Drug Safety

PI/Project Contact:

Ulku Oktem

Project description:

The objective of Drug Safety Project is (a) to better understand the impact of different factors in identification and reduction of adverse drug effects during a drug’s life cycle which extends from drug discovery to post marketing, (b) to research alternatives to the current drug development and approval system which would reduce the risk of adverse drug effects improving both public health and corporate financial performance.

The project started in 2003 by conducting systemic risk analysis in a large pharmaceutical corporation to identify gaps in their drug development and post marketing practices that could contribute to the risk of identification of adverse drug effects. Current research interests are:

  • Impact of direct to consumer advertisement on adverse drug effects
  • Alternative drug approval and marketing approach to reduce adverse drug effects
  • Developing a benefit/risk assessment tool (method) to improve decision making process through better benefit/risk information

Recent publications

The Manhattan Institute, “Prescription for Progress: The Critical Path To Drug Development“, Working Paper, June 2006. (PDF version)