Altasciences and Certara Forge Alliance to De-Risk Drug Development

LAVAL, Québec & RADNOR, Pa. – May 07, 2026 – In a strategic move poised to reshape the early stages of pharmaceutical innovation, integrated drug development firm Altasciences and biosimulation leader Certara have announced a partnership to accelerate and de-risk the creation of new medicines. The collaboration embeds Certara’s sophisticated model-informed drug development (MIDD) technologies directly into Altasciences’ comprehensive testing and execution platform, aiming to tackle the industry's notoriously high preclinical failure rate.

Fewer than half of all drug candidates that show promise in the lab successfully reach first-in-human trials. This costly attrition is often driven by unforeseen toxicity, poor pharmacokinetic profiles, or an inability to translate results from animal models to human subjects. By integrating advanced modeling from the outset, the two companies intend to provide biotech and pharmaceutical sponsors with the tools to make smarter, faster, and more confident decisions long before a candidate enters the clinic.

“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, in a statement. “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.”

A Synergy of Simulation and Execution

The partnership represents a significant fusion of two critical aspects of drug development: Certara's predictive, digital-first approach and Altasciences' hands-on execution of preclinical and clinical programs. This synergy is designed to create a seamless, data-driven workflow from initial concept to proof of concept.

Certara brings to the table a powerful arsenal of biosimulation software, which has become the gold standard in the pharmaceutical industry. Its flagship platforms include the Phoenix™ suite for pharmacokinetic and pharmacodynamic (PK/PD) modeling and the Simcyp™ Simulator, a leading physiologically-based pharmacokinetic (PBPK) platform. PBPK modeling allows researchers to create virtual patient populations to predict how a drug will behave in the human body, assessing factors like drug-drug interactions or performance in specific groups, such as children or patients with kidney impairment. In some cases, these simulations are robust enough to replace certain human trials entirely.

By integrating these tools into the Altasciences “Acceleration Platform,” sponsors can now design more efficient studies from the start. Instead of relying on traditional, often rigid protocols, they can use modeling to optimize dosing strategies, select the most relevant biomarkers, and better anticipate potential safety issues. This model-first approach means that by the time a physical study is conducted, it has already been refined and validated through countless digital simulations, maximizing its chances of success and yielding more meaningful data.

Riding a Favorable Regulatory Wave

The timing of this alliance is particularly opportune, as it aligns perfectly with a global push from regulatory bodies for more innovative and efficient drug development methodologies. The U.S. Food and Drug Administration (FDA) and other international agencies have become vocal proponents of MIDD.

Recent FDA guidance documents actively encourage the use of adaptive trial designs and PBPK analyses. The agency's 2018 guidance on PBPK, for instance, provides a clear framework for submitting simulation data in regulatory filings, acknowledging its power to inform drug labeling and, in some cases, waive the need for dedicated clinical studies. Between 2020 and 2024, PBPK models were used as pivotal evidence in over a quarter of all new drug applications approved by the FDA. Furthermore, the finalization of the international ICH M15 guideline is set to create a harmonized global framework for using MIDD, cementing its role as a core component of modern drug development.

This regulatory tailwind provides a strong foundation for the Altasciences-Certara partnership. It ensures that the data and insights generated through their integrated platform are not just scientifically sound but also well-positioned for regulatory review and acceptance, further smoothing the path for innovative therapies.

Reshaping the Competitive Landscape

From a business perspective, this partnership creates a formidable and differentiated offering in the highly competitive contract research organization (CRO) market. While many large CROs have in-house modeling capabilities, this dedicated collaboration between a specialized execution leader and a specialized simulation leader creates a deeply integrated, best-of-breed solution.

The move allows Altasciences to offer a level of predictive insight that goes beyond traditional CRO services, providing a significant competitive advantage. For Certara, it represents a powerful channel to embed its technology deeper into the drug development ecosystem, driving adoption and demonstrating value at the earliest, most critical stages.

“This partnership unlocks new opportunities to improve early development decisions for biotech sponsors and their investors,” noted 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 strategy is also reflected in Certara's recent corporate actions. The company's April 2026 agreement to sell its regulatory and medical writing business to Veristat signals a deliberate move to sharpen its focus on its core MIDD and clinical intelligence offerings. By concentrating its resources on its primary area of expertise, Certara is doubling down on the value of biosimulation, a bet that this new partnership with Altasciences exemplifies.

Ultimately, the collaboration aims to transform the economics and timelines of drug development. Independent analyses have shown that applying MIDD can save programs an average of 10 months and $5 million, while more than doubling the success rate for establishing proof of mechanism. By making these advanced capabilities more accessible and seamlessly integrated, Altasciences and Certara are not just forging a business alliance; they are building a new paradigm for bringing life-saving drugs to the people who need them, faster.