Look into drug discovery and development process: paradigms of phases and collaborations among participants
1Rennes School of Business, France; 2Grenoble Ecolede Management, France; 3Center for Innovation and Development, Chinese Academy of Sciences, China
Emerging small and medium science enterprises, large state-owned enterprises, multinationals, research institutes, etc. compose the participant diversity in Chinese biopharmaceutical industry. Aiming on clarifying the drug discovery and development process characteristics and the orchestrated collaboration format, the Zhangjiang pharmaceutical zone drug discovery and development data is gathered.
The world is constituted by events in connection of other events and can be more advanced probed with regard to smaller events (Van de Ven, 1992; Langley, Smallman, Tsoukas, Van de ven, 2013). A multi-phase development path of pharmaceutical development contains several consequent development cycles where primary objective plays the core role interacting directly with process design, resource available, product specification and clinical milestone that affect each other reciprocally (Lim, Garnsey and Gregory, 2006) which echoes the process ontology claim by Langley et al. (2013).
Kaitin (2010, p.360) illustrates a drug development process model which contains classified phases and main participants, named fully intergraded pharmaceutical network (FIPNet) where participants’ involvements in different phases are displayed, namely research prediscovery, discouvery preclinical, early phase development, latephase development, approval and Phase IV studies. Kaitin (2010) categorizes participants in a drug development process into four classes of stakeholders where their core capabilities are leveraged.
Why does the research on process study in drug discovery and development matter? Karpf (2010) point out that process research is an essential link which connects discovery chemistry and technical development and massive industrial production. Only when the process is well definite, can pharmaceutical production be efficient and optimized.
What kind of collaboration ties are formed among the organizations in different phases of drug R&D? What type of paradigm does each phase in the process follow?
Case study method serves multiple research intentions, such as exploration, description, and explanation whose object is the current event which researchers are not able or rarely control (Yin, 2009). The research question of this study requires the exploration and description of the collaboration among participants and explanation of different phases’ paradigms which is too complex for survey or experimental approaches.
A prominence of this research is the resource of the Zhanjiang pharmaceutical domain official registry data which has its debut in academic research. In order to authentically reflect the Zhangjiang High-tech Pharmaceutical Industry, the industry development yearbook of Shanghai Pharmaceutical Industry Development Report, Shanghai National Economy and Social Development Report – Biopharmaceutical Industry, Shanghai Year Book officially formulated by Shanghai Zhangjiang High-tech Pharmaceutical Industry Association are adopted as the core of the database of this study, taking the government database of Shanghai Municipal Science and Technology Commission and Shanghai Municipal Commission of Economy and Informatization as channel to acquire samples. Our database contains new drug projects information from 2009 to 2013 among 323 sample organizations in Zhangjiang pharmaceutical zone, Shanghai, China. Meanwhile, collected data was subject to many technical processing, such as text classification, information retrieval, information extraction, automatic text summarization, etc.
The drug discovery and development process matches the evolution paradigm where variation, selection and retention happen in a recurrent, cumulative and conjunctive sequence.
In preclinical phase, final state is envisioned and alternative means to reach it are generated by cumulating sequence of planning which resembles the teleology paradigm from process categories.
Dialectic paradigm represents clinical research situation where the process gains complicatedness from some predictable and unforeseen feedback from diagnostic cases where conflicts are compensated by adjusting is identical to the situation where equilibrium is disturbed by some pushing force and deconstruction is generated
The unitary propose of marketing study is fitting the market demand with aligning regulation and policy requirements. These events are prescribed by market nature flux and institutional rules that is typical life cycle paradigm processes mode.
Pharmaceutical enterprises dominate the process in each phase. Universities are directed by academic studies preferring medical and bioscience basic study. Hospitals include pathogenesis and disease samples in clinical trial. Scientific Research Institutions focus on innovation and promotion of new methods. New drug companies focus on technological development and lead development trend. Contract research organizations provide supporting services. Active pharmaceutical ingredients suppliers provide materials.
Contribution to Scholarship
Firstly, process researches emphasising on how things change over time tend to look through a dynamic social constructivist lense (Langley et al., 2013) where the interactions among different entities are focused from individual level to organisation level. This study orients to project level with associating process theories into project progresses and phases which broaden the applicability of process doctrines and enrich the process theory’s explanation coverage.
Secondly, drug discovery and development as a brunch of new product development is investigated by using social network analysis tool. From the perspective of social network, the topological structure of drug R&D actor network evolves from traditional punctate structure of independent R&D of pharmaceutical enterprises to establishment of collaboration R&D network structure of the organizations of different industry types of today.
Last but not least, the official achieves in Zhangjiang pharmaceutical zone have its debut and premiere used into academic study.
Contribution to Practice
This study raises the veil on drug discovery and development process, disclosed the paradigms of its phases and different collaboration formations among participants in its phases. This vanguard study provides not only managerial references on optimizing R&D collaboration in Chinese high-tech parks but also template models for emerging economies who are launching or plan on their high-tech area collaboration development mode construction.
Our research is relevant to this area by answering the following points which are relatively indicated in the track information: R&D and innovation models in Chinese pharmaceutical industry; forms of R&D management practices and/or transfer mechanisms for transforming research findings into commercialisations; roles of universities in R&D processes.
Kaitin, K.I., 2010. Deconstructing the drug development process: the new face of innovation. Clinical Pharmacology & Therapeutics, 87(3), pp.356-361.
Karpf, M., 2011. From Milligrams to Tons: The Importance of Synthesis and Process Research in the Development of New Drugs. Pharmaceutical Process Chemistry, pp.1-37.
Langley, A.N.N., Smallman, C., Tsoukas, H. and Van de Ven, A.H., 2013. Process studies of change in organization and management: Unveiling temporality, activity, and flow. Academy of management journal, 56(1), pp.1-13.
Lim, L.P., Garnsey, E. and Gregory, M., 2006. Product and process innovation in biopharmaceuticals: a new perspective on development. R&D Management, 36(1), pp.27-36.
Van de Ven, A.H., 1992. Suggestions for studying strategy process: A research note. Strategic management journal, 13(S1), pp.169-188.
Yin, R.K., 2009. Case study research: Design and methods (applied social research methods). London and Singapore: Sage.
The entrepreneurial university in Tunisia: fostering innovation through new approaches in higher education
1Fraunhofer Center for International Management and Knowledge Economy - IMW, Germany; 2Department of Innovation Management and Innovation Economics, University of Leipzig, Leipzig, Germany; 3Ecole Nationale d'Ingénieurs de Tunis (ENIT), University of Tunis-El Manar, Tunisia
Tunisian national science technology and innovation (STI) system lacks flexibility and needs improvements. The limited flexibility for universities, in particular to (re)design their curricula, requires new ways for bridging the gap between science and innovation and to educate future entrepreneurs.
The policies that govern and promote a national science technology and innovation (STI) system are essential to achieve a long-term inclusive growth (Şener and Sarıdoğan 2011).
Entrepreneurial universities are key actors and engage with various actors in the national STI system (Sam and van der Sijde 2014).
Universities are facing a dual challenge: students requiring new forms of teaching while financial resources are decreasing. Moreover, “over-education” – the overly focus on theoretical content – has led to a mismatch between graduates skills and the requirements of the labor market (O’Reilly et al. 2015), a phenomenon that is observed often in Tunisia (Haouas et al. 2012). Tunisian universities are strongly influenced by a Napoleonic model, where education is centrally governed (Taieb. H 2016). Consequently, there is a need to reimagine the role of universities as spaces of inspiration and innovation (Posselt et al. 2018).
Whereas entrepreneurial universities were addressed in the case of emerging countries, less focus was put on Tunisia regarding funding and innovation opportunities in higher education. Tunisian universities need to find innovative ways to revise their curricula (teaching content and methods) and to seize new funding opportunities.
In this research, we ask the question how curricula of higher education institutions in Tunisia can become more innovative, in particular: revision of content towards more consideration of real-life challenges; interactive learning methods that improve professional skills and the early involvement of actors of society, industry, and non- governmental organizations.
The paper develops cases studies of four Tunisian higher education institutions (HEIs) that benefited from a project called “Programme d'Appui à la Qualité (PAQ)” (quality support program), which has been conducted from 2006 until 2014. The cases are selected based on their field of studies, and with a focus on the disadvantaged regions of Tunisia that have the highest unemployment rates among higher education graduates. The case study approach enables one to solve the “how” research question (Yin 2012). The five steps for case studies as suggested by Runeson and Höst (2008) were followed.
The PAQ project is a competitive grant scheme developed with the World Bank that aimed at promoting academic innovation through the implementation of small projects in HEIs. Each HEI submitted a project proposal around the employability of students, not only to improve employment rate, but also the quality of the graduates’ profiles. Interviews were conducted with four project managers in four HEIs in Tunisia between July and August 2018. An interview lasted about one hour, and was based on open-ended questions. The interview captured the context, the main idea of the project, the motivations of the HEI to develop the project, and the unfolding of events of the project during and after its lifetime.
Two types of reports were included in the analysis. The first type are the reports prepared by the project team of each HEI and sent to the steering committee located at the Ministry of Higher Education and Scientific Research. Another kind of reports are those related to the evaluation of the PAQ project from World Bank and from the Ministry of Higher Education and Scientific Research.
Tunisian universities tackled three areas: revision of content to consider real-life challenges; interactive learning methods that improve professional skills, and the early involvement of society and industry. The four academic innovative projects had an impact on students, teachers, and the professional sphere. One HEI launched a practical workroom, in the form of a small factory with all processes of a production line. This contributes to integrated curricula where students from different engineering fields could work simultaneously on one single project. The students developed a systemic understanding of manufacturing processes beyond their respective areas of study, improved their communication skills, and their ability to work in multidisciplinary teams. In another project, practitioners and teachers co-supervised practical training sessions. Another HEI sets up a real model of a retail pharmacy, in which students could exercise the job via role-plays and real situation simulations while enhancing their autonomy through a learner centered approach and self-evaluation. Students showed more reactivity in a real situation, whereas and teachers more interest to develop innovative learning methods based on problem solving. The certification of students’ professional skills as part of the curricula added value to the academic degrees and to the HEIs as a source of self-financing.
Contribution to Scholarship
Our paper provides new insights into the needs and possibilities of higher education in emerging countries, in particular, Tunisia. The results can be extended to the Maghreb region. The research addresses the mechanism of teaching innovation under budget constraints as well the diffusion of innovation concepts within the HEI itself. The four case studies enrich the academic debate that argues for the importance of stronger action‐orientation of education and that studies the role of the entrepreneurial university in the innovation systems or ecosystems especially in emerging countries.
Contribution to Practice
For higher education, the research derives concrete suggestions for academic innovation such as flipped classroom, train-the trainer concepts, and role plays, focus on real-life problems in teaching, and certification of skills. These projects are completely new to the country and reveal a new form of openness to the external environment of the HEI. The outcome of these projects goes beyond the initial goal of academic innovation and contribute to the creation of synergies between universities and industry.
For Businesses, the cases show concrete solutions to work closer with HEIs and to get involved early in the education of future employees.
Our paper addresses the role of higher education to improve science, technology and innovation for developing countries, such as Tunisia. Our suggestions to implement more innovative teaching content and methods are one key foundation for improving national innovation systems and for bridging the gap between research, industry and society.
Haouas, IIham; Sayre, Edward; Yagoubi, Mahmoud (2012): Youth Unemployment in Tunisia: Characteristics and Policy Responses. In Topics in Middle Eastern and African Economies 14, pp. 395–415.
Posselt, Thorsten; Abdelkafi, Nizar; Fischer, Luise; Tangour, Cyrine (2018): Opportunities and challenges of Higher Education institutions in Europe: An analysis from a business model perspective. In Higher Educ Q 66 (3), p. 299. DOI: 10.1111/hequ.12192.
Runeson, Per; Höst, Martin (2008): Guidelines for conducting and reporting case study research in software engineering. In Empirical Software Engineering 14 (2), p. 131. DOI: 10.1007/s10664-008-9102-8.
Sam, Chanphirun; van der Sijde, Peter (2014): Understanding the concept of the entrepreneurial university from the perspective of higher education models. In High Educ 68 (6), pp. 891–908. DOI: 10.1007/s10734-014-9750-0.
Şener, Sefer; Sarıdoğan, Ercan (2011): The Effects Of Science-Technology-Innovation On Competitiveness And Economic Growth. In Procedia - Social and Behavioral Sciences 24, pp. 815–828. DOI: 10.1016/j.sbspro.2011.09.127.
Yin, Robert K. (2012): Applications of case study research. 3. ed. Los Angeles, Calif.: SAGE.
Dynamic Innovation Chain and Capabilities Linkages in Agribusiness: Insights for Emerging Countries
The transaction standard and the focus on commodities make agribusiness value chains, especially in emerging countries, market-driven, focused on mass-production solutions for food supply. These productivity-based strategies, however, tend to low the emergence of novelty. In this context, simple market relations often obscure the dynamics of innovation.
The nature of innovation in agribusiness is different from manufacturing industries (Triguero, Córcoles, & Cuerva, 2013). It goes beyond the development of inert products in an individual basis. To deal with forms of life depends on a series of processes, involving several actors in the different links of the value chain (Cantù, Corsaro, & Tunisini, 2015).
The traditional approach for agribusiness value chains, normally conducted through the lens of the Transaction Cost Economics, is however quite restricted to deal with that special nature of innovation (Zylbersztajn & Machado Filho, 2003). It tends to restrain innovation to the peer-to-peer exchange of technology.
Developing new technologies and new products in agribusiness depends on a more dynamic pattern of micro-linkages across the value chain (Fritz & Schiefer, 2008). Firms need to go beyond simple market relations to build a set of interconnected innovation capabilities (Zawislak et al, 2012).
The literature on innovation in agribusiness is mostly focused on the chain-level (Boehlje, Roucan-Kane & Bröring, 2011). However, analyzing this level provides a static view of the chain (Haggblade et al, 2014). It is necessary then to analyze the innovation dynamics based on the capabilities linkages within a chain.
How does the transactional approach limit the debate of innovation in agribusiness? What is the role of innovation capabilities in agribusiness? How do the different capabilities arrangements linkages promote the dynamics of innovation? The paper proposes the concept of Dynamic Innovation Chain and the innovation capabilities linkages along the chain.
This paper consists in an exploratory study, where a theoretical discussion is conducted. It considers different approaches to develop an analytic model, based on propositions that maybe further validated by empirical data. The structure of the paper will depict the pillars of the dynamic innovation chain concept, namely: (1) the nature of innovation in agribusiness; (2) beyond the transactional value chain; (3) the innovation capabilities of the firms in agribusiness; and (4) the patterns of innovation capabilities linkages throughout the value chain.
This paper is a theoretical paper and thus contains no empirical material.
Further than productivity-oriented solutions, such as seeds, fertilizers, pre and post harvest machinery and equipment – all them necessary process-oriented innovations –, it is necessary to focus on product and marketing oriented innovation. Especially in emerging countries, where the traditional transactional value chain governs market relations, a new pattern of innovative behavior must be found.
Firms – from S&T, producers until marketing actors – must go far beyond those simple market relations. They must participate in the construction of a set of technological interfaces among their boundaries of innovation capabilities, creating a dynamics of innovation that encompasses the whole value chain.
The Dynamic Innovation Chain considers the primary idea of connecting the different nexus of a value chain beyond the simple transaction. These linkages are made upon the combination of different individual innovation capabilities.
Each one of the major links (e.g. inputs, production, processing, retail) will have a particular arrangement of capabilities to meet specific expected outcomes. For example, upstream links are expected to be more technology development oriented than downstream ones, which tend to be more business and marketing driven. The dynamicity of the chain is determined by the combination of different dominant capability of each link.
Contribution to Scholarship
This paper may contribute to the understanding of the innovation dynamics in agribusiness, under a new perspective of the Dynamic Innovation Chain. This perspective is expected to advance the frontier of knowledge, especially considering emerging economies, by encompassing both transactional and innovative issues of any value chain in a much more comprehensive way.
The more focused on transactional issues, as for mass-production value chains, the more efficiency oriented it is. Thus, in those cases, novelty must be based on capability linkages that allow majorly production and management innovations.
The more innovative in terms of niche products with high added value and differentiation is a value chain, the more technology development and marketing oriented its innovation capability linkages have to be.
Contribution to Practice
In terms of practical contributions, this study results will help identifying the innovation dynamics in different agribusiness sectors and the patterns of innovation capabilities linkages throughout the value chain. Furthermore, this paper contributes to base innovation actions focused on the specificities of each agribusiness sectors. These contributions allow the generation of public policies through the development of programs adequate to the profile of agribusiness firms.
Developed countries already present agribusiness innovation through the idea of value-adding and specialization. Emerging countries, however, remain transaction-based with focus on cost reduction and mass production. This paper addresses this issue by proposing a model to analyze the innovation dynamics in agribusiness, basing both strategies towards innovation in emerging countries.
Boehlje, M., Roucan-Kane, M., & Bröring, S. (2011). Future agribusiness challenges: Strategic uncertainty, innovation and structural change. International Food and Agribusiness Management Review, 14(5), 53-82.
Cantù, C., Corsaro, D. and Tunisini, A. (2015), “Editorial: innovation networks: the key role of actors”, Journal of Business & Industrial Marketing, Vol. 30 Nos 3/4.
Fritz, M. and G. Schiefer. 2008. Innovation and System Dynamics in Food Networks. Agribusiness. 24 (3): 301-305.
Haggblade, S.; Theriault, V.; Staatz,J.; Dembele, N.; Diallo, B. "A conceptual framework for promoting inclusive agricultural value chain”. Michigan State University and IFAD. Retrieved 25 February 2014.
Triguero, Á., Córcoles, D., & Cuerva, M. C. (2013). Differences in innovation between food and manufacturing firms: An analysis of persistence. Agribusiness, 29(3), 273-292.
Zylbersztajn, D.; Machado Filho, C.A.P. (2003) Competitiveness of meat agri-food chain in Brazil, Supply Chain Management: An International Journal, Vol. 8 Issue: 2.
“Managing Open innovation in startups of a developing country”
1Hasselt University, Diepenbeek, Belgium; 2Neoma Business School, Reims, France; 3ESADE Business School, Barcelona, Spain
The paper analyzes how startup can organize and manage and eventually benefit from open innovation (OI) practices in a developing country (Vietnam). It is an exploratory study built on four in-depth case studies and followed up with a detail cross-case analysis.
Startups can greatly benefit from OI, but they also face multiple challenges when they engage in OI practices. Abouzeedan, Klofsten et al. (2013) and van de vrande et al, (2009)detail the financial and technical challenges faced by small firms when they innovate due to the scarcity of their resources. Lee, Park et al. (2010) point to a lack of expertise and networks for commercialization and collaboration as obstacles for adopting openness in their business model. Some scholars have identified the experience of the manager or entrepreneur as a crucial factor for the success of collaborations with outside partners (Stinchcombe 1965, Helfat and Lieberman 2002).
Vietnam is an emerging economy in Southeast Asia. Major economic reforms since 1986, have changed the direction of the Vietnamese economy. After 30 years, the country now ranks among lower-middle income countries, while it was one of the poorest nations in the 1980s (World Bank, 2016).
In the recent years, OI literature has seen significant increase in number yet most of them are focused on data of developed countries while developing countries is neglected in the existing literature. Even more, the number of studies on OI in startups in developing countries is almost equivalent to nil.
The paper analyzes how Vietnamese startups are adopting open innovation practices and how they get benefit from such practices amid certain challenges. We examine the mechanisms driving the success of strategic collaborations among startups and their partners. The paper also emphasize the crucial role of the entrepreneur.
This is an exploratory paper built on four in-depth case studies and followed by detailed cross-case analysis. The case studies illustrate open innovation practices implemented by the Vietnamese startups and how such practices are benefiting them in improving innovation performance.
Starting from interviewing 18 companies, we shortlisted four startups for in-depth study. based on their experience with open innovation, the industry, their success with open innovation practices, the number of years since their establishment, and their locations. Location was selected as a criteria for two reasons – first, as mentioned earlier the convenience, and second, to observe open innovation practices in geographically country-wide spread area (the two main business cities, Hanoi and Ho Chi Minh, located in north and south of the country respectively). The selected startups provide valuable insight into the open innovation mindset and practices adopted by Vietnamese businesses across the country.
Data was conducted primarily through detailed interviews with startup owners. Each interview lasted for almost one hour. With some startups, however, multiple interviews were conducted in order to extract more detailed information. Furthermore, information was also obtained through the companies’ websites, news, brochures, etc.
The cases discussed show that entrepreneurial insight is essential in finding not only new business opportunities but also the network of people and organizations these entrepreneurs’ know-how is critical for their success. Entrepreneur’s through their know-how and experience in the industry envisions a venture idea leading up to articulation of business model innovation. In all the four cases discussed, entrepreneurs envisions venture ideas which were totally new to the respective industries. After envisioning a strategic change, entrepreneurs started to look for required resources for which they have to include openness into their business model to overcome lack of technical and financial skills. The paper outlays how OI impact on startups' business model, development and managing of innovation network and entrepreneur's crucial role in it. The paper also highlights role of startup incubators, technology accelerators in a setting of a developing country while illustrating government's role thereof.
Contribution to Scholarship
The paper emphasize to bridge OI and entrepreneurship literature to study OI in startups especially in the context of a developing country. In addition to several new findings, paper also confirms the conclusion noted by Van de Vrande et al., 2009 and Gassman (2006) - the startups improve their internal knowledge and overcome their lack of resources and competencies through agreements and co-innovation with external partners, such as users, suppliers, complementors, universities, and incubators. To survive in such a complex environment, firms prefer to network only with trusted partners or by adopting a strategy of developing and evolving together (as also suggested in Vanhaverbeke, 2017). Partner selection is a considerable challenge for startups. Selecting the right partner is crucial for the business, especially for innovative activities. After trust, the most important factor for selecting a partner is observed to be personal relationships and then recommendations from incubators, if any.
Contribution to Practice
Startups can gain considerable benefits from adopting OI practices. These help startups to overcome their capacity problems, their lack of competencies and scarcity of resources. Selecting partners is crucial and careful consideration of potential partners is critical. While working with innovation partners, it is necessary to decide beforehand on a few rules: e.g., how decisions will be made, how bookkeeping will work, how to deal with an outlier in the network, etc. The role of incubators can be very helpful in locating appropriate resources and finding the right partners. Lastly, entrepreneurs must promote an open culture inside the firm.
The paper perfectly fits in the theme of this conference as it elaborates how startups in an emerging country can benefit from adopting new paradigm of open innovation. The practices will be helpful in understanding the phenomenon and bridging research & society to benefit from each other.
Gassmann, O. (2006). "Opening up the innovation process: towards an agenda." R&d Management 36(3): 223-228.
van de Vrande, V., J. P. J. de Jong, W. Vanhaverbeke and M. de Rochemont (2009). "Open innovation in SMEs: Trends, motives and management challenges." Technovation 29(6-7): 423-437.
Vanhaverbeke, W. (2017). Managing Open Innovation in SMEs, Cambridge University Press.