1. 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
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2. 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
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3. 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
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4. 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

5. 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