MORRISVILLE – Worldwide Clinical Trials of Morrisville has formed a strategic alliance with KinderPharm of Exton, Pa., to create what the two clinical research organizations (CROs) are calling the world’s first center of excellence for pediatric drug development and clinical research for the pharmaceutical industry.

The alliance will give pharmaceutical clients a seamless way to conduct all aspects of pediatric drug development, from an initial regulatory plan to the management of clinical trials for supporting product registration and approval, the companies said in a news release.

“Together KinderPharm and Worldwide will play an important role in the future of pediatric drug development,” said Peter Benton, president and chief operating officer of Worldwide.

“Uncommon expertise in executing global trials for sponsors targeting rare disease has always been a cornerstone of the value Worldwide delivers to emerging to midsized biopharma and pharmaceutical sponsors seeking effective, efficient clinical research support,” he said. “When combined with KinderPharm’s deep expertise in pediatric research, sponsors now have a single center of excellence to successfully navigate the complexities of pediatric studies across the globe.”

Most drugs not tested in children

About 60 percent of drugs that are used in children are not approved for pediatric use because they have not been successfully tested in pediatric clinical trials, according to the companies. Both the U.S. Food and Drug Administration and the European Medicines Agency have changed their regulations to require a pediatric component for most clinical research.

The alliance was sparked by the two companies’ recognition of the lack of integrated, specialized pediatric drug development resources and global infrastructure to conduct clinical trials for pharmaceutical clients. The companies said they have “a thorough command of the operational challenges associated with the development of medicines for children through their integrated regulatory, pharmacometric, non-clinical safety, formulation and global clinical trial capabilities.”

The companies said they would offer:

  • Clinical, technical and regulatory expertise to address the international regulatory, legal and strategic complexities of pediatric clinical development;
  • Experience in conducting rare disease clinical trials, including proven ability to access hard-to-find patient populations;
  • Established connections with sites and investigators;
  • A complete pediatrics clinical trial solution bolstered with advanced pharmacometric modeling and clinical trial simulation technologies, such as pharmacokinetic data analysis and modeling, physiologically based pharmacokinetic modeling, and population pharmacokinetic analysis to facilitate efficient pediatric trial design and minimize patient numbers;
  • Pediatric formulation and juvenile toxicology expertise; and
  • Operational consistency, quality and data integrity throughout the clinical development process.

All services will be led by a team of experienced pediatricians, clinical/medical monitors, regulatory affairs professionals, non-clinical scientists, program managers, statisticians, rare disease specialists and pharmacokineticists, combined with an established clinical trials infrastructure staffed with personnel in over 60 countries.

Cited as ‘a truly synergistic relationship’

“This strategic alliance between KinderPharm and Worldwide Clinical Trials represents a truly synergistic relationship between our two organizations,” said Dr. Martin Graham, president and CEO of KinderPharm.

“The collaboration brings together an exceptionally talented and experienced team who possess a deep knowledge of pediatric drug development with insights and solutions to the challenges of conducting clinical trials in children,” he said. “Combining this talent with cutting-edge approaches to pediatric trial design through the use of advanced computer-based modeling and simulation together with access to a global clinical trials infrastructure will be of immense benefit for our clients and patients alike.”

The companies didn’t disclose financial terms of the alliance.

Worldwide, founded in 1986, employs more than 1,600 people in 60 countries and has offices in North and South America, Eastern and Western Europe, Russia and Asia. It is a full-service CRO that conducts studies across a range of therapeutic areas including central nervous system, cardiovascular, metabolic, immune-mediated inflammatory disorders, oncology and rare diseases.

KinderPharm, founded in 2014, is a small CRO focused exclusively on pediatric drug development. In addition to its Pennsylvania headquarters, it has an office in London.

(C) N.C. Biotechnology Center