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| 6184 | Assay Guidance Workshop Agenda - July 2015 | July 17, 2015 – 9:00 a.m. – 3:30 p.m. EST Harvey W. Wiley Federal Building, FDA, Center for Food Safety and Applied Nutrition, Wiley Auditorium, Room 1A-003, 5100 Paint Branch Parkway, College Park, MD 20740 9:00 – 9:30 a.m.: Robust or Go Bust: An Introduction to the Assay Guidance Manual Nathan P. Coussens, Ph.D., NCATS, NIH 9:30 – 10:10 a.m.: The Basics of High Throughput Screening in Toxicity Testing Menghang Xia, Ph.D., NCATS, NIH 10:10 – 11:30 p.m.: Establishing Robust Biochemical and Cellular Assays Lisa Minor, Ph.D., In Vitro Strategies, LLC 11:30 – 12:30 p.m.: Lunch on Own 12:30 – 1:10 p.m.: Designing Cell-Based Assays for Screening Terry Riss, Ph.D., Promega Corporation 1:10 – 1:50 p.m.: Assay Interpretation: Studies in Mechanisms and Methods in Assay Interferences Douglas Auld, Ph.D., Novartis Institutes for BioMedical Research 1:50 – 2:30 p.m.: In Vitro Assessment of ADME and PK Properties of Lead Compounds Xin Xu, Ph.D., NCATS, NIH 2:30 – 3:10 p.m.: Assay Statistics and Data Analysis Thomas D.Y. Chung, Ph.D., Sanford-Burnham Medical Research Institute 3:10 – 3:30 p.m.: Final Remarks and Questions Acknowledgements: Chris Austin, Laura Carter, Nolan Chase, Adrian Choice, Janice Crum, Suzanne C. Fitzpatrick, Nicholas Gelardi, David Hanley, Sandy Ismail, Emet LaBoone, A. Renee Madden, Cindy McConnell, Anton Simeonov, Geoff Spencer, and Ashley Stewart | The agenda from the July 17, 2015 Assay Guidance Workshop for High-Throughput Screening and Lead Discovery | Assay Guidance Workshop Agenda - July 2015 | The agenda from the July 17, 2015 Assay Guidance Workshop for High-Throughput Screening and Lead Discovery | Assay Guidance Workshop Agenda - July 2015 | ||||
| 6181 | Assay Guidance Manual Training Workshops | Online Training ModulesUpcoming WorkshopsPast WorkshopsNCATS offers a variety of Assay Guidance Manual (AGM) training workshops throughout the year designed to share best practices and advice on robust assay design, development and implementation for researchers involved in the drug discovery process.Online Training ModulesNCATS offers an online AGM training workshop in addition to the in-person AGM workshops held throughout the year. The online training workshop also features experts sharing best practices and expert advice on assay design, development and implementation. View the video modules.Upcoming Workshops2023Dec. 1 11 a.m. to 12 p.m. ETPreclinical Translational Science: The View from BiotechNCATS’ Assay Guidance Manual (AGM) program will host a quarterly virtual webinar series in conjunction with the center’s Office of Policy, Communications and Education and Office of Drug Development Partnership Programs. This series, featuring prominent speakers in the field, is designed to communicate critical information about preclinical translational science and is particularly relevant for biomedical researchers who are conducting preclinical studies to advance research leading to interventions that will impact human health.Website/RegistrationPast WorkshopsLearn more about past training workshops and read participant testimonials.Sept. 2211 a.m. to 12 p.m. ETGene Control TherapeuticsNCATS’ Assay Guidance Manual (AGM) program will host a quarterly virtual webinar series in conjunction with the center’s Office of Policy, Communications and Education and Office of Drug Development Partnership Programs. This series, featuring prominent speakers in the field, is designed to communicate critical information about preclinical translational science and is particularly relevant for biomedical researchers who are conducting preclinical studies to advance research leading to interventions that will impact human health.Website/Agenda March 10 11 a.m. to 12 p.m. ET2023 AGM Preclinical Translational Science Webinar SeriesNCATS’ Assay Guidance Manual (AGM) program will host a quarterly virtual webinar series in conjunction with the center’s Office of Policy, Communications and Education and Office of Drug Development Partnership Programs. This series, featuring prominent speakers in the field, is designed to communicate critical information about preclinical translational science and is particularly relevant for biomedical researchers who are conducting preclinical studies to advance research leading to interventions that will impact human health.The webinar series will convey best practices in preclinical translational science to help bridge the gap between research discoveries and the delivery of new therapies. Participants will discuss topics relevant to preclinical translational science, including reproducibility, assay development, new and emerging modalities in drug discovery, and entrepreneurship. Participants also will dissect case studies about successful and unsuccessful drug discovery campaigns, with the goal of learning about strategies, methods, and approaches for accelerating drug development. Presenters will provide an overview of the AGM e-book, an important resource for detailed information about robust assay methods and best practices in quantitative biology. They also will disseminate the principles of translational science among scientists in biomedical research and demonstrate how these are applied in preclinical research.Website/Agenda 2022Oct. 18–19Assay Guidance Workshop for High-Throughput Screening and Lead DiscoveryOn Oct 18–19, NCATS Assay Guidance Manual (AGM) program is hosted a two-day workshop that covered a broad range of critical concepts underlying assay development and implementation for high-throughput screening and lead discovery projects. This workshop was designed to disseminate critical information about the implementation of robust assay methods and was particularly relevant for researchers developing molecular probes or clinical candidates. Many of the instructors have 20 to 30 years of experience in the field of drug discovery and shared information not readily found in a classroom or published material outside of the AGM. The workshop also covered emerging technologies and modalities in drug discovery, including the use of DNA-encoded libraries and 3-D tissue models in drug discovery.Website and AgendaJune 7–8Assay Guidance Workshop on 3-D Tissue Models for Antiviral Drug DevelopmentOn June 7–8, 2022, NCATS, the National Institute of Allergy and Infectious Diseases and the Bill & Melinda Gates Foundation hosted a jointly organized virtual workshop that covered a broad range of critical concepts, including practical approaches and best practices, for developing standardized 3-D cellular assays with the hope of helping the community to successfully develop therapeutics for future pandemic threats. The overall goal of this workshop was to help scientists establish robust, reproducible, scalable, consistent and advanced 3-D tissue models to study pandemic threat viruses.Website • Agenda (PDF - 168KB)Feb. 5Assay Guidance Workshop for High-Throughput Screening and Lead Discovery (Short Course)This full-day workshop covered a broad range of critical concepts underlying assay development and implementation for high-throughput screening and lead discovery projects. Many of the methodologies successfully implemented in such projects have established a good deal of “tribal knowledge” within the pharmaceutical industry, which is not readily found in a classroom or the literature. This tribal knowledge, developed over decades, has been transferred into detailed chapters within the Assay Guidance Manual to facilitate reproducible and robust assays that can identify the most promising compounds for the development of molecular probes or clinical candidates.The workshop provided participants with a broad, practical perspective on assay development so that they can (1) improve research projects involving drug discovery and know where to find further information; (2) identify reagents, methods and instrumentation that are well suited to robust assays; and (3) develop robust assays and the required counter and secondary assays for targets of interest.Website2021Nov. 16–17Assay Guidance Workshop for Cell-Based Assays and Lead DiscoveryNCATS’ Assay Guidance Manual (AGM) program hosted a two-day workshop that covered a broad range of critical concepts underlying high-content screening and analysis and complex in vitro models in drug discovery. This workshop was designed to disseminate critical information about the implementation of robust cellular assay methods and was particularly relevant for researchers developing molecular probes or clinical candidates. Many of the workshop instructors have 20–30 years of experience in the field of drug discovery and they shared information not readily found in a classroom or published material outside of the AGM.The goal of this workshop was to train scientists on the fundamentals and applications of image-based and 3-D cellular assay technologies and engage in a dialogue with those curious to understand it on a deeper level. This workshop also aimed to discuss challenges and standards for rigor to enable reproducible results and provide a future perspective on the utility of complex cellular models in drug discovery.AgendaSept. 1–2Assay Guidance Manual Virtual Workshop on DNA-Encoded Libraries for Lead DiscoveryThis workshop aimed to provide best practices and discussed standards for rigor in the DNA-Encoded Libraries (DEL) technology field to enable reproducible results. Through the combined learnings from the four sessions, participants had the opportunity to improve the quality of their research projects by utilizing DEL for hit discovery and learned where to find further information. Novice users took home practical learnings that could be immediately applied, and experienced practitioners gained a deeper appreciation for the complexities of DEL that are outside their immediate disciplines of expertise.Agenda2020Nov. 18-19Assay Guidance Workshop for High-Throughput Screening and Lead DiscoveryThis workshop covered a broad range of critical concepts underlying assay development and implementation for high-throughput screening and lead discovery projects. This workshop was designed to disseminate critical information about the implementation of robust assay methods and was particularly relevant for researchers developing molecular probes or clinical candidates.Website/AgendaJanuary 25Assay Guidance Workshop for High-Throughput Screening and Lead DiscoveryThis workshop – held during the Society for Laboratory Automation and Screening (SLAS) 2020 International Conference & exhibition – provided attendees with core principles and practices to facilitate the design and execution of a diverse range of rigorous and reproducible assays that can identify the most promising compounds for the development of molecular probes or clinical candidates.Website/Agenda2019September 11-12Assay Guidance Workshop for High-Throughput Screening and Lead DiscoveryThis workshop provided attendees with core principles and practices that facilitate the design and execution of a diverse range of rigorous and reproducible assays that can identify the most promising compounds for the development of molecular probes or clinical candidates. View the agenda (PDF - 911KB)March 10Assay Guidance Workshop for High-Throughput Screening and Lead DiscoveryHeld during the Society of Toxicology 58th Annual Meeting & ToxExpo, this workshop featured sessions designed to provide participants with “good research practices” for the rigorous development, optimization, implementation and interpretation of robust in vitro toxicological assays for reproducible results using physiologically relevant models. February 7-8Assay Guidance Workshop for High-Throughput Screening and Lead DiscoveryThis NCATS-sponsored symposium highlighted challenges and opportunities throughout the discovery and development process for addiction- and pain-related medications in the pre-competitive preclinical stage and provided a framework for more focused efforts within the research community. View the agenda (PDF - 624KB).>February 2Assay Guidance Workshop for High-Throughput Screening and Lead DiscoveryHeld during the 2019 Society for Laboratory Automation and Screening meeting, this workshop covered critical information about the implementation of robust assay methods, particularly for researchers developing bioassays for the discovery of drugs or chemical probes. View the agenda.2018September 10-11Assay Guidance Workshop for High-Throughput Screening and Lead DiscoveryThis two-day workshop covered a broad range of critical concepts underlying assay development for high-throughput screening and lead discovery projects, along with hands-on data analysis training. View the agenda.March 26-27Assay Guidance Workshop for High-Throughput Screening and Lead DiscoveryNCATS supported this two-day workshop that covered a broad range of critical concepts underlying assay development for high-throughput screening and lead discovery projects, along with hands-on data analysis training. View the agenda.2017October 23Assay Guidance Workshop for High-Throughput Screening and Lead DiscoveryNCATS supported this full-day workshop that covered a broad range of critical concepts underlying assay development for high-throughput screening and lead discovery projects. View the agenda. August 7Assay Guidance Workshop for High-Throughput Screening and Lead DiscoveryNCATS supported this full-day workshop that covered a broad range of critical concepts underlying assay development for high-throughput screening and lead discovery projects. More than 40 people participated to learn more about the implementation of robust assay methods and development of bioassays for the discovery of drugs or chemical probes. Learn more. View the agenda.February 4Assay Guidance Workshop for High-Throughput Screening and Lead DiscoveryMore than 30 industry and academic researchers from nine countries and 12 U.S. states participated in the Washington, D.C., workshop, held in conjunction with the Society for Laboratory Automation and Screening’s annual international conference. Learn more. View the agenda.2016October 27Assay Guidance Workshop for High-Throughput Screening and Lead DiscoverySee testimonials from the Assay Guidance Workshop for High-Throughput Screening and Lead Discovery hosted by NCATS and Promega scientists in Madison, Wisconsin. View the agenda.April 5–6Assay Guidance Workshop for High-Throughput Screening and Lead DiscoveryLearn about how more than 100 participants attended the Assay Guidance Workshop for High-Throughput Screening and Lead Discovery in College Park, Maryland, hosted by NCATS and the Food and Drug Administration (FDA). View the agenda.January 23Assay Guidance Workshop for High-Throughput Screening and Lead DiscoveryDiscover more about the SLAS2016 Assay Guidance Workshop for High-Throughput Screening and Lead Discovery in San Diego, California. View the agenda.2015July 17Assay Guidance Workshop for High-Throughput Screening and Lead DiscoveryRead about the Assay Guidance Workshop for High-Throughput Screening and Lead Discovery hosted by NCATS and the FDA in College Park, Maryland. View the agenda.February 6Assay Guidance Workshop for High-Throughput Screening and Lead DiscoveryLearn more about NCATS’ inaugural Assay Guidance Workshop for High-Throughput Screening and Lead Discovery at its laboratories in Rockville, Maryland. View the agenda. | Learn more about NCATS’ Assay Guidance Manual training workshops designed to share best practices and advice on robust assay design and development. | Assay Guidance Manual Training Workshops | Learn more about NCATS’ Assay Guidance Manual training workshops designed to share best practices and advice on robust assay design and development. | Assay Guidance Manual Training Workshops | ||||
| 6180 | Assay Guidance Manual (AGM) Workshop Agenda - February 2015 | February 6, 2015 – 9:00 a.m. – 4:30 p.m. EST 9800 Medical Center Drive, Rockville, MD 20850 9:00 – 9:30 a.m.: Introduction and Overview of the Assay Guidance Manual Sitta Sittampalam, Ph.D., NCATS, NIH 9:30 – 10:50 a.m.: Developing a Robust Cellular and Biochemical Assay Lisa Minor, Ph.D., In Vitro Strategies, LLC 10:50 – 11:30 a.m.: Cell-based Assays Terry Riss, Ph.D., Promega Corporation 11:30 – 12:20 p.m.: Tour of the NCATS Facility 12:20 – 1:40 p.m.: Lunch on Own 1:40 – 2:20 p.m.: Common Sources of Assay Artifacts Douglas Auld, Ph.D., Novartis Institutes for BioMedical Research 2:20 – 3:00 p.m.: Statistics and Data Analysis Thomas D.Y. Chung, Ph.D., Sanford-Burnham Medical Research Institute 3:00 – 4:30 p.m.: Small Group Discussions - Participants will be assigned to one of five small groups, based on their individual interests. Each group will include one of the workshop speakers. This section will allow participants an opportunity to receive practical feedback and advice to accelerate their own research. Acknowledgements: Chris Austin, Charles ‘Pepper’ Bonney, Nicholas Gelardi, Sandy Ismail, Cindy McConnell, Anton Simeonov, Geoff Spencer, and Adam Yasgar | The agenda from the February 6, 2015 Assay Guidance Manual (AGM) Workshop | Assay Guidance Manual (AGM) Workshop Agenda - February 2015 | The agenda from the February 6, 2015 Assay Guidance Manual (AGM) Workshop | Assay Guidance Manual (AGM) Workshop Agenda - February 2015 | ||||
| 6177 | 2016 CCIA Administrative Supplements Projects | Enhancing Network Capacity by Disseminating State-of-the-Art Methods and Tools for the Design and Analysis of Randomized Clinical Trials Optimizing Translational Veterinary Trials to Advance Human Outcomes Real-Time Genomic Analysis Using iobio Enhancing Network Capacity by Disseminating State-of-the-Art Methods and Tools for the Design and Analysis of Randomized Clinical Trials Johns Hopkins University Principal Investigator: Daniel E. Ford, M.D. Contact: Daniel Scharfstein (dscharf68@gmail.com; dscharf@jhu.edu) Website: http://www.projectdidact.org/ Representatives of the Johns Hopkins University, University of Michigan, Harvard University and Tufts University CTSA Program hubs will collaborate to disseminate state-of-the-art methods and tools for the design and analysis of randomized clinical trials. Topics being addressed include: Sequential, multiple assignment randomized trial designs; Leveraging baseline covariates to improve the efficiency of randomized trials; Causal analysis of pragmatic trials; Sensitivity analysis for randomized trials with missing outcome data; and Heterogeneity of treatment effects and individualized treatment effects. The goal is to bring a full menu of critical methods and tools to the clinical and translation research community, and to help foster a common understanding that will increase the likelihood of successful implementation of the methods. Optimizing Translational Veterinary Trials to Advance Human Outcomes Ohio State University Principal Investigator: Rebecca D. Jackson, M.D. Contact: Cheryl London Website: https://ctsaonehealthalliance.org/ There is increasing evidence that spontaneous diseases in veterinary patients represent a unique tool to generate critical data regarding the safety and efficacy of novel drugs and devices. Representatives of the Ohio State University, Tufts University, University of Minnesota and University of California-Davis CTSA Program hubs will facilitate the incorporation of large animal models of spontaneous disease into Investigational New Drug studies by creating and implementing standard operating practices and procedures for veterinary clinical trials across the four sites. Specific aims include: Optimizing and distributing a set of standard operating practices for the conduct of veterinary trials; Generating and implementing a veterinary Good Clinical Practice training module; Establishing REDCap for clinical trial management and reporting across CTSA One Health Alliance sites; Forming a data safety management board to oversee trials and facilitate institutional approval; and Developing a cohesive outreach effort to ensure consortium-wide enrollment. Successful completion of this project will enable seamless initiation of veterinary clinical trials over multiple sites, thereby establishing a well-organized, proficient network that can rapidly provide critical information to accurately inform subsequent human translational efforts. Real-Time Genomic Analysis Using iobio University of Utah* Principal Investigator(s): Carrie L. Byington, M.D., Willard H. Dere, M.D., F.A.C.P. Contact: Willard Dere Website: http://iobio.io/ Genomic analyses promise to revolutionize the diagnosis and treatment of inherited disease and cancers. However, many current genomic analysis tools are not accessible to clinicians and medical researchers because they require extensive bioinformatics training, hours or days of analysis time and produce static output files requiring expert processing and interpretation. Researchers at the University of Utah CTSA Program hub aim to improve diagnostic rates and maximize returns from DNA sequence data by incorporating a web-based analysis system, iobio, to empower all biological researchers to analyze — easily, interactively and in a visually driven manner — large biomedical data sets into clinical practice at two Utah CTSA undiagnosed disease clinics. Specifically, this supplement will: Close the gap between computational and clinical genomics by training physicians to interact directly with genomic data and results; and Increase the diagnostic rate in complex clinical cohorts of families. With the help of visually-guided tools in iobio, physicians will be able to examine patient data directly, assess its quality, and identify potentially missed disease-causing variants, thereby leading to increased diagnostic rates, better health outcomes and reduced health care costs. *This award reflects co-funding support from the NIH Big Data to Knowledge Initiative (NIH Common Fund, through the Office of Strategic Coordination/Office of the NIH Director). | To further support network capacity in the CTSA Program, NCATS is funding administrative supplements to allow investigators from two or more CTSA Program hubs to form collaborations. | 2016 CCIA Administrative Supplements Projects | To further support network capacity in the CTSA Program, NCATS is funding administrative supplements to allow investigators from two or more CTSA Program hubs to form collaborations. | 2016 CCIA Administrative Supplements Projects | ||||
| 6176 | 2016 CCIA Projects | A National IPS Cell Network with Deep Phenotyping for Translational Research Disseminating Curative Biological Therapies for Rare Pediatric Diseases Early Check: A Collaborative Innovation to Facilitate Pre-Symptomatic Clinical Trials in Newborns Leveraging Existing Registry Resources to Facilitate Clinical Trials Improving Patient-Reported Outcome Data for Research Through Seamless Integration of the PROMIS Toolkit into EHR Workflows Strengthening Translational Research in Diverse Enrollment (STRIDE) Transformative Computational Infrastructures for Cell-Based Biomarker Diagnostics A National IPS Cell Network with Deep Phenotyping for Translational Research Boston University Medical Campus Principal Investigators: Nelson Kotton, M.D., Andrew A. Wilson, M.D., Chad Cowan, Ph.D., Yoav Gilad, Ph.D., and Edward E. Morrisey, Ph.D. Grant Number: 1-U01TR001810-01 Collaborating Institutions: Harvard Medical School, University of Chicago, University of Pennsylvania The discovery of inducible pluripotent stem cells (iPSCs) provides an unprecedented opportunity for any scientist to derive an inexhaustible supply of patient-derived primary cells. These cells containing each patient's own genetic background can now be applied for in vitro human disease modeling, drug screening of personalized therapeutics and the development of future regenerative cell-based therapies. This proposal creates a CTSA Program iPSC Network led by teams who have championed an `Open Source Biology' approach, freely sharing iPSC lines and their reprogramming reagents with more than 500 labs to date across the globe. Its goals are to make patient-derived iPSCs together with the tools and expertise for their genetic manipulation available to the greater research community on a large scale to realize their promise for extending understanding of disease and developing potential therapies. Learn more about this project in the NIH RePORTER. Disseminating Curative Biological Therapies for Rare Pediatric Diseases Boston Children’s Hospital (Harvard University) Principal Investigators: David A. Williams, M.D., Donald B. Kohn, M.D. and Lilith Reeves, M.S. Grant Number: 1-U01TR001814-01 Collaborating Institutions: University of California, Los Angeles, University of Cincinnati This project will develop a network of pediatric centers with unique expertise and experience in translation of gene therapies. The overall goal is to support investigators across CTSA Program institutions to more rapidly translate complex gene therapies to early phase investigator-initiated pediatric clinical trials. The Disseminating Curative Biological Therapies for Rare Pediatric Diseases Collaborative Consortium will offer key services and expert advice in order to enhance enrollment on gene therapy clinical trials nationally. Learn more about this project in the NIH RePORTER. Early Check: A Collaborative Innovation to Facilitate Pre-Symptomatic Clinical Trials in Newborns Duke University Principal Investigators: Alex Randall Kemper, M.D., Donald B. Bailey, Ph.D., Cynthia Powell, M.D., M.S. and Nancy M.P. King, J.D. Grant Number: 1-U01TR001792-01 Collaboration Institutions: Duke University, Wake Forest University Health Sciences Health problems included in state newborn screening programs must have strong evidence of benefit before they are included in screening. But for many rare disorders, evidence of benefit is difficult to gather, especially if the treatment must be provided before symptoms appear. This project will establish a voluntary newborn screening research program to study the benefits of screening for rare disorders so that policy makers will have the evidence they need to make good decisions about newborn screening policy. Learn more about this project in the NIH RePORTER. Leveraging Existing Registry Resources to Facilitate Clinical Trials Duke University Principal Investigators: Jennifer S. Li, M.D., Jeffrey P. Jacobs, M.D. and H. Scott Baldwin, M.D. Grant Number: 1-U01TR001803-01 Collaborating Institutions: Johns Hopkins University, Vanderbilt University Medical Center Clinical trials are resource-intensive and costly. Consequently many patient populations remain understudied with limited evidence to guide clinical practice. One mechanism to improve the evidence base is to leverage existing registry resources to conduct simple, efficient and low cost trials. This proposal will demonstrate the benefits of the “trial within a registry” approach in a vulnerable and understudied patient population, neonates undergoing heart surgery with cardiopulmonary bypass. Doing so, the infrastructure for a national registry-based trials network in children undergoing heart surgery, and concomitantly develop a model for efficient and cost-effective trials in other understudied diseases and conditions will be established. Learn more about this project in the NIH RePORTER. Improving Patient-Reported Outcome Data for Research Through Seamless Integration of the PROMIS Toolkit into EHR Workflows Northwestern University Principal Investigator: Justin B. Starren, M.D., Ph.D. Grant Number: 1-U01TR001806-01 Collaborating Institutions: Harvard Medical School, University of Alabama at Birmingham, University of Chicago, University of Florida, University of Kentucky, University of Illinois at Chicago, University of Southern California, University of Utah Patient-reported outcomes (PROs) reflect the experience of health and healthcare as reported directly by the patient. There is increasing evidence that capturing PROs will be an essential component of quality measurement, quality improvement and patient engagement in care and research. The Patient-Reported Outcomes Measurement Information System (PROMIS) toolset is a PRO survey system that utilizes computer adaptive testing to provide precise measurements with a minimum number of questions, often shortening conventional PRO surveys by 10-fold or more. The goal of this project is to develop and evaluate a suite of software tools that will allow all CTSA Program sites to integrate PROMIS tools directly into their electronic health records. Learn more about this project in the NIH RePORTER. Strengthening Translational Research in Diverse Enrollment (STRIDE) University of Massachusetts Medical School, Worcester Principal Investigators: Stephenie Lemon, Ph.D., Jeroan J. Allison, M.D., M.P.H., Kenneth S. Saag, M.D., M.Sc. and Paul Harris, Ph.D. Grant Number: 1-U01TR001812-01 Collaborating Institutions: University of Alabama at Birmingham, Vanderbilt University Medical Center The goal of STRIDE (Strengthening Translational Research in Diverse Enrollment) is to develop, test, and disseminate an integrated multi-level, culturally sensitive intervention to engage African Americans and Latinos in translational research. African Americans and Latinos are not adequately represented in translational research, particularly given the widespread health disparities experienced by these groups. This study aims to develop, test and make widely available a multi-level intervention that is culturally and literacy appropriate to address this critical issue. Learn more about this project in the NIH RePORTER. Transformative Computational Infrastructures for Cell-Based Biomarker Diagnostics J. Craig Venter Institute, Inc. (University of California, San Diego) Principal Investigators: Richard H. Scheuermann, Ph.D., and Yu “Max” Qian, Ph.D. Grant Number: 1-U01TR001801-01 Collaborating Institutions: Stanford University, University of California-Irvine Flow cytometry analysis is widely used for single cell phenotyping in the translational research lab to explore the mechanisms of normal and abnormal biological processes and in the clinical diagnostic lab for the identification and classification of blood-borne malignancies. However, the current practice for cytometry data analysis using “manual gating” based on two-dimensional data plots is subjective, labor-intensive and unreliable, especially when using more complex high content staining panels. The goal of this project is to develop, validate and disseminate a user-friendly computational infrastructure for cytometry data analysis for both diagnostic and discovery applications that could help overcome the current limitations of manual analysis and provide for more efficient, objective, accurate and reproducible analysis of cytometry data. Learn more about this project in the NIH RePORTER. | In fall 2016, NCATS funded the first set of CCIA projects. | 2016 CCIA Projects | In fall 2016, NCATS funded the first set of CCIA projects. | 2016 CCIA Projects | ||||
| 6157 | 2016 Therapeutic/Indication Pairing Projects | In fall 2016, NCATS issued 11 Therapeutic/Indication Pairing projects. The funded preclinical projects will serve as “use cases” to demonstrate the utility of an independent crowdsourcing effort or a computational algorithm to predict new therapeutic uses of an existing drug or biologic. Learn more about the projects below: Anti-Virulence Drug Repurposing Using Structural Systems Pharmacology CXCR2 Antagonism in the Immunometabolic Regulation of Type 2 Diabetes Drug Repositioning in Diabetic Nephropathy Ketorolac and Related NSAIDs for Targeting Rho-Family GTPases in Ovarian Cancer Network-Driven Drug Repurposing Approaches to Treat Coronary Artery Disease Preclinical Evaluation of a Neutrophil Elastase Inhibitor for the Treatment of Inflammatory Bowel Disease Quantum Model Repurposing of Cethromycin for Liver Stage Malaria Repurposing Lesogaberan for the Treatment of Type 1 Diabetes Repurposing Misoprostol for Clostridium Difficile Colitis as Identified by PheWAS Repurposing Pyronaridine as a Treatment for the Ebola Virus Therapeutic Repurposing of Benserazide for Colon Cancer Anti-Virulence Drug Repurposing Using Structural Systems Pharmacology Hunter College Principal Investigator: Lei Xie, Ph.D. Grant Number: 1-R21-TR001722-01 The emergence of superbugs that are resistant to antibiotics of last resort poses a serious threat to human health. The repurposing of safe drugs to target bacterial virulence has emerged as an important strategy to combat drug-resistant pathogens. Using mouse models of infection and rigorous statistical analysis, this team will preclinically validate the effectiveness of raloxifene, a drug currently used to prevent osteoporosis and invasive breast cancer in postmenopausal women. The team will also identify potentially more effective drugs approved by the Food and Drug Administration that target the same biological pathway as raloxifene. Learn more about this project in the NIH RePORTER. CXCR2 Antagonism in the Immunometabolic Regulation of Type 2 Diabetes Allegheny-Singer Research Institute Principal Investigator: Nick Giannoukakis, Ph.D. Grant Number: 1-R21-TR001728-01 This team will conduct a preclinical study of CXCR2 chemokine receptor inhibitor AZD5069 in mouse models of type 2 diabetes characterized by obesity and insulin resistance. The goals of the study are to determine if AZD5069 can improve insulin sensitivity and glucose and insulin tolerance in pre-diabetic mice concurrent with prevention or delay in onset of high blood sugar, improve and stabilize insulin sensitivity in diabetic mice, and preserve and stabilize beta cell function in diabetic mice. This study could establish a novel direction for type 2 diabetes therapy and potentially for other inflammation-associated disorders of metabolism. Learn more about this project in the NIH RePORTER. Drug Repositioning in Diabetic Nephropathy University of California, San Francisco Principal Investigator: Minnie M. Sarwal, M.D., Ph.D. Grant Number: 1-R21-TR001761-01 This project team has identified potential new therapies for diabetic kidney disease (DKD) among existing therapies approved by the Food and Drug Administration to treat other diseases. The team will test these therapies in preclinical mouse models of DKD. Preclinical validation studies of these therapies will be performed to advance proposed treatments to phase 2a clinical trials in humans. Learn more about this project in the NIH RePORTER. Ketorolac and Related NSAIDs for Targeting Rho-Family GTPases in Ovarian Cancer University of New Mexico Health Sciences Center Principal Investigator: Angela Wandinger-Ness, Ph.D. Grant Number: 1-R21-TR001731-01 Ketorolac, a nonsteroidal anti-inflammatory drug (NSAID) approved by the Food and Drug Administration, is normally used for pain relief. Ketorolac has also been shown to improve ovarian and breast cancer patient survival. This project team will develop new evidence in support of phase 2 human clinical trials and regulatory approval of ketorolac as an investigational new drug to treat ovarian cancers. Learn more about this project in the NIH RePORTER. Network-Driven Drug Repurposing Approaches to Treat Coronary Artery Disease Icahn School of Medicine at Mount Sinai Principal Investigators: Chiara Giannarelli, M.D., Ph.D., and Johan M. Bjorkegren, M.D., Ph.D. Grant Number: 1-R21-TR001739-01 Coronary artery disease (CAD) is the leading cause of mortality and disability worldwide. Even in patients treated with the best standard of care, morbidity and mortality remain high. New strategies that directly target atherosclerosis (hardening of the arteries) — the main cause of CAD — are urgently needed. One innovative approach is to find drugs that target the molecular errors that drive atherosclerosis in the arterial wall. This team will rigorously validate the preclinical effectiveness of drugs already approved by the Food and Drug Administration or compounds ready for phase 2a testing, with the goal of translating the findings into human clinical trials for CAD. Learn more about this project in the NIH RePORTER. Preclinical Evaluation of a Neutrophil Elastase Inhibitor for the Treatment of Inflammatory Bowel Disease Beth Israel Deaconess Medical Center Principal Investigator: Efi G. Kokkotou, M.D., Ph.D., D.Sc. Grant Number: 1-R21-TR001753-01 An estimated 1.4 million Americans suffer from inflammatory bowel disease (IBD), a chronic, debilitating condition that affects primarily young adults. This team will evaluate a potential treatment for IBD using the neutrophil elastase inhibitor AZD9668. The drug will be tested in mouse models of experimental colitis and in biopsies from patients with IBD with the future goal of reaching the market and addressing an unmet medical need in IBD therapeutics. Learn more about this project in the NIH RePORTER. Quantum Model Repurposing of Cethromycin for Liver Stage Malaria Johns Hopkins University Principal Investigator: David J. Sullivan, M.D. Grant Number: 1-R21-TR001737-01 This team will conduct a preclinical trial in mice of cethromycin, a drug developed to treat pneumonia, as a treatment for liver-stage malaria caused by Plasmodium vivax/ Plasmodium ovale parasites. The objective of this work is to build a solid evidence base for a phase 2, controlled human malaria infection clinical trial. The potential long-term outcome is a new safe, effective malaria prevention drug and/or a replacement of primaquine as a treatment of dormant liver-stage P. vivax/P. ovale parasites. Learn more about this project in the NIH RePORTER. Repurposing Lesogaberan for the Treatment of Type 1 Diabetes University of California, Los Angeles Principal Investigator: Daniel L. Kaufman, Ph.D. Grant Number: 1-R21-TR001742-01 Lesogaberan, a drug originally developed to treat gastrointestinal reflux disease, could be a potential treatment for type 1 diabetes. This team will test the hypothesis that lesogaberan therapy alone and, to a greater degree, lesogaberan as part of combination therapy can lead to sustained disease remission in a mouse model of diabetes. This study has the potential to lead to rapid translation into clinical trials with patients. Learn more about this project in the NIH RePORTER. Repurposing Misoprostol for Clostridium Difficile Colitis as Identified by PheWAS Vanderbilt University Medical Center Principal Investigator: David M. Aronoff, M.D. Grant Number: 1-R21-TR001723-01 The bacterium Clostridium difficile is a major cause of antibiotic-associated diarrhea, a leading infectious disease in U.S. hospitals. C. difficile infection can recur multiple times despite treatment and can be fatal. This team will research a possible new application for misoprostol, a drug approved by the Food and Drug Administration, to treat the bacterium. Preclinical studies will be conducted to define the optimal dose and timing of misoprostol to prevent recurrent C. difficile colitis. Learn more about this project in the NIH RePORTER. Repurposing Pyronaridine as a Treatment for the Ebola Virus Collaborations Pharmaceuticals, Inc. Principal Investigators: Sean Ekins, Ph.D., D.Sc., and Robert A. Davey, Ph.D. Grant Number: 1-R21-TR001718-01 In 2014, the outbreak of the Ebola virus in West Africa highlighted the need for broad-spectrum antiviral drugs for this and other emerging viruses. Several groups have performed high-throughput screening and identified drugs approved by the Food and Drug Administration — including amodiaquine, chloroquine, clomiphene and toremifene — that have been shown to block the growth of the Ebola virus in the laboratory. This study will build upon these screens to characterize the properties of the compound pyronaridine, which is approved in Europe to treat malaria, prior to determining effectiveness in a mouse model of Ebola virus infection. Learn more about this project in the NIH RePORTER. Therapeutic Repurposing of Benserazide for Colon Cancer University of Texas Medical Branch at Galveston Principal Investigator: Csaba Szabo, M.D., Ph.D. Grant Number: 1-R21-TR001734-01 Hydrogen sulfide, commonly known as “swamp gas” or “sewer gas,” has been identified as a biological substance produced in colon cancer cells by a protein that, if blocked, causes cancer cells to stop growing. This project team aims to determine whether benserazide, a compound used in the treatment of Parkinson’s disease, may be suitable for repurposing to treat advanced colorectal cancer. The team will evaluate this compound in cell-based models, biochemical assays and animal models of colon cancer. Learn more about this project in the NIH RePORTER. | The projects will serve as “use cases” to demonstrate the utility of an independent crowdsourcing effort or a computational algorithm to predict new therapeutic uses of an existing drug or biologic. | /sites/default/files/ntu_brain_900px.jpg | NCATS issued 11 Bench-to-Clinic awards | The projects will serve as “use cases” to demonstrate the utility of an independent crowdsourcing effort or a computational algorithm to predict new therapeutic uses of an existing drug or biologic. | /sites/default/files/ntu_brain_900px.jpg | NCATS issued 11 Bench-to-Clinic awards | ||
| 6151 | NCATS' Achievements in Advancing Translational Sciences | NCATS was officially established on Dec. 23, 2011, to transform the translational science process so that new treatments and cures for disease can be delivered to patients faster. NCATS’ Strategic Plan and its Guiding Principles ground all Center programs and initiatives, providing context to all its efforts to improve health through smarter science. NCATS’ work spans the entire translational science spectrum; following are just a few examples of Center achievements, arranged by research stage: Preclinical Innovation Improving the Drug Development Process Stopping Metastasis in Its Tracks: New 3-D Cell Model Enables Closer Look at Cancer Progression Spotlight on Collaboration: A Journey From Biological Probes to Potential Therapeutics Ketamine Lifts Depression via a Byproduct of Its Metabolism Repurposing Drugs Allergy Drug Could Treat Hepatitis C NIH Collaboration Helps Advance Potential Zika Treatments NCATS Support Leads to Clinical Trial to Test Repurposed Cancer Treatment as Alzheimer’s Therapy NCATS Repurposing Test Identifies 53 Drugs that May Block Ebola Infection Testing and Predictive Models Tissue Chips in Space Modeling the Female Reproductive Tract in 3-D: The Birth of EVATAR™ NCATS Spotlight: Toxicology in the 21st Century Program Clinical Innovation Streamlining and Enhancing the Nation’s Capacity for Clinical Research NCATS Trial Innovation Network NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) Institutional Review Board (IRB) Reliance Platform Five Clinical and Translational Science Awards (CTSA) Program Hubs Enable NIH-Funded Research on Innovative Allergy Therapy Accelerating Rare Diseases Research Screening Platform Is a Launch Pad for Novel Treatment Combinations Therapeutics for Rare and Neglected Diseases Research Leads to NIH Trial to Test Drug for Niemann-Pick Type C1 Breathing Easier: First Treatment for Rare Lung Disease Approved Patient and Community Engagement NCATS Toolkit for Patient-Focused Therapy Development Genetic and Rare Diseases Information Center Rare Disease Day at NIH Rare Disease Patient Profiles Tools for Accelerating Research NCATS Funds Feasibility Assessment to Develop Biomedical Data Translator CTSA Program Supports New Ultrasensitive Diagnostic Test Development Small Business Innovation and Technology Transfer NCATS Small Business Award Seeds App to Improve Medication Adherence NCATS’ Small Business Funding Helps Launch New Platform for Rare Diseases Drug Discovery NCATS Plate Washing Initiative Saves Money, Keeps Plastic Out of Landfills Training and Workforce Development Translational Science Skills Assay Guidance Manual Training Workshops CTSA Program-Supported Researcher Is Translating Laboratory Discoveries into Better Hearing for Cochlear Implant Patients Doctoral Students Use NCATS Resources to Investigate Promising Disease Therapies Read more about NCATS’ achievements in the annual reports. | View a few highlights of Center achievements over the past years. | /sites/default/files/NCATS-5-year-Anniversary-900px.jpg | Achievements in Advancing Translational Sciences | View a few highlights of Center achievements over the past years. | /sites/default/files/NCATS-5-year-Anniversary-900px.jpg | Achievements in Advancing Translational Sciences | ||
| 5989 | NCATS and Promega Host Assay Guidance Workshop for High-Throughput Screening | In October 2016, NCATS and Promega scientists hosted an Assay Guidance Workshop for High-Throughput Screening and Lead Discovery in Madison, Wisconsin. More than 40 researchers from academia, government and industry participated in the workshop, which featured presenters with decades of experience in preclinical drug discovery and clinical trial recruitment. Over the course of nine lectures, the speakers covered a variety of concepts that are critical for the reproducibility of preclinical research, including best practice guidelines to support early stage assay development and target validation in drug discovery. The next workshop will be held in Washington, D.C., at the Annual International Society for Laboratory Automation and Screening conference on Feb. 4, 2017. Participants from the October 2016 Assay Guidance Workshop. | In October 2016, NCATS and Promega scientists hosted an Assay Guidance Workshop for High-Throughput Screening and Lead Discovery in Madison, Wisconsin with more than 40 researchers. | /sites/default/files/agm-workshop-group-900px.jpg | Assay Guidance Workshop | In October 2016, NCATS and Promega scientists hosted an Assay Guidance Workshop for High-Throughput Screening and Lead Discovery in Madison, Wisconsin with more than 40 researchers. | /sites/default/files/agm-workshop-group-900px.jpg | Assay Guidance Workshop | ||
| 5988 | CTSA Program FAQs for Re-entry Supplements | Who is eligible to be supported by a re-entry supplement?Can a candidate for the re-entry supplement be supported by PHS funds at the time of application?Can a candidate for the re-entry supplement be managing a clinical workload at the time of application?Under the NCATS CTSA Program, which grant mechanisms are eligible for these supplements and how much time can be requested?How much time can be requested for a supplement candidate?The UL1 mechanism is a cooperative agreement and does not directly fund research projects. What types of research projects can be proposed that would fall under the scope of the parent award?Who would be an eligible mentor under the UL1 cooperative agreement?Will NCATS consider supporting more than one re-entry supplement from a CTSA Program hub?Can a PI's/mentor’s salary be requested on a re-entry supplement?What are the allowable costs for investigators developing independent research careers?What is expected time commitment for the re-entry supplement?How should an awardee be supported once the re-entry supplement ends?What should be included in the PI's/mentor’s training and mentoring plan?What should be included in the PI's/mentor’s personal statement?What should be included in the candidate's personal statement?Who submits the application, the person to be supported or the PI of the grant?When should an application be submitted?How should an application be submitted?Are clinical trials allowed under this funding opportunity?Is research with human subjects or vertebrate animals allowed under this funding opportunity?How are re-entry supplement applications reviewed?What are the chances of success in obtaining funding?Who is eligible to be supported by a re-entry supplement?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.Can a candidate for the re-entry supplement be supported by PHS funds at the time of application?Yes, candidates that are supported by PHS funds in an administrative capacity and are not conducting research activities are eligible to apply. Candidates must meet all other eligibility criteria and circumstances as described in the funding opportunity announcement. 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. Candidates who have begun the re-entry process through a fellowship, traineeship, or similar mechanism are not eligible for this program. The PI of the parent grant should contact NCATS program staff to discuss such a situation before submitting an application for a re-entry supplement.Can a candidate for the re-entry supplement be managing a clinical workload at the time of application?Yes, candidates that are managing a clinical workload full time and are not conducting research activities are eligible to apply. The aim of these supplements is to encourage such individuals to re-enter research careers within the mission of NCATS and the goals of the CTSA program.The program is not intended to support career changes from non-research to research careers for individuals without prior research training. Candidates must meet all other eligibility criteria and circumstances as described in the FOA. The CTSA Program UL1 PD/PI should contact NCATS program staff to discuss such a situation before submitting an application for a re-entry supplement.Under the NCATS CTSA Program, which grant mechanisms are eligible for these supplements and how much time can be requested?Active NCATS UL1 cooperative agreements are eligible for re-entry supplements. Institutional Career Development Core (KL2) Training Core (TL1) programs are not eligible, however, the Program Director/Principal Investigator (PD/PI) of these programs and/or the mentor(s) of the candidate can work with the UL1 PI to submit an application.How much time can be requested for a supplement candidate?The request cannot exceed the length of time remaining for the UL1 grant project period. Potential no cost extensions are not considered as length of time remaining for these requests. A grant must have at least two years remaining to request a supplement. The requested time should be two years and the research training experience should be tailored to the candidate’s proposed research project, training and mentoring plans.The UL1 mechanism is a cooperative agreement and does not directly fund research projects. What types of research projects can be proposed that would fall under the scope of the parent award?Mentors and their candidates must propose to be conducting high quality clinical and translational science research, similar to the type of research that would fall under the purview of the CTSA Program hubs’ pilot project program, KL2 or TL1 programs.Who would be an eligible mentor under the UL1 cooperative agreement?The CTSA Program UL1 contact PD/PI is required to be listed as the first person on the Senior/Key Personnel form. However, additional mentor(s) are expected to be required to support the research training and career development of the candidate. Additional mentor(s) should be listed as key personnel, provide a biosketch, and be integrated into the career development plan for the candidate. All additional mentors must be clearly associated with the CTSA Program hub (may be key personnel, mentors of KL2 and/or TL1 programs, etc.).Will NCATS consider supporting more than one re-entry supplement from a CTSA Program hub?Yes. NCATS will consider supplemental support for more than one individual from a CTSA Program hub at all levels of training. Each request must be strongly justified and include assurances that each candidate will receive appropriate mentoring. NCATS requires that applications for individual candidates be submitted as separate applications.NCATS will accept up to two applications under the re-entry research supplement for review consideration during a fiscal year from any one CTSA Program hub award.Can a PI's/mentor’s salary be requested on a re-entry supplement?No, under the existing funding opportunity announcements, a PI's/mentor’s salary is not an allowable cost on a re-entry supplement.What are the allowable costs for investigators developing independent research careers?For investigators developing independent research careers, the supplement will provide up to and no more than $100,000 for salary, plus additional fringe benefits. Salary and fringe benefits must be in accordance with the salary structure of the grantee institution and must be commensurate with the individual’s level of effort devoted to the project. Additional funds of up to $10,000 may be requested for supplies and travel. Equipment may be purchased but requires prior approval of the NIH awarding component. Costs should be strongly justified and based upon need but may not exceed $150,000 direct costs for an application for an investigator developing an independent research career.What is expected time commitment for the re-entry supplement?Administrative supplements provided under this program may be for either part-time or full-time (equivalent to 12 person-months) support for the candidate, and all supported time is to be spent updating and enhancing research skills. Proposed part-time appointments may not be less than 50% effort (equivalent to 6 person-months).How should an awardee be supported once the re-entry supplement ends?The mentor and applicant institution are encouraged to assist the supplement awardees to identify and transition to additional means of support appropriate for their stage of development. An appropriate plan for this transition to additional means of support must be included in the application. Examples include support through research grants, appointment to an institutional training grant or receipt of an individual fellowship, etc.What should be included in the PI's/mentor’s training and mentoring plan?Training and mentoring plans should be customized to the individual candidate's strengths and weaknesses, and gaps in previous training should be addressed. In addition, the PI/mentor should indicate how the individual will be supported after the supplement ends, including any plans for helping the candidate to apply for independent support, and how the candidate will successfully transition to the next stage of their career.What should be included in the PI's/mentor’s personal statement?The PI/mentor should state his/her personal philosophy of training and describe his/her track record of successful mentoring in clinical and translational science at the career stage of the candidate.What should be included in the candidate's personal statement?The candidate should describe his/her education and long-term research training, mentoring, and career development needs and why they wish to pursue a research career in clinical and translational science.Who submits the application, the person to be supported or the PI of the grant?The CTSA Program UL1 PD/PI and the grantee institution must submit the application on behalf of the candidate.When should an application be submitted?Applications are due November 1 (or the following business day if November 1 falls on a holiday or weekend) of each year for consideration of funding for the current fiscal year, which always ends on September 30. Applications will be evaluated and decisions will be made within two to three months, but funding decisions can be influenced and delayed by other factors, including the availability of funds. Therefore, consultation with the NCATS Program Official (PO) assigned to the parent grant and NCATS scientific contacts for these funding opportunities is advised prior to submitting your application. Since it can take up to 10 weeks to review an application and reach a funding decision, applications submitted in the current fiscal year that receive a favorable review will be funded in the same fiscal year, as long as funds and time remain available. If funds are no longer available, applications may be held for funding in the following cycle. Requested start dates should be prospective, align with the budget start date of the UL1 grant and allow sufficient time for review of the request.How should an application be submitted?Applicants are required to follow the submission instructions as described in the funding opportunity announcement. Each CTSA Program hub is allowed to submit up to two re-entry supplements/applications. However, there should be only one re-entry candidate for each application. Use the NCATS-specific guidance in developing your application. Applicants are encouraged to alert the PO and grants management specialist once the application has been submitted.Are clinical trials allowed under this funding opportunity?This funding opportunity is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.Does your human subjects research study meet the NIH Definition of a clinical trial?Is research with human subjects or vertebrate animals allowed under this funding opportunity?Yes. The supplement adheres to the same NIH policies for human subjects research and vertebrate animals as the parent grant. However, depending on the candidate’s career stage, the supplement provides little to no costs for research to be conducted by the candidate. If the project is conducting research that was not described under the original U application and did not undergo review, it will undergo review of the research by NCATS. See the funding opportunity for further instructions about required supporting documentation.How are re-entry supplement applications reviewed?Applications are administratively reviewed by NCATS program staff. Program staff will evaluate supplement applications to determine the overall merit using the review criteria outlined in the funding opportunity announcements. Program staff will look at the appropriateness of the research project, career development plan, and mentorship as they relate to the candidate's career goals. In addition, emphasis is placed on the quality of the mentoring and training plan and the likelihood that the candidate will be successful at the next stage of their career.What are the chances of success in obtaining funding?Applications that are considered to be strong have a high success rate. However, the re-entry supplement program is a competitive program and there may be more applications than funds available. | FAQs for CTSA program for re-entry supplements | CTSA Program FAQs for Re-entry Supplements | FAQs for CTSA program for re-entry supplements | CTSA Program FAQs for Re-entry Supplements | ||||
| 5987 | CTSA Program FAQs for Diversity Supplements | Can a candidate for the diversity supplement be supported by Public Health Service (PHS) grant funds at the time of application?Yes, under certain circumstances, candidates conducting clinical and translational science research projects may be supported by PHS funds at the time of application, however, if the supplement application is meritorious and the candidate will be supported via the diversity supplement the candidate must not have effort on other PHS funded grants.If the candidate is supported by an institutional training grant (T32 or TL1, etc.) at the time of application, they may not be transferred to supplemental support prior to completion of the expected period of training on the program. The CTSA Program UL1 PD/PI should contact NCATS program staff to discuss such a situation before submitting an application for a diversity supplement.Who is eligible to be supported by a diversity supplement?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 wished to pursue a career in clinical and translational science research. Principal investigators of UL1 mechanisms may request supplemental funds to improve the diversity of the biomedical research workforce by supporting and recruiting graduate and health professional students, individuals in postdoctoral training and/or investigators developing independent research careers in clinical and translational science. Supplemental awards are limited to citizens or non-citizen nationals of the U.S. or to individuals who have been lawfully admitted for permanent residence in the U.S. (i.e., in possession of a Permanent Resident Card, Form I-551).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.A “new” diversity supplement for the same diversity trainee and the same training plan is not allowed under any circumstances if the original diversity supplement application received an NCATS award. Extensions of diversity supplements are not permitted.An individual who has received previous funding from NIH as an independent PD/PI on a research grant (e.g., R01, R03, R21), as the project leader on a component of a program project or center grant (e.g., UL1, P01, P50, G12), or as PD/PI on an individual research career development award (e.g., K01, K02, K07, K08, and K23), or as a Scholar on an Institutional Career Development Award (K12, KL2) is not eligible as a diversity supplement candidate.Are women considered underrepresented and therefore eligible for a diversity supplement?Women have been shown to be underrepresented in doctorate-granting research institutions at senior faculty levels in most biomedical-relevant disciplines and may also be underrepresented at other faculty levels in some scientific disciplines. NIH encourages institutions to consider women for faculty-level, diversity-targeted programs to address faculty recruitment, appointment, retention or advancement. Please see the following announcement (PA-21-071) for more information.Are persons with disabilities eligible for diversity supplements if they are not a member of an ethnic or racial minority group?Yes. The institution/university must provide a signed statement establishing the eligibility of the candidate for support under this program. If applicable, the PI/mentor should describe any reasonable accommodations that are needed and how the training and mentoring plan would address these needs.Can a PI request equipment for reasonable accommodations for a disabled candidate under the diversity supplement?Yes. Funds may be requested to make changes or adjustments in the research setting that will make it possible for a qualified individual with a disability to perform the essential functions associated with his/her role on the project. The accommodations requested under this program must be directly related to the performance of the proposed role on the research project and must be appropriate to the disabilities of the individual. Some types of accommodations that might be provided under these awards include: specialized equipment, assistive devices and personnel, such as readers, interpreters or assistants. In all cases, the total funds for accommodations requested from the supplement must be reasonable in relationship to the direct costs of the parent grant and the nature of the supplement award.How does the availability of KL2 or TL1 slots at the CTSA Program hub affect eligibility for a diversity supplement?The CTSA Program is strongly committed to the appointment of individuals from diverse backgrounds to Institutional Mentored Career Development Awards (KL2) and to Institutional Training Awards (TL1) as these provide a clear, mentored program and strong oversight for training students. As both the KL2 and the TL1 components require plans for recruitment and retention to enhance diversity it would be expected that programs would attempt to fill KL2 and/or TL1 slots with scholars or trainees from diverse backgrounds first and then have the opportunity to request additional support from the supplement program. Note that supplement appointments do not count toward the KL2 or TL1 number of scholars or trainees approved by NCATS Advisory Council; however, the supplement may not be awarded if the KL2 or TL1 appointment slots are not filled or if the hub appears not to be strongly committed to the appointment of individuals from diverse backgrounds to the KL2 or TL1. It is possible that the timing of appointments and the applicants’ availability may restrict the appointment on the KL2 and/or TL1 and the supplement may be used prior to or instead of the appointment on the KL2 and/or TL1. There may be other situations that may be justified. If there are unused slots on the KL2 or TL1 components at the same career level of that of the diversity supplement candidate, it would be difficult to justify the supplement request. Hubs are encouraged to justify any relevant situation to explain particularities.Under the NCATS CTSA Program, which grant mechanisms are eligible for these supplements and how much time can be requested?Active NCATS UL1 cooperative agreements are eligible for diversity supplements. Institutional Career Development Core (KL2) Training Core (TL1) programs are not eligible, however, the Program Director/Principal Investigator (PD/PI) of these programs and/or the mentor(s) of the candidate can work with the UL1 PI to apply. Supplements to CCIA grants will not be considered.How much time can be requested for a supplement candidate?The request cannot exceed the length of time remaining for the UL1 grant project period. Potential no cost extensions are not considered as length of time remaining for these requests. A grant must have at least two years remaining in order to request a supplement for a graduate student, postdoctoral fellow, or investigators developing independent research careers to provide an optimal career development experience for the candidate. The requested time should be two years and the research training experience is to be tailored to the candidate’s proposed research project, training and mentoring plans.The UL1 mechanism is a cooperative agreement and does not directly fund research projects. What types of research projects can be proposed that would fall under the scope of the parent award?Mentors and their candidates must propose to be conducting high quality clinical and translational science research, similar to the type of research that would fall under the purview of the CTSA Program hubs’ pilot project program, KL2 or TL1 programs. The aims of the candidate’s project can be complimentary to, but not overlapping with, the aims of an existing federally funded or foundation grant. The research plan should address specific skills, responsibilities, and activities that demonstrate increasing independence as researchers. The application should include a timeline for next steps towards obtaining independent research funding.Who would be an eligible mentor under the UL1 cooperative agreement?The CTSA Program UL1 contact PD/PI is required to be listed as the first person on the Senior/Key Personnel form. However, additional mentor(s) are expected to be required to support the research training and career development of the candidate. Additional mentor(s) should be listed as key personnel, provide a biosketch, and be integrated into the career development plan for the candidate. All additional mentors must be clearly associated with the CTSA Program hub (may be key personnel, mentors of KL2 and/or TL1 programs, etc.).Will NCATS consider supporting more than one diversity supplement from a CTSA Program hub?Yes. NCATS will consider supplemental support for more than one individual from a CTSA Program hub at all levels of training. Each request must be strongly justified and include assurances that each candidate will receive appropriate mentoring. NCATS requires that applications for individual candidates be submitted as separate applications.NCATS will accept up to two applications under the diversity supplement for review consideration during a fiscal year from any one CTSA Program hub award.Are clinical trials allowed under this funding opportunity?This funding opportunity is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.Does your human subjects research study meet the NIH Definition of a clinical trial?Is research with human subjects or vertebrate animals allowed under this funding opportunity?Yes. The supplement adheres to the same NIH policies for human subjects research and vertebrate animals as the parent grant. However, depending on the candidate’s career stage, the supplement provides little to no costs for research to be conducted by the candidate. If the project is conducting research that was not described under the original U application and did not undergo review, it will undergo review of the research by NCATS. See the funding opportunity for further instructions about required supporting documentation.Can a PI's/mentor’s salary be requested on a diversity supplement?No, under the existing funding opportunity announcements, a PI's/mentor’s salary is not an allowable cost on a diversity supplement.What are the allowable costs for investigators developing independent research careers?For investigators developing independent research careers, the supplement will provide up to and no more than $100,000/year for salary, plus additional fringe benefits. Salary and fringe benefits must be in accordance with the salary structure of the grantee institution and must be commensurate with the individual’s level of effort devoted to the project. Additional funds of up to $10,000 may be requested for supplies and travel. Equipment may be purchased but requires prior approval of the NIH awarding component. Costs should be strongly justified and based upon need but may not exceed $150,000 direct costs for an application for an investigator developing an independent research career.* Please see the guidance in the FOA for allowable costs for other career levels.How should a diversity awardee be supported once the diversity supplement ends?The mentor and applicant institution are encouraged to assist the supplement awardee to identify and transition to additional means of support appropriate for their stage of development. An appropriate transition plan to another means of support should be included in the application. This should be included as part of the training and mentoring plan. Examples include support through research grants, appointment to an institutional training grant or receipt of an individual fellowship, etc.What is expected time commitment for the diversity supplement?Short-term Investigator Research Supplement: This supplement provides short-term support for trainees to conduct full-time research in clinical and translational science for three to five months each year for at least two years during the summer or another portion of the academic year, over a maximum period of four years.Long-term Investigator Research Supplement: This supplement provides long-term research support for faculty members to conduct research in clinical and translational science. Support is usually provided for two years at a minimum of 9 person months (equivalent to 75% effort) during each 12-month period.For most long-term investigators, the awardee must commit at the minimum 9 person months, equivalent to 75% full-time professional effort, directly to their research project and career development activities. Less than 75% (but not lower than 50%) effort for certain clinical specialties (e.g., surgical and procedure-intensive specialties) is considered on a case-by-case basis. The remaining effort can be devoted to additional research, teaching, clinical work, or other efforts complementary to career development of the awardee. NIH provides some salary support as part of the supplement award, and often institutions will supplement the salary of these award PIs up to a level that is consistent with the institution’s salary scale.What should be included in the PI's/mentor’s training and mentoring plan?Training and mentoring plans should be customized to the individual candidate's strengths and weaknesses, gaps in previous training, and short- and long-term goals should be stated within the training plan. The plan must be focused on the development of the candidate’s skills and providing the support structures needed to transition into the next phase of the biomedical training/career pathway. It should be clear from the application how a diversity supplement will impact and add value to the candidate’s training, mentoring, and career development experiences. The plan should specifically focus on how the training and mentoring plan will best position the candidate for a career in clinical and translational science. In addition, the PI/mentor should indicate how the individual will be supported after the supplement ends, including any plans for helping the candidate to apply for independent support, and how the candidate will successfully transition to the next stage of their career.What should be included in the PI's/mentor’s personal statement?The PI/mentor should state his/her personal philosophy of training and commitment to promoting diversity and describe his/her track record of successfully mentoring trainees from underrepresented backgrounds at the career stage of the candidate.What should be included in the candidate's personal statement?The candidate should describe his/her long-term education and career goals and why they wish to pursue a research career in clinical and translational science.Who submits the application, the person to be supported or the PI of the grant?The CTSA Program UL1 PD/PI and the grantee institution must submit the application on behalf of the candidate.When should an application be submitted?Applications are due September 15 (or the following business day if September 15 falls on a holiday or weekend) of each year for consideration of funding for the current fiscal year. Applications will be evaluated, and decisions will be made within two to three months, but funding decisions can be influenced and delayed by other factors, including the availability of funds. Therefore, consultation with the NCATS Program Official (PO) assigned to the parent grant and NCATS scientific contacts for these funding opportunities is advised prior to submitting an application. Since it can take up to 10 weeks to review an application and reach a funding decision, applications submitted in the current fiscal year that receive a favorable review will be funded in the same fiscal year, as long as funds and time remain available. If funds are no longer available, applications may be held for funding in the following cycle. Requested start dates should be prospective, align with the budget start date of the UL1 grant and allow sufficient time for review of the request.How should an application be submitted?Applicants are required to follow the submission instructions as described in the funding opportunity announcements. Each CTSA Program hub is allowed to submit up to two diversity supplements/applications. However, there should be only one diversity candidate for each application. Use the NCATS-specific guidance in developing your application. Applicants are encouraged to alert the PO and grants management specialist once the application has been submitted.How are diversity supplement applications reviewed?Applications are administratively reviewed by NCATS program staff. Program staff will evaluate supplement applications to determine the overall merit using the review criteria outlined in the funding opportunity announcements. Program staff will look at the appropriateness of the research project, career development plan, and mentorship as they relate to the candidate's career goals. In addition, a second level of review is conducted by NCATS and DCI leadership before final funding decisions are made. Emphasis is placed on the strength and quality of the mentoring and training plan and the likelihood that the candidate will be successful at the next stage of their career in clinical and translational science.Applications will also be reviewed for relevance to the NCATS mission to transform the translational science process and the goals of the CTSA program.What are the chances of success in obtaining funding?Applications that are considered to be strong have a high success rate. However, the diversity supplement programs are competitive programs and there may be more applications than funds available. | FAQs for CTSA program for diversity supplements | CTSA Program FAQs for Diversity Supplements | FAQs for CTSA program for diversity supplements | CTSA Program FAQs for Diversity Supplements |
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