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Innovations in Healthcare — Measurement Science and Standards to Support Manufacturing and Regulatory Approval of Biologic Drugs (+$10 million)
The rising cost of healthcare and increasing prevalence of chronic diseases, such as heart disease and diabetes, are having a severe impact on U.S. economic security and quality of life. The Administration is committed to improving the delivery and efficacy of healthcare. Novel medical technologies can lead to meaningful improvements in healthcare, but a sound measurement science and standards foundation must be in place to foster innovations and instill confidence that these new drugs can be manufactured to work effectively and safely. For example, new classes of drugs called biologic drugs, created not by chemical synthesis but by living cells, have revolutionized the treatment of many life threatening diseases such as cancer and have substantially improved the quality of life of hundreds of thousands of patients. However, these lifesaving drugs can be very expensive and are often difficult to manufacture with consistent quality.
Working with stakeholders in industry, academia, and government, NIST has identified critical areas where improved measurement technologies and methods would advance innovation in the existing U.S. biopharmaceutical manufacturing industry while improving the government’s ability to effectively regulate emerging generic versions of so-called “follow-on” biologic drugs.
Proposed NIST Program
NIST’s efforts in the area of healthcare to date have focused primarily on the measurements and standards needed for accurate clinical diagnostics and medical imaging. This initiative will extend that important work, enabling NIST to:
NIST contributions to this area should have many benefits including but not limited to: