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
Monday, March 2
10:30 Conference Program Registration Open
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.
Moderator: David Cavanaugh, Partner, DeciBio
Panelists: Ester Stein, Director, Corporate Reimbursement, Government Affairs, Abbott Laboratories
Gyorgy Abel, MD, PhD,
Director, Molecular Diagnostics, & Clinical Chemistry/Immunology, Division of Pathology and Laboratory Medicine, Lahey Hospital & Medical Center, Burlington, MA
Trevor Martin, PhD, Co-Founder and CEO, Mammoth Biosciences
Jenny Rooke, PhD, Managing Director, Genoa Ventures
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
Tim 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
Lynn 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
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
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
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
Julie 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
James 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.
3:55 A Multiplexed Platform for Point-of-Care Precision Medicine and Clinical Trial Enrichment
Christopher 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
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
8:00 Organizer’s Remarks
Kaitlin Searfoss Kelleher, Conference Producer, Cambridge Healthtech Institute
8:05 Chairperson’s Remarks
Tanya Gottlieb, PhD, Vice President, Scientific Affairs, MeMed
8:10 Point-of-Care Diagnostics for Antibiotic Stewardship in the Hospital and Beyond
Larissa 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
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
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.
Moderator: 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
Panelists: Ephraim Tsalik, MD, MHS, PhD, Founder, Predigen, Inc.
Gary Schoolnik, Director, Medical Affairs, Click Diagnostics
Timothy Sweeney, MD,
PhD, CEO, Inflammatix
9:40 Refreshment Break in the Exhibit Hall with Poster Viewing, Speed Networking, Book Signing, and Meetup Group
10:40 Point of Care Technologies (POCT) for Mobile Diagnostics and Connected Health
Ping 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
Anna 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 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
Richard 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
3:15 Organizer’s Remarks
Christina Lingham, Executive Director, Conferences and Fellow, Cambridge Healthtech Institute
3:20 Keynote Introduction
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.
Moderator: Kevin
Davies, PhD, Executive Editor, The CRISPR Journal, Mary Ann Liebert, Inc.
Panelists: Stephen Kingsmore, MD, DSc, President/CEO, Rady Children’s Institute for Genomic Medicine
David 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)
Elizabeth 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
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)
Moderator:
Robin Toft, Author of WE CAN, The Executive Woman’s Guide to Career Advancement; Founder and Chairman, Toft Group Executive Search
Panelists: Camille Samuels, MBA, Partner, Venrock
Paul Hastings, President and CEO, Nkarta Therapeutics, Inc
Teresa L. Wright, MD, Staff Physician, Medicine, San Francisco Veterans Administration
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
Michael 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
Donald 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
Kenneth 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
10:40 Advanced Pharmacy Technician Roles: Ready for Point-of-Care Testing?
Hunter 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.
Moderator: Donald Klepser, PhD, MBA, Associate Professor and Vice Chair, Pharmacy Practice, University of Nebraska Medical Center
Panelists:
Michael Klepser, PharmD, FCCP, FIDP, Professor, College of Pharmacy, Ferris State University
Kenneth Hohmeier, PharmD, Associate Professor, Director of Community Affairs, Clinical Pharmacy & Translational Science, University of Tennessee Health Science Center
Hunter Hill, PharmD, Pharmacy Manager, Delta Division, Kroger Health
Allison Dering-Anderson, PharmD, RP, Clinical Associate Professor, Pharmacy Practice and Science, University of Nebraska Medical Center
12:10 pm Mobilising Diagnostics - Overcoming the Challenges in Testing Outside the Laboratory
Neil 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
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
Michael 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
Jeffrey 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