The Drug
Development
Pipeline
Investigational New Marketing
Drug application authorisation
Patent or Clinical Trial Marketing and product
Question
application application application launch
CLINICAL PHASES
Time (years) 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Discovery Pre-clinical Regulatory Post-marketing
Clinical Development
How long does it take to develop a new drug? Research Development Review development
Phase 1 Phase 2 Phase 3 Phase 4
Synthesis
Development Basic
Biological testing
phase research to
and
understand 50-100 200-400 3000 + more
pharmacological
disease volunteers patients patients patients
screening or
patients
Animal studies Long-term animal studies
Safety and pharmacokinetic studies
Chemical and pharmaceutical development
Genomics and genetics Pharmacogenetics
Number of
successful
compounds Many 1.1 1
8-15 4.8 1.8
thousands
£0 £ ?????
Cost
Stages in the discovery and development
of a new medicine
Patent Duration Cost of Drug Development
• World Trade Organisation Agreement:
The Truly Staggering Cost
• The TRIPS Agreement (Trade-Related Aspects of Intellectual
Property Rights) requires WTO Members to provide protection Of Inventing New Drugs
for a minimum term of 20 years from the filing date of a patent
application for any invention including for a pharmaceutical
product or process. http://www.forbes.com/sites/matthewherper/2012/02/1
0/the-truly-staggering-cost-of-inventing-new-drugs/
• Prior to the TRIPS Agreement, patent duration was significantly
shorter in many countries. For example, both developed and
developing countries provided for patent terms ranging from 15
to 17 years, whilst in a number of developing countries like India,
patents were granted for shorter terms of 5 to 7 years.
Trips agreement came into effect on 1 st January 1995
1
, R&D Costs (UK)
• Discovery 25%
How much does • Preclinical development 21%
each phase cost? • Clinical development 40%
• Regulatory affairs 4%
• Other functions 10%
Allocation
of R&D Declining
Investments
by Function Productivity?
Declining Productivity Declining Productivity
• Declining productivity and thinning R&D pipeline despite high R&D intensity
• R&D productivity is defined as the ratio of investment in R&D to its output. • Advances in technology and instrumentation used in drug discovery.
• R&D accounts for a large portion of the overall cost structure of the industry (~ 30-40%) • Drug companies were not producing drugs any faster than they were before.
• Key to success: increase the pace of elimination of unpromising molecules.
• 2007: FDA approved 17 new molecular entities and 2 biological applications
• Lowest number of new drugs approved by FDA since 1983. • Saves huge investments in the latter part of the drug development process.
2
Development
Pipeline
Investigational New Marketing
Drug application authorisation
Patent or Clinical Trial Marketing and product
Question
application application application launch
CLINICAL PHASES
Time (years) 0 1 2 3 4 5 6 7 8 9 10 11 12 13
Discovery Pre-clinical Regulatory Post-marketing
Clinical Development
How long does it take to develop a new drug? Research Development Review development
Phase 1 Phase 2 Phase 3 Phase 4
Synthesis
Development Basic
Biological testing
phase research to
and
understand 50-100 200-400 3000 + more
pharmacological
disease volunteers patients patients patients
screening or
patients
Animal studies Long-term animal studies
Safety and pharmacokinetic studies
Chemical and pharmaceutical development
Genomics and genetics Pharmacogenetics
Number of
successful
compounds Many 1.1 1
8-15 4.8 1.8
thousands
£0 £ ?????
Cost
Stages in the discovery and development
of a new medicine
Patent Duration Cost of Drug Development
• World Trade Organisation Agreement:
The Truly Staggering Cost
• The TRIPS Agreement (Trade-Related Aspects of Intellectual
Property Rights) requires WTO Members to provide protection Of Inventing New Drugs
for a minimum term of 20 years from the filing date of a patent
application for any invention including for a pharmaceutical
product or process. http://www.forbes.com/sites/matthewherper/2012/02/1
0/the-truly-staggering-cost-of-inventing-new-drugs/
• Prior to the TRIPS Agreement, patent duration was significantly
shorter in many countries. For example, both developed and
developing countries provided for patent terms ranging from 15
to 17 years, whilst in a number of developing countries like India,
patents were granted for shorter terms of 5 to 7 years.
Trips agreement came into effect on 1 st January 1995
1
, R&D Costs (UK)
• Discovery 25%
How much does • Preclinical development 21%
each phase cost? • Clinical development 40%
• Regulatory affairs 4%
• Other functions 10%
Allocation
of R&D Declining
Investments
by Function Productivity?
Declining Productivity Declining Productivity
• Declining productivity and thinning R&D pipeline despite high R&D intensity
• R&D productivity is defined as the ratio of investment in R&D to its output. • Advances in technology and instrumentation used in drug discovery.
• R&D accounts for a large portion of the overall cost structure of the industry (~ 30-40%) • Drug companies were not producing drugs any faster than they were before.
• Key to success: increase the pace of elimination of unpromising molecules.
• 2007: FDA approved 17 new molecular entities and 2 biological applications
• Lowest number of new drugs approved by FDA since 1983. • Saves huge investments in the latter part of the drug development process.
2
