Biotech’s Dirty Secret: AI Won’t Save You—But It Might Kill Your Funding

By Jenna Levenson, PhD, RN, MS

Everyone in biotech is talking about AI.
AI for drug discovery. AI for patient recruitment. AI for protocol design.

And while there is no denying its promise—here’s a reality no one wants to say out loud:

If your startup leads with “AI-powered” but can't explain the clinical or regulatory path behind it, you are not getting funded.

The Hype Is Real. The Risk Is Bigger.

Investors are not just looking for AI.
They are looking for de-risked models that use AI as a tool—not a pitch.

In 2024, dozens of “AI-powered” biotech startups raised funding.
In 2025, VCs are realizing many of them can’t file an IND, cannot validate a signal, and do not know the FDA’s view on their dataset.

What Biotech Founders Are Getting Wrong

1. They lead with tech, not biology.
   → AI is a tool, not a therapeutic

2. They confuse preclinical prediction with clinical validation.
   → Machine learning does not replace meaningful patient data.

3. They overestimate how much the FDA is ready to trust your algorithm.
   → Spoiler: you will still need a clear protocol, endpoints, and safety strategy.

Why Funding Is Drying Up for “AI-First” Biotech

Because investors are asking sharper questions:

• How will you generate real-world data to support this model?

• What does your regulatory roadmap look like?

• Is this AI or just a glorified clustering algorithm?

And if those answers are not ready?
They are not writing checks.

Here Is What Smart Teams Are Doing Instead

• They embed AI within a real clinical strategy—not as the story, but as the engine.

• They build protocols that reflect real-world use cases—patient burden, trial complexity, endpoint clarity.

• They use data to tell a cohesive story—to the FDA, to the PI, and to the board.

And yes, they still say “AI”—but they say it once, with substance, not spin.

Final Thought

AI is not the future of biotech.
It’s a powerful tool in the present—but it only works if your science, regulatory plan, and funding strategy are already sound.

If your pitch is “AI will revolutionize X,” but you haven’t thought through your Phase I trial or target population?

You are not disrupting the system.
You are delaying your next round.

Are you building something real—or just riding the buzz? Let’s Talk.

Or shoot me a message—this is what I help teams fix before they get ghosted by funders and regulators.