Biotech Startups’ Worst Fears — And How to Stay Ahead

By Jenna Levenson, PhD, RN, MS

Launching a BioTech startup is thrilling. You're building something that could literally change lives. But behind the science and the sizzle lies a set of very real fears that keep founders, sponsors, and clinical teams awake at night.

Let’s talk about them — and more importantly, how to stay ahead.

Fear #1: We’ll run out of money before we generate meaningful data.

Biotech is a capital-intensive game. Burn rates are high, and timelines rarely cooperate. But the biggest mistake isn’t raising too little — it’s raising without a milestone-aligned strategy.

Stay ahead: ✔ Map funding directly to data-driven inflection points ✔ Use grant funding to de-risk early milestones ✔ Don’t just tell a story — quantify the return

Fear #2: We’ll fail to design a trial that delivers.

A poorly designed trial can derail even the most promising program. The fear? Wasting years and millions on an endpoint the FDA doesn’t value or an approach investors don’t believe in.

Stay ahead:

✔ Start with the end in mind — regulatory and market success

✔ Validate feasibility early (real patients, real logistics)

✔ Use expert advisors before the protocol is finalized

Fear #3: We won’t be ready for FDA engagement.

The Pre-IND meeting isn’t a casual check-in — it’s your program’s first impression. And it shows when teams treat it like a checkbox instead of a strategic milestone.

Stay ahead:

✔ Prepare a strong narrative and data integration plan

✔ Ask targeted questions in the Pre-IND briefing

✔ Align your CMC, nonclinical, and clinical story early

Fear #4: We’ll build the wrong team — or wait too long to build it.

You can’t execute a high-stakes development plan with an understaffed or misaligned team. Founders often wait too long to bring in clinical ops, CMC, or regulatory support — and pay for it later.

Stay ahead:

✔ Build a hybrid team that scales with your science

✔ Use specialized consultants and CROs wisely

✔ Don’t hire titles — hire execution

Final Thought: Fear Is a Signal — Not a Stop Sign

If you're feeling the pressure, you're not alone. These fears are valid. But with strategy, clarity, and the right support, they’re also beatable.

Ready to go from fear to forward momentum? Let's Talk