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Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
Changing the Medical Research Paradigm
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Changing the Medical Research Paradigm

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Presentation on current state of pharmaceutical drug research and ideas for change. It addresses how the pharmaceutical industry, NIH, Government, HealthCare Law, OIG, Public Health

Presentation on current state of pharmaceutical drug research and ideas for change. It addresses how the pharmaceutical industry, NIH, Government, HealthCare Law, OIG, Public Health

Published in: Health & Medicine, Business
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  • The Predictive Safety Testing Consortium, a public–private partnership, led by the non-profit Critical Path Institute (C-Path), is facilitating the sharing of information by industry to develop new tools that can be qualified for use in drug development.  This effort is taking place under the advisement of FDA and the European Medicines Evaluation Agency (EMEA).  In May 2008, FDA and EMEA announced that they had reviewed and accepted seven new biomarkers—laboratory tests on urine that signal kidney injury.  These new tests can now be used in laboratory research to predict the safety of experimental drugs, enabling drugs to reach market faster and with greater confidence in their safety. 
  • The Predictive Safety Testing Consortium, a public–private partnership, led by the non-profit Critical Path Institute (C-Path), is facilitating the sharing of information by industry to develop new tools that can be qualified for use in drug development.  This effort is taking place under the advisement of FDA and the European Medicines Evaluation Agency (EMEA).  In May 2008, FDA and EMEA announced that they had reviewed and accepted seven new biomarkers—laboratory tests on urine that signal kidney injury.  These new tests can now be used in laboratory research to predict the safety of experimental drugs, enabling drugs to reach market faster and with greater confidence in their safety. 
  • How long will it be allowed to continue before the government play the monopoly card?
  • We to change Public awareness and perceptions Feedback from patients- use technology to report outocmes
  • To trusted 3 rd parties
  • Transcript

    • 1. Changing the Research Paradigm Regina Awe Society for Independence In Research Insert your logo in this area then delete this text box.
    • 2. Disclaimer <ul><li>The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. </li></ul><ul><li>  </li></ul><ul><li>These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. </li></ul>
    • 3. Disclosures <ul><li>Regina Awe </li></ul><ul><ul><li>Former Pfizer executive responsible for reforming the Investigator-Initiated Research, Clinical and Medical Education Grants and Scientific Exhibits Programs. Pfizer Stockholder. </li></ul></ul><ul><ul><li>Currently consult on policy and process reforms within the drug and medical device industries </li></ul></ul><ul><ul><li>Founder of the Society for Independence In Research (SIIR) IndependenceInResearch.org </li></ul></ul>
    • 4. Society for Independence In Research (SIIR) <ul><ul><li>Vision:  SIIR is an independent non-profit organization that serves as a &amp;quot;trusted third party” in supporting cooperative research between academics, private entities, non-profits and governments - for benefit of the individual </li></ul></ul><ul><ul><li>Contact : [email_address] </li></ul></ul>
    • 5. Public Scrutiny Regarding Pharma Industry Pharmaceutical Company Payments to Physicians Published: March 21, 2007 Doctors’ Ties to Drug Makers Are Put on Close View By GARDINER HARRIS and JANET ROBERTS Published: March 21, 2007
    • 6. Attention brought good change… <ul><ul><li>Code of Interactions with Healthcare professionals </li></ul></ul><ul><ul><li>FDA’s Critical Path Initiative (CPI &amp; C-Path) </li></ul></ul><ul><ul><li>Global Regulatory cooperation (FDA &amp; EMEA) </li></ul></ul><ul><ul><li>Risk vs. Benefit vs. Cost to Healthcare Systems </li></ul></ul>
    • 7. Debate and Cooperation <ul><ul><ul><li>Tort and Healthcare Reform </li></ul></ul></ul><ul><ul><ul><li>Medical Education (CME) that can improve patient outcomes </li></ul></ul></ul><ul><ul><ul><li>Government collaborations internally &amp; externally </li></ul></ul></ul><ul><ul><ul><ul><li>FDA-NIH Collaborations </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Private sector, Non-profits, Advocacy Groups &amp; Academia </li></ul></ul></ul></ul>
    • 8. <ul><ul><ul><li>Public trust in industry has eroded </li></ul></ul></ul><ul><ul><ul><li>Risk vs. Benefit - public’s expectations </li></ul></ul></ul><ul><ul><ul><li>Unabashed litigation – “Defective” drugs </li></ul></ul></ul><ul><ul><ul><li>Transparent funding disclosure </li></ul></ul></ul><ul><ul><ul><ul><li>Healthcare providers and patients </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Academic/Independent Researchers </li></ul></ul></ul></ul><ul><ul><ul><li>Government sanctions </li></ul></ul></ul><ul><ul><ul><ul><li>“ baby and the bathwater” </li></ul></ul></ul></ul><ul><ul><ul><ul><li>can’t do it all </li></ul></ul></ul></ul>Current State of Industry
    • 9. Consequence… Productivity Paralysis <ul><ul><ul><li>Noted decrease in pipelines </li></ul></ul></ul><ul><ul><ul><li>Current business model for drug development becoming financially untenable </li></ul></ul></ul><ul><ul><ul><ul><li>Mega-mergers and culture integrations </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Globally disparate regulatory &amp; transparency demands </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Risk vs. Benefit expectations &amp; liabilities </li></ul></ul></ul></ul><ul><ul><ul><ul><li>Substantial overhead costs for compliance </li></ul></ul></ul></ul><ul><ul><ul><ul><li>External price-control pressures </li></ul></ul></ul></ul>
    • 10. Industry Reaction <ul><li>“ I think we are seeing deals that are really driven more by weakness than what I would describe as strong strategic combinations. </li></ul><ul><li>They are predicated on synergies and rather massive cost cutting. That will improve short term problems but fail to answer the long term question of research productivity. ” </li></ul><ul><li>John Lechleiter, CEO of Eli Lilly from FirstWord. </li></ul>
    • 11. Consequences for Public Health <ul><ul><li>Litigious “mentality” keeps the healthcare industry in a defensive mode and drives up costs </li></ul></ul><ul><ul><li>Parties/people don’t see value to participating in clinical research under normal conditions </li></ul></ul><ul><ul><li>Industry R&amp;D hasn’t traditionally been driven by unmet medical needs </li></ul></ul><ul><ul><li>Taint of mistrust in industry-sponsored research </li></ul></ul>
    • 12. Can Big Pharma Change?
    • 13. “ It’s time to fight the Pharmascolds”* <ul><ul><ul><li>“ Not defending itself in the court of public opinion has only emboldened industry critics and disheartened employees” </li></ul></ul></ul><ul><ul><ul><li>(* Wall Street Journal article April 8, 2009) </li></ul></ul></ul><ul><ul><ul><li>Agencies whose funding is dependent on finding violations – can they remain objective over time? </li></ul></ul></ul>
    • 14. In Defense of Industry <ul><ul><ul><li>Media focus on negatives overshadows vital role of medical product companies to healthcare </li></ul></ul></ul><ul><ul><ul><li>Magnitude of complexity to get a product from discovery to market is underappreciated by the public and still confusing to Wall Street </li></ul></ul></ul><ul><ul><ul><li>Slow adoption of new technology and new treatments by all parties including payor/providers involved inhibits progress </li></ul></ul></ul><ul><ul><ul><li>New industry R&amp;D units for rare diseases </li></ul></ul></ul>
    • 15. Impediments to Medical Progress <ul><ul><li>Unwillingness to change current business models or to examine the effectiveness of regulatory systems </li></ul></ul><ul><ul><li>No incentives for industry R&amp;D driven by public needs or to share disease knowledge banks </li></ul></ul><ul><ul><li>Perceptions created by “Defective Drug” advertising for lawsuits and the media </li></ul></ul><ul><ul><li>Better tools critical to understanding risk vs. benefits </li></ul></ul><ul><ul><li>Restrictions on opening scientific discussions of potential new drugs and new uses for old ones </li></ul></ul>
    • 16. Industry Challenges… <ul><ul><ul><li>Demand driven innovation for safe, effective and affordable products </li></ul></ul></ul><ul><ul><ul><li>Improve safety surveillance and accept less control in comparative effectiveness research </li></ul></ul></ul><ul><ul><ul><li>Appropriately interact with other public and privately funded researchers to speed the progress of bringing new treatments to practice </li></ul></ul></ul><ul><ul><ul><li>Supporting ongoing medical education that shows improvements in patient outcomes </li></ul></ul></ul>
    • 17. Why Change the Research Paradigm? <ul><ul><li>Earning public trust is key to industry success </li></ul></ul><ul><ul><li>People should understand it’s importance </li></ul></ul><ul><ul><li>Focus R&amp;D incentives on breakthrough solutions for unmet medical needs </li></ul></ul><ul><ul><li>Reward knowledge sharing to prevent, manage or cure diseases </li></ul></ul><ul><ul><li>Negotiate solutions to barriers that inhibit progress </li></ul></ul><ul><ul><li>All parties need “To Do the Right Thing” </li></ul></ul>
    • 18. What Needs to Change for Industry? <ul><li>External parties will influence R&amp;D priorities </li></ul><ul><ul><li>Create rewards for the research undertaken </li></ul></ul><ul><ul><li>Data sharing of research IP is legally protected </li></ul></ul><ul><ul><li>Increase collaboration to reduce cost </li></ul></ul><ul><ul><li>Less control over comparative trials </li></ul></ul><ul><li>Eliminate unnecessary overhead thru technology </li></ul><ul><li>Tort reforms </li></ul>
    • 19. What Needs to Change for the Public? <ul><ul><li>Assurance that the development and delivery of treatment is trustworthy and in their best interests </li></ul></ul><ul><ul><li>Access to unbiased medical information, easily delivered in a manner that they can relate </li></ul></ul><ul><ul><li>Increased advocacy for unmet medical needs </li></ul></ul><ul><ul><li>Voice of the patient drives innovations </li></ul></ul><ul><ul><li>Appreciation of the risk vs. benefits &amp; the importance of participating in clinical trials </li></ul></ul>
    • 20. New Trends… <ul><ul><li>“ Move toward partnering is being driven by economic forces within Big Pharma, the growing strength of innovation from external sources, and the worldwide commoditization of R&amp;D expertise.” </li></ul></ul><ul><ul><li>Ted Torphy, CSO, Johnson&amp;Johnson Pharmaceuticals from FirstWord </li></ul></ul>
    • 21. Change is upon us <ul><ul><li>“ These trends will fuel a surge in partnerships between the pharmaceutical industry, biotech and academia that will fundamentally and irreversibly change the model by which new drugs are discovered and developed. ” </li></ul></ul><ul><ul><li>Ted Torphy, CSO, Johnson&amp;Johnson Pharmaceuticals from FirstWord </li></ul></ul>
    • 22. Time to be Creative in New Solutions
    • 23. Changing the Research Paradigm Thank you for attending Regina Awe Society for Independence In Research Independenceinresearch.org Insert your logo in this area then delete this text box.
    • 24. Society for Independence In Research <ul><li>SIIR is an independent non-profit organization </li></ul><ul><ul><li>Think tank for the people </li></ul></ul><ul><ul><li>Safe haven for scientific debate and exchange </li></ul></ul><ul><ul><li>Policy and process reforms </li></ul></ul><ul><ul><li>Independent research and EBM forums </li></ul></ul><ul><ul><li>Educational support and guidelines </li></ul></ul><ul><ul><li>Consulting and mediation for research partnership </li></ul></ul><ul><ul><li>IndependenceInResearch.org </li></ul></ul>

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