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Improved infrastructure key to cheaper drugs

By Mike Nagle, 15-Oct-2007

Related topics: Regulatory & Safety

Improving the technology infrastructure of drug development could save the industry hundreds of millions of dollars, according to a new US government study, with the ultimate winners being patients.

The report, which was sponsored by the US National Institute of Standards and Technology (NIST), found that the biopharmaceutical industry spent $1.219bn producing and maintaining the infrastructure technology to support both R&D (at $884m) and manufacturing and post market-surveillance ($335m).

 

 

 

This is indicative of a general trend over the last 20 years for many companies to increasingly concentrate on large-molecule proteins and other biopharmaceuticals - such as human insulin, gene therapies and specialised antibiotic treatments - over small molecule drugs.

 

 

 

The report notes that the biopharma industry currently spends about $21bn annually on research and development (R&D) and has commercialised over 400 products.

 

 

 

Coupled with this enormous spend on R&D are infrastructure costs: in research on bioimaging, biomarkers, informatics, and gene expression; and in commercial manufacturing and postmarket surveillance on technology such as core data, methods, and standards used to determine the quality and efficacy of biopharmaceuticals.

 

 

 

 

 

 

 

If this infrastructure were to be improved, could save between 25 and 48 per cent of the R&D expenses for each new biopharma drug approved by the US Food and Drug Administration (FDA). One relatively simple way of doing this would be through better standardisation of data collection and analysis.

 

 

 

Better technical infrastructure is also projected to reduce the average development time per approved drug by 20 per cent - from 122 months to 98 months. The study also estimated that total industry manufacturing costs could be reduced over the four major phases of manufacturing by $1.5bn, or 23 percent.

 

 

 

The authors of the study said that the ultimate beneficiaries of an improved biopharmaceutical infrastructure "are patients who gain access to a broader array of novel therapies where development is supported by an effective technology infrastructure."

 

 

Data for the study were gathered from individual researchers and organizations including a survey of 44 technical experts whose companies represent 42 percent of the combined annual R&D spending and 49 percent of the combined annual R&D sales in biopharmaceuticals.