The last few years have shone a light on many issues previously unknown to policymakers, including the vulnerability of our supply chains. Delayed cargo ships, a global pandemic, or national security , have all illustrated the need for America to begin reshoring its manufacturing capacity in all sectors of its economy.
In the health and life sciences sector, this vulnerability remains a vital issue because the United States continues to face critical drug shortages and is heavily reliant on active pharmaceutical ingredients made overseas. The API Innovation Center (APIIC) is not only determined to fix that issue but to also bring jobs and investment back to Missouri.
According to the FDA, an active pharmaceutical ingredient, or API, is “any substance or mixture of substances intended to be used in the manufacture of a drug product and that, when used in the production of a drug, becomes an active ingredient in the drug product.”
APIIC is a nonprofit entity based in St. Louis, dedicated to delivering market-competitive, commercial supply of U.S.-made APIs to strengthen the domestic pharmaceutical supply chain. “APIIC’s long-term goal of reshoring 25 medicines in five years is projected to generate $1.2 billion in economic activity, based on report data, showing that for each generic medication produced, Missouri could reap up to $51 million per molecule over the next 15 years.”
“What I find puzzling was that a country such as the United States became so dependent on foreign nations for important medicines,” stated APIIC’s Founder and Chair Tony Sardella. Sardella, along with other Missouri-based organizations, testified to the House Emerging Issues committee on the subject of Missouri’s role in the national security space and the reshoring of critical manufacturing capacity.
Sardella emphasized that APIIC’s focus is to protect and enhance America’s health security.
“The issue of reliance isn’t just about logistics. A quarter of these medicines come from countries which do not have the same [quality] standards as the U.S. when it comes to the making of these pharmaceuticals.” stated Sardella
Bringing back American pharmaceutical manufacturing does not just mean that it will help with shortage issues but also brings jobs and investment back to the U.S., as well as the Show Me state.
“Making our own medicines is one of the best economic investments we can have,” said Sardella. “The work done by APIIC helps Missouri’s small businesses as well as create jobs and invite investment here to Missouri.”
One study from the Center for Analytics and Business Insights at Washington University stated that APIIC could contribute as much as $1.2 billion in regional economic growth over the next five years through collaborative efforts to drive U.S. manufacturing of APIs used in generic drug manufacturing.
“The COVID-19 pandemic spurred many of the issues we are trying to address here at API Innovation Center,” said Aaron Willard, APIIC’s chief partnership officer. “The three biggest issues we saw were that America is over-reliant on drugs made overseas, that the pharmaceutical industry has an issue with idle manufacturing capacity, and that the drug shortage in America is more of an economic problem.”
Willard joined APIIC in the fall of 2024. He brings roughly 20 years of political experience in the Missouri legislature to APIIC as he served in multiple office roles such as chief of staff in the Missouri Speaker of the House office and later went on to serve Gov. Mike Parson as chief of staff.
His role at APIIC sees him working to develop partnerships between APIIC and others to help enhance U.S.-based pharmaceutical manufacturing, strengthen national health security, and foster economic growth.
APIIC recently secured nearly $10 million from the state of Missouri to drive U.S. health security and economic growth.
With the investment in APIIC by the state, the organization is working with other partners to resolve the current lomustine crisis. As it stands now, there is no U.S. source for lomustine, a vital chemotherapy drug used to treat glioblastoma. Glioblastoma is the most common and deadliest type of brain cancer and has killed over 13,400 Americans according to the National Brain Tumor Society. The current five-year survival rate for glioblastoma is 6.8%.
“Over 50% of U.S. manufacturing spaces are sitting idle,” Sardella told the Times. “The answer is not to deploy capital to build new buildings, but to use different methods.”
To address this issue, APIIC is utilizing the advanced technologies of continuous flow manufacturing. Continuous flow manufacturing is a fully integrated drug manufacturing process that utilizes sequential flow unit operations to produce pharmaceutical APIs and drugs. Some of the benefits associated with this method include a reduction in labor costs, an accelerated time to market and a limit to supply disruptions.
“The state of Missouri’s continued support is a testament to the transformative work being done at APIIC,” said Kevin Webb, chief operating officer of APIIC. “This funding allows us to accelerate our efforts to develop critical APIs in Missouri and bring new advanced manufacturing jobs to the state.”
Taking a data-centric focus, APIIC is working to protect American health security, reshore the nation’s access to key APIs such as lomustine, enhance the nation’s pharmaceutical manufacturing capacity with methods like continuous flow manufacturing, and bring jobs and investment to Missouri.
Jake Kroesen is a Jackson County native and a graduate of the University of Central Missouri. He holds a B.S. in Political Science.
