KinderPharm works exclusively in children’s medicine, collaboratively partnering with pharmaceutical organizations to advance innovate pediatric products through all stages of the development process. We understand the ethics of care for this vulnerable population and have wide experience of pediatric trial design and execution. As a result we can ensure that the young participants benefit from medical progress without being exposed to unnecessary risks.
KinderPharm is a clinical stage, specialty pharmaceutical company focusing exclusively on pediatric drug development providing expert and focused resources.
We work collaboratively with our partners to advance innovative pediatric products through all stages of the development process. Our “Single-Point-of Accountability” model for formulation development, juvenile toxicology, pediatric PK/PD & PBPK modeling & simulation, pediatric dose prediction, pediatric clinical trials and pediatric regulatory submission provides our customers the expertise in the required stages of pre-clinical and clinical pediatric drug development.
KinderPharm has an expert core of Pharmacometrics that provide insight to the pediatric drug development process for creating smart and efficient clinical trials. We utilize our extensive experience in pediatric modeling and clinical trial simulation to design smart clinical trials which minimize the impact on the pediatric population. For example, during clinical drug development stages, PBPK modeling can permit for efficient trial design, providing suitable starting doses and selection of optimal sampling times. In addition, models may be used to extend existing knowledge derived from preliminary clinical investigations into unstudied subpopulations and clinical scenarios. This core differentiates KinderPharm from other Clinical Research Organizations.
We create value for our clients by realizing the full commercial potential of the 6-month pediatric exclusivity incentives from the FDA and EMA. Our primary objective is to increase the availability of authorized pediatric medicines and to ensure that the medication used today is both safe and effective.