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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 Pamela Love (email).
All extramural divisions of the NIDDK primarily support investigator-initiated projects. An extensive but not exhaustive list of potential topics can be found in the current Program Descriptions and Research Topics Document, available at this link, or in the Omnibus Solicitations.
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.
Guillermo A. Arreaza-Rubin, M.D. (Diabetic Technology, Type 1 Diabetes, and Endocrine Diseases)
Teresa Jones, M.D. (Diabetic Wound Healing and Neuropathy and Type 2 Diabetes)
Bradley M. Cooke, Ph.D. (Neuromodulation 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:
I. 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 long functional life, and for glucose sensing be accurate at all glycemic ranges, particularly at concentrations below 54 mg/dl.
- Improved insulin and other pancreatic automated multi-hormone delivery systems.
- 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 of a major invasive surgical procedure.
II. 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 that can be used to diagnose biofilms, predict healing, select treatment strategies, or determine 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.
III. Immune Modulation and Cell Replacement Therapies:
- Development of immunomodulation/tolerance strategies to prevent, revert or slow progression of type 1 diabetes.
- 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 of systemic immunosuppression.
- Development of reproducible methods that improve yield/viability/function of islets/insulin producing cells and allow their ex-vivo expansion for transplantation.
IV. Screening Tests and Diagnostics:
- Development of methodologies, products, or biomarkers useful for predicting, preventing or delaying 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-reactivity T-cells and other immune parameters for autoimmune diabetes monitoring and diagnosis. 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.
V. 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
Low Priority Areas Include:
- Mobile applications for the monitoring of exercise, diet, caloric intake, or insulin usage.
- Development of therapeutics for treating glycemia in diabetes (with exclusion of novel insulin and glucagon formulations).
The Division of Digestive Diseases and Nutrition (DDN) supports research related to digestive diseases, including the alimentary tract, liver and pancreas, nutrition and obesity.
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:
- 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 techniques or modulators of neuroimmune interactions that target functional bowel disorders or inflammatory disease.
- Development of novel proteomic or metabolomic technologies designed to study digestive diseases and their complications.
- Development of assays and screening methods for detection of biomarkers for diagnosis, grading and staging digestive diseases.
A. Development of novel antifibrotic therapies for chronic progressive liver diseases.
B. Development of quantitative tests of hepatic “reserve” for assessment of therapeutic intervention, transplantation, or surgical risk in patients with liver disease.
C. Development of point-of-care, serologic, and rapid tests for rapid diagnosis, treatment requirements and genotyping of hepatitis.
D. Development of rapid, reliable and inexpensive tests for genetic screening and risk markers important in liver disease.
E. Development of sensitive and reliable non-invasive techniques to detect and monitor liver fibrosis and other chronic liver diseases and the associated complications.
F. Creation of bio-artificial organs for temporary hepatic support in patients with acute liver failure.
A. Development of and validation of therapeutic interventions for treatment of pancreatitis and its complications.
B. Development of more accurate, non-invasive approaches to the diagnosis of chronic pancreatitis by functional, radiologic, endoscopic, or pathologic/cytologic means.
A. Development of novel methods and tools to accurately evaluate nutritional status, physical activity, and energy expenditure.
B. Development of non- or minimally invasive technologies that allow access and/or delivery to discrete regions of the digestive tract.
C. Development of novel breath, urine, or blood tests to accurately measure dietary intake.
D. Development of technologies to detect, prevent, and treat acute gastrointestinal infections by foodborne pathogens.
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.
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 development of tools to improve understanding of the physiology, pathophysiology, and related diseases of the kidney, genitourinary 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 address health disparities are encouraged. Projects to develop technologies that will enhance research in kidney, urologic and hematologic diseases are encouraged. 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 nephropathy, polycystic kidney disease, hypertensive nephrosclerosis, 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
A. Development of innovative forms of renal dialysis which improve efficiency and/or have lower associated morbidity (e.g., tissue engineered artificial kidneys, implantable or wearable dialyzers).
B. Development of pharmacological agents, devices, techniques, or diagnostics that enhance maturation and longevity of a vascular access.
C. Development of dialysis membrane technologies with enhanced biocompatibility and anti-fouling properties.
D. Development of a means to provide continuous anticoagulation to permit renal replacement therapy.
E. Development of reliable, non-invasive, online monitoring systems for real-time assessment of treatment parameters such as blood volume, access flow, and urea clearance.
F. Development of new agents for sterilizing dialysis membranes and development of agents or methods to reduce catheter-related infections in hemodialysis or peritoneal dialysis.
G. Development of hemodialysis or peritoneal dialysis catheters using improved biomaterials, which decrease the foreign body response, biofouling, and biofilm formation.
H. Development of novel methods to generate dialysate for hemodialysis or peritoneal dialysis.
I. Development of devices or techniques to enhance the long-term success of kidney transplantation (e.g., techniques for kidney storage and preservation).
J. Development of technologies to improve kidney biopsies (i.e., to improve safety or tissue acquisition).
Health Information Technologies
K. Development of health information technologies or mobile technologies that enhance delivery of care, population health management, and/or research for patients with kidney diseases.
L. 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 data for research and care of individuals with kidney diseases.
M. Development of technologies to engage patients with kidney diseases in their care or to support interaction with caregivers.
Diagnostics and Imaging
N. Development of clinical assays that enable precision medicine approaches to treating kidney diseases.
O. Development of non- or minimally-invasive methods for evaluating kidney function, including in individuals with congenital genitourinary conditions.
- Reliable, non-invasive, non-radioactive methods of measuring glomerular filtration rate (GFR).
- 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.
P. Development of improved renal imaging techniques, differential renal function assessment, diagnostic assessment of non-malignant kidney diseases, or measurement of perinatal nephron endowment.
Q. Development of technology to improve 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, environmental factors which affect the development or progression of kidney disease), patient outcomes, and adherence for clinical studies.
R. 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
S. 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.
T. Development of drugs or biologics to stimulate productive kidney repair or regeneration.
U. Development of functional nephrons for transplantation.
V. 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).
W. Development of data and cell banks (e.g., of diabetic kidney disease families and polycystic kidney disease families) for use by the research community.
X. 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, and normal and abnormal lower urinary tract development, and genitourinary physiology.
Diagnostics and Imaging
A. Translation of blood or urine biomarkers in the lower urinary tract or other urologic disorders into commercial assays with clinical utility.
B. Development of non-invasive or minimally invasive methods to diagnose bladder inflammation or changes in the urothelium that are not of a cancerous origin.
C. Development of new technologies or methods with reduced radiation dose for evaluating vesico-ureteral reflux in children and infants.
D. Development of diagnostic modes to clinically and non-invasively or minimal-invasively measure bladder outlet obstruction before and after surgical or pharmaceutical intervention.
E. 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.
F. 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.
G. Development of radiation-free and accurate imaging technologies for urinary stone disease.
Drug and Device (Therapeutic) Interventions
H. 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 benign urologic diseases or conditions.
I. Development of novel neuromodulation devices, which restore function or mitigate pain conditions of the lower urinary tract.
J. Development of urinary catheters which reduce the incidence of infection in the urinary tract and decrease urethral and bladder inflammation.
K. Development of technologies for treatment of bladder outlet obstruction.
L. Development of health information technologies or mobile/wireless technologies that enhance delivery of care for patients with benign urologic diseases or conditions, including transition in lifelong care of congenital genitourinary conditions.
M. Development of bioengineered materials or structures, including cell-laden structures, for the repair or regeneration of genitourinary organs.
Health Information Technologies
N. Development of health information technologies or mobile technologies that enhance delivery of care, population health management, and/or research for patients with urologic diseases.
O. 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 data for research and care of individuals with urologic diseases.
P. Development of technologies to engage patients with urologic diseases in their care or to support interaction with caregivers.
Q. Development of tools for elucidating the role of urinary or gut microbiome in urinary stone disease or other benign urologic diseases or conditions.
R. Development of novel models of benign prostatic hyperplasia.
S. Development of technology to improve collection of real-time data (e.g., biomarkers, diet, physical activity, vital signs, psychological parameters, and 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, hematopoietic stem cell transplantation in heritable blood diseases (e.g., sickle cell disease, thalassemia, hemochromatosis, hemoglobinopathies, iron overload, anemia, and cytopenia), 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
A. Establishment of robust in vitro or animal models of benign hematologic diseases for drug discovery or development.
B. Development of therapeutics that target elements of hematopoietic stem cell niches (e.g., stromal cells, osteoblasts, endothelium, macrophages, pericytes, nerve cells).
C. Development of therapeutics that modulate blood cell production from hematopoietic stem cells and progenitors based upon understanding of physical and chemical regulatory pathways.
D. Development of therapeutics that modulate metabolism, storage, and transport of iron.
E. 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.
F. Development of therapeutics that induce fetal hemoglobin synthesis by chemical means, genome editing, or other means.
G. Development of therapeutics that target blood cell membrane structure.
Diagnostics and Imaging, Medical Technologies, and Research Tools
H. Development and validation of sensitive, specific, reproducible, quantitative, and clinically applicable assays for measuring levels or expression of iron regulatory molecules (e.g., hepcidin).
I. Development of technologies to track, purify, monitor or assay single-cells in vivo or in vitro.
J. Development of non-invasive systems for monitoring circulating blood cells, blood chemistry or blood cell production.
K. Development of imaging technology for the non-invasive measurement of bone marrow cellularity and function.
L. Development of imaging technology for the non-invasive measurement of tissue iron loading and distribution.
M. Development of technologies to understand the roles of mitochondria in benign hematologic diseases.