For any biotech company, advancing a drug candidate into late-stage clinical trials marks both progress and pressure. The stakes are higher, the costs increase, and the timelines tighten. For Leen Kawas, scientist, entrepreneur, and co-founder of Propel Bio Partners, late-stage clinical development represents the culmination of years of research and the bridge to potential patient impact. Drawing on her experience as the former chief executive of Athira Pharma, where she led late-stage programs and an initial public offering, Kawas emphasizes that success in this stage requires more than strong science. It demands discipline, strategy, and resilience.
The Transition to Scale
Early-stage research often takes place in laboratories, with small teams exploring mechanisms of action and proof-of-concept studies. Late-stage programs are different. They move beyond initial promise into rigorous, large-scale trials that must satisfy regulators and withstand scrutiny from investors. Leen Kawas explains that this transition is one of the most challenging phases for biotech companies.
The demands of late-stage development test every part of an organization. Manufacturing must scale, clinical protocols must expand across multiple sites, and trial design must align with regulatory requirements. Kawas notes that companies succeed when they plan for this scale early, rather than waiting for late-stage pressures to force rushed decisions.
Balancing Science and Business
Kawas has long argued that late-stage programs sit at the intersection of science and business. On one side, the integrity of the research must remain uncompromised. On the other, companies must manage capital efficiently to ensure trials can be completed. She emphasizes that leaders cannot afford to focus on one dimension at the expense of the other.
At Athira, she oversaw both the scientific direction and the financial strategy. This dual focus allowed the company to progress clinical programs while raising more than $400 million through its IPO. For Kawas, advancing late-stage trials required integrating scientific insight with financial stewardship, ensuring that investors saw both credible science and clear pathways to market.
Regulatory Navigation
No late-stage program can succeed without navigating regulatory complexity. Kawas highlights the importance of early and ongoing communication with regulators to align expectations. Engaging agencies before pivotal trials begin helps avoid costly redesigns later.
She stresses that regulatory frameworks are not obstacles but structures that, when understood, guide companies toward approval. By treating regulators as partners rather than adversaries, companies can reduce uncertainty and accelerate timelines. Leen Kawas believes that proactive engagement builds credibility and demonstrates seriousness of purpose.
Building the Right Team
Late-stage clinical development is too complex for leadership to carry alone. Kawas underscores the necessity of assembling teams with deep expertise in trial design, biostatistics, operations, and regulatory affairs. These professionals bring the technical precision required to manage multi-site, multi-year studies.
She also emphasizes culture. High-pressure environments can strain teams, yet resilience and collaboration are vital to success. Kawas’s leadership style has focused on empowering experts, fostering trust, and ensuring that scientific integrity remains central even under commercial pressures. The right team, she argues, transforms daunting challenges into coordinated execution.
Patient-Centered Perspective
Amid the complexity of late-stage programs, Kawas insists on maintaining a clear focus: patients. Every protocol, every endpoint, every operational decision ultimately leads back to how a therapy will affect human lives. She argues that companies lose direction when they reduce trials to metrics without considering the people behind them.
Patient engagement also strengthens trial design. By listening to patients and incorporating their experiences into endpoints and study structures, companies increase the relevance of results. Kawas sees this as both a moral responsibility and a strategic advantage, as regulators and payers increasingly demand evidence of real-world benefit.
Resilience Through Uncertainty
Late-stage trials carry high failure rates, and setbacks are common. Kawas emphasizes resilience as a defining trait for both leaders and organizations. When data disappoints or timelines shift, the ability to adapt without losing sight of the larger mission determines long-term survival.
She encourages leaders to frame setbacks as learning opportunities. Each trial, whether successful or not, provides insights that inform future approaches. This mindset prevents discouragement from derailing momentum and ensures that the organization continues moving forward. Her interview with Principal Post explores this in further detail.
Looking Ahead
As biotechnology continues to evolve, the demands of late-stage clinical programs will only grow. Rising costs, heightened competition, and increasing scrutiny make this stage more challenging than ever. Yet for Kawas, these pressures also highlight the importance of disciplined, patient-centered leadership.
Her experience shows that advancing late-stage programs requires more than science alone. It requires planning for scale, integrating business and research, building resilient teams, and keeping patients at the center. When executed with care, these programs have the power to translate scientific discovery into therapies that change lives.
Leen Kawas’s career demonstrates that the path from laboratory bench to late-stage clinical success is arduous but achievable. By blending scientific insight with entrepreneurial skill, she has shown that biotech leaders can carry innovations across the threshold where they become not only trials but potential treatments.
To learn more about the work Leen Kawas is doing, check out her profile on Crunchbase.com.