PEARSON, A.D.J., R. HEROLD, R. ROUSSEAU, C. COPLAND, B. BRADLEY-GARELIK, D. BINNER, R. CAPDEVILLE, H. CARON, J. CARLEER, L. CHESLER, B. GEOERGER, P.. KEARNS, L.V. MARSHALL, S.M. PFISTER, G. SCHLEIERMACHER, J. SKOLNIK, C. SPADONI, Jaroslav ŠTĚRBA, van den H. BERG, M. UTTENREUTHER-FISCHER, O. WITT, K. NORGA a G. VASSAL. Implementation of mechanism of action biology-driven early drug development for children with cancer. European Journal of Cancer. Oxford: Elsevier Science Inc., roč. 62, JUL 2016, s. 124-131. ISSN 0959-8049. doi:10.1016/j.ejca.2016.04.001. 2016.
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Základní údaje
Originální název Implementation of mechanism of action biology-driven early drug development for children with cancer
Autoři PEARSON, A.D.J. (826 Velká Británie a Severní Irsko), R. HEROLD (826 Velká Británie a Severní Irsko), R. ROUSSEAU (840 Spojené státy), C. COPLAND (826 Velká Británie a Severní Irsko), B. BRADLEY-GARELIK (840 Spojené státy), D. BINNER (826 Velká Británie a Severní Irsko), R. CAPDEVILLE (756 Švýcarsko), H. CARON (756 Švýcarsko), J. CARLEER (56 Belgie), L. CHESLER (826 Velká Británie a Severní Irsko), B. GEOERGER (250 Francie), P.. KEARNS (826 Velká Británie a Severní Irsko), L.V. MARSHALL (826 Velká Británie a Severní Irsko), S.M. PFISTER (276 Německo), G. SCHLEIERMACHER (276 Německo), J. SKOLNIK (840 Spojené státy), C. SPADONI (826 Velká Británie a Severní Irsko), Jaroslav ŠTĚRBA (203 Česká republika, garant, domácí), van den H. BERG (826 Velká Británie a Severní Irsko), M. UTTENREUTHER-FISCHER (276 Německo), O. WITT (276 Německo), K. NORGA (56 Belgie) a G. VASSAL (250 Francie).
Vydání European Journal of Cancer, Oxford, Elsevier Science Inc. 2016, 0959-8049.
Další údaje
Originální jazyk angličtina
Typ výsledku Článek v odborném periodiku
Obor 30200 3.2 Clinical medicine
Stát vydavatele Velká Británie a Severní Irsko
Utajení není předmětem státního či obchodního tajemství
Impakt faktor Impact factor: 6.029
Kód RIV RIV/00216224:14110/16:00092086
Organizační jednotka Lékařská fakulta
Doi http://dx.doi.org/10.1016/j.ejca.2016.04.001
UT WoS 000377385100014
Klíčová slova anglicky Paediatric oncology; Mechanisrn of action; Targeted cancer drug development
Štítky EL OK
Příznaky Mezinárodní význam, Recenzováno
Změnil Změnila: Soňa Böhmová, učo 232884. Změněno: 1. 12. 2016 12:10.
Anotace
An urgent need remains for new paediatric oncology drugs to cure children who die from cancer and to reduce drug-related sequelae in survivors. In 2007, the European Paediatric Regulation came into law requiring industry to create paediatric drug (all types of medicinal products) development programmes alongside those for adults. Unfortunately, paediatric drug development is still largely centred on adult conditions and not a mechanism of action (MoA)-based model, even though this would be more logical for childhood tumours as these have much fewer non-synonymous coding mutations than adult malignancies. Recent large-scale sequencing by International Genome Consortium and Paediatric Cancer Genome Project has further shown that the genetic and epigenetic repertoire of driver mutations in specific childhood malignancies differs from more common adult-type malignancies. To bring about much needed change, a Paediatric Platform, ACCELERATE, was proposed in 2013 by the Cancer Drug Development Forum, Innovative Therapies for Children with Cancer, the European Network for Cancer Research in Children and Adolescents and the European Society for Paediatric Oncology. The Platform, comprising multiple stakeholders in paediatric oncology, has three working groups, one with responsibility for promoting and developing high-quality MoA-informed paediatric drug development programmes, including specific measures for adolescents. Key is the establishment of a freely accessible aggregated database of paediatric biological tumour drug targets to be aligned with an aggregated pipeline of drugs. This will enable prioritisation and conduct of early phase clinical paediatric trials to evaluate these drugs against promising therapeutic targets and to generate clinical paediatric efficacy and safety data in an accelerated time frame. Through this work, the Platform seeks to ensure that potentially effective drugs, where the MoA is known and thought to be relevant to paediatric malignancies, are evaluated in early phase clinical trials, and that this approach to generate pre-clinical and clinical data is systematically pursued by academia, sponsors, industry, and regulatory bodies to bring new paediatric oncology drugs to front-line therapy more rapidly.
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