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| 5986 | CTSA Program-Specific Guidance for Diversity, Re-entry and Reintegration Research Supplements | It is critical that applicants follow the submission instructions as noted in the relevant FOAs. The NCATS CTSA Program has one receipt date per fiscal year for diversity, Re-entry, and Reintegration supplements: September 15 (or the following business day if September 15 falls on a holiday or weekend). A complete package for a Diversity or Re-entry and Reintegration Supplement request must include: A brief proposal describing the project and training/career experience (not to exceed 10 pages), including: Summary or abstract of the funded parent award or project (not to exceed one page). Provide a brief overview about how the candidate will use the CTSA Program resources to complete their research training plan and which resources will be used. Research Strategy: Description of the candidate’s proposed research strategy within the scope of the funded parent award or project (not to exceed four pages). Organize the Research Strategy section using the following sections: Research Aims, Significance, Innovation and Approach. Applicants are encouraged to use NIH’s guidance for fellowships or career development applications. Mentoring Plan: A mentoring plan for the candidate must include a plan for the candidate to contribute intellectually to the research, to enhance her/his research skills and knowledge regarding the selected area of biomedical, behavioral, clinical or social sciences science; and to interact with other individuals on the parent grant that will contribute to their research and career development plan. It also must provide evidence of a focus on the enhancement of the research capability of the candidate and that the research experience is intended to provide opportunities for development as an independent investigator. In addition, the Mentoring Plan must demonstrate that the CTSA Program UL1 program director(s)/principal investigator(s) are willing to provide appropriate mentorship. The selected mentor(s) should be an active investigator in the area of the proposed research, committed to both the career development of the candidate, and able to the direct supervision of the candidate’s research. Candidates are encouraged to identify more than one mentor, (i.e., a mentoring team [or advisory committee]), as this is deemed advantageous for providing expert advice in all aspects of the research career development plan. The mentoring plan must include a description on developing an individual development plan for the candidate (see NOT-OD-14-113) (not to exceed three pages). Additionally, a plan for the candidate’s next source of funding is required. Mentoring experience of the CTSA Program UL1 PI and selected mentors (not to exceed one page). The mentor, or a member of the mentoring team, should have a successful track record of mentoring individuals at the candidate’s career stage. The primary mentor must 1) write a brief statement about their mentoring experience and mentoring philosophy, and 2) include a table listing current and previous mentees, degree (s), their career level at time of mentorship. Inclusion of the percent of individuals mentored whose background is consistent with the Notice of NIH’s Interest in Diversity (NOT-OD-20-031) is encouraged. A timeline for the research and career development experiences proposed (not to exceed one page). Identification of the Project/Performance Site Location: Include the primary site where the proposed research training supplement activities will be performed. If a portion of the proposed supplement activities will be performed at any other site(s), identify the locations in the fields provided. Identification of Senior/Key Personnel: List the CTSA Program UL1 PD/PI as the first person (regardless of their role on the supplement activities). List the candidate proposed to be added through this supplement, or for whom additional funds are being requested through this supplement. Note: Candidates for this supplement support must have an eRA Commons account and the candidate's Commons Username must be entered in the Credential field. Biographical Sketches: Include a biographical sketch for all personnel that will contribute to the research mentoring (PI/PD, candidate, mentors and collaborators). The biographical sketch should follow NIH guidelines. The personal statement of the candidate's biographical sketch should address: Evidence of scientific achievement or interest; Any source(s) of current funding; and A statement from the candidate outlining her/his research objectives and career goals. A Proposed Budget for the Entire Project Period: Applicants should follow the instructions as indicated in the FOA. Only include funds requested for the additional supplement activities. Note that the expected time commitment of the candidate on the project must adhere to the FOA requirements. The requested time of the entire project should be no less than two years to provide an optimal career development experience for the candidate. (See the CTSA Program FAQs for Diversity Supplements.) Candidate Eligibility Statement (not to exceed one page): A signed statement from an institutional official establishing the eligibility of the candidate for support under this program. The statement must include clearly presented information on citizenship of the candidate and a description of how the appointment of this specific candidate would further the goals of this funding opportunity, consistent with the Notice of NIH’s Interest in Diversity (NOT-OD-20-031). The strength of this statement will be considered by the NIH administrative review committee along with all other material provided. Other Project Information: If applicable, attach PDF documents in the "Other Attachments" field indicating that the proposed research experience was approved by the Institutional Animal Care and Use Committee (IACUC) or human subjects Institutional Review Board (IRB) at the grantee institution. Name the documents "IACUC Documentation.pdf" and/or "IRB Documentation.pdf". Adherence to the NIH policy for including women and minorities in clinical studies must also be ensured, if additional human subjects' involvement is planned for the supplement. Home Institution Approval: Under unusual circumstances where the applicant and mentor would be at a site other than the grantee institution, an appropriately signed letter from the institution where the research is to be conducted must also be submitted. The request must be signed by the CTSA Program UL1 PD/PI, the candidate and the appropriate institutional business official. Sub-Recipient Approval: If any of the research is to be conducted at an organization other than the grantee institution, an appropriately signed letter from the institution where the research is to be conducted must be submitted. The request must be signed by the candidate, the CTSA Program UL1 and the Subsite PD/PI, and the appropriate institutional business official. If the request is for a supplement based on disability, the institution should indicate what, if any, reasonable accommodations the institution has supported or plans to provide along with a full description of how any additional support for accommodation that might be used. The relationship of the proposed accommodation to the proposed project must be described. Note Regarding Eligibility of Candidates Supplemental awards under this announcement are limited to citizens or non-citizen nationals of the United States or to individuals who have been lawfully admitted for permanent residence in the United States (i.e., in possession of a Permanent Resident Card, Form I-551). In all cases involving any type of Permanent Residency status, when an application is selected to receive an award, prior to any award being issued, a notarized statement will be required that documents that a licensed notary has seen the candidate's valid Permanent Resident Card or other valid verification from the U.S. Immigration and Naturalization Service of legal admission to the U.S. In all cases where Permanent Residency status is involved, it is the responsibility of the recipient institution to assure the individual remains eligible for the project period of the award. Eligibility for Diversity Supplements: Institutions are encouraged to identify candidates who will enhance diversity on a national basis. The diversity supplement is designed for individuals from groups underrepresented in the biomedical sciences, including racial and ethnic minorities, persons with disabilities and individuals from economically and educationally disadvantaged backgrounds who wish to pursue a career in clinical and translational science research. If a candidate received a prior NCATS diversity supplement award, regardless of career stage, they are not eligible to apply for a second NCATS diversity supplement award. Eligibility for Re-entry Supplements: In general, the duration of the career interruption should be at least one year and no more than eight years. Examples of qualifying interruptions would include a complete or partial hiatus from research activities for child rearing; an incapacitating illness or injury of the candidate, spouse, partner or a member of the immediate family; relocation to accommodate a spouse, partner or other close family member; pursuit of non-research endeavors that would permit earlier retirement of debt incurred in obtaining a doctoral degree; and military service. The program is not intended to support additional graduate training and is not intended to support career changes from non-research to research careers for individuals without prior research training. Generally, the candidate should be in complete or partial hiatus from research activities at the time of application and should not be engaged in full-time paid research activities. Preference will be given to candidates with a complete hiatus from research activities. Eligibility for Reintegration Supplements: Candidates with doctoral degrees and graduate students seeking to transition out of unsafe research environments because of discriminatory and unlawful harassment are eligible to apply for Reintegration supplements as soon as supplement support to continue research training in a new and safe research environment has been identified. Review of Applications As indicated in the respective FOAs, administrative supplements do not undergo formal peer review. Program staff will evaluate supplement applications to determine its overall merit using the review criteria outlined in the FOAs. | Follow the submission instructions for the CTSA Program Diversity, Re-entry and Reintegration research supplements. | Guidance for Diversity, Re-entry and Reintegration Supplements | Follow the submission instructions for the CTSA Program Diversity, Re-entry and Reintegration research supplements. | Guidance for Diversity, Re-entry and Reintegration Supplements | ||||
| 5909 | 2017 Industry-Provided Assets | Assets in this table are alphabetized by mechanism of action. These compounds and biologics have undergone significant preclinical and safety testing in humans. 2017 Table of Assets for Adult Indications 2017 Table of Assets for Pediatric Indications 2017 Table of Assets for Adult Indications Code Number & Link to More Information Mechanism of Action Original Development Indication(s) Route of Administration Formulation Available (CNS Penetrant+) AZD4017 (PDF - 130KB) 11-beta-hydroxysteroid dehydrogenase type 1 (11β-HSD1) inhibitor Diabetes Oral (Low) AZD5363 (PDF - 178KB) AKT serine/threonine protein kinase (also known as protein kinase B alpha) inhibitor Solid and hematological malignancies Oral (Low) AZD6738 (PDF - 139KB) Ataxia telangiectasia and Rad3 related (ATR) serine/threonine protein kinase inhibitor Chronic lymphocytic leukemia Oral (Unknown) AZD5069 (PDF - 73KB) Chemokine (C-X-C motif) receptor 2 (CXCR2) antagonist Asthma Oral (Unknown) JNJ-39269646 (PDF - 34KB) Fast dissociating D2/D3/5-HT6 antagonist Schizophrenia Bipolar depression Oral (Yes) AZD4547 (PDF - 97KB) Fibroblast growth factor receptor (FGFR) tyrosine kinase family inhibitor Solid tumors Oral (Low) AZD7325 (PDF - 117KB) Bavisant Gamma-aminobutyric acid receptor A alpha 2 & 3 (GABA Aα2,3) positive modulator General anxiety disorder Oral (Yes) AZD3355 (PDF - 100KB) Lesogaberan Gamma-aminobutyric acid receptor B (GABA B) agonist Gastroesophageal reflux disease Oral (Low) AZD1656 (PDF - 121KB) Glucokinase (GK; hexokinase 4) activator Diabetes Oral (Low) AZD5213 (PDF - 135KB) Histamine receptor 3 (H3) antagonist (inverse agonist) Cognition Daytime sleepiness Tourette syndrome Oral (Yes) AZD2014 (PDF - 104KB) Vistuserib Mammalian target of rapamycin (mTOR) serine/threonine kinase (dual TORC1 and TORC2) inhibitor Solid tumors Oral (Low) AZD3241 (PDF - 121KB) Myeloperoxidase (MPO) inhibitor Parkinson’s disease Multiple system atrophy Oral (Yes) AZD5904 (PDF - 65KB) Myeloperoxidase (MPO) inhibitor Chronic obstructive pulmonary disease Multiple sclerosis Oral (Low) AZD0328 (PDF - 97KB) Nicotinic acetylcholine receptor alpha 7 (α7 nAChR) agonist Cognitive impairment Oral (Yes) JNJ-39393406 (PDF - 65KB) Nicotinic acetylcholine receptor, alpha 7 (α7 nAChR) positive allosteric modulator Cognitive impairment in schizophrenia Oral (Yes) *AZD9668 (PDF - 63KB) Alvelestat Neutrophil elastase (NE) inhibitor Chronic obstructive pulmonary disease Bronchiectasis Cystic fibrosis Oral (Low) JNJ-19385899 (PDF - 72KB) Nociceptin/orphanin-FQ receptor (NOP) agonist Anxiety Depression Oral (Yes) AZD9150 (PDF - 85KB) Signal transducer and activator of transcription 3 (STAT3) antisense Hepatocellular carcinoma Intravenous (Low) AZD0530 (PDF - 111KB) Saracatinib Src tyrosine kinase family inhibitor Solid tumors Oral (Yes) AZD1775 (PDF - 104KB) WEE1 G2 checkpoint kinase inhibitor Advanced solid tumors Oral (Unknown) +CNS penetrant: Yes, no,maybe, low or unknown. *This asset made available by Mereo BioPharma 2017 Table of Assets for Pediatric Indications Code Number & Link to More Information Mechanism of Action Original Development Indication(s) Route of Administration Formulation Available (CNS Penetrant+) AZD7325 (PDF - 117KB) Bavisant Gamma-aminobutyric acid receptor A alpha 2 & 3 (GABA Aα2,3) positive modulator General anxiety disorder Oral (Yes) AZD3355 (PDF - 100KB) Lesogaberan Gamma-aminobutyric acid receptor B (GABA B) agonist Gastroesophageal reflux disease Oral (Low) AZD1656 (PDF - 121KB) Glucokinase (GK; hexokinase 4) activator Diabetes Oral (Low) AZD5213 (PDF - 135KB) Histamine receptor 3 (H3) antagonist (inverse agonist) Cognition Daytime sleepiness Tourette syndrome Oral (Yes) AZD9668 (PDF - 63KB) Alvelestat Neutrophil elastase (NE) inhibitor Chronic obstructive pulmonary disease Bronchiectasis Cystic fibrosis Oral (Low) AZD0530 (PDF - 111KB) Saracatinib Src tyrosine kinase family inhibitor Solid tumors Oral (Yes) AZD1775 (PDF - 104KB) WEE1 G2 checkpoint kinase inhibitor Advanced solid tumors Oral (Unknown) +CNS penetrant: Yes, no,maybe, low or unknown. | 2017 Industry-Provided Assets | 2017 Industry-Provided Assets | ||||||
| 5860 | Ketamine for the Treatment of Depression and Other Anxiety-Related Disorders | Inventors: Panos Zanos, Ruin Moaddel, Patrick J. Morris, Irving W. Wainer, Craig J. Thomas, Carlos A. Zarate, Jr., & Todd D. Gould Ref. No.: E-092-2011, E-116-2016 and E-036-2016 Abstract: In a new finding that could improve the treatment of depression and other related disorders, NIH researchers and their collaborators found that the metabolism of ketamine is critical to its antidepressant effects and that the (2R,6R)-2-amino-2-(2-chlorophenyl)-6- hydroxycyclohexanone ((2R,6R)-hydroxynorketamine (HNK)) metabolite reversed depression-like behaviors in mice without triggering anesthetic, dissociative or addictive side effects associated with ketamine. Specifically, the researchers found that the metabolite does not inhibit the non-competitive glutamatergic N-methyl-D-aspartate (NMDA) receptor and that it exerts rapid actions that activate the α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptors. Results indicate that a non-NMDA receptor dependent mechanism underlying ketamine’s antidepressant properties, which involve bioactivity of a specific metabolite (2R, 6R-HNK), could be exploited for drug development. This ketamine metabolite and associated methods of treatment are available for collaboration and licensing. Publication: NMDAR inhibition-independent antidepressant actions of ketamine metabolites. • Nature • May 4, 2016 • NCATS Chemical Genomics Center | NIH researchers and their collaborators found that the metabolism of ketamine is critical to its antidepressant effects. | Ketamine for the Treatment of Anxiety-Related Disorders | NIH researchers and their collaborators found that the metabolism of ketamine is critical to its antidepressant effects. | Ketamine for the Treatment of Anxiety-Related Disorders | ||||
| 5791 | September 2016 Council/CAN Review Board Meeting | The Sept. 15, 2016, joint meeting of the NCATS Advisory Council and the Cures Acceleration Network Review Board featured the following meeting materials. Presentations NCATS Director’s Report (PDF - 4MB) – Christopher P. Austin, M.D., director, NCATS Update on the CTSA Program and Office of Rare Diseases Research Toolkit Project (PDF - 1MB) – Petra Kaufmann, M.D., M.Sc., director, Office of Rare Diseases Research and Division of Clinical Innovation, NCATS Concept Clearance: NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules (PDF - 71KB) – Christine M. Colvis, Ph.D., director of drug development partnership programs, Office of the Director, NCATS Concept Clearance: The CTSA Program Data to Health Initiative (PDF - 95KB) – Petra Kaufmann, M.D., M.Sc., director, Office of Rare Diseases Research and Division of Clinical Innovation, NCATS Illuminating the Druggable Genome: Program Overview (PDF - 536KB) – Christine M. Colvis, Ph.D., director of drug development partnership programs, Office of the Director, NCATS Illuminating the Druggable Genome: Recent Advances (PDF - 6MB) – Tudor I. Oprea, M.D., Ph.D., professor and chief, Division of Translational Informatics, Department of Internal Medicine, University of New Mexico School of Medicine Stimulating Peripheral Activity to Relieve Conditions: Program Update (PDF - 1MB) – Danilo A. Tagle, Ph.D., M.S., associate director for special initiatives, NCATS Additional Meeting Information Agenda (PDF - 156KB) Minutes (PDF - 169KB) Videocast Federal Register Notice Concept Clearances | September 2016 Council/CAN Review Board Meeting | September 2016 Council/CAN Review Board Meeting | ||||||
| 5774 | Stimulating Peripheral Activity to Relieve Conditions (SPARC) | We provide program management and administrative support for Stimulating Peripheral Activity to Relieve Conditions, a Common Fund program.SPARC OverviewModulation of these electrical control signals could be a powerful way to treat such common conditions and diseases as rheumatoid arthritis and heart failure. Methods and medical devices that modulate peripheral nerve activity are becoming available, but more research is needed to fully understand how these therapies act on a target organ’s cells. Such understanding could help explain why a therapy might be effective in one individual but not in another and could potentially resolve the issue, which can make these therapies more effective.SPARC Program GoalsSPARC-funded investigators are working collectively as a consortium to address the program’s aims and goals via:Biological projects to develop detailed anatomical and functional maps that illustrate how peripheral nerves control organ functionTechnology development projects to create or improve tools to measure and manipulate nerve-organ interactions and isolate their functionsPartnerships between private-sector scientists and academic researchers to expedite the development of new therapeutic strategiesExpertise leveraged from many different sources, including academic laboratories, independent inventors, start-ups, small and large businesses, and international organizationsSPARC program-developed data and tools shared through a central online resourceTo achieve these goals, NIH envisions a consortium tasked with managing these four components:Anatomical and Functional Mapping of the Innervation of Major OrgansNext-Generation Tools and TechnologiesTranslational Partnerships for Human Functional Mapping and New IndicationsData and Resource CenterAn NIH-Wide InitiativeSPARC is funded through the NIH Common Fund and managed by the NIH Office of the Director in partnership with NCATS, the National Institute of Biomedical Imaging and Bioengineering, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute of Neurological Disorders and Stroke.Our role in this effort is to provide program management and administrative support, along with expertise in enabling industry collaborations. We help the NIH Common Fund administer the awards for SPARC projects that use the Other Transaction funding mechanism. We also provide programmatic management for awards under the Translational Partnerships component.Template agreements with several device manufacturers have made those companies’ neuromodulation technology (i.e., implantable devices with recording and/or stimulation capabilities) available to SPARC investigators. The aim is to promote preclinical development of these technologies, in support of an Investigational Device Exemption submission to the U.S. Food and Drug Administration (FDA) for a future pilot clinical study. These pilot clinical studies are designed to provide the initial proof-of-concept demonstrations in humans to spur the further studies needed for pursuit of FDA approval as a labeled indication. | Stimulating Peripheral Activity to Relieve Conditions (SPARC), an NIH Common Fund program, is focused on understanding the nerves that connect the brain and spinal cord to the rest of the body. | /sites/default/files/sparc-neurons-firing-900px.jpg | Stimulating Peripheral Activity to Relieve Conditions | Stimulating Peripheral Activity to Relieve Conditions (SPARC), an NIH Common Fund program, is focused on understanding the nerves that connect the brain and spinal cord to the rest of the body. | /sites/default/files/sparc-neurons-firing-900px.jpg | Stimulating Peripheral Activity to Relieve Conditions | ||
| 5773 | NIH Common Fund Programs | NIH Common Fund programs can provide a strategic and nimble approach to address key roadblocks in biomedical research that impede basic scientific discovery and its translation into improved human health. All NIH Institutes and Centers are involved with the NIH Office of Strategic Coordination in the design, implementation and evaluation of Common Fund programs. NCATS is in a unique position to administer several innovative Common Fund programs that complement the Center’s efforts to transform the translational science process so that more treatments can reach more patients more quickly. NCATS co-chairs and provides leadership on the following Common Fund programs: Current Common Fund Programs Extracellular RNA Communication (ExRNA) ExRNA communication is a recently discovered cell-to-cell signaling process that holds enormous promise for improving our understanding of a wide variety of diseases. NCATS participates in the NIH Common Fund’s program to investigate this new scientific field. Illuminating the Druggable Genome (IDG) To improve scientific understanding of understudied protein families, IDG is designed to test a two-pronged approach for exploring the druggable genome. Approximately 3,000 genes are considered part of the “druggable genome,” a set of genes encoding proteins that scientists can or predict they can modulate using experimental small molecule compounds. Yet only about 10 percent of these genes encode proteins that have been targeted successfully by an approved drug. Therefore, a large number of proteins remain for scientists to explore as potential therapeutic targets. Somatic Cell Genome Editing The Somatic Cell Genome Editing program, led by NCATS and managed by a trans-NIH working group representing multiple institutes and centers, aims to develop quality tools to perform safe and effective genome editing in humans and then make these tools widely available to the research community to reduce the time and cost of developing new therapies. Stimulating Peripheral Activity to Relieve Conditions (SPARC) SPARC is focused on understanding the peripheral nerves — nerves that connect the brain and spinal cord to the rest of the body — and how their electrical signals control internal organ function. Former Common Fund Programs Science of Behavior Change (SOBC) With support from the Common Fund, the SOBC program, in which NCATS was an active participant, successfully promoted an experimental medicine- and mechanisms-based approach to behavior change research across a range of health behaviors from 2009 to 2019. To further the dissemination of SOBC products and approaches to improve the study of health behavior change, NCATS, the National Institute on Aging, National Center for Complementary and Integrative Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institute on Drug Abuse, and Office of Behavioral and Social Sciences Research have co-funded an extension of the SOBC Resource and Coordinating Center. NCATS is engaged actively in collaborative efforts to expand the Measures Repository to facilitate the development of behavioral health interventions. This work supports NCATS’ mission by advancing the translation of knowledge of behavior change mechanisms into interventions to improve human health. | NCATS is in a unique position to administer several innovative Common Fund programs that complement the Center’s efforts to transform the translational science process. | NIH Common Fund Programs | NCATS is in a unique position to administer several innovative Common Fund programs that complement the Center’s efforts to transform the translational science process. | NIH Common Fund Programs | ||||
| 5747 | Accelerating Clinical and Translational Science Research through Collaboration and Innovation | The NCATS CTSA Program supports team-based research to develop, demonstrate and disseminate innovations that can accelerate the translational research process to turn laboratory, clinic and community observations into interventions and benefit public health more quickly. The Collaborative and Innovative Acceleration Award aims to provide support to investigators to tackle a translational science problem no one organization can solve alone. The award supports synergistic activities that accelerate the translational research process through collaboration and innovation.The notice of funding opportunity invites applications to develop, demonstrate and disseminate innovative solutions to transform the field of translational science by addressing the inefficiencies that are common across diseases and bringing more interventions to all people more quickly through collaborative science among the CTSA Program institutions; NIH institutes, centers, and offices; and/or external stakeholders. View a full-size version of the image.CTSA Program Collaborative Innovation Awards Funding OpportunityFind more information about the CCIA funding opportunity for the CTSA Program.Funded AwardsCTSA Program Collaborative Innovation Awards (CCIA)The funded projects reflect the CTSA Program goals and cover a broad spectrum of translational science, ranging from diagnostics and clinical trial design to patient-reported outcomes and community engagement.• 2022 CCIA projects• 2021 CCIA projects• 2020 CCIA projects• 2019 CCIA projectsEligible OrganizationsNCATS Clinical and Translational Science Award Program Institutions and PartnersCTSA Partner List - FY22 (updated 9.1.2022)NCATS Rare Diseases Clinical Research Network ConsortiaNIAMS Core Centers for Clinical ResearchNIAMS Centers of Research TranslationNIGMS Institutional Development Award Networks for Clinical and Translational ResearchNIMHD Research Centers in Minority InstitutionsNIMHD Centers for Multiple Chronic Disease Associated with Health Disparities | The NCATS CTSA Program supports team-based research to develop, demonstrate and disseminate innovations that can accelerate the translational research process. | CTSA Program Collaborative Awards | The NCATS CTSA Program supports team-based research to develop, demonstrate and disseminate innovations that can accelerate the translational research process. | CTSA Program Collaborative Awards | ||||
| 5746 | Trial Innovation Network | Jeffrey Burns, M.D., director of the Frontiers: University of Kansas Clinical and Translational Science Institute's Participant and Clinical Interactions Resources Program, and its Clinical and Translational Science Unit, and director of the Alzheimer's and Memory Program, monitors Howard Kemper, a participant in the Brain Aging Project. The program is studying the relationship between fitness and Alzheimer's disease. Mr. Kemper, who does not have Alzheimer's disease, is participating in this study as a "healthy" control. (Donna Peck Photo)We have built the Clinical and Translational Science Awards (CTSA) Program on the strength of more than 50 unique academic medical centers nationwide. We rely on the individual strengths of the CTSA Program institutions and partner with them to develop and implement innovative, collaborative solutions intended to transform clinical and translation research. Together, these efforts address common areas of need that call for collaborative solutions, including:• Training and cultivating the translational science workforce• Engaging patients and communities in every phase of the translational process• Promoting the integration of special and underserved populations in translational research across the human lifespan• Innovating methods and processes to increase the quality and efficiency of translational research, particularly of multisite trials• Advancing the use of cutting-edge informatics OverviewThe Trial Innovation Network is a new collaborative initiative within NCATS’ CTSA Program composed of three key organizational partners:• Trial Innovation Centers (TICs)• Recruitment Innovation Center (RIC)• CTSA Program institutionsOur vision for the Trial Innovation Network is to address critical roadblocks in clinical trials and to accelerate the translation of novel interventions into life-saving therapies. The network will focus on operational innovation, operational excellence and collaboration while leveraging the expertise, diversity and broad reach of the CTSA Program. Features will include a single institutional review board system, master contracting agreements, quality-by-design approaches, and a focus on evidence-based strategies for recruitment and patient engagement.The goal is not only to execute trials better, faster and more cost-efficiently, but also to be a national laboratory to study, understand and innovate the process of conducting clinical trials. Current AwardeesCurrent TIC and RIC awardees are:TICsJohns Hopkins Trial Innovation CenterInstitution: Johns Hopkins University Principal Investigator: Daniel F. Hanley, M.D.Vanderbilt University Medical Center’s Engaging Cooperative Sites for Trial Acceleration, Trust, Innovation and Capability (ECSTATIC)Institution: Vanderbilt University Medical CenterPrincipal Investigators: Gordon R. Bernard, M.D., Christopher J. Lindsell, Ph.D. (Duke University as of 2022), Wesley H. Self, M.D., M.P.H.RICVanderbilt University Medical Center’s Catalyzing and Harmonizing Operational Innovation for Recruitment (CHOIR) Institution: Vanderbilt University Medical CenterPrincipal Investigators: Paul A. Harris, Ph.D., and Consuelo H. Wilkins, M.D. | The Trial Innovation Network is a new collaborative initiative within NCATS’ CTSA Program, composed of Trial Innovation Centers, a Recruitment Innovation Center and CTSA Program hubs. | Trial Innovation Network | The Trial Innovation Network is a new collaborative initiative within NCATS’ CTSA Program, composed of Trial Innovation Centers, a Recruitment Innovation Center and CTSA Program hubs. | Trial Innovation Network | ||||
| 5738 | Invention E-189-2016 | Mutant IDH1 Inhibitors Useful for Treating Cancer Lead Inventor: Matthew Boxer (NCATS) Ref. No.: E-189-2016 Abstract: Mutations in isocitrate dehydrogenase 1 (IDH1), an enzyme whose normal function is to convert isocitrate to α-ketoglutarate, are common in a variety of cancers, including acute myeloid leukemia, glioma, cholangiocarcinoma, chondrosarcoma and melanoma. These IDH1 mutants catalyze the production of 2-hydroxyglutarate, an oncometabolite that has been shown to contribute to epigenetic dysregulation in cancer cells. Small molecule inhibitors of several cancer-specific mutant isoforms of IDH1 are available for licensing. Publication: Biochemical, Cellular, and Biophysical Characterization of a Potent Inhibitor of Mutant Isocitrate Dehydrogenase IDH1 • Journal of Biological Chemistry • May 16, 2014 • NCATS Chemical Genomics Center | Invention E-189-2016 | Invention E-189-2016 | ||||||
| 5672 | About SMR | The major operations of the NCATS Small Molecule Resource (SMR) include: Identifying and acquiring small molecule compounds; Applying a standard quality control (QC) regimen; Handling, storing and maintaining the compound collection within established guidelines; Distributing compound plates to the research community and Depositing compound structures into PubChem. Identification and Acquisition of Compounds The SMR compound collection began as part of the Molecular Libraries Probe (MLP) Production Centers Network (MLPCN). The collection was initially developed to supply the Network with low-molecular-weight compounds for high-throughput screening (HTS). In coordination with the External Scientific Advisory Committee of the MLPCN, the SMR developed compound selection criteria (e.g., stability, solubility, availability of sufficient quantities, ease of re-supply or re-synthesis, diversity). Compounds were obtained in several different ways, including purchase from commercial vendors, grants to medicinal and organic chemists and donations from academic investigators. Compound Availability The SMR is currently offering compound sets selected for known biological activity against specific protein targets or signaling pathways. The NIH Clinical Collection set is a plated array of approximately 700 small molecules that have a history of use in human clinical trials. Similar collections of Food and Drug Administration-approved drugs have proven to be rich sources of undiscovered bioactivity and therapeutic potential. Soon to be released, the Probe Plus set is a collection of 1,400 compounds containing probes discovered through the screening effort of the MLP. For each probe, the set contains five structural analogs that will provide important structure activity information from each screen. Quality Control (QC) The SMR processes all samples that it has received in a standard, high-throughput QC regimen that checks for weight, solubility, identity and purity. Sample weight is verified to ensure that the minimum amount required was received. Sample solubility in dimethyl sulfoxide (DMSO) is checked, and only completely soluble samples are accepted into the SMR. Liquid chromatography-mass spectrometry is used to determine sample identity and purity. The SMR accepts samples where the molecular ion is identified and the area under the curve is at least 90 percent by evaporative light scattering or ultraviolet detection. Compound Handling, Storage and Distribution The SMR immediately stores samples that pass QC tests in automated storage equipment for fast retrieval. SMR uses a three-tier storage system: long-term store, working store, and short-term store. The SMR stores the bulk sample dry in glass vials as the long-term store. Working-store samples of each compound are created in a 10-micromolar DMSO solution to be stored and used for approximately one year. The working-store samples are in turn used to create microtiter plates to be shipped to investigators, which are then held in the short-term store until shipment (typically less than one week). Compounds are stored at -20°C in all three tiers of the storage system, and all DMSO solutions are stored and handled under nitrogen atmosphere to prevent water absorption and ensure optimal stability and purity. Information on SMR Compounds in PubChem and NCBI Bookshelf Structure, chemical and biological information on all compounds in the SMR may be found in PubChem, a public-sector cheminformatics database of small organic molecules and their biological activities managed by the National Center for Biotechnology Information (NCBI). Probe reports providing extensive information on probes found in the Probe Plus set may be found on the NCBI Bookshelf under the chapter “Probe Reports of the NIH MLP.” Investigators will link to these substances when depositing HTS data. To access data on the structures of compounds in the SMR collection, click on the previous links or search the PubChem Substance records using the keyword “SMR.” | About SMR | About SMR |
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