Industry perceptions of barriers to commercialization of regenerative medicine products in the UK.

AIMS: Regenerative medicine is an emerging field with the potential to provide widespread improvement in healthcare and patient wellbeing via the delivery of therapies that can restore, regenerate or repair damaged tissue. As an industry, it could significantly contribute to economic growth if products are successfully commercialized. However, to date, relatively few products have reached the market owing to a variety of barriers, including a lack of funding and regulatory hurdles. The present study analyzes industry perceptions of the barriers to commercialization that currently impede the success of the regenerative medicine industry in the UK. MATERIALS & METHODS: The analysis is based on 20 interviews with leading industrialists in the field. RESULTS: The study revealed that scientific research in regenerative medicine is thriving in the UK. Unfortunately, lack of access to capital, regulatory hurdles, lack of clinical evidence leading to problems with reimbursement, as well as the culture of the NHS do not provide a good environment for the commercialization of regenerative medicine products. CONCLUSION: Policy interventions, including increased translational government funding, a change in NHS and NICE organization and policies, and regulatory clarity, would likely improve the general outcomes for the regenerative medicine industry in the UK.

Manufacturing clarity

A framework has been developed for the UK economy that categorizes companies who provides a more defined perspective on the structure of the economy in order to help decision makers, government and industry to achieve sustained economic growth. The Institute for Manufacturing (IfM) has established a broader definition of manufacturing that equates manufacturing to the full cycle of activities from research and development, through design, production, logistics and services, to end of life management, within an economic and social context. This approach recognizes that manufacturing firms turn ideas into products and services and that they are inventors, innovators, global supply chain managers and service providers. It is hoped that this categorization provides policy-makers with a clear frame of reference for discussing measures to adapt interventions to address the needs of the diverse set of companies.

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.

Comparative analysis of carbonization drivers in China's megacities

This study investigates the key drivers affecting emission increases in terms of population growth, economic growth, industrial transformation, and energy use in six Chinese megacities: Beijing, Shanghai, Tianjin, Chongqing, Guangzhou, and Hong Kong. The six cities represent the most-developed regions in China and they have similar per capita carbon dioxide (CO 2) emissions as many developed countries. There is an urgent need to quantify the magnitude of each factor in driving the emissions changes in those cities so that a potential bottom-up climate mitigation policy design at the city and sectoral levels can be initiated. We adopt index decomposition analysis and present the results in both additive and multiplicative approaches to reveal the absolute and relative levels of each factor in driving emission changes during 1985-2007. Among all cities, economic effect and energy intensity effect have always been the two dominant factors contributing to the changes in carbon emissions. This study reveals that there are large variations in the ways driving forces contribute to emission levels in different cities and industrial sectors. © 2012 by Yale University.

Roadmapping an emerging energy technology: An ex-ante examination of dimethyl ether development in China

Technology roadmapping has been used to strategise the development of energy technologies. However, there have been limited roadmapping applications that analyse the emergence of a new energy technology that then forms a new industry and propels broad-based low-carbon economic growth. This paper, therefore, attempts to develop a roadmapping framework by integrating the lifecycle analysis tool, in order to strategise the emergence of dimethyl ether, an alternative energy based on advanced engineering technologies such as carbon capture and storage. This paper compares two scenarios of dimethyl ether vs. diesel and finds that the superiority of dimethyl ether will not arise until 2030, when the complementary engineering technologies become available. This proposed framework can also be generalised to other clean energy industries, and we anticipate our paper will spark inspiration for roadmapping and strategising the 'right' technologies for the growth of Chinese energy industries. Copyright © 2012 Inderscience Enterprises Ltd.