Interview with a FDA Process expert...

Paradigmers, through a good friend I have organised a catch up meeting tomorrow (Thursday 16th of Sep) lunch time with a guy that has had a lot of FDA experience in the clinical trial process.

I have included a few questions I'm thinking of covering. Obviously they can only be of a general nature as he currently has nothing to do with PAR's trials and wouldn't be able to answer if he did. If any of you have any questions of a general nature in regards to the clinical trial process or how the FDA operates etc, please list them under this thread before 11am EST Thursday. I can post answers after the meeting.

I understand a few of these answers we can just glean off the internet, but thought it might be nice to hear it from someone that has actual experience.


QUESTIONS:


1) What is the typical/average time between Pre-IND and IND meetings? (in terms of normal pathway and also in the case of an Orphan labelled drug).


2) In order to declare a trial 'open', what are some of the criteria? Ie if a trial typically would go for 18 months, what would be some of the indicators/reasons to stop the trial early in order to get the drug out quicker? Is this a higher chance of occurring if the drug delivers very good efficacy without any safety concerns/issues in the case of an Orphan type indication/trial?


3) How often does a sponsor need to check in with the FDA, is it on a monthly basis or ad hoc during a phase three trial? I understand there has to be immediate (within 7 days?) if there are any noticed safety issues or AE's but I'm referring to just general checking in and general updates on how the trial is progressing etc..


4) If the immediate data, for example after a few weeks after the first batch of patients have gone through after a Phase 3 has started, looks really good, can a higher priority designation be issued at that point (eg Breakthrough/Fast Track etc) or is this generally done before the P3 starts or at the time of IND or just after that?


5) How does the relationship between FDA and EMA work? Have you had any direct experience of this? I know the meetings these days are effectively Zoom calls, were they phone calls in the past or were there some face to face meetings too?



-Mozz