MSB Trading 2021 - paradigm shift, page-7848

So from the slides from the meeting, it seems like one of the FDAs major concerns is that TNFR1 expression was identified by MSB as a standardised marker or potency, which would likely allow them to sample a batch, quantify the presence of this protein, and establish a batch potency prior to release.

The problem the FDA have with this is that using this marker as a surrogate for potency is not yet supported by either the mechanism of action, or by the studies in humans (it does not correlate with clinical response).

To rectify this, MSB will have to come up with a new marker that satisfies these requirements, a new method of demonstrating potency, or run more trials that hopefully validate this marker.

I'm guessing that paper posted from Nature published last month may have some insights about that. I still haven't managed to access it, but once I do I'll let you guys know what I find.