PLENARY SESSION

Constitution A&B

Wednesday, August 21
11:30-11:40Am

Chairperson’s Remarks

Charles Mathews, Principal, ClearView Healthcare Partners

11:40Am-12:10pm

Plenary Keynote Presentation: FDA Updates: Now and Looking to the Future

Katherine Donigan, PhD, Acting Director of Personalized Medicine, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration

Introduction and background of the new Office Director of OIR and updates on precision medicine and other initiatives at the FDA.

12:10-1:05pm

Plenary Keynote Discussion: Proposals and Solutions for Diagnostic Reform Including Oversight of Laboratory Developed Tests (LDTs)

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

• How are stakeholders influencing congressional activity on the Verifying Accurate Leading-edge IVCT Development (VALID) Act?
• How will the VALID Act change the current oversight landscape for diagnostics, including LDTs?
• How are policymakers addressing the role of CMS and CLIA in the VALID Act?
• How will increased regulatory and oversight activities at the FDA affect the diagnostics industry?
• What impact will changes in diagnostics regulation and oversight have on patient care?

Panelists:

Julie Khani, MPA, President, American Clinical Laboratory Association (ACLA)

Donald E. Horton, Jr., Senior Vice President, Global Government Relations & Public Policy, Laboratory Corporation of America Holdings

Susan Van Meter, Executive Director, AdvaMedDx

Tara Burke, PhD, Senior Director, Public Policy & Advocacy, Association for Molecular Pathology (AMP)

Laura Lasiter, PhD, Science Policy Analyst, Friends of Cancer Research