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Commercial Success (commercial + success)
Selected AbstractsOral insulin , a review of current statusDIABETES OBESITY & METABOLISM, Issue 3 2010Harish Iyer Oral insulin is one of the most exciting areas of development in the treatment of diabetes because of its potential benefit in patient convenience, rapid insulinization of liver, adequate insulin delivery avoiding peripheral hyperinsulinaemia while potentially avoiding adverse effects of weight gain and hypoglycaemia. Growing evidence that earlier initiation of intensive insulin therapy produces sustained tight glycaemic control resulting in substantial delay in complications makes an effective oral insulin product even more vital for the management of patients with diabetes. Despite knowledge of this unmet medical need, oral delivery of insulin has been unsuccessful because of several barriers. For several decades, researchers have tried to develop oral insulin using various technologies without much clinical or commercial success. This review summarizes the development status of oral insulins which are publicly reported to be undergoing clinical studies. Currently, two oral insulin products are in an advanced stage of clinical development and first data from long-term therapy are expected to be available in the second half of 2010. [source] Insulin analogues: have they changed insulin treatment and improved glycaemic control?DIABETES/METABOLISM: RESEARCH AND REVIEWS, Issue S1 2002Sten Madsbad Abstract To improve insulin therapy, new insulin analogues have been developed. Two fast-acting analogues with a more rapid onset of effect and a shorter duration of action combined with a low day-to-day variation in absorption rate are now available. Despite this favourable time,action profile most studies have not been able to show any improvement in overall glycaemic control with the fast-acting analogues. A reduced post-prandial increase in blood glucose has been found in all studies, whereas between 3 and 5,h after the meal and during the night an increased blood glucose level is the normal course. This is probably the main explanation for the absence of improvement in overall glycaemic control when compared with regular human insulin. A tendency to a reduction in hypoglycaemic events during treatment with fast-acting analogues has been observed in most studies. Recent studies have indicated that NPH insulin administered several times daily at mealtimes can improve glycaemic control without increasing the risk of hypoglycaemia. The fast-acting analogues are now also available as insulin mixed with NPH. Insulin glargine is a new long-acting insulin which is soluble and precipitates after injection, resulting in a long half-life with a residual activity of about 50% 24,h after injection. Insulin glargine is a peakless insulin and studies in both type 1 and type 2 diabetic patients indicate that glargine improves fasting blood glucose control and reduces the incidence of nocturnal hypoglycaemia. Surprisingly, the new fast,acting analogues have not achieved the expected commercial success, which emphasises the need for new strategies for basal insulin supplementation, exercise, diet and blood glucose monitoring. Copyright © 2002 John Wiley & Sons, Ltd. [source] FLT3 Antibody-based therapy for leukemiaDRUG DEVELOPMENT RESEARCH, Issue 6 2006Yiwen Li Abstract Technological advances in antibody generation and production have facilitated recent clinical and commercial success with antibody-based cancer therapeutics. The class III receptor tyrosine kinase FLT3 is highly expressed on the blast cells in most cases of acute myelogenous leukemia (AML) and B-cell acute lymphoblastic leukemia (ALL). Activating mutations of FLT3 are detected in approximately 37% AML patients. FLT3 expression in normal tissue is limited to myeloid and B-cell precursor cells. Therefore, over-expressed or mutated FLT3 is an attractive target for therapeutic intervention using monoclonal antibodies. This review will discuss recent progress in the development of anti-FLT3 antibodies as well as their therapeutic potentials in the treatment of AML and other hematological malignancies. Drug Dev. Res. 67:495,500, 2006. © 2006 Wiley-Liss, Inc. [source] Radiation Grafted Membranes for Polymer Electrolyte Fuel Cells,FUEL CELLS, Issue 3 2005L. Gubler Abstract The cost of polymer electrolyte fuel cell (PEFC) components is crucial to the commercial viability of the technology. Proton exchange membranes fabricated via the method of radiation grafting offer a cost-competitive option, because starting materials are inexpensive commodity products and the preparation procedure is based on established industrial processes. Radiation grafted membranes have been used with commercial success in membrane separation technology. This review focuses on the application of radiation grafted membranes in fuel cells, in particular the identification of fuel cell relevant membrane properties, aspects of membrane electrode assembly (MEA) fabrication, electrochemical performance and durability obtained in cell or stack tests, and investigation of failure modes and post mortem analysis. The application in hydrogen and methanol fuelled cells is treated separately. Optimized styrene,/,crosslinker grafted and sulfonated membranes show performance comparable to perfluorinated membranes. Some properties, such as methanol permeability, can be tailored to be superior. Durability of several thousand hours at practical operating conditions has been demonstrated. Alternative styrene derived monomers with higher chemical stability offer the prospect of enhanced durability or higher operating temperature. [source] Creative marketing and the art organisation: what can the artist offer?INTERNATIONAL JOURNAL OF NONPROFIT & VOLUNTARY SECTOR MARKETING, Issue 2 2002Ian Fillis The poem ,My Paintings', written in a deliberate, uncorrected dyslexic style offers an insight into the mind of a present day avant garde bad boy of British art, Billy Childish. Constantly challenging the art establishment through public demonstrations of distaste against the annual Turner Prize,[Button, V. (1999) ,The Turner Prize', Tate Gallery Publishing, London.] Childish and his cohorts launched an alternative, Stuck-ist, art manifesto,[Alberge, D. (1999) ,Rebels Get Stuck into the Brit Artists', The Times, Thursday 26th August, p. 7.] in the belief that it would assist in a shift in public perception of what good art is, as well as influence the creative practice of those artists concerned with more traditional, authentic forms of art. Childish's ex-girlfriend Tracey Emin, however, has had other ideas. She has revelled in mass media exposure and now dismisses the concept of traditional painting as a valid art from.[Brown, N. (1998) ,Tracey Emin', Art Data, UK.] These are two examples of contrasting creative, artistic behaviour. Their creativity has resulted in varying levels of commercial success. By examining the role that creativity plays in determining how the idea for a creative product is first identified, through to its commercial exploitation, there are valuable lessons contained in such a process for both profit-oriented and nonprofit art organisations alike. Instead of constantly fighting the conflicting philosophies of art for art's sake versus art for business sake, following the market and consumer demand, there is a much more effective method for establishing longer-term success, which mirrors the creative practice of the artist. The existing literature on arts marketing is examined. A critique of the usefulness of current thinking is presented, with the recommendation that the formal models of marketing offered in arts marketing literatures can only ever hope to offer general advice on marketing. What is called for is a much more in-depth analysis of how creative entrepreneurial marketers as artists can offer alternative visualisations of more appropriate models of marketing for the industry. This in turn should result in the stimulation of creative research methodologies that can inform both theory and practice within arts marketing in particular, and the wider remit of marketing in general. The use of the metaphor and the examination of published biographies of creative individuals are used to construct a manifesto of marketing artistry. Copyright © 2002 Henry Stewart Publications [source] Calibration accuracy of a judgmental process that predicts the commercial success of new product ideasJOURNAL OF BEHAVIORAL DECISION MAKING, Issue 4 2007Thomas Åstebro Abstract We examine the accuracy of forecasts of the commercial potential of new product ideas by experts at an Inventor's Assistance Program (IAP). Each idea is evaluated in terms of 37 attributes or cues, which are subjectively rated and intuitively combined by an IAP expert to arrive at a forecast of the idea's commercialization prospects. Data regarding actual commercialization outcomes for 559 new product ideas were collected to examine the accuracy of the IAP forecasts. The intensive evaluation of each idea conducted by the IAP produces forecasts that accurately rank order the ideas in terms of their probability of commercialization. The focus of the evaluation process on case-specific evidence that distinguishes one idea from another, however, and the corresponding neglect of aggregate considerations such as the base rate (BR) and predictability of commercialization for new product ideas in general, yields forecasts that are systematically miscalibrated in terms of their correspondence to the actual probability of commercialization. Copyright © 2007 John Wiley & Sons, Ltd. [source] The History and Development of the Dental Surveyor,Part IIIJOURNAL OF PROSTHODONTICS, Issue 3 2004Robert L. Engelmeier DMD The third and final installment of this series reviews noteworthy instruments that have not enjoyed the commercial success of those discussed in Parts I and II. [source] An Integrated Framework for Measuring Product Development Performance in High Technology IndustriesPRODUCTION AND OPERATIONS MANAGEMENT, Issue 2 2005Debasish N. Mallick We present an integrated framework for measuring product development performance. The framework consists of a three stage model for exploring the relationships between metrics used by design, manufacturing, marketing functions, and overall commercial success. Using a cross-sectional survey of 383 product development professionals working on 38 product development projects in the high-tech electronic assembled goods manufacturing sector, we provide empirical evidence of the proposed framework. The findings indicate that in the high-tech manufacturing sector (1) commercial success of new product development projects is primarily determined by market share, (2) gain in market share is primarily driven by lower unit cost and not by technical performance, and (3) reduction in unit cost is primarily driven by the increased speed of new product development and not by the R&D budget. The study failed to identify any significant association between R&D budget and technical performance, and development speed and technical performance. [source] Does quality assurance apply to development planning?QUALITY ASSURANCE JOURNAL, Issue 1 2002Claude Bentzinger Abstract New product development planning is a complex process and the quality of the planning will have a profound effect on time to market(s) and the commercial success of a therapeutic innovation. Quality assurance has an important role in the planning process. We have drawn up a list of quality assurance criteria applicable to the planning process in R&D, clinical investigation and new business development. The list is by no means exhaustive and we welcome thoughts and comments on other criteria and other areas. Perhaps the present review will stimulate interest and raise readers' awareness of the formidable array of different considerations that must be taken into account if we are to create better therapies for tomorrow's patients. Copyright © 2002 John Wiley & Sons, Ltd. [source] Modified Stage-Gate® Regimes in New Product Development,THE JOURNAL OF PRODUCT INNOVATION MANAGEMENT, Issue 1 2007John E. Ettlie The purpose of this research was to explore the nature of the Stage-Gate®process in the context of innovative projects that not only vary in new product technology (i.e., radical versus incremental technology) but that also involve significant new product development technology (i.e., new virtual teaming hardware-software systems). Results indicate that firms modify their formal development regimes to improve the efficiency of this process while not significantly sacrificing product novelty (i.e., the degree to which new technology is incorporated in the new offering). Four hypotheses were developed and probed using 72 automotive engineering managers involved in supervision of the new product development process. There was substantial evidence to creatively replicate results from previous benchmarking studies; for example, 48.6% of respondents say their companies used a traditional Stage-Gate®process, and 60% of these new products were considered to be a commercial success. About a third of respondents said their companies are now using a modified Stage-Gate®process for new product development. Auto companies that have modified their Stage-Gate®procedures are also significantly more likely to report (1) use of virtual teams; (2) adoption of collaborative and virtual new product development software supporting tools; (3) having formalized strategies in place specifically to guide the new product development process; and (4) having adopted structured processes used to guide the new product development process. It was found that the most significant difference in use of phases or gates in the new product development process with radical new technology occurs when informal and formal phasing processes are compared, with normal Stage-Gate®usage scoring highest for technology departures in new products. Modified Stage-Gate®had a significant, indirect impact on organizational effectiveness. These findings, taken together, suggest companies optimize trade-offs between cost and quality after they graduate from more typical stage-process management to modified regimes. Implications for future research and management of this challenging process are discussed. In general, it was found that the long-standing goal of 50% reduction in product development time without sacrificing other development goals (e.g., quality, novelty) is finally within practical reach of many firms. Innovative firms are not just those with new products but also those that can modify their formal development process to accelerate change. [source] Production of lovastatin examined by an integrated approach based on chemometrics and DOSY-NMRBIOTECHNOLOGY & BIOENGINEERING, Issue 5 2002Silvia Bradamante Abstract Microbial secondary metabolites are one of the sources of therapeutic molecules in the pharmaceutical industry. Product quality and high yields of secondary metabolites are the main goals for the commercial success of a fermentation process. Our novel approach was based on the decision-tree algorithm to determine the key variables correlated with the process outcome and on DOSY-NMR to identify both co-metabolites and impurities, and it improves fermentation systems and speeds up bioprocess development. The approach has been validated in the case of lovastatin production from Aspergillus terreus. © 2002 Wiley Periodicals, Inc. Biotechnol Bioeng 80: 589,593, 2002. [source] Development of a Highly Productive and Scalable Plasmid DNA Production PlatformBIOTECHNOLOGY PROGRESS, Issue 5 2006K. Listner With the applications of DNA vaccines extending from infectious diseases to cancer, achieving the most efficient, reproducible, robust, scalable, and economical production of clinical grade plasmid DNA is paramount to the medical and commercial success of this novel vaccination paradigm. A first generation production process based on the cultivation of Escherichia coli in a chemically defined medium, employing a fed-batch strategy, delivered reasonable volumetric productivities (500,750 mg/L) and proved to perform very well across a wide range of E. coli constructs upon scale-up at industrial scale. However, the presence of monosodium glutamate (MSG) in the formulation of the cultivation and feed solution was found to be a potential cause of process variability. The development of a second generation process, based on a defined cultivation medium and feed solution excluding MSG, was undertaken. Optimization studies, employing a plasmid coding for the HIV gag protein, resulted in cultivation conditions that supported volumetric plasmid titers in excess of 1.2 g/L, while achieving specific yields ranging from 25 to 32 ,g plasmid DNA/mg of dry cell weight. When used for the production of clinical supplies, this novel process demonstrated applicability to two other constructs upon scale-up in 2,000-L bioreactors. This second generation process proved to be scalable, robust, and highly productive. [source] IL-6 inhibition in the treatment of rheumatoid arthritisFUTURE PRESCRIBER, Issue 3 2007FRCP Professor of experimental rheumatology, Peter Taylor MA, honorary consultant rheumatologist The armentarium of potential therapeutics for rheumatoid arthritis (RA) has grown with the identification of relevant disease molecules. Of these, biologic therapeutics targeting tumour necrosis factor-alpha (TNF-alpha), particularly when used in combination with oral methotrexate, have enjoyed notable success in suppressing inflammation and markedly inhibiting the progression of structural damage previously thought to be an unavoidable characteristic of RA.1,2 However, despite the unprecedented clinical and commercial successes of TNF inhibitors, their availability is restricted by high costs and the failure of a substantial proportion of patients to demonstrate significant clinical responses. Copyright © 2007 John Wiley & Sons, Ltd. [source] | ||||||||||||||||