Journal articles on the topic 'National Memorial Institute for the Prevention of Terrorism'

This work explains the importance of regulating memorial sites in Chile by implementing a specific law. Along with explaining the contributions provided by memorial sites in the process of transitional justice, we analyze the current process that exists in Chile for them to be declared historical heritage, following the application of Law No. 17,288 on National Monuments. We then compare the process employed in the declaration and recognition of memorial sites in Uruguay and Argentina, through the application of specific norms that have been passed for this specific purpose: the Recent Past Memorial Sites and Law No. 26,691 on State Terrorism Memorial Site Preservation, Signposting and Outreach, respectively. Finally, we explain the overall guidelines of the MERCOSUR Instituto de Políticas Públicas en Derechos Humanos (Human Rights Public Policies Institute).

Political action on the cusp between social movements and militancy provides a robust test of universal theories of both collective action and terrorism. In particular, radical environmentalism and the new wave of ecoterrorism in the United States deserve social science consideration as one such radical cusp movement. Data on 84 ecoterrorist events in the United States, 1998-2005, from the Memorial Institute for the Prevention of Terrorism's Terrorism Incident Database are considered vis-à-vis previous theories to identify possible patterns. A methodology for research on clandestine organizations, the imputation of cells from incident data, is proposed. Analysis suggests that radicalism is a product of social movements and that it diffuses according to exogenous factors, in particular local political climates. Little support is found for theories of continued radicalization in militant movements, but some evidence indicates that a general life cycle of political violence exists.

AbstractIntroduction:Terrorism is a global public health burden. South Americans have been victims of terrorism for many decades.While the causes vary, the results are the same: death, disability, and suffering.The objective of this study was to perform a comprehensive, epidemiological, descriptive study of terrorist incidents in South America.Methods:This is a cross-sectional, descriptive study. Data from January 1971 to July 2006 was selected using the RAND Terrorism Chronology 1968–1997 and RAND®-Memorial Institute for Prevention of Terrorism (MIPT) Terrorism Incident database (1998–Present). Statistical significance was set at 0.05.Results:The database reported a total of 2,997 incidents in South American countries that resulted in 3,435 victims with injuries (1.15 per incident) and 1,973 fatalities (0.66 per incident). The overall case fatality ratio (CFR) was 35.8%. Colombia had the majority of incidents with 57.9% (1,734 of 2,997), followed by Peru with 363 (12.1%), and Argentina with 267 (8.9%). The highest individual CFR occurred in Paraguay (83.3%), and the lowest in Chile with 4.8%. Of the total injuries and deaths, Colombia had 66.1% (2,269 of 2,997) of all injuries and 75.2% (1,443 out of 1,920) of all deaths. Living in the country of Colombia was associated with a 16 times greater likelihood of becoming a victim of terrorist violence [odds ratio (OR) 16.15; 95% CI 13.45 to 19.40; p <0.0001].The predominant method of choice for terrorist incidents was the use of conventional explosives with 2,543 of 2,883 incidents (88.2%).Conclusions:Terrorist incidents in South America have accounted for nearly 2,000 deaths, with conventional explosive devices as the predominant method of choice. Understanding the nature of terrorist attacks and the medical consequences assist emergency preparedness and disaster management officials in allocating resources and preparing for potential future events.

<p>This inaugural memorial lecture provides an opportunity to celebrate the life of Elijah B. Saunders, MD, FACC and pays tribute to his pioneering spirit in the quest to advance health equity in the prevention and control of hypertension and cardiovascular diseases. It also enables an assessment of the state of the global burden of hypertension and related disparities. Despite the remarkable biomedical research progress made over the last half-century, hypertension remains the leading risk factor for global disease burden and the major preventable contributor to cardiovascular and all-cause mortality. Additionally, disparities in hypertension-related morbidity and mortality remain pervasive worldwide. National hypertension control rates showing progress often mask important suboptimal treatment and control in population groups defined by sex, race, ethnicity, geography, and social and environmental determinants. Within these groups, many hypertension-related disparities remain largely unchanged while other gaps have widened. In essence, current research has been relatively ineffective in guiding largescale, sustained elimination of hypertension-related disparities. An important explanation for these observations may be the significant advances made in observational epidemiological research, especially in improved surveillance and data collection that document the extent of disparities in marked contrast to the relative paucity of interventional disparities research. The paucity of these interventional research studies remains a continuing challenge. The time has come for renewed efforts in building strategic partnerships that leverage transdisciplinary, multi-sectoral expertise to provide global leadership in interventional implementation research for hypertension control and elimination of related disparities. Developing an appropriately skilled implementation research workforce will be crucial. The National Heart, Lung, and Blood Institute and its biomedical research funding partners remain committed to a strategic agenda of implementation research, training, and education for the prevention and control of hypertension and elimination of related disparities. <em>Ethn Dis. </em>2016;26(3):461-468; doi:10.18865/ed.26.3.461 </p>

A statement by 68 prominent national experts in cancer prevention, carcinogenesis, epidemiology, and public health, released at a February 4, 1992, press conference in Washington, D.C., charged that the National Cancer Institute (NCI) has misled and confused the public by repeated claims of winning the war against cancer. In fact, age-standardized incidence rates have escalated to epidemic proportions over recent decades, while the ability to treat and cure most cancers has not materially improved. Furthermore, the NCI has minimized evidence for increasing cancer rates, which are largely attributed to smoking, trivializing the importance of occupational carcinogens as non-smoking attributable causes of lung and other cancers, and to diet per se, in spite of tenuous and inconsistent evidence and ignoring the important role of carcinogenic dietary contaminants. Reflecting this near exclusionary blame-the-victim theory of cancer causation, with lockstep support from the American Cancer Society and industry, the NCI discounts the role of avoidable involuntary exposures to industrial carcinogens in air, water, food, the home, and the workplace. The NCI has also failed to provide any scientific guidance to Congress and regulatory agencies on fundament principles of carcinogenesis and epidemiology, and on the critical needs to reduce avoidable exposures to environmental and occupational carcinogens. Analysis of the $2 billion NCI budget, in spite of fiscal and semantic manipulation, reveals minimal allocations for research on primary cancer prevention, and for occupational cancer, which receives only $19 million annually, 1 percent of NCI's total budget. Problems of professional mindsets in the NCI leadership, fixation on diagnosis, treatment, and basic research, much of questionable relevance, and the neglect of cancer prevention, are exemplified by the composition of the National Cancer Advisory Board. Contrary to the explicit mandate of the National Cancer Act, the Board is devoid of members authoritative in occupational and environmental carcinogenesis. These problems are further compounded by institutionalized conflicts of interest reflected in the composition of past executive President's Cancer Panels, and of the current Board of Overseers of the Sloan-Kettering Memorial Cancer Center, the NCI's prototype comprehensive cancer center, with their closely interlocking financial interests with the cancer drug and other industries. Drastic reforms of NCI policies and priorities are long overdue. Implementation of such reforms is, however, unlikely in the absence of further support from industrial medicine professionals, besides action by Congress and concerned citizen groups.

Cervical cancer is the most common form of cancer among women in developing countries. Hospital based data in Nepal also showed cervical cancer is most commonly occurring cancer among women in Nepal. Pap smear is the very significant screening test for reduction of incidence and mortality from cervical cancer but many developing countries failed to obtain high coverage of target population. Hence failed to achieve major impact of cervical cancer screening. National guidelines for cervical cancer and prevention in Nepal is formulated in 2010 and set target population age range of 30-60 with 50% coverage of target population with in a five years span. This study was aimed to elicit baseline survey of cervical cancer screening in a locale where resource for cervical cancer screening is easily available. Population based cross sectional study was done from October 2006 to March 2007. 1547 ever married women aged 16–59 were selected with cluster randomization procedure from Bharatpur municipalities, where BPKMCH (BP Koirala Memorial Cancer Hospital) is located. Free cervical cancer screening was conducted in collaboration with International Agency for Research on Cancer (IARC) France and BPKMCH. Ethical clearance was obtained from Nepal Health Research council. Interviews were performed using a standard questionnaire to elicit required information. Out of 1033 participants 394 were 16-29 years old. Among them 117 (30%) had at least one Pap test prior coming to the clinic. 16(4%) were age 16-19, 42(11%) were age 20-24 and 59 (15%) were age 25-29. This concludes Present opportunistic cervical cancer screening in Bharatpur is directed towards screening significant proportion of women with less risk.DOI: http://dx.doi.org/10.3126/jmmihs.v1i4.11994Journal of Manmohan Memorial Institute of Health SciencesVol. 1, Issue 4, 2015page : 3-8

The article summarizes the results of the IMEMO academic affairs in the first half of the 2000s. Like before, the Institute combined fundamental theoretical and applied research. In its work, IMEMO focused on the study of global, regional and national problems of the modern world. An important achievement of the Institute during these years was the prepared long-term forecast of the world economy development until 2015. The annual (2000–2005) analytical reports on the study of armed conflicts, their prevention and control, as well as of global and regional trends in the development of military expenses can be considered another achievement of this kind. These reports were prepared at IMEMO together with the Stockholm International Peace Research Institute (SIPRI). IMEMO’s accomplishments include the fundamental work “Transitional Economy: Theoretical Aspects, Russian Problems, International Experience”. In this research, the theoretical problems of the transitional economy were deeply investigated with an emphasis on the achievements of world economic thought, international and accumulated Russian experience of transitional processes was analyzed. The IMEMO scientists were involved in comparative analysis of the influence of new factors (globalization, information civilization, integration processes, international terrorism, etc.) on modern Russia and foreign countries. Along with theoretical research, the Institute regularly prepared analytical materials and expert opinions for the Administration of the President of Russia, the Government, the Federation Council and the State Duma. The IMEMO employees took part in the preparation of materials for the annual messages of the President of Russia to the Federal Assembly, gave their recommendations on military reform and updating the Foreign Policy Concept of the Russian Federation. The Institute was engaged in constant monitoring of the economic and internal situation in various regions and major states of the modern world. The focus of IMEMO analysts was the foreign policy of the United States, the European Union countries, the states of the Middle East, Central Asia and Latin America, as well as the Asia-Pacific region. This ongoing work was carried out in various departments and sectors of the Institute. The author presents the directions and main results of the work of these scientific departments. In general, one of the indicators of the overall performance of IMEMO in 2001–2006 are 256 monographs, collections of scientific papers, conference materials, brochures and reports published by its employees. During these years, the results of current work began to be posted on the IMEMO website.

Introduction: Incidence of stroke patients is increasing in low income countries like Nepal where management of these patients is challenging due to poor healthcare resources. Ischemic stroke is related to risk factors like age, male population, hypertension, diabetes mellitus, smoking and alcohol. Identification of these risk factors in the vulnerable population is important for prevention of ischemic stroke. The purpose of this study is to find out the social and demographic characteristics of patients with acute ischemic stroke treated at Upendra Devkota Memorial National Institute of Neurological and Allied Sciences, a tertiary care hospital of Nepal. Methods: Data was collected from all acute ischemic stroke patients presenting to the hospital over a period of one year. The age, sex, medical history of hypertension and diabetes and history of smoking and alcohol consumption were recorded. Statistical analysis of data was performed using Microsoft EXCEL 2019. Result: Total 310 patients were studied, out of which two-thirds were male. The highest number of patients were within the age group of 60-80 years with the mean age being 60 years. Hypertension and diabetes were present in 67.42% and 28.53% of patients respectively. 43.93% of the patients smoked while 33.87% of the patients consumed alcohol. Conclusion: Identification of association between risk factors like age, sex, hypertension, diabetes mellitus, smoking and alcohol consumption must be the emphasis for targeted preventive action to decrease the increasing burden of ischemic stroke among developing countries.

Influenza virus is an important contributor to acute respiratory illnesses and is estimated to cause up to 650,000 respiratory deaths each year. Ghana recorded influenza viruses as far back as 1918 when the Spanish influenza pandemic led to the death of >100,000 people in a population of 4 million at the time. An outbreak of highly pathogenic avian influenza A(H5N1) among poultry in Ghana in 2007, led to the establishment of virological surveillance for influenza-like illness (ILI) by the Noguchi Memorial Institute for Medical Research (NMIMR). This surveillance system, supported by the U.S. Naval Medical Research Unit-No. 3 (NAMRU-3) and the Ghana Health Service (GHS), monitors circulating influenza strains and activity to better understand the epidemiology of influenza in Ghana. We present here the results of this surveillance system from 2011 to 2019. As part of the Integrated Disease Surveillance and Response (IDSR) system of the GHS under the Ministry of Health (MOH), oropharyngeal and nasopharyngeal swabs were collected from patients who met a modified World Health Organization (WHO) case definition for ILI or severe acute respiratory illness (SARI) through a sentinel surveillance system in the country. Samples were transported to the National Influenza Centre (NIC) at the NMIMR and tested for influenza virus using protocols defined by the United States Centers for Disease Control and Prevention (CDC). Selected isolates were sent to the WHO collaborating centre in the United Kingdom for further antigenic characterization. From 2011 to 2019, the NIC tested a total of 21,747 ILI samples and 3,429 SARI samples. Influenza positivity rates were highest in the 5–14 year old group for both ILI (20.8%) and SARI (23.8%). Compared to females, more males were seen at the health facilities for ILI and SARI symptoms with a statistically significant difference in influenza positive ILI (15% vs 13.2%, p <0.001). In terms of absolute numbers, more cases were seen at the health centres during the wet seasons (April to October) compared to the dry seasons (November to March) in Ghana. This study presents 9 years of surveillance data from outpatient and inpatient setting on influenza activity as well as the influenza A subtypes and B lineages that drive the activity. This presents useful information for influenza vaccine selection and administration. Ghana’s unique influenza activity patterns also present a challenge in predicting when an outbreak could occur.

The success of the solution to the problem of treatment and prevention of obstetric-gynecological pathology largely depends on the extent to which the relationship between the sonographic sizes` of the uterus and the ovaries with the constitutional parameters of the body will be fully and systematically studied. The purpose of the work is to establish differences in correlations of ultrasonic sizes of the uterus in different phases of the menstrual cycle (MC) with anthropo-somatotypological parameters of the body of practically healthy young women of ecto- and mesomorphic somatotypes. Primary indices of sonographic sizes of the uterus, as well as anthropometric and somatotypological parameters in 78 healthy urban young women of Podillia with duration of MC 28 days were obtained from the data bank of the research center of the National Pirogov Memorial Medical University, Vinnytsya. In a sonographic study in different phases of the MC, the length and width of the body, the length of the neck and the anterior-posterior size (thickness) of the uterus were measured for its largest size, as well as the thickness of the endometrium and myometrium. According to Bunak V. V. scheme anthropometric survey was conducted. The evaluation of the somatotype was carried out using the Carter-Heath mathematical scheme. According to the formulas of J. Matiegka fat, bone and muscle mass components are determined, and according to the American Institute of Nutrition, the muscular component of the body mass. The analysis of the correlations of the obtained results was carried out in the licensed package “Statistica 6.1” with the use of nonparametric statistics of Spearman. In young women with mesomorphic somatotype, regardless of the phase of MC, in most cases, there are numerous, mostly direct, reliable and unreliable mean strength correlations between the linear size of the uterus, the length of the cervix and the thickness of the myometrium, and most of the total and longitudinal dimensions of the body, as well as between the length of the body of cervix and the width of the distal epiphyses of the upper limb, the majority of the lower limbs girth, the thickness of the skin-fat folds on the lower extremity, and practically all the components of the body weight by Matiegka. In young women with ectomorphic somatotype, regardless of the phase of the MC, numerous, mostly direct, reliable average forces and strong and unreliable mean strength connections between all echometric dimensions of the uterus and all total, most of the longitudinal dimensions of the body (with the exception of the thickness of the endometrium), the width of the distal epiphysis forearm, most of the girth dimensions, shoulder width and muscle mass components of the body using the Matiegka method and the American Institute of Nutrition are set. Attention is drawn to the average strength, mostly reliable, feedback correlations regardless of the MC phase, between all echometric dimensions of the uterus and the ectomorphic component of the somatotype. So, between young women of meso- and ectomorphic somatotypes set differences of numerous connections of the sonographic parameters of the uterus with anthropo-somatotypological indices. In young women of mesomorphic somatotype in the follicular phase of the MC, the ovulation phase, and the luteal phase of the MC, the number and strength of the connections of the sonographic sizes of the uterus with anthropomorphic somatotypological parameters is lower than that of the representatives of the ectomorphic somatotype.

At present, Chronic kidney disease (CKD) has emerged as a significant global health concern even in Sri Lanka. The statistical data regarding the increased incidence and prevalence rate of CKD have already proven that there is still no identification of a permanent cure or solution instead of renal replacement therapy for disease management. This remains a tremendous challenge for Western and Āyurveda medical systems. Although the Āyurveda medical system is well nourished by its own concepts such as Dhātu sāratā (tissue excellence), Deha prakṛti (body constitution), which can potentially contribute to the prevention and management of CKD, their clinical applicability appears to be limited. Therefore, this study was planned to assess the status of Dhātu sāratā (the level of tissue excellence) and its association with Deha prakṛti (body constitution) in patients with CKD – Western Province, Sri Lanka. This is a prospective observational case – control study. University Nephrology Clinic at the National Hospital, Sri Lanka and the Renal Clinic at Bandaranaike Memorial Āyurveda Research Institute, Nawinna, Sri Lanka. 113 patients with a diagnosis of CKD and 122 healthy volunteers residing in the Western Province were enrolled in the study. Dhātu sāratā status of Rasa to Sattva was assessed using a standardized and validated questionnaire and ĀyuSoft software was used to assess the type of Deha prakṛti of the research participants. Data analysis was done by using Microsoft Excel 2007 version and appropriate statistical software. The study results revealed that a majority between 43 – 50 % of CKD patients exhibited a predominance of Madhyama sāra status (moderate level of tissue excellence) for Rasa, Rakta and Māṃsa dhātu. A considerable percentage (over 60%) of patients displayed Avara sāra status (inferior or lower level of tissue excellence) in their subsequent dhātu (including Sattva), commencing from Asthi. Compared to the CKD patients, the number of healthy individuals/ controls with Pravara sāra status (superior level of tissue excellence) of each dhātu and Sattva is substantially high. None of the healthy individuals had Avara sāra status of Dhātu nor Sattva. Furthermore, it was observed that the mean percentage scores of all dhātu (commencing from Rasa to Śukra dhātu) and Sattva sāratā significantly differed according to CKD stages under a 5% level of significance. It was also observed that the status of Dhātu commencing from Rasa to Śukra dhātu and Sattva sāratā was significantly associated with the Deha prakṛti types i.e., Vāta, Pitta and Kapha pradhāna prakṛti in CKD patients – Western Province, Sri Lanka, under a 5 % level of significance.It can be concluded that Dhātu sāratā status including Sattva depends on the type of Deha prakṛti in CKD patients and Sāra status of each Dhātu including Sattva declines from Pravara sāra to Avara sāra as the disease progresses. In addition, the CKD patients with Kapha pradhāna prakṛti type can be considered to have the maximum Deha bala whereas those with Pitta and Vāta pradhāna prakṛti types exhibit average and lowest levels of Deha bala respectively.

<div>As an ardent cancer researcher, Dr. Smita Asthana has a vision to create wider awareness on cancer and its prevention, and aims to work on translational research to benefit the general public through the implementation of evidence-based research. “I have been associated with the National Institute of Cancer Prevention and Research (NICPR) and Institute of Cytology and Preventive Oncology (ICPO) since November 2004 and have progressed over a period of time from being a staff scientist to the current role of a senior scientist,” says Dr. Asthana, who is presently with NICPR’s Biostatistics and Epidemiology division.</div><p> </p><p>“I have been working in various positions that deal with the design, execution, and evaluation of medical projects. Recently, we have concluded two major cervical cancer screening projects and conducted a screening of 10,000 women in rural areas,” she tells AMOR. One project, funded by the Indian Council of Medical Research, was carried out 100 km west of New Delhi in the rural town of Dadri “as part of an operational research to see the implementation of VIA (visual inspection with acetic acid) and VILI (visual inspection with Lugol's iodine) screenings with the help of existing healthcare infrastructure,” she explains.</p><p> </p><p>As a leading researcher in cervical cancer screening, she completed an Indo-US collaborative project on the clinical performance of a human papillomavirus (HPV) test, used as a strategy for screening cervical cancer in rural communities, with funding from the Bill and Melinda Gates Foundation via the international non-profit global health organization PATH. “The primary objective of the project was to observe the performance of careHPV, a new diagnostic kit, in a rural setup,” she says.</p><p> </p><p>CareHPV is a highly sensitive DNA test, which detects 14 different types of the human papillomavirus that cause cervical cancer, providing results more rapidly than other DNA tests and is designed especially for use in clinics that lack reliable clean water or electricity. It is an incredibly cost-effective option for low-resource countries seeking to develop national cervical cancer screening and treatment programs according to PATH.</p><p> </p><p>“Both projects were completed successfully and brought out research conclusions in the form of national and international publications,” Dr. Asthana says. In addition to the projects, she had also developed health education materials to create cervical cancer awareness among the women of rural Indian community, while providing training to auxiliary nurses and midwives for cervical cancer screening.</p><p> </p><p>Dr. Asthana graduated with a degree in Bachelor of Medicine and Bachelor of Surgery from King George Medical College (KGMC), Lucknow, Uttar Pradesh, India, before pursuing her Doctor of Medicine (MD) in Community Medicine from Ganesh Shankar Vidyarthi Memorial (GSVM) Medical College, Kanpur, India. Throughout her career, she has published over 40 articles in national and international journals. As a result of her hard work and dedication toward the medical field, she has been awarded first prizes for oral presentation in international conferences such as Indian Cancer Congress (ICC 2014) and Asia Oceania Research Organisation on Genital Infections and Neoplasia (AOGIN 2012).</p><p> </p><p>She is an active member of various scientific associations and societies such as the Indian Association for Cancer Research (IACR), Indian Society for Medical Statistics (ISMS), Indian Association of Preventive and Social Medicine (IAPSM), and International Epidemiological Association (IEA). In her effort to provide impactful messages via research publications, she is currently working on remodeling the cancer registry data, which includes a diversified field for incidence of childhood cancer, breast and cervical cancer, trends of major cancer, cancer burden in Northeast of India, among other things.</p><p> </p><p>According to Dr. Asthana, her vision is the utilization of voluminous cancer registry data to produce comprehensive reports in the form of research communication to give a clearer picture of different cancer burden in various Indian registries. “I have also proposed a project for establishing cancer registry at NICPR, which was approved by the Indian Council of Medical Research (ICMR) in principle, but we are currently still waiting for funding,” says the medical scientist.</p><p> </p><p>Focusing on the area of cancer epidemiology and research methodology, Dr. Asthana has faced many challenges commonly encountered by any researcher with a vision to improve medical research. “Gradually, with time and experience, I have overcome these limitations and I now conduct research methodology workshops to help clinicians have a better orientation toward research,” she says. Dr. Asthana is the coordinator of research methodology workshops, which is a series of training courses that started in 2007. Training courses/workshops are being conducted on a regular basis — two to three times a year at ICPO — and on an invitation basis, she has held workshops at other institutions such as her previous visit to Universiti Teknologi PETRONAS in Malaysia to train 30 PhD students.</p><p> </p><p>“The main aim or idea is to educate scientists/researchers and medical faculties about the basics of research methodology, which consist of descriptive statistics, statistical analysis, and clinical trial sampling, as well as research protocol development and scientific reporting/writing,” she elaborates. “The curriculum was formed and executed in such a way that new scientists gain an overall knowledge on how a research project should be planned, executed, and the results communicated,” she adds. The courses, according to her, are targeted for medical faculty members, medical post-graduate students, undergraduate students, and PhD students with a basic science background from various medical institutions.</p><p> </p><p>As a researcher with almost 14 years of experience in medical research, her passion for research does not end there. Dr. Asthana has also ventured into various other new areas that are currently lacking presence in India and other low- and middle-income countries. One such area is palliative care, where she has undergone specialized training in palliative care from the Indian Association of Palliative Care. Additionally, Dr. Asthana is working on a global systematic review project that studies smokeless tobacco attributable risk for oral cancer. She further adds, “As an officer in the district technical support team and in collaboration with World Health Organization, I have devoted quite some time in serving the rural community for leprosy monitoring.”</p><p> </p><p>When asked for her opinion about the future of cancer research, Dr. Asthana believes that targeted therapy is the future of cancer therapy, as it kills only cancer cells and not normal cells, which leads to lesser side effects. “However, the major concern is the cost of it,” she says, “and it doesn’t appear to be affordable in the near future.” Hence, “developing countries like India should focus on the prevention of cancer through the modification of risk factors and adopting healthy lifestyles,” she concludes.</p>

Problem statement. The main issues that exist in the management of strains of particularly dangerous microorganisms are primarily related to the weakening of state supervision and control. Surprisingly, nowadays, there is no single official register of owners of pathogenic microorganisms and strains of dangerous and especially dangerous infectious diseases. Some biological objects are found, even in private collections. There are no permitting procedures for handling such facilities and sanctions for violating them. That is why it is not surprising that the Prosecutor General’s Office has announced that the head of the State Research and Control Institute of Biotechnology and Microorganism Strains has identified dangerous virus strains that are known as infectious animal pathogens and can spread rapidly on a large scale across national borders. Dual-use studies should be supervised to address the risks arising from the development of biomedical sciences. Continuous monitoring and verification of scientific and technological advances sensitive from the point of view of security allow to minimize the possibility of the adoption of biological and toxic weapons and other risks. Analysis of recent sources and publications. Theoretical issues of legal regulation of activities in the field of circulation of certain groups of drugs containing strains of microorganisms, in particular in vaccination, attract the attention of many researchers. They were studied, in particular by: R.A. Maidanyk, I.Ya. Senyuta, etc. However, the peculiarities of activities in the field of particularly dangerous microorganisms’ strains treatment have been left without due attention of researchers, including specialists in medical law. Formulating Goals. The aim of the work is to study the state of relations in the field of especially dangerous microorganisms’ strains treatment legal regulation in Ukraine, analysis of the current legislation of Ukraine and the practice of its application in this area. There have been used scientific publications of leading experts and current Ukrainian legislation. The research is based on an organic combination of general scientific and special legal research methods. Presenting main material. The main sources of biological threats are: 1) epidemics and outbreaks of infectious human diseases; 2) epizootics (high incidence among animals); 3) epitophytia (spread of infectious plant disease in large areas); 4) accidents at biologically dangerous objects; 5) natural reservoirs of pathogenic microorganisms; 6) transboundary transfer of pathogenic microorganisms, representatives of flora and fauna, dangerous for ecological systems; 7) sabotage at biologically dangerous objects; 8) biological terrorism; 9) the use of biological weapons by the state. It should be noted that the regulatory framework in the field of particularly dangerous microorganisms’ strains treatment in the context of biosafety in Ukraine is fragmentary. Although the list of laws and other regulations governing biosafety and/or biosecurity in Ukraine is impressive. Nowadays, the use of strains of microorganisms is gaining popularity, in particular in agriculture, because they can be used for the needs of veterinary medicine and for the production of certain foods such as yogurt, kefir etc. Therefore, in addition to the basic law, regulation of the use of strains and protection of rights to them is regulated by other acts, in particular the Law of Ukraine “On protection of rights to inventions and utility models”. Namely, in accordance with Part 2 of Art. 6 strains of microorganisms that have been bred or would be bred shall be considered as the objects of the invention. It follows that the owner who invented the strain must certify the authorship and the right to obtain a patent or declaratory patent. However, this procedure, unlike others, is complicated. After all, to obtain a full patent, you need to conduct an appropriate qualification examination, which would establish whether the strain meets the conditions of patentability. Also, in addition to filing an application for the invention of a utility model and obtaining a patent, in accordance with the Law of Ukraine “On Veterinary Medicine” when registering a domestic veterinary immunobiological agent, the applicant must deposit strains of microorganisms in a special collection – depository. There are currently three national depositories in Ukraine, each of which specializes in a specific type: non-pathogenic strains; pathogenic to humans; pathogenic to animals. The procedure of depositing strains of microorganisms is carried out in accordance with the Instruction on the procedure of depositing strains of microorganisms in Ukraine for the purpose of patent procedure, approved by the order № 106/115 of the State Patent and the National Academy of Sciences of Ukraine of 26.06.1995. Moreover, in accordance with the Regulations on the National Center for Microorganism Strains and the procedure for depositing microorganism strains, approved by the Cabinet of Ministers of Ukraine regulation № 637 of 07.05.1998, deposit of microorganism strains in Ukraine is carried out by the National Center for Microorganism Strains. Its task is to preserve the production and control of strains of microorganisms, maintain biotechnological indicators, control the state of their population, as well as the preparation of new strains. It is necessary to pay attention to the decision of the National Security and Defense Council of Ukraine “On Biosafety of Ukraine”, which states that at the moment there is an increase in the negative impact of various biological factors on the population, which may lead to threats of biological origin. The reasons for such plural regulation are: 1) the lack of a program on biosafety and prevention of biological terrorism, no national system of counteraction to possible biothreats; 2) no automated and integrated data banks on possible threats of biological and chemical origin. Funding and logistics for laboratories also remain unsatisfactory. Also, the state supervision and control in the field of biosafety is weakened, namely when the owner of high-risk facilities changes or when there is a risk of unauthorized access to laboratories due to imperfect protection of pathogenic microorganisms and strains of dangerous and especially dangerous infectious diseases, which in turn can lead to the leakage of pathogenic microorganisms into the environment and cause mass infectious disease. In addition, there is a legal gap in the legislation of Ukraine regarding the location and control of viral and biological laboratories by foreign states. However, in almost all European countries, as well as in the United States, domestic law prohibits the placement of such laboratories in these countries, because they are potentially dangerous to the population. The danger behind viral and biological laboratories, even with the strictest observance of all necessary safety rules, is extremely great, because the pathogenic microorganisms of human and animal origin in them are considered potential agents of biological weapons. Although Ukraine ratified the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction of 10 April, 1972, an agreement was signed in 2005 between the US Department of Defense and the Ministry of Health of Ukraine (expired on 31.05.2013) regarding cooperation in the field of prevention of the spread of technologies, pathogens and knowledge that can be used in the development of biological weapons and the US Department of Defense has begun construction of its objects on the territory of our country. At the same time, microbiological laboratories and production facilities are considered to be areas of the highest biological risk. Infecting of persons while working with microorganisms in laboratories is noted throughout the existence of microbiology and is considered as an indisputable confirmation of occupational hazards. In general, there is a wide variety of ways of potential attacks involving bio-toxic weapons and there are several ways to assimilate biotechnologies with their transformation into weapons due to: 1) use of various agents (e.g., bacteria, viruses, fungi, toxins, bioregulators); 2) use against various aims (humans, animals and plants); 3) different scales of application (tactical, strategic); 4) use for various purposes (open or covert war, murder, terrorism or criminal activity). Probably because of this, in 2012 the WHO adopted the Framework Strategy for Laboratory Biorisk Management for 2012-2016, aimed at creating sustainable global, regional and national plans for biological risk management in laboratories. It recognizes that “In accordance with the International Health Regulations (IHR (2005), all participating countries have made a legal commitment to evaluate, develop and maintain their national key oversight, evaluation and response functions”. Conclusions. The current state of legal regulation of relations in the field of strain management requires, given the intersectoral nature of the issue, consideration of the creation of a single intersectoral body for the supervision of hazardous biological objects. Such a body may not only be a licensing body, but also responsible for the introduction of a register of owners of hazardous biological objects that are not economic entities (for example, individual owners of collections of such biological objects). In this paper, it is impractical to consider the circulation of products with GMOs, on the one hand, this issue is perfectly regulated in other special regulations, on the other hand, today there is an issue concerning the treatment of dangerous strains of pathogenic viruses, bacteria and other microorganisms and toxins, as well as poisons of animal and plant origin. For entities engaged in economic activities with pathogenic microorganisms and strains of dangerous infectious diseases, it is advisable to introduce licensing of this type of activity, which requires further development of a bylaw on licensing conditions. For other persons who are the owners of such biological objects and who are not engaged in economic activities, it is necessary to introduce other forms of permit, including special requirements for their handling and storage conditions. The next important bylaw should be the Regulations on the state register of pathogenic microorganisms and strains of dangerous and especially dangerous infectious diseases. Particular attention should be paid to the disposal of hazardous biological objects. Nowadays, for example, there is no effective system for the disposal of vaccines and other immunobiological drugs that have expired (for reference, the shelf life of the flu vaccine is 7-8 months). The cost of recycling is not always profitable for pharmaceutical operators. There are cases when such drugs are falsified by replacing the expiration date, which adversely affect the health of patients. In this context, it can also be mentioned the fact of importing humanitarian aid in Ukraine in the form of a vaccine against measles and rubella (from the Ukrainian diaspora in Canada). The storage temperature of this vaccine was up to minus 48 degrees. After importation into the customs territory of Ukraine, given the shortcomings of customs legislation and the lack of effective control, the temperature regime was not observed. However, the Ministry of Health still carried out compulsory vaccination of children (there were cases of deteriorating health), which is not only negative for the health of children, but also for the very idea of vaccination. In this case, the Ministry of Health, given the interest, was not able to make the right and lawful decision. This is why an independent intersectoral body of state control (supervision) is needed.

Harvey S. Levin obtained his Bachelor’s degree from City College of New York, in New York city, Ph.D. in Clinical Psychology from the University of Iowa, in Iowa City, completed his internships in Clinical Neuropsychology and Pediatric Psychology at the University of Iowa Hospitals in Iowa City and Clinical Psychology, Psychiatry and Pediatrics at the Illinois Masonic Medical Center in Chicago, and his fellowship in Neuropsychology at University of Iowa Hospitals in Iowa City.Dr. Levin started his career in 1972 as Instructor with the Department of Psychology at the University of Iowa and transitioned to The University of Texas Medical Branch (UTMB) in Galveston, Texas, in 1974, where he began an internationally renowned career in clinical work, teaching, and, most of all, pioneering research on traumatic brain injury (TBI). He ultimately became the Chela and Jimmy Storm Distinguished Professor in Surgical Research, Division of Neurosurgery, Department of Surgery in 1987. After leaving Texas for two years to take a position with the University of Maryland Medical System and Shock Trauma Institute in Baltimore, he moved back to Houston Texas in 1995 and established the Cognitive Neuroscience Laboratory (CNL) within the Department of Physical Medicine & Rehabilitation at Baylor College of Medicine, which was supported by federal grants, including funding from the National Institutes of Health, Department of Defense, Department of Veterans Affairs, and Centers for Disease Control and Prevention, and numerous private foundations. The CNL integrated rehabilitation and neuroplasticity research with multimodality brain imaging, clinical and neuropsychological assessment, and fluid biomarkers. Dr. Levin was Professor with the Departments of Physical Medicine and Rehabilitation where he served as Director of Research (1995-2014), Pediatrics, and Neurosurgery at Baylor College of Medicine. He was also a Research Scientist and the Director of the Center of Excellence for Traumatic Brain Injury at the Michael E. DeBakey Veterans Affairs Medical Center (2008-2013), and Adjunct Professor with the Department of Psychology at Rice University in Houston, Texas.Dr. Levin’s research focused on investigating both acute and long-term outcomes of mild to severe TBI in civilian and military populations, including cognitive and behavioral sequelae in relation to neuropathology using advanced brain imaging modalities. He began prospective, longitudinal studies of adults and children who had sustained TBI associated with closed head trauma upon joining UTMB and developed, in collaboration with Drs O’Donnell and Grossman, the Galveston Orientation and Amnesia Test (GOAT). The GOAT was the first measure to assess post-traumatic amnesia and orientation following moderate to severe TBI, is still most widely used by the clinicians and researchers, and it has been translated to 16 languages. The original publication, “Levin HS, O’Donnell VM, Grossman RG. The Galveston Orientation and Amnesia Test. A practical scale to assess cognition after head injury. J Nerv Ment Dis. 1979 Nov;167(11):675-84. doi: 10.1097/00005053-197911000-00004. PMID: 501342”, has over 1200 citations. This work continued with participation in the NINDS Traumatic Coma Data Bank and the organization of outcome assessments for NINDS-funded clinical trials of hypothermia to treat severe TBI. To monitor the quality of outcome data across performing sites, Dr. Levin and colleagues developed a code for the reliability of data collected and implemented the role of an outcome monitor who evaluated adherence to protocol across sites. Following establishment of the CNL, he pursued investigation of TBI outcomes across the lifespan using multimodality brain imaging and biomarkers, errorless learning, translational studies in collaboration with neuroscientists using animal models, and clinical trials of methylphenidate, progesterone, CDP-choline. Dr. Levin spent over 30 years researching neurobehavioral outcomes of head injury in children, starting with a small pilot study funded by the Shriners Hospital in 1991 and continuing with several cycles of a multicenter R01 grant funded by the National Institute of Health. In later years, he used his expertise as a member of several large consortiums, including the Long-term Impact of Military-Relevant Brain Injury Consortium \ Chronic Effects of Neurotrauma Consortium (LIMBIC-CENC) funded by the VA and DoD and the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) funded by the NINDS.During his career, Dr. Levin authored and coauthored more than 400 articles in scientific journals and over 100 books, with one of them, “Levin, H. S., Benton, A. L., & Grossman, R. G. (1982). Neurobehavioral consequences of closed head injury. Oxford University Press, USA”, having over 1100 citation, as well as book chapters that advanced knowledge of TBI, epilepsy, neurodegenerative diseases, and other illnesses that affect brain functioning. He was also very active as a reviewer on federal grant panels and as an editor and reviewer for the Journal of Neurotrauma, Journal of Clinical and Experimental Neuropsychology, Archives of Physical Medicine & Rehabilitation, Neuropsychology, Journal of the International Neuropsychological Society, Lancet, JAMA, Pediatrics, and other top-cited journals. He served as president of the International Neuropsychological Society in 1989-1990. Dr. Levin was a recipient of numerous prestigious awards, including the Javits Neuroscience Investigator Award, the Jennett-Plum Award for Research on Traumatic Brain Injury, the Distinguished Career Award by the International Neuropsychological Society, the American Congress of Rehabilitation Gold Key Award, the Distinguished Lifetime Contribution to Neuropsychology Award from the National Academy of Neuropsychology, as well as awards from other head injury and psychological organizations, including the International Brain Injury Association, the National Head Injury Foundation, the North American Brain Injury Society, Texas Psychological Association, and the Defense and Veterans Brain Injury Center. In addition to his stellar scientific accomplishments, Dr. Levin trained, mentored, and provided supervision to interns, fellows, postdocs, residents, medical and psychology students. He was the Director of an NCMRR/NIH T32 Postdoctoral Research Program, and training supervisor in neuropsychology for Baylor College of Medicine and for the Memorial Hermann TIRR Neuropsychology Postdoctoral Fellowship Programs. A passionate educator, he taught classes at Baylor College of Medicine, the University of Houston, and the National and Kapodistrian University of Athens Medical School in Greece and served as an evaluator for the American Board of Clinical Neuropsychology/American Board of Professional Psychology. He was often invited as a lecturer at numerous scientific organizations.The main objective of this symposium is to provide an overview of the current state of research in TBI while highlighting Dr. Levin’s contributions to this field. The symposium will start with a brief overview of Dr. Levin’s career (Dr. Randall S. Scheibel), followed by presentations focused on the assessment of adult TBI, including posttraumatic amnesia (Dr. Felicia C. Goldstein), the current state of pediatric TBI (Dr. L. Ewing-Cobbs), and novel imaging in TBI (Dr. Erin D. Bigler). There will be a brief discussion session at the end lead by Dr. Elisabeth A. Wilde.

Abstract Background: The current standard of care for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) is R CHOP; however, approximately 40% of patients are not cured. The CD79b-targeting antibody-drug conjugate, polatuzumab vedotin, is approved in relapsed/refractory DLBCL in combination with bendamustine and rituximab, and has also demonstrated promising first line activity and safety when combined with rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP) in a Phase Ib/II study (Tilly, et al. Lancet Oncol 2019). Thus, in the Phase III POLARIX study (NCT03274492) we compared pola-R-CHP with R-CHOP in patients with previously untreated DLBCL. Methods: In this double-blind, placebo-controlled, international study, patients with previously untreated DLBCL and an International Prognostic Index (IPI) of 2-5 were randomized 1:1 to receive six cycles of pola-R-CHP (with a vincristine placebo) or R-CHOP (with a polatuzumab vedotin placebo); all patients also received two additional cycles of rituximab. Patients received polatuzumab vedotin 1.8mg/kg or vincristine 1.4mg/m² administered on Day 1, plus intravenous rituximab 375mg/m2, cyclophosphamide 750mg/m², doxorubicin 50mg/m², and placebo on Day 1, and oral prednisone 100mg once daily on Days 1-5. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included investigator-assessed event-free survival (EFS), independent review committee-assessed complete response (CR) rate at the end of treatment by positron emission tomography-computed tomography (PET-CT), disease-free survival (DFS), overall survival (OS), and safety. Results: Overall, 879 patients were randomized, 440 to pola-R-CHP and 439 to R-CHOP. Median age was 65 (range 19-80) years, and the majority of patients had IPI 3-5 (62.0%). At the data cut-off of June 28, 2021, and after a median follow-up of 28.2 months, PFS was superior with pola-R-CHP vs R CHOP (hazard ratio [HR] 0.73; 95% confidence interval [CI]: 0.57-0.95; P&lt;0.02). The 2-year PFS rate was 76.7% (95% CI: 72.7-80.8) with pola-R-CHP vs 70.2% (95% CI: 65.8-74.6) with R-CHOP. EFS favored pola-R-CHP compared with R-CHOP (HR 0.75; 95% CI: 0.58-0.96; P=0.02). The end-of-treatment PET-CT CR rate was not significantly different with pola-R-CHP vs R-CHOP (78.0% vs 74.0%; P=0.16); however, DFS suggested responses were more durable with pola-R-CHP than with R-CHOP (HR 0.70; 95% CI: 0.50-0.98). There was no difference in OS between treatment arms (HR 0.94; 95% CI: 0.65-1.37; P=0.75). At the time of data cut-off, 99 (23%) and 133 (30%) patients in the pola-R-CHP and R-CHOP arms, respectively, had received at least one subsequent anti-lymphoma therapy. Fewer patients in the pola-R-CHP than the R-CHOP arm received subsequent anti-lymphoma treatments (radiotherapy, 9.3% vs 13.0%; stem cell transplantation, 3.9% vs 7.1%; chimeric antigen receptor T-cell therapy, 2.0% vs 3.6%). The safety profile was comparable for pola-R-CHP vs R-CHOP, including rates of grade 3-4 adverse events (AEs; 57.7% vs 57.5%), serious AEs (34.0% vs 30.6%), grade 5 AEs (3.0% vs 2.3%), and AEs leading to dose reduction (9.2% vs 13.0%), respectively. The frequency and severity of peripheral neuropathy were similar for pola-R-CHP vs R-CHOP (any grade, 52.9% vs 53.9%; grade 3-4, 1.6% vs 1.1%). Conclusion: The pola-R-CHP combination demonstrated a 27% reduction in the relative risk of disease progression, relapse, or death compared with R-CHOP, with a similar safety profile in the first-line treatment of patients with DLBCL. Disclosures Tilly: Karyopharm: Membership on an entity's Board of Directors or advisory committees; F. Hoffmann-La Roche Ltd: Membership on an entity's Board of Directors or advisory committees, Other: Meeting attendance and travel, Research Funding; AstraZeneca: Membership on an entity's Board of Directors or advisory committees; Janssen-Cilag: Membership on an entity's Board of Directors or advisory committees; Incyte: Membership on an entity's Board of Directors or advisory committees. Morschhauser: AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees; AstraZenenca: Membership on an entity's Board of Directors or advisory committees; Epizyme: Consultancy, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Consultancy, Membership on an entity's Board of Directors or advisory committees; F. Hoffmann-La Roche Ltd: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Celgene: Membership on an entity's Board of Directors or advisory committees; Chugai: Honoraria; Genentech, Inc.: Consultancy; Janssen: Honoraria; Genmab: Membership on an entity's Board of Directors or advisory committees; Servier: Consultancy; Incyte: Membership on an entity's Board of Directors or advisory committees. Sehn: Novartis: Consultancy; Genmab: Consultancy; Debiopharm: Consultancy; Teva: Consultancy, Research Funding; Roche/Genentech: Consultancy, Research Funding; AbbVie: Consultancy; Acerta: Consultancy; Amgen: Consultancy; Apobiologix: Consultancy; AstraZeneca: Consultancy; Celgene: Consultancy; Gilead: Consultancy; Incyte: Consultancy; Janssen: Consultancy; Kite: Consultancy; Karyopharm: Consultancy; Lundbeck: Consultancy; Merck: Consultancy; Morphosys: Consultancy; Sandoz: Consultancy; Seattle Genetics: Consultancy; Takeda: Consultancy; TG Therapeutics: Consultancy; Verastem: Consultancy. Friedberg: Bayer: Membership on an entity's Board of Directors or advisory committees; Acerta: Membership on an entity's Board of Directors or advisory committees; Novartis: Membership on an entity's Board of Directors or advisory committees. Trněný: Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead Sciences: Consultancy, Honoraria; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; F. Hoffmann-La Roche Ltd: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Morphosys: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Incyte: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Portola: Honoraria, Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Honoraria. Sharman: AbbVie: Consultancy; AstraZeneca: Consultancy; BeiGene: Consultancy; Bristol-Myers Squibb: Consultancy; Lilly: Consultancy; Pharmacyclics LLC, an AbbVie Company: Consultancy; TG Therapeutics: Consultancy; Centessa: Current holder of stock options in a privately-held company, Membership on an entity's Board of Directors or advisory committees; Genentech, Inc.: Consultancy; Velos: Current holder of stock options in a privately-held company, Membership on an entity's Board of Directors or advisory committees. Herbaux: Takeda: Honoraria, Research Funding; AbbVie: Honoraria, Research Funding; F. Hoffmann-La Roche Ltd: Honoraria; Janssen: Honoraria. Burke: Verastem: Consultancy; AstraZeneca: Consultancy; Morphosys: Consultancy; Adaptive Biotechnologies: Consultancy; Epizyme: Consultancy; Kura: Consultancy; AbbVie: Consultancy; BeiGene: Consultancy, Speakers Bureau; Kymera: Consultancy; Bristol-Myers Squibb: Consultancy; X4 Pharmaceuticals: Consultancy; Seattle Genetics: Consultancy, Speakers Bureau; Gilead: Consultancy; Genentech, Inc.: Consultancy. Matasar: Memorial Sloan Kettering Cancer Center: Current Employment; Merck Sharp & Dohme: Consultancy, Current holder of individual stocks in a privately-held company, Membership on an entity's Board of Directors or advisory committees; Genentech, Inc.: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Support for attending meetings and/or travel, Research Funding; F. Hoffmann-La Roche Ltd: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Support for attending meetings and/or travel, Research Funding; GlaxoSmithKline: Honoraria, Research Funding; Bayer: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Support for attending meetings and/or travel, Research Funding; IGM Biosciences: Research Funding; Pharmacyclics: Honoraria, Research Funding; Janssen: Honoraria, Research Funding; Rocket Medical: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Seattle Genetics: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Support for attending meetings and/or travel, Research Funding; ImmunoVaccine Technologies: Consultancy, Honoraria, Research Funding; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Daiichi Sankyo: Consultancy, Membership on an entity's Board of Directors or advisory committees; Juno Therapeutics: Consultancy, Membership on an entity's Board of Directors or advisory committees; Teva: Consultancy, Membership on an entity's Board of Directors or advisory committees; TG Therapeutics: Consultancy, Honoraria. Rai: Chugai Pharmaceutical Co., Ltd: Speakers Bureau; ONO Pharmaceutical Co., Ltd: Speakers Bureau; Janssen Pharmaceutical: Speakers Bureau; Eisai Co., Ltd: Speakers Bureau. Izutsu: AbbVie: Honoraria; Allergan Japan: Honoraria; AstraZeneca: Honoraria, Research Funding; Bayer: Research Funding; BeiGene: Research Funding; Celgene: Honoraria, Research Funding; Chugai: Honoraria, Research Funding; Daiichi Sankyo: Honoraria, Research Funding; Eisai: Honoraria, Research Funding; Fuji Film Toyama Chemical: Honoraria; Genmab: Honoraria, Research Funding; Huya Biosciences: Research Funding; Incyte: Research Funding; Janssen: Honoraria, Research Funding; Kyowa Kirin: Honoraria, Research Funding; MSD: Research Funding; Novartis: Honoraria, Research Funding; Ono Pharmaceutical: Honoraria, Research Funding; Pfizer: Research Funding; Solasia: Research Funding; Symbio: Honoraria; Takeda: Honoraria, Research Funding; Yakult: Research Funding. Mehta-Shah: C4 Therapeutics: Consultancy; Kiowa Hakko Kirin: Consultancy; Karyopharm: Consultancy; Ono Pharmaceuticals: Consultancy; Secura Bio: Consultancy, Research Funding; Daiichi Sankyo: Consultancy, Research Funding; AstraZeneca: Research Funding; Bristol-Myers Squibb: Research Funding; Celgene: Research Funding; Innate Pharmaceuticals: Research Funding; Roche/Genentech: Research Funding; Corvus Pharmaceuticals: Research Funding; Verastem: Research Funding. Oberic: Celgene: Honoraria; F. Hoffmann-La Roche Ltd: Membership on an entity's Board of Directors or advisory committees, Other: Support for attending meetings and/or travel; Janssen: Honoraria, Other: Support for attending meetings and/or travel; Gilead: Membership on an entity's Board of Directors or advisory committees, Other: Support for attending meetings and/or travel; AbbVie: Other: Support for attending meetings and/or travel; Incyte: Membership on an entity's Board of Directors or advisory committees. Jurczak: Maria Sklodowska-Curie National Research Institute of Oncology: Current Employment; Jagiellonian University: Ended employment in the past 24 months. Greil: Sandoz: Honoraria, Research Funding; Amgen: Honoraria, Other: Travel, Accommodations, Expenses, Research Funding; AstraZeneca: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses, Research Funding; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses, Research Funding; Sanofi: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses, Research Funding; Daiichi Sankyo: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses, Research Funding; Sankyo: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses, Research Funding; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses; Merck Sharp & Dohme: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses, Research Funding; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses, Research Funding; F. Hoffmann-La Roche Ltd: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses, Research Funding; Bristol-Myers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses, Research Funding; Takeda: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses, Research Funding. Pinto: Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Support for attending meetings and/or travel; Gilead Sciences: Honoraria, Membership on an entity's Board of Directors or advisory committees; Incyte: Honoraria, Membership on an entity's Board of Directors or advisory committees; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Support for attending meetings and/or travel; MSD: Honoraria; Servier: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Consultancy, Honoraria, Other: Support for attending meetings and/or travel; F. Hoffmann-La Roche Ltd: Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Support for attending meetings and/or travel, Speakers Bureau. Abrisqueta Costa: Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees; F. Hoffmann-La Roche Ltd: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; AstraZeneca: Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead: Honoraria; AbbVie: Honoraria, Membership on an entity's Board of Directors or advisory committees. Hirata: Genentech, Inc.: Current Employment; Genentech/Roche: Current holder of stock options in a privately-held company. Jiang: Genentech, Inc.: Current Employment; F. Hoffmann-La Roche Ltd: Current equity holder in publicly-traded company. Yan: F. Hoffmann-La Roche Ltd: Current Employment, Current equity holder in publicly-traded company. Lee: Genentech, Inc.: Current Employment; F. Hoffmann-La Roche Ltd: Current equity holder in publicly-traded company. Flowers: AbbVie: Consultancy, Research Funding; Bayer: Consultancy, Research Funding; BeiGene: Consultancy; Celgene: Consultancy, Research Funding; Denovo Biopharma: Consultancy; Epizyme: Consultancy; Roche/Genentech: Consultancy, Research Funding; Genmab: Consultancy; Gilead: Consultancy, Research Funding; Karyopharm: Consultancy; Pharmacyclics/Janssen: Consultancy; Seattle Genetics: Consultancy; Spectrum: Consultancy; 4D: Research Funding; Acerta: Research Funding; Adaptimmune: Research Funding; Allogene: Research Funding; Amgen: Research Funding; Cellectis: Research Funding; EMD: Research Funding; Guardant: Research Funding; Iovance: Research Funding; Janssen: Research Funding; Kite: Research Funding; Morphosys: Research Funding; Nektar: Research Funding; Novartis: Research Funding; Pfizer: Research Funding; Sanofi: Research Funding; Takeda: Research Funding; TG Therapeutics: Research Funding; Xencor: Research Funding; Ziopharm: Research Funding; Burroughs Wellcome Fund: Research Funding; Eastern Cooperative Oncology Group: Research Funding; National Cancer Institute: Research Funding; Cancer Prevention and Research Institute of Texas: CPRIT Scholar in Cancer Research: Research Funding; Pharmacyclics: Research Funding. Salles: Bayer: Honoraria; AbbVie: Consultancy, Honoraria; BeiGene: Consultancy, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb/Celgene: Consultancy, Honoraria; Debiopharm: Consultancy, Membership on an entity's Board of Directors or advisory committees; Epizyme: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche/Genentech: Consultancy, Membership on an entity's Board of Directors or advisory committees; Genmab: Consultancy, Membership on an entity's Board of Directors or advisory committees; Incyte: Consultancy, Membership on an entity's Board of Directors or advisory committees; Ipsen: Consultancy; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Kite/Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees; Loxo: Consultancy, Membership on an entity's Board of Directors or advisory committees; Miltenyi: Consultancy; Morphosys: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees; Rapt: Consultancy, Membership on an entity's Board of Directors or advisory committees; Regeneron: Consultancy, Honoraria; Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees; Velosbio: Consultancy, Membership on an entity's Board of Directors or advisory committees; Allogene: Consultancy. OffLabel Disclosure: Polatuzumab vedotin is an antibody-drug conjugate targeting CD79b on malignant B-cells. Polatuzumab vedotin in combination with bendamustine and rituximab (pola-BR) improved complete response rate and overall survival compared with BR alone in patients with relapsed/refractory diffuse large B-cell lymphoma. Pola-BR is approved for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least two prior therapies.

The Noguchi Memorial Institute for Medical Research (NMIMR) is a semi-autonomous institute of the College of Health Sciences, University of Ghana, Legon. Founded in 1979, the Institute was built with a grant aid from the Government of Japan as a gift to the people of Ghana in memory of the renowned Japanese medical scientist, Dr. Hideyo Noguchi, who died from Yellow fever infection while conducting research on the disease in Ghana. The Institute has a three-pronged mandate to conduct health related research, build human capacity and provide specialized diagnostic and disease monitoring services in support of the Ghana Health Service. Over the past 40 years, the Institute has grown to be a leading biomedical research institute in the African region. It has strong and long-standing collaborations with scientists and institutions in Africa, Japan, Europe, Australia and North America on several projects on diseases of public health importance. The Institute also hosts several regional and national centres such as Regional Influenza laboratory. The Institute’s research activities are relevant to the control and prevention of infectious diseases in Ghana, particularly, HIV/AIDS, Tuberculosis, Buruli ulcer, Polio, Malaria and emerging infectious diseases. The Institute also plays a technical/advisory role to government through collaborations with disease control programmes and has since inception provided the country with needed critical evidence in support of health policy as well as laboratory diagnostic services among others. Going forward, the Institute seeks to expand and consolidate its activities in areas of antimicrobial resistance (AMR), clinical trials, genomic surveillance and academic programs and in the next 25 years, NMIMR hopes to approach every research area using the one health approach.

IntroductionThe STAT3 signaling pathway regulates activation of hepatic stellate cells (HSCs) and promotes its fibrogenic behavior. Using a fragment‐based drug design approach, our group has developed HJC0416, a novel orally bioavailable small‐molecule inhibitor of STAT3. HJC0416 was found to induce apoptosis and decreased tumor growth in breast cancer models. In the present study, we studied the antifibrogenic properties of HJC0416 in activated hepatic stellate cells (HSC), which are the major effector cells of liver fibrosis.MethodsHuman (LX‐2) and rat (HSC‐T6) hepatic stellate cell lines were used. Cell proliferation was measured by Alamar Blue assay. Cellular protein expression levels were determined by Western blotting and immunofluorescence. Cell cycle was assessed by flow cytometry. Yo‐pro‐1 staining was used to measure apoptosis.ResultsHJC0416 treatment significantly inhibited LX‐2 and HSC‐T6 cell proliferation in a dose‐dependent fashion, and induced apoptosis and S‐phase cell cycle arrest. HSC activation marker α‐smooth muscle actin was also attenuated. HJC0416 suppressed Tyr705‐phosphorylated STAT3 (pSTAT3) and impaired pSTAT3 nuclear translocation and transcriptional activity. STAT3 target genes cyclin D1 and c‐myc were down‐regulated by HJC0416. Static, a well‐known STAT3 inhibitor, confirmed that HSC proliferation was suppressed by STAT3 inhibition. Extracellular matrix (ECM) proteins collagen type I (Coll.I) and fibronectin (FN) are major components of hepatic scar, with TGFβ being the most potent stimulator for ECM production. Our data revealed that endogenous Coll.I and FN expression were suppressed by HJC0416 in a dose‐dependent manner; TGFβ‐stimulated Coll.I and FN production were prevented by pretreatment with HJC0416.ConclusionHJC0416 inhibits HSC activation via the STAT3 signaling pathway. HJC0416 represents a promising anti‐hepatic fibrogenic agent.Support or Funding InformationThis work was supported by grants P50 CA097007, P30 DA028821, R21 MH098344 (JZ) from the National Institutes of Health, Cancer Prevention Research Institute of Texas award, R. A. Welch Foundation Chemistry and Biology Collaborative Grant (JZ) from the Gulf Coast Consortia, and John Sealy Memorial Endowment Fund and the Center for Addiction Research (JZ) from the University of Texas Medical Branch.

This keynote lecture is a product of many years of hard work but today this is delivered in honor of Professor and Founding President of ORLIAC, Professor Emeritus Jan Veldman. Thank you for the opportunity to host ORLIAC in Manila way back in March 2018. For those who attended this, I gave a special lecture during the celebration of World Hearing Day on March 3, 2018, when ORLIAC was held in Manila and this gives an update on how we managed in the past four and a half years, with a COVID-19 pandemic in the past two and half years. The Philippines is an archipelago of more than 7,100 islands during high tide and up to 7,600 when it is low tide. It is situated in the Southeast Asian region. It is one of the countries with the highest population density, with a total population of 110 million spread over 300,000 square kilometers. The crude birthrate is at 19.9 per 1000 – in stark contrast with surrounding Southeast Asian nations now with a decreasing population such as Thailand, Vietnam, and Malaysia among others There have been three World Health Assembly (WHA) resolutions that emphasized the prevention of deafness and hearing loss. WHA 38.19 in 1985 then ten years later WHA 48.9 in 1995 and the last WHA 70.13 in 2017. These resolutions from the World Health Assembly emphasized that prevention of deafness and hearing loss should be incorporated in primary health care. As a result of the 2017 WHA 70.13 resolution, a World Hearing Report1was formulated and released last year in 2021 (Figure 1). The WHO Call to Action in 2000 recommended that Universal Newborn Hearing Screening (NHS) be implemented in all countries where rehabilitation services are established.2 In 1998, we did the first cochlear implantation in my country3 and established as well the graduate program of Masters in Clinical Audiology at the UP College of Medicine where I now work as Dean. This graduate program is one of only two in the country and is government-subsidized such that slots are limited and entry is quite competitive. It is jointly offered with the College of Allied Medical Professions.4 We consider this program to be a key element in producing the necessary healthcare workforce needed for the implementation of programs to defeat deafness in my country. The world hearing report published last year by the World Health Organization (WHO) highlighted the increasing number of people living with hearing loss and in need of services. There is of course the disproportionate burden of hearing loss in low-to middle-income countries like the Philippines.6Our publications from 2003, from a study looking at results of newborn hearing screening in the neonatal intensive unit in the hospital7,8 then to the community, thus providing the evidence for the eventual policy on UNHS that we proposed to the Department of Health (DOH) and to congress for legislation.We initially embarked on basic epidemiological studies using otoacoustic emissions testing in the hospital then in the community. We noted the age of referral at our hospital for children with hearing impairment to be at around 34 months.9 Our focus then was just providing otological clinical services so we decided to work for the establishment of the Philippine National Ear Institute (PNEI) – a research institute formed by Republic Act 9245 and part of the National Institutes of Health of the University of the Philippines – Manila.10 The PNEI laid down the researches needed for the stable foundation of a national health program focused on newborn hearing. From 2003 to 2008, we conducted several studies to establish the prevalence of bilateral permanent hearing loss in newborns both in the hospital and community settings as a prelude to the enactment of the law, and in order to defend having a program on newborn hearing, we conducted a cost-analysis of hospital-based universal newborn hearing screening.11 Notably in 2007, a population-based study showed the prevalence of bilateral profound Congenital Hearing Loss at 1.4 per 1000 births.12 This translates to more than 3,000 babies annually or 8 babies per day who may be profoundly deaf in my country.13 If there were proper intervention for a child with hearing impairment, the cost of treating hearing translates to a lifetime savings of about 80,000 dollars or about PhP 4.3M for the patient’s family. The government and the family would have spent about PhP 4.3 M to raise, educate, and support a deaf-mute child to adulthood. This was presented to the Senate of the Philippines and highlighted during the Inaugural Congress of the ASEAN Academy of Neuro-Oto-Audiology (AANOA). This was supported by Senator Loren Legarda, PNEI Director Dr. Generoso Abes, AANOA founding member Dr. Helmi Balfas, IFOS Regional Secretary Chong Sun Kim, PSOHNS President Gil Vicente, AANOA President Dato Lokman Saim, and Hearing International Secretary Dr. Norberto Martinez (Figure 2). Mandating NHS in the country also entailed involving stakeholders, including otolaryngologists from the different regions who committed to convince their local officials and local hospital administrators the need for instituting these newborn hearing screening programs. After we had the local data at hand, the PSOHNS created a task force on NHS and crafted a position statement on the need for UNHS. As then Vice President, we drafted the position paper that will be presented to Congress while at the same time seeking support from the Department of Health under DOH Secretary Francisco Duque who agreed that Philhealth should be able to support this program when enacted into law. A Technical Working Group was formed, gathering all stakeholders and service providers. Multiple meetings were held, groundwork for launch, and implementation of newborn hearing screening program were instituted with ten Collaboration for Newborn Hearing Screening Advocacy (CONHScA) annual symposia with otolaryngology, audiology, and other hearing screening advocates all over the country.14 (Figure 3). On August 12, 2009, President Gloria Macapagal-Arroyo signed RA 9709, an act that established universalnewborn hearing screening program for the prevention, early diagnosis, and intervention of hearing loss.15 On the modality to be used, reporting, accreditation and training, monitoring and evaluation, and most especially costing of the services and financing for sustainability were also done. We advocated for legislation on UNHS, and once ratified, developed a national program with the Department of Health as lead agency and continued with policy implementation as part of a national technical working group under the DOH. This led to the creation of national Newborn Hearing Screening Reference Center (NHSRC) that was inaugurated in 2013 at the National Institutes of Health with Professor Cor Cremers of Radboud University Nijmegen as special guest. We also started to increase the awareness on the importance of NHS even on national television (Figure 4). Aside from the cost-effectiveness study of hospital-based newborn hearing screening program, we also looked at the budget impact of a community-based UNHSP in the Philippines from both the public payer and the societal perspectives. This study of Rivera et al. published in 201716 showed that cost effectiveness is sensitive to treatment rate, prevalence, follow-up rate, number of rehabilitation sessions, and coverage of the program. It was not sensitive to cost per rehabilitation session, cost of diagnosis with OAE and ABR, education costs, refer rates, recurrent costs, cost of machines, and sensitivity rates. From the societal perspective, the UNHSP was found to be cost-saving for the full range of parameters tested for cost of screening, amplification, education, rehabilitation, and fixed program costs. Ensuring treatment of at least 31 percent and follow-up rate of 24% for a community-based newborn hearing would likely be important benchmarks. The technical arm of the lead agency for this program, the Department of Health, is the Newborn Hearing Screening Reference Center that gives assistance in defining and recommending NHS testing and follow-up protocols which include hearing screening methods, devices used, location, manner, and timing of newborn hearing screening testing. The current protocol uses the 2007 JCIH recommendation of 1-3-6 rule, with screening at 1 month, confirmation of hearing loss at 3 months, and appropriate intervention at 6 months of age.17 With respect to the preferred method of screening, the recent study by Neumann K et al. showed OAE as most prevalent in the country.18 Ten years ago in 2010, an initial web registry for reporting of the OAE results was formulated up to 2014 it was used in 9 centers which allowed gathering of preliminary data on the NHS program. From the data, there was a registry card that needed manual data encoding and in order to sustain operations, a 1 USD fee was levied per registration and was reimbursable thru Philhealth that paid around 4 USD per hearing screening test done. Personnel training, device, and facility certification standards were implemented for centers that chose to perform newborn hearing screening testing. Tiered categorization of centers was also done with screening centers as Category A, screening and diagnostic centers as category B, screening, diagnostic, and essential intervention with hearing aid amplification as category C, and the highest category D for centers with genetic testing and counselling, cochlear implantation surgery and speech rehabilitation services. Recent data showed there were 1072 category A, 18 category B and C, and 9 category D centers distributed all over the country (Figure 5). While some services were initially hampered by the COVID-19 pandemic, NHSRC defined safety protocols that needed to be followed. In an updated advisory, first released in April 2020, and is still in effect to date, NHSRC emphasizes that the centers should follow hospital/institution’s procedural protocol regarding disinfection and attire. Hearing tests in infants are non-invasive and non-aerosol producing procedures. The advisory also included recommendations in terms of timing, preparation, and testing procedures. One significant development that was accelerated during the pandemic was the online adaptation of the NHS personnel certifying course that was reported in recent publications by Rozul et al.19,20 To date, there have been about 3403 trained personnel in 1099 centers with significant increase noted in 2019 compared to previous years. This was not however reflected in the report of Neumann probably due to the time when data for this publication was collected prior to 2019. From the registry alone, the percent screened in the Philippines has been reported to be at least 7-13 percent of live births from the years 2019-2021. The report from Philhealth of 800 claims for NHS from 2018-2019 is still under verification. In 2020, based on manual submission, out of 1099 facilities, 26 percent submitted reports. In 2019, 95% already submitted reports so the pandemic impacted significantly on reporting of results by excel file and paper reports (Figures 6 and 7). The program is still beset with challenges like poor compliance with data submission, loss to follow-up, poor connectivity, sustainable funding of the program from both local and national government, lack of human resources, and a need of much awareness among stakeholders regarding the importance of newborn hearing screening. In a country where 60 percent die without seeing a doctor, there is much work to do. The cost of screening equipment is a major barrier so we conceptualized a biomedical device development project working with engineers in the university to create an AABR screening device which is now on phase two with a TLR 5 early phase rating scale and will now include recruitment of more subjects and refinements for improvements. Harnessing technology and making this more affordable remain as strategies for developing a sustainable hearing screening program and is the subject of HELE, which aims to increase the rates of newborn hearing screening with novel technologies and telehealth. “Hele” stands for lullaby a mother sings to a child. We thought this as very apt for emphasizing the importance of hearing from birth for optimal development. This received a substantial phase 1 grant in 2016 and a phase 2 was launched this year for the premarket development which now stand at technology readiness level 5. It has already spawned many products like the computer-based e-learning training modules, capacity building with provision of basic OAE equipment, and many research publications. It is hoped that a pre-production HELE device can already be produced soon with validated efficacy and reproducibility of all the AABR responses in a clinical setting. With the collaboration of University of California Berkeley and UC Davis, a formidable team has been created. The electronic national newborn hearing screening registry was launched during WORLD HEARING DAY in 2022 and the usability testing results have been published by Ricalde et al.21 In the recent manual of operations and procedures, success indicators were outlined. This is aligned with the WHO standards for monitoring and evaluation, and determining success of programs. Beyond NHS, what else have we learned? Our studies on the genetic causes of the more common causes of hearing impairment such as otitis media showed a unique mutation A2ML1 that affected protease inhibitors allowing better mucosal defense of the middle ear mucosa. Our findings showed microbiome shifts and when we looked at gingivitis, this was what we found. The genetic counseling we embarked on for this indigenous community taught us clinicians many lessons. Speaking to them in their native language was important and house to house invitations were more effective. What about genetic basis of congenital hearing loss? We have found that SLC26A4 mutations were more common than GJB2. There were novel mutations seen in our cohort suggesting the need for studies looking at genetic predisposition. We saw commonalities with Indonesia in terms of the prevalence of GJB2 mutations. From our studies on A2ML1 mutations predisposing to otitis media, we are monitoring this with ongoing study on Hispanic populations. Meanwhile, a seed fund for a national cochlear implant program was approved by Congress and 20 children underwent surgery (Figure 8), while two centers, one in Visayas (Corazon Locsin Montelibano Memorial Regional Hospital in Bacolod) and another in Mindanao (Southern Philippines Medical Center in Davao) were capacitated. Virtual multidisciplinary meetings to discuss the cases were held and provided a model for optimizing use of resources and outcomes. The initial data from the 20 implanted children are very encouraging. There are goals of expanding this program to more beneficiaries by having a Z package for Cochlear implantation, funding from DOH medical assistance fund for indigent patients, and development of services for other implantable hearing devices at the Philippine General Hospital. Moreover, research on hearing need more support given that our studies on genetics of hearing loss among Filipinos yielded very important data on novel genes, uniqueness of our genetic pool as well as mutations predisposing to increased prevalence of otitis media among our marginalized and indigenous population.22-26 As a low- to middle-income country, these researches will need to be continued and may provide valuable lessons for similarly challenged countries in the works as we highlighted in 2017 during the United Nations World Hearing Assembly Advocacy Event on hearing health (Figure 9). The recent National Academy of Science and Technology health policy forum where Professor Xing Kuan Bu was featured as keynote lecturer gave important data on experiences on hearing health program development in China and in the world (Figure 10). Clearly the sustainable development goals especially 3,4,8 and 10 covered by hearing health ensures equity and should be aspirational goals for national development. This is congruent with the vision of PNEI: “No Filipino shall be deprived of a functioning sense of hearing and balance.” Lastly, as the theme of this congress is East Meets West, the Philippines had a strong history of shipbuilding in an era when the galleon trade was very active and 148 of 200 ships that plied that route were ships built in the Philippines with our hardwood. Tracing therefore the history of the countries in ASEAN in particular with the Dutch, French, British, and Spanish influences, we need to dig deeper and look at genetic markers for both health and disease so that while we develop our friendship and scientific connections, history will prove that we have always been connected in so many ways and further exploration can be done in many dimensions. Charlotte M. Chiong, MD, PhDResearch Professor 12Project Leader of HeLeDean, UP College of Medicine (2018-present) _____________________________Paper presented in the Otology Rhinology Laryngology International Academic Conference, September 26, 2022, Auditorium Antonianum, Rome, Italy. Paper prepared in fulfillment of the Alfredo T. Ramirez Professorial Chair for 2022.

In the Philippines, many people would think that items made in other countries have better quality and are more desirable.More recently, with numerous goods coming from nearby countries also having built their reputation for similar or even betterquality – for example, those coming from Japan, Taiwan and more lately, China – goods from these countries are now alsopopular. But it remains unusual that we would generally prefer local brands, i.e., those made in the Philippines.When it comes to using scientific evidence as basis for local medical practice, it should be argued that high quality localdata is superior and should be used. After all, it is derived from our countrymen who may have a different disease biology and/or natural history, sociocultural determinants, as well as clinical practices. It is unfortunate, however, that such local data arenot always available. Even if it exists, it is also not easily accessible. In this, and other issues of Acta Medica Philippina, we see some of the efforts being made by our colleagues to look intothis local experience. They offer varied insights into how global diseases are manifested locally: are there differences that weshould be aware of? As far back as 2006, the Philippine Council for Health Research and Development (PCHRD) has already facilitatedthe creation of a National Unified Health Research Agenda (NUHRA) which is reviewed every five years to identifyresearch priorities in the Philippines.1 In its latest iteration, the 2017-2022 NUHRA prioritizes among others, the holisticapproach to health and wellness that aims to produce evidence geared towards the application and recognition of traditional,sociocultural, and alternative approaches to health.2 The study by Sanico and Medina in this issue highlights this objective.It looked into the potential health benefits and risks of an indigenous fermented rice wine called tapuy. Utilizing a modernbiotechnology technique called metagenomic sequencing, the authors found significant presence of probiotic bacteria thatcan be explored for health applications. However, they also detected the presence of harmful bacteria which may indicate theneed for possible standardization of the fermentation practices. The Acquired Immunodeficiency Syndrome (AIDS) has long plagued the global landscape ever since it was first describedin 1981.3 Because cases have not been described previously, AIDS with its increasing numbers, was soon labeled as anepidemic.4,5 In the Philippines, the HIV/AIDS epidemic has been a fairly more recent one.6-9 Sadly, our country is nowidentified as one with the fastest growing HIV epidemic in the Western Pacific.10 Identifying perceptions of the generalcommunity, especially the high risk populations, can go a long way in curtailing the rising numbers.11 The article by Jamesand colleagues looked further into this by evaluating the knowledge, attitudes and practices on prevention and transmission ofHIV/AIDS among college students in Pampanga, Philippines. The participants were found to have a low knowledge of HIV/AIDS, but had a good attitude toward HIV positive individuals. The authors recommended that education on HIV/AIDScould help control the local epidemic. The study by Rogelio and Santiago looked into screening for retinopathy in patients with gestational diabetes mellitus(GDM). Their data did not support screening to be done in this population. A study had previously reported that GDM has aprevalence of 14% in the Philippines making GDM a disease that is worth addressing.12 On a related note, several internationalguidelines define how GDM can be diagnosed.13 The Philippine Obstetrics and Gynecology Society advocates for a one-stepapproach (a single OGTT using a 75-g anhydrous glucose load with fasting blood sugar ≥92 mg/dL, and a 2-hour level of<126 mg/dL). The one-step approach may be more convenient for patients as it also needs a single visit. A recent report fromAustralia, which also follows a one-step screening process, showed at least a 25% overdiagnosis and its consequent need forfurther testing and the patient anxiety that goes with it.14 An earlier US study also showed 50% more women diagnosed withGDM using the one-step approach compared to a two-step one.15 To be fair, the US study, similar to another one done alsoin Australia, showed no significant differences in the pregnancy outcomes between the two approaches.16 Although a localstudy identified numerical differences in pregnancy outcomes (e.g., risk for primary caesarean section, large for gestational ageinfants, etc.) comparing the two criteria, these were not found to be statistically significant.13 Perhaps there is a need to lookinto this matter again using larger cohorts. As the Philippines gears up for Universal Healthcare, the outcomes of screeningfor GDM can become even more important. The article by Arcilla, et al., on validation of foreign instruments to assess disease and treatment outcomes representsanother area where local data is needed.17 Such validation seeks to investigate whether an instrument developed elsewhere willlikewise yield accurate – and comparable – data for which it was intended. The BREAST-Q is a patient-reported outcomeinstrument designed to evaluate outcomes among women undergoing different types of breast surgery.18 The authors foundhigh internal consistency, test-retest reliability, and acceptability. But there was only low to moderate construct validity inthe Filipino cohort. Among other findings, the authors report respondents having difficulty in understanding some languagetranslations, and even negative reactions to some of the questions. The authors recommend further studies with a largernumber of respondents including those who have undergone nipple reconstruction. The initial results also note that it may bebetter to interpret the “sexual well-being” subscale separately because of the influence that culture may play. The study of Manalili, et al. looked into hemoperfusion as an intervention for COVID-19. The authors report a highmortality and a long length of hospital stay. To put this into perspective, the period of study was from April to September 2020,early in the pandemic period when little is relatively known about the disease. Since then, we know more about COVID-19,with vaccination and anti-virals being available that could alter the disease severity. As of December 2021, local experts donot recommend the use of hemoperfusion among patients diagnosed with COVID-19 mostly because of low certainty ofevidence.19 The option to use it in COVID-19 patients with clinical deterioration despite standard medical therapy includingtocilizumab is however still suggested. The study published here would have been more interesting if there was a comparisonof the outcomes with a similar group who did not undergo hemoperfusion. But it certainly illustrates how generating localdata and local experience goes a long way in examining relevant medical practice/s in our Philippine setting. Case reports help to enhance clinical knowledge by describing the profile and management of patients who have anuncommon or rare disease or may have presented atypically.20-22 We have the opportunity in this issue to share four of theserare cases. The report submitted by Terencio, et al. on the combination of COVID-19 and Guillain-Barre syndrome (GBS)allows us better understanding of COVID-19 and its neurologic complications. As we continue to gain more importantinformation on COVID-19, describing the possibility of GBS as a possible consequence can help clinicians anticipate additionaltreatments as in this case. The same is true for the report submitted by Ablaza and Salonga-Quimpo on abdominal dyskinesia(with its more colorful description as “belly dancer dyskinesia”). Then we have the case of SOLAMEN syndrome, reported by Maceda and colleagues. This case is more dramatic in thatit presents with disfigurement of the patient. Its management is more nuanced as it requires a multidisciplinary approachto address all the affected body parts.23,24 Unfortunately, it also has a strong genetic component as well as predilection tomalignancy which would require longer-term care. Another genetic disease, X-linked dystonia parkinsonism, is likewisereported in this issue in the article by Jamora and others. It is a rare movement disorder that is highly prevalent in Panay Islandin the Philippines.25-28 All cases described so far have been linked to Filipino ancestry, suggesting a single genetic founder andgenetic homogeneity. Although extremely rare globally, the prevalence of XDP in the Philippines is 0.31 per 100,000; and inPanay Island, 5.74 per 100,000. Ninety-five percent of affected individuals are males; the average age is 44 years (20–70 years);and the average age at onset is 39 years (12–64 years).27 Cases in patients of Filipino descent have been described in othercountries.29 The report published here is of particular interest as it is the first time the procedure called Unilateral TranscranialMagnetic Resonance-guided Focused Ultrasound Pallidothalamic Tractotomy has been tried for this condition; a conditionwhich leads to significant progressive disability but no definite treatment.27 All of these case reports may well be the first ones in the Philippines and we have it published here in Acta MedicaPhilippina. I am certain there will be many more insightful studies done locally that will be published – and had been published – inthis journal. These are testament to the recognition that even as we are able to think following the highest global standards,we are also able to act (and do studies) locally in ways that are beneficial to our own Philippine community. Joven Jeremius Q. Tanchuco, MD, MHA Department of Biochemistry and Molecular Biology College of Medicine, University of the Philippines Manila REFERENCES1. Philippine National Health Research System. National Unified Health Research Agenda 2017-2022 [Internet]. [cited 2022 Sep 9]. Available from: https://www.healthresearch.ph/index.php/nuhra2. National Unified Health Research Agenda 2017-2022. Philippine National Health Research System [Internet]. [cited 2022 Sep 9].Available from: https://doh.gov.ph/sites/default/files/publications/NUHRA.pdf3. Schmid S. The Discovery of HIV-1. Nature Communications [Internet]. [cited 2022 Sep 9]. Available from: https://www.nature.com/articles/d42859-018-00003-x#:~:text=In%201983%2C%20Luc%20Montagnier’s%20team,AIDS)%2C%20such%20as%20lymphadenopathy.4. Curran JW, Jaffe HW, Centers for Disease Control and Prevention (CDC). AIDS: the early years and CDC’s response. MMWR Suppl.2011 Oct; 60(4):64-9.5. Sencer DJ. The AIDS Epidemic in the United States, 1981-early 1990s. Centers of Disease Control and Prevention [Internet]. [cited2022 Sep 12]. Available from: https://www.cdc.gov/museum/online/story-of-cdc/aids/index.html6. Restar A, Nguyen M, Nguyen K, Adia A, Nazareno J, Yoshioka E, et al. Trends and emerging directions in HIV risk and prevention researchin the Philippines: A systematic review of the literature. PLoS One. 2018 Dec;13(12):e0207663. doi: 10.1371/journal.pone.02076637. Adia AC, Bermudez ANC, Callahan MW, Hernandez LI, Imperial RH, Operario D. “An Evil Lurking Behind You”: Drivers, Experiences,and Consequences of HIV-Related Stigma Among Men Who Have Sex With Men With HIV in Manila, Philippines. AIDS Educ Prev.2018 Aug;30(4):322-334. doi: 10.1521/aeap.2018.30.4.3228. Mateo R Jr, Sarol JN Jr, Poblete R. HIV/AIDS in the Philippines. AIDS Educ Prev. 2004 Jun;16(3 Suppl A):43-52. doi: 10.1521/aeap.16.3.5.43.355199. Farr AC, Wilson DP. An HIV epidemic is ready to emerge in the Philippines. J Int AIDS Soc. 2010 Apr;13:16. doi: 10.1186/1758-2652-13-1610. Cousins S. The fastest growing HIV epidemic in the western Pacific. Lancet HIV. 2018 Aug;5(8):e412-e413. doi: 10.1016/S2352-3018(18)30182-611. de Lind van Wijngaarden JW, Ching AD, Settle E, van Griensven F, Cruz RC, Newman PA. “I am not promiscuous enough!”: Exploringthe low uptake of HIV testing by gay men and other men who have sex with men in Metro Manila, Philippines. PLoS One. 2018Jul;13(7):e0200256. doi: 10.1371/journal.pone.020025612. Litonjua AD, Waspadji S, Pheng CS, Phin KL, Deerochanowong C, Gomez MHS, et al. AFES Study Group on Diabetes in Pregnancy.Philipp J Intern Med. 1996 Mar-Apr; 34(2):67-68.13. Urbanozo H, Isip-Tan IT. 2014. Association of Gestational Diabetes Mellitus Diagnosed using the IADPSG and the POGS 75-gramOral Glucose Tolerance Test Cut-off Values with Adverse Perinatal Outcomes in the Philippine General Hospital. J ASEAN Fed EndocrSoc. 2014;29(2):157-162. doi: 10.15605/jafes.029.02.0914. Doust JA, Glasziou PP, dʼEmden MC. A large trial of screening for gestational diabetes mellitus in the United States highlights theneed to revisit the Australian diagnostic criteria. Med J Aust. 2022 Feb;216(3):113-115. doi: 10.5694/mja2.5138815. Hillier TA, Pedula KL, Ogasawara KK, Vesco KK, Oshiro CES, Lubarsky SL, et al. A Pragmatic, Randomized Clinical Trial ofGestational Diabetes Screening. N Engl J Med. 2021 Mar;384(10): 895-904. doi: 10.1056/NEJMoa202602816. Meloncelli NJL, Barnett AG, D’Emden M, De Jersey SJ. Effects of Changing Diagnostic Criteria for Gestational Diabetes Mellitus inQueensland, Australia. Obstet Gynecol. 2020 May;135(5):1215-1221. doi: 10.1097/AOG.000000000000379017. Elangovan N, Sundaravel E. Method of preparing a document for survey instrument validation by experts. MethodsX. 2021 Apr;8:101326. doi: 10.1016/j.mex.2021.10132618. BREAST-Q User’s Manual Version 2.0 May 2015. Copyright © 2012 Memorial Sloan Kettering Cancer Center [Internet]. [cited 2022Sep 12]. Available from: https://www.rcseng.ac.uk › breastq-usermanual-2015.19. Philippine COVID-19 Living Clinical Practice Guidelines. Institute of Clinical Epidemiology, National Institutes of Health, UP Manilaand the Philippine Society of Microbiology and Infectious Diseases [Internet]. [cited 2022 Sep 1]. Available from: https://www.psmid.org/hemoperfusion-evidence-summary-2/20. Ortega-Loubon C, Culquichicón C, Correa R. The Importance of Writing and Publishing Case Reports During Medical Training.Cureus. 2017 Dec;9(12):e1964. doi: 10.7759/cureus.196421. Case Reports. CARE Case Report Guidelines [Internet]. [cited 2022 Sep 12]. Available from: https://www.care-statement.org/case-reports22. Carey JC. The importance of case reports in advancing scientific knowledge of rare diseases. Adv Exp Med Biol. 2010; 686:77-86.doi: 10.1007/978-90-481-9485-8_523. Caux F, Plauchu H, Chibon F, Faivre L, Fain O, Vabres P, et al. Segmental overgrowth, lipomatosis, arteriovenous malformation andepidermal nevus (SOLAMEN) syndrome is related to mosaic PTEN nullizygosity. Eur J Hum Genet. 2007 Jul;15(7):767-73. doi: 10.1038/sj.ejhg.520182324. Gupta SK, Sushantika, Abdelmaksoud A. Isolated SOLAMEN Syndrome. Indian J Dermatol. 2021 Sep-Oct; 66(5):561-563. doi:10.4103/ijd.IJD_675_20.25. Domingo A, Westenberger A, Lee LV, Braenne I, Liu T, Vater I, et al. New insights into the genetics of X-linked dystonia-parkinsonism(XDP, DYT3). Eur J Hum Genet. 2015 Oct;23(10):1334-40. doi: 10.1038/ejhg.2014.29226. Lee LV, Munoz EL, Tan KT, Reyes MT. Sex linked recessive dystonia parkinsonism of Panay, Philippines (XDP). Mol Pathol. 2001Dec;54(6):362-368.27. Lee LV, Rivera C, Teleg RA, Dantes MB, Pasco PMD, Jamora RDG, et al. The unique phenomenology of sex-linked dystonia parkinsonism(XDP, DYT3, “Lubag”). Int J Neurosci. 2011;121 Suppl 1:3-11. doi: 10.3109/00207454.2010.52672828. Wilhelmsen KC, Weeks DE, Nygaard TG, Moskowitz CB, Rosales RL, dela Paz DC, et al. Genetic mapping of “Lubag” (X-linkeddystonia-parkinsonism) in Filipino kindred to the pericentromeric region of the X chromosome. Ann Neurol. 1991 Feb;29(2):124-31.doi: 10.1002/ana.41029020329. Rosales RL. X-linked dystonia parkinsonism: clinical phenotype, genetics and therapeutics. J Mov Disord. 2010 Oct;3(2):32–8. doi:10.14802/jmd.10009.