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DOE OSTI2026

Cyber Halo Innovation Research Program (CHIRP) Student Research Report: Program Analysis

The Cybersecurity and Space Systems Research Program (CHIRP) conducted multi-year, mission-focused research addressing emerging cybersecurity challenges affecting space and ground systems. Students from California State University San Bernardino (CSUSB), University of Texas El Paso (UTEP), and California State University Dominguez Hills (CSUDH) conducted structured research, developed proof-of-concept demonstrations, participated in applied cybersecurity training, and collaborated with Space Systems Command (SSC), academic, and industry partners. This report documents the research questions, methodologies, findings, demonstrations, and student contributions associated with each cohort. It also summarizes the program’s workforce-development outcomes, including applied cybersecurity training, professional certifications, technical credentials, and partnerships with organizations such as CT Cubed, Inc. and ISC2. Collectively, CHIRP strengthened the space-cybersecurity workforce pipeline and produced research and prototype efforts that may inform future cybersecurity assessments, test and evaluation activities, cyber-range development, acquisition planning, operational training, and mission-assurance initiatives.

McKenzie, Penny L.↗
NASA NTRS2014

Flight Testing of the Space Launch System (SLS) Adaptive Augmenting Control (AAC) Algorithm on an F/A-18

The Marshall Space Flight Center (MSFC) Flight Mechanics and Analysis Division developed an adaptive augmenting control (AAC) algorithm for launch vehicles that improves robustness and performance on an as-needed basis by adapting a classical control algorithm to unexpected environments or variations in vehicle dynamics. This was baselined as part of the Space Launch System (SLS) flight control system. The NASA Engineering and Safety Center (NESC) was asked to partner with the SLS Program and the Space Technology Mission Directorate (STMD) Game Changing Development Program (GCDP) to flight test the AAC algorithm on a manned aircraft that can achieve a high level of dynamic similarity to a launch vehicle and raise the technology readiness of the algorithm early in the program. This document reports the outcome of the NESC assessment.

Dennehy, Cornelius J.↗
DOE OSTI2022

Epidemic Intelligence Service Alumni in Public Health Leadership Roles

Since 1951, the Epidemic Intelligence Service (EIS) of the U.S. Centers for Disease Control and Prevention (CDC) has trained physicians, nurses, scientists, veterinarians, and other allied health professionals in applied epidemiology. To understand the program’s effect on graduates’ leadership outcomes, we examined the EIS alumni representation in five select leadership positions. These positions were staffed by 353 individuals, of which 185 (52%) were EIS alumni. Among 12 CDC directors, four (33%) were EIS alumni. EIS alumni accounted for 29 (58%) of the 50 CDC center directors, 61 (35%) of the 175 state epidemiologists, 27 (56%) of the 48 Field Epidemiology Training Program resident advisors, and 70 (90%) of the 78 Career Epidemiology Field Officers. Of the 185 EIS alumni in leadership positions, 136 (74%) were physicians, 22 (12%) were scientists, 21 (11%) were veterinarians, 6 (3%) were nurses, and 94 (51%) were assigned to a state or local health department. Among the 61 EIS alumni who served as state epidemiologists, 40 (66%) of them were assigned to a state or local health department during EIS. Our evaluation suggests that epidemiology training programs can serve as a vital resource for the public health workforce, particularly given the capacity strains brought to light by the COVID-19 pandemic.

60 APPLIED LIFE SCIENCES↗
NASA NTRS2019

Using Arcane Data: Past Performance in NASA Science’s Principal Investigator (PI) Development Programs and Improving Future Peer Review for Space Flight Missions

This panel will explore challenges and initial findings from three qualitative studies that use the National Aeronautics and Space Administration's (NASA) Science Mission Directorate's(SMD) internal administrative data to begin to assess program effectiveness and document outputs and outcomes. SMD has funded both at and outside NASA, projects that promotethe development of SMD's future principal investigators (PI) workforce and science and technology investigations on space flight missions that advance the high priority science,technology, and exploration objectives. NASA's internal administrative data are arcane because they developed outside of relational databases. The studies reveal unique challenges to locating and using these data to document effective program processes, i.e.,peer review criteria for large flight missions, and results from the PI-development projects,e.g. the Hands-On Project Experience (HOPE) Training Opportunity solicitations limited to NASA Centers the Jet Propulsion Laboratory; and graduate student/postdoctoral opportunities at higher education institutions.

Sladek, Mary Frances↗
NASA NTRSDate not supplied

Students Solving Problems for ISS and Beyond: Inspiring the Next-Generation

Students Solving Problems for ISS and Beyond: Inspiring the Next-Generation Session Title: Students Solving Problems for ISS and Beyond: Inspiring the Next-Generation Session Description: NASA High school students United with NASA to Create Hardware (HUNCH) mission is to empower and inspire students through a Project-Based Learning program where 7-12 grade students learn 21st century skills and can launch their careers through participation in the design and fabrication of real-world valued products for NASA. With six different tracks consisting of Design & Prototype, Culinary Challenge, Softgoods, Precision Machining, Software, and Video Challenge, students are given the opportunity to create solutions for the International Space Station (ISS), the Moon, and beyond. Many projects are requested by the Crew to help ease living conditions, giving students the opportunity to make an impact on the lives of Astronauts. Other projects come directly from NASA and its partners. Join our session to learn how NASA is working with teachers across the country to mentor the next generation of scientists and engineers to solve some of NASA’s greatest challenges. Learning Outcomes: 1. Describe the NASA HUNCH Program, including the program objectives, goals, and strategic partnerships for middle school and high school outreach and advocacy efforts. 2. Identify the innovative strategies NASA is using to work with middle and high school students to solve real-world problems 3. Use the knowledge gained to inspire the next generation of scientists and engineers Session Track: Advocacy & Outreach Specialized Focus Area: Women in Government and Military Learning Level: Foundational Session Format: Listen & Learn Speaker Qualifications: 1. Deboshri Sadhukhan • Current Job Title: Deputy Project Manager • Topic Experience (years of experience related to proposed topic): 1-5 years • Biography: Deboshri Sadhukhan is an engineer for NASA Glenn Research Center (GRC). She has worked on numerous projects — from International Space Station (ISS) fluid technologies, to Orion European Service Module propulsion, to planetary science missions and other game-changing technologies. Her roles have ranged from Project Manager to System Safety Lead. She currently serves as a GRC Regional Mentor for the High school students United with NASA to Create Hardware (HUNCH) program. She also serves as Deputy Project Manager for an ISS payload and Safety & Mission Assurance Lead for a Radioisotope Power Systems project. In these roles, she oversees each phase of a project from beginning to end and provides leadership to increase the reliability, maintainability and system safety of hardware and personnel throughout the system life cycle. She holds a Bachelor of Science in Electrical Engineering from The University of Akron. 2. Nancy Hall • Current Job Title: Project Manager • Topic Experience: 20+ years • Biography: Nancy Rabel Hall earned a B.S. degree in Space Sciences from Florida Institute of Technology and a M.S. degree in Mechanical Engineering from the University of Toledo. She has been at NASA Glenn for over 30 years. She has led several International Space Station experiments that studied how the behavior of fluids and fluid systems behave differently in microgravity as compared to here on Earth. She is also the High school students United with NASA to Create Hardware (HUNCH) project manager, a program that allows students to design and fabricate hardware and softgoods for NASA as well as participate in a culinary and video challenge. She enjoys talking to the public and students about the work being done at NASA as well as showing students how math and science can be fun. She is an amateur radio operator, enjoys playing golf, and reading science fiction and fantasy books.

HUNCH↗
DOE OSTI2020

Design and feasibility of a novel program of cervical screening in Nigeria: self-sampled HPV testing paired with visual triage

Background: Accelerated global control of cervical cancer would require primary prevention with human papillomavirus (HPV) vaccination in addition to novel screening program strategies that are simple, inexpensive, and effective. We present the feasibility and outcome of a community-based HPV self-sampled screening program. Methods: In Ile Ife, Nigeria, 9406 women aged 30–49 years collected vaginal self-samples, which were tested for HPV in the local study laboratory using Hybrid Capture-2 (HC2) (Qiagen). HPV-positive women were referred to the colposcopy clinic. Gynecologist colposcopic impression dictated immediate management; biopsies were taken when definite acetowhitening was present to produce a histopathologic reference standard of precancer (and to determine final clinical management). Retrospective linkage to the medical records identified 442 of 9406 women living with HIV (WLWH). Results: With self-sampling, it was possible to screen more than 100 women per day per clinic. Following an audio-visual presentation and in-person instructions, overall acceptability of self-sampling was very high (81.2% women preferring self-sampling over clinician collection). HPV positivity was found in 17.3% of women. Intensive follow-up contributed to 85.9% attendance at the colposcopy clinic. Of those referred, 8.2% were initially treated with thermal ablation and 5.6% with large loop excision of transformation zone (LLETZ). Full visibility of the squamocolumnar junction, necessary for optimal visual triage and ablation, declined from 68.5% at age 30 to 35.4% at age 49. CIN2+ and CIN3+ (CIN- Cervical intraepithelial neoplasia), including five cancers, were identified by histology in 5.9 and 3.2% of the HPV-positive women, respectively (0.9 and 0.5% of the total screening population), leading to additional treatment as indicated. The prevalences of HPV infection and CIN2+ were substantially higher (40.5 and 2.5%, respectively) among WLWH. Colposcopic impression led to over- and under-treatment compared to the histopathology reference standard. Conclusion: A cervical cancer screening program using self-sampled HPV testing, with colposcopic immediate management of women positive for HPV, proved feasible in Nigeria. Based on the collected specimens and images, we are now evaluating the use of a combination of partial HPV typing and automated visual evaluation (AVE) of cervical images to improve the accuracy of the screening program.

59 BASIC BIOLOGICAL SCIENCES↗
NASA NTRS2015

Clinical Outcome Metrics for Optimization of Robust Training

The emphasis of this research is on the Human Research Program (HRP) Exploration Medical Capabilities (ExMC) "Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-flight Medical Capabilities". Specifically, this project aims to contribute to the closure of gap ExMC 2.02: We do not know how the inclusion of a physician crew medical officer quantitatively impacts clinical outcomes during exploration missions. The experiments are specifically designed to address clinical outcome differences between physician and non-physician cohorts in both near-term and longer-term (mission impacting) outcomes.

Ebert, D.↗
DOE OSTI2024

Novel Signatures Beyond the Standard Model: From Extreme Environments to Precision Measurements

Most of our universe is dark. It is dark literally—visible matter makes up only 5% of the energy density—and conceptually, as many outstanding questions remain unsolved. The discovery of particle dark matter would shed light on our dark universe and throw open a window on the highest energy scales. This research made progress toward dark matter and new particle searches in three ways. Extreme compact objects, such as black holes, neutron stars, and stellar cores, can parametrically increase the production rates of feebly interacting particles and yield observable signatures. Specifically, a process known as superradiance leads to exponential growth of the number of ultralight particles gravitationally bound to rotating black holes, and turns astrophysical black holes into particle detectors. This research broadened the scope of applicability of superradiance studies to particles with a wide range of interactions and masses, predicting multi messenger signals. When ultralight particles are produced as dark matter in the early universe, they can be detected directly in laboratory experiments. However, these feebly interacting particles lead to small signals that are inevitably difficult to tease out from backgrounds; their detection requires the theoretical development of unique signatures that can be searched for in low-noise experiments. Some dark matter particles could be detectable with thin film metamaterials combined with low noise single-photon detectors. This research develop the theoretical framework and supported experimental efforts for ambitious searches for a wider class of ultralight particles. Overall, the outcome of this theoretical particle physics program developed novel signatures of new dark matter particles, and thereby expanded the particle parameter space which can be explored with astrophysical observations and precision experiments.

72 PHYSICS OF ELEMENTARY PARTICLES AND FIELDS↗
DOE OSTI2024

Best Practices for Equitable Solar Workforce Development

The Midwest Renewable Energy Association (MREA) was selected to serve as a lead organization for the U.S. Department of Energy Solar Energy Technology Office’s Equitable Solar Communities of Practice initiative. This project, facilitated through a partnership with ENERGYWERX, aimed to develop strategies to support the expansion of equitable benefits in solar adoption across the U.S. Specifically, the MREA was chosen to lead the solar workforce development community of practice, focusing on scaling the U.S. solar workforce, to meet growing industry demands and ensure that these opportunities are accessible and beneficial to all communities. For the purpose of this initiative, we define the solar workforce in line with the National Solar Jobs Census, which defines a solar worker as someone who spends a majority of their time on solar-related work. This also includes workers who spend a plurality of their time on solar tasks. It’s important to note that manufacturing jobs were not included in this research, as the focus is primarily on solar installation, development, and related roles. To achieve the goals of the Equitable Solar Communities of Practice initiative, the MREA leveraged existing resources and engaged a diverse core team and group of stakeholders including industry professionals, educators, policymakers, and community leaders. The MREA began with a literature review and gap analysis to identify existing best practices and gaps in the solar workforce. This was followed by a community convening to gather insights from a wide range of stakeholders. The findings informed the best practices and pathways to scale the benefits of solar workforce development, focusing on training programs, workforce services, apprenticeship, and justice, inclusion, and sustainability. This report outlines the background, methodology, findings, and conclusions drawn from the landscape and gap analysis, providing valuable insights into workforce needs and training program capacities across the U.S. The outcomes of this research are presented in this report and contain recommendations for optimizing workforce development and training funding to support the equitable growth of the solar industry, ensuring that the transition to solar energy is inclusive and beneficial for all communities.

14 SOLAR ENERGY↗
DOE OSTI2025

AI‐Accelerated Optimization of Self‐Assembled Organic Mixed Ionic‐Electronic Conductors (OMIEC) (Final Report)

This document describes research activities, products and outcomes of a DOE-funded program to help accelerate development of Organic Mixed Ionic Electronic Conductors (OMIECs) using neutron scattering and high-throughput experimentation. OMIECs are organic materials that conduct both ionic and electronic charge carriers. For these new OMIEC materials, self-assembling ion-conducting block copolymers (BCPs) are used as a structural template for electronic conducting polymers. This forms OMIECs with long-range structural order that can help facilitate long-range electronic transport. The conductive properties of OMIECs are closely associated with their structure, which is affected by solution conditions and polymer macromolecular designs. Thus high-throughput experimentation has been implemented to explore this large design space effectively. The BCP-CP OMIEC systems explored are composed of ion-conducting diblock or triblock copolymers containing polyethylene oxide (PEO), di(ethylene glycol) ethyl ether acrylate (DEGEEA) or poly(ethylene glycol) methyl ether acrylate) (PEGMEA) hydrophilic blocks. These blocks will be coupled with either polypropylene oxide (PPO) or polyheptafluorobutyl acrylate (PHFBA) hydrophobic blocks to drive assembly. The electronic conducting component consists of several different types of conjugated polymers. Small angle scattering of neutrons and X-rays (SANS/SAXS) as well as electrochemical analysis have been coupled with modern algorithms for autonomous research using artificial intelligence (AI).

36 MATERIALS SCIENCE↗
NASA NTRS1992

The Center for Aerospace Research: A NASA Center of Excellence at North Carolina Agricultural and Technical State University

This report documents the efforts and outcomes of our research and educational programs at NASA-CORE in NCA&TSU. The goal of the center was to establish a quality aerospace research base and to develop an educational program to increase the participation of minority faculty and students in the areas of aerospace engineering. The major accomplishments of this center in the first year are summarized in terms of three different areas, namely, the center's research programs area, the center's educational programs area, and the center's management area. In the center's research programs area, we focus on developing capabilities needed to support the development of the aerospace plane and high speed civil transportation system technologies. In the educational programs area, we developed an aerospace engineering option program ready for university approval.

Lai, Steven H.-Y.↗
NASA NTRS2001

Quality Training and Learning in Aviation: Problems of Alignment

The challenge of producing training programs that lead to quality learning outcomes is ever present in aviation, especially when economic and regulatory pressures are brought into the equation. Previous research by Telfer & Moore (1997) indicates the importance of appropriate alignment of beliefs about learning across all levels of an organization from the managerial level, through the instructor/check and training level, to the pilots and other crew. This paper argues for a central focus on approaches to learning and training that encourage understanding, problem solving and application. Recent research in the area is emphasized as are methods and techniques for enhancing deeper learning.

Moore, Phillip J.↗
NASA NTRS2017

Evaluating the Stability of NASA's Space Launch System with Adaptive Augmenting Control

NASA's baseline Space Launch System (SLS) flight control system (FCS) design includes an adaptive augmenting control (AAC) component that modifies the attitude control system response to provide the classical gain-scheduled control architecture with additional performance and robustness. The NASA Engineering and Safety Center (NESC) teamed with the Space Launch System (SLS) Program to perform a comprehensive assessment of the stability and robustness of the FCS with AAC. This paper provides an overview of the approach, specific analysis techniques, and outcomes that were particularly relevant for the SLS Program. Multiple analysis techniques that specifically target the nonlinear AAC were commissioned as part of this assessment, which was completed outside of the Program's standard design analysis cycle. The following analyses were included, with each technique adding its own valuable insights: Lyapunov-based stability analysis, classical stability analysis with static AAC gain variations, circle criterion-based analysis of the FCS with a time-varying element, time-domain stability margin assessment, Monte Carlo simulations with expanded dispersions, and an extensive set of stressing cases. Several of the completed analyses focused on determining whether the inclusion of AAC introduced risk to the FCS, while others quantified the benefits of the adaptive augmentation.

Tannen S Vanzwieten↗
NASA NTRS2016

Clinical Outcome Metrics for Optimization of Robust Training

Introduction: The emphasis of this research is on the Human Research Program (HRP) Exploration Medical Capability's (ExMC) "Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-Flight Medical Capabilities." Specifically, this project aims to contribute to the closure of gap ExMC 2.02: We do not know how the inclusion of a physician crew medical officer quantitatively impacts clinical outcomes during exploration missions. The experiments are specifically designed to address clinical outcome differences between physician and non-physician cohorts in both near-term and longer-term (mission impacting) outcomes. Methods: Medical simulations will systematically compare success of individual diagnostic and therapeutic procedure simulations performed by physician and non-physician crew medical officer (CMO) analogs using clearly defined short-term (individual procedure) outcome metrics. In the subsequent step of the project, the procedure simulation outcomes will be used as input to a modified version of the NASA Integrated Medical Model (IMM) to analyze the effect of the outcome (degree of success) of individual procedures (including successful, imperfectly performed, and failed procedures) on overall long-term clinical outcomes and the consequent mission impacts. The procedures to be simulated are endotracheal intubation, fundoscopic examination, kidney/urinary ultrasound, ultrasound-guided intravenous catheter insertion, and a differential diagnosis exercise. Multiple assessment techniques will be used, centered on medical procedure simulation studies occurring at 3, 6, and 12 months after initial training (as depicted in the following flow diagram of the experiment design). Discussion: Analysis of procedure outcomes in the physician and non-physician groups and their subsets (tested at different elapsed times post training) will allow the team to 1) define differences between physician and non-physician CMOs in terms of both procedure performance (pre-IMM analysis) and overall mitigation of the mission medical impact (IMM analysis); 2) refine the procedure outcome and clinical outcome metrics themselves; 3) refine or develop innovative medical training products and solutions to maximize CMO performance; and 4) validate the methods and products of this experiment for operational use in the planning, execution, and quality assurance of the CMO training process The team has finalized training protocols and developed a software training/testing tool in collaboration with Butler Graphics (Detroit, MI). In addition to the "hands on" medical procedure modules, the software includes a differential diagnosis exercise (limited clinical decision support tool) to evaluate the diagnostic skills of participants. Human subject testing will occur over the next year.

Ebert, D.↗
DOE OSTI2020

Retrospective on Recent DOE-Funded Studies Concerning the Extraction of Rare Earth Elements & Lithium from Geothermal Brines (Final Report)

Rare earth elements (REE) and lithium are non-toxic metals that are considered critical materials due to their use in electronics, magnets, batteries, and a wide variety of industrial processes important for the economy and military preparedness. Demand for REE and lithium is increasing and these critical materials are imported, so identifying and exploiting domestic sources of REE and lithium is a national priority. The U.S. Department of Energy (DOE) Geothermal Technologies Office (GTO) has been in the forefront of sponsoring research investigating the potential recovery of REE, lithium, and other critical minerals from geothermal brines. It has been proposed that the future of geothermal energy should include “hybrid systems” that combine electricity generation with other revenue-generating activities, such as recovery of valuable and critical minerals, including REE and lithium. Two recent GTO funding opportunities have focused on the recovery of REE and other valuable minerals from geothermal brines. The research supported by the GTO’s mineral recovery program is focused on three areas: resource characterization, technology for the extraction of REE, and technology for the extraction of lithium (Tables 1 and 2). This report is a retrospective study examining the outcome of GTO’s two recent mineral recovery programs (DE-FOA-0001016 in FY 2014 and DE-FOA-0001376 in FY 2016). In this report, the knowledge, technology, and techniques that were developed by researchers funded by GTO are summarized and discussed. Four projects were funded to assess the concentrations and amounts of REE found in geothermal brines and oil field produced waters. The GTO-funded studies compiled publically available data on REE concentrations from brines and produced water from all over the USA. In addition, new samples were collected and characterized from major geothermal and hydrocarbon basins in the Western USA. The studies examined the relationship between lithology and REE concentrations and developed models examining the influence of geology on REE concentrations in produced brines. It was determined that REE are frequently found at higher concentrations in oil field produced water than geothermal brines, but that some geothermal areas had significant REE resources. Significant reservoirs of REE were identified in the Western USA. In some cases, concentrations of REE were more than 1000 times the concentrations found in seawater. Collectively, these studies represent a comprehensive picture of REE resources associated with geothermal and hydrocarbon systems in the USA. The studies did not examine lithium resources, but in some cases, lithium concentration data was collected. Data from these studies are housed in the Geothermal Data Repository (GDR) and represent a significant information resource and it is recommended that these data be further analyzed in a future study. Eight projects were funded to develop new technology for REE extraction from geothermal fluids. These projects investigated sorption as an approach for removal and recovery of REE from geothermal brines. The projects investigated cutting-edge technology for selective sorption of ions from complex solutions, including the application of metal-organic frameworks and biosorbent proteins. The REE sorption studies tested different combinations of metal-binding ligands and solid supports. The most promising metal-binding ligands for REE included phosphonic acid, thiol, and carboxylic acid functional groups. Ligands were attached or incorporated into a wide variety of solid supports. In most cases, attachment was via covalent bonding to organic resins, polymers, or silica-based supports. Most of the REE projects were conducted at a low technology readiness level (TRL) and showed promise, but direct comparison between technologies was not possible based on the available information. It is recommended that testing and reporting be standardized to the extent possible to facilitate comparisons between technologies. Two projects were directed at novel lithium extraction technology. Both projects investigated the use of inorganic sorbents, including manganese oxides. One study also examined the use of metal- ion imprinted polymers as selective ion-exchange resins for the separation of lithium and manganese from brines. Both approaches showed promise for the selective extraction of lithium from brines, including potentially geothermal brines. Results from these GTO studies indicated that selective REE and lithium extraction is possible, but interference from co-occurring solutes, such as calcium, magnesium, or heavy metals, will interfere with process efficiency and negatively impact process economics. Techno-economic analysis conducted as part of the resource and technology studies suggest extraction of REE from geothermal brines is unlikely to be economically viable, especially since non-geothermal produced waters frequently have higher REE concentrations. It is recommended that benchmarks for techno-economic analysis be established to the extent possible for future studies, to facilitate direct comparison of various technologies. Based on the collective results of this program, it appears that hybrid geothermal power would benefit more from recovery of lithium and other metals, rather than REE. It is recommended that future studies be conducted at a higher- TRL and that sorbents be tested against actual geothermal fluid samples. Prior higher-TRL efforts to extract metals from geothermal brines should be further evaluated for lessons learned.

36 MATERIALS SCIENCE↗
DOE OSTI2025

Pivotal trial characteristics and types of endpoints used to support Food and Drug Administration rare disease drug approvals between 2013 and 2022

Background/aims Rare disease drug development faces unique challenges, such as genotypic and phenotypic heterogeneity within small patient populations and a lack of established outcome measures for conditions without previously successful drug development programs. These challenges complicate the process of selecting the appropriate trial endpoints and conducting clinical trials in rare diseases. In this descriptive study, we examined novel drug approvals for non-oncologic rare diseases by the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research over the past decade and characterized key regulatory and trial design elements with a focus on the primary efficacy endpoint utilized as the basis of approval. Methods Using the Food and Drug Administration’s Data Analysis Search Host database, we identified novel new drug applications and biologics license applications with orphan drug designation that were approved between 2013 and 2022 for non-oncologic indications. From Food and Drug Administration review documents and other external databases, we examined characteristics of pivotal trials for the included drugs, such as therapeutic area, trial design, and type of primary efficacy endpoints. Differences in trial design elements associated with primary efficacy endpoint type were assessed such as randomization and blinding. Then, we summarized the primary efficacy endpoint types utilized in pivotal trials by therapeutic area, approval pathway, and whether the disease etiology is well defined. Results One hundred and seven drugs that met our inclusion criteria were approved between 2013 and 2022. Assessment of the 107 drug development programs identified 150 pivotal trials that were subsequently analyzed. The pivotal trials were mostly randomized (80%) and blinded (69.3%). Biomarkers (41.1%) and clinical outcomes (42.1%) were commonly utilized as primary efficacy endpoints. Analysis of the use of clinical trial design elements across trials that utilized biomarkers, clinical outcomes, or composite endpoints did not reveal statistically significant differences. The choice of primary efficacy endpoint varied by the drug’s therapeutic area, approval pathway, and whether the indicated disease etiology was well defined. For example, biomarkers were commonly selected as primary efficacy endpoints in hematology drug approvals (70.6%), whereas clinical outcomes were commonly selected in neurology drug approvals (69.6%). Further, if the disease etiology was well defined, biomarkers were more commonly used as primary efficacy endpoints in pivotal trials (44.7%) than if the disease etiology was not well defined (27.3%). Discussion In the past 10 years, numerous novel drugs have been approved to treat non-oncologic rare diseases in various therapeutic areas. To demonstrate their efficacy for regulatory approval, biomarkers and clinical outcomes were commonly utilized as primary efficacy endpoints. Biomarkers were not only frequently used as surrogate efficacy endpoints in accelerated approvals, but also in traditionally approved rare disease drugs. The choice of primary efficacy endpoints varied by therapeutic area, approval pathway, and understanding of disease etiology.

Hong, Kyungwan [Rare Diseases Team, Office of New ↗
NASA NTRS2023

Reports From EXPORTS Modeling and Data-Mining Activities

EXPORTS -EXport Processes in the Ocean from RemoTe Sensing is NASA’s large field campaign focusing on development of a predictive understanding of the export, fate and carbon cycle impacts of the global net primary production. This co-funded program (NSF, private funding1, and international participation) was conceived in 2013, with EXPORTS Science plan published in 2016 (Siegel et al 2016, EXPORTS Writing Team 2015) and its implementation plan finalized in 2016 (EXPORTS Science Definition Team 2016). More details are presented in Siegel et al (2021). EXPORTS campaign is structured as a multiyear effort (Figure 1). It started with “Pre-EXPORTS” modeling and data-mining activity followed by a first phase with two major field programs and a second synthesis and modeling phase. The “Pre-EXPORTS” projects, total of 6 of them (Table 1), funded under A.3 Ocean Biology and Biogeochemistry 2015 call, helped to plan the field campaign (Resplandy et al 2019, Rousseaux & Gregg 2017), and supporting further global synthesis with datasets mined from the literature (e.g. Bisson et al (2020), Bisson et al (2018), Kramer and Siegel (2019)), directly responding to objectives outlined in Science Plan (see section 6 in Team (2015)) and Implementation team (see Figure 1 in Team (2016)). This document presents a compilation of the final reports of the Pre-EXPORTS funded projects, in hope of synthesizing the outcomes, and insuring the legacy of this program. Each of these reports contains a list of published papers, and reader should refer to them to see results in details.

Brandi J. McCarty↗
DOE OSTI2022

How much have adverse occupational health outcomes among construction workers improved over time? Evidence from 25 years of medical screening

Background Construction workers have always had a high risk of occupational illnesses. We used 25 years of data from a medical screening program serving older construction workers to determine how much health outcomes have improved over the past 60 years. Methods We investigated changes in relative risk for chest radiographs consistent with pneumoconiosis, COPD by spirometry, lung cancer mortality, and audiometry-assessed hearing impairment among workers participating in a medical screening program. Results were stratified by decade of first construction employment: before 1960, 1960–1969, 1970–1979, 1980–1989, and after 1990. Poisson and Cox regression analyses assessed relative risk by decade adjusted for age, sex, smoking, and years of construction trade work. Results Subjects were 94% male and, on average, 60 years old with 25 years of construction work. When compared to workers employed before 1960, those first employed after 1990 experienced the following reductions in model-adjusted relative risks: chronic obstructive pulmonary disease, 32%; all pneumoconiosis, 68%; parenchymal abnormalities, 35%; pleural abnormalities, 71%; hearing impairment, 20%; and lung cancer mortality, 48%. Risks started to decline in the 1960s with greatest reductions among workers first employed after 1970. Conclusions This study demonstrates the positive impact that adoption of occupational health protections have had over the past 60 years. The greatest risk reductions were observed for outcomes with strong regulatory and legal incentives to reduce exposures and associated risks, such as those associated with inhalation hazards (asbestos and silica), while lowest improvement was for hearing impairment, for which little regulatory enforcement and few prevention incentives have been adopted.

60 APPLIED LIFE SCIENCES↗