Differentia Bio

Differentia provides knowledge-empowered modeling and simulation services for effective drug development. We enable biopharmaceutical companies leveraging our proprietary data, modeling and AI/ML analytics for a deeper understanding of biological systems. Our services accelerate the discovery and delivery of safe and effective therapies to improve healthcare outcomes worldwide. We provide model-based solutions for all phases of drug development: Non-Mechanistic Services: • Preclinical: PK/PD animal models, computing therapeutic indices, and facilitating human translation of preclinical data. • Phase I: PK/ER models, assessment of random effects, stochastic simulations for FIH dose selection, as well as submission-ready report writing with interpretation. • Phase II: Population PK/ER model development, covariate analysis, stochastic simulations for RP2D prediction, as well as submission-ready report writing with interpretation. • Phase III: Non-compartmental analysis (NCA) of Phase II data, develop base models for Population PK analysis, conduct covariate analysis, utilize stochastic simulations or Bayesian predictions to support clinical decision-making, and prepare submission-ready reports. Mechanistic Services: • Preclinical: In vitro binding models, PK(Pharmacokinetics)/RO(Receptor Occupancy)/target engagement predictions, and animal/human translational QSP (Quantitative Systems Pharmacology) disease models. • Phase I: PK/RO/target engagement prediction, Sensitivity Analysis, FIH dose/MTD prediction as well as submission-ready report writing with interpretation. • Phase II: Efficacious dose/R2PD (Recommended Phase 2 Dose) prediction, sensitivity analysis of parameters, as well as submission-ready report writing with interpretation. • Phase III: Individual patient PK fitting, Virtual patient cohort development, variability analysis, patient population stratification, biomarker identification, responder/non-responder analysis