Search results for: physiological barriers to drug delivery

Authors: Nicole Selvi Hill, Archchana Radhakrishnan

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Introduction: Traumatic brain injury (TBI) is a leading cause of mortality among trauma patients. In the management of TBI, the main principle is avoiding cerebral ischemia, as this is a strong determiner of neurological outcomes. The use of vasoactive drugs, such as vasopressin, has an important role in maintaining cerebral perfusion pressure to prevent secondary brain injury. Current guidelines do not suggest a preferred vasoactive drug to administer in the management of TBI, and there is a paucity of information on the therapeutic potential of vasopressin following TBI. Vasopressin is also an endogenous anti-diuretic hormone (AVP), and pathways mediated by AVP play a large role in the underlying pathological processes of TBI. This creates an overlap of discussion regarding the therapeutic potential of vasopressin following TBI. Currently, its popularity lies in vasodilatory and cardiogenic shock in the intensive care setting, with increasing support for its use in haemorrhagic and septic shock. Methodology: This is a review article based on a literature review. An electronic search was conducted via PubMed, Cochrane, EMBASE, and Google Scholar. The aim was to identify clinical studies looking at the therapeutic administration of vasopressin in severe traumatic brain injury. The primary aim was to look at the neurological outcome of patients. The secondary aim was to look at surrogate markers of cerebral perfusion measurements, such as cerebral perfusion pressure, cerebral oxygenation, and cerebral blood flow. Results: Eight papers were included in the final number. Three were animal studies; five were human studies, comprised of three case reports, one retrospective review of data, and one randomised control trial. All animal studies demonstrated the benefits of vasopressors in TBI management. One animal study showed the superiority of vasopressin in reducing intracranial pressure and increasing cerebral oxygenation over a catecholaminergic vasopressor, phenylephrine. All three human case reports were supportive of vasopressin as a rescue therapy in catecholaminergic-resistant hypotension. The retrospective review found vasopressin did not increase cerebral oedema in TBI patients compared to catecholaminergic vasopressors; and demonstrated a significant reduction in the requirements of hyperosmolar therapy in patients that received vasopressin. The randomised control trial results showed no significant differences in primary and secondary outcomes between TBI patients receiving vasopressin versus those receiving catecholaminergic vasopressors. Apart from the randomised control trial, the studies included are of low-level evidence. Conclusion: Studies favour vasopressin within certain parameters of cerebral function compared to control groups. However, the neurological outcomes of patient groups are not known, and animal study results are difficult to extrapolate to humans. It cannot be said with certainty whether vasopressin’s benefits stand above usage of other vasoactive drugs due to the weaknesses of the evidence. Further randomised control trials, which are larger, standardised, and rigorous, are required to improve knowledge in this field.

Keywords: catecholamines, cerebral perfusion pressure, traumatic brain injury, vasopressin, vasopressors

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Authors: Maryam Nazari

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COVID-19 is a respiratory disease triggered by the novel coronavirus, SARS-CoV-2, that has reached pandemic status today. Acute inflammation and immune cells infiltration into lung injuries result in multi-organ failure. The presence of other non-communicable diseases (NCDs) with systemic inflammation derived from COVID-19 may exacerbate the patient's situation and increase the risk for adverse effects and mortality. This pandemic is a novel situation and the scientific community at this time is looking for vaccines or drugs to treat the pathology. One of the biggest challenges is focused on reducing inflammation without compromising the correct immune response of the patient. In this regard, addressing the nutritional factors should not be overlooked not only as a matter of avoiding the presence of NCDs with severe infections but also as an adjunctive way to modulate the inflammatory status of the patients. Despite the pivotal role of nutrition in modifying immune response, due to the novelty of the COVID-19 disease, information about the effects of specific dietary agents is limited in this area. From the macronutrients point of view, protein deficiency (quantity or quality) has negative effects on the number of functional immunoglobulins and gut-associated lymphoid tissue (GALT). High biological value proteins or some amino acids like arginine and glutamine are well known for their ability to augment the immune system. Among lipids, fish oil has the ability to inactivate enveloped viruses, suppress pro-inflammatory prostaglandin production and block platelet-activating factors and their receptors. In addition, protectin D1, which is an Omega-3 PUFAs derivation, is a novel antiviral drug. So it seems that these fatty acids can reduce the severity and/or improve recovery of patients with COVID-19. Carbohydrates with lower glycemic index and fibers are associated with lower levels of inflammatory cytokines (CRP, TNF-α, and IL-6). Short-Chain Fatty acids not only exert a direct anti-inflammatory effect but also provide appropriate gut microbial, which is important in gastrointestinal issues related to COVID-19. From the micronutrients point of view, Vitamins A, C, D, E, iron, magnesium, zinc, selenium and copper play a vital role in the maintenance of immune function. Inadequate status in these nutrients may result in decreased resistance against COVID-19 infection. There are specific bioactive compounds in the diet that interact with the ACE2 receptor, which is the gateway for SARS and SARS-CoV-2, and thus controls the viral infection. Regarding this, the potential benefits of probiotics, resveratrol (a polyphenol found in grape), oleoylethanolamide (derived from oleic acid), and natural peroxisome proliferator-activated receptor γ agonists in foodstuffs (like curcumin, pomegranate, hot pepper) are suggested. Yet, it should be pointed out that most of these results have been reported in animal models and further human studies are needed to be verified.

Keywords: Covid-19, inflammation, nutrition, dietary agents

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Authors: Sonia P. Marrero Duran, Lilian Noya Dominguez, Lisandra Quintana Alvarez, Evert Martinez Perez, Ana Julia Acevedo Urquiaga

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Cuban business and economic policy are in the constant update as well as facing a client ever more knowledgeable and demanding. For that reason become fundamental for companies competitiveness through the optimization of its processes and services. One of the Cuban’s pillars, which has been sustained since the triumph of the Cuban Revolution back in 1959, is the free health service to all those who need it. This service is offered without any charge under the concept of preserving human life, but it implied costly management processes and logistics services to be able to supply the necessary medicines to all the units who provide health services. One of the key actors on the medicine supply chain is the Havana Distribution Center (HDC), which is responsible for the delivery of medicines in the province; as well as the acquisition of medicines from national and international producers and its subsequent transport to health care units and pharmacies in time, and with the required quality. This HDC also carries for all distribution centers in the country. Given the eminent need to create an actor in the supply chain that specializes in the medicines supply, the possibility of centralizing this operation in a logistics service provider is analyzed. Based on this decision, pharmacies operate as clients of the logistic service center whose main function is to centralize all logistics operations associated with the medicine supply chain. The HDC is precisely the logistic service provider in Havana and it is the center of this research. In 2017 the pharmacies had affectations in the availability of medicine due to deficiencies in the distribution routes. This is caused by the fact that they are not based on routing studies, besides the long distribution cycle. The distribution routs are fixed, attend only one type of customer and there respond to a territorial location by the municipality. Taking into consideration the above-mentioned problem, the objective of this research is to optimize the routes system in the Havana Distribution Center. To accomplish this objective, the techniques applied were document analysis, random sampling, statistical inference and tools such as Ishikawa diagram and the computerized software’s: ArcGis, Osmand y MapIfnfo. As a result, were analyzed four distribution alternatives; the actual rout, by customer type, by the municipality and the combination of the two last. It was demonstrated that the territorial location alternative does not take full advantage of the transportation capacities or the distance of the trips, which leads to elevated costs breaking whit the current ways of distribution and the currents characteristics of the clients. The principal finding of the investigation was the optimum option distribution rout is the 4th one that is formed by hospitals and the join of pharmacies, stomatology clinics, polyclinics and maternal and elderly homes. This solution breaks the territorial location by the municipality and permits different distribution cycles in dependence of medicine consumption and transport availability.

Keywords: computerized geographic software, distribution, distribution routs, vehicle problem routing (VPR)

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Authors: Sharon Millen, Sarah Miller, Laura Dunne, Clare McGeady, Laura Neeson

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This paper presents the findings from a randomised controlled trial (RCT) and process evaluation of the Lifestart parenting programme. Lifestart is a structured child-centred programme of information and practical activity for parents of children aged from birth to five years of age. It is delivered to parents in their own homes by trained, paid family visitors and it is offered to parents regardless of their social, economic or other circumstances. The RCT evaluated the effectiveness of the programme and the process evaluation documented programme delivery and included a qualitative exploration of parent and child outcomes. 424 parents and children participated in the RCT: 216 in the intervention group and 208 in the control group across the island of Ireland. Parent outcomes included: parental knowledge of child development, parental efficacy, stress, social support, parenting skills and embeddedness in the community. Child outcomes included cognitive, language and motor development and social-emotional and behavioural development. Both groups were tested at baseline (when children were less than 1 year old), mid-point (aged 3) and at post-test (aged 5). Data were collected during a home visit, which took two hours. The process evaluation consisted of interviews with parents (n=16 at baseline and end-point), and focus groups with Lifestart Coordinators (n=9) and Family Visitors (n=24). Quantitative findings from the RCT indicated that, compared to the control group, parents who received the Lifestart programme reported reduced parenting-related stress, increased knowledge of their child’s development, and improved confidence in their parenting role. These changes were statistically significant and consistent with the hypothesised pathway of change depicted in the logic model. There was no evidence of any change in parents’ embeddedness in the community. Although four of the five child outcomes showed small positive change for children who took part in the programme, these were not statistically significant and there is no evidence that the programme improves child cognitive and non-cognitive skills by immediate post-test. The qualitative process evaluation highlighted important challenges related to conducting trials of this magnitude and design in the general population. Parents reported that a key incentive to take part in study was receiving feedback from the developmental assessment, which formed part of the data collection. This highlights the potential importance of appropriate incentives in relation to recruitment and retention of participants. The interviews with intervention parents indicated that one of the first changes they experienced as a result of the Lifestart programme was increased knowledge and confidence in their parenting ability. The outcomes and pathways perceived by parents and described in the interviews are also consistent with the findings of the RCT and the theory of change underpinning the programme. This hypothesises that improvement in parental outcomes, arising as a consequence of the programme, mediate the change in child outcomes. Parents receiving the Lifestart programme reported great satisfaction with and commitment to the programme, with the role of the Family Visitor being identified as one of the key components of the programme.

Keywords: parent-child relationship, parental self-efficacy, parental stress, school readiness

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Authors: Hanan M. Hassan, Laila Abouzeid, Lamya H. Al-Wahaibi, George S. G. Shehatou, Ali A. El-Emam

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Cancer is a major public health problem and the second leading cause of death worldwide. In 2020, cancer diagnosis and treatment have been negatively affected by the coronavirus 2019 (COVID-19) pandemic. During the quarantine, because of the limited access to healthcare and avoiding exposure to COVID-19 as a contagious disease; patients of cancer suffered deferments in follow-up and treatment regimens leading to substantial worsening of disease, death, and increased healthcare costs. Thus, this study is designed to investigate the molecular mechanisms by which adamantne derivatives attenuate hepatocllular carcinoma experimentally and theoretically. There is a close association between increased resistance to anticancer drugs and defective apoptosis that considered a causative factor for oncogenesis. Cancer cells use different molecular pathways to inhibit apoptosis, BAX and Bcl-2 proteins have essential roles in the progression or inhibition of intrinsic apoptotic pathways triggered by mitochondrial dysfunction. Therefore, their balance ratio can promote the cellular apoptotic fate. In this study, the in vitro cytotoxic effects of seven synthetic adamantyl isothiorea derivatives were evaluated against five human tumor cell lines by MTT assay. Compounds 5 and 6 showed the best results, mostly against hepatocellular carcinoma (HCC). Hence, in vivo studies were performed in male Sprague-Dawley (SD) rats in which experimental hepatocellular carcinoma was induced with thioacetamide (TAA) (200 mg/kg, i.p., twice weekly) for 16 weeks. The most promising compounds, 5 and 6, were administered to treat liver cancer rats at a dose of 10 mg/kg/day for an additional two weeks, and the effects were compared with doxorubicin (DR), the anticancer drug. Hepatocellular carcinoma was evidenced by a dramatic increase in liver indices, oxidative stress markers, and immunohistochemical studies that were accompanied by a plethora of inflammatory mediators and alterations in the apoptotic cascade. Our results showed that treatment with adamantane derivatives 5 and 6 significantly suppressed fibrosis, inflammation, and other histopathological insults resulting in the diminished formation of hepatocyte tumorigenesis. Moreover, administration of the tested compounds resulted in amelioration of EGFR protein expression, upregulation of BAX, and lessening down of Bcl-2 levels that prove their role as apoptosis inducers. Also, the docking simulations performed for adamantane showed good fit and binding to the EGFR protein through hydrogen bond formation with conservative amino acids, which gives a shred of strong evidence for its hepatoprotective effect. In most analyses, the effects of compound 6 were more comparable to DR than compound 5. Our findings suggest that adamantane derivatives 5 and 6 are shown to have cytotoxic activity against HCC in vitro and in vivo, by more than one mechanism, possibly by inhibiting the TLR4-MyD88-NF-κB pathway and targeting EGFR signaling.

Keywords: adamantane, EGFR, HCC, apoptosis

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Authors: Chetna Dhand, Venkatesh Mayandi, Silvia Marrero Diaz, Roger W. Beuerman, Seeram Ramakrishna, Rajamani Lakshminarayanan

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Sturdy Insect Cuticle Sclerotization, Incredible Substrate independent Mussel’s bioadhesion, Tanning of Leather are some of catechol(amine)s mediated natural processes. Chemical contemplation spots toward a mechanism instigated with the formation of the quinone moieties from the respective catechol(amine)s, via oxidation, followed by the nucleophilic addition of the amino acids/proteins/peptides to this quinone leads to the development of highly strong, cross-linked and water-resistant proteinacious structures. Inspired with this remarkable catechol(amine)s chemistry towards amino acids/proteins/peptides, we attempted to design highly stable and water-resistant antifungal wound dressing mats with exceptional durability using collagen (protein), dopamine (catecholamine) and antifungal drugs (Amphotericin B and Caspofungin) as the key materials. Electrospinning technique has been used to fabricate desired nanofibrous mat including Collagen (COLL), COLL/Dopamine (COLL/DP) and calcium incorporated COLL/DP (COLL-DP-Ca2+). The prepared protein-based scaffolds have been studied for their microscopic investigations (SEM, TEM, and AFM), structural analysis (FT-IR), mechanical properties, water wettability characteristics and aqueous stability. Biocompatibility of these scaffolds has been analyzed for dermal fibroblast cells using MTS assay, Cell TrackerTM Green CMFDA and confocal imaging. Being the winner sample, COLL-DP-Ca2+ scaffold has been selected for incorporating two antifungal drugs namely Caspofungin (Peptide based) and Amphotericin B (Non-Peptide based). Antifungal efficiency of the designed mats has been evaluated for eight diverse fungal strains employing different microbial assays including disc diffusion, cell-viability assay, time kill kinetics etc. To confirm the durability of these mats, in term of their antifungal activity, drug leaching studies has been performed and monitored using disc diffusion assay each day. Ex-vivo fungal infection model has also been developed and utilized to validate the antifungal efficacy of the designed wound dressings. Results clearly reveal dopamine mediated crosslinking within COLL-antifungal scaffolds that leads to the generation of highly stable, mechanical tough, biocompatible wound dressings having the zone of inhabitation of ≥ 2 cm for almost all the investigated fungal strains. Leaching studies and Ex-vivo model has confirmed the durability of these wound dressing for more than 3 weeks and certified their suitability for commercialization. A model has also been proposed to enlighten the chemical mechanism involved for the development of these antifungal wound dressings with exceptional robustness.

Keywords: catecholamine chemistry, electrospinning technique, antifungals, wound dressings, collagen

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Authors: Anush Patric, M. Jadeyegowda, M. N. Ramesh, M. Ravikumar, C. R. Ajay

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Kodagu district which is situated in Central Western Ghats regions falls in one of the hottest of hot spots of biodiversity which is recognised by UNESCO. The district has one of the highest densities of community managed sacred forests in the world with rich floral and faunal diversity. It is a habitat for more than ten different types of Ethnic Indigenous tribal groups commonly called ‘Girijanas’ (Soligas, Yarvas, Jenukuruba, Bettakuruba etc.), who are having the rich knowledge of medicinal value of the plants that are commonly available in the forest. The tribal men of this region are the treasure house of the traditional plant knowledge and health care practices. An ethnobotanical survey was undertaken in tribal areas of the district to collect information about some of the indigenous medicinal plant knowledge of tribal people by semi-structured interviews, ranking exercises and field observations on their native habitat in order to evaluate the potential medicinal uses of local plants. The study revealed that, the ethnobotanical information of 83 plant species belonging to 45 families, of the total 83 species documented, most plants used in the treatment were trees (11 species), shrubs (41 species), herbs (22 species) and rarely climbers (9 species) which are used in the treatment of Hyperacidity, Respiratory disorders, Snake bite Abortifacient, Anthelmintic, Paralysis, Antiseptic, Fever, Chest pain, Stomachic, Jaundice, Piles, Asthma, Malaria, Renal disorders, Malaria and many other diseases. Maximum of 6 plant species each of Acanthaceae, Apiaceae and were used for drug preparation, followed by Asclepiadaceae, Liliaceae, Fabaceae, Verbenaceae, Caesalpinaceae, Bombaceae, Papilonaceae, Solanaceae, Rubiaceae, Myrtaceae, Amaranthaceae, Asteraceae, Ascelepidaceae, Cucurbitaceae, Apocyanaceae, and Solanaceae etc. In our present study, only medicinal plants and their local medicinal uses are recorded and presented. Information was obtained by local informants having the knowledge about medicinal plants. About 23 local tribes were interviewed. For each plant, necessary information like botanical name, family of plant species, local name and uses are given. Recent trend shows a decline in the number of traditional herbal healers in the tribal areas since the younger generation is not interested to continue this tradition. Hence, there is an urgent need to record and preserve all information on plants used by different ethnic/tribal communities for various purposes before it reaches to verge of extinction. In addition, several wild medicinal plants are declining in numbers due to deforestation and forest fires. There is need for phytochemical analysis and conservation measures to be taken for conserving medicinal plant species which is far better than allopathic medicines and these do not cause any side effects as they are the natural disease healers. So, conservation strategies have to be practiced in all levels and sectors by creating awareness about the value of such medicinal plants, and it is necessary to save the disappearing plants to strengthen the document and to conserve them for future generation.

Keywords: diseases, ethnic groups, folk medicine, Kodagu, medicinal plants

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Authors: Shelley Y. Hawkins

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Introduction/Background: As technology has grown exponentially in healthcare, nurse educators must prepare Advanced Practice Registered Nurse (APRN) graduates with the knowledge and skills in information systems/technology to support and improve patient care and health care systems. APRN’s are expected to lead in caring for populations who lack accessibility and availability through the use of technology, specifically telehealth. The capacity to effectively and efficiently use technology in patient care delivery is clearly delineated in the American Association of Colleges of Nursing (AACN) Doctor of Nursing Practice (DNP) and Master of Science in Nursing (MSN) Essentials. However, APRN’s have minimal, or no, exposure to formalized telehealth education and lack necessary technical skills needed to incorporate telehealth into their patient care. APRN’s must successfully master the technology using telehealth/telemedicine, electronic health records, health information technology, and clinical decision support systems to advance health. Furthermore, APRN’s must be prepared to lead the coordination and collaboration with other healthcare providers in their use and application. Aim/Goal/Purpose: The purpose of this presentation is to establish and operationalize telehealth-focused educational partnerships between one University School of Nursing and two health care systems in order to enhance the preparation of APRN NP students for practice, teaching, and/or scholarly endeavors. Methods: The proposed project was initially presented by the project director to selected multidisciplinary stakeholders including leadership, home telehealth personnel, primary care providers, and decision support systems within two major health care systems to garner their support for acceptance and implementation. Concurrently, backing was obtained from key university-affiliated colleagues including the Director of Simulation and Innovative Learning Lab and Coordinator of the Health Care Informatics Program. Technology experts skilled in design and production in web applications and electronic modules were secured from two local based technology companies. Results: Two telehealth-focused APRN Program academic/practice partnerships have been established. Students have opportunities to engage in clinically based telehealth experiences focused on: (1) providing patient care while incorporating various technology with a specific emphasis on telehealth; (2) conducting research and/or evidence-based practice projects in order to further develop the scientific foundation regarding incorporation of telehealth with patient care; and (3) participating in the production of patient-level educational materials related to specific topical areas. Conclusions: Evidence-based APRN student telehealth clinical experiences will assist in preparing graduates who can effectively incorporate telehealth into their clinical practice. Greater access for diverse populations will be available as a result of the telehealth service model as well as better care and better outcomes at lower costs. Furthermore, APRN’s will provide the necessary leadership and coordination through interprofessional practice by transforming health care through new innovative care models using information systems and technology.

Keywords: academic/practice partnerships, advanced practice nursing, nursing education, telehealth

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Authors: U. E. Mochalova, A. V. Demeneva, Shilkin A. G., J. Yu. Artiushina

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Objective. In medical ophthalmology OCT has been actively used in the last decade. It is a modern non-invasive method of high-precision hardware examination, which gives a detailed cross-sectional image of eye tissues structure with a high level of resolution, which provides in vivo morphological information at the microscopic level about corneal tissue, structures of the anterior segment, retina and optic nerve. The purpose of this study was to explore the possibility of using the OCT technology in complex ophthalmological examination in dogs and cats, to characterize the revealed pathological structural changes in corneal tissue in cats and dogs with some of the most common corneal diseases. Procedures. Optical coherence tomography of the cornea was performed in 112 animals: 68 dogs and 44 cats. In total, 224 eyes were examined. Pathologies of the organ of vision included: dystrophy and degeneration of the cornea, endothelial corneal dystrophy, dry eye syndrome, chronic superficial vascular keratitis, pigmented keratitis, corneal erosion, ulcerative stromal keratitis, corneal sequestration, chronic glaucoma and also postoperative period after performed keratoplasty. When performing OCT, we used certified medical devices: "Huvitz HOCT-1/1F», «Optovue iVue 80» and "SOCT Copernicus Revo (60)". Results. The results of a clinical study on the use of optical coherence tomography (OCT)of the cornea in cats and dogs, performed by the authors of the article in the complex diagnosis of keratopathies of variousorigins: endothelial corneal dystrophy, pigmented keratitis, chronic keratoconjunctivitis, chronic herpetic keratitis, ulcerative keratitis, traumatic corneal damage, sequestration of the cornea of cats, chronic keratitis, complicating the course of glaucoma. The characteristics of the OCT scans are givencorneas of cats and dogs that do not have corneal pathologies. OCT scans of various corneal pathologies in dogs and cats with a description of the revealed pathological changes are presented. Of great clinical interest are the data obtained during OCT of the cornea of animals undergoing keratoplasty operations using various forms of grafts. Conclusions. OCT makes it possible to assess the thickness and pathological structural changes of the corneal surface epithelium, corneal stroma and descemet membrane. We can measure them, determine the exact localization, and record pathological changes. Clinical observation of the dynamics of the pathological process in the cornea using OCT makes it possible to evaluate the effectiveness of drug treatment. In case of negative dynamics of corneal disease, it is necessary to determine the indications for surgical treatment (to assess the thickness of the cornea, the localization of its thinning zones, to characterize the depth and area of pathological changes). According to the OCT of the cornea, it is possible to choose the optimal surgical treatment for the patient, the technique and depth of optically constructive surgery (penetrating or anterior lamellar keratoplasty).; determine the depth and diameter of the planned microsurgical trepanation of corneal tissue, which will ensure good adaptation of the edges of the donor material.

Keywords: optical coherence tomography, corneal sequestration, optical coherence tomography of the cornea, corneal transplantation, cat, dog

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Authors: Sharmila Parmanand

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This paper examines dominant media representations of prostitution in the Philippines and interrogates sex workers’ interactions with the media establishment. This analysis of how sex workers are constituted in media, often as both innocent victims and immoral actors, contributes to an understanding of public discourse on sex work in the Philippines, where decriminalisation has recently been proposed and sex workers are currently classified as potential victims under anti-trafficking laws but also as criminals under the penal code. The first part is an analysis of media coverage of two prominent themes on prostitution: first, raid and rescue operations conducted by law enforcement; and second, prostitution on military bases and tourism hotspots. As a result of pressure from activists and international donors, these two themes often define the policy conversations on sex work in the Philippines. The discourses in written and televised news reports and documentaries from established local and international media sources that address these themes are explored through content analysis. Conclusions are drawn based on specific terms commonly used to refer to sex workers, how sex workers are seen as performing their cultural roles as mothers and wives, how sex work is depicted, associations made between sex work and public health, representations of clients and managers and ‘rescuers’ such as the police, anti-trafficking organisations, and faith-based groups, and which actors are presumed to be issue experts. Images of how prostitution is used as a metaphor for relations between the Philippines and foreign nations are also deconstructed, along with common tropes about developing world female subjects. In general, sex workers are simultaneously portrayed as bad mothers who endanger their family’s morality but also as long-suffering victims who endure exploitation for the sake of their children. They are also depicted as unclean, drug-addicted threats to public health. Their managers and clients are portrayed as cold, abusive, and sometimes violent, and their rescuers as moral and altruistic agents who are essential for sex workers’ rehabilitation and restoration as virtuous citizens. The second part explores sex workers’ own perceptions of their interactions with media, through interviews with members of the Philippine Sex Workers Collective, a loose organisation of sex workers around the Philippines. They reveal that they are often excluded by media practitioners and that they do not feel that they have space for meaningful self-revelation about their work when they do engage with journalists, who seem to have an overt agenda of depicting them as either victims or women of loose morals. In their assessment, media narratives do not necessarily reflect their lived experiences, and in some cases, coverage of rescues and raid operations endangers their privacy and instrumentalises their suffering. Media representations of sex workers may produce subject positions such as ‘victims’ or ‘criminals’ and legitimize specific interventions while foreclosing other ways of thinking. Further, in light of media’s power to reflect and shape public consciousness, it is a valuable academic and political project to examine whether sex workers are able to assert agency in determining how they are represented.

Keywords: discourse analysis, news media, sex work, trafficking

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Authors: Tanya Anand, Arun Kandasamy, L. N. Suman

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Family based therapy for adolescent substance abuse has been studied to be effective in the West. Whereas, based on literature review, family therapy and interventions for adolescent substance abuse is still in its nascent stages in India. A multidimensional perspective to treatment has been indicated consistently in the Indian literature, but standardized therapy which addresses early substance abuse, from a social-ecological perspective has not been developed and studied for Indian population. While numerous researches have been conducted in India on the need of engaging the family in therapy for the purpose of symptom reduction, long-term maintenance of gains, and reducing family burnout, distress and dysfunction; a family based model in the Indian context has not been developed and tried, to the best of our knowledge. Hence, from the aim of building a model to treat adolescent substance abuse within the family context, experts in the area of mental health and deaddiction were interviewed to inform upon the clinical difficulties, challenges, uniqueness that Indian families present with. The integration of indigenous techniques that would be helpful in engaging families of young individuals with difficulties were also explored. Eight experts' who were interviewed, have 10-30 years of experience in working with families and substance users. An open-ended interview was conducted with the experts individually and audio-recorded. The interviews were then transcribed and subjected to qualitative analysis for building a framework and treatment guideline. Additionally, interviews with patients and their parents were conducted to elicit ‘felt needs’. The results of the analysis revealed culture-specific issues widely experienced within Indian families by adolescents and young adults, centering around the theme of Individuation versus collective identity and living. Substance abuse, in this framework, was found to be perceived as one of the maladaptive ways of the youth to disengage from the family and attempt at individuation and the responsibilities that are considered entitlements in the culture. On the other hand, interviews with family members revealed them to be engaging in inconsistent patterns of care and parenting. This was experienced and observed in terms of fostering interdependence within the family, sometimes within adverse socio-economic and societal conditions, where enacted and perceived stigma kept the individual and family members in a vicious loop of maladaptive coping patterns, dysfunctional family arrangements, and often leading to burnout with poor help seeking. The paper inform upon a framework that lays down the foundation for assessments, planning, case management and therapist competencies, required to address alcohol and drug issues in an Indian family context with such etiological factors at its heart. This paper will cover qualitative results of the interviews and present a model that may guide mental health professionals for treatment of adolescent substance use and family therapy.

Keywords: Indian families, family therapy, de-addiction, adolescent, youth, substance abuse, behavioral issues, felt needs, culture, etiology, model building, framework development, interviews

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Authors: Samuel Escandón, María J. Peñaherrera-Vélez, Signe Vargas-Rosvik, Carlos Jerves Córdova, Ximena Vélez-Calvo, Angélica Ochoa-Avilés

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Overweight and obesity are considered risk factors in childhood for developing nutrition-related non-communicable diseases (NCDs), such as diabetes, cardiovascular diseases, and cancer. In Ecuador, 35.4% of 5- to 11-year-olds and 29.6% of 12- to 19-year-olds are overweight or obese. Globally, unhealthy food environments characterized by high consumption of processed/ultra-processed food and rapid urbanization are highly related to the increasing nutrition-related non-communicable diseases. The evidence shows that in low- and middle-income countries (LMICs), fiscal policies and regulatory measures significantly reduce unhealthy food environments, achieving substantial advances in health. However, in some LMICs, little is known about the impact of governments' action to implement healthy food-environment policies. This study aimed to generate evidence on the state of implementation of public policy focused on food environments for the prevention of overweight and obesity in children and adolescents in Ecuador compared to global best practices and to target key recommendations for reinforcing the current strategies. After adapting the INFORMAS' Healthy Food Environment Policy Index (Food‐EPI) to the Ecuadorian context, the Policy and Infrastructure support components were assessed. Individual online interviews were performed using fifty-one indicators to analyze the level of implementation of policies directly or indirectly related to preventing overweight and obesity in children and adolescents compared to international best practices. Additionally, a participatory workshop was conducted to identify the critical indicators and generate recommendations to reinforce or improve the political action around them. In total, 17 government and non-government experts were consulted. From 51 assessed indicators, only the one corresponding to the nutritional information and ingredients labelling registered an implementation level higher than 60% (67%) compared to the best international practices. Among the 17 indicators determined as priorities by the participants, those corresponding to the provision of local products in school meals and the limitation of unhealthy-products promotion in traditional and digital media had the lowest level of implementation (34% and 11%, respectively) compared to global best practices. The participants identified more barriers (e.g., lack of continuity of effective policies across government administrations) than facilitators (e.g., growing interest from the Ministry of Environment because of the eating-behavior environmental impact) for Ecuador to move closer to the best international practices. Finally, within the participants' recommendations, we highlight the need for policy-evaluation systems, information transparency on the impact of the policies, transformation of successful strategies into laws or regulations to make them mandatory, and regulation of power and influence from the food industry (conflicts of interest). Actions focused on promoting a more active role of society in the stages of policy formation and achieving more articulated actions between the different government levels/institutions for implementing the policy are necessary to generate a noteworthy impact on preventing overweight and obesity in children and adolescents. Including systems for internal evaluation of existing strategies to strengthen successful actions, create policies to fill existing gaps and reform policies that do not generate significant impact should be a priority for the Ecuadorian government to improve the country's food environments.

Keywords: children and adolescents, food-EPI, food policies, healthy food environment

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Authors: Mehdi Soula, Yosra Mani, Estelle Saras, Antoine Drapeau, Raoudha Grami, Mahjoub Aouni, Jean-Yves Madec, Marisa Haenni, Wejdene Mansour

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Multi-resistance to antibiotics in gram-negative bacilli and particularly in enterobacteriaceae, has become frequent in hospitals in Tunisia. However, data on antibiotic resistant bacteria in aquatic products are scarce. The aims of this study are to estimate the proportion of ESBL- and carbapenemase-producing Enterobacterales in seafood (clams and fish) in Tunisia and to molecularly characterize the collected isolates. Two types of seafood were sampled in unrelated markets in four different regions in Tunisia (641 pieces of farmed fish and 1075 mediterranean clams divided into 215 pools, and each pool contained 5 pieces). Once purchased, all samples were incubated in tubes containing peptone salt broth for 24 to 48h at 37°C. After incubation, overnight cultures were isolated on selective MacConkey agar plates supplemented with either imipenem or cefotaxime, identified using API20E test strips (bioMérieux, Marcy-l’Étoile, France) and confirmed by Maldi-TOF MS. Antimicrobial susceptibility was determined by the disk diffusion method on Mueller-Hinton agar plates and results were interpreted according to CA-SFM 2021. ESBL-producing Enterobacterales were detected using the Double Disc Synergy Test (DDST). Carbapenem-resistance was detected using an ertapenem disk and was respectively confirmed using the ROSCO KPC/MBL and OXA-48 Confirm Kit (ROSCO Diagnostica, Taastrup, Denmark). DNA was extracted using a NucleoSpin Microbial DNA extraction kit (Macherey-Nagel, Hoerdt, France), according to the manufacturer’s instructions. Resistance genes were determined using the CGE online tools. The replicon content and plasmid formula were identified from the WGS data using PlasmidFinder 2.0.1 and pMLST 2.0. From farmed fishes, nine ESBL-producing strains (9/641, 1.4%) were isolated, which were identified as E. coli (n=6) and K. pneumoniae (n=3). Among the 215 pools of 5 clams analyzed, 18 ESBL-producing isolates were identified, including 14 E. coli and 4 K. pneumoniae. A low isolation rate of ESBL-producing Enterobacterales was detected 1.6% (18/1075) in clam pools. In fish, the ESBL phenotype was due to the presence of the blaCTX-M-15 gene in all nine isolates, but no carbapenemase gene was identified. In clams, the predominant ESBL phenotype was blaCTX-M-1 (n=6/18). blaCPE (NDM1, OXA48) was detected only in 3 isolates ‘K. pneumoniae isolates’. Replicon typing on the strains carring the ESBL and carbapenemase gene revelead that the major type plasmid carried ESBL were IncF (42.3%) [n=11/26]. In all, our results suggest that seafood can be a reservoir of multi-drug resistant bacteria, most probably of human origin but also by the selection pressure of antibiotic. Our findings raise concerns that seafood bought for consumption may serve as potential reservoirs of AMR genes and pose serious threat to public health.

Keywords: BLSE, carbapenemase, enterobacterales, tunisian seafood

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Authors: Duncan Wallace, M-Tahar Kechadi

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In recent years, Machine Learning (ML) approaches have been successfully applied to an analysis of patient symptom data in the context of disease diagnosis, at least where such data is well codified. However, much of the data present in Electronic Health Records (EHR) are unlikely to prove suitable for classic ML approaches. Furthermore, as scores of data are widely spread across both hospitals and individuals, a decentralized, computationally scalable methodology is a priority. The focus of this paper is to develop a method to predict outliers in an out-of-hours healthcare provision center (OOHC). In particular, our research is based upon the early identification of patients who have underlying conditions which will cause them to repeatedly require medical attention. OOHC act as an ad-hoc delivery of triage and treatment, where interactions occur without recourse to a full medical history of the patient in question. Medical histories, relating to patients contacting an OOHC, may reside in several distinct EHR systems in multiple hospitals or surgeries, which are unavailable to the OOHC in question. As such, although a local solution is optimal for this problem, it follows that the data under investigation is incomplete, heterogeneous, and comprised mostly of noisy textual notes compiled during routine OOHC activities. Through the use of Deep Learning methodologies, the aim of this paper is to provide the means to identify patient cases, upon initial contact, which are likely to relate to such outliers. To this end, we compare the performance of Long Short-Term Memory, Gated Recurrent Units, and combinations of both with Convolutional Neural Networks. A further aim of this paper is to elucidate the discovery of such outliers by examining the exact terms which provide a strong indication of positive and negative case entries. While free-text is the principal data extracted from EHRs for classification, EHRs also contain normalized features. Although the specific demographical features treated within our corpus are relatively limited in scope, we examine whether it is beneficial to include such features among the inputs to our neural network, or whether these features are more successfully exploited in conjunction with a different form of a classifier. In this section, we compare the performance of randomly generated regression trees and support vector machines and determine the extent to which our classification program can be improved upon by using either of these machine learning approaches in conjunction with the output of our Recurrent Neural Network application. The output of our neural network is also used to help determine the most significant lexemes present within the corpus for determining high-risk patients. By combining the confidence of our classification program in relation to lexemes within true positive and true negative cases, with an inverse document frequency of the lexemes related to these cases, we can determine what features act as the primary indicators of frequent-attender and non-frequent-attender cases, providing a human interpretable appreciation of how our program classifies cases.

Keywords: artificial neural networks, data-mining, machine learning, medical informatics

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Authors: Seyed Hossein Hosseini, Seyed Majid Hashemzadeh

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Solar energy is one of the remarkable renewable energy sources that have particular characteristics such as unlimited, no environmental pollution, and free access. Generally, solar energy can be used in thermal and photovoltaic (PV) types. The cost of installation of the PV system is very high. Additionally, due to dependence on environmental situations such as solar radiation and ambient temperature, electrical power generation of this system is unpredictable and without power electronics devices, there is no guarantee to maximum power delivery at the output of this system. Maximum power point tracking (MPPT) should be used to achieve the maximum power of a PV string. MPPT is one of the essential parts of the PV system which without this section, it would be impossible to reach the maximum amount of the PV string power and high losses are caused in the PV system. One of the noticeable challenges in the problem of MPPT is the partial shading conditions (PSC). In PSC, the output photocurrent of the PV module under the shadow is less than the PV string current. The difference between the mentioned currents passes from the module's internal parallel resistance and creates a large negative voltage across shaded modules. This significant negative voltage damages the PV module under the shadow. This condition is called hot-spot phenomenon. An anti-paralleled diode is inserted across the PV module to prevent the happening of this phenomenon. This diode is known as the bypass diode. Due to the performance of the bypass diode under PSC, the P-V curve of the PV string has several peaks. One of the P-V curve peaks that makes the maximum available power is the global peak. Model-based Global MPPT (GMPPT) methods can estimate the optimal point with higher speed than other GMPPT approaches. Centralized, modular, and interleaved DC-DC converter topologies are the significant structures that can be used for GMPPT at a PV string. there are some problems in the centralized structure such as current mismatch losses at PV sting, loss of power of the shaded modules because of bypassing by bypass diodes under PSC, needing to series connection of many PV modules to reach the desired voltage level. In the modular structure, each PV module is connected to a DC-DC converter. In this structure, by increasing the amount of demanded power from the PV string, the number of DC-DC converters that are used at the PV system will increase. As a result, the cost of the modular structure is very high. We can implement the model-based GMPPT through the multi-input interleaved boost DC-DC converter to increase the power extraction from the PV string and reduce hot-spot and current mismatch error in a PV string under different environmental condition and variable load circumstances. The interleaved boost DC-DC converter has many privileges than other mentioned structures, such as high reliability and efficiency, better regulation of DC voltage at DC link, overcome the notable errors such as module's current mismatch and hot spot phenomenon, and power switches voltage stress reduction.

Keywords: solar energy, photovoltaic systems, interleaved boost converter, maximum power point tracking, model-based method, partial shading conditions

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Authors: Leo Nnamdi Ozurumba-Dwight

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Messenger ribooxynucleic acid (mRNA) molecules are compositional, protein-based. These proteins, encoding mRNA molecules (which collectively connote the transcriptome), when analyzed by RNA sequencing (RNAseq), unveils the nature of gene expression in the RNA. The obtained gene expression provides clues of cellular traits and their dynamics in presentations. These can be studied in relation to function and responses. RNAseq is a practical concept in Genomics as it enables detection and quantitative analysis of mRNA molecules. Single cell and spatial transcriptomics both present varying avenues for expositions in genomic characteristics of single cells and pooled cells in disease conditions such as cancer, auto-immune diseases, hematopoietic based diseases, among others, from investigated biological tissue samples. Single cell transcriptomics helps conduct a direct assessment of each building unit of tissues (the cell) during diagnosis and molecular gene expressional studies. A typical technique to achieve this is through the use of a single-cell RNA sequencer (scRNAseq), which helps in conducting high throughput genomic expressional studies. However, this technique generates expressional gene data for several cells which lack presentations on the cells’ positional coordinates within the tissue. As science is developmental, the use of complimentary pre-established tissue reference maps using molecular and bioinformatics techniques has innovatively sprung-forth and is now used to resolve this set back to produce both levels of data in one shot of scRNAseq analysis. This is an emerging conceptual approach in methodology for integrative and progressively dependable transcriptomics analysis. This can support in-situ fashioned analysis for better understanding of tissue functional organization, unveil new biomarkers for early-stage detection of diseases, biomarkers for therapeutic targets in drug development, and exposit nature of cell-to-cell interactions. Also, these are vital genomic signatures and characterizations of clinical applications. Over the past decades, RNAseq has generated a wide array of information that is igniting bespoke breakthroughs and innovations in Biomedicine. On the other side, spatial transcriptomics is tissue level based and utilized to study biological specimens having heterogeneous features. It exposits the gross identity of investigated mammalian tissues, which can then be used to study cell differentiation, track cell line trajectory patterns and behavior, and regulatory homeostasis in disease states. Also, it requires referenced positional analysis to make up of genomic signatures that will be sassed from the single cells in the tissue sample. Given these two presented approaches to RNA transcriptomics study in varying quantities of cell lines, with avenues for appropriate resolutions, both approaches have made the study of gene expression from mRNA molecules interesting, progressive, developmental, and helping to tackle health challenges head-on.

Keywords: transcriptomics, RNA sequencing, single cell, spatial, gene expression.

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Authors: Muhammad Shuaibu Birniwa

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Automobile Independent Workshop Service Technicians (popularly called roadside mechanics) are technical personals that repairs most of the automobile vehicles in Nigeria. Majority of these mechanics acquired their skills through apprenticeship training. Modern vehicle imported into the country posed greater challenges to the present automobile technicians particularly in the area of carrying out maintenance repairs of these latest automobile vehicles (autotronics vehicle) due to their inability to possessed autotronic skills competency. To source for solution to the above mentioned problems, therefore a research is carried out in North – Western region of Nigeria to produce a suitable maintenance training modules that can be used to train the technicians for them to upgrade/acquire the needed competencies for successful maintenance repair of the autotronic vehicles that were running everyday on the nation’s roads. A cluster sampling technique is used to obtain a sample from the population. The population of the study is all autotronic inclined lecturers, instructors and independent workshop service technicians that are within North – Western region of Nigeria. There are seven states (Jigawa, Kaduna, Kano, Katsina, Kebbi, Sokoto and Zamfara) in the study area, these serves as clusters in the population. Five (5) states were randomly selected to serve as the sample size. The five states are Jigawa, Kano, Katsina, Kebbi and Zamfara, the entire population of the five states which serves as clusters is (183), lecturers (44), instructors (49) and autotronic independent workshop service technicians (90), all of them were used in the study because of their manageable size. 183 copies of autotronic maintenance training module questionnaires (AMTMQ) with 174 and 149 question items respectively were administered and collected by the researcher with the help of an assistants, they are administered to 44 Polytechnic lecturers in the department of mechanical engineering, 49 instructors in skills acquisition centres/polytechnics and 90 master craftsmen of an independent workshops that are autotronic inclined. Data collected for answering research questions 1, 3, 4 and 5 were analysed using SPSS software version 22, Grand Mean and standard deviation were used to answer the research questions. Analysis of Variance (ANOVA) was used to test null hypotheses one (1) to three (3) and t-test statistical tool is used to analyzed hypotheses four (4) and five (5) all at 0.05 level of significance. The research conducted revealed that; all the objectives, contents/tasks, facilities, delivery systems and evaluation techniques contained in the questionnaire were required for the development of the autotronic maintenance training modules for independent workshop service technicians in the north – western zone of Nigeria. The skills upgrade training conducted by federal government in collaboration with SURE-P, NAC and SMEDEN was not successful because the educational status of the target population was not considered in drafting the needed training modules. The mode of training used does not also take cognizance of the theoretical aspect of the trainees, especially basic science which rendered the programme ineffective and insufficient for the tasks on ground.

Keywords: autotronics, roadside, mechanics, technicians, independent

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Authors: Kuldeep Rawat, Michael O'Shea, Maureen McGough

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The paper will discuss a National Institute of Justice (NIJ) funded project to provide cost-effective aviation technologies and research to support counter-poaching operations related to endangered, protected, and/or regulated wildlife. The goal of this project is to provide cost-effective aviation technology and research support to Kenya Wildlife Service (KWS) in their counter-poaching efforts. In pursuit of this goal, Elizabeth City State University (ECSU) is assisting the National Institute of Justice (NIJ) in enhancing the Kenya Wildlife Service’s aviation technology and related capacity to meet its counter-poaching mission. Poaching, at its core, is systemic as poachers go to the most extreme lengths to kill high target species such as elephant and rhino. These high target wildlife species live in underdeveloped or impoverished nations, where poachers find fewer barriers to their operations. In Kenya, with fifty-nine (59) parks and reserves, spread over an area of 225,830 square miles (584,897 square kilometers) adequate surveillance on the ground is next to impossible. Cost-effective aviation surveillance technologies, based on a comprehensive needs assessment and operational evaluation, are needed to curb poaching and effectively prevent wildlife trafficking. As one of the premier law enforcement Air Wings in East Africa, KWS plays a crucial role in Kenya, not only in counter-poaching and wildlife conservation efforts, but in aerial surveillance, counterterrorism and national security efforts as well. While the Air Wing has done, a remarkable job conducting aerial patrols with limited resources, additional aircraft and upgraded technology should significantly advance the Air Wing’s ability to achieve its wildlife protection mission. The project includes: (i) Needs Assessment of the KWS Air Wing, to include the identification of resources, current and prospective capacity, operational challenges and priority goals for expansion, (ii) Acquisition of Low-Cost Aviation Technology to meet priority needs, and (iii) Operational Evaluation of technology performance, with a focus on implementation and effectiveness. The Needs Assessment reflects the priorities identified through two site visits to the KWS Air Wing in Nairobi, Kenya, as well as field visits to multiple national parks receiving aerial support and interviewing/surveying KWS Air wing pilots and leadership. Needs Assessment identified some immediate technology needs that includes, GPS with upgrades, including weather application, Night flying capabilities, to include runway lights and night vision technology, Cameras and surveillance equipment, Flight tracking system and/or Emergency Position Indicating Radio Beacon, Lightweight ballistic-resistant body armor, and medical equipment, to include a customized stretcher and standard medical evacuation equipment. Results of this assessment, along with significant input from the KWS Air Wing, will guide the second phase of this project: technology acquisition. Acquired technology will then be evaluated in the field, with a focus on implementation and effectiveness. Results will ultimately be translated for any rural or tribal law enforcement agencies with comparable aerial surveillance missions and operational environments, and jurisdictional challenges, seeking to implement low-cost aviation technology. Results from Needs Assessment phase, including survey results and our ongoing technology acquisition and baseline operational evaluation will be discussed in the paper.

Keywords: aerial surveillance mission, aviation technology, counter-poaching, wildlife protection

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Authors: Mariia Karizhenskaia, Tanvi Nandani, Ali Tafazoli Moghadam

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Hospice palliative care (HPC) is one of the most complicated philosophies of care in which physical, social/cultural, and spiritual aspects of human life are intermingled with an undeniably significant role in every aspect. Among these dimensions of care, culture possesses an outstanding position in the process and goal determination of HPC. This study shows the importance of cultural elements in the establishment of effective and optimized structures of HPC in the Canadian healthcare environment. Our systematic search included Medline, Google Scholar, and St. Lawrence College Library, considering original, peer-reviewed research papers published from 1998 to 2023 to identify recent national literature connecting culture and palliative care delivery. The most frequently presented feature among the articles is the role of culture in the efficiency of the HPC. It has been shown frequently that including the culturespecific parameters of each nation in this system of care is vital for its success. On the other hand, ignorance about the exclusive cultural trends in a specific location has been accompanied by significant failure rates. Accordingly, implementing a culture-wise adaptable approach is mandatory for multicultural societies. The following outcome of research studies in this field underscores the importance of culture-oriented education for healthcare staff. Thus, all the practitioners involved in HPC will recognize the importance of traditions, religions, and social habits for processing the care requirements. Cultural competency training is a telling sample of the establishment of this strategy in health care that has come to the aid of HPC in recent years. Another complexity of the culturized HPC nowadays is the long-standing issue of racialization. Systematic and subconscious deprivation of minorities has always been an adversity of advanced levels of care. The last part of the constellation of our research outcomes is comprised of the ethical considerations of culturally driven HPC. This part is the most sophisticated aspect of our topic because almost all the analyses, arguments, and justifications are subjective. While there was no standard measure for ethical elements in clinical studies with palliative interventions, many research teams endorsed applying ethical principles for all the involved patients. Notably, interpretations and projections of ethics differ in varying cultural backgrounds. Therefore, healthcare providers should always be aware of the most respectable methodologies of HPC on a case-by-case basis. Cultural training programs have been utilized as one of the main tactics to improve the ability of healthcare providers to address the cultural needs and preferences of diverse patients and families. In this way, most of the involved health care practitioners will be equipped with cultural competence. Considerations for ethical and racial specifications of the clients of this service will boost the effectiveness and fruitfulness of the HPC. Canadian society is a colorful compilation of multiple nationalities; accordingly, healthcare clients are diverse, and this divergence is also translated into HPC patients. This fact justifies the importance of studying all the cultural aspects of HPC to provide optimal care on this enormous land.

Keywords: cultural competence, end-of-life care, hospice, palliative care

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Authors: Dila Ram Bhandari

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Throughout the 20th century, new governments were created where identities such as ethnic, religious, linguistic, caste, communal, tribal, and others played a part in the development of constitutions and the legal system of victim and criminal justice. Acute issues with extremism, poverty, environmental degradation, cybercrimes, human rights violations, crime against, and victimization of both individuals and groups have recently plagued South Asian nations. Everyday massive number of crimes are steadfast, these frequent crimes have made the lives of common citizens restless. Crimes are one of the major threats to society and also for civilization. Crime is a bone of contention that can create a societal disturbance. The old-style crime solving practices are unable to live up to the requirement of existing crime situations. Crime analysis is one of the most important activities of the majority of intelligent and law enforcement organizations all over the world. The South Asia region lacks such a regional coordination mechanism, unlike central Asia of Asia Pacific regions, to facilitate criminal intelligence sharing and operational coordination related to organized crime, including illicit drug trafficking and money laundering. There have been numerous conversations in recent years about using data mining technology to combat crime and terrorism. The Data Detective program from Sentient as a software company, uses data mining techniques to support the police (Sentient, 2017). The goals of this internship are to test out several predictive model solutions and choose the most effective and promising one. First, extensive literature reviews on data mining, crime analysis, and crime data mining were conducted. Sentient offered a 7-year archive of crime statistics that were daily aggregated to produce a univariate dataset. Moreover, a daily incidence type aggregation was performed to produce a multivariate dataset. Each solution's forecast period lasted seven days. Statistical models and neural network models were the two main groups into which the experiments were split. For the crime data, neural networks fared better than statistical models. This study gives a general review of the applied statistics and neural network models. A detailed image of each model's performance on the available data and generalizability is provided by a comparative analysis of all the models on a comparable dataset. Obviously, the studies demonstrated that, in comparison to other models, Gated Recurrent Units (GRU) produced greater prediction. The crime records of 2005-2019 which was collected from Nepal Police headquarter and analysed by R programming. In conclusion, gated recurrent unit implementation could give benefit to police in predicting crime. Hence, time series analysis using GRU could be a prospective additional feature in Data Detective.

Keywords: time series analysis, forecasting, ARIMA, machine learning

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Authors: Nick Toossi, Joseph Hartland

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Background: Malawi is an example of a low resource setting which faces a chronic shortage of doctors and other medical staff. This shortfall is made up for by clinical officers (COs), who are para-medicals trained for 4 years. The literature suggests to improve outcomes surgical skills training specifically should be promoted for COs in district and mission hospitals. Accordingly, the primary author was tasked with developing a basic surgical skills teaching package for COs of Mulanje Mission Hospital (MMH), Malawi, as part of a 4th year medical student External Student Selected Component field trip. MMH is a hospital based in the South of Malawi near the base of Mulanje Mountain and works in an extremely isolated environment with some of the poorest communities in the country. Traveling to Malawi the medical student author performed an educational needs assessment to develop and deliver a bespoke basic surgical skills teaching package. Methodology: An initial needs assessment identified the following domains: basic surgical skills (instrument naming & handling, knot tying, suturing principles and suturing techniques) and perineal repair. Five COs took part in a teaching package involving an interactive group simulation session, overseen by senior clinical officers and surgical trainees from the UK. Non-organic and animal models were used for simulation practice. This included the use of surgical skills boards to practice knot tying and ox tongue to simulate perineal repair. All participants spoke and read English. The impact of the session was analysed in two different ways. The first was via a pre and post Single Best Answer test and the second a questionnaire including likert’s scales and free text response questions. Results: There was a positive trend in pre and post test scores on competition of the course. There was increase in the mean confidence of learners before and after the delivery of teaching in basic surgical skills and simulated perineal repair, especially in ‘instrument naming and handling’. Whilst positively received it was discovered that learners desire more frequent surgical skills teaching sessions in order to improve and revise skills. Feedback suggests that the learners were not confident in retaining the skills without regular input. Discussion: Skills and confidence were improved as a result of the teaching provided. Learner's written feedback suggested there was an overall appetite for regular surgical skills teaching in the clinical environment and further opportunities to allow for deliberate self-practice. Surgical mentorship schemes facilitating supervised theatre time among trainees and lead surgeons along with improving access to surgical models/textbooks were some of the simple suggestions to improve surgical skills and confidence among COs. Although, this study is limited by population size it is reflective of the small, isolated and low resource environment in which this healthcare is delivered. This project does suggest that current surgical skills packages used in the UK could be adapted for employment in low resource settings, but it is consistency and sustainability that staff seek above all in their on-going education.

Keywords: clinical officers, education, Malawi, surgical skills

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Authors: Hend Ben Tkhayat , Khaled Al Zahabi, Husam Younes

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Introduction: Vildagliptin (VG), a dipeptidyl peptidase-4 inhibitor (DPP-4), was proven to be an active agent for the treatment of type 2 diabetes. VG works by enhancing and prolonging the activity of incretins which improves insulin secretion and decreases glucagon release, therefore lowering blood glucose level. It is usually used with various classes, such as insulin sensitizers or metformin. VG is currently only marketed as an immediate-release tablet that is administered twice daily. In this project, we aim to formulate an extended-release with a zero-order profile tableted lipid microparticles of VG that could be administered once daily ensuring the patient’s convenience. Method: The spray-congealing technique was used to prepare VG microparticles. Compritol® was heated at 10 oC above its melting point and VG was dispersed in the molten carrier using a homogenizer (IKA T25- USA) set at 13000 rpm. VG dispersed in the molten Compritol® was added dropwise to the molten Gelucire® 50/13 and PEG® (400, 6000, and 35000) in different ratios under manual stirring. The molten mixture was homogenized and Carbomer® amount was added. The melt was pumped through the two-fluid nozzle of the Buchi® Spray-Congealer (Buchi B-290, Switzerland) using a Pump drive (Master flex, USA) connected to a silicone tubing wrapped with silicone heating tape heated at the same temperature of the pumped mix. The physicochemical properties of the produced VG-loaded microparticles were characterized using Mastersizer, Scanning Electron Microscope (SEM), Differential Scanning Calorimeter (DSC) and X‐Ray Diffractometer (XRD). VG microparticles were then pressed into tablets using a single punch tablet machine (YDP-12, Minhua pharmaceutical Co. China) and in vitro dissolution study was investigated using Agilent Dissolution Tester (Agilent, USA). The dissolution test was carried out at 37±0.5 °C for 24 hours in three different dissolution media and time phases. The quantitative analysis of VG in samples was realized using a validated High-Pressure Liquid Chromatography (HPLC-UV) method. Results: The microparticles were spherical in shape with narrow distribution and smooth surface. DSC and XRD analyses confirmed the crystallinity of VG that was lost after being incorporated into the amorphous polymers. The total yields of the different formulas were between 70% and 80%. The VG content in the microparticles was found to be between 99% and 106%. The in vitro dissolution study showed that VG was released from the tableted particles in a controlled fashion. The adjustment of the hydrophilic/hydrophobic ratio of excipients, their concentration and the molecular weight of the used carriers resulted in tablets with zero-order kinetics. The Gelucire 50/13®, a hydrophilic polymer was characterized by a time-dependent profile with an important burst effect that was decreased by adding Compritol® as a lipophilic carrier to retard the release of VG which is highly soluble in water. PEG® (400,6000 and 35 000) were used for their gelling effect that led to a constant rate delivery and achieving a zero-order profile. Conclusion: Tableted spray-congealed lipid microparticles for extended-release of VG were successfully prepared and a zero-order profile was achieved.

Keywords: vildagliptin, spray congealing, microparticles, controlled release

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Authors: Huseyin Sinan Gunesli

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Process Safety Management is a disciplined framework for managing the integrity of systems and processes that handle hazardous substances. It relies on good design principles, well-implemented automation systems, and operating and maintenance practices. Alarm Management Systems play a critically important role in the safe and efficient operation of modern industrial plants. In that respect, Alarm Management is one of the critical factors feeding the safe operations of the plants in the manner of applying effective process safety principles. Trans Anatolian Natural Gas Pipeline (TANAP) is part of the Southern Gas Corridor, which extends from the Caspian Sea to Italy. TANAP transports Natural Gas from the Shah Deniz gas field of Azerbaijan, and possibly from other neighboring countries, to Turkey and through Trans Adriatic Pipeline (TAP) Pipeline to Europe. TANAP plays a crucial role in maintaining Energy Security for the region and Europe. In that respect, the application of Process Safety principles is vital to deliver safe, reliable and efficient Natural Gas delivery to Shippers both in the region and Europe. Effective Alarm Management is one of those Process Safety principles which feeds safe operations of the TANAP pipeline. Alarm Philosophy was designed and implemented in TANAP Pipeline according to the relevant standards. However, it is essential to manage the alarms received in the control room effectively to maintain safe operations. In that respect, TANAP has commenced Alarm Management & Rationalization program as of February 2022 after transferring to Plateau Regime, reaching the design parameters. While Alarm Rationalization started, there were more than circa 2300 alarms received per hour from one of the compressor stations. After applying alarm management principles such as reviewing and removal of bad actors, standing, stale, chattering, fleeting alarms, comprehensive review and revision of alarm set points through a change management principle, conducting alarm audits/design verification and etc., it has been achieved to reduce down to circa 40 alarms per hour. After the successful implementation of alarm management principles as specified above, the number of alarms has been reduced to industry standards. That significantly improved operator vigilance to focus on mainly important and critical alarms to avoid any excursion beyond safe operating limits leading to any potential process safety events. Following the ‟What Gets Measured, Gets Managed” principle, TANAP has identified key Performance Indicators (KPIs) to manage Process Safety principles effectively, where Alarm Management has formed one of the key parameters of those KPIs. However, review and analysis of the alarms were performed manually. Without utilizing Alarm Management Software, achieving full compliance with international standards is almost infeasible. In that respect, TANAP has started using one of the industry-wide known Alarm Management Applications to maintain full review and analysis of alarms and define actions as required. That actually significantly empowered TANAP’s process safety principles in terms of Alarm Management.

Keywords: process safety principles, energy security, natural gas pipeline operations, alarm rationalization, alarm management, alarm management application

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Authors: Alexis D'Agostino, Celeste Sununtunasuk, Jack Fiedler

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Background: Iron-folic acid (IFA) supplementation during antenatal care (ANC) has existed in many countries for decades. Despite this, low national coverage persists and women do not often consume appropriate amounts during pregnancy. USAID’s SPRING Project investigated pregnant women’s access to, and consumption of, IFA tablets through ANC. Cross-country analysis provided a global picture of the state of IFA-supplementation, while country-specific results noted key contextual issues, including geography, wealth, and ANC attendance. The analysis can help countries prioritize strategies for systematic performance improvements within one of the most common micronutrient supplementation programs aimed at reducing maternal anemia. Methodology: Using falter point analysis on Demographic and Health Survey (DHS) data collected from 162,958 women across 22 countries, SPRING identified four sequential falter points (ANC attendance, IFA receipt or purchase, IFA consumption, and number of tablets taken) where pregnant women fell out of the IFA distribution structure. SPRING analyzed data on IFA intake from DHS surveys with women of reproductive age. SPRING disaggregated these data by ANC participation during the most recent pregnancy, residency, and women’s socio-economic status. Results: Average sufficient IFA tablet use across all countries was only eight percent. Even in the best performing countries, only about one-third of pregnant women consumed 180 or more IFA tablets during their most recent pregnancy. ANC attendance was an important falter point for a quarter of women across all countries (with highest falter rates in Democratic Republic of the Congo, Nigeria, and Niger). Further analysis reveals patterns, with some countries having high ANC coverage but low IFA provision during ANC (DRC and Haiti), others having high ANC coverage and IFA provision but few women taking any tablets (Nigeria and Liberia), and countries that perform well in ANC, supplies, and initial consumption but where very few women consume the recommended 180 tablets (Malawi and Cambodia). Country-level analysis identifies further patterns of supplementation. In Indonesia, for example, only 62% of women in the poorest quintile took even one IFA tablet, while 86% of the wealthiest women did. This association between socioeconomic status and IFA intake held across nearly all countries where these data are available and was also visible in rural/urban comparisons. Analysis of ANC attendance data also suggests that higher numbers of ANC visits are associated with higher tablet intake. Conclusions: While it is difficult to disentangle which specific aspects of supply or demand cause the low rates of consumption, this tool allows policy-makers to identify major bottlenecks to scaling-up IFA supplementation during ANC. In turn, each falter point provides possible explanations of program performance and helps strategically identify areas for improved IFA supplementation. For example, improving the delivery of IFA supplementation in Ethiopia relies on increasing access to ANC, but also on identifying and addressing program gaps in IFA supply management and health workers’ practices in order to provide quality ANC services. While every country requires a customized approach to improving IFA supplementation, the multi-country analysis conducted by SPRING is a helpful first step in identifying country bottlenecks and prioritizing interventions.

Keywords: iron and folic acid, supplementation, antenatal care, micronutrient

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Authors: Salima R. Rajwani, Tazeen Ali, Rubina Barolia, Yasmin Parpio, Nasreen Alwani, Salima B. Virani

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Introduction: Nurses and physicians have a critical role in initiating lifesaving interventions during cardiac arrest. It is important that timely delivery of high quality Cardio Pulmonary Resuscitation (CPR) with advanced resuscitation skills and management of cardiac arrhythmias is a key dimension of code during cardiac arrest. It will decrease the chances of patient survival if the healthcare professionals are unable to initiate CPR timely. Moreover, traditional training will not prepare physicians and nurses at a competent level and their knowledge level declines over a period of time. In this regard, simulation training has been proven to be effective in promoting resuscitation skills. Simulation teaching learning strategy improves knowledge level, and skills performance during resuscitation through experiential learning without compromising patient safety in real clinical situations. The purpose of the study is to evaluate the effectiveness of simulation training in Advanced Cardiac Life Support Courses by using the selfefficacy tool. Methods: The study design is a quantitative research design and non-randomized quasi-experimental study design. The study examined the effectiveness of simulation through self-efficacy in two instructional methods; one is Medium Fidelity Simulation (MFS) and second is Traditional Training Method (TTM). The sample size was 220. Data was compiled by using the SPSS tool. The standardized simulation based training increases self-efficacy, knowledge, and skills and improves the management of patients in actual resuscitation. Results: 153 students participated in study; CG: n = 77 and EG: n = 77. The comparison was done between arms in pre and post-test. (F value was 1.69, p value is <0.195 and df was 1). There was no significant difference between arms in the pre and post-test. The interaction between arms was observed and there was no significant difference in interaction between arms in the pre and post-test. (F value was 0.298, p value is <0.586 and df is 1. However, the results showed self-efficacy scores were significantly higher within experimental group in post-test in advanced cardiac life support resuscitation courses as compared to Traditional Training Method (TTM) and had overall (p <0.0001) and F value was 143.316 (mean score was 45.01 and SD was 9.29) verses pre-test result showed (mean score was 31.15 and SD was 12.76) as compared to TTM in post-test (mean score was 29.68 and SD was 14.12) verses pre-test result showed (mean score was 42.33 and SD was 11.39). Conclusion: The standardized simulation-based training was conducted in the safe learning environment in Advanced Cardiac Life Suport Courses and physicians and nurses benefited from self-confidence, early identification of life-threatening scenarios, early initiation of CPR, and provides high-quality CPR, timely administration of medication and defibrillation, appropriate airway management, rhythm analysis and interpretation, and Return of Spontaneous Circulation (ROSC), team dynamics, debriefing, and teaching and learning strategies that will improve the patient survival in actual resuscitation.

Keywords: advanced cardiac life support, cardio pulmonary resuscitation, return of spontaneous circulation, simulation

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Authors: Wen Liu, Errol Haarhoff, Lee Beattie

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In 2010, New Zealand’s central government re-organise the local governments arrangements in Auckland, New Zealand by amalgamating its previous regional council and seven supporting local government units into a single unitary council, the Auckland Council. The Auckland Council is charged with providing local government services to approximately 1.5 million people (a third of New Zealand’s total population). This includes addressing Auckland’s strategic urban growth management and setting its urban planning policy directions for the next 40 years. This is expressed in the first ever spatial plan in the region – the Auckland Plan (2012). The Auckland plan supports implementing a compact city model by concentrating the larger part of future urban growth and development in, and around, existing and proposed transit centres, with the intention of Auckland to become globally competitive city and achieving ‘the most liveable city in the world’. Turning that vision into reality is operatized through the statutory land use plan, the Auckland Unitary Plan. The Unitary plan replaced the previous regional and local statutory plans when it became operative in 2016, becoming the ‘rule book’ on how to manage and develop the natural and built environment, using land use zones and zone standards. Common to the broad range of literature on urban growth management, one significant issue stands out about intensification. The ‘gap’ between strategic planning and what has been achieved is evident in the argument for the ‘compact’ urban form. Although the compact city model may have a wide range of merits, the extent to which these are actualized largely rely on how intensification actually is delivered. The transformation of the rhetoric of the residential intensification model into reality is of profound influence, yet has enjoyed limited empirical analysis. In Auckland, the establishment of the Auckland Plan set up the strategies to deliver intensification into diversified arenas. Nonetheless, planning policy itself does not necessarily achieve the envisaged objectives, delivering the planning system and high capacity to enhance and sustain plan implementation is another demanding agenda. Though the Auckland Plan provides a wide ranging strategic context, its actual delivery is beholden on the Unitary Plan. However, questions have been asked if the Unitary Plan has the necessary statutory tools to deliver the Auckland Plan’s policy outcomes. In Auckland, there is likely to be continuing tension between the strategies for intensification and their envisaged objectives, and made it doubtful whether the main principles of the intensification strategies could be realized. This raises questions over whether the Auckland Plan’s policy goals can be achieved in practice, including delivering ‘quality compact city’ and residential intensification. Taking Auckland as an example of traditionally sprawl cities, this article intends to investigate the efficacy plan making and implementation directed towards higher density development. This article explores the process of plan development, plan making and implementation frameworks of the first ever spatial plan in Auckland, so as to explicate the objectives and processes involved, and consider whether this will facilitate decision making processes to realize the anticipated intensive urban development.

Keywords: urban intensification, sustainable development, plan making, governance and implementation

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Authors: Ekemini M. Okon, Reuben C. Okocha, Babatunde T. Adesina, Judith O. Ehigie, Babatunde M. Falana, Boluwape T. Okikiola

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Antimicrobial resistance (AMR) has evolved to become a significant threat to global public health and food safety. The development of AMR in animals has been associated with antimicrobial overuse. In recent years, the number of antimicrobials used in food animals such as fish and poultry has escalated. It, therefore, becomes imperative to understand the patterns of AMR in fish and poultry and map out future directions for better surveillance efforts. This study used the Preferred Reporting Items for Systematic reviews and Meta-Analyses(PRISMA) to assess the trend, patterns, and spatial distribution for AMR research in Egypt, Nigeria, and South Africa. A literature search was conducted through the Scopus and Web of Science databases in which published studies on AMR between 1989 and 2021 were assessed. A total of 172 articles were relevant for this study. The result showed progressive attention on AMR studies in fish and poultry from 2018 to 2021 across the selected countries. The period between 2018 (23 studies) and 2021 (25 studies) showed a significant increase in AMR publications with a peak in 2019 (28 studies). Egypt was the leading exponent of AMR research (43%, n=74) followed by Nigeria (40%, n=69), then South Africa (17%, n=29). AMR studies in fish received relatively little attention across countries. The majority of the AMR studies were on poultry in Egypt (82%, n=61), Nigeria (87%, n=60), and South Africa (83%, n=24). Further, most of the studies were on Escherichia and Salmonella species. Antimicrobials frequently researched were ampicillin, erythromycin, tetracycline, trimethoprim, chloramphenicol, and sulfamethoxazole groups. Multiple drug resistance was prevalent, as demonstrated by antimicrobial resistance patterns. In poultry, Escherichia coli isolates were resistant to cefotaxime, streptomycin, chloramphenicol, enrofloxacin, gentamycin, ciprofloxacin, oxytetracycline, kanamycin, nalidixic acid, tetracycline, trimethoprim/sulphamethoxazole, erythromycin, and ampicillin. Salmonella enterica serovars were resistant to tetracycline, trimethoprim/sulphamethoxazole, cefotaxime, and ampicillin. Staphylococcusaureus showed high-level resistance to streptomycin, kanamycin, erythromycin, cefoxitin, trimethoprim, vancomycin, ampicillin, and tetracycline. Campylobacter isolates were resistant to ceftriaxone, erythromycin, ciprofloxacin, tetracycline, and nalidixic acid at varying degrees. In fish, Enterococcus isolates showed resistance to penicillin, ampicillin, chloramphenicol, vancomycin, and tetracycline but sensitive to ciprofloxacin, erythromycin, and rifampicin. Isolated strains of Vibrio species showed sensitivity to florfenicol and ciprofloxacin, butresistance to trimethoprim/sulphamethoxazole and erythromycin. Isolates of Aeromonas and Pseudomonas species exhibited resistance to ampicillin and amoxicillin. Specifically, Aeromonashydrophila isolates showed sensitivity to cephradine, doxycycline, erythromycin, and florfenicol. However, resistance was also exhibited against augmentinandtetracycline. The findings constitute public and environmental health threats and suggest the need to promote and advance AMR research in other countries, particularly those on the global hotspot for antimicrobial use.

Keywords: antibiotics, antimicrobial resistance, bacteria, environment, public health

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Authors: Sergey Kozlov, Juliya Kozlova

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Introduction: The increased attention of researchers to an explosive trauma around the world is associated with a constant renewal of military weapons and a significant increase in terrorist activities using explosive devices. Explosive wave is a well known damaging factor of explosion. The most sensitive to the action of explosive wave in the human body are the head brain, lungs, intestines, urine bladder. The severity of damage to these organs depends on the distance from the explosion epicenter to the object, the power of the explosion, presence of barriers, parameters of the body position, and the presence of protective clothing. One of the places where a shock wave acts, in human tissues and organs, is the vascular endothelial barrier, which suffers the greatest damage in the head brain and lungs. The objective of the study was to determine the pathomorphological changes of the head brain followed the action of explosive wave. Materials and methods of research: To achieve the purpose of the study, there have been studied 6 male corpses delivered to the morgue of Municipal Institution "Dnipropetrovsk regional forensic bureau" during 2014-2016 years. The cause of death of those killed was a military explosive injury. After a visual external assessment of the head brain, for histological study there was conducted the 1 x 1 x 1 cm/piece sampling from different parts of the head brain, i.e. the frontal, parietal, temporal, occipital sites, and also from the cerebellum, pons, medulla oblongata, thalamus, walls of the lateral ventricles, the bottom of the 4th ventricle. Pieces of the head brain were immersed in 10% formalin solution for 24 hours. After fixing, the paraffin blocks were made from the material using the standard method. Then, using a microtome, there were made sections of 4-6 micron thickness from paraffin blocks which then were stained with hematoxylin and eosin. Microscopic analysis was performed using a light microscope with x4, x10, x40 lenses. Results of the study: According to the results of our study, injuries of the head brain were divided into macroscopic and microscopic. Macroscopic injuries were marked according to the results of visual assessment of haemorrhages under the membranes and into the substance, their nature, and localisation, areas of softening. In the microscopic study, our attention was drawn to both vascular changes and those of neurons and glial cells. Microscopic qualitative analysis of histological sections of different parts of the head brain revealed a number of structural changes both at the cellular and tissue levels. Typical changes in most of the studied areas of the head brain included damages of the vascular system. The most characteristic microscopic sign was the separation of vascular walls from neuroglia with the formation of perivascular space. Along with this sign, wall fragmentation of these vessels, haemolysis of erythrocytes, formation of haemorrhages in the newly formed perivascular spaces were found. In addition to damages of the cerebrovascular system, destruction of the neurons, presence of oedema of the brain tissue were observed in the histological sections of the brain. On some sections, the head brain had a heterogeneous step-like or wave-like nature. Conclusions: The pathomorphological microscopic changes in the brain, identified in the study on the died of explosive traumas, can be used for diagnostic purposes in conjunction with other characteristic signs of explosive trauma in forensic and pathological studies. The complex of microscopic signs in the head brain, i.e. separation of blood vessel walls from neuroglia with the perivascular space formation, fragmentation of walls of these blood vessels, erythrocyte haemolysis, formation of haemorrhages in the newly formed perivascular spaces is the direct indication of explosive wave action.

Keywords: blast wave, neurotrauma, human, brain

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Authors: Alaa Abdellatif, Gabrièle Breda

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Background. Advanced therapy medicinal products (ATMPs) are innovative therapies that mainly target orphan diseases and high unmet medical needs. ATMP includes gene therapy medicinal products (GTMP), somatic cell therapy medicinal products (CTMP), and tissue-engineered therapies (TEP). Since legislation opened the way in 2007, 25 ATMPs have been approved in the EU, which is about the same amount as the U.S. Food and Drug Administration. However, not all of the ATMPs that have been approved have successfully reached the market and retained their approval. Objectives. We aim to understand all the factors limiting the market access to very promising therapies in a systemic approach, to be able to overcome these problems, in the future, with scientific, regulatory and commercial innovations. Further to recent reviews that focus either on specific countries, products, or dimensions, we will address all the challenges faced by ATMP development today. Methodology. We used mixed methods and a multi-level approach for data collection. First, we performed an updated academic literature review on ATMP development and their scientific and market access challenges (papers published between 2018 and April 2023). Second, we analyzed industry feedback from cell and gene therapy webinars and white papers published by providers and pharmaceutical industries. Finally, we established a comparative analysis of the regulatory guidelines published by EMA and the FDA for ATMP approval. Results: The main challenges in bringing these therapies to market are the high development costs. Developing ATMPs is expensive due to the need for specialized manufacturing processes. Furthermore, the regulatory pathways for ATMPs are often complex and can vary between countries, making it challenging to obtain approval and ensure compliance with different regulations. As a result of the high costs associated with ATMPs, challenges in obtaining reimbursement from healthcare payers lead to limited patient access to these treatments. ATMPs are often developed for orphan diseases, which means that the patient population is limited for clinical trials which can make it challenging to demonstrate their safety and efficacy. In addition, the complex manufacturing processes required for ATMPs can make it challenging to scale up production to meet demand, which can limit their availability and increase costs. Finally, ATMPs face safety and efficacy challenges: dangerous adverse events of these therapies like toxicity related to the use of viral vectors or cell therapy, starting material and donor-related aspects. Conclusion. As a result of our mixed method analysis, we found that ATMPs face a number of challenges in their development, regulatory approval, and commercialization and that addressing these challenges requires collaboration between industry, regulators, healthcare providers, and patient groups. This first analysis will help us to address, for each challenge, proper and innovative solution(s) in order to increase the number of ATMPs approved and reach the patients

Keywords: advanced therapy medicinal products (ATMPs), product development, market access, innovation

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Authors: Maria Ledinskaya

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This paper is part case study and part literature review. It seeks to introduce Agile, Lean, and Hybrid project management concepts from business, software development, and manufacturing fields to museum conservation by looking at their practical application on a recent conservation project at the Sainsbury Centre for Visual Arts. The author outlines the advantages of leaner and more agile conservation practices in today’s faster, less certain, and more budget-conscious museum climate where traditional project structures are no longer as relevant or effective. The Morris Collection Conservation Project was carried out in 2019-2021 in Norwich, UK, and concerned the remedial conservation of around 150 Abstract Constructivist artworks bequeathed to the Sainsbury Centre by private collectors Michael and Joyce Morris. It was a medium-sized conservation project of moderate complexity, planned and delivered in an environment with multiple known unknowns – unresearched collection, unknown conditions and materials, unconfirmed budget. The project was later impacted by the COVID-19 pandemic, introducing indeterminate lockdowns, budget cuts, staff changes, and the need to accommodate social distancing and remote communications. The author, then a staff conservator at the Sainsbury Centre who acted as project manager on the Morris Project, presents an incremental, iterative, and value-based approach to managing a conservation project in an uncertain environment. The paper examines the project from the point of view of Traditional, Agile, Lean, and Hybrid project management. The author argues that most academic writing on project management in conservation has focussed on a Traditional plan-driven approach – also known as Waterfall project management – which has significant drawbacks in today’s museum environment due to its over-reliance on prediction-based planning and its low tolerance to change. In the last 20 years, alternative Agile, Lean and Hybrid approaches to project management have been widely adopted in software development, manufacturing, and other industries, although their recognition in the museum sector has been slow. Using examples from the Morris Project, the author introduces key principles and tools of Agile, Lean, and Hybrid project management and presents a series of arguments on the effectiveness of these alternative methodologies in museum conservation, including the ethical and practical challenges to their implementation. These project management approaches are discussed in the context of consequentialist, relativist, and utilitarian developments in contemporary conservation ethics. Although not intentionally planned as such, the Morris Project had a number of Agile and Lean features which were instrumental to its successful delivery. These key features are identified as distributed decision-making, a co-located cross-disciplinary team, servant leadership, focus on value-added work, flexible planning done in shorter sprint cycles, light documentation, and emphasis on reducing procedural, financial, and logistical waste. Overall, the author’s findings point in favour of a hybrid model, which combines traditional and alternative project processes and tools to suit the specific needs of the project.

Keywords: agile project management, conservation, hybrid project management, lean project management, waterfall project management

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