Romain Clément Interview: Building ArcaScience to Solve Healthcare’s Biggest R&D Challenge

The pharmaceutical industry faces a sobering reality: 90% of drug candidates fail to reach market, with successful drugs costing an average of $2.3 billion and taking over a decade to develop. For most entrepreneurs, these statistics might represent an insurmountable challenge. For Romain Clément, they became the foundation of his mission.

As co-founder and CEO of ArcaScience, Clément is tackling one of healthcare’s most persistent problems through artificial intelligence. His Paris-based healthtech company has developed a platform that integrates over 100 billion biomedical data points to deliver instant benefit-risk analyses for drug candidates—transforming evaluations that traditionally take 18 months into processes completed in seconds.

But Clément’s journey to revolutionizing pharmaceutical R&D began in an unexpected place: as a patient. Diagnosed with brain cancer, he experienced firsthand the inefficiencies that plague drug development and treatment personalization. That personal encounter with healthcare’s limitations sparked the vision that would become ArcaScience.

Today, the company partners with pharmaceutical giants like Sanofi and major clinical research organizations like ICON, helping them navigate the complex landscape of drug safety and efficacy assessments. With 70,000+ patients already benefiting from treatments evaluated through their platform and a 350% revenue increase in 2024 alone, ArcaScience is positioned to capture a significant share of the $13 billion drug safety evaluation market.

In this interview, Clément shares the story behind ArcaScience’s rapid growth, explains how AI is transforming pharmaceutical decision-making, and reveals his ambitious plans to expand across the UK and US markets while launching patient-facing tools.

Let’s start at the beginning—what inspired the creation of ArcaScience, and what problem were you determined to solve in the healthtech space?

Romain: ArcaScience was born out of a personal experience. I was diagnosed with a brain cancer, and experience firsthand the healthcare industries inefficiencies in designing tailored treatments for individual patients. I took stake of just how vast and numerous the blind spots are, in how pharmaceutical companies evaluate the benefit-risk profile of new drugs. It takes 10+ years to bring a drug to market. There is a 90% fail rate and the average cost per drug that makes it to the market is $2.3bn! As a business, it’s terrible and if it weren’t for the meaning behind it – saving lifes, improving life and healthspan – no one would be in this industry!
The main reasons for this lies in the lack of efficacy and safety issues. 

That’s were ArcaScience comes into play.  We created ArcaScience to unlock the full spectrum of biomedical knowledge using AI, giving teams the clarity they need to develop safer, more effective treatments faster.

Despite major scientific advances, too many life-changing therapies fail to reach patients—not because they don’t work, but because decision-makers don’t have structured, comprehensive insight to assess them properly. We want to change that.

ArcaScience is positioned at the intersection of artificial intelligence and biomedical knowledge. How would you describe your core mission and the impact you aim to have on the pharmaceutical and clinical research ecosystem?

Romain: Our vision is to build an industry standardwide tech that allows for every strategic pharmaceutical decision to be based on a benefit-risk evaluation.

Our mission is to transform how biomedical knowledge is accessed and used, by turning unstructured data into actionable benefit-risk intelligence. A staggering 90% of the data that do not make it into the benefit-risk evaluation! We empower every stakeholder in the drug development process, from R&D to pharmacovigilance to patient advocacy, with clear, evidence-based insights. In a landscape where every day matters for patients, our impact lies in enabling faster decisions,more successful  trials, and ultimately, safer drugs.

Can you walk us through how ArcaScience’s technology works—especially in terms of how it leverages AI to transform benefit-risk assessments in drug development?

Romain: ArcaScience is the first AI solution to produce instant drug’s benefit-risk analysis

We’ve built a proprietary platform powered by several specialized AI models trained on 100 billion data points—from clinical studies to real-world patient data. These models structure and contextualize vast biomedical knowledge, surfacing critical benefit-risk patterns that are typically buried in silos. What used to take months of manual review can now be analyzed in days, supporting teams with faster, more confident decision-making.

You’ve already partnered with major players like Sanofi and ICON. What has been key to gaining traction so quickly in such a complex and competitive field?

Romain: First, the need is urgent. Pharma leaders know that benefit-risk clarity is no longer optional—it’s fundamental to clinical success and regulatory approval. Second, our tech is validated. From being selected by the French government during COVID-19 to helping optimize drug pipelines at global pharma companies, we’ve proven that our platform delivers. 

Finally, we’ve stayed laser-focused on one thing: transforming decision-making through structured knowledge. That focus has made us credible and dependable. Take our partnership with Sanofi, for instance. It has been game-changing for them. Thanks to our tech, they successfully achieved a benefit-risk drill-down prediction based on 9 times more insights coming from internal and external sources. This had a massive impact on their bottom line,  which were re-routed to other R&D projects, and the benefit-risk assessment took seconds, instead of an average 18months.  

ArcaScience Solution is poised to be deployed across all of ICON’s client in the coming 3 years as a new, trustworthy, regulatory-optimized standard.

From your earliest proof of concept to today’s live deployments, how has the company evolved, and what growth milestones are you most proud of so far?

Romain: We’ve grown from a concept to a platform used by over 70,000 patients and 10+ pharma leaders. In 2024 alone, we saw a 350% revenue increase, and we’re on track for another 300% this year. But beyond the numbers, we’re proud of having a measurable clinical impact—bringing safer drugs to patients and supporting teams who can now run better-informed trials.

The global drug safety and benefit-risk evaluation market is projected to reach nearly $13 billion. Where do you see ArcaScience positioned within that ecosystem over the next 2–3 years?

Romain: We aim to be the go-to partner for any organisation making high-stakes decisions about drug safety and efficacy. That includes pharmaceutical giants, CROs, regulatory bodies, and increasingly, patients themselves. As the market moves toward AI adoption, our goal is to play a central role in setting the standard for how benefit-risk evaluations are performed.

What are your next big product or geographic goals? Are you expanding further into specific therapeutic areas, or prioritising certain markets like the US or UK?

Romain: We have our eyes on the UK and US—two markets where regulatory and R&D complexity is high, and where our solution can make the biggest difference. On the product side, we’re launching our first patient-facing tool, with a focus on pediatric brain cancer and dermatological diseases. It’s part of a broader vision to empower patients directly, not just pharmaceutical teams.

Finally, as a founder, how do you keep your team aligned around such a high-stakes, high-impact mission? And what kind of culture are you building at ArcaScience as you scale?

Romain: We’re building a culture rooted in scientific rigor, ethical responsibility, and impact. Everyone on our team—from engineers to medical experts—is here because they believe better science leads to better lives. We operate like a mission-driven lab, but with startup urgency. That combination has helped us stay focused and move fast, even in a complex industry.

Why the name “ArcaScience”?

Romain: ArcaScience is a tribute — and a transformation — of Aaron Swartz’s fight for knowledge as a public good. Aaron believed that scientific data should be free, open, and used to serve humanity. We believe the same. But we’ve taken that belief and applied it at scale — not by disrupting from the outside, but by transforming the inside.

Our name, Arca, means “ark” — a vessel of knowledge, preservation, and purpose. It also echoes Aaron, whose legacy inspired us to build a system where open scientific data becomes actionable intelligence for those shaping the future of medicine.

In a world where drug development is slow, risky, and often blind to emerging evidence, ArcaScience brings clarity. We decode the biomedical statistics, real-world evidence, and clinical trials into a living benefit-risk framework that helps pharma make faster, safer, and smarter decisions — for patients and for progress.

We stand at the intersection of open science and industrial impact. Where Aaron fought to free knowledge, Arca gives it purpose.