EXTON, Pa. & MORRISVILLE, N.C.--(BUSINESS WIRE)--KinderPharm LLC, dedicated exclusively to pediatric clinical research, and Worldwide Clinical Trials Inc. (Worldwide), an award-winning, full-service CRO, today announced they have entered into a strategic alliance to deliver the world’s first single center of excellence for pediatric drug development and clinical research for the pharmaceutical industry. With this alliance, pharmaceutical sponsors now have the solution to seamlessly conduct all aspects of pediatric drug development – from inception of the initial regulatory plan to the conduct of clinical trials on an international basis to support product registration and approval.
Approximately 60% of drugs that are used in children are not approved for pediatric use. These drugs have not been approved for use in children because they have not been successfully tested in pediatric clinical trials. In fact, a recent study found a failure rate of up to 42% for trials that were done under the 2002 Best Pharmaceuticals for Children Act (BPCA).1 Both the FDA and European Medicines Agency (EMA) have made significant changes in their regulations and now require a pediatric component for most clinical research.
KinderPharm and Worldwide are out to change this paradigm. Recognizing the lack of integrated, specialized pediatric drug development resources and global infrastructure to conduct clinical trials available to industry, the companies possess an uncommonly 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. Specifically, they offer:
- Clinical, technical and regulatory expertise to address the international regulatory, legal and strategic complexities of pediatric clinical development;
- Deep experience in conducting rare disease clinical trials, including proven ability to access hard-to-find patient populations;
- Established connections with sites and investigators;
- The only complete pediatrics clinical trial solution bolstered with advanced pharmacometric modeling and clinical trial simulation technologies, such as Pharmacokinetic Data Analysis, PK/PD Modeling (WinNonLin), Physiologically Based PK (PBPK) Modeling (PKSim) and Population PK Analysis (NONMEM) 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 an expert 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 industry-seasoned personnel in over 60 countries. All studies will be driven by the uncommon expertise needed to strategically design and usher pediatric trials through to completion.
“This strategic alliance between KinderPharm and Worldwide Clinical Trials represents a truly synergistic relationship between our two organizations. 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. 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,” stated Dr. Martin Graham, president and CEO of KinderPharm.
“Together KinderPharm and Worldwide will play an important role in the future of pediatric drug development. 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. 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,” said Peter Benton, president and COO of Worldwide.
ABOUT KINDERPHARM WWW.KINDERPHARM.COM
KinderPharm is a specialized pediatric drug development CRO located the United States. The company comprises of a dedicated team of pediatricians, regulatory affairs professionals, pharmacokineticists, toxicologists, formulation development scientists and clinical research personnel that are focused on the efficient design and conduct of pediatric studies. KinderPharm’s regulatory affairs team develop the initial Pediatric Study Plans (iPSPs) and Pediatric Investigation Plans (PIPs) for regulatory submission to the FDA and EMA. We are committed to optimizing clinical trial designs, minimizing the number of children that need to be enrolled in studies and determining the optimal dose for pediatric use by utilizing cutting edge PK/PD modeling and simulation, Physiologically Based PK (PBPK) and Population PK methodologies. We understand the ethical challenges and barriers to patient enrollment and strive to make the conduct of our trials as efficient, cost effective and patient friendly as possible. We are committed to children’s health, and our primary mission is to bring safe and effective new medicines to the pediatric marketplace. For more information, visit www.kinderpharm.com.
ABOUT WORLDWIDE CLINICAL TRIALS WWW.WORLDWIDE.COM
Worldwide Clinical Trials employs more than 1,600 professionals around the world, with offices in North and South America, Eastern and Western Europe, Russia, and Asia. Founded by physicians committed to advancing medical science, Worldwide is out to change how the world experiences CROs – in the best possible way. From early phase and bioanalytical sciences through late phase, post-approval and real-world evidence, we provide world-class, full-service drug development services. With infrastructure and talent spanning 60 countries, we execute predictable, successful studies with operational excellence across a range of therapeutic areas, including central nervous system, cardiovascular, metabolic, immune-mediated inflammatory disorders (IMID), oncology and rare diseases. We never compromise on science or safety. We’re never satisfied with the status quo. We’re the Cure for the Common CRO. For more information, visit www.worldwide.com.
1 McCune S. FDA Awards Funding to Support Pediatric Clinical Trials Research. FDA Voice. November 9, 2017. https://blogs.fda.gov/fdavoice/index.php/2017/11/fda-awards-funding-to-support-pediatric-clinical-trials-research/. Accessed April 12, 2018.