2023 ARCHIVES

Cambridge Healthtech Institute’s Inaugural

Decentralized POC Testing

Disrupting Inefficiencies in Traditional Healthcare Models

August 22 - 23, 2023 ALL TIMES EDT

Within the last few years, we saw a seismic global shift in the acceptance and availability of point-of-care and home-based testing, bolstered by a heightened interest in and capability for decentralized processes. Healthcare systems and providers were pushed to rapidly adapt new processes, many of which persist today. With the increased prevalence of point-of-care testing, some pharmacies have started to bridge the gaps in healthcare accessibility. Direct-to-consumer mail-in testing and digital health monitoring are expanding rapidly due to their convenience and flexibility. However, these innovations do not come without various challenges, such as logistics, continuity of care, and data security. Cambridge Healthtech Institute's inaugural meeting on Decentralized Point-of-Care Testing will explore successes, obstacles, and novel areas of testing that takes place at the pharmacy, home-based, and beyond.

Sunday, August 20

Registration Open1:00 pm

Tuesday, August 22

11:30 am PLENARY PANEL DISCUSSION:

Policy and Practice Strategies to Address the Clinical Practice Gaps Affecting the Implementation of Personalized Medicine in Cancer Care

PANEL MODERATOR:

Daryl Pritchard, PhD, Senior Vice President, Science Policy, Personalized Medicine Coalition

Many oncology patients who are eligible to receive high-value personalized treatments do not. Despite a lengthy history of targeted treatment availability in advanced non-small cell lung cancer (aNSCLC), a recent study found that 644 of every 1,000 newly diagnosed aNSCLC patients (64.4%) did not receive a personalized treatment due to clinical practice gaps in the delivery of precision oncology.

What are the clinical practice and policy challenges related to diagnostic testing and the delivery of appropriate targeted therapies leading to a failure of patients to receive precision oncology strategies?
What impact does each clinical practice gap have on the population-level delivery of precision oncology?
How can we optimize biomarker testing and treatment decision-making to help best address clinical practice gaps?
What policies and practices can help assure optimal and equitable delivery of appropriate high-value personalized medicines?

PANELISTS:

Robert H. Dumanois, Director, Reimbursement Strategy, Thermo Fisher Scientific

Anthony N. Sireci, MD, Senior Vice President, Clinical Biomarkers & Diagnostics Division, Loxo@Lilly

Apostolia-Maria Tsimberidou, MD, PhD, FASCO, FAASS, Professor of Medicine, Investigational Cancer Therapeutics, University of Texas MD Anderson Cancer Center

Enjoy Lunch on Your Own12:30 pm

1:45 pm

Chairperson's Remarks

Tiffani Lash, PhD, Program Director, National Institutes of Health

1:50 pm

A Breakthrough in Colorimetric Lateral Flow Diagnostics: An LED-Based Handheld Thermal Contrast Reader

John Bischof, PhD, Professor, Mechanical & Biomedical Engineering, University of Minnesota Twin Cities

We recently developed a low-cost, handheld, LED-based thermal contrast assay (TCA) reader for colorimetric lateral flow assays (LFA). TCA utilizes the irradiation of LFAs and resulting temperature increases around the test line as a readout to approach ELISA sensitivities without the need for additional modalities or steps to increase sensitivity such as fluorescence or luminescence. TCA has until now been limited to more costly bench top readers for research use. The implementation of LED-based TCA allows a cheap, robust and easy approach to dramatically improve LFA diagnostics at the POC.

2:20 pm

The Race towards Putting a Lab in Every Space

Maikel Boot, PhD, Technical Director, PreScouter, Inc.

The SARS-CoV-2 pandemic rapidly changed our perspective on diagnostic testing. Riding this wave, major diagnostic companies are developing the next generation of diagnostic devices to be used in any office, by any person, for near-instant first-line diagnosis of abnormal health parameters that report on both host biomarkers and the presence of pathogens. In this talk, I will discuss the latest surge in diagnostic innovations relevant to achieving this goal.

2:50 pm

Point-of-Care 3D-Printed Smartphone-Enabled Fluorescence Microscopy Setup for Diagnostic Applications

Umer Hassan, PhD, Assistant Professor, Electrical & Computer Engineering, Rutgers University

Dr. Hassan's lab has developed a 3D-printed smartphone-enabled fluorescence microscopy setup for point-of-care diagnostic applications. This hand-held setup can be easily used to image cells of interest or other micro-nanoparticles used in biomedical assays. The setup is user-friendly and can be easily adaptable to different diagnostic applications.

Refreshment Break in the Exhibit Hall with Poster Viewing3:20 pm

3:30 pm SPEED NETWORKING:

How Many Contacts Can You Make in 30 Minutes? IN-PERSON ONLY

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

Bring yourself, your business or e-cards, and be prepared to share and summarize the key elements of your work in a short, two-minute sound bite. This session will be located in the exhibit hall and will be moderated.

4:00 pm PANEL DISCUSSION:

Regulatory Backdrop and Strategies for Success for Novel Point-of-Care Technologies

PANEL MODERATOR:

Tiffani Lash, PhD, Program Director, National Institutes of Health

This panel discussion features innovators and regulatory experts, who will discuss strategies that companies creating novel point-of-care testing technologies can employ throughout the development process. For new and established companies alike, navigating a changing regulatory landscape can be tricky, so staying abreast of shifts in the industry is critical. Hear about pathways to success, lessons learned from past challenges, and ongoing advancements.

PANELISTS:

Erika Tyburski, CEO & Co-Founder, Sanguina; Director of Operations, ACME-POCT

Michael Wolfson, PhD, Program Director, National Institute of Biomedical Imaging and Bioengineering (NIBIB), NIH

Close of Day5:00 pm

Wednesday, August 23

Registration Open7:15 am

7:30 amInteractive Discussions with Continental Breakfast

Interactive Discussions are informal, moderated discussions, allowing participants to exchange ideas and experiences and develop future collaborations around a focused topic. Each discussion will be led by a facilitator who keeps the discussion on track and the group engaged. To get the most out of this format, please come prepared to share examples from your work, be a part of a collective, problem-solving session, and participate in active idea sharing. Please visit the Interactive Discussions page on the conference website for a complete listing of topics and descriptions.

BREAKOUT DISCUSSION:

Looking into the Future of Point-of-Care and OTC Testing

Jordan Laser, MD, Senior Director, Clinical and Medical Affairs, Diagnostic and Genomics Segment, Bio-Techne

- What are some current trends you are seeing in the point-of-care space?

- In a post-pandemic world, is the push to OTC still progressing, or has it slowed down?

- What are the next big diagnostics to hit the point-of-care market?

BREAKOUT DISCUSSION: Taking a Closer Look at Novel and Upcoming Point-of-Care Testing and Interpretation

Maikel Boot, PhD, Technical Director, PreScouter, Inc.

- The use of AI/algorithms for results interpretation on point-of-care devices

- Reagent-free point-of-care diagnostics

- New biosensors (e.g., graphene-based)

- At-home sample collection, mail-in vs. at-home testing: which one is the future?

8:55 am

Chairperson's Remarks

Jordan Laser, MD, Senior Director, Clinical and Medical Affairs, Diagnostic and Genomics Segment, Bio-Techne

9:00 am

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

COVID-19 demonstrated that home point-of-care testing (POCT) can be a viable testing strategy for conditions of interest. Patients want to take an active role in their health care and home POCT can give them the tools they need to make informed decisions regarding their health. Unfortunately, use of home POCT without guidance may create confusion and frustration. During this session, models of care that integrated home POCT will be discussed.

9:30 am

Finding the Sweet Spot between Healthcare and Peace of Mind

Nathalya Mamane, MBA, Founder, RT MicroDx

Not all solutions need the use of handhelds or connected apps. An inside view on how RT MicroDx found a way to address the testing market by developing a simple solution that allows for easy and affordable access to diagnostics.

Coffee Break in the Exhibit Hall. Last Chance for Poster Viewing.10:00 am

11:00 am KEYNOTE PRESENTATION:

Current Complexities of at-Home Testing and Where We Are Headed

Lesley Northrop, PhD, Chief Diagnostic Officer, Everly Health

The SARS-CoV-2 pandemic brought us to the forefront of owning our healthcare, including how we can manage without having access to onsite physician care and testing. It has allowed individuals to safeguard their health and be comfortable with self-testing to confirm their symptomatology with a diagnosis. The change in having a non-clinical collection (“at home”) vs. a clinical collection (“at PCP”) is still being proven as a valid testing paradigm. Let's assess where we are today with at-home testing of common conditions Diabetes, Hyperlipidemia, Hypothyroidism, STIs and the gaps we are hoping to solve through a single digital healthcare platform.

11:30 am

Evidence Generation in Digital Health: How it Applies to Digital Solutions for POC Testing

Matthew Prime, BSc, MBBS, PHD, MRCS(Eng), Head, Evidence Generation, Roche Information Solutions, F. Hoffmann-La Roche

Digital health solutions (DHS) continue to develop, in both numbers and capabilities. They have a wide range of uses, from general wellness, to applications with a medical purpose. DHS’s have a major role to play in the effective delivery and management of POC testing services. Robust evidence of safety, efficacy, and value will drive greater adoption. Here, we discuss the unique challenges for evaluations and specific POC use cases.

Enjoy Lunch on Your Own12:00 pm

Session Break1:30 pm

Networking Refreshment Break1:40 pm

2:00 pm

Chairperson's Remarks

Jason Ausili, PharmD, Head of Pharmacy Transformation, EnlivenHealth

2:05 pm

Pharmacy Transformation: How Technology Is Mobilizing Community Pharmacy as the Epicenter of POC Testing

Jason Ausili, PharmD, Head of Pharmacy Transformation, EnlivenHealth

Community pharmacies are the most accessible healthcare destination in the U.S. and are uniquely positioned to provide POC testing services during a pandemic and beyond. Technology that automates the clinical workflow process has enabled pharmacies to scale these services for current and future public health needs. Additionally, interoperability initiatives are underway that will solidify the pharmacist’s role in team-based care, while ensuring bi-directional exchange of information and continuity of care.

2:35 pm

Partnering with Community Pharmacies to Make Sure Decentralized POC Testing Is Not Disconnected Testing

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

Point-of-care testing in pharmacies and other decentralized settings has increased patient access to care. As the number and types of tests performed in pharmacies increases, including for chronic disease management, it becomes more important to seamlessly integrate test results obtained in the pharmacy with a patient's electronic medical record. An opportunity exists for diagnostics companies and pharmacies to collaborate on digital technologies to support this integration. This session will discuss how diagnostic testing and pharmacies can work together to develop solutions connecting pharmacy-based testing results with other members of the healthcare system.

3:05 pm

At the Corner of Access and Scalability: Community Pharmacy as a Public Health Destination

Kenneth C. Hohmeier, PharmD, Associate Professor, Director of Community Affairs, PGY-1 Community-Based Pharmacy Residency Program, The University of Tennessee Health Science Center

The COVID-19 pandemic has accelerated the pace at which point-of-care (POC) testing is being adopted in the community pharmacy setting. Increasing numbers of community pharmacies are interested in developing their POC test and treat programs, including large pharmacy chains, as the US increasingly looks to this setting as a public health destination. We will discuss where pharmacy is now in terms of service offerings, and also where is it going in the future.

3:35 pm PANEL DISCUSSION:

Key Considerations for Bringing Point-of-Care Tests from Bench to Market

PANEL MODERATOR:

Albine K. Martin, PhD, Executive-in-Residence, BioHealth Innovation; Entrepreneur-in-Residence, Johns Hopkins University

Recent advancements and regulatory approvals for point-of-care diagnostics continue to accelerate the changing paradigm of bringing the lab closer to the end-user. This panel will consider the importance of early development strategies including clinical trial design, development pathways, and usability within the end-user environment. The importance of usability considerations for implementing and scaling point-of-care testing in local pharmacies will be discussed.

PANELISTS:

Gail Radcliffe, PhD, President, Radcliffe Consulting, Inc.