Meeting report: Advancing accelerated regulatory review with Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid.

The American Association of Pharmaceutical Scientists (AAPS) Chemistry, Manufacturing, and Controls (CMC) Community hosted two virtual panel discussions focusing on several novel regulatory review pathways for innovative oncology products: Real-Time Oncology Review (RTOR), Project Orbis, and the Product Quality Assessment Aid (PQAAid). The panel sessions were held on August 27, 2021, for the discussion of RTOR, and January 21, 2022, for the discussion of Project Orbis and the PQAAid. Both panel sessions included representatives from the US Food and Drug Administration (FDA) and subject matter experts from the pharmaceutical and biotechnology industries, with the aim of facilitating knowledge sharing on CMC-specific advantages, challenges, eligibility criteria for participation, and operational modifications instituted through the utilization of these acceleration initiatives. Key topics included managing cross-regional regulatory CMC requirements, adapting to expedited development timelines, coordinating interactions between health authorities and industry, and potential opportunities for future improvement and expansion of these programs. As RTOR, Project Orbis, and PQAAid are relatively new initiatives, the experiences shared by the panel experts are valuable for providing deeper insight into these new regulatory pathways and processes.

The Quality of the Digital Ecosystem in the Financial Sector

The purpose of the study of the digital transformation of the economy and its financial sector is not so much a quantitative as a qualitative assessment. The digital economy shows the emergence of the phenomenon of platform and ecosystem quality and is defined in different sectors of the economy. The sector of services to business is growing in innovation-driven and efficiency-driven economies. It has appeared and is growing in the Russian Federation. Within the framework of the platform economy and the ecosystem economy, these changes allow defining a new quality of financial and non-financial services. The range of services of banking ecosystems, financial and non-financial companies within these systems is changing. In the financial sector the ecosystems of companies and banks are expanding not only the opportunities for distance selling, but also the opportunities for green financing of economic growth. Therefore, the analysis of the financial traps of sustainable development and ESG (environmental, social, government) growth is of particular interest. From the viewpoint of systemic quality, the approach to green financing of economic growth is changing. Two new factors—digitalization and coronavirus pandemic determine the opportunities and boundaries of economic development today. Both are frame factors, introduced or non-economic ones that allows to use the institutional analysis tools. The world experience of stimulating, motivating and transferring institutions includes financial (credit rates, subsidizing bond loans, etc.) and non-financial (funds, ratings, etc.) tools to achieve a new quality of growth. The transformation of financial markets involves the redistribution of financial flows in favor of companies with an ESG policy. The main conclusion: the transformation of financial markets involves the redistribution of financial flows in favor of companies with ESG policies and is an indicator of qualitative changes. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.

SARS-CoV-2 indoor environment contamination with epidemiological and experimental investigations.

SARS-CoV-2 has been detected both in air and on surfaces, but questions remain about the patient-specific and environmental factors affecting virus transmission. Additionally, more detailed information on viral sampling of the air is needed. This prospective cohort study (N = 56) presents results from 258 air and 252 surface samples from the surroundings of 23 hospitalized and eight home-treated COVID-19 index patients between July 2020 and March 2021 and compares the results between the measured environments and patient factors. Additionally, epidemiological and experimental investigations were performed. The proportions of qRT-PCR-positive air (10.7% hospital/17.6% homes) and surface samples (8.8%/12.9%) showed statistical similarity in hospital and homes. Significant SARS-CoV-2 air contamination was observed in a large (655.25 m3 ) mechanically ventilated (1.67 air changes per hour, 32.4-421 L/s/patient) patient hall even with only two patients present. All positive air samples were obtained in the absence of aerosol-generating procedures. In four cases, positive environmental samples were detected after the patients had developed a neutralizing IgG response. SARS-CoV-2 RNA was detected in the following particle sizes: 0.65-4.7 µm, 7.0-12.0 µm, >10 µm, and <100 µm. Appropriate infection control against airborne and surface transmission routes is needed in both environments, even after antibody production has begun.

Economic stress, parenting, and adolescents’ adjustment during the COVID‐19 pandemic

Objective Background Method Results Conclusion Implications This investigation examined pathways through which financial stress impacts parents’ and adolescents’ well‐being during the COVID‐19 pandemic.Pandemic‐related stress (e.g., financial stress) experienced by parents may indirectly affect adolescents’ well‐being, although the pathways involved are currently unknown.Families currently living in the United States and having adolescents between 12 and 18 years old participated in this investigation (N = 272). Parents responded to questionnaires online about their financial situation, personal well‐being, relationship with their oldest typically developing adolescent (12–18 years old;Mage = 14.74;SDage = 1.80;46.4% young women), and their adolescents’ well‐being.Higher levels of financial stress were related to higher levels of parental psychological distress, higher levels of parenting stress, and higher levels of adolescent loneliness. Higher stay‐at‐home intensity was related to higher levels of parenting stress, higher levels of parent–adolescent conflict, and poorer adolescent adjustment. Several significant indirect paths were identified between financial stress and adolescents’ adjustment. The relationship between financial stress and adolescents’ well‐being (i.e., internalizing behaviors and loneliness) was mediated by parental psychological distress and parenting stress. When parenting stress was a mediator, the effect was more pronounced the more time families spent at home.Parents who were worried about their financial situation had greater difficulty with psychological distress and parenting stress, especially when parents were spending more time at home.Understanding the way in which financial stress influences parents’ and adolescents’ adjustment during the pandemic will inform and prepare practitioners and policymakers for similar situations in the future. [ FROM AUTHOR] Copyright of Family Relations is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

Peer mentoring for professional and personal growth in academic medicine.

Mentorship is a critical component of career development, particularly in academic medicine. Peer mentorship, which does not adhere to traditional hierarchies, is perhaps more accessible for underrepresented groups, including women and minorities. In this article, we review various models of peer mentorship, highlighting their respective advantages and disadvantages. Structured peer mentorship groups exist in different settings, such as those created under the auspices of formal career development programs, part of training grant programs, or through professional societies. Social media has further enabled the establishment of informal peer mentorship through participatory online groups, blogs, and forums that provide platforms for peer-to-peer advice and support. Such groups can evolve rapidly to address changing conditions, as demonstrated by physician listserv and Facebook groups related to the COVID-19 pandemic. Peer mentorship can also be found among colleagues brought together through a common location, interest, or goal, and typically these relationships are informal and fluid. Finally, we highlight here our experience with intentional formation of a small peer mentoring group that provides structure and a safe space for professional and social-emotional growth and support. In order to maximize impact and functionality, this model of peer mentorship requires commitment among peers and a more formalized process than many other peer mentoring models, accounting for group dynamics and the unique needs of members. When done successfully, the depth of these mentoring relationships can produce myriad benefits for individuals with careers in academic medicine including, but not limited to, those from underrepresented backgrounds.