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Additional services and capabilities in model-based drug development (MBDD) are available from PAREXEL's Quantitative Clinical Development (QCD) group.
The QCD team — boasting a dedicated team of more than 30 scientists with an aggregate of 400-plus years of combined clinical development experience — offers leadership in all strategic and quantitative aspects of clinical pharmacology for biopharmaceutical companies to help expedite drug development, minimise risk and support regulatory approval processes.
Leveraging mathematical models for a quantitative analysis of the relationship between drugs, disease and patients, modelling and simulation can predict a drug’s benefits and adverse effects in a patient population prior to conducting a clinical trial. MBDD can improve the efficiency of clinical development by providing quantitative justification for trial design, dose selection and decisions during trial execution.
Frank Hoke, PhD, vice president of QCD, PAREXEL, said: “The biopharmaceutical landscape continues to show dramatic change, putting companies under increasing pressure to deliver on their pipeline, to identify more effective means of picking the ‘winners’ and efficiently developing these medicines under financial constraints. In addition, regulatory authorities around the world have increasingly accepted model-based techniques as a standard component of new drug applications. Our goal is to reduce risk along the drug development continuum — for drug developers and for patients — while helping companies make sound investment decisions and accelerating their drug’s journey to market.”