Discovery
Development
PCC Nomination
Target identification/Selection
Hit Identification
Hit to Lead/lead Optimization
IND Enabling
Known scaffolds, HTS with real library, Virtual screening
Identify chemical space and SAR
Improve activity, selectivity, ADME and PK/PD
HTS assay development
Binding, biochemical and cellular assays
PK/PD and pharmacology
CMC workstream
Salt screening, polymorphism, synthetic route scouting and TOX batch
GMP production
Formulation
DP production
In vitro ADME screening and animal PK screening
Metabolic stability and animal PK pilot
Target tissue exposure and metabolite studies
Pharmacology Studies
DMPK Studies
BA: MD/MV
Metabolite profiling and definitive PK studies
hERG, safety panel, phototox and genotox
MTD and DRF toxicity in two species
GLP tox studies in one rodent and one high species
GLP tox study in life phase
Pathology examination and reporting
Reports final
TK Studies
Close