Manufacturing USA®

Pandemic Response and NIIMBL Update

Visiting Committee on Advanced Technology

June 9, 2020

Mike Molnar Kelvin Lee

NIST Office of Advanced Manufacturing National Institute for Innovation 

in Manufacturing Biopharmaceuticals
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Friday, April 3, 2020 – 10:30am email with a request for proposals

Friday, April 3, 2020 – 2:00pm webinar on our process

Monday April 6, 2020 – 3:00pm deadline for submissions

The NIIMBL community responded rapidly to a call to action

Submissions accepted only from NIIMBL Members, but not limited to 

biopharmaceutical manufacturing technologies.

We received well over 200 submissions in response to our request:

Small businesses

Large, global companies

Universities and Academic Medical Centers

Federal scientists

etc

Going through a process now to finalize which projects will launch.
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• Testing - antibody, PCR, other 

• Contact tracing, technologies associated with tracking for people, equipment, etc.

• Decontamination technologies

• PPE (development, manufacturing, etc.) 

• Medical countermeasures* - discovery, development, manufacturing 

• Supply chain analysis, modeling, including financial impact forecasting 

• Medical equipment (development, manufacturing) 

• Other

*Medical countermeasures included small molecules, large molecules, cell therapies, 

vaccines, and plasma therapies 

How the NIIMBL Community Can Contribute
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Provide virus 

proteins to 

improve blood 

testing 

capabilities

Assist regional 

hospital 

systems with 

validation of 

rapid in-house 

diagnostic 

testing 

capabilities

Identify 

alternative 

domestic 

supply chains 

to reduce 

foreign 

dependence 

for respirators 

and masks

Validate the 

use of 

environmental 

decontamination

approaches for 

clinical spaces

Develop 

automated 

contact tracing 

technology w/i

facilities to limit 

the spread of 

coronavirus in 

essential 

workers

Accelerate 

development of 

more flexible 

manufacturing 

platforms of 

biologic 

therapies and 

rapid release 

testing

$9 million NIST Award for NIIMBL Projects

Images: Adobe Images
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Other Developments from NIIMBL

Membership growth continues

An initiative related to workforce

An initiative related to technology

Other recent news
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Updated March 2020
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NIIMBL status – 3 years post-launch

Ecosystem -150 + members 

10 major manufacturers and OEMs

> 40% industry

24 premier research institutions

6 federal agencies

4 MEPs

Impacts

$63 M project portfolio awarded

> $9 M workforce development

3 Roadmaps published, 2 streams ongoing

3 ‘NIIMBL led’ industry-wide programs to 

launch in 2020

Actual coinvestment

(as of Feb 2019)

$22.1 M 

Federal 

Investment

$46.8 M NonFederal leverage 2.12 to 1 match

$70 M 

Federal 

Investment

$129 M 

NonFederal 

leverage

Planned over NIST 

award

1.84 to 1 match
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Highlights and Activities | NIIMBL eXperience

Building a highly-skilled and diverse workforce 

pipeline

• 5 students participated from Florida A&M University, 

Howard University, Delaware State University and 

University of Massachusetts Dartmouth 

• Learning goals

- Explore career paths in biopharmaceutical 

manufacturing

- Awareness of internship and training opportunities

- Networking with career professionals and 

mentoring

- Develop a personal brand statement and practice 

execution

Industry and Federal Agency Participants:

Hearing “how I did it” from career professional Hands on at Amgen’s Immersive Research Center

Manufacturing tour at Merck

Networking and personal branding from NSBE
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Distinguished R&D and supply chain technical leaders from 

14 major manufacturers & suppliers met and agreed:

Organization Title

Amgen Scientific Director, Technology & Engineering

AstraZeneca Head Bioprocess Technology & Engineering

BMS Head of Biologics MS&T

Eli Lilly Research Advisor

FDA Deputy Director, OBP, CDER, FDA

NIST Technical Program Manager, NIIMBL

GSK Sr. Director, MS&T

Janssen Sr. Dir. API Large Molecule Dev & Man. Sci.

Just Director

Merck & Co AVP Biologics Process R&D

Principal Scientist

EMD/Millipore Director, Next Generation Processing R&D

Novartis Head, Advanced Process & Technology Biologics

Pfizer Vice President, Technology & Innovation Strategy

Roche Head of Biologics for Tomorrow

Sanofi Senior Scientist

Sartorius Head of Advanced Materials & Processing

• Significant opportunity to impactfully 

transform CMC development & 

manufacturing through E2E integration and 

technology advancement.

• Collaboration in consortium will 

significantly accelerate transformation

• Success enabled by expertise, leadership & 

capability of committed industry leaders

• We will advocate for our companies to 

participate

• High level goals/strategy agreed: 

priorities/details to be refined after 

participants identified
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Vision: By 2029 invent, design, build and commercialize drug 

substance and product manufacturing capability enabling:

• Flexibility to supply extremely diverse and changing portfolio of products in the face of 

uncertainty and changing demand

• Improved Control, Robustness and Security of Supply

• Faster Product Development and Supply Chain Velocity

• Sustainable plastic and energy use

• Capital & Operating Cost dramatically reduced

– No longer barrier to availability of capacity, innovation or change

• DS & DP expertise and thinking integrated vial to vial
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New NIIMBL HQ Opening Q1 2020

225,000 gsf

The image we used to use...
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Buffer Stock Blending Skid
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