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NIIMBL Celebrates One Year Anniversary

March 1, 2018

NIIMBL Announcement

Today marks a significant milestone in our history as we celebrate the one-year anniversary of the launch of NIIMBL. We express our deepest appreciation for your enthusiastic participation and support throughout our first year.

“The early adopters from our community have shaped our path forward, have offered guidance and input on NIIMBL's structure and operations, and been a wellspring of enthusiasm and innovation for the biopharmaceutical manufacturing community and the patients it serves," said Kelvin Lee, NIIMBL Institute Director.

From project calls to roadmapping to breaking ground on our planned headquarters at the University of Delaware, it has been an active first year as we begin our journey to transform the biopharmaceutical industry in the U.S.

A Supportive Community

NIIMBL first offered Membership Agreement opportunities to the community in mid-April 2017, just in advance of the first National Meeting in May 2017. NIIMBL benefitted from the governance experience and advice provided by other Manufacturing USA institutes, NIST, and many of our partners who are members of other Manufacturing USA institutes including MIT, Georgia Tech, Purdue, NC State, RPI, and the University of Massachusetts, among others.

Since those first days, we have grown to nearly 80 members with more than 40% from industry. We are especially grateful to Genentech, NIIMBL's first Tier 1 industry member. The visionary leadership that Dana Andersen (VP Technical Development Project & Portfolio Management) and Genentech have provided has been vital in ensuring NIIMBL understands and addresses the needs of industry. The participation by Celgene, a leader in the cell therapy field and Merck, with expertise in vaccine manufacturing, provides NIIMBL with valuable perspectives to address the manufacturing opportunities for the products of today and tomorrow. With Millipore Sigma / EMD Serono (businesses of Merck KGaA) on board, we have one of the key suppliers to the industry with offerings that span the entire range of biopharmaceuticals.

Small-to-medium enterprises (SMEs) are often the heart of innovation in the industry and we have more than two dozen such companies as NIIMBL members. From small companies with innovative therapies to contract manufacturers to suppliers with disruptive technologies to organizations with innovative educational platforms, NIIMBL places special value on our SMEs. Through the SME Innovation Showcase at our National Meeting and dedicated staff in DE, MA, and NC that focus on the interests of small manufacturers, NIIMBL is committed to our Tier 3 industry members who have shown a similar commitment back to NIIMBL.

“NIIMBL has been a valuable platform for my small biotech company to collaborate with large biomanufacturing companies and academic institutions and to demonstrate the power of our novel bioprocessing solutions,” said Dhinakar Kompala from Sudhin Biopharmaceutical Company.

The academic community, including world-class research universities, community colleges with proven excellence in training, and non-profits focused on biopharmaceutical manufacturing, has demonstrated incredible enthusiasm to learn and engage with our industry members. In particular, we applaud our academic members’ commitment to identify, understand, and develop ways to work in the MRL 4-7 space, the central focus of NIIMBL projects.

The government is an invaluable resource. We have commitments from states and local governments such as Delaware, Massachusetts (the Massachusetts Life Science Center), North Carolina, Maryland, and Montgomery County, Maryland as well as to our federal partners and colleagues at the National Institute for Standards and Technology (NIST) in the Department of Commerce, FDA, BARDA, NIH, DOE, DOD, and even the FBI. NIIMBL could not be in a more enthusiastic and supportive community. With your support, and the continued support from Congress and the Administration, we look forward to our continued growth.

Our Projects

Technology and workforce development projects are the fundamental activity by which we achieve our mission. Through our bi-annual project calls, our members harness their collective expertise and join forces on innovative solutions for industry challenges.

“Continued innovation is critical for developing new biopharmaceutical therapies to address key medical needs. NIIMBL provides a unique opportunity to accelerate efforts to address manufacturing challenges so that novel approaches and treatments reach and benefit patients in the future,” said Dana Andersen of Genentech.

Stated John Balchunas of North Carolina State University, “Through the partnership and collaborative opportunities fostered by NIIMBL, we are able to fully understand the skills and training needed for biopharmaceutical workforce now and in the future.”

NIIMBL will soon announce a slate of eight initial projects that address key technology gaps and workforce training needs and that represents $13.25 million of activity over the next 18 months.

NIIMBL Roadmap Initiative

In addition to ongoing projects, there is a need for technology roadmapping in several areas. NIIMBL benefits from recent roadmaps in lyophilization and cell therapies and has partnered with the BioPhorum Operations Group to leverage the global roadmap established for antibodies. NIIMBL will continue to contribute to these roadmaps but has also launched roadmaps in three complementary topics: vaccines, gene therapy manufacturing, and antibody drug conjugates / bispecific antibodies. A late November 2017 visioning workshop in Baltimore included participation from 40 organizations and created a framework that will be expanded upon in 2018, leading to these three roadmaps. With leadership and engagement from members and non-members, NIIMBL plans to publish these roadmaps in 2018 and use this knowledge to guide future project investments.

The Future

While the community has established a solid foundation in Year 1, NIIMBL will continue efforts to enhance our impact and engagement within the community. We are looking forward to a revamped and improved Community Portal to facilitate participation in NIIMBL activities, track member effort and cost share by organization, and monitor and report on the progress of NIIMBL projects. In addition, we anticipate many opportunities for face-to-face partnering meetings and technical workshops, updates to the proposal submission process (including a two-stage process), and partnerships with more and diverse organizations that have a common interest in biopharmaceutical manufacturing process development, manufacturing operations, and workforce development.

We are excited for our next National Meeting on May 16-17, 2018 in Washington DC (Register here) which will include several special guests and leaders from the industry. We expect to announce project calls in May and October and have already identified a number of dates for workshops and other NIIMBL activities this year.

The University of Delaware is also making great progress on building the new NIIMBL HQ with move-in scheduled for January 2020. NIIMBL will occupy 25% of the 200,000 square foot, $156M facility which will also co-locate some biopharmaceutical discovery and process development activities from the campus. The NIIMBL space will include shared laboratories for any project team that would like to use it, house NIIMBL platform process facilities, offer a NIIMBL showcase laboratory, and include access to a workforce training facility.

Many people from our partners work hard behind the scenes to keep NIIMBL moving forward. For some, it is a part-time effort and for others, it is their primary focus. We want to express our deep gratitude to all for the hard work, visionary leadership, commitment of resources, and answers to emails and phone calls. Our success as a community is directly tied to your ability to realize value from NIIMBL engagement. Thank you and we hope to see you in Washington DC in May.

Not a NIIMBL member yet? Contact us at so your organization can join us in our journey to revolutionize biomanufacturing in the U.S.

Copyright 2017 NIIMBL. All rights reserved.

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