Now in its 13th year, the PDA Advanced Therapy Medicinal Products Conference aims to support all stakeholders in the development and commercialization of novel and effective cell and gene and tissue therapies.

The phenomenal success of CAR-T for leukaemia’s, has led to a proliferation of new immunotherapy approaches utilising all types of immune effector cells.  One obvious limitation is that these have so far primarily been autologous products, with associated high costs and manufacturing challenges at scale.  A noticeable shift is occurring with more developers exploring allogeneic approaches yet sourcing larger volumes of leukocytes from one individual remains a barrier.  One solution might be induced pluripotent stem cells (iPSC) since these could in principle be banked and supply the whole product lifecycle, thus bringing cell-based medicines a step closer to the biotech model.

This year’s theme of ATMP Heterogeneity: Can we gain deeper insights through an integrated utilisation of quality, preclinical and clinical data? hopes to bring discussion to bear on the importance of understanding product heterogeneity and how we can characterise this and bring together quality, nonclinical and clinical data.  Understanding the critical quality attributes (CQA) is an essential element to developing a commercial manufacturing process yet confirming those requires sufficient clinical efficacy data.  For cell-based medicines, in particular, cellular heterogeneity can be significant, e.g., mesenchymal stromal cells, T cells.  How can this be better understood?  Are developers too focused on the name we give to a group of cells and overlooking the role of sub-sets?

The conference will be planned as a Hybrid Event - an online platform allowing for remote participation and presentation will support the on-site event! Ample opportunities for interaction between attendees, live questionnaires, and live Q&A sessions will provide the audience with an engaging and fruitful experience, online or on-site!