Unformatted Text Preview0 Change in formulation may require bioequivalence proof
Stage 1: Discovery
Project initiation — How do companies come up with ideas?
0 Drug companies target markets, not disease
0 Each new drug now costs more than $ 1 billion to develop
0 Company must sell enough drug to recover costs and make profit
0 Market analysis
0 Competitive assessment
0 Research analysis
Market analysis — What is the ideal market for drug companies?
0 Number of potential customers
0 IKE of potential customers
0 Can they pay for the drug?
. Ex. In 19805, pharma companies evaluated whether it was worth it to go into AIDS
research, but aids was typically only contracted by addicts —) therefore the targeted
market may not actually be able to purchase the drug
0 Nature of disease
0 Life threatening, quality of life, lifestyle
0 Acute {short term} vs chronic {long term}
' Top selling drugs target chronic conditions —) patients will buy these drugs for long
periods of time —) company makes more money
0 Current treatment
0 Cost
0 Effectiveness
0 Safety
0 Convenience
Top selling drugs target chronic conditions 9 patients will buy these drugs for long periods of time 9
company makes more money *most of these drugs are antibodies*
Sales [5 billions} Share of Global
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——_
Antivirals —_
Anfi-diabetts
Bronchfld'llawrs
vaccines
amm—
Merck
Roche
Roche
ems
ems
Przer —
Roche _
Stem psoriasis m Annncoagulams
Immunosuppressants
9.7
7.2
11
"1.0
6.7
6.4
5.8
5.2
mommies