The clinical program has been designed to cover all the essential aspects of the technology to generate the data needed for the IMBG to be used in a reliable way. It is very important to consider that IMBG will NOT directly guide the physician prescription. The IMBG offers efficacy/potency information to be used with epidemiological, immunological, clinical and pharmacokinetic (TDM) variables, which altogether combined, will drive the decision.
To improve patients showing a RT hard outcome (in terms of graft failure or proven signs of immune rejection by a biopsy) the physician will have to consider not only the clinical decisions about the IS regimen to be used, but also a pool of epidemiological (ie donors age, type-death or living donor-, recipient characteristics), clinical, and immunological variables (ie level of HLA mismatch, dnDSA appearance). Clinical decisions have always been made taking into account these important variables, and pharmacodynamic (IMBG) and pharmacokinetic (TMD) data will complement them, and help physicians to make more precise therapeutic decisions.