SPECIAL FORUM: Point-of-Care Product Strategies, Market Access, and Implementation
August 19, 2024 ALL TIMES EDT
The Point-of-Care Product Strategies, Market Access, and Implementation Special Forum will review the emerging technologies, including generative AI, to provide a more customized healthcare delivery experience and improved access. It will explore the growing applications of POCT in the field of oncology for early screening and therapy selection. Pharmacogenetic testing at point-of-care is poised to transform the field of companion diagnostics by providing a valuable means of testing prior to treatment and during clinical trials to monitor progress. Lastly, it will delve into the use of PCR for rapid and decentralized testing to allow testing that is closer to the patient and led by consumers.

Chairperson:
Lawrence Worden, Founder, Principal, IVD Logix

Monday, August 19

Registration Open and Morning Coffee

Organizer's Welcome Remarks

Erin Kadelski, Associate Project Manager, Production, Cambridge Healthtech Institute

ASSESSING THE OPPORTUNITY AND VIABILITY OF POCT SOLUTIONS

Chairperson's Remarks

Lawrence Worden, Founder, Principal, IVD Logix , Principal , IVD Logix LLC

The Evolving Role of POCT Coordinators in Healthcare Systems and How IVD Manufacturers Can Support Them

Photo of Jeanne Mumford, MLS(ASCP), Manager, Point-of-Care Testing, Johns Hopkins Hospital , Manager , Point-of-Care Testing , Johns Hopkins Hospital
Jeanne Mumford, MLS(ASCP), Manager, Point-of-Care Testing, Johns Hopkins Hospital , Manager , Point-of-Care Testing , Johns Hopkins Hospital

In this session, we’ll take a look back at the evolution of point-of-care testing in the last several decades and how it has shaped the role of the point-of-care coordinator. Then, we’ll break down the responsibilities of the POCT coordinator and offer some insights on what tools vendor reps can develop to offer support to a POCT program.

THE PROMISE OF AI IN POCT APPLICATIONS

How Can Women Get Better Access to Healthcare? Point-of-Care and AI Hold the Answer

Photo of Peggy Robinson, CEO, Caza Health LLC , CEO , Caza Health LLC
Peggy Robinson, CEO, Caza Health LLC , CEO , Caza Health LLC

So few women have access to OB/GYN care locally. AI diagnosis in a family practice office may hold the solution. This talk will explore the impact that self-collection and drop-off of specimens plus the potential for more point-of-care testing using artificial intelligence can have in giving women better access to healthcare.

Intelligent Diagnostics Fusion: The Synergy of Generative AI and POCT

Photo of Bernard Gouget, PhD, Chair, IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MHBLM) , Chair IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MHBLM) , Public Health , IFCC
Bernard Gouget, PhD, Chair, IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MHBLM) , Chair IFCC Committee on Mobile Health and Bioengineering in Laboratory Medicine (C-MHBLM) , Public Health , IFCC

The presentation explores the synergy between smart point-of-care testing (POCT) technologies and Generative AI. By leveraging these tools, novel models for collaborative and integrated care systems emerge, revolutionizing healthcare delivery. This interdisciplinary approach promises to enhance diagnostic accuracy, streamline processes, and optimize patient outcomes. By embracing innovation at the intersection of healthcare and technology, this approach aims to redefine standards in healthcare delivery and prioritize patient-centered care.

Coffee Break in the Exhibit Hall with Poster Viewing

EXPANDING THE ROLE OF POCT FOR ONCOLOGY

Chairperson's Remarks 

Charudutt Shah, President, Modern Diagnostics , Chief Business Officer , Modern Diagnostics

Applying Current Oncology Screening Technologies in Low- and Middle-Income Countries

Photo of Lucy Hattingh, MBA, Principal, Lucy Hattingh Consulting , Principal , Lucy Hattingh Consulting
Lucy Hattingh, MBA, Principal, Lucy Hattingh Consulting , Principal , Lucy Hattingh Consulting

This talk will cover the current status of implementation of oncology screening technologies as they relate to different cancers and to countries at different income levels within the World Bank-designated group of nations who fall into the general category of low- and middle-income countries. It will also address ways in which these countries are planning to address the rising incidence of cancer as the lifestyle of their populations improves.

From High-Throughput to Point-of-Care Oncology Testing: Cutting-Edge Genotyping Chemistries

Photo of Florent Chang-Pi-Hin, PhD, Vice President, R&D Life Science, Meridian Bioscience , VP R&D , Life Science R&D , Meridian Bioscience Europe
Florent Chang-Pi-Hin, PhD, Vice President, R&D Life Science, Meridian Bioscience , VP R&D , Life Science R&D , Meridian Bioscience Europe

Advancements in PCR technology hold great promise for point-of-care oncology testing, offering rapid and accurate detection of crucial biomarkers. Meridian’s unique and innovative technologies streamline workflows, enable precise allelic discrimination, and have compatibility with lyophilization bringing oncology testing closer to the patient, enhancing its accessibility. These novel chemistries detect biomarkers directly from various samples without extraction and with exceptional sensitivity, revolutionizing genetic testing and bringing faster genotyping to point-of-care settings.

Pharmacogenetics at the Point-of-Care: Case Study

Photo of Charudutt Shah, President, Modern Diagnostics , Chief Business Officer , Modern Diagnostics
Charudutt Shah, President, Modern Diagnostics , Chief Business Officer , Modern Diagnostics

Precision medicine is exciting everyone in healthcare because personalized companion diagnostics and pharmacogenetics are becoming the norm. Day after day there is an impressive list of very expensive and targeted therapies being approved by regulatory bodies and many more are in the pipeline. Testing prior to treatment or testing prior to trial of drugs will remain an important paradigm in field of CDx. 

Pharmacogenetic testing at point-of-care is poised to revolutionize the field of CDx. Case studies of successful pharmacogenetic technologies at POC and collaboration between pharmaceutical and diagnostics companies to commercialize these PGx solutions will be presented.

Panel Moderator:

PANEL DISCUSSION:
Expanding the Role of POCT for Oncology

Photo of Charudutt Shah, President, Modern Diagnostics , Chief Business Officer , Modern Diagnostics
Charudutt Shah, President, Modern Diagnostics , Chief Business Officer , Modern Diagnostics

Panelists:

Photo of Florent Chang-Pi-Hin, PhD, Vice President, R&D Life Science, Meridian Bioscience , VP R&D , Life Science R&D , Meridian Bioscience Europe
Florent Chang-Pi-Hin, PhD, Vice President, R&D Life Science, Meridian Bioscience , VP R&D , Life Science R&D , Meridian Bioscience Europe
Photo of Lucy Hattingh, MBA, Principal, Lucy Hattingh Consulting , Principal , Lucy Hattingh Consulting
Lucy Hattingh, MBA, Principal, Lucy Hattingh Consulting , Principal , Lucy Hattingh Consulting

Close of POC Product Strategies, Market Access, and Implementation Special Forum

Tuesday, August 20

PLENARY SESSION

PLENARY KEYNOTE PRESENTATION:
FDA Perspectives: Trends and Challenges

Photo of Courtney H. Lias, PhD, Director, OHT7: Office of in vitro Diagnostic Devices, United States Food and Drug Administration (FDA) , Director , Office of In Vitro Diagnostic Devices , FDA CDER
Courtney H. Lias, PhD, Director, OHT7: Office of in vitro Diagnostic Devices, United States Food and Drug Administration (FDA) , Director , Office of In Vitro Diagnostic Devices , FDA CDER

Panel Moderator:

PLENARY PANEL:
Laboratory-Developed Tests: Proposed Rule, Reclassification Activities, Potential Impact, and Path Forward

Photo of B. Melina Cimler, PhD, CEO & Founder, PandiaDx LLC , CEO & Founder , PandiaDx LLC
B. Melina Cimler, PhD, CEO & Founder, PandiaDx LLC , CEO & Founder , PandiaDx LLC

Panelists:

Photo of Stefan Burde, PhD, Director, Global Strategic Business Development, TÜV SÜD America, Inc. , Dir Global Strategic Bus Dev , Global Strategic Bus Dev , Tuev Sued America Inc
Stefan Burde, PhD, Director, Global Strategic Business Development, TÜV SÜD America, Inc. , Dir Global Strategic Bus Dev , Global Strategic Bus Dev , Tuev Sued America Inc
Photo of Girish Putcha, MD, PhD, Principal & Founder, Precision Medicine & Diagnostics , Principal , Precision Medicine & Diagnostics LLC
Girish Putcha, MD, PhD, Principal & Founder, Precision Medicine & Diagnostics , Principal , Precision Medicine & Diagnostics LLC
Photo of Lakshman Ramamurthy, PhD, Vice President, Regulatory Affairs, GRAIL , Vice President, Regulatory Affairs , GRAIL Inc.
Lakshman Ramamurthy, PhD, Vice President, Regulatory Affairs, GRAIL , Vice President, Regulatory Affairs , GRAIL Inc.
Photo of Anna Scrimenti, Associate Director, Public Policy & Advocacy, Association for Molecular Pathology , Assoc Director, Public Policy and Advocacy , Public Policy & Advocacy , Association for Molecular Pathology
Anna Scrimenti, Associate Director, Public Policy & Advocacy, Association for Molecular Pathology , Assoc Director, Public Policy and Advocacy , Public Policy & Advocacy , Association for Molecular Pathology