Expanding Indications Under Open INDs

The most effective medical product development is accomplished via an integrated approach to all of the technical disciplines: CMC, Preclinical/Nonclinical, Clinical, and Regulatory Strategy. This talk will focus on modern regulatory strategies to achieve this goal, with particular attention to go/no go decision making; the addition of new indications to existing INDs; the types of studies needed to bolster the new indication(s); appropriate report types that must be submitted to the FDA; the importance of concordant clinical protocols; the critical role of the pre-IND consultation; and case studies.