Open Innovation in the Pharmaceutical Industry konferencija... · Open Innovation in the ... How...
Transcript of Open Innovation in the Pharmaceutical Industry konferencija... · Open Innovation in the ... How...
Open Innovation in the
Pharmaceutical Industry
Malcolm Skingle CBE DSc PhD
Director – Academic Liaison
Drug Discovery
28th May 2010
ASTP 10th Anniversary
Paris
Talk Plan
- Set the scene from a Pharma perspective
- Social responsibility & Neglected Tropical
Diseases
- Examples of where GSK are allowing access to
some of their proprietary technology to expand
the science base
- Few concluding remarks
Setting the scene
- GSK access world-class basic & applied science
in universities & biotechs in order to inform &
drive their internal research efforts.
- Re-structuring Pharma sector = ↑ externalisation
of some aspects of the R&D process
- Increasingly companies are allowing external
academic groups access to proprietary
technology
- This may be pre-competitive or competitive.
Setting the scene from a Pharma perspective
Research costs are increasing
Patent expiry & increasing generic competition
Pricing & reimbursement
Increasing regulatory hurdles
Late stage/product failures
Fewer Blockbuster drugs
Post–genome scientific challenges are too great for a single organisation
Partnerships are the only sensible way forward
Changing face of Innovation
The Past….Large Corporate R&D facilities
Secretive smart scientists, low level of collaboration
Closed Innovation
The Present…..leaner business units
Increased levels of collaboration
More outsourcing, more partnerships
Open Innovation
“Closed” Innovation “Open” Innovation
Open innovation
“No matter who you are, most of the smartest
people work for someone else”
Bill Joy, Sun Microsystems
Continued focus on externalisation through options-based deals
More than 80 active projects from 47 external engines
Alveonix
Pentraxin Therapeutics
Tempero Pharmaceuticals
UCL Institute of
Ophthalmology
13 new partnerships since Feb 09
The Problem: A healthcare crisis
The healthcare burden is borne disproportionately in the least
developed countries
– Africa – 34 of the 50 poorest countries; 24% of the global
disease burden
Malaria – 250 million new cases/year; 1 million
deaths/year
TB – 8 million new cases/year; 2 million deaths/year
Tropical Diseases suffer from a severe lack of research
– Difficult targets
– Slow progress
– Lack of commercial incentive
The Commitment: GSK
Reduced (tiered) pricing
Contribute to infrastructure
Promote greater collaboration
– Achieve critical mass
– Create community partnerships (PHASE, AMP, GAELF)
– Public-Private Research Partnerships (MMV, GATB,
DNDi)
– Incentivize and facilitate research
– Flexible approach to IP in the Least Developed Countries
Source: Andrew Witty Harvard speech 13th Feb 2009
Knowledge Pool
Objective: Drive the creation of medicines for
serious diseases for which there is little or no
commercial interest
Flexible approach with GSK IP
– create a pool of patented technology to advance research
into NTDs
– make available patented technology that could be used to
solve problems that arise in R&D
– contribute available know-how that may assist discovery
or development
Knowledge Pool
GSK’s Contribution:
– more than 800 patents/applications vs NTD’s
– Know-how that may assist in discovery or development
Alnylam’s Contribution:
– First partner – contributed key complementary
discovery technology
– “Fundamental” RNAi technology, >1,500 patents
– Know-how relating to the technology
Knowledge Pool
Pool Administrator
– Needed experience & expertise in
market-based incentives for R&D
creating global health innovator partnerships
providing guidance on global health priorities
– BIO Ventures For Global Health (BVGH)
Facilitate patent licensing
Disease-specific conferences
Partnering – promote utilization
Knowledge Pool Snowball Effect
GSK’s Patent Contribution: 13th Feb 2009
- 800 patents/applications
Alnylam’s Contribution: 8th July 2009
- First discovery technology partner
- BIO Ventures for Global Health (administrators)
MIT: 5th May 2010
– first academic institution
Technology Innovation Agency of South Africa
- first government agency to join pool
Knowledge Pool Patent Licenses
– Policy to incentivise development & access
– To any 3rd party with a bona fide research plan
– For research, manufacture anywhere in the world
– Know-how - donor discretion
– Limitations
Disease – NTDs (as defined by FDA)
Geographic – LDCs (as defined by UN)
Products not currently being marketed or developed
Neglected Tropical Diseases
NTDs
– Defined by FDA
– Account for
significant global
morbidity and
mortality
– In the absence of
commercial pull,
pharmaceutical
companies have
lacked incentives to
develop medicines
for these diseases
Neglected Tropical
Diseases
Morbidity/Mortality
Blinding trachoma 8 million people blinded/year
Buruli ulcer Tens of thousands of cases
Cholera More than 100,000 new cases/year; thousands of
deaths/year
Dengue fever 50 million infected; thousands of deaths/year
Dracunculiasis 5000 new cases/year
Fascioliasis At least 2.5 million new cases/year
Human African
trypanosomiasis
50,000 cases
Leishmaniasis 2 million news cases/year; 60,000 deaths/year
Leprosy 300,000 new cases/year
Lymphatic filariasis 40 million cases
Malaria 250 million new cases/year; 1 million deaths/year
Onchocerciasis 500,000 cases
Schistosomiasis 207 million cases; 280,000 deaths/year
Soil transmitted
helminthiasis
2.5 billion cases
Tuberculosis 8 million new cases/year; 2 million deaths/year
Yaws 460,000 new cases/year
United Nations - Least Developed Countries
Africa
Angola Ethiopia Niger
Benin Gambia Rwanda
Burkina Faso Guinea São Tomé and Príncipe
Burundi Guinea-Bissau Senegal
Central African Republic Lesotho Sierra Leone
Chad Liberia Somalia
Comoros Madagascar Sudan
Democratic Republic of the Congo Malawi Togo
Djibouti Mali Uganda
Euquitorial Guinea Mauritania United Republic of Tanzania
Eritrea Mozambique Zambia
Asia
Afghanistan Lao People’s Democratic Republic Solomon Islands
Bangladesh Maldives Timor-Leste
Bhutan Myanmar Tuvalu
Cambodia Nepal Vanatu
Kiribati Samoa Yemen
Latin America and the Caribbean
Haiti
Open Laboratory Drug Discovery at GSK
GSK Medicines Development Centre
Tres Cantos, Madrid
Collaborating solely on Medicines for Diseases of the
Developing World
Headed by Nick Cammack, SVP
n = 127 staff
Capacity to take up to 60 visiting scientists
Focused on R&D in malaria, TB and other neglected diseases
Collaborative with key funding partnerships
Projects prioritised by unmet medical need - not commercial benefit
GSK fighting Diseases of the Developing World
GSK Diseases of the Developing World High Level Operating Model at Tres Cantos
GSK internal resource:
MALARIA, TB,
OTHER `Open Lab´
Open Innovation - Malaria
Attempts to generate leads vs malaria
– GSK screened 2 million compounds vs the malaria
parasite P.falciparum to generate 13,500 hits
– Took 5 GSK scientists 1 year to complete
– GSK to publish the chemical structures & associated
assay data
– Data freely available via a user-friendly database
– Publication of Malaria work in high profile journal
General Principles of the Open Lab
Incoming projects will be aligned with GSK interests in TB,
malaria or other neglected diseases
Projects will benefit from the collaboration with GSK Drug
Discovery
A shared & open approach to innovation in neglected
diseases
Access to Patents and Know-how
– Partnerships
iThemba Pharmaceuticals
Emory Institute for Drug Discovery
… just one piece
Not “the solution” – one model; one piece of the jigsaw
Need to maximise contributions to the pool
Need to maximise research & collaboration under the pool
How large Corporates are
changing their business models
to embrace Open Innovation
The Academic DPU Concept
THE ACADEMIC
DISCOVERY PERFORMANCE UNIT
Innovative and flexible plans to:• Drive experimental medicine into the critical path
• Exploit the full potential of the asset
• Focus on the key “killer” question
Quality of thought of
Academics who are
leaders in their field
GSK’s drug
development
expertise
Greater ownership
Define the strategy
Integral to the project-team
Committed time
Exposure to risk
Greater transparency
Refine the strategy
Flexible support
Consistent and
maintained oversight
Share reward
High Quality Assets
The website
The Structural Genomics Consortium
CEO
Aled Edwards
SGC-Oxford
~65 staff
Chas Bountra
SGC-Toronto
~80 staff
Cheryl Arrowsmith
Scientific Committee
Kirk Clark, Chair, Novartis
Board of Directors
Wayne Hendrickson, Columbia, Chair
SGC-Stockholm
~25 staff
Pär Nordlund
Pharmaceutical
Industry
Public
Domain
GSK-WT-
SGC-NIH
Partnership
Chemical
Tractability
Chemistry (GSK)
Screening (WT-NIH)
Structure (SGC)
Chemical
Probes
No IP
No restrictions
Publication
Enable Academic
Target Validation
Drug
Discovery
Proprietary Target Validation
(Re)Screening
Lead optimization
Pharmacology
DMPK
Toxicology
Chemical development
Clinical development
Pioneer Drug Discovery
Pre-Competitive Proprietary
Q: Why place Chemical Probes in the Public Domain?A: Potent and selective small molecules provide complimentary (if not better) target validation to genetic methods as evidenced by their scientific impact
Compound Receptor Papers Citations Years h-index g-index
GW1929 PPAR 317 11063 14 47 100
GW0742 PPAR 392 7212 10 41 78
GW4064 FXR 250 4482 8 37 61
SR12813 PXR 127 4628 8 33 67
GW9662 PPAR 528 4513 8 32 50
GW3965 LXR 181 3073 7 29 53
GW7647 PPAR 118 2312 7 22 47
CITCO CAR 73 711 5 14 24
Data compiled from Google Scholar, October 5, 2007
All compounds were made available by GSK to the Public Domain
through commercial suppliers (Sigma-Aldrich and Tocris)h-index: a metric of scientific impact, combining quality and quantity of citations
g index: a modification of the h-index with more weight on highly-cited articles
Open Access Chemical Probes
Freedom of use
– Compound availability
– Chemical structure
– Potency & selectivity data
– Freedom to conduct
experiments & publish results
Protect IP
– Retain right to file patent on
the Chemical Probe
– Up to 6 months hold on
release of the chemical
structure
Open Access must achieve both goals
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GSK Consumer Healthcare
> $8 billion sales in 120 countries
2nd largest OTC
Consumer Healthcare Company
3rd largest Oral Care Company
– > 30 leading brands, 5 > $400 million
Stand-alone R&D with 2 global sites
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32
GSK Consumer HealthcareOpen Innovation Growth
GSK Consumer initially <20% external technology
Aggressive goal – 33% in 3 years
Achieved 33% in 18 months
Currently at 50%
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Open Innovation Model
WANT
Meet
consumer
needs
FIND
Internal &
external
networks to
find
solutions
GET
Evaluation &
negotiation
phase to
secure the
solution
MANAGE
Relationship
building,
tools/metrics
to monitor
success
Developing a partner scorecard
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Criteria
High
(8-10 pts)
Medium
(4-7pts)
Low
(1-3pts) Score Rationale for score
Depth/breadth of experience
Focused on science applicable
to GSK
Motivation & passion to
partner
Ability to actualize & manage
the relationship
Commitment to share/take
risks
Ability to undertake cross-
university collaboration
Emerging vs. established
player
Geographic proximity
*Partner selection: A Source of Alliance Success – Danielle Twardy-Duisters
Concluding Remarks
Summary on Open Innovation models
GSK promote a more open culture sharing ideas & data
Traditional relationships between Academia and Industry are being re-defined
Access to public funding will drive areas of science underpinning the pharmaceutical industry & will promote research into Neglected Tropical Diseases
Innovative partnership models allow both GSK & academics better access to science & technology
Thanks for listening
We are looking for
innovation wherever
it may originate