Biopharmaceutical innovation and industrial developments in South Korea, Singapore and Taiwan

South Korea, Singapore and Taiwan are well known as export-oriented developmental states which for decades employed industrial policy to target particular industries for government support. In the past fifteen years, these three countries all identified the biopharmaceutical industry as a strategic sector. This article explores, through economic analysis, the rationale for this decision and the strategies chosen for linking into the global bio-economy with the objective of catching up in biopharmaceuticals. The paper identifies three comparative advantages enjoyed by these countries in the biopharma sector: (1) public investments in basic research; (2) private investments in phase 1 clinical trials; and (3) a potentially significant contract research industry managing latter-stage clinical trials. Governments employ a range of industrial policies, consistent with these comparative advantages, to promote the biopharmaceutical industry, including public investment in biomedical hubs, research funding and research and development (R&D) tax credits. We argue that the most important feature of the biopharmaceutical industry in these countries is the dominant role of the public sector. That these countries have made progress in innovative capabilities is illustrated by input measures such as R&D expenditure as share of gross domestic product, number of patents granted and clinical trials, and volume of foreign direct investment. In contrast, output indicators such as approval of new chemical entities suggest that the process of catching up has only just commenced. Pharmaceutical innovation is at the stage of mainly generating inputs to integrated processes controlled by the globally incumbent firms.

Reaching and influencing consumers in the prescription medicine market

Purpose – Celebrex became the first of a new class of drugs known as COX-2 selective non-steroidal anti-inflammatory drugs. It improves treatment for arthritis sufferers without compromising the protective lining of the stomach. The purpose of this paper is to illustrate how direct-to-consumer advertising (DTCA) of prescription medicines can be used to rebuild faith in the cyclooxygenase-2 (COX-2) product category.

Design/methodology/approach – The case is developed using published sources and no input is required from company representatives. The presentation style follows the classic comprehensive case format used in postgraduate teaching programmes.

Findings – Business executives and strategic marketing students would benefit from a discussion on how external environmental factors can suddenly impose a review of marketing strategy. The reader learns how management addresses the business dilemma using DTCA.

Research limitations/implications – A blockbuster rival drug Vioxx is withdrawn due to cardiovascular (CV) health safety concerns. A resulting dominant market situation soon becomes a business dilemma. The Federal Drug Administration calls for a “black box” warning label on Celebrex, the most serious type of warning.

Practical implications – The implications are that having a product in a class of its own is not enough. It highlights the need to communicate to different audiences, to both the medical profession and the end-user. Getting doctors to recommend the medicine and pulling the product through the channel by stimulating patient demand after a health scare are paramount.

Originality/value – This is the first pharmaceutical business case where the withdrawal of a rival product leaves the dominant competitor in a monopoly situation. Contrary to expectation, market share plummets despite the absence of competition.

Attributes for Australian mechanical engineers through proximal and distance education

The 1996 Johnson stakeholder review of Australian engineering education recommended the development of a number of broadly defined attributes in all engineering graduates. The Institution of Engineers, Australia (now Engineers Australia) responded swiftly by switching the focus of its engineering course accreditation requirements from course content to graduate attribute outcomes. To maximise the effectiveness of this approach to the mechanical engineering discipline a clear understanding of the relative significance of a more detailed range of attributes to Australian industry is essential, yet the scope of the mechanical engineering profession is broad and views of individual practitioners contributing to debate on attribute requirements are largely influenced by their own often unique professional formation. The research presented in this thesis is unique in using a role based analysis of the relative significance of an extensive range of attributes considered relevant to Australian mechanical engineers. The study covers the six industries found to employ the greatest number of Australian mechanical engineers. The significance of these attributes in the core mechanical engineering roles of each industry are weighted according to the numbers of mechanical engineers employed in those roles. These attribute significance profiles are considered in the context of a study of the formative development of the profession under the extensive influence of 19th and 20th century UK and US practices and recent momentous changes in engineering employment and formation. A wide range of appropriate teaching strategies to develop the most significant attributes through proximal and distance learning are explored and a brief account of the candidate’s work in developing and assessing the use of technology to enhance flexible learning in the field of engineering education is also included in this thesis. Whilst major areas of the mechanical engineers knowledge base are considered as part of the main study, further case study based research is presented to assess in more detail the knowledge base requirements for Australia’s best performing manufacturing industry by ‘industry value added’ - Food, Beverage and Pharmaceuticals and as such provides an indication of the relevance of the content base of Australian mechanical (as well as chemical and electrical) engineering degree programs to an Australian industry sector.

Enhancing tris(2,2'-bipyridI)ruthenium(II) chemiluminescence

In this thesis, chemiluminescence, that is light from a chemical reaction, was applied to the determination of pharmaceuticals, amines, and organic acids. The detection of organic acids was improved substantially through the manipulation of the speed of reaction and the use of silver nanoparticles in both solution and solid states.

Sequential injection and liquid chromatography for chemiluminescent detection of opiates

This thesis encompasses the development of analytical instrumentation, software and chemical methodologies for the rapid determination of pharmaceuticals in process extracts. Sensitive detection of morphine, codeine, oripavine and thebaine was achieved by measuring the quantity of light emitted as a result of their reactions with potassium permanganate and tris(2,2'-bipyridyl)ruthenium(III).

Setting the foundation for molecular nuts and bolts

The thesis outlines effective methods of designing and constructing chiral nano-porous materials. These materials may facilitate cheaper and large-scale production of chiral molecules, such as pharmaceuticals and bioactives. Computer models of target materials correlated well with laboratory experiments and effective synthetic strategies for manufacture were developed.

Investigations into reactions involving manganese(IV) chemiluminescence

The reactivity and characterisation of solubilised manganese(IV) as a chemiluminescence reagent were systematically investigated. The analytical utility of this reagent was established for the determination of various alkaloids, pharmaceuticals and compounds of forensic interest. The methodology was then successfully applied to industrial process monitoring, clinical and illicit drug samples.

The use of cyclodextrins nanoparticles for oral delivery

This review aims to highlight many of the difficulties encountered in trying to achieve the task of delivering proteins and peptides through oral administration. The necessity of controlled protein and peptide release, protection and stability in the gastrointestinal tract, and ability to target specific areas are only a handful of the many problems associated with trying to engineer a useful solution. Current research gives strong indication that both cyclodextrins and nanoparticles could be highly useful in the search for a suitable method for such successful oral delivery of proteins and peptides. This review focuses on the use of cyclodextrins in pharmaceuticals, aiming to discuss the use of cyclodextrins in conjunction with nanoparticles for oral delivery of proteins. Both classical applications and more advanced "nanomedical" approaches are discussed. In order to achieve a complete overview this review will include background information about cyclodextrins, nanomedicine and their role in oral delivery systems. The use of absorption enhancers like cyclodextrins, bile salts and surfactants was used to facilitate bio-availability into the system. The state-of-the-art technology and challenges in this area are discussed, with typical examples.

Chimeric aptamers in cancer cell-targeted drug delivery

Aptamers are single-stranded structured oligonucleotides (DNA or RNA) that can bind to a wide range of targets ("apatopes") with high affinity and specificity. These nucleic acid ligands, generated from pools of random-sequence by an in vitro selection process referred to as systematic evolution of ligands by exponential enrichment (SELEX), have now been identified as excellent tools for chemical biology, therapeutic delivery, diagnosis, research, and monitoring therapy in real-time imaging. Today, aptamers represent an interesting class of modern pharmaceuticals which with their low immunogenic potential mimic extend many of the properties of monoclonal antibodies in diagnostics, research, and therapeutics. More recently, chimeric aptamer approach employing many different possible types of chimerization strategies has generated more stable and efficient chimeric aptamers with aptameraptamer, aptamernonaptamer biomacromolecules (siRNAs, proteins) and aptamernanoparticle chimeras. These chimeric aptamers when conjugated with various biomacromolecules like locked nucleic acid (LNA) to potentiate their stability, biodistribution, and targeting efficiency, have facilitated the accurate targeting in preclinical trials. We developed LNA-aptamer (anti-nucleolin and EpCAM) complexes which were loaded in iron-saturated bovine lactofeerin (Fe-blf)-coated dopamine modified surface of superparamagnetic iron oxide (Fe3O4) nanoparticles (SPIONs). This complex was used to deliver the specific aptamers in tumor cells in a co-culture model of normal and cancer cells. This review focuses on the chimeric aptamers, currently in development that are likely to find future practical applications in concert with other therapeutic molecules and modalities.

Global trends in marine nutraceuticals

An expanding body of scientific research indicates that the marine environment is emerging as a unique resource of functional food ingredients with health-promoting properties. Significant attention has been paid to exploration of potential nutraceuticals and pharmaceuticals derived from the ocean. Marine-based  nutraceuticals are gaining attention due to their unique features, which are absent in terrestrial-based resources. A number of new marine nutraceutical products have been introduced in the nutraceuticals and functional foods markets. The main sources and products of primary interest for marine nutraceuticals and ingredients include omega-3 fish/algal oil, phospholipids, micro/macro algal nutrition supplements, fish proteins and peptides, hydrolysates, shellfish chitin, fish collagen, and mineral supplements.

IEF pattern classification-derived criteria for the identification of epoetin-delta in urine

Epoetin-δ (Dynepo™ Shire Pharmaceuticals, Basing stoke, UK) is a synthetic form of erythropoietin (EPO) whose resemblance with endogenous EPO makes it hard to identify using the classical identification criteria. Urine samples collected from six healthy volunteers treated with epoetin-δ injections and from a control population were immuno-purified and analyzed with the usual IEF method. On the basis of the EPO profiles integration, a linear multivariate model was computed for discriminant analysis. For each sample, a pattern classification algorithm returned a bands distribution and intensity score (bands intensity score) saying how representative this sample is of one of the two classes, positive or negative. Effort profiles were also integrated in the model. The method yielded a good sensitivity versus specificity relation and was used to determine the detection window of the molecule following multiple injections. The bands intensity score, which can be generalized to epoetin-α and epoetin-β, is proposed as an alternative criterion and a supplementary evidence for the identification of EPO abuse.