New science, drug regulation, and emergent public health issues: The work of FDA's division of applied regulatory science.

The U.S. Food and Drug Administration (FDA) Division of Applied Regulatory Science (DARS) moves new science into the drug review process and addresses emergent regulatory and public health questions for the Agency. By forming interdisciplinary teams, DARS conducts mission-critical research to provide answers to scientific questions and solutions to regulatory challenges. Staffed by experts across the translational research spectrum, DARS forms synergies by pulling together scientists and experts from diverse backgrounds to collaborate in tackling some of the most complex challenges facing FDA. This includes (but is not limited to) assessing the systemic absorption of sunscreens, evaluating whether certain drugs can convert to carcinogens in people, studying drug interactions with opioids, optimizing opioid antagonist dosing in community settings, removing barriers to biosimilar and generic drug development, and advancing therapeutic development for rare diseases. FDA tasks DARS with wide ranging issues that encompass regulatory science; DARS, in turn, helps the Agency solve these challenges. The impact of DARS research is felt by patients, the pharmaceutical industry, and fellow regulators. This article reviews applied research projects and initiatives led by DARS and conducts a deeper dive into select examples illustrating the impactful work of the Division.

The Challenge of Mass Casualty Incident Response Simulation Exercise Design and Creation: A Modified Delphi Study.

BACKGROUND: A Mass Casualty Incident response (MCI) full scale exercise (FSEx) assures MCI first responder (FR) competencies. Simulation and serious gaming platforms (Simulation) have been considered to achieve and maintain FR competencies. The translational science (TS) T0 question was asked: how can FRs achieve similar MCI competencies as a FSEx through the use of MCI simulation exercises? METHODS: T1 stage (Scoping Review): PRISMA-ScR was conducted to develop statements for the T2 stage modified Delphi (mD) study. 1320 reference titles and abstracts were reviewed with 215 full articles progressing for full review leading to 97 undergoing data extraction.T2 stage (mD study): Selected experts were presented with 27 statements derived from T1 data with instruction to rank each statement on a 7-point linear numeric scale, where 1 = disagree and 7 = agree. Consensus amongst experts was defined as a standard deviation ≤ 1.0. RESULTS: After 3 mD rounds, 19 statements attained consensus and 8 did not attain consensus. CONCLUSIONS: MCI simulation exercises can be developed to achieve similar competencies as FSEx by incorporating the 19 statements that attained consensus through the TS stages of a scoping review (T1) and mD study (T2), and continuing to T3 implementation, and then T4 evaluation stages.

Increase in weight-for-age and vegetable intake in young children with cystic fibrosis treated with lumacaftor/ivacaftor for 24 weeks

Background: Modulator therapy has improved nutritional status in individuals with cystic fibrosis (CF), which is associated with favorable outcomes. Because of the high metabolic demands of CF, nutritional recommendations include energy intake of 110% to 200% of daily estimated needs for healthy individuals. With changes in energy balance after initiation of modulator therapy, these recommendations may no longer be appropriate for some people with CFand may lead to excessiveweight gain. Overweight and obesity are being reported, and nutrition concerns now include dietary quality. Dietary quality in relation to growth in young children starting lumacaftor/ivacaftor therapy has not been examined over a 24-week period and may provide new data for future nutrition guidance for individuals with CF. Method(s): The purpose of this observational study was to determine the effect of lumacaftor/ivacaftor treatment on growth and diet in medicationnaive children. Subjects aged 2 to 5 with D508/D508 mutations were recruited from the United States and Canada. Length/height, weight, and body mass index (BMI) were measured in triplicate and averaged. Z-scores were calculated using Centers for Disease Control and Prevention reference data. Dietary data were captured using 3-day weighted food records after study visits. The Healthy Eating Index (HEI) was generated using the U.S. Department of Agriculture scoring system for each recorded day and averaged. Outcomes were assessed before treatment (baseline) and 12 and 24 weeks after beginning medication. Mixed longitudinal models were used for analysis over time. Result(s): Participants (mean age 2.9 +/- 1.4, 50% female) who completed food records for at least their baseline visit plus one other visit (n = 14) had significant increases inweight-for-age z-score (WAZ) 12 (0.6 +/- 1.7, p = 0.02) and 24 (0.21 +/- 1.8, p = 0.001) weeks after therapy. There was no significant change in height-for-age (HAZ), BMI-for-age (BMIZ), or head circumference- for-age (HCZ) z-score at 12 or 24 weeks. Although not statistically significant, percentage estimated energy requirement (%EER) decreased at 12 (-7 +/- 90%, p = 0.54) and 24 (-27 +/- 90%, p = 0.08) weeks. HEI total score did not change over the 24 weeks, although vegetables and greens and beans HEI subgroup scores decreased significantly from baseline to 24 weeks (-0.73 +/- 2.2, p = 0.02;-0.68 +/- 2.1, p = 0.02, respectively). Pooled visit correlation between total vegetables and WAZ indicated a positive association (r = 0.35, p = 0.04). Conclusion(s): WAZ increased significantly over 24 weeks of lumacaftor/ ivacaftor therapy and was positively correlated with total vegetable intake, suggesting that participants with greater WAZ scores consumed more vegetables, although over the course of the study, total vegetable intake and intake of greens and beans decreased, and WAZ increased. %EER decreased over the course of the study, but not statistically significantly so, probably because of variability in energy intake within this small study sample with some COVID-19 interruptions. In summary, WAZ of children aged 2 to 5 with D508/D508 mutations increased, with no significant changes in HAZ, BMIZ, or HCZ, and they consumed fewer total vegetables and greens and beans after 24 weeks of lumacaftor/ivacaftor therapy. Acknowledgements: Supported by Vertex Pharmaceutics Inc. and the National Center for Advancing Translational Sciences, National Institutes of Health, through Grant UL1TR001878.Copyright © 2022, European Cystic Fibrosis Society. All rights reserved

Building an infrastructure to support the development, conduct, and reporting of informative clinical studies: The Rockefeller University experience.

Introduction: Clinical trials are a vital component of translational science, providing crucial information on the efficacy and safety of new interventions and forming the basis for regulatory approval and/or clinical adoption. At the same time, they are complex to design, conduct, monitor, and report successfully. Concerns over the last two decades about the quality of the design and the lack of completion and reporting of clinical trials, characterized as a lack of "informativeness," highlighted by the experience during the COVID-19 pandemic, have led to several initiatives to address the serious shortcomings of the United States clinical research enterprise. Methods and Results: Against this background, we detail the policies, procedures, and programs that we have developed in The Rockefeller University Center for Clinical and Translational Science (CCTS), supported by a Clinical and Translational Science Award (CTSA) program grant since 2006, to support the development, conduct, and reporting of informative clinical studies. Conclusions: We have focused on building a data-driven infrastructure to both assist individual investigators and bring translational science to each element of the clinical investigation process, with the goal of both generating new knowledge and accelerating the uptake of that knowledge into practice.

Proceedings of the 10th Pediatric Dermatology Research Alliance (PeDRA) Annual Conference.

The 10th Pediatric Dermatology Research Alliance (PeDRA) Annual Conference occurred November 3-5, 2022 in Bethesda, Maryland. This conference was the first in-person PeDRA conference after 2 years of a virtual format due to COVID-19. Fittingly, given the effects of the pandemic, the conference theme was "Reimagining Community." The conference included presentations and panel sessions on finding individual and collective purpose, leveraging community in pursuit of a shared goal, and creating a community of resources in collaboration with NIH. The goal of this meeting was to connect clinicians, basic scientists, patients, patient advocates, and industry partners. The reimagined community of pediatric dermatology research is a synergistic space for all members to better understand, prevent, treat, and cure dermatologic diseases and conditions in children. This two-and-a-half-day conference with over 300 attendees featured educational seminars including a keynote address, didactic lecture and panel sessions, skill-building workshops, 13 topic-specific breakout sessions, and an interactive poster session where 108 active and finished research projects could be discussed.

Translational Science 22 conference proceedings.

The Translational Science TS22 conference in Chicago in April 2022 was the first time post-pandemic that members of the Association of Clinical and Translational Science were able to meet up in person to share scientific advances. Given the remaining level of risk due to COVID-19, the meeting was designed as hybrid allowing virtual participation to some of the presentations. Prior to the meeting, JCTS Junior Editors were invited to report on the plenary sessions of the meeting. The present perspective constitutes a summary of three plenary sessions.

Improving quality and efficiency of translational research: Environmental scan of adaptive capacity and preparedness of Clinical and Translational Science Award Program hubs.

Translational science is, by definition, groundbreaking; however, without an emphasis on quality and efficiency, some innovations in healthcare may translate into unnecessary risk, suboptimal solutions, and potentially loss of well-being and even lives. The COVID-19 pandemic and the Clinical and Translational Sciences Award Consortium's response created an opportunity for quality and efficiency to be better defined, expediently and thoughtfully addressed, and further studied as central foundations in the translational science mission. This paper presents findings of an environmental scan of adaptive capacity and preparedness to illuminate the assets, institutional environment, knowledge, and forward-looking decision-making needed to optimize and sustain research quality and efficiency.

Leadership and administration to advance translational science: Environmental scan of adaptive capacity and preparedness of Clinical and Translational Science Award Program hubs.

COVID-19 reinforced the need for effective leadership and administration within Clinical and Translational Science Award (CTSA) program hubs in response to a public health crisis. The speed, scale, and persistent evolution of the pandemic forced CTSA hubs to act quickly and remain nimble. The switch to virtual environments paired with supporting program operations, while ensuring the safety and well-being of their team, highlight the critical support role provided by leadership and administration. The pandemic also illustrated the value of emergency planning in supporting organizations' ability to quickly pivot and adapt. Lessons learned from the pandemic and from other cases of adaptive capacity and preparedness can aid program hubs in promoting and sustaining the overall capabilities of their organizations to prepare for future events.

Adaptive capacity and preparedness of Clinical and Translational Science Award Program hubs: Overview of an environmental scan.

The ability of research networks and individual institutions to effectively and efficiently prepare, respond, and adapt to emergent challenges is essential for the biomedical research enterprise. At the beginning of 2021, a special Working Group was formed by individuals in the Clinical and Translational Science Award (CTSA) consortium and approved by the CTSA Steering Committee to explore "Adaptive Capacity and Preparedness (AC&P) of CTSA Hubs." The AC&P Working Group took a pragmatic Environmental Scan (E-Scan) approach of utilizing the diverse data that had been collected through existing mechanisms. The Local Adaptive Capacity framework was adapted to illustrate the interconnectedness of CTSA programs and services, while exposing how the demands of the pandemic forced them to quickly pivot and adapt. This paper presents a synopsis of the themes and lessons learned that emerged from individual sections of the E-Scan. Lessons learned from this study may improve our understanding of adaptive capacity and preparedness at different levels, as well as help strengthen the core service models, strategies, and foster innovation in clinical and translational science research.

Antimicrobial Utilization Trends during the COVID-19 Pandemic Throughout the US

Introduction: The purpose of this study is to evaluate the trends of use of various antimicrobials prior to and during the coronavirus disease 2019 (COVID-19) pandemic, which is caused by a coronavirus and is unaffected by antimicrobials. Despite the inactivity of antimicrobials against COVID-19, they are still employed due the possibility of underlying or 'just in case' scenarios of bacterial infection. Research Question or Hypothesis: We hypothesis that the utilization rates of common intravenous antimicrobials correlate to the number of hospitalized COVID-19 patients. Study Design: Retrospective evaluation. Methods: This study utilized de-identified data and was exempt from requiring IRB approval. The antimicrobial utilization was collected through the National Center for Advancing Translational Sciences (NCATS) National COVID Cohort Collaborative (N3C) from 01/01/2019 to 12/31/2021. Antimicrobials of interest included carbapenems, 3rd/4th generation cephalosporins, fluoroquinolones, and piperacillin-tazobactam. Antimicrobial utilization rate was measured using the metric days of therapy (DOT) and patient days. Results: Ten antibiotics were evaluated in this study and accounted for 7,891,986 DOT over three years. Monthly antibiotic utilization (mean±SD per 10,000 patient days [PD]) in 2019 (28.3±13.9) was significantly higher than 2020 (10.8±1.5) and 2021 (12.1±5), p<0.001. All the antibiotics evaluated had significant decreases in utilization with the exception of ceftriaxone (CRO) and piperacillin-tazobactam (TZP). Monthly CRO utilization (mean±SD per 10,000 patient days) in 2019 (3.11±0.32) and 2020 (3.18±0.23) were similar, but higher than 2021 (2.88±0.29), p=0.16. TZP had a similar DOT/10,000PD trend where utilization in 2019 (2.1±0.39) and 2020 (1.8±0.09) were constant and higher than 2021 (1.61±0.08), p<0.001. There is a negative correlation between COVID-19 cases and antibiotics evaluated, r = -0.655, p<0.001. Conclusion: The antimicrobial utilization decreased during the years 2020-2021 with the exception of CRO and TZP. We plan to develop a model to determine the influence of COVID-19 on antibiotic prescribing and evaluate antimicrobial use based on US regions.

Addressing the challenges of conducting community-engaged research during COVID-19: Rapid development and evaluation of a COVID-19 Research Patient and Community Advisory Board (PCAB).

Introduction: We created a COVID-19 Research Patient and Community Advisory Board (PCAB) to provide patient and community input into clinical and translational research studies. The purpose of this article is to describe the PCAB creation, implementation, and evaluation. Methods: We identified PCAB members who had participated in previous stakeholder engaged activities at our institution and invited their participation. We created a systematic consultation process where researchers could submit plain language research summaries and questions for the PCAB. A facilitated 1-hour virtual consultation was then held where PCAB members provided feedback. We assessed satisfaction of PCAB members and researchers who received consultations using surveys. We also reviewed video recordings of PCAB consultations and reflections from team meetings to identify key lessons learned. Results: Twenty-seven PCAB members took part in 23 consultation sessions. Twenty-two completed an evaluation survey (81% response rate). Most members agreed or strongly agreed their opinions were valued (86%), it was a productive use of time (86%) and were satisfied (86%). Nineteen researchers completed an evaluation survey (83% response rate). Researchers reported positive experiences of working with the PCAB. Additional insights include limited funding in COVID-19 research for equitable community engagement, deficiencies in researcher communication skills, and a lack of cultural humility incorporated into study activities. Conclusions: PCAB members provided recommendations that maximized the patient-centeredness and health equity focus of COVID-19 research. The detailed description of the process of developing, implementing, and evaluating our PCAB can be used as a template for others wishing to replicate this engagement model.

Adapting an Expanded Access program to enable investigational treatments for COVID-19.

Retrospective case studies of initiatives supported by the National Institutes of Health's Clinical and Translational Science Award (CTSA) hubs can be used to identify facilitators and barriers of translational science. This case study investigates how a CTSA Expanded Access program adapted to changing FDA guidance issued in 2020 to support clinicians' treatment of COVID-19 patients in Michigan. We studied how this program changed throughout the pandemic to support physicians' requests for remdesivir, convalescent plasma, and other uses of unapproved drugs and novel medical devices. A protocol for retrospective translational science case studies of health interventions developed by CTSA evaluators was used for this case study. Data collection methods included seven interviews and a review of institutional data, peer-reviewed publications, news stories, and other public records. The barriers identified include evolving guidance, misalignment of organizational operations, and the complexity of the research infrastructure. The facilitators of translation include collaboration between research and care teams, increasing engagement with a broad network of supporters, and ongoing professional development for research staff. The findings of this case study can be used to inform future investigations of the principles underlying the translational process.

Using informatics to advance translational science: Environmental scan of adaptive capacity and preparedness of Clinical and Translational Science Award Program hubs.

As the USA and the rest of the world raced to fight the COVID-19 pandemic, years of investments from the National Center for Advancing Translational Sciences allowed for informatics services and resources at CTSA hubs to play a significant role in addressing the crisis. CTSA hubs partnered with local and regional partners to collect data on the pandemic, provide access to relevant patient data, and produce data dashboards to support decision-making. Coordinated efforts, like the National COVID Cohort Collaborative (N3C), helped to aggregate and harmonize clinical data nationwide. Even with significant informatics investments, some CTSA hubs felt unprepared in their ability to respond to the fast-moving public health crisis. Many hubs were forced to quickly evolve to meet local needs. Informatics teams expanded critical support at their institutions which included an engagement platform for clinical research, COVID-19 awareness and education activities in the community, and COVID-19 data dashboards. Continued investments in informatics resources will aid in ensuring that tools, resources, practices, and policies are aligned to meet local and national public health needs.

Rapid and Sustained Decline in CXCL-10 (IP-10) Annotates Clinical Outcomes Following TNF-α Antagonist Therapy in Hospitalized Patients with Severe and Critical COVID-19 Respiratory Failure

Background. TNFα and IFN-γ may synergize to induce cytokine-driven lethal hyperinflammation and immune exhaustion in COVID-19 illness. Methods. To assess TNFα-antagonist therapy, 18 hospitalized adults with hypoxic respiratory failure and COVID-19 pneumonia received single-dose infliximab-abda therapy 5mg/kg intravenously between April and December 2020. The primary endpoint was time to increase in oxygen saturation to fraction of inspired oxygen ratio (SpO2/FiO2) by ≥ 50 compared to baseline and sustained for 48 hours. Secondary endpoints included 28-day mortality, dynamic cytokine profiles (Human Cytokine 48-Plex Discovery Assay), secondary infections, duration of supplemental oxygen support and hospitalization. Hospitalized patients with SARS-COV2 infection and pneumonia that were referred to the infliximab-abda study team for evaluation. Results. Patients were predominantly in critical respiratory failure (15/18, 83%), male (14/18, 78%), above 60 years (median 63 yrs, range 31-80), race-ethnic minorities (13/18, 72%), lymphopenic (13/18, 72%), steroid-treated (17/18, 94%), with a median ferritin of 1953ng/ml. Sixteen patients (89%) met the primary endpoint within a median of 4 days, 15/18 (83%) recovered from respiratory failure, and 14/18 (78%) were discharged in a median of 8 days and were alive at 28-day follow-up. Deaths among three patients ≥ 65 years age with pre-existing lung disease or multiple comorbidities were attributed to secondary lung infections. Mean plasma IP-10 levels declined sharply from 9183 pg/ml to 483 pg/ml at Day 3 and 146 pg/ml at Day 14/discharge. Significant declines in IFN-γ, TNFα, IL-27, IL-6 (baseline above 10pg/ml), CRP and ferritin were specifically observed at Day 3 whereas other cytokines were unaffected. Among 13 lymphopenic patients, six (46%) had resolution of lymphopenia by day 3, and 11 by day 14. CXCR3-ligand (IP-10 and CXCL-9) declines were strongly correlated among patients with lymphopenia reversal (Day 3, Pearson r: 0.98, p-value: 0.0006). following treatment with infliximab-abda. The status of the patient at last follow-up (discharged, alive or dead) is indicated. ECMO: extracorporeal membrane oxygenation Control of inflammatory markers and cytokines following infliximab therapy Values from individuals are connected with solid lines, with deceased individuals indicated in red. Statistics: n=18, paired ratio t-test compared to baseline;∗: P<0.05, ∗∗: P<0.01, ∗∗∗: P<0.001, ∗∗∗∗: P<0.0001, n.s.: not significant. Conclusion. Consistent with a central role of TNFα, the clinical and cytokine data indicate that infliximab-abda may rapidly abrogate pathological inflammatory signaling to facilitate clinical recovery in severe and critical COVID-19. Randomized studies are formally evaluating infliximab therapy in this context. Funding: National Center for Advancing Translational Sciences.

Dissemination and Implementation Science Approaches for Occupational Safety and Health Research: Implications for Advancing Total Worker Health.

Total Worker Health® (TWH), an initiative of the U.S. National Institute for Occupational Safety and Health, is defined as policies, programs, and practices that integrate protection from work-related health and safety hazards by promoting efforts that advance worker well-being. Interventions that apply the TWH paradigm improve workplace health more rapidly than wellness programs alone. Evidence of the barriers and facilitators to the adoption, implementation, and long-term maintenance of TWH programs is limited. Dissemination and implementation (D&I) science, the study of methods and strategies for bridging the gap between public health research and practice, can help address these system-, setting-, and worker-level factors to increase the uptake, impact, and sustainment of TWH activities. The purpose of this paper is to draw upon a synthesis of existing D&I science literature to provide TWH researchers and practitioners with: (1) an overview of D&I science; (2) a plain language explanation of key concepts in D&I science; (3) a case study example of moving a TWH intervention down the research-to-practice pipeline; and (4) a discussion of future opportunities for conducting D&I science in complex and dynamic workplace settings to increase worker safety, health, and well-being.

Accelerating the transition of clinical science to translational medicine.

The SARS-CoV-2 pandemic has shown the importance of medical research in responding to the urgent prevention and health needs to combat the devastating disease, COVID-19, that this ß-coronavirus unleashed. Equally, it has demonstrated the importance of interdisciplinary working to translate scientific discovery into public and patient benefit. As we come to adjust to live with this new virus, it is important to look back and see what lessons we have learnt in the way scientific medical discoveries can be more effectively and rapidly moved into public benefit. Clinical Science has had a long and distinguished history with this Journal bearing the same name and being an important contributor to the rapidly increasing use of human pathobiological data to gain mechanistic understanding of disease mechanisms leading to new diagnostic tests and treatments. The recognition that many complex diseases engage multiple causal pathways that may vary from patient to patient, and at different times across the lifecourse, has led to the emergence of stratified or precision medicine in which the right treatment is given to the right patient at the right time and, in doing so, minimise 'non-responders' and off-target side effects. Applications of omics technologies, the digitalisation of biology and the applications of machine learning and artificial intelligence (AI) are accelerating disease insights at pace with translation of discoveries into new diagnostic tests and treatments. The future of clinical science, as it morphs into translational medicine, is now creating unique possibilities where even the most intractable diseases are now open to being conquered.

Home testing for COVID-19 and other virus outbreaks: The complex system of translating to communities.

Home testing is an emerging innovation that can enable nations and health care systems to safely and efficiently test large numbers of patients to manage COVID-19 and other viral outbreaks.  In this position paper, we explore the process of moving home testing across the translational continuum from labs to households, and ultimately into practice and communities for optimal public health impact. We focus on the four translational science drivers to accelerate the implementation of systems-wide home testing programmes 1) collaboration and team science, 2) technology, 3) multilevel interventions, and 4) knowledge integration. We use the Socio Ecological Model (SEM) as a framework to illustrate our vision for the ideal future state of a comprehensive system of stakeholders utilising tech-enabled home testing for COVID-19 and other virus outbreaks, and we suggest SEM as a tool to address key translational readiness and response questions.

A compendium of community engagement responses to the COVID-19 pandemic.

INTRODUCTION: Clinical and Translational Science Award Program (CTSA)-funded institutions were charged with developing clinical and translational science programs and transforming clinical research at their institutions. Community engagement (CE) was recognized as a key component and catalyst of that transformation. CE hub capacities for working with communities and translating knowledge into practice have been illustrated through their COVID-19 responses. METHODS: CE hub leaders met and discussed their CTSA's early responses regarding the COVID-19 pandemic. The 2-hour discussion was distilled into themes which were sent to the CE hub leaders with a request for written accounts describing actions taken to engage local partners, communities, and institutions. The written reports form the basis for this compendium. RESULTS: Eighteen institutions submitted written reports describing activities in relation to six themes: (1) listen to the community and respond to concerns, (2) collect data to understand the impact of COVID-19 on distinct communities and groups, (3) communicate science and address misinformation, (4) collaborate with health departments, (5) engage hubs and underrepresented populations in COVID-19 research, and (6) support our own well-being and that of others. CONCLUSIONS: Bidirectional interactions comprise the foundation of CE, which requires trusted partnerships that sustain communication through a series of activities and goals. The nimble responses to the pandemic substantiate the need for CE programs to maintain the infrastructure necessary to achieve the primary CTSA goals of improving health within and across communities and localities as well as expanding research participation of community members.

Assessing the impact of remote work during COVID-19 on clinical and translational scientists and staff in Colorado.

The COVID-19 pandemic has required many clinical and translational scientists and staff to work remotely to prevent the spread of the virus. To understand the impact on research programs, we assessed barriers to remote work and strategies implemented to support virtual engagement and productivity. A mixed-methods RedCap survey querying the remote work experience was emailed to Colorado Clinical and Translational Sciences Institute (CCTSI) scientists and staff in April 2020. Descriptive analyses, Fisher's Exact tests, and content analysis were conducted. Respondents (n = 322) were primarily female (n = 240; 75%), 21-73 years old (mean = 42 years) with a PhD (n = 139; 44%) or MD (n = 56; 55%). Prior to COVID-19, 77% (n = 246) never or rarely (0-1 day a week) worked remotely. Remote work somewhat or greatly interfered with 76% (n = 244) of researchers' programs and 71% (n = 231) reported slowing or stopping their research. Common barriers included missing interactions with colleagues (n = 198; 62%) and the absence of routines (n = 137; 43%). Strategies included videoconferencing (n = 283; 88%), altering timelines and expectations (n = 180; 56%). Scientists and staff experienced interference with their research when they shifted to remote work, causing many to slow or stop research programs. Methods to enhance communication and relationships, support productivity, and collectively cope during remote work are available.