Biology-inspired microphysiological systems to advance patient benefit and animal welfare in drug development

The first microfluidic microphysiological systems (MPS) entered the academic scene more than 15 years ago and were considered an enabling technology to human (patho)biology in vitro and, therefore, provide alternative approaches to laboratory animals in pharmaceutical drug development and academic research. Nowadays, the field generates more than a thousand scientific publications per year. Despite the MPS hype in academia and by platform providers, which says this technology is about to reshape the entire in vitro culture landscape in basic and applied research, MPS approaches have neither been widely adopted by the pharmaceutical industry yet nor reached regulated drug authorization processes at all. Here, 46 leading experts from all stakeholders - academia, MPS supplier industry, pharmaceutical and consumer products industries, and leading regulatory agencies - worldwide have analyzed existing challenges and hurdles along the MPS-based assay life cycle in a second workshop of this kind in June 2019. They identified that the level of qualification of MPS-based assays for a given context of use and a communication gap between stakeholders are the major challenges for industrial adoption by end-users. Finally, a regulatory acceptance dilemma exists against that background. This t4 report elaborates on these findings in detail and summarizes solutions how to overcome the roadblocks. It provides recommendations and a roadmap towards regulatory accepted MPS-based models and assays for patients' benefit and further laboratory animal reduction in drug development. Finally, experts highlighted the potential of MPS-based human disease models to feedback into laboratory animal replacement in basic life science research.Toxicolog

CHERNOBYL HEALTH RADIOLOGICAL EFFECTS ON THE POPULATION OF RUSSIA: DATA OF THE NATIONAL REGISTRY

Summarized radiation-epidemiological data on health effects of the accident at the Chernobyl NPP registered in the follow-up period 1986-2006 on the Russian population are reported. Two groups of population: Chernobyl Emergency accident workers and residents of the most contaminated with radionuclides territories are examined. Impact of radiation-associated risk of solid cancers and leukaemia in these groups is assessed. Prognostic estimates of health effects of the Chernobyl accident on the Russian population are offered in the article

ASSISTED REPRODUCTIVE TECHNOLOGIES FOR FERTILITY PRESERVATION OF CANCER PATIENTS

Over the past years the number of young people diagnosed with cancer has been increasing. Aggressive chemotherapy and radiothera- py have resulted in an increased number of long-term cancer survivors of young cancer patients, but major side effects of these treat- ments are ovarian failure and subsequently lead to a loss of fertility. When cancer is diagnosed, patients and oncologists generally focus on treating the disease, and as a result, critical questions about fertility can go unasked or unanswered. If this happens, cancer patients may miss the only opportunity they have to preserve their ability to have a biological child. Fertility preservation should be an integral part of improving the quality of life in cancer survivors

МЕДИЦИНСКИЕ РАДИОЛОГИЧЕСКИЕ ПОСЛЕДСТВИЯ ЧЕРНОБЫЛЯ ДЛЯ НАСЕЛЕНИЯ РОССИИ: ДАННЫЕ НАЦИОНАЛЬНОГО РЕГИСТРА

Summarized radiation-epidemiological data on health effects of the accident at the Chernobyl NPP registered in the follow-up period 1986-2006 on the Russian population are reported. Two groups of population: Chernobyl Emergency accident workers and residents of the most contaminated with radionuclides territories are examined. Impact of radiation-associated risk of solid cancers and leukaemia in these groups is assessed. Prognostic estimates of health effects of the Chernobyl accident on the Russian population are offered in the article.В работе представлены итоговые данные радиационно-эпидемиологических исследований о медицинских последствиях аварии на Чернобыльской АЭС для населения России за период наблюдения с 1986 по 2006 годы. Рассматриваются две группы: участники ликвидации последствий аварии на Чернобыльской АЭС и жители наиболее загрязненных радионуклидами территорий России. Приводятся оценки величины радиационного риска в индукции солидных раков и лейкозов по этим группам. Даны прогнозные оценки медицинских последствий аварии на Чернобыльской АЭС для населения России