Innovation in the pharmaceutical industry:a study of the effects of regulation on the U.K. pharmaceutical industry

A history of government drug regulation and the relationship between the pharmaceutical companies in the U.K. and the licensing authority is outlined. Phases of regulatory stringency are identified with the formation of the Committees on Safety of Drugs and Medicines viewed as watersheds. A study of the impact of government regulation on industrial R&D activities focuses on the effects on the rate and direction of new product innovation. A literature review examines the decline in new chemical entity innovation. Regulations are cited as a major but not singular cause of the decline. Previous research attempting to determine the causes of such a decline on an empirical basis is given and the methodological problems associated with such research are identified. The U.K. owned sector of the British pharmaceutical industry is selected for a study employing a bottom-up approach allowing disaggregation of data. A historical background to the industry is provided, with each company analysed or a case study basis. Variations between companies regarding the policies adopted for R&D are emphasised. The process of drug innovation is described in order to determine possible indicators of the rate and direction of inventive and innovative activity. All possible indicators are considered and their suitability assessed. R&D expenditure data for the period 1960-1983 is subsequently presented as an input indicator. Intermediate output indicators are treated in a similar way and patent data are identified as a readily-available and useful source. The advantages and disadvantages of using such data are considered. Using interview material, patenting policies for most of the U.K. companies are described providing a background for a patent-based study. Sources of patent data are examined with an emphasis on computerised systems. A number of searches using a variety of sources are presented. Patent family size is examined as a possible indicator of an invention's relative importance. The patenting activity of the companies over the period 1960-1983 is given and the variation between companies is noted. The relationship between patent data and other indicators used is analysed using statistical methods resulting in an apparent lack of correlation. An alternative approach taking into account variations in company policy and phases in research activity indicates a stronger relationship between patenting activity, R&D Expenditure and NCE output over the period. The relationship is not apparent at an aggregated company level. Some evidence is presented for a relationship between phases of regulatory stringency, inventive and innovative activity but the importance of other factors is emphasised.

The role of industrial design in technological innovation

This is an exploratory study in a field which previously was virtually unexplored. The aim is to identify, for the benefit of innovators, the influence of industrial design on the commercial success of new science-based products used for professional and industrial purposes. The study is a contribution to the theory of success and failure in industrial innovation. The study begins by defining the terminology. To place the investigation in context, there is then a review of past attempts by official policy-making bodies to improve the competitiveness of British products of manufacture through good design. To elucidate the meaning of good design, attempts to establish a coherent philosophy of style in British products of manufacture during the same period are also reviewed. Following these reviews, empirical evidence is presented to identify what actually takes place in successful firms when industrial design is allocated a role in the process of technological innovation. The evidence comprises seven case studies of new science-based products used for professional or industrial purposes which have received Design Council Awards. To facilitate an objective appraisal, evidence was obtained by conducting separate semi-structured interviews, the detail of which is described, with senior personnel in innovating firms, with industrial design consultants, and with professional users. The study suggests that the likelihood of commercial success in technological innovation is greater when the form, configuration, and the overall appearance of a new product, together with the detail which delineates them, are consciously and expertly controlled. Moreover, uncertainty in innovation is likely to be reduced if the appearance of a new product is consciously designed to facilitate recognition and comprehension. Industrial design is an especially significant factor when a firm innovates against a background of international competition and comparable levels of technological competence in rival firms. The likelihood of success in innovation is enhanced if design is allocated a role closely identified with the total needs of the user and discrete from the engineering function in company organisation. Recent government measures, initiated since this study began, are corroborative of the findings.

A simultaneous examination of the effects of salesperson relationship-building activities and marketing activities on retail buyers' purchase decisions

Firms’ contemporary selling practices often not only demand that salespeople meet sales quotas, but also that they build strong, profitable relationships with customers. Given the belief that relationship-building activities can develop closer customer ties and improve sales performance, scholars have increasingly studied salesperson behaviors aimed at nurturing buyer-salesperson relations. However, while previous sales research has investigated the effects of a number of relational activities on performance outcomes in isolation, knowledge about their effectiveness in comparison to other important performance drivers is virtually absent. The present study provides some first theoretical and empirical insights into this research gap by simultaneously examining the role of specific salesperson relationship-building activities, and product-focused variables, in retail buyers’ new product purchase decisions. Following an extensive literature review, a two-part qualitative field study was conducted to explore salesperson relationship-building activities that are regarded as important by retail buyers. Two key relational behaviors were suggested by the customer-centric and retail industry-specific data; salesperson consultation (communication-based) and salesperson helping behavior (action-based). Drawing on this as well as extant literature, a conceptual framework was developed concerning the influences of these relationship-building activities and other product-focused factors on retail buyers’ new product acceptance. The study’s quantitative component contained a mail and web survey of U.S. retail buyers, resulting in a total dataset of 192 responses. After a comprehensive measure validation process, the theoretical hypotheses were tested using logistic regression analysis. Contrary to existing assertions, the results suggest that salesperson relationship-building activities themselves do not directly and/or indirectly influence purchase decisions, but instead can moderate the effects of product-focused determinants on retail buyers’ new product selections. Data on actual purchase decisions provide a high level of external validity to the findings. The study closes with a concluding discussion, including theoretical and managerial implications of the findings, limitations of the research, and directions for future inquiry.

Understanding manufacturing companies' environmental decision making structures

This paper provides an understanding of the current environmental decision structures within companies in the manufacturing sector. Through case study research, we explored the complexity, robustness and decision making processes companies were using in order to cope with ever increasing environmental pressures and choice of environmental technologies. Our research included organisations in UK, Thailand, and Germany. Our research strategy was case study composed of different research methods, namely: focus group, interviews and environmental report analysis. The research methods and their data collection instruments also varied according to the access we had. Our unity of analysis was decision making teams and the scope of our investigation included product development, environment & safety, manufacturing, and supply chain management. This study finds that environmental decision making have been gaining importance over the time as well as complexity when it is starting to move from manufacturing to non,manufacturing activities. Most companies do not have a formal structure to take environmental decisions; hence, they follow a similar path of other corporate decisions, being affected by organizational structures besides the technical competence of the teams. We believe our results will help improving structures in both beginners and leaders teams for environmental decision making across the different departments.

Making energy service companies (ESCOS) future fit

Energy service companies (ESCOs) are faced with a range of challenges and opportunities associated with the rapidly changing and flexible requirements of energy customers (end users) and rapid improvements in technologies associated with energy and ICT. These opportunities for innovation include better prediction of energy demand, transparency of data to the end user, flexible and time dependent energy pricing and a range of novel finance models. The liberalisation of energy markets across the world has leads to a very small price differential between suppliers on the unit cost of energy. Energy companies are therefore looking to add additional layers of value using service models borrowed from the manufacturing industry. This opens a range of new product and service offerings to energy markets and consumers and has implications for the overall efficiency, utility and price of energy provision.

Recombinant protein subunit vaccine synthesis in microbes:a role for yeast?

Objectives Recombinant protein subunit vaccines are formulated using protein antigens that have been synthesized in heterologous host cells. Several host cells are available for this purpose, ranging from Escherichia coli to mammalian cell lines. This article highlights the benefits of using yeast as the recombinant host. Key findings The yeast species, Saccharomyces cerevisiae and Pichia pastoris, have been used to optimize the functional yields of potential antigens for the development of subunit vaccines against a wide range of diseases caused by bacteria and viruses. Saccharomyces cerevisiae has also been used in the manufacture of 11 approved vaccines against hepatitis B virus and one against human papillomavirus; in both cases, the recombinant protein forms highly immunogenic virus-like particles. Summary Advances in our understanding of how a yeast cell responds to the metabolic load of producing recombinant proteins will allow us to identify host strains that have improved yield properties and enable the synthesis of more challenging antigens that cannot be produced in other systems. Yeasts therefore have the potential to become important host organisms for the production of recombinant antigens that can be used in the manufacture of subunit vaccines or in new vaccine development.

Reshoring:opportunities and limits for manufacturing in the UK - the case of the auto sector

In recent years, offshoring and outsourcing have transformed fundamentally nationally based auto sectors into global networks of design, production and distribution across the global value chains coordinated by the major automotive Original Equipment Manufacturers (OEMs). As manufacturing activities tended to be shifted to low-labour cost locations in Asia, Africa and Latin America, high-end design, R&D, product development have stayed anchored mostly to high-cost and high knowledge-intensive home economy locations (perhaps with the except of some design and styling activities which are often located in major end markets around the world. However, very recently the weaknesses of and risks inherent in such global value chains (GVCs) have been exposed, triggering attempts to rethink their nature and also raising possibilities to reshore some manufacturing activities to home countries. A combination of a more competitive exchange rate (despite the very recent appreciation of sterling), increased transport costs, rising wages in key areas of China, and a greater awareness of supply chain resilience have all contributed to a perceived change in some business fundamentals. The potential for some supply chain relocalisation also links in with the servitisation of manufacturing including the auto sector and shift to a hybrid model where manufacturing and services are increasingly intertwined. However, there are limits as to how far this can go and these raise some important questions and issues over the possible role for industrial policy.

An examination of NPD models in the context of business models

Most prior new product diffusion (NPD) models do not specifically consider the role of the business model in the process. However, the context of NPD in today's market has been changed dramatically by the introduction of new business models. Through reinterpretation and extension, this paper empirically examines the feasibility of applying Bass-type NPD models to products that are commercialized by different business models. More specifically, the results and analysis of this study consider the subscription business model for service products, the freemium business model for digital products, and a pre-paid and post-paid business model that is widely used by mobile network providers. The paper offers new insights derived from implementing the models in real-life cases. It also highlights three themes for future research.

The early career researcher's toolkit:translating tissue engineering, regenerative medicine and cell therapy products

Although the importance of translation for the development of tissue engineering, regenerative medicine and cell-based therapies is widely recognized, the process of translation is less well understood. This is particularly the case among some early career researchers who may not appreciate the intricacies of translational research or make decisions early in development which later hinders effective translation. Based on our own research and experiences as early career researchers involved in tissue engineering and regenerative medicine translation, we discuss common pitfalls associated with translational research, providing practical solutions and important considerations which will aid process and product development. Suggestions range from effective project management, consideration of key manufacturing, clinical and regulatory matters and means of exploiting research for successful commercialization.

Theory of hybrid computational and physical measurement-based integration of thermal and dimensional measurement

In dimensional metrology, often the largest source of uncertainty of measurement is thermal variation. Dimensional measurements are currently scaled linearly, using ambient temperature measurements and coefficients of thermal expansion, to ideal metrology conditions at 20˚C. This scaling is particularly difficult to implement with confidence in large volumes as the temperature is unlikely to be uniform, resulting in thermal gradients. A number of well-established computational methods are used in the design phase of product development for the prediction of thermal and gravitational effects, which could be used to a greater extent in metrology. This paper outlines the theory of how physical measurements of dimension and temperature can be combined more comprehensively throughout the product lifecycle, from design through to the manufacturing phase. The Hybrid Metrology concept is also introduced: an approach to metrology, which promises to improve product and equipment integrity in future manufacturing environments. The Hybrid Metrology System combines various state of the art physical dimensional and temperature measurement techniques with established computational methods to better predict thermal and gravitational effects.

Research on reliability evaluation of reconfigurable manufacturing system

It is a crucial task to evaluate the reliability of manufacturing process in product development process. Process reliability is a measurement of production ability of reconfigurable manufacturing system (RMS), which serves as an integrated performance indicator of the production process under specified technical constraints, including time, cost and quality. An integration framework of manufacturing process reliability evaluation is presented together with product development process. A mathematical model and algorithm based on universal generating function (UGF) is developed for calculating the reliability of manufacturing process with respect to task intensity and process capacity, which are both independent random variables. The rework strategies of RMS are analyzed under different task intensity based on process reliability is presented, and the optimization of rework strategies based on process reliability is discussed afterwards.

A methodological evaluation and predictive in silico investigation into the multi-functionality of arginine in directly compressed tablets

The acceleration of solid dosage form product development can be facilitated by the inclusion of excipients that exhibit poly-/multi-functionality with reduction of the time invested in multiple excipient optimisations. Because active pharmaceutical ingredients (APIs) and tablet excipients present diverse densification behaviours upon compaction, the involvement of these different powders during compaction makes the compaction process very complicated. The aim of this study was to assess the macrometric characteristics and distribution of surface charges of two powders: indomethacin (IND) and arginine (ARG); and evaluate their impact on the densification properties of the two powders. Response surface modelling (RSM) was employed to predict the effect of two independent variables; Compression pressure (F) and ARG percentage (R) in binary mixtures on the properties of resultant tablets. The study looked at three responses namely; porosity (P), tensile strength (S) and disintegration time (T). Micrometric studies showed that IND had a higher charge density (net charge to mass ratio) when compared to ARG; nonetheless, ARG demonstrated good compaction properties with high plasticity (Y=28.01MPa). Therefore, ARG as filler to IND tablets was associated with better mechanical properties of the tablets (tablet tensile strength (σ) increased from 0.2±0.05N/mm2 to 2.85±0.36N/mm2 upon adding ARG at molar ratio of 8:1 to IND). Moreover, tablets' disintegration time was shortened to reach few seconds in some of the formulations. RSM revealed tablet porosity to be affected by both compression pressure and ARG ratio for IND/ARG physical mixtures (PMs). Conversely, the tensile strength (σ) and disintegration time (T) for the PMs were influenced by the compression pressure, ARG ratio and their interactive term (FR); and a strong correlation was observed between the experimental results and the predicted data for tablet porosity. This work provides clear evidence of the multi-functionality of ARG as filler, binder and disintegrant for directly compressed tablets.

Linking design and manufacturing domains via web-based and enterprise integration technologies

The manufacturing industry faces many challenges such as reducing time-to-market and cutting costs. In order to meet these increasing demands, effective methods are need to support the early product development stages by bridging the gap of communicating early design ideas and the evaluation of manufacturing performance. This paper introduces methods of linking design and manufacturing domains using disparate technologies. The combined technologies include knowledge management supporting for product lifecycle management systems, Enterprise Resource Planning (ERP) systems, aggregate process planning systems, workflow management and data exchange formats. A case study has been used to demonstrate the use of these technologies, illustrated by adding manufacturing knowledge to generate alternative early process plan which are in turn used by an ERP system to obtain and optimise a rough-cut capacity plan. Copyright © 2010 Inderscience Enterprises Ltd.

Expanding the biomass resource:sustainable oil production via fast pyrolysis of low input high diversity biomass and the potential integration of thermochemical and biological conversion routes

Waste biomass is generated during the conservation management of semi-natural habitats, and represents an unused resource and potential bioenergy feedstock that does not compete with food production. Thermogravimetric analysis was used to characterise a representative range of biomass generated during conservation management in Wales. Of the biomass types assessed, those dominated by rush (Juncus effuses) and bracken (Pteridium aquilinum) exhibited the highest and lowest volatile compositions respectively and were selected for bench scale conversion via fast pyrolysis. Each biomass type was ensiled and a sub-sample of silage was washed and pressed. Demineralization of conservation biomass through washing and pressing was associated with higher oil yields following fast pyrolysis. The oil yields were within the published range established for the dedicated energy crops miscanthus and willow. In order to examine the potential a multiple output energy system was developed with gross power production estimates following valorisation of the press fluid, char and oil. If used in multi fuel industrial burners the char and oil alone would displace 3.9 × 105 tonnes per year of No. 2 light oil using Welsh biomass from conservation management. Bioenergy and product development using these feedstocks could simultaneously support biodiversity management and displace fossil fuels, thereby reducing GHG emissions. Gross power generation predictions show good potential.

A European competence framework for industrial pharmacy practice in biotechnology

Project Report: The PHAR-IN ("Competences for industrial pharmacy practice in biotechnology") looked at whether there is a difference in how industrial employees and academics rank competences for practice in the biotechnological industry. A small expert panel consisting of the authors of this paper produced a biotechnology competence framework by drawing up an initial list of competences then ranking them in importance using a three-stage Delphi process. The framework was next evaluated and validated by a large expert panel of academics (n = 37) and industrial employees (n = 154). Results show that priorities for industrial employees and academics were similar. The competences for biotechnology practice that received the highest scores were mainly in: . "Research and Development", . "Upstream" and "Downstream" Processing', " . "Product development and formulation", " . "Aseptic processing", ."Analytical methodology", . "Product stability", and . "Regulation". The main area of disagreement was in the category "Ethics and drug safety" where academics ranked competences higher than did industrial employees.