Re: Can we succesfully control diabetes with encapsulated beta-cells?

Scaling up to man can be a complicated matter in all therapeutic models. 
The evaluation of a successful or not therapy can last up to ten years 
through three main stages. In each stage the drug/therapeutic model must 
fullfill certain criteria and specifications when applied to animals 
(stage I), volunteers (stage II), and finally clinical cases (stage III) 
So the key word successful or not is rather intrinsic. The main criteria 
to say that a drug is successful are: High therapeutic efficiency/low side 
effect frequency, Pharmacoeconomics versus to therapeutic models that 
already exist.
The word product is also a complicated aspect as per the origin of it. A 
product of an R&D Lab can be successful but completely useless for 
therapeutic reasons. Experimental models are always models leading to 
improvements and modifications necessary for scaling up to man.

Sincerely, 
Michaleas Sotiris
Pharmacist, PhD