Transcript Dr. Swaminathan Subramaniam - IGMORIS

Strategies for developing India as a
contract research hub
Swaminathan Subramaniam
Chief Operating Officer
Aurigene Discovery Technologies
The drug discovery value chain
TARGET
GENERATION
&
VALIDATION
Assay
Development
LEAD
GENERAT
Hit
Identification
LEAD
OPTIM
Candidate
Drug
PRECLINICAL
Selection
Candidate
Lead Ident.
Lead
Selection
Disaggregating the Drug discovery
value chain
Candidate
Drug
Selection
LEAD
GENERAT
LEAD
OPTIM
TARGET
GENERATION
&
VALIDATION
PRECLINICAL
Risk & Value in Discovery
VALUE
RISK
1050
104 103
TARGET
GENERATION
&
VALIDATION
102
102
LEAD
GENERAT
101
LEAD
OPTIM
100
Candidate
Drug
Selection
PRECLINICAL
Modes of discovery
• The Classical Approach
– Understanding of disease  Understanding of
mechanism  Understanding of biochemical effectors
 Molecular screens
• The Patent-busting and ICE approach
– Look at existing knowledge of disease and drugs to
find improvements that are novel
– Analogs, enantiomerically pure versions
• Post-genomic drug discovery
Drug Discovery : the post-genomic version
a
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m
a
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genomics/ proteomics
cloning/protein expression
bioinformatics
structure determination
domain architecture models
mine data for known ligands for similar/related domains
select potential ligand class
synthesize library of similar compounds
assay
hits
leads
c
o
m
p
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t
a
t
i
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Drivers for outsourcing
• Capacity mismatch
• Capability mismatch
• Need to focus resources and use capital
efficiently
• Declining R&D productivity
There is a decline in R&D Productivity
50
70
Annual R&D
Expenditure ($ Bn)
40
60
30
50
20
40
10
NCEs Launched per Year
30
85
87
Source: PricewaterhouseCoopers Study
89
91
93
95
0
97
99
The Research Productivity Equation
Discover More
IND’s GENERATED
RESEARCH PRODUCTIVITY =
RESOURCES USED
Discover for Less
Relationship between resource
usage and IND generation
Big Pharma
IND’s
generated
Small
biotech
Resources Used
Resistors to outsourcing
• Loss of project control
• Loss of IP
• Loss of inhouse expertise
• Lack of motivation to be fast for CRO
Source: Datamonitor, 2001
Pharmaceutical industry:
Blockbusted
• Profitable heritage  internal inefficiency,
investment decisions not tightly linked to
creation of shareholder value
• Facing a leaner, more cost-sensitive
environment  patents covering 80% of
todays blockbusters will expire by 2007
(USD 67 billion value)
Reuters business insight
R&D spend by stage in US
US R&D spend/NDA in USD million
250
260
Drug Discovery
and Pre-Clinical
Clinical Trials
290
Other
TOTAL
USD 800 Million
Cost savings by stage in India
R&D spend/NDA in USD million
290
250
260
70%
40%
45%
Drug Discovery
and Pre-Clinical
Clinical Trials
Other
TOTAL
USD 800 Million
SAVING
USD 400 Million
Why India can meet the needs of the
customer (platitudes!!)
• English speaking Scientific and Technical
talent
• Institutions
• Time-zone???
• Costs
Opportunity, Challenge and
Danger!
Opportunity
The Emerging Industrialization of Research
HTS Factory
Core TA focused
Discovery Research
Group
(Target Validation;
Lead Discovery;
Lead Optimization)
High Throughput
Structure Determination
Chemical Synthesis
Preclinical
CRO
Tox; ADME;
Counterscreens
Opportunity
Role for niche providers
• There are 5 big players in the CRO
business today
• The one stop shop has not
emerged…there is still a role for niche
providers
Challenge
Global collaboration
Transcending geographic distance
• Communication tools; internet; eTechnologies
(Real-time research)
• On-shoring
• Hiring local talent
Danger!
Product Performance
The Biotechnology S-curve
Early
Growth
Maturity
Time / Effort
New
Invention
Period
Ill-defined
Technology
Toxicogenomics
Explosive
Growth
Period
Well-defined
Technology
SBDD
Maturation
Period
Mature
Technology
Radioligand binding
Danger!
• The easy business models in Drug
Development outsourcing may prevent
adequate focus on and investment in Drug
Discovery outsourcing companies
• Becoming vendors for hire providing
undifferentiated and commoditized
services
Environment
• Infrastructure and regulatory environment
• Intelligent risk capital; corporate venturing
• Entrepreneurial and scientific talent
Building the ‘India’ brand for
Research Services
• Association of Biotechnology Led
Enterprises – Nasscom for the
biotech/lifescience sector
• A well publicized voluntary code of
conduct
Closing observations
• Niche opportunities make it possible for
smaller players to find a place
• Integration of engineering, information and
lifescience technologies is a unique
opportunity for India