Regulatory Strategies for POC Diagnostics | Next Generation Dx Summit | August 19-21

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

8:20 AM

Organizer's Welcome Remarks

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

8:25 AM

Co-Chairperson's RemarksÂ

Alberto Gutierrez, PhD, Partner, NDA Partners LLC , Partner , NDA Partners LLC

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

8:30 AM

KEYNOTE PRESENTATION:
Brief Review of Key Topics for Successful POC Submissions

Photo of Timothy Stenzel, MD, PhD, Former Director, Office of in vitro Diagnostics and Radiological Health, FDA , Dir , Ofc of In Vitro Diagnostics & Radiological Health , FDA CDER — Timothy Stenzel, MD, PhD, Former Director, Office of in vitro Diagnostics and Radiological Health, FDA , Dir , Ofc of In Vitro Diagnostics & Radiological Health , FDA CDER

Brief Review of Key Topics for Successful POC Submissions.

Panel Moderator:

9:00 AM

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

Photo of Gail Radcliffe, PhD, President, Radcliffe Consulting, Inc. , President , Radcliffe Consulting Inc — Gail Radcliffe, PhD, President, Radcliffe Consulting, Inc. , President , Radcliffe Consulting Inc

Panelists:

Photo of Teresa Abraham, PhD, Vice President, Scientific and Technical Affairs, Sapphiros , Director, External Partnerships , Scientific & Tech Partnerships , Sapphiros — Teresa Abraham, PhD, Vice President, Scientific and Technical Affairs, Sapphiros , Director, External Partnerships , Scientific & Tech Partnerships , Sapphiros

Photo of Alberto Gutierrez, PhD, Partner, NDA Partners LLC , Partner , NDA Partners LLC — Alberto Gutierrez, PhD, Partner, NDA Partners LLC , Partner , NDA Partners LLC

Photo of Michaela R. Hoffmeyer, Director, Regulatory Affairs and Data Management, TE Medical Innovations , Dir Regulatory Affairs , Regulatory Affairs & Data Mgmt , TE IVD Solutions — Michaela R. Hoffmeyer, Director, Regulatory Affairs and Data Management, TE Medical Innovations , Dir Regulatory Affairs , Regulatory Affairs & Data Mgmt , TE IVD Solutions

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

Photo of Chermaen Lindberg, President, CovarsaDx Corporation , President , Covarsa — Chermaen Lindberg, President, CovarsaDx Corporation , President , Covarsa

10:30 AM

Coffee Break in the Exhibit Hall with Poster Viewing

PLENARY SESSION

11:30 AM

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:

12:00 PM

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, TÃœV SÃœD America, Inc. , Dir Global Strategic Bus Dev , Global Strategic Bus Dev , Tuev Sued America Inc — Stefan Burde, PhD, Director, Global Strategic Business Development, TÃœV SÃœD 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

1:10 PM

Luncheon Presentation (Sponsorship Opportunity Available) or Enjoy Lunch on Your Own

2:10 PM

Close of Regulatory Strategies for Point-of-Care Dx Conference

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