Translational Clinical Pharmacology for Complex Development Decisions
At MBPharmaco Consulting, we provide strategic quantitative clinical pharmacology and model-informed drug development (MIDD) expertise to support critical development decisions across discovery, early clinical development, and regulatory submission.
Our experience spans small molecules, biologics, immuno-oncology, and translational pharmacology, integrating PK/PD, biomarker modelling, exposure–response analyses, and simulation-based approaches to support candidate selection, dose optimisation, and clinical development strategy.
With four decades of pharmaceutical industry experience, including successful contribution to 10 primary New Drug Applications (NDAs), we deliver high-quality clinical pharmacology strategy and submission-ready documentation across multiple therapeutic areas.
Model-Informed Strategies Tailored to Development Goals
We work closely with our partners to develop quantitative and translational strategies aligned with programme-specific objectives, integrating pharmacology, PK/PD, biomarker, and simulation-based approaches to support informed development decisions.
Our deliverables include strategic clinical pharmacology plans, exposure–response analyses, translational modelling, regulatory documentation, and submission-ready clinical pharmacology reports.
Selected Publications & Scientific Contributions
Our team has authored publications across model-informed drug development (MIDD), clinical pharmacology, pharmacokinetics/pharmacodynamics, and translational drugdevelopment, including applications in dose optimisation, exposure–response analyses, and clinical trial strategy.
