Biotech teams, take note—these are the 3 FDA pain points you don’t want to learn the hard way.
If your IND is on the horizon, this might save you months of delays, rework, or worse... a clinical hold.

I’ve worked with teams at every stage of drug development, and these issues come up again and again. Let’s talk about what the FDA wishes you knew before you hit submit.

If you're counting on NIH funding to launch or scale your biotech program, pay attention. The rules are changing—and those who align early will be the ones who lead tomorrow's breakthroughs.

Biotech has always been one of the most exciting—and most volatile—investment spaces.
The potential for life-changing breakthroughs sits side-by-side with the harsh realities of regulatory hurdles, scientific risk, and operational complexity.

Image from: rr finance

We’ve all seen the headlines:
“AI is revolutionizing drug development.”
“Machine learning will accelerate clinical trials.”
But here’s the real question biotech teams should be asking:
Are we building with AI—or just marketing with it?

In the world of biotech, there are few decisions more critical—or more misunderstood—than choosing and budgeting for a Contract Research Organization (CRO). On the surface, it may seem straightforward: compare quotes, pick the most cost-effective option, and move forward.

But here’s the truth no one wants to admit…

Everyone talks about endpoints, but the FDA is listening for something else entirely. If your trial doesn’t include this, you’re already behind.

The next 2–3 years promise big changes—and big potential—for preclinical contract research organizations (CROs). As the industry evolves, CROs are being called to do more than just deliver services. Sponsors now want innovation, speed, strategic collaboration, and a tech-forward mindset.

Whether you're leading a CRO or partnering with one, here’s what to watch for—and how CROs can adapt to stay competitive and valuable in a fast-moving environment.

The research outsourcing landscape is evolving faster than ever-driven by innovation, global shifts, and increasing pressure to bring therapies to market faster. For sponsors, staying ahead means more than just choosing the right partner. It means strategically aligning with a future that prioritizes agility, specialization, and smart technology.

So what’s happening now—and where is it all headed in the next 3–5 years?

Selecting the right preclinical Contract Research Organization (CRO) is a pivotal decision for sponsors in the drug development process. The right partner can significantly influence the trajectory of a project, impacting timelines, budgets, and ultimate success. In this blog post, we will explore the key factors sponsors prioritize when selecting a preclinical CRO partner, with a particular focus on the importance of alignment with therapeutic areas and regulatory aspects.

You see the IRB submission, but I see the iceberg under the surface.

And that iceberg…
It’s what’s silently sinking your timeline.