Journal ArticleDOI
Trends in Risks Associated With New Drug Development: Success Rates for Investigational Drugs
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The study examined the development histories of these investigational compounds from the time point at which they first entered clinical testing through June 2009 and estimated clinical approval success rates and phase transition probabilities differed significantly by therapeutic class.Abstract:
This study utilizes both public and private data sources to estimate clinical phase transition and clinical approval probabilities for drugs in the development pipelines of the 50 largest pharmaceutical firms (by sales). The study examined the development histories of these investigational compounds from the time point at which they first entered clinical testing (1993-2004) through June 2009. The clinical approval success rate in the United States was 16% for self-originated drugs (originating from the pharmaceutical company itself) during both the 1993-1998 and the 1999-2004 subperiods. For all compounds (including licensed-in and licensed-out drugs in addition to self-originated drugs), the clinical approval success rate for the entire study period was 19%. The estimated clinical approval success rates and phase transition probabilities differed significantly by therapeutic class. The estimated clinical approval success rate for self-originated compounds over the entire study period was 32% for large molecules and 13% for small molecules. The estimated transition probabilities were also higher for all clinical phases with respect to large molecules.read more
Citations
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Journal ArticleDOI
Innovation in the pharmaceutical industry: New estimates of R&D costs
TL;DR: The research and development costs of 106 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms and used to estimate the average pre-tax cost of new drug and biologics development.
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Clinical development success rates for investigational drugs.
TL;DR: The most comprehensive survey of clinical success rates across the drug industry to date shows productivity may be even lower than previous estimates.
Journal ArticleDOI
Diagnosing the decline in pharmaceutical R&D efficiency.
TL;DR: The aim of this work is to provoke a more systematic analysis of the causes of the decline in R&D efficiency, and discusses four factors that it considers to be primary causes: the 'better than the Beatles' problem; the 'cautious regulator' problem'; the 'throw money at it' tendency; and the 'basic research–brute force' bias.
Journal ArticleDOI
The therapeutic monoclonal antibody market
TL;DR: Since the commercialization of the first therapeutic monoclonal antibody product in 1986, this class of biopharmaceutical products has grown significantly so that, as of November 10, 2014, forty-seven monoclotal antibody products have been approved in the US or Europe for the treatment of a variety of diseases.
Journal ArticleDOI
The support of human genetic evidence for approved drug indications
Matthew R. Nelson,Hannah Tipney,Jeffery L. Painter,Judong Shen,Paola Nicoletti,Yufeng Shen,Aris Floratos,Pak C. Sham,Mulin Jun Li,Junwen Wang,Lon R. Cardon,John C. Whittaker,Philippe Sanseau +12 more
TL;DR: It is estimated that selecting genetically supported targets could double the success rate in clinical development, and using the growing wealth of human genetic data to select the best targets and indications should have a measurable impact on the successful development of new drugs.
References
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Journal ArticleDOI
The price of innovation: new estimates of drug development costs
TL;DR: The research and development costs of 68 randomly selected new drugs were obtained from a survey of 10 pharmaceutical firms and used to estimate the average pre-tax cost of new drug development.
Journal ArticleDOI
Can the pharmaceutical industry reduce attrition rates
Ismail Kola,John Landis +1 more
TL;DR: The pharmaceutical industry faces considerable challenges, both politically and fiscally, and the fiscal pressures that face the industry from the perspective of R&D are dealt with.
Journal ArticleDOI
Cost of innovation in the pharmaceutical industry.
TL;DR: The research and development costs of 93 randomly selected new chemical entities (NCEs) were obtained from a survey of 12 U.S.-owned pharmaceutical firms and used to estimate the pre-tax average cost of new drug development.
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The cost of biopharmaceutical R&D: is biotech different?
TL;DR: The results should be viewed with some caution for now given a limited number of biopharmaceutical molecules with data on cash outlays, different therapeutic class distributions for biophARMaceuticals and for pharmaceutical company drugs, and uncertainty about whether recent growth rates in pharmaceutical company costs are different from immediate past growth rates.
Journal ArticleDOI
Risks in new drug development: approval success rates for investigational drugs.
TL;DR: It is necessary to select patients suitable for vaginal or laparoscopic mesh placement for use in the neonatal intensive care unit based on prior history and once they provide informed consent for surgery.