strategies for developing india as a contract research hub swaminathan subramaniam chief operating...
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Strategies for developing India as a contract research hub
Swaminathan Subramaniam
Chief Operating Officer
Aurigene Discovery Technologies
The drug discovery value chain
TARGETGENERATION
&VALIDATION
LEADGENERAT
LEADOPTIM
CandidateDrug
SelectionPRECLINICAL
AssayDevelopment
Hit Identification
Candidate Lead Ident.
LeadSelection
Disaggregating the Drug discovery value chain
TARGETGENERATION
&VALIDATION
LEADGENERAT
LEADOPTIM
CandidateDrug
Selection
PRECLINICAL
Risk & Value in Discovery
TARGETGENERATION
&VALIDATION
LEADGENERAT
LEADOPTIM
CandidateDrug
SelectionPRECLINICAL
1050 104 103 102 102 101 100
VALUE
RISK
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
genomics/ proteomics
domain architecture models
structure determination
bioinformaticscloning/protein expression
mine data for known ligands for similar/related domains
select potential ligand class
synthesize library of similar compounds
assay
hits
leads
automation
computation
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
30
40
70
60
50
9593918987 9985 97
20
10
30
0
40
50
Annual R&D Expenditure ($ Bn)
NCEs Launched per Year
Source:Source: PricewaterhouseCoopers Study PricewaterhouseCoopers Study
The Research Productivity Equation
RESEARCH PRODUCTIVITY =
IND’s GENERATED
RESOURCES USED
Discover More
Discover for Less
Relationship between resource usage and IND generation
Big Pharma
Smallbiotech
Resources Used
IND’sgenerated
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
290260250
Drug Discoveryand Pre-Clinical
Clinical Trials Other
US R&D spend/NDA in USD million
TOTAL USD 800 Million
Cost savings by stage in India
70%45%40%
290260250
Drug Discoveryand Pre-Clinical
Clinical Trials Other
R&D spend/NDA in USD million
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!
OpportunityThe Emerging Industrialization of Research
Core TA focusedDiscovery Research
Group(Target Validation;Lead Discovery;
Lead Optimization)
HTS Factory
High ThroughputStructure Determination
Chemical Synthesis
Tox; ADME;Counterscreens
PreclinicalCRO
OpportunityRole 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
ChallengeGlobal collaborationTranscending geographic distance
• Communication tools; internet; eTechnologies (Real-time research)
• On-shoring
• Hiring local talent
Early MaturityGrowth
Time / Effort
Pro
duct
Per
form
ance
Danger!The Biotechnology S-curve
New InventionPeriodIll-definedTechnology
Explosive GrowthPeriodWell-definedTechnology
MaturationPeriodMatureTechnology
Radioligand bindingToxicogenomics SBDD
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