PAREXEL expands model-based discovery services

Expansion of QCD group fueled by absorption of GSK pharmacology

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WALTHAM, Mass.—Multinational contract research organization PAREXEL International Corp. announced expanded services and capabilities in model-based drug development this summer. The expansion occurred in the company’s Quantitative Clinical Development group, now among the largest groups in the industry that provide modeling and simulation.
The expansion of services resulted from the transition of a number of scientists from GlaxoSmithKline’s Clinical Pharmacology Modeling and Simulation department to PAREXEL’s Clinical PK/PD and Pharmacometrics group, according to Dr. Frank Hoke, PAREXEL International’s vice president of quantitative clinical development. The union of these two groups facilitated a significant expansion of PAREXEL’s capacity to deliver quantitative clinical pharmacology and pharmacometric services.
Model-based drug development uses simulations and mathematical models to characterize the relationship between a drug, patients and disease in an effort to predict the drug’s effects—both positive and negative—in a broader patient population before a clinical trial even begins. Model-based drug development can provide quantitative justification for clinical trial design, dose selection and other decisions that can improve the efficiency of clinical development. These simulations can help to minimize risks during clinical development and expedite the overall drug development process.
“As an example of model-based drug development, PAREXEL has developed models to characterize both the efficacious and adverse effects of drugs on hematopoiesis for hematological disorders and oncology,” says Hoke. “These models often take on features of the underlying physiology, thereby enhancing the ability of the model to make predictions about the timing of dose as well as the dose level itself. This modeling and simulation approach offers the ability to more effectively achieve therapeutic levels while minimizing adverse effects.”
In addition, PAREXEL’s services include providing quantitative clinical pharmacology throughout the life cycle of a drug candidate, which supports the regulatory approval process.
PAREXEL provides a range of contract research, consulting, medical communications and technology solutions and services to the pharmaceutical, biotechnology and medical device industries worldwide. The company’s offerings span the entire drug development and commercialization spectrum, from Phase 1 to 4 clinical research services to regulatory outsourcing, integrated product development, marketing and other consulting services. Their services cover a broad spectrum of therapeutic areas including oncology and hematology, cardiovascular and metabolic diseases, central nervous system disorders and infectious disease.
“For more than 30 years, PAREXEL has helped simplify the complex drug development journey so new products can reach patients more quickly,” says Hoke. “Through our informatics business, PAREXEL delivers integrated platforms and applications, as well as clinical data services, to make drug development faster, more accurate and efficient.”
Beyond model-based drug discovery, PAREXEL’s key offerings include strategic partnerships that enable biopharmaceutical companies to optimize their clinical development, through which the company has collaborated with hundreds of the world’s most successful biopharmaceutical organizations. According to the company’s website, PAREXEL has been involved in the development of 94 percent of the top 200 best-selling drugs in the world.
The company also launched its BioPharm Unit in 2012 to help emerging small to mid-sized companies expand their in-house expertise and position themselves among larger industry players, as well as providing access to venture capital or funding partners.
The company’s specialties extend to developing, testing and marketing products in three categories within the healthcare industry: small-molecule pharmaceuticals, large-molecule biologics and medical devices. Founded in 1982 and headquartered near Boston, PAREXEL today operates in 80 locations in 51 countries and employs more than 18,000 people worldwide.
Among the company's other offerings is its open eClinical solution, Perceptive MyTrials, which features a collaborative design environment designed to accelerate clinical trial design, implementation and optimization; randomization and supply management; data collection and management; and data retrieval, verification, reporting and analysis.
In fact, it was just in June that the company launched what it called “next-generation risk-based monitoring capabilities” with an expansion of Perceptive MyTrials’  Data-Driven Monitoring (DDM) solution to better enable cross-study analysis of quality, risk, and monitoring work by combining analytics, reporting and monitoring activity into a single cohesive solution. These improvements are said to increase a drug developer’s ability to demonstrate appropriate oversight and control of site-related risk, quality and performance while simplifying monitoring governance and execution.
“Centralized monitoring methods are being encouraged by the U.S. Food and Drug Administration and other regulatory bodies. By combining our DDM and monitoring solution, PAREXEL clients now have the ability to bridge real-time information gaps between centralized analysts and in-the-field monitoring teams, reducing risk, ensuring documentation and increasing quality,” Drew Garty, senior director of product management at PAREXEL, said at the time.

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