- -

How to shorten the market entry innovation in a highly regulated market. The case of Early access programs in the pharmaceutical industry

RiuNet: Repositorio Institucional de la Universidad Politécnica de Valencia

Compartir/Enviar a

Citas

Estadísticas

  • Estadisticas de Uso

How to shorten the market entry innovation in a highly regulated market. The case of Early access programs in the pharmaceutical industry

Mostrar el registro sencillo del ítem

Ficheros en el ítem

dc.contributor.author Schiavone, Francesco es_ES
dc.contributor.author Bastone, Anna es_ES
dc.contributor.author Carli, Maria Rosaria es_ES
dc.contributor.author Juárez Varón, David es_ES
dc.date.accessioned 2023-12-18T19:07:01Z
dc.date.available 2023-12-18T19:07:01Z
dc.date.issued 2023-10-04 es_ES
dc.identifier.uri http://hdl.handle.net/10251/200873
dc.description.abstract [EN] Government regulation impacts deeply on the innovation process. Regulatory frameworks influence firms' innovativeness. This study aims to provide an exploratory investigation of Early Access programs as a tool to shorten the time to place innovation in highly regulated markets. Thus, our research question is: How do institutional actors push the entry of innovation in highly regulated markets? To address the research question, a qualitative analysis was conducted using the multiple case study method among different countries. The analysis practised an inductive approach. The results provide an inductive conceptual framework to identify different configurations of Early Access programs based on three characterizing dimensions: (1) authorities involved, (2) eligibility criteria and (3) applicant. This study provides implications for both theory and practice. Future research will be needed to investigate the emerging aspects further and make the model generalisable. es_ES
dc.language Inglés es_ES
dc.publisher Springer-Verlag es_ES
dc.relation.ispartof International Entrepreneurship and Management Journal es_ES
dc.rights Reserva de todos los derechos es_ES
dc.subject Early access es_ES
dc.subject Highly regulated markets es_ES
dc.subject Innovation es_ES
dc.subject Market entry es_ES
dc.subject.classification INGENIERIA DE LOS PROCESOS DE FABRICACION es_ES
dc.title How to shorten the market entry innovation in a highly regulated market. The case of Early access programs in the pharmaceutical industry es_ES
dc.type Artículo es_ES
dc.identifier.doi 10.1007/s11365-023-00893-y es_ES
dc.rights.accessRights Embargado es_ES
dc.date.embargoEndDate 2024-10-05 es_ES
dc.contributor.affiliation Universitat Politècnica de València. Escuela Politécnica Superior de Alcoy - Escola Politècnica Superior d'Alcoi es_ES
dc.description.bibliographicCitation Schiavone, F.; Bastone, A.; Carli, MR.; Juárez Varón, D. (2023). How to shorten the market entry innovation in a highly regulated market. The case of Early access programs in the pharmaceutical industry. International Entrepreneurship and Management Journal. 1-21. https://doi.org/10.1007/s11365-023-00893-y es_ES
dc.description.accrualMethod S es_ES
dc.relation.publisherversion https://doi.org/10.1007/s11365-023-00893-y es_ES
dc.description.upvformatpinicio 1 es_ES
dc.description.upvformatpfin 21 es_ES
dc.type.version info:eu-repo/semantics/publishedVersion es_ES
dc.identifier.eissn 1555-1938 es_ES
dc.relation.pasarela S\500353 es_ES
dc.description.references Adams, R., Bessant, J., & Phelps, R. (2006). Innovation management measurement: A review. International Journal of Management Reviews, 8(1), 21–47. https://doi.org/10.1111/j.1468-2370.2006.00119.x es_ES
dc.description.references Aday, S., & Aday, M. S. (2020). Impact of COVID-19 on the food supply chain. Food Quality and Safety, 4(4), 167–180. https://doi.org/10.1093/fqsafe/fyaa024 es_ES
dc.description.references Aldieri, L., Bruno, B., Senatore, L., & Vinci, C. P. (2020). The future of pharmaceuticals industry within the triad: The role of knowledge spillovers in the innovation process. Futures, 122, 102600. https://doi.org/10.1016/j.futures.2020.102600 es_ES
dc.description.references Amable, B., Ledezma, I., & Robin, S. (2016). Product market regulation, innovation, and productivity. Research Policy, 45(10), 2087–2104. https://doi.org/10.1016/j.respol.2016.08.003 es_ES
dc.description.references Apolone, G., Ardizzoni, A., Buzzetti, G., Clerico, M. A., Conte, P., de Braud, F., ... & Scroccaro, G. (2019). Early access in oncology: why is it needed? Global & Regional Health Technology Assessment, 2019, 2284240319857072. https://doi.org/10.1177/2284240319857072 es_ES
dc.description.references Bansal, P., Smith, W. K., & Vaara, E. (2018). New ways of seeing through qualitative research. Academy of Management Journal, 61(4), 1189–1195. https://doi.org/10.5465/amj.2018.4004 es_ES
dc.description.references Baregheh, A., Rowley, J., & Sambrook, S. (2009). Towards a multidisciplinary definition of innovation. Management Decision. https://doi.org/10.1108/00251740910984578 es_ES
dc.description.references Berger, J. (2019). Signaling can increase consumers' willingness to pay for green products. Theoretical model and experimental evidence. Journal of Consumer Behaviour, 18(3), 233–246. https://doi.org/10.1002/cb.1760 es_ES
dc.description.references Bettinazzi, E. L., & Zollo, M. (2017). Stakeholder orientation and acquisition performance. Strategic Management Journal, 38(12), 2465–2485. https://doi.org/10.1002/smj.2672 es_ES
dc.description.references Blind, K. (2016). The impact of regulation on innovation. In Handbook of innovation policy impact (pp. 450–482). Edward Elgar Publishing. https://doi.org/10.4337/9781784711856.00022 es_ES
dc.description.references Blind, K., Petersen, S. S., & Riillo, C. A. (2017). The impact of standards and regulation on innovation in uncertain markets. Research Policy, 46(1), 249–264. https://doi.org/10.1016/j.respol.2016.11.003 es_ES
dc.description.references Bonnafous-Boucher, M., & Rendtorff, J. D. (2016). Stakeholder theory: A model for strategic management. Springer. ISBN: 978-3-319-44356-0. es_ES
dc.description.references Bossle, M. B., de Barcellos, M. D., Vieira, L. M., & Sauvée, L. (2016). The drivers for adoption of eco-innovation. Journal of Cleaner Production, 113, 861–872. es_ES
dc.description.references Branstad, A., & Solem, B. A. (2020). Emerging theories of consumer-driven market innovation, adoption, and diffusion: A selective review of consumer-oriented studies. Journal of Business Research, 116, 561–571. https://doi.org/10.1016/j.jbusres.2020.01.028 es_ES
dc.description.references Brem, A., Viardot, E., & Nylund, P. A. (2021). Implications of the coronavirus (COVID-19) outbreak for innovation: Which technologies will improve our lives? Technological Forecasting and Social Change, 163, 120451. https://doi.org/10.1016/j.techfore.2020.120451 es_ES
dc.description.references Carayannis, E. G., Grigoroudis, E., Campbell, D. F., Meissner, D., & Stamati, D. (2018). The ecosystem as helix: An exploratory theory-building study of regional co-opetitive entrepreneurial ecosystems as Quadruple/Quintuple Helix Innovation Models. R&D Management, 48(1), 148–162. https://doi.org/10.1111/radm.12300 es_ES
dc.description.references Cavaleri, M., Enzmann, H., Straus, S., & Cooke, E. (2021). The European Medicines Agency’s EU conditional marketing authorisations for COVID-19 vaccines. The Lancet, 397(10272), 355–357. https://doi.org/10.1016/S0140-6736(21)00085-4 es_ES
dc.description.references Cobelli, N., & Chiarini, A. (2020). Improving customer satisfaction and loyalty through mHealth service digitalization: New challenges for Italian pharmacists. The TQM Journal. https://doi.org/10.1108/TQM-10-2019-0252 es_ES
dc.description.references Costa, E., & Magrini, N. (2022). Verso un modello integrato di sviluppo, approvazione e accesso dei farmaci per malattie rare in Europa. Recenti Progressi in Medicina, 113(7), 407–410. https://doi.org/10.1701/3850.38333 es_ES
dc.description.references Deloitte. (2016). Innovation mining Australia 2016. Retrieved from https://www.deloitte.com/au/en/pages/energy-and-resources/articles/innovation-mining.html es_ES
dc.description.references Ding, Z., Wang, Y., & Zou, P. X. (2016). An agent based environmental impact assessment of building demolition waste management: Conventional versus green management. Journal of Cleaner Production, 133, 1136–1153. https://doi.org/10.1016/j.jclepro.2016.06.054 es_ES
dc.description.references Donaldson, T., & Preston, L. E. (1995). The stakeholder theory of the corporation: Concepts, evidence, and mplications. Academy of Management Review, 20(1), 65–91. es_ES
dc.description.references Donbesuur, F., Ampong, G. O. A., Owusu-Yirenkyi, D., & Chu, I. (2020). Technological innovation, organisational innovation and international performance of SMEs: The moderating role of domestic institutional environment. Technological Forecasting and Social Change, 161, 120252. https://doi.org/10.1016/j.techfore.2020.120252 es_ES
dc.description.references Eisenhardt, K. M. (1989). Building theories from case study research. Academy of Management Review, 14(4), 532–550. https://doi.org/10.5465/amr.1989.4308385 es_ES
dc.description.references Eisenhardt, K. M., & Graebner, M. E. (2007). Theory building from cases: Opportunities and challenges. Academy of Management Journal, 50(1), 25–32. https://doi.org/10.5465/amj.2007.24160888 es_ES
dc.description.references Elias, A. A. (2016). Analysing the stakes of stakeholders in research and development project management: A systems approach. R&D Management, 46(4), 749–760. https://doi.org/10.1111/radm.12122 es_ES
dc.description.references Elton, J., & O'Riordan, A. (2016). Healthcare disrupted: Next generation business models and strategies. John Wiley & Sons. es_ES
dc.description.references FARMINDUSTRIA. (2022). Gli indicatori farmaceutici. Retrieved December 2022, from https://www.farmindustria.it/app/uploads/2022/07/IndicatoriFarmaceutici2022.pdf es_ES
dc.description.references Ferreira, A., & Sandner, P. (2021). Eu search for regulatory answers to crypto assets and their place in the financial markets’ infrastructure. Computer Law & Security Review, 43, 105632. https://doi.org/10.1016/j.clsr.2021.105632 es_ES
dc.description.references Fliaster, A., & Kolloch, M. (2017). Implementation of green innovations–The impact of stakeholders and their network relations. R&D Management, 47(5), 689–700. https://doi.org/10.1111/radm.12257 es_ES
dc.description.references Frishammar, J., Richtnér, A., Brattström, A., Magnusson, M., & Björk, J. (2019). Opportunities and challenges in the new innovation landscape: Implications for innovation auditing and innovation management. European Management Journal, 37(2), 151–164. https://doi.org/10.1016/j.emj.2018.05.002 es_ES
dc.description.references Garousi Mokhtarzadeh, N., Amoozad Mahdiraji, H., Jafarpanah, I., Jafari-Sadeghi, V., & Cardinali, S. (2020). Investigating the impact of networking capability on firm innovation performance: Using the resource-action-performance framework. Journal of Intellectual Capital, 21(6), 1009–1034. https://doi.org/10.1108/JIC-01-2020-0005 es_ES
dc.description.references Gioia, D. A., Corley, K. G., & Hamilton, A. L. (2013). Seeking qualitative rigor in inductive research: Notes on the Gioia methodology. Organizational Research Methods, 16(1), 15–31. es_ES
dc.description.references Goffin, K., & Mitchell, R. (2017). Innovation management. Red Globe Press. es_ES
dc.description.references Gopal, G., Suter-Crazzolara, C., Toldo, L., & Eberhardt, W. (2019). Digital transformation in healthcare–architectures of present and future information technologies. Clinical Chemistry and Laboratory Medicine (CCLM), 57(3), 328–335. https://doi.org/10.1515/cclm-2018-0658 es_ES
dc.description.references Greenwood, R., & Suddaby, R. (2006). Institutional entrepreneurship in mature fields: The big five accounting firms. Academy of Management Journal, 49(1), 27–48. https://doi.org/10.5465/amj.2006.20785498 es_ES
dc.description.references Greif, A., & Kingston, C. (2011). Institutions: rules or equilibria? In Political economy of institutions, democracy and voting (pp. 13–43). Berlin, Heidelberg: Springer Berlin Heidelberg. es_ES
dc.description.references Gruenhagen, J. H., & Parker, R. (2020). Factors driving or impeding the diffusion and adoption of innovation in mining: A systematic review of the literature. Resources Policy, 65, 101540. https://doi.org/10.1016/j.resourpol.2019.101540 es_ES
dc.description.references Hashai, N., & Markovich, S. (2017). Market entry by high technology startups: The effect of competition level and startup innovativeness. Strategy Science, 2(3), 141–160. https://doi.org/10.1287/stsc.2017.0033 es_ES
dc.description.references Hashmi, R., & Alam, K. (2019). Dynamic relationship among environmental regulation, innovation, CO2 emissions, population, and economic growth in OECD countries: A panel investigation. Journal of Cleaner Production, 231, 1100–1109. https://doi.org/10.1016/j.jclepro.2019.05.325 es_ES
dc.description.references Hörisch, J., Schaltegger, S., & Freeman, R. E. (2020). Integrating stakeholder theory and sustainability accounting: A conceptual synthesis. Journal of Cleaner Production, 275, 124097. https://doi.org/10.1016/j.jclepro.2020.124097 es_ES
dc.description.references Jakhar, S. K., Mangla, S. K., Luthra, S., & Kusi-Sarpong, S. (2019). When stakeholder pressure drives the circular economy: Measuring the mediating role of innovation capabilities. Management Decision, 57(4), 904–920. https://doi.org/10.1108/MD-09-2018-0990 es_ES
dc.description.references Jin, W., Zhang, H. Q., Liu, S. S., & Zhang, H. B. (2019). Technological innovation, environmental regulation, and green total factor efficiency of industrial water resources. Journal of Cleaner Production, pp. 211, 61–69. https://doi.org/10.1016/j.jclepro.2018.11.172 es_ES
dc.description.references Jommi, C., Apolone, G., Cicchetti, A., Conte, P., Fattore, G., Mantoan, D., ... & Buzzetti11, G. (2019). Prezzo, rimborso e accesso ai farmaci in Italia: le proposte di riforma di quattro panel di esperti. Politiche Sanitarie, 20, 168–79. https://doi.org/10.1706/3289.32610 es_ES
dc.description.references Jommi, C., Armeni, P., Costa, F., Alberti, C., Bandello, F., Bordonaro, R., ... & Villa, F. (2021). Early access programs and managed entry agreements for medicines in Italy: results of a Focus Group (Early Access Programs and Managed Entry Agreement). Recenti Progressi in Medicina, 112(11), 749–756. https://doi.org/10.1701/3696.36853 es_ES
dc.description.references Länsisalmi, H., Kivimäki, M., Aalto, P., & Ruoranen, R. (2006). Innovation in healthcare: A systematic review of recent research. Nursing Science Quarterly, 19(1), 66–72. es_ES
dc.description.references Lee, M. T., & Raschke, R. L. (2020). Innovative sustainability and stakeholders’ shared understanding: The secret sauce to “performance with a purpose.” Journal of Business Research, 108, 20–28. https://doi.org/10.1016/j.jbusres.2019.10.020 es_ES
dc.description.references Lee, R. (1998). What is an exchange? Automation, management, and regulation of financial markets. OUP Oxford. es_ES
dc.description.references Leite, H., Lindsay, C., & Kumar, M. (2020). COVID-19 outbreak: Implications on healthcare operations. The TQM Journal. https://doi.org/10.1108/TQM-05-2020-0111 es_ES
dc.description.references Lin, D., Bezemer, C. P., & Hassan, A. E. (2018). An empirical study of early access games on the Steam platform. Empirical Software Engineering, 23, 771–799. https://doi.org/10.1007/s10664-017-9531-3 es_ES
dc.description.references Löblová, O., Csanádi, M., Ozierański, P., Kaló, Z., King, L., & McKee, M. (2019). Alternative access schemes for pharmaceuticals in Europe: Towards an emerging typology. Health Policy, 123(7), 630–634. https://doi.org/10.1016/j.healthpol.2019.05.012 es_ES
dc.description.references Luthra, S., Garg, D., & Haleem, A. (2016). The impacts of critical success factors for implementing green supply chain management towards sustainability: An empirical investigation of Indian automobile industry. Journal of Cleaner Production, 121, 142–158. https://doi.org/10.1016/j.jclepro.2016.01.095 es_ES
dc.description.references Magistretti, S., Allo, L., Verganti, R., Dell’Era, C., & Reutter, F. (2021). The microfoundations of design sprint: How Johnson & Johnson cultivates innovation in a highly regulated market. Journal of Knowledge Management, 25(11), 88–104. https://doi.org/10.1108/JKM-09-2020-0687 es_ES
dc.description.references Mariani, M. M., & Wamba, S. F. (2020). Exploring how consumer goods companies innovate in the digital age: The role of big data analytics companies. Journal of Business Research, 121, 338–352. https://doi.org/10.1016/j.jbusres.2020.09.012 es_ES
dc.description.references Marino, M., Parrotta, P., & Valletta, G. (2019). Electricity (de) regulation and innovation. Research Policy, 48(3), 748–758. https://doi.org/10.1016/j.respol.2018.11.005 es_ES
dc.description.references Markman, G. D., Gianiodis, P., Tyge Payne, G., Tucci, C., Filatotchev, I., Kotha, R., & Gedajlovic, E. (2019). The who, where, what, how and when of market entry. Journal of Management Studies, 56(7), 1241–1259. https://doi.org/10.1111/joms.12448 es_ES
dc.description.references McGahan, A. M. (2021). Integrating insights from the resource-based view of the firm into the new stakeholder theory. Journal of Management, 47(7), 1734–1756. https://doi.org/10.1177/0149206320987282 es_ES
dc.description.references Mohan, S. (2020). Private standards and producer risk: A framework for analysis of development implications. European Review of Agricultural Economics, 47(2), 403–437. https://doi.org/10.1093/erae/jbz005 es_ES
dc.description.references Mukundhan, K. V., & Nandakumar, M. K. (2016). Stakeholder influences on the choice and performance of FDI-based market entry modes: A conceptual model. International Studies of Management & Organization, 46(1), 63–74. https://doi.org/10.1080/00208825.2015.1007017 es_ES
dc.description.references Najafi-Tavani, S., Najafi-Tavani, Z., Naudé, P., Oghazi, P., & Zeynaloo, E. (2018). How collaborative innovation networks affect new product performance: Product innovation capability, process innovation capability, and absorptive capacity. Industrial Marketing Management, 73, 193–205. https://doi.org/10.1016/j.indmarman.2018.02.009 es_ES
dc.description.references Newton, M., Scott, K., & Troein, P. (2022). EFPIA Patients WAIT Indicator 2021 Survey. WAIT (Waiting to Access Innov Ther Surv Indic 2020) 2021, 51. https://www.efpia.eu/media/602652/efpia-patient-wait-indicator-final-250521.pdf. Accessed March 23, 2022. es_ES
dc.description.references OECD, OECD Staff, & Development (OECD) Staff. (1997). The OECD Report on Regulatory Reform: Sectoral Studies (Vol. 1). Organisation for Economic Co-operation and Development. es_ES
dc.description.references Paolone, F., Cucari, N., Wu, J., & Tiscini, R. (2022). How do ESG pillars impact firms’ marketing performance? A configurational analysis in the pharmaceutical sector. Journal of Business & Industrial Marketing. https://doi.org/10.1108/JBIM-07-2020-0356 es_ES
dc.description.references Parente, R., Rong, K., Geleilate, J. M. G., & Misati, E. (2019). Adapting and sustaining operations in weak institutional environments: A business ecosystem assessment of a Chinese MNE in Central Africa. Journal of International Business Studies, 50, 275–291. https://doi.org/10.1057/s41267-018-0179-z es_ES
dc.description.references Santoro, G., Bertoldi, B., Giachino, C., & Candelo, E. (2020). Exploring the relationship between entrepreneurial resilience and success: The moderating role of stakeholders’ engagement. Journal of Business Research, 119, 142–150. https://doi.org/10.1016/j.jbusres.2018.11.052 es_ES
dc.description.references Saunders, M., Lewis, P., & Thornhill, A. (2007). Research Methods for Business Students Fourth Edition. es_ES
dc.description.references Schiavone, F., & Simoni, M. (2019). Strategic marketing approaches for the diffusion of innovation in highly regulated industrial markets: The value of market access. Journal of Business & Industrial Marketing, 34(7), 1606–1618. https://doi.org/10.1108/JBIM-08-2018-0232 es_ES
dc.description.references Schneider, T., & Sachs, S. (2017). The impact of stakeholder identities on value creation in issue-based stakeholder networks. Journal of Business Ethics, 144, 41–57. https://doi.org/10.1007/s10551-015-2845-4 es_ES
dc.description.references Storbacka, K. (2019). Actor engagement, value creation and market innovation. Industrial Marketing Management, 80, 4–10. https://doi.org/10.1016/j.indmarman.2019.04.007 es_ES
dc.description.references Suchman, M. C. (1995). Managing legitimacy: Strategic and institutional approaches. Academy of Management Review, 20(3), 571–610. https://doi.org/10.5465/amr.1995.9508080331 es_ES
dc.description.references Sultana, J., Addis, A., Braga, M., Campomori, A., Capuano, A., Corrao, G., ... & Trifirò, G. (2020). What can real-world evidence contribute to regulatory science in pre-and post-marketing setting. Pharmadvances, 2(2), 51–8. https://doi.org/10.36118/pharmadvances.02.2020.02 es_ES
dc.description.references Thomas, V. J., & Maine, E. (2019). Market entry strategies for electric vehicle start-ups in the automotive industry–Lessons from Tesla Motors. Journal of Cleaner Production, 235, 653–663. https://doi.org/10.1016/j.jclepro.2019.06.284 es_ES
dc.description.references Tomino C., De Lorenzo F., Prada M., Gori S., Pinto C. (2017). 9° Rapporto sulla condizione assistenziale dei malati oncologici I tempi di accesso ai farmaci oncologici: dall’EMA al malato a cura. es_ES
dc.description.references van de Bovenkamp, H. M., Stoopendaal, A., van Bochove, M., & Bal, R. (2020). Tackling the problem of regulatory pressure in Dutch elderly care: The need for recoupling to establish functional rules. Health Policy, 124(3), 275–281. https://doi.org/10.1016/j.healthpol.2019.12.017 es_ES
dc.description.references Vargo, S. L., Akaka, M. A., & Wieland, H. (2020). Rethinking the process of diffusion in innovation: A service-ecosystems and institutional perspective. Journal of Business Research, 116, 526–534. https://doi.org/10.1016/j.jbusres.2020.01.038 es_ES
dc.description.references Villa, F., Tutone, M., Altamura, G., Antignani, S., Cangini, A., Fortino, I., ... & Jommi, C. (2019). Determinants of price negotiations for new drugs. The experience of the Italian Medicines Agency. Health Policy, 123(6), 595–600. https://doi.org/10.1016/j.healthpol.2019.03.009 es_ES
dc.description.references Wang, C., & Hu, Q. (2020). Knowledge sharing in supply chain networks: Effects of collaborative innovation activities and capability on innovation performance. Technovation, 94, 102010. https://doi.org/10.1016/j.technovation.2017.12.002 es_ES
dc.description.references Woodward, R. T., & Kaiser, R. A. (2002). Market structures for US water quality trading. Applied Economic Perspectives and Policy, 24(2), 366–383. https://doi.org/10.2307/1349766 es_ES
dc.description.references Yin, R. K. (1994). Discovering the future of the case study. Method in Evaluation Research. Evaluation Practice, 15(3), 283–290. https://doi.org/10.1177/109821409401500309 es_ES
dc.description.references Yin, R. K. (2009). Case study research: Design and methods (Vol. 5). Sage. es_ES
dc.description.references Yin, R. K. (2013). Validity and generalization in future case study evaluations. Evaluation, 19(3), 321–332. https://doi.org/10.1177/1356389013497081 es_ES
dc.description.references Yin, R. K. (2017). Case Study Research and Applications: Design and Methods. Sage publications, Thousand Oaks. https://doi.org/10.33524/cjar.v14i1.73 es_ES
dc.description.references Yu, X., & Li, Y. (2020). Effect of environmental regulation policy tools on the quality of foreign direct investment: An empirical study of China. Journal of Cleaner Production, 270, 122346. https://doi.org/10.1016/j.jclepro.2020.122346 es_ES


Este ítem aparece en la(s) siguiente(s) colección(ones)

Mostrar el registro sencillo del ítem