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By Jake Cole
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Biotech has entered an era of extraordinary scientific ambition, from highly targeted oncology treatments to advanced gene and cell therapies designed around individual patient needs. In recent months, the BBC has reported the launch of the new cancer therapy Zi-MA4-1, while the FDA announced the approval of new cellular and gene therapy products. Yet behind the scientific momentum is a growing industry concerned that approval does not guarantee adoption, and innovation does not automatically translate into commercial success.
The financial stakes are enormous. According to PhRMA, developing a new medicine can cost more than $2 billion when accounting for research, clinical trials, and the long development timelines required to bring products to patients. Despite those investments, many companies discover that regulatory approval represents the start of a new challenge. Building market demand, educating healthcare providers, and scaling sales organizations often determine whether a therapy reaches its potential.
Recent industry trends have placed greater scrutiny on commercialization. As reported by Pharmaceutical Technology, biotech companies have faced increased pressure from investors to demonstrate sustainable growth after approval, while venture funding has shifted toward organizations that can show stronger operational strategies alongside scientific innovation. As specialty therapies become more complex, commercial infrastructure has become a strategic asset.
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The industry’s traditional narrative has focused on discovery: the breakthrough molecule, the successful trial, the regulatory milestone. However, executives and investors are increasingly examining what happens after those moments. A company can develop a transformative therapy and still struggle if its teams are not prepared to execute the launch, align around strategy, and adapt quickly once the product reaches the market.
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Amy Vie has spent much of her career operating inside those critical moments. A pharmaceutical executive with experience across Johnson & Johnson, Pfizer, Baxter, and Alimera Sciences, Vie has been brought into companies facing performance challenges and tasked with strengthening teams, developing leaders, and creating operating systems designed for long-term growth. Her perspective is rooted in a belief that commercial success is built intentionally, not discovered after a product reaches approval.
Vie believes many organizations underestimate the role execution plays in determining whether a strategy succeeds. She argues that companies often spend significant time developing plans but fail to create the alignment and accountability required to carry those plans into action.
“They have great strategy, they have great whiteboards, they have all that stuff,” Vie says. “But they fail on execution.” She advises having an approach that begins with understanding the people responsible for delivering results. After entering struggling organizations, Vie notes that her first priority is not immediately changing structures or imposing new processes. Instead, she focuses on establishing trust with the teams already in place.
“The first thing is to build trust. I never felt my title made me entitled. I feel like I’m an equal with those who report to me. We’re one big team,” she says, pointing to a leadership style shaped by her early career in healthcare. Vie began as a trauma and neurosurgery nurse before transitioning into pharmaceutical leadership, a background she believes influenced the way she evaluates problems and manages organizations.
“Nursing teaches you cause and effect,” Vie says. “If I do this, something is going to happen. You learn to look at what you’re doing, what you expect to happen, and what you need to watch for.”
She applies that same analytical mindset to commercial organizations. In her view, underperforming teams often share common challenges, including unclear expectations, ineffective structures, and people positioned in roles that do not match their strengths.
Fixing those issues requires leaders willing to have direct conversations and make difficult decisions.
Hiring, she adds, must include that same emphasis on understanding people instead of just evaluating resumes. Vie believes traditional interview methods built around scripted situational questions often reveal rehearsed answers rather than genuine insight into a candidate’s character.
“When I interview, it’s just a conversation. If you can have a conversation with a stranger that lasts an hour and a half and you feel good when you leave, that’s your candidate,” Vie explains.
In her view, the strongest commercial professionals are not defined only by past achievements. She looks for individuals with a persistent desire to continue improving regardless of their current performance level. She points to one representative she hired who later became a consistent top performer, crediting his preparation and commitment as early indicators of success.
The same principle applies to leadership development. Vie believes high-performing employees should be viewed as future organizational leaders, even if they do not immediately seek traditional management roles. Creating those leaders requires trust, responsibility, and opportunities to influence others.
She also challenges companies to rethink how they approach goals. While objectives remain important, Vie believes organizations achieve more when they focus on the systems that make progress possible.
“My father was CEO of a large insurance company, and he always said, ‘Don’t have goals because you’ll miss opportunity,’” Vie says. “Have systems in place, people and processes, and you will achieve more than whatever goal you put in front of you.”
Biotech is entering its next phase of growth, where the competitive landscape may increasingly be determined by what happens outside the laboratory. Scientific breakthroughs will continue to drive the industry forward, but companies will need commercial organizations capable of turning those breakthroughs into meaningful outcomes.
According to Vie, execution determines whether innovation reaches its full potential. “You could have the cure for cancer, but if you can’t execute, it doesn’t matter,” she says.
Biotech’s next chapter will be shaped by how effectively organizations translate scientific progress into real-world adoption. As therapies become more specialized and commercialization becomes more complex, the launch teams, operating systems, and leadership cultures built around a therapy will influence whether scientific breakthroughs achieve their intended impact.
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