Date & Time

Wed, 02/02/2011


Issues regarding the safety and efficacy of new medical products intersect at the table where FDA regulators and companies negotiate approvals. At present, both parties are constrained: regulators face many “but what if” disincentives, and companies are wary of losing money and development time. Too often, inaction seems the safest course.

Patient advocates could strengthen this process by serving as mediators. In his newly published Hastings Center Report article, “A Third Seat at the Table,” Roth proposes a model that would give patient representatives a role in weighing product safety and efficacy concerns. Speaking for the people who have the most at stake in health care advances, patient advocates can help regulators and companies identify new pathways to nurture innovation, build public trust, cut costs, and address “quality of life” issues.



Duane Roth, A Third Seat at the Table: An Insider’s Perspective on Patient Representatives (Hasting Center Report)

KPBS These Days: “Should Patients Have A Voice In FDA Drug Approvals?”

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Duane Roth

Duane Roth is CEO and member of the Board of CONNECT, an organization that has fostered entrepreneurship in the San Diego region since its inception in 1985. He also is Vice Chairman of the citizens’ oversight board of the California Institute of Regenerative Medicine (CIRM). He founded Alliance Pharmaceutical Corp., where he is Chairman of the Board of Directors. He has served on the Board of Directors, and executive committees of the Biotechnology Industry Organization, the California Healthcare Institute, and BIOCOM.

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