Innovative capabilities, entrepreneurial process and the dynamic growth of university spin-outs: A process-oriented study with evidence from China

This research aims to develop a conceptual framework in order to enquire into the dynamic growth process of University Spin-outs (hereafter referred to as USOs) in China, attempting to understand the capabilities configuration that are necessary for the dynamic growth. Based on the extant literature and empirical cases, this study attempts to address the question how do USOs in China build and configure the innovative capabilities to cope with the dynamic growth. This paper aims to contribute to the existing literature by providing a theoretical discussion of the USOs' dynamic entrepreneurial process, by investigating the interconnections between innovation problem-solving and the required configuration of innovative capabilities in four growth phases. Further, it presents a particular interest on the impact to the USOs' entrepreneurial innovation process by the integrative capabilities, in terms of knowledge integration, alliance, venture finance and venture governance. To date, studies that have investigated the dynamic development process of USOs in China and have recognized the heterogeneity of USOs in terms of capabilities that are required for rapid growth still remain sparse. Addressing this research gap will be of great interest to entrepreneurs, policy makers, and venture investors. ©2009 IEEE.

Regulation: A Burden in Biopharmaceutical Industry? The Case of EU-Risk Management Plans

The generation of new medicinal products is both a contributor to global economic growth and a source of valuable benefits to human health. Given their direct responsibility for public health, regulatory authorities monitor closely both the development and exploitation of the underlying technologies and the products derived from them. The manner in which such regulation is implemented can result in regulators constraining or facilitating the generation of new products. This paper will study as an example the impact of EU Risk Management Plans (EU-RMPs), which have been mandatory for the approval of new medicines since 2005, on both the industry and regulatory authorities. In interviews, the responses of those who had experience of the implementation of EU-RMPs were mixed. Although the benefits of a more structured and predictable approach to the evaluation of risk were appreciated, some respondents perceived the regulation as an excessive burden on their organisations. The exploration of factors that influence how EU-RMP regulation affects individual firms provides new insights for both regulators and managers, and demonstrates one aspect of the complexity of the process by which new medicinal products are brought to market.

Regulation: A burden in biopharmaceutical industry? The case of EU-risk management plans

The generation of new medicinal products is both a contributor to global economic growth and a source of valuable benefits to human health. Given their direct responsibility for public health, regulatory authorities monitor closely both the development and exploitation of the underlying technologies and the products derived from them. The manner in which such regulation is implemented can result in regulators constraining or facilitating the generation of new products. This paper will study as an example the impact of EU Risk Management Plans (EU-RMPs), which have been mandatory for the approval of new medicines since 2005, on both the industry and regulatory authorities. In interviews, the responses of those who had experience of the implementation of EU-RMPs were mixed. Although the benefits of a more structured and predictable approach to the evaluation of risk were appreciated, some respondents perceived the regulation as an excessive burden on their organisations. The exploration of factors that influence how EU-RMP regulation affects individual firms provides new insights for both regulators and managers, and demonstrates one aspect of the complexity of the process by which new medicinal products are brought to market. © 2010 IEEE.

Entrepreneurial innovation problems associated with the dynamic growth of university spin-outs in China: A capabilities perspective

This research aims to develop a capabilities-based conceptual framework in order to study the stage-specific innovation problems associated with the dynamic growth process of university spin-outs (hereafter referred to as USOs) in China. Based on the existing literature, pilot cases and five critical cases, this study attempts to explore the interconnections between the entrepreneurial innovation problems and the configuration of innovative capabilities (that acquire, mobilise and re-configure the key resources) throughout the lifecycle of a firm in four growth phases. This paper aims to contribute to the literature in a holistic manner by providing a theoretical discussion of USOs' development through adding evidence from a rapid growth emerging economy. To date, studies that have investigated the development of USOs in China recognised the heterogeneity of USOs in terms of capabilities still remain sparse. Addressing this research gap will be of great interest to entrepreneurs, policy makers and venture investors. © Copyright 2010 Inderscience Enterprises Ltd.