Board of Directors Meeting
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BOARD OF DIRECTORS MEETING December 15, 2016 CSIS Building WASHINGTON, D.C. PERSONALIZED MEDICINE COALITION BOARD MEETING December 15, 2016 10:00 a.m. to 2:00 p.m. CSIS Building Washington, D.C. 9th Floor Turret Room Agenda Chairman’s Report 1. Approval of May 25, 2016 Minutes 2. Nominations Committee President’s Report 3. 2016 Progress Report 4. Plans for 2017 5. Finance and Budget 6. Membership 7. Public Policy 8. Science Policy 9. Communications New Business December 2016 Board Meeting Table of Contents Agenda 1. Minutes – May 25, 2016 2. Nominations • Current Board Members • Board Composition by Category • Board of Directors Duties • Bylaws 3. Progress Report • 2016 Progress Report • Conference Program (back pocket) 4. Plans for 2017 • Strategic Plan for 2017 • Clinical and Economic Value of Next-Generation Sequencing • The Personalized Medicine Education Initiative • International Comparative Landscape Analysis • Evidence for Coverage and Payment of Personalized Medicine Diagnostics • Personalized Medicine in Value Assessment Frameworks • Turning the Tide Against Cancer 2017 Conference Prospectus • CRD Proposal: Public Policy • Jen Leib Biography • PMC Vice President, Public Policy: Job Description • Kayla Smith Resume 5. Finance and Budget • 2017 Budget • Historical Budget • 2016 Sponsorships • Friends of PMC • Cash and Investments • Chart: Revenues & Expenses • Chart: Membership & Financial Performance • Chart: Cumulative Net Assets • Investment Detail 6. Membership Status • Chart: PMC Membership Numbers • Dues Schedule for Members and Sponsors • Organizations that have withdrawn from PMC since 2007 • Chart: Analysis of 2015 and 2016 Membership Non-Renewal by Reason • 2016 and 2017 New Members • Target List for 2017 Membership • List of PMC Members • Chart: PMC Membership Numbers by Category • 2016 Sponsorships 7. Public Policy • Letter to CMS on 2016 Preliminary Gapfill Payment Determinations • 2016 BIO International Convention: Personalized Medicine and Diagnostics Program Track • Letter to ICER on Non-Small Cell Lung Cancer Scoping Document • Letter to ICER on Proposed Process Improvements to Value Assessment Framework • Letter to FDA on Codevelopment • “Where We Agree When It Comes to Regulating Laboratory-Developed Diagnostics” in Personalized Medicine in Oncology 8. Science Policy • “Strategies for Integrating Personalized Medicine into Health Care Practice” (Manuscript) • Letter to FDA on Standards for Regulatory Oversight of NGS Oversight and the Use of Public Genetic Variant Databases to Support Clinical Validity for NGS-based IVDs • Policy Meeting Agenda: Envisioning the Value of Personalized Medicine (June 21, 2016) • Policy Meeting Agenda: An Update on the Precision Medicine Initiative (October 11, 2016) • Policy Meeting Agenda: PCORI & FDA in 2017 (December 7, 2016) • PMC Blog: “An Infrastructure for Innovation: How the 21st Cenury Cures Bill Could Establish a More Favorable Landscape for Personalized Medicine in 2017” • The Personalized Medicine Report 9. Communications • Impact Report • 2016 Press Releases 1. PMC to Recognize Raju Kucherlapati With 12th Annual Leadership in Personalized Medicine Award (June 29, 2016) 2. PMC Commends ICER for Extending Public Comment Period for Scope of Work in Non-Small Cell Lung Cancer (Jul 1, 2016) 3. Coalition Applauds Progress on Precision Medicine Initiative, Encourages Additional Efforts in Regulation, Reimbursement (July 7, 2016) 4. PMC Commends ‘Moonshot’ Panel for Recognizing Personalized Medicine’s Importance in Research Recommendations, Encourages Complementary Efforts From Policymakers (September 7, 2016) • 2016 Member Updates o Example • 2016 Blogs 1. Of Moonshots and Precision Medicine: Why the Time is Ripe for a National Cancer Moonshot (Kenna Shaw, Ph.D.: May 19, 2016) 2. Informed Perspectives: A Preview of the Personalized Medicine & Diagnostics Track at the 2016 BIO International Convention (Chris Wells: May 31, 2016) 3. ICER & Personalized Medicine: Time to Engage (Amy Miller, Ph.D.: June 29, 2016) 4. What ICER is Missing (Amy Miller: September 1, 2016) 5. Think the Diagnostics Community Doesn’t Agree on Anything When It Comes to LDT Regulation? Think Again. (Amy Miller: September 20, 2016) 6. Beyond the Barriers: Deconstructing the Regulatory and Reimbursement Hurdles for Companion Diagnostics (Alessandra Cesano, M.D., Ph.D.: October 3, 2016) 7. Can We Assess the Value of Personalized Medicine in Treating Cancer? (Dan Leonard, M.A.: October 19, 2016) 8. It’s Time to Protect Patient Care and Rethink the Way We Define and Assess Clinical Utility in Molecular Diagnostics (Elaine Lyon, Ph.D.: November 4, 2016) 9. A Chancellor’s Tale: Transforming Academic Medicine (Ralph Snyderman, M.D.: November 8, 2016) 10. An Infrastructure for Innovation: How the 21st Century Cures Bill Established a More Favorable Landscape for Personalized Medicine in 2017 (Daryl Pritchard, Ph.D.: December 6, 2016) 11. Advancing the Promise of Personalized Medicine With Liquid Biopsies and Analysis of ctDNA (John Beeler, Ph.D.: December 8, 2016) • Twitter Engagement: @permedcoalition • 2016 Speaking Engagements • 2016 Staff Publications • 2016 Earned Media 2016 Impact Report (spiral-bound) • 2016 Impact Report • List of Staff Publications • List of 2016 Media Mentions • Full Text of Selected Publications & Placements Supplements • Board Directory (front pocket) Finalized Publications (back pocket) • Personalized Medicine in Brief • 12th Annual Personalized Medicine Conference Program 1. Minutes – May 25, 2016 MINUTES OF THE MEETING OF THE PERSONALIZED MEDICINE COALITION BOARD OF DIRECTORS OF MAY 25, 2016 MEMBERS PRESENT: Edward Abrahams (PMC), President; Amy Abernethy (Flatiron Health), Secretary; Donna Cryer (Global Liver Institute); William Dalton (M2Gen), Chair; Neil de Crescenzo (Change Healthcare); Stephen Eck (Astellas), Vice Chair; Michael Kolodziej (Aetna); Howard McLeod (Moffitt); Michael Pellini (Foundation Medicine); Kim Popovits (Genomic Health); Lori Reilly (PhRMA); Hakan Sakul (Pfizer); Jay Wohlgemuth (Quest) OTHERS PRESENT: Amy M. Miller (PMC Executive Vice President); Daryl Pritchard (PMC Vice President, Science Policy); Faswilla Sampson (PMC Director, Operations & Secretary to the Board); Christopher Wells (PMC Director, Communications); Mary Bordoni (PMC Director, Membership & Development); David Davenport (PMC Office Administrator); Marina Polyakova (Rogers & Company Principal) A meeting of the Personalized Medicine Coalition (PMC) Board of Directors was held at the National Press Club in Washington, D.C. A quorum being present, Board Chair William Dalton called the meeting to order at 8:25 a.m. Chairman’s Report Dalton asked for and received approval of the Board meeting minutes of November 21, 2015. Finance and Budget Abrahams introduced Marina Polyakova, Principal of Rogers and Company, PMC’s outside auditor, to explain its report for 2015 (Attachment 1). She noted that PMC is financially sound, with over eight months’ cash reserves and $1.35 million in unrestricted net assets. She informed the Board that while PMC lost about $42,000 in its investment portfolio in 2015 as a result of market fluctuation, the paper loss had not had a significant impact and was in keeping with that experienced by many non- profits during 2015. She also said that PMC’s financial statements were “clean.” Her team, she said, experienced no difficulty when auditing them and confirmed that proper internal controls are in place, thanks to PMC’s careful financial management. Following the presentation of the audit, Dalton asked for and received approval of the IRS Form 990 for 2015 (Attachment 2) that all non-profits are required to file. 1 Leadership Award While there were many strong candidates, the Board identified two finalists for the 12th Annual Award for Leadership in Personalized Medicine: Raju Kucherlapati of Harvard Medical School and Ellen Sigal of Friends of Cancer Research. Kucherlapati received exalted praise and expressions of support from the Board for his work in personalized medicine, as did Ellen Sigal for her forceful leadership. In a subsequent discussion, Amy Abernethy summarized the factors that, in her view, the Board should consider when selecting the winner of the award: leadership, timing, and purpose. Donna Cryer suggested that the Board also consider who best represents PMC’s brand and mission. Jay Wohlgemuth said Kucherlapati has been the premier agent working in personalized medicine across the three areas PMC focuses on: science, business, and policy. A few members raised the concern about various recipients’ availability to accept the award at the conference. Kim Popovits encouraged the Board to consider other means of allowing recipients to accept the award (e.g. video acceptance) and not simply select recipients because they can be present at the conference. The Board unanimously selected Raju Kucherlapati as the recipient of the 2016 Leadership Award. Nominating Committee Noting their commitment to personalized medicine and to PMC, Dalton asked that the current slate of officers be re-elected and serve until the end of the year. They are Bill Dalton, Chair; Stephen Eck, Vice Chair; Stafford O’Kelly, Treasurer; and Amy Abernethy, Secretary. Regarding the growth of the Board, Dalton indicated that the Coalition should focus on securing additional representation from insurance companies, and asked Michael Kolodziej how the Coalition can best meet the needs of insurers. Kolodziej responded that asking for payers to assume a Board seat or become dues-paying