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INNOVATION AT UCT
5 000 to 10 000
compounds
250
5
1
Best timeline assuming
availability of adequate funding
and skilled resources. Not
necessarily representative of
current SA situation
1 TO 2 YEARS
2 YEARS
3 YEARS
6 TO 7 YEARS
0.5 TO 2 YEARS
IDENTIFY DISEASE
Scientists and clinicians work
on understanding the characteristics
of the disease and its causes as the
basis for drug discovery.
IDENTIFY AND VALIDATE DRUG TARGET
Selection of a suitable target for
the new drug to act on. Need to validate
that it is indeed involved in the disease.
COMPOUND SCREENING-
IDENTIFY HITS
In vitro activity and selectivity is monitored to
identify compounds that show promise.
LEAD IDENTIFICATION
In vivo
activity & selectivity.
LEAD OPTIMISATION:
in
vitro
and
in
vivo
activity.
PRE-CLINICAL TRIALS
Laboratory and animal testing to
check safety ahead of human trials.
PHASE 1 CLINICAL TRIAL
Drug is tested on small group
(20 to 100) of healthy volunteers.
Establish human safety and side effects.
PHASE 2 CLINICAL TRIAL
Drug is tested on a small group of patients
(100 to 500). Short-term side effects, risks
and efficacy are assessed.
PHASE 3 CLINICAL TRIAL
Large group of patients (1 000 to 5 000)
are administered the drug to generate
statistically significant safety and efficacy data.
FDA REVIEW AND APPROVAL
LARGE-SCALE MANUFACTURING.
POST-MARKET SURVEILLANCE.
Industry
partner
Industry
partner
Groote Schuur
Hospital
Health Sciences
Faculty
Dept. Chemistry
Dept. Chemistry
Dept. Chemistry
Dept. Chemistry
Division of Pharmacology
Division of
Pharmacology
Division of
Pharmacology
Dept Medicine
UCT Lung
Institute
Dept.
Medicine
UCT Lung
Institute
Physical properties
LEAD
Selectivity
TOXICITY ASSAYS
FDA APPROVED
PRODUCT
in
vitro
+
in
vivo
absorption, distribution
metabolism and excretion
Optimised lead
or development
candidate
I IDMM
I IDMM I IDMM I IDMM I IDMM
I IDMM
I IDMM
I IDMM
Figure 7
UCT players in the innovation stages from drug discovery through to commercialisation