Project Planning

Chiral Switch Project Outline.pdf19.58 KB

Based on past experience with "Chiral Switch" projects in a commercial environment, I have drafted the attached document as a summary of my understanding of the aims of the PZQ project in the context of what would be needed (technically) to get (R)-PZQ to market in the western world.  This does not examine manufacture per se, but rather the many necessary steps to obtain permission to market.  I am sure there are some which I may have missed, but the point is that there would (in my past experience) be far more going on than focussing as at present on "manufacture" and "cost of goods", however important these will be in the long-run. 
It is necessary to prove both safety & effectiveness.  Now this may already be in place, but it is not yet evident on this site, and the expected standards change over time.  This is why I suggest a critical review of the existing data, to identify any gaps in 21st-Century terms.  If these are found to exist, then they can only presently be addressed through re-supply of (R)-PZQ by chromatographic means, which is a project in itself.  Commercially, this would be pursued in parallel with the efforts to identify a viable manufacturing route to the single enantiomer.
This is intended as a discussion document, and I am receptive to amendments or additions.  Some of the points made by "guest" under the PZQ Manufacturing Capacity thread are quite relevant.