Improving biopharmaceutical companies' technology infrastructure could save the industry hundreds of millions of dollars a year, according to a new study sponsored by the National Institute of Standards and Technology (NIST), a non-regulatory agency within the US Department of Commerce.

The report estimates that, overall, biopharmaceutical companies spend $1.2 billion annually on infrastructure technology: in other words, “the tools, methods, and data that enable or support R&D, products, and services”. So, for example, infrastructure encompasses activities and kit ranging from calibration of lab instruments to advanced software.

R&D accounts for most of the infrastructure investment: $884 million per year. Gene expression systems and biomarkers together account for over half of the R&D total: 30% and 24% respectively. Bio-imaging and informatics account for 15% and 22% respectively.

The study suggests that improvements to this infrastructure, such as better standardisation of data collection and analysis, could save between 25% and 48% of R&D expenses for each new biopharmaceutical approved by the FDA. Better technical infrastructure could also reduce average development time per approved drug by 20% from 122 months to 98 months.

Increasing approval probability

Furthermore, such improvements potentially increase the probability of FDA approval for the average investigational new drug from 30.2% to 40.0% or 45.0% under conservative and optimistic assumptions respectively, the study calculates.

Biopharmaceutical companies also invest $335 million in the infrastructure for post-marketing surveillance and commercial manufacturing, which account for 52% and 48% respectively of that sum. Post-marketing surveillance and commercial manufacturing cost $656,000 and $613,000 per approved drug respectively.

The report suggests that industry could cut its manufacturing costs by 23% through, for example, lowering ongoing manufacturing costs, improving manufacturing tolerances and making post-marketing surveillance more efficient and responsive. For example, improved infrastructure could reduce pre-production and downstream processing costs by 29% and 22% respectively.

“The broader biopharmaceutical and biotechnology industry would benefit from greater efficiency and effectiveness with a nationally co-ordinated standardisation effort supported by an independent research organisation with proven technical expertise, technology transfer abilities and access to financial and technical resources,” the report concludes. “The ultimate beneficiaries are patients, who gain access to a broader array of novel therapies where development is supported by an effective technology infrastructure.”

The full report is available for download at: http://www.nist.gov/director/prog-ofc/report07-1.pdf.