Altasciences, an integrated drug development solution company, and Certara, a global leader in model-informed drug development, have launched a strategic partnership. This collaboration aims to accelerate early-phase drug development programs and improve the success rate of therapeutic candidates.
Addressing Preclinical Roadblocks Data from both companies indicate that fewer than half of preclinical drug candidates successfully reach first-in-human trials. Failure factors typically include toxicity, poor pharmacokinetics, lack of efficacy, and issues translating animal results to humans.
-
Integrated Solutions: The partnership integrates Certara’s biosimulation technology and strategic services into Altasciences’ Acceleration Platform.
-
Optimizing Study Design: By embedding modeling insights into execution, sponsors can refine dosing strategies and study designs, enabling more confident, informed decision-making.
Aligning with Modern FDA Guidance The collaboration arrives as the U.S. FDA advances new guidance supporting more adaptive, data-driven, and real-time approaches to drug development.
-
Seamless Integration: The partnership enables programs to move more cohesively across clinical, nonclinical, bioanalytical, and manufacturing services.
-
Reducing Uncertainty: Altasciences leadership emphasized that the collaboration is about “reducing uncertainty at the moments that matter most,” helping biotech sponsors and investors establish earlier proof of mechanism.
By embedding modeling and simulation directly into development execution, Altasciences and Certara aim to provide a faster, more informed path to bringing innovative treatments to patients.