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@ARTICLE{Krackhardt:132720,
      author       = {A. M. Krackhardt$^*$ and B. Anliker and M. Hildebrandt$^*$
                      and M. Bachmann$^*$ and S. Eichmüller$^*$ and D.
                      Nettelbeck$^*$ and M. Renner and L. Uharek$^*$ and G.
                      Willimsky$^*$ and M. Schmitt$^*$ and W. S. Wels$^*$ and M.
                      Schüssler-Lenz},
      title        = {{C}linical translation and regulatory aspects of
                      {CAR}/{TCR}-based adoptive cell therapies-the {G}erman
                      {C}ancer {C}onsortium approach.},
      journal      = {Cancer immunology immunotherapy},
      volume       = {67},
      number       = {4},
      issn         = {1432-0851},
      address      = {Berlin},
      publisher    = {Springer},
      reportid     = {DKFZ-2018-00374},
      pages        = {513 - 523},
      year         = {2018},
      abstract     = {Adoptive transfer of T cells genetically modified by TCRs
                      or CARs represents a highly attractive novel therapeutic
                      strategy to treat malignant diseases. Various approaches for
                      the development of such gene therapy medicinal products
                      (GTMPs) have been initiated by scientists in recent years.
                      To date, however, the number of clinical trials commenced in
                      Germany and Europe is still low. Several hurdles may
                      contribute to the delay in clinical translation of these
                      therapeutic innovations including the significant complexity
                      of manufacture and non-clinical testing of these novel
                      medicinal products, the limited knowledge about the
                      intricate regulatory requirements of the academic developers
                      as well as limitations of funds for clinical testing. A
                      suitable good manufacturing practice (GMP) environment is a
                      key prerequisite and platform for the development,
                      validation, and manufacture of such cell-based therapies,
                      but may also represent a bottleneck for clinical
                      translation. The German Cancer Consortium (DKTK) and the
                      Paul-Ehrlich-Institut (PEI) have initiated joint efforts of
                      researchers and regulators to facilitate and advance early
                      phase, academia-driven clinical trials. Starting with a
                      workshop held in 2016, stakeholders from academia and
                      regulatory authorities in Germany have entered into
                      continuing discussions on a diversity of scientific,
                      manufacturing, and regulatory aspects, as well as the
                      benefits and risks of clinical application of CAR/TCR-based
                      cell therapies. This review summarizes the current state of
                      discussions of this cooperative approach providing a basis
                      for further policy-making and suitable modification of
                      processes.},
      subtyp        = {Review Article},
      cin          = {L701 / G182 / L301 / L101 / L201 / L501},
      ddc          = {610},
      cid          = {I:(DE-He78)L701-20160331 / I:(DE-He78)G182-20160331 /
                      I:(DE-He78)L301-20160331 / I:(DE-He78)L101-20160331 /
                      I:(DE-He78)L201-20160331 / I:(DE-He78)L501-20160331},
      pnm          = {317 - Translational cancer research (POF3-317)},
      pid          = {G:(DE-HGF)POF3-317},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:29380009},
      doi          = {10.1007/s00262-018-2119-y},
      url          = {https://inrepo02.dkfz.de/record/132720},
}