The Potential Need for Measurement Standards to Facilitate the Research and Development of Biologic Drugs

Opening Statement By Chairman David Wu

I want to welcome everyone to this Subcommittee’s hearing on the metrology—or measurement science—needs to support the development of biologics and biosimilars.

While I am aware that other policy issues related to biologics and biosimilars are being considered by Congress, today we are here to focus on the role of the federal government in helping develop the underlying science needed to support the growing biologics industry.

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.  At this point, methods to fully characterize the complex molecules used in biologics have not yet been developed. 

I have learned as a Member of this Subcommittee that if you can’t measure it, it doesn’t exist.  I believe this is the crux of the inconclusive nature of the biologics debate, which is why the Subcommittee has convened this hearing.

This is not a new area of inquiry for the Science and Technology Committee.  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. 

Along the same line, today’s hearing will focus on the metrology needs of the biologics industry.  This is the first in a series of hearings the Subcommittee will hold on the metrology issues surrounding personalized medicine and genetic diagnostic testing.

One additional issue I want to address today is the interaction between industry and the federal government to date.  I welcome the suggestions of our industry witnesses on how the relationship between NIST and industry might be enhanced to ensure that NIST can fully anticipating industry metrology needs.  The thrust of these questions is not to criticize, but to learn how a good working relationship might be made better.

I thank our witnesses for appearing before the Subcommittee and I look forward to their comments and suggestions.

Witnesses

Panel

0 - Dr. Anthony Mire-Sluis
Executive Director Global Product Quality and Quality Compliance Amgen, Inc Global Product Quality and Quality Compliance Amgen, Inc
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0 - Dr. Patrick VJJ Vink
Senior Vice President and Global Head of Biologics Mylan GmbH Mylan GmbH
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0 - Dr. Steven Kozlowski
Director Office of Biotechnology Products Office of Pharmaceutical Science Office of Biotechnology Products Office of Pharmaceutical Science
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0 - Dr. Willie May
Director Chemical Science and Technology Laboratory National Institute of Standards and Technology (NIST) Chemical Science and Technology Laboratory National In
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