Global CRO Parexel International has launched expanded services and capabilities in model-based drug development (MBDD) through its Quantitative Clinical Development (QCD) group. The Parexel QCD team also offers leadership in all strategic and quantitative aspects of clinical pharmacology for biopharmaceutical companies to help expedite drug development, minimize risk and support regulatory approval processes.
Leveraging mathematical models for a quantitative analysis of the relationship between drugs, disease and patients, modeling 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. In addition, quantitative clinical pharmacology throughout the lifecycle of a drug candidate supports high quality regulatory packages to help secure regulatory approval.
"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," said Frank Hoke, Ph.D., vice president of QCD, Parexel. "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."
Parexel’s Quantitative Clinical Development is led by Hoke and supported by a dedicated team of more than 30 scientists. Hoke and a number of colleagues joined Parexel from GlaxoSmithKline's Clinical Pharmacology Modeling and Simulation department.