Paula Kim , TRAC- Translating Research Across CommunitiesAAAS-FDLI Personalized Medicine: Planning for the FutureColloquium 1: Diagnostics and Diagnoses: Paths to Personalized Medicine Washington DC • June 1, 2009

Taking Research and Development To The Clinic… Are We

There Yet?

The Art of Translation…The Art of Translation…

“ “ From the standpoint of medicine From the standpoint of medicine as an art for the preparation and as an art for the preparation and cure of disease, the man who cure of disease, the man who translates the hieroglyphics of translates the hieroglyphics of science into the plain language of science into the plain language of healing is certainly more useful.”healing is certainly more useful.”

-Sir William Osler, -Sir William Osler, PhysicianPhysician

Physical Physical

BehavioralBehavioral

SocialSocial

CulturalCultural

EconomicEconomicPoliticalPoliticalSpiritualSpiritualTechnologicTechnologicalal

Across The Scientific Across The Scientific SpectrumSpectrum

H PE

• JourneyJourney•DestinatioDestinationn•VehicleVehicle•HighwayHighway•Road MapRoad Map•CompassCompass

For Our Road Trip… How Do We For Our Road Trip… How Do We Describe Personalized Medicine?Describe Personalized Medicine?

Personalized medicine?

Donate tissue?

Biospecimen?

Biopsy? 2nd pass?

Targeted Therapies?

Genomics? Proteomics?

Invasive ? Non-invasive?

Academic Center ? Local ?

Informed Consent?

How to pick treatment?

Do my kids need genetic testing?

Where is my tissue?

Eligible ? Insurance ?

Am I Going to Live?

Patient Dilemma with Words Patient Dilemma with Words and Decisions…and Decisions…

The PromiseThe Promise Personal Targeted TherapiesPersonal Targeted Therapies Seek and Control instead of Seek and Control instead of

Search and DestroySearch and Destroy Genetic TestingGenetic Testing Reduced ToxicitiesReduced Toxicities Predictive/Preventive Predictive/Preventive

CapabilityCapability Reduced drug failure ratesReduced drug failure rates A CURE A CURE

Hype or

Not?

POSITIVE MESSAGE ?

NEGATIVE MESSAGE ?

OR MIXED MESSAGE ?

Currently…Currently… No coordinated system to assist No coordinated system to assist

patients patients

Many patients with difficult to treat Many patients with difficult to treat disease have poor prognosis, disease have poor prognosis, limited options, and a very short limited options, and a very short timeframe to make decisions; lack timeframe to make decisions; lack access to internetaccess to internet

Patients and caregivers often Patients and caregivers often receive very little direction & receive very little direction & guidance for treatment, system guidance for treatment, system navigation and financial optionsnavigation and financial options

Hide and Seek?

Treatment Decision Making: Treatment Decision Making: Outside Sources of Info for PatientsOutside Sources of Info for Patients

Source: TRAC Perspectives on Costs of Cancer Care Survey-2006

Answer OptionsAnswer OptionsGreatlyGreatly

influences influences Somewhat Somewhat influences influences

Barely Barely influences influences

Does not Does not influence influence

Not Not applicable applicable

Information received from a Information received from a patient advocacy organization patient advocacy organization 1515 6363 1919 77 1111

Information read in the Information read in the newspaper or mainstream newspaper or mainstream magazinemagazine

55 3737 3535 2727 1010

Information heard on the TV or Information heard on the TV or radioradio 11 2020 4141 4141 1111

Information retrieved on the Information retrieved on the internetinternet 1111 6060 2525 99 88

Understanding Choices In Order To Understanding Choices In Order To Make Decisions: What Patients WantMake Decisions: What Patients Want

Source: TRAC Perspectives on Costs of Cancer Care Survey-2006

The Law and Spice of The Law and Spice of LifeLife

““Variability is the law of life, and as no Variability is the law of life, and as no two faces are the same, so no two two faces are the same, so no two bodies are alike, and no two bodies are alike, and no two individuals react alike and behave individuals react alike and behave alike under the abnormal conditions alike under the abnormal conditions which we know as disease.which we know as disease.””

-Sir William Osler, Physician-Sir William Osler, Physician

1849-19191849-1919

Ready or not, personalized medicine Ready or not, personalized medicine is moving… towards becoming the is moving… towards becoming the norm and not the exception…How norm and not the exception…How fast we get there…will depend on fast we get there…will depend on many factors with perhaps two of many factors with perhaps two of the most important ones being the most important ones being

the access and use of high quality the access and use of high quality well annotated biospecimens…well annotated biospecimens…and how well or not everyone…and how well or not everyone…

behaves along the way. behaves along the way.

Hide and Seek…Hide and Seek……Olly Olly Oxen Free…Olly Olly Oxen Free

Who is in the Biospecimen Sandbox?Who is in the Biospecimen Sandbox?Who is in the Biospecimen Sandbox?Who is in the Biospecimen Sandbox?

PatientsPatients

CaregiversCaregivers

PublicPublic

OrganizationsOrganizations

AdvocacyAdvocacy

ResearchersResearchers

Clinical Trial PIClinical Trial PI

Community MDsCommunity MDs

Academic Center MDs and Academic Center MDs and PhDsPhDs

PathologistPathologist

Research and Medical

Research and Medical

NCINCI

FDAFDA

CMSCMS

HRSAHRSA

AHRQAHRQ

NIHNIH

33rdrd Party Payers Party Payers

IndustryIndustry

P&P Agencies and Industry

P&P Agencies and Industry

PKI © 2008 All Rights Reserved

Personalized Medicine

Challenges and Challenges and Questions That Will AriseQuestions That Will Arise

•Do We Have a National SystemDo We Have a National System

•Will It Level the Playing Field or Will It Level the Playing Field or NotNot

•Will Access Be More Inclusive or Will Access Be More Inclusive or ExclusiveExclusive

•How Does This Affect Me and My How Does This Affect Me and My FamilyFamily

•Just Because You Build It, Does Just Because You Build It, Does Not Mean They Will ComeNot Mean They Will Come

Why We Must Get This Right…Why We Must Get This Right…

“ “ We must harness the scientific, We must harness the scientific, industrial, and social will to industrial, and social will to accelerate discoveries into accessible accelerate discoveries into accessible and meaningful clinical applications. and meaningful clinical applications. Patients, families, friends, and loved Patients, families, friends, and loved one are counting on us…Because in one are counting on us…Because in the end, it’s not about you, or me, or the end, it’s not about you, or me, or the science, it’s about the patient.”the science, it’s about the patient.”

Paula Kim - Research & Patient AdvocatePaula Kim - Research & Patient Advocate

Patient & Advocate Patient & Advocate PerspectivesPerspectives Don’t Leave Home Without

Them

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