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 Remarks

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

    Co-Chairperson's Remarks 

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

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

    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:

    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

    Coffee Break in the Exhibit Hall with Poster Viewing

    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, 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

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