Transcript Slide 1

How Canada might develop its drug discovery sector
SGC Toronto
SGC Oxford
SGC Stockholm
Drug Discovery/Development
• Multifaceted, complicated, lengthy process
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F
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O-
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OH
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NH2
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NHCH3
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H2N
Products
CO2H
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O2S
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CF3
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Discovery
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Exploratory Development
Full Development
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Phase I
0
Phase II
5
Phase III
10
15
Drug
Idea
12 -15 Years
Drug discovery getting less productive
Pioneer drugs particularly dismal
Yearly FDA Approvals
120
100
New Drug Approvals
New Chemical Entities
Priority Reviewed NCEs
80
60
1312 18
10 1619
9
40
9
7 7
17
9
13
20
6 7
7
Public Data from Center of Drug Evaluation and
Research: www.fda.gov/cder/
0
• Number of pioneer drugs
(Priority Reviewed NCEs) has
not increased from 1993-2008
• Investment in pharmaceutical
R&D has risen dramatically
over this period
• >90% failure rate in clinical
trials for pioneer drugs due to
lack of efficacy
Economics of novel drug discovery
• > $50B in health-related R+D invested by governments in
academia
• > $50B in R+D invested by biotech and pharma
• ~ 60 approved drugs are approved
• ~ 40-45 of these are “re-worked” existing drugs
• ~ 20 are “new” chemical entities
• 1 “new” medicine per ~$5B spent in health research
Another way of looking at it
• >>300,000 scientists work in pharma R+D (on top of ~$60B
in basic research funded by governments and charities)
• ~ 60 approved drugs are approved
• ~ 40-45 of these are “re-worked” existing drugs
• ~ 20 are “new” chemical entities
• 1 approved medicine for every ~5,000 people-years of work
• 1 novel medicine for every 15,000 people-years of work
The pharmaceutical pipelines are dry
1.1% growth
predicted over next 5
years
And the population is aging
What’s the problem?
Drugs fail - and no one can predict which ones
But there is hope…..
We know the root of the problem:
Lack of scientific understanding
But what gets in the way?
Policy
Biomedical reagents: A world gone crazy
25
Academia
20
number of MTAs
Industry
15
10
5
0
0-5
6-10
11-15
16-20
weeks
21-30
more than 30
Universities and “ROI”
How to tackle the problem?
1.
Continue to fund “blue-sky” research
- Need blue sky to discover new things (e.g. RNAi)
2.
Fund focused research
- Random research does not put people on moon, nor will
solve the core problems in drug discovery
3.
The focused research must enable creative people to be happy:
short-term “wins” on route to long-term goal
4.
Ensure that the research is of maximal benefit by making it
widely and freely available and with minimal duplication
Why open-access science in drug discovery?
1. Open access minimizes duplication of effort
1. Not enough resources to duplicate (e.g. patient pool)
1. Open access mobilizes best brains in all sectors
1. IP agreements slow transfer of knowledge
1. IP positions cripple freedom to operate, even for noncommercial projects
Suggested organization of open-access projects
• Form research partnerships to tackle science
- Academia and industry each bring something to table
• Funded by both public and private sectors
• Operated within academic institutions
• Very defined objectives; managed jointly by all funders
• All results into public domain, with no restriction on use
But do open access projects work?
The Structural Genomics Consortium
A model for open access public-private partnership
Structural Genomics Consortium:
(SGC) is a public-private partnership with a mandate to place protein
structures of relevance to human health into the public domain, free from
restrictions on use.
Funders:
Canada, GSK, Ontario, Merck, Novartis, Sweden, Knut and Alice Wallenberg
Foundation, Wellcome Trust
Protein targets:
Proteins are nominated by the Funders to the SGC Target List, which now
comprises ~2400 proteins. Targets are selected with therapeutic view. No
funder (public or private) has access to progress of SGC Targets through
pipeline.
Objectives:
660 more structures by July 2011 (including 8 integral membrane proteins)
Organization
Board of Directors
Funder nominated
Scientific Committee
CEO (me)
SGC-Oxford, ~70 staff
Chas Bountra
SGC-Toronto, ~85 staff SGC-Stockholm, ~30 staff
Cheryl Arrowsmith
Johan Weigelt
Science is selected with therapeutic view. No funder has proprietary access to results.
Open Access Chemical Probe Partnership
Industry-SGC-NIH
-Academia
Partnership
Chemical
Tractability
Public
Domain
Chemical
Probes
Chemistry (Phrma, Acad) Synthesized and
distributed by
Screening (Acad-NIHchemical supplier
Phrma-SGC)
Structure (SGC)
No restrictions
QC Assays (Acad)
on use or
publication
Pharmaceutical
Industry
Drug
Discovery
Proprietary Target Validation
(Re)Screening
Lead optimization
Pharmacology
DMPK
Toxicology
Chemical development
Clinical development
Enable Academic
Target Validation
Open Access
Proprietary
Next steps: Open access clinical trials
Take-home messages
1. The structure of the pharma sector will change
2. Drug discovery biotech has lost more money than it has
made; it is wealth redistribution.
3. Change means opportunities for Canada in developing
partnerships
Take-home messages
What limits our competitiveness?
1. We are conservative – not a risk-taking culture
- University sector is innovative highlight of Canada
1. Our regulatory climate is byzantine and resistant to
change