Meeting Preclinical Data Requirements For Cell & Gene Therapies


Carlos R. Plata-Salamán, CSO, CMO and Head of R&D, Esteve

The application of novel animal models, cutting edge in vitro and in silico tools and innovation in the biomarkers realm all hold the potential to drive cell & gene therapy product candidates into First-in-Human trials. But how are regulators’ requirements evolving as the field and its technologies mature? And which tools and techniques will deliver the clinical insights critical to longer term success?

  • Current and likely future preclinical requirements for established and emerging cell & gene therapy modalities
  • Accelerating toxicology studies
  • Addressing the need for predictive tools in immunotherapy