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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.

 

 

 

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.

Teresa Jones, M.D. (Diabetes Complications)

Administrative and Business Management Contact

Natasha Loveless (email)

DEM Small Business Program

The efforts of the small businesses supported by SBIR & STTR awards from DEM have led to development of commercial products, available to clinical and research communities, have resulted in positive commercialization outcomes (e.g., mergers and acquisitions), and impact clinical care. In addition to the Omnibus and Direct-to-Phase II solicitations, DEM supports a number of targeted funding opportunities, including those supporting development of Technologies for the Complications of Type 1 Diabetes and Reagents for Glucagon and Incretin Research. Research in these areas is also supported by the Type 1 Diabetes Special Statutory Funding Program.

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

I.  Sensors, Hormone Replacement, and Delivery Devices:

  • Assessment of non-invasive, minimally invasive or implantable sensors for monitoring blood or interstitial fluid glucose for prevention of hypo- and hyperglycemia in diabetic patients. NIDDK will give priority to research that has already progressed to an in vivo model or to be clinically tested.
  • Integration of glucose sensor and hormone delivery systems to create an artificial pancreas.
  • Development of novel sensors for monitoring of nutrients and metabolites that may be integrated into a closed loop system for better metabolic control.
  • Development of improved insulin and other pancreatic hormone delivery methods or devices.
  • Development of novel insulin and glucagon formulations showing improved kinetics and stability.
  • Development of novel and more accurate non-enzymatic based glucose detection technologies.
  • Development of telemedicine/remote monitoring approaches that can be incorporated as components/and or adjuvants of an artificial pancreas for better diabetes self-management.
  • Development of technologies that may promote and facilitate adherence/compliance by users of glucose monitoring and control devices.
  • Development of biomaterials that can deliver drugs or biologics to a diabetic foot ulcer to improve healing.
  • Development of sensors, algorithms and patient interfaces that can provide feedback to diabetic individuals with insensate feet to prevent or off-load diabetic foot ulcers.

II.  Screening Tests, Diagnostics and Biologic Tools:

  • Development of techniques or products/biomarkers useful for predicting, preventing or delaying progression of diabetes, including tests for identifying patients at risk, and methods of monitoring disease progression.
  • High throughput - Point of care technologies (reliable, accurate, cost-effective, highly sensitive, standardized having rapid turnaround time) for autoantibody detection, T cell –subsets-auto-reactivity and other immune parameters for autoimmune diabetes diagnosis and follow-up.
  • Development of methods to measure changes in the immune status that may be used as markers to follow the immune-modulatory activity and beneficial effect (beta cell mass preservation, reduction of inflammation at the target organ, etc.,) of biologic agents tested in clinical trials for the prevention and/or treatment of T1D.
  • Development of high throughput assays based on biologic pathways likely involved in the pathogenesis of diabetes and its complications.
  • Development of methods/techniques/assays to measure adipose tissue in different depots in humans, including marrow fat.
  • Develop validated, highly sensitive, and specific assays for glucagon detection.
  • Development of reagents for assessment/manipulation of glucagon receptor activity in the pancreatic islet and other tissues.
  • Reagents to be used to improve our understanding of pancreatic alpha-cell biology particularly in response to glucagon and incretins.
  • Reagents and assays for the accurate expression and quantitation of functional incretin receptors in the endocrine/exocrine cells of the pancreas and relevant extrapancreatic tissues.
  • Development of materials and technologies for the support of microphysiological platforms used for pre-clinical testing and/or modeling of physiological and pathophysiological aspects of diabetes, endocrine and metabolic disorders.
  • Bio-immuno-engineering-based tools, methods and technologies to better elucidate the pathogenesis and pathophysiology of autoimmune endocrine disorders.  
  • Bioengineering based tools, methods and technologies to improve diagnosis, monitoring and treatment of diabetes, endocrine and metabolic disorders.
  • Development and validation of tools for use by health care providers/systems to improve diabetes care and prevention.
  • Development of non-invasive imaging as well as other methods for the in vivo measurement/ evaluation of pancreatic beta cell mass, function or inflammation.
  • Point of care low cost /portable technologies for diabetes and pre-diabetes diagnosis.
  • Development of innovative technologies to accurately measure and to predict and prevent hypoglycemia.
  • Development of clinical measures of the molecular and cellular damage from diabetes, such as oxidative stress, advanced glycation end-products and chronic inflammation that can be used as predictive or diagnostic biomarkers for diabetes complications.
  • Development and validation of biomarkers to monitor disease progression and response to therapy for diabetic neuropathy, including peripheral sensory, autonomic and painful diabetic neuropathy.
  • Development of diagnostic and predictive biomarkers for diabetic foot ulcers that can be used to diagnose infections, predict healing, select treatment strategies or determine risk of primary or secondary occurrence of foot ulcers.

 

III.  Interventions and Therapies:

Diabetes and Endocrine Diseases

  • Development of immunomodulation/tolerance induction strategies to prevent or slow progression of type 1 diabetes.
  • Development of methods that protect islet grafts after transplantation with no need of immunosuppression, including alternative transplantation sites, immunoisolation strategies, and immunomodulation/tolerance induction.
  • Development of reproducible methods that improve yield/viability/function of islets and allow ex-vivo expansion of human islets/insulin producing cells while still retaining appropriate functional islet characteristics and the ability to be successfully transplanted.
  • Development of methods utilizing replenishable cell sources, especially stem cells that produce functional islet like cells/tissues that can be successfully transplanted or tested in microphysiological systems and/or in vivo models of the disease.
  • Immuno-engineering strategies to improve cell replacement therapies for diabetes and other endocrine disorders.
  • Development of educational or psychosocial approaches that increase adherence to recommended diabetes treatment regimens.
  • Development of novel technologies that may facilitate self -management of diabetes and adherence to treatment.
  • 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.
  • Development of 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.
  • Development of new therapies or devices to prevent and treat diabetic foot ulcers and neuropathy, including autonomic and painful diabetic neuropathy.
  • Development of new therapies to correct the underlying metabolic defects that result from diabetes, such as reactive oxygen species production and glycation of proteins.
  • Development of therapies that can prevent or mitigate episodes of hypoglycemia.
  • Identification of new ligands for previously unclassified (orphan) nuclear receptors and development of partial agonists or antagonists with therapeutic potential for obesity and endocrine diseases within the mission of NIDDK.
  • Development of Selective Receptor Modulators (SRMs) with tissue specificity and profiles that provide beneficial effects without the side effects secondary to therapies based on naturally occurring hormones.
  • Development of novel diagnostic and therapeutic strategies for autoimmune endocrine disorders associated with diabetes or not.
  • Development of novel methods/technologies to elucidate the endocrine and metabolic role of the bone.

 

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Division of Digestive Diseases & Nutrition

Overview

The Division of Digestive Diseases and Nutrition (DDN) supports research related to digestive diseases, including the alimentary tract, liver and pancreas, nutrition and obesity.

Program Contact

Christine Densmore, M.S.

Christopher Lynch, Ph.D. (Office of Nutrition Research)

Administrative and Business Management Contact

Jennifer Cho (email)

DDN Small Business Program

DDN supports a diverse portfolio of small businesses. The efforts of the DDN's SBIR & STTR grantees have led to development of commercial products, available to clinical and research communities, have resulted in positive commercialization outcomes (e.g., mergers and acquisitions), and impact clinical care. In addition to investigator-initiated projects, DDN is also seeking applications to develop New Technologies for Viral Hepatitis and New Technologies for the Study of Lymphatics in the Digestive and Urinary Systems.

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

I.  DIGESTIVE AND LIVER DISEASES (CLINICAL)

 

  • Development of assays and new genetic screening methods for detection of biomarkers for genetic predisposition to GI-relevant diseases, pancreatitis and liver diseases.
  • Development of improved means for detecting Barrett’s esophagus, GERD, and other GI disorders.
  • Development of methods for gastrointestinal endoscopy without the need for sedation.
  • Development of agents to treat motility disorders (e.g., pseudo-obstructive disorder, chronic constipation, and slow bowel transit).
  • Development of surrogate markers and non-invasive imaging methods to quantitatively assess GI and liver disease, including pancreatic disorders.Development of non- or minimally-invasive tools that have improved therapeutic capabilities and visualization capabilities for detecting digestive disorders (e.g., mucosal abnormalities and pathologies).
  • Development of novel antifibrotic therapies for progressive liver failure.
  • Development of quantitative tests of hepatic “reserve” which would be of use, for example, in assessing the risk of surgery in patients with liver disease.
  • Development of humanized monoclonal antibodies against HCV and HBV to be used for prevention of recurrent disease in liver transplant patients.
  • Development of and validation of therapeutic interventions for treatment and/or progression of pancreatitis and its complications.
  • Development of more accurate and useful approaches to the diagnosis of chronic pancreatitis by functional, radiologic, endoscopic, or pathologic/cytologic means.


II.  DIGESTIVE AND LIVER DISEASES (BASIC)

 

  • Development of molecular probes for the diagnosis of mucosal dysplasia in inflammatory bowel disease.
  • Development of gut immune-modulators, or non-antigenic gliadin in celiac disease.
  • Development of new techniques, including non-invasive imaging, to measure motility/intestinal transit at various sites within the gastrointestinal tract.
  • Development of techniques for the preservation and transplantation of the liver, small intestine, and pancreas.
  • Development of novel proteomic or metabolomic technologies designed to study digestive and liver diseases, and their complications.
  • Development of a test for determining the hepatotoxic potential of drugs, agents or additives that is more sensitive than testing in mice and reflects the human response to the test compound.
  • Development of non- and better animal models to study hepatotoxic agents.
  • Development of non-invasive techniques to detect liver disease.
  • Creation of artificial organs or development of effective xenographic techniques for liver transplantation.
  • Development of biomarkers that quantitatively assess the degree of cold and warm ischemia injury in donor liver organs.
  • Development of non-invasive measures of pancreatic exocrine function.
  • Development of humanized mouse models of multi-allelic diseases.
  • Development of measurements to quantitate phenotypic or metabolic markers of disease progression in animal models, thus reducing the numbers of animals needed.


III.  NUTRITION, OBESITY, AND EATING DISORDERS

 

  • Development of subcutaneous sensors for continuous monitoring of single or multiple nutrients and metabolites beyond glucose.
  • Development of technologies that allow visualization, sensing, biopsy, collection, or sample delivery within discrete regions of the digestive tract.
  • Development of novel methods and tools to accurately evaluate nutritional status, physical activity, and energy expenditure.
  • Development of novel breath, urine, or blood tests to accurately measure dietary intake.
  • Development of better means to detect food borne pathogens with the goals of (1) preventing their inclusion in foodstuffs and (2) better treatment of acute gastrointestinal (GI) infections.
  • Development of safe drugs that inhibit appetite or increase energy expenditure.

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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. Each major portfolio of this division is supported by a program director:

Program Contact

Daniel Gossett, Ph.D.

Administrative and Business Management Contact

Pamela Love (email)

KUH Small Business Program

The efforts of the small businesses supported by SBIR & STTR awards from KUH have led to development of commercial products, available to clinical and research communities, have resulted in positive commercialization outcomes (e.g., mergers and acquisitions), and impact clinical care.The Division of Kidney, Urologic, and Hematologic Diseases supports research into basic mechanisms of the organ and tissue function, and the diseases of the kidney, urologic and hematologic systems. Projects are expected to help develop an understanding of the physiology, pathophysiology, and related diseases of the kidney, urinary tract, and blood and blood forming systems so that rational treatments, prevention strategies, and/or arrest of diseases may be devised. Support for advances in the technology of cell and molecular biology that will enhance research in kidney, urologic and hematologic diseases is encouraged. Development of –omics, bioinformatics, and multi-scale technologies for the study of these systems, especially where these systems interact, is 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:


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, 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 which improve efficiency and/or have lower associated morbidity (e.g., tissue engineered artificial kidneys, implantable or wearable dialyzers).
  • 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.
  • Development of reliable, non-invasive, online monitoring systems for real-time assessment of treatment parameters such as blood volume, access flow, and urea clearance.
  • Development of new agents for sterilizing dialysis membranes and development of agents or methods to reduce catheter-related infections in hemodialysis or peritoneal dialysis.
  • Development of hemodialysis or peritoneal dialysis catheters using improved biomaterials, which decrease the foreign body response, biofouling, and biofilm formation.
  • Development of devices or techniques to enhance the long-term success of kidney transplantation (e.g., techniques for kidney storage and preservation).
  • Development of health information technologies or mobile technologies that enhance delivery of care for patients with kidney diseases.
  • Development of technologies to improve kidney biopsies (i.e., to improve safety or targeting).

 

Diagnostics and Imaging

  • 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.
  • 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 collection of real-time data (e.g., biomarkers, diet, physical activity, vital signs, psychological parameters, environmental factors), patient outcomes, and adherence for clinical studies (e.g., studies of gene-environment interactions in the manifestation of kidney diseases).
  • 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.

 

Drug 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 to stimulate productive kidney repair or regeneration.
  • Development of functional nephrons for transplantation.
  • 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, and normal and abnormal lower urinary tract development, and genitourinary physiology.

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 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.

 

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 benign urologic diseases or conditions.
  • 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 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.
  • Development of bioengineered materials or structures, including cell-laden structures, for the repair or regeneration of genitourinary organs.

 

Research Tools

  • Development of tools for elucidating the role of urinary or gut microbiome in urinary stone disease or other benign urologic diseases or conditions.
  • Development of novel models of benign prostatic hyperplasia.
  • 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.

NIDDK does not support clinical trials in hematologic diseases. 

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 therapeutics that modulate blood cell production from hematopoietic stem cells and progenitors based upon understanding of physical and chemical regulatory pathways.
  • Development of therapeutics that modulate metabolism, storage, and transport of iron.

 

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 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 (e.g., hepcidin).
  • 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 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 benign hematologic diseases.

 

 

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