From Approval to Adoption: Why Biotech's Greatest Challenge Lies Beyond the Lab
Key Insights
Regulatory approval represents the starting line, not the finish line, for pharmaceutical companies transitioning from development to commercialization, with market success demanding entirely new capabilities beyond scientific rigor.
ARS Pharma's experience launching Neffy (epinephrine nasal spray) reveals that cultural tension between development teams' analytical caution and commercial teams' market responsiveness is the most underestimated risk in the transition.
Industry executive Amy Vie emphasizes that execution—not strategy—determines whether breakthrough therapies reach their full potential, noting that even a cure for cancer fails without proper commercial execution.
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. Yet behind the scientific momentum is a growing industry concern that regulatory 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. As specialty therapies become more complex, commercial infrastructure has become a strategic asset.
The Execution Gap: Where Strategy Meets Reality
Amy Vie, a pharmaceutical executive with experience across Johnson & Johnson, Pfizer, Baxter (search), and Alimera Sciences, has spent much of her career operating inside the critical moments following drug approval. 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. "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."
Culture Clash: The Most Underestimated Commercial Risk
Richard Lowenthal, M.S., MSEL, Cofounder and CEO of ARS Pharmaceuticals, echoes similar themes from his company's firsthand experience transitioning from development to commercialization following the approval of Neffy (epinephrine nasal spray) for emergency treatment of allergic reactions including anaphylaxis (search) in adults and children who weigh 33 lbs. or greater.
"Perhaps the most underestimated challenge in the development-to-commercial transition is cultural," Lowenthal writes. Development teams are trained to question assumptions, demand statistical significance, and move cautiously. Commercial teams operate differently—driven by speed, narrative, and responsiveness to market feedback.
ARS Pharma experienced this tension directly. "Marketing decisions that 'felt right' did not always align with learnings from R&D execution. Commercial urgency sometimes conflicted with analytical caution that was engrained in our company during the development stage," Lowenthal explains. His role as CEO became less about choosing sides and more about forcing clarity: "What did we learn? What data supports this decision? And if it doesn't work, how quickly will we know? And do we need to pivot?"
Launch Preparedness as Strategic Leverage
Lowenthal emphasizes that launch preparation is not just an operational necessity—it is strategic leverage and a value driver. "If you reach approval without a credible path to market, value stagnates. Regulators don't reward inactivity, and neither do investors or potential acquirers," he states.
ARS Pharma evaluated multiple paths as approval approached, including a potential transaction. Yet the company continued preparing for commercialization because leadership understood it had to be a viable path regardless of whether a transaction materialized. "You don't really decide to sell a company; someone decides to buy it," Lowenthal notes. Ultimately, ARS Pharma moved forward with commercialization independently, and Lowenthal's takeaway is clear: "Commercialization must be the default plan. That preparation creates optionality, whether you ultimately partner, transact, or launch independently."
Building Teams for Long-Term Growth
Vie applies an analytical mindset to commercial organizations, observing that underperforming teams often share common challenges: 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.
Her approach to hiring departs from conventional methods. "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. She looks for individuals with a persistent desire to continue improving regardless of their current performance level.
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. "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."
The Real Milestone Is Company Maturity
Lowenthal frames the development-to-commercial evolution as a company maturity test. It changes and intensifies the needs for strategic planning, culture, and governance, forcing leaders to confront whether the company can evolve without losing its core strengths.
"Success at approval does not guarantee success in the market," Lowenthal writes. "The companies that navigate this transition best are not those with the flashiest launches, but those willing to adapt organizationally, culturally, and strategically to the new realities that come with commercialization."
Complexity scales faster than expected. In development, the stakeholder environment is relatively narrow. After launch, it expands immediately—across payers, pharmacy benefit managers, physicians, patients, distributors, and investors, all operating with different incentives. Performance becomes visible in real time, and the CEO's role shifts from driving toward a milestone to managing a dynamic system.
As Vie puts it succinctly: "You could have the cure for cancer, but if you can't execute, it doesn't matter." For an industry built on scientific breakthroughs, the next phase of growth may increasingly be determined by what happens outside the laboratory.