“We’re not trying to be everything for everyone. Our specialized focus has been very exciting for me.”
Franco Negron, CEO of Simtra BioPharma Solutions, has transformed a 65-year sterile manufacturing legacy into an independent CDMO since the company’s carve-out from Baxter International (Baxter) in October 2023. Franco has led over $500 million in capital investments to double capacity and create mirrored capabilities across sites in Indiana, US and Halle/Westfalen, Germany.
Franco brings industry experience from Procter & Gamble, Johnson & Johnson, Novartis, and Patheon, which became part of Thermo Fisher Scientific, where he helped shape integrated CDMO strategies.
In this PharmaSource podcast, Franco explains how Simtra is navigating supply chain challenges, tariff uncertainties, and injectable manufacturing complexity, from GLP-1s to antibody drug conjugates.
Managing Tariffs and Supply Chain Risk
The business that is now Simtra separated from Baxter in October 2023. This gave the new company agility, faster decision-making, and the ability to make focused investments in sterile liquid manufacturing.
Simtra operates manufacturing sites in both the United States and Germany. “By having capacity both in the US and in Europe, Simtra is in a unique situation to help customers with a regional focus,” Franco notes. The company’s dual-site strategy addresses tariff exposure, supply chain continuity, and regulatory requirements for local manufacturing.
By 2027, both locations will offer high-potency antibody drug conjugate capabilities, pre-filled syringe production, and standard injectable manufacturing. “Redundancy in your supply chain is important,” Franco emphasizes. “When you think about global products that are important for our customers, having that redundancy is a win-win.”
Specializing in Injectables
Injectable drug products present unique manufacturing challenges requiring dedicated expertise and uncompromising quality standards.
“The reason why there’s a strong market and demand for injectables is that it’s not an easy business,” Franco says. “Many things can go wrong, so you have to be very dedicated and focused with tremendous expertise to do millions of doses right, time after time.”
The company handles emerging therapeutic areas including GLP-1 weight loss drugs, cancer treatments with antibody drug conjugates, and novel vaccines. “What a fabulous time for cancer patients, where technology is coming together to make cancer treatment more effective,” Franco observes.
Simtra’s CDMO model requires operational flexibility that internal manufacturing may not need. “We might run six, seven, or eight products on our lines,” Franco explains. “That specialization of being very good at running multiple products without creating any supply chain interruptions or quality issues is where CDMOs thrive.”
Customer Experience and Workforce Development
Simtra is applying artificial intelligence across operations, with priorities that differ from typical cost-reduction narratives.
“The main priorities are enabling the company to build better products at a faster pace, strengthening the way customers work with us, and ensuring our decisions support long-term success,” Franco says.
The company uses AI to accelerate proposal development, improve product development timelines, and enhance supply chain responsiveness. Another key application focuses on workforce development. “In order to have the best workforce, you need to train them the best you can,” Franco notes. “We’re using AI on our training systems to enable our workforce to be the best in the industry.”
Purpose-Driven Operations
Franco repeatedly emphasizes purpose, ensuring every employee understands that their work directly affects patient lives.
“At the heart, we make important products that save people’s lives and enhance people’s life,” he says. “We’re committed to the highest quality, and therefore we will never compromise our commitment to quality and compliance.”
Franco defines success not primarily through financial metrics but through how communities, customers, and employees perceive the company.
“In five years, our communities will look at our sites and say they’re unique in the sense of how we support them,” he explains. “Our customers will talk about Simtra without hesitation as the best supplier they have in their portfolio.”
Strategic Partnerships Combine Complementary Strengths
Simtra recently announced a partnership with Merck KGaA focused on accelerating antibody drug conjugate development and manufacturing.
“That partnership comes from both companies’ passion to bring ADCs to the market faster because we have that common passion for the patients,” Franco explains. “When you combine two companies that bring the best of the best, you can rest assured that customers will see that benefit.”
Franco expects Simtra to announce additional strategic partnerships in coming months.
Sustainability as Operational Philosophy
Simtra issued its first sustainability report in 2024, framing environmental responsibility as deeper than regulatory compliance.
“It’s driven by doing what is right,” Franco says. “It’s part of our purpose and our values.”
The company focuses on energy consumption reduction, water efficiency, and waste minimization. Beyond operational efficiency, Simtra engages in community environmental initiatives, from tree planting programs to supporting schools teaching environmental responsibility.
The Five-Year Vision
When asked to define success five years from now, Franco centers on relationships and reputation rather than revenue targets.
“Our customers will say that Simtra really understands what we need,” he envisions. “We have been noticed for using technology to enable customer experience. Our workforce is recognized for always doing what is right.”
The confidence stems from what the team has accomplished in two years as an independent company: major capacity investments, capability expansion, strategic partnerships, and sustained customer trust. “After two years, I feel very encouraged,” Franco says. “The trust that customers are putting in us, and the support has been incredible.”
