Journal articles: 'Pharmaceutical industry Australia Evaluation'

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Buxton, Meredith, Brian Alexander, Donald Berry, Webster Cavenee, Howard Colman, John de Groot, Benjamin Ellingson, et al. "CTNI-38. UPDATE ON GBM AGILE: A GLOBAL, PHASE 2/3 ADAPTIVE PLATFORM TRIAL TO EVALUATE MULTIPLE REGIMENS IN NEWLY DIAGNOSED AND RECURRENT GLIOBLASTOMA." Neuro-Oncology 24, Supplement_7 (November 1, 2022): vii80. http://dx.doi.org/10.1093/neuonc/noac209.303.

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Abstract BACKGROUND GBM AGILE (Glioblastoma Adaptive, Global, Innovative Learning Environment) is a biomarker based, multi-arm, international, seamless Phase 2/3 response adaptive randomization platform trial designed to rapidly identify experimental therapies that improve overall survival and confirm efficacious experimental therapies and associated biomarker signatures to support new drug approvals and registration. GBM AGILE is a collaboration between academic investigators, patient organizations and industry to support new drug applications for newly diagnosed and recurrent GBM. METHODS The primary objective of GBM AGILE is to identify therapies that effectively improve the overall survival in patients with ND or recurrent GBM. Bayesian response adaptive randomization is used within subtypes of the disease to assign participants to investigational arms based on their performance. Operating under a Master Protocol, GBM AGILE allows multiple drugs from different pharmaceutical/biotech companies to be evaluated simultaneously and/or over time against a common control. New experimental therapies are added as information about promising new drugs is identified while therapies are removed as they complete their evaluation. The master protocol/ trial infrastructure includes efficiencies through an adaptive trial design, shared control arm and operational processes to serve the goal of helping patients receive optimal care in a fast and efficient manner. GBM AGILE has screened over 1200 patients and enrollment rates are 3 to 4 times greater than traditional GBM trials, with active sites averaging 0.75 to 1 patients/sites/month. There are 41 active sites in the US, 4 active sites in Canada and 3 active sites in Europe with more sites anticipated to open across 5 countries in Europe. Expansion to China and Australia are under progress. Through the use of improved and flexible processes, GBM AGILE serves as a global trial that supports the efficient and rapid incorporation and evaluation of new experimental therapies for patients with GBM.Clinical trial information: NCT03970447.

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Buxton, Meredith Becker, Brian Michael Alexander, Donald A. Berry, Webster K. Cavenee, Howard Colman, John Frederick De Groot, Benjamin M. Ellingson, et al. "GBM AGILE: A global, phase II/III adaptive platform trial to evaluate multiple regimens in newly diagnosed and recurrent glioblastoma." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): TPS2579. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.tps2579.

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TPS2579 Background: Glioblastoma (GBM) is an aggressive brain tumor with few effective therapies and is invariably fatal. Developing new therapies for patients with GBM requires focused interaction between industry, academia, nonprofits, patient advocacy, and health authorities, and novel approaches to clinical trials. Industry is wary of developing drugs for GBM due to the high failure rate and high cost of drug development. GBM Adaptive Global Innovative Learning Environment (GBM AGILE) Trial was designed by over 130 global key opinion leaders in consultation with health authorities to provide an optimal mechanism for phase II/III development in GBM. The Sponsor of GBM AGILE is the Global Coalition for Adaptive Research (GCAR), a non-profit organization. GCAR’s mission is to speed the discovery and development of treatments for patients with rare and deadly diseases by serving as sponsor of innovative trials. Methods: GBM AGILE is an international, seamless phase II/III platform trial designed to evaluate multiple therapies in newly diagnosed and recurrent GBM. Its goals are to identify effective therapies for GBM and match effective therapies with patient subtypes, with data generated to support regulatory filing for new drug applications. Bayesian response adaptive randomization is used within subtypes of the disease to assign participants to investigational arms based on their performance. The primary endpoint is overall survival. The trial is being conducted under a master Investigational New Drug Application/Clinical Trial Agreement and Master Protocol, allowing multiple drugs/drug combinations from different pharmaceutical companies to be evaluated simultaneously and/or over time. The plan is to add experimental therapies as new information is identified and remove therapies as they complete their individual evaluation against a common control. GBM AGILE received IND approval from the FDA in April 2019, enrolling its first patient in June 2019. Site activation is ongoing in the US, with approximately 40 US planned. The trial received CTA approval from Health Canada in January 2020. Expansion to Europe, China, and Australia is also underway. Clinical trial information: NCT03970447 .

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Wu, Allan Ya-Huan, Victoria Janine Little, and Brian Low. "Inbound open innovation for pharmaceutical markets: a case study of an anti-diabetic drug in-licensing decision." Journal of Business & Industrial Marketing 31, no. 2 (March 7, 2016): 205–18. http://dx.doi.org/10.1108/jbim-10-2013-0236.

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Purpose – This paper aims to increase understanding of how firms can more effectively identify valuable and profitable innovations in the pharmaceutical industry and to identify the issues and challenges posed by current managerial decision-making practices. Design/methodology/approach – A case study of a single project is presented: a drug in-licensing decision made by a team of three managers in a large Australian pharmaceutical firm. Using participant-observation, interviews and archival analysis, the authors followed the managers as they identified and evaluated 122 late-stage anti-diabetic drug variants for further development. Findings – The managers used decision heuristics to arrive at a short list of three drugs from a choice set of 122. While the process was ostensibly rational and systematic, there was evidence of data quality issues, misleading mental models and cognitive bias. The authors concluded a high probability of accepting a poor candidate or rejecting a stronger candidate (i.e. making Type I and II errors). Research limitations/implications – This paper focuses on initial market and technology evaluation stage only (i.e. not commercialization) and is a single case study design; therefore, care should be taken in generalizing to other decisions or other contexts. This paper highlights the need for further research integrating organizational decision-making and open innovation from a multi-disciplinary perspective. Practical/implications – This paper raises awareness of potential decision-making pitfalls and includes a detailed audit framework to support improved managerial decision processes and double rather than single loop learning. Social/implications – The findings support better decision-making and therefore supports higher quality drug selection and development, leading to improved population health outcomes. Originality/value – Multi-disciplinary, draws attention of marketing and new product development scholars to open innovation research. It adds to knowledge about open innovation practices at the project level. It also provides an extended model of market opportunity analysis for high technology markets.

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Raycheva, Ralitsa, and Rumen Stefanov. "VP81 Health Technology Assessment And Rare Disease Decision Making: Focus On Orphan Drugs." International Journal of Technology Assessment in Health Care 33, S1 (2017): 186–87. http://dx.doi.org/10.1017/s0266462317003518.

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INTRODUCTION:Health Technology Assessment (HTA) is applied to determine the value of innovative technologies. It usually relies on robust assessment of the clinical cost-effectiveness of the technology, while clinical and economic evidence required for this purpose are often not available for orphan drugs (OD) (1,2). The objective of the study is to undertake a systematic comparison between HTA agencies worldwide in order to identify similarities and differences in the methods and processes in HTA of OD.METHODS:A cross-sectional web-based survey was conducted between September 2013 and May 2015. The data were obtained from a semi-structured questionnaire. We received responces from 161 HTA organizations based in 39 countries.RESULTS:HTA of OD is performed by agencies in South America (38.5 percent), followed by agencies in Australia (37.5 percent) and Europe (36.1 percent). The agencies in high income countries produce more assessments of OD (36.8 percent), which in 31.2 percent they determine as innovative technologies compared with 11.8 percent of the units based in low income countries and active in OD assessment (11.1 percent). We prove association (p< .05) between (i) the type of HTA and income per capita; the level at which the organization operates; its main activity; and the level of recommendation dissemination; (ii) the main target group and consumers of the final HTA product; the stage of evolution of the technology, on which it is likely to be assessed; and approaches to identify innovative technologies. The most active in the preparation of HTA reports are biomedical companies or other organizations in the private sector (50.0 percent) and organizations in the pharmaceutical and/or medical industry (66.7 percent). HTA bodies that assess OD develop (36.0 percent) and distribute recommendations (35.9 percent) nationally; their main activity is to produce guidelines for good clinical practice (46.9 percent). Agencies that perform OD assessment are active in evaluation of innovative (37.2 percent) and emerging (35.9 percent) technologies, which are able to be identified by developing early warning systems (32.0 percent).CONCLUSIONS:Making coverage decisions based on HTA recommendations control the technologies introduction into the healthcare system, that is why it's very important that this tool is properly adjusted to the specific needs of OD assessment (3).

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Weller, M., B. Ellingson, B. Alexander, P. Wen, E. Sulman, H. Colman, D. Berry, et al. "P11.65.B GBM AGILE: A global, phase 2/3 adaptive platform trial to evaluate multiple treatment regimens in newly diagnosed and recurrent glioblastoma." Neuro-Oncology 24, Supplement_2 (September 1, 2022): ii73. http://dx.doi.org/10.1093/neuonc/noac174.254.

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Abstract Background GBM AGILE (Glioblastoma Adaptive, Global, Innovative Learning Environment) is a biomarker based, multi-arm, international, seamless Phase 2/3 Response Adaptive Randomization platform trial designed to rapidly identify experimental therapies that improve overall survival and confirm efficacious experimental therapies and associated biomarker signatures to support new drug approvals and registration. It is a collaboration between academic investigators, patient organizations and industry, under the sponsorship of the non-profit organization, Global Coalition for Adaptive Research, to support new drug applications for newly diagnosed and recurrent GBM. Material and Methods The primary objective of GBM AGILE is to identify therapies that effectively improve overall survival in patients with newly diagnosed or recurrent GBM. Bayesian response adaptive randomization is used within subtypes of the disease to assign participants to investigational arms based on their performance. Operating under a master protocol, GBM AGILE allows multiple drugs from different pharmaceutical companies to be evaluated simultaneously and/or over time against a common control arm. Based on performance, a drug may graduate and move to a Stage 2 (Phase 3) within the trial, and the totality of the data can be used for a new drug application and registration process. New experimental therapies are added as information about promising new drugs is identified while other therapies are removed as they complete their evaluation. The master protocol/ trial infrastructure includes efficiencies through an adaptive trial design, shared control arm and operational processes such as risk-based monitoring and enhanced remote activities. With its adaptable structure, GBM AGILE has continued trial activation, inclusion of new investigational therapies, and enrollment globally through the challenges of a global pandemic.GBM AGILE provides an efficient mechanism to screen and develop robust information regarding the efficacy of proposed novel therapeutics and associated biomarkers for GBM and to quickly move therapies and biomarkers into clinic. GBM AGILE received initial approval from the United States FDA in April 2019, and in Europe through the Voluntary Harmonization Procedure (VHP) in April, 2021. As of 2022, AGILE has screened over 1000 patients studying multiple investigational treatments. Enrollment rates are 3 to 4 times greater than traditional GBM trials, with active sites averaging 0.75 to 1 patients/site/month. Currently, there are 41 sites activated in the US, 4 in Canada and 2 in Switzerland and an estimated 24 sites yet to open in Germany, France, Switzerland, Italy and Austria. In addition to the continued expansion in Europe, effort is undergoing to extend the trial to China and Australia as well. Clinical trial information: NCT03970447

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Graser, H.-U., B. Tier, D. J. Johnston, and S. A. Barwick. "Genetic evaluation for the beef industry in Australia." Australian Journal of Experimental Agriculture 45, no. 8 (2005): 913. http://dx.doi.org/10.1071/ea05075.

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Genetic evaluation for beef cattle in Australia has been performed using an animal model with best linear unbiased prediction since 1984. The evaluation procedures have evolved from simple to more complex models and from few to a large number of traits, including traits for reproduction, growth and carcass characteristics. This paper describes in detail the current beef cattle genetic evaluation system ‘BREEDPLAN’ used for the Australian beef cattle industry, the traits analysed and underlying models, and presents a short overview of the challenges and planned developments of coming years.

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Borra Vamsi, Hemanth Kumar S, Patel P R, and Gowrav M P. "Vendor Qualification and Evaluation in Pharmaceutical Industry." International Journal of Research in Pharmaceutical Sciences 11, no. 2 (April 18, 2020): 1987–94. http://dx.doi.org/10.26452/ijrps.v11i2.2129.

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To deliver a high quality and safe medicines, it is a must to certify the vendor according to the GMP requirement. This qualification is done to prevent the adverse events, prevent the recalls or serious illness or death due to the low standard quality of manufactured medicines. Vendor qualification is the process by which a vendor is assessed to determine, if it can provide the required goods or services to the standards that the purchasing company requires. This article explains about the detailed procedure for qualifying raw material vendors, packaging vendors and service providers. This also explains the vendor assessment and the reassessment. Vendor re-assessment must be carried out at least once a year for each packaging material and the raw material. The manufactured part number is used for tracking. Supply Chain Management team (SCM) should request the QA department to generate Manufacturing Part Number. Explained about the vendor rating. The vendor must be disqualified if the batch will not adhere to specification of critical tests. For further evaluation and investigation, vendor must be once again qualified. Vendor must be informed regarding the removal and the reasons must be explained clearly. Vendor Relationship Management (SRM), is systematic planning and managing of all interactions with suppliers to maximize its value.

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Hirst, Christine A. "GOVERNMENT INITIATIVES IN THE DEVELOPMENT OF A PHARMACEUTICAL INDUSTRY IN AUSTRALIA." Clinical and Experimental Pharmacology and Physiology 19, no. 1 (January 1992): 57–61. http://dx.doi.org/10.1111/j.1440-1681.1992.tb00398.x.

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Lau, Edith, Alice Fabbri, and Barbara Mintzes. "How do health consumer organisations in Australia manage pharmaceutical industry sponsorship? A cross-sectional study." Australian Health Review 43, no. 4 (2019): 474. http://dx.doi.org/10.1071/ah17288.

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Objective The aim of this study was to investigate how health consumer organisations manage their relationships with the pharmaceutical industry in Australia. Methods We identified 230 health consumer organisations that received pharmaceutical industry support from 2013 to 2016 according to reports published by Medicines Australia, the industry trade association. A random sample of 133 organisations was selected and their websites assessed for financial transparency, policies governing corporate sponsorship and evidence of potential industry influence. Results In all, 130 of the 133 organisations evaluated received industry funding. Of these 130, 68 (52.3%; 95% confidence interval (CI) 43.4–61.1%) disclosed this funding. Nearly all (67; 98.5%) reported the identity of their industry donors, followed by uses (52.9%), amount (13.2%) and proportion of income from industry (4.4%). Less than one-fifth (24/133; 18.0%; 95% CI 11.9–25.6%) had publicly available policies on corporate sponsorship. Six organisations (7.2%; 95% CI 2.7–15.1%) had board members that were currently or previously employed by pharmaceutical companies, and 49 (36.8%; 95% CI 28.6–45.6%) had company logos, web links or advertisements on their websites. Conclusion Industry-funded health consumer organisations in Australia have low transparency when reporting industry funding and few have policies governing corporate sponsorship. Relationships between health consumer organisations and the industry require effective actions to minimise the risks of undue influence. What is known about this topic? Pharmaceutical industry funding of health consumer organisations is common in the US and Europe, yet only a minority of such organisations publicly disclose this funding and have policies regulating their relationships with industry. What does this paper add? Industry-funded health consumer organisations in Australia have inadequate financial transparency and rarely have policies addressing corporate funding. Organisations that have received more industry funding are more likely to report it publicly. What are the implications for practitioners? Robust policies addressing corporate sponsorship and increased transparency are needed to maintain the independence of health consumer organisations. Governments may also consider regulating non-profit organisations to ensure public reporting of funding sources.

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АЛЬМУРЗАЕВА, А. А., К. С. ЖАКИПБЕКОВ, У. М. ДАТХАЕВ, М. З. АШИРОВ, and З. А. ДАТХАЕВА. "COMPETITIVENESS OF PHARMACEUTICAL INDUSTRY: INDICATORS AND EVALUATION CRITERIA." Farmaciâ Kazahstana, no. 2 (June 14, 2022): 4–9. http://dx.doi.org/10.53511/pharmkaz.2022.26.21.001.

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Актуальность. На современном этапе развития рыночных отношений эффективность деятельности аптечных организаций как субъектов фармацевтического рынка во многом зависит от уровня их конкурентоспособности. Методы. При подготовке данного исследования применялись сравнительные, описательные, системные, ретроспективные методы, SWOT-анализ. Результаты. Для развития фармацевтической промышленности в Казахстане предприятиям необходимо направить свою стратегию на рост основных показателей и целевых индикаторов: создание и модернизация высокопроизводительных рабочих мест; увеличение производительности труда в фармацевтической и медицинской отрасли; увеличение доли высокотехнологичной и наукоемкой продукции в общем объеме производства; доля лекарственных средств отечественного производства; экспорт лекарственных средств и медицинских изделий. Выводы. Для достижения этих целей руководителям производств необходимо использовать научно обоснованные подходы, которые позволят определить и повысить уровень конкурентноспособности собственной организации. Relevance. At the present stage of development of market relations, the effectiveness of pharmacy organizations as subjects of the pharmaceutical market largely depends on the level of their competitiveness. Methods. In preparing this study, comparative, descriptive, systematic, retrospective methods, SWOT analysis were used. Results. For the development of the pharmaceutical industry in Kazakhstan, enterprises need to direct their strategy towards the growth of key indicators and target indicators: creation and modernization of high-performance jobs; increase in labor productivity in the pharmaceutical and medical industries; increase in the share of hightech and science-intensive products in the total volume of production; share of domestically produced medicines; export of medicines and medical devices.

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Karanges, Emily Aspasia, Conrad Nangla, Lisa Parker, Alice Fabbri, Cynthia Farquhar, and Lisa Bero. "Pharmaceutical industry payments and assisted reproduction in Australia: a retrospective observational study." BMJ Open 11, no. 9 (August 31, 2021): e049710. http://dx.doi.org/10.1136/bmjopen-2021-049710.

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ObjectivesTo investigate the extent and nature of pharmaceutical industry payments related to fertility and assisted reproduction in Australia.Design and settingThis retrospective observational study employed four databases compiled from publicly available pharmaceutical industry transparency reports on educational event sponsorship (October 2011–April 2018), payments to healthcare professionals (October 2015–April 2018) and patient group support (January 2013–December 2017). Analyses were restricted to fertility-related payments by two major manufacturers of fertility medicines in Australia: Merck Serono and Merck, Sharp and Dohme (MSD).Primary and secondary outcome measuresDescriptive statistics on fertility-related payments and other transfers of value (counts, total and median costs in Australian dollars) for educational events and to healthcare professionals and patient groups.ResultsBetween October 2011 and April 2018, Merck Serono and MSD spent $A4 522 263 on 970 fertility-related events for healthcare professionals, including doctors, nurses and fertility scientists. 56.8% (551/970) events were held by fertility clinics and 29.3% (284/970) by professional medical associations. Between October 2015 and April 2018, Merck Serono spent $A403 800 across 177 payments to 118 fertility healthcare professionals, predominantly for educational event attendance. Recipients included obstetricians and gynaecologists (76.3% of payments, 135/177), nurses (11.3%, 20/177) and embryologists/fertility scientists (9.6%, 17/117). The highest paid healthcare professionals held leadership positions in major fertility clinics. Merck Serono provided $A662 850 to fertility-related patient groups for advocacy and education (January 2013–December 2017).ConclusionsThe pharmaceutical industry sponsored a broad range of fertility clinicians and organisations, including doctors, nurses, embryologists, professional medical organisations, fertility clinics and patient groups. This sponsorship may contribute to the overuse of fertility services.

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Kerridge, Ian. "Comment: Interactions Between the Medical Profession and the Pharmaceutical Industry in Australia." Australasian Psychiatry 16, no. 3 (January 2008): 166–68. http://dx.doi.org/10.1080/10398560802005092.

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Simonet, Daniel. "Evaluation of downstream integration in the US pharmaceutical industry." International Journal of Pharmaceutical and Healthcare Marketing 1, no. 2 (July 3, 2007): 143–58. http://dx.doi.org/10.1108/17506120710762997.

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PurposeThis paper aims to review the vertical or quasi‐vertical integration that characterized the pharmaceutical industry in the mid‐1990s. The acquisitions and vertical partnerships that linked pharmacy benefits managers and drug manufacturers modified the structure of the market at that time. What were the motivations of those agreements? Did they induce any distortion on competition in the drug market? And why did they fail to achieve their desired strategic advantages?Design/methodology/approachThe paper uses established theoretical perspectives, such as the resource‐based view and the theory of contestable markets, as the basis for a descriptive analysis, documenting strategic decisions of vertical integration using supporting literature in marketing and strategy.FindingsVertical integration did not obtain the intended results (e.g. acquisition of competitive advantages). This perspective provides a framework to examine vertical integration strategies, applicable to other industries.Originality/valueThe paper reviews the objectives of vertical integration strategies of US drug firms in the 1990s and their hidden agendas.

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Larson, Karen A., and Michael L. King. "Evaluation of Supercritical Fluid Extraction in the Pharmaceutical Industry." Biotechnology Progress 2, no. 2 (June 1986): 73–82. http://dx.doi.org/10.1002/btpr.5420020206.

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Piña-Mavarez, Enzo, and María Eugenia Suárez-Serrano. "Regulation Mechanisms in the Spanish Pharmaceutical Industry: An Evaluation of the Government-Pharmaceutical Industry Stability Pact 2001-2004." Journal of Globalization, Competitiveness, and Governability 3, no. 1 (September 24, 2014): 88–103. http://dx.doi.org/10.3232/gcg.2009.v3.n1.05.

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Fabbri, Alice, Swestika Swandari, Edith Lau, Agnes Vitry, and Barbara Mintzes. "Pharmaceutical Industry Funding of Health Consumer Groups in Australia: A Cross-sectional Analysis." International Journal of Health Services 49, no. 2 (January 15, 2019): 273–93. http://dx.doi.org/10.1177/0020731418823376.

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Relationships between consumer organizations and pharmaceutical manufacturers are the focus of transparency efforts in some jurisdictions, including Australia. This study describes the frequency and nature of industry sponsorship of Australian health consumer organizations and examines the link between sponsorship of the most highly funded organizations and manufacturers’ requests for public reimbursement of products for related health conditions. We downloaded 130 transparency reports covering the period January 2013 to December 2016 from the website of Medicines Australia and carried out a descriptive analysis. For the most heavily funded organizations and their sponsors, we examined Public Summary Documents of the Pharmaceutical Benefits Advisory Committee to identify relevant products under consideration for public reimbursement over the study period. Thirty-four pharmaceutical companies provided 1,482 sponsorships to 230 organizations, spending a total of AU$34,507,810. The top clinical areas in terms of amount of funding received were cancer, eye health, and nervous system disorders. The sponsors of the most highly funded groups were companies that in most cases had drugs under review for public reimbursement for conditions covered by these organizations. Interactions between the pharmaceutical industry and consumer organizations are common and require careful management to prevent biases that may favor sponsors’ interests above those of patients and the public.

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Boumil, Sylvester James, Ashiyana Nariani, Marcia M. Boumil, and Harris A. Berman. "Whistleblowing in the pharmaceutical industry in the United States, England, Canada, and Australia." Journal of Public Health Policy 31, no. 1 (March 4, 2010): 17–29. http://dx.doi.org/10.1057/jphp.2009.51.

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Zhao, Bing, Dong Sheng Zhang, and Yong Zheng Zhao. "Construction Competitiveness Evaluation System of Regional BioPharma Industry and Case Study." International Journal of Advanced Pervasive and Ubiquitous Computing 3, no. 2 (April 2011): 13–20. http://dx.doi.org/10.4018/japuc.2011040102.

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Biological pharmaceutical industry not only has the continuous pulling action to region economy, also makes a positive contribution on the human productivity and quality of life. Biological pharmaceutical industry will become the leading industry of the century in quite a long time in the future. Taking Shijiazhuang as an example, according to the regional biopharmaceutical industry planning needs, building the industry competitiveness evaluation system, this paper analyzes the comparative advantage of Shijiazhuang in developing bio-pharmaceutical industry from 4 level evaluation index, including: the industry environment and policy, R & D capability, competitiveness of economic scale and industry support system. Provide a reference for local governments and business.

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Rockers, Peter C., Richard O. Laing, Nancy Scott, Paul Ashigbie, Erin H. Lucca, Chukwuemeka Anthony Umeh, and Veronika J. Wirtz. "Evaluation of pharmaceutical industry-led access programmes: a standardised framework." BMJ Global Health 4, no. 4 (August 2019): e001659. http://dx.doi.org/10.1136/bmjgh-2019-001659.

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Pharmaceutical industry-led access programmes are increasing in number and scope worldwide. We present a new standardised framework for evaluation of these programmes that includes three components: a taxonomy of 11 access programme strategies; a series of logic models, one for each strategy and a set of measurement indicators. The logic models describe pathways of potential programme impact. Concepts relevant across a broad range of strategies were prioritised for inclusion in logic models to ensure consistency and to facilitate synthesis and learning across programmes. Each concept has at least one corresponding measurement indicator with metadata that includes the definition, details on how it should be measured and recommended data sources. The framework establishes a shared language for the collection and reporting of meaningful industry-led access programme information. Broad adoption by programme developers and implementing partners in the for-profit sector and beyond could facilitate shared learning on effective strategies and best practices.

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Krol, Thomas F., James C. Coleman, and Patrick J. Bryant. "Consultant evaluation for scientific competitive intelligence in the pharmaceutical industry." Competitive Intelligence Review 3, no. 3-4 (1992): 43–46. http://dx.doi.org/10.1002/cir.3880030312.

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Doostzadeh, Ebrahim, Hussein Shabaninejad, Hesamoddin Madani, and Zahra Ahani Amineh. "A FRAMEWORK FOR EVALUATION OF PHARMACEUTICAL INDUSTRY DEVELOPMENT IN DEVELOPING COUNTRIES: EVIDENCE FROM IRAN." Asian Journal of Pharmaceutical and Clinical Research 9, no. 5 (September 1, 2016): 50. http://dx.doi.org/10.22159/ajpcr.2016.v9i5.10099.

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ABSTRACTObjectives: The pharmaceutical market is a complex market due to its complicated supply chain and the extent of government regulations in allaspects of the trade lifecycle of drug development. Considering the importance of pharmaceuticals for society and the relevant trend of globalization,managing pharmaceutical industry effectively and efficiently is vital, particularly in developing countries. The present study determines the factorsaffecting the development of the Iranian pharmaceutical industry based on pharmaceutical mangers’ point of view.Methods: In this study, we assessed managers’ perspective about the internal and external key factors affecting the development of pharmaceuticalindustry. Finally, their perspective about the solutions for the development of pharmaceutical industry was assessed. Accordingly, a self-designedquestionnaire was sent to 65 managers at Tamin Pharmaceutical Investment Company, of which, 51 questionnaires were answered by the managers. Result: Most managers believed generic scheme reflect negatively on the development of the pharmaceutical industry and that external factors havea great impact on its improvement. They believe that branded generic transition along with supporting regulations, investment in Research andDevelopment, and joint venture with foreign companies will improve the pharmaceutical industry.Conclusion: To sum up, for improving the pharmaceutical industry in the shortest time possible, improvement of technological capabilities andinvestment in R&D should be considered.Keywords: Pharmaceutical industry, Key factors, Generic scheme.

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Qureshi, Athar Mahmood Ahmed, and Nina Evans. "Deterrents to knowledge-sharing in the pharmaceutical industry: a case study." Journal of Knowledge Management 19, no. 2 (April 7, 2015): 296–314. http://dx.doi.org/10.1108/jkm-09-2014-0391.

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Purpose – This study aims to explore deterrents to knowledge-sharing in pharmaceutical manufacturing. Effective knowledge-sharing is fundamental to stimulation of the process of knowledge absorption. The limited proximal communication between the employees in the pharmaceutical industry stifles their knowledge-sharing behaviour significantly. Design/methodology/approach – A cross-sectional case study, consisting of semi-structured interviews with managers and scientists, was conducted in a multinational pharmaceutical company in Australia. Respondents were asked to answer questions regarding their current knowledge-sharing practices and to identify organisational deterrents to knowledge-sharing. The data were condensed into themes according to the thematic analysis method. Findings – The pharmaceutical industry is extensively regulated and its excessive competitiveness is cultivating organisational reticence towards the development of a knowledge-sharing culture. Nine categories of deterrents to intra- (within) and inter-organisational (between organisations) knowledge-sharing have been identified. These categories include high cost of sharing knowledge, information technology limitations, knowledge-hiding, lack of socialisation, lack of trust culture, non-educational mindset, organisational politics, poor leadership and time pressure. Research limitations/implications – The population of this study consists of managers and practitioners working for a pharmaceutical company. Hence, the generalisability of the findings to other health-care settings is unknown. Practical implications – The findings have implications for leaders and managers who should be aware of these professional diversities, instigators as well as the ripple effects of limited knowledge-sharing to guide the organisation towards developing an optimal knowledge-sharing culture. Originality/value – A focussed investigation of knowledge-sharing behaviour within the pharmaceutical industry in Australia, considering the pressure applied to this industry over the past decade. This case study specifically focusses on the diversity of deterrents to knowledge-sharing in the pharmaceutical manufacturing industry.

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Fabbri, Alice, Quinn Grundy, Barbara Mintzes, Swestika Swandari, Ray Moynihan, Emily Walkom, and Lisa A. Bero. "A cross-sectional analysis of pharmaceutical industry-funded events for health professionals in Australia." BMJ Open 7, no. 6 (June 2017): e016701. http://dx.doi.org/10.1136/bmjopen-2017-016701.

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Parker, Lisa, Emily A. Karanges, and Lisa Bero. "Changes in the type and amount of spending disclosed by Australian pharmaceutical companies: an observational study." BMJ Open 9, no. 2 (February 2019): e024928. http://dx.doi.org/10.1136/bmjopen-2018-024928.

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ObjectivesTo describe and quantify disclosed payments from the pharmaceutical industry to the healthcare sector, and to examine the impact of the 2015 changes to Australia’s self-regulated system of transparency.DesignObservational database study.SettingAustralia.ParticipantsPublicly available reports submitted by members of Australian pharmaceutical industry trade organisations, Medicines Australia and the Generic and Biosimilar Medicines Association (GBMA) (October 2011–December 2017).ExposureChanges to transparency reporting requirements with the updates of pharmaceutical industry Codes of Conduct in 2015.Main outcome measuresElements of healthcare sector spending that members of industry organisations are required to publicly disclose; cumulative amount of disclosed spending (monthly average) in the year prior to and following the revision.ResultsThere was a 34.1% reduction in disclosed spending from Medicines Australia member companies in the year after the 2015 changes to the Code of Conduct were introduced ($A89 658 566 in the preceding year, October 2014–September 2015; $A59 052 551 in the following year). The new Code allowed for reduced reporting of spending on food and beverages at events and for sponsored healthcare professionals. However, there was enhanced transparency around identification of individual health professionals receiving payments. GBMA member reporting totalled $A2 580 402 in the year prior to the revision, then ceased.ConclusionsThis study shows the limitations of a self-regulatory system around industry disclosure of spending. We advocate for robust regulatory systems, such as legislation, to promote mandatory long-lasting public transparency.

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Kosari, Sam, Vera H. Buss, Gregory M. Peterson, Kwang Choon Yee, Mark Naunton, Mary Bushell, Leroy Chiu, and Jackson Thomas. "Evaluation of Pharmaceutical Compounding Training in the Australian Undergraduate Pharmacy Curricula." Pharmacy 8, no. 1 (February 26, 2020): 27. http://dx.doi.org/10.3390/pharmacy8010027.

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Introduction: In recent decades the role of the Australian community pharmacist has evolved to focus primarily on pharmaceutical care provision. Despite this, compounding remains an important product service offered by pharmacists. The aim of this study was to qualitatively describe the current integration of training in compounding within Bachelor of Pharmacy courses in Australia. Methods: The Australian Health Practitioner Regulatory Agency website was searched to identify eligible university courses. Subsequently, the educational providers’ homepages were consulted, and Bachelor of Pharmacy handbooks and curricula perused. All relevant information regarding training in compounding was extracted. Results: In total, 16 Bachelor of Pharmacy courses were identified. All of these contain compounding training in their curricula, including laboratory classes. Most curricula have units specifically dedicated to compounding and drug formulation. Three universities offer a curriculum which is organ-systems based, and include compounding relevant to the individual organ systems. Discussion and Conclusions: In Australia, the training in compounding is well integrated into pharmacy curriculum and is more emphasised than in many other developed countries. This is congruent with the International Pharmaceutical Federation’s needs-based approach to local pharmacy education. In Australia there is a need for pharmacists to routinely dispense simple compounded products. Further research is required to evaluate Australian pharmacy graduates’ compounding abilities and how best to promote the achievement of the required knowledge and skills to enable simple compounding.

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Harvey, Roy. "And on the cover of the Guide were two words in red - Don't Panic." Australian Health Review 24, no. 2 (2001): 15. http://dx.doi.org/10.1071/ah010015.

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Roy Harvey is a consultant in health financing, works both in Australia and in developing countries and hasundertaken research and analysis on the economics of the pharmaceutical industry and the PBS since 1968.

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El-Gohary, F. A., S. I. Abou-Elela, and H. I. Aly. "Evaluation of biological technologies for wastewater treatment in the pharmaceutical industry." Water Science and Technology 32, no. 11 (December 1, 1995): 13–20. http://dx.doi.org/10.2166/wst.1995.0389.

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Wastewater from a pharmaceutical and chemical company provides the material of this study. The company produces drugs, diuretics, laboratory chemicals and others. The company is located 30 km north of Cairo, and discharges both industrial (1050 m3/d) and human wastewater (8400 m3/d) without treatment into a near-by evaporation pond. Reduction of pollutants in the wastewater down to permissible concentrations is necessary for the protection of ground water and the environment. Analysis of the combined wastes indicated that it is very acidic and contains high concentrations of organic compounds and total solids. Combined wastes were subjected to different treatment processes for final disposal into surface water, or reuse for irrigation purposes. Biological treatment of the combined wastes was carried out using both batch and continuous flow systems. The biological treatments included activated sludge process, fixed film reactor, and fixed film reactor followed by activated sludge process. Technical feasibility studies indicated that good quality effluent could be obtained using either extended aeration (20 hr aeration) or a fixed film reactor followed by activated sludge (11 hr detention time). Residual BOD5, COD, oil and grease concentrations in the treated effluent were complying with the National Regularity Standards. When constructional cost was considered, extended aeration was the first choice. Engineering designs of the proposed treatment options are included.

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Tišler, Tatjana, and Jana Zagorc-Končan. "Toxicity evaluation of wastewater from the pharmaceutical industry to aquatic organisms." Water Science and Technology 39, no. 10-11 (May 1, 1999): 71–76. http://dx.doi.org/10.2166/wst.1999.0632.

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The aim of our research was to evaluate the acute and chronic toxicity of wastewater from the pharmaceutical industry to some aquatic organisms. The toxicity of three 24h proportional samples of wastewater was determined with the acute toxicity tests using the bacterium Vibrio fischeri and daphnid Daphnia magna. The inhibition of bacterial luminescence was measured after a 30 min exposure period and the immobility of daphnids was determined after 24 and 48h. The chronic effects on daphnid survival and reproduction were observed for three weeks. The toxicity tests indicated that all investigated samples were acutely toxic to the organisms, but in each sample the responses of bacteria and daphnids were quite different. Acute and chronic effects on daphnids were observed when testing the first sample of wastewater, but no influence on bacteria was determined. The second sample was acutely toxic to both organisms. The third sample was toxic only to bacteria, while no influence on daphnid survival and reproduction was found. The reason for the different toxicity of the samples lay in their compositions. The comparison between chemical analyses and toxicity data showed that for daphnids the main cause of toxic effects was zinc.

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Jacob, Bobby, and Samuel Peasah. "Evaluation of first year student pharmacists’ perceptions of the pharmaceutical industry." Currents in Pharmacy Teaching and Learning 10, no. 5 (May 2018): 637–42. http://dx.doi.org/10.1016/j.cptl.2018.01.005.

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Pan, Yuxiang, Yimin Huang, and Ershi Qi. "Chinese manufacturing industry development strategy from the financial perspective." Grey Systems: Theory and Application 6, no. 2 (August 1, 2016): 203–15. http://dx.doi.org/10.1108/gs-02-2016-0003.

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Purpose – Based on literature review, the purpose of this paper is to design a comprehensive evaluation system for pharmaceutical industry from the financial perspective, and then analyses the development strategy of Chinese pharmaceutical industry according to the data of listed companies. Design/methodology/approach – This paper analyses the development strategy of Chinese pharmaceutical industry through building the grey dominance evaluation model including absolute degree of grey incidence model and relative degree of grey incidence model. Findings – Through the analysis of the grey dominance evaluation model, the authors find that four factors including total assets turnover, quick ratio, inventory turnover and current ratio can be grouped into first grade assessment indicator when evaluating the performance of Chinese pharmaceutical industry. These four indexes contain the concept of operational efficiency which shows that operation capability is the key to support the development of Chinese pharmaceutical industry, needing to be highly valued when organizations making business policy. When it comes to velocity of development, the contribution of R & D intensity is relatively small, which shows innovation ability of China’s pharmaceutical industry is still weak. Innovation is the lifeblood of enterprise development, needing to be improved to promote enterprise’s core competitiveness in the future development. Originality/value – This paper selects Y1-Y7 as the performance evaluation system of pharmaceutical manufacturing enterprises, while X1-X15 as performance evaluation index system from the financial perspective, which indicated that the evaluation system is scientific and practical. The empirical result shows that the operation capability makes the largest contribution to the performance of China’s pharmaceutical industry, while R & D ability and the enterprise core competitive ability are weak.

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Rae, Ian D. "Vitamin A and Australian Fish Liver Oils." Historical Records of Australian Science 25, no. 1 (2014): 55. http://dx.doi.org/10.1071/hr14005.

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Research by an organic chemist at the University of Melbourne and support from Australia's Council for Scientific and Industrial Research provided the basis for a wartime industry when Australia was unable to maintain access to traditional supplies of cod liver oil from Britain and Norway in the 1940s. Two major pharmaceutical companies gathered oil from the livers of sharks in southern Australia that was rich in vitamin A, and so met domestic and military needs for this nutritional supplement. Other companies joined in and by the end of the war Australia had a flourishing industry that derived synergy from the marketing of shark flesh for human consumption. South Africa was a leader among countries that expanded fish-oil production in the late 1940s, as a result of which Australian producers suffered from import competition. A Tariff Board hearing found that the Australian industry was unable to meet local needs and so did not recommend increased tariffs. The industry struggled for years until the perceived nutritional benefits of other components of the fish oils helped to revive markets.

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Pearl, Alastair Owen, Gerry M. Rayner, Ian Larson, and Laurence Orlando. "Thinking about critical thinking: An industry perspective." Industry and Higher Education 33, no. 2 (September 2, 2018): 116–26. http://dx.doi.org/10.1177/0950422218796099.

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There has been a drive towards enhancing the critical thinking (CT) skills development of students in the science, technology, engineering and mathematics (STEM) disciplines, both in Australia and internationally. One debate among CT theorists centres on whether CT comprises a set of generalizable skills or is content- and context-dependent. While previous studies have considered CT skills development and its assessment in pharmacy courses, there appears to have been limited scholarly research within the pharmaceutical sciences discipline. In seeking to address this, it is vital to understand how companies conceptualize CT and its use by Bachelor of Pharmaceutical Sciences graduates. This research identifies five major categories used to conceptualize CT in the companies interviewed: being systematic, having strong business sense, considering multiple solutions, considering implications and identifying problems and potential solutions. The study finds that, while these skills are dependent on the business context, they may be generalizable across a range of industries.

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Li, Xingyu, Robert N. Emery, Grey T. Coupland, Yonglin Ren, and Simon J. McKirdy. "Evaluation of the Likelihood of Establishing False Codling Moth (Thaumatotibia leucotreta) in Australia via the International Cut Flower Market." Insects 13, no. 10 (September 28, 2022): 883. http://dx.doi.org/10.3390/insects13100883.

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Kenya and some other African countries are threatened by a serious pest Thaumatotibia leucotreta (Meyrick) (Lepidoptera: Tortricidae), the false codling moth. The detection of T. leucotreta is quite difficult due to the cryptic nature of the larvae during transportation and is therefore a concern for Australia. This insect is a known pest of agriculturally important crops. Here, Maxent was used to assess the biosecurity threat of T. leucotreta to Australia. Habitat suitability and risk assessment of T. leucotreta in Australia were identified based on threatened areas under suitable climatic conditions and the presence of hosts in a given habitat. Modeling indicated that Australia is vulnerable to invasion and establishment by T. leucotreta in some states and territories, particularly areas of western and southern Australia. Within these locations, the risk is associated with specific cropping areas. As such, invasion and establishment by T. leucotreta may have serious implications for Australia’s agricultural and horticultural industries e.g., the fruit and vegetable industries. This study will be used to inform the government and industry of the threat posed by T. leucotreta imported via the cut flower industry. Targeted preventative measures and trade policy could be introduced to protect Australia from invasion by this pest.

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Condon, Wayne, and Justin Lambert. "The vexed issue of therapeutic combinations and contributory patent infringement in Australia." Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 9, no. 4 (December 2012): 207–13. http://dx.doi.org/10.1177/1741134312469806.

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The Australian Patents Act includes a provision which deems the supplier of a product to a person who will use that product in a manner which infringes a patent to infringe that patent as a contributory infringer. The concept of contributory patent infringement is one known to the patent laws of many countries, but in many respects the way in which Australian Courts have approached contributory patent infringement gives far greater scope to a patentee than in many of those jurisdictions. The consequence for the generic pharmaceutical industry in Australia is potentially far-reaching. This article looks at the practical consequences of some recent Australian Federal Court decisions which have been decided in the area and which create practical hurdles that any generic entrant into the Australian marketplace will need to navigate.

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Ross, Victoria, Neil Caton, Sharna Mathieu, Jorgen Gullestrup, and Kairi Kõlves. "Evaluation of a Suicide Prevention Program for the Energy Sector." International Journal of Environmental Research and Public Health 17, no. 17 (September 3, 2020): 6418. http://dx.doi.org/10.3390/ijerph17176418.

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There is evidence indicating that traditionally male-dominated occupations are associated with greater risk of suicide. In Australia, MATES in Construction was developed as an occupational health initiative to prevent suicides in the industry. The program has recently been applied to the energy industry; however, little is known regarding exposure to suicide and suicide prevention interventions in this sector. The study aimed to examine the effectiveness of MATES in Energy general awareness training (GAT), and estimate the prevalence of recent suicidal ideation and exposure to suicidal behaviors in workers. A before and after design was used to examine the effectiveness of GAT training. Data were collected from 4887 participants undertaking GAT training at energy sites across Queensland, Australia. In total, 2% (97) of participants reported recent suicidal thoughts, 65% of participants reported they had known someone who had attempted suicide, and 69% had known someone who died by suicide. Significant improvements were found on all suicide literacy items after GAT training. Younger people were more likely to be positively affected by the intervention. The results indicate that the MATES in Energy program is successfully transitioning from the construction industry, and offers the first empirically supported suicide intervention tailored to the energy sector.

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Carlsen, Jack. "A Review of MICE Industry Evaluation and Research in Asia and Australia 1988-1998." Journal of Convention & Exhibition Management 1, no. 4 (August 30, 1999): 51–66. http://dx.doi.org/10.1300/j143v01n04_05.

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Anaman, Kwabena A., and Stephen C. Lellyett. "Producers' evaluation of an enhanced weather information service for the cotton industry in Australia." Meteorological Applications 3, no. 2 (January 10, 2007): 113–25. http://dx.doi.org/10.1002/met.5060030202.

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Trivedi, Ritvij D., Dipak S. Vyas, and Sejal M. Patel. "Hybrid UASB Reactor: A Research Evaluation for Treatment of Pharmaceutical Industry Wastewater." International Journal of Current Microbiology and Applied Sciences 8, no. 04 (April 10, 2019): 1453–61. http://dx.doi.org/10.20546/ijcmas.2019.804.170.

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Masood, Imran, Mohamed Izham Mohamed Ibrahim, Mohamed Azmi Ahmad Hassali, Mahmood Ahmad, and Peter R. Mansfield. "Evaluation of pharmaceutical industry – sponsored educational events attended by physicians in Pakistan." Journal of Medical Marketing: Device, Diagnostic and Pharmaceutical Marketing 12, no. 1 (February 2012): 22–29. http://dx.doi.org/10.1177/1745790411435373.

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Malmfors, T., and A. Teiling. "LD50 - its value for the pharmaceutical industry in safety evaluation of drugs." Acta Pharmacologica et Toxicologica 52 (March 13, 2009): 229–46. http://dx.doi.org/10.1111/j.1600-0773.1983.tb02692.x.

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Nicholson, Susan, Janet Peterson, and Behin Yektashenas. "Pharmaceutical industry perspective on risk evaluation and mitigation strategies: manufacturer take heed." Expert Opinion on Drug Safety 11, no. 2 (January 10, 2012): 299–314. http://dx.doi.org/10.1517/14740338.2012.650689.

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Ghauri, Ehtasham. "Performance evaluation of sales employees: a comparative investigation in the pharmaceutical industry." International Journal of Business Performance Management 19, no. 3 (2018): 253. http://dx.doi.org/10.1504/ijbpm.2018.092756.

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Ghauri, Ehtasham. "Performance evaluation of sales employees: a comparative investigation in the pharmaceutical industry." International Journal of Business Performance Management 19, no. 3 (2018): 253. http://dx.doi.org/10.1504/ijbpm.2018.10011846.

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Davies, Jill, and Steve Hemingway. "Pharmaceutical influences – Nurse prescribers: eyes wide open." Nurse Prescriber 1, no. 12 (December 2004): 1–4. http://dx.doi.org/10.1017/s146711580400224x.

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SummaryThe role of the Pharmaceutical Industry within healthcare has been a debate amongst our medical colleagues for the past decade. However, with the growing number of nurses who are now qualified to prescribe, this controversial aspect of professional practice is becoming an area of interest to nurses. This article reviews some of the literature on prescribing and the pharmaceutical Industry, in an attempt to raise nurses awareness. Nurses have skills that are central to their education of assessment and evaluation. It argues that nurses are well placed to utilise these skills to identify the influences of the Pharmaceutical Industry. The role of the Pharmaceutical Industry in professional development is debated, suggesting that nurses have the skills to analyse the potential impact of this form of education. Concepts of Ethics are discussed in relation to prescribing, patient care and professional education and practice.

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Ikediashi, Cornelius, and Bassam Bjeirmi. "Oil and gas project management and success: a critical evaluation of oil and gas project management success in Australia." APPEA Journal 59, no. 1 (2019): 82. http://dx.doi.org/10.1071/aj18056.

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Australia remains in pole position to become the world’s leading exporter of liquefied natural gas (LNG) and the number one exporter in the future. Maintaining this trajectory will require the oil and gas industry in Australia to remain competitive in project delivery to continue to attract investments. Yet, the Australian project delivery environment poses a big threat to this trajectory. Several research studies, organisations and institutions have come up with a long list of generic factors contributing to project management success and failure. The aim of this study is to examine oil and gas projects in Australia with a view to ascertain their success or otherwise and the specific contributing factors. This study has used a qualitative method of research by examining secondary sources of information on four recent Western Australia LNG projects (Gorgon, Wheatstone, Prelude and Ichthys) and presenting them as case studies. Specifically, the research has used mostly online sources that are either independent reports or information sourced from company websites. The key findings suggest that major oil and gas projects in Australia fail, and that failure or success is determined by the ability of the project management team to deliver the project on budget and on schedule. This is exemplified by the projects examined in this study, which have all shown cost and schedule overruns. Six critical factors are observed as contributing to cost and schedule overrun: project location, high cost of executing projects in Australia versus overseas, skills shortages, overseas manufacturing, project complexity and cultural and environment issues. Innovation, collaboration and standardisation, as adopted from other regions, are the initial practices suggested for the Australian industry to overcome all six factors and encourage further investment.

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Karanges, Emily A., Natasha Ting, Lisa Parker, Alice Fabbri, and Lisa Bero. "Pharmaceutical industry payments to leaders of professional medical associations in Australia: Focus on cardiovascular disease and diabetes." Australian Journal of General Practice 49, no. 3 (March 1, 2020): 151–54. http://dx.doi.org/10.31128/ajgp-08-19-5041.

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Sundgren, Mats, Marcus Selart, Anders Ingelgard, and Curt Bengtson. "Dialogue-Based Evaluation as a Creative Climate Indicator: Evidence from the Pharmaceutical Industry." Creativity and Innovation Management 14, no. 1 (March 2005): 84–98. http://dx.doi.org/10.1111/j.1476-8691.2005.00328.x.

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Schosser, R. "Risk/Benefit Evaluation of Drugs: The Role of the Pharmaceutical Industry in Germany." European Surgical Research 34, no. 1-2 (2002): 203–7. http://dx.doi.org/10.1159/000048910.

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Benagiano, G. "Post-marketing evaluation of fertility-regulating drugs as viewed by the pharmaceutical industry." Human Reproduction 2, no. 3 (April 1987): 241–47. http://dx.doi.org/10.1093/oxfordjournals.humrep.a136521.

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Kapeghian, John C., and Vincent M. Traina. "The role of experimental toxicology in safety evaluation: Challenges facing the pharmaceutical industry." Medicinal Research Reviews 10, no. 2 (April 1990): 271–80. http://dx.doi.org/10.1002/med.2610100205.

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Journal articles on the topic 'Pharmaceutical industry Australia Evaluation'

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