A Successful Pre-IND Enabling Next Stage Of Development

A small research and development precision medicine biotech company embarked on the journey of bringing its inaugural asset, supported by robust pre-clinical data, through the critical IND-enabling phase.

The company's team members, who have limited prior experience in dealing with the U.S. Food and Drug Administration (FDA), recognized the need for regulatory expertise if they planned to navigate a productive and successful interaction with the FDA to advance to the next development stage. To be successful, this process would have to go without incurring additional costs or time delays in their overall development program. At the same time, they aimed to foster a robust partnership with the FDA but would need regulatory consulting to assess gaps in their current program development.

Discover how Halloran was able to do just that, as well as extend leadership and technical expertise in their application review and provide coaching for FDA communication and interaction.