There are numerous data and modelling challenges for cell and gene therapy, often characterized by complex, novel relationships and small sample sizes. Typical statistical approaches methods are limited in application in these situations. However, we have a choice to leverage statistical methods commensurate with the scientific demands. In this session, the advantages of Bayesian statistical methods to address these challenges are presented.
Upon completion, participant will be able to list a few common complexities of data associated with cell/gene therapy and any accelerated approval products
Upon completion, participant will be able to describe the limitations and negative consequences of application of classic statistical methods to the complex data situations common to cell and gene therapy products and accelerated approval products
Upon completion, participant will be able to describe the fundamental advantages of Bayesian statistical methods to predict performance to assure quality when there are complex data relationships and limited sample sizes