Scientific Program Areas of the NIDDK

The NIDDK SBIR & STTR programs are supported by three extramural divisions, specializing in different areas of research and medicine. The links below will take you to program descriptions and contacts in each of the divisions. For general programmatic inquiries, contact Daniel Gossett (email), or for general inquiries regarding administrative and business management matters, contact Christina Coriz (email).
 

All extramural divisions of the NIDDK primarily support investigator-initiated projects. Please also find the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Strategic Plan for Research, published in December 2021, at https://www.niddk.nih.gov/about-niddk/strategic-plans-reports/niddk-strategic-plan-for-research

Division of Diabetes, Endocrinology, & Metabolic Diseases

Overview

The Division of Diabetes, Endocrinology, and Metabolic Diseases (DEM) provides research funding and support for basic and clinical research in the areas of type 1 and type 2 diabetes and other metabolic disorders, including cystic fibrosis; endocrinology and endocrine disorders; obesity, neuroendocrinology, and energy balance; and development, metabolism, and basic biology of liver, fat, and endocrine tissues.

Program Contacts

Guillermo A. Arreaza-Rubin, M.D. (Diabetic Technology, Type 1 Diabetes and Endocrine Diseases)

Yan Li, Ph.D. (Diabetic Foot Ulcer and Wound Healing)

Brad Cooke, Ph.D. (Neuromodulation, Diabetic Peripheral Neuropathy, Obesity, and Type 2 Diabetes Drug Discovery)

Administrative and Business Management Contact

Natasha Loveless (email)

DEM Small Business Program

The Division of Diabetes, Endocrinology, and Metabolic Diseases supports SBIR/STTR projects in the areas of type 1 and type 2 diabetes, endocrine disorders, and neuroendocrinology. High-priority topic areas are listed below:

Sensors, Hormone Replacement, Delivery Devices, and Other Technologies for Diabetes Treatment:

• Novel, accurate, reliable, and user-friendly continuous monitoring sensor technologies relevant to diabetes treatment and monitoring. Preferably, these sensors should have a long functional life and, for glucose sensing, be accurate at all glycemic ranges, particularly at concentrations below 54 mg/dl.
• Use of Artificial Intelligence and Machine Learning (AI/ML) tools to enable fully automated closed-loop pancreatic hormone delivery systems in response to multi-analyte physiological input.
• Novel insulin and glucagon formulations showing improved kinetics and stability.
• Telemedicine/remote monitoring approaches that can be incorporated as components/and or adjuvants of closed-loop systems for better diabetes self-management.
• Technologies that may promote and facilitate adherence/compliance by users of diabetes monitoring and control devices.
• More reliable and efficient biocompatible infusion sets for automated hormone delivery and improved kinetics.
• New implantable and easy-to-replace technologies that may mimic the beneficial effect of gastric bypass/bariatric surgery for the treatment of diabetes without the need for a major invasive surgical procedure.

Diabetic Wound Healing and Diabetic Neuropathy:

• Drugs, biologic therapies, and novel delivery systems that accelerate healing of diabetic foot ulcers and prevent recurrences.
• Off-loading devices that improve patient acceptability and adherence.
• Diagnostic and predictive biomarkers, including improved outcome measures, for diabetic foot ulcers can be used to diagnose biofilms, predict healing, select treatment strategies, or determine the risk of primary or secondary occurrence of foot ulcers. The biomarkers may use biosamples, images, or sensors.
• Educational approaches and new technologies that increase adherence to preventative measures for diabetic foot ulcers in high-risk patients or increase adherence to off-loading and other recommended treatment regimens for diabetic foot ulcers.
• Disease-modifying therapies for the prevention and treatment of diabetic neuropathy.
• Sensors, algorithms, and patient interfaces that can provide feedback to diabetic individuals with insensate feet to prevent diabetic foot ulcers.
• Biomarkers to monitor disease progression and response to therapy for diabetic neuropathy, including peripheral sensory, autonomic, and painful diabetic neuropathy.

Immune Modulation and Cell Replacement Therapies:

• Development of immunomodulation/tolerance strategies, including cell-based, to prevent, revert, or slow the progression of type 1 diabetes.
• Development and optimization of engineered islet cell replacement sources with improved transplant graft attributes, including but not exclusive to: graft function durability under transplantation and metabolic stress; graft survival with lowered or no systemic immunosuppression and non-invasive quantitative monitoring of graft mass.
• Novel biomimetic and immuno-engineering strategies for the development of immune evasive cells/islets and biomaterials/devices for successful long-term engraftment with no need for systemic immunosuppression.
• Development of reproducible methods that improve yield/viability/function of islets/insulin-producing cells and allow their ex-vivo expansion for transplantation.

Prediction, Screening, Diagnostics, and Monitoring:

• The development of methodologies, products, or biomarkers is useful for predicting, preventing, or delaying the progression of pre-diabetes or diabetes, including tests for identifying patients at risk and methods of monitoring disease progression.
• Validated tests for autoantibody detection, auto-reactive T-cells, and other immune/metabolic parameters for type 1 diabetes early diagnosis and monitoring. Improvements could include higher throughput - point-of-care technologies (reliable, accurate, cost-effective, highly sensitive, and standardized with rapid turnaround time).
• Multiplexed assays for peptides and proteins that are used as biomarkers in diabetes and metabolic diseases (e.g., insulin, pro-insulin, glucagon, c-peptide, HbA1c..etc).
• Development of non-invasive technologies such as imaging for the in vivo measurement/evaluation of pancreatic islet’s cell mass, function, and inflammation.
• Artificial Intelligence, Machine Learning, and Deep Learning driven methods and technologies that may optimize the prediction, diagnosis, monitoring, and treatment of diabetes, endocrine, and metabolic disorders.

Pre-Clinical Research and Disease Modeling:

• Development and optimization of microphysiological/organ-on-chip platforms in the application of pre-clinical testing and/or modeling of physiological and pathophysiological aspects of diabetes, endocrine, and metabolic disorders.
• Development of methods utilizing replenishable cell sources that generate functional islet-like cells/tissues that can be successfully tested in micro-physiological systems and/or in vivo models of the disease.
• Development and testing of in silico/simulation models with predictive capability to complement and/or replace in vitro and in vivo pre-clinical testing.

Tools for Measuring Peripheral Neurotransmitters and Neuromodulation:

• Devices that modulate or control the hepatic or pancreatic branches of the vagus nerve with the aim of relieving diabetes or other metabolic disorders. Projects concerned with the liver should be focused on the regulation of glucose or lipid metabolism. Technologies would include closed- or open-loop neural stimulators of sensory or motor nerves originating from or terminating in the endocrine pancreas or liver.
• Tools that provide high spatio-temporal resolution of neurotransmitter release in the endocrine pancreas or liver.
• Tools that measure autonomic activity in the liver, endocrine pancreas, or adipose tissue in animal models or humans.

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Division of Digestive Diseases & Nutrition

Overview

The Division of Digestive Diseases and Nutrition supports research in diseases and disorders of the digestive tract; esophagus, stomach, intestine, colon, anorectum, pancreas, liver, gallbladder, and biliary tract; as well as research in nutrition and obesity. Innovative investigator-initiated projects that are not mentioned below are also encouraged.

Program Contacts

Christine Densmore, M.S. (Liver, Pancreatic, and Neurobiological Disorders and Diseases)

R. Dwayne Lunsford, Ph.D. (Gastrointestinal, Obesity, and Nutrition Disorders and Diseases)

Administrative and Business Management Contact

Jennifer Cho (email)

DDN Small Business Program

The Division of Digestive Diseases and Nutrition supports research in diseases and disorders of the digestive tract; esophagus, stomach, intestine, colon, anorectum, pancreas, liver, gallbladder, and biliary tract; as well as research in nutrition and obesity. Innovative investigator-initiated projects that are not mentioned below are also encouraged.

The NIDDK encourages any application that falls within its purview. Research topics of potential interest to small businesses include, but are not limited to:

Gastrointestinal:

• Development of new diagnostic techniques and tests, including non-invasive tests and imaging for detecting Barrett’s esophagus, GERD, and other intestinal disorders.
• Development of agents and techniques to measure, diagnose, stimulate regeneration of enteric neurons, and treat motility disorders.
• Development of novel therapies to modulate/enhance GI lymphatic function for the treatment of GI pathologies.
• Development of gut-derived biomarkers of neurodegenerative brain disease.
• Development of approaches to simultaneously interrogate or modulate the central nervous system (CNS) and the gastrointestinal system.
• Development and validation of neurotechnologies that improve the association of symptoms, pathophysiology, and function for gastrointestinal disorders.
• Development of novel proteomic or metabolomic technologies designed to study digestive diseases and their complications.
• Development of assays and screening methods for the detection of biomarkers for diagnosis, grading, and staging digestive diseases.
• Development of Live Biotherapeutic Products (LBPs), such as probiotic organisms for the prevention or treatment of gastrointestinal conditions, or to enhance the nutritional properties of dietary components. These LBPs would not include vaccines, oncolytic bacteria, or gene therapy agents.

Liver:

• Development of novel antifibrotic therapies for chronic progressive liver diseases.
• Development of quantitative tests of hepatic “reserve” for assessment of therapeutic intervention, transplantation, or surgical risk in patients with liver disease.
• Development of point-of-care, serologic, and rapid tests for rapid diagnosis, treatment requirements, and genotyping of hepatitis.
• Development of rapid, reliable, and inexpensive tests for genetic screening and risk markers important in liver disease.
• Development of sensitive and reliable non-invasive techniques to detect and monitor liver fibrosis and other chronic liver diseases and the associated complications.
• Creation of bio-artificial organs for temporary hepatic support in patients with acute liver failure.

Pancreas:

• Development of and validation of therapeutic interventions for the treatment of pancreatitis and its complications
• Development of more accurate, non-invasive approaches to the diagnosis of chronic pancreatitis by functional, radiologic, endoscopic, or pathologic/cytologic means.

Nutrition/Obesity:

• Development of novel methods and tools to accurately evaluate nutritional status, physical activity, and energy expenditure.
• Development of non- or minimally invasive technologies that allow access and/or delivery to discrete regions of the digestive tract.
• Development of novel breath, urine, or blood tests to accurately measure dietary intake.
• Development of non-invasive neurotechnologies to stimulate and/or modulate hormone/peptide release from the gastrointestinal system for the treatment of metabolic disorders such as obesity.

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Division of Kidney, Urologic, & Hematologic Diseases

Overview

The Division of Kidney, Urologic, & Hematologic Diseases (KUH) provides research funding and support for basic, translational, and clinical research studies of the kidney, urinary tract, and disorders of the blood and blood-forming organs.

Program Contact

Jason Conage-Pough, Ph.D. (Drug Development in Kidney, Urologic, & Hematologic Diseases)

Daniel Gossett, Ph.D. (Device, Diagnostic, and Other Technology Development in Kidney, Urologic, & Hematologic Diseases)

Administrative and Business Management Contact

Pamela Love (email)

KUH Small Business Program

The Division of Kidney, Urologic, and Hematologic Diseases provides research funding and support for basic, translational, and clinical research studies of the kidney, urinary tract, and disorders of the blood and blood-forming organs. Projects may include the development of tools to improve understanding of the physiology, pathophysiology, and diseases of the kidney, urinary tract, and blood and blood-forming systems or to develop rational diagnostics, treatments, and prevention strategies for these diseases. Projects may be to develop tools/technologies to support clinical care, population health and/or pragmatic research to improve health outcomes in populations with kidney diseases and/or urologic conditions. Projects to develop tools or technologies to address health disparities or promote health equity are encouraged. NIDDK encourages research that takes a holistic perspective of human health by considering biological, behavioral, and social contributors to the scientific exploration, prevention, and management of these diseases/conditions. Development of -omics, bioinformatics, and multi-scale technologies for the study of these systems, especially where these systems interact, is also encouraged. Research opportunities that may be of interest to small businesses include, but are not limited to:

I. Kidney Diseases:

 Areas of research include chronic kidney disease, end-stage renal disease, diabetic kidney disease, polycystic kidney disease, hypertensive kidney injury, acute kidney injury, kidney donation (delayed graft function and chronic rejection), congenital kidney disorders, glomerular and tubulointerstitial diseases, IgA nephropathy, hemolytic uremic syndrome, fluid and electrolyte disorders, kidney repair and regeneration, and normal and abnormal kidney development and physiology.

Dialysis, Devices and Medical Technologies

• Development of innovative forms of renal dialysis that improve efficiency, have lower associated morbidity (e.g., tissue-engineered artificial kidneys, implantable or wearable dialyzers), reduce side effects and constraints of dialysis treatment, and/or improve access, experience, and quality of life.
• Development of functional nephrons for transplantation.
• Development of pharmacological agents, devices, techniques, or diagnostics that enhance maturation and longevity of a vascular access.
• Development of dialysis membrane technologies with enhanced biocompatibility and anti-fouling properties.
• Development of a means to provide continuous anticoagulation to permit renal replacement therapy.
• Development of reliable, non-invasive, wearable, or online monitoring systems for real-time assessment and adjustment of treatment parameters such as blood volume, access flow, and urea clearance.
• Development of hemodialysis or peritoneal dialysis catheters using improved biomaterials, which reduce catheter-related infections, the foreign body response, biofouling, and biofilm formation.
• Development of novel methods to generate dialysate for hemodialysis or peritoneal dialysis.
• Development of devices or techniques to enhance the long-term success of kidney transplantation (e.g., techniques for repairing kidneys or for kidney storage and preservation).
• Development of technologies to improve kidney biopsies (i.e., to improve safety or tissue acquisition).

Health Information Technologies

• Development of health information technologies or mobile technologies that enhance delivery of care, population health management, health equity, and/or research for patients with kidney diseases.
• Development of applications or application programming interfaces that use health data standards (e.g., Fast Healthcare Interoperability Resources [FHIR], clinical terminologies) to improve accessibility, accuracy, and/or completeness of real-world health, behavioral, and societal/contextual data for research and care of individuals with kidney diseases.
• Development of technologies to engage patients with kidney diseases in their care or to support interaction with caregivers.
• Development of innovative technologies or platforms to facilitate kidney research training and education, which could include software or simulation tools.

Diagnostics and Imaging

• Development of clinical assays that enable biopsychosocial precision medicine approaches to treating kidney diseases.
• Development of technologies that use artificial intelligence/machine learning (AI/ML) or other advanced statistical approaches to integrate disparate data types to inform the diagnosis of kidney diseases. AI/ML approaches should leverage data from diverse populations and apply equity considerations to ensure resulting models do not further embed structural racism or discrimination.
• Development of platforms for pre-analytical preparation, imaging, and automated analysis of kidney tissue.
• Development of non- or minimally invasive methods for evaluating kidney functions, including in individuals with congenital genitourinary conditions.
  • Reliable, non-invasive, non-radioactive methods of measuring glomerular filtration rate (GFR) or tubular functions.
  • Translation of biomarkers of acute kidney injury or chronic kidney disease with clinical utility into commercial assays.
  • Translation of biomarkers for early detection of kidney diseases or prediction of kidney disease progression, recovery, or drug response.
• Development of improved renal imaging techniques, differential renal function assessment, diagnostic assessment of non-malignant kidney diseases, or measurement of perinatal nephron endowment.
• Development of technology to improve the collection of real-time data (e.g., biomarkers, diet, physical activity, patient-reported outcomes, vital signs, patient experience of kidney or urologic disease or its treatment, social or environmental factors that affect the development or progression of kidney disease), patient outcomes, and adherence for clinical studies.
• Development of imaging or molecular analysis technologies to enhance information extraction from renal biopsies and development of antibodies or other probes for unique cell types of the kidney.

Therapeutics Discovery and Development

• Lead optimization and preclinical development of pharmacological agents that might be used to intervene in acute or chronic renal disorders and in disorders of renal hemodynamics, blood pressure, electrolyte metabolism, and extracellular volume regulation.
• Development of drugs or biologics designed to specifically target kidney cell types.
• Development of drugs or biologics to stimulate productive kidney repair or regeneration.
• Development of technologies to enhance the validation of kidney disease targets or to screen compounds for efficacy or toxicity (e.g., kidney organoids or tissue chips, more relevant animal models of acute kidney injury).
• Development of data and cell banks (e.g., of diabetic kidney disease families and polycystic kidney disease families) for use by the research community.
• Development of preventative measures for acute kidney injury (e.g., during coronary artery bypass grafting, sepsis, or treatment with nephrotoxic agents).

II. Urologic Diseases:

Areas of research include benign prostatic hyperplasia, lower urinary tract symptoms (LUTS) including urinary incontinence, urinary tract infections, urinary stone disease, erectile dysfunction, urologic chronic pelvic pain syndromes (including interstitial cystitis and chronic prostatitis), congenital urologic disorders, repair and regeneration of lower urinary tract organs, normal and abnormal lower urinary tract development, and physiology of the urinary system and male genital organs (excluding applications targeting male fertility).

Diagnostics and Imaging

• Translation of blood or urine biomarkers in the lower urinary tract or other urologic disorders into commercial assays with clinical utility.
• Development of non-invasive or minimally invasive methods to diagnose bladder inflammation or changes in the urothelium that are not of a cancerous origin.
• Development of new technologies for rapid clinical diagnosis and characterization of urinary tract infection (UTI).
• Development of new technologies or methods with reduced radiation dose for evaluating vesico-ureteral reflux in children and infants.
• Development of diagnostic modes to clinically and non-invasively or minimal-invasively measure bladder outlet obstruction before and after surgical or pharmaceutical intervention.
• Development of objective diagnostic devices or methods for the assessment of urinary storage and voiding disorders, including stress, urge, and mixed incontinence, in both adults and children.
• Development of wireless and non-invasive or minimally invasive measurement technologies for real-time assessment of lower urinary tract function, which can include neuro-pharmacological/neuro-physiological urodynamics.
• Development of radiation-free and accurate imaging technologies for urinary stone disease.
• Development of technologies that use artificial intelligence/machine learning (AI/ML) to integrate disparate data types to inform diagnosis of urologic diseases. AI/ML approaches should leverage data from diverse populations and apply equity considerations to ensure resulting models do not further embed structural racism or discrimination.
• Development of platforms for pre-analytical preparation, imaging, and automated analysis of genitourinary tissues.

Drug and Device (Therapeutic) Interventions

• Lead optimization and preclinical development of pharmacological agents for treatment or prevention of urinary stone disease, urological chronic pelvic pain syndromes, urinary tract infections, or other urologic diseases or conditions within NIDDK’s mission.
• Development of novel neuromodulation devices, which restore function or mitigate pain conditions of the lower urinary tract.
• Development of urinary catheters which reduce the incidence of infection in the urinary tract and decrease urethral and bladder inflammation.
• Development of technologies for treatment of bladder outlet obstruction.
• Development of bioengineered materials or structures, including cell-laden structures, for the repair or regeneration of genitourinary organs.

Health Information Technologies

• Development of health information technologies or mobile technologies that enhance the delivery of care, population health management, health equity, and/or research for patients with urologic diseases or conditions.
• Development of applications or application programming interfaces that use health data standards (e.g., Fast Healthcare Interoperability Resources [FHIR], clinical terminologies) to improve accessibility, accuracy, and/or completeness of real-world health, behavioral, or social data for research and care of individuals with urologic diseases or conditions.
• Development of technologies to engage patients with urologic diseases or conditions in their care or to support interaction with caregivers.
• Development of innovative technologies or platforms to facilitate urology research training and education, which could include software or simulation tools.

Research Tools

• Development of tools for elucidating the role of urinary or gut microbiome in urinary stone disease or other urologic diseases or conditions within NIDDK’s mission.
• Development of novel models of benign prostatic hyperplasia.
• Development of technology to improve the collection of real-time data (e.g., biomarkers, diet, physical activity, vital signs, psychological parameters, and social or environmental factors), patient-reported outcomes, and adherence for clinical studies (e.g., studies of gene-environment interactions in the manifestation of urologic diseases).

III. Hematologic Diseases:

The NIDDK hematology research program focuses on understanding basic cellular and molecular mechanisms that underlie the production and function of blood cells in health and disease. The program emphasizes translational applications of new insights and knowledge gained from basic research in these areas toward the development of novel or improved approaches for the diagnosis, stratification, and treatment of hematologic diseases. This includes the development of disease biomarkers, gene targeted therapies, or hematopoietic stem cell transplantation for acquired and heritable blood diseases (e.g., hemoglobinopathies, such as sickle cell disease or thalassemia; hemochromatosis, iron overload, porphyrias, amyloidosis, iron deficiency anemia, and cytopenias resulting from bone marrow failure disorders, congenital dyserythropoietic anemias, Schwachman-Diamond syndrome, myelodysplastic syndrome, neutropenias, myelofibrosis, essential thrombocythemia, or polycythemia vera), and the measurement and chelation of tissue iron in iron overload disorders. The NIDDK hematology research program provides resources for basic and preclinical development efforts leading up to IND or IDE submissions but does not fund clinical trials. The program has a particular focus on myeloid lineage and hematopoietic stem cells, including the effects of aging on hematopoiesis.

Drug Discovery and Development

• Establishment of robust in vitro or animal models of benign hematologic diseases for drug discovery or development.
• Development of therapeutics that target elements of hematopoietic stem cell niches (e.g., stromal cells, osteoblasts, endothelium, macrophages, pericytes, nerve cells).
• Development of novel bone marrow conditioning regimens that promote hematopoietic stem cell homing, engraftment, and hematopoiesis.
• Development of therapeutics that modulate blood cell production from hematopoietic stem cells and progenitors based upon an understanding of physical and chemical regulatory pathways.
• Development of therapeutics that modulate metabolism, storage, and transport of iron or heme.

Cell Therapies

• Development of equipment, chemically defined reagents, and methods for high volume ex vivo expansion, isolation, and/or differentiation of highly purified human hematopoietic stem and progenitor cells.
•  Development of equipment, chemically defined reagents, and methods for selective removal or destruction of diseased human hematopoietic stem and progenitor cells (e.g., in myelodysplastic syndrome, MDS). Treatment of malignant clones and blood cancers are not within the scope of the NIDDK Hematology mission.
• Development of therapeutics that induce fetal hemoglobin synthesis by chemical means, genome editing, or other means.
• Development of therapeutics that target blood cell membrane structure.

Diagnostics and Imaging, Medical Technologies, and Research Tools

• Development and validation of sensitive, specific, reproducible, quantitative, and clinically applicable assays for measuring levels or expression of iron regulatory molecules or for measuring misfolded or aggregate amyloid proteins such as amyloid A transthyretin or immunoglobulin light chain in blood.
• Development of technologies to track, purify, monitor or assay single-cells in vivo or in vitro.
• Development of non-invasive systems for monitoring circulating blood cells, blood chemistry or blood cell production.
• Development of imaging technology for the non-invasive measurement of bone marrow cellularity, fibrosis, and function.
• Development of imaging technology for the non-invasive measurement of tissue iron loading and distribution.
• Development of technologies to understand the roles of mitochondria in non- malignant hematologic diseases.
• Development of technologies that use artificial intelligence/machine learning (AI/ML) to integrate disparate data types (e.g., histomorphology, karyotyping, next generation sequencing, immunophenotyping, and flow cytometry) to inform diagnosis of non- malignant hematologic diseases. AI/ML approaches should leverage data from diverse populations and apply equity considerations to ensure resulting models do not further embed structural racism or discrimination.
• Development of platforms for pre-analytical preparation, imaging, and automated analysis of the bone marrow.
• Development of innovative technologies or platforms to facilitate hematology research training and education, which could include software or simulation tools.

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