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

IF 6.2 3区管理学 Q1 BUSINESS International Entrepreneurship and Management Journal Pub Date : 2023-10-04 DOI:10.1007/s11365-023-00893-y

Anna Bastone, Francesco Schiavone, Maria Rosaria Carli, David Juárez-Varón

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Abstract

Abstract 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.

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如何在高度管制的市场中缩短市场进入创新。制药行业的早期准入项目

政府监管对创新过程有着深刻的影响。监管框架影响企业的创新能力。本研究的目的是提供一个探索性的调查早期访问计划的工具，以缩短时间，将创新在高度管制的市场。因此，我们的研究问题是:在高度监管的市场中，制度参与者如何推动创新进入?为了解决研究问题，采用不同国家的多案例研究方法进行了定性分析。分析采用了归纳法。研究结果提供了一个归纳性的概念框架，根据三个特征维度来确定不同的Early Access项目配置:(1)涉及的机构，(2)资格标准，(3)申请人。本研究具有理论和实践意义。未来的研究将需要进一步调查新出现的方面，使模型具有普遍性。

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来源期刊

International Entrepreneurship and Management Journal Multiple-

CiteScore

12.50

自引率

3.60%

发文量

期刊介绍： The International Entrepreneurship and Management Journal (IEMJ) publishes high quality manuscripts dealing with entrepreneurship, broadly defined, and the management of entrepreneurial organizations. The journal will expand the study of entrepreneurship and management by publishing innovative articles based on different perspectives using a variety of methodological approaches and showing the practical implications of the research for its readership. IEMJ is unique; providing a multi-disciplinary forum for researchers, scholars, consultants, entrepreneurs, businessmen, managers and practitioners in the field of entrepreneurship. The journal covers the relationship between management and entrepreneurship including both conceptual and empirical papers, leading to an improvement in the understanding of international entrepreneurial perspectives of the organisations concerned. Entrepreneurial studies are important in creating new economic activity that in turn increases innovation, employment, economic wealth and growth. The journal focuses on the diverse and complex characteristics of entrepreneurship in SMEs and large companies in local, regional, national or international markets that lead to competitiveness in the face of the effects of globalization. Though preference will be given to manuscripts that are international in scope, papers focused on domestic contexts and issues are welcome also, in order to facilitate the sharing of knowledge and potential generalizability of findings worldwide. IEMJ will publish original papers which contribute to the advancement of the field of entrepreneurship and the interface between management and entrepreneurship, as well as articles on business corporate strategy and government economic policy. On occasions, the journal will also feature case studies of successful firms or other cases having important practical implications. The journal places great emphasis on the quality of the papers it publishes. Submission of a paper will imply that it contains original unpublished work and is not being submitted for publication elsewhere. Officially cited as: Int Entrep Manag J