Presentation at China DIA 2011

1. Utilizing Digital Healthcare Data to Create a New Business Model in Drug Safety Michael A. Ibara Pfizer, Inc. TRACK 5 Capability & Capacity Building, Clinical Development Modernize Clinical Development Through New Technology

6. “ The transition from a paradigm in crisis to a new one from which a new tradition of normal science can emerge is far from a cumulative process, one achieved by an articulation or extension of the old paradigm. Rather it is a reconstruction of the field from new fundamentals, a reconstruction that changes some of the field's most elementary theoretical generalizations as well as many of its paradigm methods and applications. During the transition period there will be a large but never complete overlap between the problems that can be solved by the old and by the new paradigm. But there will also be a decisive difference in the modes of solution. When the transition is complete, the profession will have changed its view of the field, its methods, and its goals.” Thomas Kuhn The Structure of Scientific Revolutions (1962), 84-5.

8. THE PROBLEM AS P R O C E S S

11. THE PROBLEM AS D A T A

12. Silos and Underreporting = stranded data Regulator Underutilized sources Pharma replicating the same front-end process across companies Consumers Doctors Hospitals Health Information Exchanges Large Medical Practices Lab Data Rx Data

13. THE PROBLEM AS S Y S T E M D E S I G N

14. "A design representation suitable to a world in which the scarce factor is information may be exactly the wrong one for a world in which the scarce factor is attention.” Herbert Simon The Sciences of the Artificial p.144

15. "A design representation suitable to a world in which the scarce factor is information may be exactly the wrong one for a world in which the scarce factor is attention . Herbert Simon The Sciences of the Artificial p.144 The task is not to design information-distributing systems but intelligent information-filtering systems.“

16. THE PROBLEM AS C U L T U R E

17. M.Ibara ASTER "Management scholars have identified a strong attachment to the status quo in many organizations and a tendency to commit “sunk cost” errors by pursuing a course of action because so much has already been invested in it … … there was an attitude of “comfort with existing beliefs” that justified a resistance to internal or external criticism and a stifling of dissenting views…” The Future of Drug Safety:Promoting and Protecting the Health of the Public IOM, 2007

18. We’ve electronified our old business model We need business models that will take advantage of digitized healthcare data

19. ADE Spontaneous Triggered Electronic Reports David Westfall Bates, MD, M.Sc. Chief of the Division of General Internal Medicine at the Brigham and Women's Hospital; Professor of Medicine at Harvard Medical School and Professor of Health Policy and Management at the Harvard School of Public Health (Co-Director of the Program in Clinical Effectiveness) Jeffrey A. Linder, MD, MPH, FACP - PI of *ASTER Assistant Professor of Medicine, Harvard Medical School Division of General Medicine and Primary Care, Brigham and Women's Hospital, Boston MA

22. 10:30:00 A doctor is working at an ambulatory clinic in the metropolitan Boston area. They discontinue a patient’s drug due to an adverse event…

23. Screen Shots EHR

24. Screen shots #2 EHR

25. Screen shots #3

26. Screen shots #4

27. Screen shots #7 EHR

28. 10:30:00 The doctor goes back to seeing the patient 10:31:00

29. 10:40:00 A MedWatch report* derived directly from the source document (EHR), validated by the doctor, is delivered to FDA * The report is MedDRA coded and has an initial ‘serious/nonserious’ assessment

30. "Overall ASTER was well-accepted by the participating physicians, who felt it was unobtrusive and who saw the public health potential. “ The clinicians, most of whom submitted no reports in the prior year - submitted over 200 reports in 3 months." Jeffrey A. Linder, MD, MPH, FACP Brigham and Women ’ s Hospital / Partners Healthcare PI on ASTER Study

39. A Public Health / Drug Safety Model Built on the ASTER Model Central Organization Regulatory Functions Technical Functions Safety Data SFDA Doctors Consumers Patients Pharma Qualified Researchers Medical Organizations Patients Consumer Portal Physician Portal

41. Thank you michael.ibara@pfizer.com Utilizing Digital Healthcare Data to Create a New Business Model in Drug Safety