Hi Matthew, thanks for engaging and for your thoughtful comments/questions.
In non-pandemic times, yes. Australia has less requirements for a IND-type submission (GMP certificate only needed prior to enrollment, not at submission); you only need the HREC approval (IRB equivalent) and no national regulatory approval (just a rubber stamp); and depending on the indication and competitive pressures you usually get faster enrollment.
Agreed. I was talking more about regulatory speed to get into FIH.
You can still get a pre-IND meeting with US regulators and get their feedback before or in parallel to conducting a AU P1 (I recommend before, but if there are few/no uncertainties you might consider in parallel). So you don’t have to choose. Agreed that FDA has requirements for foreign data, but it is a low bar (GCP, IRBs, ICs), and you could still get a majority of your data from outside the US. Rule of thumb is you need 20% of your data for an NDA/BLA to be from US populations, but even that rule has been broken successfully.
These are great points, I don’t have a lot of experience with NDA/BLA submissions to foreign countries so your insights are valuable. I’ll just note I was specifying people use Australia for P1. Agree that P2s and P3s are another ballgame.
Hi Matthew, thanks for engaging and for your thoughtful comments/questions.
In non-pandemic times, yes. Australia has less requirements for a IND-type submission (GMP certificate only needed prior to enrollment, not at submission); you only need the HREC approval (IRB equivalent) and no national regulatory approval (just a rubber stamp); and depending on the indication and competitive pressures you usually get faster enrollment.
Agreed. I was talking more about regulatory speed to get into FIH.
You can still get a pre-IND meeting with US regulators and get their feedback before or in parallel to conducting a AU P1 (I recommend before, but if there are few/no uncertainties you might consider in parallel). So you don’t have to choose. Agreed that FDA has requirements for foreign data, but it is a low bar (GCP, IRBs, ICs), and you could still get a majority of your data from outside the US. Rule of thumb is you need 20% of your data for an NDA/BLA to be from US populations, but even that rule has been broken successfully.
These are great points, I don’t have a lot of experience with NDA/BLA submissions to foreign countries so your insights are valuable. I’ll just note I was specifying people use Australia for P1. Agree that P2s and P3s are another ballgame.