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Environmental epigenetics is increasingly employed to understand the health outcomes of communities who have experienced historical trauma and structural violence. Epigenetics provides a way to think about traumatic events and sustained deprivation as biological "exposures" that contribute to ill-health across generations. In Australia, some Indigenous researchers and clinicians are embracing epigenetic science as a framework for theorising the slow violence of colonialism as it plays out in intergenerational legacies of trauma and illness. However, there is dispute, contention, and caution as well as enthusiasm among these research communities.In this article, we trace strategies of "refusal" (Simpson, 2014) in response to epigenetics in Indigenous contexts. Drawing on ethnographic fieldwork conducted in Australia with researchers and clinicians in Indigenous health, we explore how some construct epigenetics as useless knowledge and a distraction from implementing anti-colonial change, rather than a tool with which to enact change. Secondly, we explore how epigenetics narrows definitions of colonial harm through the optic of molecular trauma, reproducing conditions in which Indigenous people are made intelligible through a lens of "damaged" bodies. Faced with these two concerns, many turn away from epigenetics altogether, refusing its novelty and supposed benefit for Indigenous health equity and resisting the pull of postgenomics., (© 2023. Springer Nature Switzerland AG.)

Regulators and pharmaceutical companies across the world are intensifying efforts to get increasingly complex and innovative drugs to patients with high unmet medical need in the shortest possible time frame. This article reviews pathways to expedite drug development and approval available in member countries of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and Australia. It is concluded that the increasing availability of expedited regulatory pathways and associated modernisation of regulatory systems changes the current regulatory paradigm and requires sponsors to rethink drug development and regulatory strategy. A transformation of the current sequence of regulatory submissions, favouring those countries/collaborations that are best regulatory equipped to make innovative medical need drugs available to patients in the shortest time frame is imminent., (© 2022. The Author(s).)

National Regulatory Authorities (NRAs) globally are facing the challenge of evaluating pharmaceutical products in a speedy manner, whilst simultaneously ensuring adequate efficacy, safety and quality of approved products. Additionally, common expectations include that the evaluation process is competent, flexible, commensurate with risk, efficient and rapid. In 2014, the Australian regulatory system was out of step with global regulatory developments which led to a comprehensive regulatory review and reform process. As part of the reforms, two Facilitated Regulatory Pathways (FRP) were developed for prescription medicines: Priority Review (PR) and Provisional Approval (PA). Furthermore, regulatory reliance and recognition arrangements have been expanded with the Therapeutic Goods Administration (TGA) making increased use of evaluation reports by trusted NRAs. The new pathways have been utilised by the pharmaceutical industry in Australia since 2017, with the number of medicines going through these pathways gradually increasing. Additional facilitated pathways have been developed following the review, providing alternatives to the standard pathway for registration of prescription medicines in Australia. The reform is timely, helping to position Australia well in the current global regulatory climate., (© 2022. The Author(s).)

Objective: To examine the prevalence of young childrens' reported experiences of racial discrimination and to assess whether discriminatory experiences vary by gender, religion and country of birth., Methods: Data came from Speak Out Against Racism (SOAR), a cross-sectional study of 4664 public school students in grades 5-9 in two Australian states in 2017. An adaption of the Adolescent Discrimination Distress Index (ADDI), as a measure of discrimination, was used across four Indigenous and ethnic categories (Indigenous, Asian and non-Asian visible minorities, Anglo/European). Effect-measure modification (EMM) examined how experiences of racial discrimination across ethnic groups varied by gender, country of birth and religion., Results: A sizeable proportion (40%) of students reported experiencing racial discrimination. Indigenous, Asian and non-Asian visible minority students reported higher rates of experiencing racial discrimination than their Anglo-European peers. Male students reported higher rates of experiencing racial discrimination than female students. Foreign-born students reported experiencing racial discrimination more often than native-born students, and both Christian and religious minorities experienced racial discrimination more often than students identifying with the dominant "No religion" group., Conclusions: The findings highlight the prevalence of racial discrimination among adolescents and how gender, country of birth and religion can increase risk of these experiences., (© 2021. W. Montague Cobb-NMA Health Institute.)

The concept of age acceleration, the difference between biological age and chronological age, is of growing interest, particularly with respect to age-related disorders, such as Alzheimer's Disease (AD). Whilst studies have reported associations with AD risk and related phenotypes, there remains a lack of consensus on these associations. Here we aimed to comprehensively investigate the relationship between five recognised measures of age acceleration, based on DNA methylation patterns (DNAm age), and cross-sectional and longitudinal cognition and AD-related neuroimaging phenotypes (volumetric MRI and Amyloid-β PET) in the Australian Imaging, Biomarkers and Lifestyle (AIBL) and the Alzheimer's Disease Neuroimaging Initiative (ADNI). Significant associations were observed between age acceleration using the Hannum epigenetic clock and cross-sectional hippocampal volume in AIBL and replicated in ADNI. In AIBL, several other findings were observed cross-sectionally, including a significant association between hippocampal volume and the Hannum and Phenoage epigenetic clocks. Further, significant associations were also observed between hippocampal volume and the Zhang and Phenoage epigenetic clocks within Amyloid-β positive individuals. However, these were not validated within the ADNI cohort. No associations between age acceleration and other Alzheimer's disease-related phenotypes, including measures of cognition or brain Amyloid-β burden, were observed, and there was no association with longitudinal change in any phenotype. This study presents a link between age acceleration, as determined using DNA methylation, and hippocampal volume that was statistically significant across two highly characterised cohorts. The results presented in this study contribute to a growing literature that supports the role of epigenetic modifications in ageing and AD-related phenotypes., (© 2022. The Author(s).)

The Asia Pacific (AP) region is diverse and dynamic. It comprises over 40 economies, with about 24 markets that are relatively more active in terms of promulgating and implementing regulations that impact the biopharmaceutical industry and advance drug development. Although many country- and territory-specific regulations, often driven by the local economy and market dynamics, exist, the overall trend in the AP region is toward international harmonization and global convergence. More markets are now participating in the International Council on Harmonization (ICH), and there is growing interest in identifying and incorporating best practices from competent regulatory agencies. These include expedited pathways to speed access to new medicines, and incentives and other means to encourage innovation. In this paper, we provide a summary of recent activities in select AP markets.

This paper presents a review of the literature, including government legislations, policies, guidelines, and recommendations available in the European Union, the United States of America, and Australia pertaining to the availability, development, and distribution of written medicine information (WMI) for prescription medicines. The online databases searched were Embase, International Pharmaceutical Abstracts, Medline, and PubMed, together with Google as the Internet search engine. The design and content of WMI documents have similarities and differences across all the 3 geographical regions. All the 3 regions have legislations in place to evaluate and regulate WMI documents for health care professionals (HCPs) and, to some degree, for patients; however, the degree of regulation varies between the 3 regions. The regulations around the content and information design of WMI impacts how well the WMI performs and consequently influences patients' knowledge and medication-taking behavior. Legislation in certain areas could be seen as more beneficial and can be implemented across the 3 regions. Furthermore, the required legislation on the evaluation of the content of WMIs can be seen in some areas to be more stringent and comprehensive, which when taken onboard across the 3 regions can be valuable when creating WMIs for both patients and HCPs.

This paper describes one complete and one ongoing empirical study in which philosophical analyses of the concept of the gene were operationalized and tested against questionnaire data obtained from working biologists to determine whether and when biologists conceive genes in the ways suggested. These studies throw light on how different gene concepts contribute to biological research. Their aim is not to arrive at one or more correct 'definitions' of the gene, but rather to map out the variation in the gene concept and to explore its causes and its effects.