Posted at 1:48 PM
Today at the University of Delaware, U.S. Secretary of Commerce Penny Pritzker announced the latest addition to the Manufacturing USA network: the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). This is the first U.S. Department of Commerce-led institute to join the network and the first awarded under the 2014 bipartisan Revitalize American Manufacturing Innovation (RAMI) Act using an “open topic” competition. Commerce-led institutes focus on taking technologies from lab to market where there is the greatest potential, and the addition of NIIMBL will add another 150 members to the existing 1,300 partners within the Manufacturing USA network.
During her remarks, Secretary Pritzker underscored the economic, public health, and national security benefits of innovations in biopharmaceutical manufacturing, but emphasized that in many cases, critical health and safety regulations disincentive innovation in this sector. To address this, NIIMBL will spread the risks and share the benefits across the industry of developing and gaining approval for innovative processes, catalyzing growth and innovation.
NIIMBL joins the other institutes in the Manufacturing USA network, which break down silos between the U.S. private sector and academia to collaborate on taking industry-relevant technologies from lab to market in the next 5 to 7 years. Like all of the institutes in the network, NIIMBL will continue to seek new members and to increase its industry investments.
Remarks as Prepared for Delivery
Good morning! I am thrilled to be here today at the University of Delaware to announce the latest addition to the Manufacturing USA network: the National Institute for Innovation in Manufacturing Biopharmaceuticals – or NIIMBL.
When President Obama launched Manufacturing USA in 2012, he set out to create a stronger, more agile American manufacturing sector – one where the brightest minds and the most innovative companies come together to develop the most cutting-edge technology in the world.
Four years later, in communities from coast to coast, the Manufacturing USA network is breaking down silos between the U.S. private sector and academia to take industry-relevant technologies from lab to market.
With today’s announcement, the network adds another 150 members – from 25 states including Massachusetts, Maryland, and New Jersey – to its more than 1,300 partners. NIIMBL is the first Commerce-led Manufacturing USA institute. Let me repeat: NIIMBL is the first Commerce-led Manufacturing USA institute. We are so excited. Hopefully it is not the last.
To determine its area of focus, we solicited proposals from across all sectors of the economy and from all across the country. Industry leaders told us that the biopharmaceutical sector has huge growth potential but needed a venue for the private sector and academia to innovate more boldly and collaborate more broadly together.
Our Department will invest $70 million to create that space at NIIMBL – and our tax dollars will be matched by at least $129 million from private companies, state governments, research universities, and community colleges. While the institutes led by other Departments are limited by their agency’s mission, the Commerce-led institutes focus on taking technologies from lab to market where there is the greatest potential.
Let me explain why this institute is so important. Biologics are significantly more complex to manufacture than traditional drugs, and their manufacturing processes in addition to their products are subject to regulation by the FDA. These regulations are critically important to ensuring that any medical product hitting the market is safe, effective, and consistently high quality.
But this disincentivizes innovation. Making changes and improvements to the manufacturing process requires re-review by the FDA, which is time consuming and expensive. Imagine if Henry Ford was locked into the same production process he used to build the first Model T. We might still be driving Model Ts today!
The institute announced today is a resource that will spread the risks and share the benefits across the industry of developing and gaining approval for innovative processes. For existing products, this opens the door to increasing the speed and flexibility in the manufacturing process. For new products, the innovations created here will make it easier for industry to scale up production and provide the most ground-breaking new therapies to more patients sooner.
This means when we face a public health crisis like a new strain of the flu, we can innovate and produce life-saving solutions more quickly. The ability to take a new formula to scale is particularly important since most biopharmaceutical products have a shortened shelf life, which means we cannot easily stockpile them in anticipation of a crisis.
This institute will also create a venue for industry and academia to find solutions together to the growing skills gap facing the biopharmaceutical sector. Jobs in biopharmaceuticals pay twice as much as the national average. But companies often struggle to find skilled workers to make these next-generation drugs.
NIIMBL will work with community colleges and universities across the country to develop curricula, internships, and faculty sabbaticals that meet the technical demands of biopharmaceutical manufacturers. It will also implement STEM-education programs at the K-12 level to deliver a highly trained and diverse workforce to meet the opportunities in this growing sector of our economy.
By keeping product innovation proprietary to industry while partnering on process innovation and training programs that better prepare our workers, this institute will help ensure the American biopharmaceutical industry remains the world’s leader.
I want to thank Congress for providing the funds for the first institute focused on a high potential technology that was suggested by industry. As a result of our original Department of Commerce solicitation, we have additional prospects that are ready to go if we get funding. I believe these advanced manufacturing institutes are critical to keeping America competitive in the 21st century.
From Samuel Slater’s textile mill to Henry Ford’s Model T to today’s biopharmaceuticals, we are a country that innovates. A country that makes. A country that sells to the world. The National Institute for Innovation in Manufacturing Biopharmaceuticals will join the rest of the Manufacturing USA network in bringing together the best of the public and private sectors to continue that proud tradition and shore up American competitiveness.
The work done here will ensure that “Made in America” remains not just one of the world’s best brands but the hallmark of an innovative, constantly evolving industry that builds lasting careers and stronger communities. Congratulations to the entire team that created and is committed to the vision of this institute. Thank you.