Utilizing Digital Healthcare Data to Create a New Business Model in Drug Safety  Michael A. Ibara Pfizer, Inc. TRACK 5 Cap...
Agenda <ul><li>THE IMPACT OF THE DIGITIZATION OF HEALTHCARE DATA </li></ul><ul><li>AN EXAMPLE FROM DRUG SAFETY: THE ASTER ...
Agenda <ul><li>THE IMPACT OF THE DIGITIZATION OF HEALTHCARE DATA </li></ul><ul><li>AN EXAMPLE FROM DRUG SAFETY: THE ASTER ...
Digitization of Healthcare Data <ul><li>The digitization of healthcare data will be one of the most significant events in ...
A Paradigm Shift <ul><li>Applying new technologies using old assumptions will deliver incremental improvements </li></ul><...
“ The transition from a paradigm in crisis to a new one from which a new tradition of normal science can emerge is far fro...
“ The transition from a paradigm in crisis to a new one from which a new tradition of normal science can emerge is far fro...
THE PROBLEM AS   P R O C E S S
Inconvenience Constrains Reporting   <ul><li>Not part of normal routine </li></ul><ul><li>Not available at point of recogn...
M.Ibara ASTER  Regulations Drive The Process &quot; Overall, the fulfillment of regulatory requirements…has become too gre...
THE PROBLEM AS   D A T A
Silos and Underreporting = stranded data Regulator Underutilized sources Pharma replicating the same front-end process acr...
THE PROBLEM AS   S Y S T E M D E S I G N
&quot;A design representation suitable to a world in which the scarce factor is information may be exactly the wrong one f...
&quot;A design representation suitable to a world in which the scarce factor is information may be exactly the wrong one f...
THE PROBLEM AS   C U L T U R E
M.Ibara ASTER  &quot;Management scholars have identified a strong attachment to the status quo in many organizations and a...
We’ve electronified our old business model We need business models that will take advantage of  digitized healthcare data
ADE Spontaneous Triggered Electronic Reports David Westfall Bates, MD, M.Sc. Chief of the Division of General Internal Med...
The Hypothesis <ul><li>Current post marketing safety reporting model in U.S. is built on  vertical organizations  having t...
ASTER at Brigham and Women’s Patient Service Provider Regulator <ul><li>* AE Report </li></ul><ul><li>EHR pt data </li></u...
10:30:00 A doctor is working at an ambulatory clinic in the metropolitan Boston area. They discontinue a patient’s drug du...
Screen Shots EHR
Screen shots #2 EHR
Screen shots #3
Screen shots #4
Screen shots #7 EHR
10:30:00 The doctor goes back to seeing the patient 10:31:00
10:40:00 A MedWatch report* derived directly from the source document (EHR), validated by the doctor, is delivered to FDA ...
&quot;Overall ASTER was well-accepted by the  participating physicians, who felt it was unobtrusive and who saw the public...
<ul><li>Paper or separate site </li></ul><ul><li>36 minutes </li></ul><ul><li>Several days or more </li></ul><ul><li>0 rep...
ASTER Safety Consortium <ul><li>A group of like-minded companies and individuals determined to take full advantage of digi...
Agenda <ul><li>THE IMPACT OF THE DIGITIZATION OF HEALTHCARE DATA </li></ul><ul><li>AN EXAMPLE FROM DRUG SAFETY: THE ASTER ...
Implications for Safety <ul><li>As regulations become more demanding and data becomes more available, the distinction betw...
Implications for Safety (cont.) <ul><li>In the same way, the requirements for a company monitoring an individual drug will...
Agenda <ul><li>THE IMPACT OF THE DIGITIZATION OF HEALTHCARE DATA </li></ul><ul><li>AN EXAMPLE FROM DRUG SAFETY: THE ASTER ...
Drug Safety in China <ul><li>Pharmaceutical companies developing and marketing drugs in China must monitor the safety of t...
An Example <ul><li>When a patient receives a drug, they are given an email address and a phone number to text or call if t...
A Public Health / Drug Safety Model Built  on the ASTER Model Central Organization Regulatory Functions Technical Function...
China’s Drug Safety Challenge <ul><li>Digitization of healthcare data provides an opportunity for advancement of public he...
Thank you michael.ibara@pfizer.com  Utilizing Digital Healthcare Data to Create a New Business Model in Drug Safety
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China Annual Drug Information Association Meeting

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  • 05/26/11 There is a fundamental problem that is always referred to when discussing SRS – and this is it So here is a root problem with SRS as we know it today..
  • 05/26/11
  • 05/26/11
  • China Annual Drug Information Association Meeting

    1. 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
    2. 2. Agenda <ul><li>THE IMPACT OF THE DIGITIZATION OF HEALTHCARE DATA </li></ul><ul><li>AN EXAMPLE FROM DRUG SAFETY: THE ASTER STUDY </li></ul><ul><li>IMPLICATIONS FOR RESEARCH AND INDUSTRY </li></ul><ul><li>CHINA AS EXAMPLE </li></ul>
    3. 3. Agenda <ul><li>THE IMPACT OF THE DIGITIZATION OF HEALTHCARE DATA </li></ul><ul><li>AN EXAMPLE FROM DRUG SAFETY: THE ASTER STUDY </li></ul><ul><li>IMPLICATIONS FOR RESEARCH AND INDUSTRY </li></ul><ul><li>CHINA AS EXAMPLE </li></ul>
    4. 4. Digitization of Healthcare Data <ul><li>The digitization of healthcare data will be one of the most significant events in the history of the pharmaceutical industry </li></ul><ul><li>It allows for the emergence of new business models based on digitized data rather than current practices evolved from paper and pen </li></ul><ul><li>As a result, dramatic improvements are possible, although this is not a linear path of continuous improvement – it is a nonlinear change in direction </li></ul>
    5. 5. A Paradigm Shift <ul><li>Applying new technologies using old assumptions will deliver incremental improvements </li></ul><ul><li>We only gain dramatic benefits by applying the new technologies to new business models </li></ul><ul><li>This is what Thomas Kuhn, historian of science, called a ‘Paradigm Shift’ </li></ul><ul><li>A Paradigm Shift doesn’t entail new solutions to old problems – it changes the very nature of the problem </li></ul>
    6. 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.
    7. 7. “ 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. <ul><li>The old ways aren’t working any more… </li></ul><ul><li>- costs </li></ul><ul><li>efficiency </li></ul><ul><li>process driven </li></ul><ul><li>- outsourcing </li></ul><ul><li>- transparency </li></ul>
    8. 8. THE PROBLEM AS P R O C E S S
    9. 9. Inconvenience Constrains Reporting <ul><li>Not part of normal routine </li></ul><ul><li>Not available at point of recognition </li></ul><ul><li>Duplicate data entry </li></ul><ul><li>High nuisance factor </li></ul>Reporting interrupts the routine of providing care and imposes a burden on providers – greatly decreasing the probability that events will be reported
    10. 10. M.Ibara ASTER Regulations Drive The Process &quot; Overall, the fulfillment of regulatory requirements…has become too great a process driver that has diverted attention away from scientific approaches to gaining better evidence…” <ul><ul><ul><li>Waller, P.C. and Evans, S.J.W. </li></ul></ul></ul><ul><ul><ul><li>“ A model for the future conduct of pharmacovigilance” </li></ul></ul></ul><ul><ul><ul><li>Pharmacoepidemiology and Drug Safety 2003; 12: 17–29 </li></ul></ul></ul>
    11. 11. THE PROBLEM AS D A T A
    12. 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. 13. THE PROBLEM AS S Y S T E M D E S I G N
    14. 14. &quot;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. 15. &quot;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. 16. THE PROBLEM AS C U L T U R E
    17. 17. M.Ibara ASTER &quot;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. 18. We’ve electronified our old business model We need business models that will take advantage of digitized healthcare data
    19. 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
    20. 20. The Hypothesis <ul><li>Current post marketing safety reporting model in U.S. is built on vertical organizations having the resources to find, collect and process safety information </li></ul><ul><li>Manufacturers have been the de facto owners of safety information and responsible for it (focus of regulations) because they were the only organizations able to afford the transaction costs </li></ul><ul><li>Two developments allow for a dramatic lowering of the ‘transaction cost’ of finding, collecting and reporting safety information </li></ul><ul><li>Healthcare data is moving toward greater digitization </li></ul><ul><li>There are established and evolving standards for exchanging safety information </li></ul><ul><li>Once transaction costs drop, new business models will be possible </li></ul>
    21. 21. ASTER at Brigham and Women’s Patient Service Provider Regulator <ul><li>* AE Report </li></ul><ul><li>EHR pt data </li></ul><ul><li>Physician Assessment </li></ul><ul><li>Coding & Bus Rule Results </li></ul><ul><li>Electronic Wrapper </li></ul>* Coding Bus Rules * * ”Triggered” Adverse Event Reports CDISC/IHE RFD Physician EHR Ambulatory Clinics Manufacturer
    22. 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. 23. Screen Shots EHR
    24. 24. Screen shots #2 EHR
    25. 25. Screen shots #3
    26. 26. Screen shots #4
    27. 27. Screen shots #7 EHR
    28. 28. 10:30:00 The doctor goes back to seeing the patient 10:31:00
    29. 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. 30. &quot;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.&quot; Jeffrey A. Linder, MD, MPH, FACP Brigham and Women ’ s Hospital / Partners Healthcare PI on ASTER Study
    31. 31. <ul><li>Paper or separate site </li></ul><ul><li>36 minutes </li></ul><ul><li>Several days or more </li></ul><ul><li>0 reports per physician </li></ul><ul><li>1 page of information </li></ul><ul><li>At point of care </li></ul><ul><li>60 seconds </li></ul><ul><li>20 minutes (triaged) </li></ul><ul><li>5 reports per physician </li></ul><ul><li>7 pages of information </li></ul>Traditional ASTER
    32. 32. ASTER Safety Consortium <ul><li>A group of like-minded companies and individuals determined to take full advantage of digitized healthcare data </li></ul><ul><li>Goals are twofold : </li></ul><ul><ul><li>Explore the implications of the ASTER model to improve pre/post safety reports and other areas of clinical research </li></ul></ul><ul><ul><li>Design and execute a working model in the real world </li></ul></ul><ul><li>Pfizer </li></ul><ul><li>GSK </li></ul><ul><li>Astra Zeneca </li></ul><ul><li>Cerner </li></ul><ul><li>GE </li></ul><ul><li>Greenway Medical </li></ul><ul><li>CDISC </li></ul>
    33. 33. Agenda <ul><li>THE IMPACT OF THE DIGITIZATION OF HEALTHCARE DATA </li></ul><ul><li>AN EXAMPLE FROM DRUG SAFETY: THE ASTER STUDY </li></ul><ul><li>IMPLICATIONS FOR RESEARCH AND INDUSTRY </li></ul><ul><li>CHINA AS EXAMPLE </li></ul>
    34. 34. Implications for Safety <ul><li>As regulations become more demanding and data becomes more available, the distinction between pre-marketing safety and post-marketing safety is disappearing </li></ul><ul><li>Companies will be required to monitor the safety of their drugs in a much more active manner </li></ul>
    35. 35. Implications for Safety (cont.) <ul><li>In the same way, the requirements for a company monitoring an individual drug will merge with the need to monitor the larger public health, which includes drug safety </li></ul><ul><li>The consumer and patient will become direct and significant sources for information on drug safety </li></ul>
    36. 36. Agenda <ul><li>THE IMPACT OF THE DIGITIZATION OF HEALTHCARE DATA </li></ul><ul><li>AN EXAMPLE FROM DRUG SAFETY: THE ASTER STUDY </li></ul><ul><li>IMPLICATIONS FOR RESEARCH AND INDUSTRY </li></ul><ul><li>CHINA AS EXAMPLE </li></ul>
    37. 37. Drug Safety in China <ul><li>Pharmaceutical companies developing and marketing drugs in China must monitor the safety of their companies’ drugs </li></ul><ul><li>At the same time, China has the task of monitoring the public health of it’s citizens, including the safety of drugs </li></ul><ul><li>Should China develop a drug safety monitoring system the same as the West has done historically, when we see how many problems the West now faces as a resulting of the digitization of healthcare data? </li></ul>
    38. 38. An Example <ul><li>When a patient receives a drug, they are given an email address and a phone number to text or call if they believe they are having problems caused by the drug </li></ul><ul><li>When they email/text/call, the information is recorded centrally and they receive a simple form asking a few more questions </li></ul><ul><li>This information is evaluated centrally and it is determined whether to follow up more directly with the patient and/or their doctor </li></ul><ul><li>These reports form the basis of the drug safety / public health system </li></ul>
    39. 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
    40. 40. China’s Drug Safety Challenge <ul><li>Digitization of healthcare data provides an opportunity for advancement of public health and drug safety </li></ul><ul><li>China can take full advantage of developments without having to recapitulate Western development </li></ul><ul><li>To do this will require a deep understanding of the fundamentals and a willingness to think in new ways </li></ul><ul><li>If this is done, China could create a modern public health, industry utility model which is one of the first of it’s kind </li></ul>
    41. 41. Thank you michael.ibara@pfizer.com Utilizing Digital Healthcare Data to Create a New Business Model in Drug Safety
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