Biotech on the Brink: The Toughest Challenges Facing Small Companies
By Jenna Levenson, PhD, RN, MS
1. Capital is Scarce—Especially for First-Timers
Venture capital is rightfully cautious while public markets are punishing. Big pharma partnerships now require de-risked assets and bulletproof data packages. Early-stage founders are learning that raising money today means having a clinical strategy and a commercialization story from day one.
What to do: Build investor-ready narratives that link your science to unmet needs, clinical value, and commercial potential. Know your data, and know how to pitch it.
2. Regulatory is No Longer Just a Box to Check
The FDA is demanding more transparency—especially around AI/ML, decentralized trials, and real-world evidence. For small teams without in-house regulatory depth, it's easy to lose time or make costly missteps.
What to do: Bring regulatory strategy into the fold early. This applies not just for the IND or IDE—but to de-risk your trial design, endpoints, and market access down the line.
3. Trial Complexity is Crushing Timelines and Budgets
Even with a strong molecule, many startups falter in trial execution. Site selection delays, protocol amendments, enrollment struggles, and inconsistent data capture derail progress—especially when there is no room for error.
What to do: Prioritize operational clarity. Invest in trial readiness checklists, predictive analytics for site performance, and real-time data monitoring. Don’t let a good product get buried in a bad trial.
4. AI Is a Double-Edged Sword
Everyone is racing to integrate AI—from target ID to patient stratification. However, few small biotechs have the internal expertise to vet vendors, validate models, or ensure regulatory alignment. The risk? Overhype, underdelivery, financial landmines.
What to do: Treat AI like any other clinical tool: validate it, document it, and align it with your strategic goals.
5. Scientific Isolation is a Silent Killer
Many small biotechs operate in silos—overprotective of IP, under-engaged with broader networks. This results in missed opportunities for collaboration, co-development, and early validation.
What to do: Show up to conferences, focus on joint publications, and pre-competitive partnerships which can amplify your reach and accelerate your science.
Biotech has never been for the faint of heart—but today’s environment demands more than passion and great science. It demands strategic clarity, operational excellence, and adaptive leadership.
I help early-stage biotech teams align strategy, research, and execution—so their science can see the light of day. If you are navigating one of these challenges, Let's Talk.
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