PMC Policy Committee Meeting April 24, 2018 12:00 p.m. ET – Welcome & Introduction Darryl Pritchard, Ph.D. Senior Vice President, Science Policy Personalized Medicine Coalition 14th Annual State of Personalized Medicine Luncheon Address, releasing “Public Perspectives on Personalized Medicine: A Survey of U.S. Public Opinion” May 23, 2018 National Press Club Washington, D.C. Personalized Medicine & Diagnostics Track (co-hosted by PMC/BIO) at the 2018 BIO International Convention June 4-7, 2018 Boston Convention & Exhibition Center Boston, MA (continued)

PMC Policy Committee Meeting April 24, 2018 12:10 p.m. ET – A Discussion of CMS’ Final National Coverage Determination for Next Generation Sequencing for Medicare Beneficiaries with Advanced Cancer Introduction: Cynthia A. Bens Senior Vice President, Public Policy Personalized Medicine Coalition   Guest speaker: Katherine B. Szarama, Ph.D. Analyst Division of Medical and Surgical Services Coverage and Analysis Group Center for Clinical Standards and Quality Centers for Medicare and Medicaid Services (continued)

PMC Policy Committee Meeting April 24, 2018 1:10 p.m. ET – Business Meeting Cynthia A. Bens Senior Vice President, Public Policy Personalized Medicine Coalition Public Policy Updates CMS’ Coverage of Next Generation Sequencing for Medicare Beneficiaries with Advanced Cancer "Diagnostic Accuracy and Innovation Act (DAIA)” NIH and FDA Appropriations “Advancing Access to Precision Medicine Act” Patient Advocacy Organization Working Group Pharma & Diagnostics Working Group FDA Tissue Agnostic Therapies: Regulatory Considerations for Orphan Drug Designation Workshop and Comment Opportunity (continued)

PMC Policy Committee Meeting April 24, 2018 1:10 p.m. ET – Business Meeting (cont’d) Daryl Pritchard, Ph.D. Senior Vice President, Science Policy Personalized Medicine Coalition Science Policy Updates Final guidance documents on use of databases for regulatory oversight of next-generation sequencing tests Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics Considerations for Design, Development and Analytical Validation of NGS-Based In Vitro Diagnostics of Suspected Germline Diseases Integration of Personalized Medicine into Health Care Initiative Health Care Working Group The Integration of Personalized Medicine into U.S. Health Systems: A Landscape Analysis

PMC Policy Committee Meeting April 24, 2018 1:10 p.m. ET – Business Meeting (cont’d) Daryl Pritchard, Ph.D. Senior Vice President, Science Policy Personalized Medicine Coalition Science Policy Updates (cont’d) The Clinical and Economic Value of Whole Exome Sequencing (WES) in Rare and Undiagnosed Diseases Consumer Genetic Testing: Updating PMC’s Informational Guide Clinical and Economic Value of Next-Generation Sequencing Diagnostics ASCO Annual Meeting June 1-5, 2018, Chicago, IL Value Assessment Frameworks ISPOR Annual International Meeting May 20-23, 2018, Baltimore, MD New Business