Description: To begin a study in cell and Gene therapies requires careful planning. A new IND containing information of a novel cell and gene therapy requires careful planning, interactions with FDA to get advices to plan the CMC and preclinical developments, as well as pre-IND meetings to agree what information is required for the first-in-human study. This presentation will provide an overview of the activities required prior to an IND submission, a checklist for CMC, preclinical and clinical activities, and lesson-learned examples to help companies planning a new IND and to avoid a clinical hold imposed by FDA due to data deficiencies.
Learning Objectives:
Upon completion, participant will be able to understand what pitfalls can trigger a clinical hold in cell and gene therapy INDs
Upon completion, participant will be able to use the checklist to plan IND activities to avoid submitting an IND that leads to a clinical hold
Upon completion, participant will be able to have a strategy to respond to a clinical hold imposed by FDA