🌍 PCMG25: Annual Assembly 2025

This case study between Azafaros and Thermo Fisher Clinical Services became a blueprint for what a modern biotech-CRO relationship can look like. What stood out was not just the scientific potential of the trial but the level of transparency and adaptability that both sides demonstrated. The CRO’s willingness to adjust timelines, payment models, and internal processes to fit the biotech’s constraints made a measurable difference in project momentum.

Critically, the teams moved beyond rigid SOPs and embraced a mindset of “what do we need to achieve, and how do we get there together?” Rather than focusing solely on deliverables, the partnership thrived by aligning operational goals with business realities. And the impact was real: study startup timelines were accelerated, regulatory approvals came earlier than expected, and investor confidence was maintained.

One of the most eye-opening presentations came from Ali Pashazadeh, CEO and Founder of Treehil Partners, who offered a striking comparison between the biotech landscape in 1995 and today. Back then, the path to success was clearer: monotherapies, long patent windows, and a steady stream of new therapeutic targets. Fast forward to 2025, and CEOs are expected to navigate everything from biomarker-driven combinations to compressed IP timelines and unpredictable licensing opportunities.

Today’s biotech leaders must also contend with investor skepticism, a cluttered therapeutic landscape, and the burden of holding assets deep into Phase III. What was once a straightforward build-to-license model has become a years-long commitment with shifting commercial benchmarks and rising regulatory complexity. It’s no longer enough to be a scientist with vision—you must also be a strategist, fundraiser, and operator with deep cross-functional awareness.

One of the most sobering discussions focused on the “capabilities gap” afflicting early-stage biotechs. According to Treehill Partners, roughly 70% of companies presenting at major investor meetings are simply not fundable—not because the science is flawed, but because they lack the operational maturity to execute. They don’t have regulatory clarity, robust clinical designs, or teams that inspire confidence in execution.

The takeaway? Great science is no longer enough. Without the infrastructure, talent, and strategy to support execution, these companies will continue to struggle. The industry is facing a bifurcation: healthy companies will find partners and capital, while the rest may never leave the dock. CROs, large pharma, and new “bridge builders” must decide if—and how—they will step in to close this gap.

Important points were made about strengthening the early engagement between aspiring biotechs and their prospective “big pharma” R&D partners and the importance of incorporating future partner feedback early in the operational design and the execution strategy.

One particularly memorable metaphor compared today’s CRO models to eBay—fragmented, inconsistent, and buyer-beware. Each transaction is treated as a standalone event, requiring time-consuming diligence and offering little continuity. What the industry needs is something more like Amazon: a seamless, centralized, end-to-end service where quality, consistency, and accountability are built-in.

This shift requires rethinking not just operational handoffs but also relationship structures. CROs that invest in long-term, full-service models—where sponsor relationships are continuous, data is interoperable, and teams are retained across programs—will gain significant market advantage. The future belongs to CROs that build loyalty, not just revenue.

The Radio Trial, an EU-based decentralized diabetes study, provided a grounded look at how DCTs are actually playing out, as Bart Lagerwaard, professor at University of Utrecht presented. While patients showed a strong preference for hybrid or fully remote trials, the operational complexity of delivering these models was evident. From regulatory inconsistencies to site readiness and patient support, implementing DCTs remains a challenge—but one worth pursuing.

Perhaps most compelling was the nuanced patient feedback: while digital technologies and home visits were appreciated, satisfaction dropped when participant and site burden increased without sufficient support. DCTs require more than tools—they require intentional design, continuous feedback loops, and a rethinking of what support looks like when the site is no longer central.

AI is already transforming how we screen, design, and manage clinical trials—but the infrastructure to support it remains fragmented. Kai Langel, Bert Hartog, Kevin Taylor and Stephen Pyke discussed and showcased real examples, like using voice biomarkers to prescreen Alzheimer’s patients or AI-enabled protocol generation, yet emphasized the limitations: lack of interoperability, regulatory uncertainty, and unclear ownership of data.

Equally important was the discussion on sustainability addressed by Clare Campbell-Cooper. As trials become more global and digital, we must consider not only the carbon footprint of clinical operations but the long-term impact of over-collecting data, duplicating processes, and relying on legacy systems. “You can’t cut your way to net-zero,” one speaker said, “but you can innovate your way there.”

One of the most important but often overlooked sessions addressed diversity, equity, and inclusion (DEI) in clinical research. The central argument was simple: underrepresentation is not just a patient issue—it’s a design flaw. Patients from underserved communities are often excluded by default due to physician bias, language barriers, or a lack of proactive engagement.

We heard multiple examples of patients saying they would have joined a study—if only someone had asked. We also saw the importance of working with community leaders, not just advocacy groups, and embedding cultural sensitivity into recruitment materials and trial design. True DEI isn’t about checklists—it’s about changing how, where, and with whom we engage from the beginning.