Biotech has never lacked scientific innovation. What the industry continues to underestimate is how difficult it is to turn promising science into an actual therapy that reaches patients.
Over the last several years, I have seen strong assets struggle for reasons that had little to do with the investigational drug mechanism, safety, or efficacy. Companies run into manufacturing issues too late. Clinical programs are not designed with commercialization in mind. Regulatory strategy becomes reactive instead of proactive. Trial execution slows timelines. CapEx is expanding unchecked and capital disappears before meaningful milestones are reached.
None of those problems are scientific. They are operational.
For a long time, biotech rewarded scientific novelty first and execution second. That worked in a market where capital was abundant and timelines were more forgiving. Today, the environment looks very different.
Smaller biotech companies are under pressure to operate more efficiently, prioritize clearer regulatory paths, and prove they can execute against near-term milestones. Between 2021 and 2024, the biotech sector experienced a significant market pullback, particularly among small and mid-sized companies. Investors are paying much closer attention to operational risk than they were five years ago.
That shift is healthy for the industry.
One of the biggest misconceptions in biotech is that good clinical data alone creates a successful product. It does not.
A therapy can meet endpoints and still fail because the company underestimated what happens after the data readout. Physicians may view the treatment as too difficult to administer. Patients may struggle with adherence. Manufacturing may not scale efficiently. Payers may not see enough differentiation to justify reimbursement.
Those considerations are often treated as late-stage commercialization questions. In reality, they should shape development strategy from the beginning.
This becomes even more important in diseases with significant unmet need.
Chronic Hepatitis D illustrates this challenge well. Considered the most severe form of viral hepatitis, it remains without an FDA-approved therapy in the United States, leaving patients waiting for treatment options. The scientific challenge is significant, but so is the practical one: can a company realistically develop, manufacture, position, and deliver a therapy that is convenient and efficient enough to reach the people who need it?
Answering that question requires much more than strong science.
It requires companies to think carefully about clinical design, regulatory alignment, physician adoption, supply chain readiness, pricing strategy, convenient product profile and long-term scalability much earlier in the process than many biotech teams historically have.
This is also changing how experienced investors evaluate opportunities.
Scientific innovation still matters enormously, but operational capability increasingly determines which assets move forward successfully. Investors want management teams that understand the full lifecycle of development, not just how to raise capital around promising data.
That includes:
- regulatory execution,
- manufacturing readiness,
- commercialization planning,
- capital discipline,
- and the ability to make difficult strategic decisions early.
The companies that consistently succeed are usually not the ones doing the most innovative science. They are the ones removing the most execution risk.
Another important shift is the growing collaboration between biotech companies and major academic institutions. Academic research continues to drive some of the most important discoveries in medicine, but discovery alone does not move therapies through regulatory approval and commercialization.
This is one reason collaborations between biotechnology companies and leading academic institutions have become increasingly valuable. Scientific expertise paired with strong operational infrastructure can create a clearer path from discovery to patient impact.
Biotech will continue to generate breakthrough science. I do not think innovation is the industry’s core problem. Execution is.
The companies that will define the next decade of biotech won’t just be the ones with the most compelling science. They will be the ones that can consistently translate that science into approved, accessible, commercially viable therapies. Biotech today faces a gap between discovery and delivery. Breakthroughs are increasingly common; successful execution is not. The next generation of leaders will be defined not just by what they discover, but by how well they deliver.
Author Bio
Leen Kawas is a biotechnology executive and investor with deep experience in drug development, commercialization, and capital markets. She is CEO and CFO of EIT Pharma, leading the development of late‑stage antiviral therapies for chronic hepatitis D and acute respiratory infections. She is also the co-founder and Managing General Partner of Propel Bio Partners, a biotech‑focused investment firm.
Kawas previously co‑founded and led Athira Pharma, guiding the company from early research through IPO and advanced clinical development. She holds a PhD in Pharmaceutical Sciences, a Pharmacy degree, and has completed executive education at Wharton and the University of Washington.
