In December 2016, Manufacturing USA, a newly developed unit within the Commerce Department’s National Institute for Standards and Technology (NIST), announced it had received Congressional funding for its newest and 11th institute – the National Institute for Innovation in Manufacturing Biopharmaceuticals, or NIIMBL for short. With the formal NIST announcement on March 1, 2017, came a federal government five-year pledge of initial funding of $70 million for the public/private institute. Additionally, NIIMBL would be housed in facilities being constructed on the University of Delaware’s STAR Campus, and Kelvin Lee, Gore Professor of Chemical and Biomolecular Engineering, would be NIIMBL’s first director. In January 2019, the Bill and Melinda Gates Foundation pledged an additional $1.5 million to speed up NIIMBL’s progress. A year later, in early 2020, the institute was preparing a spring move into the nearly completed Ammon Pinizzotto Biopharmaceutical Innovation Center when the COVID-19 pandemic forcefully shut down all on-site research operations at the university. But in a bad news-good news turn of events, in June 2020, the advent of COVID-19  also spurred the federal government to award NIIMBL approximately $8.9 million in additional funding for technology innovation projects to combat the disease. Now, five years after its genesis and rapid growth, two questions can be asked:  how big a deal to Delaware’s stature is NIIMBL, and what does its report card look like thus far? [caption id="attachment_212034" align="alignnone" width="1024"] Kelvin Lee, Gore Professor of Chemical and Biomolecular Engineering, spearheaded the effort to to qualify University of Delaware as the 11th Manufacturing USA Institute. His life - and Delaware's biopharma sector - hasn't been the same since | DBT PHOTO BY ERIC CROSSAN[/caption] Investing in the future On a sunny mid-May morning this spring – the day before the university would announce that all its research operations, including those of NIIMBL, could pretty much get back to business as usual – Lee, informally dressed in a black Dogfish Head T-shirt, warmly greets a visitor in the still-deserted lobby of NIIMBL headquarters at 590 Avenue 1743. “Only one person is allowed in an elevator, so go to the sixth floor, and I’ll meet you there,” he said. NIMBL’s new offices seem equally deserted, but, perhaps in a show of protocol, Lee said, “Let me see if the conference room is available.” It is. Lee, who is still on Delaware’s research faculty, is both cordial and confident, straightforward in his answers and relaxed in conversation. If the weight of running an important institute during a pandemic weighs heavily on him, he does not show it.  Lee began his academic career at Princeton, where he received his bachelors in 1991. He was awarded both his masters (1993) and doctorate (1995) in chemical engineering from Cal Tech. Before coming to Delaware, Lee worked in the biotechnology field in Switzerland and was on the faculty at Cornell. He has served prominently in state biotechnology organizations. “In about 2016, the Department of Commerce announced a competition for a new biotechnology institute as part of Manufacturing USA,” Lee recalls. “We submitted a grant application. I don’t know how many competitors there were, but we won.” He gives a slight grin. “Since then, my life has never been the same.” The United States has long been a biotechnology leader, but Manufacturing USA’s mission was to further develop the speed and efficiency of its critical manufacturing capabilities, which were seen as flagging. NIIMBL’s role was to target biotechnology manufacturing by integrating research efforts of industry, the government and nonprofit organizations. “We operate at manufacturing readiness levels 5, 6 and 7,” Lee said, explaining that this is the area of technology maturation and risk reduction that comes after a product has been discovered and gone through proof of concept but before a pilot plant is constructed, an area  sometimes called “the valley of death.” “We check to be sure the process works as expected, how it can be scaled up and how it can be de-risking,” Lee said. At this point, intellectual properties have been established, so collaborative work can take place. Additionally, it gives great exposure for academic researchers and small companies to shop ideas, concepts and products to potential business partners.  NIIMBL industry members pay annual fees from $5,000 to $750,000 on a tiered basis, and academic and nonprofit membership ranges from $1,000 to $40,000.  Last year, NIIMBL invested approximately $6.7 million in eight new technology innovation projects.  It also grew its membership to 155 organizations from around the country.  Indeed, developments have moved so rapidly that NIIMBL came close to outgrowing its initial funding. ‘Delaware leading development’ In late 2019, U.S. Sen. Chris Coons, who was instrumental in the creation of Manufacturing USA and has been a strong ally of NIIMBL from its inception, co-sponsored with nine other senators from both sides of the aisle a piece of legislation known as the Global Leadership in Advanced Manufacturing Act, or GLAM Act, which eliminated NIIMBL’s strict funding window. Instead, the act, passed Dec. 11, 2019, now requires institutes such as NIIMBL to undergo a performance review every five years before additional funding is allocated. “It brings me great pride that Delawareans are leading the world in the development, testing and production of medicines of the future,” Coons said in a statement at the time. “With  this bill, and the vital federal funding opportunity it creates, Delaware’s innovators will continue to not only save lives, but also create jobs for generations of high-skilled Delawareans who will manufacture these lifesaving drugs. Also, other states are empowered to follow Delaware’s lead by forming new institutes specializing in other vital areas of manufacturing.” The importance of the biopharmaceutical industry to the United States goes far beyond its health benefits, although those were ably demonstrated during the pandemic in the search for treatments, and, more importantly, effective vaccines. The industry is also a significant driver of the U.S. economy, contributing, according to NIIMBL figures, $1.1 trillion annually in economic activity and directly or indirectly employing more than four million individuals. But the industry is far from failsafe, Lee explains. “We hope that NIIMBL will make a difference in the U.S. by being a leader in how medicines are manufactured.” Identifying and developing projects are keys to that.  “We go to industry members, and we ask them, ‘What are your project needs?’  We talk about them, then we prioritize and open calls for solutions. Any [NIIMBL] member can decide whether they want to address that need.” For example, a recently completed project titled “Blaze Microchip System for Real-time Characterization of Intact Biopharmaceuticals” was initiated by Intabio, a small company in Newark, Calif.  Participating members in the project were Merck, MilliporeSigma, Bristol-Myers Squibb and Genentech. NIIMBL facilitated the testing of Intabio’s Blaze™ analysis system with member company cells to validate efficiencies and improve market access, potentially bringing drugs to market 1 to 3 years faster. Additionally, Intabio was able to increase its number of Early Access Program companies from two to three prior to NIIMBL to 20 after joining NIIMBL. [caption id="attachment_212036" align="alignnone" width="1024"] Students Lauren Cordova (left) and Sofia Alfieri work together in an NIMBL lab. DBT PHOTO BY ERIC CROSSAN[/caption] Uniting across biopharma sector But now there are also NIIMBL-led projects as well. “As we grew, it became apparent that we needed a strategic plan around our higher-level goals,” Lee said, “We needed to talk to end-users about their five-year vision, about where they expected biopharmaceuticals manufacturing to be in five years.” Although Lee emphasizes that NIIMBL remains a member-led organization, the need for long-range strategic outlook has led to the recent designation of a few NIIMBL-led projects. In addition to the projects, NIIMBL also relies on one low-tech, ages-old resource to allow its membership and newcomers to do creative networking:  an annual meeting. This year, it will be a hybrid affair with both in-person and virtual attendance July 14-16 in Washington, D.C. How, then, does Lee and the NIIMBL leadership periodically evaluate its progress? How is success measured? “We have some basic goals,” he said, “such as advancement of the technology of manufacturing and de-risking it.  I think we have been successful at that.  We also have an important role in education and providing resources for training. I’d give a check mark for that.” Indeed, during NIIMBL’s 2019-2020 fiscal year it invested more than $3 million for six new workforce development projects including both hands-on and blended learning. A new program, called the NIIMBL eXperience, was created to provide biopharmaceutical industry exposure to under-represented communities of students such as Black, Latinx and Native American students at historically black colleges and universities and NIIMBL-member institutions. Lee also thinks the institute has done a good job in enrolling participation “across the biopharma ecosystem – pharmaceuticals companies, and not just those in the manufacturing space, academia, nonprofits as well as small and medium companies including startups.” The COVID-19 experience and the challenge to be actively involved in it gave NIIMBL an unexpected chance to be, well, nimble. “It was chaos at first,” Lee said, “but we immediately ran a project call to our community and made decisions in a week that might have previously taken months.” NIIMBL teams began working in areas such as creating diagnostic testing for COVID-19 variants using only small amounts of protein, better sanitization of clinical areas, new materials for PPE masks (“we made millions of masks), assuring sterility of vaccine manufacturing and acceleration of projects already in progress. Local community, nationwide progress Although NIIMBL’s membership and project activities stretch across the country, the fact that Delaware is a hub of biopharmaceuticals and general biotechnological activities was a major reason the Commerce Department located the institute here. “We have a locally strong community,” Lee said, pointing to members such as the Delaware Biotechnology Association, pharma companies such as AstraZeneca, technology stalwarts such as ILC Dover and, of course, the universities and colleges. “We can leverage these relationships because we already know each other,” he said. “We have such a strong sense of trust.” The feeling is mutual, as there appear to be none of the turf wars within the Delaware bio community that often arise where there are overlapping agendas. “NIIMBL has been a catalyst for innovation,” said Michael Fleming, president of the Delaware BioScience Association, noting that Lee is also a Delaware Bio board member and provides regular updates about the institute.  “The work being done at NIIMBL provides a huge manufacturing opportunity for the U.S. and for Delaware,” Fleming said. The advocacy of Coons in Washington has been advantageous, as well. “I was co-sponsor of the bipartisan bill that created Manufacturing USA in 2014 (the American Manufacturing Competitiveness Act),” he said in a recent interview. “I had first tried to get the advanced composites institute located in Delaware, but that went to the University of Tennessee at Knoxville. Then I asked Kelvin in which area Delaware could be competitive, and I helped him develop the NIIMBL proposal.” In the institute’s first five years, Coons said, “Kelvin’s leadership has been outstanding.” Mike Molnar is the founding director of the Office of Advanced Manufacturing at the National Institute of Standards and Technology (NIST) and thus is in charge of Manufacturing USA.  As such, his office acts in an advisory and budget approval capacity to NIIMBL and could, in theory step, in if it felt the institute was acting in a way not in the national interest or not in keeping with its charter, “But,” Molnar hastens to add, “that hasn’t been necessary.” “NIST just this month [May 2021] completed an assessment of NIIMBL’s performance since the institute launched in March 2017,” Molnar said. “NIST used an external evaluation panel composed of industry, small and large, academia and government representatives to independently review NIIMBL’s progress.   “While we can’t disclose the full details of that review, we can confirm that the panelists were impressed by the progress that NIIMBL has made in bringing industry together to solve the problems that can’t really be tackled by any single company,” he continues. “As for NIST, we can say that we agree with the panel’s consensus and have offered NIIMBL the opportunity to  extend its funding for another five years based on the value we’ve seen during the first five years.”