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Defining and measuring innovation in a changing biomedical landscape

The biomedical innovation ecosystem continues to evolve and enhance the processes by which treatments are developed and delivered to patients. Given this changing biomedical innovation landscape, it is imperative that all stakeholders work to ensure that development programs, regulatory practices, and the policies that enable them are aligned on and achieving a common set of goals. This will require a thorough reexamination of our understanding of biomedical innovation – and the subsequent ways in which we seek to incentivize it – in order to more effectively bridge research and analysis of the process itself with the science and policy underpinning it.

Traditional research into the efficiency and effectiveness of drug development programs has tended to focus on the ‘inputs’ and process trends in product development, quantifying the innovation as discrete units. At the opposite end of the research spectrum are potential measures that could be categorized as “value” or “outcomes” metrics. Identifying the appropriate measures across this spectrum – from inputs and technological progress through outcomes and value – and how such metrics can be in conversation with each other to improve the innovation process will be the focus of this expert workshop. On October 14, the Center for Health Policy at Brookings, under a cooperative agreement with the U.S. Food and Drug Administration, convened a roundtable discussion that engaged key stakeholders from throughout the innovation ecosystem to explore the factors and characteristics that could improve our understanding of what constitutes modern “innovation” and how best to track its progress.

Agenda

Welcome

Defining innovation: Traditional approaches and a framework for improvement

J

Janet Woodcock

Director, Center for Drug Evaluation and Research - US Food and Drug Administration

Bridging metrics gaps: Comprehensive measures for improving analysis

K

Ken Kaitin

Director, Tufts Center for the Study of Drug Development, and Professor - Tufts University School of Medicine

P

Paul Kluetz

Acting Deputy Director, Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research - U.S. Food and Drug Administration

P

Peter Neumann

Professor of Medicine, Sackler School of Graduate Biomedical Sciences - Tufts University

M

Marta Wosinska

Director of Economics Staff, Office of Strategic Programs, Center for Drug Evaluation and Research - U.S. Food and Drug Administration

Establishing a common understanding of the dimensions of innovation: Implications for policy, research, and development

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