Parexel expands model-based drug development services
Mathematical models that can analyze the relationship between drugs, disease and patients can help predict a drug’s benefits and adverse effects prior to conducting a clinical trial.
Frank Hoke, VP of QCD, told Outsourcing-Pharma.com that the unit was created with a group of Clinical Pharmacology Modeling and Simulation scientists from GlaxoSmithKline, and employees from Parexel’s Clinical Pharmacokinetics/Pharmacodynamics (PK/PD) department. Expanded services under this new unit “include, but are not limited to mechanistic modeling, systems pharmacology, and clinical trial simulation,” Hoke said.
By providing quantitative justification for trial design, dose selection, and decisions during trial execution, MBDD can improve the efficiency of clinical development. Quantitative clinical pharmacology can also boost the quality of a drug’s regulatory package, the company says.
“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,” Hoke said.
