Overall, the project plan is currently composed of about 5 main Work Packages, but this may be detailed further throughout the project application phase:
1.CONSORTIUM MANAGEMENT AND ADMINISTRATION
2.REGULATORY AFFAIRS
a.Regulatory strategy plan for marketing authorisations in the EU and US
b.EMA-COMP consultation (protocol assistance meetings)
c.FDA consultation meetings
d.Risk management planning (pre-study safety considerations for exposure of Oxabact to immunosuppressed patients)
3.CLINICAL TRIAL(s)
a.Patient recruitment strategy plan (prevalence study)
b.Transplant centres network and infrastructure
c.Proof-of-concept study A: Continued treatment in PH: from dialysis to post-rTX
d.Proof-of-concept study B: Prevention of PH in rTX patients
e.Proof-of-concept study C: Treatment of recurrent PH after rTX
4.BIOMARKERS AND SURROGATE ENDPOINTS
a.Immunology markers/immune staining
b.Molecular profiling
c.miRNA profiling in urine
5.EXPLOITATION AND DISSEMINATION
a.Publication and dissemination
b.Business development