The 5 Highest-Risk Landmines in Biotech and Clinical Trials Right Now (And What Smart Teams Are Doing to Avoid a Blow-Up)
By Jenna Levenson, PhD, RN, MS
Biotech is booming. Funding is flowing. Innovation is off the charts.
But let’s be honest… beneath the surface?
Risk is everywhere.
From regulatory shifts to feasibility fails, biotech teams are balancing on a high wire—and one misstep could cost you your timeline, your funding, or your next FDA conversation.
If you're in the trenches of clinical development, these aren’t just hypotheticals. These are the pressure points you’re navigating daily.
Let’s talk about the 5 highest-risk areas in biotech and clinical trials in 2025—and what the savviest teams are doing right now to stay ahead.
1. Over-Engineered Protocols That Crash in the Real World
On paper? Perfect.
In practice? Delays, deviations, and dropout disasters.
Smart teams are:
Designing with site and patient burden in mind
Cutting unnecessary endpoints (yes, even the sexy exploratory ones)
Running protocols past real-world investigators before locking them in
If you need a 12-tab Excel to explain your visit schedule, it’s not ready.
2. The Compliance Cliff: AI, Real-World Data & the Regulators
Yes, the FDA wants innovation.
No, that doesn’t mean your AI model or RWD strategy gets a free pass.
Smart teams are:
Documenting data provenance and model validation
Looping regulatory affairs in before they hit “launch” on anything digital
Using FDA pilot programs and advisory meetings to test the waters
No clarity = high risk. Don’t innovate in a vacuum.
3. The Feasibility Mirage: When Your Sites Say Yes... But Can’t Deliver
Site enthusiasm doesn’t equal site execution.
Especially when startup timelines are tight, and the protocol reads like a novel.
Smart teams are:
Vetting site performance historically, not just through interest surveys
Prioritizing relationships overreach (a few great sites > 40 mediocre ones)
Creating site engagement strategies that go beyond the SIV
Site performance can make or break your trial. Plan accordingly.
4. Patient Voice is Still Being Treated Like a Buzzword
The FDA is watching. Investors are watching. And most importantly—patients are watching.
But many teams are still bolting on PROs at the last minute like a garnish.
Smart teams are:
Involving patient advisory boards early
Designing outcomes that matter to patients’ actual lives
Using qualitative data to enhance protocols—not just validate them
Patient-centered ≠ patient-optional.
5. Milestone Madness: When Fundraising Timelines Clash with Trial Reality
VC expectations: “Hit this milestone in 9 months.”
Trial reality: “We just got our IRB letter... and it's a request for 47 clarifications.”
Smart teams are:
Aligning trial design with investor expectations up front
Building in operational buffers (because delays aren’t “if,” they’re “when”)
Communicating transparently about real risks, not just the pitch-deck version
You can’t fund science on vibes alone.
So What Do You Do With All This?
If you’re a clinical lead, biotech founder, or regulatory strategist—start here:
✔️ Re-evaluate your protocol with feasibility, not just endpoints, in mind
✔️ Audit your AI, RWD, and digital tool integration for compliance gaps
✔️ Prioritize meaningful patient involvement from day one
✔️ Use your site data like your funding depends on it—because it probably does
✔️ Don’t just sell the vision—plan for the messiness of reality
Need Help Navigating These Risks?
This is what I do.
At Levenson Consulting, we help biotech teams design fundable, feasible, FDA-aligned clinical programs that don’t fall apart under pressure.
· Check out Let’s Talk About Biotech for tactical guidance
· Grab the FREE Let’s Build BioTech workbook series to operationalize strategy
· Or let’s connect for a quick consult: Talk to Jenna Levenson because the future of biotech isn’t just bold—it’s strategic.
And if you’re not planning for the pitfalls? You’re standing on them.