american innovation at work...2017/04/11 · 9 american innovation at work niimbl proposal facts...
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AMERICAN INNOVATION AT WORK 1
AMERICAN INNOVATION AT WORK NIIMBL Funding Opportunities
NC State Webinar [email protected]
©2017 NIIMBL | All Rights Reserved | For Authorized Use Only
AMERICAN INNOVATION AT WORK 2
Outline of Presentation
• Objectives and process for project calls and proposal submission
• Results of surveys on technology areas of industry interest
• Results of surveys on workforce development areas of interest to industry
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Our Mission The NIIMBL mission is 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.
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Manufacturing USA Network of Institutes Focus 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, Director NIST Advanced Manufacturing Office
Industry-focused Industry-led Sustainable
AMERICAN INNOVATION AT WORK 5 Content Credit: Mike Molnar, Director NIST Advanced Manufacturing Office
Other institutes: Flexible Hybrid Electronics
Additive Manufacturing Integrated Photonics Digital Mfg & Design
Light Metal Manufacturing Advanced Composites
Wide Bandgap Semiconductors Advanced Textiles
Smart Manufacturing Process Intensification
Advanced Robotics Adv. 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
Industry Academia and National Labs
Government
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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
$180,000,000 Other Commitments
$250 million
Funding
NIIMBL is funded by a $70,000,000 cooperative agreement from the National Institute of Standards and Technology and leverages >$180,000,000 in other commitments.
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NIIMBL Proposal Facts and Figures • 140+ Partners (60 industry, 35+ academic, 35+ non-profit) • 25 States • $ 70 MM from NIST over 5 years • $180 MM from industry, states, universities • Involvement of FDA, NIST, DOD, NIH, NSF, DOE • Principal academic institutions:
o U. Delaware (Lead, Delaware Biotechnology Institute) o NC State (BTEC) o U. Maryland (IBBR) o MIT (BioMan Program) o J. Hopkins o U. Mass Lowell (Mass Biologics) o Ga. Tech (Stem Cell Biomanufacturing Program)
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Expected Member Dues, Rights and Benefits
1 50% of T1/T2 industry fees are cash, 50% in-kind 2 2/3 voice and vote from industry members 3,4 Some/all payable by third party non-federal source 5 Non-exclusive royalty-free, commercial license
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NC Participation in NIIMBL
NC State (BTEC, MEP) – Tier 1 UNC Chapel Hill – Tier 2 UNC Wilmington – Tier 1 UNC Charlotte (SoyMed) – Tier 3 NC Central (BRITE) – Tier 2 East Carolina – Pitt CC – Tier 3 NCCCS (NC BioNetwork) – Tier 3 North Carolina Biotechnology Center (NCBC) Tier 3 NC Biosciences Organization (NCBIO) – Tier 3
$10 MM Cost Share from State of NC (SUBJECT TO LEGISLATURE APPROVAL)
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Project Selection
Award and Project Launch Selection by GC
Proposed Project Evaluation
Distribute Project Calls
Twice Per Year
Project Calls by TAC/WAC & GC
Technology Roadmap &
Workforce Needs Established /
Updated by TAC/WAC
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Project Type When Approval Support Federal Cost-Share
Commercial IP Sharing
Project IP Plan
Req’d
Institute-Wide Submitted 2x/Yr
TAC/GC Committees
Pooled Cash Yes
Participants Tier1
Selected Tier 2 Govt*
Yes
Partner-Specific
Submitted 2x/Yr
TAC/GC Committees
Pooled Cash Yes Participants
Govt* Yes
Proprietary Anytime Participants Extra Cash No Participants Yes
*Standard govt march-in rights
Three Types of Projects
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Intellectual Property Plan
Specific IP terms for technology projects established case by case
Overall IP terms established in institute Bylaws and Membership Agreement
Ownership based on inventorship.
IP inventorship based on USA patent law.
Rights based on membership level.
Project-specific IP management plans required.
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Funding Opportunities
Project Calls for both Technical and Workforce Development Projects
Budget: 15% Management, 20% Workforce Development, 65% Technical Projects
Two Project Calls/Year
One Project Call, Fall 2017
Quick Start Projects launched in July 2017
Technical Projects can have a Workforce Development Component
At steady-state, 20 projects / year, $1M to $3M, 1-2 year duration
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Project Proposal Requirements
Project should involve academia, industry, SME + government
All Technical Projects require at least ONE small and medium enterprise
Approval of Governing Committee (GC)
Approval of Technology Activities Committee (TAC)
All Projects require minimum 1:1 match (NIIMBL Funds : Sum of Participant Cost Share)
Regional and national impact on biopharmaceutical manufacturing
Tier 1 companies play a major role in TAC and GC Companies have 2/3 of vote
Existing-Emerging Products MRL 4-7 Demonstrations Testing Validation Industry environment
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Example: Rapid Release Testing
Envisioned Partners on Project Team: NIST, FDA, BARDA (study design and execution) Major manufacturers (mAbs, cell therapies, etc.) Suppliers (OEMs, kit/reagents, etc.) Research Universities (to collect data) Colleges (workforce training) Standards-setting bodies
Next generation sequencing vs current methods for adventitious agent testing (virus, mycoplasma)
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APPROACH AND JUSTIFICATION Raw material variability is a concern, especially with respect to impact
on bioreactor performance and quality attributes. Raw material release relies on supplier’s certificate of analysis
coupled with in-house performance testing. No standardized methods exist to assure consistent performance prior to use.
Standard measurement methods, as well as reference standard materials, will be co-developed (with NIST) for key attributes of raw materials (media components, disposables, excipients, etc.). These will utilize non invasive high resolution methods that can be used at the suppliers such that incoming raw materials control can occur “at the supplier’s loading dock”.
Suppliers can certify materials in accordance with new methods. Third party testing will be available to independently qualify batches.
IMPACT • Product and process consistency will be enhanced.
PARTNERS NIST FDA Major manufacturers Analytical vendors
PRODUCT FOCUS AREAS • Established Platforms • New Platforms • Emerging Platforms CROSS CUTTING THEMES • Upstream • Formulation & Delivery • Regulatory
Goal: Raw material supplies will be qualified in a common way. Acceptable ranges established.
Methods to Ensure Raw Material Consistency
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APPROACH AND JUSTIFICATION • Product release testing is currently performed after completion
of the manufacturing process, i.e. without opportunity to influence quality attributes via process control elements.
• Novel assays will reveal quality attributes via in-process tests at a point of controllability via feedback loops
• Release testing will be limited to safety related assays via rapid in line or at line contaminant assays.
IMPACT • Tighter process control via feedback loops • Increased process success rate based on timely process
information through relevant in process assays • Reduced inventory levels due to reduced overall process success
risk
PARTNERS NIST FDA Major manufacturers Analytical vendors
New Assays & Approaches for Process Control and Product Release
PRODUCT FOCUS AREAS • Established Platforms • New Platforms • Emerging Platforms CROSS CUTTING THEMES • Process control • Analytical • Regulatory
Goal: feedback control based on relevant in process testing of critical quality attributes
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Education and Workforce Training Program
Establishment of competency standards.
Engagement at all educational levels.
Dissemination of best practices within a
national network of community colleges.
Development of custom on-site or
off-site training programs.
Combination of online and in-
person training in GMP environments.
Establishment of training programs
for stackable credentials & certifications.
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Getting Ready to Respond to NIIMBL RFPs Identify individual areas of interest, NC, NC State partners
Upstream, Downstream, Formulation, Process Control Workforce Development
Attend regional and national NIIMBL meetings
Present capabilities Identify academic, industry partners, national labs
Begin preparing for proposals prior to the formal RFP
Information from CTO and TAC Identify needs to ensure success
Partners, space, equipment, supplies, personnel
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NC State (Tier 1) Representatives to NIIMBL
GC Representative – Jon Horowitz Chief Technology Officer (CTO) – Ruben Carbonell, CBE, BTEC TAC Representative – Michael Flickinger, CBE, BTEC WAC Representative – John Balchunas, BTEC RCC Representative – Rick Lawless, BTEC
Office of Research, Innovation and Economic Development (ORIED) • Information dissemination – website • Financial, IP management and reporting • Space and facilities • Proposal processing (pre- and post-award)
NIIMBL NC State
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Next Steps
Benefits to early sign-up for major manufacturers and suppliers
March 1, 2017 official launch
Launch vetted, quick start projects (technology, workforce) by July-Aug
Sign up members and establish committees (through May-June)
Expand membership, define priorities, launch first project call
First NIIMBL National Meeting, May 4-5, 2017
Quick Start Project Call as early as April 30, 2017
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NIIMBL National Meeting, May 4-5, 2017 Washington, DC
Thursday, May 4 – National Academy of Sciences Building (Open to members and prospective members) • Presentations by senior administration officials • Roundtable discussions by biopharmaceutical executives • Networking and brainstorming opportunities • SME rapid-fire presentations • Poster presentations by academics, SMEs Friday, May 5 – DoubleTree Hotel Crystal City (Open to members only) • First meetings of the GC, TAC, WC, RCC
Registration NIIMBL Website www.niimbl.org