It is without argument that the point-of-care market is one of the fastest growing markets in life sciences – POC diagnostics are quicker and more efficient, can reach more patients, can eliminate follow-up visits, and ultimately will save money in the healthcare system. Cambridge Healthtech Institute’s 9th Annual Point-of-Care Diagnostics Strategy and Implementation conference program will address new developments in POC diagnostics, as well as the integration of current tests in hospital systems, pharmacies, critical care settings, mobile settings, and resource-limited settings. Special attention will be paid to the role of point-of-care diagnostics in addressing antimicrobial resistance and stewardship. 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_Bryan

Bryan 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

POCT IN THE HOSPITAL: ENSURING BETTER CARE

2:20 Chairperson’s Remarks

Elsie Yu, PhD, DABCC, FAACC, System Director, Chemistry, Toxicology and Point-of-Care Testing, Geisinger Medical Laboratories; Clinical Associate Professor, Geisinger Commonwealth School of Medicine

2:25 Is Faster Always Better? Identifying Care Opportunity and Ensuring Proper Clinical Utilization of Point-of-Care Testing

Yu_ElsieElsie Yu, PhD, DABCC, FAACC, System Director, Chemistry, Toxicology and Point-of-Care Testing, Geisinger Medical Laboratories; Clinical Associate Professor, Geisinger Commonwealth School of Medicine

The ability to have test results immediately makes POCT an attractive option at a wide variety of settings. At this presentation, we will provide concrete examples of how POCT aids patient management. We will also review cases where POCT is not suitable and could potentially be harmful. Finally, we will explore some unfilled care opportunities where transitioning to POCT can provide significant improvement and cost saving.

2:55 Operator Non-Compliance with Policies and Procedures: The Most Significant Risk Associated with Point-of-Care Testing, a Real-Life Example

Shaw_JulieJulie Shaw, Head, Division of Biochemistry and Director of Point-of-Care Testing, Pathology and Laboratory Medicine, The Ottawa Hospital and Eastern Ontario Regional Laboratories Association

Operator non-compliance with POCT policies and procedures is a significant risk. Repeat testing of critical POC glucose results prevents potentially dangerous treatment in the case of an erroneous result. Our data demonstrate consistent operator non-compliance with critical glucose repeat policies. Analysis of POC glucose results revealed significant differences with up to 30% of repeat results, highlighting the risk to patient safety when POCT policies and procedures are not adhered to.

3:25 Opportunities for Point-of-Care Testing in Modern Healthcare

Nichols_JamesJames Nichols, PhD, DABCC, FAACC, Medical Director, Clinical Chemistry and Point-of-Care Testing, Professor of Pathology, Microbiology and Immunology, Vanderbilt University School of Medicine

Point of care testing (POCT) is laboratory testing performed close to the site of patient care. With the advantage of rapid turnaround time and device portability, POCT is finding new applications as healthcare expands into the community. This presentation will explore the variety of ways that POCT is being deployed and finding new avenues for delivering faster testing for improved patient management. The future of new POCT technologies will be explored with opportunities for personalized medicine through POCT mobile health and social media.

mBio-Diagnostis 3:55 A Multiplexed Platform for Point-of-Care Precision Medicine and Clinical Trial Enrichment

Myatt_ChristopherChristopher Myatt, CEO, MBio Diagnostics, Inc.

Heterogeneity of septic shock is a major challenge. For clinical trials, it is unclear which patients will benefit from new treatment approaches. A robust risk stratification tool has been developed to aid decision-making in the context of pediatric sepsis. A 5-protein biomarker adaptation of the PERSEVERE risk stratification panel has been developed on the MBio point-of-care platform. The panel has been run on banked clinical samples, and comparisons with the original Luminex-based assay are underway.

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 ROLE OF MOBILE HEALTH AND TELEMEDICINE IN POINT-OF-CARE

10:40 Point of Care Technologies (POCT) for Mobile Diagnostics and Connected Health

Wang_PingPing Wang, PhD, DABCC, FAACC, Chief of Clinical Chemistry and Core Laboratory, Pathology and Lab Medicine, University of Pennsylvania

I will talk about the value proposition of POCT in mobile diagnostics and connected health, go over some examples of current applications of POCT in this field, and also review emerging POCT that are likely to have an impact on care delivery in the near future.

11:10 Errors, Risk Mitigation Strategies, and Quality Metrics in Point-of-Care Testing in Mobile Health and Other Settings

Fuezery_AnnaAnna Füzéry, North Sector POCT Medical Lead, Alberta Public Laboratories

This presentation focuses on errors in point of care testing (POCT). The presentation will first review error classification in POCT, followed by examples of errors in mobile health settings. The presentation will then discuss risk mitigation strategies and how to monitor their success through quality metrics. The presentation will conclude with an overview of some of the work that is happening in Alberta, Canada to develop quality metrics for POCT.

11:40 Optimized Lyophilization: Providing Options for You, Your Products, and Your IVD and RUO Customers

Meredith Pearcy, Application Consultant, BIOLYPH

Lyophilization is the highest quality form of preservation, and LyoSpheres™ maximize the benefits of lyophilization. Enjoy room temperature stability, storage, and transport, more robust performance, greatly increased shelf life, superior ease of use, limitless reagent cocktails, instant rehydration, and device flexibility for your MDx, POCT, NGS and liquid biopsy products   

11:55 Comprehensive Formulations to Simplify the Development of Lyophilized or Air-Dried Molecular Diagnostic Assays

Gianpiero SpedaleGianpiero Spedale, PhD, Manager, Research and Development, Meridian Life Science

Ambient temperature stabilization of molecular diagnostic assays is attractive for users and developers and is currently achieved through Lyophilization or Air-drying technologies. Although, establishing designs compatible with these technologies is a time consuming and challenging activity, it can be facilitated by the newly developed MLS PCR formulations.

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_AllisonAllison 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


POINT-OF-CARE OUTSIDE THE HOSPITAL: PHARMACY AND SELF-TESTING

8:00 Organizer’s Remarks

Kaitlin Searfoss Kelleher, Conference Producer, Cambridge Healthtech Institute

8:05 Chairperson’s Remarks

Donald Klepser, PhD, MBA, Associate Professor and Vice Chair, Pharmacy Practice, University of Nebraska Medical Center

8:10 Growing Point-of-Care Testing in Pharmacies Beyond Influenza and Strep Testing

Klepser_MichaelMichael Klepser, PharmD, FCCP, FIDP, Professor, College of Pharmacy, Ferris State University

While POCT in pharmacies has grown, the menu of tests has been limited. Now that value of using POCT in pharmacies to support influenza and acute pharyngitis management services has been established it is time to look ahead and grow this market. Opportunities for new services utilizing POCT will be discussed. Additionally, areas of interest not currently met by the POC industry will be identified.

8:40 Barriers to and Opportunities for Expanding the Market: Clinical Programs, Regulations, and the Advent of Self-Testing

Klepser_DonaldDonald Klepser, PhD, MBA, Associate Professor and Vice Chair, Pharmacy Practice, University of Nebraska Medical Center

This presentation will focus on the opportunities and challenges to expand the market for point-of-care testing in community pharmacy and other novel settings.

9:10 Accelerating Implementation: How an Implementation Strategy Can Catalyze Point-of-Care Test Use in Community Pharmacies

Hohmeier_KennethKenneth Hohmeier, PharmD, Associate Professor, Director of Community Affairs, Clinical Pharmacy & Translational Science, University of Tennessee Health Science Center

It takes on average 17 years for a new healthcare innovation to scale – do you have time to wait for market penetration? Learn how to develop an “Implementation Strategy” specifically targeted for the community pharmacy using the most recent advances in our understanding of Implementation Science and tailored around the unique challenges of FDA, other regulatory bodies, and the POC industry.

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

POINT-OF-CARE OUTSIDE THE HOSPITAL: PHARMACY AND SELF-TESTING (CONT.)

10:40 Advanced Pharmacy Technician Roles: Ready for Point-of-Care Testing?

Hill_HunterHunter Hill, PharmD, Pharmacy Manager, Delta Division, Kroger Health

Point-of-care testing (POCT) is an increasingly popular service offered by community pharmacies, but it is often met with multiple barriers. As technicians’ roles continue to advance there is an opportunity to utilize them as pharmacy extenders and lead POCT services. Learn how pharmacy technician-supported POCT, including sample collection, can minimize these barriers.

11:10 PANEL DISCUSSION: The Future of Point-of-Care Testing in the Pharmacy

What’s next in POCT in the pharmacy? What implementation, technology, and business needs must be addressed to bring pharmacy-based POCT to the mainstream? How does self-testing come into the picture? This panel discussion will address these questions and more as it relates to the advancement of simple point-of-care tests in the pharmacy and beyond.

Klepser_DonaldModerator: Donald Klepser, PhD, MBA, Associate Professor and Vice Chair, Pharmacy Practice, University of Nebraska Medical Center


Klepser_MichaelPanelists: Michael Klepser, PharmD, FCCP, FIDP, Professor, College of Pharmacy, Ferris State University


Hohmeier_KennethKenneth Hohmeier, PharmD, Associate Professor, Director of Community Affairs, Clinical Pharmacy & Translational Science, University of Tennessee Health Science Center


Hill_HunterHunter Hill, PharmD, Pharmacy Manager, Delta Division, Kroger Health


dering-anderson_AllisonAllison Dering-Anderson, PharmD, RP, Clinical Associate Professor, Pharmacy Practice and Science, University of Nebraska Medical Center


 

BBI_Solutions 12:10 pm Mobilising Diagnostics - Overcoming the Challenges in Testing Outside the Laboratory

Polwart_NeilNeil Polwart, PhD, Head, Mobile, BBI Solutions

Combining the ease of use of smartphones with low-cost POCT, we have revolutionized the application of diagnostic tests for some of the most challenging non-clinical settings, such as field applications in low-income countries or at home monitoring, using our Novarum™ technology. We will demonstrate the use of a smartphone to guide users through a POCT workflow, including critical test timings, visual cues and our patented image capture software to record and analyze the test outcome.

 


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

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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