Presentation Title: Key Elements of a Well Composed Nonclinical Section of an IND Application
New oligonucleotide therapeutics under investigation offer unique challenges relative to other pharmaceuticals. During preparation and submission of an investigational new drug (IND) application there are a number of regulatory gray areas due to the large heterogeneity in the type of oligonucleotide therapeutics and our knowledge of any particular subclass. Based on lessons learned, this talk will describe selected general considerations to a successful non-clinical IND submission.