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@ARTICLE{Reaman:294420,
      author       = {G. Reaman and L. Stancato and G. Vassal and J. M. Maris},
      title        = {{C}rossing {O}ceans: {P}reclinical {C}ollaboration to
                      {I}mprove {P}ediatric {D}rug {D}evelopment.},
      journal      = {Educational book / American Society of Clinical Oncology},
      volume       = {40},
      number       = {40},
      issn         = {1548-8748},
      address      = {Alexandria, VA},
      publisher    = {American Society of Clinical Oncology},
      reportid     = {DKFZ-2024-02249},
      pages        = {409 - 416},
      year         = {2020},
      abstract     = {Changes in the regulatory environment affecting pediatric
                      cancer drug development in the United States and the
                      European Union provide unprecedented opportunity to advance
                      the concept of precision medicine to children with cancer.
                      Increasing evidence suggests that new drugs and biologic
                      products directed at molecular targets presumed to be
                      etiologically associated with many adult cancers may well
                      provide therapeutic options for selected subsets of children
                      with cancer despite their histologic and biologic
                      differences. Regulatory requirements for early evaluation of
                      appropriate new drugs for children based on their molecular
                      mechanism of action, rather than the specific clinical
                      indications for which they are developed and/or approved,
                      will shorten the unacceptable time lag between
                      first-in-human and first-in-children studies. The relative
                      scarcity of pediatric patients eligible for
                      biomarker-directed studies and the ever-expanding compendium
                      of new targeted agents mandate rational, science-based
                      decision-making in selecting and prioritizing appropriate
                      drugs to study early in development. A critical component of
                      the evidence base in such decision-making includes
                      preclinical testing of relevant drugs in pediatric
                      tumor-specific in vitro and in vivo models. Established
                      preclinical testing programs with academic
                      investigator-industry collaborations are actively engaged in
                      such activities. International collaboration is required to
                      address the resource constraints and increasing number of
                      potential products to be tested in a timely, efficient,
                      nonduplicative, and cost-effective manner.},
      keywords     = {Child / Drug Development / Humans},
      ddc          = {610},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:32207673},
      doi          = {10.1200/EDBK_278893},
      url          = {https://inrepo02.dkfz.de/record/294420},
}