NC3Rs/ABPI collaborative primate initiative
In partnership with the Association of the British Pharmaceutical Industry (ABPI), the NC3Rs has developed a strategy to examine and review the scientific rationale for the use of primates in drug discovery and development, with the aim of minimising their use and enhancing the implementation of the 3Rs.  Under the umbrella of an expert steering group, three working groups, each including appropriate international and regulatory experts, have been established to consider primate use in each of three areas -
The general approach of each working group is to review the added scientific value of primates over and above other species, such as rodents, and in turn whether rodents give added scientific value, over and above in vitro and in silico techniques. To carry out a robust review, members from companies involved in the working groups are contributing expertise and data. Challenging primate use in monoclonal antibody development - a working example -
An international workshop was held in March 2006 to consult experts. The workshop was attended by 50 delegates from the pharmaceutical and biotechnology industries, contract research organisations, academia and regulatory bodies from UK, Europe and the USA. The objective at the workshop was to develop a contingency plan for mAb development if primate use were no longer possible as a result of disease outbreak, legislative changes or logistical problems with supply. A report of the workshop has now been published and a summarised version appeared as a paper in Nature Reviews Drug Discovery in February 2007. -
An international expert working group has been established with membership comprising most of the organisations present at the workshop. The group has identified priority areas for minimising primate use using the contingency mAb development pathway developed at the workshop as a basis for discussion. -
Members of the working group are currently sharing information in areas such as study design and availability of surrogate antibodies with the common goal of minimising primate use in mAb development. All three groups are taking a similar approach to challenging primate use but are aware of the various limitations which make this project a long-term commitment (eg following scientific acceptance of an alternative approach, regulatory change may be required for there to be a significant impact on primate use).
Related Documents NC3Rs Biologicals Workshop Report (PDF, 486KB)
NC3Rs/ABPI NHP strategy (PDF, 44KB)
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