life sciences caucus...5 confidential american innovation at work niimblis funded by a $70,000,000...

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CONFIDENTIAL AMERICAN INNOVATION AT WORK 1 AMERICAN INNOVATION AT WORK Life Sciences Caucus September 22, 2017 Ruben G. Carbonell, CTO, [email protected] ©2017 NIIMBL | All Rights Reserved | For Authorized Use Only

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Page 1: Life Sciences Caucus...5 CONFIDENTIAL AMERICAN INNOVATION AT WORK NIIMBLis funded by a $70,000,000 cooperative agreement from the National Institute of Standards and Technology and

CONFIDENTIAL AMERICAN INNOVATION AT WORK1

AMERICAN INNOVATION AT WORKLife Sciences Caucus

September 22, 2017Ruben G. Carbonell, CTO, [email protected]

©2017 NIIMBL | All Rights Reserved | For Authorized Use Only

Page 2: Life Sciences Caucus...5 CONFIDENTIAL AMERICAN INNOVATION AT WORK NIIMBLis funded by a $70,000,000 cooperative agreement from the National Institute of Standards and Technology and

CONFIDENTIAL AMERICAN INNOVATION AT WORK2

Our Mission…To accelerate biopharmaceutical manufacturing innovation, support the development of standards that enable more efficient and rapid manufacturing capabilities, and educate and train a world-leading biopharmaceutical manufacturing workforce, fundamentally advancing U.S. competitiveness in this industry.

Addressing…High cost of production, advent of biosimilars, rapidly development of new therapies, novel analytical techniques, regulatory science, enhanced safety, efficacy and potency for existing and emerging products, better access of medicine to patient populations

Page 3: Life Sciences Caucus...5 CONFIDENTIAL AMERICAN INNOVATION AT WORK NIIMBLis funded by a $70,000,000 cooperative agreement from the National Institute of Standards and Technology and

CONFIDENTIAL AMERICAN INNOVATION AT WORK3

Manufacturing USA Network of InstitutesFocus is to address market failure of insufficient industry R&D in the “missing middle” to de-risk/speed-up promising new technologies

— AND —

Address the education and workforce gaps on these technologies

Content Credit: Mike Molnar, DirectorNIST Advanced Manufacturing Office

Industry-focusedIndustry-ledSustainable

Page 4: Life Sciences Caucus...5 CONFIDENTIAL AMERICAN INNOVATION AT WORK NIIMBLis funded by a $70,000,000 cooperative agreement from the National Institute of Standards and Technology and

CONFIDENTIAL AMERICAN INNOVATION AT WORK4 Content Credit: Mike Molnar, DirectorNIST Advanced Manufacturing Office

Other institutes:Flexible Hybrid Electronics

Additive ManufacturingIntegrated PhotonicsDigital Mfg & Design

Light Metal ManufacturingAdvanced Composites

Wide Bandgap SemiconductorsAdvanced Textiles

Smart ManufacturingProcess Intensification

Advanced RoboticsAdv. Tissue Biofab.

Manufacturing Innovation Institute

• Applied research • Technology development• Prototype labs/shops• Manufacturing software development• Education and workforce development

Shared Use Facilities• Manufacturing demonstrations• Technology workshops• Manufacturing technology services

Large Companies

Small and Mid-Sized Enterprises

Federal Government

Universities

State and Local Government

Economic Development Organizations

Community Colleges

National Labs Start-ups

Manufacturing USA Institute Network

IndustryAcademia and National Labs

Government

Page 5: Life Sciences Caucus...5 CONFIDENTIAL AMERICAN INNOVATION AT WORK NIIMBLis funded by a $70,000,000 cooperative agreement from the National Institute of Standards and Technology and

CONFIDENTIAL AMERICAN INNOVATION AT WORK5

NIIMBL is funded by a $70,000,000 cooperative agreement from the National Institute of Standards and Technology and leverages >$150,000,000 in other commitments.

NIST is a non-regulatory federal agency within the U.S. Department of Commerce. NIST's mission is to promote U.S. innovation and industrial competitiveness by advancing measurement science, standards, and technology in ways that enhance economic security and improve our quality of life.

$70,000,000 National Institute of Standards

and Technology

$150,000,000Other Commitments

$220 million

Five-Year Funding Plan

Page 6: Life Sciences Caucus...5 CONFIDENTIAL AMERICAN INNOVATION AT WORK NIIMBLis funded by a $70,000,000 cooperative agreement from the National Institute of Standards and Technology and

CONFIDENTIAL AMERICAN INNOVATION AT WORK6

NIIMBLGovernment =Non-profits +Academia +Industry +

PARTNERS NOTIONAL, PENDING SIGNED MEMBERSHIP AGREEMENT

Page 7: Life Sciences Caucus...5 CONFIDENTIAL AMERICAN INNOVATION AT WORK NIIMBLis funded by a $70,000,000 cooperative agreement from the National Institute of Standards and Technology and

CONFIDENTIAL AMERICAN INNOVATION AT WORK7

NIIMBL National Map

NIIMBL ECOSYSTEM150+ Partners, 60 Industry

Members,35+ Academic Members, 35+

Non-profits

Page 8: Life Sciences Caucus...5 CONFIDENTIAL AMERICAN INNOVATION AT WORK NIIMBLis funded by a $70,000,000 cooperative agreement from the National Institute of Standards and Technology and

CONFIDENTIAL AMERICAN INNOVATION AT WORK8

North Carolina Participation in NIIMBL

Tier 1 NC State (BTEC, MEP)UNC Wilmington

Tier 2 UNC Chapel HillNC Central (BRITE) East Carolina University

Tier 3 NCCCS (NC BioNetwork)UNC CharlotteBrunswick Community College Forsyth Community CollegeNorth Carolina Biotechnology Center (NCBC) NC Biosciences Organization (NCBIO)

$2 MM Cost Share from State of NC, 2017-2018

Page 9: Life Sciences Caucus...5 CONFIDENTIAL AMERICAN INNOVATION AT WORK NIIMBLis funded by a $70,000,000 cooperative agreement from the National Institute of Standards and Technology and

CONFIDENTIAL AMERICAN INNOVATION AT WORK9

NIIMBL Programs

• Technical Development Projects (2 Project calls / year)• Education and Workforce Development Projects (2 Project calls / year)• Standards and Regulatory Science Projects

• Regional nodes of excellence• K-12 Outreach• Manufacturing Extension Partnership (MEP)• Active involvement of NIST and regulatory agencies (FDA)• US-Specific roadmap for Biopharmaceutical Manufacturing• Teaming Meetings, National Meetings, Special Workshops• Community Portals: Assetts, programs, jobs, internships

Page 10: Life Sciences Caucus...5 CONFIDENTIAL AMERICAN INNOVATION AT WORK NIIMBLis funded by a $70,000,000 cooperative agreement from the National Institute of Standards and Technology and

CONFIDENTIAL AMERICAN INNOVATION AT WORK10

NIIMBL Benefits to North Carolina

• Recognition of NC leadership in Biopharmaceutical Manufacturing• National visibility for NCBioImpact, NCBC, NCBIO, others• National network of industry, academic and government leaders• New range of partnerships• Opportunities to attract new companies• Opportunities to foster small companies, jobs, economic development• Significant source of funding for technical and educational programs• Direct line to the industry’s future: Cell & gene therapies, vaccines,

personalized medicine, immunotherapies• Safer, more effective, more accessible drugs for patients

Page 11: Life Sciences Caucus...5 CONFIDENTIAL AMERICAN INNOVATION AT WORK NIIMBLis funded by a $70,000,000 cooperative agreement from the National Institute of Standards and Technology and

CONFIDENTIAL AMERICAN INNOVATION AT WORK11

Thank You!

Ruben G. Carbonell (CTO)[email protected]