2026 PLENARY SESSION

TUESDAY, AUGUST 25 | 11:30 – 11:40 AM

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)

TUESDAY, AUGUST 25 | 11:40 AM – 12:15 PM

Plenary Fireside Chat: Regulatory Outlook for Diagnostics

The diagnostics industry is experiencing the first-ever detection milestones driven by artificial intelligence (AI) and multi-biomarker tests. Regulatory oversight needs to keep step with technology progress and innovation. Featuring perspectives from FDA leaders and industry experts, this plenary session will examine the regulatory, economic, and policy forces shaping the future of diagnostic innovation.

PANEL MODERATOR:
Brian P. Carey, JD, Partner, Hogan Lovells US LLP

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

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

Zach Rothstein, JD, Executive Director, AdvaMedDx

Susan Van Meter, President, American Clinical Laboratory Association

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

TUESDAY, AUGUST 25 | 12:15 – 1:05 PM

Plenary Fireside Chat: Business of Diagnostics and Future Outlook

PANEL MODERATOR:
Phillips Kuhl, Founder & Chairman, Cambridge Healthtech Institute

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

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

Elissa Quinn, Medical Director, Cancer Screening & Early Detection, AstraZeneca

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