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Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials

Sewell, F and Chapman, K and Baldrick, P and Brewster, D and Broadmeadow, A and Brown, P and Burns-Naas, LA and Clarke, J and Constan, A and Couch, J and Czupalla, O and Danks, A and DeGeorge, J and Haan, LD and Hettinger, K and Hill, M and Festag, M and Jacobs, A and Jacobson-Kram, D and Kopytek, S and Lorenz, H and Moesgaard, SG and Moore, E and Pasanen, M and Perry, R and Ragan, I and Robinson, S and Schmitt, PM and Short, B and Lima, BS and Smith, D and Sparrow, S and Bekkum, YV and Jones, D (2014) Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials. Regul Toxicol Pharmacol .

Abstract

An international expert group which includes 30 organisations (pharmaceutical companies, contract research organisations and regulatory bodies) has shared data on the use of recovery animals in the assessment of pharmaceutical safety for early development. These data have been used as an evidence-base to make recommendations on the inclusion of recovery animals in toxicology studies to achieve scientific objectives, while reducing animal use. Recovery animals are used in pharmaceutical development to provide information on the potential for a toxic effect to translate into long-term human risk. They are included on toxicology studies to assess whether effects observed during dosing persist or reverse once treatment ends. The group devised a questionnaire to collect information on the use of recovery animals in general regulatory toxicology studies to support first-in-human studies. Questions focused on study design, the rationale behind inclusion or exclusion and the impact this had on internal and regulatory decisions. Data on 137 compounds (including 53 biologicals and 78 small molecules) from 259 studies showed wide variation in where, when and why recovery animals were included. An analysis of individual study and programme design shows that there are opportunities to reduce the use of recovery animals without impacting drug development

Item Type: Article
Additional Information: NIBR author: Hill, M institute: NIBR contributor address: UK National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs), Gibbs Building, 215 Euston Road, London, NW1 2BE, UK. Electronic address: fiona.sewell@nc3rs.org.ukUK National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs), Gibbs Building, 215 Euston Road, London, NW1 2BE, UKCovance Laboratories Ltd, Otley Road, Harrogate, HG3 1PY, UKVertex Pharmaceuticals Inc., 50 Northern Avenue, Boston, MA 02139, USAHuntingdon Life Sciences Ltd, Occold, Eye, Suffolk, IP23 7PX, UKFood and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD 20993, USAGilead Sciences, Inc., 333 Lakeside Drive, Foster City, CA 94404Biogen Idec, Cambridge, MA 02142, USAInfinity Pharmaceuticals, 780 Memorial Drive, Cambridge, MA 02139, USAGenentech, Inc., 1 DNA Way, South San Francisco, CA, 94080, USABayer Pharma AG, Mullerstrasse 170, 13353 Berlin, GermanyCharles River Laboratories, Preclinical Services, Tranent, Edinburgh, EH33 2NEMerck, 770 Sumneytown Pike, Mailstop WP45-201, West Point, PA 19486, USAMedImmune, Granta Park, Cambridge CB21 6GH, UKAustrian Agency for Health and Food Safety, Traisengasse 5, 1200 Vienna, AustriaNovartis Institutes for BioMedical Research (NIBR), Basel, SwitzerlandRoche Pharmaceutical Research and Early Development, Roche Innovation Center Basel, CH - 4070 Basel, SwitzerlandFood and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD 20993, USAFood and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD 20993, USACelgene, 86 Morris Avenue, Summit, New Jersey 07901, USAbbVie Deutschland GmbH& Co. KG, Knollstrasse, 67061 Ludwigshafen, GermanyNovo Nordisk A/S, Novo Nordisk Park, Maaloev, DenmarkHuntingdon Life Sciences Ltd, Alconbury, Huntingdon, Cambridgeshire, PE28 4HS, UKUniversity of Eastern Finland, Faculty of Health Sciences, School of Pharmacy, Kuopio, FinlandPfizer Drug Safety Research and Development, 455 Eastern Point Rd., Groton, CT 06340, USABoard member, NC3Rs, Gibbs Building, 215 Euston Road, London, NW1 2BE, UKAstraZeneca, Alderley Park, Macclesfield, Cheshire SK10 4TG, UKPaul-Ehrlich-Institute, Federal Agency for Vaccines and Biomedicines, Langen, GermanyAllergan, Drug Safety Evaluation, 2525 Dupont Dr, RD-2A, Irvine, CA 92612-1599, USAiMED, UL, University of Lisbon, PortugalMillenium: The Takeda Oncology Company, 40 Landsdowne St., Cambridge, MAGlaxoSmithKline, Park Road, Ware, Hertfordshire, SG12 0DP, UKJanssen Research & Development, Turnhoutseweg 30, 2340, Beerse, BelgiumMedicines Healthcare Products Regulatory Agency (MHRA)
Date Deposited: 13 Oct 2015 13:12
Last Modified: 13 Oct 2015 13:12
URI: https://oak.novartis.com/id/eprint/23416

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