Public-Private Sector Collaboration for Improving Population Health: Sharing Tools for Research

Ken Buetow, Ph.D. Associate Director, Bioinformatics and IT

National Cancer InstituteHealth IT Summit for Government Leaders

February 3, 2010

21st Century Biomedical Paradigm

• Personalized, Predictive, Preemptive, Participatory……

• Unifies clinical research, clinical care, and discovery (bench- bedside-bed) into a seamless continuum

• Results in improved clinical outcomes

• Accelerates the time from discovery to patient benefit

• Enables a health care system, not a disparate “sector”

• Empowers consumers in managing their health over a lifetime

• Reporting of serious/fatal ADRs

• Re-labeling (or recall) as needed

• Additional indications as warranted

• Candidate selection and Optimization

• Pre-clinical testing

• Phase I, II, III

• New Drug application and Approval

• Product launch

• Clinical adoption

• Biological pathways

• Target identification and validation

DiscoveryDiscovery ProductProductDevelopmentDevelopment

Outcomes &Outcomes &SurveillanceSurveillanceClinical CareClinical Care

But We Still Operate in a 20th Century Research > Care Paradigm

Issues:• Ph IV not conducted uniformly

or consistently• Efficacy and ADR patterns are

recognized very slowly• New indications are gained

painstakingly from regulators• Recalls are financially

disasterous

Issues:• Linear, sequential

process• Information is trapped in

silos• Each trial demands re-

creation of infrastructure• No economies of scale• Failed candidates hard to

resucitate

Issues:• Launches and product

detailing are costly• Adoption can be slow• Traditional physician

outreach methods now constrained

• Process is slow and uni- directional

Issues:It’s difficult to:• Access clinical

outcomes data on relevant populations

• Access biospecimens of high quality with clinical data

• Validate in silico

DiscoveryDiscovery ProductProductDevelopmentDevelopment

Outcomes &Outcomes &SurveillanceSurveillanceClinical CareClinical Care

But We Still Operate in a 20th Century Research > Care Paradigm

Information on clinical experience with products is not captured systematically. Observations are “locked away” or ignored, and little new

knowledge is gained or leveraged.

ProductProductDevelopmentDevelopment

Outcomes &Outcomes &SurveillanceSurveillance

Clinical Clinical CareCare

Analysis and Analysis and LearningLearning

DiscoveryDiscovery

21th Century Biomedical Paradigm: a Learning Health System

Biomedical Knowledge Cloud

Consumer

CommunityHospital

ResearchHospital Research

Institution

ComparativeEffectiveness

Quality

Pharmaco- Vigilance

Industry

DecisionSupport

DataAggregators

AnalyticsBiomedicalResearch

Bio- Surveillance

Practice

Biomedicine Can Be An Interconnected Ecosystem

IT-enabled Connectivity

The cancer Biomedical Informatics Grid® (caBIG®) is a virtual network of interconnected data, individuals, and organizations that redefines how research is conducted, care is provided, and patients/participants interact with the biomedical research enterprise.

caBIG®: Biomedical Information Highway

Clinical Research

PathologyMolecular Biology

Imaging

Molecular MedicineMolecular Medicine

caBIG® Capabilities Enable Discovery > Translation > Clinical Research

Clinical Research

PathologyMolecular Biology

Imaging

• Track clinical trial registrations

• Facilitate automatic capture of clinical laboratory data

• Manage reports describing adverse events during clinical trials

• Combine proteomics, gene expression, and other basic research data

• Submit and annotate microarray data

• Integrate microarray data from multiple manufacturers and permit analysis and visualization of data

• Utilize the National Cancer Imaging Archive repository for medical images including CAT scans and MRIs

• Visualize images using DICOM-compliant tools

• Annotated Images with distributed tools

• Access a library of well characterized, clinically annotated biospecimens

• Use tools to keep an inventory of a user’s own samples

• Track the storage, distribution, and quality assurance of specimens

Molecular MedicineMolecular Medicine

caBIG® Capabilities Enable Discovery > Translation > Clinical Research

Clinical Research

PathologyDiscovery Research

Imaging

Clinical CareClinical Care

caBIG® Capabilities Enable Discovery > Clinical Research > Clinical Care

Oncology- Extended Electronic Health Record: A collaborative national effort

Oncology- Extended Electronic Health Record: A collaborative national effort

• American Society of Clinical Oncologists (ASCO)• Began evaluating issue, involving end users• Engaged the vendor community EHR lab (30), utilizing

unique case scenarios• High level requirements document/white paper outlining

the issue• cancer Biomedical Informatics Grid (caBIG®)

• Vendor technology evaluation• Problem assessment• Technical Specification

• NCI Community Cancer Center Program (NCCCP)• Oncology EHR Laboratory

• 30+ EHR vendors

Research Unit

IT-enabled ecosystem

Imaging

Biospecimen Data

Clinical Data

Molecular Data

Research Center

Security Advertisement / Discovery

Federated QueryWorkflow

Metadata Management

Dorian GTS Index Service

Federated Query

Service

Workflow Management

Service

Vocabularies & Ontologies

GME Schema Management

Common Data Elements

Medical Center

Research Center

Research Center

Medical Center

Medical Center

Medical Unit

Research Center

Research Center

Security Advertisement / Discovery

Federated QueryWorkflow

Metadata Management

Dorian GTS Index Service

Federated Query

Service

Workflow Management

Service

Vocabularies & Ontologies

GME Schema Management

Common Data Elements

Research Unit

Research Center

Medical Center

Research Center

Research Center

Medical Center

Medical Center

Medical Unit

Research Center

Research Center

Biomedical Knowledge CloudGrid Services Infrastructure

IT-enabled ecosystem

Security Advertisement / Discovery

Federated QueryWorkflow

Metadata Management

Dorian GTS Index Service

Federated Query

Service

Workflow Management

Service

Vocabularies & Ontologies

GME Schema Management

Common Data Elements

Research Unit

Research Center

Medical Center

Research Center

Research Center

Medical Center

Medical Center

Medical Unit

Research Center

Research Center

Biomedical Knowledge CloudGrid Services Infrastructure

Biomedical Knowledge CloudGrid Services Infrastructure

IT-enabled ecosystem

caBIG® is Linking the Cancer Community

caBIG® Works through International Collaborations

caBIG®, the world’s largest biomedical research “highway”, connects a growing number of individuals and organizations across the globe

United States, Mexico, Chile, Uruguay, Argentina, Brazil, UK, The Netherlands, Germany, Czech Republic, Finland, Jordan, India, China, New Zealand

Pioneering a 21st Century Biomedical Ecosystem:

The BIG Health Consortium™

BIG Health Consortium™

Mission:The BIG Health Consortium™ is a collaboration among stakeholders in biomedicine, including government, academe, industry, non-profit, and consumers, who come together in a novel organizational framework to demonstrate the feasibility and benefits of the personalized medicine paradigm.

Vision:A biomedical system that synergizes the capabilities of the entire community

to realize the promise of personalized medicine

The Ecosystem Has Multiple Constituencies

GovernmentGovernment

ResearchersResearchers

Clinical Communities

Discovery ScienceInformation Technology

Underwriters/Payors

Care Deliverers

Care Deliverers

Consumers/ Patients

Consumers/ Patients

FoundationsFoundations

Payers / Insurance

Companies

Payers / Insurance

Companies

IndustryIndustry

AcademiaAcademiaResearch

Infrastructure Research

Infrastructure Electronic

Health Records Electronic

Health Records

21st Century Biomedical Ecosystem

Research

Participants Patients join research networks, grant consent, agree to be “sought” and to enroll – “on-demand” participants

Biospecimen Collections Researchers can access and query large collections of well-characterized, clinically annotated specimens

Discovery of Correlations Biomarkers are identified and validated; disease sub-groups emerge

Individualization of Treatment Patients are identified by sub-groups and treated appropriately

Clinical Practice

Electronic Health Records EHRs can connect to clinical trials in hospital settings

Research Finding Knowledgebases Large-scale databases of latest research findings are connected to health delivery encounter

Learning Healthcare System Local and national clinical encounter information is fed back to care providers to help inform clinical decision making

21st Century Biomedical Ecosystem

Consumer

My Genomic Profile Consumers get their genetic and predisposition risk information

My Prevention Strategies Consumers work with genetic counselors; coordinate with health care provider

My Clinical Record Consumers link to their clinical histories with geneticprofiles; access clinical research; participate in volunteer networks

21st Century Biomedical Ecosystem

Standards

Interoperability

Data Sharing

Connectivity

21st Century Biomedical Ecosystem

The Ecosystem in Action: BIG Health Projects

Lance Armstrong Foundation: Adolescent and Young Adult Biorepository

Objectives

• Build an infrastructure to support biospecimen collection, storage, and sharing among academic sites

• Address patient privacy and intellectual property issues• Integrate into a centralized portal

Adolescent and Young Adult Oncology Biorepository: Federated Network

Vanderbilt University Nashville, TN.

Oregon Health and Science UniversityPortland, OR.

Indiana University School of Medicine, Indianapolis, IN.

Kaiser Foundation HospitalsPortland, OR.

Nationwide Children’s Hospital, Columbus, OH.

LIVESTRONG, Austin.TX.

MD AndersonHouston, TX.

BIG Health Network

Athena Breast Cancer Network

Athena Breast Cancer Network

• The Athena Breast Health Network will integrate clinical care and research to drive innovation in prevention, screening, treatment and management of breast cancer

• This project will improve survival and reduce suffering from breast cancer by accelerating research discovery and the time it takes to implement innovations in clinical practice

• 5 hospitals (total of 13 sites in San Francisco, San Diego, Davis, Los Angeles, Irvine) will work together fueled by financial resources from outside the university system

• Will encompass 400,000 women

Athena IT Infrastructure

Proteomics DataExpression Array DataSNPArray Data Radiological DataClinical DataPatient Samples

Data Warehouse

Data WarehouseAPI Hosted

SystemsHosted

SystemsCTODS

caExchange - Hub

Tolven CTMS Suite

APIGrid-EnabledcaBIG® ApplicationsGrid-EnabledcaBIG® Applications

caTissue

caArray

Cancer Genome Workbench

API

caGWAS CPAS

caGRID

Consumer-centric research: the Love Army of Women

BIG Health is partnering with the Love/Avon Army of Women to build a consumer-owned online

cohort of one million women

Health of Women Study

• Members of Army of Women are invited to join the Health of Women study and respond to periodic secure online questionnaires concerning health history

• Authorized researchers access data and design study protocols based on clinical profiles and data of potential research participants

• Database enables “interactive” and “dynamic” process – as researchers conceive new projects and women add more health information, new theories can be generated and additional opportunities for participation arise

• Researchers propose to the consumers studies that they would like to conduct. Woman decide, on-line which studies in which they want to participate. Any additional information collected as part of the study is electronically “connected” back to the Army

Research Study

Army of Women “Ecosystem”

Research Study

Health of Women Cohort

Research Study

Research Study

Research Study

Research Study

Research Study

Research Study

Research Study

Research Study

www.bighealthconsortium.org http://cabig.cancer.gov

For more information, contact: connector@BIGHealthConsortium.org