Awards
Grand Challenges is a family of initiatives fostering innovation to solve key global health and development problems. Each initiative is an experiment in the use of challenges to focus innovation on making an impact. Individual challenges address some of the same problems, but from differing perspectives.
Showing page 1 out of 54 with 50 results per page.
A Self-Sampling System for Collection of Large Volumes of Plasma for Monitoring HIV Care
Ayokunle Olanrewaju, and collaborators Ashleigh Theberge and Erwin Berthier, of the University of Washington in the U.S. will develop a platform for at-home self-collection of blood, serum separation, and sample stabilization at sufficient sample volumes for comprehensive HIV monitoring. An existing device for home blood collection will be expanded with the development of serum separation using a simple filtration system and connected to a standard blood collection tube with serum-stabilizing reagents. The device design will be optimized to ensure that over 1 mL of blood can be processed. The resulting design will then be tested for its effectiveness for RNA and protein analysis to monitor HIV viral load and biomarkers associated with HIV treatment and care. Performance of the device will be compared to standard blood processing, using blood from healthy volunteers spiked with either HIV RNA or C-reactive protein as a model biomarker. They envision a system that can readily integrate with standard laboratory or point-of-care diagnostic workflows to enable maximal deployability.
Levonorgestrel Vaginal Film for Heavy Menstrual Bleeding and Contraception
Lisa Rohan of the University of Pittsburgh in the U.S., with Thesla Palanee-Phillips of the Wits Health Consortium (Pty) Ltd in South Africa, will develop a vaginal film technology for the sustained release of the hormone levonorgestrel as a product that provides contraception and reduces heavy menstrual bleeding. Levonorgestrel is a progestin, a synthetic hormone that mimics the effects of progesterone. They will create and compare vaginal films with differences in mechanical properties, mucoadhesion, and drug release profiles to design a product that is low-cost, self-administered, and active for one month. They will also conduct a pilot trial of two prototype placebo films without levonorgestrel, evaluating them for safety, acceptability, and mucoadhesion in 20 women in South Africa, half with heavy menstrual bleeding.
Optimizing the Measurement of Heavy Menstrual Bleeding Burden Using an Integrated, Locally Adapted Tool
Joyce Were of the Kenya Medical Research Institute in Kenya will develop a screening tool for assessing heavy menstrual bleeding that is adapted for use in Kenya by integrating two globally used questionnaires, adding material to incorporate the impact on women in the Kenyan context, and translating it into the locally spoken languages Swahili and Luo. Through consultations with experts, the tool will combine the Menstrual Bleeding Questionnaire (MBQ) with the Screening Assessment and Measurement of Atypical and Normal Menstrual Patterns Tool for Adolescents and Adults (SAMANTA), and it will incorporate new questions. The tool will be iteratively modified through small pilot tests. It will then be administered to adolescent girls and young women in Western Kenya as part of the Health and Demographic Surveillance System (HDSS) of the Kenya Medical Research Institute (KEMRI), with 70,000 participants surveyed with either the new tool or the MBQ or SAMANTA tools for comparison.
Innovative Patient-Centered Care and Treatment Strategies for Heavy Menstrual Bleeding in Low-Resource Settings
Jennifer Anyanti of the Society for Family Health with Clara Ejembi from Ahmadu Bello University, both in Nigeria, will evaluate patient experiences and treatment outcomes in women with heavy menstrual bleeding in Nigeria, with a focus on increasing the effectiveness, acceptability, and accessibility of hormonal contraceptives as treatment. Clinical data will be collected for a cohort of women receiving care for the condition in Kaduna state in Nigeria, together with qualitative data from interviews with patients, care providers, and supply chain managers. This information will be used to design and pilot targeted interventions to increase access to acceptable and effective treatment, such as community health education, supply chain improvements, and treatment programs. Such interventions can be iteratively improved with the original evaluation framework, generating a sustainable data management system to guide improvements in patient-centered care for heavy menstrual bleeding.
Advancing Kenya's Women's Health through Policy and Fem-Tech Capacity Building
Anne Beatrice Kihara with Moses Madadi, both of the University of Nairobi in Kenya, will pilot a multipronged approach to support research and development for women’s health in Kenya. They will co-develop a policy and regulatory framework that integrates gender equity, working with government stakeholders, including the Ministry of Health and regulators, as well as civil society groups and women-led organizations. They will develop case studies of healthcare technologies for women’s health, focused on how accessible these technologies are for women in underserved communities; launch community-based campaigns to increase awareness and understanding of women’s health and healthcare solutions; and train healthcare professionals in applying an equity perspective in women’s health research and care. Community feedback will guide an iterative approach throughout these efforts.
Genetic and Phenotypic Variability in Drug Metabolism in African Populations
Mathew Njoroge of the University of Cape Town in South Africa, with Roslyn Thelingwani of the African Institute of Biomedical Science and Technology in Zimbabwe, will analyze liver tissue from an African patient biobank to characterize the variability in drug metabolism in African populations. The analysis will combine genotyping, in vitro physiology studies, and pharmacokinetic modeling. Using the biobank samples, they will perform targeted sequencing of genes known to be associated with drug absorption, distribution, metabolism, and excretion, and then use the genotyped samples for in vitro analysis of drug clearance. This data will be combined with data modeling to predict the variability of drug pharmacokinetics in vivo to guide drug development and inform the design, monitoring, and interpretation of clinical trials.
Advancing Early Preeclampsia Detection: A Cohort Study on Urinary Biomarkers Activin A and Inhibin A
Denali Dahl of Kalia Health, Inc. in the U.S. will evaluate Activin A and Inhibin A as urinary biomarkers for prediction and detection of preeclampsia early in pregnancy. This work builds on an ongoing biomarker validation study in Bloemfontein, South Africa. Through collaborations, clinical studies will be performed with blood and urine sampling in cohorts of pregnant women. Studies in Stellenbosch, South Africa will assess how levels of the two proteins vary in urine during pregnancy, and studies in Bloemfontein, South Africa will assess how early in pregnancy they can serve to predict preeclampsia risk. Activin A and Inhibin A levels in urine will be measured by MSD, and their diagnostic value will be compared to a standard assay for the biomarker protein ratio sFlt1/PIGF in blood and to clinical diagnosis by the treating physician.
Exploring Heavy Menstrual Bleeding Among Adolescent Girls in Informal Settlements in Nairobi Kenya
Cliveland Ogallo of the Center for Public Health and Development (CPHD) with Anne-Beatrice Kihara of the University of Nairobi, both in Kenya, will assess the impact of heavy menstrual bleeding on the health and well-being of adolescent girls in an underserved community in Kenya. Girls in the Kibera urban informal settlement will be surveyed, along with guardians and health workers, to assess the prevalence of self-reported heavy menstrual bleeding; menstrual health literacy and associated cultural narratives; hygiene practices; access to healthcare products and services; and impacts including anemia, school absenteeism, and psychosocial well-being. Small-scale interventions will also be piloted, such as introducing menstrual kits with educational packets and dedicated physical spaces for menstrual hygiene.
Multi-Functional and Multi-Stage Immunity to Transform Malaria Vaccine Efficacy
James Beeson of the Burnet Institute with Stephen Scally of The Walter and Eliza Hall Institute, both in Australia, will develop candidate malaria mRNA vaccines designed to confer multiple types of immunity over multiple lifecycle stages of the malaria parasite. They will start with lead candidates that target Plasmodium merozoites, screening them with a human organoid model of the germinal center for their ability to activate B cell responses. Based on these tests, they will add antigens and test the resulting multi-antigen vaccines in animal models to create candidates that confer anti-merozoite, anti-sporozoite, and transmission-blocking immunity.
Inducing Liver-Specific Immunity for Malaria Using Arcturus Self-Amplifying mRNA
Brian Sullivan of Arcturus Therapeutics, with Sean Murphy of the University of Washington Foundation, both in the U.S., will pilot test a self-amplifying mRNA vaccine technology as a platform for developing malaria vaccines. They will use a mouse model of malaria, establishing infections in parallel with two different Plasmodium parasite species. They will test preventive treatments in this model, comparing self-amplifying mRNA vaccine technology to conventional mRNA and comparing intramuscular versus intravenous administration. They will assess the ability of each test vaccine to protect against liver-stage infection, determining the number of liver-stage parasites and how well the vaccine elicits potent, malaria-specific T-cell responses in the liver. The prolonged antigen expression characteristic of self-amplifying mRNA vaccines could be particularly valuable in inducing long-term protection against malaria.
Point-of-Care Lateral Flow Assay for Early Preeclampsia Risk Stratification in Remote Settings
Neha Lasure of Intignus Biotech Pvt. Ltd. in India will develop an affordable point-of-care diagnostic platform for prediction and detection of preeclampsia early in pregnancy. The diagnostic test is a lateral flow immunoassay that detects two key preeclampsia biomarker proteins in blood: sENG and PIGF. They will generate monoclonal antibodies against these proteins, manufacture test kits, and train frontline health care workers to administer and interpret the test. They will then perform a pilot study with 2,000 pregnant women in the Indian states of Pune and Mumbai, evaluating prediction accuracy compared to clinical outcomes and standard existing clinical tests.
ISILUNA: Global Citizen Science Impact on Menstrual Products on the Vaginal Microbiome
Sarah Leeber of the University of Antwerp in Belgium, with Marie Josiane Kenfack of the Center for Research on Emerging and Reemerging Diseases (CREMER) in Cameroon, will add DNA sequencing analysis of the vaginal microbiota as a component for a set of clinical trials of menstrual hygiene products in Belgium, Switzerland, Cameroon, and Peru. The longitudinal trials compare use of different menstrual products, with participants using either the same product over time or different products in sequence, including pads, tampons, cups, and underwear. Surveys and group discussions will be used to gather data on user perceptions of the products and how acquiring knowledge of the microbiome may influence attitudes and practices. Shotgun metagenomic sequencing from self-collected samples will reveal changes in the vaginal microbiota associated with different products. Together, this data will provide a more comprehensive understanding of both the biological and behavioral dimensions of menstrual product use.
Diaspora-Powered Virtual Ecosystem for Supporting Senior Scientists and Institutions in Africa
Almaz Negash of the African Diaspora Network in the U.S. will build an AI-augmented collaboration hub that matches senior African scientists with experienced researchers and innovators in the African diaspora. The hub will include AI-assisted profiling of skills and needs, focusing on areas including pharmacogenetics, pharmaceutical manufacturing for preclinical and clinical trials, infectious disease control, and data science. The hub will host monthly masterclasses and peer-learning sessions, and it will support co-designed research, co-supervision of students, joint grant applications, and technology transfers. It will be launched with an inaugural cohort of Africa-based scientists, including the Calestous Juma Fellows as an existing network of science leaders already embedded in African universities and research centers.
HELES Patch: Novel Microneedle Patch for Treatment of Heavy Menstrual Bleeding
Margaret Ilomuanya of the University of Lagos in Nigeria will develop a multifunctional microneedle patch for delivery of agents that treat heavy menstrual bleeding while preventing disease from sexually-transmitted viral infections. The patch will be designed for use on the abdomen or thigh, and it will have a layered architecture to deliver multiple drugs: tranexamic acid and the progesterone-mimic levonorgestrel to reduce bleeding (with levonorgestrel also having contraceptive activity) and the antiviral drug tenofovir. Microneedle-delivered tranexamic acid and levonorgestrel will be tested, both for their safety and their ability to control bleeding, in assays including clotting in vitro, a rat model, and a rabbit model of menstruation. Women experiencing heavy menstrual bleeding will be engaged for group discussions to assess the acceptability, usability, and desirability of the microneedle patch compared to existing treatment options, such as oral tranexamic acid and hormonal intrauterine devices.
Improving Data-Driven Understanding and Management of Heavy Menstrual Bleeding in South Asia and Sub-Saharan Africa
Sara Khalid of the University of Oxford in the United Kingdom will use large data sets from Kenya, Pakistan, and the United Kingdom to better understand the health impact and treatment challenges associated with heavy menstrual bleeding in low-resource settings. The project is a collaboration between Oxford University, Aga Khan University Kenya, and Aga Khan University Hospital Pakistan, with analysis of existing data sets in these three countries covering over twenty years of data for women diagnosed with heavy menstrual bleeding. For Kenya and Pakistan, analysis will encompass disease burden and epidemiology; patterns in treatment access, adherence, and effectiveness; and risk factors, with a risk prediction tool generated for heavy menstrual bleeding and its adverse outcomes. Equivalent analysis will be performed with data from the United Kingdom stratified by ethnic group to identify unique and shared features of the condition across settings.
High-Throughput Growth Inhibition Assays for Antimalarial Protein Drugs
Brandon DeKosky of the Massachusetts General Hospital, with Carole Long of the National Institute of Allergy and Infectious Diseases, both in the U.S., will develop a high-throughput, microfluidic screening platform to identify antibodies active against blood-stage malaria parasites. The platform is based on individual droplets containing a mix of Plasmodium parasite-infected and uninfected red blood cells together with mammalian cells secreting monoclonal antibodies. Each droplet serves as a parasite neutralization assay: antibodies that block parasite invasion of new red blood cells limit growth of the parasite population, and this is readily quantified using parasite-specific protein activity. With miniature droplets assayed in parallel, mammalian cells expressing a library of monoclonal antibodies can be rapidly screened for antimalarial activity.
Heavy Menstrual Bleeding Across the Lifecourse in India and a Discrete Choice Experiment
Nadia Diamond-Smith of the University of California San Francisco in the U.S. will characterize the prevalence and impact of heavy menstrual bleeding as well as treatment preferences in a cohort of women in the state of Rajasthan in India. Building on an ongoing survey, new data will be acquired from 1,500 women in Rajasthan, including newly married women and their mothers-in-law. The prevalence of heavy menstrual bleeding will be determined, and the data will be modeled for its impact on women's physical and mental health. Twenty-five in-depth interviews will be performed, with the information used to design and launch a discrete choice experiment through a survey of 300 women from the cohort with heavy menstrual bleeding. This survey will uncover women's preferences across treatment options for the condition, including their willingness to pay for them, setting the stage for designing treatment programs based on the local context.
Scaling HIV Multabody Production with Light-Regulated Expression
Ianessa Morantte of Prolific Machines Inc. in the U.S. with Arif Jetha of Radiant Biotherapeutics Inc. in Canada, are combining complementary platforms to enhance the production of broadly neutralizing antibodies (bnAbs) against HIV. Radiant has developed the Multabody platform™, which uses a self-multimerizing scaffold to multimerize antibody fragments. These fragments will be expressed using Prolific's proprietary Photomolecular Biomanufacturing Platform, which leverages light-controlled (optogenetic) cell lines that provide tunable gene expression control, facilitating expression of complex biotherapeutics. Stable, optogenetic host cell lines will be engineered by Prolific Machines to express multimers, each with a different combination of antibody fragments. The system will be assessed for its ability to increase Multabody yields by separating growth and production, and provide control over antibody fragment ratios with light, with the goal to pursue scale-up at a cost low enough to broadly increase access.
Transforming Preeclampsia Risk Screening and Prevention in Sub-Saharan African Countries
Annie McDougall of the Burnet Institute in Australia will develop a digital tool for point-of-care prediction of preeclampsia risk early in pregnancy, using data from clinical trials in Sub-Saharan Africa. A predictive model will be developed and validated using data from an ongoing set of clinical treatment studies in Ghana, Kenya, and South Africa: the PEARLS trial (Preventing Preeclampsia: Evaluating Aspirin Low-Dose Regimens Following Risk Screening). This model will be used to develop a tool for automated preeclampsia risk stratification to support clinical decision making by antenatal care workers. It will be designed for integration into existing digital health platforms, including real-time patient data entry. The tool will be evaluated for usability, feasibility, and acceptability through interviews and workshops with patients and care workers in two of the PEARLS trial countries.
Point-of-Care Rapid Test for Early Diagnosis of Preeclampsia via sFlt1
Javan Esfandiari of Chembio Diagnostics, Inc. in the U.S. will develop an affordable point-of-care diagnostic platform for prediction and detection of preeclampsia early in pregnancy. The diagnostic test is a semi-quantitative lateral flow immunoassay to monitor the level of the key preeclampsia biomarker protein sFlt1 in whole blood from a finger prick. The test will discriminate between two levels of the biomarker, identifying patients at either low, medium, or high risk of developing preeclampsia, and it will be integrated into a low-cost, portable reader device. Through local collaboration, the prototype device will be tested in France, Nigeria, and Benin. In each country, 100 women with identified risk of preeclampsia will participate. For comparison with the diagnostic test results and predicted preeclampsia risk, patient clinical outcomes will be recorded, and serum samples will be tested at a central laboratory, using existing tests to measure sFlt1 and the sFlt1/PIGF biomarker ratio.
Synthetic Alphavirus-Like Vesicles as Alternative Antigen Delivery Platforms
Brandon Wilder with Daniel Streblow, both of Oregon Health and Science University in the U.S., will develop a vaccine platform based on virus-like vesicles (VLVs) as a vaccine vector that can be launched in vivo from nucleic acids and express proteins that elicit cellular and humoral immunity. They will optimize in vitro-generated VLVs for expression of an established Plasmodium berghei antigen and for immunogenicity in a mouse model of malaria. They will then vaccinate mice with gene gun-delivered, optimized plasmid DNA to demonstrate that VLVs can be generated in vivo, to assess their persistence and tissue distribution, and to test whether immunity can be boosted by a second vaccination.
Addressing Heavy Menstrual Bleeding Among Adolescent and Young Women in Kenya
Irene Njuguna of Emory University in the U.S. will determine the prevalence and impact of heavy menstrual bleeding in adolescent girls and young women in a variety of community settings in Kenya, as well as the barriers to treatment delivery and uptake. Two thousand adolescent girls and young women aged 10-24 across rural and urban communities in Kenya will be surveyed to determine heavy menstrual bleeding prevalence, and their hemoglobin levels will be measured to assess for anemia as a consequence. Interviews and focus group discussions with participants as well as with care providers will be performed to assess the available options for care and treatment of the condition, including patient referral pathways, and to identify barriers hindering patients from seeking care and providers from delivering it.
Develop Functional Assays for the Endometrium from Human Pluripotent Stem Cells
Maneesha Inamdar of the Institute for Stem Cell Biology and Regenerative Medicine in India will develop a standardized organoid model of the human endometrium, together with a reproducible and scalable process for generating these organoids. Protocols for deriving endometrial organoids from established human pluripotent stem cell lines will be optimized. This includes generating fluorescent reporter cell lines as visible readouts of secreted products to monitor development and differentiation of the input cells, as well as determining the assays for comparing organoid function with that of human endometrial tissue. The resulting model system will enable automated analysis with equipment for routine cell culture and without the need for human clinical samples, and it will facilitate human endometrial biology research to identify therapeutic targets and treatments for heavy menstrual bleeding.
Magnetic Capturing Technique for Sputum Sample Processing
Jianghong Rao of Stanford University in the U.S. will develop a magnet-based system for capturing and concentrating the TB bacterium from sputum biosamples to facilitate TB diagnosis. The system is based on conjugating magnetic nanoparticles to bacteriophage specific to Mycobacterium tuberculosis, so that a simple magnet can capture phage-bound TB bacteria from patient sputum. This process will be optimized, including the stability and activity of the magnetized phage in a lyophilized powder form and at a high ambient temperature. A prototype device for the magnetic phage system will be designed and tested for its ability to generate purified target bacteria ready for lysis and PCR-based diagnostic testing. Initial tests will use a non-TB Mycobacterium species, and subsequent tests in collaboration with Niaz Banaei at Stanford Health Care Clinical Microbiology Laboratory will use clinical TB patient samples.
Nanomaterial-Integrated Microfluidic Membrane for Enhanced Lysis in Point-of-Care TB Diagnostics
Suman Chakraborty of the Indian Institute of Technology Kharagpur in India will develop a membrane filtration system for Mycobacterium tuberculosis lysis and DNA purification from patient samples to enhance TB diagnosis. A paper-based membrane will be impregnated with two chemical agents, each in a separate layer, for sequential sample processing. Cell lysis will be performed in the first layer by zinc oxide nanoflowers, nanoscale structures that lyse bacterial cells through both mechanical and chemical mechanisms. DNA purification will be performed in the second layer by silica nanoparticles. This membrane system can be attached to a DNA amplification chamber with lyophilized reagents for colorimetric Loop-Mediated Isothermal Amplification (LAMP). This instrument-free, integrated process for TB diagnosis will be tested in a research setting and a clinical pathology laboratory setting.
Strengthening Ethics Capacity for Health AI Innovation
Liya Wassie of the Armauer Hansen Research Institute in Ethiopia, with Richa Vashishtha of the Biotechnology Industry Research Assistance Council (BIRAC) in India, will develop resources for investigators in low- and middle-income countries (LMICs) to integrate ethical principles into the design and deployment of health-related AI technologies. They will establish and coordinate a multi-country AI ethics working group to develop a practical ethics guide for AI innovators, and the guide will be finalized through two public workshops. They will also launch public discussion sessions on key AI topics, such as algorithmic bias and data privacy, and coordinate an internship program on AI ethics for early- and mid-career LMIC investigators.
Evaluating the Impact of an AI-Powered Chatbot for Heavy Menstrual Bleeding and Sexual and Reproductive Health for Women in India
Sweta Kanavaje of the Myna Mahila Foundation in India will evaluate the effectiveness of the Myna Bolo chatbot in providing confidential, culturally sensitive, and medically accurate guidance on heavy menstrual bleeding to women in poor urban communities in Mumbai. The chatbot incorporates Large Language Models and currently provides tailored sexual and reproductive health information through multiple platforms in local languages. The chatbot will be evaluated specifically for advice on heavy menstrual bleeding through a randomized controlled trial with 400 women from Mumbai, comparing the chatbot to standard in-person counseling and to telehealth counseling. Primary outcomes of the trial, assessed through questionnaires and focus groups, include diagnostic accuracy compared to clinical assessments, reduction in time to seek and begin treatment, and improved understanding of menstrual health.
MAGNILyser: Next-Generation TB Sample Preparation Through Inductive Heating and Mechanical Lysis
David Erickson of Cornell University in the U.S. will develop a device for heat inactivation and mechanical lysis of Mycobacterium tuberculosis from patient samples to enhance TB diagnosis. A prototype device will be engineered, using a non-TB Mycobacterium for testing as a proxy. The device combines an alternating magnetic field and magnetic beads to inductively heat inactivate bacterial samples and actuate lysis by a bead-beating mechanism. The protype will be pilot tested in a collaboration at the Infectious Diseases Institute in Kampala, Uganda where patient samples with presumptive TB will be processed with the standard protocol for TB diagnosis and in parallel with the prototype.
Mycobacteriophagemids: A Synthetic Biology Approach to Rapid and Low-Cost Mycobacterium tuberculosis Concentration and Lysis
Sam Nugen of Cornell University in the U.S. will develop a bacteriophage-based system for the rapid concentration and lysis of Mycobacterium tuberculosis from patient samples to enhance TB diagnosis. A mycobacteriophage will be engineered to express the streptavidin protein, enabling low-cost magnetic particles to capture and concentrate the phage along with the TB bacterium to which it naturally binds. The phage will also be engineered to accelerate lysis of the TB bacterium after it is bound, and phage replication genes will be deleted to ensure that the phage can only replicate in a modified host bacterium or an in vitro system, not self-replicate. This low-cost, easily propagated system provides a streamlined, instrument-free solution to improve the efficiency of TB diagnosis in resource-limited settings.
Scaling Advocacy Against Postpartum Hemorrhage via the EndPPH Initiative Run for Her
Moses Madadi of the University of Nairobi in Kenya, with Annettee Nakimuli of Makerere University in Uganda, will establish a platform for coordinated advocacy to reduce the burden of postpartum hemorrhage, a major cause of maternal mortality and morbidity. The platform will build on the inaugural advocacy meeting called Run for Her, which was held in Kenya in 2024. This meeting brought together an international group of healthcare practitioners, politicians, policy makers, students, and religious leaders to raise awareness about postpartum hemorrhage. They will establish an African continent-wide network, expanding from Kenya to ten additional African countries, with annual advocacy events to directly engage local communities and other key stakeholders. The platform will raise awareness and inform data-driven policies for procuring essential medications and therapies, training and reskilling healthcare workers, and establishing systems for ongoing data collection.
Enhancing the Diagnosis of Tuberculosis Using Mycobacteriophages
Lily Telisinghe of University Hospitals Plymouth NHS Trust together with Ben Swift at PBD Biotech Ltd in the United Kingdom will develop a system combining a biological agent and mechanical disruption for the rapid lysis of Mycobacterium tuberculosis from patient samples to enhance TB diagnosis. Tests will be performed to determine if there are constraints for two biosample types, tongue swabs and blood, on how soon after sampling they must be analyzed. These sample types will then be spiked with the BCG vaccine strain and used to determine the optimal combination of factors for cell lysis. This combination of conditions will then be used to test how the lysis system performs for TB diagnosis in patients in the United Kingdom and Indonesia.
A Plasma Separator Enabling HIV Viral Load Tests in Decentralized Settings
Meng Sun of the Zymeron Corporation in the U.S. will develop a small, handheld, low-cost device for rapid plasma separation from whole blood for HIV diagnostic testing. Existing versions of the device will be modified to be able to process a larger volume of blood and deliver 100-200 microliters of plasma. The device is designed for untrained users. It can readily be modified to connect with blood drawing devices, including automatically sampling a fixed volume of blood to process, either by capillary action or direct loading, and delivering a fixed volume of plasma. It can also readily be integrated to deliver plasma to different diagnostic platforms, such as those based on microfluidics and lateral flow systems.
Blood Sample Preparation for Sensitive HIV Detection in Low- and Middle-Income Countries
Salus Discovery in the U.S. will optimize a prototype of their simple and inexpensive SnapTab platform technology for processing of finger-prick blood for HIV diagnostic testing. SnapTab components and chemistry will be optimized for blood plasma separation, viral lysis, and in a final step, nucleic acid purification and stabilization. The output can then be directly used in standard quantitative PCR amplification reactions for HIV detection. To evaluate the performance of SnapTab for HIV, sample extraction/purification results will be compared against existing approaches including the plasma separation card and traditional bead-based processing of plasma.
Prompt HIV Point-of-Care Sample Preparation
Jeffrey Burke of Prompt Diagnostics, Inc. in the U.S. will develop a low-cost, automated platform integrating blood sample input, plasma separation, and HIV RNA extraction for HIV diagnostic testing. The platform will be based on magnetofluidic cartridge technology in which sequential bioassay steps are conducted via transfer of magnetic beads between reagents: red blood cell-binding beads in the plasma separation step and RNA-binding beads in the virion lysis step. A prototype cartridge will be built and optimized, including reagents in shelf-stable formats, and a low-cost, battery-powered device will be built to house the cartridge and drive the transfer of magnetic beads. The prototype platform will be tested for RNA quality and extraction efficiency, using blood samples spiked with HIV virions and comparing directly to standard clinical laboratory procedures.
Simple Blood Collection to Improve HIV Testing Access
Rainer Ng of Baebies, Inc. in the U.S. will develop a system for finger-prick blood self-collection and sample processing that yields a sample ready for HIV diagnostic testing either at the point of care or after delivery to a central laboratory. A simple, disposable sample collection device will incorporate a membrane for plasma separation. Squeezing the device delivers plasma to a tube in which HIV-binding magnetic beads concentrate virions and reagents stabilize them. The prototype system will be optimized to ensure it generates over 100 microliters of plasma from self-collected blood, captures virions of sufficient quality and quantity to enable standard RT-PCR testing, and stabilizes virions sufficiently for diagnostic testing over three days after sample collection.
Advancing Non-Clinical Capabilities for Drug Discovery in Eastern Africa
Atunga Nyachieo of the Kenya Institute of Primate Research (KIPRE) in Kenya, with Alfred Botchway of Attentive Science in the U.S., will perform a pilot study as a first step in creating an integrated, preclinical, toxicology testing hub at KIPRE to accelerate drug discovery. The pilot will begin with a toxicology study in rodents to assess existing protocols, including those for dose formulation, oral administration, observation and recording of clinical signs of toxicity, collection and processing of blood and tissue, and histopathology review of tissue slides. This assessment will identify gaps as well as guiding the development of standard operating procedures and of specialized training programs in toxicology and related disciplines.
SCoRe: Self-Scaling Continuous Recovery for Exceptionally Low-Cost Antibodies
Christopher Love with Hadley Sikes of the Massachusetts Institute of Technology in the U.S. will develop a biomanufacturing platform for low-cost production of monoclonal antibodies based on a multidomain synthetic protein enabling both capture and purification of the antibody in a chromatography-free process. The synthetic protein will concentrate and recover antibodies in a single, mobile fluid phase, based on studies of the liquid-liquid phase transition of proteins into condensates that occur naturally in key cellular processes. They will design and test protein agents for affinity-based capture and condensation of monoclonal antibodies including the antimalarial MAM01, assess the co-expression of the synthetic protein and the target antibody product in a microbial expression system, and determine conditions for continuous recovery of the product. They will also create models of the technical and economic factors required for low-cost production from either microbial or mammalian cell expression systems.
This grant is one of three grants that are funded and administered by LifeArc.
Deciphering Cellular Heterogeneity in Endometrium Biopsies from Women with Heavy Menstrual Bleeding
Rohini Nair of Gujarat Biotechnology University in India will explore the cellular heterogeneity and molecular pathways associated with heavy menstrual bleeding to better understand the condition, using single-cell transcriptional profiling of the endometrium in patients. In collaboration with Rohina Aggarwal of the Institute of Kidney Diseases and Research Centre in India, 60 premenopausal women with self-identified heavy menstrual bleeding will be recruited: one subgroup with irregular menstrual cycles (half with uterine fibroids and half with adenomyosis) and one subgroup with regular menstrual cycles and no discernible pelvic pathology. A control group of women without clinical symptoms will also be recruited. Single-cell RNA sequencing will be performed on endometrial samples taken during participants' menstrual period to reveal potential biological mechanisms shared and unique across patients with the condition.
A Simple Solution for Non-Mechanical Preparation of Mycobacterial DNA from Infected Samples
Tim Bull of City St George's University of London in the United Kingdom will develop a system for the non-mechanical lysis of Mycobacterium tuberculosis from patient samples to enhance TB diagnosis. The system is based on lytic peptides that are active against host cells and can release intracellular TB bacteria, plus a combination of agents that directly lyse the TB bacterium, with candidates including a mycobacteriophage, antimicrobial peptides, and the lytic enzyme from the phage. Experiments will be performed to determine the components and conditions that optimize the speed and efficiency of lysis. These conditions will be used to test lysis across different sample types, using mock samples spiked with defined bacterial loads and focusing on sputum and tongue swabs. The mycobacteriophage will also be explored for selective capture of the TB bacterium in samples prior to lysis to improve the sensitivity of detection.
Leveraging the Women's Health Equity Index (WHEI) to Transform Women's Health Measurement in Nigeria
Lilian Okeke of the African Field Epidemiology Network in Uganda will develop a health index as a comprehensive, integrated measure of women’s health in Nigeria. The index will be based on existing datasets, including Nigeria’s Demographic and Health Surveys and its Health Management Information System as well as World Bank gender data, with new data collection to fill gaps where feasible. Health outcomes across women’s life course will be stratified by geography, socioeconomic status, and gendered barriers. The index will integrate factors such as education, employment, social protection, and gender-based violence; and data modeling and statistical methods will be incorporated to reveal hidden inequities. The index will be piloted in two Nigerian states, testing its ability to generate actionable evidence to guide health policy, resource allocation, and targeted interventions for more equitable women’s health outcomes.
Holistic, Life Course-Based Multidimensional Women's Health Index: A Scalable Data-Driven Approach in Ethiopia
Getachew Tilahun of Haramaya University in Ethiopia will develop a health index as a comprehensive, integrated measure of women’s health in Ethiopia. Health indicators will be developed that incorporate the sociocultural and economic context of women across their life course. Based on data from Ethiopia’s Demographic and Health Surveys, these indicators will be used to create a series of health indices, each specific for an age group. New data covering mental health will be integrated by adding questions to the household surveys conducted regularly under Ethiopia’s Health and Demographic Surveillance System. The age-specific indices will be aggregated into a composite index, spanning early childhood to late adulthood. Data modeling will be used to predict the effects on the women’s health index of changes over time in climate, land use, health policy, and health interventions.
Targeted Protein Degradation as a Novel Approach to Discover Antimalarials
Lyn-Marie Birkholtz with Erick Strauss, both of Stellenbosch University in South Africa, will develop antimalarial drugs that work by targeting parasite proteins for degradation rather than inhibiting their activity. This strategy involves creating proteolysis-targeting chimeras (PROTACs), which are linker proteins designed to bind specific parasite proteins and target them for degradation by an endogenous intracellular protease. This project builds on ongoing work with the approach applied to bacterial proteins for TB drug development. They will design and synthesize PROTACs against essential Plasmodium falciparum proteins, then evaluate their activity in phenotypic assays using drug-sensitive and drug-resistant parasite strains as well as multiple stages of parasite development. They will validate that any observed activity is due to the predicted PROTAC mechanism of action, as well as using in vitro assays to measure how effectively the parasites resist the antimalarial activity.
TurboLysis: A Low-Cost, Small-Footprint Device for Efficient Mycobacterium tuberculosis Cell Lysis
John Metcalfe of the University of California San Francisco in the U.S. will improve the turboLysis device for mechanical lysis of Mycobacterium tuberculosis from patient samples to enhance TB diagnosis. This device uses magnet-actuated steel beads to disrupt bacterial cells. A redesigned lower-cost version of the existing device will be built, and improvements will be tested, such as adding epoxy-coated paramagnetic beads in a sample cleanup step that eliminates the need for later centrifugation to remove cell debris. Patient samples in multiple formats will be tested for direct use in the device, including the tips of oral swabs and a filter with TB bacteria captured from sputum. Device performance will be compared to a commercial bead-beating device, including testing the turboLysis device in parallel to the standard protocol in an ongoing clinical trial in South Africa.
Optimizing AI-Assisted Heavy Menstrual Bleeding Diagnostics and Management for Low- and Middle-Income Countries
Susan Ontiri of the International Centre for Reproductive Health Kenya in Kenya will explore AI-enabled ultrasound for diagnosis of structural causes in the uterus of heavy menstrual bleeding, as well as exploring multiple treatment options for the condition. A cohort of 120 women with heavy menstrual bleeding will be recruited at the Coast General Teaching and Referral Hospital in Kenya. Participants will receive the standard clinical assessment together with an ultrasound evaluation. The accuracy and feasibility of the two diagnostic methods will be compared, and the ultrasound images will be annotated by experts and used to develop an AI-based model to enhance diagnosis by ultrasound. A pilot treatment trial will also be performed. Treatments including hormonal therapy, tranexamic acid, and non-steroidal anti-inflammatory drugs (NSAIDs) will be assessed, comparing feasibility, acceptability, adherence, and effectiveness.
PREVENT: Preeclampsia Detection - Verifying a Novel Rapid Test
Mathias Wipf of MOMM Diagnostics GmbH will improve their préXclude test to better enable its use in low- and middle-income countries (LMICs) as an affordable point-of-care diagnostic platform for prediction and detection of preeclampsia early in pregnancy. The existing test is contained in a single-use cartridge connected to an inexpensive handheld reader. It is based on an electrochemical enzyme-linked lateral flow immunoassay that quantifies the levels and ratio of two key preeclampsia biomarker proteins, sFlt1 and PIGF, in whole blood from a finger prick. Multiple aspects of the test will be improved to enhance usability and analytical performance, with the goal of developing a prototype platform that meets a target product profile appropriate for LMIC settings.
Advancing a New Maternal-Fetal Treatment for Early-Onset Preeclampsia
Sébastien Mazzuri of the EspeRare Foundation in Switzerland and its partners will reposition an oral drug previously evaluated in cardiovascular patients as a treatment candidate for early-onset preeclampsia. The drug has an extensive data package and advanced to Phase 3 trials before discontinuation for lack of superiority over standard of care. Leveraging preliminary research suggesting it could beneficially rebalance key physiological disruptions underlying preeclampsia, EspeRare will drive translational proof-of-concept studies in established preclinical models and coordinate advisory board consultations to guide the clinical trial design. The goal is to confirm the drug's therapeutic potential in preeclampsia and accelerate regulatory clearance for clinical evaluation. Ultimately this new therapeutic approach aims to significantly improve survival and health outcomes for pregnant women and their unborn children, with a focus on accessibility in high-burden regions.
Epidemiologic Modeling to Advance Women's Health and Wellbeing in South Africa
Katherine Rucinski of Johns Hopkins University in the U.S. will develop a platform for understanding the determinants of women’s heath inequities in South Africa and for modeling the effects of health interventions. The project will be implemented through collaboration with the Pan African Centre for Epidemics Research, which is part of the University of Johannesburg and the South African Medical Research Council. Machine learning will be applied to datasets publicly available in South Africa to identify the factors underlying the co-occurrence of chronic health conditions that disproportionally affect women. Data modeling will then be performed to identify interventions that most efficiently and effectively reduce these health disparities. This approach will be integrated into a web-based simulation tool for epidemiological modeling of women’s health across diverse contexts.
Proteome-Scale Approach to Antibiotic Drug Discovery
Garry Pairaudeau of DaltonTx Limited in the United Kingdom, with Gemma Turon of the Fundació Ersilia Open Source Initiative in Spain, will develop a computational platform for analyzing large, in silico, chemical libraries to identify chemical starting points for drugs that target Mycobacterium tuberculosis. They will use AI-based protein structure modeling focused on the several-hundred known proteins whose targeting can inhibit M. tuberculosis growth. They will incorporate information on ligand binding from available databases of chemical library screening experiments and the ChemBL database of bioactive molecules with drug-like properties. Together, this information will highlight the target proteins and the binding sites most likely to be amenable to in silico screening. This predictive modeling will be distilled and deployed through the Ersilia Model Hub platform as an open resource for virtual screening of compound libraries for tuberculosis drug discovery.
A Multidimensional Data Modeling to Advance Gender-Sensitive Health Measurement and Inform Policy
Anne Yonkeu of the Clinton Health Access Initiative in Cameroon will develop a health index as a comprehensive, integrated measure of women’s health in Cameroon. Using existing national data sources that reflect the multidimensional determinants of women’s health, health indicators will be developed and integrated into a composite index. These determinants will include factors such as reproductive health, gender-based violence, unpaid care work, nutrition, and access to services. Data modeling and statistical methods including geospatial analysis will be incorporated so that the index can serve as a digital tool for revealing and visualizing hidden inequities in women’s health at the subnational level and strengthening gender-sensitive health monitoring. The tool will be piloted, testing its ability to generate actionable evidence at the national and subnational levels to guide health policy, resource allocation, and targeted interventions for more equitable women’s health outcomes.
BioFET: A New Generation of Preeclampsia Diagnostic Point-of-Care Kits for Personal Use
Offer Erez with Gil Shalev of Ben-Gurion University of the Negev in Israel, in collaboration with Diomede Ntasumbumuyange of the University of Rwanda in Rwanda, will develop an affordable point-of-care diagnostic platform for prediction and detection of women at risk for preeclampsia early in pregnancy. The sensor system is an electronic biochip composed of biological field-effect transistors (bio-FETs) incorporating antibodies to sFlt1 and PIGF, two key preeclampsia biomarker proteins. It will be designed for simultaneous (multiplex) monitoring of blood and urine levels of these two biomarkers, accommodating whole blood and not requiring pre-measurement processing of the sample or the sensor, making it suitable for out-of-hospital use. They will evaluate the system with an existing inexpensive read-out device, testing it with samples of whole blood and urine spiked with the biomarker proteins, as well as samples collected from pregnant women in Israel and in Rwanda, and compare these clinical sample test results to those using a conventional FDA approved ELISA.