The Cancer Biomedical Informatics Grid An Information Infrastructure

The Cancer Biomedical Informatics Grid: An Information Infrastructure for Healthcare and Life Sciences Amy Walker CEO and Healthcare IT Strategist Center for Biomedical Informatics and Information Technology Working for the National Cancer Institute SAIC-F Health Tech. Net Mc. Lean, VA June 17, 2010

Key Concepts • ca. BIG® provides a rich collection of standards-based infrastructure and tools to facilitate and accelerate the critical functions in today’s discovery R&D processes • ca. BIG® approaches enable any organization to break down silos within their 4 walls, as well as between them and the outside world • ca. BIG® web-based services enable organizations to partake of capabilities a-la-carte or comprehensively across the discovery-development-care continuum • Since ca. BIG® has been developed by NCI, all capabilities are freely available and open to all • Use of ca. BIG® is widely supported through a diverse collection of government, academic, and commercial sources

The National Cancer Institute (NCI) • Federal Government's principal agency for cancer research and training • Part of the National Institutes of Health (NIH), one of 11 agencies that compose the Department of Health and Human Services (HHS) • Established under National Cancer Institute Act of 1937, scope broadened by National Cancer Act of 1971 • Coordinates National Cancer Program, including: – NCI-designated Cancer Centers – Cooperative Groups – National Community Cancer Centers Program

21 st Century Biomedicine • 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

How are we doing? Still Fighting a War • We (think we) know “how cancer works” • BUT: • Estimated US cancer deaths 2009: 562, 340 (American Cancer Society) • Estimated new US cancer cases 2009: 1, 479, 350 (American Cancer Society) • Cost of cancer deaths: $960. 7 billion in 2000, estimated $1, 472. 5 billion in 2020 (Journal of the National Cancer Institute, Dec. 9, 2008)

The Cancer Biomedical Informatics Grid (ca. BIG®) ca. BIG® Vision: A virtual web of interconnected data, individuals, and organizations that redefines how research is conducted, care is provided, and patients/participants interact with the biomedical enterprise. ca. BIG® Mission: • Connect the cancer research community through a shareable, interoperable infrastructure • Deploy and extend standard rules and a common language to more easily share information • Build or adapt tools for collecting, analyzing, integrating and disseminating information associated with cancer research and care

ca. BIG® Core Principles • Open Access • ca. BIG® is open to all, enabling wide -spread access to tools, data, and infrastructure • Open Development • Planning, testing, validation, and deployment of ca. BIG® tools and infrastructure are open to the entire research community • Open Source • The underlying software code of ca. BIG® tools is available for use and modification • Federation • Resources can be controlled locally, or integrated across multiple sites

Unprecedented challenges, Unprecedented opportunities

The Cancer Biomedical Informatics Grid: An Information Infrastructure for Healthcare and Life Sciences John Speakman Associate Director, Clinical Sciences Center for Biomedical Informatics and Information Technology National Cancer Institute Health Tech. Net Mc. Lean, VA June 17, 2010

Biomedicine is Decades Behind the “Knowledge Economy” Curve • Translational research and personalized medicine require integration of multiple modalities and dimensions of data (clinical care / clinical trials / pathology / imaging / gene expression / population data, etc. ) • This integration is currently achieved by custom-built point solutions, if at all • As a result, the data is often locked away in incompatible formats and systems • Research studies are artisanal, handcrafted from one-of-a-kind components; clinical trials take too long to initiate, too long to accrue patients and too long to report outcomes • Access to, and maturity of, informatics tools within the research community is inconsistent

ca. BIG® Overcomes the Obstacles to Data Integration 40+ Software Tools National Grid for Data Sharing Tsunami of Genomic and Clinical Data Islands of Information Standardized Vocabularies Standard Language Interoperability IT Systems Do Not Interoperate

How do you use it? Adopting involves installing software applications already made to ca. BIG® standards, integrating them into your workflow, and connecting to ca. Grid. Adapting involves modifying your existing software applications to be ca. BIG® compatible, and then connecting to ca. Grid. Adapter between your Application and the Grid

20 th Century Biomedical Paradigm Discovery • Biological pathways • Target identification and validation Product Development • Candidate selection and Optimization • Pre-clinical testing • Phase I, III • New Drug application and Approval Clinical Care Outcomes & Surveillance • Product launch • Reporting of serious/fatal ADRs • Clinical adoption • Re-labeling (or recall) as needed • Additional indications as warranted

21 th Century Biomedical Paradigm: a Learning Health System Analysis and Learning Outcomes & Surveillance Discovery Product Development Clinical Care

Software-Enabled Bridging of Research and Care RESEARCH SOFTWARE Group A (10 mg) CTMS Group B (30 mg) Clinical Trial Group C (control) Electronically Executed Protocol

Software-Enabled Bridging of Research and Care RESEARCH SOFTWARE Group A (10 mg) CARE Electronic Health CTMS Infrastructure Treatment Plan Optimum Dose (30 mg) Group B (30 mg) Clinical Trial Physician Group C (control) Electronically Clinical Executed Protocol Practice Plan

A Diverse NCI-Fostered Biomedical Ecosystem Clinical Communities Underwriters/Payors Consumers/ Patients Government Foundations Care Deliverers Payers / Insurance Companies Researchers Industry Research Infrastructure Information Technology Electronic Health Records Academia Discovery Science

Example Project: 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

Defining Electronic Health Records for Oncology NCI has worked with ASCO to obtain requirements for an “Oncologyextended EHR”, now working with HL 7 to define a structured specification, will subsequently develop a reference implementation Oncology-extended EHR Chemotherapy drugs

Utilizing “Smart” Electronic Health Records to Accelerate Research Data on hundreds of thousands of patient encounters can be fed into the Patient Outcomes Data Service electronically 0101 0 1010 1 01010101 01 101 0 1 Patient Outcomes Data. Service Repository 0 This Service enables physicians to submit outcome data on patients, and query it for outcomes patterns.

Outcomes Portal

The Patient Outcomes Data Service is one of Many Services, Planned and Existing, for the Biomedical Community Cancer Knowledge Cloud Adverse Event Service Clinical Trials Service Patient Outcomes Data Service Patient Calendar Service Decision Support Service Treatment Plan Service

Researchers Can Query the Data in the Cancer Knowledge Cloud Epidemiologists Cancer Knowledge Cloud 0 0101 1010 01 1 0 1 10 01 010 Basic Researchers 10 010101010101 0101 • Query data to seek correlations among genes, environment, outcome • Develop standing online cohorts of volunteers • Generate new hypotheses • Identify biomarkeroutcome correlations • Validate biomarkers in silico Clinical Researchers 0101 0 101 • Seek clinical trial participants • Enrich clinical studies with appropriate sub-groups • Identify new indications

Digression: Data Sharing Framework

Researchers Can Query the Data in the Cancer Knowledge Cloud Epidemiologists Cancer Knowledge Cloud 0 0101 1010 01 1 0 1 10 01 010 Basic Researchers 10 010101010101 0101 • Query data to seek correlations among genes, environment, outcome • Develop standing online cohorts of volunteers • Generate new hypotheses • Identify biomarkeroutcome correlations • Validate biomarkers in silico Clinical Researchers 0101 0 101 • Seek clinical trial participants • Enrich clinical studies with appropriate sub-groups • Identify new indications

New Knowledge From Research is Fed into the Cancer Knowledge Cloud Epidemiologists 1010 010 1 010 0101 New links to behaviors and exposures that increase / decrease risk of disease or disease reoccurrence 01 0101 Cancer Knowledge Cloud Basic Researchers 010101010101 New drug targets Clinical Researchers 0101 01 Targeted drugs for molecularly-defined sub-groups

All Stakeholders Benefit from the Cancer Knowledge Cloud Physicians 01 10 0 1 0 01 1 0 1 10 0 1 1 1 010 Cancer Knowledge Cloud Alerts to potential drug interactions Individualizing Clinical Care Clinical Decision Support Tools Comparisons with other patients Alerts to genetic disease risks Opportunities for clinical trial enrollment

All Stakeholders Benefit from the Cancer Knowledge Cloud Physicians Individualizing Clinical Care Patients / Consumers Cancer Knowledge Cloud 101 0 1 10 01 010 10101 How do I compare to others? Understanding my options How do I get into a clinical trial? What should I expect from this treatment?

Contribute your Knowledge to Conquer Cancer

All Stakeholders Benefit from the Cancer Knowledge Cloud Physicians Individualizing Clinical Care Patients / Consumers Cancer Knowledge Cloud Understanding my options 10101010 10101 Improving the Healthcare System Comparative Effectiveness Quality Pharmacovigilance

Take-Home Messages • ca. BIG® provides standards-based infrastructure and tools to facilitate and accelerate critical functions in research and, increasingly, healthcare processes • The Cancer Community writ large is moving towards large-scale data sharing, and those who are ca. BIG®-connected have an advantage • ca. BIG® web-based services will soon enable organizations to partake of a-la-carte or comprehensive capabilities across the discovery-development-care continuum • As the U. S. moves towards EHRs and full digitalization of health care, the ca. BIG® standards-based data interoperability will enable organizations to move data between regulators, health care providers, etc. • Since ca. BIG® has been developed by NCI, all capabilities are freely available and open to all

Finding What You Need… • If you want additional general information about ca. BIG® • http: //cabig. cancer. gov/ • If you want to receive our monthly e-newsletter • http: //cabig. cancer. gov/resources/newsletter/ • If you want a complete overview of the ca. BIG® program • https: //cabig. nci. nih. gov/training/cabigessentials/player. html • If you want a complete list of ca. BIG® tools • https: //cabig. nci. nih. gov/adopt/ • If you want a demo-for-the-perplexed • Call (301) 594 -3602

john. speakman@nih. gov