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2026 PLENARY SESSION

Courtney H. Lias, PhD

PLENARY KEYNOTE PRESENTATION:

Outlook for IVDs

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

Plenary Fireside Chat: Regulatory Outlook for Diagnostics

Brian P. Carey, JD

Panel Moderator:
Brian P. Carey, JD
Partner, Hogan Lovells US LLP

Courtney H. Lias, PhD

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

Jai Pandey, PhD

Jai Pandey, PhD
Head, Global Device Regulatory IVD/CDx and Digital Health, Sanofi

Zach Rothstein, JD

Zach Rothstein, JD
Executive Director, AdvaMedDx

Sheila D. Walcoff, JD

Sheila D. Walcoff, JD
Founding Principal & CEO, Goldbug Strategies LLC


Plenary Fireside Chat: Business of Diagnostics and Future Outlook

Phillips Kuhl

Panel Moderator:
Phillips Kuhl
Founder & Chairman, Cambridge Healthtech Institute

Christine C. Ginocchio, PhD

Panelists:
Christine C. Ginocchio, PhD
MT(ASCP), CMO Qiagen

Taylor Jensen, PhD

Taylor Jensen, PhD
Vice President, Head of Science, Oncology, Labcorp

Ipsita G. Smolinski, MBA

Ipsita G. Smolinski, MBA
Managing Director, Capitol Street; Faculty, Georgetown University

WHY ATTEND

Breakthrough Tech. Expert Insights. Real-World Impact.

  • 400+ diagnostics professionals from across the industry
  • 130+ speakers leading innovation in clinical and molecular Dx
  • 6 highly focused tracks spanning emerging technologies and commercial strategy
  • Unmatched networking with partners, labs, regulators, and investors
  • Emerging company spotlight with novel platform technologies

Next Generation Dx Summit is where the diagnostics ecosystem converges to accelerate innovation and expand patient access

EVENT SNAPSHOT

Gain the latest insights in:

  • Clinical implementation and validation of diagnostic technologies
  • Point-of-care innovation and at-home testing
  • Early detection and enhanced screening of single cancers and MCEDs
  • AI, digital, and emerging applications in companion diagnostics
  • AI in lab management, testing, clinical decision support, and analysis
  • Regulatory trends, including FDA, CMS, PAMA, and IVDR

Who Attends?

  • Clinical and hospital lab leaders
  • Molecular and assay development teams
  • Diagnostic platform developers and manufacturers
  • Regulatory, quality, and compliance professionals
  • Commercial, business development, and strategy leaders
  • Investors and innovation scouts

Hear from Past Attendees on What Makes the Next Generation Dx Summit a Unique and Must-Attend Event

Testimonials Video One
Testimonials Video One

Scenes from Next Generation Summit

Engage with Next Generation Dx Summit: Key Contacts

Christina Lingham

For meeting questions or suggestions, please contact:

Christina Lingham
Executive Director,
Conferences and Fellow
Cambridge Healthtech Institute
(+1) 508-813-7570
email

Christine Benners

For media and association partnerships, please contact:

Christine Benners
Director of Product Marketing
Cambridge Healthtech Institute
email

Jon Stroup

For partnering & sponsorship,
please contact:

Jon Stroup
Lead Business Development Manager
Cambridge Healthtech Institute
(+1) 781-972-5483
email