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| 12598 | CTSA Program PAR-18-940 Application Information | Modifications Compared to Previous PAR There continue to be three due dates per year for which applicants may choose to submit their applications. Application due dates have been adjusted so that applications are due April 15, 2019, August 15, 2019, December 16, 2019, April 15, 2020, August 17, 2020, December 15, 2020, April 15, 2021, and August 15, 2021. Budget allocations for certain UL1 components/cores have been changed from discrete dollar amounts to a percentage of the UL1 award direct costs to enhance flexibility of the CTSA Program Hubs’ abilities to address institutional needs. The number of KL2 scholars requested per year is no longer capped but should be well justified for any Institutional Career Development Core. (See NOT-TR-19-010.) There is no longer a cap on the number of TL1 training slots, but the maximum allowed for each TL1 budget request is determined by the UL1 and KL2 budgets (direct costs). Applicants may choose to describe a transition period of up to three years for currently appointed trainees only to complete the planned training as described in the current award. (See NOT-TR-19-013.) CTSA Program Hubs are expected to use central resources (e.g., the CTSA Program Coordinating Center, the Trial Innovation Network, and the CTSA Program National Center for Data to Health) in order to support collaboration, interoperability of IT platforms, and consistent messaging and communication among CTSA Program hubs. The updated FOA clarifies the requirement for a “Hub Liaison Team to Central Resources” within the Network Capacity Core, instead of RIC/TIC liaisons. Applicants are expected to include a Letter of Support from an authorized institutional official stating that the institution is willing to sign or is a current signatory to the CTSA Program SMART IRB Reliance Agreement. (See NOT-TR-19-014.) Application Information Please note: The primary source of all information regarding PAR-18-940 is the FOA itself and any notices linked therein. Application Timing CTSA Program hubs with more than 16 months of support remaining on the day of the submission deadline are not eligible to apply. If a CTSA Program grant has a May 31, 2020, project period end date, the earliest date on which another application can be submitted in response to this funding opportunity announcement (FOA) is January 25, 2019. Budget Requests A partner is defined based on the use of its NIH funding for the purpose of determining the maximum total award direct costs for the CTSA U54 application. Partners included in one CTSA U54 application may not be included as partners in another CTSA U54 application for the purposes of determining the maximum award direct costs. Cost Share: This FOA does not require cost share. In accordance with Uniform Guidance Section 2 CFR 200.306, any support pledged by the applicant institution on a voluntary basis that is quantified in the proposal budget will be considered Voluntary Committed Cost Share and be a binding requirement upon receipt of award. A link to the table that provides information about the total institutional NIH direct cost (DC) funding for the Federal Fiscal year prior to the submission of the application is provided in the online FOA. The hyperlink to this table is updated in the FOA after January when the NIH updates and freezes the data from the previous fiscal year. Types of Applications Renewal: This Funding Opportunity Announcement (PAR-18-940) allows renewal applications (Type 2) from institutions that were funded under previous FOAs (as described in PAR-18-940) or the current FOA. New: Applications from institutions that currently do not have a CTSA Program award or that have an award funded under previous CTSA Program hub award FOAs (as described in PAR-18-940) will be considered as new applications (Type 1). The following content is not allowed anywhere in a new A0 application or its associated components (e.g., letters of support, other attachments): Introduction page(s) to respond to critiques from a previous review Mention of previous overall or criterion scores or percentiles Mention of comments made by previous reviewers Mention of how the application or project has been modified since its last submission Marks in the application to indicate where the application has been modified since its last submission Resubmission: Resubmission applications are accepted in response to the review of an earlier application as A1 resubmissions. (See the NIH policy on resubmissions.) Application Format and Page Limits The page limits specified in this FOA are the same for every applicant, regardless of the amount of funds being requested and whether the applicant already has a CTSA Program grant. Instructions in the FOA supersede the more general instructions in Form F SF424 (PDF - 8.05MB). Applicants should follow the PAR-18-940 detailed instructions for preparing an application. NIH previously announced the requirement for organizations to submit an Interim Research Performance Progress Report (Interim RPPR) while their renewal application is under consideration. If the recipient organization has submitted a renewal application on or before the date by which a Final RPPR would be required for the current competitive segment, then submission of an Interim RPPR via eRA Commons is now required. For details, see NOT-OD-17-037. Human Subjects (HS) and Vertebrate Animals (VA) The Translational Endeavors Clinical and Translational Research Core should provide funding under the Pilot Translational and Clinical Studies function for a program that provides pilot funding to support translational research projects. It is expected that some of these planned pilots will contain human subjects and/or vertebrate animals that will require approval by NIH prior to initiation. As such, the U54 application is recommended to answer “Yes” to the questions “Are human subjects involved?” and “Are vertebrate animals used?” in the R&R Other Project Information tab under the Overall component. All instructions in the SF424 (R&R) Application Guide must be followed. For the Administrative and each Clinical and Translational Research Core, applicants need to answer the questions “Are human subjects (HS) involved?” and “Are vertebrate animals (VA) used?” in the R&R Other Project Information tab of ASSIST. All instructions in the SF424 (R&R) Application Guide must be followed. For the K and T components, please follow the detailed guidance in the Form F SF424 Training Instructions (PDF - 8.05MB). Letters of Support General letters of support for the CTSA Program application should be submitted with the Overall section in ASSIST. A letter of support that mentions all components by name should be considered a general letter of support and included once, with the Overall section only. Letters of support should be clear expressions of commitment consistent with achieving the goals of the Program. Applicants are encouraged to limit their letters of support to no more than 30. Letters of support that specifically mention individual components (KL2 or TL1) or Cores (i.e., Informatics or Community and Collaboration) can be submitted under each of the components mentioned. Applicants are expected to include a Letter of Support from an authorized institutional official stating that the institution is willing to sign or is a current signatory to the CTSA Program SMART IRB Reliance Agreement. (See NOT-TR-19-014.) Appendix Materials Effective Jan. 25, 2018, NIH policy has eliminated most allowable appendix material for applications. Progress Report for Renewal and Revision Applications submitted via Grants.gov to NIH using the SF424 (R&R) Follow the guidance for MULTI - PROJECT INSTRUCTIONS FOR NIH AND OTHER PHS AGENCIES SF424 (R&R) APPLICATION PACKAGES. For the UL1: See page M-101 of the instructions: Note that the Progress Report falls within the Research Strategy and is therefore included in the page limits for the Research Strategy. For the TL1 and KL2: See page M-142 of the instructions: A “Progress Report” attachment is required only if the type of application is renewal. (The KL2 section in PAR-18-940 instructs applicants to follow the M.420 - PHS 398 Research Training Program Plan Form in the MULTI - PROJECT INSTRUCTIONS.) Publications: Progress Report publications are required for renewal applications and must be uploaded as an attachment. The attachment upload can be included in either the U54 Overall Component or within each Other Component, but the same information should not be included in multiple locations. See page M-102. Bibliography and References Cited The “Bibliography and References Cited” is a required attachment and applicants have the option of including the “Bibliography and References Cited” attachment in the Overall, Other Components, or both sections. This is separate from the progress report publication list that is required for renewal applications. Hyperlinks and URLs (see NIH — How to Apply) Hyperlinks and URLs are allowed only when specifically noted in FOA and form field instructions. It is highly unusual for an FOA to allow links. Hyperlinks and URLs may not be used to provide information necessary for review of the application. Reviewers are not obligated to view linked sites and are cautioned that they should not access any website that could compromise their anonymity, unless the link to the site was specifically requested in application instructions. Training and Career Development The Scholars for whom support is requested should be stated as the number supported per year — for example, “support is requested for five Scholars per year.” Applicants must include the requested number of Scholars for each year of the five-year project period in the application. The number of KL2 scholars requested per year should be well justified, for any Institutional Career Development Core. The distribution of pre- and post-doctoral trainee appointments for which support is requested should be stated as the number supported per year (e.g., “support is requested for three pre-doctoral trainees and five post-doctoral trainees per year”). The distribution of pre- and post-doctoral appointments may be altered over the course of the grant period, but only in a cost-neutral manner and with NCATS’ prior approval. Required data tables: K component data tables. The updated Form F SF424 Training Instructions (PDF - 8.05MB) provide a detailed description of the research training tables. The Introduction to the Data Tables linked under the Form F SF424 Training Instructions provides an overview of the tables, their contents, and the templates. Tables 2 and 8C are required for new, renewal, and revision applications. T component data tables. The required data tables will differ depending on the type of application (i.e., new versus renewal/resubmission) and whether the program includes pre- or post-doctoral or short-term training or mixed variations of these. The Form F SF424 Training Instructions provide a detailed description of the required data tables. There is no limit on the number of mentors who may be listed for the Institutional Career Development Core (KL2) or the Training Core (TL1). Participating faculty members should be listed in Table 2 of the required training data tables. Scholar candidate information is required, and applicants should follow the Form F SF424 Training Program Instructions referenced under the Training Program Plan. Substitute the term “Scholars” for all references to “trainees” in the Instructions. The TL1 provides stipend, tuition, training related expenses and travel funds to the trainees. No Administrative Costs are allowed under the TL1. However, staff salaries and non-trainee personnel travel costs may be included in the Administrative Core of the UL1 and are not included in the maximum total costs for the UL1 and KL2 components. Up to $1,500 per year per trainee may be requested for travel. (See NOT-TR-19-014.) What if applicants have questions? Please direct questions via email to CTSAFOAQuestions@mail.nih.gov. Information in response to emailed questions may be added to this page at a later date. | CTSA Program PAR-18-940 Application Information | CTSA Program PAR-18-940 Application Information | ||||||
| 12568 | Collaborate with NCATS Intramural Scientists | Early Translation Late-Stage Translation Training and Education Collaborate on Other Intramural Projects NCATS aims to address scientific and operational challenges that slow the development of new interventions to improve human health. Center researchers strive to make translational science more efficient, less expensive and less risky. Experts in NCATS’ Division of Preclinical Innovation actively seek collaborators on various research projects. As a research collaborator, NCATS provides a highly skilled translational science workforce, state-of-the-art facilities and informatics capabilities, a strong commitment to team science, and access to innovative partnerships. Through this relationship, NCATS can help its research partners accelerate science, maximize efficiency and conserve limited resources. Find out how to collaborate with our intramural research team and learn more about the expertise and resources they can offer. Below are some of the ways and areas researchers can collaborate with NCATS. Early Translation Using quantitative high-throughput screening, NCATS experts identify promising compounds to engage novel targets. The Center’s medicinal chemists work to improve potency, selectivity and pharmacokinetic properties needed for an in vitro/in vivo pharmacological probe of each novel target. NCATS experts then test these probes using induced pluripotent stem cells or 3-D bioprinting platforms, or in animal efficacy models. Early translation capabilities include: 3-D Tissue Bioprinting: NCATS experts are applying the techniques of 3-D bioprinting to develop tissue models that mimic the organization and physiology of cells in the tissues of living organisms, in a microplate format for drug screening. Contact Marc Ferrer, Ph.D., or Sam Michael to learn more about collaboration opportunities. Analytical Chemistry: Analytical chemistry experts support research throughout the Center, across NIH and with other partners. Primarily focused on small molecule analysis and purification, their state-of-the-art laboratory has a wide variety of instrumentation for medicinal, synthetic and analytical chemistry to support early-stage chemical development. Contact Chris LeClair, Ph.D., for more information. Assay Development and Screening Technology (ADST): ADST experts work to advance therapeutic development through research and development of innovative assay designs and chemical library screening methods. Find out more and contact Manju Swaroop to get started. Automation: NCATS automation experts maintain, operate and continuously improve a full range of laboratory instrumentation and processes, and support activities in high-throughput screening and assay development and optimization. Contact Sam Michael for more information. Chemistry Technology: Chemistry technology experts at NCATS develop small molecules and screening approaches that other scientists can use to pursue innovations in therapeutic development. NCATS supports innovative chemistry technology projects ranging from novel library design to inventive bioanalysis techniques. Contact Jennifer Kouznetsova to learn more about how to access program experts and resources. Compound Management: These experts provide follow-up and dose-response library-plating services for NCATS screening activities. Screening access to NCATS’ compound libraries is provided through collaboration. Requests for new collaborations should be directed to Kelli M. Wilson, Ph.D. Early Translation Branch (ETB): ETB 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. Collaborators also have access to assay development and high-throughput screening, chemistry and chemistry technology, automation, and informatics. To learn more and to obtain ETB probe molecules, contact Matthew D. Hall, Ph.D. Functional Genomics Lab: The Functional Genomics Lab, administered by staff in NCATS’ Division of Preclinical Innovation, is designed to help NIH investigators use the latest functional genomics technology to advance drug discovery and scientific knowledge about health and disease. NIH investigators can submit proposals to the Functional Genomics Lab. Contact Ken Cheng, Ph.D. for additional information. Informatics: NCATS informatics experts aim to transform raw numeric data obtained from large-scale experiments into actionable decisions in chemistry and biology by developing algorithms and software to disseminate research results to the broader community. Contact Ewy A. Mathé, Ph.D., to learn more. Stem Cell Translation Laboratory (SCTL): Through the SCTL, NCATS provides researchers across various disciplines and organizations with the ability to establish collaborations to advance the translation of regenerative medicine applications. NCATS seeks stem cell research collaborators from the biotechnology, pharmaceutical, and NIH intramural and extramural communities on an ongoing basis. Proposal receipt dates are July 1, November 1 and March 1. To learn more, contact Carlos A. Tristan, Ph.D. Toxicology in the 21st Century (Tox21): The goal of Tox21 is to develop more efficient and less time-consuming approaches to predict how chemicals may affect human health. Any investigator may propose the development of in vitro assays with toxicological relevance 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 - 25KB) to Menghang Xia, Ph.D. Late-Stage Translation NCATS staff can provide expertise that enables and accelerates Investigational New Drug (IND) applications. Investigators or companies who have identified promising small molecules, biologics or gene therapies can form joint project teams with NCATS’ Therapeutic Development Branch staff — including Bridging Interventional Development Gaps (BrIDGs) and Therapeutics for Rare and Neglected Diseases (TRND) scientists — to develop IND-ready therapies for consideration by the Food and Drug Administration for clinical testing. Late-stage translation capabilities include: BrIDGs: NCATS assists researchers in advancing promising therapeutic agents through late-stage preclinical development toward Investigational New Drug applications and clinical testing. To discuss a potential collaboration with BrIDGs scientists, contact askTDB@nih.gov. TRND: Through this program, NCATS provides collaborators with access to significant in-kind resources and expertise in the preclinical and early clinical development of new therapeutics for rare conditions and neglected tropical diseases. To discuss a potential collaboration with TRND scientists, contact askTDB@nih.gov to learn more. Training and Education NCATS aims to increase awareness and understanding of translational science through the development, demonstration and dissemination of educational and training resources to the larger biomedical research community. It also fosters a highly skilled, creative and diverse translational science workforce by developing and supporting innovative translational science training methods and programs. Access some of these resources: Assay Guidance Manual: Through this initiative, NCATS provides best practices and training resources devoted to the successful development of robust, early-stage drug discovery assays. Contact G. Sitta Sittampalam, Ph.D. to learn more. Translational Science Training at NCATS: NCATS provides a variety of onsite training opportunities for high school, undergraduate and graduate students, as well as postdoctoral trainees. For more information, contact Amanda Vogel, Ph.D., M.P.H. Collaborate on Other Intramural Projects For more information on how to collaborate with NCATS on other intramural research topics, contact Ann Knebel, Ph.D., RN. To view existing project collaborations, visit the NIH Intramural Database and select “National Center for Advancing Translational Sciences (NCATS)” in the “Select Institute or Center to search” drop-down menu. | /sites/default/files/collaborate_intramural_900x600.jpg | Collaborate with NCATS Intramural Scientists | /sites/default/files/collaborate_intramural_900x600.jpg | Collaborate with NCATS Intramural Scientists | ||||
| 12565 | Intramural Research at NCATS | Experts in NCATS’ Division of Preclinical Innovation (DPI) develop system approaches that improve the efficiency and effectiveness of the translation process. Examples include advancing new technologies to make preclinical research more predictive and efficient or de-risking potential drug targets or research projects to make them more attractive for commercial investment. NCATS intramural scientists have a scientific and operational freedom not bound by one system, disease or condition. Working within a flexible and productive environment, our scientific team can leverage state-of-the-art laboratories and collaborative relationships among government, industry, academia, and patient and rare disease communities to develop and test more robust translational science systems. Resources Available to Scientific Collaborators NCATS intramural scientists and staff have expertise across the entire preclinical translational space, including: Systems biology Chemical synthesis and optimization State-of-the-art informatics capabilities Regulatory requirements for drug development NCATS’ state-of-the-art laboratories, centralized in one location, offer a broad array of capabilities, such as: High-throughput screening technology RNAi screening Well-designed chemical libraries Stem cell technology 3-D tissue bioprinting Analytical chemistry Assay development Late-stage preclinical development Project management With this combination of a highly skilled translational science workforce, state-of-the-art facilities and informatics capabilities, and a strong commitment to team science and innovative partnerships, NCATS can help its research partners accelerate science, maximize efficiency and conserve limited resources. Learn more about how to collaborate with NCATS’ intramural team. Division of Preclinical Innovation Staff Contact the staff listed below for more information about the NCATS Division of Preclinical Innovation: Anton Simeonov, Ph.D., NCATS Scientific Director Ann R. Knebel, Ph.D., RN, Deputy Scientific Director Chih-Chien (Ken) Cheng, Ph.D., Team Leader, Functional Genomics Lab Marc Ferrer, Ph.D., Leader, 3-D Bioprinting, Early Translation Branch David L. Gerhold, Ph.D., Leader, Genomic Toxicology, Toxicology in the 21st Century, Chemical Genomics Branch Matthew D. Hall, Ph.D., Director, Early Translation Branch Sharie J. Haugabook, Ph.D., Staff Scientist, Project Management, Therapeutic Development Branch Mark J. Henderson, Ph.D., Staff Scientist, Biology, Early Translation Branch Junfeng Huang, Ph.D., Leader, Synthesis, Chemistry Manufacturing, and Controls, Therapeutic Development Branch Wenwei Huang, Ph.D., Leader, Early Discovery — Medicinal Chemistry, Therapeutic Development Branch James Inglese, Ph.D., Leader, Assay Development and Screening Technologies, Chemical Genomics Branch Haksong Jin, Pharm.D., M.S., Team Leader, Drug Formulation, Chemistry Manufacturing and Controls, Therapeutic Development Branch Chris LeClair, Ph.D., Team Leader, Director, Analytical Chemistry Juan Jose Marugan, Ph.D., Leader, Chemistry, Early Translation Branch Ewy A. Mathé, Ph.D., Director, Informatics Core Sam Michael, Chief Information Officer, Director, Research Services Core Elizabeth A. Ottinger, Ph.D., Acting Director, Therapeutic Development Branch Samarjit Patnaik, Ph.D., Staff Scientist, Chemistry, Early Translation Branch Ganesha Rai, Ph.D., Staff Scientist, Chemistry, Early Translation Branch Phillip E. Sanderson, Ph.D., Staff Scientist, APP Chemistry, Therapeutic Development Branch Min Shen, Ph.D., Leader, Informatics, Early Translation Branch Gregory J. Tawa, Ph.D., Staff Scientist, Computational Chemistry, Therapeutic Development Branch Pramod Terse, Ph.D., Leader, Safety Evaluation/Toxicity, Therapeutic Development Branch Craig J. Thomas, Ph.D., Leader, Chemistry Technologies, Chemical Genomics Branch Carlos A. Tristan, Ph.D., Acting Director, Stem Cell Translation Laboratory Menghang Xia, Ph.D., Leader, Systems Toxicology, Toxicology in the 21st Century, Chemical Genomics Branch Xin Xu, Ph.D., Senior Scientist, Director, Drug Metabolism and Pharmacokinetics Core Alexey V. Zakharov, Ph.D., Staff Scientist, Informatics/APP AI Group, Early Translation Branch Wei Zheng, Ph.D., Leader, Early Discovery — Biology, Therapeutic Development Branch | Intramural Research at NCATS | Intramural Research at NCATS | ||||||
| 13174 | ASPIRE Design Challenge 1: Integrated Chemistry Database for Translational Innovation in Pain, Opioid Use Disorder and Overdose | Summary of NCATS ASPIRE Design ChallengesSummary of NCATS ASPIRE Design Challenge 1: Integrated Chemistry Database for Translational Innovation in Pain, Opioid Use Disorder and OverdoseHow to EnterDates and DeadlinesThe IC’s Statutory Authority to Conduct the ChallengeSubject of the Challenge CompetitionConcurrent Companion NCATS ASPIRE Design ChallengesRegistration Process for InnovatorsThe PrizeEvaluation and Winner SelectionBasis upon Which Submissions Will Be EvaluatedSummary of NCATS ASPIRE Design ChallengesThe National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH), is inviting novel design solutions for A Specialized Platform for Innovative Research Exploration (NCATS ASPIRE) Design Challenges as part of the NCATS ASPIRE Program. The goal of the NCATS ASPIRE Design Challenges is to reward and spur innovative and catalytic approaches toward solving the opioid crisis through development of (1) novel chemistries, (2) data mining and analysis tools and technologies, and (3) biological assays that will revolutionize discovery, development and preclinical testing of next-generation, safer and non-addictive analgesics to treat pain, as well as new treatments for opioid use disorder (OUD) and overdose. The first phase of these prize competitions is implemented through a suite of concurrent companion Design Challenges that comprises separate Challenges for each of four areas — chemistry database, electronic laboratory knowledge portal for synthetic chemistry, algorithms and biological assays — and an additional Challenge for a combined solution to at least two Challenge areas. At this stage, innovators are expected to submit designs, not final products or prototypes.NCATS envisions following these Design Challenges with a follow-on but distinct final Reduction-to-Practice Challenge, which will aim to invoke further scientific and technological development of the model system. Winners of the Design Challenges will be invited to present their designs so that, in the envisioned follow-up Reduction-to-Practice Challenge, an open competition, teams will be able to form multidisciplinary collaborations to advance and integrate the most feasible and promising approaches to the multiple Challenges into a single integrative platform. Innovators will be invited to demonstrate final solutions.The NCATS ASPIRE Design Challenges are part of NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information about the HEAL Initiative is available at https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative.NCATS refers to participants in the NCATS ASPIRE Design Challenges as “innovators,” because all solutions will require highly innovative approaches to achieve success. Innovators should clearly state how and why the proposed solution would provide significant advances over currently available tools. Innovators may choose to compete in one or more individual Challenges to address a single area (Challenges 1-4) or propose a combined solution for at least two Challenge areas (Challenge 5).Back to topSummary of NCATS ASPIRE Design Challenge 1: Integrated Chemistry Database for Translational Innovation in Pain, Opioid Use Disorder and OverdoseChallenge 1 aims to address the need for an open-source, controlled-access database that incorporates all currently available chemical, biological and clinical data of known opioid and non-opioid based analgesics, drugs of abuse and drugs used to treat drug abuse. This Challenge requires submission of only a detailed description of the design of a database, not the final working database. In order to serve the purpose of the NCATS ASPIRE Program, the database should be highly disease-specific (focusing only on opioid- and non-opioid-based analgesics, drugs of abuse and drugs used to treat drug abuse) but able to be adapted for scalability and/or use for other disorders. Data and data management systems could be accessed and utilized using an application programming interface (API). The database should offer effective visualizations through a built-in graphical user interface (GUI) representing an analytics dashboard and/or an external porting mechanism to other visualization tools, and it should offer functionality that facilitates data use in training and validating advanced machine learning algorithms or applications developed in Challenge 3.Evaluation criteria that reviewers will be asked to address are specified below.Back to topDates and DeadlinesSolutions must be submitted to Challenge.gov by NOON Eastern Time on May 31, 2019. The Challenge begins: December 31, 2018Submission period: December 31, 2018-May 31, 2019Judging period: June 17, 2019-August 2, 2019Winners announced: August 2019For further information send an email to NCATSASPIREChallenge@mail.nih.govBack to topThe IC’s Statutory Authority to Conduct the Challenge The general purpose of NCATS is to coordinate and develop resources that leverage basic research in support of translational science and to develop partnerships and work cooperatively to foster synergy in ways that do not create duplication, redundancy and competition with industry activities (42 USC 287(a)). In order to fulfill its mission, NCATS supports projects that will transform the translational process so that new treatments and cures for diseases can be delivered to patients faster by understanding the translational process in order to create a basis for more science-driven, predictive and effective intervention development for the prevention and treatment of all diseases. NCATS is also conducting this Challenge under the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010, 15 U.S.C. 3719. In line with these authorities, this Challenge(s) will lead to innovative designs for developing technology to revolutionize discovery, development and preclinical testing of new and safer treatments of pain, opioid use disorder (OUD), and overdose; the result will be generalizable tools that will be widely available to fill longstanding gaps that have impeded the marriage of basic and translational sciences.Back to topSubject of the Challenge CompetitionCHALLENGE 1: Integrated Chemistry Database for Translational Innovation in Pain, Opioid Use Disorder and Overdose. The first Challenge aims to reward and spur innovative solutions to the development of an open-source, controlled-access database that will contain extensive chemical, biological and clinical data on currently available pain drugs, opioids and treatments for addiction and overdose. This Challenge requires submission of only a detailed description of the design of a database, not the final working database. The database should include but not be limited to the structures of known analgesics and opioids; information on the corresponding drug targets and, if available, known/predicted mechanisms of action; information on the structure and chemical synthesis; available in vitro and in vivo biological screening data; and any clinical data relevant to the effectiveness, as well as side effects, including risk of addiction etc. In order to serve the purpose of the NCATS ASPIRE Design Challenges, all deposited information (including chemical structures, published chemical synthesis steps and conditions, safety data, etc.) is required to be in a format that is suitable for use in training and validating advanced machine learning applications. The data can be aggregated from available public (assembled from publications and public databases) and/or private (including industry-based collaborators) sources. If using data from non-public sources, innovators must certify that they have proper freedom of operation to utilize and present the data in an open-source format (i.e., for all included datasets, innovators should provide the license and terms under which they are provided for this Challenge). It is expected that the developed database will be utilized by other innovators in other NCATS ASPIRE Design Challenges during the Reduction-to-Practice stage that is envisioned to follow the Design Challenge.Back to topConcurrent Companion NCATS ASPIRE Design ChallengesNCATS has recently explored the development of A Specialized Platform for Innovative Research Exploration (ASPIRE) to aid in the discovery and development of novel and effective treatments while at the same time making the process faster and more cost-effective. The NCATS ASPIRE Program aims to develop and integrate automated synthetic chemistry, biological screening and artificial intelligence approaches in order to significantly advance our understanding of the relationship between chemical and biological space and enable further access into biologically relevant chemical space. The platform will utilize currently available knowledge to develop innovative algorithms and predict and synthetize novel structures capable of interacting with specific targets; enable small-scale synthesis of the predicted molecules; and incorporate in-line, rapid biological testing of the molecules. Any new data obtained through this process would then be fed back into the system to further improve design, synthesis and biological characteristics of molecules.Over 25 million people in the United States experience pain every day (2012 National Health Interview Survey data) and need safe, addiction-free treatments to alleviate their suffering. This clinical demand is of tremendous importance given that overprescribing of opioids for managing acute and chronic pain has fueled the current epidemic of opioid use disorder and overdose deaths, and the effectiveness of opioids for long-term pain management is being questioned. Safe, effective and non-addictive drugs (small molecules and biologics) to treat pain, mitigate addiction and reverse overdose are key to addressing the opioid crisis. Given failures and limitations of previous drug development efforts, drugs that recognize novel targets, have novel structures and can be identified in human-based, physiologically relevant in vitro systems are needed. To advance the NCATS ASPIRE Program and reward and spur innovative solutions to the development of new drugs for pain, addiction and overdose, NCATS is issuing this Challenge and concurrent companion Challenges to highly collaborative innovators interested in designing novel approaches that would lead to efficacious and non-addictive pain treatments and/or novel treatments for addiction and overdose.The ultimate goal of the NCATS ASPIRE Program is development of a platform that a wide spectrum of scientists can use to advance their translational science relevant to development and preclinical testing of new and safer treatments of pain, opioid use disorder (OUD) and overdose. Furthermore, it is essential that the approaches described and proposed here are applicable to any translational problem.Challenge 2: Electronic Synthetic Chemistry Portal for Translational Innovation in Pain, Opioid Use Disorder and Overdose rewards and spurs innovative solutions to the design of a next-generation open-source electronic lab notebook (eLN) that collects, organizes and analyzes data relevant to the chemical synthesis and analyses of known opioid- and non-opioid-based analgesics, drugs of abuse and molecules used to treat drug abuse into an electronic laboratory knowledge portal for synthetic chemistry (electronic synthetic chemistry portal; eSCP).Challenge 3: Predictive Algorithms for Translational Innovation in Pain, Opioid Use Disorder and Overdose rewards and spurs innovative solutions to the design of open source, advanced machine learning algorithms that would facilitate the discovery of novel, efficacious and non-addictive analgesics and/or treatments for drug abuse by utilizing the data collected in open source databases (Challenge area 1), eSCPs (Challenge area 2) and biological assays (Challenge area 4).Challenge 4: Biological Assays for Translational Innovation in Pain, Opioid Use Disorder and Overdose rewards and spurs innovative solutions to the design of novel, physiologically relevant biological assays that accurately replicate the safety profile and effectiveness of existing drugs to treat addiction and/or overdose and that can be reliably used in predictive risk assessments of new analgesics or drugs to treat addiction and/or overdose and/or be able to anticipate the degree of addictiveness of an analgesic prior to clinical testing.Challenge 5: Integrated Solution for Translational Innovation in Pain, Opioid Use Disorder and Overdose rewards and spurs the design of innovative, comprehensive solutions to the opioid crisis through innovative approaches that integrate solutions to at least two Challenge areas (Challenges 1-4: Integrated Chemistry Database, Electronic Synthetic Chemistry Portal, Predictive Algorithms and Biological Assays, respectively) into a single platform.Note: Each component of Challenge 5 (above) is also available as an individual Challenge at Challenge.gov.Back to topRegistration Process for InnovatorsInnovators may access the registration and submission platform in one of the following ways:Access www.challenge.gov and search for “NCATS ASPIRE Design Challenge”Back to topThe PrizeAmount of the Prize; Award-Approving Official. The total prize purse is $500,000. Up to five (5) winners will be selected. NIH reserves the right to cancel, suspend and/or modify this Challenge at any time through amendment to this notice. In addition, NIH reserves the right to not award any prizes if no solutions are deemed worthy. The Award Approving Official will be Christopher P. Austin, M.D., Director of the National Center for Advancing Translational Sciences (NCATS).Payment of the Prize. Prizes awarded under this competition will be paid by electronic funds transfer and may be subject to federal income taxes. HHS/NIH will comply with the Internal Revenue Service withholding and reporting requirements, where applicable.Matching Requirement. A for-profit private entity solver (innovator) receiving a prize under this Challenge must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018. Such a winner(s) will be required to demonstrate that matching funds and/or in-kind contributions were committed to achieve the winning solution. Such a winner(s) must identify the source and amount of funds used to meet the matching requirement or describe how the value for in-kind contributions was determined.Back to topEvaluation and Winner SelectionBasis upon Which Winners Will Be Selected. A panel of federal and non-federal reviewers, with expertise directly relevant to the Challenge, will evaluate the solutions based on feasibility and ability to achieve the criteria listed below. The solutions and evaluation statements from the technical panel will then be reviewed by federal employees serving as judges, who will select the Challenge winners, subject to the final decision by the Award Approving Official. The NCATS will provide feedback from the technical experts and judges to the winners and non-winners on their respective submissions.The points assigned to each set of evaluation criteria are guidelines from NCATS to suggest which scientific milestones are of emphasis and interest to the Center. All winners are highly encouraged to participate in future NCATS ASPIRE Reduction-to-Practice Challenges that NCATS is planning. Only complete submissions will be reviewed.Submission Requirements and TemplateInstructions for submission: Please format the proposal using the Submission Template and submit it to Challenge.gov as a PDF. Brief instructions on the submission process can be found below. Detailed instructions are provided in the submission template.Back to topBasis upon Which Submissions Will Be EvaluatedCHALLENGE 1: Integrated Chemistry Database for Translational Innovation in Pain, Opioid Use Disorder and Overdose. The first Challenge rewards and spurs solutions to the development of an open-source, controlled-access database that will contain extensive chemical, biological and clinical data on currently available pain drugs, opioids and treatments for addiction and overdose. The database should include but is not limited to the structures of known analgesics and opioids; information on the corresponding drug targets and, if available, known/predicted mechanisms of action; information on the structure and chemical synthesis; available in vitro and in vivo biological screening data; and any clinical data relevant to the effectiveness, as well as side effects, including risk of addiction etc. In order to serve its purpose of the NCATS ASPIRE Design Challenges, all deposited information (including chemical structures, published chemical synthesis steps and conditions, safety data, etc.) is required to be in a format that is suitable for use in training and validating advanced machine learning applications. The data can be aggregated from available public (assembled from publications and public databases) and/or private (including industry-based collaborators) sources. If using data from non-public sources, innovators must provide the license and terms under which such data are provided for this Challenge. Pursuant to Rule 15 of the Challenge, by participating in this Challenge, each individual (whether participating singly or in a group) assures NCATS that any data used for the purpose of submitting an entry for this Challenge competition were obtained legally through authorized access to such data. It is expected that the developed database will be utilized by other innovators in other NCATS ASPIRE Design Challenges during the Reduction-to-Practice stage that is envisioned to follow the Design Challenge.Judging criteria:Evaluation Criterion 1: Impact and Innovation (20 points)What are major strengths and weaknesses of the solution proposed?Given that innovation is considered using a groundbreaking or paradigm-shifting approach or using existing approaches in an innovative way, to what degree is the proposed design innovative, creative and original?How feasible is the proposed approach, and what is the likelihood of the approach to succeed?Has the innovator or team of innovators demonstrated that appropriate expertise was utilized during development of the design?To what extent does the proposed solution provide the required information necessary for development of novel treatments and therapies for pain, drug addiction and/or overdose?Did the team identify potential roadblocks and suggest additional expertise that would be utilized to facilitate resolution of roadblocks to implementation?Evaluation Criterion 2: Data Complexity, Accuracy, and Interconnectivity (20 points)How well does the database design integrate multiple data sources?Are all the data annotated by source/reference?How well is structural and functional variability/complexity of currently available pain drugs, opioids and treatments for addiction and overdose represented in the database?Do the collected data meet the FAIR requirements (findable, accessible, interoperable and reusable: https://www.nature.com/articles/sdata201618)?How well have the innovators defined standards for data types, format, quality, curation, annotation and common data elements so that data sets are mineable and comparable?Is adequate online back-end infrastructure such as storage and cloud computing capability available?To what extent have the innovators developed a framework for enabling meaningful comparisons across heterogeneous data sets, including individual and population comparisons at the intra- and interspecies levels?Have the innovators designed tools to harmonize disparate data formats?Evaluation Criterion 3: Data Accessibility (10 points)Will all study materials, data and procedures be made broadly available and readily accessible to the research community (e.g., are plans for transitioning the database to be publicly accessible included in the solution)?Have the innovators designed a web portal front-end or complete API that enables clear and easy management and retrieval of data and tools and is accessible to the general scientific community across a variety of platforms?How well is the database design documented with a broad extensible format that allows for broader contextual relationships?Have the innovators proposed appropriate tools for batch data retrieval to allow independent computation of the data on the user end?How well have the innovators designed strategies for data curation and updates (e.g., how will new data be incorporated)?Does the solution adequately address how it will remain compliant with data privacy regulations, specifically those that are obtained from human subjects?Back to top | ASPIRE Design Challenge 1: | ASPIRE Design Challenge 1: | ||||||
| 12511 | Templates for Success: Speeding the Formation of Public-Private Partnerships | Translational Science Highlight NCATS is speeding the formation of innovative private-public partnerships through the development, demonstration and dissemination of template agreements, enabling smarter, faster science. Public-private partnerships are an important way to accelerate translational science. Each party brings its unique expertise and assets to the table to solve a common challenge. But establishing this kind of partnership can be its own kind of challenge — one that can delay scientific progress for a year or more. NCATS’ Discovering New Therapeutic Uses for Existing Molecules (New Therapeutic Uses) program is an innovative effort that focuses on establishing public-private partnerships to advance the development of promising therapeutic candidates. It is designed to bring together partners from the pharmaceutical industry and academic institutions to crowdsource ideas for new uses of existing molecules. These molecules are proven to be safe in humans but were not effective against the diseases they were developed to treat. NCATS’ goal is to repurpose these drugs and speed the development of new therapies. NCATS knew that one major roadblock to success was time: It takes a while to set up a collaborative research agreement between the company that owns a molecule and the academic institution of the researchers proposing a new use. This legal agreement describes how intellectual property such as patents will be handled in the project. Agreement negotiations can take a long time — sometimes a year or more — and a “new uses” project cannot start until they are completed. “Protracted agreement negotiations can be a bottleneck in public-private collaborations, significantly delaying research progress,” said Lili Portilla, M.P.A., director of NCATS’ Office of Strategic Alliances. Portilla and others at NCATS saw an opportunity to speed the negotiation process, so they created template legal agreements that academic institutions and pharmaceutical companies could use as a launching point for negotiations. A pilot test of these was impressive. “Most of the pilot project agreements were formed within three to four months instead of a year or more,” Portilla said. “For patients who are sick now, cutting six to nine months off the time it takes to get a study started is a big deal. These template agreements really kick-started negotiations.” The template agreements are an example of the kind of operational research hurdles NCATS is addressing. Developing solutions that streamline the processes of carrying out translational science speed not just a project or research on a specific disease, but the overall process of translating discoveries into interventions and therapies for patients. When successful, NCATS’ efforts can also result in dissemination and adoption by the wider research community to effect broad, lasting changes for patients’ benefit. In this case, the templates proved so successful that others within and outside NIH have adapted them to jump-start a wide range of innovative research initiatives. Negotiating a Strong Foundation To create the New Therapeutic Uses template agreements, NCATS’ Office of Strategic Alliances worked closely with the NIH Office of the General Counsel, the NIH Office of Technology Transfer and pharmaceutical companies experienced in forming agreements with academic researchers. Not everyone in the academic community was initially supportive of the idea, since NIH had not previously been involved in agreements between academia and industry at this level. But skepticism decreased once it was clear the templates can be modified to fulfill the needs of both the company and the academic institution, and most important, that the templates are accelerating agreements. They also help a company and an institution to reach an agreement before NIH funding is awarded, allowing projects to begin more quickly. “The availability of the templates helped facilitate a very rapid turnaround of a collaborative research agreement with AstraZeneca,” said Mark Dransfield, M.D., a professor of medicine at the University of Alabama at Birmingham. Dransfield and his team became involved with the New Therapeutic Uses program in 2018 to test an AstraZeneca drug as a treatment for lung damage in patients with the rare genetic disease Alpha-1 antitrypsin deficiency. “AstraZeneca has participated in the New Therapeutic Uses program since its inception in 2012,” said Kumar Srinivasan, vice-president of Scientific Partnering and Alliances for AstraZeneca’s Innovative Medicines and Early Development (IMED) Biotech Unit. “The template agreements simplified the contracting process, enabling our project teams and investigators to move forward more expeditiously to initiate the programs.” Disseminating Solutions that Work The benefits of the New Therapeutic Uses templates did not go unnoticed in the NIH community. The NIH BRAIN Initiative, launched in 2014, is an ambitious effort to revolutionize scientists’ understanding of the brain to find new ways to treat, prevent and cure related disorders. One approach is to use medical devices that stimulate the brain to treat various disorders or record brain activity to learn more about a disease. Increasingly, more of these devices are being approved for patients. Similar to the New Therapeutic Uses program, the BRAIN Initiative team wanted to capitalize on their work by funding researchers to test the medical devices for potential new uses. BRAIN Initiative staff worked with medical device companies and the academic community to adapt the New Therapeutic Uses template agreements for their unique needs. “NCATS’ New Therapeutic Uses program served as a model for our efforts,” said Nick B. Langhals, Ph.D., M.S.E., program director of neural engineering at the NIH National Institute of Neurological Disorders and Stroke and a scientific program team member for the BRAIN Initiative. “The success of the program’s templates in facilitating negotiations between industry and academia made us optimistic that we could create a similar framework for central nervous system devices.” Medical devices also have been approved to stimulate peripheral nerves, which are the nerves that connect the brain and spinal cord to the rest of the body, to treat conditions such as obstructive sleep apnea and chronic pain. The NIH Common Fund’s Stimulating Peripheral Activity to Relieve Conditions (SPARC) program focuses on understanding peripheral nerves and how their electrical activity controls organ function. Through SPARC, NIH funds researchers to test these medical devices for new conditions ranging from diabetes to irregular heart rhythms to gastroparesis, also called delayed stomach emptying. When the SPARC program launched in 2016, the New Therapeutic Uses template agreements were used to enable studies on the devices to start sooner. “SPARC investigators were able to complete collaborative research agreements very quickly,” said Siavash Vaziri, Ph.D., a SPARC program manager at NCATS. “This does not usually happen in academia and was made possible through the templates.” Sharing Tools to Speed Progress The template agreements from the New Therapeutic Uses program are free and publicly available for researchers or companies to adapt to their own needs. As expected, downloads of the templates spike when NCATS announces new funding opportunities, but even when there are no related funding opportunities, the templates are popular. This suggests that those in the broader research community are finding the templates useful in negotiating public-private partnerships and demonstrates how NCATS is disseminating solutions as part of its mission to get more treatments to more patients more quickly. Posted September 2018 | NCATS is speeding the formation of innovative private-public partnerships through the use of standardized legal agreements. | /sites/default/files/ntu_template_1260x630.jpg | Templates for Success | NCATS is speeding the formation of innovative private-public partnerships through the use of standardized legal agreements. | /sites/default/files/ntu_template_1260x630.jpg | Templates for Success | ||
| 12475 | 3-D Tissue Bioprinting: An Emerging Path to Better Drug Development | Translational Science HighlightNCATS is addressing a new area of opportunity to better predict how potential new drugs will affect humans. Center scientists are developing 3-D tissue models that more closely mimic the complexity of tissues in the human body in a reproducible, automated and scalable manner using bioprinting techniques. These innovative, human-like tissue models are used for compound testing and could accelerate drug development for treatments of both rare and common diseases.Current methods of developing and delivering new drugs to patients take decades, cost billions of dollars and are unsuccessful about 95 percent of the time. The vast majority of potential new drugs fail in clinical trials because they are found to be ineffective or are unexpectedly toxic for patients, despite promising early results during preclinical testing.Traditional drug development involves analyzing the effects of potential drugs in 2-D laboratory-grown cells that have indicators of disease — so-called in vitro assays — and in laboratory animal models that have been developed with a disease either the same as or similar to a disease in humans.As one effort to improve the predictive success of preclinical drug development, NCATS launched the 3‑D Tissue Bioprinting program. NCATS researchers are using the techniques of 3-D bioprinting to combine living cells with scaffolding materials, to create testing platforms of laboratory-grown human tissues that closely mimic natural tissues in human organs. These innovative tissue models could help scientists better predict the way patients will respond to potential new therapies.Working in Three DimensionsKristy Derr with a 3-D printer.“The way we do compound testing for drug discovery now is using cells that are grown in 2-D on plastic surfaces,” said Marc Ferrer, Ph.D., director of the NCATS 3-D Tissue Bioprinting program. “It’s easy to grow cells in 2-D, but that’s not how cells grow in the human body. By recreating the body’s 3-D tissue structure through 3-D bioprinting, we can grow cells in the same way as they are found in the body. The hope is that the cells will respond to potential drugs in the same way that they do in a patient.”The 3-D Tissue Bioprinting program builds on internal expertise at NCATS in assay development for drug screening, automation technologies, stem cell biology, tissue engineering and advanced imaging techniques. Living cells and scaffolding, or support, materials can now be combined into complex 3-D functional tissues produced on multi-well plates (tissue-in-a-well), which are used in preclinical drug testing. These tissues are created using either induced pluripotent stem cells (iPSCs) or primary cells taken directly from living tissue, such as skin.“Bioprinting tissues is an art,” Ferrer said. “You have to mix human cells with Jell-O–like materials called bioinks that enable the bioprinting of the cells in a specific geometry that resembles human tissues. The mixture of cells and bioinks can’t be too thick or too thin — it has to be just the right consistency so that the cells can be dispensed through a needle, stay alive and form the shape of the tissue.”Achieving ReproducibilityThe primary focus of the 3-D Tissue Bioprinting program is to develop “disease-relevant tissue models” that can be tested against various compounds to learn with greater accuracy how potential new treatments might affect the body. A challenge in using 3-D tissue models as a drug screening platform is producing tissues that look the same, function consistently and are reproducible from assay to assay in a multi-well plate format. This consistency helps ensure that screening results are reliable. With the use of 3-D bioprinters, NCATS can begin to industrialize production of 3-D tissues in an efficient, reproducible and scalable manner.Sam Michael, NCATS’ chief information officer and director of automation and compound management, said the challenges of refining the technology to make it reliably reproducible are daunting.“The printer is the simplest part of the process,” Michael said. “We can print tissues in about 30 minutes, as opposed to it taking months to grow them in plates.”The challenge is making the bioprinter configurable for different types of tissue.“We need to be able to use a variety of dispensing techniques,” Michael explained. “It’s so complex, and points of failure are so many, that I’m amazed any of this works. You have to be resilient, because most of what we do fails. It’s like a sliver of success versus an ocean of failure.”Collaborating with Disease ExpertsPictures of 3-D bioprinted tissues in a 12-well transwell plate showing reproducible tissue shape from well to well. Two initial areas of investigation for 3-D bioprinting involve age-related macular degeneration (AMD) — the leading cause of irreversible blindness — and skin diseases.For the AMD project, collaborators from NCATS and the National Eye Institute (NEI) are creating 3-D bioprinted retinal tissue to develop in vitro disease models. The goal is to study patient-specific disease processes, set up high-throughput drug screening tests and develop cell-based therapies for retinal degenerative disease.Initial work is focused on the retinal pigment epithelium (RPE), a layer of cells located in the back of the eye. Researchers suspect that abnormal changes in the RPE can lead to degenerative eye diseases such as AMD. The NCATS/NEI collaboration combines iPSCs produced from patients’ cells and high-throughput screening assays to identify novel compounds that could potentially reverse the effects of these devastating diseases.NCATS is also collaborating with Rockefeller University and Columbia University in New York City to develop 3-D printed skin tissue that can be used to investigate possible therapies for diseases such as cancer and psoriasis. The skin is the largest organ of the human body. It is highly complex and provides protection from the environment, microbes, parasites, heat, ultraviolet rays and water loss. 3‑D printing of skin promises to be an invaluable way to accurately test potential disease therapies.Applications for the FutureBioprinted tissues and their associated technologies have promise for civilian and military research applications, such as pandemic diseases, biodefense and national security. For example, cell and tissue replacement for injured soldiers and development of novel medicines for field use — such as antibiotics and drugs for mental illness, trauma and surgery — are areas of huge potential.“We’re working to develop better assays for drug discovery, so that we can make the process more efficient,” Ferrer said. “The closer the testing platforms are to mimicking humans, the better we will be at discovering new drugs for the patients who need them.”Posted September 2018 | Using 3-D bioprinting techniques, NCATS scientists are developing 3-D tissue models that more closely mimic the complexity of tissues in the human body. | /sites/default/files/3d-kristy_printer_1260x630.jpg | 3-D Tissue Bioprinting: An Emerging Path to Better Drug Development | Using 3-D bioprinting techniques, NCATS scientists are developing 3-D tissue models that more closely mimic the complexity of tissues in the human body. | /sites/default/files/3d-kristy_printer_1260x630.jpg | 3-D Tissue Bioprinting: An Emerging Path to Better Drug Development | ||
| 12460 | CTSA Program Researcher Studies Barriers to HIV Prevention | Rupa Patel, M.D., M.P.H. (Washington University in St. Louis Photo) Through an intervention called pre-exposure prophylaxis (PrEP), people at risk for HIV can take medicine daily to decrease their chances of becoming infected. But many people who could benefit from PrEP do not receive a prescription. At Washington University in St. Louis, an NCATS Clinical and Translational Science Awards (CTSA) Program hub, Rupa R. Patel, M.D., M.P.H., is studying the barriers that keep young adults from obtaining PrEP. In 2015, while establishing a new clinical program, Patel became a CTSA Program KL2 Mentored Clinical Research Scholar. Patel initiated a research study of individuals who visit the clinic to discuss PrEP. She collects data such as whether these individuals have health insurance or risk factors for acquiring HIV, and she records whether they actually start taking the medication. Patel has used insights gained from the research and from conversations with patients to provide a better clinic experience. She offers a program that offers patients a clinic visit, laboratory tests, PrEP prescription, and assistance with insurance or medication paperwork in a single day. Through a 2018 study, Patel learned that two-thirds of her clinic’s patients had primary care doctors but were not comfortable asking their doctors for PrEP or were told that those physicians did not offer PrEP care. She concluded that primary care doctors could benefit from more education about what PrEP is and how to deliver it. Patel has shared her findings with a broad range of local and international public health officials. She also serves on the World Health Organization’s technical advisory group for PrEP implementation. She has been given opportunities to assist with developing PrEP implementation plans with stakeholders in several countries in Africa and Asia. “The KL2 changed my life,” Patel said. “It provided the structured mentorship and the time to research, write and revise, and contemplate and reflect about my work.” Posted September 2018 | With NCATS-supported mentoring and training, an early-stage investigator is studying barriers that keep young adults from obtaining HIV prevention medicines. | /sites/default/files/patel_1260x630.jpg | CTSA Program Researcher Studies Barriers to HIV Prevention | With NCATS-supported mentoring and training, an early-stage investigator is studying barriers that keep young adults from obtaining HIV prevention medicines. | /sites/default/files/patel_1260x630.jpg | CTSA Program Researcher Studies Barriers to HIV Prevention | ||
| 12409 | NCATS-Supported Research Shows Promise for Stretchable, Wearable Electronics | A 3-D stretchable electronics device next to a U.S. dollar coin. (University of California, San Diego Photo/Zhenlong Huang) Electronics that are soft and stretchable are a dream for biomedical researchers and health care professionals. These devices could be used as bandage-like wearable sensors to measure heart signals, track eye movements or control a robotic limb. But until now, a major technological hurdle has blocked progress: how to build stretchable electronics in 3-D so that they can perform more functions without taking up a lot of space. Part of what makes modern electronics so powerful is that they can house dozens of layers of circuits on a small area, with thousands of tiny, intricate connections between the layers. Now researchers at the Altman Clinical and Translational Research Institute (CTRI), an NCATS Clinical and Translational Science Awards (CTSA) Program hub at the University of California, San Diego, have found a way to make stretchable electronics in 3-D. The team used lasers to burn precise holes in the stacked circuit layers, then they filled the holes with materials that conduct electrical signals. As a proof of concept, the researchers created a prototype multifunctional, stretchable device worn on the skin to monitor electrical signals in the body, such as signals from the heart or brain. The work is published in the Aug. 13, 2018, issue of Nature Electronics. The project was supported through CTRI’s Galvanizing Engineering in Medicine (GEM) program, which is designed to create collaborations between engineers and physicians. Through GEM, clinicians propose specific clinical problems that could be addressed with a device or software solution. Engineers then compete for funding by proposing the best solutions to the highest-ranked clinical problems. GEM is an example of how CTSA Program hubs catalyze innovation through multidisciplinary teamwork. Read more about the development of 3-D stretchable electronics. Posted September 2018 | CTSA Program-supported researchers found a way to make stretchable electronics in 3-D, enabling potential new diagnosis and treatment avenues. | /sites/default/files/ctsa-san-diego-coin_1260x630.jpg | NCATS Supports Research for Stretchable, Wearable Electronics | CTSA Program-supported researchers found a way to make stretchable electronics in 3-D, enabling potential new diagnosis and treatment avenues. | /sites/default/files/ctsa-san-diego-coin_1260x630.jpg | NCATS Supports Research for Stretchable, Wearable Electronics | ||
| 12385 | NCATS Funding Available to Repurpose Existing Drugs | NCATS researcher Crystal McKnight examines a compound source screening plate prior to high-throughput screening. (NCATS)September 6, 2018NCATS has announced funding opportunities to use partially developed therapeutic candidates (also known as assets) to identify new treatments for a broad range of diseases. Through the Discovering New Therapeutic Uses for Existing Molecules (New Therapeutic Uses) program, NCATS helps academic researchers and pharmaceutical companies establish collaborations to test existing drugs and biologics for possible new uses.Investigators can propose new treatments using assets supplied by NCATS’ pharmaceutical partners: AstraZeneca, Janssen Research & Development, LLC, and Pfizer Inc. These assets have cleared several key steps in therapeutics development and testing, providing scientists with a strong starting point for their research. Pharmaceutical partners make certain information about experimental drugs and biologics available so that researchers can suggest new uses. By providing templates for research agreements between academic institutions and pharmaceutical companies, the New Therapeutic Uses program significantly shortens the time required to establish collaborations.View the new funding opportunities:PAR-18-909: Pre-Application for the NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules (X02) (Clinical Trial Not Allowed)NOT-TR-18-032:Notice of Change to Receipt Date on Pre-application for the NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules (X02 Clinical Trial Not Allowed) (PAR-18-909)PAR-18-910: Limited Competition for NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules (U01) (Clinical Trial Required)Application deadlines are listed below. Interested researchers should submit a letter of intent 30 days before the application date.X02 Application Deadlines2018201920202021Oct. 31, 2018March 4, 2019March 4, 2020March 4, 2021 Oct. 31, 2019Oct. 31, 2020 U01 Application Deadlines201920202021May 3, 2019May 4, 2020May 3, 2021Aug. 26, 2019Aug. 26, 2020Aug. 26, 2021Selected researchers whose X02 pre-applications are highly meritorious and relevant to NIH priorities will be matched with the appropriate pharmaceutical company. Once matched, applicants will work with the pharmaceutical partner to finalize terms and conditions of a confidential disclosure agreement before exchanging data and determining whether to begin negotiating a collaborative research agreement.Pre-applications should outline clinical trial plans in the U01 phase. NCATS is authorized to support clinical trial activities through the end of Phase II for all diseases or conditions, and through the end of Phase III for rare diseases or conditions. | Interested in identifying new treatments for a broad range of diseases by using partially developed therapeutic candidates? Access two new funding opportunities. | /sites/default/files/ntu-foa_900x600.jpg | NCATS Funding Available to Repurpose Existing Drugs | Interested in identifying new treatments for a broad range of diseases by using partially developed therapeutic candidates? Access two new funding opportunities. | /sites/default/files/ntu-foa_900x600.jpg | NCATS Funding Available to Repurpose Existing Drugs | ||
| 12364 | NCATS-Supported Study Shows Eating Before 3 p.m. Can Improve Health | Courtney Peterson, Ph.D., measures a participant’s body mass and fat with a DEXA scan. (University of Alabama at Birmingham Photo) Fasting for certain periods during the day can help people lose weight, which may lead to additional health benefits such as lowering blood pressure and diabetes risk. It was not known previously whether weight loss through fasting was directly related to these other health benefits. That connection is now clearer based in part on the work of investigators supported through the NCATS Clinical and Translational Science Awards (CTSA) Program hub at the University of Alabama at Birmingham (UAB). Through a small, rigorously controlled trial, the research team found that eating all meals by midafternoon and fasting the rest of the day can improve blood pressure and insulin sensitivity, even without weight loss. The results are reported in Cell Metabolism. The investigators tested a type of intermittent fasting that involves eating all meals within a six-hour window before 3 p.m. Eight men with prediabetes followed this schedule for five weeks. They later switched to the typical American meal schedule, where they ate the same number of calories spread over 12 hours. “Our proof-of-concept trial is the first clinical trial in humans to show that intermittent fasting’s benefits are not simply due to eating less or losing weight,” said Courtney Peterson, Ph.D., an assistant professor at UAB, who led the study. “It points to the benefits of daily fasting as well as eating early, which puts you in sync with circadian rhythms in metabolism.” Eating in sync with circadian rhythms — which are daily 24-hour rhythms that arise from our body clock — promotes better blood sugar control and greater energy expenditure in the morning, suggesting this is the optimal time to eat. Peterson plans to tease apart the effects of fasting versus circadian timing in upcoming clinical trials in her laboratory. Peterson was a scholar in NCATS’ CTSA Program Mentored Clinical Research Scholars (KL2) training program, which supported the study. Learn more about Peterson’s experience as a KL2 scholar. Posted August 2018 | CTSA Program-supported investigators at the University of Alabama at Birmingham have found that eating before 3 p.m. and fasting afterward can improve overall health. | /sites/default/files/fasting_peterson_1260x630.jpg | NCATS-Supported Study Shows Eating Before 3 p.m. Can Improve Health | CTSA Program-supported investigators at the University of Alabama at Birmingham have found that eating before 3 p.m. and fasting afterward can improve overall health. | /sites/default/files/fasting_peterson_1260x630.jpg | NCATS-Supported Study Shows Eating Before 3 p.m. Can Improve Health |
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