life science innovation imperative slides
TRANSCRIPT
The Life Science Innovation Imperative
Professor Iain Gillespie (Edinburgh) Professor David Castle (Edinburgh) Professor Joyce Tait (Edinburgh)
Professor Joanna Chataway (RAND, OU)
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A Economic and Moral Imperative to Innovate
Iain M M Gillespie
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Innovation is key to growth…
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Contributions to labour productivity growth, 1995-2006, in %
* Investment in intangibles and multi-factor productivity growth account for between two-thirds and three-quarters of labour productivity growth.
…and accounts for major differences between economies
4
Decomposi)on of cross-‐country differences in GDP per capita into their determinants, 2005
(United States = 100)
GDP PPP per capita TFP Human capital Physical capital Employment
United States 100.0 100.0 100.0 100.0 100.0 Canada 83.5 72.0 103.3 105.8 106.0 Japan 72.6 52.6 100.4 130.7 105.1 China 9.8 13.6 57.3 105.2 119.5 India 5.2 12.7 47.7 98.3 87.1 Brazil 20.5 29.3 70.1 103.1 96.8 Russian Federa)on 28.6 31.5 84.9 97.4 99.3
EU27 + EFTA 64.7 67.8 91.2 114.1 91.3
Total World 22.8 27.9 64.2 104.2 95.8
Source: OECD.
Innovation can help address global & social challenges, such as climate change
5
Potential technological contributions to CO2 emission reductions
Note: WEO refers to the IEA’s 2007 World Energy Outlook. Source: International Energy Agency, Energy Technology Perspectives 2008: Scenarios and Strategies to 2050.
Green Innovation
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Pollution
(e.g., CO2 , toxic chemicals)
Economic Growth (e.g., employment, GDP)
Conventional technology
Sustainability via green innovation
Eco-efficiency &
renewable feedstock
WE HAVE AN ECONOMIC AND MORAL RESPONSIBILITY TO
INNOVATE
7
National innovation policy mix 2010���United Kingdom
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The financing of R&D has changed over ���time …
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OECD Area, 1981-2005
0
100,000
200,000
300,000
400,000
500,000
600,000
700,000
800,000 19
81
1982
19
83
1984
19
85
1986
19
87
1988
19
89
1990
19
91
1992
19
93
1994
19
95
1996
19
97
1998
19
99
2000
20
01
2002
20
03
2004
20
05
Other national
Government
Industry
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But public investment remains key, for example in the life sciences
10
Reliance of Pharmaceutical patents on science citations (biochemistry)
BOTH PRIVATE AND PUBLIC SECTORS MUST CONTINUE TO
INVEST IN INNOVATION
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Science is increasingly international…
12
Canada
Korea
ItalyNetherlands
Switzerland
India
BelgiumSweden
Russian Federation
Poland
Australia
Brazil
Spain
United States
Germany
France
China
Japan
United Kingdom
1998 2008
Canada
Korea
ItalyNetherlands
Switzerland
India
BelgiumSweden
Russian Federation.
Poland
China
Japan
Australia
Brazil
Spain
United States
Germany
France
United Kingdom
Source: OECD (2010) Measuring Innovation: A New Perspective
Modern technologies are the sum of ���many parts
13
The composition of investment has shifted towards intangible assets
14 Source: Corrado, Hulten and Sichel (2007).
14
§ Within many OECD countries intangible investment (software, R&D, training and organisational factors) is now larger than investment in machinery, equipment and buildings.���
§ Intangibles are often not included in firm (& national) accounts.���
§ But market analysts know this and are probing.
Successful investment in innovation demands enlightened collaboration and networking of knowledge
§ A New Enlightenment…���
§ Putting society back at the core of the Innovation Enterprise
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Innovation and Intellectual Property David Castle
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Coupling or Chain Link Model
17 Rothwell 1994
Intellectual Property in Context
§ Knowledge management is inclusive of intellectual property rights;
§ Systems of intellectual property rights are not monolithic, consistent, or perfected;
§ Knowledge management strategies dictate the tactics of intellectual property rights
§ Interpreting the purpose of patents is contextualised in knowledge management
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Intellectual Property in Context
§ Knowledge mobilisation versus returns to inventors in university-based TTOs;
§ ‘Publish or perish’, or ‘patent or perish’? § Social control of knowledge includes intellectual
property rights drive toward public goods § There is no definitive role for patents in the
management of knowledge in innovation systems with respect to increasing / decreasing innovation.
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Intellectual Property in Context
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Intangible Asset Framework
Producing
Accountability Tracking
Ownership 21
1. Producing Knowledge
§ Research know-how must be augmented with an understanding of how to create knowledge with direct applications.���
§ How do researchers come to recognize something as an innovation, attribute value to it, and develop applications that would have relevance to national innovation systems or international relevance?
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2. Tracking Knowledge
§ Before knowledge is legally protected, commercialised, or otherwise disseminated, a number of judgments are made about its worth, whether to share knowledge, who the intended beneficiaries are, and how and when to respond to incentives to diffuse the knowledge.���
§ These pre-commercialisation activities, particularly as they bear on downstream knowledge transfer, are poorly understood.
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3. Ownership
§ Public coordination of R&D is conjoined with private legal control over IP
§ Open innovation challenges existing models of IP,
knowledge management and incentive structures
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4. Accountability
§ Reasonable questions arise about the sources of knowledge production, IP protection, and method of knowledge diffusion (tech transfer v. advice or trouble-shooting).���
§ New governance structures may be necessary, to capture the transactions and other interactions with, and between national innovation systems and international bodies (e.g. WTO or TRIPS).
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Innovation and Knowledge Flows
26 Maleki1997
Observations
§ Leonard Nakamura estimated the US economy generated ~1 T in intangibles per annum
§ The central challenge remains measurement (Baruch Lev et al.)
§ Consider the following question: § R&D expenditures are measurable § Once the money is spent, the work completed,
and the knowledge generated….. § Which side of the ledger should do the
reporting – as ‘costs’ or as ‘assets’? 27
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Public private partnerships in health innovation: ���
Why and what works? Joanna Chataway
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Outline
§ An increase in public and private sector collaboration
§ The evolving rationale behind collaboration
§ Bad pharma? Bad academia? A good mix?
§ Publics and privates as new ‘social technologies’
Partnerships: a growing phenomenon
§ Public private partnerships in health innovation are growing in number, diversifying in nature and are a major feature of the policy landscape
§ UK Life Science Strategy puts partnerships and collaborations, including those related to personalised medicine, at the heart of government policy: § Strategy for UK Life Sciences: Building a Life Sciences Ecosystem § Innovation Health and Wealth: Accelerating adoption and
diffusion in the NHS (includes opening up NHS patient data)
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There are a range of different collaborations between public and private sector actors emerging in health innovation
§ Public private collaborations in health innovation vary with regards to their: § range of activities § structure and size of networks § roles of partners § rewards/incentives § risks for partners���
§ A lot of experimentation but a fragmented and limited evidence base and a lack of scenarios and evaluations
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Outline
§ An increase in public and private sector collaboration
§ The evolving rationale behind collaboration
§ Bad pharma? Bad academia? A good mix?
§ Publics and privates as new ‘social technologies’
Then and Now
Then § Market failure���
§ Insufficient returns to
private investors���
§ Public sector funding for basic research
Now § Extensive patenting
further upstream���
§ Public and private collaboration and joint funding upstream and downstream
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A framework for examining PPPs
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Institutions provide the operating framework
Social technologies
shape the uptake
Physical technologies Social technologies are the
means by which the application of physical technologies are coordinated – how we produce the cake
Institutions include regulations, governance structures, health systems and the ‘operational environment’ – the kitchen
Physical technologies are the science and tech we can put our hands on – the ‘recipe’ for baking a cake
Ideas and concepts in this slide are informed by Nelson and Sampat, 2001; Chataway, et al, 2010, Nelson, et al, 2011
Why is more clarity useful?
§ Without a clearer understanding of the basis of collaboration and a shared understanding of the common boundaries, transaction costs are likely to be higher���
§ Collaboration and partnership will be subject to political fashion and could become a political football (especially likely around privacy issues?) and without a clear understanding of the rationale collaborations are vulnerable
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Outline
§ An increase in public and private sector collaboration
§ The evolving rationale behind collaboration
§ Bad pharma? Bad academia? A good mix?
§ Publics and privates as new ‘social technologies’
Bad pharma?
§ Argument is that pharma puts pressure on knowledge producers to obscure and hide results
§ This is ethically unacceptable § Also bad because data about efficacy and
effectiveness is not shared § Adds up to a less productive system § Recommendation is that we need better regulation
and stronger academic voice in clinical trial conduct
37
Bad academics?
§ Increasing evidence that the quality of basic health research is very low (Prinz, 2011; Ioannides, 2010)
§ Publishing in Nature, Amgen researchers report that they were unable to replicate 47 out of 53 ‘landmark’ basic science publications in cancer which had originated in academia
§ Might more private sector presence in basic research increase the quality at that point in the research value chain?
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Outline
§ An increase in public and private sector collaboration
§ The evolving rationale behind collaboration
§ Bad pharma? Bad academia? A good mix?
§ Publics and privates as new ‘social technologies’
Public and private social technologies driving better science
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Institutions build trust and openness
New patterns of public and
private partnership across basic and applied
research
Improved and faster
development of physical
technology ‘ingredients’
Do we need a new set of public and private engagements to drive better and faster innovation?
To build new ways of working….
§ We need better understanding of different public private partnerships actually deliver
§ Better articulation of the rationale: The language of market failure, leveraging investment and de-risking does not capture the issue
§ Increased clarity on potential benefits for the health innovation ecosystem
41
Good Governance and Responsible Innovation
Joyce Tait
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A Policy Revolution: from “Government” to “Governance”
Government § Pre 1980s – “Powers
over” § A top-down legislative
approach § Attempts to regulate the
behaviour of people and institutions in detailed and compartmentalised ways
Governance § Post 1980s – “Powers
to” § Sets the parameters of
the system within which people and institutions behave so that self-regulation achieves the desired outcomes
43
Outcomes of Adopting a Governance Approach in Life Sciences
The Precautionary Principle
+ Upstream Engagement
= An innovation process that has been at the mercy of
media campaigns and ideologically manipulated public opinion
44
Governance and Regulation – from Science to Market Place
45
���Upstream ���Regulation
���Upstream ���
Engagement
Scientific Research
Translation
Application
���10-15 years and ���£500M – 1Bn
Downstream, Product���Regulation
���Downstream ���Engagement
Process regulation
Product regulation
Anticipatory and Adaptive Governance
Anticipatory Governance The new governance agenda claims to be lighter-touch, less top-down, but in effect it has extended the regulatory process into areas that used to be left to market forces. It claims to be more democratic, involving a wider range of stakeholders in the decision making process, but in effect it has merely led to a shift in power relations away from industry and commerce and in favour of advocacy groups with equally limited claims to represent ‘society’.
Adaptive Governance
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An adaptive risk governance approach is enabling of innovation, minimises risks to people and the environment, and balances the interests and values of all relevant stakeholders. It provides for trade-offs between these factors and supports smarter regulatory approaches that seek to balance potential social benefits and potential risks, particularly where both are uncertain in the early stages of technology development.
Smart, Adaptive Governance of Innovative Technology – Upstream and Downstream
§ Regulation can be modified in the light of changes in risk assessment, e.g. improved scientific understanding of the technology and its impacts and the levels of uncertainty associated with them, or changes in the policy and political context.
§ Recognises its role in enabling innovation § Balances the risks and benefits to people and the
environment § Balances the interests and values of ALL relevant
stakeholders § Is explicit about political influences on policy decisions § REGULATORY SCIENCE – Is able to consider ‘technical
fixes’ as an alternative or complement to regulation
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Critical Stakeholder Engagement – upstream and downstream § Be equitably skeptical about the motivations of those
with whom you engage § Consider innovation and regulatory processes, as well
as science § Consider benefits of the technology and balance
against costs and risks § Develop standards for engagement, including
standards for the quality of evidence on which decisions are based
§ In a plural democracy, maintain choice as far as possible
48 Tait, J. and Barker, G., (2011) EMBO Reports, 12, pp763-768. ���Tait, J. (2009) EMBO Reports. , 10, pp 18-22
Ethical principles - NCOB
1. The development should not be at the expense of people’s essential rights;
2. The development should be environmentally sustainable;
3. The development should contribute to a net environmental benefit;
4. Products should be developed in accordance with trade principles that are fair;
5. The costs and benefits of a development should be distributed in an equitable way;
6. If the first five principles are respected and the development can mitigate environmental and social harm, then depending on market and economic considerations, there is a duty to undertake the development. 49
