Tony Sardella: Expanding Olin’s network of health innovation

In one sense, Tony Sardella’s current role leading a public-private partnership to remake Missouri’s drug manufacturing industry might seem like a detour.

The WashU Olin adjunct lecturer and senior advisor to the Center for Analytics and Business Insights (CABI) has made a career using advanced machine learning technology to analyze public emotions and perceptions and provide meaningful insights to companies and institutions. It’s what he teaches students in Olin’s master’s programs: How to support strategic decision-making by tapping into websites and social media to analyze vast amounts of data and uncover the public’s concerns and fears.

Sardella said that emphasis on public emotion led him to his current project: the API Innovation Center (APIIC). The center aims to reshore production of advanced pharmaceutical ingredients (APIs,­­­ the active components of medications), back to the United States — specifically to Missouri.

“As I was researching the landscape of material societal issues that we would face, one that came to the forefront was people’s concerns about our drug supply chain and shortages,” Sardella said. “I decided to point my research into that area and really start reviewing and analyzing it.”

The result is APIIC, and its five-year goal to bring production of 25 generic medications to Missouri, with an estimated economic impact of $1.2 billion. Further on, that impact could expand to 350 medicines and $17.85 billion, according to a CABI analysis. This development reverses a long decline in U.S. drug manufacturing that has led to shortages of critical medications, including antibiotics, antivirals, blood pressure pills, and steroids.

Now, Olin is tapping Sardella’s expertise in building partnerships to solve real-world problems as part of the school’s Business of Health initiative. As a Distinguished Fellow for Health Innovation, Sardella will assist in the university’s efforts to commercialize health innovations by working with industry and other vital stakeholders.

Tony has already been an amazing partner to us as we think through how our catalyzing of innovation is going to manifest at Olin.

—Dean Mike Mazzeo

The data trail from Monsanto to Olin to APIIC

Sardella, a native of Canada, got his start in toxicology, working for Monsanto Canada. He later moved to the company’s St. Louis headquarters and turned his focus to data analytics, helping his employer understand the public emotions and perceptions of Monsanto’s genetically modified seeds and other inventions. Sardella said that for many innovative companies, success depends less on the product’s merits than on what customers, consumers, and society believe about the innovation — particularly how they perceive its risks.

“In some cases, it can create quite a bit of concern and fear, as in our case, our discoveries around genetic modifications for crops.”

Eventually, he left Monsanto to start his own data science company, using AI and machine learning to analyze data including social media, comments, and reviews on retail sites and provide insights for clients that included major global companies in the Fortune 100.  

“Our efforts were focused on understanding concerns and fears that we’re facing in society at large that would impact a company’s ability to commercialize their innovations and their technologies or their products,” he said. “All of this can inform a company’s strategies: Am I really resonating with my products? Is my company position consistent with value shifts?”

For the past 18 years, he’s taught at WashU Olin, helping students understand how to leverage advanced technology to inform corporate strategy.  He teaches them how to find the right datasets — trustworthy, relevant, and representative of the audience a company is trying to reach. And how to use the power of machine learning not just to analyze emotion, but to predict what events might flow from it.

Over time, Sardella’s research into public emotion began to reveal problems in a specific area — U.S. drug distribution issues.

“We started understanding risks, such as supply chain risks for drugs and medical supplies, and what it meant to people,” he said. “People started experiencing significant shortages and they expressed great concern. So, our research started focusing on what is the risk? How bad is this risk? How is the industry structured?”

What he found was troubling. His 2021 study of pharmaceutical infrastructure showed that 83 of the top 100 generic medications consumed in the United States had no domestic producer for their APIs — a situation that left the United States vulnerable to shortages caused by weather, geopolitics, or other disruptions. The breadth and complexity of the problem prompted Sardella to move beyond studying the problem to working to solve it.

“It became abundantly clear why we were experiencing shortages,” he said during congressional expert testimony on the topic. “It’s an economic issue, not a supply issue. We started determining what would be the right economic model to foster manufacturing and having a U.S. industrial base to manufacture medicines.”

Invest — contract — partner

That model invests in innovative manufacturing processes, then partners with government and private industry to create production capacity for new APIs. To build it, the API Innovation Center started with Missouri’s strong drug manufacturing base; the state already ranked first in the United States for the number of API manufacturers of essential medicines.

Sardella also drew on existing relationships with government and business organizations, including those in the pharma industry (he chaired the Olin Brookings Commission project to detect and prevent illegal opioid diversions).

Now, in addition to his teaching work, he frequently travels to D.C. to meet with government agencies. “I share research findings, assist with understanding the underlying issues, and provide updates on APIIC efforts — what is working and what we are learning.”

In less than three years, the center has helped establish St. Louis as a hub for reshoring U.S. drug manufacturing. Six APIs are currently in development, representing a regional economic impact of $306 million. Among them is lomustine, a crucial chemotherapy drug for the most common and deadly type of brain cancer. In December, APIIC announced new contracts with a local manufacturer for two additional APIs.

“It’s a long ramp to solve it, because it took over 30 years for our manufacturing to leave the country and move to other regions,” Sardella said. “We have a 10-year-plan to bring back the production we require to have a stable, resilient, strong supply chain.”

The effort also has gotten a boost from the federal government — a $14 million grant from the U.S. Department of Health and Human Services. Sardella believes this support and cooperation will continue on the federal level, regardless of changes in administration.

“Both the Trump and Biden administrations had policy positions that we need to produce more of our medicines here in the United States, that our system is very fragile and very vulnerable.” In particular, he said, Donald Trump’s promised tariffs on Chinese goods could make foreign generics more expensive, providing an even greater opening for domestic competitiveness.

A new challenge with the Business of Health

Sardella’s success at bringing together stakeholders and leveraging innovation is a valuable skill set as Olin launches its Business of Health initiative.

One major goal of the fellowship hinges on fostering relationships with leading industry and health organizations to help shepherd great ideas from university innovators to the market. Sardella will also be responsible for facilitating research opportunities between Olin and WashU Medicine.

He’ll serve as a mentor on matters of intellectual property, the regulatory approval process, and go-to-market strategy. And he’ll continue to work with government entities, advocate for Olin in policy discussions, and publish research to support Olin’s health and innovation goals.

Meanwhile, after 17 years, Sardella recently sold his AI company to focus on solving the drug supply problem. He sees a growing role for Olin and WashU as APIIC grows, particularly in helping to determine how advanced manufacturing processes affect the pricing model for drugs.

“We’re embarking on some additional collaborations and research,” he said. “We need to understand pricing and costs before we commence a project. We’ll partner with the university, do research across schools and within the business school so we know which molecules or drug products will be economically viable and at what price we can produce them.”