Regulatory Open Forum

When should one plan to discuss with FDA about dose optimization ? Would it be after the dose escalation part of the Phase 1 study and before the dose expansion part ? FDA seems very keen lately on sponsors discussing dose optimization early in development and wouldn't let sponsors proceed to Phase 2 study without discussion and agreement between FDA and sponsors on the dose optimization plan. There's even the risk that studies can be put on clinical hold without agreement on the dose optimization. Please share your recent meeting experience with FDA on dose optimization (without sharing confidential information). Thanks ! 

I'd recommend (logically) for NCE/NBE after dose escalation and possibly once you reach MTD or other appropriate criteria to determine recommended phase 2 dose. This stage of development is still considered early development phase!  

Your statement "There's even the risk that studies can be put on clinical hold without agreement on the dose optimization" is not accurate. This situation is most likely for a drug with a safety signals in early stage study or studies.

Good luck!