National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) National Meeting

Remarks as prepared.

Good morning. Thank you, Kelvin and the NIIMBL team, for inviting me here today. Thank you, Senator Coons, for your support for NIIMBL and NIST. I appreciate your steadfast advocacy for federal investment in technical programs that advance our national and economic security.  

I also want to thank all of you in attendance for your commitment to NIIMBL. NIIMBL is one of 17 institutes in the Manufacturing USA network, and the first institute in the network that is sponsored by the Department of Commerce and NIST. Manufacturing USA was founded in 2014 to bring together people, ideas, and technology to solve advanced manufacturing challenges and help cement America’s technological leadership. The 17 institutes cover a wide variety of industry sectors as well as cross-cutting tools like automation and robotics, smart systems, and sustainability.  

There are two more institutes planned to join the network. As you may have seen, NIST is thrilled to have announced a funding opportunity for a new Digital Twin for Semiconductors CHIPS Manufacturing USA institute. A second funding opportunity for a new AI for Resilient Manufacturing institute is also expected soon.  

All Manufacturing USA institutes help new tools, processes, and products prove out so they can make it to the marketplace and improve the state of the art. The Manufacturing USA network enables businesses of all sizes, including small and medium-sized enterprises that otherwise may not have access to test beds or capitally intensive equipment and collaborations with experts and market leaders.  

Manufacturing USA institutes also help to create the skilled workforce that is so much in demand by growing tech sectors. In turn, more Americans gain access to high-wage jobs.  

My own experience as a scientist and inventor is relevant to the very complex biopharmaceutical manufacturing environment. I know how important it is that the sector has a neutral space where members of industry, academia, and federal labs can work together on problems that are too large for a single entity to solve.  

NIIMBL’s work has impact far beyond this, and that’s the beauty of the Manufacturing USA institute model. Yes, technical barriers are overcome through collaboration. These activities help to ensure that America develops and maintains innovation and manufacturing capacity in biopharma, which in turn draws more investment and production to our shores.  

Domestic manufacturing capacity for biologics is especially important in the event of a pandemic. During the worst of the COVID-19 pandemic, we learned that the security and resilience of the associated supply chain are also critical. NIIMBL’s ecosystem approach was always designed to address these issues. Funding through the CARES Act and American Rescue Plan jump-started NIIMBL’s pandemic response. The more than 40 projects funded will help us prepare for and even prevent future public health crises.  

As NIIMBL helps to grow the biopharmaceutical industry’s footprint in America, it is also growing the STEM-ready workforce. NIIMBL has built a network of more than 50 community colleges, technical schools, and research universities to provide training in the skills needed by biopharmaceutical manufacturers. I especially appreciate NIIMBL’s outreach to communities that are traditionally under-represented in STEM through the NIIMBL eXperience program, which has already reached students at 69 institutions and is expanding. Increasing access to jobs in biopharma introduces diverse perspectives that enhance innovation and helps aspiring STEM professionals imagine themselves in similar roles, which helps to further increase the diversity of the STEM pipeline.  

I also want to thank David Strauss and Peter Marks for being here today, and the additional FDA staff members who are deeply involved with NIIMBL. It’s so beneficial for the FDA to have access to innovations for biopharma manufacturing as they happen, well before regulatory submissions are drafted. And for the private sector to have access to critical information important for the delivery of quality, expedient public health solutions.

Finally, but by no means least, I want to thank the NIST staff members and scientists who have and will continue to contribute to NIIMBL’s success through their engagement on committees, case studies and projects. Biopharmaceutical manufacturing relies so much on measurements that are reliable and replicable, and on the development of new measurements and methods. Working with NIIMBL’s member community helps NIST experts learn about the measurement needs of the sector, and helps us disseminate the results of our work.  

Which leads me neatly back to the NIST mission, which is to leverage those measurement science advances, along with technology and standards, to promote U.S. innovation and industrial competitiveness for enhanced economic security and quality of life. NIIMBL is a vital part of that mission. Thank you all for growing the nation’s capacity to provide therapies that improve and save lives.