PLENARY PANEL DISCUSSIONS

Tuesday, August 23 | 11:25 AM – 12:15 PM

LEGISLATIVE EFFORTS TO MODERNIZE DIAGNOSTIC OVERSIGHT

  • Why has there been a sustained, multi-year push for legislation to modernize the regulatory and oversight landscape for diagnostics?
  • How will leading legislative proposals, like the Verifying Accurate Leading-edge IVCT Development (VALID) Act, change diagnostics regulation and oversight? What impacts will these changes have on the diagnostics industry and on patient care?
  • How have legislative proposals such as the VALID Act evolved over time based on extensive stakeholder feedback and technical assistance from the federal agencies?
  • Are there lessons from the COVID-19 pandemic that the Food and Drug Administration and the diagnostics industry have learned that will serve as a foundation for regulatory and oversight activities in the future?

PANEL MODERATOR:
Cynthia A. Bens, Senior Vice President, Public Policy, Personalized Medicine Coalition

PANELISTS:
Jeff Allen, PhD, President and CEO, Friends of Cancer Research
Zach Rothstein, PhD, Executive Director, AdvaMedDx, and Senior Vice President, Technology & Regulatory Affairs, AdvaMed
Sarah Thibault-Sennett, PhD Director, Public Policy & Advocacy, Association for Molecular Pathology
Lauren R. Silvis, PhD, Senior Vice President, External Affairs, Tempus, Inc.
Susan Van Meter, President, American Clinical Laboratory Association

Tuesday, August 23 | 12:15 PM – 1:00 PM

SELF-TESTING- APPLYING WHAT WE HAVE LEARNED FROM THE PANDEMIC FOR FUTURE APPLICATIONS

  • In your opinion, what is the single most important advance in diagnostic testing that has occurred with the COVID-19 pandemic?
  • What are the pluses and minuses of self-swabbing for respiratory viruses (can be other specimen sources for self-collections, e.g., HPV, STD)?
  • What are the pluses and minuses of self-testing for respiratory viruses (e.g., COVID self-testing antigen tests)?
  • What have we learned from the EUA FDA approval process for COVID testing (antigen, nucleic acid amplification, antibody)? Can this approach be applied for any LDT validation as proposed by the FDA?
  • What is the next big advance you see in diagnostic testing especially related to self-collection and self-testing?

PANEL MODERATOR:
Franklin R. Cockerill III, MD, Founding Partner, Trusted Health Advisors; Adjunct Professor, Medicine, Rush University

PANELISTS:
Karen A. Heichman, PhD, Deputy Director, Bill & Melinda Gates Foundation
Jack Jeng, MD, MBA, CMO Hone Health
Elizabeth M. Marlowe, PhD, D(ABMM) Senior Scientific Director, Head R&D Infectious Diseases & Immunology, Quest Diagnostics Nichols Institute
Raquel M Martinez, PhD, Director, System & Core Lab, Clinical & Molecular Microbiology, Geisinger Health System
Nicole Zitterkopf, PhD, D(ABMM), MPH, MT(ASCP), Vice President Laboratory, Service Line Advancement Team, OptumHealth