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WTP
They couldn't have run any clinical trials without CMC work and data - they'd never have been given regulatory approval to dose a single patient without it. So yes, it has been going on and it's part and parcel of all drug development. As for who previously carried out the work, I'm not sure whether Scancell contracted any of it out, but if not, Sally Adams and her small team were probably covering it.
There have been many (justified) comments on this bb re. the apparent bottleneck when it comes to translating Lindy Durrant's innovation into hard products and taking them into the clinic. This is the one area, that was most in need of funding and hopefully will be transformed by Redmile's investment. It's going to take time but you can see by the positions being recruited that Scancell clearly have recognised the need.
Worth noting that one of the first things Scancell did after the second, large round of funding from Redmile was to go out and recruit Dr Gillies O'Bryan-Tear as Chief Medical Officer and Dr Robert Miller as Medical Director - both of whom have a wealth of clinical development experience. I'm sure they'll be instrumental in building the required infrastructure to improve upon the clinical development of Scancell's products.
By the way, still a baby bio in my books but with the potential now to become something more.
WTP,
I'd say Scancell are very much still a "baby" bio. They rely on their parents (Redmile/Vulpes) for financial support as they are unable to stand on their own two feet at the moment. Perhaps they will never grow up, like Peter Pan?
And like real kids, they can get through mum and dad's money a a fair rate of knots lol!
Thanks Bermuda, I got the gist from the article but your extra context definitely helped. What I don't understand is that was someone on the scientific team doing this before even though it was not their primary role? Or were they not trying to meet CMC requirements up until now? If so, I guess there is a very specific requirement now for CMC, covidity perhaps?
But it is impressive is Scancell seem to be recruiting for very specific roles now. As crumbs says Scancell are no baby bio anymore.
Dracula makes a good point, the wage bill must be eye watering now. But on the same token, there must be huge confidence going forward (and a current requirement) to take on so many more new staff.
WTP
CMC stands for Chemistry, Manufacturing, and Controls, it's an integral part of all stages of drug development and is all about safety and quality control of the actual drug product - ie. the composition and characteristics, the testing, the manufacture etc.
When Scancell submits a clinical trial application they have to submit lengthy and detailed CMC information. This will include things like, characterisation of the drug, the formulation, the manufacture, dose, stability testing etc. etc. They'll have to submit this info. for each and every application, for every stage of clinical trial and to all regulators, whether it's the FDA, MHRA or SAHPRA. It's an important role that can make all the difference between a smooth and bumpy path when it comes to dealing with the regulators, so it's vital to get it right .
P.s. Can someone expand on CMC Regulatory please, not that familiar with it. And it's context with regards to that recent appointment.
BTW scancell now looks more NASDAQ listable.... not saying that is on the cards yet I'd expect trials and data first but.... it was the way of Immunocore and Adaptimmune....
There you go second broker too!! I can't keep up lol
Scancell were a Notts Uni research spinout they are not anymore they are a real baby bio now ...again could pharma/s be looking in and even to a degree directing this... yes it is possible certainly main thing is getting the trials on... then there will be no ignoring scancell
@ crumbs, RE radio silence, yep we've had to turn detective using linkedin and job recruitment sites to get an idea of what's going.
But was it Dalester who said it felt like some due diligence was happening? Most obvious answer for the silence IMO, because we can see (even the dormers) from all the recruitment that lots is happening.
Don't forget the new broker!
It is why I'm not getting these err dormer posts .... scancell is rapidly growing in an exciting way.... now I'm not saying they are communicating that to us well..... we have to go snooping on Linkedin..... but I suppose it is all part of the redmile money plan again no chance to my mind of any lowball buyouts.... add value to create value.... scancell in theory could be multiple companies each platform could be a potential unicorn in its own right.... yes I do want to know what Zac is all about and sure please tell us more about SA trial and the none injection techs and we do deserve a modi1 update but come on no one can say there is not all kinds of potential multibagger work going on at scancell at the moment... OXT presentation vid will be a welcome viewing and could possibly come with an update too...
As highlighted by crumbs, I really think it's worth looking at who is listed as working for Scancell atm (according to Linkedin that is). The team has expanded perphaps even more than we realised:
https://www.linkedin.com/search/results/people/?keywords=scancell&origin=CLUSTER_EXPANSION
For example Scancell have also recently hired a CMC Regulatory Associate.
https://www.avomeen.com/understanding-chemistry-manufacturing-and-controls-cmc/
It seems multiple new roles have actively started in the last two months, and not just the ones we spotted as being advertised.