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.

Value roadmapping: A structured approach for early stage technology investment decisions

Deciding to invest in early stage technologies is one of the most important tasks of technology management and arguably also the most uncertain. It assumes a particular significance in the rise of technology companies in emerging economies, which have to make appropriate investment decisions. Technology managers already have a wide range of methods and tools at their disposal, but these are mostly focussed on quantitative measures such as discounted cash flow and real options techniques. However, in the early stages of technology development there seems to be a lot of dissatisfaction with these techniques as there appears to be a lack of accuracy with respect to the underlying assumptions that these models require. In order to complement these models this paper will discuss an alternative approach that we call value road-mapping. By adapting roadmapping techniques the potential value streams of early stages technologies can be plotted and hence a clearer consensus based picture of the future potential of new technologies emerges. Roadmapping is a workshop-based process bringing together multifunctional perspectives, and supporting communication in particular between technical and commercial groups. The study is work in progress and is based on a growing number of cases. (c) 2006 PICMET.

A structured modelling approach to simulating dynamic behaviours in complex organisations

This article reports a case study application of a systematic approach to modelling complex organisations, centred on simulation modelling (SM). The approach leads to populated instances of complementary model types, in ways that systematically capture, validate and facilitate various uses of organisational understandings, knowledge and data normally distributed amongst multiple knowledge holders. The model-driven approach to decision making enables improved manufacturing responsiveness. Literature on modelling technologies relevant to manufacturing systems organisation design and change is presented, as is literature on production planning and control. This provides a rationale for the development of a new modelling methodology which combines the use of enterprise, causal loop and SM. Subsequently, this article describes how in the case of a specific manufacturing enterprise the combined modelling techniques have informed the choice of alternative production planning and control policies. An example enterprise model of a capacitor manufacturing company is illustrated as derivative causal-loop models that structure and enable the design and use of a general purpose simulation model.

Tree-Structured Stick Breaking Processes for Hierarchical Data

Many data are naturally modeled by an unobserved hierarchical structure. In this paper we propose a flexible nonparametric prior over unknown data hierarchies. The approach uses nested stick-breaking processes to allow for trees of unbounded width and depth, where data can live at any node and are infinitely exchangeable. One can view our model as providing infinite mixtures where the components have a dependency structure corresponding to an evolutionary diffusion down a tree. By using a stick-breaking approach, we can apply Markov chain Monte Carlo methods based on slice sampling to perform Bayesian inference and simulate from the posterior distribution on trees. We apply our method to hierarchical clustering of images and topic modeling of text data.

Structured precision modelling with Cholesky basis superposition for speech recognition

Structured precision modelling is an important approach to improve the intra-frame correlation modelling of the standard HMM, where Gaussian mixture model with diagonal covariance are used. Previous work has all been focused on direct structured representation of the precision matrices. In this paper, a new framework is proposed, where the structure of the Cholesky square root of the precision matrix is investigated, referred to as Cholesky Basis Superposition (CBS). Each Cholesky matrix associated with a particular Gaussian distribution is represented as a linear combination of a set of Gaussian independent basis upper-triangular matrices. Efficient optimization methods are derived for both combination weights and basis matrices. Experiments on a Chinese dictation task showed that the proposed approach can significantly outperformed the direct structured precision modelling with similar number of parameters as well as full covariance modelling. © 2011 IEEE.

Enhanced integrated modelling approach to reconfiguring manufacturing enterprises

Dynamism and uncertainty are real challenges for present day manufacturing enterprises (MEs). Reasons include: an increasing demand for customisation, reduced time to market, shortened product life cycles and globalisation. MEs can reduce competitive pressure by becoming reconfigurable and change-capable. However, modern manufacturing philosophies, including agile and lean, must complement the application of reconfigurable manufacturing paradigms. Choosing and applying the best philosophies and techniques is very difficult as most MEs deploy complex and unique configurations of processes and resource systems, and seek economies of scope and scale in respect of changing and distinctive product flows. It follows that systematic methods of achieving model driven reconfiguration and interoperation of component based manufacturing systems are required to design, engineer and change future MEs. This thesis, titled Enhanced Integrated Modelling Approach to Reconfiguring Manufacturing Enterprises , introduces the development and prototyping a model-driven environment for the design, engineering, optimisation and control of the reconfiguration of MEs with an embedded capability to handle various types of change. The thesis describes a novel systematic approach, namely enhanced integrated modelling approach (EIMA), in which coherent sets of integrated models are created that facilitates the engineering of MEs especially their production planning and control (PPC) systems. The developed environment supports the engineering of common types of strategic, tactical and operational processes found in many MEs. The EIMA is centred on the ISO standardised CIMOSA process modelling approach. Early study led to the development of simulation models during which various CIMOSA shortcomings were observed, especially in its support for aspects of ME dynamism. A need was raised to structure and create semantically enriched models hence forming an enhanced integrated modelling environment. The thesis also presents three industrial case examples: (1) Ford Motor Company; (2) Bradgate Furniture Manufacturing Company; and (3) ACM Bearings Company. In order to understand the system prior to realisation of any PPC strategy, multiple process segments of any target organisation need to be modelled. Coherent multi-perspective case study models are presented that have facilitated process reengineering and associated resource system configuration. Such models have a capability to enable PPC decision making processes in support of the reconfiguration of MEs. During these case studies, capabilities of a number of software tools were exploited such as Arena®, Simul8®, Plant Simulation®, MS Visio®, and MS Excel®. Case study results demonstrated effectiveness of the concepts related to the EIMA. The research has resulted in new contributions to knowledge in terms of new understandings, concepts and methods in following ways: (1) a structured model driven integrated approach to the design, optimisation and control of future reconfiguration of MEs. The EIMA is an enriched and generic process modelling approach with capability to represent both static and dynamic aspects of an ME; and (2) example application cases showing benefits in terms of reduction in lead time, cost and resource load and in terms of improved responsiveness of processes and resource systems with a special focus on PPC; (3) identification and industrial application of a new key performance indicator (KPI) known as P3C the measuring and monitoring of which can aid in enhancing reconfigurability and responsiveness of MEs; and (4) an enriched modelling concept framework (E-MUNE) to capture requirements of static and dynamic aspects of MEs where the conceptual framework has the capability to be extended and modified according to the requirements. The thesis outlines key areas outlining a need for future research into integrated modelling approaches, interoperation and updating mechanisms of partial models in support of the reconfiguration of MEs.