2024 ARCHIVES
Tuesday, August 20
Registration Open10:30 am
FDA Perspectives: Trends and Challenges
Courtney H. Lias, PhD, Director, OHT7: Office of in vitro Diagnostic Devices, United States Food and Drug Administration (FDA)
Laboratory-Developed Tests: Proposed Rule, Reclassification Activities, Potential Impact, and Path Forward
B. Melina Cimler, PhD, CEO & Founder, PandiaDx LLC
Laboratory-developed tests (LDTs) are an important part of healthcare. The FDA released a final rule on May 6, 2024, to amend the FDA’s regulations to make explicit that IVDs are devices under the Federal FD&C Act, including when the manufacturer of the IVD is a laboratory. FDA issued a policy under which the FDA intends to provide greater oversight of LDTs, through a phaseout of its general enforcement discretion approach.
This panel brings together stakeholders to:
Stefan Burde, PhD, Director, Global Strategic Business Development, TÜV SÜD America, Inc.
Girish Putcha, MD, PhD, Principal & Founder, Precision Medicine & Diagnostics
Lakshman Ramamurthy, PhD, Vice President, Regulatory Affairs, GRAIL
Anna Scrimenti, Associate Director, Public Policy & Advocacy, Association for Molecular Pathology
Enjoy Lunch on Your Own1:10 pm
Organizer's Welcome Remarks2:25 pm
Erin Kadelski, Associate Project Manager, Production, Cambridge Healthtech Institute
Chairperson's Remarks
Giulia Pilla, PhD, Clinical Lead, Nostics
Point-of-Care 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, portable, 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-nano particles used in different biological assays.The validation of the device with clinical samples will be shown in the talk. The setup is user-friendly and can be easily adaptable to different diagnostic applications.
A Novel Point-of-Care Diagnostics Platform to Revolutionize Antibiotic Prescription Practices
Nostics is developing a point-of-care diagnostics platform integrating photonics, nanotechnology, and machine learning, to detect and identify pathogens at species-level within minutes. With our first application DUTI, we target the identification of bacteria causing urinary tract infections from urine samples during the first patient visit, enabling more effective antibiotic treatments. The platform can be expanded to other pathogens (e.g., fungi) and sample types (e.g., blood cultures), revolutionizing infectious disease testing.
Developing Cost-Effective, Rapid-Response Diagnostics for Snakebite Envenomation in Decentralized Healthcare Settings
Jonas Jürgensen, MSc, Co-Founder, CEO, VenomAid
Snakebite envenoming, one of the world's most neglected diseases, causes significant morbidity and mortality annually. Diagnosis largely relies on patient history and symptomatic assessment, with the availability of diagnostic tests varying globally. Timely diagnosis and treatment are warranted, emphasizing the need for novel, rapid, and affordable diagnostics to improve outcomes in both established and decentralized healthcare settings. This could enhance patient outcomes and reduce costs in resource-scarce healthcare institutions worldwide.
Refreshment Break in the Exhibit Hall with Poster Viewing4:05 pm
Point-of-Care Diagnostics for Global Health
David Erickson, PhD, SC Thomas Sze Director, Professor, Director, PORTENT Center for Point-of-Care Technologies for Nutrition, Infection, and Cancer in Global Health, Mechanical, and Aerospace Engineering, Cornell University
In this talk, I will discuss our recent work on the development of, primarily, point-of-care diagnostic technologies for the differential diagnosis of febrile illnesses, quantification of antibiotic resistance, and some virus-causing cancers. In addition to covering the basic engineering science advancements that led to the development of these technologies, I will discuss our strategies for deployment and commercialization.
Innovations to Enable Distributed Diagnostics to Drive Public Health, Medicine and Clinical Trials
Michael J. Mina, MD, PhD, CSO, eMed
Decentralized diagnostics have proven value as critical medical and public health tools, from self pregnancy tests, to HIV self testing, to the international COVID-19 response and much more. However, truly decentralized POC testing is too often seen as antithetical to public health for lack of robust test monitoring, reporting and connectivity to EHRs. In 2022, the Biden Administration and the NIH launched the Home Test to Treat Program to leverage home diagnostics to support fast treatment and public health reporting. That program leveraged eMed's Test-to-Treat platform, developed in conjunction with the CDC, and enabled millions of Americans to return to the US during the early days of the pandemic, based on a self test. With appropriate innovations, distributed diagnostics can overcome traditional barriers and accelerate medicine, trials and responses to public health emergencies.
Close of Day5:45 pm
Wednesday, August 21
Registration Open7:15 am
Interactive Discussions with Continental Breakfast7:30 am
Interactive discussions provide an opportunity to discuss a focused topic with peers from around the world in an open, collegial setting. Select from the list of topics available and join the moderated discussion to share ideas, gain insights, establish collaborations or commiserate about persistent challenges. Please visit the interactive discussions page on the conference website for a complete listing of topics and descriptions.
TABLE 1: How to Successfully Partner with DDDI and BARDA (IN-PERSON ONLY BREAKOUT)
Christopher J. Knickerbocker, Contracting Officer Representative, United States Department of Health and Human Services
Kristy Stoudt, PhD, Biologist and Project Officer, Biomedical Advanced Research and Development Authority (BARDA)
Donald G. Klepser, PhD, MBA, Professor and Senior Associate Dean for Academic Affairs, College of Pharmacy, University of Nebraska Medical Center
Reimbursement Models That Support Sustainable and Scalable Point-of-Care Testing Services in Non-Traditional Settings
With recent legislative changes, many regulatory barriers to providing point-of-care testing services in pharmacies and other non-traditional settings have been removed. Reimbursement for services in these settings remains as the largest barrier to wide-scale adoption and sustainability. While a barrier, models exist to reimburse providers for their services. In this session, current and potential reimbursement models for non-traditional settings will be presented along with the role diagnostic manufacturers can play in supporting reimbursement efforts.
Transforming Colorectal Cancer Screening: A Collaborative, Novel Approach to Patient-Direct Cologuard Testing
Tom Draney, MHA, Associate Director, Customer Experience, Exact Sciences
Kate Sowerwine, MD, CMO, Recuro Health
Explore the success story of our innovative collaboration, where Recuro Health's virtual care delivery seamlessly integrates with Exact Sciences, bringing large-scale colorectal cancer screening and care to patients nationwide within the comfort of their homes. Our talk will highlight the program's practical value, the rich data generated, and its notable success so far for Exact Sciences.
Zero to Waiver: Challenges, Innovation, Lessons and Principles
Chris Harder, PhD, Chief Technology Officer, Kenota Health
Join me on a journey of developing an IVD medical device from scratch to obtaining CLIA Waiver. The challenges of creating a non-conventional Point-of-Care IVD are unique and varied. I will take you through the development process during the pandemic (non-COVID), from concept to regulatory clearance. I’ll describe our innovation, share the challenges we encountered, explore the lessons we learned, and outline the principles we believe enable success. The goal is to inform, encourage, share, and inspire others on this journey and suggest ways to collaborate in bringing safe and effective products to market as soon as possible.
Networking Coffee Break10:00 am
Operationalizing a Service and Expanding the Scope of the Community Pharmacist
Brian Strong, PharmD, Director, New Services Development, Walgreens Co.
As patient needs evolved throughout the pandemic, Walgreens stepped up to uncover and address the challenges and root issues that continue to impact community health. From parking lot testing sites to over 7000 testing locations, learn how Walgreens operationalized testing, assessment, and treatment services to not only offer alternatives to traditional channels but also allow our pharmacists to provide services to and help bridge care gaps.
Pushing Past the Tipping Point: Scalability of Pharmacy-Based Testing Models
Michael E. Klepser, PharmD, FCCP, FIDP, Professor, Ferris State University College of Pharmacy
During this session, panelists will: discuss the current state of community-based POCT services, provide prospective about the types of POCT and services that have been successful, identify historical barriers that have begun to fall, discuss what needs to happen to allow for testing services to continue to grow and expand, and suggest future tests and services that may be viable in this space.
John Warren, Owner and Principal Consultant, Gettysburg Healthcare Consulting, LLC
Enjoy Lunch on Your Own12:00 pm
Adam S. Chesler, PharmD, MBA, Senior Vice President, Pharmacy Integration and Strategic Alliances, VillageMD
Nationwide Study of Influenza POCT in U.S. Community Pharmacies
Kenneth C. Hohmeier, PharmD, Associate Professor, Director of Community Affairs, PGY-1 Community-Based Pharmacy Residency Program, The University of Tennessee Health Science Center
Community pharmacists remain one of the most accessible healthcare providers in the U.S., with 9 in 10 Americans living within five miles of a pharmacy. Post-pandemic, there continues a shift in the perception of the role of the pharmacist as it relates to acute infectious disease treatment. However, there is sparse literature on pharmacist POCT service impact. This session will shed light on the topic with insights from a nationwide study.
Supporting CLIA-Waived POCT in Community Pharmacies
Integrating CLIA-waived POCT into the workflow of a pharmacy is critical to the success of a testing service. Means to track scheduling, clinical notes, and other data are essential for such programs. Additionally, understanding and tracking compliance with state-level legislative requirements for disease reporting, record keeping, and training of personnel is vital.
Empowering Pharmacists—Point-of-Care Testing for Enhancing Patient Care
This presentation aims to empower pharmacists and technicians in point-of-care testing (POCT) for improved patient care. Attendees will gain insights into the pivotal role pharmacists and technicians can play in POCT, explore the process and workflow of pharmacy-conducted POCT, and discover how these practices can elevate value-based care.
How Point-of-Care Testing Can Fight Antibiotic Resistance—Antimicrobial Stewardship and the CHARM Project
Benjamin Pontefract, PharmD, BCPS, Director of Research, CHARM; Assistant Professor, College of Pharmacy, Ferris State University
Point-of-care testing (POCT) provides unprecedented amounts information to outpatient healthcare practitioners. If used correctly, these tests can help reduce inappropriate antibiotic use by a substantial amount. In this talk, we will discuss how the appropriate use of POCTs can fuel antimicrobial stewardship efforts. We will also discuss the Collaboration to Harmonize AntiMicrobial Registry Measures (CHARM) project and how tracking antibiotic use is essentially to monitoring antimicrobial stewardship efforts.
Close of Summit3:15 pm
2025 Conference Programs
Enabling Point-of-Care Diagnostics
Advanced Diagnostics for Infectious Disease
Coverage and Reimbursement for Advanced Diagnostics
Clinical Biomarkers and Companion Diagnostics
Early Cancer Surveillance
Liquid Biopsy for Disease Management