When Is the Best Time for a Pre-IND Meeting?

Prior to submitting an initial Investigational New Drug (IND), sponsors can (and most likely should) solicit the FDA’s feedback on their planned development program and/or IND-readiness through a Pre-IND meeting.

The timing of the Pre-IND meeting relative to the initial IND submission is dependent on the sponsor’s goals for the meeting, identified risks, and the novelty of their development program.

The recommended timing for a Pre-IND meeting relative to initial IND submission is as follows:

• Greater than one year: sponsors intending to rely on novel manufacturing strategies and/or nonclinical evaluations to support clinical studies.
• Six to nine months: sponsors that have completed most of their IND-enabling nonclinical pharmacology/pharmacokinetics studies and early toxicology studies and are now seeking FDA’s confirmation of their planned, definitive toxicology studies and clinical study synopsis. Sponsors should also have a developed chemistry, manufacturing, and controls (CMC) plan and early manufacturing data.
• Less than three months: sponsors with complete (or nearly complete) CMC and nonclinical packages, and a fully developed clinical study synopsis, seeking confirmation of the adequacy of their overall IND package to support human studies.
• No Pre-IND meeting: sponsors pursuing an indication in which significant precedent exists and have not identified any potential risks during their development program. This also may be necessary when a sponsor cannot afford to delay their IND submission and/or alter their development program based on FDA feedback.
  
  

Halloran almost always recommends that sponsors have a Pre-IND meeting.

Halloran can help you determine the most appropriate timing for a Pre-IND meeting, support the development of your Pre-IND meeting package, and provide strategic input in preparation.

Learn more about Halloran’s services and solutions.