Exton, PA, September 01, 2015 --(PR.com
)-- The acquisition will better serve the needs of KinderPharm’s customers by meeting the FDA “Critical Path Initiative” of implementing PK/PD modeling and simulation into all pediatric trials by 2020.
Pediatric PK/PD modeling and simulation is a rapidly evolving science. Application of these strategies can have an enormous impact on the design of pediatric studies, providing insight and guidance on the rational selection of pediatric doses and dose regimens.
PopPK analysis can be used to estimate pharmacokinetic parameters from very sparse datasets (e.g. one or two samples) collected at random sampling times through the disposition of the drug. This is a particularly valuable tool in pediatric drug development as it can be used to analyze PK data in children with a minimal number of blood draws. In addition to PopPK strategies, PKPD Bioscience scientists also make use of computer-based algorithms to design optimized blood-draw schedules to minimize the number of samples that need to be taken from children to obtain PK data.
“Our acquisition of PKPD Bioscience complements our overall pediatric drug development offering so we can provide minimal exposure to clinical testing to children, advance proof of concept through modeling and simulation techniques and provide cost savings to Pharmaceutical and Biotech partners through expedited drug development processes. This investment represents an important strategic opportunity to offer a full service model enabling us to efficiently and cost-effectively advance pediatric products through all the required stages of pre-clinical and clinical development,” said Lynda Graham, CFO of KinderPharm LLC. “The acquisition also adds to the talents and experience of our people, to provide us with a unique set of expertise, skill and insight to tackle the most challenging of development issues.”
About KinderPharm and PKPD Bioscience
KinderPharm, LLC, based in Exton, PA, is an expert pediatric co-development partner, focusing exclusively on pediatric drug development. Our out-sourced “Pediatric Center of Excellence” model is a unique resource of pediatricians, pharmacometricians, regulatory, drug safety and formulation scientists that develop pediatric drugs through all stages of development. Our seasoned teams bring expertise and insight to help effectively navigate the complex pediatric regulatory environments in the US and Europe. We are dedicated to one single goal namely “Bringing better medicines to children.” To learn more information about KinderPharm visit www.kinderpharm.com
PKPD Bioscience is a division of KinderPharm. LLC, providing advanced pharmacokinetic data analysis services to the pharmaceutical and biotechnology industry. PKPD utilizes cutting edge, computer-based drug modeling and clinical trial simulation techniques to develop optimized dosing regimens during pre-clinical and clinical drug development. Drug modeling and simulation has been recognized by the FDA as a “critical path” enabling technology that assists pharmaceutical and biotechnology companies in the selection of safe and effective dosing regimens for late stage clinical development and registration. PKPD Bioscience aims to be the primary provider of innovative and rational approaches to pediatric drug development, assisting companies to more rapidly and safely advance new medicines for children to the marketplace for an earlier return on investment. To learn more about PKPD Bioscience, visit www.pkpdinc.com
For further information, please contact:
- Martin Graham, PhD, Chief Executive Officer, (610) 458-1052
- Janet Welsko, Chief Operating Officer, (610) 458-1052
- Lynda Graham, MBA, Chief Financial Officer, (610) 458-1052
For media inquiries, please contact:
- Kristin Liezenga, Business Development Executive, (610) 458-1502