Harlan launches translational medicine offering
Dedicated programme will speed up drug development and reduce risk of failure
Harlan Laboratories Contract Research Services (CRS) has further extended its service offering with the launch of a dedicated translational medicine programme that the company says will help to speed up drug development, minimise the risk of failure at a later stage and greatly reduce the costs of bringing a new product to market.
The company is grouping together its longstanding and proven expertise in areas such as metabolic profiling, genotoxicity, skin penetration, immunology, pharmacology and bioproducts, as well as its in-depth knowledge of regulatory requirements, to offer a range of tailored screening and modelling packages. These will help to detect as early as possible in the drug development process signals of toxicity, efficacy and unwanted pharmacokinetics behaviour.
The information and data from this will enable Harlan to predict safety and efficacy targets that will help to optimise the next steps in the drug development process, speeding up the pre-clinical and phase I, II and III stages. For example, it can make easier the choice between two or three structural analogues with minor differences and generate the crucial data that is necessary before starting regulatory development or a First in Man study.
Harlan’s comprehensive screening and modelling capabilities incorporate a huge range of expertise and disciplines covering areas such as early TOX/PK screenings including metabolic stability/ID and fast Ames tests; Proof of Concept studies; PK/PD early efficacy predictability in vivo modelling; Allometric scaling and extrapolation of maximum safe starting dose (MTC) in Human Phase I study; early stage drug interactions for combination therapies; and gene sequencing. These will provide valuable insight into the development of both NCEs and combination therapies or reformulations.
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, fast bioanalytical development and early safety assessment.
A key focus for successful PK profiling and Safety Assessment will be in the effective creation of a suitable formulation, either IV or PO, at the earliest stage of the drug development. Harlan says a critical factor in this process will be the bioanalytical function which will help to guarantee the reliability of the results and eliminate the need for validation.
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 minimising costs
As well as the depth of expertise within Harlan Laboratories CRS, the company is also establishing partnerships with external bodies in key areas such as behavioural pharmacology, biosciences and immunology to provide additional input and the widest possible knowledge base in every screening and modelling project.
‘Our Translational Medicine Service will deliver comprehensive data and support for every stage of development from pre-clinical and in vitro to in vivo and First in Man,’ explains 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 minimising costs.’