European Medicines Agency - Regulatory - Regulation of medicines

3 - Specific competencies and capacity to provide export advice



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Newcastle-CCLG - Newcastle Children's Cancer and Leukaemia Pharmacology Studies Group

Number of peer reviewed publications in the last 5 years 10 Veal, GJ, Cole, M, Chinnaswamy, G, Sludden, J, Jamieson, D, Errington, J, Malik, G, Hill, CR, Chamberlain, T, Boddy, AV. Cyclophosphamide pharmacokinetics and pharmacogenetics in children with B-cell non-Hodgkin’s lymphoma. Eur J Cancer 2016 55: 56-64 Walsh, C, Bonner, JJ, Johnson, TN, Neuhoff, S, Ghazaly, EA, Gribben, JG, Boddy, AV, Veal, GJ. Development of a physiologically based pharmacokinetic model of actinomycin D in children with cancer. Br J Clin Pharmacol 2016 (In press; doi: 10.1111/bcp.12878) Errington, J, Malik, G, Evans, J, Baston, J, Parry, A, Price, L, Johnstone, H, Peters, S, Oram, V, Howe, K, Whiteley, E, Tunnacliffe, J, Veal, GJ. Investigating the experiences of childhood cancer patients and parents participating in optional non-therapeutic clinical research studies in the UK – a qualitative study. Paed Blood Cancer 2016 (In press) Veal, GJ, Errington, J, Sastry, J, Chisholm, J, Brock, P, Morgenstern, D, Pritchard-Jones, K, Chowdhury, T. Adaptive dosing of anticancer drugs in neonates – facilitating evidence-based dosing regimens. Cancer Chemother Pharmacol 2016 (In press; doi: 10.1007/s00280-016-2975-0) Siebert, N, Eger, C, Seidel, D, Jüttner, M, Zumpe, M, Wegner, D, Kietz, S, Ehlert, K, Veal, GJ, Siegmund, W, Weiss, M, Loibner, H, Ladenstein, R, Lode, HN. Pharmacokinetics and pharmacodynamics of ch14.18/CHO in relapsed/refractory high-risk neuroblastoma patients treated by long term infusion in combination with IL-2. mAbs 2016 (In press; doi: 10.1080/19420862.2015.1130196) Veal, GJ, Errington, J, Hayden, J, Hobin, D, Murphy, D, Dommett, RM, Tweddle, DA, Jenkinson, H, Picton, S. Carboplatin therapeutic monitoring in preterm and full-term neonates. Eur J Cancer 2015 51: 2022-2030 Hill, CR, Cole, M, Errington, J, Malik, G, Boddy, AV, Veal, GJ. Characterisation of the clinical pharmacokinetics of actinomycin D and the influence of ABCB1 pharmacogenetic variation on actinomycin D disposition in children with cancer. Clin Pharmacokinet 2014 53: 741-751 Veal, GJ, Errington, J, Rowbotham, SE, Illingworth, NA, Malik, G, Cole, M, Daly, AK, Pearson, ADJ, Boddy, AV. Adaptive dosing approaches to the individualization of 13-cis-retinoic acid (isotretinoin) treatment for children with high-risk neuroblastoma. Clinical Cancer Research 2013 19: 469-79 Veal, GJ, Nguyen, L, Paci, A, Riggi, M, Amiel, M, Valteau-Couanet, D, Brock, P, Ladenstein, R, Vassal, G. Busulfan pharmacokinetics following intravenous and oral dosing regimens in children receiving high-dose myeloablative chemotherapy for high-risk neuroblastoma as part of the HR-NBL-1/SIOPEN trial. Eur J Cancer 2012 48: 3063-3072 Chinnaswamy, G, Errington, J, Foot, A, Boddy, AV, Veal, GJ, Cole, M. Pharmacokinetics of cyclophosphamide and its metabolites in pediatric patients receiving high-dose myeloablative therapy. Eur J Cancer 2011 47: 1556-1563
Number of competitive grants obtained in the last 5 years 9 Pharmacology studies were conducted, data compiled and publication written by members of the network. Only those publications directly related to the activities of the network as a whole have been included.
Access to expert groups Yes
Capacity to answer external scientific questions Yes Members of the network have extensive experience in conducting clinical pharmacology studies in children with cancer and have previously provided expert opinion to pharmaceutical companies and other agencies regarding the conduct of such studies. Members sit on a number of committees, e.g. CCLG Working Parties, SIOPEN sub-committees and DMCs for pharma trials.
Site feasibility Yes
Participant recruitment Yes
Budget calculation for studies Yes