After the Win, Before the Wave

Entrepreneur

16 hours ago

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When Luca Emili stepped off the stage at The AI Summit London, clutching the event's top innovation prize, it wasn't just a moment of recognition - it was a quiet inflection point. For InSilicoTrials Technologies, the win marked more than validation; it signalled a shift in how the future of drug development might be written - not in wet labs or waiting rooms, but in algorithms, simulations, and code. "Winning The AI Summit London Package was a meaningful milestone for us. It confirmed the strength of the technology we have developed and validated the mission we are committed to."
That mission? To embed safe, scalable, and regulatory-ready AI into the heart of clinical trials. Not as an optional extra, not in a decade's time - but now. "Our goal is to bring safe, scalable, and regulatory-ready AI into the core of drug development. The exposure we gained through this recognition is already opening new doors." InSilicoTrials has been developing regulatory-grade simulation platforms - once considered bleeding-edge science fiction - into practical tools now used by pharma leaders and regulators. But Emili is quick to point out: this isn't about chasing trends. It's about being ahead of them.
"This recognition also arrived at a very timely moment. The FDA recently launched Elsa, their first agency-wide AI platform. It is a strong signal that computational methods and artificial intelligence are now central to regulatory science." Where others are racing to adapt to Elsa, Emili's clients have already been using similar tools. "While many in the industry are just starting to react to this development, our clients have been preparing for it for years. They have used our platform to build submissions that are already aligned with what regulators like the FDA are starting to expect."
In other words, InSilicoTrials didn't pivot to AI and regulation - they built for it from day one. "They are generating transparent, validated, and machine-readable outputs that speak the same computational language as these new AI-enabled review systems." The message is clear: the future isn't catching up to InSilicoTrials. InSilicoTrials is helping shape it. "For us, winning this package was more than an award. It was a signal that the work we have been doing is now fully aligned with where the future of drug development is headed. We are not adjusting to this shift. We have helped lead it."
And the momentum is building. "Now, with greater visibility and momentum, we are ready to accelerate our impact even further." The AI Summit London wasn't just a trophy moment. It was a rare, public-facing moment of proof - an opportunity to demystify a deeply technical domain in front of investors, innovators, and the broader AI community. "Presenting our technology at The AI Summit London gave us an exceptional opportunity to engage with a wide range of stakeholders. These included investors who understand the long-term vision required in deep tech and AI innovators looking for practical impact. It also gave us a chance to demonstrate that regulatory-grade simulation is no longer a concept for the future. It is already operational, and it is actively influencing how clinical trials are being designed and optimised today."
But behind the technical elegance of Emili's platform is a hard-earned lesson about building in one of the world's most regulated - and risk-averse- sectors."One of the most difficult aspects has been managing the balance between rapid innovation and the cautious pace of regulatory acceptance. In healthcare, especially when working with something as novel as AI-driven simulation, speed alone is not enough." Instead, Emili has focused on building trust through credibility and transparency - both in the product and the ecosystem surrounding it. "This is precisely why I chose to launch and then co-edit Toward Good Simulation Practice, an open-access book published by Springer Nature that since March 2024 has been distributed in more than 44,000 copies. This project was the result of a global collaboration that included experts from the FDA, the Avicenna Alliance, and the VPH Institute. It establishes clear best practices for how modeling and simulation should be used in regulatory decision-making." This dual mission - building the tools and the standards that validate them - sets InSilicoTrials apart. Emili's vision is not just to innovate within the system, but to help mature it. "Our goal was not only to innovate but also to actively contribute to the creation of the standards that will help this innovation mature and gain widespread acceptance."
And how did they find product-market fit in such a complex space? Not by guessing, but by building alongside the people who would use the tools. "We reached product-market fit by staying very close to the needs of those who would eventually use our platform. Rather than developing in isolation, we collaborated from the beginning with researchers, clinicians, and regulatory teams. We focused on building technology that integrates easily into existing workflows and enhances decision-making without disrupting what is already in place."
For other founders entering the tricky terrain of health tech and AI, Emili offers a sober but inspiring roadmap. "The most important advice I can give is to focus on building trust. In health tech, having a powerful algorithm or a sophisticated platform is only part of the equation. You need to make your work explainable and verifiable. It is also critical to build a team that understands both the science and the healthcare system. This is a multidisciplinary industry that demands depth in many areas."
And perhaps most importantly, grit. "Be ready to commit for the long term. The path is complex, but the potential to create meaningful change in patient outcomes and healthcare efficiency makes the effort more than worthwhile." In a world chasing AI hype cycles, Emili and InSilicoTrials stand as something different: a company that's not just riding the wave, but laying the tracks beneath it.