Harlan Laboratories Contract Research Services (CRS) has launched a dedicated Translational Medicine program aimed at speeding drug development, minimizing late-stage risk of failure, and reducing costs. The company will combine its expertise in metabolic profiling, genotoxicity, skin penetration, immunology, pharmacology and bioproducts, with its knowledge of regulatory requirements, to offer a range of screening and modeling packages to help to detect signals of toxicity, efficacy and unwanted pharmacokinetics. 
 
Special screening packages have been created for specific requirements, such as early ADMET information covering PK screening for early pharmacokinetic profiling and biodistribution, plasma protein binding, in vitro metabolic stability, acute toxicity, bioanalytical development and early safety assessment. According to the company, a key focus for successful PK profiling and Safety Assessment will be in the creation of a suitable formulation, either IV or PO, at the earliest stage of the drug development. 
 
“Our Translational Medicine Service will deliver comprehensive data and support for every stage of development from preclinical and in vitro to in vivo and First in Man,” said Harlan CRS president Manuela Leone. “It provides a flexible approach that can be adapted to the precise needs of each study.  The availability of such informed data at the earliest stages will speed up the development process and reduce the risk of drug candidate failure at an advanced stage, both of which will have a significant impact in minimizing costs.”