D.Zucker Draft-EB09 Ethics & Academic Technology Transfer: Patients, Products and Public Trust Deborah Zucker, MD, PhD, Tufts Medical Center

D.Zucker Draft-EB09 Research Knowledge Products Interventions Patient Care Public Health Research to Improve Health Who does what? Missions, Goals and Participants in the Research Enterprise

D.Zucker Draft-EB09 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

D.Zucker Draft-EB09 Research Knowledge Product Development Patient Care Public Health Research to Improve Health Product Testing Acad+++ Indus+++ Who’s doing what?

D.Zucker Draft-EB09 What’s the concern with increasing -University – Industry Interactions? -Institutional/Investigator Focus on Commercialization?

D.Zucker Draft-EB09 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) Corresponding author: Dr. Researcher, Academic University; This work was funded by TheCompany (manufacturer of DrugX) *Dr. Researcher, Academic University; OR “Patent pending”

D.Zucker Draft-EB09 Consider the Real / Perceived Impacts on: 1.What we research 2.How we research 3.How we interpret results 4.How and What we disseminate 5.What and How things are put into practice 6.How and what outcomes are assessed What are your concerns? Bias - Research Integrity Financial/Non-Financial Conflicts of Interest Consider Missions- Goals– Processes – Where do they overlap? Where do they differ?

D.Zucker Draft-EB09 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 …. Mission – Goals

D.Zucker Draft-EB09 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....

D.Zucker Draft-EB09 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.

D.Zucker Draft-EB09 Potential Risks and Benefits with increasing -University – Industry Interactions? -Institutional/Investigator Focus on Commercialization? For: 1.Researchers/ Clinician Researchers 2.Institutions 3.Companies 4.Insurers (Private and Public) 5.Government 6.PATIENTS -PARTICIPANTS

D.Zucker Draft-EB09 Potential Risks and Benefits for: Researchers/Faculty Academic Freedom – measuring success? Can I talk about my work with colleagues? Financing your work My patients and my research- “double agents” Access to new interventions for evaluation Funding for Research Expertise in production, Clinical Trials and Marketing Institutions- Autonomy and financial viability Oversight- Biting the hands that feed you Funding for Research for Faculty Return on Investments in Research (Royalties)

D.Zucker Draft-EB09 Companies Proprietary considerationsAccess to Patients “Academic” connection Insurers (Private & Government) What data can we trust?Unbiased evaluations Government Public Funding --Public Benefit? Translation of Research into interventions Patients In whose best interest? Trust – Easy to lose …Very hard (impossible?) to win back! Access to potentially effective new medications

D.Zucker Draft-EB09 Conflicts of Interest always exist— How can they be minimized and managed?