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Dissertations / Theses on the topic 'Pharmaceutical biotechnology'
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Ashton, Gabrielle Anne. "The impact of biotechnology on pharmaceutical R&D." Thesis, Cardiff University, 2001. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.273542.
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Chen, Allen Kuan-Liang Biotechnology & Biomolecular Sciences Faculty of Science UNSW. "Enhanced biocatalyst production for (R)-phenylacetylcarbinol synthesis." Awarded by:University of New South Wales. School of Biotechnology and Biomolecular Sciences, 2006. http://handle.unsw.edu.au/1959.4/32825.
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The enzymatic production of R-phenylacetylcarbinol (R-PAC), with either whole cells or partially purified pyruvate decarboxylase (PDC) as the biocatalyst, requires high PDC activity and an inexpensive source of pyruvate for an economical feasible biotransformation process. Microbial pyruvate produced by a vitamin auxotrophic strain of Candida glabrata was selected as a potential substrate for biotransformation. With an optimal thiamine concentration of 60 ??g/l, a pyruvic acid concentration of 43 g/l and yield of 0.42 g/g glucose consumed were obtained. Using microbially-produced unpurified pyruvate resulted in similar PAC concentrations to those with commercial pure substrate confirming its potential for enzymatic PAC production. To obtain high activity yeast PDC, Candida utilis was cultivated in a controlled bioreactor. Optimal conditions for PDC production were identified as: fermentative cell growth at initial pH at 6.0 followed by pH downshift to 3.0. Average specific PDC carboligase activity of 392 ?? 20 U/g DCW was achieved representing a 2.7-fold increase when compared to a constant pH process. A mechanism was proposed in which the cells adapted to the pH decrease by increasing PDC activity to convert the accumulated internal pyruvic acid via acetaldehyde to ethanol thereby reducing intracellular acidification. The effect of pH shift on specific PDC activity of Saccharomyces cerevisiae achieved a comparable increase of specific PDC carboligase activity to 335 U/g DCW. The effect of pyruvic acid at pH 3.0 on induction of PDC activity was confirmed by cultivation at pH 3 with added pyruvic acid. Using microarray techniques, genome-wide transcriptional analyses of the effect of pH shift on S. cerevisiae revealed a transient increased expression of PDC1 after pH shift, which corresponded to the increase in specific PDC activity (although the latter was sustained for a longer period). The results showed significant gene responses to the pH shift with approximately 39 % of the yeast genome involved. The induced transcriptional responses to the pH shift were distinctive and showed only limited resemblance to gene responses reported for other environmental stress conditions, namely increased temperature, oxidative conditions, reduced pH (succinic acid), alkaline pH and increased osmolarity.
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Hansen, Zeynep. "Contractual arrangements under technological uncertainty: Analysis of pharmaceutical and biotechnology collaborations." Diss., The University of Arizona, 2002. http://hdl.handle.net/10150/280007.
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This dissertation investigates the conditions that shape the governance structure of contractual agreements and how different contract types address the potential problems that can arise in R&D partnerships under technological uncertainty. The motivation for this study arises from the emergence of new forms of R&D organization to cope with challenges as well as opportunities created by rapid technological change. This dissertation demonstrates the significance of technological uncertainty in determining the observed variety of contractual arrangements in the biotechnology industry. It also shows that the returns from collaborative arrangements as measured by the number of successful patents differ among various contract types. The first part of this research focuses on biotechnology alliances with pharmaceutical companies involving drug discovery research. It demonstrates how advances in technology affect the structure of R&D contracts. Using contractual data over time, it is shown that newer technologies associated with higher uncertainty result in the choice of more equity participation by the pharmaceutical partner and more hierarchical contractual arrangements. This result supports the transaction cost arguments that as contractual difficulties arise, allying firms are more likely to choose a more hierarchical governance form over simpler arrangements. The second part of the dissertation investigates the significance of external R&D investments by large pharmaceutical companies to their overall innovation process. The performance of collaborations on the overall R&D productivity are evaluated in terms of their impact on successful patent production. This study measures the innovative returns to R&D collaborations separate from in-house R&D resources and possible knowledge spillovers. Using a panel data set of large pharmaceutical companies, a knowledge production function is estimated. The results indicate that the implied long-run elasticity of successful patent output with respect to all active R&D alliances is lower than the elasticity estimate with respect to in-house R&D investments. In addition, marginal returns to R&D collaborations differ among various contractual types, in terms of their contribution to patent production process. It is also shown that knowledge spillovers by competitors contribute to patent production, but scientific publications hinder it.
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Smedsrud, Sabina, Simon Ekdahl, and Emil Näslund. "Optimising a launch : Important factors affecting a new pharmaceutical launch in Sweden." Thesis, Uppsala universitet, Industriell teknik, 2019. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-384677.
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This master thesis explores the launch process of new pharmaceuticals in Sweden. The path of a pharmaceutical from idea to innovation is a long and arduous process with only few new products actually reaching the patients in the end. Seeing as the drug development is also an expensive process, it is of importance that the products that get approval meet their expected revenue. New pharmaceuticals can also be life changing for the patient, and thus it is important that once approval is received the patients gain access to the new treatments. This study focuses on the post regulatory approval processes in Sweden, as well as activities carried out by the companies that affect the adoption of a new product. By utilizing a qualitative study, this thesis aims to describe the internal and external factors that affect the pharmaceutical launch process in Sweden. As well as exploring what future initiatives and possible changes that might affect it. Ten interviews with different company representatives as well as six interviews with governmental and regional stakeholders were analysed using grounded theory to answer what factors affect the adoption of new pharmaceuticals. Factors that were found to be important were: Utilisation of cross-functional teams, clear and simple strategy that includes the whole organisation, communicating with national and regional authorities, and get feedback from these, communicate with patient representatives and organisations as well as developing utility services for the product. From a couple of these factors a trend towards the servicification of the pharmaceutical industry was discovered.
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Alimov, Azizjon. "Innovations, real options, risk and return : evidence from the pharmaceutical and biotechnology industries /." view abstract or download file of text, 2007. http://proquest.umi.com/pqdweb?did=1421619401&sid=1&Fmt=2&clientId=11238&RQT=309&VName=PQD.
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Thesis (Ph. D.)--University of Oregon, 2007.Typescript. Includes vita and abstract. Includes bibliographical references (leaves 109-114). Also available for download via the World Wide Web; free to University of Oregon users.
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Gunawan, Cindy Biotechnology & Biomolecular Sciences Faculty of Science UNSW. "Bioprocess development for (R)-phenylacetylcarbinol (PAC) synthesis in aqueous/organic two-phase system." Awarded by:University of New South Wales. School of Biotechnology and Biomolecular Sciences, 2006. http://handle.unsw.edu.au/1959.4/25711.
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(R)-phenylacetylcarbinol or R-PAC is a chiral precursor for the synthesis of pharmaceuticals ephedrine and pseudoephedrine. PAC is produced through biotransformation of pyruvate and benzaldehyde catalyzed by pyruvate decarboxylase (PDC) enzyme. The present research project aims at characterizing a two-phase aqueous/organic process for enzymatic PAC production. In a comparative study of several selected yeast PDCs, the highest PAC formation was achieved in systems with relatively high benzaldehyde concentrations when using C. utilis PDC. C. tropicalis PDC was associated with the lowest by-product acetoin formation although it also produced lower PAC concentrations. C. utilis PDC was therefore selected as the biocatalyst for the development of the two-phase PAC production. From an enzyme stability study it was established that PDC deactivation rates in the twophase aqueous/octanol-benzaldehyde system were affected by: (1) soluble octanol and benzaldehyde in the aqueous phase, (2) agitation rate, (3) aqueous/organic interfacial area, and (4) initial enzyme concentration. PDC deactivation was less severe in the slowly stirred phase-separated system (low interfacial area) compared to the rapidly stirred emulsion system (high interfacial area), however the latter system was presumably associated with a faster rate of organic-aqueous benzaldehyde transfer. To find a balance between maintaining enzyme stability while enhancing PAC productivity, a two-phase system was designed to reduce the interfacial contact by decreasing the organic to aqueous phase volume ratio. Lowering the ratio from 1:1 to 0.43:1 resulted in increased overall PAC production at 4??C and 20??C (2.5 M MOPS, partially purified PDC) with a higher concentration at the higher temperature. The PAC was highly concentrated in the organic phase with 212 g/L at 0.43:1 in comparison to 111 g/L at 1:1 ratio at 20??C. The potential of further two-phase process simplification was evaluated by reducing the expensive MOPS concentration to 20 mM (pH controlled at 7.0) and employment of whole cell PDC. It was found that 20??C was the optimum temperature for PAC production in such a system, however under these conditions lowering the phase ratio resulted in decreased overall PAC production. Two-phase PAC production was relatively low in 20 mM MOPS compared to biotransformations in 2.5 M MOPS. Addition of 2.5 M dipropylene glycol (DPG) into the aqueous phase with 20 mM MOPS at 0.25:1 ratio and 20??C improved the production with organic phase containing 95 g/L PAC. Although the productivity was lower, the system may have the benefit of a reduction in production cost.
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Gretton, Linda Burak. "The rhetorical helix of the biotechnology and pharmaceutical industries strategies of transformation though definition, description and ingratiation /." Greensboro, N.C. : University of North Carolina at Greensboro, 2007. http://libres.uncg.edu/edocs/etd/1435/umi-uncg-1435.pdf.
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Thesis (Ph.D.)--University of North Carolina at Greensboro, 2007.Title from PDF t.p. (viewed Oct. 22, 2007). Directed by Nancy Myers; submitted to the Dept. of English. Includes bibliographical references (p. 209-228).
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Nel, Izak Bartholomeus Jacques. "The relationship between global pharmaceutical companies and the biotechnology industry in South Africa : implications for an emerging biotechnology industry in South Africa." Thesis, Stellenbosch : Stellenbosch University, 2003. http://hdl.handle.net/10019.1/53672.
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Mini-study project (MBA)--University of Stellenbosch, 2003.ENGLISH ABSTRACT: This report reviews the global and South African pharmaceutical and biotechnology industries and provides an overview of the changes taking place within these two industries. It highlights the impact this relationship will have on a developing South African biotechnology industry. Since the 1980s the pharmaceutical industry has experienced phenomenal growth in sales and profits. By the mid 1990s drug sales exceeded USD250 billion. Today the pharmaceutical industry is dominated by multi-national corporations with extensive R&D budgets, widespread use of trademarks and patents and complex commercial process technology. However they face threats from depleted product pipelines, patent expiry on billion dollar drug products, generic competition, increases in drug approval times, costs and price pressures. The entrepreneurial biotechnology industry promises to solve a number of the pharmaceutical industry's problems. In recent years biotechnology companies proved more effective in the development of new molecular entities. They promise individualised therapeutics, novel and more efficacious drug discovery and development of preventative treatments. However the decrease in equity financing after 2001 left almost 40% of biotechnology companies with less than 1 year of R&D funding. The industry experienced losses again in 2002 and the world is divided over the ethical, environmental and economic implications of biotechnological applications. The biotechnology and pharmaceutical industries have a symbiotic but antagonistic relationship. The change in this relationship will hugely affect South Africa's ideals of developing a biotechnology industry. Various diseases plague South Africa including HIV/AIDS, TB, obesity, diabetes, hypertension and infective diseases. These diseases will have a huge impact on South Africa's society. Yet only 10% of global R&D funding is committed to third world diseases and existing drugs and treatments are either not effective or too expensive for developing countries. It is in this situation that biotechnology and the development of a biotechnology industry could playa major role in alleviating South Africa's health burden. South Africa is already capable in first generation biotechnology, but third generation applications holds the most promise. Developing countries face various obstacles and challenges, but all boast well for South Africa. The government has committed R400 million (over a three year period) to utilize South Africa's biotechnology potential. Further, the country has highly skilled researchers, indigenous plant and animal species, a diverse population and a favorable exchange rate (low R&D costs).
AFRIKAANSE OPSOMMING: Die projek ondersoek beide die globale en Suid Afrikaanse farmaseutiese en biotegnologie industrieë. Verder word die veranderinge wat plaasvind in die industrieë onder die soeklig geplaas. Die projek beklemtoon die impak wat die verhouding sal hê op 'n ontwikkelende biotegnologie industrie in Suid Afrika. Die farmaseutiese industrie het sedert die 1980s dubbel syfer groei getoon in omsete en wins. Teen die middel 90's het verkope van farmaseutiese middels US$250 miljard wêreldwyd oorskry. Vandag word die farmaseutiese industrie oorheers deur multi-nasionale korporasies met omvattende navorsing en ontwikkelings begrotings, algemene gebruik van handelsmerkte, patente en komplekse proses-tegnologieë. Ten spyte hiervan word die industrie bedreig deur leë produksie-lyne, verval van patente, miljard dollar farmaseutiese produkte, generiese kompetisie, verlengde produk-goedkeurings periodes en prys-mededinging. Die biotegnologie industrie met sy innoveerende eienskappe beloof om verskeie van die farmaseutiese industrie se probleme op te los. Onlangs het biotegnologie maatskappye getoon dat hulle meer effektief is in die ontwikkeling van nuwe molekulêre eenhede. Biotegnologie beloof nuwe en meer effektiewe produk-ontwikkeling asook beter individuele terapieë en voorkomende behandelings. Die industrie staar finansiële krisisse in die gesig. Slegs 40% van biotegnologie maatskappye het voldoende navorsing en ontwikkelings-kapitaal tot 2004. Dit is hoofsaaklik as gevolg van 'n afname in eienaars-finansiering na 2001. Die industrie as 'n geheel het weereens 'n verlies gelei in 2002 en die wêreld is verdeeld oor die etiese, omgewings en ekonomiese implikasie van biotegnologiese toepassings. Die biotegnologie en farmaseutiese industrieë het 'n simbiotiese maar tog vyandige verhouding. 'n Verandering in die verhouding gaan Suid Afrika se ideale om 'n biotegnologie industrie te skep grootliks beïnvloed. Suid Afrika gaan gebuk onder verskeie siektes insluitende MIVNIGS, TB, vetsugtigheid, diabetes, hipertensie en infeksie siektes. Hierdie siektes het 'n groot impak op Suid Afrika se samelewing. Tog word slegs 10% van die globale navorsings en ontwikkelingsfondse aangewend om 'n oplossing te vind vir derdewêreld siektes. Verder is bestaande produkte en behandelings oneffektief of onbekostigbaar vir ontwikkelde lande. Dit is in sulke gevalle waar biotegnologie en die ontwikkeling van 'n biotegnologie industrie 'n groot rol kan speel in die verligting van Suid Afrika se gesondheids-las. Suid Afrika is vaardig in eerste-generasie biotegnologie, maar wêreld wyd hou derde generasie biotegnologie die meeste belofte in. Die tegnologie is tot op hede onderbenut in Suid Afrika. Ontwikkelende lande staar verskeie uitdagings in die gesig, maar Suid Afrika het talle sterk punte. Die regering het R400 miljoen (oor 'n drie jaar periode) beskikbaar gestel vir die ontwikkeling van Suid Afrika se biotegnologie potensiaal. Die land beskik ook oor navorsers van hoogstande gehalte, onbenutte inheemse plante en dier spesies, 'n diverse populasie en 'n gunstige wisselkoers (lae navorsings en ontwikkelings kostes).
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Vazquez, Toro Guillermo J. "Patent Quality And Company Performance| A Sample within the USA Biotechnology and Pharmaceutical Industry." Thesis, Inter-American University of Puerto Rico (Puerto Rico), 2014. http://pqdtopen.proquest.com/#viewpdf?dispub=3577982.
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This Dissertation investigates the relationship between patent quality and company performance for a sample from the US Biotechnology and Pharmaceutical Industry. The methodology devised comprehensively examines patent worth (patent’s references), patent protection (claims and family patents) and patent quality (references, claims and family patents) to determine their implications on firm leverage (SE, TA), profits (ROE, ROA), and market value (B/M, MCap). The selected sample comprises 1,536 companies, and 285,000 patents from 1999 to 2009. The results show that total revenue just responds to changes in R&D; intensity, and patenting intensity. A 10 percent increase in patent value results in a corresponding increase rate on the market capitalization index for the full sample and a 14 percent increase for the chemicals and allied products group (SIC 28). Increases (10%) in patent protection and quality present average increases of 15 percent on market capitalization for the full sample and 8 percent for the chemicals and allied products group (SIC 28). The medical devices group (SIC 38) results suggest that Mcap increases 10 percent by the same increase in patent value index. Patent protection and quality increases (10%) suggest an average 8 percent increase in Mcap. Results suggest that profits, leverage and market indices respond differently to 10 percent increases in patent value, patent protections and patent quality. The aforementioned effects suggest that the qualitative indexes follow company related market activities and business valuations for the chemical and allied products, and medical devices industrial sectors.
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Pavúk, Šimon. "Aplikácia investičnej analýzy na biotechnologicko- farmaceutický sektor." Master's thesis, Vysoká škola ekonomická v Praze, 2010. http://www.nusl.cz/ntk/nusl-76239.
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The principal aim of this thesis is to describe methods of fundamental analysis of three major companies from sectors of Biotechnology and Pharmaceuticals, namely Johnson & Johnson, Pfizer and Amgen. Among used methods we are able to find 2 -- stage discounted cashlow models Free-cashflow-to-equity FCFE and Free-cashflow-to-firm FCFF, Gordon's dividend discount model a relative valuation methods using P/E, P/BV and P/S. Descriptive part of this thesis describes legal and regulatory environment, which has significant impact on the development process of new innovative drugs and therapies. Further it sets investment recommendations and looks closer at investment opportunities in biotechnological companies.
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Fung, Ho Ki. "Synthesis and development of manufacturing processes for biopharmaceuticals /." View Abstract or Full-Text, 2003. http://library.ust.hk/cgi/db/thesis.pl?BIEN%202003%20FUNG.
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Pooni, Gurkanwal Singh. "The creation and development of technology by MNEs within the chemical, pharmaceutical and biotechnology industries." Thesis, University of Reading, 2001. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.393242.
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Houston, Chad Allen. "Biotechnology valuation an examination of the drug development pipeline and board of director composition /." View electronic thesis (PDF), 2009. http://dl.uncw.edu/etd/2009-3/r1/houstonc/chadhouston.pdf.
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Engberg, Erica, and Emilia Johansson. "Ozonation of pharmaceutical residues in a wastewater treatment plant : Modeling the ozone demand based on a multivariate analysis of influential parameters." Thesis, Linköpings universitet, Teknisk biologi, 2018. http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-151565.
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Most pharmaceutical residues in wastewater treatment plants (WWTPs) end up in the hydrosphere where they cause negative effects on the aquatic life and might disrupt ecosystems. By implementing an ozonation step (treatment with ozone) in the wastewater treatment process, these pharmaceutical residues can be reduced. The purpose of this project was to verify that the ozonation process works in full-scale, thereby verifying a pilot study conducted in 2014 at Tekniska Verken i Linköping AB (TVAB). Additionally, the purpose was to investigate which parameters influence the ozone demand in order to formulate a model for the ozone demand. The initial phases during this thesis were a pre-study and a literature study. This was followed by the multivariate analysis and model construction based on different data from the pilot study. Measurements were performed on the wastewater in the full-scale facility in order to verify the results from the pilot study. Moreover, measurements were performed to find new ozone consuming parameters. The reduction of pharmaceutical residues was similar to the pilot study, although slightly lower. Several parameters and factors that were different between pilot study and new measurements affected the reduction of pharmaceutical residues. For example, DOC and nitrate concentrations have increased since the pilot study in 2014. Also, factors such as the growth in population in Linköping and the differences in design between the pilot plant and the full-scale facility have influenced the reduction of pharmaceutical residues. A control strategy based on a linear relationship between ozone sensitive Ultra Violet Absorption (UVA) left and remaining pharmaceutical residues after ozonation could potentially be used. Moreover, three models were constructed and the Multivariate Analysis 1 (MVA1)-model was deemed as the best, this model includes ozone residual, nitrite, turbidity, simulated Chemical Oxygen Demand (COD(sim)) and ozone dose. The variations in the dose compared to the input parameters for the validation data show that the model predict the ozone dose well. However, in future other interesting parameters can be included in the model to further improve the accuracy in the ozone dose predicted by the model.Många läkemedelsrester i avloppsreningsverken hamnar i hydrosfären där de kan orsaka negativa effekter på det akvatiska livet och högre ekosystem. Genom att införa ett ozoneringssteg (behandling av ozon) på avloppsreningsverken, kan läkemedelsresterna reduceras. Syftet med det här examensarbetet var att verifiera att ozoneringsprocessen fungerade i fullskala och därmed verifiera en pilotstudie som utfördes år 2014 på Tekniska Verken i Linköping AB (TVAB). Syftet var också att undersöka vilka parametrar som påverkade ozonbehovet för att kunna konstruera en modell för ozonbehovet. De initiala faserna under examensarbetet var en förstudie och en litteraturstudie. Dessa följdes av en multivariat analys och modellkonstruktioner baserat på olika data ifrån pilotstudien. Mätningar på fullskaleanläggningen gjordes också för att hitta nya ozonkonsumerande parametrar. Reduktionen av läkemedelsrester liknande reduktionen under pilotstudien, men var dock något lägre. Flera parametrar och faktorer var värden skiljde sig mellan pilotstudien och fullskala påverkade reduktionen av läkemedelsrester. Till exempel, har DOC och nitratkoncentrationen ökat sedan pilotstudien år 2014. Faktorer så som befolkningsökningen i Linköping och de skillnader som fanns i designen hos de två anläggningarna kan också ha påverkat reduktionen av läkemedelsrester. En kontrollstrategi baserat på ett linjärt samband mellan ozonkänslig ultraviolett absorption (UVA) kvar och kvarvarande läkemedelsrester efter ozonering kan eventuellt användas. Tre modeller konstruerades där Multivariat analys 1 (MVA1)-modellen ansågs vara den bästa. Den här modellen inkluderade ozonresidual, nitrit, turbiditet, simulerad chemical oxygen demand (COD(sim)) och ozondos. Variationerna i dosen jämfört med inputparametrarna för validerade data visade att modellen predikterade ozondosen bra. I framtiden kan andra intressanta parameter inkluderas i modellen för att vidare förbättra trovärdigheten i ozondosen som predikteras av modellen.
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Faragalla, Jane Eliza. "Development of isoflavonoid-derived anti-prostatic cancer agents." Access electronically, 2005. http://www.library.uow.edu.au/adt-NWU/public/adt-NWU20060516.121728/index.html.
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Possnert, Oliver, and Adam Schön. "A case study research of asymmetrical relationshipsbetween service providers and emerging companieswithin the healthcare industry." Thesis, Uppsala universitet, Institutionen för biologisk grundutbildning, 2018. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-353334.
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This master thesis report aims to highlight the importance ofinterorganizational relationships between experienced serviceproviders and emerging biopharmaceutical (EBP) companies within theSwedish healthcare industry. A shift in innovation strategiesregarding new pharmaceutical- and medical device products hasprompted a paradigm shift within a complex industry wherecollaborations between organisations has become increasinglycrucial. With a better understanding of how these companiesoperates, increased collaboration efforts could result in a fasterand more precise product development with new products reaching themarket improving the health for people around the world. In order toallow experienced service providers to enhance services towards EBPcompanies, a fundamental understanding of how decision makers withinthese EBP companies prefer to conduct relationships is needed. Wehave examined relationship preferences of EBP companies byconducting a qualitative case study through 14 interviews withdecision makers combined with a quantitative conjoint analysis.Eight factors was identified as important for when EBP companiesdecide to engage with a service provider: cost behavior,professional competence, adaptability, communication, personalrelationship, stability, EBP insight and size. The factorsadaptability, personal relationship, cost and size were used in theconjoint analysis to determine their relative importance which showthat adaptability and cost behavior was of the largest importance.With descriptions of each factor, we have provided a meaningfulguide to action of how to address these factors as a serviceprovider. The relationships is largely investigated as relationshipsbetween contract research organizations (as service providers) andEBP companies, but we have created a framework applicable forservice providers within the healthcare industry in general.
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Wall, Nicola. "Further evolution in the pharmaceutical sector : changes in the division of labour and the markets for technology." Thesis, University of Manchester, 2011. https://www.research.manchester.ac.uk/portal/en/theses/further-evolution-in-the-pharmaceutical-sector-changes-in-the-division-of-labour-and-the-markets-for-technology(b294c155-8bc9-4db1-9d34-b39de22dba1d).html.
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The pharmaceutical sector has undergone many changes, particularly in the past several decades. The purpose of this research was to ascertain the existence of further changes to the division of labour and changes in the markets for technology within the sector. This research was also undertaken to understand the specific issues that may be impacting the division of labour and the changes in the markets for technology including the role of finance and the role of a surplus of unexploited knowledge. The division of labour between large and small new firms was initially more pronounced as the fully integrated firms continued to develop, manufacture and market drugs while 'classical biotechnology' firms pursued an exploratory business model of supplying knowledge and early stage drug candidates to these fully integrated companies (McKelvey, 2008). However, firms are changing in this sector and changes may be evident that have not been discussed in the literature to date. A new type of firm is evident within this sector, the No Research Development Only (NRDO) firm, as well as changes in the existing firms. This has impacted markets for technology as changes are also apparent in the way in which firms exchange products and knowledge. A combined quantitative and qualitative study was used to answer the research questions. A random sample of 100 EU and US companies that own and develop drug products was generated. Descriptive statistics were gathered to form a database of information and case studies were compiled to provide in-depth data related to a sample of eight firms. The newly identified NRDO firms do not possess internal capabilities to discover their own products; surprising given the historically research intensive nature of the types of small firms that operate in this sector. There also appears to be changes in the markets for technology as large firms are selling drug candidates to these hitherto research-intensive discovery and development (DD) firms who are willing to in-license these drug candidates to bolster pipelines and financial valuations. Markets for knowledge in this sector have undoubtedly evolved and a more complex set of arrangements are evident. The roles of finance and a surplus of unexploited knowledge have played an important part in these changes as the sustained level of exploration in the sector has resulted in a greater number of exploitation opportunities. Overall there is evidence to support further evolution in the sector.
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Boca, Madalina Brindusa. "Research into process validation in pharmaceutical companies, with specific reference to Roche, South Africa." Pretoria : [s.n.], 2009. http://upetd.up.ac.za/thesis/available/etd-10132009-181630/.
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Otieno, Charles J. "Analysis of strategic alliance deals in the global CNS industry /." Burnaby B.C. : Simon Fraser University, 2006. http://ir.lib.sfu.ca/handle/1892/2741.
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Larsen, David Mark. "The discursive function and the embedding of capitalism : British state policy on the pharmaceuticals and biotechnology sector." Thesis, University of Cambridge, 2010. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.608970.
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Volk, Jennifer M. "Do Investors View Excess Capacity as a Determinant of Mergers and Acquisitions in the Pharmaceutical and Biotechnology Industry?" Scholarship @ Claremont, 2010. http://scholarship.claremont.edu/cmc_theses/15.
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I examine investors’ reaction to the announcement of mergers and acquisitions in the pharmaceutical and biotechnology industry from 2002 to 2008. Over this period, investors anticipate the announcements, as demonstrated by the fact that the cumulative abnormal returns are not statistically significant. In addition, I test to determine the effect of excess capacity on investors’ reactions. From 2002 to 2004, investors do not recognize acquisitions as a response to excess capacity, as the excess capacity measures utilized have no effect on the size of the cumulative abnormal return. From 2005 to 2008, however, excess capacity measures have a positive effect on cumulative abnormal return, indicating that investors started to recognize the threat of excess capacity and acquisitions as a response to that threat.
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SCALVENZI, Laura. "Amazonian plants from ethnomedicine to biotechnology through pharmaceutical biology approaches: a PhD experience in connecting forest with laboratory." Doctoral thesis, Università degli studi di Ferrara, 2011. http://hdl.handle.net/11392/2389376.
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The South american Natives, Shuar and Achuar people and their ethnomedical culture constitute the
background subject of the Phd research, performed both in Ecuador (Salesian Politechnic University,
Quito), and in Italy (Pharmaceutical biology labs, University of Ferrara). Based on ethnomedical
responses, Piper aduncum, Maytenus macrocarpa, Schinus molle, Tecoma stans and Eugenia hallii were
chosen as amazonian plant species subject of the research.
AIMS
The research has been focused on:
− checking the presence of endophytic fungi in plants;
− isolating and subculturing pure endophytic strains;
− checking the biotransformation capacity of the isolated endophytes on pure compounds; the most
performing endophytes were also tested on phytocomplexes and pure chemicals obtained by the
plant from which the fungi were isolated;
− phytochemical characterization and bioactivity assays of plant extracts: P. aduncum.
−
METHODS
Biotransformations. Fresh aerial plant parts were properly washed in sanitizing solutions and in vitro
cultured using adequate solid media to isolate endophytes. (+/-)-cis-bicyclo[3.2.0]hept-2-en-6-one,
acetophenone, 1-indanone, 2-furyl methyl ketone, 2-methylcyclopentanone, 2-methylcyclohexanone, 2-
methoxycyclohexanone were chosen as substrate model for biotransformations. The cultures were
sampled after 1, 3, 7, 10 days of culturing, and ethyl acetate extracted to verify by GC-MS the presence of
possible biotransformation products. Biotransformations were also checked on P. aduncum whole
essential oil and on dillapiol, cis-ocimene, piperitone, (-)-terpinen-4-ol as most abundant chemicals.
Chemical fingerprinting of P. aduncum essential oil. Steam distillation was adopted to obtain the essential
oil, then characterized by GC-MS, NMR analyses.
In vitro bioassays of P. aduncum essential oil. Antimicrobial activities were checked in vitro using proper
agarized media to reach MIC. Antioxidant capacities were checked through DPPH test, ABTS and
photochemiluminescence assays. Born's turbidimetric method and Writhing test were respectively
adopted to check platelet-aggregation and anti-nociceptive properties. Mutagenic, antimutagenic
properties and toxicity were assayed using classical and modified Ames test.
MAIN RESULTS
364 fungal strains were in vitro isolated. Among all, 5 strains performed biotransformations on
acetophenone to (S)-1-phenylethanol, with important yields (78-97%) and enantiomeric excess (78-
100%). Three strains gave also phenols probably by enzymatic reactions (Baeyer-Villiger oxidations). 15
fungal strains gave the lactones (-)-(1S,5R)-2-oxabicyclo[3.3.0]oct-6-en-3-one and (-)-(1R,5S)-3-
oxabicyclo[3.3.0]oct-6-en-2-one from (+/-)-cis-bicyclo[3.2.0]hept-2-en-6-one, probably as result of
monooxygenase activation. Phytochemical characterization of P. aduncum essential oil has evidenced
dillapiol as the most abundant terpene, followed by cis-ocimene, piperitone and terpinen-4-ol. Only cisocimene
and piperitone gave several biotransformation products through dehydrogenation and
hydroxylation reactions. The essential oil has evidenced non-mutagenic properties and interesting
antifungal and antioxidant activities.
CONCLUSIONS
Several endophytic fungal strains from Amazonian plants were isolated and checked for
biotransformations on pure chemicals and on P. aduncum essential oil. Data obtained will be useful for
possible following patents about micro-organisms able to transform pharmaceutically interesting
chemicals. Taxonomical characterization of the most performing fungal strains is still in progress. P.
aduncum essential oil can be considered genotoxically safe and provides interesting antifungal and
antioxidant properties, supporting its ethnomedical use as cicatrising and disinfectant crude drug and
suggesting an extension of its employ as preservative ingredient.
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Luu, Paula. "An investigation of the Mechanisms Behind the Pharmaceutical Removal in Ekeby Wetland WWTP." Thesis, KTH, Skolan för kemi, bioteknologi och hälsa (CBH), 2020. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-278593.
Full textAbstract:
Pharmaceutical residues are being released into the aquatic environment through domestic wastewater effluents all around the world. Ekeby wetland located in Eskilstuna has been shown to degrade pharmaceutical residues in wastewater but the mechanism of how and where in the wetland these substances are removed were not known. The aim of this Master’s thesis was to study the mechanism behind the pharmaceutical removal in Ekeby wetland. The presence of 22 selected pharmaceuticals were examined in water-, sediment- and plant samples collected from the wetland. Additionally, the concentration of nutrients’, pH and temperature of the water were examined. With this data, the correlations between the concentration of pharmaceuticals in the water and the concentration of selected nutrients could be determined. Nine out of 22 substances were detected in the sediment samples and 10 out of 22 was detected in the plant sample. The five pharmaceutical substances that required additional removal were citalopram, diclofenac, erythromycin, oxazepam and sertraline. Citalopram, diclofenac and sertraline were found in the sediment and plant samples. A significant negative correlation was found between the concentration of pharmaceuticals in water samples and total suspended solids (TSS) indicating that an increase of TSS, decreases the pharmaceutical concentration in the water. The main mechanism behind the pharmaceutical removal in Ekeby wetland was determined to be by sedimentation and plant uptake, mainly by Phragmites australis. The wetland system could also remove metoprolol, propranolol, tramadol, trimethoprim, naproxen, venlafaxine and carbamazepine. Hence, to increase the pharmaceutical removal in the wetland it’s recommended to increase the amount of plants, mainly P. australis. Thus, wetland systems could be of great advantage in the development of sustainable wastewater management.Via avloppsvattnet släpps mängder av läkemedelsrester ut i vårt vatten. Ekeby våtmark i Eskilstuna har visat sig bryta ner läkemedelsrester från avloppsvatten, men mekanismen för hur och vart dessa ämnen tas bort är sedan tidigare okänt. Målet med detta examensarbete var att studera mekanismerna bakom läkemedelsnedbrytningen i Ekebys våtmark. Halterna av 22 läkemedelssubstanser i vatten-, sediment-och växtprover tagna från våtmarken undersöktes. Även koncentrationen av näringsämnen, pH och temperatur bestämdes i vattenprover tagna från våtmarken. Utifrån detta kunde sambanden mellan läkemedelskoncentrationerna och halterna av tidigare nämnda ämnen i vattnet studeras. Nio av 22 substanser uppmättes i sedimentproverna och 10 av 22 uppmättes i växtprovet. De fem läkemedel som krävde ytterligare rening var citalopram, diclofenac, erythromycin, oxazepam, och sertraline. Citalopram, diclofenac och sertraline uppmättes i sediment och växtproverna. I vattnet erhölls ett signifikant negativ samband mellan koncentration av läkemedel och suspenderade ämnen. Detta indikerar på att en ökning av suspenderade ämnen minskar läkemedelskoncentrationen i vattnet. Mekanismen bakom läkemedelsnedbrytningen i Ekebys våtmark fastställdes till sedimentation och växtupptag, främst av växten Phragmites australis. Våtmarken kunde även avlägsna metoprolol, propranolol, tramadol, trimetroprim, naproxen venlafaxin och carbamazapine. För att öka nedbrytningen av läkemedel i våtmarken är det därför rekommenderat att öka mängden växter. Våtmarkssystem kan därmed vara till stor fördel när man utvecklar reningsprocesser för läkemedel av avloppsvatten som är miljömässigt hållbara.
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Langer, Lynn Johnson. "How Scientist/Founders Lead Successful Biopharmaceutical Organizations: A Study of Three Companies." [Yellow Springs, Ohio] : Antioch University, 2008. http://www.ohiolink.edu/etd/view.cgi?acc_num=antioch1217337156.
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Thesis (Ph.D.)--Antioch University, 2008."A dissertation submitted to the Ph.D. in Leadership & Change Program of Antioch University in partial fulfillment of the requirements for the degree of Doctor of Philosophy May 2008."--from the title page. Title from PDF t.p. (viewed July 30, 2008). Advisor: Alan Guskin, Ph.D.. Keywords: biotechnology, biopharmaceutical, leadership, founder, success, management, case study Includes bibliographical references (p. 207-218).
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Rybička, Miloš. "Analýza vybraných průmyslových sektorů v ČR a v SRN a komparace jejich konkurenceschopnosti jako podklad pro strategická rozhodování." Master's thesis, Vysoká škola ekonomická v Praze, 2012. http://www.nusl.cz/ntk/nusl-162363.
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The goal of this Masters Thesis is to analyze three selected industry sectors in the Czech Republic and in Germany. Concretely the industries in focus are engineering, motor vehicle manufacturing and finally pharmacy along with bio- and nanotechnology. Furthermore, factors limiting but also supporting the industry development are identified and described in the Thesis. In the Thesis, analytical instruments will be used, especially the SWOT analysis and benchmarking. The Thesis is mainly intended for managers, employees, consultants and all other direct or indirect interest groups of both Czech and German industry companies and their suppliers but also for potential investors who are deciding whether to enter a market in the CEE region.
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Fornander, Erik. "Ozone Treatment Targeting Pharmaceutical Residues : Validation and Process Control in a Wastewater Treatment Plant." Thesis, Linköpings universitet, Teknisk biologi, 2018. http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-154012.
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Major studies conducted in Europe and North America has concluded that the current processes in wastewater treatment plants insufficiently degrade micropollutants e.g. pharmaceutical residues. Several sorption and oxidation methods has therefore been investigated with the purpose of removing or degrading micropollutants in wastewater. The main purpose of this project was, firstly, to validate the results from a pilot study conducted by Tekniska verken i Linköping AB (2014) which investigated the use of ozone to degrade pharmaceutical residues. Secondly, to investigate and design a suitable process control strategy for the ozonation process. Four different tests were conducted during the project, a dose-response test, step-response tests, a trace test, and a performance test. A poorer average reduction of pharmaceutical residues was observed in this project compared to the pilot study. An average reduction of approximately 80% was observed at the highest tested dose, 0.67 mg O3/mg DOC, N corr. Whilst an average reduction of 90% was observed at approximately 0.46 mg O3/mg DOC, N corr, in the pilot study. However, the quality of the wastewater was worse during this project compared to the pilot study. ΔUVA254 and offgas concentration of ozone were found to be suitable control parameters for process control. A control strategy based on a combination of these parameters was designed, where ΔUVA254 was used as the main control parameter and the off-gas concentration of ozone was used as a limiting controller to ensure a sufficient mass transfer in the system. In conclusion, a suitable flow proportional base ozone dose valid for current water conditions has been identified, 10 mg/L. Differences in wastewater quality which heavily influence the ozonation process have been identified. Lastly, a control strategy for process control of the ozonation have been identified, designed and is ready for implementation.
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Cavalcante, Fernando Castro Silva. "Uma alternativa para o fortalecimento da inovação nas áreas farmacêutica e de biotecnologia no Brasil." Universidade de São Paulo, 2009. http://www.teses.usp.br/teses/disponiveis/87/87131/tde-28042009-122237/.
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O presente trabalho apresenta uma alternativa para despertar nos principais players do setor da inovação farmacêutica e biotecnológica um interesse maior em utilizar os resultados das invenções brasileiras de empresas e instituições de pesquisa na produção de novos medicamentos. Considerando o atraso brasileiro em relação aos processos de inovação que derivam do conhecimento cientifico e as inúmeras peculiaridades dessas inovações nas áreas farmacêuticas e biotecnológicas apresentamos algumas sugestões de incremento no arcabouço jurídico nacional com base em estruturas legais e, também, usando parte da legislação americana como paradigma para algumas mudanças. Nesse sentido, sugerimos a criação de sociedades de propósito específico entre os setores público e privado para o desenvolvimento da inovação, o que permitiria que questões estratégicas, como a co-titularidade das patentes, fossem dirimidas em acordos societários (quotistas ou acionistas). Além disso, recomendamos a constituição de um núcleo de inovação tecnológica em institutos de pesquisa como no Instituto Butantan para usufruir dos benefícios da lei de inovação, principalmente em relação ao licenciamento de patentes e, nos moldes do Bayh Dole Act em vigor nos Estados Unidos, sugerimos que o setor público, ao licenciar as patentes, privilegie as empresas nacionais de pequeno porte.The present work suggests alternatives in the pharma and biotechnology innovation areas to use the results of Brazilian inventions obtained in research institutes and biotechnology companies for the production of novel drugs. We present some suggestions to improve the Brazilian legal system based on legal structures and using examples of the American legal system as a reference. Thus, we suggested setting up specific purposes companies between the public and private sector to develop innovation, which would allow solving strategic questions, such as patent co-ownership, through corporate agreements (quotaholders or shareholders). In addition, we recommend the establishment of a technology innovation office in researches institutes, such as Instituto Butantan to allow it to be able to take advantages offered by the Brazilian innovation law and, along the lines of the Bayh Dole Act, duly in force in United States, we suggested that the public sector, when licensing its patents, grant privileges to small national companies.
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Delagustin, Maria Gabriele. "Caracterização e avaliação da estabilidade do ácido lactobiônico e de diferentes lactobionatos produzidos por Zymomonas mobilis visando à utilização na área farmacêutica." reponame:Repositório Institucional da UCS, 2016. https://repositorio.ucs.br/handle/11338/1796.
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O ácido lactobiônico e seus sais (lactobionatos), compostos que apresentam aplicações na área farmacêutica, foram obtidos via ação do complexo enzimático glicose-frutose oxidorredutase (GFOR)/gliconolactonase (GL) - presente no periplasma de células da bactéria Zymomonas mobilis - imobilizado em alginato de cálcio. Nas reações catalisadas por este sistema enzimático, o pH do meio deve ser controlado em valores ligeiramente ácidos. Para este fim, foram empregados NaOH, KOH ou Ca(OH)2 e, como consequência, os respectivos sais foram formados. O estudo da cinética de formação dos lactobionatos de sódio, potássio e cálcio e do próprio ácido lactobiônico foi seguido das etapas de purificação, caracterização e avaliação da estabilidade físico-química, visando à potencial utilização destes compostos na área farmacêutica. Em ensaios de bioprodução dos lactobionatos de sódio, potássio e cálcio, foram obtidos rendimentos de 74, 77 e 84%, respectivamente. Em bateladas sucessivas de bioconversão, totalizando 96 h de uso do biocatalisador, rendimentos de 80 e 56 % em lactobionatos de cálcio e de potássio foram atingidos. Na etapa de purificação dos sais, foram alcançados teores de pureza de aproximadamente 95%, sendo então procedida a caracterização dos compostos por cromatografia líquida de alta eficiência, espectrometria de massas e RMN de 13C. Nos estudos de estabilidade acelerada, de longa duração e degradação forçada, os lactobionatos de sódio, potássio e cálcio obtidos nos ensaios de bioconversão conduzidos em maior volume reacional, foram inicialmente purificados e, então, comparados frente ao ácido lactobiônico, obtido por troca iônica a partir do lactobionato de sódio, e com o ácido lactobiônico comercial (Sigma-Aldrich). Nos testes de estabilidade acelerada e de longa duração, foi constatada a estabilidade de todos os compostos por até seis meses quando expostos a 30 e 40oC e 75% de umidade relativa. Por outro lado, a presença da lactobionolactona foi identificada nas amostras dos compostos na forma ácida. Com relação aos testes de degradação forçada, os lactobionatos de sódio, potássio, e cálcio e o ácido lactobiônico se mostraram estáveis frente à exposição a soluções ácidas e alcalinas e às temperaturas avaliadas. Contudo, observou-se degradação no tratamento com solução oxidativa, com cinética de degradação de ordem zero para os sais e de segunda ordem para o ácido lactobiônico. Elevadas concentrações de produtos - lactobionatos de sódio, potássio e cálcio - foram atingidas com a utilização do sistema GFOR/GL imobilizado em alginato de cálcio. Considerando o conjunto de informações obtido, quanto à caracterização físico-química dos compostos produzidos, foi demonstrada a estabilidade frente aos diferentes parâmetros avaliados atendendo aos requisitos mínimos legais para sua aplicação na área farmacêutica.Submitted by Ana Guimarães Pereira (agpereir@ucs.br) on 2017-03-09T14:08:07Z No. of bitstreams: 1 Dissertacao Maria Gabriele Delagustin.pdf: 3945297 bytes, checksum: e76bd0d7370a803326a4ebd56fb7e6b1 (MD5)
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior, CAPES.
Lactobionic acid and its salts (lactobionate) are substances that have several applications in pharmaceutical area. These products were obtained by enzymatic complex glucose-fructose-oxidoreductase (GFOR)/gluconolactonase (GL) present in the periplasm of Zymomonas mobilis cells that were immobilized in calcium alginate. In the reactions catalyzed by this enzyme system, the medium pH must be controlled at slightly acid values. For this purpose, NaOH, KOH, or Ca(OH)2 were used and as a result the respective salts were formed. The kinetic study on the formation of sodium, potassium and calcium lactobionate and lactobionic acid itself was followed by the steps of purification, characterization and evaluation of the physicochemical stability, aiming the potential use of these compounds in the pharmaceutical area. In the assays for the bioproduction of sodium, potassium or calcium lactobionates, yields of 74, 77 and 84% were obtained, respectively. In repeated bioconversion batches, totalizing 96 hours of use of the biocatalyst, yields of 80 and 56% were attained for calcium and potassium lactobionate. In the salts purification step, purity levels of approximately 95% were achieved, and subsequently these compounds were characterized by high performance liquid chromatography, mass spectrometry, and C13 NMR. In the studies of accelerated, long term and forced degradation stability, the production of sodium, potassium and calcium lactobionate was carried out at higher reaction volume. The products were purified and then evaluated together with lactobionic acid that was obtained by ion-exchange from sodium lactobionate, and with a commercial lactobionic acid (Sigma-Aldrich). In the accelerated and long term stability tests, it was demonstrated the stability of all compounds when exposed to 30 and 40oC and of 75%of relative humidity for up to six months. On the other hand, the presence of lactobionolactone was identified in samples of compounds in the acid form. With respect to the forced degradation tests, sodium, potassium and calcium lactobionates and lactobionic acid have shown to be stable after exposing to both acidic and alkaline solutions and the temperatures evaluated. However, degradation was observed in the treatment with oxidative solution, with a zero-order degradation kinetics for the salts forms and second-order for lactobionic acid. High concentrations of products - sodium, potassium and calcium lactobionate - were achieved by using the Ca-alginate immobilized GFOR/GL complex. Considering the set of information obtained in regarding to physicochemical characterization, it was demonstrated the high stability of these compounds in front of different parameters evaluated, endorsing the legal minimum requirements for their application in the pharmaceutical area.
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Patkar, Anuprita D. "Understanding Off-Label Utilization Patterns of Two Biotechnology Drugs, Recombinant Erythropoietin Alfa and Darbepoetin Alfa: A Multi-Hospital Study." VCU Scholars Compass, 2005. http://scholarscompass.vcu.edu/etd_retro/47.
Full textAbstract:
The American Medical Association (AMA) has estimated that as many as 40 percent of all prescriptions are issued for off-label use. Off-label prescribing is considered to be clinically beneficial and rational in certain life-threatening situations. However, off-label use can pose risks to patients in terms of adverse drug events as well as contribute to rising pharmaceutical costs. The anti-anemic drugs erythropoietin and darbepoetin are costly, and there are significant off-label uses for these drugs some of which are not supported with clinical evidence, hence were selected as study drugs. Our study goals included quantification of the prevalence rate and appropriateness of off-label use of erythropoietin and darbepoetin across U.S. hospitals, and identification of possible predictors of off-label use from the domains of patient characteristics, physician specialty, hospital characteristics and drug characteristics. To address the research questions we performed a retrospective review of 464,834 discharged patients across 515 hospitals who have received erythropoietin and darbepoetin from the time periods between 2001and 2004. The data was supplied by Solucient®. The uses of the two drugs have been categorized using an evidence-based medicine framework that classifies them into: a) on-label use (approved by the FDA), b) off-label use supported (use not approved by FDA but there is strong clinical evidence supporting off-label use), and c) off-label use unsupported (lack of clinical evidence). A multinomial logistic regression model clustered by hospitals was conducted to determine predictors of off-label use. The results of this study revealed that more than half of the utilization of the two erythropoietic drugs is for off-label purposes, the majority of which is supported with evidence. Among the covariates, physician specialty, patient age group, race, drug coverage and length of hospital stay were significant (0.05 level) predictors of off-label use (supported and unsupported) relative to on-label. It is useful to understand the extent and appropriateness of off-label utilization in order to ensure safe and cost-effective use in patients. The availability of empirically derived knowledge on the national level could precipitate the promulgation of more meaningful post-marketing surveillance measures.
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Rasmussen, Bruce. "Creating and capturing value in the biopharmaceutical sector." full-text, 2008. http://eprints.vu.edu.au/1946/1/Bruce_Rasmussen_PHD_2009.pdf.
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This study addresses the ongoing implications of the realignment of the pharmaceutical industry knowledge base – from small molecule methods to new biomedical technologies – for the competitive positions of traditional pharmaceutical companies and biopharmaceutical start-ups. The theoretical approach draws on the modern theory of the firm and related concepts, to define and develop the concept of the business model. This is employed to guide the empirical analysis, which utilises a combination of data analyses and case studies based on several sources, including detailed company reports and alliance databases. The thesis analyses how the pharmaceutical companies have successfully adjusted their business models to meet the challenge of biotechnology and so retain their powerful position in the industry. Central to this has been the breadth and depth of knowledge transfer through alliance formation. Not only has this been critical to the adjustment process for the large pharmaceutical companies but also for the development of the many biopharmaceutical start ups. Nonetheless the business models of these smaller companies have many weaknesses, which have led to the erosion of the value of their initial strategic assets. Despite the poor financial performance of the vast majority of these firms, the biopharmaceutical sector as a whole has created significant value. This has been captured disproportionately by a handful of large fully integrated biopharmaceutical firms and, to a lesser extent, by the largest dozen pharmaceutical firms.
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Volk, Anna-Luisa. "Cell line and protein engineering tools for production and characterization of biologics." Doctoral thesis, KTH, Proteomik och nanobioteknologi, 2017. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-212931.
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Our increasing understanding of disease mechanisms coupled with technological advances has facilitated the generation of pharmaceutical proteins, which are able to address yet unmet medical needs. Diseases that were fatal in the past can now be treated with novel biological medications improving and prolonging life for many patients. Pharmaceutical protein production is, however, a complex undertaking, which is by no means problem-free. The demand for more complex proteins and the realization of the importance of post-translational modifications have led to an increasing use of mammalian cells for protein expression. Despite improvements in design and production, the costs required for the development of pharmaceutical proteins still are far greater than those for conventional, small molecule drugs. To render such treatments affordable for healthcare suppliers and assist in the implementation of precision medicine, further progress is needed. In five papers this thesis describes strategies and methods that can help to advance the development and manufacturing of pharmaceutical proteins. Two platforms for antibody engineering have been developed and evaluated, one of which allows for efficient screening of antibody libraries whilst the second enables the straightforward generation of bispecific antibodies. Moreover, a method for epitope mapping has been devised and applied to map the therapeutic antibody eculizumab’s epitope on its target protein. In a second step it was shown how this epitope information can be used to stratify patients and, thus, contribute to the realization of precision medicine. The fourth project focuses on the cell line development process during pharmaceutical protein production. A platform is described combining split-GFP and fluorescence-activated droplet sorting, which allows for the efficient selection of highly secreting cells from a heterogeneous cell pool. In an accompanying study, the split-GFP probe was improved to enable shorter assay times and increased sensitivity, desirable characteristics for high-throughput screening of cell pools. In summary, this thesis provides tools to improve design, development and production of future pharmaceutical proteins and as a result, it makes a contribution to the goal of implementing precision medicine through the generation of more cost-effective biopharmaceuticals for well-characterized patient groups.QC 20170828
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Guedri, Zied. "Performance variations among strategic group members in the pharmaceutical industry : an examination of individual sustainable growth capabilities, 1995-1997." Thesis, Connect to online version, 1998. http://0-wwwlib.umi.com.mercury.concordia.ca/cr/concordia/fullcit?pMQ39083.
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Chan, Leong. "Developing a Strategic Policy Choice Framework for Technological Innovation: Case of Chinese Pharmaceuticals." PDXScholar, 2013. https://pdxscholar.library.pdx.edu/open_access_etds/1041.
Full textAbstract:
With the growing trend of globalization and rapid development of high technologies, emerging economies face more challenges in technology development because they are chasing a fast-moving frontier. They need to identify global technology trends and adapt to local needs and capabilities. Strategies for technology development differ among countries at different developmental stages.
In this research, a technology policy choice framework is developed to link prospective high-tech areas, technology development strategies, and various innovative resources. The research approach is to develop a hierarchical decision model (HDM) and apply the analytic hierarchical process (AHP). Experts are invited from diverse sources to provide a balanced perspective representing different stakeholders. This research focuses on the fast developing Chinese biopharmaceutical industry as a case study.
The results of this research have identified thirteen prospective biotech areas that China should invest more resources for development. These technology areas include: recombinant therapeutic proteins, recombinant vaccines, monoclonal antibody technology, cell and tissue engineering, gene therapy, antisense therapy, RNAi, nanobiotechnology, synthetic biology, bioinformatics, pharmacogenetics, gene sequencing, and biotechnology diagnostics. For most of these technology areas, the results have indicated an imitative innovation strategy should be taken as a better strategy under current technological conditions in China. The research has further found that high-tech small-to-medium companies and multinational corporations are major innovation contributors in the Chinese biopharmaceutical sector.
The research outcomes can serve as guidelines in resource allocation and policy making for technology development. Based on the overall research findings, policy-makers can apply more specific policy instruments to support innovation activities. Appropriate policy measures may help the country to construct an innovative ecosystem that can serve as the driving force for future technology development.
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Schmidt, Stefan. "Merger and acquisition between small biotech and large pharmaceutical companies - a winning combination? : Case study on the acquisitions of CAT by AstraZeneca and Abgenix by Amgen; MBA thesis in marketing." Thesis, University of Gävle, Department of Business Administration and Economics, 2008. http://urn.kb.se/resolve?urn=urn:nbn:se:hig:diva-3261.
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This study aims at introducing and describing a novel multi parameter analysis method to identify potential acquisition targets and to qualitatively and quantitatively evaluate the overall match between a target company and its acquirer. The method was tested with two recent real cases involving each an antibody based biotech company and a large fully integrated pharmaceutical company. The model was validated by comparing two independent antibody companies against the real cases, testing if they would have made better targets. It was found out that the in reality acquired companies scored highest, thus proving the validity of the method. One of the four potential targets got the highest scores for both acquirers. Consequently one of the acquired targets was only the second best match. The still independent companies would not have been better targets. The lowest scoring target company did get identical scores for both acquiring companies. Despite the proper prediction of targets, the scoring did not reveal the true underlying motives for the acquisitions, nor could significant parameters be identified to discriminate between target and non-target. This study adds a novel, valuable tool to the still limited arsenal of methods to qualitatively and quantitatively measure a match between target and acquirer solely based on publicly available data.
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Cinman, José Luiz Ferreira [UNESP]. "Desenvolvimento de um novo sistema dinâmico para avaliação da liberação de fármacos." Universidade Estadual Paulista (UNESP), 2014. http://hdl.handle.net/11449/124398.
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000837513.pdf: 748713 bytes, checksum: f6c3f2e57d1d839e2a01a84e58c8b82b (MD5)Sistemas de liberação de fármacos tornaram-se importantes no campo da farmacologia e da biomedicina, uma vez que podem reduzir a dose terapêutica através da liberação local e evitar possíveis efeitos da droga durante sua passagem pelo organismo. Biomembranas de látex natural extraído da Hevea brasiliensis têm mostrado interessantes resultados na área da biomedicina por apresentarem proteínas que estimulam a angiogênese, acelerararem processos de cicatrização, constituirem próteses e pelo bom desempenho como matriz para liberação de fármacos, extratos vegetais, nanopartículas e proteínas. Este trabalho apresenta a elaboração e a utilização de um novo sistema, dito dinâmico, onde a liberação se dá sob fluido circulante e utilizando biomembranas de látex natural como carreador da liberação. A fim de complementar as propriedades cicatrizantes do látex, foi escolhido o cetoprofeno como modelo de fármaco, devido à sua ação antiinflamatória, analgésica e antipirética, de uso veterinário e humano. As biomembranas foram produzidas misturando látex natural com uma solução de cetoprofeno pelo método de deposição, e secas à temperatura ambiente. Um novo sistema dinâmico para liberação de fármacos com fluxo circulante foi implementado, onde foram comparados resultados de liberações estáticas (sem fluxo) e dinâmicas, em mesmas condições, a fim de se obter a influência do fluxo na liberação. As biomembranas foram caracterizadas por Microscopia Eletrônica de varredura (MEV), espectroscopia no infravermelho por transformada de Fourier (FTIR) e teste mecânico de tração. Os resultados de MEV mostram a existência de fármaco superficial nas membranas e os resultados de FTIR mostram que não há interação entre o biomaterial e o fármaco, porém o cetoprofeno torna a biomembra mais frágil com a redução do modulo de Young, da porcentagem de alongamento...
Drug delivery systems have become important in the field of pharmacology and biomedicine, as they may reduce the therapeutic dose through the local release, avoiding possible effects during its passage through the body. Biomembranes made of natural latex extracted from Hevea brasiliensis has shown interesting results in biomedicine, by presenting proteins that stimulate angiogenesis, wound healing, constitute prostheses and good performance as a matrix for release of drugs, plant extracts, nanoparticles and proteins. This paper presents the development and use of a new system, said dynamic, where the release occurs from circulating fluid and using natural latex biomembranes as carrier for the releases. In order to supplement its healing properties, ketoprofenwas chosen as model drug because of its anti-inflammatory, analgesic and antipyretic properties, in the veterinary and human use. Biomembranes were produced by mixing natural rubber latex with a ketoprofen solution by the casting, and dried at room temperature. A new dynamic system for drug delivery with circulating flow was implemented and the static (no flow) and dynamic releases were compared in order to obtain the influence of the flow in the release. The biomembranes were characterized by scanning electron microscopy (SEM), Fourier transform infrared spectroscopy (FTIR) and mechanical testing. The SEM results showed the existence of the drug in the surface membranes. The FTIR results showed that there is no interaction between the drug and biomaterial, although the incorporation of ketoprofen makes the biomembranes more fragile by reducing the Young's modulus, elongation at break and tensile strength, indicating that the drug is only interleaved in the matrix polymer. These results indicate differences between static and dynamic release, since the dynamic released 30% more drug than static. Mathematical modeling showed that the initial release...
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Cinman, José Luiz Ferreira. "Desenvolvimento de um novo sistema dinâmico para avaliação da liberação de fármacos /." Assis, 2014. http://hdl.handle.net/11449/124398.
Full textAbstract:
Orientador: Rondinelli Donizetti HerculanoBanca: Catarina dos Santos
Banca: André Gonzaga dos Santos
Resumo: Sistemas de liberação de fármacos tornaram-se importantes no campo da farmacologia e da biomedicina, uma vez que podem reduzir a dose terapêutica através da liberação local e evitar possíveis efeitos da droga durante sua passagem pelo organismo. Biomembranas de látex natural extraído da Hevea brasiliensis têm mostrado interessantes resultados na área da biomedicina por apresentarem proteínas que estimulam a angiogênese, acelerararem processos de cicatrização, constituirem próteses e pelo bom desempenho como matriz para liberação de fármacos, extratos vegetais, nanopartículas e proteínas. Este trabalho apresenta a elaboração e a utilização de um novo sistema, dito dinâmico, onde a liberação se dá sob fluido circulante e utilizando biomembranas de látex natural como carreador da liberação. A fim de complementar as propriedades cicatrizantes do látex, foi escolhido o cetoprofeno como modelo de fármaco, devido à sua ação antiinflamatória, analgésica e antipirética, de uso veterinário e humano. As biomembranas foram produzidas misturando látex natural com uma solução de cetoprofeno pelo método de deposição, e secas à temperatura ambiente. Um novo sistema dinâmico para liberação de fármacos com fluxo circulante foi implementado, onde foram comparados resultados de liberações estáticas (sem fluxo) e dinâmicas, em mesmas condições, a fim de se obter a influência do fluxo na liberação. As biomembranas foram caracterizadas por Microscopia Eletrônica de varredura (MEV), espectroscopia no infravermelho por transformada de Fourier (FTIR) e teste mecânico de tração. Os resultados de MEV mostram a existência de fármaco superficial nas membranas e os resultados de FTIR mostram que não há interação entre o biomaterial e o fármaco, porém o cetoprofeno torna a biomembra mais frágil com a redução do modulo de Young, da porcentagem de alongamento...
Abstract: Drug delivery systems have become important in the field of pharmacology and biomedicine, as they may reduce the therapeutic dose through the local release, avoiding possible effects during its passage through the body. Biomembranes made of natural latex extracted from Hevea brasiliensis has shown interesting results in biomedicine, by presenting proteins that stimulate angiogenesis, wound healing, constitute prostheses and good performance as a matrix for release of drugs, plant extracts, nanoparticles and proteins. This paper presents the development and use of a new system, said dynamic, where the release occurs from circulating fluid and using natural latex biomembranes as carrier for the releases. In order to supplement its healing properties, ketoprofenwas chosen as model drug because of its anti-inflammatory, analgesic and antipyretic properties, in the veterinary and human use. Biomembranes were produced by mixing natural rubber latex with a ketoprofen solution by the casting, and dried at room temperature. A new dynamic system for drug delivery with circulating flow was implemented and the static (no flow) and dynamic releases were compared in order to obtain the influence of the flow in the release. The biomembranes were characterized by scanning electron microscopy (SEM), Fourier transform infrared spectroscopy (FTIR) and mechanical testing. The SEM results showed the existence of the drug in the surface membranes. The FTIR results showed that there is no interaction between the drug and biomaterial, although the incorporation of ketoprofen makes the biomembranes more fragile by reducing the Young's modulus, elongation at break and tensile strength, indicating that the drug is only interleaved in the matrix polymer. These results indicate differences between static and dynamic release, since the dynamic released 30% more drug than static. Mathematical modeling showed that the initial release...
Mestre
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Rasmussen, Bruce. "Creating and capturing value in the biopharmaceutical sector." Thesis, full-text, 2008. https://vuir.vu.edu.au/1946/.
Full textAbstract:
This study addresses the ongoing implications of the realignment of the pharmaceutical industry knowledge base – from small molecule methods to new biomedical technologies – for the competitive positions of traditional pharmaceutical
companies and biopharmaceutical start-ups. The theoretical approach draws on the modern theory of the firm and related concepts, to define and develop the concept of the business model. This is employed to guide the empirical analysis, which utilises a combination of data analyses and case studies based on several sources, including detailed company reports and alliance databases. The thesis analyses how the pharmaceutical companies have successfully adjusted their business models to meet the challenge of biotechnology and so retain their powerful position in the industry. Central to this has been the breadth and depth of knowledge transfer through alliance formation. Not only has this been critical to the adjustment process for the
large pharmaceutical companies but also for the development of the many biopharmaceutical start ups. Nonetheless the business models of these smaller companies have many weaknesses, which have led to the erosion of the value of
their initial strategic assets. Despite the poor financial performance of the vast majority of these firms, the biopharmaceutical sector as a whole has created significant value. This has been captured disproportionately by a handful of large fully integrated biopharmaceutical firms and, to a lesser extent, by the largest dozen pharmaceutical firms.
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Rolan, Paul Edward. "The exploratory clinical development of tucaresol, an antisickling agent, using a novel surrogate marker /." Title page, contents and abstract only, 1995. http://web4.library.adelaide.edu.au/theses/09M.D/09m.dr744.pdf.
Full textAbstract:
Thesis (M.D.)--University of Adelaide, Dept of Clinical and Experimental Pharmacology, 1995.Copies of author's previously published articles inserted. Describes the exploratory clinical development of tucaresol, consisting of three studies performed on humans and subsequent in vitro and animal studies investigating the possible effects on the immune system. Demostrates that rational drug design may be an efficient way of selecting potential therapeutic candidates.
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Swarna, Kailash 1963. "The evaluation of system-wide financial incentives in pipeline decisions in the pharmaceutical and biotechnology industry : the paradox of R&D spend Vs. new drug approvals." Thesis, Massachusetts Institute of Technology, 2012. http://hdl.handle.net/1721.1/72888.
Full textAbstract:
Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management, 2012.Cataloged from PDF version of thesis.
Includes bibliographical references (p. 98-102).
For several decades, the ascendancy of the Pharma & Biotech sector was largely driven by favorable macro-economic conditions combined with an astonishing level of innovation and a clear focus on addressing unmet medical needs. Significant R&D investments led to innovative drugs that changed clinical practice across multiple illnesses and contributed to an overall rise in life expectancy around the world. Unfortunately, this trend has not continued. Since the mid-90s', the approval of novel drugs has plummeted despite record levels of R&D investment. It is estimated that between 2000 and 2010, the top 10 global Pharma and Biotech companies have collectively invested over $500 Billion in R&D. In the same period, only about 150 novel drugs entered the market. This is partly explained by the fact that quick-wins have been harvested, and that further progress in treating grievous illness is harder to achieve. This is compounded by increasing concerns about the longterm safety of drugs and the conservative regulatory climate that has prevailed since 2000. In this challenging regulatory and cost environment, the basic economic model of the industry is now being questioned. In this work I review the recent financial performance of ten major global pharmaceutical companies, and the challenges faced by the industry in moving from a deterministic, blockbuster era to a more stochastic era defined by multiple unknowns.
by Kailash Swarna.
M.B.A.
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Guezguez, Hella. "Innovations et alliances stratégiques : une analyse en termes d'intégration des connaissances appliquée à l'industrie bio-pharmaceutique." Phd thesis, Université Nice Sophia Antipolis, 2013. http://tel.archives-ouvertes.fr/tel-00932410.
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En prenant pour point de départ l'émergence de technologies nouvelles, ce travail s'interroge sur la capacité des acteurs d'une industrie à réorganiser leurs bases de connaissances. Dans ce but, nous nous intéressons aux processus d'intégration des connaissances que nous définissons comme la recherche de complémentarité technologique dans les bases de connaissances des acteurs engagées dans des processus d'innovation. Dans un environnement technologique donné, larecherches de complémentarité technologique définit la recherche des combinaisons technologiques les plus productives. Deux angles de recherche sont ainsi privilégiés : les processus d'intégration intra-organisationnelle des connaissances et les processus d'intégration inter-organisationnelle des connaissances. Appliqué à l'étude des biotechnologies et de l'industrie pharmaceutique, ce travail de nature économétrique mobilisant des bases de données innovations, brevets et alliancesnous permet d'avancer deux principaux résultats. Dans le cadre des processus d'intégration intra-organisationnelle des connaissances, nous montrons que la recherche de complémentarité technologique est déterminée par la détention de connaissances fondamentales qui favorise la capacité des firmes à combiner leurs savoirs et par conséquent leur capacité à innover. Dans le cadre des processus d'intégration inter-organisationnelle des connaissances, nous montrons que la recherche de complémentarité technologique détermine le choix pour les acteurs d'une industrie de former une alliance stratégique et que cette recherche de complémentarité technologique évolue tout au long du cycle de vie de la technologie
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Rivas, Santos Pep. "Design and synthesis of engineered peptides to target undruggable PPIs: from in silico to in vitro studies." Doctoral thesis, Universitat de Barcelona, 2019. http://hdl.handle.net/10803/668150.
Full textAbstract:
Major unsolved diseases such as Cancer, cardiopathies or neurodegenerative disorders are frequently related with the malunction of complex protein networks. These networks are integrated by the interaction of multiple proteins that in case of a misregulation can trigger an undesired effect. Therefore, disruption of protein-protein interactions (PPIs), that are involucrated in a protein signalling cascade which is relevant for a particular diseases, is a hot topic in pharmaceutical industry. Unfortunately, traditional small molecules have been found to not be the most suitable inhibitiors of these therapeutic targets as PPI interfaces are characterized by a flat area with a lack of cavities that can fit a small molecule.
In this scenario, peptides has called the attention in the drug discovery field for be a more appropiate candidates to target PPIs. Peptides are found in the chemical space between small molecules and antibodies, usullay contain between 2-50 amino acids and have an approximated weight of 250-10.000 Da. Then, their medium size allows a efficient recognition of the target protein without the need of well formed cavieties on the protein surface. However, peptides are characterized by a poor permeability and low stability in blood stream which had limited their therapeutic application in the past. Opportunately, introduction of non-natural amino acids and D-amino acids, N-alkylations of peptide backbone, cyclization and N-terminal and C-terminal modified cappings improve the biophysical properties along with the affinity for the receptor protein.
Then, the use of engineered peptides, so-called peptidomimetics, is a promissing approach to target PPIs that can improve the binding potency of natural peptides and overcoming their major drawbacks at the same time.
This thesis was carried out at Iproteos, a biotech company positioned in the use of peptidomimetics to target intracellular PPIs. The company has developed an in-house technology coined IPROTech, which is a platform that applys different in silico tools that are focused in the design of peptidomimetics, which are synthesized manually, quantified and finally evaluated in vitro. The experimental results are reintroduced in the platform and the process is repeated iteratively until achieve a final lead candidate.
Hence, in the present work, IPROTech was applied to found de novo peptidomimetic molecules that inhibit the interaction of 4 different PPIs that are considered of therapeutic importance, Talin- Vinculin (Cancer), Rad51-BRCA2 (Cancer), Ras-Effectors (Cancer) and Retromer-L2 (HPVs infection). For each PPI, a collabration project with an academic group expert in field was setted up. Iproteos was in charge of the in silico studies of the target protein in order to design and synthesized a set peptidomimetic sequences that were predicted to disrupt the PPI of interest. On the other hand, the collaborators were responsible of the experimental evualtion of the synthesized compounds.
In this terms, at least 1 hit was found for each PPI when evaluated in vitro, demonstrating an outsanding overall succes-rate of 31 % when all synthesized peptidomimetics were evaluated in vitro. Additinoally, the inclusion of new fancy builduing blocks into the compounds sintheysis, N-alkylation of the peptidomimetics backbone, pearmeability across biological barriers or the use of cyclodextrins as solvating excipient were other points studied as well.Trobar nous fàrmacs capaços de trencar interaccions proteïna-proteïna, que d’alguna manera estan involucrades amb una malaltia, és de gran interès en el camp de la indústria farmacèutica. No obstant això, aquest tipus de diana terapèutica normalment no presenten cap cavitat ben definida a la seva superfície, característica necessària per albergar les tradicionals molècules petites. Per aquest motiu, la utilització de pèptids com a possibles fàrmacs és una aproximació molt prometedora perquè en tenir una mida molecular superior poden establir més interaccions amb la proteïna receptora afavorint així la seva unió. Però, aquesta aproximació està limitada per les propietats bioquímiques dels pèptids, ja que normalment són poc permeables i amb una baixa estabilitat un cop administrats. Afortunadament, els avanços fets en la síntesi de pèptids ha permès afegir modificacions sobre la seqüència dels pèptids per tal de millora les seves propietats, això inclou amino àcids no naturals, N-alquilacions, diferent tipus de N-terminals i C-terminals, entre altres. Els compostos obtinguts quan s’aplica aquesta enginyeria es coneixen com a peptidomimetics. Aquesta tesi es va realitzar a Iproteos. Iproteos és una petita empresa biotecnològica, focalitzada en l’ús de peptidomimetics per tal d’inhibir IPPs relacionades amb alguna malaltia. Per fer possible aquesta tasca, Iproteos ha creat una tecnologia, IPROTech, que agrupa tècniques computacionals per tal de cribrar la proteïna d’interès i genera estructures peptidometiques que més tard són sintetitzades, purificades i quantificades. Per aquesta tesi, es va aplicar la tecnologia IPROTech per trobar peptidomimetics amb la capacitat d’inhibir quatre IPP de rellevància terapèutica, Talina-Vinculina (càncer), Rad51- BRCA2 (càncer), Ras-Effectors (càncer) i Retromer-L2 (HPVs). Per cadascuna d’aquestes dianes, a Iproteos es va realitzar els estudis in silico i la síntesi dels peptidomimetics mentre que l'avaluació experimental la van fer grups acadèmics experts en cada camp. En tots els casos es va trobar almenys un compost capaç de trencar amb la interacció. Addicionalment propietats com la solubilitat, permeabilitat o estabilitat van ser avaluades per aquells compostos actius. Finalment, gràcies a les dades generades, alguns d’aquests compostos es van poder optimitzar obtenint un candidat final més potent encara.
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Santos, Luciana Fernandes Silva. "Catequina e epicatequina minimizam a toxicidade induzida pela amiodarona em fibroblasto de pulmão humano (MRC-5)." reponame:Repositório Institucional da UCS, 2015. https://repositorio.ucs.br/handle/11338/1083.
Full textAbstract:
A amiodarona é um dos fármacos mais usados para o tratamento de arritmias cardíacas, tanto ventriculares como supraventriculares. Apesar de sua eficácia, o uso da amiodarona está associado a vários efeitos adversos, incluindo a toxicidade pulmonar. O mecanismo pelo qual a amiodarona causa lesão nas células pulmonares humanas não é inteiramente conhecido, mas estudos em cultura de células hepáticas humanas e pulmonares de ratos têm sugerido que a disfunção mitocondrial e o estresse oxidativo têm um papel importante na citotoxicidade da amiodarona. Os compostos fenólicos, incluindo catequina e epicatequina são amplamente distribuídos na natureza e conhecidos por sua capacidade de reduzir o estresse oxidativo. Além disso, alguns compostos fenólicos são capazes de modular a atividade mitocondrial. Em vista disso, o objetivo deste trabalho foi avaliar a capacidade dos compostos fenólicos catequina e epicatequina em a disfunção mitocondrial e os danos oxidativos causados pela amiodarona em células de fibroblasto de pulmão humano (MRC-5). Para atingir os objetivos as células MRC-5 foram tratadas com diferentes concentrações de catequina e epicatequina e após foram expostas a amiodarona 100 μM. A disfunção mitocondrial foi determinada através da atividade do complexo I da cadeia de transporte de elétrons e a biossíntese de ATP usando kits específicos. A viabilidade celular foi avaliada através do ensaio de 3-[4,5- dimetiltiazol 2-il]-2,5 difenil brometo de tetrazolina. A atividade das enzimas superóxido dismutase e catalase foram determinadas espectrofotometricamente. Os danos oxidativos a lipídeos e proteínas foram verificados através dos ensaios de substâncias reativas ao acido tiobarbitúrico e a proteínas carboniladas, respectivamente, e os níveis de óxido nítrico foram avaliados usando o método de Griess. Os resultados mostraram que a amiodarona inibiu a atividade do complexo I da cadeia de transporte de elétrons em 53% e a biossíntese de ATP em 9,5% e tanto a catequina como a epicatequina foram capazes de evitar estes efeitos em todas as concentrações (5, 10, 20 μM) testadas. Verificou-se que a amiodarona reduziu a atividade das enzimas superóxido dismutase e catalase (indicando produção de superóxido e peróxido de hidrogênio) e aumentou os danos oxidativos a lipídeos e proteínas. Os compostos fenólicos catequina e epicatequina foram capazes de minimizar as alterações no metabolismo redox induzidos pela amiodarona e aumentar a viabilidade nas células MRC-5. Catequina e epicatequina reduziram a depleção de óxido nítrico causada pela amiodarona. Este trabalho mostrou, pela primeira vez, que o mecanismo de toxicidade da amiodarona em células MRC-5 está associado à disfunção mitocondrial, principal causa de geração de dano oxidativo celular e que estes efeitos tóxicos são em parte reduzidos pela catequina e epicatequina. Embora outros estudos sejam necessários, estes dados abrem novas perspectivas para estudos visando o desenvolvimento de medicamentos que minimizem os efeitos tóxicos da amiodarona.Submitted by Ana Guimarães Pereira (agpereir@ucs.br) on 2015-12-09T15:32:21Z No. of bitstreams: 1 Dissertacao Luciana Fernandes Silva Santos.pdf: 1790981 bytes, checksum: 4f3e8dbb7bc255b525503174b7e1a3d2 (MD5)
Made available in DSpace on 2015-12-09T15:32:21Z (GMT). No. of bitstreams: 1 Dissertacao Luciana Fernandes Silva Santos.pdf: 1790981 bytes, checksum: 4f3e8dbb7bc255b525503174b7e1a3d2 (MD5)
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior, CAPES.
Amiodarone is among the most widely used drugs for the treatment of ventricular and supraventricular cardiac arrhythmias. However, the use of amiodarone is associated with several side effects including pulmonary toxicity. The mechanism of amiodarone toxicity is not well known, but studies in human liver cells and rats lung cells have been suggested that mitochondrial dysfunction and oxidative stress play important role in the amiodarone cytotoxicity. Phenolic compounds, including catechin and epicatechin are widespread in nature and known for their ability to reduce oxidative stress. In addition, some phenolic compounds are able to modulate mitochondrial activity. Therefore, the objective of this study was to evaluate the ability of phenolic compounds catechin and epicatechin to minimize the mitochondrial dysfunction and oxidative damage induced by amiodarone in human lung fibroblast cells (MRC-5). To achieve the objectives, MRC-5 cells were treated with different concentrations of catechin and epicatechin and then amiodarone 100 μM. Mitochondrial dysfunction was determined by the activity of complex I of the electron transport chain and ATP biosynthesis using specific kits. Cell viability was assessed by 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide assay. The activity of the enzymes superoxide dismutase and catalase were determined spectrophotometrically. The oxidative damage to lipids and proteins have been verified through the test substances reactive to the thiobarbituric acid and carbonyl protein, respectively, and nitric oxide levels were evaluated using the Griess method. The results showed that amiodarone inhibit 53% of the activity of complex I of the electron transport chain and 9.5% of ATP biosynthesis and both catechin and epicatechin were able to avoid these effects in all concentrations (5 10, 20 mM) tested. It was found that amiodarone reduced the superoxide dismutase and catalase activities (indicating the production of radicals superoxide and hydrogen peroxide) and increased oxidative damage to lipids and proteins. Phenolic compounds catechin and epicatechin were able to minimize alterations in the redox metabolism and increase in viability of MRC-5 cells. Furthermore, catechin and epicatechin reduced nitric oxide depletion caused by amiodarone. This study showed, for the first time, that toxicity of amiodarone in human lung cultured cells is associated, at least, in part, with mitochondrial dysfunction which was avoided by catechin and epicatechin. Although further studies are needed, these data open new perspectives for studies aiming the development of drugs that minimize the toxic effects of amiodarone.
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Einarsson, Ellen. "Evaluation of 5´- and 3´-UTR Translation Enhancing Sequences to Improve Translation of Proteins in CHO Cells." Thesis, Linköpings universitet, Teknisk biologi, 2018. http://urn.kb.se/resolve?urn=urn:nbn:se:liu:diva-150363.
Full textAbstract:
The purpose of this project was to identify and evaluate nucleotide sequences enhancing translation of proteins in Chinese hamster ovary (CHO) cells. Candidate sequences were placed in the 5´-untranslated region (UTR) or 3´ UTR respectively and evaluated in a CHO-based expression system with a fluorescent Fc-fusion protein as a model protein.Five plasmid vectors were constructed, two of which designed to have a randomized nucleotide library in their 5´ and 3´ UTR respectively, and three of which designed to hold varying repeats of a known enhancing translation (ET) sequence in their 5´ or 3´ UTR. The plasmid constructs were transfected into CHO cells and the protein expression was analyzed both by fluorescence intensity in single cells using flow cytometry and in bulk by monoclonal antibody titer analysis based on Protein A affinity.The main result is that both flow cytometry and titer analysis indicate that insertion of five repeats of the ET in the 5´UTR has a negative effect on protein expression as compared to the control which had no ET repeats. Results related to the insertion of three ETs in the 5´ UTR were ambiguous. The titer analysis indicated that it had a negative effect on the protein expression compared to the control which had no ET repeats, whereas the flow cytometry results suggest that the effect is negligible. Transfection of library plasmids was unsuccessful; hence no library expression analysis results were achieved. Due to the time constraints of the project, the reason for the unsuccessful transfection of library plasmids was not investigated, but the LTX transfection method is stated as a highly plausible cause.Based on the outcome of this study, two recommendations for future work are suggested. The first one is to continue the focus on UTR sequences in terms of library screening, and to improve the method of transfecting library plasmid constructs into CHO cells using lipofection. The second suggestion for further studies is to test different UTR sequence lengths without involving potential ETs, to rule out the effect and positions of the ETs and investigate the expressional effect of UTR length solely.
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Capão, Pedro Tiago Madeira Esteves Canteiro. "Barreiras na Difusão de Inovação Biofarmacêutica." Master's thesis, Instituto Superior de Economia e Gestão, 2010. http://hdl.handle.net/10400.5/3728.
Full textAbstract:
Mestrado em Economia e Gestão de Ciência Tecnologia e InovaçãoA biotecnologia farmacêutica tem provocado algumas desilusões quanto aos resultados produzidos nos últimos anos. As primeiras descobertas, nomeadamente de técnicas como o ADN recombinante, faziam prever uma revolução na saúde das populações mas o que se regista hoje é uma biotecnologia ainda dominada pela tecnologia química anterior, representando apenas 10% do mercado farmacêutico e sem conseguir atingir as patologias com maior prevalência. As principais causas do atraso do sucesso da biotecnologia farmacêutica podem estar em diversas fases do percurso do medicamento, desde a investigação de novos alvos terapêuticos e novos princípios activos até à difusão dos novos medicamentos no mercado. Este estudo foca o processo de difusão de inovações biofarmacêuticas em Portugal e as barreiras que possam existir no acesso óptimo dos doentes a estas terapêuticas. Para isso recorreu-se a uma recolha de dados primários através de inquérito a um painel de peritos de diversas áreas de especialidade directamente relacionadas com produtos farmacêuticos biotecnológicos. As questões incidiram sobre seis temas de possíveis barreiras na difusão de inovações biofarmacêuticas: oferta, regulamentação, distribuição, prescrição, administração e segurança. A análise dos dados recolhidos permitiu concluir que existem barreiras na difusão de inovações biofarmacêuticas em Portugal. As barreiras identificadas como as mais relevantes assentam nas características da oferta dos produtos inovadores, o preço elevado e a oferta para poucas indicações terapêuticas. Os resultados também revelaram uma dicotomia entre maior segurança e melhor acessibilidade presente também na regulamentação farmacêutica portuguesa que incute regimes de exclusividade e heterogeneidade na disponibilidade e acesso de doentes a estas inovações com consequências também nas práticas de prescrição. Por fim, conclui-se que o mercado ainda não está completamente preparado para receber a biotecnologia como tecnologia farmacêutica dominante devido, principalmente, à complexidade da biotecnologia e aos investimentos na reorganização de processos e desenvolvimento de tecnologias complementares necessários para a mudança do paradigma tecnológico farmacêutico.
Pharmaceutical biotechnology has became a disappointment about the results produced. Early findings, such as recombinant DNA techniques, did predict a revolution in health however, biotechnology is still dominated by the old pharmaceutical chemical technology, representing only 10% of the pharmaceutical market and unable to reach the most prevalent diseases. The main causes for the delay of biopharmaceuticals success can be present in various stages of the medicine path, from new therapeutic targets and new active ingredients research to the market diffusion of these new drugs. This study focuses on the process of diffusion of biopharmaceutical innovations in Portugal and the barriers that may exist in patients optimal access to these therapies. To pursue this, it was used a primary data collection through a survey applied to a panel of experts from different areas of expertise directly related to pharmaceutical biotechnology. The questions were about six main themes of probable barriers in the biopharmaceutical innovation diffusion: supply, regulation, distribution, prescription, administration and safety. Analysis of the collected data showed that there are barriers in the diffusion of biopharmaceutical innovations. The most important barriers identified were based on the supply characteristics of the innovative products, high price and few therapeutic indications. The results also revealed a dichotomy between greater safety and improved accessibility also present in the Portuguese pharmaceutical regulation based on exclusivity and heterogeneity regimes in the availability and access to these innovations with consequences on prescription practices. Finally, we conclude that the market is not yet fully prepared to receive biotechnology as the dominant pharmaceutical technology, mainly due to the complexity of biotechnology and the investments in process reorganization and complementary technologies development required for changing the pharmaceutical technological paradigm.
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Lu, Qiang. "Potent short-chain fatty acid-based histone deacetylase inhibitors as anti-tumor agents." Connect to resource, 2005. http://rave.ohiolink.edu/etdc/view?acc%5Fnum=osu1117541292.
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Thesis (Ph. D.)--Ohio State University, 2005.Title from first page of PDF file. Document formatted into pages; contains xix, 116 p.; also includes graphics. Includes bibliographical references (p. 106-116). Available online via OhioLINK's ETD Center
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Costa, Magnólia Maria Almeida dos Santos. "I & D e inovação na indústria farmacêutica : o caso português." Master's thesis, Instituto Superior de Economia e Gestão, 1998. http://hdl.handle.net/10400.5/18810.
Full textAbstract:
Mestrado em Economiae e Gestão de Ciência e TecnologiaA evolução da indústria farmacêutica nas últimas décadas, embora integrando-se no quadro de desenvolvimento global da economia, preserva a sua própria autonomia, devido ao carácter eminentemente social, traduzível nos seus objectivos de combate à doença e à morte, bem como de busca progressiva do bem estar físico e psíquico da humanidade. E porque nesse domínio, nada é imutável, o grau crescente de exigência quanto a níveis de qualidade, de eficácia e de segurança no sector implica uma postura dinâmica e criativa do lado da oferta. Neste contexto, a I&D e a Inovação têm sido importantes motores da indústria farmacêutica, processos em que a dimensão imaterial predomina, influenciando o comportamento dos demais factores das actividades inovadoras. Assim, este estudo tem como âmbito a indústria farmacêutica, num contexto de globalização económica, com incidência nos vectores de l&D e de Inovação e como objectivo responder fundamentalmente a duas questões: i) Num sector em que a Inovação e a l&D são essenciais, como é o caso da indústria farmacêutica, saber qual a influência da procura, e designadamente a do consumidor final, no seu desenvolvimento; ii) na identificação do desempenho das empresas de pequena dimensão e das empresas de grande dimensão, quais as relações, de complementaridade ou de predominância, que se estabelecem entre elas no quadro da l&D e da Inovação farmacêuticas. Para responder a estas questões recorremos à revisão da literatura conhecida, que complementámos com a análise empírica de casos relativos a empresas farmacêuticas, nacionais e estrangeiras, implantadas em território português.
The evolution of the pharmaceutical industry in the last decades, although integrated in the general frame of economical development, preserves its own autonomy, owing to the eminent social nature of its objectives of action against desease and death and of progressivo search for human physical and psychic well-being. Because on this realm nothing is unchangeable, the growing dregree of exigency as to the leveis of quality, efficiency and security in the sector implies a dynamic and creative approach from the supply side. Therefore, Research and Development and Innovation have been important motors of the pharmaceutical industry, as processes where the immaterial dimension prevails and exerts influence upon the behaviour of the other factors related to the innovating activities. Consequently, the scope of the present work is the pharmaceutical industry, in a context of economical globalization, with emphasis on the R&D and Innovation vectors, being its main objective the answer to two fundamental questions: 1) In a sector where Innovation and R&D, are essential, as it is the case of the pharmaceutical industry, to know the influence that the demand, and particularly the final consummer, may exercise on its development; 2) when identifying the performance of small and big companies, what kind of complementary and/or predominance relations are established among them within the ambit of R&D and pharmaceutical innovation. In order to answer these questions, we proceeded to the re- examining of known literature, which we completed with the empirical analisys of cases related to pharmaceutical companies, both national and foreign, operating in Portugal.
info:eu-repo/semantics/publishedVersion
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Umeda, Aiko. "Studies in pharmaceutical biotechnology : protein-protein interactions and beyond." Thesis, 2011. http://hdl.handle.net/2152/ETD-UT-2011-05-3045.
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Pharmaceutical biotechnology has been emerging as a defined, increasingly important area of science dedicated to the discovery and delivery of drugs and therapies for the treatment of various human diseases. In contrast to the advancement in pharmaceutical biotechnology, current drug discovery efforts are facing unprecedented challenges. Difficulties in identifying novel drug targets and developing effective and safe drugs are closely related to the complexity of the network of interacting human proteins. Protein-protein interactions mediate virtually all cellular processes. Therefore both identification and understanding of protein-protein interactions are essential to the process of deciphering disease mechanisms and developing treatments. Unfortunately, our current knowledge and understanding of the human interactome is largely incomplete. Most of the unknown protein-protein interactions are expected to be weak and/or transient, hence are not easily identified. These unknown or uncharacterized interactions could affect the efficacy and toxicity of drug candidates, contributing to the high rate of failure. In an attempt to facilitate the ongoing efforts in drug discovery, we describe herein a series of novel methods and their applications addressing the broad topic of protein-protein interactions. We have developed a highly efficient site-specific protein cross-linking technology mediated by the genetically incorporated non-canonical amino acid L-DOPA to facilitate the identification and characterization of weak protein-protein interactions. We also established a protocol to incorporate L-DOPA into proteins in mammalian cells to enable in vivo site-specific protein cross-kinking. We then applied the DOPA-mediated cross-linking methodology to design a protein probe which can potentially serve as a diagnostic tool or a modulator of protein-protein interactions in vivo. To deliver such engineered proteins or other bioanalytical reagents into single live cells, we established a laser-assisted cellular nano-surgery protocol which would enable detailed observations of cell-to-cell variability and communication. Finally we investigated a possible experimental scheme to genetically evolve a fluorescent peptide, which has tremendous potential as a tool in cellular imaging and dynamic observation of protein-protein interactions in vivo. We aim to contribute to the discovery and development of new drugs and eventually to the overall health of our society by adding the technology above to the array of currently available bioanalytical tools.text
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TSAI, CHIA-CHUN, and 蔡佳純. "An Application of Real Option to Pharmaceutical Biotechnology Industry." Thesis, 2003. http://ndltd.ncl.edu.tw/handle/61792328454256527223.
Full textAbstract:
碩士國立臺灣科技大學
企業管理系
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A great deal of effort has been made on real option pricing. What seems to be lacking, however, is an application with numbers for executives to value whole projects to their industry. The pharmaceutical biotechnology industry is a high-return combined high uncertainty industry, in which, companies must have significant valuations long before they earn any profits from selling their products. There is a general agreement that using a real option pricing theory will catch the flexibility value in this kind of industry. This paper is intended as a valuation to whole new-drug development project by Merton’s jump diffusion model and binomial method. We use the characteristics of successful probability in new-drug development process to divide the option pricing into two stages.
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Schneider, Amelie Teresa. "Mergers & acquisitions : pharmaceutical and biotechnology sector case study." Master's thesis, 2015. http://hdl.handle.net/10400.14/22087.
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A glance at the worldwide M&A activity of pharmaceutical companies tells us that consolidation within this sector has not been reached and won’t be soon. The trend of acquiring small biotech start-ups with promising research pipelines is essential for big pharmas to survive their highly competitive sector. Additionally, the global population is rapidly aging and hence, age-related diseases like Alzheimer Disease (AD) will increase and, with them, the need for treatments will rise. Therefore, big pharmaceutical companies need to strengthen their product pipelines with efficient, innovative market-disrupting solutions.
For Roche, one of the world’s largest pharmaceuticals, the need to enhance their neuroscience product pipeline has recently increased, due to the failure in passing Phase III of its most promising AD drug in 2014. To “solve” this issue, this work provides a detailed evaluation of a potential M&A deal between Roche and the small German biotech Probiodrug, which, through an innovative approach, created a highly promising AD product, currently in Phase II. With successful approval of this product this deal will provide Roche with an increase in future sales and gives more potential for further research.
This work argues that Roche should make an offer with a 41% premium over todays share price, which is equal to EUR 29,78 per share. The total deal value will be EUR 202 mm and paid 100% in cash. Considering the possible synergy creation of the acquisition, in negotiations the total offer price might range from 41% up to 120% over the current share price.
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Canelas, Francisco Manuel Lourenço Prates. "Stochastic methods applied in the pharmaceutical and biotechnology sector." Master's thesis, 2021. http://hdl.handle.net/10400.14/35806.
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This paper evaluates the efficiency of a stochastic approach called Arithmetic Brownian Motion in the pharmaceutical sector. This method allows us to assess companies accurately, deciding whether they are undervalued or overvalued. Through some literature review, I concluded the strengths of using this method when evaluating companies, as it can also incorporate multiple risks when comparing with the Geometric Brownian Motion. This thesis provides a reliable prediction of the pharmaceutical companies, as I evaluate more than one Company and compare my results with some specialists. Also, I consider some robustness tests to check other scenarios in my forecasting. These tests provide evidence about similarities in the capital structure from American pharma/biotech companies, while Europeans differ when comparing the results.Esta tese avalia a eficiência de um método estocástico chamado Airthmetic Brownian Motion no setor farmacêutico. Este método permite-nos aferir empresas eficientemente, decidindo se elas estão desvalorizadas ou sobrevalorizadas. Através de alguma revisão de literatura, eu concluí as valências de usar este método quando se trata de avaliar empresas, sendo que é capaz de incorporar inúmeros riscos quando comparamos com o Geometric Brownian Motion. Esta tese proporciona uma previsão eficiente das farmacêuticas ao passo que avalio mais que uma e comparo os meus resultados com alguns especialistas. Para além do mais, eu elaborei alguns testes de robustez para estudar outros cenários no meu exercício de previsão. Estes testes proporcionam evidência acerca de algumas semelhanças na estrutura de capital de farmacêuticas/biotecnológicas americanas, enquanto as europeias diferem quando comparados os resultados finais.