CROs have an important role to play in reducing the number of animals used in drug development and – potentially – much to gain by doing so, according to the European Commission.
Last week Cytotest Cell Research – a unit of preclinical contract research organisation (CRO) Harlan – joined EU-NETVAL, a Europe-wide network of labs researching alternatives to animal testing as part of a project managed by EURL ECVAM*.
A representative of EURL ECVAM told Outsourcing-pharma.com that: “Harlan Cytotest Cell Research GmbH was proposed by the NCP of Germany and complied with all the eligibility criteria . Thus, they were included in the list of EU-NETVAL members.”
EURL ECVAM’s goal is to support the development, validation, regulatory acceptance and use of alternative methods in any sector that “relies on animal testing.”
This aim will be easier to achieve in some industries than in others. For example, in March Europe banned the sale of cosmetics tested on animals, which accelerated and intensified efforts to develop alternatives.
Drugs are a different story. While various cell culture and chemical alternatives are available for cytotoxicity, genotoxicity and phototoxicity testing, it is a regulatory requirement that all candidate therapies are assessed in animals before they enter clinical trials.
Nevertheless, there are still opportunities to reduce the number of animals used in preclinical development according to EURL ECVAM.
“Typically there are many opportunities to reduce the reliance on animal testing during the drug development process through the intelligent use of existing data and the combination of alternative approaches such as computational modelling and in vitro methods.”
The spokeswoman added that: “We believe that embracing the development and application of alternative methods provides a win-win-win opportunity, namely, in addition to the 3Rs, the possibility to further increase the level of protection of human health and the environment, and contribute to innovation and competitiveness.
“CROs have an important role to play in achieving these goals and have potentially much to gain in the process.”
Fee for development
One thing Cytotest and other members of the lab network are likely to gain is a fee. Last week the firm told Outsourcing-pharma.com that EURL ECVAM would fund its work, which was confirmed by the organisation.
“The details concerning the financing of the activities of the network are still being finalised but it is very likely that the financing model will vary in nature depending on the specific activity or project, whether it be for example a ring-trial supporting a validation project or the development of training materials or courses.”
The EURL ECVAM representative added that: “In general we expect the costs of EU-NETVAL activities to be covered by a combination of direct and indirect financing from Member States, network members, and the Commission.”
*note for acronym fans, EURL ECVAM is the European Union Reference Laboratory for alternatives to animal testing.