Subcommittee Investigates Ways to Improve the Measurement Science for Life-Saving Biologic Drugs
(Washington, DC) – Today, the House Committee on Science and Technology’s Technology and Innovation Subcommittee held a hearing to discuss the need for reference standards and analytical tools to improve the development and regulatory approval process of biologic drugs, and to help ensure patients receive safe and effective medicines. Specifically, the hearing examined ways to improve the quality of the manufacturing process of biologics and provide tools to the biotechnology industry and the federal government to facilitate drug development and approval. Subcommittee Members questioned witnesses about the analytical tools, methods, and reference standards needed to improve the quality of biologic drugs and speed up the regulatory approval process, and the appropriate role for the National Institute of Standards and Technology (NIST) in assisting with their development.
“As I studied the challenges of developing biologic drugs, I realized some of the issues facing researchers may be addressed through the same paradigm used for traditional pharmaceutical drug development, where measurement tools to completely characterize relevant pharmacological products exist,” stated Subcommittee Chairman David Wu (D-OR). “At this point, methods to fully characterize the complex molecules used in biologics have not yet been developed.”
Biologics and biologic drugs refer to a class of medicinal products that are created through a biological process, as opposed to being chemically manufactured, or include molecules created through a biological process. Biologics are a new approach to medicine that offer hope for patients who develop once incurable and life-threatening diseases. Biologic drugs are used to treat complex diseases such as cancer, diabetes, and multiple sclerosis. The lack of scientific knowledge about biologics, however, presents challenges that can result in additional risks to patient safety, including potentially triggering life-threatening adverse reactions.
“This is not a new area of inquiry for the Science and Technology Committee,” added Wu. “The S&T Committee was the first in Congress to hold hearings on the science and potential of other growing scientific fields, such as recombinant DNA, cloning, genome mapping, and genetic testing. The Committee’s emphasis has always been focused on meeting the metrology needs that allow these new technologies to move forward. Given the state of these fields today, I would like to think the S&T Committee was successful in realizing that goal.”
This is the first in a series of hearing the Subcommittee will hold on measurement science issues surrounding personalized medicine and genetic diagnostic testing.
For more information, visit the Committee’s website.
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