Grant List
Represents Grant table in the DB
GET /v1/grants?page%5Bnumber%5D=1392&sort=awardee_organization
{ "links": { "first": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1&sort=awardee_organization", "last": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1405&sort=awardee_organization", "next": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1393&sort=awardee_organization", "prev": "https://cic-apps.datascience.columbia.edu/v1/grants?page%5Bnumber%5D=1391&sort=awardee_organization" }, "data": [ { "type": "Grant", "id": "14703", "attributes": { "award_id": "1R15HD114022-01", "title": "Benefits of, challenges with, and suggestions for improving pediatric telehealth: The perspectives of adolescents", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)" ], "program_reference_codes": [], "program_officials": [ { "id": 6227, "first_name": "Tracy", "last_name": "King", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-03-07", "end_date": "2027-02-28", "award_amount": 468000, "principal_investigator": { "id": 31397, "first_name": "Gergana Damianova", "last_name": "Kodjebacheva", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2493, "ror": "", "name": "UNIVERSITY OF MICHIGAN AT FLINT", "address": "", "city": "", "state": "MI", "zip": "", "country": "United States", "approved": true }, "abstract": "Telehealth is defined as the remote provision of health care and education. Its use greatly increased as a result of the COVID-19 pandemic and is expected to continue being widely used. The problem is the lack of understanding on how to best offer telehealth to adolescents. This study will interview 105 adolescents to ask about their perspectives on the benefits of, challenges with, and suggestions for improving telehealth. Pediatric research regarding perspectives on telehealth focused primarily on parents/caregivers who offered opinions on behalf of their adolescents. Our preliminary qualitative study using surveys and interviews with parents/caregivers revealed that it was important to interview adolescents to better understand how to improve telehealth. We identified studies in the U.S.A. that interviewed 15 to 38 adolescents on benefits and challenges of telehealth but not on suggestions for improvement. We have established relationships with pediatrician offices that have participated in research with us in the past and that will assist with recruitment of adolescents in Genesee County, Michigan. A total of 105 individuals aged 14 to 17 will participate in a 1-hour online or telephone interview to offer their perspectives on telehealth. Questions as part of the interview will build on concepts in the “Telemedicine and doctor-patient communication” theoretical framework. Parents/caregivers will complete a survey to provide the socio- demographic information of their adolescent and household. Adolescents should have used any telehealth at least once over the past year to be eligible to participate. Qualitative analyses of the interview transcripts and quantitative analyses of surveys will take place. Four university students will be a part of the research team. Students will receive training on qualitative research and ethical issues, develop study materials, conduct interviews, perform qualitative and quantitative data analyses, and engage in manuscript writing for publication. They will present in at least one national conference. Through interviewing adolescents, the specific aims are to: 1) Describe the benefits of, challenges with, and suggestions for improving synchronous (i.e., video visits) and asynchronous (i.e., mobile applications) telehealth; 2) Compare benefits, challenges, and suggestions between adolescents of different socio- demographic groups; 3) Based on the findings from aims 1-2, develop a conceptual framework on factors that promote effective communication between adolescents and healthcare providers and subsequently improve health outcomes through telehealth. Understanding telehealth perspectives among adolescents can develop youth-specific health care improvements such as more effective communication with the healthcare provider. Future randomized- controlled trials developed based on the suggestions offered by the adolescents in the proposed study have great potential in improving youth’s satisfaction with health care and health outcomes.", "keywords": [ "Adolescent", "Adolescent Health Services", "Appointment", "COVID-19 pandemic", "Caregivers", "Caring", "Childhood", "Communication", "Consent", "Consultations", "Cost Savings", "County", "Data Analyses", "Devices", "Education", "Eligibility Determination", "Empathy", "Enhancement Technology", "Ethical Issues", "Feeling", "Future", "Health", "Health Care Costs", "Health Personnel", "Health Services", "Health education", "Healthcare", "Hour", "Household", "Housing", "Individual", "Internet", "Interview", "Joints", "Low income", "Manuscripts", "Michigan", "Outcome", "Outcomes Research", "Parents", "Patients", "Pediatric Research", "Persons", "Prevention", "Privacy", "Privatization", "Publications", "Publishing", "Qualitative Research", "Randomized Controlled Trials", "Reduce health disparities", "Research", "Sampling", "Speed", "Students", "Suggestion", "Surveys", "Technology", "Telemedicine", "Telephone", "Telephone Interviews", "Thinking", "Time", "Training", "Transcript", "Travel", "Trust", "Visit", "Writing", "Youth", "adolescent health", "aged", "differences in access", "experience", "improved", "innovation", "mobile application", "patient-clinician communication", "pediatrician", "preference", "recruit", "remote health care", "remote visit", "satisfaction", "sociodemographic group", "sociodemographics", "socioeconomics", "symposium", "telehealth", "university student", "video visit" ], "approved": true } }, { "type": "Grant", "id": "14741", "attributes": { "award_id": "1I21RX004652-01A1", "title": "Leg Stretching Using a Controllable Wearable Exoskeleton on Demand for People with Spasticity", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2024-01-01", "end_date": "2025-12-31", "award_amount": null, "principal_investigator": { "id": 31428, "first_name": "Steven W.", "last_name": "Brose", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2494, "ror": "", "name": "SYRACUSE VA MEDICAL CENTER", "address": "", "city": "", "state": "NY", "zip": "", "country": "United States", "approved": true }, "abstract": "Spasticity is a debilitating condition in people with upper motor neuron disorders that interferes with an individual’s activities of daily living and sleep. Spasticity can lead to loss of body control and balance resulting in falls, pressure injury of the skin, contractures, and pain. Spasticity hinders the ability to functionally use voluntary muscle contraction; thus, limiting body transfers, ambulation, and exercise. Despite the negative impact of spasticity in people with spinal cord injury (SCI), the available tools to manage spasticity and overcome functional deficits are limited. Oral medications are typically prescribed at the start of treatment due to its ease of administration; however, they may induce significant side effects including drowsiness and muscle weakness, and their effectiveness is sensitive to dosing fluctuations. Neurosurgery can treat severe spasticity, but it carries surgical risks, and the long-term benefits vary across individuals. Manual therapy and leg stretching are primary treatments for a large subset of people with spasticity, which is usually performed by caregivers and nurses with relatively low adverse effects. Manual stretching can provide relief from muscle spasms, decrease joint stiffness, normalize muscle tone, reduce pain, and improve range of motion. However, providing on-demand, reliable manual limb stretching is caregiver intensive and imposes a heavy burden on nurses in hospitals and caregivers at veterans’ homes. COVID-19 has exacerbated difficulties in receiving manual stretching to manage spasticity by limiting physical assistance in veterans with SCI due to family visit restrictions and staffing shortages. Moreover, existing devices used to mitigate spasticity such as passive stretchers, casts and night splinters do not fully conform to the user's body and are typically bulky and lack versatility to customize the forces applied to the user. People wearing them may feel discomfort, weakness, or pain, and even experience pressure sores. Our long-term research goal is to develop novel, non-invasive rehabilitation strategies addressing the debilitating effects of spasticity, which can play an integral role in improving quality of life and independence in persons with upper motor neuron injury. This feasibility study will establish preliminary evidence for the development of a novel wearable, portable leg exoskeleton capable of providing leg stretching - similar to the manual stretching provided by caregivers. The objectives in this project are to 1) integrate a wearable exoskeleton and its closed-loop control algorithm to provide strategic joint forces to assist dynamic leg stretching; and 2) evaluate the stretching approach in 10 veterans with spasticity to establish safety, acceptability, ease of use, and user satisfaction. Our central hypothesis is that the intelligent velocity control of the wearable device can apply safe forces about the hip and knee joints to yield safe, automated stretching as needed in veterans with spasticity. The control algorithm enables leg stretching while veterans lie on a bed (supine position with their knee extended) and sit down (with their knee flexed) with customized stretching rates to account for differences in range of motion across participants. Questionnaires are used to collect veteran’s and clinician’s feedback on the device performance. This study contributes to advancing non-invasive, non-pharmacological tools to manage spasticity by establishing the feasibility of the wearable stretching device in veterans with SCI. The project can lead to a customized, on-demand tool for the clinic and home, which can alleviate the burden on caregivers, aid quantifying the long-term effects of stretching using clinical and functional measures, and facilitate the integration of the device with other treatment modalities.", "keywords": [ "Activities of Daily Living", "Address", "Adverse effects", "Algorithms", "Ankle", "Articular Range of Motion", "Beds", "Botox", "COVID-19", "Caregiver Burden", "Caregivers", "Chronic", "Client satisfaction", "Clinic", "Clinical", "Contracture", "Custom", "Data", "Development", "Devices", "Disease", "Dose", "Drowsiness", "Effectiveness", "Equilibrium", "Exercise", "Family", "Family Nursing", "Family member", "Feasibility Studies", "Feedback", "Future", "Goals", "Health", "Hip Joint", "Home", "Hospitals", "Human", "Individual", "Injury", "Intelligence", "Joints", "Knee", "Knee joint", "Leg", "Limb structure", "Long-Term Effects", "Manipulative Therapies", "Manuals", "Measures", "Modality", "Motor Neurons", "Movement Disorders", "Muscle", "Muscle Contraction", "Muscle Tonus", "Muscle Weakness", "Myalgia", "Nurses", "Oral", "Pain", "Participant", "Patients", "Performance", "Persons", "Pharmaceutical Preparations", "Play", "Positioning Attribute", "Posture", "Predisposition", "Quality of life", "Questionnaires", "Research", "Role", "Safety", "Sedation procedure", "Self-Help Devices", "Skeletal Muscle", "Skin injury", "Sleep", "Spasm", "Spinal cord injury", "Stretching", "Stroke", "Supination", "Supine Position", "System", "Techniques", "Technology", "Testing", "Time", "Traumatic Brain Injury", "Veterans", "Visit", "Walking", "clinical care", "decubitus ulcer", "design", "exoskeleton", "experience", "falls", "foot", "functional electrical stimulation", "implementation barriers", "improved", "joint stiffness", "light weight", "motor neuron injury", "neurosurgery", "novel", "pain reduction", "portability", "rehabilitation strategy", "satisfaction", "side effect", "spasticity", "surgical risk", "tool", "vibration", "volunteer", "wearable device" ], "approved": true } }, { "type": "Grant", "id": "14749", "attributes": { "award_id": "1OT2OD037636-01", "title": "AOU WI Area of Interest 1: Community, Participant and Provider Engagement, Enrollment...", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "NIH Office of the Director" ], "program_reference_codes": [], "program_officials": [ { "id": 28291, "first_name": "IRENE", "last_name": "PRABHUDAS", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-01-01", "end_date": "2024-07-31", "award_amount": 4000000, "principal_investigator": { "id": 21340, "first_name": "ELIZABETH S", "last_name": "BURNSIDE", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 799, "ror": "", "name": "UNIVERSITY OF WISCONSIN-MADISON", "address": "", "city": "", "state": "WI", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 31438, "first_name": "Lisa Anne", "last_name": "CadmusBertram", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 31439, "first_name": "Dorothy Farrar", "last_name": "Edwards", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 31440, "first_name": "Zachary", "last_name": "Franco", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 31441, "first_name": "Scott Joseph", "last_name": "Hebbring", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 31442, "first_name": "Todd A", "last_name": "Mahr", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 31443, "first_name": "SANJAY K", "last_name": "SHUKLA", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 31444, "first_name": "JEFFREY C.", "last_name": "WHITTLE", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2495, "ror": "", "name": "MARSHFIELD CLINIC RESEARCH FOUNDATION", "address": "", "city": "", "state": "WI", "zip": "", "country": "United States", "approved": true }, "abstract": "1. ABSTRACT The All of Us Research Program (AoURP) has experienced dramatic change over the last five years. To list just a few of the many examples: AoURP conducted multiple retention eligible campaigns (e.g., mental health campaign), began distributing genetic results to participants, initiated the first ancillary study (Nutrition for Precision Health), and made available the Research Workbench to scientists. Throughout the many changes that have occurred over the years, the most challenging was the SARS-Cov-2 pandemic which disrupted every facet of society and impacted how AoURP's partnering institutions functioned. But with change comes opportunity, and opportunity is possible for organizations that are highly adaptable and innovative. This includes the All of Us Wisconsin Consortium (AoU-WI). AoU-WI was one of the last RMCs to join the national program. As time progressed, AoUWI matured, strengthened close collaborations across WI and nation, and developed diverse strategies in engagement, enrollment, and retention. The diversity at all levels of AoU-WI is something we are most proud of and has allowed our program to flourish in the ever-changing AoURP. To maintain AoU-WI's momentum, we will leverage lessons learned from the last five years. AoU-WI will constantly reassess, modify, and diversify its strategies to ensure AoURP is available to all. Continued diversity in our program will be essential as AoURP persistently changes over the next five years. In this application, we will describe how AoU-WI will not only maintain successful activities that has allowed our program to be leaders in engagement, enrollment, and retention, but how we intend to innovate. We will conduct outreach and engagement activities to promote the enrollment of communities who are historically underrepresented in biomedical research (Aim 1). AoU-WI will also engage, enroll, and retain participants who reflect the rich diversity of the US (Aim 2). This will be done with both adults and pediatrics (Aim3) while ensuring participants have access to technology for study activities (Aim 4). Lastly, AoU-WI will engage and collaborate with health care providers serving communities that are historically underrepresented in biomedical research to facilitate enrollment and retention (Aim5). We will do this by expanding the AoU-WI consortium to include Advocate Aurora Health, the ninth largest not-for-profit integrated healthcare system in the U.S. By successfully achieving these aims, AoU-WI ensures our continuous contribution to the mission of \"accelerating health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us.\"", "keywords": [ "Academy", "Acceleration", "Adult", "Advocacy", "Advocate", "All of Us Research Program", "American", "Ancillary Study", "Appointment", "Area", "Asian population", "Awareness", "Biomedical Research", "Black race", "COVID-19 pandemic", "Caring", "Censuses", "Childhood", "Clinic", "Collaborations", "Collection", "Communities", "Complex", "Computer Literacy", "Computers", "Consent", "Consent Forms", "Data", "Dedications", "Development", "Disease", "Education", "Electronics", "Eligibility Determination", "Enrollment", "Ensure", "Environment", "Ethics", "Ethnic Origin", "Faith", "Family", "Friends", "Frontline worker", "Genetic", "Geography", "Health", "Health Campaign", "Health Personnel", "Health system", "Healthcare", "Healthcare Systems", "Hispanic", "Hospitals", "Hour", "Household", "Indigenous", "Individual", "Infrastructure", "Inpatients", "Institution", "Institutional Review Boards", "Intake", "Integrated Health Care Systems", "Intuition", "Learning", "Letters", "Life Style", "Link", "Location", "Measurement", "Medical", "Mental Health", "Minority Groups", "Mission", "Modeling", "Mothers", "Native American population", "Newborn Infant", "Older Population", "Outpatients", "Paper", "Parents", "Participant", "Pediatric Hospitals", "Pediatrics", "Pharmacy facility", "Population", "Population Heterogeneity", "Positioning Attribute", "Precision Health", "Process", "Productivity", "Provider", "Recontacts", "Refugees", "Research", "Research Personnel", "Research Training", "Rural", "Rural Population", "Scientist", "Site", "Social Work", "Societies", "Source", "Southeastern Asia", "Special Population", "Surveys", "Technology", "Time", "United States", "United States National Institutes of Health", "Universities", "Urban Community", "Vietnam", "Visit", "Walking", "War", "Wisconsin", "Youth", "biobank", "care delivery", "care providers", "career", "community center", "community partners", "demographics", "disability", "ethnic diversity", "experience", "flexibility", "follow-up", "health care service organization", "human disease", "illiteracy", "individualized prevention", "innovation", "interest", "literacy", "medical schools", "meetings", "member", "migration", "outreach", "pandemic disease", "participant enrollment", "participant retention", "pediatrician", "precision medicine", "precision nutrition", "programs", "racial diversity", "recruit", "retention rate", "retiree", "rural area", "social", "success" ], "approved": true } }, { "type": "Grant", "id": "15251", "attributes": { "award_id": "3OT2OD037636-01S1", "title": "AOU WI Area of Interest 1: Community, Participant and Provider Engagement, Enrollment...", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "NIH Office of the Director" ], "program_reference_codes": [], "program_officials": [ { "id": 31839, "first_name": "Stephanie Melania", "last_name": "Alexander-troupe", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-08-01", "end_date": "2025-07-31", "award_amount": 2000000, "principal_investigator": { "id": 21340, "first_name": "ELIZABETH S", "last_name": "BURNSIDE", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [ { "id": 799, "ror": "", "name": "UNIVERSITY OF WISCONSIN-MADISON", "address": "", "city": "", "state": "WI", "zip": "", "country": "United States", "approved": true } ] }, "other_investigators": [ { "id": 31438, "first_name": "Lisa Anne", "last_name": "CadmusBertram", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 31441, "first_name": "Scott Joseph", "last_name": "Hebbring", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 31442, "first_name": "Todd A", "last_name": "Mahr", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 31443, "first_name": "SANJAY K", "last_name": "SHUKLA", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, { "id": 31840, "first_name": "Zeno E", "last_name": "Franco", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2495, "ror": "", "name": "MARSHFIELD CLINIC RESEARCH FOUNDATION", "address": "", "city": "", "state": "WI", "zip": "", "country": "United States", "approved": true }, "abstract": "1. ABSTRACT The All of Us Research Program (AoURP) has experienced dramatic change over the last five years. To list just a few of the many examples: AoURP conducted multiple retention eligible campaigns (e.g., mental health campaign), began distributing genetic results to participants, initiated the first ancillary study (Nutrition for Precision Health), and made available the Research Workbench to scientists. Throughout the many changes that have occurred over the years, the most challenging was the SARS-Cov-2 pandemic which disrupted every facet of society and impacted how AoURP's partnering institutions functioned. But with change comes opportunity, and opportunity is possible for organizations that are highly adaptable and innovative. This includes the All of Us Wisconsin Consortium (AoU-WI). AoU-WI was one of the last RMCs to join the national program. As time progressed, AoUWI matured, strengthened close collaborations across WI and nation, and developed diverse strategies in engagement, enrollment, and retention. The diversity at all levels of AoU-WI is something we are most proud of and has allowed our program to flourish in the ever-changing AoURP. To maintain AoU-WI's momentum, we will leverage lessons learned from the last five years. AoU-WI will constantly reassess, modify, and diversify its strategies to ensure AoURP is available to all. Continued diversity in our program will be essential as AoURP persistently changes over the next five years. In this application, we will describe how AoU-WI will not only maintain successful activities that has allowed our program to be leaders in engagement, enrollment, and retention, but how we intend to innovate. We will conduct outreach and engagement activities to promote the enrollment of communities who are historically underrepresented in biomedical research (Aim 1). AoU-WI will also engage, enroll, and retain participants who reflect the rich diversity of the US (Aim 2). This will be done with both adults and pediatrics (Aim3) while ensuring participants have access to technology for study activities (Aim 4). Lastly, AoU-WI will engage and collaborate with health care providers serving communities that are historically underrepresented in biomedical research to facilitate enrollment and retention (Aim5). We will do this by expanding the AoU-WI consortium to include Advocate Aurora Health, the ninth largest not-for-profit integrated healthcare system in the U.S. By successfully achieving these aims, AoU-WI ensures our continuous contribution to the mission of \"accelerating health research and medical breakthroughs, enabling individualized prevention, treatment, and care for all of us.\"", "keywords": [], "approved": true } }, { "type": "Grant", "id": "14752", "attributes": { "award_id": "1R43AI181354-01", "title": "IND-enabling development of MM010, a PEG-specific intervention that blocks allergic response and restores repeated dosing for select PEGylated medicines impacted by anti-PEG antibody", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [ { "id": 9207, "first_name": "Michael", "last_name": "Minnicozzi", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-01-22", "end_date": "2025-12-31", "award_amount": 291458, "principal_investigator": { "id": 31447, "first_name": "Keiichiro", "last_name": "Kushiro", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2496, "ror": "", "name": "MUCOMMUNE, LLC", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "Project Summary: Polyethylene glycol (PEG) is routinely used in protein and nanoparticle therapeutics, with dozens of PEGylated drugs approved to date. Although PEG itself is exceptionally safe, patients can form high titers of anti-PEG antibodies (APA) to some PEGylated drugs. This results not only in loss of efficacy from APA- induced rapid clearance of the drug, but also increases the risks of severe allergic responses, as exemplified by adverse clinical experiences with Krystexxa, Oncaspar and Palynziq that leave tens of thousands of Americans without viable treatments. Furthermore, APA induced by one drug can impact the efficacy and safety of a second PEGylated drug. Given the increasing number of PEGylated drugs on the market (including COVID-19 mRNA vaccines), there is an urgent need for safe and effective interventions that prevent APA induction and PEG-allergy. Mucommune has in-licensed a technology that can safely and effectively overcome the impact of APA on PEGylated medicines, without the need for broad immunosuppression or new polymers to replace PEG. The technology is based on the use of high MW free PEG to competitively saturate circulating APA and B-cell receptors on the surface of APA+ B-cells, thereby limiting the “hapten” effect of PEG-drugs. In published and pilot studies, free PEG markedly suppresses APA-induction against PEG-liposomes and Krystexxa (PEG- uricase) in immunocompetent mice and swine, and effectively restored the prolonged circulation of both in animals with high APA titers. Importantly, repeated injection of free PEG does not simulate further APA induction, unlike PEG-proteins or PEG-liposomes. Perhaps most surprisingly, free PEG completely eliminated hypersensitive reactions to PEG-liposomes in swine (the gold standard model for PEG-induced pseudoallergy). Swine receiving PEG-liposomes alone experienced strong anaphylaxis requiring immediate epinephrine intervention and resuscitation. These findings strongly underscore the promise of using free PEG to overcome allergic response to PEGylated medicines and to restore their efficacious use. Free PEG is inexpensive (pennies per dose), offers outstanding safety, and can be rapidly advanced into late stage clinical studies. Our overarching goal in this Phase 1 SBIR proposal is to establish the foundation to quickly advance this intervention into the clinic. We will file a pre-IND (Type B) application with the FDA to confirm the suitability of our proposed preclinical and clinical pathway, and will develop and qualify key assays for quantifying APA and free PEG necessary to support GLP and future clinical studies. We will then execute a GLP tox study in rats (a common model for PEG-drugs) to support first-in-human studies. Successful completion of these activities will allow us to file IND for MM010, putting us at the doorstep of advancing this intervention into the clinic, potentially providing relief for the tens of thousands of Americans suffering from responses to PEG-drugs that limit their use of essential treatments.", "keywords": [ "Acceleration", "Allergic Reaction", "American", "Anaphylaxis", "Animal Model", "Animals", "Antibodies", "Antibody Response", "Antibody titer measurement", "B-Cell Antigen Receptor", "B-Lymphocytes", "Binding", "Biological", "Biological Assay", "Buffers", "COVID-19", "Case Study", "Circulation", "Clinic", "Clinical", "Clinical Pathways", "Clinical Research", "Clinical Trials", "Data", "Development", "Dose", "Drug Kinetics", "Emergency Situation", "Ensure", "Enzyme-Linked Immunosorbent Assay", "Epinephrine", "Evaluation", "Family suidae", "Feedback", "Formulation", "Foundations", "Future", "Goals", "Government", "Haptens", "High Pressure Liquid Chromatography", "Human", "Hypersensitivity", "Immunocompetent", "Immunologics", "Immunosuppression", "Individual", "Infusion procedures", "Injections", "Intervention", "Licensing", "Lipids", "Liposomes", "Marketing", "Measures", "Mediating", "Medicine", "Methods", "Modeling", "Molecular", "Mus", "No-Observed-Adverse-Effect Level", "Outcome", "Pathway interactions", "Patients", "Pegaspargase", "Persons", "Pharmaceutical Preparations", "Pharmacologic Substance", "Phase", "Phase I Clinical Trials", "Pilot Projects", "Plasma", "Polyethylene Glycols", "Polymers", "Production", "Proteins", "Publishing", "Qualifying", "RNA vaccine", "Rattus", "Reaction", "Recovery", "Reporting", "Research", "Research Design", "Resuscitation", "Risk", "Runaway", "Safety", "Sampling", "Small Business Innovation Research Grant", "Specimen", "Sprague-Dawley Rats", "Standard Model", "Surface", "Technology", "Time", "Toxic effect", "Toxicokinetics", "Toxicology", "Urine", "Work", "allergic response", "assay development", "clinical development", "clinical lot", "clinical translation", "cost", "cost effective", "design", "drug clearance", "effective intervention", "experience", "first-in-human", "lot production", "nanomedicine", "porcine model", "pre-clinical", "prevent", "response", "risk mitigation", "therapeutic nanoparticles" ], "approved": true } }, { "type": "Grant", "id": "15560", "attributes": { "award_id": "5R43AI181354-02", "title": "IND-enabling development of MM010, a PEG-specific intervention that blocks allergic response and restores repeated dosing for select PEGylated medicines impacted by anti-PEG antibody", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Allergy and Infectious Diseases (NIAID)" ], "program_reference_codes": [], "program_officials": [ { "id": 9207, "first_name": "Michael", "last_name": "Minnicozzi", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-01-22", "end_date": "2025-12-31", "award_amount": 291458, "principal_investigator": { "id": 31447, "first_name": "Keiichiro", "last_name": "Kushiro", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2496, "ror": "", "name": "MUCOMMUNE, LLC", "address": "", "city": "", "state": "NC", "zip": "", "country": "United States", "approved": true }, "abstract": "Project Summary: Polyethylene glycol (PEG) is routinely used in protein and nanoparticle therapeutics, with dozens of PEGylated drugs approved to date. Although PEG itself is exceptionally safe, patients can form high titers of anti-PEG antibodies (APA) to some PEGylated drugs. This results not only in loss of efficacy from APA- induced rapid clearance of the drug, but also increases the risks of severe allergic responses, as exemplified by adverse clinical experiences with Krystexxa, Oncaspar and Palynziq that leave tens of thousands of Americans without viable treatments. Furthermore, APA induced by one drug can impact the efficacy and safety of a second PEGylated drug. Given the increasing number of PEGylated drugs on the market (including COVID-19 mRNA vaccines), there is an urgent need for safe and effective interventions that prevent APA induction and PEG-allergy. Mucommune has in-licensed a technology that can safely and effectively overcome the impact of APA on PEGylated medicines, without the need for broad immunosuppression or new polymers to replace PEG. The technology is based on the use of high MW free PEG to competitively saturate circulating APA and B-cell receptors on the surface of APA+ B-cells, thereby limiting the “hapten” effect of PEG-drugs. In published and pilot studies, free PEG markedly suppresses APA-induction against PEG-liposomes and Krystexxa (PEG- uricase) in immunocompetent mice and swine, and effectively restored the prolonged circulation of both in animals with high APA titers. Importantly, repeated injection of free PEG does not simulate further APA induction, unlike PEG-proteins or PEG-liposomes. Perhaps most surprisingly, free PEG completely eliminated hypersensitive reactions to PEG-liposomes in swine (the gold standard model for PEG-induced pseudoallergy). Swine receiving PEG-liposomes alone experienced strong anaphylaxis requiring immediate epinephrine intervention and resuscitation. These findings strongly underscore the promise of using free PEG to overcome allergic response to PEGylated medicines and to restore their efficacious use. Free PEG is inexpensive (pennies per dose), offers outstanding safety, and can be rapidly advanced into late stage clinical studies. Our overarching goal in this Phase 1 SBIR proposal is to establish the foundation to quickly advance this intervention into the clinic. We will file a pre-IND (Type B) application with the FDA to confirm the suitability of our proposed preclinical and clinical pathway, and will develop and qualify key assays for quantifying APA and free PEG necessary to support GLP and future clinical studies. We will then execute a GLP tox study in rats (a common model for PEG-drugs) to support first-in-human studies. Successful completion of these activities will allow us to file IND for MM010, putting us at the doorstep of advancing this intervention into the clinic, potentially providing relief for the tens of thousands of Americans suffering from responses to PEG-drugs that limit their use of essential treatments.", "keywords": [ "Acceleration", "Allergic Reaction", "American", "Anaphylaxis", "Animal Model", "Animals", "Antibodies", "Antibody Response", "Antibody titer measurement", "B-Cell Antigen Receptor", "B-Lymphocytes", "Binding", "Biological", "Biological Assay", "Buffers", "COVID-19", "Case Study", "Circulation", "Clinic", "Clinical", "Clinical Pathways", "Clinical Research", "Clinical Trials", "Data", "Development", "Dose", "Drug Kinetics", "Emergency Situation", "Ensure", "Enzyme-Linked Immunosorbent Assay", "Epinephrine", "Evaluation", "Family suidae", "Feedback", "Formulation", "Foundations", "Future", "Goals", "Government", "Haptens", "High Pressure Liquid Chromatography", "Human", "Hypersensitivity", "Immunocompetent", "Immunologics", "Immunosuppression", "Individual", "Infusion procedures", "Injections", "Intervention", "Licensing", "Lipids", "Liposomes", "Marketing", "Measures", "Mediating", "Medicine", "Methods", "Modeling", "Molecular", "Mus", "No-Observed-Adverse-Effect Level", "Outcome", "Pathway interactions", "Patients", "Pegaspargase", "Persons", "Pharmaceutical Preparations", "Pharmacologic Substance", "Phase", "Phase I Clinical Trials", "Pilot Projects", "Plasma", "Polyethylene Glycols", "Polymers", "Production", "Proteins", "Publishing", "Qualifying", "RNA vaccine", "Rattus", "Reaction", "Recovery", "Reporting", "Research", "Research Design", "Resuscitation", "Risk", "Runaway", "Safety", "Sampling", "Small Business Innovation Research Grant", "Specimen", "Sprague-Dawley Rats", "Standard Model", "Surface", "Technology", "Time", "Toxic effect", "Toxicokinetics", "Toxicology", "Urine", "Work", "allergic response", "assay development", "clinical development", "clinical lot", "clinical translation", "cost", "cost effective", "design", "drug clearance", "effective intervention", "experience", "first-in-human", "lot production", "nanomedicine", "porcine model", "pre-clinical", "prevent", "response", "risk mitigation", "therapeutic nanoparticles" ], "approved": true } }, { "type": "Grant", "id": "14767", "attributes": { "award_id": "1I01HX003667-01", "title": "Leveraging Knowledge of Chronic Multisymptom Illness to Improve Care for Veterans", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [], "program_reference_codes": [], "program_officials": [], "start_date": "2023-12-01", "end_date": "2027-11-30", "award_amount": null, "principal_investigator": { "id": 31468, "first_name": "Lisa Marie", "last_name": "McAndrew", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [ { "id": 31469, "first_name": "Shannon", "last_name": "Nugent", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "awardee_organization": { "id": 2497, "ror": "https://ror.org/003g0xf19", "name": "VA New Jersey Health Care System", "address": "", "city": "", "state": "NJ", "zip": "", "country": "United States", "approved": true }, "abstract": "An estimated 10-50% of patients develop persistent, disabling, & poorly understood symptoms after COVID-19 (PASC). For many, PASC is phenomenologically like CMI (e.g., Gulf War Illness). A meta-synthesis found patients with PASC have poor experiences with care. Patients report that, at best, clinicians want to support them but do not know how, and at worst, clinicians dismiss them as having a “mental health” disorder. Clinicians report poorly understood conditions, like PASC, are the most difficult conditions to manage. These descriptions of care for PASC are like those found in decades of research with CMI. Prior research has found as many as 60% of patients with these conditions are dissatisfied with care, which results in low uptake of evidence-based treatments and poor health outcomes. A critical gap exists in our understanding of how to improve the experience of care for patients with poorly understood conditions, like PASC. Our team is well- positioned to lead research to improve experiences with care for Veterans with PASC. We have led VA research efforts to understand and improve care for Veterans with CMI. This work has found 3 factors account for 40% of the variance in satisfaction with care for CMI. We have termed our approach, Concordant Care. The evidence-based Concordant Care approach involves engaging in processes that: 1) validate the patient's experience, 2) develop a shared understanding of the condition, and 3) create a patient-centered, whole health-oriented action plan to manage the condition. This is consistent with published expert opinion that Concordant Care underlies patients' (and clinicians') positive experiences of care for poorly understood conditions. Despite strong evidence supporting this care approach, there are no interventions to train clinicians on practices to provide Concordant Care for Veterans with poorly understood conditions. Our objective is to adapt, optimize, then test if a Concordant Care training improves VA clinicians' engagement in recommended practices to achieve Concordant Care (i.e., validate, shared understanding, action plan) for Veterans with PASC. Achieving this objective is feasible as we have already developed and piloted a CMI Concordant Care training for >300 VA clinicians, who rated it positively and reported it improved their practice. Our preliminary experiences suggests that our training is feasible, acceptable, and perceived as useful by VA clinicians and valued by VA program offices. Design: In Aim 1, we will adapt and optimize our Concordant Care training for PASC. The Concordant Care clinician training will include didactics, tele-mentoring sessions, and a clinician pocket card. Veterans who are cared for by trained clinicians will get a prompt to raise PASC concerns with their clinician. In Aim 2, we will conduct a randomized parallel cluster clinical trial to determine if Concordant Care training improves primary care clinicians' (n=60) provision of Concordant Care among Veterans with PASC (n=240), as compared to education packet control. Specific Aims: Aim 1. Adapt and refine Concordant Care training for PASC using an interactive, iterative, and user-centered design process informed by qualitative interviews and focus groups to optimize clinician access, uptake, and utilization. Aim 2. Determine if Concordant Care training increases clinicians' engagement in recommended practices to provide Concordant Care. Exploratory Aim 3: Explore effectiveness of Concordant Care on Veterans' with PASC care outcomes including satisfaction, adherence, and disability. Significance. Prior research with Gulf War Veterans showed the danger in waiting until we better understand the condition and best treatments before providing Concordant Care. This proposal aims to leverage our experiences with CMI to prevent another generation of Veterans from leaving the VA, feeling betrayed, and not receptive to new treatments when they become available. It is also responsive to President Biden's April 5, 2022 executive order addressing the need to quickly improve care for PASC. Long-term we will use our findings to propose a randomized clinical trial to determine the effectiveness of Concordant Care training on Veterans with PASC care outcomes.", "keywords": [ "Address", "Adherence", "COVID-19", "Caring", "Chronic", "Chronic Care", "Clinical Trials", "Diagnosis", "Disabling", "Education", "Effectiveness", "Evaluation", "Evidence based practice", "Evidence based treatment", "Expert Opinion", "Feeling", "Focus Groups", "Generations", "Gulf War veteran", "Health", "Inequity", "Intervention", "Interview", "Knowledge", "Lead", "Learning", "Mental disorders", "Methods", "Military Personnel", "Mission", "Outcome", "Patient Care", "Patient Education", "Patients", "Pattern", "Persian Gulf Syndrome", "Phenotype", "Positioning Attribute", "Post-Acute Sequelae of SARS-CoV-2 Infection", "Process", "Publishing", "Randomized", "Recommendation", "Reporting", "Research", "SARS-CoV-2 infection", "SARS-CoV-2 infection history", "Symptoms", "Testing", "Training", "Veterans", "Work", "acute COVID-19", "arm", "care outcomes", "clinical phenotype", "crosslink", "design", "disability", "effectiveness evaluation", "evidence base", "experience", "health inequalities", "improved", "military veteran", "operation", "patient oriented", "persistent symptom", "phenomenological models", "poor health outcome", "prevent", "primary care clinician", "programs", "randomized clinical trials", "satisfaction", "symposium", "symptomatology", "uptake", "user centered design", "whole health" ], "approved": true } }, { "type": "Grant", "id": "14778", "attributes": { "award_id": "3R43NS129363-01A1S2", "title": "A Mobile Health Application to Detect Absence Seizures using Hyperventilation and Eye-Movement Recordings", "funder": { "id": 4, "ror": "https://ror.org/01cwqze88", "name": "National Institutes of Health", "approved": true }, "funder_divisions": [ "National Institute of Neurological Disorders and Stroke (NINDS)" ], "program_reference_codes": [], "program_officials": [ { "id": 24585, "first_name": "EMILY LAURA", "last_name": "Caporello", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2023-09-19", "end_date": "2024-08-31", "award_amount": 55000, "principal_investigator": { "id": 31476, "first_name": "Rachel", "last_name": "Kuperman", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2498, "ror": "", "name": "EYSZ, INC.", "address": "", "city": "", "state": "CA", "zip": "", "country": "United States", "approved": true }, "abstract": "Research Strategy 1. Executive Summary of Predicate SBIR Phase I Grant and Team The overall goal of our predicate SBIR Phase I grant is to validate the Eysz mobile health (mHealth) application and develop algorithms to diagnose and monitor childhood absence epilepsy (CAE) in the clinical setting. Eysz, Inc. is developing a mobile health (mHealth) application and algorithms to remotely diagnose and monitor CAE to improve outcomes. Currently, absence seizures are challenging to identify,leading to diagnostic delays and difficulty measuring treatment efficacy. Untreated seizures place children at risk for accidental injury and learning loss. The gold standard for seizure detection is video EEG (VEEG), but it is expensive, limited to clinical settings, and hard to access. As a result, clinicians rely on self-reports, despite studies showing patients report only 6% of all absence seizures, and caregivers report only 14%. Even primary care providers have difficulty identifying absence seizures and rely on VEEG, referring 5 patients for every 1 diagnosed. Once diagnosed with CAE, children are started on anti-seizure medications (ASM), which result in seizure freedom in less than 60% of children. However, no new treatments have been approved since the 1990s, partially due to difficulty measuring seizures.4 Other strategies to monitor seizures, such as ambulatory EEG, lack the sensitivity and specificity of VEEG, and can add to the stigma of people with epilepsy. Thus, there is a critical need for a remote diagnostic/monitoring tool for absence seizures. The aim of the SBIR proposal is to test and further develop an mHealth app that uses (1) supervised guided hyperventilation (HV), with (2) eye movement and facial biometric data to monitor seizure susceptibility and treatment responses in CAE. Achieving these goals will decrease costs of care, morbidity, and mortality and improve quality of life for those with childhood absence epilepsy. CAE is the most common pediatric epilepsy syndrome, affecting 10–17% of all children with epilepsy. Seizures occur many times daily and consist of brief losses of consciousness (LOC), with immediate return to baseline awareness and activity. Seizures typically manifest as staring spells, sometimes with rhythmic eye blinking or motor automatisms. As LOC may occur at any time without warning, absence seizures have a significant impact on quality of life (QOL), and accidental injury is common, with 20% of young adults—3% per year—suffering an injury during a seizure. The clinical course of CAE is variable, and remission rates are far lower than in other idiopathic epilepsies. In five prospective cohort studies, only 57–74% achieved seizure freedom. Thus, there is a critical need for new therapeutics for absence epilepsy and better tools for monitoring therapeutic responses. The current standard of care for measuring treatment outcomes is self-reported data. Large-scale clinical trials, including those testing new antiseizure medications, population-based assessments, and other epidemiological studies also use self-reporting to determine optimal therapy regimens. Critically, however, multiple clinical studies show patient seizure counts provide inaccurate information. Patients report only 6% of all experienced absence seizures, whereas caregivers report only 14%. In a recent study examining self-documentation of absence seizures by adults with idiopathic generalized epilepsy, inaccurate seizure counts were found to substantially impact outpatient management and treatment. The gold standard for detecting and characterizing seizure activity is a neurologist reading of a VEEG. In the home setting, where > 99% of seizures occur, VEEG is not readily available because of poor patient acceptability, poor detection capability, high cost and continued reliance on asynchronous review. The FDA has approved two non-EEG-based devices to detect convulsive seizures, but these are responsible for only < 25% of all seizure activity. To address this significant unmet market need, Eysz is developing an mHealth app and accompanying algorithms to improve diagnosis and monitoring of CAE. The mHealth app standardizes the approach for administering and quantitating the effectiveness of HV-induced seizures. The app uses animations and interactive graphics to guide users through HV while capturing audiovisual data. Eye movements, facial biometrics, number and length of exhales, and other associated data will be used to measure the effectiveness of HV to detect HV-induced seizure activity, providing an affordable and accessible tool to reliably monitor absence seizures. This initial grant focuses on an in-clinic release with additional work needed prior to the release of the device in a home setting. This proposal focuses on developing algorithms for analysis of video quality, effectiveness of HV, and seizure identification using a smartphone-based guided HV app. The Specific Aims are: Aim 1: Collect data from the Eysz mHealth app concurrently with VEEG and assess usability. Aim 2: Evaluate the potential for a new “gold standard” metric for algorithm validation. Evaluate if the the majority of 3 epileptologists reading the video produced by the Eysz mHealth app identify absence seizures with >80% sensitivity and specificity compared with the majority agreement of 3 independent epileptologists reviewing VEEG. Aim 3. Develop ML methods that use facial biometrics and eye tracking data to quantitate seizures. Our proposed I-Corp team will include the following 3 members, who are committed to the time requirements of the program. Member Name Role Rachel Kuperman, MD PI/PD Parth Amin C-Level Corporate Officer (COO) Tracey Fisher Industry Expert 2. I-Corps team and Project Plan The aim of our predicate SBIR Phase I grant is to validate that a clinician read of the video from the Eysz mHealth App is equivalent to video EEG read and develop AI based algorithm for seizure identification. Achieving these aims will signal successful completion of Phase I and our readiness to transition to Phase II. The learnings from the Phase I grant will be incorporated into the app to improve usability and allow for the App to be tested in the home environment, and validate our seizure detection algorithm as we work towards FDA clearance and commercialization readiness. The Eysz team participated in the NIH I-Corp program during our previous SBIR phase 1 grant. While the results of the SBIR were technically successful, the data collected during the I-Corp program informed our decision to pivot from a continuous use wearable eye tracking glass to an intermittent usage smartphone based app to better meet the customer and market needs. Given the significant pivot, our goal with this NIH I-Corp is to work towards commercial readiness by refining our business model including: reimbursement strategy, business/pricing models, and understanding the purchasing process as we work towards FDA clearance. Our proposed I-Corps team will include the following 3 members. Member Name Role Rachel Kuperman, MD PI/PD Parth Amin C-Level Corporate Officer Tracey Fisher Industry Expert The team, which has been collaborating since February 2020, has demonstrated expertise in clinical research, product development, and commercialization. The following is a summary of their expertise: Rachel Kuperman, MD (PI/PD) leads the management team and clinical research. Rachel is a neurologist with dual certification in epilepsy and neurology and has over 10 years’ experience directing the clinical epilepsy and research programs at UCSF Benioff Children’s Hospital, Oakland. She is also the inventor of the core technology and has a strong background in clinical research, having served as the PI on multiple clinical trials, including being the PI for multiple SBIR Phase I grants. Her undergraduate degree in physics from UCSD, and her neurology and neurophysiology training at Columbia and UCSF, have helped her bridge the clinical/computational divide. Early in her career, Dr. Kuperman was identified as a leader at Children’s Hospital, where she was invited to participate in the UCSF Physician Leadership Program in 2011. Dr. Kuperman was awarded $80K in grants from UCSF, including the Junior Investigator Award for research, towards development of her patent. She was recognized by the Epilepsy Foundation of Northern California with the Volunteer of the Year award in 2016. Dr. Kuperman was a Fall 2018 Fellow at UC Berkeley Law Form and Fund, which focuses on the core legal, financial, and organizational aspects of starting and scaling a business. She has since received the Ferolyn Fellowship award from the Fogarty Institute for Innovation, which provides mentoring to rising medtech leaders with a passion to transform healthcare. Parth Amin, our Chief Operating Officer, brings 20 years of medical device experience, including having worked for global healthcare companies such as Siemens Healthineers, Varian Medical Systems, and Omnicell. He has held a variety of pivotal roles in the areas of product management, program management, and alliance management while successfully attaining objectives related to innovation, product development, revenue, and market share growth. His expertise in product development and alliances, with an emphasis on go-to-market strategies involving partnered solutions, has allowed us to start identifying and establishing key technology, clinical, and commercial partners, who in turn will enable us to translate this meaningful innovation into a commercially viable product. As part of 3-2 Dual Degree Program, Mr. Amin holds a BE in Electrical Engineering from Washington University and B.S in Pre-Engineering from Birmingham-Southern College. Tracey Fisher is an accomplished business executive with over 20 years of global healthcare marketing experience. She has built and led marketing teams that have launched medical device products and brands that became global market leaders and generated over $1B in revenue, while working at Siemens Healthineers and Varian Medical Systems. Through collaboration with patient advocacy, government advocacy, regulatory, reimbursement, sales, and product teams she has defined business/pricing models and value propositions to build successful new product introduction and marketing strategies and oversee the execution. With her expertise and guidance, we are confident that we will achieve our aims for the NIH-I Corps program. During the early stages of our company formation, we participated in the National Science Foundation (NSF) I-Corps program, which was extremely beneficial in helping us understand the epilepsy ecosystem and craft our initial value proposition. At that time, our team performed 111 interviews of patients, family members, physicians, payors, pharmaceutical researchers, competitors and potential collaborators. During our previous NIH I-Corp program we completed over 100 interviews that significantly changed the course of our product and research. Since the NIH program, we have had an additional Pre-Sub meeting with the FDA, completed our initial clinical study and pivoted towards a product with better market fit. Based on the interactions with our partners, and clinical collaborators, we have reformulated our value proposition, pursued additional patents and refined our regulatory and reimbursement strategy. The overall goal of participating in the NIH I-Corps is to take our vision and value proposition and add the granularity which will align our clinical research milestones, regulatory strategy, IP strategy,reimbursement strategy and fundraising milestones, ultimately leading to successful commercialization strategy which will position us to obtain venture funding and a Phase II SBIR. We particularly need to do additional risk mitigation around our revenue model, which focuses on use of existing reimbursement codes and possibly applying for additional codes, obtaining payment from payers, and ensuring our unit costs and channel partners are aligned for scaling growth. A structured, healthcare-focused program like that offered by NIH I-Corps would build upon the tremendous work to date and set the company up for success as we advance our current NIH-funded initiative to the next phase of development. Our team is ideally positioned to have maximal benefit from the NIH I-Corps program. Our SBIR Phase I grant has allowed us to develop and align as a team from a technical perspective. The I-Corps program will enable us to expand our current technical focus to pre-commercialization topics. We believe that customer discovery interviews and the lean launchpad system are a timely, structured method to assist our company as we make this transition from our previous position and have benefited us greatly in the past. Commercial Potential Through > 200 customer discovery interviews supported by the NSF + NIH I-Corps program and continued customer discovery interviews – with epilepsy patients, clinicians, pharmaceutical companies, EEG manufacturers, and patient advocacy groups – we are confident in the commercialization potential of our technology. By establishing and growing a partner ecosystem, we are minimizing commercial risks while expanding our commercial opportunities. While our initial plan was to partner with eye tracking manufacturers, our new product focuses on using existing smartphone technology reducing many of the hurdles that we identified during our previous I-Corp. In particular it will significantly reduce our time to market, decrease the funding requirements, improve user satisfaction and significantly simplify distribution. Lastly, pharmaceutical companies have expressed strong interest, as shown by financial investments and planned clinical partnerships to use our solution to assess the efficacy of anticonvulsants in clinical studies. Eysz has received grant support from Greenwich Biosciences. UCB Pharma, the largest epilepsy drug developer, has also invested in Eysz. We are focused on the clinical care market. In the digital health space, commercialization relies heavily on developing a reimbursement strategy. We plan on leveraging existing CPT codes including behavioral health codes, remote monitoring codes and nonspecific neurodiagnostic codes. This planning has been complicated by recent COVID-related changes in telehealth and remote monitoring reimbursement, but we are reassured that the headwinds towards additional coverage are supporting our reimbursement strategy. We estimate the overall U.S. market opportunity to be around $3.4 Billion dollars, given the direct costs associated with epilepsy. With our initial FDA clearance for absence seizures, we expect to capture 5% of the market ($170M) in 5 years. Target Customer For the clinical care market, our end user will be pediatricians and neurologists at a Level 3 + 4 Epilepsy Center. We understand that purchasing decisions are not solely made by clinicians, but they are influential in the decision-making process. As part of the I-Corps program, we aim to better understand how products are recommended for purchasing by neuro service line managers, and pediatric managers, how reimbursement decisions are made by payors, how best to reach influencers and decision-makers, and the level of integration with existing workflow required to facilitate adoption. Clinical Need and Current Alternatives More than 70 million people worldwide—including ~1% of the U.S. population—suffer from epilepsy, a debilitating, unpredictable chronic condition in which abnormal electrical activity in the brain produces physical disturbances including loss of consciousness (LOC) and/or convulsions. Epilepsy is associated with disability, reduced quality of life, and an elevated risk of comorbidities, including seizure-related injuries; respiratory, cardiovascular, and neurologic dysfunctions; and psychological conditions such as anxiety and depression. Outcomes include long-term disability and increased risk of mortality, and epilepsy accounts for 0.5% of the global burden of disease based on years of life lost (YLL) and years lost to disability (YLD). Globally, the costs associated with epilepsy are staggering. In the U.S. alone, direct costs have more than doubled in less than a decade—from $12B to $28B—while outcomes have not improved for almost 3 decades. In addition, epilepsy accounts for more than 1 million emergency department (ED) visits and over 280,000 hospital admissions annually in the U.S., with aggregate hospital costs for epilepsy totaling approximately $2.5 billion. Seizures represent the key symptom of epilepsy and the primary target of epilepsy treatment. Detection of seizures is the first step in choosing an appropriate treatment regimen, and appropriate anticonvulsants can decrease seizures by 50%. Unfortunately, current detection technologies are impractical or have limited effectiveness outside of clinical settings, as described below: Self-reporting/Observation: As for many other chronic conditions, epilepsy patients are often asked to keep a seizure diary. Critically, however, patient-reported seizure counts do not provide accurate information. Studies have shown that during video EEG, caregivers and patients fail to recognize more than 50% of seizures. In addition, constant seizure observation substantially reduces quality of life due to loss of sleep, schedule disruption, and anxiety about missing seizure activity. Thus, both patients and clinicians are aware of the need for a feasible ambulatory technique for the objective detection and registration of seizures. Outpatient EEG: There have been many attempts to convert the gold standard of EEG plus video observation into a less burdensome mobile platform. To date, however, video EEG remains expensive, largely limited to hospital settings, uncomfortable for patients, and associated with a significant delay between seizure activity and diagnosis. A proposed alternative is ambulatory EEG platforms, which forego the video portion to enable use at home, but these too have significant limitations. In particular, removal of the video portion of the EEG significantly reduces EEG sensitivity and specificity. Neurologists are taught not to make decisions based on EEG alone, severely limiting the utility of video-free outpatient EEG detection methods. Another recent approach is to remove the role of physicians in EEG interpretation and instead to develop ML-based algorithms to identify seizures in EEGs in real time, but these are not yet sensitive or specific enough to use without physician review. Finally, while EEG-based wearables have increased in number and improved in usability and aesthetics, the challenges associated with the use of EEG as an underlying technology have still not been addressed. Non-EEG Devices: Given the limitations of adapting video-based and non-video-based EEG seizure detection devices, other solutions have been developed that rely on a combination of different detection methods, including accelerometers, electromyography, infrared motion detectors, or other means to track convulsive seizures (i.e., generalized tonic-clonic seizures, or GTCs, which make up < 25% of all seizures). These mobile devices use signals from biometric sources such as limited EEG, heart rate, motion sensors, limb acceleration/movement, electrodermal activity, muscle activation, and audio/video. However, these solutions are not comprehensive enough to cover both GTC and non-convulsive seizures, have high false-positive rates, and/or have clinically unacceptable sensitivity/specificity. Due to the limitations of current technologies outlined above, there remains a critical need for a more robust technology that can detect a broader variety of seizures and alert caregivers or healthcare providers to ensure timely intervention. Competitive Advantage Eysz is developing an mHealth app and accompanying algorithms to improve diagnosis and monitoring of CAE. A standard HV tool that could aid doctors in patient diagnosis and supplement home seizure diaries will improve CAE diagnosis, management and therapeutic development. Doctors and caregivers currently do not have an accurate way to identify changes in absence seizure frequency or reliably monitor treatment benefits. Since clinicians struggle to identify absence seizures, the utilization of the Eysz mHealth tool in PCP offices will lead to faster, more appropriate referrals. For neurologists, the Eysz tool will help with titrate medicines and guide the decision to perform a VEEG for seizure freedom. As pharmaceutical studies currently rely on self-reported seizure counts and >24-hour VEEGs in hospital settings, Eysz would decrease costs and improve patient access to clinical studies for absence epilepsy. As a more accurate, reproducible method of seizure monitoring, the app has the potential to transform the diagnosis and management of absence seizures, improving drug development, medical decision-making, and patient QOL. Eysz intends to first demonstrate the utility of the mobile seizure monitoring in CAE, then expand into the larger patient population of focal impaired awareness seizures (FIAS). Price Estimate EEG hardware costs $20K–30K per unit, with charges of $500/hour for an outpatient EEG or $2500–5000/day for inpatient EEG (average hospitalization of 2–3 days). Smartphone technology is ubiquitous and costs are anticipated to decrease significantly in the coming years. These compatible technologies could potentially be used for several months/years without losing performance. Existing CPT codes, which could be utilized for the Eysz solution, reimburse $100–200 per month, making the Eysz solution a highly affordable option compared to EEG. As part of the I-Corps program, we aim to understand how to price for clinical value when reimbursement may not be present, understand channel costs, pricing models for fee for service institutions and fee for value institutions, and scalability of this approach. 4. Project Plan With our previous clinical study we were able to develop a technically sound product. We pivoted our product based on extensive customer discovery. This SBIR phase 1 plans to validate our App based solution and transition our AI based algorithm developed in our previous SBIR. Thus, in this Phase I SBIR, Eysz plans to obtain data from 45 children with absence seizures and 30 without and to use a combination of traditional signal processing and ML techniques to refine an algorithm to achieve the high sensitivity required for use as a seizure monitor. Towards that goal the clinical study is in IRB review. We are confident in our ability to enroll the necessary patients based on Cincinnati Children’s high patient volume. During this technical phase we plan on doing extensive work towards our pre-commercialization, with an emphasis on developing channel partners, regulatory and reimbursement strategies.", "keywords": [ "Absence Epilepsy", "Acceleration", "Accelerometer", "Accidental Injury", "Address", "Adoption", "Adult", "Advocacy", "Affect", "Agreement", "Algorithmic Analysis", "Algorithms", "Anticonvulsants", "Anxiety", "Appointment", "Area", "Automatism", "Award", "Awareness", "Bachelor&apos", "s Degree", "Biological Sciences", "Biometry", "Blinking", "Brain", "Businesses", "COVID-19", "California", "Cardiovascular system", "Caregivers", "Cellular Phone", "Certification", "Charge", "Child", "Childhood", "Chronic", "Clinic", "Clinical", "Clinical Research", "Clinical Trials", "Code", "Collaborations", "Convulsions", "Current Procedural Terminology Codes", "Data", "Data Reporting", "Decision Making", "Degree program", "Detection", "Development", "Devices", "Diagnosis", "Diagnostic", "Diagnostic Procedure", "Direct Costs", "Disease remission", "Documentation", "Ecosystem", "Educational process of instructing", "Effectiveness", "Electrical Engineering", "Electroencephalography", "Electromyography", "Emergency department visit", "Engineering", "Enrollment", "Ensure", "Epilepsy", "Esthetics", "Excision", "Exhalation", "Eye Movements", "Face", "Family member", "Fee-for-Service Plans", "Fees", "Fellowship", "Foundations", "Freedom", "Frequencies", "Funding", "Generalized Epilepsy", "Glass", "Goals", "Government", "Grant", "Growth", "Health Personnel", "Healthcare", "Healthcare Market", "Heart Rate", "Home", "Home environment", "Hospital Costs", "Hospitalization", "Hospitals", "Hour", "Hyperventilation", "Impairment", "Improve Access", "Industry", "Influentials", "Injury", "Innovation Corps", "Inpatients", "Institution", "Institutional Review Boards", "Intervention", "Interview", "Investments", "Laws", "Leadership", "Learning", "Legal", "Legal patent", "Length", "Limb structure", "Long term disability", "Low income", "Manufacturer", "Marketing", "Measures", "Medical", "Medical Device", "Medicine", "Mental Depression", "Mentors", "Methods", "Mobile Health Application", "Modeling", "Monitor", "Morbidity - disease rate", "Motion", "Motor", "Motor Seizures", "Movement", "Muscle", "Names", "Neurologic Dysfunctions", "Neurologist", "Neurology", "Outcome", "Outpatients", "Patient Self-Report", "Patient advocacy", "Patients", "Pediatric Hospitals", "Performance", "Periodicity", "Persons", "Pharmaceutical Preparations", "Pharmacologic Substance", "Phase", "Physician&apos", "s Role", "Physicians", "Physics", "Population", "Positioning Attribute", "Predisposition" ], "approved": true } }, { "type": "Grant", "id": "14837", "attributes": { "award_id": "2409838", "title": "Postdoctoral Fellowship: PRFB: Understanding the impacts of simultaneous stressors on bat immunity and spillover risks", "funder": { "id": 3, "ror": "https://ror.org/021nxhr62", "name": "National Science Foundation", "approved": true }, "funder_divisions": [ "Biological Sciences (BIO)", "Biology Postdoctoral Research" ], "program_reference_codes": [], "program_officials": [ { "id": 30092, "first_name": "Joel", "last_name": "Abraham", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-10-01", "end_date": null, "award_amount": 240000, "principal_investigator": { "id": 31512, "first_name": "Molly", "last_name": "Simonis", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2499, "ror": "", "name": "Simonis, Molly C", "address": "", "city": "", "state": "OH", "zip": "", "country": "United States", "approved": true }, "abstract": "This action funds an NSF Postdoctoral Research Fellowship in Biology for FY 2024, Integrative Research Investigating the Rules of Life Governing Interactions Between Genomes, Environment, and Phenotypes. The fellowship supports research and training of the fellow that will contribute to the area of Rules of Life in innovative ways. A long-standing challenge of disease ecology is how to scale individual variation in immune responses up to population-level pathogen spread. This challenge is further complicated by how individual differences in immunity can be caused by stressors (e.g. energetically costly life stages, exposure to contaminants). This project investigates how stressors affect immunity and infection as well as how differences in immunity translate to pathogen spread within the larger host population. This project will broaden participation by providing research experiences to underrepresented undergraduate students in the field and in the lab as well as provide quantitative training to undergraduate and graduate students.<br/><br/>Host immunity is the primary barrier to infection and, as such, can determine disease risks in natural populations. Intrinsic and extrinsic stressors throughout the lifespan of a host can alter immunity, which can then impact pathogen dynamics within the host population. This research aims to understand the complex interplay between wildlife stressors, immunity, and infection. Specifically, this research will quantify wildlife immunity under simultaneous stressors of reproduction and contaminant exposure at the individual level, then use mathematical models to scale those responses up to shape infection dynamics at the population level. Simonis will build epidemiological models and explore how varying relationships between contaminant exposure and immune-relevant parameters drive infection prevalence across the host annual cycle. For empirical data collection, Simonis will capture big brown bats in Oklahoma, which are regularly exposed to contaminants due to their resiliency in human-disturbed habitats and also harbor coronaviruses across their range in North America. Blood, saliva, fecal, and fur samples will be collected from bats to measure contaminant exposure, innate immunity, and coronavirus infection status and intensity. Underlying empirical relationships will inform immune-relevant parameters in epidemiological models, and Simonis will identify parameter combination(s) that have the greatest likelihood for influencing coronavirus prevalence in the field. This project will inform how human-induced environmental disruptions can drive seasonal epidemics in natural populations and will provide the mentorship and training needed for Simonis’ research goals in disease ecology and ecoimmunology and to obtain a tenure-track faculty position.<br/><br/>This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.", "keywords": [], "approved": true } }, { "type": "Grant", "id": "14842", "attributes": { "award_id": "2343881", "title": "The Aggregate Impact of Working from Home", "funder": { "id": 3, "ror": "https://ror.org/021nxhr62", "name": "National Science Foundation", "approved": true }, "funder_divisions": [ "Social, Behavioral, and Economic Sciences (SBE)", "Economics" ], "program_reference_codes": [], "program_officials": [ { "id": 1865, "first_name": "Nancy", "last_name": "Lutz", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] } ], "start_date": "2024-07-01", "end_date": null, "award_amount": 493362, "principal_investigator": { "id": 7351, "first_name": "Nicholas", "last_name": "Bloom", "orcid": null, "emails": "", "private_emails": "", "keywords": null, "approved": true, "websites": null, "desired_collaboration": null, "comments": null, "affiliations": [] }, "other_investigators": [], "awardee_organization": { "id": 2500, "ror": "", "name": "National Bureau of Economic Research Inc", "address": "", "city": "", "state": "MA", "zip": "", "country": "United States", "approved": true }, "abstract": "Work from home (WFH) has surged in America, rising from 5% of workdays in 2019, peaking at about 60% in May 2020 during the lockdown, to stabilize at about 27% by May 2023. This five-fold increase in working from home, including both full time remote and part time telework, has been possibly the largest change to US labor markets since World War II. This WFH surge has generated major economic and policy questions over the impact of this on many areas of the US economy. This project will investigate the impact of this WFH surge on the aggregate US economy and labor market, arising from the impacts on productivity (which could be positive or negative), and on labor force participation. These questions are important academically, for monetary and fiscal policymakers, for businesses and managers, and for investors planning for the impact of WFH on goods and labor markets. <br/><br/>This project has three major strands to advance research on this topic. First is the Survey of Working Arrangements and Attitudes (SWAA) which will collect detailed WFH information for around 8,000 working Americans a month aged 20 to 64 on current practices, intentions and impacts on lifestyle, productivity and living arrangements. This provides detailed monthly data on exactly the working patterns across regions, industries and occupations across the US. Second, the project will also develop an employee-employer dataset from a leading US payroll processing firm to examine where people live and work pre and post pandemic. Payroll data usually has accurate home and work location data, and by examining a panel of employees and individuals it is possible to examine impacts of WFH on locational choice and infer WFH patterns. Third, the team will examine the impact of working from home on aggregate US productivity and worker welfare using a general equilibrium model. This aim will provide results on individual workers’ relative productivity while working from home and then enable counterfactual exercises to see how economy-wide welfare and productivity would differ if, for example, we forced working from home back to the low levels from before the pandemic. This will be invaluable for considering some of the larger, long-run aggregate impacts of the roughly 5-fold increase in rates of working from home experienced post-pandemic.<br/><br/>This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.", "keywords": [], "approved": true } } ], "meta": { "pagination": { "page": 1392, "pages": 1405, "count": 14046 } } }