While AI grabs headlines, regulators are quietly rewriting the rulebook. From diversity action plans to digital compliance, the new regulatory landscape demands attention early. Is your biotech ready for what the FDA and EMA expect in 2025?

In biotech, great science is not enough. Companies that invest in early-phase strategy—diverse protocols, regulatory engagement, and data infrastructure—are the ones winning investor confidence and accelerating timelines. If you are waiting until Phase 2 to get serious, you may already be too late.

Everyone talked about AI revolutionizing clinical trials—but the real challenge is implementation. From site selection to protocol optimization, success now depends on clean data, regulatory alignment, and operational readiness. The future of AI in biotech is no longer about vision—it is about execution.

Discover six essential strategies to run a successful Phase 1 clinical trial—from protocol design and site selection to real-time data monitoring and regulatory alignment. Ideal for biotech leaders, clinical researchers, and startup teams aiming to de-risk early-phase trials and accelerate development timelines.

Clinical research is being squeezed. Funding is drying up, trials are shrinking, and biotech is silent. This article exposes the uncomfortable truths the industry isn’t talking about—and what must happen next.

In today’s volatile biotech landscape, small companies are battling shrinking capital, complex trials, and regulatory uncertainty—all while racing to prove their science. In this article, I break down the five most pressing challenges and offer actionable insights for founders and teams navigating the road from molecule to market.

From funding fatigue to protocol complexity, today’s researchers face major hurdles. Here’s what’s going wrong—and how biotech teams can get ahead.

Looking to secure NIH funding for your biotech venture? Here are the 5 hottest areas of focus in 2025—and how to strategically position your proposal.

Discover what VCs really want from biotech startups and how founders can strategically position themselves for investment success. Plus, tips for building trust, reducing risk, and creating long-term value.

Biotech’s AI buzz is fading—but now comes the real work. Here’s a 90-day action plan to turn hype into operational success.

Biotech is still chasing AI dreams while bleeding cash. It's time to rethink how we integrate AI—with clarity, purpose, and ROI in mind.

Everyone is betting on AI to revolutionize drug development. But what if it's more smoke than substance? Here's what biotech insiders need to know before pouring more money into the hype.

Explore the top challenges facing the biotech industry in 2025 and discover strategic solutions to navigate funding constraints, regulatory shifts, and workforce dynamics.

Biotech startup funding is collapsing under outdated metrics, risk-averse investors, and inflated promises. Here's how to rebuild smarter.

Biotech investors are still chasing crowded, overhyped pipelines—while the real opportunities lie in scalable, underfunded disease areas and trial innovation. This article breaks down where VCs and startups should focus to win funding in today’s clinical development landscape. Stop pitching potential. Start delivering value at scale.

Cancer trials dominate biotech R&D, but are we chasing real cures or inflating a therapeutic bubble? This article breaks down why oncology’s outsized investment may be delivering less impact than we think—and what that means for the future of clinical development.

A provocative look into the bloated oncology clinical trial landscape. Is the industry prioritizing profit over progress—and what does that mean for investors, CROs, and patients?

AI is the hot topic in biotech, but is it really the game-changer everyone claims it is? In this article, I break down why relying solely on AI might put your biotech startup at risk—and how to harness its power without falling for the hype. Ready to learn how AI can work for you? Let’s dive in!

Everyone’s pitching “AI-powered” drug discovery in biotech—but here’s the truth no one wants to say out loud: AI won’t save your startup if you don’t have a real regulatory or data strategy.
In my latest article, I break down why funders are pulling back, and what smart teams are doing differently to stand out in 2025.

Discover the top 5 highest-risk areas in biotech and clinical trials in 2025—from protocol feasibility failures to regulatory landmines with AI and RWD. Learn how leading biotech teams are navigating these challenges with smarter strategy, patient-centered design, and operational resilience.