Newswise — Improvements to the technology infrastructure for researching and developing new biopharmaceuticals could save the industry hundreds of millions of dollars annually, according to a new study conducted by RTI International for the National Institute of Standards and Technology (NIST).
The study analyzed expenditures in four major categories of technical infrastructure: bioimaging, biomarkers, bioinformatics, and gene expression, as well as expenditures for infrastructure supporting processing and quality control for commercial manufacturing and activities involved with postmarket surveilliance.
The study notes that the biopharmaceutical industry currently spends about $21 billion annually on research and development and has commercialized more than 400 products.
According to the report, improvements to this infrastructure, such as better standardization of data collection and analysis, could save between 25 and 48 percent of research and development expenses for each new biopharmaceutical drug approved by the Food and Drug Administration.
Better technical infrastructure also could reduce the average development time per approved drug by 20 percent, from 122 months to 98 months. The study further estimated that total industry manufacturing costs could be reduced over the four major phases of manufacturing by 23 percent or $1.5 billion.
"The ultimate beneficiaries of improved biopharmaceutical infrastructure are patients," said the report's lead author, Jeff Petrusa, of RTI International. "By lowering the costs and reducing the time required for development, patients would gain access to a broader array of novel therapies."
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 research and development spending, and 49 percent of the combined annual research and development sales in biopharmaceuticals.
Other findings:
During the past two decades, emphasis in new drug development has shifted from small-molecule chemicals to large-molecule proteins and other biopharmaceuticals such as human insulin, gene therapies and specialized antibiotic treatments.
Industry spends about $1.2 billion annually to produce and maintain the infrastructure that supports R&D, manufacturing and postmarket surveillance, including core data, methods, and standards used to determine the quality and efficacy of biopharmaceuticals.The full report, "Economic Analysis of the Technology Infrastructure Needs of the U.S. Biopharmaceutical Industry," is available online at the NIST Web site (http://www.nist.gov/director/prog-ofc/report07-1.pdf).
About RTI International RTI International is one of the world's leading research institutes, dedicated to improving the human condition by turning knowledge into practice. With projects in more than 40 countries and a staff of more than 2,600, RTI offers innovative research and technical solutions to governments and businesses worldwide in the areas of health and pharmaceuticals, education and training, surveys and statistics, advanced technology, democratic governance, economic and social development, energy, and the environment. For more information, visit http://www.rti.org.
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