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| 157 | Clinical Research Toolbox | NCATS supports a broad range of clinical research tools that facilitate clinical trial design, patient recruitment and regulatory compliance. For example, through the Clinical and Translational Science Awards (CTSA) Program, many of these tools are developed, perfected and shared broadly throughout the CTSA Program network. Designed to be shared, these resources can further enable and accelerate research collaboration, particularly for multisite studies. Selected clinical research tools are listed below. NCATS also provided supplemental grant funding to support a CTSA Program network project entitled, “Enhancing Clinical Research Professionals’ Training and Qualifications” (3UL1TR000433-08S1). View the results of this work (PDF - 139KB). Following are NCATS and other selected clinical research tools: Accelerated Clinical Trial Agreement, developed through a CTSA Program initiative, is a standardized contract model designed to reduce negotiation time and contracting delays for industry-sponsored multisite clinical studies, including Phase IIb and Phase III trials. BEST (Biomarkers, EndpointS, and other Tools) Resource is an online glossary developed by a Food and Drug Administration and NIH joint committee to clarify terms used in translational science and medical product development, with a focus on study endpoints and biomarkers. ClinRegs is a public website developed by NIH’s National Institute of Allergy and Infectious Diseases to help researchers navigate country-specific regulatory information as they plan and implement clinical trials. Good Clinical Practice (GCP) Social and Behavioral Research E-Learning Course was developed with CTSA Program support to provide researchers with training that applies GCP principles to social and behavioral research. GCP is an international ethical and scientific quality standard that helps assure the safety, integrity, and quality of clinical trials. NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Reliance Platform, including an authorization agreement and joinder, the first of which is an umbrella agreement that establishes a harmonized approach for roles and responsibilities of the single institutional review board (IRB) and participating sites. The joinder enables institutions to sign on to or join the authorization agreement. The NCATS Toolkit for Patient-Focused Therapy Development is a centralized collection of online resources that can help patient groups advance through the research and development process for new treatments. PhenX Toolkit offers well-established, broadly validated measures of phenotypic traits and environmental exposures of interest to investigators in human genomics, epidemiology and biomedical research. REDCap is an easy-to-use, freely available tool for clinical study management and data capture, providing investigators with the ability to build and manage online surveys and databases. ResearchMatch provides a way to connect people who are trying to find research studies with researchers who are seeking people to participate in their studies. | ||||||||
| 156 | Small Molecule Probes | The NCATS Chemical Genomics Center is designed to bring advanced technologies and expertise to researchers who need specialized tools and support. Capabilities include high-throughput screens and follow-up medicinal chemistry efforts to identify and optimize small molecule probes of novel, unexplored cellular targets. These probes offer the research community proof-of-concept pharmacological tools that may serve as starting points for therapeutic development. Results from probe projects are disseminated to the scientific community through the public PubChem database and via peer-reviewed publications. To date, NCATS researchers, in collaboration with hundreds of academic, nonprofit and private-sector scientists, have developed more than 60 probes that are freely available to the scientific community. Project descriptions are in the National Library of Medicine’s e-book Probe Reports from the NIH Molecular Libraries Program. | ||||||||
| 155 | PubChem | PubChem is a free database of information about small organic molecules and their activities against biological assays. It was created by NIH in 2004 and is maintained by the National Library of Medicine. The database connects chemical information with biomedical research and clinical information, organizing facts in numerous databases into a unified whole. PubChem consists of three dynamically growing databases: PubChem Compound: Contains pure and characterized chemical compounds. PubChem Substance: Contains mixtures, extracts, complexes and uncharacterized substances. PubChem BioAssay: Contains database results from high-throughput screening programs with several million values. The integration of these databases makes PubChem a critical tool to speed the development of new treatments for patients, bringing information about the biological activities of chemical substances to biomedical researchers on a broad scale. NCATS makes assay data available in PubChem. PubChem Data Guideline The quantitative high-throughput screening (qHTS) data in PubChem are preliminary. For this reason and because of limited compound quantities, PubChem does not supply probe compounds to investigators other than those who originally submitted the assay. NCATS-generated data presented in PubChem represent primary qHTS data. Each sample is tested as a titration series to provide a concentration-response output. Although the results accurately describe the effect of the sample on the assay end point, the “actives” are not necessarily due to effects on the intended target (i.e., false-positives). PubChem provides these primary data to enable analysis using cheminformatic algorithms, to guide the selection of compounds for subsequent chemistry optimization, and to populate the “chemical genomics” database of compound-activity profiles. The value of this database increases as additional assays and compounds are added. In interpreting and using qHTS data, investigators should remember the following: The sample tested is limited in quantity, so NCATS cannot supply screening samples upon request. Some samples are commercially available and can be purchased inexpensively from vendors directly. The effect of the sample on the assay described in PubChem may reflect artifacts that result from the sample’s physical or spectroscopic properties, such as its interference in the assay due to aggregation in aqueous buffer or absorbance of emitted fluorescence for signal detection. Flags indicating the propensity for interfering phenomenon from samples in the library are included in the data set. Quality control information is not necessarily current. The results are determined from “samples” because the term “compound” implies a single chemical entity. Subsequent analysis by liquid chromatography-mass spectrometry and verification of the activity are performed for a subset of the samples, and these data are entered into PubChem. The IC50/EC50s (referred to as AC50s) determined from the normalized titration-response data (n = 1) are estimates. Curve-fitting artifacts can occur due to the high-throughput nature of the analysis. Flags indicating whether a curve fit is verified are updated over time. The primary data are available for interpretations by others. | ||||||||
| 154 | ExRNA Communication Projects | In 2013, the NIH Common Fund provided support for 30 research projects designed to explore and enhance scientists’ understanding of exRNA communication. Of those 30 awards, NCATS administered 18 projects. In 2019, the Common Fund provided support for a second phase of research projects to address the complexity in the types of carriers that transport exRNA molecules between cells, called extracellular vesicles (EVs), and the different types of exRNA molecules associated with the carriers. The 13 Phase 2 projects will support the development of tools and technologies that address these complexities. NCATS is administering six projects that focus on better understanding and characterizing EVs by improving EV sorting, isolation and analysis of cargo. Learn more about the Phase 1 awards: View the 2015 projects to create exRNA biomarkers. View the 2015 projects to explore exRNA treatments. View the 2013 projects to develop exRNA biomarkers. View the 2013 projects to investigate exRNA treatments. Learn more about the Phase 2 awards: View the 2019 projects to improve EV sorting, isolation and analysis of cargo. View the full list of exRNA project awards on the NIH Common Fund website. | ||||||||
| 151 | ExRNA Communication Funding Information | See Current Funding Opportunities and Expired Announcements. Phase 1 In 2013, the NIH Common Fund awarded approximately $130 million over six years to scientists nationwide for projects to improve our understanding of exRNA communication. NIH funded 30 multidisciplinary research projects that address a number of critical scientific areas: exRNA biogenesis, biodistribution, uptake and effector function — how cells make and release exRNA, how and where exRNAs travel through body fluids to other cells, how the cells take in these exRNA molecules, and how exRNAs change cell function. Reference profiles — to generate a catalogue of exRNA from a diverse range of healthy human body fluids. Biomarker development — how exRNAs from human body fluids might help scientists diagnose and monitor disease progression and response to therapy. Therapy development — how exRNAs might be used as therapeutic agents. Data management — how to develop a community-wide resource for exRNA standards, protocols and data. NCATS administered and provided scientific oversight to 18 of the 30 projects, which focused on the development of biomarkers from exRNA found in body fluids and the design of new ways to use exRNA in treatments. Learn more about the Phase 1 ExRNA Communication projects from the NIH Common Fund. Phase 2 In 2019, Phase 2 of the ExRNA Communication program began when the NIH Common Fund made a new set of 13 awards focused on developing tools, technologies and methods to better understand the extracellular vesicles (EVs) that carry exRNA and other molecular cargo throughout the body. NCATS is administering and providing scientific oversight for six of these projects. Learn more about the Phase 2 ExRNA Communication projects from the NIH Common Fund or see a list of all projects funded as part of the program. Current Funding Opportunities There are no open funding opportunities at this time. Expired Announcements RFA-OD-20-018: Emergency Awards: Exosome-based Non-traditional Technologies Towards Multi-Parametric and Integrated Approaches for SARS-CoV-2 (U18 Clinical Trial Not Allowed). This emergency FOA provided an expedited funding mechanism as part of the Rapid Acceleration of Diagnostics-Radical (RADx-rad) initiative. RFA-RM-18-028: Advancing Extracellular RNA (exRNA) Communication Research: Towards Single Extracellular Vesicle (EV) Sorting, Isolation, and Analysis of Cargo (UG3/UH3 Clinical Trial Not Allowed) RFA-RM-18-027: Advancing Extracellular RNA (exRNA) Communication Research: Improved Isolation and Analysis of exRNA-Carrier Subclasses (UG3/UH3 Clinical Trial Not Allowed) RFA-RM-18-026: Limited Competition: Data Management and Resource Repository (DMRR) on Extracellular RNA (U54 Clinical Trial Not Allowed) RFA-RM-12-010: Data Management and Resource Repository (DMRR) on Extracellular RNA (U54) RFA-RM-12-012: Extracellular RNA Biogenesis, Biodistribution, Uptake, and Effector Function (U19) RFA-RM-12-013: Clinical Utility of Extracellular RNA for Biomarker Development (UH2/UH3) RFA-RM-12-014: Clinical Utility of Extracellular RNA for Therapy Development (UH2/UH3) RFA-RM-13-014: Defining A Comprehensive Reference Profile of Circulating Human Extracellular RNA (U01) | ||||||||
| 149 | About ExRNA Communication | Until recently, scientists believed RNA worked mostly inside the cell that produced it. Some types of RNA help translate genes into proteins that are necessary for organisms to function. Other types of RNA control which proteins and how much of those proteins the cells make. Now, investigators have shown that cells can release RNA — in the form of exRNA — to travel through body fluids and affect other cells. ExRNA can act as a signaling molecule, communicating with other cells and carrying information from cell to cell throughout the body. A better understanding of basic exRNA biology could open doors to improving the diagnosis, prognosis and treatment of diseases and conditions such as cancer, bone marrow disorders, heart disease, Alzheimer's disease and multiple sclerosis. YouTube embed video: <a data-cke-saved-href="https://www.youtube.com/watch?v=bfMg3RhxNm8" href="https://www.youtube.com/watch?v=bfMg3RhxNm8"&a…; A Collaborative NIH Effort NIH launched the cross-cutting Extracellular RNA Communication program to advance the field of exRNA research and address collective scientific needs. The program's goal, which spans the entire spectrum of translational research from discovery to treatment, is to find out: How cells make and release exRNAs. How exRNAs move through the body. How it targets specific cells and affects other cells. How the amount and types of exRNA can change in disease. How scientists can use exRNAs to develop new therapies. Funded scientists have formed an ExRNA Consortium to collaborate, share information, and spread knowledge to the larger scientific community and the public. Specifically, they are exploring the use of some exRNAs as biomarkers, or indicators of the presence, absence or stage of a disease. These biomarkers may enable scientists to understand and diagnose diseases earlier and more effectively. They also will use exRNAs to develop molecular treatments for conditions including neurological disorders and cancer. Learn more about these projects. The NIH Common Fund supports the ExRNA Communication program, which is led by a trans-NIH team including NCATS; the National Cancer Institute; the National Heart, Lung and Blood Institute; and the National Institute on Drug Abuse. Learn more about funding for the ExRNA Communication program. | ||||||||
| 148 | NCATS Pharmaceutical Collection | The NCATS Pharmaceutical Collection is a comprehensive, publicly accessible collection of approved molecular entities for high-throughput screening that provides a valuable resource for both validating new models of disease and better understanding the molecular basis of diseases and interventions. Nearly 3,000 small molecular entities have been approved for clinical use by U.S., European Union, Japanese, Australian and Canadian authorities and also are suitable for high-throughput screening. Of these, NCATS currently has 2,900 as part of its screening collection. The collection already has generated several useful probes for studying a diverse cross section of biology, including novel targets and pathways. NCATS provides access to the collection’s content through the Therapeutics for Rare and Neglected Diseases program and the Toxicology in the 21st Century initiative. A dedicated online browser enables searching and exporting. NCATS makes regular updates to the browser to improve features and content. Download the latest version. Sources for the current collection include traditional chemical suppliers, specialty collections, pharmacies and custom synthesis. All data generated through this effort are deposited in PubChem, including the full concentration-response profile of each compound in each assay. Detailed information on the sourcing of the collection, including regulatory status, supplier information, compound structures, target information and indication, are made available as time permits. NCATS developed a new OpenData Portal to share COVID-19-related drug repurposing data and experiments for all approved drugs. To develop the portal, researchers used SARS-CoV-2-related assays to screen over 10,000 compounds, including the compounds from the NCATS Pharmaceutical Collection, for their activity against the virus. View the infographic below to learn more about the NCATS Pharmaceutical Collection. The NCATS Pharmaceutical Collection is described in more detail in a recent publication and an NCATS Director’s Message. Credit: National Center for Advancing Translational Sciences Browser: Ruili Huang, Ph.D. Other questions: ETB Team | ||||||||
| 147 | Preclinical Research Toolbox | NCATS and other NIH Institutes and Centers have developed tools and resources to help scientists conduct preclinical research. Selected resources and software tools are listed below. Small Molecules, Compounds & Probes Assay Guidance Manual contains detailed information on developing appropriate assays for high-throughput screening projects. The Compound Management team acquires chemical libraries for small molecule screening. Screening access to NCATS’ compound libraries is provided through collaboration. NCATS Pharmaceutical Collection is a publicly available, Web-based application that provides complete information on active pharmaceutical ingredients, including small molecule drugs that have been approved by regulatory agencies from the United States, Canada, Europe and Japan, as well as all compounds that have been registered for human clinical trials. PubChem is a freely accessible database of small organic molecules and their activities against biological assays. Probes developed by scientists at NCATS, in collaboration with hundreds of extramural scientists, are freely accessible to the scientific community. Phenotypic Drug Discovery Resource, supported through a collaboration with Eli Lilly and Company’s Open Innovation Drug Discovery program, enables access to disease-relevant assays to explore the effects of small molecules on molecular processes. BioPlanet is a publicly available, comprehensive database that details the body’s biological pathways. Researchers can use it to study gene activity, disease mechanisms, cell toxicity and more. Biomarkers BEST (Biomarkers, EndpointS, and other Tools) Resource is an online glossary developed by a Food and Drug Administration and NIH joint committee to clarify terms used in translational science and medical product development, with a focus on study endpoints and biomarkers. Informatics Tools & Information Systems Global Ingredient Archival System is a registration system for the ingredients in medicinal products that makes it easier for stakeholders to exchange information about substances in medicines, supporting scientific research on the use and safety of these products. NCATS Chemical Genomics Center CurveFit serves as a public, stand-alone, open-source version of the Center’s own curve-fitting software. This application automatically fits and classifies thousands of dose-response curves. Additional software and informatics tools, including specialized browsers, are available under “Software” in the right-hand column of the Tripod server. Patents NCATS has filed patent applications on several technologies developed by Center investigators. To ensure that these new technologies are further developed and commercialized, NCATS seeks collaboration and licensing partners. Therapy Development The NCATS Toolkit for Patient-Focused Therapy Development is a centralized collection of online resources that can help patient groups advance through the research and development process for new treatments. | Learn about the tools and resources NCATS and other NIH Institutes and Centers have developed to help scientists conduct preclinical research. | /sites/default/files/Scientist_Microscope_900x600px.jpg | Preclinical Research Toolbox | Learn about the tools and resources NCATS and other NIH Institutes and Centers have developed to help scientists conduct preclinical research. | /sites/default/files/Scientist_Microscope_900x600px.jpg | Preclinical Research Toolbox | ||
| 144 | Work with NCATS | NCATS offers an array of funding programs and in-kind support services designed to help researchers translate basic scientific knowledge into interventions that improve human health. Learn more about all the ways that collaborators can access NCATS to advance translational science. Collaboration & Funding Opportunities NCATS encourages partnerships across all scientific disciplines and research sectors, including with investigators from NIH, universities and medical centers, other federal agencies, small businesses and industry, and patient groups and advocacy organizations. Find out how to collaborate with NCATS intramural scientists, or select your program of interest from the NCATS Programs & Initiatives page. Funding Opportunities for Researchers Nationwide The majority of NCATS awards are for applications sent in response to targeted funding opportunities. NCATS develops these funding opportunities with an aim to stimulate translational research in areas of greatest need and for identified gaps in diagnostics and therapy development. View open opportunities. Research Opportunities at NCATS Researchers in the NCATS Division of Preclinical Innovation do not focus on a particular system, disease or condition; they explore the entire system of preclinical discovery and development and are uniquely positioned to develop system approaches that improve the efficiency and effectiveness of the translational process. Connect with our preclinical experts. Small Business Grants & Contracts NCATS’ small business programs, including Small Business Innovation Research and Small Business Technology Transfer, help entrepreneurs develop and commercialize new translational technologies through grant and contract awards. NCATS supports further development of preclinical and clinical tools, instruments, devices and related methodologies that may have broad application to translational research. Expertise & Resources NCATS staff are experts in many different fields relevant to translational research and science policy, from small molecules to licensing to protections for human subjects. The Center supports innovation in new technologies and approaches and provides expertise in preclinical and clinical research as well as resources for patient/community engagement and health information. Preclinical Research Expertise NCATS and other NIH Institutes and Centers have developed tools and resources to help scientists conduct preclinical research. View a selection of these resources and software tools. Clinical Research Expertise NCATS supports a broad range of clinical research expertise and tools that facilitate clinical trial design, patient recruitment and regulatory compliance. View some of these areas of expertise and resources. Licensing, Technology Transfer & Patents The dedicated strategic alliances team at NCATS makes it easy for industry and academia to interact and partner with Center laboratories and scientists. The Center’s support for technology development and partnership includes day-to-day negotiations of transactional agreements between NCATS and outside parties, including universities, pharmaceutical companies and biotechnology companies. Training and Education The NCATS Education Branch is committed to developing the tools, resources and programs needed to broadly increase understanding and awareness of, and engagement in, translational science. View our training opportunities and resources. Patient Information & Resources NCATS offers a variety of patient and community engagement resources in addition to a wealth of knowledge about rare diseases research. Genetic and Rare Diseases The Genetic and Rare Diseases Information Center provides up-to-date health information about numerous rare and genetic diseases. Patient-Focused Therapy Development The NCATS Toolkit for Patient-Focused Therapy Development is a collection of online resources that can help patient groups advance through the process of therapy development. | Learn how collaborators can access NCATS to advance translational science. | /sites/default/files/workwithus_austin_900x600.jpg | Work With NCATS | Learn how collaborators can access NCATS to advance translational science. | /sites/default/files/workwithus_austin_900x600.jpg | Work with NCATS | ||
| 63 | Small Business Resources | Small businesses considering SBIR and STTR funding may find the following information and resources helpful. Resources from NCATS Application Resources from NIH Sample SBIR/STTR Applications from NIH Additional Resources Tips for Women-Owned and Socially and Economically Disadvantaged Small Businesses Federal and State Support for Awardees Resources from NCATS Webinars Leverage SBIR STTR Funding and Other Resources to Create a Diverse Workforce in Science and Technology Date: June 23, 2022 Description: Learn about the funding opportunities and resources available to small business entrepreneurs in the field of translational sciences in the Southwest IDeA States Region. Speakers from NCATS and NHLBI talk about the SBIR and STTR funding program structure, eligibility, resources, and best practices and answer attendee questions. They are joined by leaders of the XLerater Network and XLerateHealth program, which offer multiple programs to help prepare and support researchers looking to commercialize their innovations, including programs specially designed for those coming from Historically Black Colleges and Universities, Hispanic-Serving Institutions, and Women-Owned businesses. Featured Speakers: Meena U. Rajagopal, Ph.D., Program Officer, Office of Strategic Alliances, NCATS, NIH Stephanie Davis, Ph.D., Small Business Program Coordinator, NHLBI, NIH Eugene Krentsel, Ph.D., Chief Scientific Officer and Vice President – Strategic Partnerships and Alliances, XLerateHealth Almesha L. Campbell, Ph.D., Assistant Vice President for Research and Economic Development, Jackson State University Total Length of Video: 1:18:58 Watch the webinar on YouTube A version of this webinar with audio description is available Read a transcript of the event (PDF — 245.87KB) Download the presentation slides (PDF — 4.98MB) Peer Review for Small Business Funding: An Overview of the Process Date: Feb. 24, 2022 Description: The rigorous peer review process for small business funding is a critical component of the selection process, which many awardees later leverage to attract additional funders and collaborators. Because it evaluates both the science and the business proposal, it differs from traditional peer reviews, from who sits on the panel to what they look for in an application. In this webinar, Allen Richon, Ph.D., a Scientific Review Officer in the NIH Center for Scientific Review explains the review process, shares what reviewers look for in an SBIR/STTR application, and answers applicant questions. Featured Speakers: Allen Richon, Ph.D., Scientific Review Officer and SBIR/STTR Review Coordinator, NIH Center for Scientific Review Meena U. Rajagopal, Ph.D., Program Officer, Office of Strategic Alliances at NCATS Total Length of Video: 1:16:39 Watch the webinar on YouTube A version of this webinar with audio description is available Read a transcript of the event (Word — 75KB) Download the presentation slides (PDF — 2.7MB) A Decade of Innovation: How NCATS Is Impacting Translational Science through Small Business Growth Date: Dec. 8, 2021 Description: For ten years, the National Center for Advancing Translational Sciences (NCATS) has worked with researchers, clinicians, entrepreneurs, patients and other stakeholder to design new approaches and technologies that ultimately will deliver more treatments to more people more quickly. To mark this milestone, NCATS invited leaders from three companies who used the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) program funding and resources to develop transformative innovations in translational science. Hear about their innovations, their inspirations, and the lessons they have learned while building their businesses, Recursion Pharmaceuticals, Intabio and GoDX. The stories shared here by researchers and others are about what they do, what inspires their work and why they find translational science exciting. Featured Speakers: Lili M. Portilla, M.P.A., Director, Office of Strategic Alliances at NCATS Chris Gibson, Ph.D., Co-Founder and CEO, Recursion Pharmaceuticals Lena Wu, Ph.D., Co-Founder and Former CEO and President, Intabio, Inc. Chang Hee Kim, Ph.D., CEO, GoDx, Inc. Total Length of Video: 1:08:52 Note: If you would like an MP4 file of the webinar, please email your request to NCATS‑SBIRSTTR@mail.nih.gov. Watch the webinar on YouTube A version of this webinar with audio description is available. Read a transcript of the event (Word — 64KB) Download the presentation slides (PDF — 1.8MB) NCATS SBIR/STTR Presents: Essential Intellectual Property Advice for Small Business Commercialization Featuring USPTO Patent Application & Examination Processes Date: Jan. 29, 2020 Co-Host: United States Patent and Trademark Office Description: NCATS welcomes Ram Shukla, Ph.D., from the United States Patent and Trademark Office (USPTO) to present on the processes for protecting a small business’ intellectual property, the role the USPTO plays in the patenting process, and the patent and trademarking resources available to the small business community. The program includes a brief overview of the NCATS SBIR and STTR program and research interests, as well. Q&A (begins at 1:00:05): Shukla answers audience questions on what can and cannot be patented; the differences between patents, trademarks and trade secrets; the difference between “obvious” and “non-obvious” in patent law; reviving “abandoned” patent applications; and working with patent examiners. Total Length of Video: 1:17:09 Note: An audio described version of the webinar will be made available upon request. Watch the webinar on YouTube. Read a transcript of the event (Word — 53KB). Download the presentation slides (PDF — 3.2MB). NCATS Small Business Funding: Early-Stage Support to Commercialize Your Translational Science Innovation Date: Jan. 23, 2020 Co-Host: Georgia Bio Description: Learn about the structure and application process for the NCATS SBIR and STTR funding program, as well as tips for developing a successful application, specific small business research interests, examples of grantee successes, and helpful resources to further support commercialization efforts. Q&A (begins at 48:46): Lili Portilla, M.P.A., director of the NCATS Office of Strategic Alliances, answers questions on eligibility requirements, including acceptable business structures and partnerships; determining the right funding mechanism to apply through; resources such as the I-Corps™ at NIH program, BrIDGs and TRND; and specific research interests. Total Length of Video: 1:05:33 Note: An audio described version of the webinar will be made available upon request. Watch the webinar on YouTube. Read a transcript of the event (Word — 50KB). Download the presentation slides (PDF — 3.2MB). NCATS Small Business Support for Biotech Entrepreneurs and Researchers (with robust Q&A) Date: Jan. 30, 2018 Co-Hosts: North Carolina Biosciences Organization and Virginia Bio Description: Information about SBIR and STTR funding and NCATS resources for researchers and entrepreneurs focused on advancing translational research and technologies. Q&A (begins at 32:06): Lili Portilla, M.P.A., director of the NCATS Office of Strategic Alliances, answers questions related to the difference between funding phases, the application process and tips for success, guidelines for an eligible team, intellectual property (IP) rights and more. Watch the webinar on YouTube. Download the webinar video (MP4 — 45.4 MB). Read a transcript of the event (Word — 121KB). NCATS SBIR & STTR Support for Biotech Entrepreneurs and Researchers Date: Nov. 14, 2017 Co-Hosts: Life Science Washington, New Mexico Biotechnology & Biomedical Association, Oregon Bioscience Association and Montana BioScience Alliance Description: Information about funding and resources for researchers and entrepreneurs focused on advancing translational research and technologies that will improve disease prevention, detection and treatment. The webinar covers an overview of the program, tips for successful application and other NCATS small business resources. Q&A (begins at 41:06): Focused areas of discussion include the following: “How do I know if my proposal is a good fit for NCATS? What funding announcement should I apply under? Can I switch from an SBIR mechanism to an STTR mechanism? How many grants may I submit in a grant cycle?” Watch the webinar on YouTube. Download the webinar video (MP4 — 50MB). Read a transcript of the event (Word — 46KB). Support for Women Entrepreneurs and Researchers in Biotech Date: July 14, 2016 Co-Hosts: NCI, NINDS and the Biotechnology Innovation Organization (BIO) Description: Information about funding opportunities and resources to support biotechnology and health care small businesses, including those owned by women and individuals from socially and economically disadvantaged backgrounds. At 1:40, BIO discusses challenges for women in the biotechnology field. Q&A (begins at 51:25): Focused areas of discussion include the following: “What constitutes a Phase I feasibility study? What is the composition of SBIR review groups? Do I need to file a patent prior to grant submission?” Note: Webinar audio begins at 0:13. Watch the webinar on YouTube. Download the webinar video (MP4 — 552MB). Read a transcript of the event (Word — 63KB). NCATS Opportunities for Women Entrepreneurs in Biotech and Healthcare Webinar Date: Mar. 2, 2016 Co-Hosts: NHLBI, NCI and the Association for Women in Science (AWIS) Description: Information about programs and funding opportunities available to support women-owned small businesses (WOSB) and women in research and technology transfer organizations. Statistics on women-owned biomedical businesses/entrepreneurs were provided by AWIS Director of Research and Analysis Heather Metcalf, Ph.D. Success rates for WOSB applying for NIH SBIR and STTR grants are discussed. Q&A (begins at 50:48): The section provides application tips as well as a discussion on virtual companies applying for NIH SBIR and STTR grants and foreign component in grants. Watch the webinar on YouTube. Download the webinar video (WMV — 73MB). Read a transcript of the event (Word — 72KB). Other NCATS Resources Small Business Research Priorities Fact Sheet (PDF — 5.7MB) This fact sheet lists the priority research areas for the NCATS SBIR and STTR programs. NIH RePORTER This searchable online database provides information about all NIH-funded projects, including NCATS’ SBIR and STTR awards. NCATS Small Business Team Contact NCATS for more information about small business opportunities from the Center. Application Resources from NIH NIH SBIR & STTR Website This website provides a wealth of information and resources for the SBIR and STTR programs at NIH. NIH SBIR & STTR Application Guide This guide offers step-by-step instructions for submitting an application. NIH SBIR/STTR Application Process Infographic This graphic provides visual steps for preparing an SBIR or STTR application. NIH eSubmission Tips for Small Businesses These tips can help applicants produce a successful eSubmission. eRA Commons Help & Tutorials This page provides resources to help you navigate eRA systems, including step-by-step instructions and video tutorials. eRA Commons FAQs Find answers to common questions about using the eRA Commons system. NIH Tips for Applying Presentation This presentation offers an overview of the SBIR and STTR programs and submission process. Electronic Submission Process for Grants This page outlines the steps for successfully submitting grants through the electronic application submission process. Technical and Business Assistance (TABA) Part of NIH’s Technical and Business Assistance (TABA) Program, the TABA Needs Assessment Report provides a third-party, unbiased assessment of a Phase I awardee’s project progress in 10 technical and business areas that are critical to success in the competitive healthcare marketplace. In addition to suggesting the highest priority steps participants can take to improve the commercial potential of a product or service, the no-cost report provides a strong foundation for Phase II funding applications. You can view the SEED webinar and find informational slides on the NIH SBIR/STTR Engage & Connect page. The TABA Needs Assessment Report Program is not accepting applications at this time. Thank you for your interest. Sample SBIR/STTR Applications from NIH If you are new to writing grant applications, sometimes seeing how someone else has presented their idea can help as you are developing your own application. With the gracious permission of successful investigators, some institutes have provided samples of funded applications, summary statements, sharing plans, leadership plans, and more. When referencing these resources, it is important to remember: These applications were developed using the application forms and instructions that were in effect at the time of their submission. Forms and instructions change regularly. Read and carefully follow the instructions in the funding opportunity announcement to which you are responding and the current application instructions carefully. The best way to present your science may differ substantially from the approach taken by those who wrote the example applications. Seek feedback on your draft application from mentors and others. Samples are not available for all grant programs. Many programs have common elements and the available samples can still provide helpful information. Email the NCATS-SBIRSTTR@mail.nih.gov for advice and to determine if your proposed technology fits the NCATS mission. Sample SBIR/STTR Applications: National Cancer Institute (NCI) National Institute on Aging (NIA) National Institute of Allergy and Infectious Diseases (NIAID) National Institute on Drug Abuse (NIDA) Additional Resources 2022 SBIR/STTR Omnibus Solicitation Resources 2022 Program Descriptions and Research Topics (PDF — 2MB) NIH SBA-Approved SBIR/STTR Topic Budget Waivers (PDF — 386KB) SF 424 (R&R) Application Guide for SBIR/STTR Grant Applications SF 424 (R&R) Application Instructions (PDF – 4.3MB) Annotated SF424 SBIR/STTR Form Set (PDF — 4.6MB) Other Resources 2022 Resource Guide for Small Businesses (PDF — 6.7MB) This guide from the Small Business Administration provides helpful guidance for interested small businesses. Premarket Submission Information The Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) have established a pilot program for concurrent review of certain FDA premarket review submissions for medical devices and CMS national coverage determinations. Reducing the interval between FDA marketing approval and Medicare coverage facilitates the development of innovative products and shortens the time it takes to bring these products to patients. Tips for Women-Owned and Socially and Economically Disadvantaged Small Businesses Through its SBIR/STTR programs, NCATS supports both women-owned small businesses and entrepreneurs and researchers from socially and economically disadvantaged backgrounds. Businesses can self-certify during the application process if they meet the criteria for one or both of the categories below. Certification information is encouraged but not required. It is used for federal tracking purposes only to help NCATS and other NIH Institutes and Centers gain a better understanding of applicant demographics during specific funding opportunity cycles. What Is a Women-Owned Small Business? A women-owned business must be a minimum of 51 percent owned and controlled by one or more women and primarily managed by one or more women who are U.S. citizens. A business is classified “small” in its primary industry in accordance with the Small Business Administration (SBA) size standards for that industry. Small business applicants must self-certify on the SF424 (R&R) Form. What Is a Socially and Economically Disadvantaged Small Business? A socially and economically disadvantaged business must be a minimum of 51 percent owned and controlled by one or more disadvantaged people. The disadvantaged person or people must be both socially disadvantaged and economically disadvantaged. The business is classified “small” in its primary industry in accordance with the SBA size standards for that industry. Applicants must self-certify by registering in the System for Award Management. Federal and State Support for Awardees Small businesses may have access to state and federal support after receiving an NCATS SBIR/STTR award. Read more to find some current funding and technical assistance resources available from other federal agencies and state organizations. | /sites/default/files/woman-scientist_900x600.jpg | Small Business Resources | /sites/default/files/woman-scientist_900x600.jpg | Small Business Resources |
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