Combining formulation expertise and predictive modeling to make smarter development decisions earlier and reduce clinical development risk.
LAVAL, Quebec (September 15, 2026) — Corealis Pharma (“Corealis”) and PhinC Group (“PhinC”) have announced a strategic collaboration to integrate physiologically based biopharmaceutics modeling (PBBM) and physiologically based pharmacokinetic (PBPK) modeling directly into oral solid dosage form development.
The collaboration brings together Corealis’ formulation and manufacturing expertise with PhinC Group’s predictive biopharmaceutics modeling capabilities to provide earlier insight into how formulation properties may influence clinical performance. The approach is particularly well suited to development-stage oral small-molecule programs where solubility limitations, release-profile optimisation, food effects, formulation bridging, or bioavailability uncertainty can significantly influence development strategy.
“Too often, formulation decisions are made with limited visibility into how a drug product will ultimately perform in patients. By integrating PhinC’s predictive modeling capabilities with Corealis’ formulation and manufacturing expertise, we can evaluate critical development questions earlier, focus resources on the most promising approaches, and help our clients advance toward the clinic with greater confidence, stronger scientific rationale and reduced development risk.” said David Leroux-Petersen, CEO of Corealis Pharma.
The integrated approach uses API, formulation and dissolution data within PBBM/PBPK models to evaluate key factors such as release rate, solubility, particle size and food effects, guiding targeted prototype development and formulation selection. For biotech companies, the result is a more focused development strategy with the potential to reduce experimental iterations, generate earlier insight into human performance, prioritise formulation risks and increase confidence before committing valuable API, time and clinical resources.
“The value of modeling is greatest when it informs development decisions,” said Samia Ezzine, Chief Scientific Officer, North America at PhinC Group. “Working with Corealis allows us to connect formulation characteristics to predicted human exposure and focus on the experiments that matter most.”
Together, Corealis and PhinC aim to enable a more predictive, science-driven approach to formulation development, helping sponsors make critical development decisions earlier and with greater confidence.
Corealis Pharma is a specialized oral solid dosage (OSD) CDMO supporting pharmaceutical and biotechnology companies from early formulation development through GMP clinical manufacturing and clinical supply. With integrated formulation, analytical and manufacturing capabilities, Corealis helps development-stage programs advance efficiently toward the clinic through science-driven formulation strategies, flexible manufacturing and experienced project execution. For more information, visit www.corealispharma.com
PhinC Group specializes in model-informed drug development, applying advanced pharmacometric approaches including PBPK and PBBM to support drug development decision-making. By integrating drug, formulation and physiological data into predictive models, PhinChelps pharmaceutical and biotechnology companies better understand drug performance, anticipate clinical outcomes and make more informed development decisions. Learn more at www.phinc-group.com