Altasciences and Certara Form Strategic Partnership to Accelerate Early-Phase Drug Development
核心洞察
Altasciences (搜索) and Certara announced a strategic partnership to integrate model-informed drug development capabilities into early-phase development programs.
The collaboration aims to address the significant failure rate in drug development, where fewer than half of preclinical candidates successfully reach first-in-human trials.
The partnership combines Altasciences (搜索)' Acceleration Platform with Certara's biosimulation technology to enable earlier proof of mechanism establishment and more informed go/no-go decisions.
Altasciences (搜索), a fully integrated drug development solution company, and Certara (Nasdaq: CERT), a global leader in model-informed drug development (MIDD), have announced a strategic partnership designed to accelerate early-phase development programs and address critical challenges in drug development success rates.
Addressing Drug Development Challenges
The pharmaceutical industry faces significant hurdles in translating preclinical research into successful clinical programs. According to the companies, fewer than half of preclinical drug candidates successfully reach first-in-human trials. These failures are primarily driven by toxicity issues, poor pharmacokinetics, lack of efficacy, and challenges in translating results from animal studies to human applications.
The partnership aims to mitigate these risks through a fully integrated model-informed drug development approach that combines Altasciences (搜索)' existing capabilities with Certara's advanced modeling and simulation technologies.
Integration of Platforms and Technologies
Building on Altasciences (搜索)' Acceleration Platform, the collaboration will integrate Certara's strategic drug development services and biosimulation technology. This integration is designed to enable sponsors to establish proof of mechanism earlier in the development process, design more efficient studies, and make informed go/no-go decisions with greater confidence.
The partnership embeds modeling insights and digital workflows directly into development execution, allowing for optimized study designs, refined dosing strategies, and more seamlessly integrated programs across nonclinical, clinical, bioanalytical, and manufacturing services.
"At Altasciences (搜索), 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."
Regulatory Alignment and Market Timing
The partnership announcement comes as the FDA continues to advance new guidance supporting more adaptive, data-driven, and real-time drug development approaches. The integrated MIDD execution models that the partnership will deliver are positioned to align with these evolving regulatory expectations.
"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."
Company Backgrounds and Capabilities
Altasciences (搜索) brings over 30 years of experience in drug development, offering integrated, full-service solutions including preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, and data management. The company's services are customizable to specific sponsor requirements across pharmaceutical and biotechnology companies.
Certara serves more than 2,600 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries. The company specializes in biosimulation software, technology, and services designed to transform traditional drug discovery and development processes.
Strategic Impact
Together, the companies are advancing what they describe as a model-first, fully integrated, and resource-efficient approach to early drug development. This methodology is intended to accelerate the path to proof of concept for biotech innovators, investors, and pharmaceutical companies globally, potentially improving the overall success rate of drug development programs while reducing time and costs associated with early-phase studies.