CBIIT’s Roadmap: A Look Ahead Caterina E.M. Lasome, PhD, MBA, RN, CPHIMS Chief Operating Officer Center for Biomedical Informatics & Information Technology

1 National Cancer Institute Mission: Coordinates the National Cancer Program, which conducts and supports research, training, health information dissemination, and other programs with respect to the cause, diagnosis, prevention, and treatment of cancer, rehabilitation from cancer, and the continuing care of cancer patients and the families of cancer patients

2  Mission: Interconnect the biomedical enterprise with an interoperable, standards-based framework that bridges research and care, driving and enabling 21 st century medicine in support of eliminating the burden of cancer.  Role: CBIIT catalyzes and organizes a biomedical ecosystem – comprised of connectivity, content and community -- that dynamically drives knowledge and improves health.  Vision: A learning health system in which ubiquitous information is appropriately accessed and utilized by all members of the biomedical enterprise to achieve pre-emptive, predictive, personalized and participatory medicine. CBIIT

3 21st Century Biomedical Paradigm: A “Learning Health System”  The diagram shows a person surrounded by a continuous cycle of targeted cancer care that includes a Bench and a Bedside category:  Pathology  Clinical Outcomes Data  Targeted Pharmaceuticals  Cancer Treatments  Leads to Bedside  Which then leads to Treatment and Care  Genetic Data  Surgical & Radiotherapeutic Technologies  Laboratory Data  Proteomic Data  Which then leads to Bench and the cycle repeats itself  Personalized, Predictive, Pre-emptive, Participatory…  Unifies discovery, clinical research, and clinical care (bench-bedside- back) into a seamless continuum  Accelerates the time from discovery to patient benefit  Enables a health care system, not disparate “sectors” or “silos”  Empowers consumers to manage their health over a lifetime  Results in improved clinical outcomes

4 Describing Complex Systems  From NCICB caBIG™ to CBIIT BIG Health: –More stakeholders  –More agendas  –More complexity  Multiple vertical levels of organization and horizontal processes which – in order to produce the system’s products- of-value for its stakeholders/user – cross vertical (interface) boundaries. (adapted from Ivar Jacobson) Experience in multiple domains has repeatedly shown that complexity is most effectively managed through layering and use of standards at the “interface boundaries.”

5 caBIG ® : A Growing Community…  More than 2300 individuals from 740+ institutions  56 NCI-designated Cancer Centers  16 NCI Community Cancer Centers  Attendees at 2009 caBIG ® Annual Meeting  Workspaces (18 Special Interest Groups)  Commercial Sector (15 licensed companies)  Four pictures of individuals attending the annual meetings and working at their workspaces

6 Expanding Partnerships*…  Abbott Laboratories  Astra Zeneca  Cardiff University (UK)  Center for the Development of Advanced Computing (CDAC – IN)  Centocor  Curie Institute (FR)  Dublin Institute of Technology (IR)  Drexel University  Eli Lily  Erasmus Medical Center (NL)  FDA  Friedrich Miescher Institute for Biomedical Research (CH)  Genentech  Genesis R&D Inc (NZ)  Glaxo Smith Kline  Hiroshima University (JP)  Imperial College of London (UK)  INSERM (FR)  Medarex  Moscow State University (RU)  National University of Singapore (SG)  National Yang-Ming University (TW)  Ontario Cancer Institute (CA)  Pune University (IN)  Queensland University (AU)  Roche Holding AG (DE)  Taiho Pharmaceutical Co., Ltd. (JP)  Takeda  Tulane University  University of Crete (CR)  University of Edinburgh (UK) * Not a complete list

7 caBIG Community Organization  Shown are the caBIG(R) workspaces: –CTMS –ICR –TBPT –Imaging –VCD (E) –ARC (H) –DIS (C)  The ones that go up and down are cross- cutting: –VCD (E) –ARC (H) –DIS (C)

8 caBIG Community Organization  The Deployment community spans across all of the workspaces (CTMS, ICR, TBPT, Imaging, VCD (E), ARC (H), DIS (C)

9 CBIIT Development: Bringing Standards to the Community CBIIT consumes and develops conformant standards-based specifications to resolve business problems CBIIT validates the applicability of specifications via reference implementations CBIIT informs the commercial and open-source vendor communities of the “state of the art” by deploying/handing off its reference implementations. The diagram demonstrates how CBIIT brings standards to the community. They do so by: 1)Consuming and developing conformant standards-based specifications to resolve business problems 2)Validating the applicability of specifications via reference implementations 3)Informing the commercial and open-source vendor communities of the “state of the art” by deploying/handing off its reference implementations. 9

10 Oncology-Extended EHR (caEHR): A collaborative national effort  American Society of Clinical Oncologists (ASCO)  Initial evaluation of need (involving end-users)  Engagement of vendor community (30) utilizing unique case scenarios  Produced high-level requirements document as baseline  NCI Community Cancer Center Program (NCCCP)  Oncology EHR Laboratory  cancer Biomedical Informatics Grid (caBIG ® ) – V2  Semantic infrastructure  Team in place, executing 3-month Release Cycles  Iterative/incremental releases over 18-months  Goals/deliverables aligned to meaningful use criteria  Business capability priority recommendations by stakeholders, but ultimately determined by the CBIIT Director  Document lessons learned and adjust processes as needed

11 Vision: A biomedical system that synergizes the capabilities of the entire community to realize the promise of personalized medicine 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. Strategy: Through a series of personalized medicine Projects, with an expanding number of collaborators, BIG Health will bootstrap a new approach in which clinical care, clinical research, and scientific discovery are linked. Ecosystem: The BIG Health Consortium™

12  A diverse biomedical ecosystem consists of categories: –Clinical Communities –Underwriters/Payors –Discovery Science –Information Technology  Within each category, there a components that link each category together to demonstrate a ecosystem. –Clinical Communities Researchers Care Deliverers Consumers/Patients –Underwriters/Payors Government Foundations Payers/Insurance Companies –Discovery Science Industry Academia –Information Technology Electronic Health Records Research Infrastructure A Diverse Biomedical Ecosystem Government Researchers Clinical Communities Discovery Science Information Technology Underwriters/Payors Care Deliverers Consumers/ Patients Foundations Payers / Insurance Companies Industry Academia Research Infrastructure Electronic Health Records

13 Working “Outside” the System: caBIG ® and the Love Army of Women Picture is of a group of women tagged with: ONE million women, research goal, revolutionary opportunity. Together we can prevent breast cancer. caBIG ® is partnering with the Love/Avon Army of Women to build the first online cohort of one million women, called the Health of Women (HOW) Study

14 AOW/caBIG ® Collaboration: Leveraging Web 2.0 for 21 st Century Research  Members of AOW invited to join the HOW 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

15 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

16 CBIIT “BIG 3” Priorities for Enterprise-Level Interoperability –Our applications, data, and analytic services need the capacity to connect and meaningfully exchange information and coordinate behavior.

17 CBIIT “BIG 3” Priorities for Enterprise Security –Develop and implement a clear, integrated enterprise strategy and operational tactics that unify and integrate our approach to security.

18 CBIIT “BIG 3” Priorities for Deployment Support –Comprehensively support the requirements of the 21 st -century healthcare community, including On-going stakeholder identification and management; and Development of technology-independent specifications and reference implementations of software that provides clear benefit to that community.

19 Operational Imperatives for Success  Moving from historical silos to translational medicine continuum (i.e. value propositions, business case analyses) –Know funding priorities & follow the money  Documented improvement in patient and population outcomes (i.e. meaningful use, comparative effectiveness)  Leverage lessons learned from early successes –Modify approaches to meet new requirements Problem-focused vs discipline-focused Complexity is understood via the intersection of dimensions (aspects) and perspectives disciplines, roles, etc.)

20 Q & AQ & A