Altasciences and Certara Form Strategic Partnership to Advance Model-Informed Drug Development
Altasciences and Certara have announced a strategic partnership aimed at accelerating early-stage drug development through the integration of model-informed drug development technologies, biosimulation tools, and fully integrated research services.
The collaboration brings together Altasciences’ integrated drug development platform with Certara’s expertise in modeling, simulation, and strategic development services. The companies stated that the partnership is intended to help biotechnology and pharmaceutical sponsors improve decision-making during the early phases of development, reduce uncertainty, and increase the likelihood of successfully advancing drug candidates into human clinical studies.
The announcement reflects the growing importance of model-informed drug development, commonly known as MIDD, within the pharmaceutical industry. Drug development remains a costly, time-consuming, and high-risk process, particularly during the transition from preclinical research into first-in-human clinical trials.
Industry data consistently show that fewer than half of preclinical drug candidates successfully progress into early-stage human studies. Failures are frequently linked to issues such as toxicity, unfavorable pharmacokinetics, insufficient efficacy, or difficulties translating animal study findings into human biology.
Both companies believe that a more integrated, data-driven development strategy can help address many of these challenges earlier in the process.
Under the partnership, Certara’s modeling and biosimulation capabilities will be incorporated into Altasciences’ Acceleration Platform, a framework designed to support sponsors from early discovery through proof-of-concept development. The combined approach is intended to enable earlier identification of promising candidates, improved study design, and more informed go/no-go development decisions.
According to the companies, embedding modeling insights directly into operational workflows can optimize development programs across nonclinical research, clinical development, bioanalytical services, and manufacturing activities.
Model-informed drug development has become increasingly important as pharmaceutical companies seek to improve efficiency and reduce the high attrition rates associated with experimental therapies. Biosimulation and predictive modeling technologies allow researchers to evaluate how a drug may behave in the body before extensive human testing begins.
These approaches can help predict dosing requirements, evaluate potential safety concerns, assess pharmacokinetic and pharmacodynamic relationships, and identify optimal study designs. By using computational models alongside laboratory and clinical data, developers can potentially reduce development timelines and improve resource allocation.
The partnership also aligns with broader industry trends toward digital transformation and data-centric research strategies. Pharmaceutical companies are increasingly integrating artificial intelligence, predictive analytics, and simulation technologies into development programs to improve productivity and reduce costs.
Marie-Hélène Raigneau, Chief Executive Officer of Altasciences, stated that the company already supports sponsors through critical stages of development, from initial safety assessments to proof-of-concept studies.
According to Raigneau, integrating Certara’s modeling capabilities into Altasciences’ platform will allow sponsors to make critical development decisions earlier and with greater confidence. She emphasized that the collaboration is focused on reducing uncertainty during some of the most important decision-making stages in drug development.
The companies also noted that the partnership comes at a time when the U.S. Food and Drug Administration continues promoting more adaptive and data-driven regulatory and development strategies.
In recent years, the FDA has increasingly encouraged the use of model-informed approaches to support dose optimization, trial design, and regulatory submissions. Regulatory agencies have shown growing interest in computational modeling and simulation as tools capable of improving development efficiency while maintaining scientific rigor and patient safety.
The evolving regulatory environment is creating additional momentum for integrated MIDD platforms capable of combining operational execution with advanced analytical technologies.
Jon Resnick, Chief Executive Officer of Certara, stated that the partnership creates new opportunities for biotechnology sponsors and investors seeking to improve early-stage development decisions.
Resnick explained that embedding modeling and simulation directly into development execution can support faster and more informed decision-making processes, which may ultimately improve outcomes for patients by accelerating the advancement of promising therapies.
Certara has established itself as a major player in the field of model-informed drug development, providing biosimulation software, regulatory consulting, and drug development services to pharmaceutical and biotechnology companies worldwide. The company’s technologies are widely used across the industry to support pharmacokinetic modeling, clinical trial simulation, and regulatory planning.
Meanwhile, Altasciences operates as a fully integrated drug development solutions provider offering services that span preclinical research, clinical pharmacology, manufacturing, and analytical support. By combining their respective capabilities, the companies aim to create a more seamless development pathway for sponsors navigating the complexities of early-stage drug development.
The collaboration may be particularly valuable for smaller biotechnology companies and emerging drug developers that often face significant financial and operational constraints during the early stages of development. Efficient resource allocation and rapid decision-making can be critical for these organizations as they seek to demonstrate proof of mechanism and secure additional investment or partnership opportunities.
The companies believe that integrating biosimulation earlier into development planning can help sponsors identify potential issues sooner, prioritize the most promising candidates, and avoid unnecessary expenditures on programs with lower probabilities of success.
Beyond improving development efficiency, the partnership also reflects a broader shift toward more predictive and personalized approaches within pharmaceutical research. As drug development becomes increasingly complex, the ability to integrate data from multiple sources into unified decision-making frameworks is becoming more important across the industry.
The combination of computational modeling, real-time data analysis, and integrated operational execution may ultimately help reduce development timelines and improve the probability of clinical and regulatory success.
Altasciences and Certara stated that together they are advancing a model-first, resource-efficient approach designed to accelerate the path toward proof of concept for biotechnology innovators, pharmaceutical companies, and investors around the world.
As competition intensifies within the global biopharmaceutical sector, partnerships focused on improving development productivity and reducing clinical risk are expected to play an increasingly important role in shaping the future of drug innovation.
About Altasciences
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.
Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.
About Certara
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.
