Failure Is Not An Option: How to Avoid and Recover From an IND Clinical Hold

Description: While essential for protecting public health, the prospect of a clinical hold is often a concern of Sponsors. Although data suggests that most holds are eventually lifted, the time and cost associated with resolving identified deficiencies can be substantial and is rarely accounted for in project timelines.

Experience says that regardless of therapeutic modality or indication, the risk of a hold can often be anticipated and greatly reduced by advancing a regulatory strategy that is equally informed by guidance, regulatory precedent, and core principles like risk management and quality by design.

This session will provide engaging presentations for each of the core IND disciplines (nonclinical, clinical, and quality) in turn – emphasizing what is needed for a complete application and the value of strategic thinking in evaluation and mitigation of identified risks.