit Singh, PhD, Partner, Artiman Ventures

Nathan Davis, Analyst, RA Capital Management

John W. Czajka, PhD, MBA, Director, Strategy and Innovation, BD Integrated Diagnostic Solutions

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

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

Transition to Sessions9:15 am

CLINICAL METAGENOMIC SEQUENCING FOR INFECTIOUS DISEASE DIAGNOSIS
感染症診断向け臨床メタゲノムシーケンス

9:20 am

Chairperson's Remarks

Nathan Ledeboer, PhD, Professor and Vice Chair, Pathology and Medical Director, Medical College of Wisconsin

9:25 am

Clinical Metagenomic Sequencing for Diagnosis of Infections

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

Clinical metagenomic next-generation sequencing (mNGS) is an emerging approach to diagnose nearly all potential infections, whether viral, bacterial, fungal, or parasitic, in a single assay. Here we will discuss validation and implementation of these mNGS assays in the clinical laboratory and their clinical impact. We will also discuss concurrent host response analyses performed on metagenomic data to aid in the differential diagnosis of infections.

9:55 am

Utility of Microbial Metagenomics in a Cancer Patient Population

Esther Babady, PhD, D(ABMM), FIDSA, FAAM, Chief, Clinical Microbiology Service, Memorial Sloan Kettering Cancer Center

Immunocompromised patients, including cancer patients, are at increased risk for infections. Several methods are currently available for diagnosis of infectious diseases, each with advantages and limitations. Microbial metagenomics has been evaluated for its potential to provide a more comprehensive, pathogen-agnostic approach to infectious disease diagnostics. In this talk, the utility of microbial metagenomics in an immunocompromised cancer patient population will be examined and opportunity for further optimization discussed.

Sponsored Presentation (Opportunity Available)10:25 am

Coffee Break in the Exhibit Hall with Poster Viewing10:55 am

CLINICAL METAGENOMIC SEQUENCING FOR INFECTIOUS DISEASE DIAGNOSIS (CONT.)
感染症診断向け臨床メタゲノムシーケンス(続き)

11:35 am

Chairperson's Remarks

Nathan Ledeboer, PhD, Professor and Vice Chair, Pathology and Medical Director, Medical College of Wisconsin

11:40 am

Integrated Host-Microbe Plasma Metagenomics for Precision Diagnosis of Sepsis

Chaz Langelier, MD, PhD, Associate Medical Director, Hospital Epidemiology & Infection Prevention; Associate Professor, Medicine, University of California San Francisco, Chan Zuckerberg Biohub

Sepsis, a leading cause of death worldwide, involves a dysregulated host response to infection. Existing clinical sepsis diagnostics, however, either detect only microbes or host biomarkers of infection. This presentation will describe a new method for accurate sepsis diagnosis based on integrating host gene expression profiling and metagenomic pathogen detection from plasma nucleic acid.

12:10 pm PANEL DISCUSSION:

With SARS-CoV-2 in the Rear-View Mirror, Will Clinical Microbiology Labs Finally Bring on NGS?

PANEL MODERATOR:

Nathan Ledeboer, PhD, Professor and Vice Chair, Pathology and Medical Director, Medical College of Wisconsin

Prior to the SARS-CoV-2 pandemic, clinical microbiology laboratories had been slow to adopt next-generation sequencing into routine testing. With an increase in sequencing experience gained as a result of the pandemic, this panel will explore if clinical microbiology laboratories are moving into sequencing, what barriers need to be overcome, and what targets could be considered for such testing.

PANELISTS:

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

Esther Babady, PhD, D(ABMM), FIDSA, FAAM, Chief, Clinical Microbiology Service, Memorial Sloan Kettering Cancer Center

Sponsored Presentation (Opportunity Available)12:40 pm

Session Break1:10 pm

Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own1:15 pm

Refreshment Break in the Exhibit Hall with Last Chance for Poster Viewing1:45 pm

DIAGNOSTICS TO SUPPORT OUTPATIENT ANTIMICROBIAL STEWARDSHIP
診断による外来患者の抗菌薬管理

2:25 pm

Chairperson's Remarks

Michael E. Klepser, PharmD, FCCP, FIDP, Professor, Ferris State University College of Pharmacy

2:30 pm

Use of CLIA-Waived and Home Diagnostics to Support Outpatient Antimicrobial Stewardship

Michael E. Klepser, PharmD, FCCP, FIDP, Professor, Ferris State University College of Pharmacy

Infections associated with the respiratory tract account for more than 40% of the antibiotics prescribed. Unfortunately, a substantial portion of these antibiotics may not be warranted. One of the factors driving overuse of antibiotics in this setting is failure to identify the pathogen responsible for the infection. Advances in CLIA-waived and home-use diagnostics can help establish a causative pathogen and decrease unnecessary antibiotic use.

3:00 pm

Use of POCT to Improve Outpatient Antibiotic Use - The Community Pharmacy Experience

Donald G. Klepser, PhD, MBA, Professor and Associate Dean for Academic Affairs, College of Pharmacy, University of Nebraska Medical Center

Optimizing outpatient antibiotic use in the outpatient setting often means managing patient expectations. Some inappropriate antibiotic prescribing is a result of it being easier to prescribe an antibiotic for a patient than explain why it may be unnecessary. The patient expectation of an antibiotic may be related to the time and cost necessary to be seen in most healthcare settings. Point-of-care testing in pharmacies or at home has the potential to improve outpatient antibiotic use by lowering the costs and adherence to prescribing guidelines. This session will discuss how diagnostic testing in pharmacy and home settings has been shown to improve outpatient antibiotic use.

3:30 pm PANEL DISCUSSION:

Use of CLIA-Waived POCT in the Outpatient Setting to Support Antimicrobial Stewardship

PANEL MODERATOR:

Michael E. Klepser, PharmD, FCCP, FIDP, Professor, Ferris State University College of Pharmacy

The pandemic has spotlighted the use of CLIA-waived POCT in the outpatient setting. Advances in technology have increased the performance of individual tests, and the move toward multiplex testing is improving testing workflow. The panel will explore how CLIA-waived POCT can be leveraged to develop disease management programs that encourage appropriate antimicrobial use.

PANELISTS:

Donald G. Klepser, PhD, MBA, Professor and Associate Dean for Academic Affairs, College of Pharmacy, University of Nebraska Medical Center

Nicholas Halzack, Director, Health Policy, Roche Diagnostics

Cheryl Miller, Vice President, Retail Sales and Marketing, QuidelOrtho

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

Close of Conference4:00 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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