Pharmaceutical Development Phases A Duration Analysis药物开发阶段的持续时间分析.pptVIP

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Pharmaceutical Development Phases A Duration Analysis药物开发阶段的持续时间分析.ppt

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Pharmaceutical Development Phases A Duration Analysis药物开发阶段的持续时间分析

Spending on Drug Development Spending on New Drug Development Disclaimer: This presentation does not necessarily represent the views of the FTC or any individual Commissioners. Industry Background $16b or 9% of all industry RD expenditure (NSF 2003). Medical care expenditure $1,589b or 17% of total personal consumption (BEA 2006). Saves lives. Overview Drug Development Process Cost of Drug Development Vaccines vs. Drugs Incentives to Develop New Drugs Summary Overview Drug Development Process Cost of Drug Development Vaccines vs. Drugs Incentives to Develop New Drugs Summary Drugs Development Process: Summary Preclinical Testing - arrays and animal models. Investigational New Drug (IND) filed with FDA. Phase I – Safety tests with 20-30 healthy patients. Phase II – Safety and efficacy with 200-300 patients. Phase III – Efficacy with 2000-3000 patients. New Drug Application (NDA) filed with FDA. FDA marketing approval. Overview Drug Development Process Cost of Drug Development Vaccines vs. Drugs Incentives to Develop New Drugs Summary Cost of Drug Development June 16 2005 Economist “In most industries such figures on the cost of product development are of purely internal interest. In the pharmaceuticals business, however, they have become the subject of public debate because they are (incorrectly) linked to drug prices.” Cost of Drug Development DiMasi et al (2003): $802m per New Molecular Entity Two parts to the estimation Actual expenditure on drugs in development. Probability of success and successful durations. Cost of Drug Development Expenditure on Drug Development Match number of drugs in development per firm per year with data on annual expenditure on pharmaceutical RD. Development data: Pharmaprojects RD expenditure: CompuStat and Global Vantage Cost of Drug Development Expenditure on Drug Development $25m per drug per year in Clinical Trials. $17m in Phase I (DiMasi et al $15m) $32m in Phase II (DiMasi et al $25m) $19m in Phase III (DiMasi et al $