Hill, Marilyn (2014) NC3Rs/MHRA working group on Recovery animals Global cross-company data sharing to examine the use of recovery animals in safety assessment to support first-in-human clinical trials? Global cross-company data sharing to examine the use of recovery animals in safety assessment to support first-in-human clinical trials (70). pp. 413-429.

Abstract

Global cross-company data-sharing on the use of recovery animals for human safety assessment

Recovery animals are used in pharmaceutical development to provide information on the potential for human toxicity. They may be included on various toxicology studies to assess whether effects observed during the dosing period persist, or are partially/fully reversible. However, recovery groups are often included as default without study specific consideration of their value or necessity. This increases animal use and may prolong the length of study, with subsequent implications for welfare and resources. A global initiative which includes 32 organisations (pharmaceutical and biotechnology companies, contract research organisations and regulatory bodies) has shared data on the use of recovery animals in the assessment of human safety. This initiative is led by the UK National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) in collaboration with the Medicines and Healthcare products Regulatory agency (MHRA).

The group devised a questionnaire to collect information on the use of recovery animals in general regulatory toxicology studies to support first-in-man-clinical studies. Questions focused on study design (e.g. species, recovery duration and the number of animals used), the rationale behind inclusion or exclusion (case-specific vs. default inclusion), and the impact that this had on internal and regulatory decisions. Data on 137 compounds (53 biologicals and 78 small molecules) and 259 studies has been provided by 22 companies. The data shows differences in the use of recovery animals between small and large molecules and that in many cases reducing the number of recovery animals does not impact drug development. The evidence-base will be used to make recommendations on the inclusion of recovery animals to best assess human safety.

Authors:
Fiona Sewell, NC3Rs
Kathryn Chapman, NC3Rs
Ian Ragan, Independent
Paul Baldrick, Covance
David Brewster, Vertex
Alan Broadmeadow, Huntingdon Life Sciences
Paul Brown, Food and Drug Administration
Leigh-Ann Burns Naas, Gilead
Janet Clark, Biogen Idec
Alex Constan, Infinity
Jessica Couch, Genentech
Oliver Czupalla, Bayer
Andy Danks, Charles River Laboratories
Joseph DeGeorge, Merck
Lolke De Haan, MedImmune
Matthias Festag, Roche
Mark Gold, Boehringer Ingelheim
Sophia Gry Moesgaard, Novo Nordisk
Klaudia Hettinger, Austrian Agency for Health and Food Safety
Marilyn Hill, Novartis
David Hutto, Eisai
Abby Jacobs, Food and Drug Administration
David Jacobson Kram, Food and Drug Administration
David Jones, Medical and Healthcare products Regulatory Agency
Stephan Kopytek, Celgene
Ruth Lightfoot-Dunn, Amgen
Helga Lorenz, AbbVie
Emma Moore, Huntingdon Life Sciences
Markku Pasanen, University of Eastern Finland
Rick Perry, Pfizer
Gabriele Reichmanin, Paul-Ehrlich-Institut
Sally Robinson, Astrazenca
Achim Schenk, Boehringer Ingelheim
Julia Schlichtiger, Boehringer Ingelheim
Petra Schmitt, Paul-Ehrlich-Institut
Brian Short, Allergan
Beatriz Silva Lima, iMED, University of Lisbon and Infarmed
Diane Smith, Millenium
Sue Sparrow, GlaxoSmithKline
Yvette van Bekkum, Janssen

Item Type:	Article
Date Deposited:	29 Apr 2016 23:45
Last Modified:	29 Apr 2016 23:45
URI:	https://oak.novartis.com/id/eprint/20536