Altasciences and Certara have announced a strategic partnership aimed at accelerating early-stage drug development by integrating advanced modeling and simulation technologies into preclinical and clinical research programs.
The collaboration combines Altasciences’ fully integrated drug development platform with Certara’s expertise in model-informed drug development (MIDD) and biosimulation technologies. The companies said the partnership is designed to help biotech and pharmaceutical sponsors reduce development risks, optimize study designs, and make faster, data-driven decisions before advancing therapies into human trials.
The agreement comes as the pharmaceutical industry faces ongoing challenges in translating preclinical discoveries into successful clinical outcomes. Industry data show that fewer than half of preclinical drug candidates progress successfully into first-in-human studies, with failures often linked to toxicity concerns, inadequate pharmacokinetics, poor efficacy, or difficulties translating animal data into human responses.
Through the partnership, sponsors using Altasciences’ Acceleration Platform will gain direct access to Certara’s modeling capabilities and strategic drug development services. By incorporating biosimulation and predictive analytics earlier in the development process, the companies aim to establish proof of mechanism sooner and improve confidence in critical go/no-go decisions.
The integrated approach is expected to streamline workflows across nonclinical, clinical, bioanalytical, and manufacturing operations. According to the companies, embedding modeling insights directly into execution could lead to more efficient trial designs, refined dosing strategies, and reduced uncertainty throughout development programs.
Marie-Hélène Raigneau, Chief Executive Officer of Altasciences, said the collaboration builds on the company’s ability to help sponsors move rapidly from safety assessment to proof of concept.
“By embedding Certara’s modeling capabilities into our platform, we can further inform critical decisions earlier and with greater confidence,” Raigneau said. “This collaboration is about reducing uncertainty at the moments that matter most.”
The partnership also aligns with broader regulatory trends as the U.S. Food and Drug Administration continues to encourage adaptive and data-driven drug development approaches. Regulatory agencies have increasingly supported the use of real-time analytics, predictive modeling, and simulation tools to improve development efficiency and reduce unnecessary clinical risks.
Certara CEO Jon Resnick said integrating modeling and simulation into operational execution would create new opportunities for biotechnology companies and investors seeking faster development timelines.
“By embedding modeling and simulation directly into execution, we enable faster, more informed decision-making that ultimately benefits patients,” Resnick said.
The companies stated that the partnership reflects growing demand for resource-efficient development models that can accelerate the path to proof of concept while helping innovators control costs and improve decision-making during the earliest and most critical phases of drug development.
As competition intensifies across the biotechnology sector, integrated model-informed development strategies are becoming increasingly important for companies seeking to bring therapies to market more efficiently and with higher probabilities of success.