- -

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 completo del ítem

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

Por favor, use este identificador para citar o enlazar este ítem: http://hdl.handle.net/10251/200873

Ficheros en el ítem

Metadatos del ítem

Título: How to shorten the market entry innovation in a highly regulated market. The case of Early access programs in the pharmaceutical industry
Autor: Schiavone, Francesco Bastone, Anna Carli, Maria Rosaria Juárez Varón, David
Entidad UPV: Universitat Politècnica de València. Escuela Politécnica Superior de Alcoy - Escola Politècnica Superior d'Alcoi
Fecha difusión:
Fecha de fin de embargo: 2024-10-05
Resumen:
[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 ...[+]
Palabras clave: Early access , Highly regulated markets , Innovation , Market entry
Derechos de uso: Embargado
Fuente:
International Entrepreneurship and Management Journal. (eissn: 1555-1938 )
DOI: 10.1007/s11365-023-00893-y
Editorial:
Springer-Verlag
Versión del editor: https://doi.org/10.1007/s11365-023-00893-y
Tipo: Artículo

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

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

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 [+]
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

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

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

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

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

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

Baregheh, A., Rowley, J., & Sambrook, S. (2009). Towards a multidisciplinary definition of innovation. Management Decision. https://doi.org/10.1108/00251740910984578

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

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

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

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

Bonnafous-Boucher, M., & Rendtorff, J. D. (2016). Stakeholder theory: A model for strategic management. Springer. ISBN: 978-3-319-44356-0.

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.

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

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

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

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

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

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

Deloitte. (2016). Innovation mining Australia 2016. Retrieved from https://www.deloitte.com/au/en/pages/energy-and-resources/articles/innovation-mining.html

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

Donaldson, T., & Preston, L. E. (1995). The stakeholder theory of the corporation: Concepts, evidence, and mplications. Academy of Management Review, 20(1), 65–91.

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

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

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

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

Elton, J., & O'Riordan, A. (2016). Healthcare disrupted: Next generation business models and strategies. John Wiley & Sons.

FARMINDUSTRIA. (2022). Gli indicatori farmaceutici. Retrieved December 2022, from https://www.farmindustria.it/app/uploads/2022/07/IndicatoriFarmaceutici2022.pdf

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

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

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

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

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.

Goffin, K., & Mitchell, R. (2017). Innovation management. Red Globe Press.

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

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

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.

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

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

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

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

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

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

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

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

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.

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

Lee, R. (1998). What is an exchange? Automation, management, and regulation of financial markets. OUP Oxford.

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

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

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

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

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

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

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

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

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

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

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

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

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.

OECD, OECD Staff, & Development (OECD) Staff. (1997). The OECD Report on Regulatory Reform: Sectoral Studies (Vol. 1). Organisation for Economic Co-operation and Development.

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

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

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

Saunders, M., Lewis, P., & Thornhill, A. (2007). Research Methods for Business Students Fourth Edition.

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

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

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

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

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

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

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.

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

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

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

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

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

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

Yin, R. K. (2009). Case study research: Design and methods (Vol. 5). Sage.

Yin, R. K. (2013). Validity and generalization in future case study evaluations. Evaluation, 19(3), 321–332. https://doi.org/10.1177/1356389013497081

Yin, R. K. (2017). Case Study Research and Applications: Design and Methods. Sage publications, Thousand Oaks. https://doi.org/10.33524/cjar.v14i1.73

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

[-]

recommendations

 

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

Mostrar el registro completo del ítem