CONTACT

The National Institute for Innovation in Manufacturing Biopharmaceuticals

F.A.Q.

Last Updated: May 3, 2017

NIIMBL Operation, Leadership & Membership

  1. What makes NIIMBL different from existing consortia and biopharma trade groups?

    There are many aspects of NIIMBL that distinguish it from existing consortia and trade groups: (a) NIIMBL has a much broader reach of technology topics than consortia that are generally focused on a specific narrow area of technology or regulatory science; (b) NIIMBL is the only consortium that offers technical programs that are coordinated with workforce development efforts; (c) NIIMBL offers shared facilities, demonstration and testing sites across the country that provide unique opportunities for industry to consider new technology innovations; (d) NIIMBL is the only consortium that can engage teams of industry and academic groups, together with federal laboratories, to solve industry-relevant problems; (e) The NIIMBL focus on integrating Small and Medium Enterprises (SME) and small start-up companies in technology development is unique to Manufacturing USA institutes; (f) biopharma trade organizations generally do not have the resources available to NIIMBL to address industry technical and workforce needs.

  2. Is there an overlap between ARMI and NIIMBL?

    There are clear synergies between ATB ARMI and NIIMBL as well as complementarity. We anticipate joint project efforts in areas that impact both institutes (e.g. raw material impacts) as well as synergistic collaborations in other cases. Both NIST and the DOD are working very closely to ensure that these institutes are effectively aligned. Read more about these two institutes at: https://www.manufacturingusa.com/sites/prod/files/ATB%20and%20NIIMBL%20synergies.pdf

  3. Does NIIMBL have a long-term sustainability plan?

    We are confident that as NIIMBL facilitates broader partnerships among companies, academics, non-profits, and federal scientists, that the value in continued membership will be apparent, and will support the sustainability of NIIMBL. In addition, the NIIMBL innovation ecosystem will be a recognized resource for workforce development initiatives and targeted technology-related initiatives that will generate revenue from public and private funding sources.

  4. Will the membership agreements be standardized?

    The current Membership Agreement is the standard form of agreement for all NIIMBL applicants.

  5. Is there a database of companies & Institutions?

    NIIMBL is working to establish a members-accessible electronic resource of partners, their interests and expertise.

  6. Will NIIMBL facilitate academic/industry interactions?

    One of the most important needs in the NIIMBL community will be facilitated teaming, which will lead to successful project efforts. NIIMBL will facilitate interactions among all stake-holders though electronic databases, WebEx meetings, in-person local/regional events, and in-person national events.

  7. What are the benefits for Tier 3 industry members?

    Tier 3 companies may participate on project teams (at least one Tier 3 Member is generally required to be included on each technology project team), may network with major manufacturers, may access shared facilities for prototyping and/or clinical manufacturing, may access NIST Manufacturing Extension Partnership (MEP) program personnel, and receive internal business IP rights on projects that they participate on, among other benefits. We expect that the number of Tier 3 members participating on a given project will be a factor in proposal evaluation as a means to encourage Tier 3 engagement.

  8. How do members receive credit in NIIMBL membership fees for participating existing consortia?

    There is a discount on the cash portion of the Tier 1 membership fee for industry members that are members of other qualifying consortia. The maximum benefit would be capped at $50,000 per year ($25,000 benefit for participation in each qualifying consortium) and would have to be made up with in-kind cost share (e.g. $700,000 cash, $800,000 in-kind).

  9. How are states involved with NIIMBL?

    Some states provide significant cost share that may be used in a variety of ways depending on the state requirements. State contributions may provide cost share towards workforce or technology projects or may even be used to support membership fees for Tier 3 companies and Tier 3 academic institutions. States with significant cost share ($1+ million / year) will comprise a State Advisory Committee that will help guide NIIMBL. State agencies from other states may join NIIMBL at any time. Those that contribute significant cost share will be represented on the Governing Committee through a State Advisory Committee.

  10. How many delegates are on the RCC, TAC, WAC and GC?

    The number of representatives on the respective committees depends upon the number of organizations that have executed a Membership Agreement, and those members’ Tier 1, Tier 2 or Tier 3 status.

  11. How will NIIMBL interact with other biopharma associations?

    NIIMBL will be able to leverage the expertise and resources of many of the relevant trade organizations through opportunities to serve the local and regional communities as well as to help advocate for the interests of the industry. Discussions with individual biopharma associations will help determine the appropriate mechanisms of involvements and interactions with each group.

Intellectual Property

  1. How will IP Ownership be determined?

    Ownership will be based on inventorship, according to US patent law. For technology projects, the proposing team will agree to a project-specific IP management plan prior to project launch that will provide further details on ownership and commercialization rights.

  2. Have companies provided input to IP management plans?

    Yes, several potential industry members have had a chance to make comments on drafts of the NIIMBL Membership Agreement and Bylaws describing the IP management plan and the project-specific IP plan.

  3. How will Background IP be handled?

    Background IP will be negotiated prior to project launch per the project-specific IP management plan. If background IP from a project team member is needed, that organization can negotiate the use of that background IP on the project. If third-party background IP is required for a project, the proposing team must develop a plan to access that IP prior to project launch.

  4. How will IP and legal fees be funded?

    These will be funded through mechanisms defined in the project-specific IP management plan.

Funding

  1. How are funds distributed to projects?

    Once a project has been approved by the Governing Committee, NIIMBL will execute sub-award agreements with all relevant parties in accordance with the budget that was approved.

  2. Describe the Cost Share Ratios.

    Each project team must submit a budget that includes at least a 1:1 cost share of NIIMBL funds. This cost share is likely to be in the form of documented time, shared materials, equipment, access to specialized facilities, reduced/waived tuition, reduced/waived indirect costs, among others. We expect that the amount of cost share proposed by a project team will be a factor in the final evaluation of proposals. Cost share of individual projects by an organization will be counted towards the overall cost share commitment made upon signing the membership agreement. For example, if a Tier 1 industry has an overall cost share commitment of $750,000 for a given year, but provides cost share for a given project of $100,000, they would only have to provide a cost share of $650,000 for that particular year.

  3. Do projects have a minimum or maximum funding level?

    There will not be a minimum funding level. Maximum funding levels will be determined by resources available to fund projects during any given project call. It is expected at NIIMBL will use its overall budget in a similar way as other Manufacturing USA institutes, with 15% of the funding going to management, 65% going towards technical program and 20% going to the workforce development program.

  4. Will state funds support SME membership?

    That depends on the state. In some cases, yes. If you have questions about the plans within your state, feel free to contact NIIMBL. State funds can be used for a variety of purposes, including cost sharing of NIIMBL projects, helping SMEs within their states with their membership fees, space renovations and equipment purchases, etc.

Federal Interactions

  1. How is the FDA involved?

    The FDA will have participation on committees as well as on education and technology project teams. The RCC will have the ability to launch projects with approval by the GC, that address a pressing regulatory science issues. This committee will also provide feedback to the TAC and the WAC on projects that could support the advancement of regulatory science.

  2. How can NIIMBL facilitate implementation & regulatory approval of technologies?

    Regulatory approval is under the purview of the relevant health authorities. We believe that NIIMBL can de-risk efforts to incorporate new technologies and methods into processes by supporting collaborative studies demonstrating the performance of such technologies and methods. It is expected that NIIMBL will also reach out to foreign regulators to determine the best way of exchanging information with them for the benefit of Biopharmaceutical Manufacturing in the U.S.

Project Operations

  1. Will the TAC have working groups or subcommittees?

    Each NIIMBL committee will have the opportunity to develop subcommittees to facilitate the execution of their missions. For example, the TAC could decide to have subcommittees for the two product types: existing and emerging, or perhaps around drug substance, drug product and process control. It is also likely that separate committees will be organized for evaluation of proposals, and progress on NIIMBL technical projects.

  2. Are tools and technologies suitable projects?

    NIIMBL’s focus is on advancing biomanufacturing technologies for whole-of-industry innovation. Enabling tools and technologies are within the scope.

  3. Who will choose Quick Start Projects?

    The Governing Committee will select project awards. The Governing Committee will have a vote that is tilted 2/3 in favor of industry representatives. Only organizations that have fully executed the Membership Agreement by the time the quick start project selection process reaches the GC will be eligible to vote. Topics for Quick Start Projects will be discussed by the TAC and WAC and suggested to the GC.

  4. How will In Kind Contributions be tracked/managed, who assigns value to FTE’s?

    In kind contributions will be tracked and managed by NIIMBL based on information provided from member organizations using a template. Each organization is expected to assign their own value to FTEs, in accordance with the Bylaws. The value of other in-kind contributions should be compliant with 2 CFR 200.306.

  5. When will the first call for projects go out?

    We expect the first quick start project call to be announced in May with proposals due approximately one month after the announcement. We expect the first full NIIMBL project call to launch around August with proposals due in October with earliest possible project start date of December 1, 2017.

  6. How long will the project review period take?

    Between 3-6 weeks. It will be shorter during the first year of operations to facilitate rapid project launches.

  7. Can Non-members be involved in projects?

    It is possible that a non-member organization could be on a project team. However, the participation must be well-justified and will be limited: A) the organization must meet Tier 3 member qualifications, B) the organization must have a unique capability/ technology/ expertise not available among any other existing NIIMBL member.

  8. How many projects will be ongoing? What is the duration of NIIMBL projects?

    We expect that at steady-state NIIMBL will be running 20 projects in parallel at any one time with an average duration of about 1-1.5 years, and funding levels of $2 - $6 M total costs per project.

  9. What are the reporting requirement for projects?

    The TAC will be charged with developing a reporting methodology to ensure that funded projects are making reasonable progress. Quarterly and annual reports of progress with suitable metrics and goals will be expected.

Industry/Companies

  1. How many Tier 1 companies?

    The number of T1 and T2 companies will be based on those that have executed Membership Agreements. As of April 2017, executable Membership Agreements have been distributed to the community and signed agreements should begin to be executed in a relatively short time period.

  2. Can non-US Companies join? Non US HQ companies?

    Yes, there is recognition that this is a global industry. Foreign-owned companies can participate provided: 1) they have some significant US presence and 2) subject to NIST approval.

  3. Can CMO’s and Service Providers or Suppliers Join?

    Yes.

  4. How will small companies and start up companies join?

    Smaller companies can join by signing a membership agreement. For questions, please write to info@niimbl.org.

  5. How will small companies benefit if large companies choose projects?

    One of the primary benefits offered by NIIMBL is the facilitated partnership across the biopharmaceutical manufacturing ecosystem. As such, each project team is required to have at least one small company as a participant. Moreover, we anticipate that the extent to which there are more small companies participating on a project team, the more favorable the review of that application. Small companies will also have opportunities to interact and network with large companies as well as gain access to shared facilities and manufacturing capabilities that they may not otherwise be able to access.

Academic Institutions

  1. How will universities inform faculty of project calls?

    Each institution will select a point of contact and that individual will be responsible for communicating project calls through their institution. Information will also be available on-line on the NIIMBL webpage.

  2. Do any academic members have GMP Facilities?

    Yes, a number of academic partners have GMP facilities, and access to these facilities is one of the major benefits of the NIIMBL partnership.

Communications

  1. Will NIIMBL sponsor forums or host brain storming sessions?

    Yes. NIIMBL will play an active role in helping bring the community together to find complementary expertise and interests and foster collaborations and networking.

  2. Is a copy of the Regional Meeting slide deck available?

    Yes. Please contact info@niimbl.org

  3. How do I contact NIIMBL or Leadership Team members?

    Please send email to info@niimbl.org

  4. Who and how will a Technology Roadmap be developed?

    There are a number of existing relevant technology roadmaps including NIST AMTech funded roadmaps as well as third party roadmaps (e.g. BioPhorum Operations Group). NIIMBL plans to leverage existing roadmaps, identify and address gaps in roadmaps, and facilitate ongoing roadmapping moving forward in partnership with the global community.

  5. Will there be an annual review or annual NIIMBL Conference?

    Yes! The first NIIMBL meeting will be on May 4-5, 2017 in the Washington DC area. May 4 will be an open event with participation invited by all. May 5 will be a half day of meetings among organizations that have signed the NIIMBL Membership Agreement by May 4, 2017.

Workforce Development

  1. Is there a connection between Project Proposals and Workforce Training?

    Workforce development projects can be proposed as part of the project proposal process. For example, a team may request the purchase of a piece of equipment to establish a short course in the use of that equipment. In addition, all Project Calls will involve both Technology Development as well as Workforce Development projects. The Workforce Activities Committee (WAC) will be responsible for setting the direction and implementing the education and workforce development agenda for NIIMBL.


Copyright 2017 NIIMBL. All rights reserved.

Department of Commerce National Institute of Standards and Technology Manufacturing USA USA Bio