Journal articles: 'Pharmaceutical industry – Italy'

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Ciliberti, Stefano, Laura Carraresi, and Stefanie Bröring. "Drivers of innovation in Italy: food versus pharmaceutical industry." British Food Journal 118, no. 6 (June 6, 2016): 1292–316. http://dx.doi.org/10.1108/bfj-10-2015-0405.

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Airaghi, R., S. Berlingozzi, S. Cannata, G. Dal Negro, E. Melloni, and F. Motta. "Routine laboratory analysis for preclinical research in the pharmaceutical industry in Italy: An overview." Comparative Haematology International 4, no. 3 (September 1994): 136–42. http://dx.doi.org/10.1007/bf00798353.

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Patarnello, Francesca, Emiliano Briante, and Federico Villa. "Value generated by the multiplier effect of investments by the pharmaceutical industry in Italy: proposals to promote competitiveness and attractiveness." Global & Regional Health Technology Assessment 9 (October 5, 2022): 117–22. http://dx.doi.org/10.33393/grhta.2022.2440.

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Pharmaceutical industry investments in Italy must be supported with a reform process that promotes simplifications to generate an attractive ecosystem that can enhance innovation. Key actions include facilitating the start-up of clinical trials, promoting public-private partnerships to support technology transfer, integrating data infrastructures to overcome the logic of silos, expanding programs for prevention and early identification of diseases, simultaneous reimbursement for therapy and diagnostic testing, and launching a structural program for early access to therapies. The total contribution of the sector in the last 10 years to the Italian economy was € 315 bn. Looking at employment (67 thousand people employed in the sector in 2020), it is possible to estimate about 280 thousand jobs activated in Italy just in 2020. An Altems study quantified a leverage effect of 2.77 in terms of benefits to the Italian NHS from direct investment in clinical research, which means that for every € 1 invested by companies in clinical trials, € 1.77 of additional savings were generated for the NHS. Applying the multiplier on R&D investments of the entire pharmaceutical sector in 2020 (€ 1.6 bn), we could estimate approximately € 4.4 bn in benefits for the NHS. In addition to these benefits there are the noneconomic benefits of clinical research, including early access for patients to innovative therapies, resulting in improved clinical outcomes and quality of life for patients and caregivers in general.

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Jurkowski, Joseph Henry, and Dion D. Daly. "MINTS The Next Economic Frontier for Investment – A Financial Analysis of the Pharmaceutical Industry." International Journal for Innovation Education and Research 4, no. 8 (August 31, 2016): 132–45. http://dx.doi.org/10.31686/ijier.vol4.iss8.581.

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We have heard a great deal recently of the BRIC countries (Brazil, Russia, India, China), and the PIGS (Portugal, Italy, Greece, Spain) but now the focus seems to be on the MINT countries, (Malaysia, Indonesia, Nigeria, and Turkey) as the leading emerging economies in the world. Rising labor and other costs now have companies looking for new opportunities in rapid growth markets. But not without specific risks that companies must be willing to take. Corruption, rampant communicable disease, drug abuse and criminal activity, religious issues and disagreements are a few of the challenges companies must face in the new frontier. This paper will attempt to look at four pharmaceutical companies in each of the MINT countries to determine their potential profitability as an investment opportunity. This industry is especially unique since these countries have a growing population which will increase the labor force and also create a need for pharmaceutical products. Each of these countries is located in an advantageous geographical location which will provide an advantage in growing their economies. Mexico is next to the U.S. and the rest of Latin America. Indonesia is located in the heart of Southeast Asia with strong ties to China. Turkey has positioned itself to have both Eastern and Western influences. Nigeria is in a prime spot as it ls located in the prime economic powerhouse of a continent, Africa. If they get their acts together, solve their problems of corruption, energy, and infrastructure, these four countries could potentially overtake China as a leading economy of the world.

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Guseo, Renato, Alessandra Dalla Valle, Claudia Furlan, Mariangela Guidolin, and Cinzia Mortarino. "Pre-launch forecasting of a pharmaceutical drug." International Journal of Pharmaceutical and Healthcare Marketing 11, no. 4 (November 6, 2017): 412–38. http://dx.doi.org/10.1108/ijphm-07-2016-0036.

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Purpose The emergence of a pharmaceutical drug as a late entrant in a homogeneous category is a relevant issue for strategy implementation in the pharmaceutical industry. This paper aims to suggest a methodology for making pre-launch forecasts with a complete lack of information for a late entrant. Design/methodology/approach The diffusion process of the emerging entrant is estimated using the diffusion dynamics of pre-existing drugs, after an appropriate assessment of the drug’s entrance point. The authors’ methodology is applied to study the late introduction of a pharmaceutical drug in Italy within the category of ranitidine. Historical data of seven already active drugs in the category are used to assess and estimate ex ante the dynamics of a late entrant (Ulkobrin). Findings The results of applying the procedure to the ranitidine market reveal a high degree of accuracy between the ex post observed values of the late entrant and its ex ante mean predicted trajectory. Moreover, the assessed launch date corresponds to the actual date. Research limitations/implications The category has to be homogeneous to ensure a high degree of similarity among the existing drugs and the late entrant. For this reason, radical innovations cannot be forecast with this methodology. Originality/value The proposed approach contributes to the still challenging research field of pre-launch forecasting by estimating the dynamic features of a homogeneous category and exploiting them for forecasting purposes.

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Negro, Carmine, Alessio Aprile, Andrea Luvisi, Luigi De Bellis, and Antonio Miceli. "Antioxidant Activity and Polyphenols Characterization of Four Monovarietal Grape Pomaces from Salento (Apulia, Italy)." Antioxidants 10, no. 9 (September 1, 2021): 1406. http://dx.doi.org/10.3390/antiox10091406.

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The wine industry annually produces millions of tons of by-products rich in polyphenolic compounds that can be reused as secondary raw material in the food, cosmetic and pharmaceutical industries. The purpose of this work was to describe the presence of nutraceutical compounds and to evaluate the antioxidant activity of pomaces from three Apulian (South Italy, Italy) grape varieties (Negroamaro, Malvasia di Lecce and Primitivo) and to compare them with one of the most cultivated wines in Europe (Cabernet Sauvignon). The main classes of polyphenolic substances were characterized via high performance liquid chromatography/diode array detector/mass spectrometer time of flight (HPLC/DAD/TOF) and the antioxidant activity was evaluated with three different methods. The four investigated grape marcs have shown different polyphenols and antioxidant activities. Primitivo marc showed the higher antioxidant activity due to the excellent level of polyphenols, followed by the Negroamaro cultivar. In addition, marcs from traditional Apulian vines showed higher antioxidant activities than Cabernet Sauvignon because of an elevated level of active polyphenolic substances such as catechin, epicatechin, quercetin and its derivatives.

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Cornago, Dante, and Livio Garattini. "Il mercato dei dispositivi per stomia in cinque paesi europei: lezioni per l’Italia." Farmeconomia. Health economics and therapeutic pathways 2, no. 2 (June 15, 2001): 115–23. http://dx.doi.org/10.7175/fe.v2i2.724.

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Aim of the present study is to analyze the international market of the ostomy devices in Italy, France, Germany, U.K. and Denmark. The ostomy systems are technologically mature devices, and the more interesting market developments are about innovative modality of distribution and patients technical support, like home distribution. For every country it has been applied a common pattern, based on four aspect of the ostomy devices market: 1. the legislative aspect; 2. the prescription procedure; 3. the different models of distribution; 4. the competitive systems of pharmaceutical industry. All the data in this study has been galthered through relevant literature and interviews with the area operators. The ostomy devices are repayable against medical prescription in all the studied countries; significant legislative differences are registered in the repayment prices determination. For all the studied countries, in the decisional process related to the choice of one or another device, the essential role is played by the ostomy hospital nurse, that advises the patient immediately after the surgery. Finally, the more significant examples to innovate purchase and distribution process of ostomy devices in Italy comes from Denmark and U.K., where the home distribution is already available and it is working.

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Lazorenko, Valeriia, Liudmyla Saher, and Adam Jasnikowski. "Web management as a marketing management determinant: case for pharmaceutical enterprises." Health Economics and Management Review 2, no. 2 (2021): 105–14. http://dx.doi.org/10.21272/hem.2021.2-10.

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Nowadays, the online business is fast-growing since it is convenient, more profitable, and less energy-consuming. The changing consumers’ needs force companies and organizations to adjust and modernize their marketing strategies. The authors emphasized that Internet advertising channels would overcome the traditional ones. Therefore, it is relevant to consider the latest trends in e-commerce to provide effective advertising campaigns. This study aims to conduct the competitive analysis of Ukrainian veterinary enterprises’ websites as one of the key marketing management determinants. The study object are the most prominent Ukrainian veterinary enterprises. The methodological basis for this paper includes trend, bibliometric, and comparative content analysis. The trend analysis results showed a constant interest in web management worldwide. In turn, there are significant fluctuations over the previous five years in Ukraine. The findings indicated that search requests for «pharmaceutics» worldwide are gradually increasing, while there is not enough statistic data in Ukraine. The bibliometric analysis for Scopus publications addressed the marketing management in the pharmaceutical were visualized by 4 clusters. The first cluster covers marketing, management, and risk issues; the second – pharmaceutical industry, the third – economy; and the fourth – quality control. The findings showed that veterinary medicine was mostly associated with drug efficacy, management, investment, management, risk, organization and management, patents, and quality control. This issue has been most actively studied by scientists from the United States, Britain, Germany, India, and Italy. This study provided the comparative analysis of veterinary enterprises web sites based on the main indicators as follows: usability, site structure, site indexation, number of external pages, overall traffic, behavioral factors (bounce rate, pages per visit, time on site), traffic sources (direct, referrals, SEO, SMM, e-mail, and display advertising), and adaptability to the mobile versions. The obtained results showed that all Ukrainian biological vaccines manufacturers for animals were represented on the Internet. In turn, as of September 2020, Biotestlab most effectively used the Internet to promote products. In second place is the Sumy Biological Factory, and then – Kherson Biological Factory.

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Eandi, Mario, and Carlo Della Pepa. "I farmaci “generici” in Italia: opportunità di ricerca e sviluppo di prodotti di qualità a prezzi competitivi." Farmeconomia. Health economics and therapeutic pathways 4, no. 2 (June 15, 2003): 65–76. http://dx.doi.org/10.7175/fe.v4i2.770.

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Every drug whose copyright coverage has expired can be manufactured by a pharmaceutical company other than the one that developed it, giving rise to the market of the so-called generic drugs. It can be distinguished among two types of generic drugs: branded and unbranded, according to the choice of the manufacturer to assign it a fantasy name or to sell it with the name of the active principle, followed by the company’s name. In order to be accepted for marketing, every new drug has to pass the registration procedures of the Italian Ministry of Health, which are simplified for generics, as it’s sufficient to demonstrate the bioequivalence, considered a reliable proxy of therapeutic equivalence, of the new drug with the standard formulations it copies. The bioequivalence of two drugs depends on various parameters, related to the quality of the raw materials employed and the industrial processes they go through. There are several ways of assessing the equivalence between pharmaceutical products, and it is important the registration studies are conducted following strict rules, in order to guarantee the quality of generics, fundamental for achieving the trust of health operators and patients. The reason to be of generic drugs is essentially economic, as they bare no therapeutic innovation, and their introduction is mainly aimed to contain drug expenditures and to facilitate a competitive market, but to do so, they need to be widely accepted by the medical community and the population. In Italy, the market of generic drugs is very young and relatively underdeveloped if compared to what is observed in other industrialized countries such as the USA, Germany or UK, but it has a good expansion potential, as it also represents a chance for quality enhancement for the Italian pharmaceutical industry.

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Mohammad, Al Sayasneh, O. A. Ruban, I. V. Kovalevska, and O. M. Ievtushenko. "Аnalysis of the market of medicinal products for the conservative treatment of hemorrhoids in order to determine the marketing opportunities for a domestic manufacturer." Social Pharmacy in Health Care 8, no. 4 (December 19, 2022): 46–58. http://dx.doi.org/10.24959/sphhcj.22.274.

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The spread of diseases of the rectum, namely hemorrhoids, leads to the deterioration of the physical and psychological health of the working-age population, increases the budget costs of the healthcare system, insurance companies, and the population’s own funds. In this regard, the development of new complex medicinal products is always relevant for domestic pharmacy. Aim. To form a modern idea of the market structure and trends in the consumption of drugs for the conservative treatment of hemorrhoids, determine the possible potential for domestic developers and manufacturers. Materials and methods. The research was conducted using the structural analysis logical and graphic methods, methods of marketing analysis. Results. It was found that recently the market of antihemoroidal agents for topical application and capillary-stabilizing agents developed quite vigorously – the market growth rates in the period of 2020-2021 were from 15 to 23 % in physical units and from 28 to 40 % in monetary units. However, according to the structure of the producing countries, the market remains import-dependent. Drugs from France, Switzerland, Bulgaria, Germany, Spain, Slovenia, Italy, and the United States are available on the market. The leaders of sales are products manufactured by Servier (France), Innotek International (France), and Teva (Israel). The leaders in the supply of domestic drugs of this group are Borshchagovsky Chemical Pharmaceutical Plant, JSC “Galichpharm”, Kyiv Vitamin Plant, PJSC “Darnitsa” Pharmaceutical company”, PJSC “Monpharm”. The most popular dosage forms are tablets, capsules, gels, ointments, suppositories. Conclusions. Based on the changes identified, certain proposals have been developed for the domestic pharmaceutical industry – the market has a relatively small range of domestic complex medicines combining components of chemical and natural origin, including the plant raw material. The market has a positive development trend; therefore, further search for an effective complex drug is expedient.

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Massari, Stefania, Vittoria Carolina Malpassuti, Alessandra Binazzi, Lorena Paris, Claudio Gariazzo, and Alessandro Marinaccio. "Occupational Mortality Matrix: A Tool for Epidemiological Assessment of Work-Related Risk Based on Current Data Sources." International Journal of Environmental Research and Public Health 19, no. 9 (May 6, 2022): 5652. http://dx.doi.org/10.3390/ijerph19095652.

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Mortality from occupational diseases significantly afflicts society, in terms of both economic costs and human suffering. The International Labour Organization (ILO) estimated that 2.4 million workers die from work-related diseases every year. In Europe, around 80,000 workers die from cancer attributed to occupational exposure to carcinogens. This study developed the Occupational Mortality Matrix (OMM) aimed to identify significant associations between causes of death and occupational sectors through an individual record linkage between mortality data and the administrative archive of occupational histories. The study population consisted of 6,433,492 deceased subjects in Italy (in the period 2005–2015), of which 2,723,152 records of work histories were retrieved (42%). The proportional mortality ratio (PMR) was estimated to investigate the excess of mortality for specific causes associated with occupational sectors. Higher PMRs were reported for traditionally risky occupations such as shipbuilding for mesothelioma cases (PMR: 8.15; 95% CI: 7.28–9.13) and leather production for sino-nasal cancer (PMR: 5.04; 95% CI: 3.54–7.19), as well as for unexpected risks such as male breast cancer in the pharmaceutical industry (PMR: 2.56; 95% CI: 1.33–4.93) and brain cancer in railways (PMR: 1.43; 95% CI: 1.24–1.66). The OMM proved to be a valid tool for research studies to generate hypotheses about the occupational etiology of diseases, and to monitor and support priority actions for risk reduction in workplaces.

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Madeddu, Silvia, Alessandra Marongiu, Giuseppina Sanna, Carla Zannella, Danilo Falconieri, Silvia Porcedda, Aldo Manzin, and Alessandra Piras. "Bovine Viral Diarrhea Virus (BVDV): A Preliminary Study on Antiviral Properties of Some Aromatic and Medicinal Plants." Pathogens 10, no. 4 (March 29, 2021): 403. http://dx.doi.org/10.3390/pathogens10040403.

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Plant products provide an alternative and successful source of lead compounds for the pharmaceutical industry. The present study was aimed to evaluate, in cell-based assays, the antiviral properties of essential oils obtained from plants that commonly grow in Sardinia, Italy, against a broad spectrum of RNA/DNA viruses. The essential oils of Helichrisumitalicum (Roth) G. Don ssp. microphyllum (Willd.) Nyman, Laurus nobilis L., Mirtuscommunis L., Pistacia lentiscus L., Salvia officinalis L., Saturejathymbra L., Lavandula angustifolia Mill., Foeniculum vulgare Mill., and Eucalyptus globulus Labill. were extracted by hydrodistillation and analyzed by gas chromatography mass spectrometry (GC–MS). Interestingly, the essential oil of Salvia officinalis showed moderate activity against bovine viral diarrhea virus (BVDV), an enveloped RNA virus belonging to the Flaviviridae family. BVDV is responsible for several clinical manifestations in bovines, including respiratory, gastroenteric, and reproductive diseases, with a significant economic impact. With the aim to individuate the constituent of the Salvia officinalis responsible for the biological activity, we tested the major components of the oil: camphene, β-pinene, limonene, 1,8-cineole, cis-thujone, camphor, (E)-caryophyllene, and α-humulene. Here, we describe α-humulene as an active component that is non-cytotoxic and active against BVDV (EC50 = 36 µM). Its antiviral effects were evaluated using virucidal cytopathic effect inhibition and viral yield reduction assays. This is the first scientific report showing the anti BVDV effects of Salvia officinalis essential oil and α-humulene as the main active component.

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Zaniolo, Orietta, Mario Eandi, and Pier Luigi Zinzani. "Il prezzo dei farmaci orfani in Italia: il caso di Citarabina Depot (DepoCyte®) nella meningite linfomatosa." Farmeconomia. Health economics and therapeutic pathways 5, no. 3 (September 15, 2004): 141–50. http://dx.doi.org/10.7175/fe.v5i3.793.

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Orphan drugs definition should be related to prevalence criteria. In Europe the prevalence criterion is 5/10.000. These drugs are called “orphans” because the pharmaceutical industry has little interest under normal market conditions in developing and marketing products intended for only a small number of patients. For this reason governments have emphasized the need for economic incentives to encourage drug companies to develop and market orphan drugs. Aim of this study is the analysis of the contributing factors involved in the price definition of orphan drugs in Italy, focusing on the case of DepoCyte®, a new orphan drug recently approved by the European Medicines Agency. DepoCyte® is a slow-release formulation of cytarabine designed for intrathecal administration in the treatment of neoplastic meningitis due to metastatic cancers. It maintains cytotoxic concentrations of free cytarabine in the cerebrospinal fluid for more than 14 days following a single injection. In two randomized clinical trials DepoCyte® was compared to standard formulation of cytarabine, showing a better time to neurologic progression and survival trend in favor of DepoCyte®, associated with an improved mean change about quality of life in Karnofsky performance score. The innovative technology and the efficacy of DepoCyte® allow to frame some interesting pharmacoeconomical consequences: the results of the present work showed that DepoCyte® is more expensive but also more effective than standard formulation, and the new formulation-correlated improvement in the patients’ quality of life seems to justify the difference between the costs of the two alternatives.

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Beteinakis, Stavros, Anastasia Papachristodoulou, Peter Kolb, Paul Rösch, Stephan Schwarzinger, Emmanuel Mikros, and Maria Halabalaki. "NMR-Based Metabolite Profiling and the Application of STOCSY toward the Quality and Authentication Assessment of European EVOOs." Molecules 28, no. 4 (February 11, 2023): 1738. http://dx.doi.org/10.3390/molecules28041738.

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Extra virgin olive oil (EVOO) possesses a high-value rank in the food industry, thus making it a common target for adulteration. Hence, several methods have been essentially made available over the years. However, the issue of authentication remains unresolved with national and food safety organizations globally struggling to regulate and control its market. Over the course of this study, the aim was to determine the origin of EVOOs suggesting a high-throughput, state-of-the-art method that could be easily adopted. A rapid, NMR-based untargeted metabolite profiling method was applied and complemented by multivariate analysis (MVA) and statistical total correlation spectroscopy (STOCSY). STOCSY is a valuable statistical tool contributing to the biomarker identification process and was employed for the first time in EVOO analysis. Market samples from three Mediterranean countries of Spain, Italy, and Greece, blended samples from these countries, as well as monocultivar samples from Greece were analyzed. The NMR spectra were collected, with the help of chemometrics acting as “fingerprints” leading to the discovery of certain chemical classes and single biomarkers that were related to the classification of the samples into groups based on their origin.

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Mykhailenko, O. O. "Investigation of the biological active compounds of crocus sativus stigmas (saffron) from Ukraine." Farmatsevtychnyi zhurnal, no. 6 (December 21, 2019): 70–76. http://dx.doi.org/10.32352/0367-3057.6.19.08.

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Saffron, the most expensive spice in the world, comes from the Crocus sativus stigmas. Saffron grows well in the areas with the cold winters and warm dry summers, which have a positive effect on the quality of the raw material obtained. This explains the interest in saffron cultivation and production in Ukraine. Since 2015, large-scale saffron cultivation for food purposes has been started in various regions of Ukraine. Cultivation methods, environmental factors of different regions differ and directly affect on the composition and quality of biologically active compounds of raw materials. In addition, according to recent pharmacological studies, saffron stigma exhibit a wide range of biological activity: anticancer, anti-inflammatory, antidiabetic, antihypertensive, anticonvulsant and other actions that are caused by the composition of biologically active compounds of the saffron stigmas – crocin, picrocrocin and safranal. Therefore, the aim of the work was to establish the content of crocin, safranal and picrocrocin in Crocus rstigmas grown in different regions of Ukraine in accordance with the requirements of ISO 3632. For research, we used saffron stigmas (Crocus sativus L.) harvested in Kherson, Zaporizhia, Vinnytsia, Odessa, Chernihiv regions in Ukraine in October 2018 and the sample of commercial saffron from Italy (Migros Bio, 2018). The quality of the raw material was established in accordance with ISO 3632 according to the indicators: weight loss of drying, ash total, content of picrocrocin, crocin and safranal by UV-Vis spectroscopy. In the saffron samples the weight loss of during and the ash total ranged from 6.7–9.2% to 4.3–6.4%, respectively. The content of picrocrocin ( 257 нм nm) in saffron samples ranged from 90 in Kherson and up to 101 in the Chernihiv sample; safranal content ( 330 nm) ranged from 34 for Chernihiv to 42 in the Kherson sample; crocin content ( 440 nm) of 228 in Vinnitsa and up to 262 in Zaporozhye. The obtained data showed that all samples of Ukrainian saffron belong to the first quality category according to ISO classification. In the commercial sample from Italy, the test showed a high content of safranal (330 nm was 59) and crocin (440 nm was 259). Different values between regions and a commercial sample are usually due to different environmental conditions and cultivation practices. Crocus sativus is an important medicinal and food plant that has been successfully cultivated in Ukraine for food purposes and is of great economic importance. The quality of Ukrainian saffron from different regions has been determined to ISO 3632. The 2018 crop samples are in compliance with international standards and are of category I. It is important that crocin and safranal exhibit high anticancer and antioxidant activity, so growing in our country stable high content of BACs, makes it possible to use saffron not only in the food industry, but also makes it a potentially relevant raw material for the pharmaceutical industry. This study provides significant information on the quality and prospects of saffron production in Ukraine, as both the food and pharmacological raw materials.

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Cozzolino, Rosaria, José S. Câmara, Livia Malorni, Giuseppe Amato, Ciro Cannavacciuolo, Milena Masullo, and Sonia Piacente. "Comparative Volatilomic Profile of Three Finger Lime (Citrus australasica) Cultivars Based on Chemometrics Analysis of HS-SPME/GC–MS Data." Molecules 27, no. 22 (November 14, 2022): 7846. http://dx.doi.org/10.3390/molecules27227846.

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Finger lime is receiving growing attention as an ingredient of gastronomic preparations of haute cuisine for its delicious flavor and fragrance and for its appealing aspect. Volatile compounds play a crucial role in determining the organoleptic characteristics of the fruit and its pleasantness for consumers. The aim of the present study was to investigate the volatile profiles by headspace solid phase micro-extraction (HS-SPME) coupled to gas chromatography–mass spectrometry (GC–MS) in the peel and, for the first time, in the pulp of three Australian finger lime cultivars grown in Sicily (southern Italy): Pink Pearl, Sanguinea, and Faustrime, allowing to overall identify 84 volatile organic compounds (VOCs). The analytical data showed that the three cultivars were characterized by distinct volatile chemotypes: limonene/sabinene/bicyclogermacrene in the Pink Pearl, limonene/γ-terpinene/bicyclogermacrene in the Sanguinea, and limonene/β-phellandrene/γ-terpinene in the Faustrime. Moreover, some volatiles, found exclusively in one cultivar, could be considered potential markers of the individual cultivar. PCA allowed us to clearly discriminate the samples into three clusters: the first related to the Sanguinea peel, the second to the Faustrime peel, and a third group associated with the Pink Pearl peel along with the pulp of the three cultivars. Accordingly, the VOCs that mostly contributed to the differentiation of the three finger lime cultivars were also identified. Among them, D-limonene, sabinene γ-terpinene, α-pinene, α-phellandrene, β-myrcene, p-cymene, linalool, δ-elemene, ledene, bicyclogermacrene β-citronellol, α-bergamotene, α-caryophillene, and β-bisabolene, have been previously reported to exhibit important biological activities, suggesting that these cultivars, in addition to possessing unique volatile profiles, can show promise for several applications in pharmaceutical and food industry, namely for development of functional foods.

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Monleon, Clara, Mondher Toumi, Hans-Martin Späth, Claude Dussart, and Carlos Crespo. "PP114 The Influence Of Implicit Factors On The Health Technology Assessment Deliberative Process: A Survey In Five European Countries." International Journal of Technology Assessment in Health Care 38, S1 (December 2022): S78. http://dx.doi.org/10.1017/s0266462322002379.

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IntroductionImplicit factors can be defined as any criteria that play a role in the health technology assessment (HTA) deliberative process but are not part of the HTA framework. To date, very few studies have explored the influence of implicit factors on this process. This survey of HTA experts in five European countries aimed to analyze the influence of implicit factors on the HTA deliberative process.MethodsSemi-structured interviews with 20 HTA experts from five European countries (France, Germany, Italy, Spain, and the United Kingdom) were conducted from February to May 2021. The main topics of the interviews were: the HTA deliberative process; the degree of influence on the HTA deliberative process of a set of factors previously identified in a systematic literature review performed by the authors; and recommendations for improving the deliberative process.ResultsAll but two of the experts concurred that implicit factors played a role in the deliberative process. German experts considered that the factors explored had a low influence on the process. Burden of disease and unmet need scored highest, followed by the professional experience of the people involved in the HTA deliberative process. To improve the deliberative process, experts suggested expanding the external stakeholder perspective (i.e., including patients, the pharmaceutical industry, and the public), increasing transparency when revealing implicit factors, and implementing a methodology to mitigate the influence of implicit factors.ConclusionsOur survey indicates a need to increase external involvement in the process and to develop a methodology for unmasking the implicit factors in the deliberative process. This may be achieved by either updating the current frameworks to include these implicit factors or by developing new methods to address them. Further research may explore approaches to acknowledge the implicit factors in the HTA deliberative process in a systematic manner.

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Bianchini, Petra, Francesca Merlo, Federica Maraschi, Rosaria Brescia, Mirko Prato, Antonella Profumo, and Andrea Speltini. "From Rice Husk Ash to Silica-Supported Carbon Nanomaterials: Characterization and Analytical Application for Pre-Concentration of Steroid Hormones from Environmental Waters." Molecules 28, no. 2 (January 11, 2023): 745. http://dx.doi.org/10.3390/molecules28020745.

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Rice husk (RH) in the rice industry is often air-burnt to obtain energy in the form of heat and RH ash (RHA) residue. In this work, RHA was applied as a starting material to obtain silica-supported carbon nanomaterials, resulting in a new reuse of a globally produced industrial waste product, in a circular economy approach. The preparation involves ultrasound-assisted one-pot oxidation with a sulfonitric mixture followed by wet oven treatment in a closed vessel. A study of oxidation times and RHA amount/acid volume ratio led to a solid material (nC-RHA@SiO2) and a solution containing silica-supported carbon quantum dots (CQD-RHA@SiO2). TEM analyses evidenced that nC-RHA@SiO2 consists of nanoparticle aggregates, while CQD-RHA@SiO2 are carbon-coated spherical silica nanoparticles. The presence of oxygenated carbon functional groups, highlighted by XPS analyses, makes these materials suitable for a wide range of analytical applications. As the main product, nC-RHA@SiO2 was tested for its affinity towards steroid hormones. Solid-phase extractions were carried out on environmental waters for the determination of target analytes at different concentrations (10, 50, and 200 ng L−1), achieving quantitative adsorption and recoveries (RSD < 20%, n = 3). The method was successfully employed for monitoring lake, river, and wastewater treatment plant water samples collected in Northern Italy.

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Jommi, Claudio, Federico Pantellini, Lisa Stagi, and Marianna Cavazza. "Economic impact of compassionate use of medicines." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): e18840-e18840. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.e18840.

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e18840 Background: The economic impact of clinical trials in the perspective of trial sites has been already investigated. Instead, there is no evidence on the economic net benefit of compassionate use programs for medicines (CUP). This research aims to fill the information gap, investigating the economic consequences of 8 CUP in Italy carried out from May 2015 to December 2020 in the hospitals’ perspective. These programs concern five cancer medicines (alectinib, atezolizumab, cobimetinib, polatuzumab vedotin, trastuzumab emtansine TDM-1), for a total of 8 programs. Methods: Economic net benefit includes avoided costs for standard of care (SoC) the patient would have received if he/she has not joined the CUP and costs not covered by the pharmaceutical industry and sustained by the hospital hosting CUP. The latter include costs of adverse event (only severe sides effects generating hospitalisation and ascribed to medicines used in CUP), combination therapies and diagnostic procedures not covered by the sponsor. SoC costing relied on publicly available estimation. Adverse events and diagnostic procedures were retrieved from the CUP and monetized using the relevant fee for episode. Results: 1635 cancer patients were treated in eight CUPs. The SoC mean cost per patient ranges from €13355 to €28098 for all cancer drugs. The total cost of the SoC ranges from €21.8 - €45.9 million. The mean cost per patient covered by hospitals hosting CUP was equal to €2732 for cancer drugs, with a total cost of €4.5 million. The net economic benefit ranges from €17.4 million to €41.5 million for cancer treatments. Conclusions: Despite its limitations this paper illustrates for the first time the net economic impact of CUP in oncology patients in the perspective of payers. Additional evaluations are ongoing to better understand the overall effects of CUP implementation, i.e. the economic value of the comparative benefit profile of medicines used in CUP versus the SoC, including potential effects on indirect costs.

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Khan, Abdullah M. "Trends in innovation activities in manufacturing industries across development echelons." International Journal of Business and Social Research 7, no. 6 (July 7, 2017): 13. http://dx.doi.org/10.18533/ijbsr.v7i6.1057.

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<p>This empirical paper explores trends in innovation activities measured by a countries’ total patent application submission intensity relative to its population, and by analyzing U.S. granted patents data for cohorts of developed countries and developing countries. In addition to tabular and graphical analyses, I use a baseline regression model and a variant model thereof to assess the relative influence of a set of aggregate variables on innovation activities in eight manufacturing industries across two cohorts of countries (developed and developing) where each cohort contains eight individual countries. Eight industries included in this study are: Chemical, Petroleum, electrical and electronics equipment, machinery, pharmaceutical, plastic, computer, and textile. The cohort of developed countries includes Australia, Canada, Czech Republic, France, Italy, Poland, Switzerland, and the United States. The cohort of developing countries includes Brazil, China, India, Malaysia, Mexico, Russia, South Africa, and Turkey. Per regression results, ethnic diversity is a statistically significant positive determinant of innovation for all industry aggregate patent count for both high income and developing countries. Also, per capita electricity usage, R&D expenditure as percent of GDP, and percent of population with internet access are three positive factors of innovation irrespective of industrial subsectors and position of a country in the development echelon. Interestingly, impact of ICT-services export is statistically significant and innovation boosting in developing countries in the cohort relative to countries in the cohort of developed countries. It also appears that trade openness served as a stronger stimulant of innovation activities for developing countries’ but not as much for the cohort of developed or high-income countries. This paper attempts to extend the literature on cross-country comparison of innovation activities by using two measures of innovation activities across developed and developing countries, and by analyzing both aggregate and sector-level data for eight manufacturing industries both graphically and utilizing panel regression models. </p>

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Molokhova, E. I., E. I. Ponomareva, Yu V. Sorokina, I. V. Alekseeva, T. E. Ryumina, V. V. Novikova, A. L. Golovanenko, E. S. Berezina, and Yu M. Ladutko. "Experimental substantiation of the composition of gelatin mass for obtaining capsules with essential oils." Drug development & registration 10, no. 4 (December 24, 2021): 63–68. http://dx.doi.org/10.33380/2305-2066-2021-10-4(1)-63-68.

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Introduction. Soft gelatin capsules are a promising dosage form comprising essential oils as active agents. Joint research of the staff of the Perm State Pharmaceutical Academy, the Research Institute of Nutrition of the Ministry of Energy and Industry of the Republic of Tajikistan have proposed the composition of gelatin mass for encapsulation by the rotary matrix method. The mechanical and physical-technological parameters required to preserve the strength and elasticity of the capsule shell during the production process and storage are determined.Aim. Study of the rheological properties of gelatin masses based on gelatin of different grades, as well as the migration of essential oils through capsule shells.Materials and methods. Pharmaceutical active substances "Lipovitol" and "Limoneol" obtained in the Republic of Tajikistan were used as active substances introduced into the composition of soft gelatin capsules. Sunflower oil was used as the solvent. Gelatin samples were used to obtain gelatin masses: 1 – Foodchem (China), 2 – Brodnickie Zaklady Zelatyny Sp. zo.o. (Poland), 3 - Italgelatine s.p.a. (Italy), 4 – Ewald-Gelatine GmbH (Germany), 5 – Weishardt International (France); glycerol; sunflower oil. Gelatin mass for manufacturing soft capsules was prepared in a closed reactor. Capsules were prepared on an automatic encapsulation line RJWJ – 115 Soft Gelatin Encapsulator Machine (China). The structural and mechanical properties of soft gelatin masses were determined on a rotary viscometer RV type "Reotest 2" (Germany). The dynamics of the process of migration of essential oils and its components were studied by changing their amount in a capsule by chromato-mass spectrometry method on a chromatograph Varian CP 3800 with a quadrupole mass spectrometer 4000 MS as a detector (USA).Results and discussion. When studying the rheological properties of model compositions, it was found that for all samples of gelatin masses there is a decrease in values of effective viscosity when the shear rate increases, which characterizes the tested samples as a structured dispersion system. Additional studies have shown that the gelatin masses have thixotropic properties. Samples of gelatin masses 3–5 had narrower hysteresis loops, while sample 5 the narrowest, restoration of the structure took place quite quickly. Capsules obtained from gelatin mass 3 and 4 samples had a strong seam and were well cut out of the tape. From the mass of sample 5, high strength ribbons were obtained, a high temperature was required to seal the capsules, in some capsules the seam was not glued on one side, as a result, the capsules were rigid and brittle. As a result of the study, the rheological optimum of the gelatin mass suitable for preparing capsules by a rotary matrix method was determined, which has boundaries in the ranges of shear rates of 0.556–243 s-1 and viscosity ranges of 11.46-5028.76 Pa ⋅ s and shear stress of 2788–2808 Pa developing at these rates. When studying the migration of active substances through the capsule shell, it was found that over three years of storage of capsules in a closed polymer can, the content of essential oil in Lipovitol capsules decreased by 4.88 %, in Limoneol capsules by 5 %, which indicates partial migration of oil through the gelatin shell. The content remained within the permissible deviations (±10 %). The content of essential essential oil components also remained within acceptable deviations throughout the shelf life.Conclusion. The optimal composition of the shell for producing soft capsules by a rotary matrix method is justified. It was found that the rheological optimum of gelatin mass is characterized by viscosity ranges of 11.46-5028.76 Pa ⋅ s and shear stress of 2788–2808 Pa. According to the results of the study of the migration of essential oils through the shell, has been established the shelf life of soft gelatin capsules in glass jars made of dark glass and a temperature of 15 to 25 °C – 3 years.

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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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Cornago, Dante, and Livio Garattini. "Analisi comparativa del mercato dei dispositivi per incontinenza in cinque paesi europei." Farmeconomia. Health economics and therapeutic pathways 1, no. 2 (June 15, 2000): 103–10. http://dx.doi.org/10.7175/fe.v1i2.714.

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The aim of the paper is to compare and valutate the market of the incontinence devices in five European countries: Italy, France, Germany, U.K. and Denmark. We chose incontinence devices because they are strictly connected with the development of the home delivery. France, Germany and U.K. has been analysed for their politic and territorial importance, while Denmark has been considered for its home assistance system. A common pattern has been applied in every country: first of all there is a general outline of the legislative aspect of the incontinence devices, then the study presents prescription procedure and the different models of distribution. Finally, it shows the competitive systems of the pharmaceuticals industry in every single country. The necessary information has been gathered through relevant literature and interviews with the area operators. The incontinence devices are repayable in all the studied countries, except from France. Every country has different health system (Italy, U.K and Denmark had a public health system; France and Germany has a mutualist health system). There isn’t an evident correlation between the type of the health system and the market of the incontinence devices.

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Seror, R., G. Baron, M. Camus, D. Cornec, E. Perrodeau, S. J. Bowman, M. Bombardieri, et al. "OP0286 DEVELOPMENT AND PRELIMINARY VALIDATION OF THE SJÖGREN’S TOOL FOR ASSESSING RESPONSE (STAR): A CONSENSUAL COMPOSITE SCORE FOR ASSESSING TREATMENT EFFECT IN PRIMARY SJÖGREN’S SYNDROME." Annals of the Rheumatic Diseases 81, Suppl 1 (May 23, 2022): 189.2–190. http://dx.doi.org/10.1136/annrheumdis-2022-eular.2583.

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BackgroundToday, there are still no DMARDs licensed for primary Sjögren Syndrome (pSS) patients. Among the explanations, are the limitations of current outcome measures used as primary endpoints: e.g; high placebo response rate, evaluation of either symptoms or systemic activity, and important features not being assessed. The NECESSITY consortium (https://www.necessity-h2020.eu/), including pSS experts from academia, pharmaceutical industry and patient groups formed to develop a new composite responder index, the Sjögren’s Tool for Assessing Response (STAR) that solve the issues of current outcome measures in pSS and is intended for use in clinical trials as an efficacy endpoint.ObjectivesTo develop a composite responder index in primary Sjögren’s syndrome (pSS): the STAR.MethodsTo develop the STAR, the NECESSITY consortium used data-driven methods, based on 9 randomized controlled trials (RCTs), and consensus techniques, involving 78 experts and 20 patients. Based on reanalysis of rituximab trials (TRACTISS and TEARS) and literature review, the Delphi panel identified a core set of domains to include in the STAR, with their respective outcome measures. STAR options combining these domains were designed and proposed to the panel to select and improve them. For each STAR option, sensitivity to change was estimated by the C-index (derived from Effect size) in all 9 RCTs. Delphi rounds were run for selecting STAR among these options. The Delphi panel also voted to classify trials as positive, negative or “in between” in regards to primary but also key secondary endpoints. For the options remaining before the final vote, meta-analyses of the RCTs were performed separately for positive and “in between” trials together, and for negative trials.ResultsThe Delphi panel identified 5 core domains (systemic activity, patient symptoms, lachrymal gland function, salivary gland function and biological parameters), and 227 STAR options, combining these domains, were selected to be tested for sensitivity to change. After two Delphi rounds, meta-analyses of the 20 remaining options were performed. The candidate STAR was selected by a final vote based on metrological properties and clinical relevance. In positive/in between trials, candidate STAR detected a difference between arms (OR 3.29, 95%-CI [2.07;5.22], whereas it did not in negative trials (OR 1.53, 95%-CI [0.81;2.91]).ConclusionThe candidate STAR is a composite responder index, including in a single tool all main disease features, and is designed for use as a primary endpoint in pSS RCTs. Its rigorous and consensual development process ensures its face and content validity. The candidate STAR showed good sensitivity and specificity to change. The candidate STAR will be prospectively validated in a dedicated three arms RCT of the NECESSITY consortium that will evaluate combination of synthetic DMARDs (hydroxychloroquine + lefunomide or hydroxychloroquine + mycophenolate vs placebo). We encourage the use of STAR in any ongoing and future trials.Table 1.Candidate STARDomainPointDefinition of responseSystemic activity3Decrease of clinESSDAI ≥ 3Patient reported outcome3Decrease of ESSPRI ≥ 1 point or ≥ 15%Lachrymal gland function1Schirmer:If abnormal score at baseline: increase ≥ 5 mm from baselineIf normal score at baseline: no change to abnormalOrOcular Staining Score:If abnormal score at baseline: decrease ≥ 2 points from baselineIf normal score at baseline: no change to abnormalSalivary gland function1Unstimulated Whole Salivary Flow:If score > 0 at baseline: increase ≥ 25% from baselineIf score is 0 at baseline: any increase from baselineorUltrasound:Decrease ≥ 25% in total Hocevar score from baselineBiological1Serum IgG levels: decrease ≥ 10%orRheumatoid Factor levels: decrease ≥ 25%Candidate STAR responder≥ 5 pointsESSDAI: EULAR Sjögren syndrome disease activity index; ESSPRI: EULAR Sjögren syndrome patient reported index; IgG: Immunoglobulin G;AcknowledgementsNECESSITY WP5 STAR development participants: Suzanne Arends (University Medical Center Groningen, Department of Rheumatology and Clinical Immunology, Groningen 9700 RB, Netherlands), Francesca Barone (Centre for Translational Inflammation Research, Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK), Albin Björk (Division of Rheumatology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden), Coralie Bouillot (Association Française du Gougerot Sjögren et des Syndromes Secs, France), Guillermo Carvajal Alegria (University of Brest, Inserm, CHU de Brest, LBAI, UMR1227, Brest, France; Service de Rhumatologie, Centre de Référence Maladies Autoimmunes Rares CERAINO, CHU Cavale Blanche, Brest, France), Wen-Hung Chen (GlaxoSmithKline, Research Triangle Park, North Carolina, USA), Kenneth Clark (GlaxoSmithKline Medicines Research Centre, Gunnels Wood Road, Stevenage, Hertfordshire SG1 2NY, United Kingdom), Konstantina Delli (Department of Oral and Maxillofacial Surgery, University Medical Center Groningen (UMCG), University of Groningen, The Netherlands), Salvatore de Vita (Rheumatology Clinic, University Hospital of Udine, Italy), Liseth de Wolff (University Medical Center Groningen, Department of Rheumatology and Clinical Immunology, Groningen 9700 RB, Netherlands), Jennifer Evans (Novartis Pharmaceuticals corporation USA), Stéphanie Galtier (Institut de Recherches Internationales Servier (IRIS), Suresnes Cedex, France), Saviana Gandolfo (Rheumatology Clinic, Department of Medical area, University of Udine, ASUFC, 33100 Udine, Italy), Mickael Guedj (Institut de Recherches Internationales Servier (IRIS), Suresnes Cedex, France), Dewi Guellec (CHU de Brest, Service de Rhumatologie, Inserm, CIC 1412, Brest, France), Safae Hamkour (Center of Translational Immunology, Department of Immunology, University Medical Center Utrecht, Utrecht 3584 GA, Netherlands), Dominik Hartl (Novartis Institutes for BioMedical Research, Basel, Switzerland), Malin Jonsson (Section for Oral and Maxillofacial Radiology, Department of Clinical Dentistry, Faculty of Medicine and Dentistry, University of Bergen, Norway), Roland Jonsson (Broegelmann Research Laboratory, Department of Clinical Science, University of Bergen, Department of Rheumatology, Haukeland University Hospital, Bergen, Norway), Frans Kroese (University Medical Center Groningen, Department of Rheumatology and Clinical Immunology, Groningen 9700 RB, Netherlands), Aike Albert Kruize (University Medical Center Utrecht, Department Rheumatology and Clinical Immunology, Utrecht, Netherlands), Laurence Laigle (Institut de Recherches Internationales Servier (IRIS), Suresnes Cedex, France), Véronique Le Guern (AP-HP, Hôpital Cochin, Centre de référence maladies auto-immunes et systémiques rares, service de médecine interne, Paris, France), Wen-Lin Luo (Department of Biometrics and Statistical Science, Novartis Pharmaceuticals, East Hanover, New Jersey), Esther Mossel (University Medical Center Groningen, Department of Rheumatology and Clinical Immunology, Groningen 9700 RB, Netherlands), Wan-Fai Ng (Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne NE2 4HH, UK), Gaëtane Nocturne (Department of Rheumatology, Université Paris-Saclay, INSERM U1184: Centre for Immunology of Viral Infections and Autoimmune Diseases, Assistance Publique-Hôpitaux de Paris, Hôpital Bicêtre, Le Kremlin Bicêtre, Paris, France), Marleen Nys (Global Biometric Sciences, Bristol Myers Squibb, Braine L’Alleud, Belgium), Roald Omdal (Clinical Immunology Unit, Department of Internal Medicine, Stavanger University Hospital, PO Box 8100, 4068, Stavanger, Norway), Jacques-Olivier Pers (LBAI, UMR1227, University of Brest, Inserm, Brest, France and CHU de Brest, Brest, France), Maggy Pincemin (Association Française du Gougerot Sjögren et des Syndromes Secs, France), Manel Ramos-Casals (Department of Autoimmune Diseases, Hospital Clinic de Barcelona Institut Clinic de Medicinai Dermatologia, Barcelona, Catalunya, Spain), Philippe Ravaud (Centre d’Epidémiologie Clinique, Hôpital Hôtel-Dieu, Assistance Publique-Hôpitaux de Paris, Paris, France), Neelanjana Ray (Global Drug Development - Immunology, Bristol Myers Squibb Company, Princeton, New Jersey, USA), Alain Saraux (HU de Brest, Service de Rhumatologie, Univ Brest, Inserm, UMR1227, Lymphocytes B et Autoimmunité, Univ Brest, Inserm, LabEx IGO, Brest, France), Athanasios Tzioufas (Rheumatology Clinic, Department of Medical area, University of Udine, ASUFC, 33100 Udine, Italy), Gwenny Verstappen (University Medical Center Groningen, Department of Rheumatology and Clinical Immunology, Groningen 9700 RB, Netherlands), Arjan Vissink, Marie Wahren-Herlenius (Division of Rheumatology, Department of Medicine, Karolinska Institutet, Stockholm, Sweden). We thank the following experts: Esen Karamursel Akpek, Alan Baer, Chiara Baldini, Elena Bartoloni, Marí-Alfonso Begona, Johan Brun, Vatinee Bunya, Laurent Chiche, Troy Daniels, Paul Emery, Robert Fox, Roberto Giacomelli, John Gonzales, John Greenspan, Robert Moots, Susumu Nishiyama, Elizabeth Price, Christophe Richez, Caroline Shiboski, Roser Solans Laque, Muthiah Srinivasan, Peter Olsson, Tsutomu Takeuchi, Frederick Vivino, Paraskevi Voulgari, Daniel Wallace, Ava Wu, Wen Zhang. We thank the anonymous patients from the NECESSITY Patient Advisory Group and the Sjögren Foundation for their valuable contribution to the Delphi process. We thank EW StClair and AN Baer who generated the baminercept data and made them publicly available.Disclosure of InterestsRaphaèle Seror Consultant of: GlaxoSmithKline, Boehringer, Janssen and Novartis, Grant/research support from: GlaxoSmithKline and Amgen, Gabriel Baron: None declared, Marine Camus: None declared, Divi Cornec Consultant of: GlaxoSmithKline, Bristol Myers Squibb, Janssen, Amgen, Pfizer and Roche, Elodie Perrodeau: None declared, Simon J. Bowman Consultant of: Abbvie, Astra Zeneca, Galapagos and Novartis Pharmaceuticals, Michele Bombardieri Consultant of: UCB, Amgen/Medimmune, Janssen, and GlaxoSmithKline, Grant/research support from: Amgen/Medimmune, Janssen, and GlaxoSmithKline, Hendrika Bootsma: None declared, Jacques-Eric Gottenberg Consultant of: AbbVie, Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Pfizer, Roche, Sanofi, Novartis, MSD, CSL-Behring and Genzyme, Grant/research support from: Bristol Myers Squibb, Benjamin Fisher Speakers bureau: Bristol Myers Squibb and Novartis, Consultant of: Novartis, Bristol Myers Squibb, Janssen and Servier, Grant/research support from: Servier, Galapagos and Janssen, Wolfgang Hueber Shareholder of: Novartis Pharma, Employee of: Novartis Pharma, Joel van Roon: None declared, Valerie Devauchelle-Pensec: None declared, Peter Gergely Shareholder of: Novartis Pharma, Employee of: Novartis Pharma, Xavier Mariette Consultant of: Bristol Myers Squibb, Galapagos, GlaxoSmithKline, Janssen, Novartis, Pfizer and UCB, Grant/research support from: Ose Pharmaceuticals, Raphaël Porcher: None declared

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Delahaye, Lisa, Salvatore Calogero, Cara Gunning, Terence Hetzel, Tessa McDonald, Coral Munday, Michele Protti, et al. "Feedback from the Sixth European Bioanalysis Forum Young Scientist Symposium." Bioanalysis 13, no. 9 (May 2021): 669–74. http://dx.doi.org/10.4155/bio-2021-0051.

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As part of the European Bioanalysis Forum mission to provide development opportunities for scientists, a Young Scientist Symposium has been organized every year since 2014. The meetings, organized by and for young scientists, aim at immersing talent from industry and academia in the scientific and process challenges important for their (future) professional environment. In an ideal world, the setting of an interactive symposium in stimulating auditorium sets the foundation for long lasting peer scientific relationship. This year, a pandemic has descended across all continents, changing the dynamics of the meeting. This manuscript summarizes the discussions at the Sixth EBF Young Scientist Symposium, originally planned as a face-to face event in March 2020 in Bologna, Italy but finally executed as a hybrid meeting in Cyberspace and on location in a few regions across Europe between 24–25 September 2020.

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Bottinelli, Marco, Michele Gastaldelli, Micaela Picchi, Arianna Dall’Ora, Lorena Cristovao Borges, Ana Sofía Ramírez, Andrea Matucci, and Salvatore Catania. "The Monitoring of Mycoplasma gallisepticum Minimum Inhibitory Concentrations during the Last Decade (2010–2020) Seems to Reveal a Comeback of Susceptibility to Macrolides, Tiamulin, and Lincomycin." Antibiotics 11, no. 8 (July 29, 2022): 1021. http://dx.doi.org/10.3390/antibiotics11081021.

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Mycoplasma gallisepticum (Mg) is a highly contagious avian pathogen responsible for significant economic losses for the poultry industry. In some circumstances, antimicrobial treatment is useful to contain clinical signs of Mg infection in birds. However, antimicrobial resistance emergence is now common among animal pathogens, becoming a worldwide health concern. The collection of minimum inhibitory concentration (MIC) data is fundamental for an appropriate antimicrobial use and for fighting antimicrobial resistance emergence. However, MIC data can only be generated in specialized laboratories, and therefore they are not regularly available. MICs of 67 non-vaccine-derived Mg isolates collected in Italy between 2010 and 2020 were obtained. Although 79.1% of the Mg isolates showed enrofloxacin MICs ≥ 8 µg/mL, a statistically significant trend toward low MICs of erythromycin, tylosin, tilmicosin, spiramycin, tiamulin, and lincomycin was observed, indicating a comeback to susceptibility of Mg toward these drugs. Doxycycline proved to be slightly more effective than oxytetracycline. The present study shows that Mg changed its susceptibility toward many of the drugs most commonly used for its containment over a ten-year period.

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Attili, Anna-Rita, Alessandro Bellato, Patrizia Robino, Livio Galosi, Cristiano Papeschi, Giacomo Rossi, Eleonora Fileni, et al. "Analysis of the Antibiotic Resistance Profiles in Methicillin-Sensitive S. aureus Pathotypes Isolated on a Commercial Rabbit Farm in Italy." Antibiotics 9, no. 10 (October 5, 2020): 673. http://dx.doi.org/10.3390/antibiotics9100673.

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The breeding of meat rabbits is an important sector in the livestock industry in Italy. The focus of this study was to describe the antibiotic resistance profile distribution among the Methicillin-sensitive Staphylococcus aureus isolated in a rabbit farm. From 400 animals of different ages and three farm workers, 96 randomly selected strains isolated from various anatomical sites and lesions were analysed. According to spa typing and the resistance profiles towards veterinary and human antibiotics, 26 pathotypes were identified. The highest resistance was observed against Tetracyclines (92.3%) and Macrolides (80.8%), while almost all were susceptible to Penicillins, according to the limited use of β-lactams on the farm. In total, 92.3% of pathotypes were multidrug resistant (MDRs). Two MDR pathotypes belonging to the t2802 spa type were isolated from both farmers and rabbits. Age categories harboured significantly different pathotypes (p = 0.019), while no association was found between pathotypes and lesions (p = 0.128) or sampling sites (p = 0.491). The antibiotic resistance was observed to increase with the time spent in the farm environment (age category). The selective pressure exerted by antibiotic use acted by giving advantage to more resistant strains rather than by lowering susceptibility to various drug categories within strains.

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Pylypchuk, Oleh, Oleh Strelko, and Yulia Berdnychenko. "PREFACE." History of science and technology 10, no. 2 (December 12, 2020): 160–62. http://dx.doi.org/10.32703/2415-7422-2020-10-2-160-162.

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The year 2020, verging to a close, is one of the most difficult and hardest years in the life of mankind over the last century. Unfortunately, it is in the 20th year of each century for the last several hundred years that human civilization has been suffering from another global pandemic (to say nothing of local and regional pandemics)… Several pandemics of plague killed at least 300 million people, and the highest incidence in Europe occurred in 1720‒1722. In 1817‒1824, the First Cholera Pandemic spread across the world. One hundred years later, in 1918‒1920, fifty million lives worldwide were claimed by the Spanish flu (H1N1). For a year now, starting in December 2019 and throughout 2020, the entire world is fighting the 21st century pandemic – the global COVID-19 outbreak caused by the SARS-CoV-2 coronavirus. Despite all the difficulties that humanity faces today, life goes on, and the world scientific community is persistently looking for ways to get out of the latest pandemic trap. The world has learned the lessons of pandemics and learned to use the acquired knowledge and scientific legacy of past generations. This led to a quick response to the challenges that life presents us. In December 2020, at this writing, several pharmaceutical companies have already announced the invention of vaccines and the final stages of their trials. We hope that our esteemed authors and readership will witness yet another victory of science over the world's evil. 10 years ago to the day, creation of the History of Science and Technology journal began. Therefore, we would like to summarize some of the work undertaken over the years. The first issue of History of Science and Technology was published in 2011. The founder of the journal was the State Economy and Technology University of Transport. State Economy and Technology University of Transport was one of the three universities in Ukraine that mainly trained specialists for the railway industry. It is the teachers, students and staff of the State Economy and Technology University of Transport who became the primary authors of the first journal issues. Therefore, in the first years after the journal was created, its focus on the study of the history of the development of railway transport and related areas was apparent. Back then the journal was titled History of Science and Technology: Collection of scientific papers of the State Economic and Technological University of Transport. Printed versions of the journal were regularly distributed in libraries of higher educational institutions and research institutions of Ukraine. The electronic version of the full-text issue of the journal (without division into separate articles) was posted on the University library website. Gradually, the journal began to gain popularity, and as far back as in 2013‒2015 it received a large audience of readers and authors across regions and organizations from all over Ukraine. Accordingly, the themes of the articles changed, being no longer limited to rail transport, but extended to the study of the history of all branches of science and various technologies instead. In 2016, the journal History of Science and Technology replaced its founder. It was the State University of Infrastructure and Technologies which was established through the decree of Ukrainian government dated February 29, 2016 by way of merger of two metropolitan higher educational institutions – Kyiv State Maritime Academy named after hetman Petro Konashevych-Sahaidachnyi and State Economy and Technology University of Transport. Accordingly, the name of the journal has changed into History of Science and Technology: Collection of scientific papers of State University of Infrastructure and Technologies. The next stage in the life of the journal was the creation of its separate website in March 2018. Since then, work has begun on a deeper reform of the journal, which continues to this day. History of Science and Technology journal is constantly changing. Thus, steps have been taken to improve the design of the journal and bring it into line with internationally recognized standards. The composition of the journal's editorial board has undergone significant personnel changes. In April 2019, it underwent state re-registration of the print media and acquired its current name – History of Science and Technology journal. However, fundamental steps have been taken towards filling the journal with original and high-qualty scientific content that would be of interest not only to the Ukrainian reader but also to foreign reader. Strict analysis in the selection of articles, strict plagiarism policy, independent double-blind peer review, as well as numerous other steps and innovations, have affected the number of published articles. If in 2019 approximately 25% of submitted articles were rejected, in 2020 this figure reaches almost 60%. Although hopefully, a change in quality of articles for the better followed the change in their number. They have really become interesting to the international world community, as evidenced by statistics on daily visits to the journal's website by representatives from around the world. The journal generated interest among authors from different countries and continents. In the first issue of History of Science and Technology for the year 2020, articles by authors representing universities and research organizations from Ghana, Canada, USA, Spain, Russia and Ukraine were published. Thus, in the second issue of 2020, History of Science and Technology journal introduces its readers to articles by authors from around the world, namely Azerbaijan, India, Indonesia, Italy, Spain and Ukraine. While summing up our 10 years’ work, we would like not to be limited to bare figures. Thus, History of Science and Technology has published 10 volumes and 17 issues over the years, which include more than 400 articles by various authors. And of course, each of these published articles has undergone a great deal of work by authors, editors, reviewers, proof-readers, print workers, etc. All these people primarily have always been trying to make History of Science and Technology journal interesting for you, our Readers! Our team will keep working enthusiastically and persistently on it!

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Ferhanoglu, Burhan, Tae Min Kim, Amado Karduss, David Brittain, Gayane Tumyan, Mubarak Al Mansour, Marta Zerga, et al. "Results from the International, Multi-Center, Retrospective B-Holistic Study: Describing Treatment Pathways and Outcomes for Classical Hodgkin Lymphoma." Blood 136, Supplement 1 (November 5, 2020): 32–34. http://dx.doi.org/10.1182/blood-2020-134885.

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Background: Despite therapeutic advances in classical Hodgkin lymphoma (cHL), only half of patients with relapsed/refractory (R/R) cHL are cured with salvage chemotherapy followed by stem cell transplantation (SCT). Most studies to date have been undertaken in Europe or North America and data on treatment patterns and clinical outcomes from other regions are limited. We present the results from the B-CD30+ HOdgkin Lymphoma International Multi-center Retrospective Study of Treatment PractIces and OutComes (B-HOLISTIC), which assessed cHL treatment pathways, clinical outcomes and healthcare resource utilization across East Asia, Latin America, Middle East, South Africa, Australia and Russia (data as of 04 March 2020). Methods: Data were collected retrospectively for patients (≥18 years) diagnosed with stage IIB-IV cHL or R/R cHL between 01 January 2010 and 31 December 2013, until death or last follow-up (whichever occurred first) across 13 countries. Patients with initial diagnosis of cHL and subsequent progression to R/R cHL were included in both groups, provided R/R cHL was diagnosed within the study period. The primary endpoint was progression-free survival (PFS) in patients with R/R cHL. Secondary endpoints included overall survival (OS), best clinical response, and adverse events (AEs). Results: In total, 1703 patients were enrolled from East Asia (n=426), Latin America (n=366), Middle East and South Africa (n=694), Australia (n=56) and Russia (n=161): 1598 and 426 patients were eligible for the cHL and R/R cHL groups (321 patients in the cHL group progressed to R/R cHL and were included in both groups). Median study follow-up was 65.2 and 53.2 months for the cHL and R/R cHL groups. Baseline patient characteristics are shown in Table 1. All patients in the cHL group received first-line chemotherapy: the most common regimens were ABVD (1363/1598; 85.3%) and BEACOPP (104/1598; 6.5%). First-line radiotherapy was given to 357/1598 (22.3%) patients in the cHL group. For R/R cHL, intensive chemotherapy was used as first-line salvage in 372/426 (87.3%) patients: the most common regimens were ESHAP (98/372; 26.3%) and DHAP (65/372; 17.5%), with an overall response rate of 62.0% (complete remission in 30.8% and partial remission in 31.2%). Of the 426 patients with R/R cHL, 292 (68.5%) were eligible for SCT at relapse/refractory diagnosis; 10 patients who were initially ineligible for SCT subsequently became eligible. In total, 222/302 (73.5%) eligible patients underwent SCT; 63/222 (28.4%) patients relapsed after SCT. Median PFS (95% CI) for the R/R cHL group was 13.2 (9.9-20.2) months following initial therapy (Figure 1), with estimated 1-, 3- and 5-year PFS rates of 51.2%, 38.7%, and 33.9%, respectively (Table 2). Median PFS was not reached for the first-line cHL group. Factors for PFS in the R/R cHL group are shown in Table 3. Median OS was not reached for both groups. All-cause, any grade AEs were reported by 783/1598 (49.0%) patients with cHL and by 233/426 (54.7%) patients with R/R cHL. Serious AEs were reported by 303/1598 (19.0%) patients with cHL and by 103/426 (24.2%) patients with R/R cHL: the most common (≥2.0%) were febrile neutropenia, pneumonia and pyrexia for cHL, and febrile neutropenia and pyrexia for R/R cHL. Conclusion: Results from B-HOLISTIC show that PFS rates remain low in patients with R/R cHL receiving salvage therapy; the greatest risk was among patients with inadequate response to salvage chemotherapy. The low PFS rates highlight the importance of considering novel targeted therapies to address unmet medical needs. PFS rates in patients with cHL were comparable with previous studies from Italy, Spain, and Israel (Avigdor A et al. EHA 2020) and the ECHELON-1 study (Bartlett NL et al. ASH 2019). The higher OS rates compared to PFS rates may be related to the effect of modern salvage regimens. Approximately half of patients with R/R cHL underwent SCT which may support the use of targeted therapies. Overall, these results from 2010-2013 show that despite the differences in healthcare systems, ethnicities and treatment patterns in B-HOLISTIC, clinical outcomes remain consistent. The authors note that given that the management of high-risk cHL has changed dramatically since 2013, further investigation in diagnostic criteria, response assessment and treatment patterns is needed. Study support: Data analysis (IQVIA) and medical writing (Synergy Vision) funded by Takeda Pharmaceuticals. Disclosures Ferhanoglu: Takeda: Other: Advisory Board; Abbvie: Other: Advisory Board; Roche: Other: Advisory Board; Janssen: Other: Advisory Board. Kim:Novartis: Consultancy; AstraZeneca and Korea Health Industry Development Institute: Research Funding; Sanofi: Consultancy; F. Hoffmann-La Roche Ltd/Genentech, Inc.: Consultancy; Voronoi: Consultancy; Boryung: Consultancy; AstraZeneca: Consultancy; Takeda: Consultancy. Karduss:Takeda: Honoraria. Rivas-Vera:Takeda: Current Employment, Other: Steering Committee in Clinical Research; Roche: Consultancy. Lim:National Cancer Centre Singapore: Current Employment. Yeh:AbbVie: Membership on an entity's Board of Directors or advisory committees; Amgen: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees; Astellas: Membership on an entity's Board of Directors or advisory committees; Astex: Membership on an entity's Board of Directors or advisory committees. Abdillah:Takeda: Current Employment. Huang:Takeda: Current Employment. Dalal:Takeda: Current Employment, Current equity holder in publicly-traded company. Wan:Takeda: Current Employment. Hertzberg:Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Support of parent study and funding of editorial support; Gilead: Membership on an entity's Board of Directors or advisory committees; MSD: Membership on an entity's Board of Directors or advisory committees; Abbvie: Honoraria; BMS: Honoraria; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees.

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Atella, Vincenzo, Jayanta Bhattacharya, and Lorenzo Carbonari. "Pharmaceutical Industry, Drug Quality and Regulation - Evidence from US and Italy." SSRN Electronic Journal, 2008. http://dx.doi.org/10.2139/ssrn.1316805.

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Timur, Aysegul, and Gabriel Picone. "Regulating The Pharmaceutical Industry In The European Union: A Dilemma Of Achieving A Single Market." International Business & Economics Research Journal (IBER) 9, no. 7 (December 20, 2010). http://dx.doi.org/10.19030/iber.v9i7.595.

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Pharmaceutical pricing and reimbursement regulations create a dilemma to achieve a single pharmaceutical market in the European Union (EU). Although considerable progress has been made in the past years in harmonization of the pharmaceutical markets, the pricing decisions or systems have continued to be operated on a national basis, which results in price differences across the member states. These price differences create opportunity for parallel trade which, in combination with the EU single market principle calling for the free movement of goods, could lead to reduction in price differences. Among the harmonization efforts by the European Commission, national decisions on pricing and controls, plus parallel trade dilemma, we attempt to analyze the bilateral drug price differences using a sample of countries that represent from strict to relatively less pharmaceutical regulations. Almost all member countries regulate pharmaceutical prices, either directly or indirectly, in the EU, which creates less or more price differences despite market integration. This paper is simply aimed at analyzing price differences in the European pharmaceutical market, employing annual 1994–2003 IMS Health Data from five EU countries (Germany, the United Kingdom, France, Italy and Spain) on prices of molecules used to treat cardiovascular disease. The analysis includes a two step approach. First, we calculate the common use of Laspeyres and Paasche weighted price and quantity indices to make comparisons for both bilaterally matched molecules (considering Spain as the base country) and diffused molecules that are available for five countries. Second, we adopt a hedonic price regression to control observable quality and market characteristics and then re-analyze price differentials. The study concludes that price differences still exist, but are decreasing over time. Even though the results are sensitive to sample and methods used, we found implicit evidence that harmonization efforts by the European Commission may ease reducing price differences in the long run, but it should not be interpreted as moving toward complete elimination of price differences due to complexities in this industry.

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Danieli, Diletta. "Excessive pricing in the pharmaceutical industry: adding another string to the bow of EU competition law." Health Economics, Policy and Law, May 21, 2020, 1–12. http://dx.doi.org/10.1017/s1744133120000109.

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Abstract The paper addresses the issue of excessive price abuse under Article 102(a) of the Treaty on the Functioning of the European Union (TFEU), by drawing inspiration from a recent stream of cases (developed first at the national and then at the EU level) involving pharmaceutical companies marketing off-patent drugs. In particular, the two ‘most advanced’ cases are analysed: Aspen in Italy and Pfizer/Flynn in the United Kingdom. This new-found attention towards exploitative practices in the form of excessive and unfair pricing by dominant undertakings that have traditionally been subject to a cautious antitrust scrutiny seems worth exploring for a number of reasons, as illustrated in the paper. Ultimately, it is argued that this further ‘interference’ of competition law into the realms of regulation may be actually justified, albeit subject to precise conditions for enforcement, and may pursue policy objectives in the wider context of EU health law.

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Polignano, Maurizio Gaetano, Giuseppe Pasculli, Pietro Trisolini, Michele Albino Di Lorenzo, Giuseppe Dalfino, and Gianluigi Giannelli. "Economic impact of industry-sponsored clinical trials in inflammatory bowel diseases: Results from the national institute of gastroenterology “Saverio de Bellis”." Frontiers in Pharmacology 13 (November 22, 2022). http://dx.doi.org/10.3389/fphar.2022.1027760.

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Introduction: The majority of the money spent on possible new medications’ clinical trials is accounted for by the innovative pharmaceutical sector, which also stimulates the economy of a nation. The objective of this study was to evaluate the impact of pharmaceutical industry-sponsored clinical trials (ISCTs) in inflammatory bowel diseases (IBDs) towards the national health service (NHS) in terms of avoided costs and leverage effect.Methodology: The research was conducted at National Institute of Gastroenterology, “Saverio De Bellis”, Castellana Grotte (Apulia, Italy) collecting data from profit ISCTs of pharmaceutical products conducted over the time period 2018-2020 with focus on inflammatory bowel diseases. After the quantification of health services and drug costs from the latter studies, avoided costs and leverage effects were then estimated.Results: The results on the avoided costs for healthcare facilities deriving from the conduct of clinical studies show that, in relation to the sample of five drug companies participating in our 2018-2020 analysis, out of a total of 235,102.46 €, identified as direct investment, 628,158.21 € of avoided costs for the NHS were measured, with an additional saving (leverage effect) for the NHS of 3.67 € for each € invested by the companies promoting clinical trials.Conclusion: Conducting profit clinical trials has practical benefits and a favourable macroeconomic impact that, by completing its limited resources, helps to sustain one country NHS thanks to the avoided costs while also contributing to locational and industrial policy while guaranteeing novel therapeutics and health services for the patients enrolled.

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Ponzio, M., M. Trojano, M. Capobianco, M. Pugliatti, M. Ulivelli, P. Mosconi, F. Patti, P. Zaratin, V. Lepore, and M. A. Battaglia. "Italian multiple sclerosis register as the basis for post-authorization safety studies." European Journal of Public Health 30, Supplement_5 (September 1, 2020). http://dx.doi.org/10.1093/eurpub/ckaa166.1255.

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Abstract While the safety and efficacy of Disease Modifying Therapy (DMT) in multiple sclerosis (MS) are assessed in clinical trials, these are of relatively short duration and always confined to highly selected patient groups. The evaluation of real-world data such as patient registries, is vital as it offers long-term data collection and is patient rather than product-focused during the lifetime of MS, and allows to document a patient's treatment history throughout the disease course. Patient registries can play an important role in monitoring the safety of drus. Regulators and the pharmaceutical industry have shown interest in complementing or even replacing phase 4 clinical studies with data from MS registries. The Italian MS Register (IMSR), in collaboration with the Big MS Data initiative, that also includes the national MS registries of Denmark, France, and Sweden and the international database network MSBase, came together with industry to conduct studies on post-authorization safety (PASS) and treatment effectiveness. The IMSR includes the clinical history of approximately 55,000 patients, or approximatively 45% of the estimated cases of MS in Italy. More than 10,000 patients have a follow-up duration of over 10 years. A Core Protocol outlining principles of PASS projects was created in which aggregated results made available to sponsors and health authorities. The Core Protocol specifies variables, emphasizes improved capture of adverse events, in particular cancer, non-melanoma skin cancers and immunosuppression-related infections, all MedDRA-coded. EUROCAT codes for pregnancy outcomes are also documented. Regulators, the pharmaceutical industry and national-level registries have jointly identified a format of collaboration on PASS for DMT in MS to benefit patients and the larger society. In this way, we hope to contribute to a framework that will include emerging and existing registries with the common goal of contributing to the advancement of knowledge in MS. Key messages The real-world data can contribute to understanding of the impact of disease-modifying therapy on long term. A format of collaboration among clinical research, regulators and pharmaceutical industry could be a winning framework to improve the knowledge on safety and treatment effectiveness in MS.

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SOARES JÚNIOR, Wolney da Cunha. "Off-Label Use of Medicines: A Comparative Study on the Regulation of Medicinal Products in Selected European Union Member States." European Journal of Risk Regulation, December 2, 2020, 1–22. http://dx.doi.org/10.1017/err.2020.104.

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Many governments have implemented a controlled off-label use of medicines as a tool combined with reimbursement decisions, among other policies, to avoid pharmaceutical firms gaming regulatory systems based on the requirement for marketing authorisation. This article aims to compare the drug regulations in selected European Union countries (France, Italy and Germany) in order to identify specific provisions and concrete solutions implemented by them regarding that matter. The employment of an economic analysis of the law as a theoretical framework allows for the identification of the incentives created in the long run by the referred regulations. The scholarly literature identifies a myriad of drawbacks and advantages associated with off-label practices, and a welfare analysis is ambiguous. Off-label practices are a reality; thus, it is advisable to elaborate policy measures in order to address these practices and condition them on some requirements, taking into account that off-label practices imply trade-offs among access to healthcare, protection of public health, competitiveness and innovation in the industry.

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Wang, Ting, Neil McAuslane, Lawrence Liberti, Helga Gardarsdottir, Wim Goettsch, and Hubert Leufkens. "Companies’ Health Technology Assessment Strategies and Practices in Australia, Canada, England, France, Germany, Italy and Spain: An Industry Metrics Study." Frontiers in Pharmacology 11 (December 3, 2020). http://dx.doi.org/10.3389/fphar.2020.594549.

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Background: Health technology assessment (HTA) has increased in importance in supporting payer decision making by assessing the relative effectiveness and cost effectiveness of new medicines. Thus, pharmaceutical companies need to address the HTA requirements early during development to improve reimbursement outcomes. Currently, there is a lack of research to assess the impact of HTA on development and jurisdictional outcome from companies’ perspectives. This study aimed to assess companies’ HTA strategy and characterise HTA practice in seven jurisdictions.Methods: A multi-year, annual study collected information for individual products, focusing on development activities regarding inclusion of HTA requirements and selection of global comparators. The generation of local contextual information, submission strategies and predictability of HTA outcomes was examined jurisdictionally in Australia, Canada, England, France, Germany, Italy and Spain. The study questionnaire was built into a secure online data collection platform and data were provided annually by participating companies.Results: Data for 169 compounds were provided by nine international companies between 2014 and 2018. HTA requirements were implemented in evidence generation plan for 63% of products during development. Global comparators were accepted by HTA bodies for more than half of studied products; Spain showed the highest acceptance rate (85%). Companies took advantages of parallel process in Australia and Canada to shorten product rollout time. Australia demonstrated general consistency in HTA review time, and England had the longest variation (interquartile range, 216 days). Requirements for additional information after submission occurred at all HTA bodies. Germany and Italy showed the highest percentage of products being reimbursed as per regulatory label (80 and 68%, respectively). Canada was the most predictable jurisdiction, with the highest proportion of review outcome (90%) that met companies’ expectations.Conclusion: Companies are addressing HTA requirements during development for many products; however, they are challenged by varying requirements and practices and product success ultimately depends on how HTA organisations and payers assess added value in the context of the national healthcare systems. This ongoing study created a baseline to help capture fact-based changes for company HTA strategies and HTA body practices.

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Jommi, Claudio, Federico Pantellini, Lisa Stagi, Maria Verykiou, and Marianna Cavazza. "The economic impact of compassionate use of medicines." BMC Health Services Research 21, no. 1 (December 2021). http://dx.doi.org/10.1186/s12913-021-07255-w.

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Abstract Background Compassionate use programs (CUP) for medicines respond to the ethical imperative of providing access to medicines before marketing approval to patients not recruited in trials. The economic impact of clinical trials has previously been investigated. No evidence on the net economic benefit of CUP exists. This research aims to address this information gap by estimating the economic consequences of 11 CUP in Italy conducted between March 2015 and December 2020 from the perspective of public health care system in Italy (National Health Service). Eight programs concern cancer treatments, two refer to spinal muscular atrophy, and one is indicated for multiple sclerosis. Methods Since CUP medicines are covered by the industry, the net economic benefit includes: (i) avoided costs of the Standard of Care (SoC) the patients would have received had they not joined the CUP, (ii) costs not covered by the pharmaceutical industry sponsor, but instead sustained by payers, such as those associated with adverse events (only severe side effects resulting in hospitalisation and attributable to CUP medicines), and (iii) costs for combination therapies and diagnostic procedures not used with the SoC. The SoC costing relied on publicly available data. Information on adverse events and diagnostic procedures was retrieved from the CUP and monetized using the relevant fee for episode or service. One CUP was excluded since a SoC was not identified. Results 2,713 patients were treated in the 11 CUP where a SoC was identified. The SoC mean cost per patient ranged from €11,415 to €20,299. The total cost of the SoC ranged between €31.0 and €55.1 million. The mean cost per patient covered by hospitals hosting CUP was equal to €1,646, with a total cost of €4.5 million. The net economic benefit ranged €26.5 million - €50.6 million. Conclusions Despite research limitations, this paper illustrates for the first time the net economic impact of CUP from a public payer perspective. It is important to integrate these estimates with the prospective effects of CUP implementation, i.e., the economic value of the comparative benefit profile of medicines used in CUP versus the SoC, including effects from a societal perspective.

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Ecarnot, Fiona, Gaetano Crepaldi, Philippe Juvin, John Grabenstein, Giuseppe Del Giudice, Litjen Tan, Susan O’Dwyer, et al. "Pharmacy-based interventions to increase vaccine uptake: report of a multidisciplinary stakeholders meeting." BMC Public Health 19, no. 1 (December 2019). http://dx.doi.org/10.1186/s12889-019-8044-y.

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Abstract Background Despite the existence of efficacious vaccines, the burden of vaccine-preventable diseases remains high and the potential health benefits of paediatric, adolescent and adult vaccination are not being achieved due to suboptimal vaccine coverage rates. Main body of abstract Based on emerging evidence that pharmacy-based vaccine interventions are feasible and effective, the European Interdisciplinary Council for Ageing (EICA) brought together stakeholders from the medical and pharmacy professions, the pharmaceutical industry, patient/ageing organisations and health authorities to consider the potential for pharmacy-based interventions to increase vaccine uptake. We report here the proceedings of this 3-day meeting held in March 2018 in San Servolo island, Venice, Italy, focussing firstly on examples from countries that have introduced pharmacy-based vaccination programmes, and secondly, listing the barriers and solutions proposed by the discussion groups. Conclusions A range of barriers to vaccine uptake have been identified, affecting all target groups, and in various countries and healthcare settings. Ease of accessibility is a potentially modifiable determinant in vaccine uptake, and thus, improving the diversity of settings where vaccines can be provided to adults, for example by enabling community pharmacists to vaccinate, may increase the number of available opportunities for vaccination.

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Vitale, Matteo, and Santi Maria Cascone. "Orange peels as a potential ecological thermal insulation material for building application." Rivista Tema 08, no. 02 (December 20, 2022). http://dx.doi.org/10.30682/tema0802d.

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Most of the national orange production, estimated at 900,000 tons per year, is processed in several cities in the south area of Italy. Half part of this amount corresponds to the peels, which are separated in the orange selection and processing plants. In this work, the possibility of using orange peels as raw material for the manufacture of building materials for the civil construction industry is studied. Recently, some attempts to reuse by-products derived from citrus waste have been proposed. For example, it was used as a source of nutrients in food, pharmaceutical, and cosmetic industries and as a source for energy production. There are precedents in the use of biomass residues in different building blocks, mainly with the aim of generating insulating materials. With this objective, insulating materials were obtained from agriculture by-products also manufactured without a binder. After a drying process, orange peels were characterized with electronic scanning analysis and thermal analysis in order to analyze the application in the building sector. The same by-products for the production of samples in the form of panels were used. In order to establish the best panel composition, physical and thermal properties, as well as mechanical and durability performances of the samples, were characterized.

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Karen, K. "The use of Real-World Data (RWD) by Health Technology Assessment (HTA) agencies." European Journal of Public Health 31, Supplement_3 (October 1, 2021). http://dx.doi.org/10.1093/eurpub/ckab164.574.

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Abstract Issue There are divergent views between HTA bodies and pharmaceutical industry on the potential for RWD to inform determination of added benefit or value for money of new medicines. However, exploration of use of RWD is now essential as more high-cost innovative therapies come to market with short-term uncontrolled trials. Description of problem Payers are increasingly seeing use of RWD to fill evidence gaps in clinical development programmes, including external control arms or collection of RWD after initial assessment to determine real-life effectiveness or duration of benefit. An international multi-stakeholder initiative, RWE4Decisions, led by the Belgian Payer - RIZIV/INAMI - has explored these issues over the past few years. They have proposed that all stakeholders including industry, clinicians, regulators, patients and methodologists need to be involved to determine what questions can be answered by RWD and ensuring data is of sufficient quality to generate robust real-world evidence (RWE). Alongside this, the IMPACT HTA Project has reviewed use of RWD in specific rare disease case studies. Results Several HTA/Payers have implemented RWD collection schemes, but few have been successful in delivering sufficient evidence to enable re-assessment of treatment value. Italy is an exception, with a national web-based registry system. Other countries prefer to rely on secondary use of health system data and links to clinical registries, but curating and analysing these data can be complex. The case studies show how more recently some countries are overcoming these challenges by entering into more formal agreements with stakeholders to ensure purposive data collection. Lessons There is a need to publish protocols and reports related to RWD collection in an international portal. If possible, dialogues among bodies should happen in advance to align RWD collection requirements and facilitate data analysis.

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Ruggeri, Matteo, Americo Cicchetti, Silvia Coretti, Carlo Cammà, Nicola Caporaso, and Antonio Gasbarrini. "A new decision model for economic evaluation of novel therapies for HCV." Farmeconomia. Health economics and therapeutic pathways 15, no. 3 (September 30, 2014). http://dx.doi.org/10.7175/fe.v15i3.945.

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In 2014, the European Medicines Agency (EMA) has given the license to two new direct-acting antiviral: sofosbuvir and simeprevir. The evidence provided by the studies, reported a high rate of SVR even in patients with decompensated cirrhosis. This and other innovative elements are potentially adept at changing the entire natural course of HCV. However, the dramatic prevalence rates of HCV observed in Italy, and the high prices that are expected to be required by the pharmaceutical industry, raises some critical issues about how to regulate access to such drugs. The objective of this article is to present a new decision model for the evaluation of novel therapies for HCV. This model is intended to provide a tool for the decision-maker that seeks to address the main issues related to the introduction of HCV new treatments. The model that we have structured follows the classic Bayesian approach, using data from reference literature for staging the action of treatments depending on the level of fibrosis (F0, F1, F2, F3, F4). The model is designed to consider patients with all genotypes and allows to make comparisons between innovative and traditional therapies (dual, triple, IFN free, PI combinations, etc.), for both experienced and naïve patients. In addition, the model is used to simulate mixed cohorts of patients, representing a population with HCV with different levels of fibrosis and different genotypes. To show the potential of the model, we created some simple scenarios assuming different levels of SVR and pricing. The results of our model show that, even assuming an SVR rate of 100%, the administration of new treatments for HCV subjects F1 / 2 has an incremental cost-effectiveness ratio not sustainable. In contrast, for the subjects F3 and F4, low incremental SVR rates and an incremental cost of the innovative therapy of € 40,000 would be cost effective. The added value of this model is its versatility and applicability to diverse assessment needs. In addition, the model offers an opportunity for reflection even to the industry, which in the years to come will have to develop strategies for entering the market and offer sustainable prices for decision-makers and at the same time remunerate the investment in research and development consistently with the expectations of the shareholders.

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Gelato, Paola, and Stefano Vergano. "IP Licensing Contracts in Italy ‒ Royalty Rate Determination and Dispute Resolution Clauses." GRUR International, January 27, 2021. http://dx.doi.org/10.1093/grurint/ikaa202.

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Abstract The present work is aimed at exploring IP license agreements under Italian law, with a focus on trademark licensing in the fashion, cosmetics and perfumery sectors, as well as on patent and know-how licensing in the pharmaceuticals industry. In particular, we will address the issue of royalty rate determination and dispute resolution clauses, which constitute key elements of a license agreement. These clauses will be analyzed in light of the above-mentioned fields of interest, in order to show how IP contractual tools may vary, in consideration of a particular sector. Moreover, the article tries to combine the legal analysis with the economic implications for business and entrepreneurs. The fact is that license agreements are business-oriented contracts, the study of which is particularly useful for understanding how and to what extent an IP agreement may influence and even shape, in some cases, a whole sector, as we will see with, for example, the perfumery sector.

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Farrapeira, Rafael, Yasmine Andrade, Laíza Krause, Thiago Bjerk, Elina Caramão, and Jaderson Schneider. "GC×GC in the Characterization of the Bio-Oil from Brazilian Biomass: A Review." Brazilian Journal of Analytical Chemistry 8 (August 9, 2021). http://dx.doi.org/10.30744/brjac.2179-3425.rv-58-2021.

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This study presents and discusses the state of the art of Two-Dimensional Comprehensive Gas Chromatography (GC×GC) developed in Brazil. GC×GC has been the focus of studies in Brazil since 2009, based on successful experiences in cooperation with researchers from Australia and Italy. The result of these researches led to the installation of many laboratories in Brazilian Universities and Research Centers, similar to others in foreign countries and the development of research, mostly involving applications of the technique to Brazilian matrices. In this review we present applications of GC×GC involving the pyrolysis of Brazilian agroindustrial residues, such as cane straw, sawdust, coconut fiber, fruit seeds, rice husks, spent coffee grounds, among others. The most used detection techniques for GC×GC have been mass spectrometry with fast quadrupole analyzer (GC×GC/qMS) and time of flight (GC×GC/TOFMS). These studies showed the possibility of identifying many organic compounds in the bio-oils produced, especially oxygenated ones such as phenols, ketones, acids and esters. Several studies suggest catalytic pyrolysis as a way to generate less oxygen-compounds directing the application of this bio-oil to the area of biofuels. However, the compounds found and their relative concentration, indicates that the best uses should be associated with the processing industry such as pharmaceuticals, chemicals, polymers and food.

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Van Khanh, Nguyen, Nguyen Thanh Hai, Nguyen Thi Dieu Thuy, Teruhiko Kido, Shoji F. Nakayama, Tomohiko Isobe, Mitunobu Okuyama Okuyama, and Seijiro Honma. "Highly Sensitive Simultaneous Measurement of Steroid Hormone in Human Serum by Liquid Chromatography-electrospray Ionization Tandem Mass Spectrometry." VNU Journal of Science: Medical and Pharmaceutical Sciences 38, no. 1 (March 24, 2022). http://dx.doi.org/10.25073/2588-1132/vnumps.4395.

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A high sensitive simultaneous determination method of nine steroid hormones including Estrone (E1), estradiol (E2), testosterone (T), dihydrotestosterone (DHT), 17-hydroxyprogesterone (17OH-P4), androstenedione (AN), progesterone (P4), dehydroepiandrosterone (DHEA), and cortisol by liquid chromatography-electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) was established in a positive mode using recently developed picolinyl derivatization. Steroid hormones were derived with picolinic acid and 2-methyl-6-nitrobenzoic anhydride, then purified by solid-phase extraction with InterSep SI cartridge. The LC-ESI-MS/MS method enhanced the specificity and sensitivity for E1, E2, T, DHT, DHEA, and cortisol. The method validation indicated that the limits of quantification for E1, E2, T, DHT, 17OH-P4, AN, P4, DHEA, and cortisol were 1, 1, 1, 2, 2, 2, 2, 20, and 100 pg/tube, respectively with acceptable accuracy and precision within ± 15%. The present method was applied to the measurement of nine steroid hormones in children’s serums with high reliability and reproducibility. Keywords: LC-ESI-MS/MS, steroid hormone, picolinyl derivatization, human serum, solid-phase extraction. References [1] A. R. Vasconcelos, J. V. C. Costa, C .H. Mazucanti, C. Scavone, E. M. Kawamoto, The Role of Steroid Hormones in the Modulation of Neuroinflammation by Dietary Interventions, Front Endocrinol (Lausanne), Vol. 7, 2016, pp. 1-14, https://doi.org/10.3389/fendo.2016.00009.[2] D. French, Advances in Bioanalytical Techniques to Measure Steroid Hormones in Serum, Bioanalysis, Vol. 8, No. 11, 2016, pp. 1203-1219, https://doi.org/10.4155/bio-2015-0025.[3] R. Schoenheimer, D. Rittenberg, Deuterium as an Indicator in the Study of Intermediary Metabolism, Science, Vol. 82, No. 2120, 1935, pp. 156-157, https://doi.org/ 10.1126/science.82.2120.156.[4] P. Eneroth, K. Hellstroem, R. Ryhage, Idenfication and Quatification of Neutral Fecal Steroids by Gas-liquid Chromatography and Mass Spectrometry: Studies of Human Excretion during Two Dietary Regimens, J Lipid Res, Vol. 5, 1964, pp. 245-262.[5] R. Rhyage, Use of a Mass Spectrometer as a Detector and Analyzer for Effluent Emerging from High Temperature Gas Liquid Chromatography Columns, Vol. 36, No.4, 1964, pp. 759-764, https://doi.org/10.1021/ac60210a019 36. [6] G. E. Abraham, Solid-phase Radioimmunoassay of Estradiol-17 Beta, J Clin Endocrinol Metab, Vol. 29, No. 6, 1969, pp. 866-870, https://doi.org/10.1210/jcem-29-6-866.[7] M. Zendjabil, Z. Chellouai, O. Abbou, Role of Mass Spectrometry in Steroid Assays, Ann Endocrinol (Paris), Vol. 77, No. 1, 2016, pp. 43-48, https://doi.org/10.1016/j.ando.2016.01.004.[8] C. Shackleton, Clinical Steroid Mass Spectrometry: a 45-year History Culminating in HPLC-MS/MS Becoming an Essential Tool for Patient Diagnosis, J Steroid Biochem Mol Biol, Vol. 121, No. 3-5, 2010, pp. 481-490, https://doi.org/10.1016/j.jsbmb.2010.02.017.[9] M. Závada, K. Šafarčik, O. Topolčan, Some Problems of Radioimmunoassay Control, Journal of Radioanalytical Chemistry, Vol. 46, No. 1, 1978, pp. 57-66.[10] M. Z. Nouri, K. J. Kroll, M. Webb, N. D. Denslow, Quantification of Steroid Hormones in Low Volume Plasma and Tissue Homogenates of Fish using LC-MS/MS, Gen Comp Endocrinol, Vol. 296, pp. 1-15, https://doi.org/10.1016/j.ygcen.2020.113543.[11] N. Kadian, K. S. R. Raju, M. Rashid, M. Y. Malik, I. Taneja, M. Wahajuddin, Comparative Assessment of Bioanalytical Method Validation Guidelines for Pharmaceutical Industry, J Pharm Biomed Anal, Vol. 126, 2016, pp. 83-97, https://doi.org/10.1016/j.jpba.2016.03.052.[12] Food and Drug Administration, Bioanalytical Method Validation Guidance for Industry, USA, 2018, pp. 1-44.[13] European Medicines Agency, Guideline on Bioanalytical Method Validation, Italy, 2012, pp. 1-23.[14] T. Higashi, S. Ogawa, Chemical Derivatization for Enhancing Sensitivity during LC/ESI-MS/MS Quantification of Steroids in Biological Samples: a Review, J Steroid Biochem Mol Biol, Vol. 162, 2016, pp. 57-69, https://doi.org/10.1016/j.jsbmb.2015.10.003.[15] L. Aksglaede, A. Juul, H. Leffers, N. E. Skakkebaek, A. M. Andersson, The Sensitivity of the Child to Sex Steroids: Possible Impact of Exogenous Estrogens, Hum Reprod Update, Vol. 12, No. 4, 2006, pp. 341-349, https://doi.org/10.1093/humupd/dml018.[16] E. Benyi, L. Sävendahl, The Physiology of Childhood Growth: Hormonal Regulation, Horm Res Paediatr, Vol. 88, No. 1, 2017, pp. 6-14, https://doi.org/10.1159/000471876.[17] J. Cui, Y. Shen, R. Li, Estrogen Synthesis and Signaling Pathways during Aging: From Periphery to Brain, Trends in Molecular Medicine, Vol. 19, No. 3, 2013, pp. 197-209, https://doi.org/10.1016/j.molmed.2012.12.007.[18] G. Jasienska, R. G. Bribiescas, A. S. Furberg, S. Helle, A. N. L. Mora, Human Reproduction and Health: an Evolutionary Perspective, Lancet, Vol. 390, No. 10093, 2017, pp. 510-520, https://doi.org/10.1016/S0140-6736(17)30573-1.[19] A. E. Kulle, F. G. Riepe, D. Melchior, O. Hiort, P. M. Holterhus, A Novel Ultrapressure Liquid Chromatography tandem Mass Spectrometry Method for the Simultaneous Determination of Androstenedione, Testosterone, and Dihydrotestosterone in Pediatric Blood Samples: Age- and Sex-specific Reference Data, J Clin Endocrinol Metab, Vol. 95, No. 5, 2010, pp. 2399-409, https://doi.org/10.1210/jc.2009-1670.[20] A. L. Southren, S. Tochimoto, N. C. Carmody, K. Isurugi, Plasma Production Rates of Testosterone in Normal Adult Men and Women and in Patients with the Syndrome of Feminizing Testes, The Journal of Clinical Endocrinology & Metabolism, Vol. 25, No. 11, 1965, pp. 1441-1450, https://doi.org/10.1210/jcem-25-11-1441.[21] R. S. Swerdloff, R. E. Dudley, S. T. Page, C. Wang, W. A. Salameh, Dihydrotestosterone: Biochemistry, Physiology, and Clinical Implications of Elevated Blood Levels, Endocr Rev, Vol. 38, No. 3, 2017, pp. 220-254, https://doi.org/10.1210/er.2016-1067.[22] J. P. Mulhall, L. W. Trost, R. E. Brannigan,E. G. Kurtz, J. B. Redmon, K. A. Chiles, D. J. Lightner, M. M. Miner, M. H. Murad, C. J. Nelson, E. A. Platz, L. V. Ramanathan, R. W. Lewis, Evaluation and Management of Testosterone Deficiency: AUA Guideline, J Urol, Vol. 200, No. 2, 2018, pp. 423-432, https://doi.org/10.1016/j.juro.2018.03.115.[23] H. Frederiksen, T. H. Johannsen, S. E. Andersen,J. Albrethsen, S. K. Landersoe, J. H. Petersen, A. N. Andersen, E. T. Vestergaard, M. E. Schorring, A. Linneberg, K. M. Main, A. M. Andersson, A. Juul, Sex-specific Estrogen Levels and Reference Intervals from Infancy to Late Adulthood Determined by LC-MS/MS, J Clin Endocrinol Metab, Vol. 105, No. 3, 2020, pp. 754-68, https://doi.org/10.1210/clinem/dgz196.[24] K. Yamashita, M. Okuyama, R. Nakagawa, S. Honma, F. Satoh, R. Morimoto, S. Ito, M. Takahashi, M. Numazawa, Development of Sensitive Derivatization Method for Aldosterone in Liquid Chromatography–electrospray Ionization Tandem Mass Spectrometry of Corticosteroids, Journal of Chromatography A, Vol. 1200, No. 2, 2008, pp. 114-121, https://doi.org/10.1016/j.chroma.2008.05.034.[25] K. Yamashita, Y. Miyashiro, H. Maekubo, M. Okuyama, S. Honma, M. Takahashi,M. Numazawa, Development of Highly Sensitive Quantification Method for Testosterone and Dihydrotestosterone in Human Serum and Prostate Tissue by Liquid Chromatography-electrospray Ionization tandem Mass Spectrometry, Steroids, Vol. 74, No. 12, 2009, pp. 920-926, https://doi.org/10.1016/j.steroids.2009.06.007.

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Stratta, Emanuela, Gaetano Gallo, and Mario Trompetto. "Conservative treatment of haemorrhoids." Reviews on Recent Clinical Trials 15 (May 6, 2020). http://dx.doi.org/10.2174/1574887115666200506090507.

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: 1. INTRODUCTION Hemorrhoids are vascular cushions underlying the distal rectal mucosa and contributing for approximately 15–20% of the resting anal pressure with a complete closure of the anal canal. They can become pathological (hemorrhoidal disease, HD) being the most common cause of painless rectal bleeding during defecation with or without prolapsing anal tissue1 . In this case the blood is bright red, not mixed with faeces but instead coated on their outer surface, or dropping after bowel movement. HD is generally classified by its location in internal (originated above the dentate line and covered by anal mucosa) and external (originated below the dentate line and covered by anoderm). Internal hemorrhoids are commonly graded based on the degree of prolapse, according to Goligher’s classification2 . Its treatment must be tailored both to the severity of disease and patient’s expectation: conservative treatment, including dietary and lifestyle modifications, is effective in managing the majority of patients complaining of early stages of the disease. Surgery is required only for the most advanced stages, when non-operative approaches have failed, or complications have occurred. External hemorrhoids require no specific treatment unless become acutely thrombosed or causes severe patient discomfort3 . According to a recent Consensus Statement, excisional hemorrhoidectomy is the gold standard technique for III and IV degree HD, but surgery should be used as last resort because medical treatment can relief symptoms in the majority of cases, also if it cannot cure the underlying prolapse4,5 . 2. DIETARY AND LIFESTYLE MODIFICATIONS Patients with HD of any degree could benefit from an appropriate dietary and lifestyle modifications that often lead to an improvement in defecation reducing straining and symptoms. A high-fibre diet and adequate water intake is the first medical advice to all patients with HD6 . Fiber has well-known beneficial effects on human bowel regularity, increasing fecal weight and reducing colonic transit time. Sielezneff et al. demonstrated that dietary imbalance (increased fat, alcohol and pepper intake) together with smoking, low water intake and constipation were more frequently observed in patients with HD than in healthy volunteers7 . A systematic review and meta-analysis stated that oral fiber supplementation reduce the risk of persisting symptoms and bleeding for HD by approximately 50% (RR 0.50, 95% CI 0.28–0.89), but does not improve the other symptoms such as prolapse, pain, and itching8 . Recently, the traditional definition of dietary fiber (polysaccharides and lignin, resistant to digestion by human digestive enzymes) has been expanded to oligosaccharides, such as inulin, and resistant starches9 . Using the energy guideline of 2000 kcal/day for women and 2600 kcal/day for men, the recommended daily dietary fiber intake is 28 g/day for adult women and 36 g/day for adult men10 . Moreover, the addition of fiber supplements as calcium polycarbophil, methylcellulose, and psyllium_ that have had FDA approval for laxation_may play an important role in helping to achieve adequate ifber intakes11 . These products are safe and low-cost. Of course, increasing the intake of fluid is mandatory for their mechanism of action. According to Garg et al.12,13 the “TONE method” (T, three minutes at defecation; O, once-daily defecation frequency; N, no straining and no mobile phone or newspaper in the toilet; and E, enough fiber) can correct the three well-known causes of HD or rather increased straining, prolonged defecation-time, and frequent bowel-motions, the so-called “deranged defecation habits (DDH)”, reducing the progression of HD and further episodes of bleeding. Potential negative effects of fiber include reduced absorption of vitamins, minerals, protein, and calories. It is unlikely that healthy adults who consume fiber in amounts within the recommended ranges will have problems with nutrient absorption, but high-fiber intakes may not be appropriate for children and the elderly people. Moreover, with the ingestion of a large amount of high fiber, a large proportion of the dietary intake will be unabsorbed and the subsequent bulky faecal material can be difficult to evacuate in a patient with pre-existing evacuatory problems14 . The empiric and widely diffuse opinion about the role of spicy foods on the onset and deterioration of HD symptoms is not supported by epidemiological studies, and it has been confrimed by a randomized controlled trial based on the blind assumption of a moderate dosage of chili pepper in patients with symptomatic III degree HD15 . Lastly, regardless of fiber intake, is also important to adopt the correct position during defecation 16 . According to Sikirov D. sitting position requires more straining if compared with the squatting position17 . 3. MEDICAL TREATMENT Medical treatment consists of phlebotonics and topical agents. Their main goal is the control of the symptoms rather than cure HD. Most phlebotonics are extracted from plants (i.e. flavonoids), such as oxerutin, diosmin, hesperidin, coumarin, rutosides and quercetin, whereas others are synthetic compounds (i.e. calcium dobesilate). Regarding oral preparation, hesperidin in combination with diosmin (Dalfon®, Servier, Neuilly-Sur-Seine, France) is the most widespread. All these drugs act as scavengers of hydroxyl radicals, improving venous tone as well as stabilizing capillary permeability and increasing lymphatic drainage. A meta-analysis including 14 trials and 1514 patients found that the use of lfavonoids decrease the risk of worsening or persisting symptoms by 58% showing an apparent reduction of bleeding, persistent pain, itching and recurrence 18 . A Cochrane review of 24 randomized controlled trials and 2344 patient concluded that phlebotonics show a statistically significant beneficial effect in comparison with a control group for pruritus (p=0.02), bleeding (p=0.0002), post‐ haemorrhoidectomy bleeding (p=0.004), discharge and leakage (p=0.0008) and overall symptoms improvement (p< 0.00001). However, there was no statistically significant effect in pain and post‐haemorrhoidectomy pain scores 19 . Both the abovementioned Cochrane review and meta-analysis underline the limitations in methodological quality and the heterogeneity of the included trials, so the real efficacy of phlebotonics is still on debate. Another common medical prescription in patients with acute and thrombosed HD is Mesoglycan (PRISMA®, Mediolanum Farmaceutici, Milan, Italy) derived from a group of glycosaminoglycans as amino hexose polysaccharides contained in mucoproteins, glycoproteins, and blood group substances that have demonstrated proifbr.nolytic activity20 . After two old studies regarding its use in acute HD21,22 recently Gallo et al. demonstrated the efficacy of mesoglycan in reducing postoperative thrombosis and pain at 7-10 days after an open diathermy excisional hemorrhoidectomy, permitting a faster return to normal activities23 . Topical therapy is an alternative treatment for the acute symptoms of HD. A large number of creams and suppositories are avalaible, although the evidence supporting their efficacy is weak. The primary objective of these approaches is to control symptoms by exerting a local anesthetic effect which eliminates burning and itching associated with hemorrhoidal prolapse. These medications are often multicomponents drugs containing local anesthetics, corticosteroids, antibiotics and antiinflammatories. They have no effect on bleeding, even if frequently used for this specific indication24 with the risk of causing allergic reactions or dermatitis in the long-run25,26 . CONCLUSIONS Conservative treatment plays an important role in the management of symptoms from HD being the treatment of choice in the early stages of the disease. Nevertheless, it should be considered a bridge to surgery for more advanced stages. Dietary and lifestyle modifications to achieve regular defecation and soft stool as well as the use of topical medications or phlebotonics, particularly during the acute phase or in the post-hemorrhoidectomy period can also be beneficial. Very few randomized controlled trials have been carried out and up to date we cannot know the real validity of these drugs27 . Moreover, in many trials funding by the pharmaceutical industry can bias results and this leaves doubts about the real benefit of all types of drugs in the treatment of early stages of HD.

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Thompson, Bill. "Evoking terror in film scores." M/C Journal 5, no. 1 (March 1, 2002). http://dx.doi.org/10.5204/mcj.1939.

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It is peculiar that we so urgently seek out the emotion of fear in film. We have a thirst for fear, and we go to elaborate means to experience it. It would be convenient if we could invoke the experience of fear without the apparatus of a cinema, but such intermediaries are necessary. We cannot will ourselves to be afraid. To evoke an emotion, we must organize our environment -- or invoke mental images of such an environment -- which then triggers the emotion. One of the great discoveries of the 20th century was the powerful effect of combining film with musical representations of emotion. It is possible to combine these two media in a way that reflects no naturally occurring visual-auditory correlation, such as the correlation between the sight and sound of a person running. That two such distinct media should combine so readily may seem puzzling. Background music is not part of the diegesis of the film and has the potential to create confusion (Cohen, 2). This potential was illustrated in Mel Brooks' comedy Blazing Saddles (1974). A sheriff rides in the desert set to suitable background music, but then meets the Count Basie Band performing the now foreground music. The music, initially interpreted on a subconscious or emotional level, is unexpectedly thrust into the fictional component of the film and processed on a conscious level. Such exceptions aside, there is usually no such confusion because film and music are integrated on an emotional rather than an analytic level. Fear responses do not require brain structures needed for consciousness and analytic thought but can be processed without conscious awareness by subcortical structures (i.e., the amygdala). A frightening score that is not part of the diegesis of the film combines with visual information at sub-cortical levels to create a unified experience of fear, with no sense that there are two sources of emotional meaning -- fictional and musical. The lack of literal connection between visual and auditory sources is not confusing. We do not question the logic of musicians playing triumphant music at every battle in Star Wars, or sentimental music inside the police station on Hill Street Blues. The combination of film and music is exceptionally potent because both are highly influential media. Economic activity reflects their influence (Huron, 3). In the United States, the largest export sector is entertainment, led by music and film. Film makers are so confident that they invest billions of dollars in them. In 1999 the average budget for a single Hollywood film was 76 million. The prevalence of music in industrialized society is also massive: the music industry is larger than the pharmaceutical industry. As a film composer, I've learned that I can induce fear most readily by turning my attention away from conventional music structures. In an important sense, writing fearful music should not involve composition in the usual sense of the term. Rather, one may rely on the fact that sound is inherently frightening when stripped of the comforting structuring properties of language and music. It is difficult to express fear using conventional forms. Fear is sometimes expressed in Opera but using unconventional forms. Fear is also associated with the bhayanaka rasa in Classical Indian music, but evidence suggests that sensitivity to rasas is related to basic acoustic properties such as pace, loudness, and complexity (Balkwill & Thompson, 1). The major and minor modes in Western music are associated with happiness and sadness, but the evocation of fear seems antithetical to such conventions. When music is recognizable, as in a melody with a traditional harmonic accompaniment, we experience reassurance. Conventional music evokes a comforting feeling that we are "among our own" and there is safety in numbers. The possibility of fear arises when familiar music structures are removed. It is certainly possible to create a creepy atmosphere using traditional forms by repeatedly pairing a musical segment with a frightening image or event. Such learned associations are used in the practice of leitmotiv, in which a musical theme is paired repeatedly with a character until it comes to represent that character. Consider Mike Oldfield's circular melody in The Exorcist or Beethoven's ninth symphony in A Clockwork Orange. Through learned association, both scores created extremely disturbing atmospheres. The most effective way to induce terror, however, is to manipulate basic acoustic properties, also called secondary musical parameters. Primary parameters include melody and harmony: aspects of music that are culturally shaped and recognizable as traditional forms. Secondary parameters include pace, loudness, timbre, and pitch height: elements of sound that are perceived similarly across cultures. The use of musical convention is deeply connected with one's emotional intention. We create fear most powerfully by stripping music of conventional forms. Composers aiming to design a fearful score often import and embed frightening sounds into traditional compositional structures, such as a melody with harmonic accompaniment. They do this as a musical challenge or out of concern that their score might otherwise be perceived as unsophisticated. What evokes fear, however, are not those recognizable conventions of composition but rather, elements of the score that are unrelated to conventional structures. We fear surprising or unfamiliar sounds: sudden changes in loudness, jittery sounds, deep hollow textures, and unpredictable pitch combinations or movement. Sounds are more frightening than visual images, and hence soundtracks are essential to thriller flicks. Visual images are experienced as "out there" and emotionally distant. We've learned to detach ourselves emotionally from visual images by habituating to the continuous stream of horrifying TV and film images. When we actually witness a terrifying event, it seems "like a movie." Sounds are experienced as both outside and inside our heads. We feel sound in our bones, making it difficult to distance ourselves from them. They are less easily localized than visual images, creating nervousness about possible escape routes. Their sources are not always identifiable, creating uncertainty. Prey rely heavily on sounds to alert them of predators, linking sound to fear. The fear centre of the brain -- the amygdala -- lies deep inside the temporal lobe, which processes sound (LeDoux, 4). From an evolutionary standpoint, we can assume that humans, like all animals, evolved a sensitivity to the potential dangers associated with sounds. Brain systems that generate fear are highly conserved throughout evolutionary history, suggesting that fear responses in modern brains are similar to fear responses in early hominids. Large, aggressive, or unfamiliar animals are potentially life-threatening and it is adaptive for us to fear them. Low pitches are associated with large sound-producing cavities and hence, animals with big mouths. Loud low-pitched sounds signal aggression. High-pitched screeches are perceived as alarm calls. During the stabbing scene in the film Psycho, repeated screeching sounds or "alarm-calls" combine with the visual scene to induce excruciating fear. In industrialized society, fear of predation is largely non-existent, replaced with a fear of our own technology: car and airplane accidents, nuclear disasters, weapons. But fear responses today are the result of adaptive pressures that took place thousands of years ago when predation was a constant threat. We are acutely sensitive to alarm calls and predatory sounds. When predators of humans are portrayed in film, as in Jaws or Jurassic Park, the experience of fear is unbearable. Why do we so urgently seek out this unpleasant emotion? One possibility relates to social cohesion. Group solidarity is enhanced when there is a common enemy. The object of fear in film distinguishes "us against them" and secures a bond between those experiencing the terror. The representation of fear identifies an enemy (the object of fear) to enhance solidarity. Teenagers -- who have the greatest need for social bonding and self definition -- are voracious consumers of terror films. Shared experiences of film-induced fear are extremely widespread. In the week ending May 28th, 2000, there were over 3,100 screening of Gladiator in the United States. America dominates the world market in film and music (only India has resisted this domination). For better or worse, Hollywood emotions are globally shared. People from Japan, China, Italy, Spain, and Brazil have a common bond on the basis of having seen The Matrix or The Exorcist. Fear in film also performs another function. Films are externalized representations of cultural memory, and of culturally significant or meaningful experiences. They are a mechanism for accumulating and transmitting knowledge of the environment, preparing ourselves for circumstances in which we might find ourselves. Terror films stimulate the development of cognitive strategies for coping with challenging circumstances. All of us -- teenagers especially -- feel a need to prepare ourselves for hostile environments. Terror films not only nurture social bonding, they motivate the refinement of an essential human trait: courage. By situating ourselves within an environment that presents various hypothetical sources of terror, we test our courage, and we activate the development of important strategies for coping with the very real fears with which we will inevitably be confronted. References Balkwill, L.L. & Thompson, W.F. "A cross-cultural investigation of the perception of emotion in music: Psychophysical and cultural cues." Music Perception, 17, 43-64, 1999. Cohen, A. "Music as a source of emotion in film." In Patrik Juslin & John Sloboda (Ed.) Music and Emotion: Theory and Research. Oxford: Oxford University Press, 2001. Huron, D. "Is music an evolutionary adaptation?" In Robert Zatorre & Isabelle Peretz (Ed.), The Biological Foundations of Music. New York: Annals of the New York Academy of Sciences, Volume 930. New York, 2001. LeDoux, J. The Emotional Brain: The Mysterious Underpinnings of Emotional Life. New York: Touchstone, 1996. Citation reference for this article MLA Style Thompson, Bill. "Evoking Terror In Film Scores" M/C: A Journal of Media and Culture 5.1 (2002). [your date of access] < http://www.media-culture.org.au/0203/evoking.php>. Chicago Style Thompson, Bill, "Evoking Terror In Film Scores" M/C: A Journal of Media and Culture 5, no. 1 (2002), < http://www.media-culture.org.au/0203/evoking.php> ([your date of access]). APA Style Thompson, Bill. (2002) Evoking Terror In Film Scores. M/C: A Journal of Media and Culture 5(1). < http://www.media-culture.org.au/0203/evoking.php> ([your date of access]).

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