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The NIGMS supports research and research training in the basic medical sciences and related natural and behavioral sciences and in specific clinical areas (i.e., clinical pharmacology, trauma and burn injury, sepsis and anesthesiology). The NIGMS also supports health-related research that is otherwise not assigned to another of the PHS components. The three divisions and one center that support research of potential interest to small businesses and their collaborators include: Division of Cell Biology and Biophysics Division of Genetics and Developmental Biology Division of Pharmacology, Physiology, and Biological Chemistry Center for Bioinformatics and Computational Biology For additional information about areas of interest to the NIGMS, please visit our home page at This site includes staff contact information by program area ( It also includes links to program announcements that highlight NIGMS areas of special emphasis ( In some cases, these announcements specifically mention the SBIR and STTR grant mechanisms, in most cases they do not. However, it is clear that small businesses could make contributions to the research objectives described in these announcements. Phase IIB Competing Renewal Awards NIGMS will accept Phase IIB SBIR-only Competing Renewal grant applications to continue the process of developing products that ultimately require 1) clinical evaluation, 2) approval by a Federal regulatory agency, and 3) continuing refinements to durable medical equipment (DME) designs such as cost reduction, testing for safety, durability, and reliability, and meeting or establishing standards. This renewal grant should allow small businesses to get to reach a stage where interest and investment by third parties is more likely. Such products include, but are not limited to biological products, devices, drugs, medical implants, etc. related to the mission of the NIGMS. The previously funded Phase II SBIR grant need not have been submitted in response to a particular solicitation, as long as the research is appropriate to the purpose of this solicitation. Budgets up to $750,000 total costs per year and time periods up to 2 years may be requested for this Phase IIB Competing Renewal opportunity. These awards are intended to support completion of research needed to obtain an IND or IDE. Applicants must provide evidence that they have consulted formally with the FDA concerning the research needed for the development of a drug, biologic or medical device and that the proposed research will address these regulatory requirements. Such evidence should include FDA correspondence from a pre-IND meeting for an IND application or a pre-IDE meeting for an IDE application, and the status of the project in a timeline related to Federal regulatory approval processes. Prospective applicants are strongly encouraged to contact NIH staff listed at the end of this NIGMS topics announcement prior to submission of a Phase IIB Competing Renewal application. Prospective applicants are strongly encouraged to submit to the program contact a letter of intent that includes the following information: • Descriptive title of the proposed research • Name, address, and telephone number of the Principal Investigator • Names of other key personnel • Participating institutions • Funding Opportunity Announcement Number (e.g., PA-10-XXX) Division of Cell Biology and Biophysics Research on membrane synthesis, structure, and function; membrane models; membrane transport; cell division; cell organization; cell motility; and biophysics of proteins, nucleic acids, and biological assemblies, including viral entry, packaging, maturation, and release, as well as the development of instrumentation, components, and methods for the analysis of cellular components and macromolecules by imaging, spectroscopy, and diffraction analysis. SBIR and STTR applications on the application of cell biology, biophysics, biochemistry, physics, mathematics, and chemistry to biomedical problems, and the development of instrumentation to facilitate research in cell biology and biophysics, such as, but not limited to, the topics listed below are welcome. A. Development and improvement of methods for the expression, solubilization, and purification of milligram quantities of regulatory, cellular, and membrane associated proteins, as well as for the preparation of specifically labeled macromolecules and the recovery of proteins from inclusion bodies. B. Development of novel ligands, inhibitors, and other probes for spectroscopic and microscopic analysis of cellular assemblies and viral structures, macromolecules and components, their localization and function in vivo and at a single molecule level. C. Development of instrumentation, devices, and methods for detecting in real time, analyzing, and separating biologically important compounds, macromolecules, and their interactions. D. Development of new methods and materials directed toward the solution of biological macromolecule structures by, but not limited to, x-ray diffraction, electron diffraction, and NMR spectroscopy. 1. New methods for the determination of the structures of membrane associated proteins. 2. New methods for the determination of macromolecular structures in a high throughput mode, including improved detectors, data collection, automated data analysis, and faster software for structure calculations and comparisons. 3. New methods designed to improve the efficiency of beam line use at synchrotrons. 4. New methods and technology which enhance the efficiency and reduce the costs of structural genomics protein structure determination pipelines. 5. New methods to facilitate the structure determination of large macromolecular assemblies. E. Development of technology for the imaging of molecules and cells, including but not limited to: 1. Reagents, methods, instrumentation and software for existing and potential kinds of microscopy of molecules and cells (including light, electron, X-ray, scanning probe, and others). Improved probes and supporting technologies for dynamic (real-time) imaging of molecules and molecular events in living cells by light microscopy. 2. Reagents, methods, and software for conventional and cryo-electron microscopy, including automated apparatus for controlled and reproducible specimen preparation. 3. Instrumentation, methods and technologies for analysis and manipulation of cells, subcellular components, and single molecules, including atomic force microscopy, atomic forceps and tweezers, and solid state microscopy. 4. Development of analytical systems and tools such as imaging systems and probes, to be used at the nanoscale. 5. Methods, probes, and data analysis for spectroscopy, including magnetic resonance, fluorescence spectroscopy, and EPR. F. Theoretical methods for, but not limited to: 1. Analysis of macromolecular structures. 2. Prediction of the three dimensional structures of biological macromolecules. 3. Improved methods for structure-based drug design. 4. Improved methods for the simulation and prediction of the dynamics of biological macromolecules. G. Development of computerized tools that might be used in the presentation of the concepts of cell and structural biology to audiences at a variety of levels. Division of Genetics and Developmental Biology Research on developing a better understanding of fundamental processes and mechanisms of development and inheritance in health and disease. Support of basic topics in genetics and developmental biology, including nucleic acid chemistry, the structure of genetic material, the mechanisms of transmission and expression of genetic information, cellular regulation of growth and differentiation, and population genetics. Areas that may be of interest to small businesses include, but are not limited to: A. Development of computer software for the analysis of the primary and secondary structures of nucleic acids as these relate to genetic problems. B. Improvement in procedures for the separation and analysis of nucleic acids and proteins as these relate to genetic problems. C. Improvement of methodology (technology) for genetic analysis (e.g., gene expression, probes). D. Development of probes for detection of human genetic polymorphisms, including disease genes. E. Development of improved procedures for cytogenetics and diagnostic array technology. F. Improvement in procedures (statistical, computational, laboratory) for the analysis of gene flow and gene dynamics in human populations. G. Development of improved vectors for gene transfer. H. Development of valid animal models for genetic diseases and birth defects. I. Development of quantitative approaches to the analysis of complex biological systems. J. Development of tools and technologies to detect and monitor complex human phenotypes or traits. K. Development of technology to derive and expand pluripotent cell populations from non-embryonic sources, for example, induced pluripotent stem cells (iPS). L. Development of improved technology to scale up the growth of induced pluripotent stem cells in culture and to regulate their differentiation state M. Development of markers, reagents and tools to characterize the unique properties of iPS cell lines and to distinguish them from adult stem cells and more differentiated cells. N. Development of existing human embryonic stem cell lines and new or existing iPS cells as a model system for drug discovery. O. Development or improvement of methodology for generation of antibodies or other affinity reagents for proteins and other small molecules in non-mammalian genetic model systems. P. Development of methods for chemical modifications that improve the properties of nucleic acids for gene silencing. Q. Improvement in procedures (statistical, computational, laboratory) for the high- and medium-throughput analysis of gene expression patterns and regulatory networks. R. Development or improvement of methods for high throughput detection of epigenomic changes. S. Development or improvement of methods for characterizing the metabolic interactions of complex communities of microorganisms particularly those involved in host-microbe interactions. T. Development of improved or novel methodology for structure/function analysis of very large macromolecular complexes involved in transmission or expression of genetic material. Division of Pharmacology, Physiology, and Biological Chemistry Research related to the actions of therapeutics, including anesthetics, and the development of biotechnological methods for their production and investigation. Research on cell signaling molecules and signaling intermediates, particularly those related to G-protein coupled receptors. Research in the field of glycomics, especially tool and methods development for this emerging field. Research on pain management as it relates to anesthesia and the perioperative period. Research on responses to traumatic injury, including burn injury, and methods to mitigate these responses. Research on wound healing and tissue repair. Research on the causes and treatments for common complications of critically ill patients (sepsis, systemic inflammatory response syndrome, multiple organ failure), especially directed towards the role of the inflammatory and innate immune responses. Research leading to new knowledge of physiological functions at the molecular, cellular, and organ systems levels. Research on the structure, function, and biosynthesis of cellular components and cellular metabolism, bioenergetics, and mechanisms of enzyme action, regulation, and inhibition. Research leading to the synthesis of new chemical entities or development of new chemical methods to probe biological phenomena or to alter the behavior of biological systems. Examples include, but are not limited to: A. Methods for isolation, characterization, and production of natural and bio-engineered products. 1. Metabolic engineering for the production of biochemicals through genetic and bioengineering manipulation of biosynthetic pathways. 2. Biosensors for use both in vivo and in vitro in process engineering. 3. Methods for rapid purification of natural products. 4. Methods for rapid determination of natural product structures. 5. Methods for efficient production of natural products. 6. Universal expression systems for heterologous production of natural products. B. Development of innovative synthetic chemistry. 1. Catalytic asymmetric methods and methods for large-scale synthesis. 2. New methods applicable to combinatorial library construction, design, analysis, and/or handling. 3. Improved methods for preparation of isotopically labeled amino acids, peptides, proteins, and prosthetic groups, and therapeutic agents. C. Development of enzymes, catalytic antibodies, ribozymes, artificial enzymes, and host molecules as drugs or synthetic tools. 1. Synthesis of suicide substrates, affinity labeling agents, and transition state analogs as potential therapeutic agents. 2. New enzyme assays to reduce the reliance on radio-isotopes. 3. General approaches for high throughput screening. D. Isolation, characterization, and development of factors involved in tissue repair and wound healing, i.e., growth factors. Tissue engineering. Development of artificial skin and skin replacements. E. Development of strategies, methods, or molecular based treatments to improve the speed and outcome of wound healing or to induce regeneration as a substitute to normal wound healing. F. Metabolomics/metabonomics of injury and/or critical illness. G. Improved systems for collection, processing, and analysis of real time physiological data from injured or critically ill patients. Application of systems biology or complexity theory approaches towards understanding the physiology of injured and critically ill organisms. H. Development of tools, software, algorithms, etc. needed to link clinical, demographic, physiological, genomic, proteomic or other datasets of injured or critically ill organisms. I. Development of strategies, methods, or new technologies to improve the delivery, monitoring, safety and efficacy of anesthesia. J. Research to improve drug design. 1. Methods for understanding of structure-activity relationships. 2. Mechanisms of drug-receptor interactions. 3. Development of molecular diversity libraries. K. Research to improve drug bioavailability by improved understanding of factors that influence absorption, metabolism, transport, or clearance of therapeutics and underlying mechanisms. 1. Determination of structure-activity relationships for drug metabolizing enzymes. 2. Determination of structure-transport relationships for active and passive transport of drugs and metabolites. 3. Research on drug transporter structure, function, and regulation. 4. Development and validation of models for prediction of drug bioavailability and metabolism in humans. 5. Research on inter- and intra-individual differences in bioavailability. 6. Methods to improve sensitivity, accuracy, speed, and simplicity for measurements of drugs and their metabolites in complex biological matrices. L. Application of pharmacokinetic and pharmaceutical principles to the study of large biomolecules, such as proteins, polypeptides, and oligonucleotides. M. Development of novel targeted delivery systems for both conventional drugs and large molecules. N. Research to discover, detect, and understand the genetic basis of individual differences in drug responses. 1. Identification of polymorphisms in human drug receptor and drug metabolizing enzymes. 2. Development of laboratory-based and computational approaches for pharmacogenetic and pharmacogenomic mechanistic studies. 3. Development of statistical analysis methods related to research in pharmacogenomics. 4. Development of genotyping and phenotyping tests to support research in pharmacogenomics. 5. Development of proteomic and metabolomic methodologies related to research in pharmacogenomics. 6. Creation of appropriate databases, specimen, and cell culture collections to support research in this area. O. Development of novel in vivo and in vitro methods to predict toxicities of pharmacologic agents. P. Development of differentiated hepatic cell lines from human stem cells that are equivalent to adult hepatocytes to characterize metabolic profiles of pharmacological candidates by phase 1 and 2 enzymes. Q. Development of bioinformatic, mathematical, and/or computational approaches/resources and/or pharmacokinetic modeling programs which utilize ADME parameters of drugs and pharmacogenomic information of individual patients or patient populations to reduce adverse drug reactions in individual patients. R. Development of ontologies and modules useful for combining and mining databases containing genotype and phenotype information in order to discover correlations for drug effects, either therapeutic or adverse. S. Development of methods and tools for the field of glycomics including but not limited to: 1. Development of carbohydrate specific databases as well as informatics tools to mine carbohydrate data bases. 2. Development of new facile methodologies to rapidly synthesize and expand defined carbohydrate libraries, especially those applicable for screening for glycomic biomarkers, assessing carbohydrate protein interactions, and development of glycan arrays. 3. Development of linker methods for carbohydrates. 4. Development of methods for exploring glycan-protein, glycan-lipid, and glycan-glycan interactions. 5. Development of well characterized commercial sources of glycosyltransferases and glycosidases that can be used as research tools by the scientific community. 6. Development of methods for high throughput structural analysis of the glycoconjugates of proteins and lipids. 7. Development of defined antibodies as tools for the field of glycomics. T. Development and application of methods and materials for the elucidation of membrane protein structures at or near atomic resolution. 1. Novel vector and host cell systems for over-expression of membrane proteins, in both unlabeled and isotopically labeled forms. 2. Novel and high purity detergents and non-detergent solubilization agents for the purification and crystallization of membrane proteins. 3. Apparatus to facilitate crystallization and manipulation of fragile crystals for data collection. 4. Reagents for heavy atom derivatization of membrane protein crystals. U. Development of high-throughput methods for sequencing and resequencing of mitochondrial genes and relevant nuclear genes and for proteomic and/or functional profiling of mitochondria in diagnosis of mitochondrial diseases. V. Development of methods to create site-directed and knock-out mutations of mitochondrially-encoded genes in higher eukaryotic cells and experimental animals. W. Development of new metal ion chelators and other tools to probe and/or alter the localization and concentration of metal ions in cells and in whole organisms. Research to exploit metal metabolism and metal-regulated cellular control and cell-cell signaling processes to probe and/or alter cell function. Research to develop investigational and therapeutic applications of metal-complexes and to understand the factors governing their pharmacology and toxicology. X. Development of high-throughput methods and strategies to characterize the function of proteins and enzymes and/or define the functional interrelationships of proteins and enzymes. Y. Development of research tools to promote scientific collaboration in any of the above areas of research. For example, applications software for secure peer-to-peer networking to facilitate the exchange of scientific data and research materials or to construct a searchable distributed database. Z. Development of tools to characterize oxidative stress and oxidative stress related molecules (NO, peroxynitrite, hydrogen peroxide, lipoxidation products modified proteins, DNA modifications, etc.) including the extent and/or localization (by organ/tissue/cell/organelle) of oxidative stress. Center for Bioinformatics and Computational Biology A. Development of tools and methods to model complex biological systems that fall within the mission of NIGMS. B. Development of tools and methods for behavioral and social modeling. C. Development and enhancement of databases and data formats for activities that fall within the mission of NIGMS. D. Development of tools and methods for scientific visualization, data mining, and integration and interoperability of different databases and varying modalities of data. E. Design and development of software and hardware for improving the effectiveness of computational approaches in biomedical research. Other Research Topic(s) Within the Mission of the Institute For additional information on research topics, contact: Cell Biology and Biophysics Charles Edmonds, Ph.D. National Institute of General Medical Sciences 301-594-0828, Fax: 301-480-2004 Email: Genetics and Developmental Biology Stefan Maas, Ph.D. National Institute of General Medical Sciences 301-594-0943, Fax: 301-480-2228 Email: Pharmacology, Physiology, and Biological Chemistry Scott Somers, Ph.D. National institute of General Medical Sciences 301-594-3827, Fax: 301-480-2802 Email: Center for Bioinformatics and Computational Biology Peter Lyster, Ph.D. National Institute of General Medical Sciences 301-451-6446, Fax: 301-480-2802 Email: For administrative and business management questions, contact: Ms. Patrice Molnar National Institute of General Medical Sciences 301-594-5136, Fax: 301-480-2554 Email:
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