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Altasciences, a fully integrated drug development solution company, and Certara, a global leader in model-informed drug development, announced a strategic partnership to accelerate early-phase development programmes.
Fewer than half of preclinical drug candidates successfully reach first-in-human trials. Failures are driven by toxicity, poor pharmacokinetics, lack of efficacy, and challenges translating results from animals to humans. Many of these risks can be mitigated through a fully integrated model-informed drug development approach.
Building on Altasciences’ Acceleration Platform, the integration of Certara’s strategic drug development services and biosimulation technology enables sponsors to establish proof of mechanism earlier, design more efficient studies, and make informed go/no-go decisions with greater confidence. By embedding modelling insights and digital workflows directly into development execution, study designs are optimized, dosing strategies are refined, and programmes are more seamlessly integrated across nonclinical, clinical, bioanalytical, and manufacturing services.
“At Altasciences, we already help sponsors move from first safety assessment to proof of concept with speed and precision,” said Marie-Hélène Raigneau, chief executive officer of Altasciences. “By embedding Certara’s modelling 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 comes at an opportune time as the US Food and Drug Administration continues to advance new guidance supporting more adaptive, data-driven, and real-time drug development approaches, capabilities that integrated model-informed drug development execution models are well positioned to deliver.
“This partnership unlocks new opportunities to improve early development decisions for biotech sponsors and their investors,” said Jon Resnick, chief executive officer of Certara. “By embedding modelling and simulation directly into execution, we enable faster, more informed decision-making that ultimately benefits patients.”
Together, Altasciences and Certara are advancing a model-first, fully integrated, and resource-efficient approach to early drug development that accelerates the path to proof of concept for biotech innovators, investors, and pharmaceutical companies across the globe.
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical study programs, including formulation, manufacturing, and analytical services. For over 30 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions.
Certara accelerates medicines using biosimulation software, technology, and services to transform traditional drug discovery and development. Its clients include more than 2,600 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.
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