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Research Knowledge

Ethics & Academic Technology Transfer: Patients, Products and Public Trust Deborah Zucker, MD, PhD, Tufts Medical Center. Research to Improve Health. Research Knowledge. Products Interventions. Patient Care Public Health. Who does what?

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Research Knowledge

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  1. Ethics & Academic Technology Transfer: Patients, Products and Public TrustDeborah Zucker, MD, PhD, Tufts Medical Center

  2. Research to Improve Health Research Knowledge Products Interventions Patient Care Public Health Who does what? Missions, Goals and Participants in the Research Enterprise

  3. Historically: University Industry Relations-- • Closer ties in Physical Sciences– Government Labs, Defense • Bayh-Dole Act and the rise of Biotechnology • Increase in Commercialization by Faculty • Increased University–Industry Ties - in Biological Sciences • and Medicine • Reduced NIH Funding—Need for funding • The rise of Managed Care • Increased focus on Health Services Research

  4. Research to Improve Health Who’s doing what? Research Knowledge Product Development Patient Care Public Health Product Testing

  5. What’s the concern with increasing -University – Industry Interactions? -Institutional/Investigator Focus on Commercialization?

  6. Drug X is Effective in Treating ConditionA. Dr. Researcher*, BioMed PeerReview 1:1-10 What do you think when you also read: *Corresponding author: Dr. Researcher, TheCompany (manufacturer of DrugX) OR • Corresponding author: • Dr. Researcher, Academic University; • This work was funded by TheCompany (manufacturer of DrugX) OR *Dr. Researcher, Academic University; “Patent pending”

  7. What are your concerns? Bias - Research Integrity Financial/Non-Financial Conflicts of Interest • Consider the Real / Perceived Impacts on: • What we research • How we research • How we interpret results • How and What we disseminate • What and How things are put into practice • How and what outcomes are assessed Consider Missions- Goals– Processes – Where do they overlap? Where do they differ?

  8. Mission – Goals • ACADEMIC INSTITUTIONS: • Colleges—Education, Developing Knowledge • Universities – Broader Missions— • e.g., Provide Quality Patient Care, from primary care to • the most advanced available technologies; • Advance Economic Development • Encourage responses to healthcare needs • Preserve and optimize human life • Research to improve basic understanding of the causes, • mechanisms, treatment and prevention of disease, • and the social interactions related to human health; • Education & service programs to serve the community • ….

  9. Missions – Goals GOVERNMENT AGENCIES: NIH: NIH is the steward of medical and behavioral research for the Nation. Its mission is science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend healthy life and reduce the burdens of illness and disability. NSF: Mission and purpose: To promote the progress of science; to advance the national health, prosperity, and welfare; to secure the national defense....

  10. Missions – Goals COMPANIES: Pfizer: Mission - We will become the world's most valued company to patients, customers, colleagues, investors, business partners and the communities where we work and live. Purpose - We dedicate ourselves to humanity's quest for longer, healthier, happier lives through innovation in pharmaceutical and consumer health products. Genentech: Mission..to be the leading biotechnology company, using human genetic information to discover, develop, manufacture and commercialize biotherapeutics that address significant unmet medical needs. We commit ourselves to high standards of integrity in contributing to the best interests of patients, the medical profession, our employees and our communities, and to seeking significant returns to our stockholders based on the continual pursuit of scientific and operational excellence.

  11. Potential Risks and Benefits with increasing • -University – Industry Interactions? • -Institutional/Investigator Focus on Commercialization? • For: • Researchers/ Clinician Researchers • Institutions • Companies • Insurers (Private and Public) • Government • PATIENTS -PARTICIPANTS

  12. Conflicts of Interest always exist— How can they be minimized and managed?

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