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Altasciences Partners with Certara on Model-Informed Drug Development

COMPANY PROFILE
  • Altasciences and Certara have entered a strategic partnership focused on accelerating early-phase drug development through model-informed drug development (MIDD).
  • The collaboration integrates Certara’s biosimulation and modeling technologies into Altasciences’ drug development platform to support study design and decision-making.

Altasciences and Certara have announced a strategic partnership aimed at accelerating early-phase drug development programs through the integration of model-informed drug development (MIDD) capabilities.

Under the collaboration, Certara’s biosimulation technology and strategic drug development services will be integrated into Altasciences’ Acceleration Platform. The companies stated that the combined approach is intended to help sponsors establish proof of mechanism earlier, optimize study designs, refine dosing strategies, and improve go/no-go decision-making during development.

According to the companies, many preclinical drug candidates fail before reaching first-in-human trials because of toxicity, pharmacokinetic challenges, lack of efficacy, and difficulties translating animal data into human outcomes. The partnership is designed to address these challenges by embedding modeling insights and digital workflows into nonclinical, clinical, bioanalytical, manufacturing, and contract development activities.

“By embedding Certara’s modeling capabilities into our platform, we can further inform critical decisions earlier and with greater confidence.” The companies also noted that the partnership aligns with increasing regulatory interest in adaptive and data-driven drug development approaches, including recent FDA guidance supporting such methods.

Marie-Hélène Raigneau, CEO of Altasciences

Certara CEO Jon Resnick said the collaboration is intended to improve early development decisions for biotech sponsors and investors. The companies stated that the partnership supports a fully integrated and resource-efficient approach to accelerating proof-of-concept timelines across global pharmaceutical and biotechnology programs.

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