NICHD Priorities for the SBIR/STTR Programs

The CDBB encourages innovative, developmentally sensitive, theoretically grounded, evidence-based small business initiatives that develop technology and products addressing the psychological, social and emotional, psychobiological, language, numerical, literacy, cognitive, and intellectual development and health of persons from infancy to maturity. Products that target at-risk populations and/or exploit new technologies that can expand the effective reach or inclusion of underserved populations to encourage healthy development and/or our understanding of the influences of context and/or behavior on development are especially encouraged.

Foci of specific interest for both clinical trial and non-clinical trial research include:

• Enhancing Bilingual and Biliteracy Development: Adaptive learning technology to enhance bilingual and/or biliteracy development in English-language learning children and youth
• Measures of Neurodevelopment: Developing easy-to-administer neurodevelopmental measures from evidence-based neurocognitive research specific to typically developing infants and toddlers that are shown to correlate with development of brain connectivity and activation
• Pediatric Primary Care Behavioral and Health Promotion Interventions: Facilitate research on the impact of behavioral and health promotion interventions in pediatric primary care and related clinical settings with a focus on end result child and adolescent health outcomes
• Psychosocial Adjustment for Individuals in High-Risk Environments: Develop measures to identify and tools to stimulate developmental factors and mechanisms which promote short- and long-term psychosocial adjustment for children and adolescents exposed to high-risk family and neighborhood environments
• School Readiness Skills in Economically and Socially Disadvantaged Children: Develop mobile device apps and/or hand-held devices that promote the development of school readiness skills and abilities in diverse populations of children as well as measures of home, child care and preschool environments and practices that are related to child learning and development
• Reading, Writing, and Mathematics Struggling Learners: Develop assistive technology to enhance learner outcomes for individuals that struggle to acquire literacy and numeracy skills
• Assessment and Enhancement of Reasoning Development: Develop validated and specific assessment tools that are sensitive to contributing factors (e.g., biobehavioral, environmental, cultural, academic, and cognitive factors) to facilitate research on and the promotion of neurocognitive development of reasoning (e.g., quantitative, deductive, inductive, causal) in typically developing populations

Program Officer:
Dr. Kathy Mann Koepke

The CRB emphasizes developing new and improved methods of fertility regulation as well as research on the benefits and risks of contraceptive drugs, devices, and surgical procedures. Areas of interest for both clinical trial and non-clinical trial research include:

• Development of new and improved methods of fertility regulation, for men and women, that are safe, effective, inexpensive, reversible and acceptable
• Synthesis and testing of novel chemical compounds that are potential contraceptives
• Multipurpose technologies designed to prevent sexually transmitted infections, such as HIV, as well as pregnancy

Program Officer:
Dr. Steven Kaufman

The DBSVB supports biomedical research on the cellular, molecular, and genetic aspects of normal and aberrant embryonic and fetal development including early embryogenesis, organogenesis, causative factors in teratogenesis, and topics in regenerative biology. Areas of interest for non-clinical trial small business include:

• Development of new animal model systems to understand developmental mechanisms and causes of structural birth defects
• Innovative technologies for in vivo imaging of developmental processes (cell and tissue dynamics) and gene expression
• Development of antibodies, novel ligands, and other probes to facilitate our understanding of normal and abnormal embryonic development in model organisms
• Technologies for quantitative measurement of physical properties of cells/tissues in vivo
• Innovative and high throughput genomic and proteomic techniques
• Technologies to facilitate and advance systems biology approaches to the study of embryonic development and structural birth defects
• Innovative technologies to facilitate and advance high throughput chemical screening (including small molecules) for advancing structural birth defects research
• Software development to facilitate the collection and analyses of data generated using high throughput screening platforms in model organisms
• Technologies/methodologies to generate and software to mine data related to wound healing and regenerative responses across animal species
• Novel reagents for activation and mobilization of endogenous/adult stem cells to promote in vivo tissue regeneration
• High throughput screening technologies of small molecules in human embryonic stem cells or Induced Pluripotent Stem Cells (iPSCs) and disease specific iPSCs for targeted modification of signaling pathways affected in structural birth defects
• Technologies for iPSC-based regenerative medicine in the context of structural birth defect
• Innovative technologies for studying metabolomics in developing vertebrate embryos

Areas of interest for clinical trials required projects include diagnostics and therapeutics aimed at ameliorating structural birth defects.

Program Officer:
Dr. Mahua Mukhopadhyay

The FI Branch studies the reproductive processes of men and women and of animals with similar reproductive systems related to developing safer and more effective means of regulating, preserving, or achieving fertility.

Particular areas of programmatic interest for both clinical trial and non-clinical trial small business initiatives include:

• Development of reagents to facilitate study of reproductive and developmental processes
• Development of improved methods of growing and differentiating stem cell lines in vitro, including feeder cell-free approaches
• Development of novel assays, kits, and devices to monitor fertility and treat infertility and gynecological disorders
• Use of genomics and proteomics to develop novel diagnostics and treatments for reproductive diseases and disorders
• Development of high-resolution technologies to provide invasive or noninvasive assessments of reproductive and developmental competence
• Development of experimental animal models for studying the physiology and pathophysiology of reproductive processes
• Development of techniques and identification of novel biomarkers to produce, identify, and use healthy gametes
• Development of improved and novel technologies for the preservation of human gametes
• Development of improved technologies for preimplantation genetic diagnosis
• Development of improved technologies for the reprogramming of cells, including embryonic stem cells or adult cells, into eggs and sperm
• Development of in vitro model systems that are useful for understanding human embryo implantation.
• Development of innovative technologies for point-of-care testing for infertility and reproductive diseases and disorders
• Development of new methods to alter the function of trophoblast cells so that the embryo/fetus can be protected from ill effects of maternal viral infection

Program Officer:
Dr. Ravi Ravindranath

The GHDB supports biomedical research related to gynecologic health throughout the reproductive lifespan, beginning at puberty and extending through early menopause. Within the context of both clinical trial and non-clinical trial small business projects, areas of interest include:

• Development of new diagnostic approaches and treatments for female pelvic floor disorders, including drugs, and devices used for treatment of pelvic organ prolapse, urinary incontinence, fecal incontinence and other female pelvic floor disorders
• Development of new diagnostic methods and novel surgical and non-surgical treatments for uterine fibroids, endometriosis, adenomyosis, and benign ovarian cysts
• Production of marketable novel or improved methods, devices, and technologies for the diagnosis, monitoring and therapy of gynecologic pain disorders including chronic pelvic pain, vulvodynia, and dysmenorrhea
• Generation of new approaches for the diagnosis, monitoring and treatment of abnormal menstrual cyclicity

Program Officer:
Dr. Lisa Halvorson

The IDDB sponsors research aimed at preventing, diagnosing, and ameliorating intellectual and developmental disabilities (IDD), including common and rare neuromuscular and neurodevelopmental disorders, such as Down, Fragile X, and Rett syndromes, mitochondrial conditions, inborn errors of metabolism, autism spectrum disorders, and others.

Areas of interest for clinical trial and non-clinical trial research include:

• Innovative tools, including molecular, imaging, statistical, or behavioral tools, to characterize the etiology and pathophysiology of abnormal nervous system development
• Methods and devices to delineate genetic, genomic, and epigenetic causes of IDD and develop gene-based treatments
• Methods or devices designed to screen for and diagnose IDD and other conditions, particularly those identified or identifiable by newborn screening
• Assessment tools for use in the clinic or community settings to enable the accurate measurement of change in response to interventions
• Development of early interventions leading toward the prevention, diagnosis, and treatment of IDD
• Methods or devices to develop or apply smart technologies to enhance screening, diagnosis, prevention, treatment, or management of IDD conditions
• Development of assessment measures or treatments for comorbid symptoms in IDD that can include: disordered sleep, self-injurious behaviors, obesity, gastrointestinal dysfunction, seizures/epilepsy, attention deficit/hyperactivity disorder, and other mental health disorders

Program Officer:
Dr. Dantua Krotoski

The MPIDB supports domestic and international research on HIV/AIDS and related infections (such as tuberculosis, hepatitis, and malaria) in women of childbearing age, pregnant women, mothers, fetuses, infants, children, and adolescents. Specific areas of interest include epidemiology, clinical manifestations, pathogenesis, transmission, treatment and prevention (including vaccines and other biomedical modalities) of HIV infection, Zika infection, and other infectious diseases in children, adolescents and pregnant women, including prevention of mother to child transmission of HIV and other congenital infections, and HIV-related and other infectious-disease related complications in these populations.

Additional areas of interest for both clinical trial and non-clinical trial projects include:

• New technologies relevant to resource-limited countries for:
  • Screening, diagnosis, and management of infectious diseases in pregnant women, infants and children, including but not limited to HIV (e.g., congenital cytomegalovirus, Zika virus)
  • Rapid assays to monitor disease activity and response to therapy for as well as immune response to vaccinations against relevant infections in infants and children (e.g., malaria, tuberculosis), which can be used at the individual level and/or as part of public health campaigns (e.g., eradication of outbreaks and prevention of spread)
  • Diagnosis and treatment of HIV-related comorbidities (e.g., diagnosis of tuberculosis in children)
  • Diagnosis and treatment of Zika-related outcomes in mothers and infants
  • Simple and less technologically demanding point-of-care assays to monitor CD4 cell percentage/count, HIV viral load, or other surrogate markers of HIV disease progression in children
  • Interventions designed to promote or optimize medication adherence
• Child-friendly formulations (preferably not liquid preparations) of drugs used to treat or prevent HIV infection, complications of HIV infection, and/or other high-priority infections, such as tuberculosis, hepatitis, and malaria relevant to children, particularly in resource-limited countries; fixed-dose drug formulations and innovative methodologies for development of solid heat-stable formulations capable of being administered to young children (e.g., sustained release beads, etc.) and/or improve pill or volume burden
• Innovative long-lasting drug formulations for antiretroviral and other anti-infective drugs that would allow less frequent drug administration (e.g., once daily, weekly, or monthly)
• Simple, standardized, validated tools to evaluate neurodevelopmental outcomes in children in resource-limited settings
• Biomedical modalities, including vaccines, to prevent acquisition of HIV and other infectious diseases in children, adolescents, and women
• Topical microbicide agents, alone or as part of multipurpose prevention technologies, to prevent sexual acquisition of HIV and other sexually transmitted infections in adolescents, adult women, and pregnant or postpartum women
• New, non-invasive technologies to evaluate complications of antiretroviral drugs (e.g., mitochondrial toxicity, bone toxicity) in HIV-infected infants, children, adolescents, pregnant women, and their fetuses
• New technologies for measuring the HIV latent reservoir, including high-throughput, reliable, and sensitive assays.

Program Officer:
Dr. Sonia Lee

The OPPTB promotes research to improve the safety and efficacy of pharmaceuticals and to ensure centralization and coordination of research, clinical trials, and drug development activities for obstetric and pediatric populations. This includes developing and supporting a comprehensive national effort to increase the knowledge base for understanding how to appropriately treat disease during pregnancy, infancy, and childhood using pharmaceuticals that are appropriately tested within their target populations. Clinical trial and non-clinical trial small business projects of interest include:

• Research and tools to better characterize the impact of physiological and developmental changes on pharmacokinetics, pharmacodynamics, drug disposition, and drug response
• Advancements in pharmacokinetic/pharmacodynamics modeling, which improve therapeutic approaches during pregnancy, among preterm infants, children, and adolescents
• Research on devices to monitor the state of various organ systems during therapy in pregnancy or infancy
• Development of novel technologies for blood sampling for limited blood volumes
• Development of novel models for drug assay development that can be utilized across therapeutic areas
• Development of non-invasive devices for evaluating adherence to chronic therapy in life-threatening conditions (e.g., HIV, diabetes, asthma, liver and kidney transplantation)
• Development of novel approaches for oral mucosal, transdermal, nasal, ocular, and pulmonary drug delivery systems and device technologies
• Use of a materials science approach to overcome solubility limitations of pediatric drugs, increase bioavailability, decrease excipient exposure, and provide effective taste masking
• Development of nanosized formulations to optimize efficacy and minimize toxicity of pediatric drugs
• Identification of targets for pregnancy associated/induced diseases that can lead to the development of new targeted therapeutics for diseases like preeclampsia, gestational diabetes, and preterm labor

Program Officer:
Dr. Katerina Tsilou

The PGNB supports research designed to support short and long-term health so that children can achieve their full potential through an expanded understanding of factors that influence metabolism, growth (body composition and linear growth), and neurodevelopment. An additional focus includes biological (e.g., genetic, nutritional, endocrinological) factors that contribute the early life origins of non-communicable disease (e.g., obesity, diabetes, cardiovascular disease, osteoporosis). The PGNB encourages research that focuses on detecting the biological antecedents of these conditions during pregnancy, infancy. and childhood. Areas of interest for clinical trial and non-clinical trial projects include:

• New research tools, improved measurement methods, and technologies that enhance our understanding of:
  • Growth:
    • Physical growth, body composition, bone health, nutrition, and obesity
    • Determinants of normal bone mineral accretion and peak bone mass. Interactions of muscle and bone during infancy and childhood
    • Neuroendocrinology of puberty, linear growth, body composition
    • Mechanisms of hormone action during linear growth, pubertal maturation, and other aspects of physical development
  • Biological antecedents of childhood obesity and its short and long-term consequences:
    • Genetic and molecular mechanisms of obesity, psychosocial risks of obesity, and therapeutic interventions for obesity in children and adolescents
    • Impact of early life exposures including infant feeding practices on short and long-term health and development
  • Biology of nutrition as it pertains to health and development (physical and neurological function) during pregnancy, infancy and childhood including discovery, development and deployment of biomarkers for early detection of:
    • Mal-(over-/under) nutrition; including biomarkers of exposure, status, function and effect (i.e., impact on early life development including neurodevelopment)
    • Enhanced understanding of the role of human milk in child health and development.
    • Maternal nutrition (pre-pregnancy, pregnancy, and lactation)
    • Novel approaches to enhanced infant feeding practices in term and pre-term infants
  • Developmental origins of adult disease including:
    • Ascertain biomarkers early in life that predict the onset of chronic diseases such as diabetes, osteoporosis, and the metabolic syndrome later in life. The PGN Branch emphasizes the life course model to develop primary preventive approaches to these chronic diseases.
    • Develop platforms for implementation of biomarkers of disease status, nutritional status, and biological function from infancy through adolescence

Program Officer:
Dr. Andrew Bremer

The PTCIB supports research and research training in pediatric trauma, injury prevention, and critical illness across the continuum of care. Projects include: research on the prevention, treatment, and management of physical and psychological trauma and the surgical, medical, psychosocial, and systems interventions needed to improve outcomes for critically ill and injured children and youth; studies of the continuum of psychosocial, behavioral, biological, and physiological influences that affect child health outcomes in trauma, injury, and critical care; basic, clinical, and translational studies that explore short- and long-term consequences of such traumatic experiences as exposure to natural or man-made disasters, all forms of violence against children, as well as experiences of bereavement, grief, and loss; and research linking the science of pediatric emergency and critical care medicine to the epidemiology, prevention, and treatment of trauma and injury in infants, children, and adolescents. Applications of interest for both clinical trials and non-clinical trials projects include:

• Research and development on pediatric-specific technologies, devices, and equipment used by emergency and trauma care personnel as well as pediatric critical care personnel
• Research and development of novel strategies or approaches in caring for injured children prior to and during transport to treatment settings
• Development of tools and technologies for efficient screening and determination of the nature of and extent of injuries related to forms of child maltreatment
• Research and development of devices and innovative therapeutic technologies for management of medical conditions and related problems stemming from and critical illness and serious or life-threatening injuries
• Development of preventive intervention tools, materials, and technologies designed to improve clinical practice, parenting, and social system support for injured children or traumatized children
• Development and testing of preventive intervention tools, materials, and technologies designed to reduce pediatric trauma exposure and the number and severity of pediatric injuries and deaths
• Research and development of effective tools and technologies to improve the environment of pediatric intensive care including resources to promote patient safety and to enhance clinical education and training of critical care personnel
• Development of tools and technologies that support the diagnoses and treatment of critical illness in children, including nosocomial infections and iatrogenic injury

Program Officer:
Dr. Valerie Maholmes

The PDB supports research and research training in: demography (study of human populations, including fertility, mortality and morbidity, migration, the causes and consequences of demographic change, etc.); reproductive health (behavioral and social science research on STDs, HIV/AIDS, family planning, etc.); and population health (human health, productivity, behavior, and development at the population level). For clinical trial and non-clinical trial small business projects, applications are encouraged in these areas:

• Technological innovations or inventions to improve collection of biomarker data in large population-representative surveys
• Hardware or software to improve collection of accurate cause of death information or health diagnosis in large population-representative surveys or in administrative datasets
• Methods for integrating geographical information systems, spatial network analysis, and/or simulation methods for demographic research
• Methods for improving collection, documentation, archiving, and dissemination of population representative data sets, especially datasets that are complex, multilevel, or multimodal
• Methods for protecting and assuring confidentiality for human subjects when collecting, archiving, or disseminating population-representative datasets, especially datasets that are longitudinal or that include both spatial and individual-level data
• Methods for reducing cost of collecting and disseminating large population-representative datasets
• Development of effective tools for prevention research and intervention programs related to STD/HIV, pregnancy, contraception use, child health, at-risk youth, and other health-related topics and dissemination of such tools
• Innovative approaches to teaching population studies and other behavioral and social sciences at the undergraduate and graduate level
• Innovative approaches for research design, data collection techniques, measurement, and data analysis techniques in the social and behavioral sciences, with attention to methodology and measurement issues in studying diverse populations, sensitive behaviors, confidential behaviors; in issues related to the protection of research subjects; and in issues related to the archiving and disseminating complex datasets

Program Officer:
Dr. Juanita Chinn

The PPB supports research in the following areas: the physiology of pregnancy and labor; high-risk pregnancies; fetal pathophysiology; premature labor and birth; devices and instruments for newborns in the nursery and in neonatal intensive care unit (NICU); routine and extended care of newborns; products and agents related to breastfeeding; supplies specifically used in the care of newborns; nanotechnology and its application for the care of newborns; instruments and devices assessing and monitoring the nursery environment (noise, lighting, and odor); disorders of the newborn; sudden infant death syndrome; and biological and behavioral antecedents of low birth weight. The following topic areas are of high priority:

The following topic areas are of high priority for neonatal and perinatal non-clinical trial projects:

• Non-invasive (or minimally invasive) methods to assess fetal well-being, spontaneous preterm birth, preeclampsia, and stillbirth
• Methods to longitudinally assess the structure and functions of human placenta
• Lab-on-a-chip, non-, or minimally-invasive approaches for assessing: metabolic profile (e.g., glucose and lactate/pyruvate), ketone body bilirubin (unconjugated, free, indirect, and total), major chemicals (Na+ Ca+ Cl+ K+ etc.), and serum levels of administered medications; fetal and neonatal kidney functions
• Rapid methods for diagnosis of bacterial infections and inflammation and antibiotic sensitivity
• Improved syringes, needles, and injection set ups to help administer small doses of medications over prolonged periods (i.e., insulin for treating hyperglycemia)

The following topic areas are of high priority for neonatal and perinatal clinical trials required projects:

• Non-invasive or minimally invasive methods for assessing cardiovascular, cerebrovascular, renal, gastrointestinal, neurosensory, and pulmonary functions, including methods to predict long-term outcomes
• Devices, instruments, and tools to minimize bacterial colonization, reduce proclivity for thrombus formation, and reduce healthcare-associated infection risks
• Methods to assess pain in the newborn, analgesia, and evaluate neonatal abstinence syndrome (NAS) secondary to withdrawal of narcotic dependence developed during the fetal life
• Non-invasive measures to assess brain energy utilization in the newborn, especially glucose, oxygen, lactate, ketones, and other energy substrates, as well as methods for prognostication
• Improved devices and instruments for assisted ventilators for use in neonatal intensive care unit

Program Officer:
Caroline Signore

The NCMRR supports innovative research on the restoration, replacement, enhancement, or adaptation of function for people with chronic physical disabilities. This activity includes rehabilitative approaches across etiologies and the lifespan, as well as the environmental and other factors that promote full participation. We encourage studies that integrate biomedical, engineering, and/or psychosocial approaches to develop practical and creative solutions to the daily functioning of people with disabilities and their families. Learn more about the NCMRR mission and its specific program areas. Examples of both clinical trial and non-clinical trial small business projects may include:

• Adaptation and Plasticity: Develop noninvasive and surrogate measures of plasticity appropriate for use in a clinical setting to target rehabilitation therapies and monitor treatment effectiveness (e.g., biomarkers, imaging)
• Novel Technology: Orthotics, prosthetics, and robotics devices and interfaces; assistive technologies; invasive and noninvasive biological sensors, prosthetic systems or implants to improve function; new control methods and improved sensory feedback; strategies for controlling and adapting to the environment; advanced wheelchair designs and enhancements and other mobility devices; biomaterials and tissue interfaces, nanotechnology, bionics
• Rehabilitation Interventions: Development and use of robotics; gaming applications; virtual and augmented reality; simulations; m-health and other approaches to promote participation, understand and support healthy behaviors, reduce health disparities and enhance clinical compliance, especially in children with physical disabilities
• Chronic Symptom Management: Methods to increase screening for chronic conditions or preventable secondary conditions in individuals with physical disability; prevention and treatment strategies for mitigating symptoms associated with multiple chronic conditions in individuals with physical impairments, including persistent pain, symptoms of obesity, diabetes, cardiovascular deconditioning,  fatigue, symptoms of overuse injuries, pressure ulcers, sleep disturbances, and depressive symptoms; improving muscle capacity in chronic physical disability to include therapeutic or adaptive exercise and muscle stimulation; muscle-disuse syndromes and contractures; rehabilitation interventions for improvement of physical disability and comorbid cognitive, sensory, or somatic consequences of impairment, disease or injury; autonomic function in the context of injury or specific conditions
• Rehabilitation in the Community: Strategies to build or modify community and/or environmental resources that provide effective rehabilitation and health promotion services within the individual's own community; development of engineering, crowdsourcing, and social science approaches to promote, monitor, and sustain outcomes in real-world settings

Investigators proposing budgets that exceed the stated guidelines are encouraged to contact program staff 6 weeks prior to submitting the application.

Program Officer:
Louis A. Quatrano, Ph.D.