Translational Medicine Business Architecture Model – Touch-points Clinical Trials and Pop Sci

1. Translational Medicine Business Architecture Model – Touch-points Clinical Trials and Pop Sci Michele Ehlman Essex Management caBIG® CTMS Workspace Face-to-Face Meeting July 2010 – Madison, Wisconsin

2. Agenda • Translational Medicine Business Architecture Model (BAM) Overview • History • Current Status • Life Sciences • Clinical Research • Touch-points with other workspaces • POP-Sci – Touch-points • Review Pop-Sci Use cases

3. History

4. BAM Participants 3rd Millennium • Elaine Feund • Charlie Mead Baylor College of Medicine • Lauren Boyd • Pam Mayfield • David Steffen Booz Allen Hamilton • Anna Fernandez caBIG® Patient Advocate / Colorectal Cancer Coalition • Kate Murphy Cancer Research Center of Hawaii • Lynne Wilkens Cancer Therapy Evaluation Program (CTEP) • Shanda Finnigan • George Redmond • Donna Shriner • Steve Friedman Case Western • Bob Lanese CBIIT • Mary Agnes Templeton City of Hope • Joyce Niland • Susan Pannoni Columbia University • Ben May • Janie Weiss Consumer Advocates in Research and Related Activities • Diane Paul CTMS Task Force Member • Darlene Douglas-Post Dana Farber Cancer Institute Harvard • Kerry Higgins • Jane Brzozowski • Jomol Mathew Dartmouth • Paul Thompson Duke University • Bob Annechiarico • Vijaya Chadaram • Salvatore Mungal • Kim Johnson Essex Management • Gene Kraus

5. BAM Participants (Slides 2) Gynecological Oncology Group (GOG) • Bill Elgie Marybird Perkins Cancer Center • Donna Bryant Mayo Clinic Cancer Center • Sharon Elcombe MD Anderson Cancer Center • Charles Martinez • Susie Bullock Memorial Sloan Kettering • Dawn Caron-Fabio NCI Cancer Imaging Program • Mia Levy NCI CBIIT • Dianne Reeves • Ann Setser • Brian McIndoe • Juli Klemm • John Speakman • Christo Andonyadis NCI Division of Cancer Prevention (DCP) • Troy Budd • Anne Tompkins • Beverly Meadows Northwestern University • Warren Kibbe Office of Communications (OCC) • Pat Winkler Oregon Health and Science University • Lara Fournier Patient Advocate • Virginia Hetrick • Greg Bielawski • Carolyn Petersen • Craig Lustig SAIC • John Freymann • Brenda Maeske Sanford Health • Holly Johnson Sapient • Stephen Goldstein • Michael Otjen • Malcolm James

6. BAM Participants (Slides 3) ScenPro, Inc. (CBIIT Contractor) • Smita Hastak • Wendy Ver Hoef Semantic Bits • Paul Baumgartner St. Judes • Tad McKeon The Jackson Laboratory • Grace Stafford Theradex • Ronald LaCanna Thomas Jefferson University • Jack London UCLA • Buddy Dennis University of Texas - Austin • Scott Hunicke-Smith University California Irvine • Christine McLaren University of Alabama • John Sandefur University of Arkansas for Medical Sciences (UAMS) • Laura Hutchins • Dorothy Miles • Umit Topaloglu • Jeannette Lee University of California San Francisco (UCSF) • Sorena Nadaf University of Michigan • Julie Wietzke University of Nebraska Medical Center (UNMC) • Marsha Ketcham University of New Mexico • Robert Milius University of Wisconsin Madison • Rhoda Arzoomanian University Pittsburgh Medical Center • Uma Chandran Wake Forest University • Bob Morrell West Michigan Cancer Center • Raymond Lord

7. Work to date Total – 312 use cases developed • Life Sciences 79 use cases to date • Clinical Research 181 use cases + 37 Reports • Population Science - 13 Uses cases to extend Plan Study (continued work required to address Initiate, conduct and reporting) • Imaging workspace - 35 Use cases identified date to extend • Patients - 4 Use cases to extend to date

8. Life Sciences • 70 use cases v1.0 • 9 additional v1.1

9. Clinical Research – Plan Study • 48 use cases

10. Clinical Research – Initiate Study • 21 Use Cases

11. Clinical Research – Conduct Study • 87 use cases

12. Clinical Research – Report and Analyze • 25 use case • 37 reports

13. A Translational Medicine Business Architecture Model (BAM) "A blueprint of the enterprise that provides a common understanding of the organization and is used to align strategic objectives and tactical demands." Object Management Group, Business Architecture Working Group, Definition The Translational Medicine Business Architecture Model (BAM) is a blueprint of translational medicine. It documents a common understanding of the information, “what, who, how, where and when,” necessary to realize research, so that it is accessible to someone, who is not directly involved in research to align strategic objectives and meet tactical demands - providing a communications platform.

14. Components of the Translational Medicine BAM Use Cases Scenarios A scientist is trying to identify a new genetic biomarker for HER2/neu negative stage I breast cancer patients. Using a caGRID-aware client, the scientist queries for HER2/neu negative tissue specimens of Stage I breast cancer patients Identify Specimens Workflow/Activity diagrams Common Vocabulary (EVS, caDSR & CRFs) Domain Analysis Models

15. Researcher Biorepository Coordinator Use Case Model (BAM) Storyboards in use case s define the work flow and data flow that identify the pre- and post-conditions Activity Diagram Work Flow Data Flow Actors Static Elements Domain Models Class Diagrams Data elements exchanged in a data flow are fully specified in class diagrams Activities in activity diagrams could inform the work flow and functions of the applications Applications

16. Scenarios • Paint the picture of a goal to be accomplished and generally captures workflow represented as an outline or manuscript of the projected sequence of events which contains the primary and secondary (or more) goals required to realize the ultimate goal. • There are two main types • Broad Spectrum • Find a cure for breast cancer • Specific • Treat HER-2 positive breast cancer with chemotherapy

17. BAM Use Cases • The Biomedical Research Business Architecture Model is meant to represent the processes required for research. • They contain • Description • Storyboard • Actors • Pre-conditions • Basic Flow of events • Alternate Flows (as required) • Post-conditions • Alternate post-conditions • Notes (as required) • Definitions (as required) • They are meant to direct the functional requirements required for service development– not to define them.

18. Workflows and Activity Diagrams Workflows • Serves as a visual representation of step-by-step activities and actions, in logical order, with support for choice, iteration and concurrency required to accomplish a specific goal (use case) • Provides basic knowledge so that the goal can be easily communicated and understood. Activity diagrams • A graphical representations of the over all process flow which is made up of multiple workflows Note: In the Unified Modeling Language, activity diagrams can be used to describe the business and operational step-by-step workflows of components in a system.

19. Domain Model (DAM) & Vocabulary • A Domain Analysis Model (DAM) is an abstract representation of a subject area of interest which is complete enough to allow instantiation of all necessary concrete classes needed to develop specialized, DAM-derived design artifacts. A complete DAM contains a static model (class and instance diagrams) and a dynamic model (activity and occasional state diagrams) PLUS a glossary that unambiguously defines all of the relevant terms used in the two models. The relationship between the static and dynamic models should be consistent, e.g. static structures referenced in process flows should be fully explained in the static model and states named as members of the value set for a statusCode attribute for a given class should be fully defined in the context of a detailed state diagram which describes the life cycle of instances of the class. 2 • a shared view of the dynamic and static semantics for an area of interest. It relates the concepts and objects of the domain to each other • This model does not include software • The objects in the domain model are candidates for programming objects 2 - http://ec2-174-129-196-76.compute-1.amazonaws.com/mediawiki/index.php/5_BIG_HEAS:_Components_of_EAF

20. What Pop Sci Group has accomplished to date • Reviewed 8 Population Sciences Scenarios • Scenario 1: Comparing the Lozenge to the Patch for Smoking Cessation • Scenario 2: Families understanding Risks • Scenario 3: Survival Associates with Treatment vs. Observation • Scenario 4: Use Case for Mammography Screening Study • Scenario 5: Tailored Behavioral Intervention Study • Scenario 6: Cohort Study – Recruit Study Participants through the Army of Love / Health of Women Initiative • Scenario 7: Cross Sectional Survey • Scenario 8: Outcomes Study • Identified business specific goals (use cases) for each scenario

25. What Pop Sci Group has accomplished to date • Mapped the use cases in the current clinical research and life science BAMs • Reviewed current use cases and extended as needed to include population sciences • Identified 13 additional use cases to expand current clinical research BAM

26. What Pop Sci Group has accomplished to date The Pop Sci BAM working group is identifying overlap and laying the ground work for integrating the existing BAM work into an overarching Translational Medicine Model

27. Questions

28. Working Group Members • Subject Matter Experts • Eric Ross • Nancy Avis • Jane Brzozowski • Gene Krauss • Project Management • Riki Ohira • Richa Gandhi • Analyst • Michele Ehlman • Leadership • Leslie Derr

29. Thank-you Michele Ehlman michele.ehlman@nih.gov 860-235-8125