Cell and gene therapies (CGTs), such as CAR-T cells, oligonucleotide therapies and viral-vector-based gene therapies, have the potential for substantial efficacy in treating diseases with high unmet needs. Reflecting this potential and the clinical validation of multiple CGT technology platforms, the number of industry-sponsored development programmes for CGTs
has grown rapidly. However, anecdotally, there have been numerous reports of delays in development programmes for CGTs, reminiscent of the growing pains associated with the very early days of other therapeutic modalities such as monoclonal antibodies (mAbs).