AMERICAN INNOVATION AT WORK...2017/04/11 · 9 AMERICAN INNOVATION AT WORK NIIMBL Proposal Facts and Figures • 140+ Partners (60 industry, 35+ academic, 35+ non-profit) • 25 States

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


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


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


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.


NIIMBL Government = Non-profits + Academia +



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)



Organization

2/3 vote on GC and TAC from industry members.

NIST

SMEs


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


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)


Technical Scope Overview


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


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


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.


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


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


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)


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


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


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.


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


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


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


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


Documents

AMERICAN INNOVATION AT WORK...2017/04/11 · 9 AMERICAN INNOVATION AT WORK NIIMBL Proposal Facts and Figures • 140+ Partners (60 industry, 35+ academic, 35+ non-profit) • 25 States