a pharma perspective on healthcare needs and innovation in drug discovery
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A Pharma perspective on healthcare needs and innovation in drug discovery. Patrick Vallance Head of Drug Discovery GlaxoSmithKline. A New Mindset. “We need to adopt a new mindset. We in big pharma should never take for granted our right to exist; our business model - PowerPoint PPT PresentationTRANSCRIPT
A Pharma perspective on healthcare needs and innovation in drug discovery
Patrick VallanceHead of Drug DiscoveryGlaxoSmithKline
“We need to adopt a new mindset. We in big pharma should never take
for granted our right to exist; our business model is not written into any country’s constitution.
So we should be turning up to work every day with the mindset that we are earning the right to exist.
We are earning it by meeting the expectations of society. When you start to think like this,
you see the world differently.“
Andrew Witty, CEO, GlaxoSmithKline – Harvard, February 2009
A New Mindset
Science in Society – DTI MORI 2005
Public trust is low
The Challenges are Significant
In the past 20 years modern drugs have revolutionised the practice of Medicine and the outlook for patients
The unmet need remains high
The bar is also high
placebo
changing expectations
cost
the public health agenda
Fabry’s Disease
Pain throughout the body
Impaired sweating
Heat/cold intolerance
Skin rashes (angiokeratomas)
Corneal whorling
Hearing problems
Gastrointestinal problems
Heart problems
Kidney problems
Nervous system problems
Psychological issues
Pain throughout the body
Impaired sweating
Heat/cold intolerance
Skin rashes (angiokeratomas)
Corneal whorling
Hearing problems
Gastrointestinal problems
Heart problems
Kidney problems
Nervous system problems
Psychological issues
Large improvement in pain in Fabry’s Disease
Active Placebo
Large improvement in pain in Fabry’s Disease
The Challenges are Significant
In the past 20 years modern drugs have revolutionised the practice of Medicine and the outlook for patients
The unmet need remains high
The bar is also high
placebo
changing expectations
cost
the public health agenda
R&D for a New Medicine: 10+ years, $1 bn+
Sources: Drug Discovery and Development: Understanding the R&D Process, www.innovation.org; CBO, Research and Development in the Pharmaceutical Industry, 2006
IndefiniteIndefinite
Drug Drug DiscoveryDiscovery PreclinicalPreclinical Clinical TrialsClinical Trials
RegulatoryRegulatoryReviewReview
Scale-Up to Scale-Up to ManufactureManufacture
Post-Post-MarketingMarketing
SurveillanceSurveillance
1Approved
NewMedicine
0.5 – 2 0.5 – 2 YearsYears6 – 7 Years6 – 7 Years3 – 6 Years3 – 6 Years
Number Of Patients / Subjects
PhasePhaseII
PhasePhaseIIII
PhasePhaseIIIIII
55250250~ 5,000 – ~ 5,000 – 10,00010,000
CompoundsCompounds
Pre
-Dis
cove
ryP
re-D
isco
very
20 – 100
100 – 500 1,000 – 5,000
IND
Sub
mitt
ed
ND
A S
ubm
itted
… … a big challenge for addressing both developed and developing world diseasesa big challenge for addressing both developed and developing world diseases
Source: Burrill & Company; US Food and Drug Administration.Note: NMEs do not include BLAs
26 2522
28
53
39
30
35
2724
17
21
31
18 18
14
$12 $13 $13$15
$17$19
$21$23
$26
$30$32 $33
$39 $39
$43
$54
0
10
20
30
40
50
60
0
5
10
15
20
25
30
35
40
45
50
$55
New Drug Approvals (NMEs) PhRMA Member R&D Spending
New
Dru
g App
rova
ls (N
MEs)
Pha
rma
R&
D ($
billi
ons)
92 93 94 95 96 97 98 99 00 01 02 03 04 05 06 07
R&D Productivity Gap
The realities of having the best pipeline
0.0x 0.1x 0.2x 0.3x 0.4x 0.5x 0.6x 0.7x
Lehman Brothers PharmaPipelines (Sept 2007)Pharma Replacement Power – NPV
Pipeline renews 60% of sales
LB Method: [NPV of recent launches (06-07) + NPV of pipeline opportunities from ‘08-’13] / NPV of products marketed before 2006.
GlaxoSmithKlineMerck
Bristol Myers Squibb
Novartis
Johnson & Johnson
Sanofi-Aventis
AstraZeneca
Pfizer
Wyeth
Eli Lilly
Roche
Abbott Labs
Schering Plough
AVERAGE
R&D for a New Medicine: 10+ years, $1 bn+
Sources: Drug Discovery and Development: Understanding the R&D Process, www.innovation.org; CBO, Research and Development in the Pharmaceutical Industry, 2006
IndefiniteIndefinite
Drug Drug DiscoveryDiscovery PreclinicalPreclinical Clinical TrialsClinical Trials
RegulatoryRegulatoryReviewReview
Scale-Up to Scale-Up to ManufactureManufacture
Post-Post-MarketingMarketing
SurveillanceSurveillance
1Approved
NewMedicine
0.5 – 2 0.5 – 2 YearsYears6 – 7 Years6 – 7 Years3 – 6 Years3 – 6 Years
Number Of Patients / Subjects
PhasePhaseII
PhasePhaseIIII
PhasePhaseIIIIII
55250250~ 5,000 – ~ 5,000 – 10,00010,000
CompoundsCompounds
Pre
-Dis
cove
ryP
re-D
isco
very
20 – 100
100 – 500 1,000 – 5,000
IND
Sub
mitt
ed
ND
A S
ubm
itted
… … a big challenge for addressing both developed and developing world diseasesa big challenge for addressing both developed and developing world diseases
Scientific publications in biomedicine
A disconnect between discovery and invention?
New Medicines
The opportunity has never been greater
Reintroduce Scientific Judgement
CEEDD
Evolution From Monolith
Virtualization of Drug
Discovery
External Resources
InternalResources
CEDDs
Pharma
CentralizedControl/Management
De-CentralizedControl/Management
ScientificOpportunity
ScientificOpportunity
Patient needPatient need
Market sizeMarket size
How should we choose where to invest discovery effort?
External Internal
Pipeline strength
Organisationalstructure
The Market
Source: Pharma Pipelines – Strategic Analysis and Conclusions 2006 – Lehman Brothers
The Lehman Brothers analysis of predicted global sales for 2006 does not include generic drugs and estimates that their database captures 80% of branded drug sales.
Diabetes, cancer and inflammation projected to be the biggest growth opportunities
2006 Estimated Global Sales
18,
808
43,
928
15,
337
11,
549
65,
275
17,
793
76,
850
26,
875
19,
481
39,
910
0
10,000
20,000
30,000
40,000
50,000
60,000
70,000
80,000
90,000
Diabet
es
Cance
r
Infla
mm
atio
n
Derm
atolo
gy
Met
abolis
m/E
ndocrin
ology
Drugs
Genito
-Urin
ary
Haem
atolo
gy
Sexual
Dys
funct
ion
Imm
une Sys
tem
Ophthal
mic
Dru
gs
CNS
Respira
tory
2005 - 2010 Market Growth p.a.
0%
2%
4%
6%
8%
10%
12%
14%
16%
18%
Diabet
es
Cance
r
Infla
mm
atio
n
Derm
atolo
gy
Met
abolis
m/E
ndocrin
ology
Drugs
Genito
-Urin
ary
Haem
atolo
gy
Sexual
Dys
funct
ion
Imm
une Sys
tem
Ophthal
mic
Dru
gs
CNS
Hormone
Control
Cardio
vasc
ular
Respira
tory
Gastro
inte
stin
al
Anti-In
fect
ives
Hormone
Control
Cardio
vasc
ular
Gastro
inte
stin
al
Anti-In
fect
ives
Glo
bal
Sal
es
$m
Public Funding
ScientificOpportunity
ScientificOpportunity
Patient needPatient need
Market sizeMarket size
How should we choose where to invest discovery effort?
External Internal
Pipeline strength
Organisationalstructure
Small integrated, empowered teams
35 internal engines
35 external engines
Corporate Venture Fund
New/expanded in 2008/2009 YTD
Pharma partnerships
R&D for a New Medicine: 10+ years, $1 bn+
Sources: Drug Discovery and Development: Understanding the R&D Process, www.innovation.org; CBO, Research and Development in the Pharmaceutical Industry, 2006
IndefiniteIndefinite
Drug Drug DiscoveryDiscovery PreclinicalPreclinical Clinical TrialsClinical Trials
RegulatoryRegulatoryReviewReview
Scale-Up to Scale-Up to ManufactureManufacture
Post-Post-MarketingMarketing
SurveillanceSurveillance
1Approved
NewMedicine
0.5 – 2 0.5 – 2 YearsYears6 – 7 Years6 – 7 Years3 – 6 Years3 – 6 Years
Number Of Patients / Subjects
PhasePhaseII
PhasePhaseIIII
PhasePhaseIIIIII
55250250~ 5,000 – ~ 5,000 – 10,00010,000
CompoundsCompounds
Pre
-Dis
cove
ryP
re-D
isco
very
20 – 100
100 – 500 1,000 – 5,000
IND
Sub
mitt
ed
ND
A S
ubm
itted
… … a big challenge for addressing both developed and developing world diseasesa big challenge for addressing both developed and developing world diseases
Leading the pack – ATM Index
Source: Access to Medicines Index (Innovest)
DDW Partners – Tres Cantos