Pharmaceutical Industry: A Changing Paradigm, New Opportunities

Pharmaceutical Industry:
A Changing Paradigm,
New Opportunities
Dr Nigel Spurr
18th April 2007
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The Perfect Storm ...
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January 2007 - Nature Reviews Drug Discovery
Drug Failures
Exanta- anticoagulant, Astra Zeneca
NXY 059, stroke, Astra Zeneca
Pargluva- cardiovascualar, BMS
Torcetrapib Combination statin↓ & HDL↑, Pfizer
Generic Drugs
Increased pressure from generic
companies
Apotex Vs. BMS Sanofi-Aventis
and generic plavix
Clinical Trials
TGN1412- phase I trial, adverse reaction using Mab
Tighter regulation of phase I trials
Patent Issues
e.g. Modulation of NFKB pathway
Ariad Vs. Lilly
Drug Safety & Risk Assessment
Vioxx has led to increased pressure for longer term
Follow up and post marketing studies, increasing
drug costs
M&A
Increasing M & A activity in all sectors
of the
Pharmaceutical and biotechnology
sector
Decreasing Productivity 1996-2006
FDA Drug Approvals
Owens Nature Reviews Drug Discovery 6, 99–101 (February 2007) | doi:10.1038/nrd2247
Priority Reviews and Orphan Drugs
Biopharmaceuticals
NMEs
Owens Nature Reviews Drug Discovery 6, 99–101 (February 2007) | doi:10.1038/nrd2247
Owens Nature Reviews Drug Discovery 6, 99–101 (February 2007) | doi:10.1038/nrd2247
2006 Drug Approvals by Therapeutic Area
Economies of Scale, productivity Vs Size
Owens Nature Reviews Drug Discovery 6,173–174 (March 2007) | doi:10.1038/nrd2284
However, not all has been failure….
Owens Nature Reviews Drug Discovery 6, 99–101 (February 2007) | doi:10.1038/nrd2247
Opportunities to
Work with industry
Drug Development Pipeline: Opportunities for Collaboration
Target identification
&
Validation
Gene to
to target
Commit to
Gene
Target to
Lead
Model Systems
Lead to
Candidate
Commit Commit to Lead
to Target
Series
(CEDD entry)
12-24m
12-24m
Candidate
to FTIH
Commit to
Candidate
Selection
30-33m
FTIH to
PoC
Commit
to FTIH
8-12m
Pharmacogenetics
Drug Safety & Efficacy
Chemical
Synthesis
PoC to Commit
to Phase III
Commit to
Product
Development
12-44m
Commit
to Phase
III
0-30m
File &
Launch
Phase III
Commit to
Filing and
Launch
18-66m
Lifecycle
mgt
Regulatory
Approval &
Launch
Post
Launch
Review
10-13m
9 - 16 y
Cellular Assays
Chemical libraries
Biomarkers &
Genomics
Clinical Studies
Pharmacovilliance & Extension studies
How might Estonia contribute to these
issues?
¾
Several key areas:
z
Drug target identification and validation
Development of screening assays
Biological assays and animal models
Novel chemistry
Chemical synthesis (pathways etc)
Natural product screens
Development of clinically relevant biomarkers
Experimental medicine
z
This is not an exhaustive list
z
z
z
z
z
z
z
Drug target
identification and
validation
All the genes are known,
Need to understand function
2001 Human genome known and bounded
How do you identify a suitable target for drug
development?
Genome
Disease
Select protein of interest
Genetics
Link with disease or
disease process
Potential Drug Target
Pathology
Selection of
Biological Target
Target Class Focus
ReoPro
Zantac
Serevent
Amprenovir
Integrins
7TM Receptors
Avandia
Fluticosone
Informatics
Biology
Chemistry
Nuclear Receptors
Proteases
Lotronex
Lamictal
MEDICINES
Gleevec
Ion Channels
Kinases