Kelley C. Rogers, Ph.D.

Technical Program Director for Biosciences, 

Material Measurement Laboratory

NIST and the Biosciences
‘In 10 years we have developed strong core 

capabilities in target areas of molecular and 

cellular analysis.

To have impact in the next wave of the building 

bioeconomy requires a great deal of additional 

sophistication to examine system-level complexity.’

MML Director, Laurie Locascio, 2015 VCAT
2015 VCAT RECOMMENDATIONS FOR NIST BIOSCIENCES PROGRAMS

Increase visibility in bio expertise to better 

recruit world-class talent. 

Complement existing protein analytical tools 

with higher throughput, lower cost screening 

technologies. 

Leverage existing partnerships to expand 

technological capacity.

Continued investment in the biosciences 

portfolio.

1

2

3

4
MML: Biomolecular Measurements Division

and Chemical Sciences Division

MML: Biosystems and Biomaterials Division

Collaborations 

with ITL, PML, 

CNST

Collaborations 

with CNST, 

NCNR

NIST CORE STRENGTH IN BIOLOGICAL MEASUREMENTS
CUSTOMERS FOR NIST BIO PROGRAMS

• Clinical Medicine Community

• Biopharmaceutical Industry

• Regulatory Agencies

• DNA Forensics Community

• Mass Spectrometry Community

• Synthetic Biology Industry

• Equipment Manufacturers

Our customers span the entire Bioeconomy.
NIST Biological Sciences Strategic Priorities

 Complex Biotherapeutics

Develop measurement science,

standards and tools to support the

quantitative definition of complex

biologic therapeutics and correlation

of their structural differences with

clinical outcomes.

 Engineering Biology 

Develop the measurements and models

for engineering biology to map the

fundamental principles that drive the

development of the next generation of

bio-based products.

 Microbial Metrology 

Develop measurement infrastructure

for microbial measurements in health

and environmental applications.

 Precision Medicine 

Develop measurement science and

standards to ensure confidence in

clinical decision-making, and ultimately

enable adoption of precision medicine.

 Reproducibility of Biomedical Research 

Establish NIST as the agency for measurement

assurance to enable reproducibility of biomedical

research results.

https://mmlstrategy.nist.gov/
NIST Basic Research in ‘BioMetrology’

NIST Products for Biosciences

Precision 

Medicine

Reference 

Materials 

for Cancer 

Biomarkers

Confidence in 

Biomedical 

Research

Reference Cell 

Standard for HIV 

Monitoring

(CD4+ cell count)

Documentary 

Standards for 

Cell Line 

Authentication

Genomic DNA 

Reference 

Material

Mass 

Spectral 

Database

NISTmAb

Reference 

Material

Label-less 

3D Chemical 

Imaging for 

Cells/Tissues

Imaging Tools & 

Algorithms for 

Qualification of 

Stem Cells

Next-Gen 

Protein 

Sequencing

Microbial 

Metrology

Complex 

Biotherapeutics

Engineering 

Biology

*Living 

Genetic Sensor 

Foundry 

*Precision 

CryoEM

Microfluidic 

Control of Antibiotic Resistance 

Potential 

MRI Phantom 

Imaging 

Standards

‘Body on a 

Chip’ sensor 

integration
NIST PROGRAM IN BIOMANUFACTURING

Objectives:

Develop measurement science, standards, data & technology to support

development, manufacturing, & regulatory approval of innovative, highquality biologics

Vision:

Be a global leader in providing high impact measurement solutions for

the biopharmaceutical industry

NIST:

• Focus is on measurements and standards for protein therapeutics

• $9M program (4 MML Divs., NCNR)

• Works closely with biopharma industry, FDA, equipment vendors to

identify key infrastructural measurement problems

• Scientifically trusted, impartial 3rd party that promotes crossindustry collaboration & open data sharing
HIGHLIGHTS IN BIOSCIENCES: 2015-2017

• Release of first Monoclonal Antibody Reference

Material

• Human and Microbial Genomic Reference Materials

released building on pilot

• HER2 Genomic DNA Standard (Tumor profiling)

Released

• NIST ‘Engineering Biology Standards Development

Foundry’ for 2018

• Cryo-EM capability for biopharmaceuticals for 2018

• Two new advanced manufacturing institutes awarded

in the ‘Manufacturing USA’ network

• NIST: The National Institute for Innovation in

Manufacturing Biopharmaceuticals (NIIMBL)

• DoD: Advanced Tissue Biofabrication

(rebranded ‘BioFabUSA’)
‘BioManufacturingUSA’ – synergy with NIST Biosciences

• Process innovation for existing

biopharmaceuticals (mAbs, vaccines)

• Scalable manufacturing processes for

emerging classes of biologics (cell/gene,

microbial, chimeric products)

• Standards development

• Building blocks for tissues and scaffolds

• Bioprinting technology and other fabrication

innovation

• ‘Tissue on a chip’ technology for drug

screening

• Standards development for tissue-based

products

Extensive Stakeholder 

Ecosystems

Opportunity to 

Leverage Resources

Recognized NIST 

Expertise

$80 M DoD, + $214 M non-fed

$70 M DoC, + min $129 M non-fed
2015 VCAT RECOMMENDATIONS FOR NIST BIOSCIENCES PROGRAMS

Increase visibility in bio expertise to better 

recruit world-class talent. 

Complement existing protein analytical tools 

with higher throughput, lower cost screening 

technologies. 

Leverage existing partnerships to expand 

technological capacity.

Continued investment in the biosciences 

portfolio.

1

2

3

4
2015 VCAT RECOMMENDATIONS FOR NIST BIOSCIENCES PROGRAMS

Increase visibility in bio expertise to better recruit world-class 

talent. 1

• Staffing for critical programs: a three-pronged approach to

attract, retain & unfetter talent

• Aggressive participation in the NRC Postdoctoral Associateships

Program

• Invest in Ph.D. staff with the resources to do high-level

measurement science and service development

• Leverage existing partnerships as a talent pipeline for recruiting

Justin Zook (Leader -

Genome-in-a-Bottle 

Consortium) – 2017 

Presidential Early 

Career Award for 

Work life balance Scientist and Engineers 

Merit promotion Collaborative and collegial environment
Increase visibility in bio expertise to better recruit world-class 

talent. 

1

NIST Visibility – highlights 2015-2017:

• High-Impact publications in Engineering Biology

• Biomanufacturing Leadership: NIIMBL and BioFabUSA

• New consortia:

• Regenerative Medicine SCB

• Gene-editing Standards Consortium (forming)

• NIST Workshops:

• Biomanufacturing for CAR-T

• Cell Counting (with FDA)

• Pathogen Detection (with FDA)

• Microbiome Measurements (with NIH)

• Advanced Imaging for Precision Medicine

• New NIST website to facilitate external access to NIST

expertise

CRISPR standards 

NATURE METHODS | VOL.14 NO.6 | JUNE 2017 | 541

With the ever-expanding use of CRISPR technology, the development of standards to quantitatively 

benchmark on- and off-target activity needs to keep pace. 

Sec. 3036 of 21st Century Cures Act: Requires HHS (FDA) in consulation

with NIST and stakeholders to “facilitate an effort to coordinate and

prioritize the development of standards...”

2015 VCAT Recommendations for NIST Biosciences Programs
2015 VCAT RECOMMENDATIONS FOR NIST BIOSCIENCES PROGRAMS

Leverage existing partnerships to expand technological 

capacity. 2

• Expanded collaboration in CryoEM capabilities.

• UMD membership in NIIMBL will strengthen alignment in

biomanufacturing focus areas.

• Refinement of tech scope for JIMB partnership with Stanford

to ‘DNA Read and Write’ (Genomics and Synthetic Biology)

• Shared research facility being established-

• NIST SRM development

• Collaborative ‘Platform Labs’

• Commercial Partnering Space

Goal is to maximally leverage these partnerships (technical complementarity, facilities, pipeline for talent). 

NIIMBL and BioFabUSA ‘constellation’ further expand our partnership reach.
2015 VCAT RECOMMENDATIONS FOR NIST BIOSCIENCES PROGRAMS

Complement existing protein analytical tools with higher 

throughput, lower cost screening technologies. 3

• NIST products enable development of technology

agnostic platforms

• NISTmAb use by innovator stakeholders

• NIST basic research offers disruptive potential

• IMS for next-gen protein sequencing

• NIIMBL consortium focus will provide industryprioritized needs, and partnering opportunities
2015 VCAT RECOMMENDATIONS FOR NIST BIOSCIENCES PROGRAMS

Continued investment in the biosciences portfolio. 4

• Calls for NIST efforts in biosciences exceed available funding

• Cell measurements/Regenerative Medicine

• Gene-editing standards

• Engineering Biology

• Biomanufacturing process technology

• Non-base funding opportunities are fully leveraged

• IMS awards

• Director’s Reserve funds

• Strategic and Emerging Research Initiative (SERI) Program

• Other agency funding (FDA, DHS, DARPA, NIH)

• Opportunity and challenge within NIIMBL
EXPLOSIVE GROWTH AREAS FOR BIOTECHNOLOGIES

• Wearable Health Technology

• Complex Biologics

• Gene Editing Tools

• Meta ‘omics’ and context effects in biological systems

• Precision Imaging

• Process Analytical Technology for Biomanufacturing

• Data and Informatics –

Biology is inherently complex – as will be the ‘biometrology’ 

tool kit needed to measure it.