The #1 Issue Plaguing Biotech Startups Today
By Jenna Levenson, PhD, RN, MS
Let’s cut to the chase: the biggest problem in biotech right now isn’t funding.
It’s not recruitment.
It’s not even the FDA.
It’s brilliant science with no strategy to back it up.
Science Without Strategy Is Sinking Startups
I constantly see founders sitting on incredible data — novel platforms, rare disease targets, even positive early-stage results — but their development plan reads like a scientific journal, not an executable roadmap.
The result?
VCs walk away.
CROs can’t scope the project.
The FDA has more questions than answers.
Biotech Is Not Just Science. It Is Execution.
The science is table stakes. What sets great biotech companies apart is their ability to connect that science to:
A clear regulatory strategy
A milestone-driven capital plan
A trial design that delivers real, decision-making data
And a team that can pull it off
Without this alignment, the most promising molecule will stall — not because it does not work, but because no one’s sure how to get it to market.
What You Can Do Right Now
If you are leading a biotech startup, ask yourself:
Does your strategy answer investor, FDA, and clinical stakeholder questions before they’re asked?
Are your milestones mapped to value — not just time?
Is your team built to execute, or still stuck in “academic mode”?
Final Thought: No Plan, No Progress
Biotech is full of smart people. But the companies that win do not just have smart science — they have strategic clarity. That is the edge.
That’s why I built the Let’s Build Biotech™ workbook series — to help founders move from idea to IND with clarity, alignment, and speed.
Because if your science is ready, your strategy better be too.
📘 Explore the workbook series