Emergence of biopharmaceutical innovators in China, India, Brazil, and South Africa as global competitors and collaborators

Rezaie, Rahim; McGahan, Anita M.; Frew, Sarah E.; Daar, Abdallah S.; Сингер, Петер

doi:10.1186/1478-4505-10-18

Cited by 40 publications

(31 citation statements)

References 27 publications

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“…In the current rigorous global regulatory scenario for biopharmaceuticals products, both innovative and generic, 1,2 the implementation of Process Analytical Technology (PAT) and Quality by Design (QdB), initiatives proposed by the American Agency "Food and Drugs Administration" (FDA), is essential. These initiatives lead a better understanding and robustness regarding manufacturing process, in order to increase quality and ensure the effectiveness and security of the associated products.…”

Section: Introductionmentioning

confidence: 99%

Use of uniform designs in combination with neural networks for viral infection process development

Buenno¹,

Rocha²,

Leme

et al. 2015

Biotechnology Progress

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This work aimed to compare the predictive capacity of empirical models, based on the uniform design utilization combined to artificial neural networks with respect to classical factorial designs in bioprocess, using as example the rabies virus replication in BHK-21 cells. The viral infection process parameters under study were temperature (34°C, 37°C), multiplicity of infection (0.04, 0.07, 0.1), times of infection, and harvest (24, 48, 72 hours) and the monitored output parameter was viral production. A multilevel factorial experimental design was performed for the study of this system. Fractions of this experimental approach (18, 24, 30, 36 and 42 runs), defined according uniform designs, were used as alternative for modelling through artificial neural network and thereafter an output variable optimization was carried out by means of genetic algorithm methodology. Model prediction capacities for all uniform design approaches under study were better than that found for classical factorial design approach. It was demonstrated that uniform design in combination with artificial neural network could be an efficient experimental approach for modelling complex bioprocess like viral production. For the present study case, 67% of experimental resources were saved when compared to a classical factorial design approach. In the near future, this strategy could replace the established factorial designs used in the bioprocess development activities performed within biopharmaceutical organizations because of the improvements gained in the economics of experimentation that do not sacrifice the quality of decisions.

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Section: Introductionmentioning

confidence: 99%

Use of uniform designs in combination with neural networks for viral infection process development

Buenno¹,

Rocha²,

Leme

et al. 2015

Biotechnology Progress

View full text Add to dashboard Cite

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“…Confirming this trend, Eren Vural in this volume reports that in Turkey patent applications submitted by MNCs increased (staggeringly) from 346 in 2004 to 1195 in 2010 (while local pharma applications increased only from 18 to 63). Some analysts identify increased local innovation in emerging economies and view the extension of IPRs as a positive incentive for LMIC innovator firms (Rezaie et al, 2012). This is a promise or theoretical assumption about patents that any LMIC negotiator in the Uruguay Round would recognize, yet, as shows, patents are issued mostly to foreign companies for incremental modifications of existing drugs, and little innovative activity focused on developing country needs is evident.…”

Section: Surging Drug Markets In the Global Southmentioning

confidence: 98%

The New Political Economy of Pharmaceuticals

2013

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“…China has a coherent holistic strategy that integrates policy on traditional local and foreign R&D as well as venture capital and science locations to cluster firms. Resaie et al (2012) characterise Brazilian and South African biopharma policy objectives as focused primarily on import substitution and lowering the cost of health products for local populations. They characterise Indian and Chinese policies as more oriented at nurturing 'an innovation eco-system and a vibrant bioeconomy' (p1).…”

Section: Promoting Local Innovation and Catch-upmentioning

confidence: 99%

Bioeconomy and the global economy: industrial policies and bio-innovation

Wield

2013

Technology Analysis & Strategic Management

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The last decades have witnessed major growth in the bioeconomy. Emergence of the bioeconomy as a broad, creative and rapidly expanding part of the global economy coincides with the maturation of the established drug discovery system. This paper presents research evidence focused on the relationships between changes in the bioeconomy and changes in the global economy. It argues that new forms of governance and regulation are key to strengthen industrial policies needed for emerging and developing countries to take account of the complex interactions in life science innovation between technology, markets, regulation and civil society, which could significantly impact on global distribution of the industry.Keywords: bioeconomy, global economy, pharmaceuticals, innovation, global health IntroductionThere is strong evidence that the post-1950s evolution of the pharmaceutical industry is maturing rapidly (Mittra and Williams 2007; Orsenigo and Tait 2008). It is becoming harder to find truly new drugs in spite of continuing high R&D expenditure. Pharmaceutical company profit rates are falling, although volumes are massive and keep big pharmaceutical firms in the top global companies worldwide (Mittra et al. 2010). Another indicator of instability is that large companies are constantly attempting to restructure: cutting in-house R&D units, such as Pfizer's decision in 2011 to close a set of R&D units (Mittra et al. 2011); shaving costs through mergers (Mittra 2007); outsourcing R&D to universities and specialist biotechnology firms; and, organisational changes such as encouragement of smaller 'fleetfooted' innovation units within big pharma companies. The pharma-production model has been increasingly tightly rigidified -increasing layers of regulatory enforcement, and industrial responses, resulting in restriction of innovation to a stage by stage, 'linear' innovative process with more and more sub-stages of clinical trials.The relatively simple staged 'linear' drug discovery innovation model for highly regulated health markets, has given way to a complex mix of, often contradictory, drivers of innovation. The changes may herald a major transformation of health bio-innovation raising the question: Is a major restructuring of pharmaceuticals and health delivery on the cards (OECD 2009;Wield et al. 2013)? If the answer to this question is yes, it leads to two further questions:2 Could these changes bring a broader more globally dispersed set of powerful agents, with resultant implications for the global economy? That is, will changes 2 in the global economy drive a broader range of nations to become bioeconomy players or will they be left behind?3 To what extent can firms in emerging and developing economies take advantage of the transformations to catch-up in some segments?Already there are some changes, perhaps most apparent in agro-biotechnology, where Brazil leads in first generation biofuels. In health, some developing countries, such as India and East Asian, have managed to move from imitation of off-patent ...

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Emergence of biopharmaceutical innovators in China, India, Brazil, and South Africa as global competitors and collaborators

Cited by 40 publications

References 27 publications

Use of uniform designs in combination with neural networks for viral infection process development

Use of uniform designs in combination with neural networks for viral infection process development

The New Political Economy of Pharmaceuticals

Bioeconomy and the global economy: industrial policies and bio-innovation

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