Cambridge Healthtech’s 3rd Annual
Emerging Technologies at the Point-of-Care
Enabling Clinicians with Cutting Edge Technology to Improve Patient Health Outcomes at the Point-of-Care
August 21-22, 2019
Point-of-care testing (POCT) allows clinicians to make rapid decisions to improve clinical outcomes, cost and patient satisfaction. Join us at Emerging Technologies at the Point-of-Care as we discuss the newest technologies in the fastest growing sectors
of diagnostics to improve clinical care and their path to clinical use.
Final Agenda
WEDNESDAY, AUGUST 21
10:30 am Registration
Constitution A&B
11:30 Plenary Keynote Session
11:30 Chairperson’s Remarks
Charles Mathews, Principal, ClearView Healthcare Partners
11:40 NEW: Plenary Keynote Presentation: FDA Updates: Now and Looking to the Future
Katherine Donigan, PhD, Acting Director of Personalized Medicine, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration
Introduction and background of the new Office Director of OIR and updates on precision medicine and other initiatives at the FDA.
12:10-1:05 pm Plenary Keynote Discussion: Proposals and Solutions for Diagnostic Reform Including Oversight of Laboratory Developed Tests (LDTs)
Moderator:
Cynthia A. Bens, Senior Vice President, Public Policy, Personalized Medicine Coalition
- How are stakeholders influencing congressional activity on the Verifying Accurate Leading-edge IVCT Development (VALID) Act?
- How will the VALID Act change the current oversight landscape for diagnostics, including LDTs?
- How are policymakers addressing the role of CMS and CLIA in the VALID Act?
- How will increased regulatory and oversight activities at the FDA affect the diagnostics industry?
- What impact will changes in diagnostics regulation and oversight have on patient care?
Panelists:
Julie Khani, MPA, President, American Clinical Laboratory Association (ACLA)
Donald E. Horton, Jr., Senior Vice President, Global Government Relations & Public Policy, Laboratory Corporation of America Holdings
Susan Van Meter, Executive Director, AdvaMedDx
Tara Burke, PhD, Senior Director,
Public Policy & Advocacy, Association for Molecular Pathology (AMP)
Laura Lasiter, PhD, Science Policy Analyst, Friends of Cancer Research
1:05 pm Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own
1:35 Ice Cream & Cookie Break in the Exhibit Hall with Poster Viewing
2:05 Chairperson’s Opening Remarks
David Deetz, Co-Founder, CTO, Ativa Med
2:15 How Siemens is Enabling Precision Diagnostics
Manish Deshpande, PhD, Vice President, R&D, Point of Care BU, Siemens Healthcare
2:25 Focus on Sensor Tech for POCT
Prasad V. A Pamidi, PhD, Director, Sensor Development, R&D, Instrumentation Laboratory, A Werfen Company
2:35 Guiding R&D for the Next Generation Diagnostics
Matt Bates, Head of R&D, Abbott
2:45 Mastering New Product Spaces and Competitive Landscapes
Nina Menezes, Head, Marketing Innovation, Abbott
2:55 Keynote Panel Discussion: What Makes Emerging Technology Attractive?
Moderator: David Deetz, Co-Founder, CTO, Ativa Med
Panelists: Manish Deshpande, PhD, Vice President, R&D, Point of Care BU, Siemens Healthcare
Prasad V. A Pamidi, PhD, Director, Sensor Development, R&D, Instrumentation Laboratory, A Werfen Company
Matt Bates, Head of R&D, Abbott Point-of-Care
Nina Menezes, Head, Marketing Innovation, Abbott Point-of-Care
- Analysis of the latest trends in lab testing
- Identification of hot new tests and the value they create
- Creating new uses for established tests by adding in new tech
3:40 The Future of Near Patient Testing
Bryan Bothwell, Director, Strategy and Business Development, Qorvo Biotechnologies, LLC
Qorvo Biotechnologies biosensor platform creates a paradigm shift in point of need testing. Bulk acoustic wave detection arrays combined with microfluidics and electronics integration enables centralized lab results at the true point of need- breaking
technological barriers limiting ubiquitous deployment.
4:10 Refreshment Break in the Exhibit Hall with Poster Viewing
4:55 Chairperson’s Remarks
Matt Quinn, MBA, Senior Advisor, Health Technology, HRSA
5:00 Advancing Use of Innovative Health Technologies in the Safety Net
Matt Quinn, MBA,
Senior Advisor, Health Technology, HRSA
The Health Resources and Services Administration (HRSA), an agency of the U.S. Department of Health and Human Services, is the primary federal agency for improving healthcare to people who are geographically isolated, economically or medically vulnerable.
This session will describe how HRSA advances the use of health technologies to achieve its mission of improving health and achieving health equity through access to quality services, a skilled health workforce and innovative programs.
5:30 Smart and Connected Molecular Diagnostics at the Point-of-Care
Changchun Liu, Associate Professor, Biomedical Engineering Department, University of Connecticut, UConn Health
Smartphones have a growing and pervasive influence on our daily life. Especially, with the rapid development of microfluidics technology, the incorporation of microfluidics technology with smartphone-based detection technology will create a new paradigm
shift towards affordable, smart and connected health monitoring. In this talk, I will introduce our synergistically enhanced colorimetric molecular detection method, molecular diagnostic chips, smart connected systems and their applications in early
cancer screening (e.g., HPV-associated cancer) and infectious disease detection (e.g., Zika virus, HIV virus) at the point-of-care.
6:00 Q-POC – Molecular Diagnostics Point-of-Care 2.0
Jonathan
O’Halloran, CSO, QuantuMDx Group Ltd
QuantuMDx has developed a novel, low-cost sample to answer molecular diagnostics device aimed at both low and high resource settings. The device performs both qPCR and end-point PCR followed by a microarray, all within a single ultra-low-cost disposable.
The company’s first assay is an HPV assay, due for launch in 2020, that individually genotypes 13 high-risk sub-types of the virus, directly from a swab sample in under 30 minutes.
6:30 Close of Day
6:30 Dinner Short Course Registration
6:45 - 9:15 pm Recommended dinner Short Course*
SC15: Microfluidics and Lab-on-a-Chip Devices for POCT: Technologies and Commercialization
Chris Myatt, Founder &
CEO, MBio Diagnostics, Inc.
Additional Speakers to be Announced
This short course will provide an overview of microfluidic techniques, including valved and valve-less devices, pumped systems, and capillary flow approaches. Practical examples will keep the discussion grounded in the realization of commercializable
devices. We will discuss engineering approaches to enhance the advantages and minimize the challenges. Throughout, the science will be linked to the commercial case for these devices, including a full discussion of a recent success story of a centrifugal
microfluidic molecular assay system.
*Separate registration required.
thursDAY, AUGUST 22
7:15 am Registration
Independence B-E and Foyer
7:30 Problem Solving Breakout Discussions with Continental Breakfast
Technologies to Enable Point-Of-Care… Anywhere?
Moderators: Dionysios Christodouleas, PhD, Assistant Professor, Department of Chemistry, University of Massachusetts Lowell
Shawn Mulvaney, PhD, Section Head, Surface Nanoscience and Sensor Technology Section, Chemistry, US Naval Research Laboratory
- In the future, POCT will be common at the home, in the battle field, etc. How can we start planning now?
- So your sensor works, but what about the sample prep? Does that strategy work at home? In a field?
- Do you have the "Tricorder"? How sophisticated does POCT medicine get before my backpack gets too full?
Multiplex at the POC
Moderator: Mehdi Javanmard, PhD, Assistant Professor, Department of Electrical and Computer Engineering, Rutgers University
- How to balance increasing technological complexity with the need for low cost?
- Integrating new biomarkers, ex. miRNA, protein, etc
- How to tackle sample prep, integration on chips/assays?
- Translating from the bench to a cartridge
The Next Big Step Forward in Microfluidics; Microstructured Films Combined with Polymer or Glass Parts
Moderators: Maria Bauer, PhD, CEO, Myropartners, Salzburg, Austria
Violeta Tacheva, MSc, Project Engineer, Stratec Consumables, Cambridge MA, USA
- What are microstructured films and foils
- Advantages of the roll to roll process
- Industrial partnership with the Kurz Group
- Applications of microstructured foils in POC and IVD applications
8:25 Chairperson’s Remarks
Jonathan O’Halloran, CSO, QuantuMDx Group Ltd
8:30 Clinical Needs, Validation and Implementation Strategies for Novel Point-of-Care Technologies
Ping Wang, PhD, DABCC, Chief,
Clinical Chemistry, Director, Core Laboratory Hospital of University of Pennsylvania
The field of point-of-care technologies has witnessed strong growth, as evidenced by new clinical or consumer products, or research and development directions. Only when combined with appropriate strategies for clinical needs assessment, validation and
implementation, these technologies may significantly impact care delivery and associated outcomes and costs. In this presentation, I will discuss clinical needs, validation and implementation strategies for novel point-of-care technologies from two
perspectives: as a practicing clinical laboratory director, and as a technology researcher and developer.
9:00 Diagnostic Workstation: A New Approach to Diagnosing Primary-Care Patients Enables New Processes
David Deetz, Founder,
CTO, Ativa Med
Ativa’s Diagnostic Workstation integrates a synergistic array of breakthrough diagnostic and AI technologies that has the potential to disrupt the current process of primary care because it facilitates:
- Much faster diagnoses - It permits healthcare personnel to run the major blood/urine panels immediately themselves, which enables the provider to diagnose a patient within moments, rather than hours or days
- Improved diagnoses – Its cloud-based AI enables protocol-driven test selection and provides meaningful interpretation to improve diagnoses
- Expanded ability to detect serious diseases in primary care
9:30 Evaluation of Continuously Learning AI/ML-enabled Medical Devices
Alexej Gossmann, PhD, Staff Fellow, Division of Imaging, Diagnostics, and Software Reliability, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration (FDA)
The use artificial intelligence (AI) and machine learning (ML) in medicine is growing at an accelerating pace while the capabilities of AI/ML are rapidly improving. It can be expected that soon AI/ML-enabled medical devices will continue to learn, change,
and adapt based on real-world use after regulatory approval. Our research addresses new questions related to the evaluation of such AI/ML systems. We also discuss potential regulatory approaches.
10:00 Coffee Break in the Exhibit Hall with Poster Viewing
11:00 Chairperson’s Remarks
Karl Poterack, MD, Medical Director, Applied Clinical Informatics, Mayo Clinic
11:05 Catalytic Nanoparticles as Labels in Lateral Flow Immunoassays
Shawn Mulvaney,
PhD, Section Head, Surface Nanoscience and Sensor Technology Section, Chemistry, US Naval Research Laboratory
Lateral-flow immunoassays (LFIs of LFIAs) are widely used point-of-care technology. Visually-read, LFIAs typically use colloidal gold or colored latex as the reporter elements for the antibody-antigen binding event. Due to their visual extinction coefficients,
the intensity of these labels are limited which ultimately limits the sensitivity of the assay. We have substituted specially-prepared, colloidal palladium for the traditional labels and use it as a chemical catalyst to produce an easily-observable,
stable, blue dye that localizes at the capture line. Importantly, the catalyst is heat stable, functions at room temperature, under physical conditions, and results in up to a 500-fold increase in sensitivity with only five additional minutes of development.
11:35 Paper Devices for Medical Self-testing at Home: Opportunities and Challenges
Dionysios Christodouleas, PhD, Assistant Professor, Department of Chemistry, University of Massachusetts Lowell
Diagnostic devices for home use should operate with minimal user involvement, be able to analyze untreated samples, and have low cost. Paper devices are inexpensive and, if they are designed carefully, could be capable of analyzing untreated samples
and be fully integrated. In this presentation, I will discuss examples of paper devices that allow biochemical testing without user involvement and point toward areas of future research in paper diagnostics to address current challenges.
12:05 pm Paper-Based Surface-Enhanced Raman Scattering Lateral Flow Strips for Point-of-Care Applications
Nianqiang (Nick) Wu, Professor,
Mechanical and Aerospace Engineering, West Virginia University
This presentation will present our effort to develop plasmonic nanostructures for amplifying surface-enhanced Raman scattering (SERS) signals. It will also show how to incorporate SERS sensors into paper-based lateral flow strips (PLFS) as point-of-care
tools. The PLFS is composed of the on-chip sample pretreatment, flow control and detection components. Moreover, this talk will demonstrate measurement of the traumatic brain injury (TBI) protein biomarkers in clinical samples by the SERS-based
PLFS.
12:35 Enjoy Lunch on Your Own
1:35 Dessert Break in the Exhibit Hall with Poster Viewing
2:15 Chairperson’s Remarks
Wilbur A. Lam, MD, PhD, Associate Professor, Wallace H. Coulter Department of Biomedical Engineering and Department of Pediatrics, Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta, Georgia Institute of Technology and
Emory University School of Medicine
2:20 Wearable Monitors in Health Care: Signal or Noise?
Karl Poterack,
MD, Medical Director, Applied Clinical Informatics, Mayo Clinic
Widely used wearable devices like activity trackers and smart watches continuously measure physiologic data during everyday activities. Utilizing this data requires a paradigm shift for health care, since traditionally this data was only collected
during patients’ healthcare visits. This presentation will cover the types of data that can be collected, the associated technical challenges, as well as the system changes required in order to be able to utilize this data to improve care
and outcomes.
2:50 Development of a Smartphone App for Non-Invasive Detection of Anemia Using Only Patient-Sourced Photos
Wilbur A. Lam, MD, PhD,
Associate Professor, Wallace H. Coulter Department of Biomedical Engineering and Department of Pediatrics, Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta, Georgia Institute of Technology and Emory University
School of Medicine
We introduce a paradigm of non-invasive, on-demand diagnostics for hematologic diseases using only a smartphone app and photos. We initially targeted anemia, characterized by low blood hemoglobin levels, which afflicts >2 billion people. Our app
estimates hemoglobin levels by analyzing color and metadata of fingernail smartphone photos and screens for anemia (hemoglobin levels <12.5 g/dL) with a 97% sensitivity (n = 100 subjects). Moreover, with personalized calibration, this system
achieves an accuracy of ±0.92 g/dL compared to gold standard hemoglobin levels (n = 16 subjects), empowering chronic anemia patients to serially monitor their hemoglobin levels instantaneously and non-invasively.
3:20 Portable and Wearable Electro-Fluidic Micro/Nanotechnologies for Health and Environmental Monitoring
Mehdi Javanmard, PhD, Assistant Professor, Department of Electrical and Computer Engineering, Rutgers University
Portable and wearable devices for measuring physical parameters such as ECG, pulse oximetry, and temperature are widely used for health monitoring. The ability to continuosly monitor physiology at the biomolecular leveI can further provide significant
information in understanding the state of health. 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 wearable platforms
we are developing for detection of cells and also inflammatory proteins in blood and saliva. I will then discuss a novel scheme for barcoding microparticles nanoelectronically, for multiplexed detection of analytes. I will then discuss our development
of 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 groups efforts in developing novel
probes for detection of toxic compounds in our regional water sources.
3:50 Future Trends in POC Diagnostics
Jim Sackrison,
Consultant
This talk will discuss the future trends in POC diagnostics and where the field may be in the next 5, 10, 20 years.
4:20 End of Summit