Transcript Methods of Development

Developing sustainable competitive advantage
in the biopharmaceutical industry, through the
use of network innovation strategies
Chris Jeffs
Senior Lecturer in Strategic Management and International Business
Newcastle Business School
Northumbria University
England
Research map
Innovation/creativity
Outline of lecture
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Biopharmaceutical Industry
Biopharmaceutical networks
Projects within networks
Knowledge transfer
Limitations of Biopharmaceutical knowledge
transfer
Optimising biopharmaceutical innovation through
innovation networks
Pharmaceutical Value Chain
Basic
Research
Academic
Government
Disease
Discovery
Business Strategy
Disease
Understanding
Target
Identification
Private
•Structural genomics
•Genetics
•Biomedical Research
•Mammalian natural
products research
TargetValidation
•Prior validation
•Functional genomics
•Human genetics
•Animal genetics
(knockouts & transgenics)
•Exploratory clinical
studies (academic research)
•Research
–Transcriptional Profiling
–Proteomics
–Biomedicine
Drug
Discovery
Drug
Development
Assay Development
Process Research
Lead Compound
Selection
Scale Up
Generate Compounds
•Historical Libraries
•Natural Products
•Combinatorial Chemistry
•Targeted Synthesis
•Rational Design
Evaluate Compounds
•Characterize compounds
•Screen for activity
•Hi Thru-put Screening
(Hits)
Optimize Compounds
•Late stage synthesis
•Identification/Purification
•Secondary screening
•Testing in animals
•Prelim bioavailability
•Specificity, Metabolism
•Pharmacology
(Leads)
Development
Candidate Discovery
•Evaluate Mfg Process
•Environmental safety
•IP
Stability &
Formulation Testing
Safety Testing -InVivo
•Animal testing
•Toxicity Testing (side effects)
•Metabolism (DMPk)
•Pharmacokinetics
•ADME
•Bioavailability
Clinical Plan
Exploratory Drug
Candidate (EDC)
(Clinical Candidate)
Investigational New
Drug (IND) (CTX)
Informatics
Clinical Trials
Manufacturing
& Post Market
Surveillance
Phase I Trials
•Initial testing of humans (50)
•Normal population
•Safety profile
•Human metabolism
•Pharmacokinetics
Manufacturing
•Process Monitoring
•QA/QC
•Troubleshooting
Phase II Trials
•Human testing (100-300)
•Control studies - patients
•Efficacy (does it work?)
•Dosage (amount, frequency)
•Safety and Metabolism
•Final mfg process definition
Phase III Trials
•Human testing (1000's)
•Safety testing, long duration
•Multicenter studies
•Comparative trial (to existing
therapeutics)
•3 years
New Drug
Application (NDA)
(PLA international)
Post Market
Survey
•Ongoing monitoring of
patients
Phase IV
Clinical Trials
•New indications
•New dosages
Generics/ OTC
•Bioequivalence to
existing drugs
Background
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Biopharmaceuticals are used therapeutically
Biopharmaceuticals include proteins, antibodies
and nucleic acids, and are produced by means
other than direct extraction biological source.
The first such substance approved for therapeutic
use was biosynthetic 'human' insulin made via
recombinant DNA technology.
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It was developed by Genentech under the trade name
Humulin, but licensed to Eli Lilly and Company, who
manufactured and marketed the product from 1982.
Sustainable Competitive Advantage through
Collaborative Networking
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Relational capabilities
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Facilitate innovation by network linkages
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National/Political
Social
Cultural
Integrative capabilities (Owen-Smith et al, 2002)
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(Owen-Smith et al, 2002)
Translation of basic research into commercial applications
Switching strategy (Lampel, 2001 )
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Seeking high quality opportunities wherever they may be
found; trying to capture these opportunities, and then
turning their attention to transforming these opportunities
into revenues
GlaxoSmithKline (2009)
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We enjoy a strong record in establishing and
maintaining collaborations with scientists and
organizations in both industry and academia.
Since its inception, GlaxoSmithKline has
established over 50 compound alliances, which
now represent over 40% of GlaxoSmithKline’s
development pipeline, along with a wealth of
technology and academic alliances.
http://www.gsk.com/about/downloads/busdev-brochure.pdf
Crystal Genomics
Dr Joong Myung Cho, CEO.
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SEOUL-headquartered is a structure-based drug delivery and
development company. The company was founded in 2000 and
was listed on the KOSDAQ in early 2006. It has a wholly-owned
subsidiary, CG Pharmaceuticals, in Emerville, US.
Crystal Genomics has a diverse pipeline in the disease areas of
inflammation, anti-infectives and cancer
Because Korea is still relatively unknown in the biotech and
pharmaceutical industries, it takes extra efforts to be noticed by
potential global partners to consider CrystalGenomics as a
collaborating partner or to in-license our assets for further
development.
Crystal Genomics collaborations
Biopharmaceutical collaboration
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Rapid technological change, uncertainty & risk leads
to increased numbers of collaborative ventures
Collaboration may be to
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Fill in gaps in the value chain / gain resources
Increase the likelihood of market success
Increase the product portfolio
Gain access to knowledge
Embed the organisation into a community of practice
Biopharmaceutical collaboration
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Collaboration is typically as focal hubs
Collaboration raises entry barriers
Exclusivity is not always essential, competitors may also be
partners, profit can be made at all stages of the value chain
XOMA collaborative product development
www.pharmalicensing.com
Alliances by stage
Garnsey, Leong (2007)
Project Classifications
Newell et al (2007)
Complex
Simple
Project Ecology
(Time, space, # of organisations involved)
Multiple dispersed projects
involved but each operating
independently on tasks with
output pooled or sequentially
added
Multiple dispersed projects
working together reciprocally
on tasks in order to integrate
knowledge
Small number of co-located
projects each operating
independently on tasks with
output pooled or sequentially
added
Small number of co-located
projects working together
reciprocally on tasks in order
to integrate knowledge
Low
High
Project Interactivity
(How task interdependencies are managed across projects)
Knowledge transferability
Type of knowledge
Description
Individual tacit
knowledge
(Polanyi, 1966)
Developed through
Protected by good HRM
experience and hard to processes to motivate
put into words, or even and retain employees
to detect until required
‘Sticky’ collective
tacit knowledge
(Szulanski, 1996)
Knowledge embedded
in social structures
about how to act in
particular situations
Protected as distributed
through a collection of
people. Damaged if social
structures are disrupted
‘Leaky’ explicit
knowledge
(Szulanski, 1996)
Knowledge that is
explicit and inherently
mobile
Protected through forms
of data protection &
patents, trademarks etc
Adapted from McKenzie, J. & Van Winkelen, C. (2004).
Protection issues
Knowledge transfer across boundaries:
Integrated 3-T framework (Carlile, 2004)
Increasing Novelty
Pragmatic
Transformation
Semantic
Translation
Actor A
Syntactic
Transfer
Actor B
Known
Knowledge transfer in networks
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Inter or Intra organisational networks based on shallow/weak
ties more effective for the integration of explicit knowledge
(Hansen, 1999)
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Interpersonal networks, involving deep trust based
relationships more appropriate for the integration of tacit forms
of knowledge (Oliver & Liebeskind, 1998)
Reciprocal interdependence, Sub-tasks must continuously
interact because the outputs and decisions from one will have
a direct impact on the other; i.e. knowledge flows to and fro
between those involved. (Thompson, 1967)
Opportunities for networked innovation are seen as
increasingly important to organisational performance
facilitating the creation of new knowledge, rather than just the
transfer of existing knowledge. (Gulati, 1999)
Barriers to knowledge transfer
within networked collaborations
Processes
Technologies
Cultural
differences
Boundaries
Power
relationships
Boundaries, innovation &
competitive advantage
Most innovation happens at boundaries
between disciplines or specialisations
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(Leonard,1995)
Innovation is most likely to form at the
interstices of collaborating groups and
organisations (Powell et al, 1996)
Innovation is difficult to maintain due to
‘knowledge boundaries’ (Brown & Duguid, 2001)
Knowledge is both a source of and barrier to
innovation (Carlile, 2002)
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Processes
Technologies
Cultural
differences
Boundaries
Power
relationships
Boundaries to innovation in
complex networks (Carlile, 2004)
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Processes
Technologies
Cultural
differences
Boundaries
Power
relationships
Not just a bundle of resources but a bundle
of different boundaries where knowledge
must be shared and assessed.
Boundary management essential and where
novelty arises it must be addressed
Actors tend to reuse knowledge which limits
capacity to recognise when novelty is
represented
Innovation leading to sustainable
competitive advantage (Lampel, 2001)
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Requires:
Trust between partners in the partner selection
process
Entrepreneurial competencies – quickly sizing up
and judge which opportunities and relationships are
worth exploring or avoiding
Able to handle relationships with diverse partners
and deal with unforeseen contingencies as they
arise.
Complex innovation networks/ project ecologies rely
on “a collaborative effort by a group of organisations
in which none wields complete control”
Limitations to biopharmaceutical
knowledge transfer (Carlile, 2002)
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Complex project ecologies pose distinct
challenges for coordination of project work.
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Knowledge regime
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IP framework unfavourable to collective learning
Power dynamics
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Conflict rather than interaction
Knowledge transfer dependent on changeable relations
and interests
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Resource dependency relationships
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Pisano (2006)
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Existing anatomy of biopharmaceutical industry
not appropriate, giving the long-term risks and
uncertainty of projects
Need for knowledge transfer and integration
across disciplines is not being met
Long-term collaborations rather than shorter
term contracts
Monetizing IP is not sustainable
More inter-disciplinary research required
References (1)
Brown, J.S. Duguid, P. (2001). Knowledge and organisation: A social practise perspective.
Organizational Science. 12. pp. 198-213
Carlile, P. (2002). A pragmatic view of knowledge and boundaries: Boundary objects
in
new product development. Organisational Science. 13. pp. 442-455
Conway, S. (1995). Informal boundary spanning communication in the innovation processan empirical study. Technology Analysis and Strategic Management. 7 (3). pp. 327-342
De Long, D. W. & Fahey, L. (2000). Diagnosing cultural barriers to knowledge management.
The Academy of Management Executive. 14 (4). pp. 113-127
Elg, U. & Johansson, U. (1997). Decision making in inter-firm networks as a political
process. Organisation studies. 18. (3). pp. 361-380
Garnsey, E. Leong, Y.Y. (2007). Combining resourced based and evolutionary theory: A
synthesis applied to Bio-technology networks. University of Cambridge, Institute for
Manufacturing. 03. pp. 1-60
Goleman, D. (1995). Emotional Intelligence: Why it can matter more than IQ. New York:
Bantam Books
Grabher, G. (2002). The project ecology of advertising: tasks, talents and teams. Regional
studies. 36 (3), pp. 245-262
References (2)
Gulati, R. (1999). Network location and learning: The influence of network
resources and firm capabilities on alliance formation. Strategic Management
Journal. 20 (5). pp. 397-420
Hansen, M.T. (1999). The search transfer problem: The role of weak ties in
sharing knowledge across organisational sub-units. Administrative Science
Quarterly. 44. pp. 82-111
Hardy, C. Phillips, N. (1998). Strategies of Engagement: Lessons from the
Critical Examination of Collaboration and Conflict in an Inter-organizational
Domain. Organization Science. 9(2). pp. 217-230
Inkpen, A.C. (1996). Creating knowledge through collaboration. California
Management Review. 39 (1). pp. 123-140
Lampel, J. (2001). The core competencies of effective project execution: the
challenge of diversity. International Journal of Project management. 19 (8).
pp 480
Leonard, D. (1995). Well springs of knowledge: Building and sustaining the
sources of innovation. Harvard Business School Press: Boston, MA
McKenzie, J. & Van Winkelen, C. (2004). Understanding the knowledgeable
organisation: Nurturing knowledge competence. Thompson:Lonon
References (3)
Newell, S. & Swan, J. (2000). Trust and Inter-organisational working. Human
Relations. 53 (10). pp. 1287-328
Newell, S. Goussevskaia, A. Swan J. Bresnen, M. Obembe, A. (2007).
Interdependencies in complex project ecologies: The case of biomedical
Innovation. Long Range Planning, 41, pp 33-54
Oliver, A.L. & Liebeskind, J.P. (1998). Three level of networking for sourcing
intellectual capital in biotechnology. International Studies of Management
and Organisation. 27 (4). pp. 76-103
Owen-Smith, J. Riccaboni, M. Pammolli, F. Powell, W. (2002). A comparison
of US and European university-industry relations in the life sciences.
Management Science. 48 (1). pp. 24-43
Phillips, N. Lawrence, T.B. Hardy, C. (2000). Inter-organisational collaboration
and the dynamics of institutional fields. Journal of management studies.
37(1). pp. 23-43
Polyani, M. (1966). The Tacit Dimension. Garden City, NY: Doubleday
Powell, W. Koput, W. Smith-Doerr, L. (1996). Interorganisational Collaboration
and the locus of innovation: networks of learning in Biotechnology.
Administrative Science Quarterly 41 (1), pp. 116-130
References (4)
Ring, P.S. & Van de Ven, A.H. (1994). Developmental processes of
cooperative Interorganisational relationships. Academy of Management
Review. 19 (1). pp. 90-118
Swan, J. & Scarborough, H. (2005). The politics of Networked Innovation.
Human relations. 58 (7). pp. 913-943
Szulanski, G. (1996). Exploring internal stickiness. Impediments to the transfer
of best practise within the firm. Strategic Management Journal. 17. pp. 2743
Thompson, J. (1967). Organisations in Action, McGraw Hill: New York.