2024 ARCHIVES

SPECIAL FORUM: Regulatory Strategies for Point-of-Care Diagnostics

August 20, 2024 ALL TIMES EDT

The Regulatory Strategies for Point-of-Care Diagnostics Special Forum will allow you to learn from industry experts who will share their insights and experience with success stories as well as guidance for obtaining FDA clearance for POC diagnostics. Join us for the first of its kind forum designed for learning about essential components and nuances that are pivotal for regulatory approval. For companies developing POC diagnostics, this is an unprecedented chance to gain insights and avoid costly pitfalls later in development. We hope to see you this August for a highly productive and interactive forum.

Co-Chairpersons:
Alberto Gutierrez, PhD, Partner, NDA Partners LLC
Gail Radcliffe, PhD, President, Radcliffe Consulting, Inc.

Tuesday, August 20

Organizer's Welcome Remarks8:20 am

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

8:25 am

Co-Chairperson's Remarks

Alberto Gutierrez, PhD, Partner, NDA Partners LLC

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

8:30 am KEYNOTE PRESENTATION:

Brief Review of Key Topics for Successful POC Submissions

Timothy Stenzel, MD, PhD, Former Director, Office of in vitro Diagnostics and Radiological Health, FDA

Brief Review of Key Topics for Successful POC Submissions.

9:00 am PANEL DISCUSSION:

Regulatory Strategies for Point-of-Care Diagnostics: Learning from Success Stories and Avoiding Pitfalls

PANEL MODERATOR:

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

How many samples do I need for a multiplex respiratory panel clinical study?
Multiplexing for non-respiratory tests—what is needed for clinical studies and analytical studies?
Understanding differences between OTC and POC products for labeling and flex studies
CLIA vs. Non-CLIA waived pathways—what is needed for waiver clinical studies?
How do you control clinical studies in an uncontrolled environment?
Addressing user training issues
Increased reliance on unconditional labeling such as pictograms, and video accessed via QR codes and hyperlinks. Are these methods accepted by FDA? Pros and cons of these tools
Precision and reproducibility study designs with untrained users for POC tests using inactivated viruses
Flex studies—not used for 510K but used for CLIA waiver. How does one determine what is needed? e.g., timing, volume, temperature, pressure, etc.
Mechanics of running a CLIA waiver trial, using comparators that are in the central lab which requires sample stability during transport—example glucose testing
The importance of clinical matrix in analytical studies
Key studies for OTC diagnostic claims

PANELISTS:

Teresa Abraham, PhD, Vice President, Scientific and Technical Affairs, Sapphiros

Alberto Gutierrez, PhD, Partner, NDA Partners LLC

Michaela R. Hoffmeyer, Director, Regulatory Affairs and Data Management, TE Medical Innovations

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

Chermaen Lindberg, President, CovarsaDx Corporation

Coffee Break in the Exhibit Hall with Poster Viewing10:30 am

11:30 am PLENARY KEYNOTE PRESENTATION:

FDA Perspectives: Trends and Challenges

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

12:00 pm PLENARY PANEL:

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

PANEL MODERATOR:

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: