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| 8002 | Collaborate with NCATS Scientists (January 2016) | Bridging Interventional Development Gaps (BrIDGs) Through its BrIDGs program, NCATS assists researchers in advancing promising therapeutic agents through late-stage preclinical development toward an Investigational New Drug application and clinical testing. NCATS is accepting proposals on an ongoing basis to collaborate with BrIDGs scientists. For more information, contact BrIDGs@mail.nih.gov. NCATS Chemical Genomics Center (NCGC) NCATS’ NCGC program staff offer biomedical researchers access to large-scale screening capacity and medicinal chemistry and informatics expertise to develop chemical probe molecules. These resources can help scientists study the functions of genes, cells and biochemical pathways. The program also features assay development and high-throughput screening, chemistry and chemistry technology, automation, and informatics. To learn more and to obtain NCGC probe molecules, contact Ajit Jadhav. NIH RNA Interference (RNAi) Initiative Through the NIH RNAi initiative, NCATS provides NIH intramural researchers with state-of-the-art, high-throughput RNAi genome-wide screens for humans and mice. Contact Anna Rossoshek to learn more. Pfizer's Centers for Therapeutic Innovation (CTI) for NIH Researchers NCATS is facilitating Pfizer's CTI program at NIH, which pairs NIH intramural researchers and clinicians with Pfizer resources to pursue scientific and medical advances through joint therapeutic development of biologic compounds. To apply, submit a completed pre-proposal brief to your NIH Institute or Center's technology transfer office by June 17, 2016. For more information, contact NIH-PfizerCTI@mail.nih.gov. Therapeutics for Rare and Neglected Diseases (TRND) The TRND program provides collaborators with access to significant in-kind resources and expertise to develop new therapeutics for rare and neglected diseases. NCATS is accepting proposals on an ongoing basis through the TRND program for collaborative projects that focus on preclinical and early clinical development of new drugs for rare and neglected tropical diseases. Email TRND@mail.nih.gov to learn more. Toxicology in the 21st Century (Tox21) The goal of the Tox21 program is to test 10,000 chemicals and evaluate their potential to cause health problems. Any investigator may propose the development of biological assays for high-throughput screening. Proposed assays must be compatible with the high-throughput screening guidelines described in the assay guidance criteria. To suggest an assay, submit a nomination form (PDF - 44KB) to Menghang Xia, Ph.D. | Collaborate with NCATS Scientists (January 2016) | Collaborate with NCATS Scientists (January 2016) | ||||||
| 7893 | Rare Diseases Registry Program (RaDaR) | NCATS launched the Rare Diseases Registry Program (RaDaR) website to provide the rare diseases community with easily accessible guidance on how to set up and maintain high-quality registries. A registry is a collection of information about individuals, usually focused around a specific diagnosis or condition. The goal is to enable rare diseases patient organizations to better promote and support patient-focused research. RaDaR will serve as a living website. NCATS staff will continue to expand the content to include additional instructions, best practices, testimonials and shared resources from the rare diseases community in a phased approach. Currently, NCATS is in the first phase of this process as outlined below, and the website focuses on the types of information collected by patient advocacy groups for their registries: Phase 1: Contact and Demographic Information Using your registry to communicate and connect with researchers. Identify patients who are interested in participating in research studies. Describe the personal characteristics of participants in your registry. Contact participants to inform them about new studies. Phase 2: Patient Experience Data and Patient-Reported Outcomes Discover trends and common needs of participants. Phase 3: Natural History and Clinical Trial Data Improve scientific understanding of the disease. Build the foundation for therapy development with your disease. This website is an educational platform based on the NCATS Toolkit for Patient-Focused Therapy Development. You can find information and tools developed for and by patient groups in concert with their academic, government, industry and advocacy partners in order to create and maintain registries. Share your suggestions, resources, or tools today! Learn more about what RaDaR offers in this printable resource (PDF - 413KB). Contact Eric Wk Sid, M.D., M.H.A. NCATS Division of Rare Diseases Research Innovation | Rare Diseases Registry Program (RaDaR) | Rare Diseases Registry Program (RaDaR) | ||||||
| 7816 | News Brief: NCATS Scientists Participate in NIH Research Festival | NCATS postdoctoral fellow Kirill Gorshkov presents an NCATS poster at the 2017 NIH Research Festival. NCATS scientists highlighted their recent work at the NIH Research Festival, held Sept. 13-15, 2017, on the NIH campus in Bethesda, Maryland. This year’s festival featured scientific advances from nearly all NIH Institutes and Centers. NCATS displayed 12 posters on a variety of translational achievements in several areas, including cancer, cell biology, chemical biology, neurology and pharmacology research. Following are abstracts of the NCATS posters: Cancer A High-Throughput Screen of an Annotated Small Molecule Library Identifies Substrates of P-Glycoprotein Author(s): TD Lee, OW Lee, C Cardarelli, KR Brimacombe, MM Gottesman, M Shen, MD Hall, L Chen, R Guha Cell Biology High-Throughput Assay Development for Niemann-Pick Type A Small Molecule Therapeutics Author(s): K Gorshkov, M Xu, S Yang, W Zheng Tocopherol Enters Cell Through the Endocytic Pathway and Regulates Lysosomal Exocytosis Author(s): M Xu, ZD Shi, S Titus, BY Xu, RE Swenson, W Zheng ZIKV Infection Elicit Mitochondria Fragmentation Author(s): S Yang, K Gorshkov, M Xu, W Zheng Chemical Biology Characterizing Small Molecule Inhibitors of ALDH1A1 with Biochemical, Biophysical and High-Throughput Cell-Based Assays Author(s): AS Yasgar, SM Yang, Y Wang, C Danchik, SA Titus, B Baljinnyam, DM Cheff, XS Wang, DJ Maloney, A Jadhav, M Lal-Nag, V Vasilou, U Opperman, A Simeonov, NJ Martinez Discovery of Potent Small Molecule Inhibitors of Mutant Isocitrate Dehydrogenase 1 Author(s): S Karavadhi, JM Rohde, R Pragani, M Davis, D Urban, N Martinez, T Lee, D Cheff, K Brimacombe, L Liu, M Henderson, S Titus, Y Fang, P Shah, J Covey, M Davis, M Hollingshead, WJ Moore, A Mclver, H Zheng, MD Hall Repurposing Drugs for ADPKD: Assay Development and High-Throughput Screening Author(s): C Danchik, R Asawa, A Zakharov, M Boutin, J Trott, D Wallace, A Simeonov, R Weiss, N Martinez Neurology Development and Validation of Cell-Based Assays in Quantitative High-Throughput Formats for Identification of Acetylcholinesterase Inhibitors Author(s): SZ Li, RH Huang, MF Santillo, MH Xia Identification of Acetylcholinesterase Inhibitors Using Homogenous Cell-Based Assays in Quantitative High-Throughput Screening Platforms Author(s): SZ Li, RL Huang, S Solomon, YL Liu, Bin Zhao, MF Santillo, MH Xia Pharmacology Preclinical Pharmacokinetic of a Lead Peptide for Bronchopulmonary Dysplasia Prevention Author(s): KM Konrath, MD Singleton, AQ Wang, X Xu Validation of an Extended Metabolic Stability Assay Using Human Liver Subcellular Fractions Author(s): M Kabir, P Shah, X Xu Research Supplements Role of Metabolite Identification in Lead Optimization of Fibrodysplasia Ossificans Progressiva Compounds Author(s): EC Padilha, P Shah, A Wang, J Jiang, RG Peccinini, X Xu Posted September 2017 | NCATS scientists highlighted their recent work at the NIH Research Festival, held Sept. 13-15, 2017, on the NIH campus in Bethesda, Maryland. | /sites/default/files/research-festival.jpg | NCATS Scientists Participate in NIH Research Festival | NCATS scientists highlighted their recent work at the NIH Research Festival, held Sept. 13-15, 2017, on the NIH campus in Bethesda, Maryland. | /sites/default/files/research-festival.jpg | NCATS Scientists Participate in NIH Research Festival | ||
| 7815 | News Brief: CTSA Program Collaboration Aims to Improve Brain Cancer Drug Testing | A human brain tumor mass (green) that has been engrafted into and is actively growing within a rat brain slice explant. The red immunostaining shows the resident microglial immune cells of the rat brain tissue starting to gather at the margins of the tumor. (Duke University Photo/Bijal Shah and Linda Kaltenbach, Ph.D.) Neurobiologist Donald Lo, Ph.D., and cancer researcher Albert Baldwin, Ph.D., believed they would make an effective team for bridging translational science divides in brain cancer research. With support from NCATS’ Clinical and Translational Science Awards (CTSA) Program, they are now working together to develop a novel technique — with promising early results — to test drugs against glioblastoma multiforme. Glioblastoma is the most common form of brain cancer, killing approximately 14,000 people annually in the United States. It is deadly and difficult to treat, infiltrating the brain and nearly impossible to completely eradicate with drugs, radiation therapy and surgery. Lo, director of the Center for Drug Discovery and associate professor of neurobiology at Duke University, and Baldwin, associate director of basic research at the University of North Carolina Lineberger Comprehensive Cancer Center, are growing tiny human brain tumors in the laboratory that they hope will be a powerful way to model glioblastoma to better understand and predict how individual tumors respond to therapies. The system may enable them to screen drugs to determine the best treatments for patients. The new approach may be able to circumvent a number of translational roadblocks, speeding the development of compounds into drug candidates and, ultimately, new medicines to treat glioblastoma. “Closing translational gaps in brain cancer treatment could lead to a range of new personalized approaches,” said Lo. One roadblock, and a reason glioblastoma is difficult to treat, is the differences among cells within tumors. A therapy that might be effective against one cell type might not work as well against another. A tumor’s makeup also can change over time, particularly after treatment. “Glioblastoma is made up of multiple cell populations, with dozens of cell lineages forming in the same patient’s tumors,” Baldwin said. “Different cell lineages within tumors can behave differently and can drive drug resistance and recurrence. If a test could anticipate that and predict the drug sensitivity for individual tumors, then we could design combination drug therapies for tumor cell subtypes.” The standard way to study glioblastoma in the laboratory — implanting human tumors into animals that lack a functional immune system — is less than ideal. Instead, Lo and Baldwin remove clusters of glioblastoma cells from patients and engraft the cells into slices of brain tissue grown in the lab, to develop tumors in an environment that more closely mirrors the human brain. The resulting brain tumors may enable Lo and Baldwin to reproduce tumor cell lineages for study and for the development of new drug therapies. For now, the researchers are using the model to measure the sensitivity of glioblastoma tumor cell lineages to typical chemotherapy drugs and are trying to characterize the properties of the different tumor cell lineages and their responses. The early results indicate that patients and the different tumor cell lineages respond to drugs in similar ways. Lo and Baldwin also will examine the characteristics of laboratory-grown glioblastoma tumors in response to investigational drugs and combinations. The CTSA Program hubs at Duke University (Duke Clinical and Translational Science Institute) in Durham, North Carolina and the University of North Carolina (North Carolina Translational and Clinical Sciences Institute) at Chapel Hill supported this work. Posted September 2017 | CTSA Program-supported scientists work to develop novel technique to test drugs against the most common form of brain cancer, glioblastoma multiforme. | /sites/default/files/duke_unc-brain_900.jpg | CTSA Program Collaboration Aims to Improve Brain Cancer Drug Testing | CTSA Program-supported scientists work to develop novel technique to test drugs against the most common form of brain cancer, glioblastoma multiforme. | /sites/default/files/duke_unc-brain_900.jpg | CTSA Program Collaboration Aims to Improve Brain Cancer Drug Testing | ||
| 7814 | News Brief: NCATS Staff to Test Innovative Ideas for HHS | Tiina K. Urv, Ph.D., (left) program director in the NCATS Division of Clinical Innovation, and Anne R. Pariser, M.D., (right) deputy director of the NCATS Office of Rare Diseases Research. Two NCATS teams were recently selected to take part in the seventh round of the U.S. Department of Health and Human Services (HHS) Ignite Accelerator. Ignite Accelerator provides selected HHS staff a startup environment to test innovative ideas to improve how their program, office or agency works. Through Accelerator, small teams receive design and entrepreneurship training along with three months of support to develop and test their ideas with real users. The two selected NCATS projects are designed to tackle challenges across the translational spectrum. The team of Anne R. Pariser, M.D., deputy director of the NCATS Office of Rare Diseases Research, and Tiina K. Urv, Ph.D., program director in the NCATS Division of Clinical Innovation, have proposed exploring the adaptation of “agile” methods from the software industry to accelerate drug development for rare diseases. These methods enable industry to adapt to change quickly and to continuously improve through iterative and flexible project management practices. Pariser and Urv are exploring whether agile approaches could help identify areas within rare diseases research where efficiencies may be gained and collaborations enhanced to support the development of drugs for rare diseases. NCATS Division of Clinical Innovation program directors H. Timothy Hsiao, Ph.D., (left) and Olga Brazhnik, Ph.D. (right). NCATS Division of Clinical Innovation program directors H. Timothy Hsiao, Ph.D., and Olga Brazhnik, Ph.D., plan to help NIH grantees attract private investments and corporate partnerships to more efficiently advance innovative technologies and therapies to market. They proposed to create a collaborative business development program called Advanced Clinical and Translational Innovation Ventures (ACTIV). The program will be powered by an online platform and voluntary NIH awardees who coordinate engagement and matching with investors and corporate partners. ACTIV is expected to be particularly relevant for NIH grantees not working in or near major biotech hubs. Through the Ignite Accelerator, Hsiao and Brazhnik will test and pilot this concept before presenting the evidence to request the NCATS leadership’s approval for deployment. Read more about the fall 2017 Ignite Accelerator teams and how they were selected. Posted September 2017 | The U.S. Department of Health and Human Services chose four NCATS staff to test innovative ideas to improve the way their program, office or agency works. | /sites/default/files/tiina_anne_900x600.jpg | News Brief: NCATS Staff to Test Innovative Ideas for HHS | The U.S. Department of Health and Human Services chose four NCATS staff to test innovative ideas to improve the way their program, office or agency works. | /sites/default/files/tiina_anne_900x600.jpg | News Brief: NCATS Staff to Test Innovative Ideas for HHS | ||
| 7813 | News Brief: NYU CTSA Program Hub Releases Research Study Recruitment E-Book | The New York University Clinical and Translational Science Institute has developed an electronic how-to book aimed at helping researchers recruit and retain participants in research studies. The resource, Tools and Considerations for Recruitment into Clinical Trials and Health Research, features information about data sources, classes and continuing education, translation and interpretation services, recruitment and retention strategies, and more. To obtain a copy of the e-book, contact Rachel Thornton. Posted September 2017 | NYU CTSA Program Hub Releases Research Study Recruitment E-Book | NYU CTSA Program Hub Releases Research Study Recruitment E-Book | ||||||
| 7732 | SCTL Frequently Asked Questions | Why is NIH seeking collaborations on stem cell projects? What are major research goals for NCATS’ SCTL? An NIH Guide notice announced the opportunity to collaborate with the SCTL. Is the collaboration considered a funding opportunity? Will the SCTL provide funding to selected collaborators? What is the process to establish a collaboration project with the SCTL? When should potential collaborators submit a proposal? What is the review process for submitted proposals? Will SCTL staff establish an agreement with collaborators? How will SCTL staff implement and/or terminate collaborative projects? Why is NIH seeking collaborations on stem cell projects? Part of the NIH Common Fund Regenerative Medicine Program (RMP), the Stem Cell Translation Laboratory (SCTL) at NCATS is seeking new collaborations to help achieve common goals in induced pluripotent stem cell (iPSC) biology in a faster and more coordinated fashion. Interested investigators may propose to collaborate with the SCTL on projects to bring iPSC technology closer to clinical application, drug discovery and regenerative medicine. View NOT-RM-17-030 for more details. What are major research goals for NCATS’ SCTL? Using a multidisciplinary collaborative team approach, NCATS’ SCTL scientists aim to: Establish detailed quality control (QC) standards to define pluripotency and differentiated cell types; Use multi-omics methods to assess molecular and cellular variations/signatures in cellular phenotypes derived from iPSCs; Develop standardized methods for producing mature cells from iPSCs that meet QC and reproducibility standards; and Discover, validate and disseminate small molecule reagents to replace expensive recombinant proteins, xenogenic material and undefined media components in cell differentiation protocols. An NIH Guide notice announced the opportunity to collaborate with the SCTL. Is the collaboration considered a funding opportunity? Will the SCTL provide funding to selected collaborators? NIH Guide notice NOT-RM-17-030 is not a grant application, and no external funding is available. Rather, it is an opportunity to collaborate with NCATS scientists and have access to the expertise and resources of the SCTL. What is the process to establish a collaboration project with the SCTL? Prospective collaborators are encouraged to contact the SCTL for additional details about preparing a proposal. Proposals will be assessed for scientific merit, technical feasibility, fit with available resources and alignment with SCTL programmatic goals. View the SCTL Proposal Process to learn more about this process. When should potential collaborators submit a proposal? Interested investigators may submit proposals to collaborate with the SCTL throughout the year. Proposals will be accepted on July 1, November 1 and March 1. Peer review of submitted proposals will be held in August, December and April of each year. What is the review process for submitted proposals? NCATS staff expect collaborative projects to emphasize overcoming technological hurdles impeding the transition of iPSC research from “bench” to “bedside” (e.g., significant protocol improvement). Proposals will be assessed for scope and availability of internal SCTL resources. Then, NCATS staff will seek stem cell experts’ feedback on select proposals to measure enthusiasm for the proposed science, competitiveness within the research area and feasibility of success. Finally, there will be a second level of review to ensure programmatic fit with SCTL goals. The review process will solicit feedback in the following areas: Strength of current data package; Feasibility to complete goals; Translational impact relative to current standard; and Likelihood of external adoption and broad impact. Details of the NIH and external expert deliberations are kept confidential by SCTL program staff, but investigators will receive a letter regarding the proposal’s final outcome. All materials submitted to the SCTL via proposalCENTRAL are considered confidential. Following the scientific assessment, SCTL staff will evaluate select proposals further, conducting face-to-face meetings with potential collaborators. During this time, SCTL staff may request additional supporting data. Portfolio balance and availability of resources will also affect final decisions. Will SCTL staff establish an agreement with collaborators? Research projects are governed by formal NIH collaborative agreements. When a collaborative agreement is agreed to and signed by all parties, the collaborative project will start. Learn more about NCATS’ standard model agreements. How will SCTL staff implement and/or terminate collaborative projects? Once a collaborative agreement has been executed, a project team will be formed. In consultation with the collaborating investigator, the project team will develop and define the following elements: Project plan Timeline Milestones and deliverables Go/no-go decision points At that point, a project plan and any subsequent changes will be approved by SCTL leadership. The project team will make go/no-go decisions based on the project plan. In coordination with governance team members, SCTL leadership will make the final decision regarding changes to project scope or termination. SCTL leadership may terminate a project if it fails to meet timelines, milestones and/or deliverables or if the governance team recommends it. Whenever possible, SCTL staff will provide collaborating investigators with guidance on how to move the project forward. | /sites/default/files/stemcell-01.jpg | SCTL Frequently Asked Questions | /sites/default/files/stemcell-01.jpg | SCTL Frequently Asked Questions | ||||
| 7717 | Translator in Action | We launched the Biomedical Data Translator (Translator) program to speed up biomedical translation for the research community. Through this program, we will combine existing biomedical data to help reveal new relationships within those data and also figure out novel opportunities for research. Read the latest news about this program below.September 2019NCATS Announced Funding Opportunity for up to 15 Translator ProjectsWe released a new funding opportunity, which closed in November 2019, to form a Biomedical Data Translator Development consortium, with initial funding for up to 15 awards in fiscal year 2020. | Through this program, NCATS will integrate existing biomedical data to help reveal new relationships within those data and also identify novel opportunities for research. | /sites/default/files/nerve-cells-2-translator-program-900px.jpg | Translator in Action | Through this program, NCATS will integrate existing biomedical data to help reveal new relationships within those data and also identify novel opportunities for research. | /sites/default/files/nerve-cells-2-translator-program-900px.jpg | Translator in Action | ||
| 7710 | Frequently Asked Questions About NOT-TR-17-023 | Overview What is the intent of the FY 2017 initiative? Why isn’t the funding opportunity announcement (FOA) posted publicly? Will NCATS provide public feedback on an application? Are program staff available to discuss scientific or technical questions by phone? Does the concept letter need to be sent by the university business office? Should the summary vision statement describe the reasoning tool to be built during the 10-month project period or detail what would be possible over a longer period? What information should be included in the abbreviated biosketch, and is there an example of one? Does a bibliography or list of references for the project plan section need to fit within the page limit? Data Types/Sources, Data Sharing and Public Access Is it realistic to expect that the Translator will work only with comprehensive data? Eligibility Why is NCATS using a challenge to determine eligibility? If an applicant works closely with other computational scientists, and wants to submit a joint application, how can they do that to work on the challenge together? If an applicant has the right skills to build a reasoning tool, but doesn’t have time to work on the challenge, how can he/she apply? Can an applicant still apply if he/she doesn’t have the required registrations (DUNS and SAM) and will not have them in time to submit the application? Does an applicant need to be associated with an organization, company or academic institution? Are applications from foreign institutions allowed? If an applicant is partnering with an organization, not just an individual, how does he/she address this in the application? Are parallel, coordinated proposals or one larger, consolidated proposal preferred? Are other federal government agencies, such as the Food and Drug Administration (FDA), eligible to receive funding under this initiative? Investigative Team and Collaboration Does an applicant need to identify all members of the proposed team? Can an applicant budget for additional members? Are applications with multiple principal investigators (PIs) allowed? The previous Translator FOA allowed only one application per institution. For this FOA, will NCATS accept only one concept letter per institution? Does a “lead institution” need to be identified in the concept letter? Is there any preference for how partnering organizations or institutions work together? Can applicants name a PI at each partnering institution? Should applicants name multiple PIs on a single application or list co-PIs as key personnel? Are there restrictions on an individual investigator participating in multiple applications through sub-awards? What is the nature and extent of the collaboration that is requested among the awardees? Are current Translator awardees and investigators eligible to apply? Can an investigator be multi-PI (MPI) on multiple applications? Would it be useful to demonstrate a connection to related NIH initiatives? Should co-investigators include letters of support for the concept letter? We submitted a concept letter, but we have not heard anything about the outcome of the review. Have the successful groups been notified? Overview What is the intent of the FY 2017 initiative? In January 2017, NCATS decided to explore the potential use of a blackboard architecture consisting of three types of components: (1) a blackboard — a tool that contains data relevant to the current state of the problem and its solutions; (2) knowledge sources — independent agents that encode (domain) knowledge needed to solve the problem incrementally; and (3) a reasoning tool — an independent module that dynamically controls knowledge source invocations at runtime. Current awards focus on novel integrations of data that advance translational research and on making knowledge sources interoperable with the blackboard. To complement this work and complete our feasibility assessment of the proposed architecture, NCATS is seeking applicants to submit innovative ideas on how to develop a reasoning tool that can direct the collection of data and models needed to address translational research questions. This complements ongoing program activities that explore not just novel integrations of existing biomedical data but also new analytic capabilities that are powered by such data. Successful applicants will contribute their expertise and resources and also must be willing to collaborate to revolutionize translational science and propel new discoveries and best practices for practitioners across the translational spectrum, from biologists to chemists to computer scientists and from scientists doing target validation to clinicians seeing patients. Why isn’t the funding opportunity announcement (FOA) posted publicly? Under other transaction authority (OTA), NCATS can make research awards that are not grants, contracts or cooperative agreements. To demonstrate that they have the requisite skills to develop a reasoning tool, prospective applicants must complete a challenge to initiate the application process. The challenge tasks themselves are designed to provide important background and insight into the task of building a biomedical reasoning tool prototype for this program and thereby improve the quality of proposals received. The challenge is a multilevel computational exercise. The challenge may be completed by an individual or by the team that will be part of the proposal, provided that the team is using a common login. Upon successful completion of each level, additional sections of the funding opportunity will be revealed. Applicants who cannot complete the challenge will not be given access to all the instructions necessary for submitting the required concept letter. After the submission period for the concept letter has closed, the entire FOA will be made available on the NCATS website. Will NCATS provide public feedback on an application? NCATS does not provide public feedback on applications. Are program staff available to discuss scientific or technical questions by phone? Program staff are not available for discussions by phone. Questions may be submitted to translator-questions@nih.gov. Does the concept letter need to be sent by the university business office? Even if a full application will be submitted by a university or organization, the concept letter may be emailed by the applicant or the team leader for the project. Should the summary vision statement describe the reasoning tool to be built during the 10-month project period or detail what would be possible over a longer period? The summary vision statement should describe the applicant’s vision for the reasoning tool that could be developed over a longer period, based on what would be accomplished during the 10-month project period. What information should be included in the abbreviated biosketch, and is there an example? There is no example of an abbreviated biosketch. Include a CV or abbreviated NIH biosketch that is no more than one page for each of the key personnel who have committed to participating in the project if it is awarded. In the context of the program, it is especially important to highlight contributions of personnel to existing open source projects, standards, and initiatives, as well as evidence of ability to work collaboratively. Does a bibliography or list of references for the project plan section need to fit within the page limit? A bibliography, reference list or citation list relevant to the proposal may be provided outside of the page limit of the project plan section. Applicants should provide only citations to publications, not the full articles. Back to top Data Types/Sources, Data Sharing and Public Access Is it realistic to expect that the Translator will work only with comprehensive data? Many of the datasets within data types will be incomplete, and part of the feasibility assessment is to entertain different approaches to address this fact. This funding opportunity will help to assess the technical feasibility and architectural design for developing the Translator; the actual development of a comprehensive system is not part of this funding opportunity. Back to top Eligibility Why is NCATS using a challenge to determine eligibility? The qualifying challenge helps NCATS assess applicants’ ability to produce reasoning tool software within the aggressive timeline of the program. The challenge is also an engaging way to provide background about the program and introduce key technical concepts about the Translator that applicants will need to address in their concept letters. If an applicant works closely with other computational scientists and wants to submit a joint application, how can they do that to work on the challenge together? The unique link provided in the registration email can be shared with team members, any of whom can help complete each part of the challenge. Submission of a concept letter requires the applicant to provide the email address used during registration, to confirm that the applicant completed the qualifying challenge. If an applicant has the right skills to build a reasoning tool but doesn’t have time to work on the challenge, how can he/she apply? This funding opportunity requires an applicant to access the FOA through the qualifying challenge. Can an applicant still apply if he/she doesn’t have the required registrations (DUNS and SAM) and will not have them in time to submit the application? Yes, such individuals may still apply; however, to receive an award, these registrations must be in place by November 27, 2017. To ensure timely award processing, applicants are strongly encouraged to begin the registration process for a Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number and to register in the System for Award Management (SAM) at the time of or before concept letter submission. The registration process can take six weeks or more. An applicant’s eligibility to receive an award may be jeopardized if the process is not completed on time. Does an applicant need to be associated with an organization, company or academic institution? Any U.S. or foreign entity or individual U.S. citizen is eligible to receive an award. Applicants who have not previously done business with the federal government may be subject to additional oversight and an extended vetting process, in addition to being required to register with DUNS and SAM. Are applications from foreign institutions allowed? Non-domestic (non-U.S.) entities (foreign institutions) are eligible to apply. However, foreign individuals not affiliated with a U.S. or foreign entity are not eligible to receive an award. If an applicant is partnering with an organization, not just an individual, how does he/she address this in the application? A description of the contribution from the organization should be included in both the project and collaboration plans. In addition, a letter of support from a leader of the organization that describes its contribution to the project must be provided. Are parallel, coordinated proposals or one larger, consolidated proposal preferred? Applicants should propose whatever makes the most scientific sense to be responsive to the funding opportunity and to best address the specified goals of the program. Please refer to the FOA to review the evaluation criteria. Are other federal government agencies, such as the Food and Drug Administration (FDA), eligible to receive funding under this initiative? Eligible federal government agencies, including the FDA, may apply. Applicants from federal agencies are responsible for adhering to any limitations set by their own agencies on applying for and receiving funding support from NIH. There also may be additional limitations and restrictions on the types of costs that are allowable. For example, NIH cannot provide funding support for federal employees’ salaries. Back to top Investigative Team and Collaboration Does an applicant need to identify all members of the proposed team? Can an applicant budget for additional members? It is important to provide evidence of the proposed team’s ability to work collaboratively. Competitive applications are expected to identify most key team members and to include a single-page CV or NIH biosketch for each member. If a key team member has not been identified, the qualifications of the individual needed should be described. Are applications with multiple principal investigators (PIs) allowed? Yes. More than one individual may be named as PIs on a single application. The previous Translator FOA allowed only one application per institution. For this FOA, will NCATS accept only one concept letter per institution? This FOA does not have a limit on the number of concept letters allowed from a single institution, provided each letter is scientifically distinct. Does a “lead institution” need to be identified in the concept letter? If invited to submit a full application, and if the application would be submitted by an institution or organization, then yes, the lead organization must be identified. Is there any preference for how partnering organizations or institutions work together? There is no NIH preference for how partners work together or who serves as the lead organization. Can applicants name a PI at each partnering institution? Applicants may use the multi-PI model; however, the designated contact PI must be affiliated with the applicant institution or organization. Should applicants name multiple PIs on a single application or list co-PIs as key personnel? This decision should be based on the science. Applicants have the option to use a multi-PI model as well as designating key scientific contributors. In the multi-PI model, the contact PI listed must be affiliated with the applicant institution. Are there restrictions on an individual investigator participating in multiple applications through sub-awards? There are no restrictions on an individual investigator participating in more than one application. What is the nature and extent of the collaboration that is requested among the awardees? NCATS expects that this project will be intensely collaborative among new and existing research partners and NIH staff and that the unrestricted exchange of source code and software tools written as part of this program will be essential to a successful outcome. NCATS anticipates that each awardee will contribute at least intellectually to all aspects of the feasibility assessment and architecture design challenges. Are current Translator awardees and investigators eligible to apply? Yes; however, because NCATS staff will not provide any information to existing awardees that is not available in the public domain, existing awardees will not have an advantage over new applicants. Can an investigator be multi-PI (MPI) on multiple applications? Investigators may be MPI on multiple applications; however, the designated contact PI must be affiliated with the applicant organization. Would it be useful to demonstrate a connection to related NIH initiatives? Applicants should leverage all resources that strengthen their application. Should co-investigators include letters of support for the concept letter? No letters of support should be submitted for the concept letter. We submitted a concept letter, but we have not heard anything about the outcome of the review. Have the successful groups been notified? The notification letters have been sent. If you did not receive a notification email from NCATS, the application is not progressing to Step 3 of the application process. | /sites/default/files/translator-foa-900x.jpg | Frequently Asked Questions About NOT-TR-17-023 | /sites/default/files/translator-foa-900x.jpg | Frequently Asked Questions About NOT-TR-17-023 | ||||
| 7704 | NCATS Funding Opportunity Aimed at Building Computational “Brain” Prototype to Mine Disparate Data | This image captures the many layers of nerve cells in the retina. Credit: Wei Li, National Eye Institute, NIH NCATS announced that it is seeking applications to develop reasoning tool prototypes for its Biomedical Data Translator (Translator) program. Through a unique funding mechanism, candidates must complete a series of computational tasks in the first part of a three-step application process to access the complete funding opportunity announcement (FOA). The tasks, or “challenge,” are designed to provide important background and insights for building a biomedical reasoning tool prototype. Through its Translator program, NCATS aims to develop a computational platform that brings together disconnected biomedical data types to reveal complex relationships that help scientists better understand disease behavior and biology, and develop treatment options. Through this latest FOA, NCATS intends to fund up to three awards of approximately $1 million each to create Translator reasoning tool prototypes. The tool, or “brain,” will contain software algorithms needed to coordinate the different data sources and types to find relevant patterns and relationships among them and assemble the appropriate information to answer complex biomedical questions. NCATS supports Translator through its Cures Acceleration Network (CAN), which enables high-risk, high-reward research funding and includes Other Transaction authority (OTA). OTA allows NCATS to employ innovative methods to support applications outside the normal National Institutes of Health funding approaches. This particular Translator “challenge” process will help ensure applicants have the requisite technical and problem-solving skills to develop a reasoning tool in a relatively short period of time. By successfully completing each challenge task, the applicant gains access to the next part of the FOA, and ultimately, the instructions for submitting the required concept letter which is due on Sept. 22, 2017. “The challenge questions are aimed at attracting innovative, persistent individuals who can bring unique approaches to developing a Translator reasoning tool,” said Noel Southall, Ph.D., informatics, NCATS. In recent years, the need for a tool like the Translator has become increasingly clear. Powerful new technologies are reshaping the landscape, enabling scientists to map and decipher the 3 billion chemical letters that make up the human genome. Electronic medical records contain warehouses of patient information and clinical databases house details on genomic and environmental variants that can affect disease susceptibility. Despite the ever-growing amounts of data, researchers’ ability to make sense of them has not kept up. Ideally, scientists would easily mine different types of data from different sources to gain new insights into the causes of disease and the relationship between disease biology and clinical signs and symptoms. However, scientists frequently have a difficult time manually sifting through all of the data to make these connections. In fall 2016, NCATS funded research groups to determine the feasibility of building Translator. They currently are working together on “demonstration” projects aimed at assessing whether a biomedical data translator can be created. “The currently funded teams are taking advantage of each other’s expertise and resources to determine the possibilities for Translator,” said Christine Colvis, Ph.D., NCATS Drug Development Partnership Programs director. “We expect the next stage of this research will bring these into clearer focus.” Posted September 2017 | NCATS seeks applications to develop reasoning tool prototypes designed to help scientists better understand disease and develop treatment options. | /sites/default/files/translator-foa-900x.jpg | NCATS Funding Challenge to Mine Disparate Data | NCATS seeks applications to develop reasoning tool prototypes designed to help scientists better understand disease and develop treatment options. | /sites/default/files/translator-foa-900x.jpg | NCATS Funding Challenge to Mine Disparate Data |
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