NISTMML Measurement Assurance for Biological Systems Laurie E

NIST/MML: Measurement Assurance for Biological Systems Laurie E. Locascio, Ph. D. Director, MML/NIST

NIST- WHO WE ARE TODAY The National Metrology Institute global harmonization of measurement and traceability to the SI “Industry’s National Laboratory” Non-regulatory agency partnering/serving industry to help maintain US leadership in science and technology products Department of Commerce developing standards to support international trade and commerce

Material measurement laboratory National reference laboratory for measurements in the chemical, biological, and material sciences providing research, measurement services, and measurement quality assurance tools in areas that include: • assessment of climate change • forensics and homeland security • renewable energy • health care measurements • the nation’s aging infrastructure • manufacturing (ranging from • environmental quality advanced materials to • food safety and nutrition photovoltaics to biologic drugs) MML is also responsible for coordinating the NIST-wide Standard Reference Materials and Standard Reference Data programs

Measurement Science and Standards to Assure Confidence in Biological Data standard reference materials standard methods and community based consensus methods for biological measurements Lyophilized cells for benchmarking performance of CD 4+ T cell enumeration Variety of standards and control materials to support measurements of RNA, DNA, Proteins and cells including first standard for global monitoring of HIV ISO Biotechnology Standards Committee NIST leads US Delegation developing documentary standards for biobanking, bioanalytical methods, and bioprocessing and promoting US agenda in international standards impacting trade. (Partners: FDA, USDA, USTR, NIH, DOE, ITA, US industry)

Stakeholder Driven Standards and Innovation For greatest impact, we: • Develop deep ties with our federal agencies (NIH and FDA are key) • Establish close relationships with our industry stakeholders • Strategically partner with US biotechnology leaders to leverage federal dollars against private sector investment

NIST Program in Biomanufacturing Objectives: Develop measurement science, standards, data & technology to support development, manufacturing, & regulatory approval of biologics NIST: • Works closely with stakeholders (biopharma industry, FDA, equipment vendors) to identify key measurement problems focusing on protein therapeutics • Draws from a broad array of unique, cutting-edge expertise, resources, and facilities available at NIST • Is a scientifically trusted, impartial 3 rd party that works to promote cross-industry collaboration & open data sharing • Program coordinator: Mike Tarlov (Michael. Tarlov@nist. gov)

Stakeholder Driven Standards And Innovation

sometimes the community isn’t ready for standards measurement science research to better understand how to characterize product.

when the need for standards arises we work closely with stakeholders to make the measurements and standards that you need to make your products better.

Targeted Areas of Strategic Importance from 2005 -2015 Omics Measurements Develop the measurement capabilities to support growing needs in genomics, proteomics, metabolomics (health) Biomanufacturing Develop measurement science, standards and technologies for biopharma industry focusing on protein therapies (health, manufacturing) Cell and System Analysis New methods and technologies for probing cells and systems including tissue and organism level measurements (health)

Areas of Strategic Importance 2015 -2020 Engineering biology Develop the measurements and models for engineering biology to map out the fundamental principles that drive development of next generation biobased products (manufacturing, health) Microbial Measurements Develop measurement infrastructure for microbial measurements (health, environment) Data and Informatics Provide validated data and informatics tools to support confident decisionmaking (all sectors) Quantitative Tools for Characterization of Complex Biologics Define complex biomolecules/biologics through quantitative measurements to enable prediction of biological function in healthcare applications (manufacturing, health) Precision Medicine Develop measurement science and standards to ensure confidence in clinical decision-making, and ultimately enable adoption of precision medicine (health)