EXPANDING THE FRONTIERS OF PERSONALIZED MEDICINE

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EXPANDING THEFRONTIERS OFPERSONALIZEDMEDICINEThrough Education, Advocacy andEvidence DevelopmentA STRATEGIC PLAN FOR ADVANCING THE FIELD IN 2021

MISSIONThe Personalized Medicine Coalition, representinginnovators, scientists, patients, providers andpayers, promotes the understanding and adoptionof personalized medicine concepts, services, andproducts to benefit patients and the health system.2Expanding the Frontiers of Personalized Medicine

President’s LetterPresident’s LetterDear Colleague:In November 2004, some 20 institutions launched the Personalized MedicineCoalition based on the assumption that a new paradigm in medicine — one that linkstherapies to diagnostics — would not happen just because the science suggests itshould. Then, as now, the Coalition’s supporters contended that the interveningvariables related to public policies and medical practices would condition the pace atwhich personalized medicine delivers on its promise of better patient outcomes andmore efficient health systems.As we examine the landscape for personalized medicine in 2021, this assumptionresonates with increasing clarity. Although the number of personalized drugs withbiomarker strategies on their labels in the United States has grown from five in2008 to 286 today, complicated policy challenges and clinical adoption obstaclescontinue to make it difficult for health care systems around the world to capitalizeon groundbreaking science and technology that point to a new era in the history ofmedicine that for the first time promises to put the individual at the center of care.In fact, amidst the tumult of COVID-19 and a turbulent political landscape, mostAmericans have never heard the words “personalized medicine.”It is in this context that I am pleased to present Expanding the Frontiers of PersonalizedMedicine Through Education, Advocacy and Evidence Development: A Strategic Plan forAdvancing the Field in 2021. With reference to the initiatives PMC will complete withthe support of its more than 210 members, as well as those that we could undertakewith additional sponsorship dollars, this three-part plan outlines our proposed roadmapto the brighter future we can build for patients and health systems with a continuedfocus on targeting the right treatments to the right patients at the right time.Sincerely yours,Edward AbrahamsPresidentExpanding the Frontiers of Personalized Medicine3

OVERVIEWPART I: EDUCATION1. P ersonalized Medicine 101: A Package of Programs Designed toEducate Decision-Makers About the Significance of PersonalizedMedicine (page 6)2. M ore Than a Number: A Patient-Focused Educational CampaignAbout Personalized Medicine and Its Benefits (page 6)PART II: ADVOCACY3. P olicies and Personalized Medicine: A Series of AdvocacyPriorities Designed to Cultivate a Friendlier Landscape forAdvancing the Field (page 8)PART III: EVIDENCE DEVELOPMENT4. U nderstanding and Delivering the Clinical and Economic Benefitsof Personalized Medicine: A Research Program (page 10)Membership (page 12)Board of Directors (page 14)PMC Staff (page 15)4Expanding the Frontiers of Personalized Medicine

PART IEducationAs global leaders adapt to shifting political landscapes and seekto mitigate COVID-19’s impact in 2021, it is imperative that theyunderstand the importance of considering how their choices mayaffect the pace of progress in personalized medicine. With mostconsumers still unaware of what personalized medicine is andwhy it matters, patient-facing educational efforts are also neededto prompt more point-of-care conversations about molecularlytargeted treatments and the ways in which various medicalinterventions can alter patients’ lives.The Coalition’s educational activities will address both of thesechallenges in 2021.

EducationPersonalized Medicine 101:A Package of Programs Designedto Educate Decision-Makers Aboutthe Significance of PersonalizedMedicineMore Than a Number: A PatientFocused Educational CampaignAbout Personalized Medicine andIts BenefitsSupported by PMC Membership Dues andSponsorships for the Annual PersonalizedMedicine ConferenceTo prompt patients to ask their physicians aboutthe extent to which various prevention andtreatment plans are tailored to their biologicalcharacteristics, circumstances, and values,PMC will partner with Genome Creative, acommunications firm dedicated exclusively tosupporting efforts to raise awareness aboutpersonalized medicine, to develop and promotea series of patient-facing educational tools aboutpersonalized medicine across a wide range oftraditional and social media channels. The MoreThan a Number initiative will feature apatient-friendly website with downloadableresources including:PMC’s flagship package of educational programs,titled Personalized Medicine 101, will help decisionmakers track and tackle key challenges facingpersonalized medicine. In 2021, PMC will leverageits traditional and social media presence as wellas its mailing list of 8,000 leaders in the publicand private sectors to maximize the impact of thefollowing educational initiatives:6 T he State of Personalized Medicine in 2021:A Virtual Seminar Exploring the Landscapefor the Field ersonalized Medicine at FDA: The ScopeP& Significance of Progress in 2020(an annual research report) P ersonalized Medicine 101(a one-page overview of the field) U nderstanding Personalized Medicine and ItsSignificance: A Series of Educational BriefingsCo-hosted by PMC and the CongressionalPersonalized Medicine Caucus Personalized Medicine Today(a monthly e-newsletter) P ersonalized Medicine in Brief(a bi-annual print/PDF landscape analysis) The 16th Annual Personalized MedicineConference at Harvard Medical SchoolExpanding the Frontiers of Personalized MedicineA Supplemental Sponsorship Opportunity M ore Than a Number: Better Health BeginsWith You (an educational infographic) A Consumer’s Guide to Genetic Health Testing M oving Beyond Population Averages:A Patient-Centered Research Agenda AdvancingPersonalized MedicineIn Partnership With

PART IIAdvocacyIn recent years, the continued advancement of personalized medicinehas raised new questions about how and when to regulate, pay for,and integrate the innovative diagnostics and treatments underpinningthe field into health systems whose capacity is already stretched byefforts to develop and equitably deploy one-size-fits-all medical interventions. To overcome these challenges, proponents for personalizedmedicine must shape and advocate for policies that will help pave theway for more tailored prevention and treatment plans in 2021.PMC will lead the way in this area.Expanding the Frontiers of Personalized Medicine7

AdvocacyPolicies and Personalized Medicine:A Series of Advocacy PrioritiesDesigned to Cultivate a FriendlierLandscape for Advancing the Fieldresources to support activities at FDA to advancepersonalized medicine in the context of thePrescription Drug and Medical Device User Feeprogram reauthorizations. M odernizing Regulatory Policies: By approvingand clearing personalized medicine products andservices in an efficient manner, FDA facilitatespatient access to the treatments and some teststhat make personalized health care possible.PMC will continue its efforts to ensure thatlegislation, emerging guidances for stakeholders,policies, and major initiatives preserve andimprove the regulatory landscape for the field. M odernizing Coverage and Payment Policies: Toensure that patients have access to personalizedmedicine, PMC advocates for flexible coveragepolicies and adequate payment rates for personalized medicine products and services. PMCwill continue to work with Congress and theCenters for Medicare and Medicaid Services toinform strategies that can document the valueof and facilitate access to personalized medicineto support arrangements that promise betteroutcomes and a more efficient health system. M odernizing Value Assessment Methodologies:By influencing decisions made by patients,providers, payers, and policymakers, valueassessment frameworks (VAFs) could accelerateor undermine progress in personalized medicine.PMC will continue to inform the developmentof VAFs and health technology assessments thataccount for the value of personalized medicine.Supported by PMC Membership DuesTo help facilitate the development of personalizedmedicine tests and therapies, PMC will advocatefor continued investments in biomedical researchas well as modernized regulatory, coverage, andpayment policies that support access to personalized medicine. In 2021, the Coalition’s advocacyefforts will focus on:8 G uiding an Agenda for the CongressionalPersonalized Medicine Caucus: After inspiringthe launch of a Congressional PersonalizedMedicine Caucus through its advocacy onCapitol Hill last year, PMC will continue to play aleading role in shaping an agenda for the caucusand growing the caucus’ membership in 2021. I ncreasing Funding for Critical Federal HealthAgencies: Investments in scientific researchconducted by the National Institutes of Health(NIH) drive many of the discoveries that underpinpersonalized prevention and treatment strategies.The U.S. Food and Drug Administration (FDA)serves as the gateway for many personalizedmedicine products entering the market. Throughcongressional testimonies, public statements,and meetings with members of Congress, PMCwill actively advocate for increases to NIH andFDA’s budgets for FY 2022. PMC will also call forExpanding the Frontiers of Personalized Medicine

PART IIIEvidenceDevelopmentDespite the extraordinary pace of technological progress inpersonalized medicine, payers and providers rightly demand evidencedemonstrating that personalized medical interventions can beintegrated into health systems in ways that deliver both clinical andeconomic value. Absent this evidence, they will likely remain wary ofutilizing the tests and treatments underpinning the field.In 2021, PMC’s research portfolio will focus on generating evidenceto support the clinical adoption of personalized medicine.Expanding the Frontiers of Personalized Medicine9

Evidence DevelopmentUnderstanding and Deliveringthe Clinical and Economic Benefitsof Personalized Medicine:A Research ProgramA Supplemental Sponsorship OpportunityTitled Understanding and Delivering the Clinical andEconomic Benefits of Personalized Medicine, PMC’sresearch portfolio in 2021 will focus on evaluatingthe pace of progress in the field, assessing personalized medicine’s clinical and economic utility, anddefining the landscape for clinical adoption.Evaluating Progress in Health Care1. U nderstanding Genomic Testing Utilizationand Coverage in the US, a workstream PMC isdeveloping in collaboration with the Blue CrossBlue Shield Association, Concert Genetics, andIllumina, analyzes the extent to which healthsystems are utilizing genomic tests in variouscontexts related to coverage and access.2. P harmacogenomics in Clinical Guidelines andat FDA will benchmark clinical progress inpersonalized medicine by providing a list ofthe circumstances in which current clinicalguidelines combined with the labels ofFDA-approved therapies support the use ofpersonalized medicine strategies that tailorcare based on scientific knowledge aboutdrug-gene interactions.10Expanding the Frontiers of Personalized MedicineAssessing Clinical and Economic Value3. E valuating the Clinical and Economic Value ofSequencing-Based Diagnostic Tests for PatientsWith Rare and Undiagnosed Diseases will provideevidence for sequencing platform developers,payers, and providers about the clinicaland economic utility of sequencing-baseddiagnostics when applied to patients with rareor undiagnosed diseases.4. I mprovements in Clinical Care Associated WithPersonalized Medicine will determine based ondata submitted by a representative sampleof health care providers in the United Stateswhether more holistic integration of personalized medicine as measured by a multi-factorialassessment of clinical adoption yields superiorclinical outcomes.Examining Research and Integration Strategies5. T he Integration of Personalized Medicine intoUS Health Systems: A Landscape Analysis willexplore through survey research and interviewsthe extent to which providers throughout theU.S. health care system are already integratingpersonalized medicine in clinical settings.6. D efining the Clinical Utility of Genomic Testing inCancer Care will advance a more comprehensivedefinition of clinical utility in cancer care thatcan prompt more widespread clinical adoptionof genomic testing technologies by highlightingunderappreciated benefits of testing.

7. A ddressing Practice Gaps in the Implementationof Personalized Medicine in Cancer Care willexamine barriers that are discouraging theclinical integration of genetic testing and theappropriate utilization of testing results incancer care.8. A ddressing Disparities and Improving Health Equityin Research Advancing Personalized Medicine willhelp support the development of personalizedmedicine for racial, ethnic and socioeconomicgroups that have historically been underrepresented in biomedical research by outliningstrategies researchers can employ to betterengage more diverse patient populations.9. A ddressing Challenges in Data Management toAdvance Personalized Medicine will explain howdecision-makers can catalyze new discoveries inpersonalized medicine by adopting policies andprocesses that encourage institutions to moreeffectively manage and share data for researchpurposes without jeopardizing patient privacy.Expanding the Frontiers of Personalized Medicine11

MembershipPMC MembershipJANUARY 2021CLINICAL LABORATORYTESTING SERVICESDasman Diabetes InstituteInvitaeLaboratory Corporation ofAmerica (LabCorp)Quest DiagnosticsFreenomeHelixImmatics USLegend BiotechRegeneronTango TherapeuticsWuXiNextCODEDIAGNOSTIC COMPANIESAdmera HealthAgendia NVAgilent TechnologiesAlacris Theranostics GmbHAlmac DiagnosticsAsuragenCaprion ProteomicsCaris Life SciencesCirculogeneCofactor GenomicsDiaceuticsExact SciencesFoundation Medicine, Inc.GeneCentric TherapeuticsGenomindGRAIL, Inc.Guardant HealthIncellDxMyriad GeneticsNanoString TechnologiesNuProbe, USAOlaris TherapeuticsOncocytePersonalisQIAGEN, Inc.Roche DiagnosticsRxGenomixScipher MedicineSiemens Healthcare Diagnostics, Inc.SomaLogic, Inc.ThriveZionexa US CorporationHEALTH INSURANCE COMPANIESHarvard Pilgrim Health CareEMERGING BIOTECH/PHARMACEUTICAL COMPANIESAdaptive BiotechnologiesElevation Oncology, Inc.EQRx12INDUSTRY/TRADE ASSOCIATIONSAmerican Clinical LaboratoryAssociationBIO (Biotechnology InnovationOrganization)BiocomPhRMAIT/INFORMATICS COMPANIES2bPreciseAssurance Health DataChange HealthcareConcert GeneticsDNAnexusFlatiron HealthGNS xSyapseTranslational SoftwareXIFIN, Inc.LARGE BIOTECH/PHARMACEUTICAL COMPANIESAbbVieAmgen, Inc.AstraZeneca PharmaceuticalsBausch Health CompaniesBayerBiogenBluebird bioBlueprint MedicinesExpanding the Frontiers of Personalized MedicineBristol-Myers SquibbEli Lilly and CompanyGenentech, Inc.GileadGlaxoSmithKlineJohnson & JohnsonMerck & Co.NovartisPfizer, Inc.Takeda Pharmaceuticals, Inc.NUTRITION, HEALTH &WELLNESS COMPANIESPreventive PartnersPATIENT ADVOCACY GROUPSAccelerated Cure Project forMultiple SclerosisAiArthritisAlliance for Aging ResearchAlzheimer’s Foundation of AmericaAmerican Association of KidneyPatients (AAKP)Bulgarian Association forPersonalized MedicineCanadian Organization forRare DisordersCancer CommonsClearity FoundationColorectal Cancer AllianceCureDuchenneEmily’s EntourageEveryLife Foundation for Rare DiseasesFight Colorectal CancerFriends of Cancer ResearchGlobal Liver InstituteGO2 Foundation for Lung CancerHealthyWomenInternational Cancer AdvocacyNetwork (“ICAN”)LUNGevity FoundationMultiple Myeloma ResearchFoundationNational Alliance Against Disparitiesin Patient HealthNational Alliance for Hispanic HealthNational Health Council

MembershipNational Patient Advocate FoundationSynGAP Research FundTeam TrevorPERSONALIZED MEDICINESERVICE PROVIDERSCareDxCoriell Life SciencesGenome MedicalMichael J. Bauer, M.D., &Associates, Inc.Sema4SengenicsTempusRESEARCH, EDUCATION &CLINICAL CARE INSTITUTIONSAmerican Association for CancerResearch (AACR)American Medical Association (AMA)American Society of Health-SystemPharmacists (ASHP)Arizona State UniversityAssociation for Molecular Pathology(AMP)Brown UniversityBusiness FinlandCancer Treatment Centers of AmericaCello Health BioConsultingCollege of American PathologistsColorado Center for PersonalizedMedicineCommonSpirit HealthCoriell Institute for Medical ResearchDuke Center for Research onPersonalized Health CareEssentia Institute of Rural HealthEuropean Infrastructure forTranslational MedicineHarvard Business SchoolHospital Albert EinsteinHudsonAlpha Institute forBiotechnologyiCANInstituto de Salud Carlos IIIIntermountain HealthcareJohns Hopkins Individualized HealthKing Faisal Specialist Hospital andResearch CentreMaineHealth Accountable CareOrganizationManchester University Schoolof PharmacyMarshfield ClinicMayo ClinicMD Anderson – Institute forPersonalized Cancer TherapyMITRE CorporationMoffitt Cancer CenterMorehouse School of MedicineNational Pharmaceutical CouncilNicklaus Children’s Hospital ResearchInstituteNorthShore University Health SystemNorth Carolina Biotechnology CenterPrecision Health Initiative atCedars-SinaiQatar BiobankSanford Imagenetics, Sanford HealthTeachers’ Retirement Systemof KentuckyThe Christ HospitalThe Jackson LaboratoryThomas Jefferson UniversityTranslational Genomics ResearchInstitute (Tgen)UC Davis Mouse Biology ProgramUniversity of Alabama, BirminghamUniversity of California, San Francisco(UCSF)University of PennsylvaniaHealth SystemUniversity of RochesterUniversity of South Florida MorsaniCollege of MedicineVanderbilt University Medical CenterWest Cancer CenterRESEARCH TOOL COMPANIESIllumina, Inc.Thermo Fisher ScientificSTRATEGIC PARTNERSAccentureArnold & PorterArtisan Healthcare ConsultingBioscience Valuation BSV GmbHBlue Latitude HealthBoston Healthcare AssociatesBradford PowerBruce Quinn AssociatesCambridge Cancer GenomicsCambridge Healthtech InstituteConTextConvergeHEALTH by DeloitteDefined HealthEdgeTech Law, LLPFoley & Lardner, LLPFoley Hoag, LLPGoldbug Strategies, LLCHealth Advances, LLCHogan Lovells, LLPInnovation HorizonsInnovation Policy SolutionsJane Binger, Ed.D.Jared Schwartz, M.D., Ph.D., LLCKPMGL.E.K. ConsultingMcDermott Will & EmeryMichael StocumNeil A. Belson, LLCOgilvyPriya Hays, M.D., Ph.D.S D Averbuch Consulting, LLCSlone PartnersThe Journal of Precision MedicineThe SynergistTruc Nguyen, M.D., Ph.D.United States PharmacopeialConvention (USP)W2OWilliam P. Stanford, M.D., Ph.D.VENTURE CAPITALGreyBird Ventures, LLCHealth Catalyst Capital Management,LLCKleiner Perkins Caufield & ByersSection 32Third Rock Ventures, LLCExpanding the Frontiers of Personalized Medicine13

Board of DirectorsBoard of DirectorsJANUARY 2021CHAIRJay G. Wohlgemuth, M.D.Chief Medical Officer, Senior Vice President,Quest DiagnosticsVICE CHAIRWilliam S. Dalton, Ph.D., M.D.Founder, Executive Chairman, M2GenTREASURERMark P. StevensonExecutive Vice President, Chief Operating Officer,Thermo Fisher ScientificSECRETARYMichael J. Pellini, M.D.Managing Partner, Section 32Bonnie J. AddarioCo-Founder, Chair, GO2 Foundationfor Lung CancerAntonio L. Andreu, M.D., Ph.D.Scientific Director, European Infrastructurefor Translational ResearchRandy BurkholderVice President, Policy and Research, PhRMAStephen L. Eck, M.D., Ph.D.Chief Medical Officer, MacroGenicsLori Frank, Ph.D.Memory Screening Advisory Board,Alzheimer’s Foundation of AmericaBrad GrayPresident, CEO, NanoString TechnologiesKris Joshi, Ph.D.Executive Vice President, President, NetworkSolutions, Change Healthcare14Expanding the Frontiers of Personalized MedicinePeter Maag, Ph.D.Executive Chairman, CareDxAnne-Marie Martin, Ph.D.Senior Vice President, Glob

Expanding the Frontiers of Personalized Medicine 9 PART III Evidence Development Despite the extraordinary pace of technological progress in personalized medicine, payers and providers rightly demand evidence demonstrating that personalized medical interventions can be integrated into health systems in ways that deliver both clinical and

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