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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.

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Inhaled Oxytocin: Bringing Gold Standard Postpartum Hemorrhage Prevention to Women in Greatest Need

Victoria OliverMonash UniversityClayton, Victoria, Australia
Grand Challenges for Development
Saving Lives at Birth
19 Dec 2016

This project seeks to substantially expand access to oxytocin through the development of an affordable, simple to administer inhaled oxytocin delivery system. Using innovative technology, inhaled oxytocin is formulated as a fine powder that can withstand the climatic conditions common in tropical regions without the need for refrigeration. The product therefore removes the requirement for cold chain supply and storage, potentially allows task-shifting to lower tier healthcare and community workers and has the potential to save 146,000 lives over 8 years.

Evaluating the Approach to Administration and Dose of Bovine Lactoferrin to Prevent Neonatal Infections in Low Birthweight Newborns in Pakistan

Michael DibleyThe University of SydneySydney, New South Wales, Australia
Grand Challenges for Development
Saving Lives at Birth
19 Dec 2016

The goal of this project is to improve newborn survival among low birth weight (LBW) infants through a daily prophylactic dose of bovine lactoferrin (bLF). A two-stage project will be conducted with formative research followed by randomized controlled trial (RCT) to evaluate the appropriate daily dose of bLF and its efficacy in preventing neonatal infections.

Development and Evaluation of the RELI Delivery System - An Innovative, Simplified, Low-Cost Infusion Pump for Obstetric and Newborn Emergencies

Mike EisensteinProgram for Appropriate Technology in Health (PATH)Seattle, Washington, United States
Grand Challenges for Development
Saving Lives at Birth
6 Dec 2016

PATH's novel infusion pump, the RELI Delivery System, was designed to address many of the barriers surrounding access to infusion pumps in LRS: it does not require electricity or a battery, is inexpensive to manufacture and operate, does not require expensive consumables, and has a simple user interface. We will develop a functional prototype and related job aids to share with stakeholders.

Outpatient Treatment of Neonatal Sepsis by the Rectal Administration of Gentamicin

David McAdamsProgram for Appropriate Technology in Health (PATH)Seattle, Washington, United States
Grand Challenges for Development
Saving Lives at Birth
6 Dec 2016

We propose to investigate the feasibility of a needle-free method of administration for the antibiotic gentamicin via the rectal route. Under this project we would conduct laboratory release studies, preclinical rectal bioavailability studies and stakeholder interviews to assess the feasibility of novel concept. This delivery method would improve access to outpatient treatment of neonatal sepsis in areas serviced by low level healthcare providers and would remove the inherent risks associated with parenteral delivery.

Field Validation of a New Protein-To-Creatinine (PrCr) Strip Test: An Impactful New Tool to Improve Diagnosis of Preeclampsia at the Front Lines of Antenatal Care in Low-Resource Settings

Nicole AdvaniProgram for Appropriate Technology in Health (PATH)Seattle, Washington, United States
Grand Challenges for Development
Saving Lives at Birth
1 Dec 2016

PATH seeks to improve access to improved preeclampsia screening in routine antenatal care (ANC) by addressing the need for a low-cost, accurate proteinuria screening tool to replace the protein-only dipstick as the standard used in routine ANC in LRS. PATH is working in collaboration with LifeAssay Diagnostics, Ltd. (South Africa) to develop and support validation of a simple, low-cost protein-to-creatinine ratiometric urine dipstick test and is seeking to demonstrate the feasibility for implementation and use of the test within routine ANC.

ELICIT: Early Life Interventions for Childhood Growth and Development in Tanzania

Estomih MdumaHaydom Lutheran HospitalHaydom Mbulu, Tanzania
Grand Challenges
All Children Thriving
30 Nov 2016

Microarray Patch for Delivery of a Combination of Antibiotics for the Treatment of Neonatal Sepsis

Mary KearneyQueen's University BelfastBelfast, United Kingdom
Grand Challenges for Development
Saving Lives at Birth
30 Nov 2016

This team proposes to develop and test an innovative microarray patch to deliver a combination of antibiotics for the treatment of neonatal sepsis. An easy-to-use, less-invasive, affordable delivery method for amoxicillin and gentamicin could expand access to lifesaving outpatient antibiotic treatment for infants with severe infection during the neonatal period.

Safer Deliveries Using Point-of-Care Decision Support and Monitoring

Marc MitchellD-Tree InternationalWeston, Massachusetts, United States
Grand Challenges for Development
Saving Lives at Birth
29 Nov 2016

The Safer Deliveries project will improve the ability of nurses and midwives to identify danger signs for a woman and her baby during the critical period of labor and delivery and link these measures to specific decision support rules that guide the health worker in taking corrective action. Using ultra-low-cost disposable ECG leads, D-tree International will build a phone based device that provides continuous tracking of fetal and maternal heart rate and uterine contractions during labor and delivery leading to more timely and effective interventions to save the life of the mother and infant.

Life-saving Instruction for Emergencies (LIFE) Delivered Using Serious Games and mHealth Technologies

Mike EnglishUniversity of OxfordOxford, United Kingdom
Grand Challenges for Development
Saving Lives at Birth
29 Nov 2016

Drawing on 10 years of experience developing and delivering essential newborn care training, this project will develop 3D games using an iterative co-design process in UK and Kenya so it excites users and addresses needs and preferences. This project will explore incentives for learning and develop data capture tools to understand who is playing as well as where and when they are playing. This project will also design a test of the effectiveness of our training in Kenya, explore how to extend the approach to maternal care and plan for dissemination and testing.

Testing and Implementation of Low-cost Breathing Aid for Infants in Tigray, Ethiopia

Anjelica GonzalezYale UniversityNew Haven, Connecticut, United States
Grand Challenges for Development
Saving Lives at Birth
29 Nov 2016

PremieBreathe has built a functional infant breathing aid for $450, one tenth the price of commercial models. The device, a humidified high flow nasal cannula (HHFNC), is the gold standard of non-invasive neonatal respiratory care in high-income countries. With the support of Saving Lives at Birth, PremieBreathe will conduct initial trials at Ayder Referral Hospital in the Tigray region of Ethiopia, and identify design, manufacturing, and distribution partners to prepare for scaled production and dissemination.

Structural-Based Design of HIV Vaccine Targeting the Native Conformation of Neutralizing Epitopes in gp41 MPER

Ling YeEmory UniversityAtlanta, Georgia, United States
Grand Challenges China
China - New Interventions
28 Nov 2016

Ling Ye of Emory University in the U.S., working with Lu Lu of Shanghai Medical College, Fudan University in China, will design a potent HIV vaccine using selected sequences of one of the virus's envelope proteins to trigger the production of broadly neutralizing antibodies. This has been problematic due to the diversity of the viral envelope glycoprotein and its glycosylation shield which prevent the immune system from recognizing it. The membrane-proximal external region (MPER) of the viral envelope protein has been identified as an attractive target for inducing neutralizing antibodies and they have fused it with another viral protein to form a chimera that can partly neutralize infection. They will build on this result by modifying the structure of the MPER to stabilize it in a more active conformation and by fusing it with slightly different viral proteins that can then be immunized altogether. They will evaluate whether this vaccine strategy further stimulates broadly neutralizing antibody production and can fully neutralize HIV in several animal models.

Structural-Based Design of HIV Vaccine Targeting the Native Conformation of Neutralizing Epitopes in gp41 MPER

Lu LuFudan UniversityShanghai, China
Grand Challenges China
China - New Interventions
28 Nov 2016

Lu Lu of Shanghai Medical College, Fudan University in China working with Ling Ye of Emory University in the U.S., will design a potent HIV vaccine using selected sequences of one of the virus's envelope proteins to trigger the production of broadly neutralizing antibodies. This has been problematic due to the diversity of the viral envelope glycoprotein and its glycosylation shield, which prevent the immune system from recognizing it. The membrane-proximal external region (MPER) of the viral envelope protein has been identified as an attractive target for inducing neutralizing antibodies, and they have fused it with another viral protein to form a chimera that can partly neutralize infection. They will build on this result by modifying the structure of the MPER to stabilize it in a more active conformation, and by fusing it with slightly different viral proteins that can then be immunized altogether. They will evaluate whether this vaccine strategy further stimulates broadly neutralizing antibody production and can fully neutralize HIV in several animal models.

Development of a Cost-Effective Automated Vaccine Manufacturing System Combining Vero Cell Lines High-Density Bioreactor and High-Performance Membrane Purification Platform in a Self-Contained Miniaturized Facility

José CastilloUnivercellsBrussels, Belgium
Grand Challenges
Vaccine Manufacturing
23 Nov 2016

José Castillo of Univercells in Belgium will create a compact low-cost and automated vaccine manufacturing platform by integrating three new technologies to produce more affordable vaccines at around 0.15USD per dose. Vaccine doses are generally 1-10USD most of which is due to inefficient production and high manufacturing costs including the need for major infrastructure. This relatively high cost prohibits their widespread use particularly in developing countries with limited funds. Starting with an inactivated poliovirus vaccine they will design and develop a compact high cell density bioreactor that concentrates vaccine production and high affinity capture membranes to streamline purification. They will house the technologies in a compact series of isolators that can be accommodated in a smaller laboratory space and perform pilot testing at a manufacturer's site to evaluate productivity and analyze purity and concentration of the vaccine.

An Intergenerational Prebiotic Approach to Establishment of a Healthy Colonic Microbiome in Infants

Balakrishnan RamakrishnaSRM Institutes for Medical ScienceChennai, , India
Grand Challenges India
All Children Thriving
21 Nov 2016

The study intends to develop an inter-generational intervention to ameliorate neonatal gut microbiota. It is based on the hypothesis that consuming prebiotic starches such as high amylose maize starch (HAMS) by mothers during the third trimester of pregnancy will modify their fecal microbiota and will subsequently lead to a beneficial variation in the fecal microbiota of the newborn infant. This will consequently guide favorable intestinal activity, thus enhancing growth, and intellectual competence of the infant in the intermediate and long term.

Ultra Low-cost Transferable Automated (ULTRA) Platform for Vaccine Manufacturing

Tarit MukhopadhyayUniversity College LondonLondon, United Kingdom
Grand Challenges
Vaccine Manufacturing
18 Nov 2016

Tarit Mukhopadhyay of University College London in the United Kingdom will develop a manufacturing platform to reduce the production costs of recombinant protein vaccines. Current manufacturing procedures involve serial batch operations in large complex facilities requiring highly trained operators and extensive testing and are inefficient and costly. They will build a platform that integrates and automates key steps to reduce labor costs and capital expenditure and improves product design and control procedures to reduce quality control requirements. Their aim is to maximize the number of doses with the minimal starting material leading to recombinant subunit vaccines at 0.15USD per dose rather than the current costs of several USD per dose. They will develop their approach initially using a rotavirus vaccine candidate.

The Maternity Episode of Care Prototype (Liberia)

Sarah ScheeningOpen Development, LLCWashington, District of Columbia, United States
Grand Challenges for Development
Saving Lives at Birth
16 Nov 2016

This project will build and test a prototype application that streamlines and automates patient, provider and payer transactions across the maternal/newborn EOC. The goal is to pilot the application in Liberia, where the government must overcome operational challenges to engage private providers in the Liberia Health Equity Fund.

Segmented Filamentous Bacteria as a Vaccination Platform to Protect Young Children Against Enteric Pathogens

Pamela SchnupfParis Descartes UniversityParis, France
Grand Challenges
Global Health Interventions
15 Nov 2016

Pamela Schnupf of Paris Descartes University in France will develop an oral vaccine to prevent infectious diarrhea in children by engineering a non-pathogenic bacteria to express pathogen molecules that can be safely delivered in bacterial spores. Diarrheal disease caused largely by Shigella and enterotoxigenic Escherichia coli is a major cause of morbidity and mortality in children under five years of age in low-resource settings. Segmented filamentous bacterium (SFB) is non-pathogenic and normally colonizes the human gut during infancy and stimulates the immune system to protect against infections. They will establish methods to genetically engineer SFB to express selected antigens from enterotoxigenic E.coli and test whether it can stimulate an immune response and protect against infection using established mouse models.

An Affordable and Robust Diagnostic Platform for Neonates and Young Children in Low-Resource Settings

Rashed ShahSave the Children Federation, IncWestport, Connecticut, United States
Grand Challenges for Development
Saving Lives at Birth
15 Nov 2016

Save the Children proposes an affordable and exclusive point-of-care diagnostic device for accurate measurement and interpretation of key vital signs (oxygen saturation, respiratory rate and temperature) among young infants (0-59 days) and children (2-59 months). It is equipped with a unique universal pulse oximeter sensor. The device will improve the quality of pneumonia case management and possible serious bacterial infections at community and health facility levels in low-resource settings.

Using Biomarkers to Predict TB Treatment Duration

Qian GaoFudan UniversityShanghai, China
Grand Challenges China
China - New Interventions
14 Nov 2016

Qian Gao of Shanghai Medical College Fudan University in China, working with Clif Barry of The National Institute of Allergy and Infectious Diseases in the U.S., will support a clinical trial to shorten the treatment time for tuberculosis (TB) from six months to four months by helping to identify predictive biomarkers in individuals that only require the shorter treatment. Shortening treatment when possible will substantially reduce costs and the emergence of drug resistance which is a major barrier to eradicating this deadly disease. The phase 2b clinical trial will recruit 620 TB patients at multiple clinics in South Africa and China who will be monitored for disease burden by PET/CT scans and diagnostic assays during treatment and will supply blood and sputum samples for testing. He will analyze RNA and inflammatory markers in serum samples from the Chinese trial participants to identify more robust biomarkers for predicting shorter treatments. He will also determine the strains of the causative Mycobacterium tuberculosis the source of any reinfection (relapse or new infection) and the presence of drug resistant bacteria in these patients and how these link with treatment duration and disease outcome.

Using Biomarkers to Predict TB Treatment Duration

Clif BarryNational Institute of Allergy and Infectious DiseasesBethesda, Maryland, United States
Grand Challenges China
China - New Interventions
14 Nov 2016

Clif Barry of The National Institute of Allergy and Infectious Diseases in the U.S., working with Qian Gao of Shanghai Medical College Fudan University in China, will support a clinical trial to shorten the treatment time for tuberculosis (TB) from six months to four months by helping to identify predictive biomarkers in individuals that only require the shorter treatment. Shortening treatment when possible will substantially reduce costs and the emergence of drug resistance, which is a major barrier to eradicating this deadly disease. The phase 2b clinical trial will recruit 620 TB patients at multiple clinics in South Africa and China who will be monitored for disease burden by PET/CT scans and diagnostic assays during treatment, and will supply blood and sputum samples for testing. He will analyze RNA and inflammatory markers in serum samples from the Chinese trial participants to identify more robust biomarkers for predicting shorter treatments. He will also determine the strains of the causative Mycobacterium tuberculosis, the source of any reinfection (relapse or new infection), and the presence of drug resistant bacteria in these patients, and how these link with treatment duration and disease outcome.

Validation Study of an Electricity-free Oxygen Concentrator in Western Uganda.

Roger RassoolUniversity of MelbourneMelbourne, Victoria, Australia
Grand Challenges for Development
Saving Lives at Birth
9 Nov 2016

One of the reasons oxygen therapy is not reaching the many thousands of babies and children it could save is due to the fact that electricity is not always available in small health facilities. To address this problem, this team has successfully developed FREO2, an electricity-free oxygen concentrator which runs on the energy from water flowing in a nearby stream, and which requires no fuel. This project will enable a major field trial in a health center in Western Uganda, where the design for this innovation will be refined in close collaboration with the health workers.

An Accurate, Rugged and Low-Power Syringe Pump for Maternity and Neonatal Care in Resource Limited Settings

Maria OdenRice UniversityHouston, Texas, United States
Grand Challenges for Development
Saving Lives at Birth
9 Nov 2016

There is international consensus that syringe pumps are an essential medical device to support care of mothers and newborns at district hospitals. Yet, they are often unavailable in low-resource settings because of high cost, technical complexity, and lack of brand name consumables. The project's idea is to scale AutoSyp, a low cost, low power, syringe pump in maternity and neonatal wards of hospitals in Malawi.

Dissolvable Microneedle Manufacturing Platform Technology: Two-Dose Thermostable IPV Patch

Michael SchraderVaxess Technologies Inc.Boston, Massachusetts, United States
Grand Challenges
Vaccine Manufacturing
7 Nov 2016

Michael Schrader of Vaxess Technologies Inc. in the U.S. will develop a microneedle patch that stabilizes vaccines and can deliver multiple doses through the skin at defined times thereby reducing cost waste and the need for repeat immunizations. Vaccinations delivered intradermally via microneedles are at least as effective as intramuscular delivery via injection but reduce the requirement for needles and trained health workers. The patch uses a silk fibroin protein that protects the vaccine against high temperatures removing the need for cold storage and controls the timing of release through the skin. They will refine the material for delivering two doses of inactivated poliovirus vaccine evaluate its safety and activity in animal models and optimize the manufacturing process to ensure reduced costs.

Reversible Contraceptives that Block Primordial Follicles

Patricia DonahoeMassachusetts General HospitalBoston, Massachusetts, United States
Grand Challenges Explorations
Contraceptive Discovery
1 Nov 2016

Patricia Donahoe and David Pepin of Massachusetts General Hospital in the U.S. are using a cell-based screening platform to develop a new class of hormonal contraceptive that works at the early stage of primordial follicle activation to prolong the contraceptive effect and reduce side effects, thereby promoting wider use particularly in the developing world. This early stage of follicle development in the ovary is suppressed by a hormone (Mullerian inhibiting substance or MIS) to regulate egg production. They considered that a drug that could mimic MIS could completely suppress ovulation and act as a powerful contraceptive. In contrast, most available hormonal contraceptives work once ovulation has begun, thereby requiring daily dosage, and share unwanted side effects including migraine and increased risk of some diseases. In Phase I, they designed a luciferase-based screening platform using engineered mammalian cells and screened 5,500 compounds from which they validated three candidate contraceptive compounds with high specificity and activity and limited toxicity. In Phase II, they will adapt their assay for higher throughput screening and screen 100,000 compounds to identify diverse classes of molecules for evaluation as ovarian suppressants. The contraceptive efficacy of validated candidates with favorable properties will then be tested in mice.

Gene Knockdown System for Cryptosporidium

William WitolaUniversity of Illinois at Urbana-ChampaignUrbana, Illinois, United States
Grand Challenges Explorations
Cryptosporidium Infection
1 Nov 2016

William Witola of the University of Illinois in the U.S. will help develop new drugs for treating children infected with the protozoa Cryptosporidium by using a gene knockdown approach to evaluate candidate drug targets. Found in contaminated water, Cryptosporidium is the second most common cause of potentially lethal diarrhea in young children in developing countries. There are no safe and effective drugs available due largely to the lack of genetic tools for studying Cryptosporidium in the laboratory. Phosphorodiamidate morpholino oligomers (PPMOs) are small molecules that can be designed to bind and silence specific genes also in protozoa. If these genes encode for proteins critical for vital cellular functions, the PPMOs can cause death. To evaluate his approach, he will design PPMOs and test their ability to silence essential Cryptosporidium genes and thereby block chronic infection in mice.

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