Finbarr Livesey

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.

Proposed classification scheme for direct writing technologies

Purpose – The purpose of this paper is to propose and discuss a definition and a classification scheme for direct writing (DW) technologies.Design/methodology/approach – Both the definition and the classification are developed based on the perspectives of the growing DW community in the UK, through consultation with members, workshops and a survey across the community. In addition, current DW technologies and literature on classification techniques are reviewed.Findings – The classification is structured in order to encompass current technologies, but also to be expandable to accommodate new ones that could be identified in the future as belonging to the DW remit. It is developed considering three dimensions related to DW: “Technology” to encompass all the processes, apparatuses, principles and tools which allow DW manufacturing; “Applications” to consider all the “types of manufactured goods” which could be produced with the DW technologies; and “Materials” which could be employed in DW manufacturing. Th...

Regulation of tissue-engineered products in the European Union: where are we heading?

The emergence of tissue-engineered products (TEPs) raises a standard question for regulators: is the existing regulatory regime appropriate or is there a case for a new regulatory framework? In the USA, the FDA has developed a risk-based approach to TEPs, whereas in Europe, a common regulatory strategy for these products has not yet been implemented. In order to fill this perceived gap, member states have set up domestic rules, which has led to an unclear and patchy regulatory situation. The Regulation on Advanced Therapy Medicinal Products, voted on by the European Commission in November 2005, has been developed by European Union regulators to provide the necessary framework to regulate TEPs. As the text is still to be discussed and to be passed, many concerns have been raised regarding the appropriateness of the proposed framework.

The Need for a New Understanding of Manufacturing and Industrial Policy in Leading Economies

Kingdom following the 2008 financial crisis have given a new primacy to manufacturing within the two countries’ respective economies. President Obama’s 2012 State of the Union address focused on manufacturing as the bedrock of future growth. The contrast to the financial sector was writ large when he said, “We will not go back to an economy weakened by outsourcing, bad debt, and phony financial profits” and called for “an economy built on American manufacturing.” In a similar vein, the UK coalition government has focused on the theme of rebalancing the economy, which is characterized as increasing the role of manufacturing. David Cameron’s first economic speech after becoming prime minister set the trend, when he stated, “Our economy has become more and more unbalanced, with our fortunes hitched to a few industries in one corner of the country, while we let other sectors like manufacturing slide.” It is as yet unclear whether these reactions to the crisis caused by the near collapse of the global financial system represent a well-formed approach to achieving long-term growth. The rules of the global economic game continue to change, and the current narratives on the economy, manufacturing, and growth are sadly out of date. Trapped within a framework that has become less and less representative of the economy, laden with ideological baggage, and lacking new thinking on how manufacturing has evolved in terms of production technologies, company organization, and impact on the economy, it should not be a surprise that our current responses to the call for rebalancing and growth might be off the mark. This article investigates attempts by the UK and the U.S. to focus on and provide support for manufacturing in the wake of the financial crisis. We focus on these two countries due to the significant attention being paid there to this debate, and because their actions highlight the general weaknesses in how policymakers are considering the future evolution of manufacturing.

What can be learnt from the Japanese regulatory approach to tissue engineered products

The Japanese government has recognized the challenges its rapidly aging population presents, especially in terms of healthcare provision, and is focusing on the potential of regenerative medicine to address them. The country has consequently embarked upon a national program to support development of this field. In 1999 Japan initiated a national research project in science and technology, known as the Millennium Project, whose areas of research include tissue engineering covering skin, cornea, bone, cartilage, blood vessels, nerves and bone marrow. In this context, at a time when regulations for tissue engineered products are being developed and revised in the USA and at the European level, it is interesting to investigate what type of framework Japanese regulators have designed to deal with these products in order to see what lessons might be learnt by UK, US and EU regulators. This paper reviews negative and positive aspects of the current regulatory situation that applies to tissue engineered products in Japan but will mostly focus on examples of good practice, such as the pragmatism that underpins the Japanese regulatory strategy, the international involvement of the country when it comes to developing regulatory standards and the promotion of a supportive public environment.

Will regulation determine the science agenda? A look at hESCs

Given the significant controversy over human embryonic stem cell (hESC) isolation and research, regulation of such work around the world has proceeded in an uncoordinated manner. In general, advances in science cause a need or desire for regulation; however, it has been the opposite for hESC research--regulation and policy have set certain boundaries for scientific research and defined other research questions. This is especially evident in the USA, where federal funding policies have engendered specific research towards novel methods for isolating such cells that do not require destruction of human embryos. Due to the multiplicity of national policies, it will be almost impossible to reach global consensus in the near future. Nonetheless, this paradigm of regulation leading science may have significant implications for future research projects. Changes in hESC policy in the short term will influence longer-term research potential.

Why are Material Efficiency Solutions a Limited Part of the Climate Policy Agenda? An application of the Multiple Streams Framework to UK policy on CO2 emissions from cars

Dr. Cooper-Searle is supported by a UK Engineering and Physical Sciences Research Council (EPSRC) PhD studentship EP/L504920/1, Dr. Livesey was supported by EPSRC grant EP/K039598/1 and Professor Allwood was supported by EPSRC grant EP/N02351X/1.

Towards a national design scoreboard: A model to enable comparison of performance between countries

Recognising the growing importance of design at a national level, this paper reports on the development of a suite of measures relating to national design performance. These measures are based around a simplified model of design as a system at a national level, developed through a workshop with government, industry and design sector representatives. Detailed data on design in the UK is presented to highlight the difficulties in collecting reliable and robust data. Evidence is compared with four countries (Spain, Canada, South Korea and Sweden). This comparison highlights the inherent difficulties in comparing performance and a revised set of measures is proposed.