Altasciences and Certara have announced a strategic partnership aimed at accelerating early-stage drug development by tightening the link between modeling, simulation, and real-world study execution.

 

The collaboration targets one of biotech’s biggest bottlenecks: failure in early development. Fewer than half of preclinical drug candidates ever make it into human trials, with toxicity, weak pharmacokinetics, lack of efficacy, and poor translation from animal models among the leading causes.

 

By combining Altasciences’ integrated development platform with Certara’s model-informed drug development (MIDD) technologies and biosimulation tools, the companies aim to help sponsors identify risks earlier, refine study design, and make faster, more confident go/no-go decisions.

 

“At Altasciences, we already help sponsors move from first safety assessment to proof of concept with speed and precision,” said Marie-Hélène Raigneau, CEO of Altasciences. 

 

“By embedding Certara’s modeling capabilities into our platform, we can further inform critical decisions earlier and with greater confidence. This collaboration is about reducing uncertainty at the moments that matter most.”

 

The partnership also aligns with evolving regulatory expectations, as the FDA continues to support more adaptive and data-driven development approaches, including greater use of modeling and real-time decision frameworks.

 

“This partnership unlocks new opportunities to improve early development decisions for biotech sponsors and their investors,” said Jon Resnick, CEO of Certara. “By embedding modeling and simulation directly into execution, we enable faster, more informed decision-making that ultimately benefits patients.”

 

The companies say the combined approach will embed predictive insights directly into development workflows—spanning nonclinical, clinical, bioanalytical, and manufacturing stages—to streamline study design and optimize dosing strategies.

 

Together, Altasciences and Certara are positioning the partnership as a shift toward a “model-first” development paradigm—one designed to reduce uncertainty, improve efficiency, and accelerate the path to proof of concept for biotech and pharmaceutical programs worldwide.