Bringing a Breakthrough Rare Disease Therapy to Market with Rapid Speed for Patients 

Launching a first‑in‑class therapy for patients, particularly in rare disease, requires more than strong clinical data. It demands speed, precision and a commercialization strategy built for complexity.  

Precigen’s recent FDA approval and launch of Papzimeos, the first treatment for adults with recurrent respiratory papillomatosis (RRP), offers a clear example of how emerging biopharma organizations can successfully make that transition. 

In a two‑part Pharmaceutical Executive interview series, Helen Sabzevari, President and CEO of Precigen, and Greg Skalicky, President of EVERSANA, shared perspectives on the launch of Papzimeos and what it takes to commercialize a breakthrough therapy efficiently without sacrificing execution quality or flexibility. 

From Breakthrough Science to a New Standard of Care 

Papzimeos represents a paradigm shift for patients with RRP, a rare and chronic condition historically managed through repeated surgeries. As the first and only FDA‑approved therapy designed to address the underlying disease biology, Papzimeos establishes a new standard of care and introduces a non‑surgical treatment option for patients. 

For Precigen, the launch also marked a milestone: the company’s transition to a commercial‑stage biopharmaceutical organization. That shift required a commercialization approach capable of moving quickly while managing the inherent complexity of a rare disease launch. 

“By leveraging an external commercialization partner, we were able to accelerate time to market, reduce fixed costs, and maintain strategic flexibility, while ensuring high‑quality execution,” said Helen Sabzevari, President and CEO, Precigen. 

Read Helen’s full interview.  

Speed, Integration, and Execution at Scale 

Rare disease launches compress timelines while expanding operational demands. In Papzimeos, that meant aligning market access, medical affairs, field teams, patient services, and operations under a single, coordinated plan—before approval. 

According to Skalicky, success depended on integration, not coordination. 

“Integration beats coordination,” he explained. “When core launch capabilities operate on a single plan with shared KPIs, teams gain speed and eliminate the handoffs that typically slow rare‑disease launches.” 

Working under an accelerated timeline, the joint team built and executed more than 300 integrated workstreams in under a year, enabling Precigen to launch efficiently while maintaining rigorous standards for access, education, and patient support. 

Read Greg’s full interview. 

A Repeatable Commercialization Model 

For Precigen, the Papzimeos launch validated a model built on disciplined execution, capital efficiency, and partnership. 

“Bringing Papzimeos to market efficiently was an important proof point for Precigen,” Sabzevari noted. “It demonstrated our ability to execute across the full value chain without losing momentum.” 

For other emerging biopharma companies, a critical lesson is clear: commercialization models should match organizational reality. Integrated approaches can reduce risk, improve time‑to‑market, and create a foundation for long‑term growth, especially when resources are focused and stakes are high. 

Supporting Commercialization from Strategy Through Scale 

At EVERSANA, we support emerging and established life sciences companies with integrated commercialization solutions designed to accelerate access while maintaining efficiency and executional rigor—from launch planning and market access to field engagement and ongoing lifecycle support. 

Learn more about EVERSANA COMPLETE Commercialization®