In the name of the Program Planning Committee, we would like to warmly invite you to join us for the 2021 PDA Advanced Therapy Medicinal Products Conference, to be held online on 23-24 June!
The PDA will be hosting its 13th two-day event that 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 leukaemias 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 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 and/or phenotypic heterogeneity represent a significant challenge for product characterization. How can this be better understood? Are developers too focussed on the name we give to a group of cells and overlooking the role of sub-sets? How can product characteristics be linked to clinical efficacy?
The conference will be a Virtual Event with an online platform allowing for remote participation and presentation! Ample opportunities for interaction between attendees and live Q&A sessions will provide an engaging and fruitful experience!
Dayue Chen, PhD, Genentech/Roche
Christopher Bravery, PhD, Advanced Biologicals
SCIENTIFIC PROGRAM PLANNING COMMITTEE
- Dayue Chen, Genentech/Roche - Chair
- Christopher Bravery, Advanced Biologicals - Chair
- Manuel Carrondo, ibet
- Francesco Cicirello, EVELO BIOSCIENCES
- Richard Denk, SKAN
- Marco Fadda, Comecer
- Fabio D’Agostino, Claris Ventures
- Andre Raposo, Oxford BioMedica
- Irving Ford, Bristol-Myers Squibb
- Josh Eaton, PDA
- Falk Klar, PDA Europe
- Sylvia Becker, PDA Europe, Senior Manager Programs & Events