- 감염성 질환용 분자진단 -

The role of advanced molecular diagnostics for infectious disease continues to grow – not only are these assays moving into the clinic, but they are being used for infection surveillance and outbreak control, appearing in the pharmacy, and continuing to improve care in resource-limited settings. Cambridge Healthtech Institute’s 5th Annual Molecular Diagnostics for Infectious Disease conference program will feature the latest in NGS and metagenomics, the latest regulatory and reimbursement challenges, and updates in the public health sphere. We’ll further examine the role of host response vs. pathogen detection in the clinic, the potential for microbiome analysis, and other novel approaches to infectious disease diagnosis. Special attention will be paid to antimicrobial resistance, from the clinical challenges to the emerging technologies, and novel technologies being developed specifically for resource-limited settings. We will also address the state of the industry from the point-of-view of numerous stakeholders: industry, regulatory, investment, technology, and clinical.

Final Agenda

3월 1일(일)

2:00 - 5:00 pm Afternoon Short Courses*

*Separate registration required

5:30 - 8:30 Dinner Short Courses*

*Separate registration required

3월 2일(월)

8:00 - 11:00 am Morning Short Courses*

*Separate registration required

10:30 Conference Program Registration Open

특별 패널 디스커션:POC(POINT-OF-CARE)와 감염성 질환 관련 업계의 상황

11:45 Organizer’s Opening Remarks

Kaitlin Searfoss Kelleher, Conference Producer, Cambridge Healthtech Institute

11:50 Chairperson’s Remarks

David Cavanaugh, Partner, DeciBio

11:55 Leading the Pack: The Strategic Revamp POC Dx Needs before Disrupting MDx

Clinical adoption and real-world use of point-of-care diagnostic (POC Dx) technologies have fallen short of their hype and promise. The field has become increasingly crowded, with hundreds of players narrowing the runway for each company to carve out differentiated market opportunities and strategies. Disruption of the larger MDx market will require POC Dx companies to create “winning strategies” by establishing competitive differentiation from one another, driving successful adoption and implementation, and navigating regulatory and reimbursement hurdles.

Cavanaugh_DavidModerator: David Cavanaugh, Partner, DeciBio

Stein_EsterPanelists: Ester Stein, Director, Corporate Reimbursement, Government Affairs, Abbott Laboratories

Abel_GyorgyGyorgy Abel, MD, PhD, Director, Molecular Diagnostics, & Clinical Chemistry/Immunology, Division of Pathology and Laboratory Medicine, Lahey Hospital & Medical Center, Burlington, MA

Martin_TrevorTrevor Martin, PhD, Co-Founder and CEO, Mammoth Biosciences

Rooke_JennyJenny Rooke, PhD, Managing Director, Genoa Ventures

Panelist to be Announced, Qorvo

12:55 pm Session Break

1:05 Luncheon Presentation I to be Announced


1:35 LUNCHEON PRESENTATION II: Commercialization of an IVD in a Changing Global Environment

Stephenson_LynnLynn Stephenson, PhD, Marketing Manager, Dx Manufacturing & OEM, MilliporeSigma

Changes in international standards and regulations have created challenges and roadblocks to the commercialization of diagnostic devices. The choice of a contract manufacturing (CM) partner with the expertise to provide guidance and manufacturing capabilities is one strategy diagnostics companies can use to mitigate risk.  A well-chosen CM partner can accelerate the commercialization process by anticipating potential roadblocks.  In this session, we will discuss best practices and key considerations for vetting contract manufacturing partners.

2:05 Session Break

차세대 시퀀싱과 임상 메타게노믹스

2:20 Chairperson’s Remarks

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

2:25 The Promise of Culture-Free Microbiology: Are Clinical Labs Ready and Will Metagenomics Deliver on the Promise?

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

Next Generation Sequencing offers the potential to interrogate clinical specimens for the presence of infectious diseases in a completely unbiased manner. However, significant challenges confront clinical microbiology laboratories attempting to implement metagenomics using traditional clinical workflows. This presentation will discuss targeted implementation of a metagenomics assay for the detection of mycobacteria and nocardia from clinical specimens.

2:55 Clinical Metagenomic Sequencing – New Technologies and Advances in the Near Future

Chiu_CharlesCharles 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 potentially game-changing technology for infectious disease diagnosis as it enables detection of nearly all pathogens in a single assay. This approach has been made feasible by the rapid advances in sequencing technology, bioinformatics analysis, and reference databases. In this talk I will discuss how we overcome challenges in development and validation of an mNGS-based assay in a CLIA laboratory regulatory environment. I will discuss efforts to expand clinical mNGS validation and testing to new body fluids, as well as new transformative tech.

3:25 Towards Clinical Implementation of Rapid Metagenomics for the Diagnosis of Nosocomial Pneumonia

OGrady_JustinJustin O’Grady, PhD, Associate Professor, Quadram Institute Bioscience

The rise in antimicrobial resistance (AMR) is predicted to cause 10 million deaths per year by 2050 unless steps are taken to prevent this looming crisis. Microbiological culture is the gold standard for the diagnosis of bacterial/fungal pathogens and antimicrobial resistance and takes 48 hours or longer. Hence, antibiotic prescriptions are rarely based on a definitive diagnosis and patients often receive inappropriate treatment. Rapid diagnostic tools are urgently required to guide appropriate antimicrobial therapy, thereby improving patient outcomes and slowing the development of AMR. In this talk, I will discuss the application of rapid (~6hr) clinical metagenomics for the diagnosis of hospital-acquired and ventilator-associated pneumonia.

SerImmune 3:55 Talk Title to be Announced

Patrick Daugherty, PhD, CSO and Founder, Serimmune

4:25 Refreshment Break and Transition to Plenary Keynote


4:35 Welcome Remarks

Cindy Crowninshield, RDN, LDN, HHC, Executive Event Director, Cambridge Healthtech Institute


Thomas Westerling-Bui, PhD, Senior Scientist, Regional Business Development, Aiforia

5:00 PLENARY KEYNOTE PRESENTATION: High-Performance Medicine

Eric Topol, MD, Founder and Director, Scripps Research Translational Institute (SRTI); Author, Deep Medicine: How Artificial Intelligence Can Make Healthcare Human Again





6:00 Grand Opening Reception in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group

7:30 End of Day

3월 3일(화)

7:30 am Registration Open and Morning Coffee

특별 세션:미국국립보건원(NIH)과 미국 생물의학고등연구개발당국(BARDA)의 그랜드 챌린지를 통한 항생제 내성 문제에 대한 대처

8:00 Organizer’s Remarks

Kaitlin Searfoss Kelleher, Conference Producer, Cambridge Healthtech Institute

8:05 Chairperson’s Remarks

Chairperson to be Announced, MeMed

8:10 Point-of-Care Diagnostics for Antibiotic Stewardship in the Hospital and Beyond

May_LarissaLarissa May, MD, MSPH, MSHS, Professor and Director of ED and Outpatient Antibiotic Stewardship, Emergency Medicine, UC Davis Health

This presentation will focus on opportunities for expanding POC diagnostics for management of infectious diseases in the ED and other areas in the health system. We will demonstrate successful implementation, lessons learned, and regulatory and practical considerations.

8:35 The Global Challenge: Geospatial “Hot Spots” in Need of Rapid Point-of-Care Diagnostics for Antimicrobial Resistance

Kost_GeraldGerald 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

We will develop a framework for deploying novel point-of-care technologies that detect antimicrobial resistance. Hot spots occur across world locations no longer limited geospatially. We can integrate geoscience tools and point-of-care testing to quickly, directly, and efficiently detect microbial and viral threats. Spatial patterns of resistance will allow us to target therapy cost-effectively.

9:00 PANEL DISCUSSION: Finalists from the NIH-BARDA Grand Challenge Address Approaches to Antimicrobial Resistance

Antimicrobial resistance represents a growing public health concern, leading the NIH to develop the AMR Diagnostic Challenge. This challenge has charged participants with developing innovative and novel rapid diagnostic tests to identify resistant bacteria or to distinguish between viral and bacterial infections to reduce over-prescription of antibiotics. Three of the five finalists will present their work and the challenges their technologies address.

Kost_GeraldModerator: 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

Tsalik_EphraimPanelists: Ephraim Tsalik, MD, MHS, PhD, Founder, Predigen, Inc.

Schoolnik_GaryGary Schoolnik, Director, Medical Affairs, Click Diagnostics


9:40 Refreshment Break in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group

시퀀싱 기술의 진보와 현대 감염성 질환 진단에서의 역할

10:40 Improving Openness, Reproducibility and Scalability in Microbial Genomics and Bioinformatics for Public Health

MacCannell_DuncanDuncan MacCannell, PhD, CSO, Office of Advanced Molecular Detection, Centers for Disease Control and Prevention

Advances in sequencing technology have fundamentally changed laboratory approaches to infectious disease diagnostics, pathogen characterization, molecular epidemiology and surveillance. Operationalizing these technologies requires significant investments in bioinformatics infrastructure and workforce. This presentation will discuss efforts to improve the openness, reproducibility and scalability of microbial genomics applications across a range of public health laboratory settings.

11:10 Role of NGS-Based Microbiome Studies in Pediatric Infectious Diseases

Raj_PrivthiPrithvi Raj, PhD, Assistant Professor, Immunology, UT Southwestern Medical Center

Host microbiota impact virulence, infection load, and drug resistance of infectious agents in pediatric population is largely unknown. This talk will address how microbiota can impact the susceptibility to infectious diseases in pediatric population and how NGS-based microbiome studies can be new methods in infectious diseases diagnosis and treatment. Our longitudinal study investigates this question by profiling immune repertoire, microbiome, and clinical disease in a cohort of young children.


11:25 Presentation to be Announced




11:40 Presentation to be Announced


12:10 pm Session Break

ximedica 12:20 LUNCHEON PRESENTATION I: Navigating Novel Product Development - Considerations for High Value Commercialization

Robert_ReneRene Robert, Director, Engineering, Ximedica






3:00 Luncheon Presentation II to be Announced


1:20 Refreshment Break in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group

2:00 Breakout Discussions in the Exhibit Hall (please click here for details)

3:00 Transition to Keynote Session

기조 세션

3:15 Organizer’s Remarks

Christina Lingham, Executive Director, Conferences and Fellow, Cambridge Healthtech Institute

3:20 Keynote Introduction

3:35 What Does the New Era of Genomic Medicine Look Like? Effects on Patient Care, Therapeutics, and Diagnostics

20 years after the completion of the first draft of the Human Genome Project, there is compelling evidence of genomics delivering the rich promise of precision medicine. There have been major advances in the throughput and affordability of genome sequencing, enhanced tools for genome analysis and interpretation, new paradigms for therapeutics and strong signs of clinical benefit using genome editing. But major challenges remain. In this special plenary roundtable, three established pioneers of genomic medicine – David Haussler, Stephen Kingsmore, and Liz Worthey – offer their insights on the extraordinary advances in genomic medicine over the past 1-2 decades and share their hopes and concerns for the future of our field.

Davies_KevinModerator: Kevin Davies, PhD, Executive Editor, The CRISPR Journal, Mary Ann Liebert, Inc.

Kingsmore_StephenPanelists: Stephen Kingsmore, MD, DSc, President/CEO, Rady Children’s Institute for Genomic Medicine

Haussler_DavidDavid Haussler, PhD, Investigator, Howard Hughes Medical Institute; Distinguished Professor, Biomolecular Engineering, University of California, Santa Cruz; Scientific Director, UC Santa Cruz Genomics Institute; Scientific Co-Director, California Institute for Quantitative Biosciences (QB3)

Worthey_LizElizabeth Worthey, PhD, Director, Genomic Medicine, University of Alabama, Birmingham School of Medicine

4:50 Spring Fling Celebration in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group

6:00 End of Day

6:30 - 9:30 Dinner Short Courses*

*Separate registration required

3월 4일(수)

6:45 am Registration Open

7:00 BREAKFAST PANEL DISCUSSION: The Time is NOW: Creating Meaningful Change for Women in the Workplace (Sponsorship Opportunity Available)

Toft_RobinModerator: Robin Toft, Author of WE CAN, The Executive Woman’s Guide to Career Advancement; Founder and Chairman, Toft Group Executive Search

Samuels_CamillePanelists: Camille Samuels, MBA, Partner, Venrock

Hastings_PaulPaul Hastings, President and CEO, Nkarta Therapeutics, Inc

Wright_TerryTeresa L. Wright, MD, Staff Physician, Medicine, San Francisco Veterans Administration

첨단 분석법, 알고리즘, 기계학습의 진단에서의 활용

8:00 Organizer’s Remarks

Kaitlin Searfoss Kelleher, Conference Producer, Cambridge Healthtech Institute

8:05 Chairperson’s Remarks

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

8:10 Machine Learning to Detect Antibiotic Resistance: Progress and Challenges

Greenberg_DaveDavid Greenberg, MD, Associate Professor, Microbiology and Internal Medicine, University of Texas Southwestern

This talk will discuss the use of next generation sequencing approaches for predicting antibiotic resistance. It will focus on the application and development of bioinformatic pipelines to help predict resistance accurately without the need for phenotypic testing. Examples of success as well as challenges in the field will be explored.

8:40 Talk Title to be Announced

Speaker to be Announced, MeMed

9:10 Developing an mRNA-Based Panel for Pre-Symptomatic Detection of Sepsis

Wang_KaiKai Wang, PhD, Principal Scientist, Institute for Systems Biology

Using longitudinal samples from patients undergoing elective surgery, we identified a blood mRNA-based panel that could diagnose sepsis 2 to 3 days prior to the onset of clinical symptoms, allowing for much earlier therapeutic intervention. The panel was optimized using a biological function-based algorithm to reduce the number of features in the assay without affecting the performance. The diagnostic performance of the panel was validated with validation cohort.

9:40 Refreshment Break in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group

감염성 질환용 분자진단의 사례

10:40 CO-PRESENTATION: From Bench to Bedside: Real-World Cases in Molecular Diagnostics for Infectious Diseases

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

Butler_Wu_SusanSusan Butler-Wu, PhD, D(ABMM), Associate Professor of Clinical Pathology, Keck School of Medicine, University of Southern California, Director of Clinical Microbiology, LAC+USC Medical Center

Development of molecular assays has increased exponentially in the past decade and have revolutionized testing in the clinical laboratories. But how are tests being offered and reported in the laboratory? Further, how are results being interpreted by providers? This session will provide adult and pediatric case examples of the pros and woes of molecular diagnostics for infectious diseases. An interactive discussion on current and future directions of diagnostic assays will follow.

Lucira_Health12:10 pm Improving Influenza Outcomes Through OTC Molecular Diagnostics

Frank Myers, PhD, Director of Engineering, Lucira Health

Nearly 90% of patients with influenza do not seek medical treatment within the 48 hour window necessary for antiviral treatment. Lucira Health is developing an over-the-counter influenza diagnostic which better fits patient relief-seeking habits at symptom onset, enabling more timely and effective access to antiviral treatment and improved flu outcomes.

12:25 Sponsored Presentation (Opportunity Available)

12:40 Session Break

12:50 Precision Health Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

1:20 Refreshment Break in the Exhibit Hall with Last Chance Poster Viewing, Speed Networking, Book Signing, and Meetup Group

특별 세션:리소스가 한정된 환경에서 POC(POINT-OF-CARE) 진단의 실현

2:00 Chairperson’s Remarks

Michael Loeffelholz, Senior Director, Medical Affairs, Cepheid

2:05 Challenges and Opportunities in Resource-Limited Settings for POC IVD Manufacturers

Loeffelholz_MichaelMichael Loeffelholz, Senior Director, Medical Affairs, Cepheid

The impact of point-of-care technologies in resource-limited settings is profound, but the development, funding, and implementation of these technologies is not always easy. There are several challenges and opportunities for POC IVD manufacturers in resource-poor settings: technology, development, regulatory, cost considerations, to name a few. We’ll examine the industry and business perspective, as well as the clinical implementation and, most importantly, the impact these point-of-care technologies have on patient care.

2:35 The Challenges Associated with Implementation of POC Testing in Resource-Limited Settings

Berry_GregoryGregory Berry, PhD, D(ABMM), Director, Molecular Diagnostics, Assistant Director, Infectious Disease Diagnostics, Northwell Health Laboratories; Director, Microbiology, Long Island Jewish Medical Center; Assistant Professor, Pathology and Laboratory Medicine, Donald and Barbara Zucker School of Medicine at Hofstra

There are numerous challenges associated with the implementation of point-of-care testing. We will touch on several of these challenges and also discuss strategies to handle them. We will also discuss how these challenges may differ in a resource-rich vs. a resource-limited setting.

3:05 Point-of-Care Testing: Bringing the Laboratory to the Patient in Low- and Middle-Income Country Settings

Klausner_JeffreyJeffrey Klausner, MD, MPH, Professor of Medicine and Public Health, David Geffen School of Medicine, University of California, Los Angeles

I will review studies across three continents demonstrating the acceptability, feasibility, and value of point-of-care diagnostic testing for sexually transmitted infections in pregnant women.

3:35 Close of Conference

* 주최측 사정에 따라 사전 예고없이 프로그램이 변경될 수 있습니다.

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