The point-of-care market is growing – new technologies are being developed and older technologies are being refreshed in order to meet the ever-increasing needs of hospitals, pharmacies, critical and home care, and resource-limited settings. Cambridge Healthtech Institute’s Inaugural Enabling Point-of-Care Technologies conference program will address not only the latest developments in technology itself – from traditional lateral flow methods to updates in biosensors, but the continued challenges in validation and regulation. We will discuss microfluidics, nanosensors, and miniaturized devices. Special attention will be paid to technologies being developed for antimicrobial resistance testing, as well as 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

 

Sunday, March 1

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

*Separate registration required

5:30 - 8:30 Dinner Short Courses*

*Separate registration required

Monday, March 2

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

*Separate registration required

10:30 Conference Program Registration Open

FEATURED PANEL DISCUSSION: STATE OF THE POINT-OF-CARE AND INFECTIOUS DISEASE INDUSTRY

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

 

 

 

 

Bothwell_BryanBryan Bothwell, Director, Strategy and Business Development, Qorvo Biotechnologies

 

 

 

 

 

Joseph San Filippo, PhD, Director, Business Development, Roche Molecular Solutions

 

12:55 pm Session Break

1:05 LUNCHEON PRESENTATION I: Karius Microbial Cell-free DNA for Non-invasive Identification & Prediction of Infections in Immunocompromised Patients

Blauwkamp_TimTim Blauwkamp, PhD, CSO, Karius

Immunocompromised patients are vulnerable to a wide variety of infections. The Karius Test uses next-generation sequencing of microbial cell-free DNA in blood to help diagnose infections throughout the body, offering a non-invasive alternative with higher diagnostic yield than conventional methods.  We present current applications in clinical practice and describe potential future applications in predicting infections in high-risk immunocompromised patients.


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

DNA- AND RNA-BASED BIOSENSORS

2:20 Chairperson’s Remarks

Kiana Aran, PhD, Assistant Professor, Medical Diagnostics and Therapeutics, Henry. E. Riggs School of Applied Life Sciences, Keck Graduate Institute

2:25 Noninvasive Magneto-Nanosensors for Point-of-Care Gene Expression Analysis

Wang_ShanShan Wang, PhD, Professor, Materials Science and Engineering, and Electrical Engineering, Stanford University

Gene expression analysis at the POC is important for rapid disease diagnosis, but traditional techniques are limited by multiplexing capabilities, bulky equipment and cost. We present a giant magnetoresistive (GMR) biosensor platform well suited for multiplexed transcript detection and quantification. The technology has shown great promise in detecting influenza detection and vaccination response based on influenza meta signature (IMS) resulting from host immune responses to viral infections.

2:55 CRISPR-Chip: CRISPR-Powered Transistors for DNA Biosensing

Aran_KianaKiana Aran, PhD, Assistant Professor, Medical Diagnostics and Therapeutics, Henry. E. Riggs School of Applied Life Sciences, Keck Graduate Institute

CRISPR-chip is a graphene field effect transistor (gFET) electronic biosensor that utilizes the sequence-specific targeting capabilities of CRISPR to detect target DNA sequences. The graphene surface of the CRISPR-Chip is functionalized with nuclease-deactivated CRISPR RNA-guided ribonucleoproteins (dRNPs) which scan the genomic sample, bind to their target sequence, and produce a detectable change in the gFET signal output. CRISPR-Chip harnesses the search function of CRISPR/Cas9 and the ultra-sensitivity of graphene-based nanoelectronics to detect two distinct mutations in patients with confirmed muscular dystrophy disorder without the need for gene amplifications.

ARTIFICIAL INTELLIGENCE IN POINT-OF-CARE TECHNOLOGIES

3:25 Artificial Intelligence-Enhanced Ecosystem of Point-of-Care Technologies for Antimicrobial Resistance Detection

Tran_NamNam Tran, PhD, HCLD (ABB), FACB, Associate Professor and Director of Clinical Chemistry, Special Chemistry/Toxicology, and Point-of-Care Testing, Pathology and Laboratory Medicine, University of California, Davis

Artificial intelligence (AI) may provide new opportunities for predicting and perhaps preventing antimicrobial resistance in the community. The application of AI at the point of care (POC) could help identify infectious disease trends within patients and/or whole populations to optimize antimicrobial prescribing practices and combat the emergence of resistant pathogens. Lastly, the integration of POC testing with other laboratory methods under a diagnostic “ecosystem” is instrumental prior to leveraging AI analytics.

3:55 Point-of-Care, Quantitative Procalcitonin Test Using Electrochemistry Sensors

Tan_MingMing Tan, PhD, CEO, Wainamics

Point-of-care (POC) testing of procalcitonin allows rapid confirmation of blood stream bacterial infection and assessment antibiotics treatment. Wainamics presents here a low cost, disposable microfluidic cartridge for high-sensitivity, quantitative measurement of procalcitonin. Together with a compact instrument, such system provides a platform for high precision POC testing.

Invetech_no_tagline 4:10 Drivers for Utilizing Cloud Solutions in POC Device Development

Valcke_ChristianChristian Valcke, PhD, Global Director, Software Engineering, Invetech

The rise of connected devices, centralized data storage, and machine learning are changing the way POC diagnostics deliver value. We consider the critical success factors of POC device development (timeline, cost, differentiation) and how the adoption of cloud solutions can impact those factors as products are defined, developed and deployed.

4:25 Refreshment Break and Transition to Plenary Keynote


PLENARY KEYNOTE SESSION

(please see Keynote pages for details)

4:35 Welcome Remarks

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

4:45 PLENARY KEYNOTE INTRODUCTION

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

 

Tuesday, March 3

7:30 am Registration Open and Morning Coffee

FEATURED SESSION: ADDRESSING ANTIMICROBIAL RESISTANCE THROUGH THE NIH-BARDA GRAND CHALLENGE

8:00 Organizer’s Remarks

Kaitlin Searfoss Kelleher, Conference Producer, Cambridge Healthtech Institute

MeMed_New 8:05 Chairperson’s Remarks

Gottlieb_TanyaTanya Gottlieb, PhD, Vice President, Scientific Affairs, 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 Geospatial “Hot Spots” in Need of Rapid Point-of-care Diagnostics for Highly Infectious Threats and 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: Addressing Antimicrobial Resistance Through Public-Private Partnerships and the NIH-BARDA Grand Challenge

Antimicrobial resistance represents a growing public health concern, leading to BARDA and the NIH working with private companies to develop novel diagnostics. The NIH-BARDA Grand 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. Two of the five finalists will present their work and the challenges their technologies address. We will also hear from a company collaborating directly with BARDA to advance and commercialize their assay.

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


Sweeney_TimTimothy Sweeney, MD, PhD, CEO, Inflammatix


 

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

THE UPHEAVAL OF POC AND BLOOD-BASED DIAGNOSTICS DEVELOPMENT

10:40 PANEL DISCUSSION: The Altering Landscape of Diagnostics Development in the Age of Machine Learning and Advanced Data Analytics

Advanced data analytics and machine learning are driving the diagnostics business to points it’s never before been. This panel of experts will discuss how data technologies are altering the landscape of not only lab-based blood tests, but ultimately the point-of-care diagnostics industry.

Moderator: David Deetz, Co-Founder, CEO, Ativa Medical

Panelists: Richard Spero, Co-Founder and CEO, RedBud Labs

James Fackler, MD, Director, Pediatric Critical Care Medicine, Associate Professor of Anesthesiology and Critical Medicine, Johns Hopkins Medicine

 

11:25 Translating Benchtop Assays for Microfluidic POC Devices – The Secrets to Success

Cristiano_BrionyBriony Cristiano, PhD, Head, Bioscience, Minifab

Creating a successful POC diagnostic product requires overcoming unique challenges associated with translating benchtop assays to microfluidic scale. In this session you will learn about overcoming the technical difficulties and reagent stabilization and integration hurdles associated with combining microfluidic and biological workflows into complex POC Diagnostic devices.

11:40 Qorvo Biotechnologies Novel Platform for Point of Need Applications

Bothwell_BryanBryan Bothwell, Director, Strategy and Business Development, Qorvo Biotechnologies

Qorvo Biotechnologies has developed a biosensor platform that creates a paradigm shift in point of need testing. By combining novel multi-GHz bulk acoustic wave detection arrays with microfluidics and electronics integration, centralized lab results at the true point of need are enabled- breaking the technological barrier limiting ubiquitous deployment of liquid-based biosensors across all markets. Sample flexibility and performance across both Immunoassays and Molecular Dx make this a truly universal platform.

12:10 pm Session Break

12:20 LUNCHEON PRESENTATION I: Liquid Biopsy

Juan Roman, Vice President, Business Development, Ximedica

Liquid biopsy technologies have the potential to change the dynamics of cancer management and treatment. Juan F Roman will talk at TriCon 2020 about the evolution and barriers to adoption in this exciting field of cancer diagnostics.

12:50 LUNCHEON PRESENTATION II: Old Beads, New Tricks: Porting Legacy Assays to Point-of-Care

Spero_Richard-ChasenRichard Chasen Spero, PhD, CEO, Redbud Labs, Inc.

As our industry’s attention turns to point-of-care platforms, life science companies struggle to deploy the power of their benchtop tools, like beads, buffers and centrifuges, in a microfluidic context. Fundamental microfluidics limitations cause protocols for lysis, purification, and amplification to underperform on-cartridge. Using cartridge-ready™ components and Redbud Post technology, we have developed a method to achieve bead-based assays on cartridge with performance equal to or better than the laboratory equivalent.

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

KEYNOTE SESSION

3:15 Organizer’s Remarks

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

3:20 Keynote Introduction

Mallory_Allison

Allison Mallory, PhD, Director, R&D Molecular Biology, Stilla Technologies

 

 

 

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

Wednesday, March 4

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)

(please see Women in Science page for details)

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


INCORPORATING MICROFLUIDICS, NANOSENSORS, AND MINIATURIZED DEVICES

8:00 Organizer’s Remarks

Kaitlin Searfoss Kelleher, Conference Producer, Cambridge Healthtech Institute

8:05 Chairperson’s Remarks

Richard Spero, Co-Founder and CEO, RedBud Labs

8:10 Current Tech Trends and Innovation in POCT

Abel_GyorgyGyorgy Abel, MD, PhD, Medical Director, Molecular Diagnostics, Pathology and Laboratory Medicine, Lahey Hospital & Medical Center, Beth Israel Lahey Health

With the formation of integrated healthcare systems and decentralization of care, POCT is gaining ground. POCT is also critically important in providing access to laboratory testing in resource-limited settings. The need for speed, improved quality, and lower cost necessitates constant innovation and introduction of novel technologies. This talk reviews some of the latest technology and utilization trends, and highlights the unique nature of the innovation and commercialization process for POCT.

8:40 NEW: Pinpoints 30 – Second Handheld Coronavirus Test

Diamond_LisaLisa Diamond, CEO, Pinpoint Science, Inc.

Pinpoint’s novel nanosensor technology enables accurate, low-cost handheld detection and quantification of viral, bacterial and fungal pathogens in 30 seconds. Direct, label-free detection in biofluids (blood, saliva, milk, urine) with no laboratory, no technicians, no sample preparation, allows affordable real-time screening and surveillance of global health threats such as influenza, malaria, Ebola, and Zika. This presentation will describe the underlying science, validation results, market opportunities, and commercialization strategy for Pinpoint’s revolutionary new nanosensor technology.

9:10 Miniaturized Devices for Point-of-Care Molecular Diagnostics in Resource-Limited Settings

Wong_SeasonSeason Wong, President and Co-Founder, AI Biosciences, Inc.

Our company has been developing technologies that will enable low-cost and rapid molecular diagnostics in resource-limited settings. These enabling technologies are low-cost, portable, and easy to use. In this presentation, we will describe our recent efforts in optimizing technologies that isolate, amplify, and detect target nucleic acids from biospecimens. Examples of POC pathogen detection will be given.

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

INCORPORATING MICROFLUIDICS, NANOSENSORS, AND MINIATURIZED DEVICES (CONT.)

10:35 Chairperson’s Remarks

Shawn Mulvaney, Section Head, Surface Nanoscience and Sensor Technology, Chemistry Division, U.S. Naval Research Laboratory

10:40 Miniaturized Electrofluidic Technologies for Health and Environmental Monitoring

Javanmard_MehdiMehdi Javanmard, PhD, Associate Professor, Electrical and Computer Engineering, Rutgers University New Brunswick

In this talk, I will discuss my group’s work on fabricating micro- and nanosensing platforms for biomolecular and biochemical detection. In the first part of my talk, I will discuss a digital microfluidic platform for detection of inflammatory proteins in blood and saliva. I will then discuss a novel scheme for barcoding microparticles nanoelectronically, for multiplexed detection of analytes. We have also developed a novel electrochemical sensor using reduced graphene oxide for detection of inflammatory markers in exhaled breath condenstate for management of chronic respiratory diseases. Finally, I will talk about my group’s efforts in developing novel probes for characterization of biological organisms on-the-field in environmental samples, along with sensors for detection of toxic compounds in our regional water sources.

MODERNIZING PAPER-BASED LATERAL FLOW ASSAYS

11:10 Recent Progress with Rapid Single-Use NAAT-Based Pathogen Detection Devices

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

Detection of pathogens by untrained users in low resource environments is challenging. Our current approach is to use isothermal nucleic acid amplification. As opposed to the prevalent instrument/disposable paradigm, we have been emulating the simplicity of the user interface of the modern home pregnancy test. Ongoing projects include detection of tuberculosis using oral swabs, detection of chlamydia using urine, and detection of HIV from finger-stick blood samples.

11:40 Catalytic Enhancement of Lateral Flow Immunoassays: More Signal Amplifies Our Opportunity

Mulvaney_ShawnShawn Mulvaney, Section Head, Surface Nanoscience and Sensor Technology, Chemistry Division, U.S. Naval Research Laboratory

In field forward and remote settings, lateral flow immunoassays are one of the most important diagnostic technologies. However, they are limited by their sensitivity. We have developed a catalytic enhancement scheme where Pd replaces the traditional Au labels and we are realizing orders of magnitude more sensitivity. Our approach promises to reinvigorate a classic technology resulting in far more capable diagnostic that is perfectly suited for the most remote of locations, yet applicable to many more.

Triple_Ring 12:10 pm Reducing Manufacture Costs of Autologous Cellular Immunotherapy via a Benchtop System for QA/QC Automation

Zhou_XinyiXinyi Zhou, PhD, Senior Engineer, Triple Ring Technologies

Autologous cell therapies have shown unprecedented promise for patients with previously incurable disease. However, skyrocketing costs limit patient access to these life-saving therapies. QA/QC of autologous cell therapies accounts for up to 50% of manufacture cost due to the need for QA/QC of a small (single-patient) batch. We present a prototype for benchtop automation of common sterility and purity assays. A compact QC/QA instrument paired with disposable cartridges can reduce labor costs in cell therapy manufacture and increase patient access to care.

12:25 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

FEATURED SESSION: IMPLEMENTING POINT-OF-CARE DIAGNOSTICS IN RESOURCE-LIMITED SETTINGS

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.

2:50 NEW: 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

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