Among the keynote speakers at the International Conference of Alternatives to Animal Experimentation in Portugal in May will be independent drug development consultant Dr Robert Coleman whose talk will be : Humanising drug safety testing: a pragmatic validation study.
Dr Coleman published a paper in the latest issue of FRAME’s scientific journal ATLA (Alternatives to Laboratory Animals) on a similar topic. In it he discusses how the original concept of the Three Rs is being changed by the most recent developments in research and calls for a greater emphasis on the first R: Replacement.
“With growing evidence of the shortcomings of laboratory animal testing to reliably predict human responsiveness to chemicals, questions are being asked as to whether it is appropriate to use animals as human surrogates at all, “ he says.
“This raises the question of whether, of the original Three Rs, two – Reduction and Refinement – are potentially redundant.”
He suggests that future research should be based on Replacement and rooted firmly in human biology. The paper looks at current alternative technologies that have revealed information about the human body and considers their strengths and weaknesses. It also looks at how to progress towards greater replacement of animal models.
A number of objections against human-based testing have been put forward to justify the continuing use of animals in laboratories. They include the lack of information about fully-integrated responses when only individual organs are studied; problems in obtaining sufficient and appropriate human tissue samples; lack of experience in using human tissues; and the availability of only a small number of validated tests. He says: “While each of these undoubtedly represents a challenge, there is no reason to believe that any of them is insuperable.”
The hurdles slowing the advent of Replacement fall basically into two categories: technical ability, and acceptance by industry and regulators. There is still some way to go in both areas, he concludes.
Human-based Systems in Drug and Chemical Safety Testing — Toward Replacement, the ‘Single R’. ATLA 42.6 2014 is available online by clicking here.
The conference takes place in Lisbon, Portugal on 8 & 9 May, 2015. For more details click here.