Study material MLSI Articles
Lecture 2
Innovating in large life sciences companies
- Munos, B. (2009). Lessons from 60 years of pharmaceutical innovation. Nature
Reviews Drug Discovery, 8(12), 959-968.
- Scannell, J. W., Blanckley, A., Boldon, H., & Warrington, B. (2012). Diagnosing the
decline in pharmaceutical R&D efficiency. Nature reviews Drug discovery, 11(3), 191-
200
Project-based innovations
- Lo, A., & Pisano, G. (2016). Lessons from Hollywood: A new approach to funding R&D.
MIT Sloan Management Review, 57(2), 47.
- Edmondson, A. C., Bohmer, R. M., & Pisano, G. P. (2001). Disrupted routines: Team
learning and new technology implementation in hospitals. Administrative Science
Quarterly, 46(4), 685-716.
Lecture 3
Rise of small biotechcompanies
- Metcalfe, J. S., James, A., & Mina, A. (2005). Emergent innovation systems and the
delivery of clinical services: The case of intra-ocular lenses. Research Policy, 34(9),
1283-1304.
- Pisano, G.P. (2006) Chapter 5: The autonomy of a science-based business. In: Science
business – the promise, the reality, and the future of biotech. Harvard Business
School Press, Boston.
Biotech business models
- Lehoux, P., Daudelin, G., Williams-Jones, B., Denis, J. L., & Longo, C. (2014). How do
business model and health technology design influence each other? Insights from a
longitudinal case study of three academic spin-offs. Research Policy, 43(6), 1025-
1038.
- Willemstein, L., van der Valk, T., & Meeus, M. T. (2007). Dynamics in business
models: An empirical analysis of medical biotechnology firms in the Netherlands.
Technovation, 27(4), 221-232.
Tutorial 3: Digital healthcare innovation
- Steinberg, D., Horwitz, G., & Zohar, D. (2015). Building a business model in digital
medicine. Nature biotechnology, 33(9), 910-920.
- Sim, I. (2019). Mobile Devices and Health. New England Journal of Medicine, 381(10),
956-968.
Lecture 4: Public innovation: innovation at universities and hospitals
- Boon, W.P.C. Universitair medisch centra als innovatiehubs. In: Boon, W.P.C. &
Horlings, E. (2013) Kenniscoproductie voor de grote maatschappelijke vraagstukken.
Rathenau Instituut, Den Haag.
- Christensen, C.M. (2009) Disrupting the hospital business model. In: The innovator’s
prescription. McGraw-Hill, New York.
The role of Public-private partnership
- Stolk, P. (2013). Background Paper 8.1: Public Private Partnerships. Retrieved from:
http://www.who.int/medicines/areas/priority_medicines/BP8_1PPPs.pdf.
, - Aerts, C., Sunyoto, T., Tediosi, F., & Sicuri, E. (2017). Are public-private partnerships
the solution to tackle neglected tropical diseases? A systematic review of the
literature. Health Policy.
Lecture 5: Market of technology, IPR and financing innovation
- Arora, A., Fosfuri, A., & Gambardella, A. (2001) Markets for technology and their
implications for corporate strategy. Industrial and corporate change, 10(2), 419- 451.
- Hopkins, M.M., P.A. Crane, P. Nightingale, C. Baden-Fuller (2013) Buying big into
biotech: scale, financing, and the industrial dynamics of UK biotech, 1980-2009.
Industrial and Corporate Change.
Tutorial 5: Alliances and innovation networks in life sciences
- Stuart, T.E., S.Z. Ozdemir, W.W. Ding (2007) Vertical alliance networks: the case of
university-biotechnology-pharmaceutical alliance chains. Research Policy 36, 477-
498.
- Powell, W. W., Koput, K. W., & Smith-Doerr, L. (1996). Interorganizational
collaboration and the locus of innovation: Networks of learning in biotechnology.
Administrative science quarterly, 116-145.
Lecture 6a: Role of users in innovations in the life sciences
- Smits, R. E., & Boon, W. P. (2008). The role of users in innovation in the
pharmaceutical industry. Drug Discovery Today, 13(7), 353-359.
- Gittelman, M. (2016). The revolution re-visited: Clinical and genetics research
paradigms and the productivity paradox in drug discovery. Research Policy, 45(8),
1570-1585.
Lecture 6b Regulation and institutional entrepeneurship
- Blind, K. (2004) Chapter 2: A Conceptual Framework to Analyse the Relationship
Between Innovation and Regulation. Pp. 3-16. In: New Products and Services:
Analysis of Regulations Shaping New Markets. Fraunhofer Institute, Karlsruhe.
- Hansen, A. (2001). Biotechnology regulation: Limiting or contributing to biotech
development?. New Genetics and Society, 20(3), 255-271.
Tutorial 6 Ethics in life sciences innovations
- Carroll, A. B., & Shabana, K. M. (2010). The business case for corporate social
responsibility: a review of concepts, research and practice. International Journal of
Management Reviews, 12(1), 85-105.
- Schurman, R. (2004). Fighting “Frankenfoods”: Industry opportunity structures and
the efficacy of the anti-biotech movement in Western Europe. Social Problems, 51(2),
243-268.
, Lecture 2
Innovating in large sciences companies
Scannel (2012): Diagnosing the decline in pharmaceutical R&D efficiency, due to;
- Better than the beatles problem: “Imagine how hard it would be to achieve
commercial success with new pop songs if any new song had to be better than the
Beatles, if the entire Beatles catalogue was available for free, and if people did not
get bored with old Beatles records.”
- Cautious regulator problem: “Progressive lowering of the risk tolerance of drug
regulatory agencies obviously raises the bar for the introduction of new drugs, and
could substantially increase the associated costs of R&D. Each real or perceived sin by
the industry, or genuine drug misfortune, leads to a tightening of the regulatory
ratchet, and the ratchet is rarely loosened, even if it seems as though this could be
achieved without causing significant risk to drug safety”
“The availability of safe and effective drugs to treat a given disease raises the
regulatory bar for other drugs for the same indication.” not likely to change
- Throw money at it tendency: “The lack of understanding of factors affecting return
on R&D investment that contributed to relatively indiscriminate spending during the
good times could mean that cost cutting is similarly indiscriminate. Costs may go
down, without resulting in a substantial increase in productivity”
- Basic research-brute force bias: “The tendency to overestimate the ability of
advances in basic research (particularly in molecular biology) and brute force
screening methods (embodied in the first few steps of the standard discovery and
preclinical research process) to increase the probability that a molecule will be safe
and effective in clinical trials.”
Solution: CDDO; Chief Dead Drug Officier; “This role would be focused on drug failure at
all stages of R&D, and the CDDO would have a fixed time from appointment to compose a
detailed report that aims to explain the causes of Eroom’s Law.
Munos (2009): Lessons from 60 years of pharmaceutical innovation. Nature Reviews Drug
Discovery.
“The new-drug output from pharmaceutical companies in this period has essentially been
constant, and remains so despite the attempts to increase it. The new-drug output is not
depressed, but may simply reflect the limitations of the current R&D model.”
- “The performance of the current business model cannot satisfy stakeholders, M&A
are not a solution, and the process improvements and cost cutting measures that are
commonly used cannot make a sufficient difference.”
Redesign:
- Change its innovation dynamics to move beyond constant NME (new molecular
entity) output and venture away from its comfort zone
- Open architecture for R&D; it heightens competition, reduces costs and increases
agility by making it easier to initiate and terminate projects. And makes it easier to
manage disruptive innovation, by locating it outside the corporate walls, where it can
thrive unencumbered.
- Not focus on short-term priorities, this makes them rely on break-through discoveries
Rethink process culture; not let success depend on random occurrence of a few ‘black swan’
products. No assume that R&D is scalable, could be industrialized and could be driven by
detailed metrics and automation.
Lecture 2
Innovating in large life sciences companies
- Munos, B. (2009). Lessons from 60 years of pharmaceutical innovation. Nature
Reviews Drug Discovery, 8(12), 959-968.
- Scannell, J. W., Blanckley, A., Boldon, H., & Warrington, B. (2012). Diagnosing the
decline in pharmaceutical R&D efficiency. Nature reviews Drug discovery, 11(3), 191-
200
Project-based innovations
- Lo, A., & Pisano, G. (2016). Lessons from Hollywood: A new approach to funding R&D.
MIT Sloan Management Review, 57(2), 47.
- Edmondson, A. C., Bohmer, R. M., & Pisano, G. P. (2001). Disrupted routines: Team
learning and new technology implementation in hospitals. Administrative Science
Quarterly, 46(4), 685-716.
Lecture 3
Rise of small biotechcompanies
- Metcalfe, J. S., James, A., & Mina, A. (2005). Emergent innovation systems and the
delivery of clinical services: The case of intra-ocular lenses. Research Policy, 34(9),
1283-1304.
- Pisano, G.P. (2006) Chapter 5: The autonomy of a science-based business. In: Science
business – the promise, the reality, and the future of biotech. Harvard Business
School Press, Boston.
Biotech business models
- Lehoux, P., Daudelin, G., Williams-Jones, B., Denis, J. L., & Longo, C. (2014). How do
business model and health technology design influence each other? Insights from a
longitudinal case study of three academic spin-offs. Research Policy, 43(6), 1025-
1038.
- Willemstein, L., van der Valk, T., & Meeus, M. T. (2007). Dynamics in business
models: An empirical analysis of medical biotechnology firms in the Netherlands.
Technovation, 27(4), 221-232.
Tutorial 3: Digital healthcare innovation
- Steinberg, D., Horwitz, G., & Zohar, D. (2015). Building a business model in digital
medicine. Nature biotechnology, 33(9), 910-920.
- Sim, I. (2019). Mobile Devices and Health. New England Journal of Medicine, 381(10),
956-968.
Lecture 4: Public innovation: innovation at universities and hospitals
- Boon, W.P.C. Universitair medisch centra als innovatiehubs. In: Boon, W.P.C. &
Horlings, E. (2013) Kenniscoproductie voor de grote maatschappelijke vraagstukken.
Rathenau Instituut, Den Haag.
- Christensen, C.M. (2009) Disrupting the hospital business model. In: The innovator’s
prescription. McGraw-Hill, New York.
The role of Public-private partnership
- Stolk, P. (2013). Background Paper 8.1: Public Private Partnerships. Retrieved from:
http://www.who.int/medicines/areas/priority_medicines/BP8_1PPPs.pdf.
, - Aerts, C., Sunyoto, T., Tediosi, F., & Sicuri, E. (2017). Are public-private partnerships
the solution to tackle neglected tropical diseases? A systematic review of the
literature. Health Policy.
Lecture 5: Market of technology, IPR and financing innovation
- Arora, A., Fosfuri, A., & Gambardella, A. (2001) Markets for technology and their
implications for corporate strategy. Industrial and corporate change, 10(2), 419- 451.
- Hopkins, M.M., P.A. Crane, P. Nightingale, C. Baden-Fuller (2013) Buying big into
biotech: scale, financing, and the industrial dynamics of UK biotech, 1980-2009.
Industrial and Corporate Change.
Tutorial 5: Alliances and innovation networks in life sciences
- Stuart, T.E., S.Z. Ozdemir, W.W. Ding (2007) Vertical alliance networks: the case of
university-biotechnology-pharmaceutical alliance chains. Research Policy 36, 477-
498.
- Powell, W. W., Koput, K. W., & Smith-Doerr, L. (1996). Interorganizational
collaboration and the locus of innovation: Networks of learning in biotechnology.
Administrative science quarterly, 116-145.
Lecture 6a: Role of users in innovations in the life sciences
- Smits, R. E., & Boon, W. P. (2008). The role of users in innovation in the
pharmaceutical industry. Drug Discovery Today, 13(7), 353-359.
- Gittelman, M. (2016). The revolution re-visited: Clinical and genetics research
paradigms and the productivity paradox in drug discovery. Research Policy, 45(8),
1570-1585.
Lecture 6b Regulation and institutional entrepeneurship
- Blind, K. (2004) Chapter 2: A Conceptual Framework to Analyse the Relationship
Between Innovation and Regulation. Pp. 3-16. In: New Products and Services:
Analysis of Regulations Shaping New Markets. Fraunhofer Institute, Karlsruhe.
- Hansen, A. (2001). Biotechnology regulation: Limiting or contributing to biotech
development?. New Genetics and Society, 20(3), 255-271.
Tutorial 6 Ethics in life sciences innovations
- Carroll, A. B., & Shabana, K. M. (2010). The business case for corporate social
responsibility: a review of concepts, research and practice. International Journal of
Management Reviews, 12(1), 85-105.
- Schurman, R. (2004). Fighting “Frankenfoods”: Industry opportunity structures and
the efficacy of the anti-biotech movement in Western Europe. Social Problems, 51(2),
243-268.
, Lecture 2
Innovating in large sciences companies
Scannel (2012): Diagnosing the decline in pharmaceutical R&D efficiency, due to;
- Better than the beatles problem: “Imagine how hard it would be to achieve
commercial success with new pop songs if any new song had to be better than the
Beatles, if the entire Beatles catalogue was available for free, and if people did not
get bored with old Beatles records.”
- Cautious regulator problem: “Progressive lowering of the risk tolerance of drug
regulatory agencies obviously raises the bar for the introduction of new drugs, and
could substantially increase the associated costs of R&D. Each real or perceived sin by
the industry, or genuine drug misfortune, leads to a tightening of the regulatory
ratchet, and the ratchet is rarely loosened, even if it seems as though this could be
achieved without causing significant risk to drug safety”
“The availability of safe and effective drugs to treat a given disease raises the
regulatory bar for other drugs for the same indication.” not likely to change
- Throw money at it tendency: “The lack of understanding of factors affecting return
on R&D investment that contributed to relatively indiscriminate spending during the
good times could mean that cost cutting is similarly indiscriminate. Costs may go
down, without resulting in a substantial increase in productivity”
- Basic research-brute force bias: “The tendency to overestimate the ability of
advances in basic research (particularly in molecular biology) and brute force
screening methods (embodied in the first few steps of the standard discovery and
preclinical research process) to increase the probability that a molecule will be safe
and effective in clinical trials.”
Solution: CDDO; Chief Dead Drug Officier; “This role would be focused on drug failure at
all stages of R&D, and the CDDO would have a fixed time from appointment to compose a
detailed report that aims to explain the causes of Eroom’s Law.
Munos (2009): Lessons from 60 years of pharmaceutical innovation. Nature Reviews Drug
Discovery.
“The new-drug output from pharmaceutical companies in this period has essentially been
constant, and remains so despite the attempts to increase it. The new-drug output is not
depressed, but may simply reflect the limitations of the current R&D model.”
- “The performance of the current business model cannot satisfy stakeholders, M&A
are not a solution, and the process improvements and cost cutting measures that are
commonly used cannot make a sufficient difference.”
Redesign:
- Change its innovation dynamics to move beyond constant NME (new molecular
entity) output and venture away from its comfort zone
- Open architecture for R&D; it heightens competition, reduces costs and increases
agility by making it easier to initiate and terminate projects. And makes it easier to
manage disruptive innovation, by locating it outside the corporate walls, where it can
thrive unencumbered.
- Not focus on short-term priorities, this makes them rely on break-through discoveries
Rethink process culture; not let success depend on random occurrence of a few ‘black swan’
products. No assume that R&D is scalable, could be industrialized and could be driven by
detailed metrics and automation.
