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22096	NIH, FDA and 15 Private Organizations Join Forces to Increase Effective Gene Therapies for Rare Diseases	3D rendering of genetic medicine with DNA isolated. (xsense/Shutterstock)October 27, 2021The National Institutes of Health, U.S. Food and Drug Administration, 10 pharmaceutical companies and five non-profit organizations have partnered to accelerate development of gene therapies for the 30 million Americans who suffer from a rare disease. While there are approximately 7,000 rare diseases, only two heritable diseases currently have FDA-approved gene therapies. The newly launched Bespoke Gene Therapy Consortium (BGTC), part of the NIH Accelerating Medicines Partnership (AMP) program and project-managed by the Foundation for the National Institutes of Health (FNIH), aims to optimize and streamline the gene therapy development process to help fill the unmet medical needs of people with rare diseases, in particular those diseases that are too rare to be of commercial interest.“Most rare diseases are caused by a defect in a single gene that could potentially be targeted with a customized or ‘bespoke’ therapy that corrects or replaces the defective gene,” said NIH Director Francis S. Collins, M.D., Ph.D. “There are now significant opportunities to improve the complex development process for gene therapies that would accelerate scientific progress and, most importantly, provide benefit to patients by increasing the number of effective gene therapies.”A single rare disease affects small numbers of people, but rare diseases collectively affect millions. Most rare inherited diseases stem from a specific gene mutation that is already known, making gene therapy a promising therapeutic approach. However, gene therapy development for rare diseases is highly complex, time consuming and expensive. Moreover, the development process is stymied by limited access to tools and technologies, lack of standards across the field, and a one-disease-at-a-time approach to therapeutic development. A standardized therapeutic development model that includes a common gene delivery technology (a vector) could allow for a more efficient approach to specific gene therapies, saving time and cost.“Rare diseases affect 25 to 30 million Americans, but because any given rare disorder affects so few patients, companies often are reluctant or unable to invest the years of research and millions of dollars necessary to develop, test and bring individualized gene therapy treatments for a single disease to market,” said Joni L. Rutter, Ph.D., acting director of NCATS. “The BGTC aims to make it easier, faster and less expensive to pursue bespoke gene therapies in order to incentivize more companies to invest in this space and bring treatments to patients.”“By leveraging on experience with a platform technology and by standardizing processes, gene therapy product development can be accelerated to allow more timely access to promising new therapies for patients who need them most,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “FDA is committed to developing a regulatory paradigm that can advance gene therapies to meet the needs of patients with rare diseases.”A primary aim of BGTC is to improve understanding of the basic biology of a common gene delivery vector known as the adeno-associated virus (AAV). BGTC researchers will examine the biological and mechanistic steps involved in AAV vector production, vector delivery of genes into human cells and how therapeutic genes are activated in target cells. These results will provide important information for improving the efficiency of vector manufacturing and enhancing the overall therapeutic benefit of AAV gene therapy.To improve and accelerate gene and vector manufacturing and production processes, the BGTC program will develop a standard set of analytic tests to apply to the manufacture of viral vectors made by consortium researchers. Such tests could be broadly applicable to different manufacturing methods and make the process of developing gene therapies for very rare conditions much more efficient.A clinical component of BGTC-funded research will support between four and six clinical trials, each focused on a different rare disease. These diseases are expected to be rare, single-gene diseases with no gene therapies or commercial programs in development and that already have substantial groundwork in place to rapidly initiate preclinical and clinical studies. The trials will employ different types of AAV vectors that have been used before in clinical trials. For these trials, the BGTC will aim to shorten the path from studies in animal models of disease to human clinical trials.The BGTC also will explore methods to streamline regulatory requirements and processes for the FDA approval of safe and effective gene therapies, including developing standardized approaches to preclinical testing (e.g., toxicology studies).NIH and private partners will contribute approximately $76 million over five years to support BGTC-funded projects. This includes about $39.5 million from the participating NIH institutes and centers, pending availability of funds. NCATS, which developed the related Platform Vector Gene Therapy (PaVe-GT) program and is the NIH lead institute for BGTC, expects to contribute approximately $8 million over five years.Private partners include Biogen Inc., Cambridge, Massachusetts; Janssen Research & Development, LLC, Raritan, New Jersey; Novartis Pharma AG, Cambridge, Massachusetts; Pfizer Inc., New York, New York; REGENXBIO Inc., Rockville, Maryland.; Spark Therapeutics, Philadelphia, Pennsylvania; Takeda Pharmaceutical Company Limited, Deerfield, Illinois; Taysha Gene Therapies, Dallas, Texas; Thermo Fisher Scientific Inc., Waltham, Massachusetts; and Ultragenyx Pharmaceutical, Novato, California. Several non-profit partners also are involved, including the Alliance for Regenerative Medicine (ARM), Washington, D.C.; the American Society of Gene and Cell Therapy, Milwaukee, Wisconsin; CureDuchenne, Newport Beach, California; National Institute for Innovation in Manufacturing Biopharmaceuticals, Newark, Delaware; and the National Organization for Rare Disorders (NORD), Quincy, Massachusetts. In addition to NCATS, participating NIH institutes include the Eunice Kennedy Shriver National Institute of Child Health and Human Development; National Eye Institute; National Heart, Lung, and Blood Institute; National Human Genome Research Institute; National Institute of Arthritis and Musculoskeletal and Skin Diseases; National Institute of Dental and Craniofacial Research; National Institute of Mental Health; National Institute of Neurological Disorders and Stroke; National Institute on Deafness and Other Communication Disorders; and the Brain Research Through Advancing Innovative Neurotechnologies (BRAIN) Initiative.The BGTC is the first AMP initiative focused on rare diseases. Other ongoing AMP projects bring together scientific talent and financial resources from academia, industry, philanthropy, and government, and focus on improving the productivity of therapeutic development for schizophrenia, Parkinson’s disease, Alzheimer’s disease, type 2 diabetes and the autoimmune disorders rheumatoid arthritis and systemic lupus erythematosus.Media Contact: NCATS Communications BranchAbout the Foundation for the National Institutes of Health: The Foundation for the National Institutes of Health (FNIH) creates and manages alliances with public and private institutions in support of the mission of the NIH. The FNIH works with its partners to accelerate biomedical research and strategies against diseases and health concerns in the United States and across the globe. Established by Congress in 1990, the FNIH is a not-for-profit 501(c)(3) charitable organization. For additional information about the FNIH, please visit https://fnih.org/.About the National Center for Advancing Translational Sciences (NCATS): NCATS conducts and supports research on the science and operation of translation — the process by which interventions to improve health are developed and implemented — to allow more treatments to get to more patients more quickly. For more information about how NCATS helps shorten the journey from scientific observation to clinical intervention, visit https://ncats.nih.gov.About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit https://www.nih.gov.About the Food and Drug Administration (FDA): The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.NIH…Turning Discovery Into Health®	The Bespoke Gene Therapy Consortium was created to speed the development of FDA-approved gene therapies for rare diseases.		NIH and Others Partner to Increase Gene Therapies for Rare Diseases	The Bespoke Gene Therapy Consortium was created to speed the development of FDA-approved gene therapies for rare diseases.		NIH and Others Partner to Increase Gene Therapies for Rare Diseases
22030	NIH Study Suggests People with Rare Diseases Face Significantly Higher Health Care Costs	October 22, 2021 Check out an article co-authored by NCATS Acting Director Joni L. Rutter, Ph.D., that summarizes recent studies and reports on the total direct and indirect costs of rare diseases in the United States, which are likely more than $1 trillion. Click image to expand. Findings in the graphic are from the publication, "The IDeaS Initiative: Pilot Study to Assess the Impact of Rare Diseases on Patients and Healthcare Systems." Close A new, retrospective study of medical and insurance records indicates health care costs for people with a rare disease have been underestimated and are three to five times greater than the costs for people without a rare disease. The study, led by NCATS, provides new evidence of the potential impact of rare diseases on public health, suggesting that nationwide medical costs for individuals with rare diseases are on par with those for cancer and heart failure. The study’s results were published Oct. 21 in the Orphanet Journal of Rare Diseases. “There needs to be greater public awareness of the large and growing medical footprint of rare diseases in society,” said senior author Anne Pariser, M.D., director of the NCATS Office of Rare Diseases Research. “Only about 10% of rare diseases have an FDA-approved therapy for their treatment. The findings underscore an urgent need for more research, and earlier and more accurate diagnoses of and interventions for these disorders.” Most of the approximately 7,000 to 10,000 known rare diseases disproportionately affect children, adolescents and young adults. Individually, most rare diseases might affect only a few hundred to a few thousand people worldwide. However, rare diseases are collectively common, affecting an estimated 25 million to 30 million people in the United States. Many of these diseases have a genetic cause, are serious or life-threatening and are hard to diagnose and treat. The pilot study was a collaborative effort among NCATS; Eversana Life Sciences, Chicago; Oregon Health & Science University, Portland; Sanford Health, Sioux Falls, South Dakota; and a health insurer in Australia. Pariser and colleagues analyzed patients’ diagnosis information in medical records and billing codes. They used International Classification of Diseases (ICD) codes, which designate a disease diagnosis and other methods, to determine those individuals with rare diseases and their direct medical costs for 14 rare diseases in four health care systems compared to non-rare disease patients of a similar age. The pilot study aimed to test the feasibility of this approach in analyzing data on rare diseases prevalence and costs. The 14 rare diseases represented a diverse set of disorders that differ in prevalence, organ systems affected, age of onset, clinical course, and availability of an approved treatment or specific ICD code. Examples of the selected rare diseases include sickle cell disease, muscular dystrophy and eosinophilic esophagitis. The analysis showed wide variations of rare diseases prevalence in the various health care systems, which the researchers attributed in part to geographic differences, as well as the use of public versus private insurance, which may include different patient group representation. In addition, some genetic diseases can occur more frequently in certain populations, depending on the demographic make-up of a region. The team determined approximate medical costs by examining health care system data from NCATS and Eversana. In every case, the cost per patient per year (PPPY) for those with a rare disease exceeded costs for non-rare diseases patients of the same age. According to the Eversana health care system database, which included estimates from commercial and insurance payors over nearly 15 years, PPPY costs ranged from $8,812 to $140,044 for rare diseases patients compared to $5,862 for those without a rare disease. The NCATS data, which drew from estimates mostly from Florida Medicaid information over five years, indicated PPPY costs ranging from $4,859 to $18,994 for rare diseases patients versus $2,211 for those without a rare disease. The team reported that extrapolating the average costs estimate for the approximately 25 to 30 million individuals with rare diseases in the United States would result in total yearly direct medical costs of approximately $400 billion, which is similar to annual direct medical costs for cancer, heart failure and Alzheimer’s disease. The researchers also used patient medical records to trace the diagnostic journeys of four people with a rare disease, including two individuals who had a form of Batten disease, an inherited neurological disorder, and two others with cystic fibrosis, an inherited disease that severely affects the lungs. The journey “maps” provided detailed descriptions of direct medical costs, such as for hospitalizations and procedures associated with these diseases, and provided insights into patient clinical management before and after disease diagnosis. The researchers noted that analyzing medical records revealed that rare diseases patients often share a consistent group of symptoms (e.g., seizures, infections, and developmental delay) and characteristics, which could help clinicians make diagnoses more quickly and begin treatment earlier. Because many individuals are diagnosed with a rare disease at a young age and because most rare diseases are serious conditions, rare disease patients are likely to require more time in the hospital and incur greater medical expenses over a lifetime than those without rare diseases. Such commonalities among rare disease patients could point to the potential use of machine learning techniques on health care system databases to improve diagnoses, said NCATS Acting Director Joni L. Rutter, Ph.D., a co-author on the study. The research team also would like to determine if the methodologies they used for exploring the prevalence and associated costs for a small set of rare diseases could be scaled to thousands of other known rare diseases. “Ultimately, to improve the lives of people with rare diseases,” said Rutter, “we need to find innovative ways, including new technologies, to help shorten the lengthy diagnostic odysseys so many patients and families experience and make more treatments available faster.” Media Contact: NCATS Information Officer, ncatsinfo@mail.nih.gov About the National Center for Advancing Translational Sciences (NCATS): NCATS conducts and supports research on the science and operation of translation — the process by which interventions to improve health are developed and implemented — to allow more treatments to get to more patients more quickly. For more information about how NCATS helps shorten the journey from scientific observation to clinical intervention, visit https://ncats.nih.gov. About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit https://www.nih.gov. NIH…Turning Discovery Into Health®	NCATS-led study finds health care costs associated with rare diseases are similar to those for more common diseases.	/sites/default/files/NCATS_RareDiseases_Infographic_P4_900x600_0.jpg	Study Suggests People with Rare Diseases Likely Face Higher Health Car	NCATS-led study finds health care costs associated with rare diseases are similar to those for more common diseases.	/sites/default/files/NCATS_RareDiseases_Infographic_P4_900x600_1.jpg	Study Suggests People with Rare Diseases Likely Face Higher Health Car
22066	2021 CCIA Projects	Implementation of Whole-Genome Sequencing as Screening in a Diverse Cohort of Healthy Infants CRITICAL: Collaborative Resource for Intensive care Translational science, Informatics, Comprehensive Analytics, and Learning A Consortium Effort to Translate Therapies for Neurological Diseases via an Ex Vivo Organotypic Platform Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers: A Mixed Methods Approach Implementation of Whole-Genome Sequencing as Screening in a Diverse Cohort of Healthy Infants Brigham and Women’s Hospital (Harvard University) Principal Investigator: Robert C. Green, M.D., M.P.H. Grant Number: 1U01TR003201-01A1 Collaborating Institutions: Baylor College of Medicine; Boston Children’s Hospital (Harvard University); Broad Institute (Harvard University); Harvard Pilgrim Health Care, Inc. (Harvard University); HudsonAlpha Institute for Biotechnology (University of Alabama at Birmingham); Icahn School of Medicine at Mount Sinai; University of Alabama at Birmingham This team performed the first randomized controlled trial of genomic sequencing—which can be used to screen for genetic predisposition to disease—in newborns and now plans to expand that project to a diverse cohort. The first project identified and disclosed disease risks in 11 percent of the infants sequenced; health care providers were able to constructively manage the information reported, and no increased distress, disruptions to the parent–child relationship or downstream increases in cost were detected. This study will build on that project to study genomic sequencing as a screening method in a population of infants from underserved minority populations, primarily African American and Hispanic groups. Researchers will develop, implement and evaluate a sustainable approach that uses community engagement to minimize distrust and maximize benefit. Learn more about this project in the NIH RePORTER. Note: This U01 was co-funded by NCATS and the Eunice Kennedy Shriver National Institute Of Child Health & Human Development CRITICAL: Collaborative Resource for Intensive care Translational science, Informatics, Comprehensive Analytics, and Learning Northwestern University Principal Investigator: Yuan Luo, Ph.D. Grant Number: 1U01TR003528-01A1 Collaborating Institutions: Massachusetts Institute of Technology (Tuft University); Tufts Medical Center (Tuft University); University of Alabama at Birmingham; Washington University in St. Louis; University of Texas Health Science Center at Houston; Columbia University Translational research in artificial intelligence (AI) has been hindered by the lack of shared data resources with sufficient depth, breadth and diversity. This project will leverage multiple Clinical and Translational Science Awards (CTSA) sites with diverse racial, ethnic and geographic profiles to develop and evaluate a multisite, de-identified intensive care unit (ICU) data set, which will facilitate accelerated translational research in AI and deep-learning approaches to understand, track and predict the pathophysiological state of patients. The created data set will include more geographic regions, larger quantities of time-series data and more patient diversity than many existing ICU data sets, as well as regional population differences and practice variations that could have clinical impact. Learn more about this project in the NIH RePORTER. A Consortium Effort to Translate Therapies for Neurological Diseases via an Ex Vivo Organotypic Platform The University of North Carolina at Chapel Hill Principal Investigator: Shawn Hingtgen, Ph.D. Grant Number: 1U01TR003715-01 Collaborating Institutions: Duke University; University of Florida This project will identify, develop and initiate translation of therapeutic neurological agents using the organotypic brain slice culture (OBSC) platform. These OBSC models leverage existing cellular and extracellular milieu in live brain slices to allow rapid, functional testing on brain tissue. The multidisciplinary team will expand the OBSC platform to improve the care of patients with brain disorders by sharing disease models, therapeutic agents, molecular tool kits and clinical patient tissue. Capabilities relevant to neurodegenerative disease, brain cancers and ischemic disease will be added to the platform, which also can screen therapeutic agents and enable new immune-based approaches. These approaches will create an expandable infrastructure built around OBSC technology, accelerate the discovery of new and effective therapeutic strategies, and initiate translation toward ultimate human patient trials to treat multiple disorders of the brain. Learn more about this project in the NIH RePORTER. Optimizing Efficiency and Impact of Digital Health Interventions for Caregivers: A Mixed Methods Approach University of Virginia Principal Investigator: Kelly McLean Shaffer, Ph.D. Grant Number: 1R21TR003522-01A1 Collaborating Institutions: University of Pittsburgh One in six American adults provide care for a loved one with disabling illness, and these family caregivers are more likely to experience insomnia and other psychological concerns than the general population. Multiple existing evidence-based digital health interventions may effectively address caregivers’ psychosocial needs and increase their access to supportive care, but the level of tailoring necessary for optimal engagement with and efficacy of these interventions for caregivers remains unknown. This project will provide Sleep Healthy Using the Internet (SHUTi) to caregivers with insomnia, then align engagement with SHUTi and improvement in sleep with factors related to caregiving, which will support the goal of tailoring SHUTi to users and advancing the science of digital health interventions for caregivers. Learn more about this project in the NIH RePORTER.	Listing of 2021 CCIA Projects		2021 CCIA Projects	Listing of 2021 CCIA Projects		2021 CCIA Projects
21778	2020 NCATS ASPIRE Reduction-to-Practice Challenge Winners, Stage 1	NCATS is happy to announce the winners of the 2020 NCATS ASPIRE Reduction-to-Practice Challenge, Stage 1: Planning Comprehensive Integrated Platforms. *According to the rules for these ASPIRE Design Challenges, non-U.S. citizens and non-permanent residents were not eligible to win a monetary prize (in whole or in part). Iterative Learning and Automated Modular Platform for Optimum Nonaddictive Analgesic Discovery Accelerating Molecular Innovation in Pain through an AI-Driven, Human-Guided and Automated Open Drug Discovery Platform Closed Loop Bio-Assay-Chemputer for Next Generation Analgesics (BioChemputer) Development of a Comprehensive Integrated Platform for Translational Innovation in Pain, Opioid Abuse Disorder and Overdose Biotech-in-a-Box, CDD’s Solution for Combating the Opioid Crisis Iterative Learning and Automated Modular Platform for Optimum Nonaddictive Analgesic Discovery Gaurav Chopra Ram Samudrala R. Graham Cooks Connor W. Coley Panayotis K. Thanos Jun-Xu Li Purdue University State University of New York (SUNY) Purdue University Massachusetts Institute of Technology University at Buffalo University at Buffalo Accelerating Molecular Innovation in Pain through an AI-Driven, Human-Guided and Automated Open Drug Discovery Platform Daniel H. Robertson Timothy I. Richardson Gaurav Chopra Richard M. van Rijn Indiana Biosciences Research Institute Indiana University School of Medicine Purdue University Indiana University School of Medicine Closed Loop Bio-Assay-Chemputer for Next Generation Analgesics (BioChemputer) Babak Esmaeli-Azad Leroy Cronin Sara I. Walker Philip J. Kitson S. Hessam M. Mehr James Zapf Evan Snyder Larry H. Ellisman Shaochen Chen CiBots, Inc. University of Glasgow Arizona State University University of Glasgow University of Glasgow Visionary Pharmaceuticals Inc. Sanford Consortium for Regenerative Medicine University of California, San Diego University of California, San Diego Development of a Comprehensive Integrated Platform for Translational Innovation in Pain, Opioid Abuse Disorder and Overdose Jeffrey Skolnick Andre Ghetti Nicole Jung Hongyi Zhou Georgia Institute of Technology ANABIOS Corporation Karlsruhe Institute of Technology Georgia Institute of Technology Biotech-in-a-Box, CDD’s Solution for Combating the Opioid Crisis Barry Bunin Jacob Bloom Peter Gedeck Samantha Jeschonek Lawrence Callahan Christopher Lipinski Collaborative Drug Discovery Collaborative Drug Discovery Collaborative Drug Discovery Collaborative Drug Discovery U.S. FDA Christopher A Lipinski, Ph.D., LLC. Back to top Contact Dobrila D. Rudnicki, Ph.D.	NCATS announced the winners of the ASPIRE Reduction-to-Practice Challenge, Stage 1.		Winners of the NCATS ASPIRE Reduction-to-Practice Challenge, Stage 1	NCATS announced the winners of the ASPIRE Reduction-to-Practice Challenge, Stage 1.		Winners of the NCATS ASPIRE Reduction-to-Practice Challenge, Stage 1
22657	ASPIRE Day 2021	Please enable JavaScript in your browser settings to properly view this page! .event-content { padding: 0; display: none; } .toggle { /cursor: pointer;/ transition: color ease-out .8s; } .badge { cursor: pointer; } .toggle:before { content:""; overflow: hidden; font-size: 0; -webkit-transition: font-size .2s; transition: font-size .2s; transition-timing-function: linear; } .toggle.open { transition: color ease-out .1s; } .event-content > p:nth-child(1) { margin-top: 0; } .footnote { font-size: 12px; } #body-content > div > div > div > div > div > p { margin-left: 40px; } On June 3 and 4, 2021, NCATS held what it hopes will be the first in a series of yearly symposia about progress made toward achieving ASPIRE’s ultimate goal: enabling real-time translational science. Although ASPIRE Day 2021 was conducted virtually, we hope future symposia will take place in person. The selection of project summaries and videos below provides an opportunity to gain a better understanding of how we are tackling key challenges of applying automation strategies to improve how NCATS gets more treatments to more patients more quickly. Some of the PowerPoint presentations are available upon request as PDFs; presentations marked with an asterisk () below are not available. If you wish to receive a PDF of a speaker's slides, please contact Alex Godfrey. Virtual Event Schedule Day 1: Thursday, June 3, 2021, 1:00–5:00 p.m. Moderator: Jayme L. Dahlin, M.D., Ph.D. Watch All Day 1 Presentations Introduction, Day 1 Joni L. Rutter, Ph.D., Acting Director, NCATS, NIH Watch Presentation ASPIRE: Realizing Real-Time Translational Science Alex Godfrey, Ph.D., Automated Chemistry Consultant, ASPIRE, NCATS Watch Presentation Keynote Address: NCATS’ A Specialized Platform for Innovative Research Exploration (ASPIRE) Geoff Ling, M.D., Ph.D., Co-Founder and CEO, On Demand Pharmaceuticals Watch Presentation Walkthrough #1: Reaction Informatics Innovations in ASPIRE Gergely Zahoranszky-Kohalmi, Ph.D., Informatics Lead, ASPIRE, NCATS Expand Watch Presentation The creation of an autonomous chemistry platform — such as the one envisioned in the ASPIRE program — requires an integrative, iterative and collaborative approach. In the pilot phase of the program, the ASPIRE Informatics Team focused on creating the prototype of the ASPIRE Integrated Computational Platform (AICP), which provides the foundation for the chemical intelligence that will power the ASPIRE platform. The prototype of AICP is equipped with state-of-the-art reaction informatics modules for evidence-based synthesis route design and interactive reaction data visualization and analysis. Furthermore, we developed a first-in-class blockchain-based technology to protect intellectual property–sensitive chemical information and to promote collaborative research. In this talk, we demonstrate the architecture and the functionalities of the AICP with the help of a reaction knowledgebase that incorporates more than 100,000 reactions from the U.S. Patent and Trademark Office (USPTO) reaction data set. Moreover, we discuss how ASPIRE will transform structure optimization efforts of lead candidates in the medicinal chemistry research at NCATS. The results and findings of the ASPIRE pilot phase pave the way and guide the direction of future reaction informatics research toward developing high-throughput synthesis capabilities at NCATS. Walkthrough #2: DashChem: Smart (IoT) Lab Dashboard Meghav Verma, Robotics Engineer, ASPIRE, NCATS Expand Watch Presentation The DashChem presentation will be centered around inductive chemistry laboratory automation. We will talk about creating an ecosystem of old and new laboratory equipment that a user can interact with through a universal dashboard application, either in person or remotely. We will demonstrate the dashboard features and the devices that have been integrated and show how users can check the status of the device, run experiments and analyze data using the technology. Walkthrough #3: Re-Imagining Compound Biological Annotation with ASPIRE: Autonomous Robots, AI-Driven Optimization and On-Demand Fully Automated High-Yield Assays* Jayme L. Dahlin, M.D., Ph.D., Preclinical Medical Director, NCATS Carleen Klumpp-Thomas, Head of Automation, NCATS Expand Watch Presentation This presentation will summarize the high-throughput biology efforts in the ASPIRE initiative. The ASPIRE biology team plans to support on-demand, project-specific biological assays, as well as a set of high-yield core assays for routine mapping of chemical matter produced from automated syntheses. Leveraging the extensive experience of NCATS in high-throughput screening, core philosophies of ASPIRE biology include reproducibility, adaptability, efficiency, sustainability and usability. Examples of pilot programs will be presented, including the use of autonomous intelligent vehicles for sample ferrying, autonomous biological assay optimization and unbiased high-content imaging assays to generate mechanism-of-action hypotheses. Collaboration Opportunities Sam Michael, Chief Information Officer, NCATS Watch Presentation Closing Comments, Day 1* Matthew Hall, Ph.D., Director, Early Translation Branch, Department of Preclinical Innovation, NCATS Watch Presentation Day 2: Friday, June 4, 2021, 8:30–11:45 a.m. Moderator: Jayme L. Dahlin, M.D., Ph.D. Introduction, Day 2* Christopher P. Austin, M.D., CEO-Partner, Flagship Pioneering Watch Presentation Virtual Poster Session: Four Breakout Rooms (15-minute presentation and 5-minute Q&A) ASPIRE team members and collaborators Breakout #1: Biology/Other Moderator: Jayme L. Dahlin, M.D., Ph.D. Expand Watch Presentation Utility of 3-D Printing in Laboratory Automation Pranav Bende, Robotics Engineer, ASPIRE, NCATS, presenter Alex Godfrey, Ph.D., Automated Chemistry Consultant, ASPIRE, NCATS Expand Watch Presentation We present here the value of applying 3-D printing technology as a rapid and effective prototyping strategy in a research laboratory setting. A few select examples of innovative tools for use at the bench are demonstrated to showcase the utility of 3-D printing parts to be used in automating various lab processes with the goal of increasing the efficiency of critical research tasks done by the scientists. Applying Adaptive Optimization Techniques and Cross-Platform Communication to Enable Informatics-Driven Experimentation Jayme L. Dahlin, M.D., Ph.D., Preclinical Medical Director, NCATS Carleen Klumpp-Thomas, Head of Automation, NCATS Jameson Travers, Laboratory Automation Specialist, NCATS Expand Watch Presentation Current high-throughput screening assay optimization is often a manual process, although this can be enhanced by design-of-experiment approaches. An artificial intelligence-driven assay optimization was developed as part of the NCATS ASPIRE initiative to accelerate preclinical drug discovery. We describe the development of an autonomous, cloud-based Bayesian optimization system using the Kebotix adaptive optimization algorithm and a cell-free assay for papain enzymatic activity as proof of concept. The algorithm found suitable conditions and optimal assay performance with only 55 experiments with up to 20 experiments running simultaneously. This setup was sufficient for the Kebotix algorithm to identify and test the global optimum as determined from a brute-force experiment testing all 294 possible assay conditions. The algorithm could achieve a fivefold reduction in costs for laboratory supplies and high-throughput experimentation run time. This technology should enable future work toward applying autonomous optimization to more complex biological assays and automated chemistry reaction screening. An Open Port Sampling Interface for High-Throughput Mass Spectrometry: Emerging Biotechnology for Screening and Reaction Optimization in Drug Discovery John Janiszewski, Research Scientist, NCATS, presenter Sam Michael, Chief Information Officer, NCATS Meghav Verma, Robotics Engineer, ASPIRE, NCATS Expand Watch Presentation The open port sampling interface for mass spectrometry (OPSI-MS) is a constant-flow sample introduction module fitted to an ESI-source inlet.1 The OPSI inlet can be used for direct sampling in multiple formats (e.g., via acoustically dispensed droplets, direct pipet, infusion, surface sampling). Here we describe development and integration of OPSI-MS with an EDC/ATS-100 acoustic dispense module for high-throughput MS/MS quantification. In addition, we describe development of an OPSI-MS workbench that can be used to test both acoustic and nonacoustic sampling applications. 1Van Berkel, G. J., and Kertesz, V. (2015) An open port sampling interface for liquid introduction atmospheric pressure ionization mass spectrometry. Rapid Commun Mass Spectrom 29: 1749–1756. Advances Toward Developing an Automated Purification Platform Christopher LeClair, Ph.D., Analytical Chemistry Lead, ASPIRE, NCATS Expand Watch Presentation The Analytical Chemistry Core within the Division of Preclinical Innovation at NCATS is collaborating with the ASPIRE program to develop an automated purification platform that can operate as a stand-alone system or an integrated module within the automated synthetic laboratory. The concepts of throughput and cycle time are of great significance as we endeavor to increase experimental capacity while also reducing the therapeutic discovery and development timeline to rapidly bring more treatments to patients. Purification is an important stage in the progression of small molecules from synthesis to biological assay. However, it poses a serious bottleneck in an automated workflow due to the serial nature of liquid chromatography (LC). A major advancement to our purification process is the design of a dual-arm fraction collection bed incorporating analytical and purification LC systems into a single automated platform to provide a more efficient and parallel technique. Standardization of system protocols in conjunction with automated method development aim to accommodate highly diverse chemotypes, as well as enable greater sample throughput. We have focused our efforts additionally on fully automating post-purification sample processing, which is an essential aspect of the initiative. This involves identity verification, purity analysis, sample consolidation, material distribution, compound registration and data management. Breakout #2: Chemistry Moderator: Alex Godfrey, Ph.D. Expand Watch Presentation qNMR as a General Tool for Aiding Integration of Automated Chemistry Workflows Cullen Klein, Ph.D., Automation Chemist, ASPIRE, NCATS Expand Watch Presentation Quantitative nuclear magnetic resonance (qNMR) is a valuable quantification method and a compelling alternative to chromatographic techniques. Although other quantification techniques face challenges — such as specific response factors and the corresponding need to create calibration curves — qNMR is a direct method that only requires complete solubility and the presence of NMR active nuclei. At the same time as delivering quantitative information, qNMR can obtain qualitative information for identity confirmation. qNMR is thus both a comprehensive and flexible method that can be deployed rapidly to understand the result outcomes of automated chemistry operations, from simple evaporations to solid-phase extractions to assessing yield and conversion for complex reaction mixtures. The ASPIRE team and the NCATS Analytical Chemistry Core are collaborating to develop analytical qNMR techniques and workflows to aid in answering these chemistry integration questions. We will discuss specific ways that qNMR will be utilized for the ASPIRE project, as well as future opportunities and challenges to making qNMR a standard method fully integrated into the complete automated workflow. The Development of Indigo Reactor for Automated Chemical Synthesis Mark Ding, Ph.D., Automation Chemist, ASPIRE, NCATS Expand Watch Presentation Indigo Reactor is an automated chemical synthesis platform with eight independently controlled reactors — allowing separate thermal, reflux, stirring speed, inerting and pressure control — including interchangeable adapters that accommodate either a 10 mL or 20 mL removable glass reactor. This presentation will review the function of the Indigo Reactor and will cover hardware and software development. After conducting the benchmark reaction, we can verify the function for each reactor lane. I will introduce how to transfer a chemical reaction condition into a recipe, which is an important function for this reactor, and how to use it for reaction condition screening, recording the reaction and reproducing chemistry reaction repeatedly with the precise recipe. I also will cover the next-step upgrade for the hardware and software. Early Successes of Automated Reaction Screening for NCATS Medicinal Chemists Dave Calabrese, Ph.D., Automation Chemist, ASPIRE, NCATS Expand Watch Presentation Medicinal and organic chemists commonly synthesize molecules that have never been made before. However, finding optimal or even working reaction conditions to make these compounds is often a time- and resource-consuming task involving manually setting up and monitoring a handful of conditions. Automated, high-throughput reaction screening accelerates the process of preparing, analyzing and standardizing a higher volume of reaction conditions. The ASPIRE team has developed a reaction screening platform with the goal to provide chemists with same-day solutions to their synthetic challenges. For setting up and executing reactions, we use an Unchained Labs Junior, which is capable of liquid handling and solid loading for hundreds of reactions in parallel at multiple temperatures. The screens are analyzed quickly using Virscidian analysis software connected to a dedicated UPLC (Ultra-high Performance Liquid Chromatograph). We have used this platform successfully to determine optimal reaction conditions for ongoing medicinal chemistry projects. Furthermore, we are using this platform to design and prepare reaction screening kits for common medicinal chemical reactions to be used by chemists or ourselves on demand. Our platform is ready to assist users and provide expedient solutions. N-Trifluoromethylation of Heteroarenes and Amines Enabled by Electro/Photochemical Approach Jagadeesh Nagendra Manda, Ph.D., Postdoctoral Fellow, Early Translation Branch, NCATS, presenter Ganesha Rai Bantukallu, Ph.D., ASPIRE, NCATS Dave Calabrese, Ph.D., ASPIRE, NCATS Alex Godfrey, Ph.D., ASPIRE, NCATS Cullen Klein, Ph.D., ASPIRE, NCATS Expand Watch Presentation Novel synthetic methodologies that enable late-stage modifications of small molecules during hit-to-lead or lead optimization are highly desirable to accelerate the drug discovery process. Additionally, such robust methodologies provide an opportunity to explore a new chemical space during lead optimization. Nitrogen-containing compounds, particularly heterocycles, share a major chemical space in drug discovery. Because the introduction of the fluorine (F) atom into small molecules is a powerful approach to modulate the pharmacological properties, late-stage integration of the trifluoromethyl (CF3) group into nitrogen heterocycles would be an interesting, rational strategy to optimize the lead compounds. Moreover, it is essential to understand the effect of the N-trifluoromethyl (NCF3) group on activity and pharmacological properties because it provides valuable information for other and future drug discovery programs. Surprisingly, limited studies have been done in this area mainly because of scarcity of synthetic methodologies. This study aims at developing a new method for late-stage N-trifluoromethylation of heteroarenes and amines by employing electro/photochemical strategies and thereby investigating the in vitro activity, ADME properties and in vivo pharmacokinetic studies in comparison to their methyl (NCH3 vs. NCF3) counterparts. Optimization of experimental methods is currently underway by utilizing the ASPIRE reaction screening resources and automation platform. Breakout #3: Informatics Moderator: Gergely Zahoranszky-Kohalmi, Ph.D. Expand Watch Presentation The NCATS ASPIRE Program: Building Unique Intramural-Extramural Collaborations to Explore Novel Biologically Relevant Chemical Space Dobrila D. Rudnicki, Ph.D., Program Director, Office of Special Initiatives, NCATS, presenter Sean Gardner, Scientific Program Manager, Office of Special Initiatives, NCATS, presenter Expand Watch Presentation Recently, NCATS has started a new initiative that will transform chemistry from an individualized craft to a modern, information-based science through the ASPIRE program. ASPIRE seeks to advance preclinical drug discovery by enabling a more rapid exploration of biologically relevant chemical space. To facilitate ASPIRE, we have developed an extramural component of the program that will enable and support effective collaborations between the greater scientific community and the NCATS DPI Intramural ASPIRE Laboratory. The program’s goals are to build upon the DPI ASPIRE infrastructure and capabilities through unique contributions from extramural scientists facilitated by the exchange of ideas, to develop co-funding opportunities between multiple government agencies, and to engage a wide spectrum of stakeholders including, but not limited to, professional societies, private industry and patient advocacy groups. The ASPIRE program was initiated in 2018 with funding from The Helping to End Addiction Long-termSM Initiative (or NIH HEAL Initiative). The funding was used to develop and support 2018 NCATS Aspire Design Challenges and a follow-up 2020 NCATS Reduction-to-Practice Challenge. These challenges were designed to address critical development of new treatments for pain, opioid use disorder and overdose, using cutting-edge solutions in artificial intelligence (AI) and automation. The grand prize winner of this competition will be determined by DPI ASPIRE laboratory as to which of the innovative solutions has achieved an integrated approach combining data science and data mining, biological assays, and AI and machine learning (ML) toward novel analgesics and pain/overdose medications. In addition to the challenges, funding opportunities recently were developed to support extramural investigators in taking advantage of the unique research opportunities available at the NCATS ASPIRE Laboratory and develop innovative, automated modules that will facilitate identification of novel chemical entities targeted toward currently undrugged biological space. Here we present an update on the ASPIRE program and lessons learned that continue to shape the ASPIRE program’s ultimate goal: to make the process of drug discovery and development cheaper and faster and to bring treatments to all who need them. IoT Infrastructure (Behind the Scenes) Vishakha Goyal, Robotics Engineer, ASPIRE, NCATS Expand Watch Presentation The poster on Internet of Things (IoT) infrastructure will be an in-depth discussion regarding the fundamentals of our entire IoT-based laboratory dashboard. This presentation is for anyone interested in learning about the engineering details behind laboratory automation using IoT. SeeMyLabs: Legacy Instrument Modernization Biju Mathew, Program Manager, ASPIRE, NCATS Chinapong Songchan, Software Engineer, ASPIRE, NCATS Expand Watch Presentation Modern instruments are often web enabled, app based, wireless and autonomous. Yet many of the instruments used in the laboratories these days are systems of the past and, therefore, do not have these modern features of convenience and automatization. Because these instruments are fully functional and play crucial roles in laboratory processes, we have become stagnant in our research methods and unable to update our traditional methodologies to reduce some of our in-person involvement. However, what if these older instruments could be modernized (i.e., web enabled), opening us to a new realm of possibilities. In this presentation, we will discuss the potential of transforming our outdated systems to increase researcher convenience. Multilayer Reaction Knowledgebase Development Towards Retrosynthesis Design* Qian Zhu, Ph.D., Informatics Scientist, ASPIRE, NCATS Expand Watch Presentation Retrosynthesis is a technique for solving problems in the planning of organic syntheses. This is achieved by transforming a target molecule into simpler precursor structures regardless of any potential reactivity or interaction with reagents, which is one of the most complex issues in the field of organic chemistry. With a huge number of available reactions accumulated — such as around 1.8 million reactions available from the USPTO — how to find the most appropriate reactions for the target molecule with consideration of critical functional groups surrounding the reaction center is one of the main challenges in this field. To address this problem, one possible solution is to transform and represent such a large amount of reaction data in a more meaningful way that is suitable for retrosynthesis design computationally. Inspired by the three-layer reaction model designed by InfoChem for the purpose of reaction classification, we propose to develop a multilayer reaction knowledgebase to capture fundamental information for retrosynthesis. More specifically, we will define a reaction data model composed of three layers, namely the layers of reaction center (RC), maximum common structure (MCS) and specific reaction (SR), to capture the full spectrum of reaction information. In addition, not only will we consider the backbone structure of RC and MCS, but also the rest of structures will be represented as R-groups to allow R-group similarity comparison while reaction matching with the target molecule. Subsequently, we will be able to develop the multilayer reaction knowledgebase with accommodation of USPTO reaction data and, from there, build up retrosynthesis applications. Breakout #4: Extramural Partners Moderator: Gurusingham Sittampalam, Ph.D. Expand Noninvasive Application of Dissolved Carbon Dioxide Sensor in Cell Culture Vida Rahmatnejad, Department of Chemical and Biological Engineering, University of Maryland Baltimore County (UMBC), presenter Xudong Ge, Ph.D., Department of Chemical and Biological Engineering, UMBC Govind Rao, Ph.D., Department of Chemical and Biological Engineering, UMBC Michael Tolosa, Ph.D., Department of Chemical and Biological Engineering, UMBC Expand Dissolved oxygen (DO) and pH are factors impacting the growth characteristics of the cell. Glucose is the most important supporting factor in rapid proliferation of cells because it is the main nutrient used by the cells. High levels of carbon dioxide are toxic to cell culture, such that it acts as an inhibitory factor affecting cell metabolism. Small-scale cell culture studies in academia, as well as in industry, currently are conducted in single-use vessels that are not equipped with systems monitoring the aforementioned factors despite the fact that they play a major role in cell culture condition. As a result, findings from small-scale cell culture studies are not as useful from an analytical point of view. This fact makes these kinds of experiments less repeatable and reliable. The Center for Advanced Sensor Technology has developed noninvasive pH and DO sensors (featuring a patch attached to the bottom of the vessel), as well as dissolved carbon dioxide (DCO2) and glucose sensors to monitor cell culture environment. These sensors are suitable for various kinds of bioreactors because of their low profile. Currently, the DCO2 sensor is integrated with the T flask (featuring a sampler mounted outside of the vessel). The evaluation of the noninvasive monitoring system for DCO2 shows promising results. In future work, standard cell culture flasks equipped with sensors for DO, pH, DCO2 and glucose will provide continuous monitoring. Application of these sensors will improve the understanding of the small-scale cell culture microenvironment and provide real-time information on the nutrients and metabolites. The analytical data from the monitoring system will be used to interpret the effect of microenvironmental conditions on cell behavior. Synthetically Accessible Virtual Inventory (SAVI) Marc Nicklaus, Ph.D., Head, Computer-Aided Drug Design (CADD) Group, National Cancer Institute, NIH Expand We have created a database of 1.75 billion compounds predicted to be easily synthesizable: the Synthetically Accessible Virtual Inventory (SAVI). SAVI was generated via a set of transforms based on an adaptation and extension of the CHMTRN/PATRAN programming languages describing chemical synthesis expert knowledge, which originally stem from the Lhasa project. The chemoinformatics toolkit CACTVS was used to apply a total of 53 transforms to about 150,000 readily available building blocks from Enamine. Only single-step, two-reactant syntheses were calculated for this database, even though the technology can execute multistep reactions. The possibility to incorporate scoring systems in CHMTRN allowed us to subdivide the database into sets rated by their predicted synthesizability, with the most-synthesizable class comprising 1.09 billion synthetic products. Manufacturing Therapeutics at the Point of Care Using Cell-Free Systems Shayan Borhani, Department of Chemical and Biological Engineering, UMBC, presenter Max Levine, M.S., Chemical Engineering Department, Stanford University, presenter Govind Rao, Ph.D., Department of Chemical and Biological Engineering, UMBC James Swartz, Sc.D., Chemical Engineering Department, Stanford University Expand Point-of-care (POC) technologies have brought medical diagnostics and treatments to patients who would otherwise go without medical care. Currently, POC technologies are focused mainly on medical diagnostics — such as COVID-19 antigen test kits — and little investment has been made to manufacture therapeutics at the point of care. Additionally, COVID-19 has highlighted the genuine utility of POC technologies by displaying the urgency of providing medicines in pandemic hot spots. For this reason, a POC manufacturing platform that seeks to produce therapeutics is an essential part in future pandemic preparedness. Here, we report the utility of cell-free protein synthesis (CFPS) coupled with a POC manufacturing platform (BioMOD) capable of expression and purification of a variety of therapeutics ranging from monoclonal antibodies to insulin. Specifically, CFPS systems are the preferred method of POC expression of these therapeutics because they provide a rapid, scalable and versatile platform for synthesis of a variety of different proteins. Moreover, the capacity of CFPS reactions to be lyophilized and subsequently hydrated to synthesize novel proteins allows them to be a novel technology for POC diagnostics and treatments. With recent advances in microfluidics, these products can then be purified rapidly in continuously automated purification processes, generating a final product on the time scale of hours. To this end, we have selected the known broad-spectrum antiviral lectin Griffithsin as an ideal candidate to pilot the BioMOD system due to preliminary studies demonstrating its ability to function as an inhibitor of SARS-CoV2 infections. Currently, we are able to successfully express soluble Griffithsin within an E. coli CFPS system and plan to investigate the application of this protein on the BioMOD system. Optimizing End-to-End Automation for Demanding Peptide Drug Discovery Dale Thomas, Ph.D., Mytide Therapeutics Liam Kelly, Ph.D., Mytide Therapeutics Roundtable Discussion #1: Making the Most of Collaborations* Alex Godfrey, Ph.D., Automated Chemistry Consultant, ASPIRE, NCATS Expand What constitutes a successful collaboration? What do you consider to be some general strategic objectives behind collaborations? Can you have too many collaborations? Roundtable Discussion #2: Innovating on the Problems of the Future for Automated Chemistry* ASPIRE core team Expand Bench-level automation made easy for chemists. What does it look like now and in 5 to 10 years? Training medicinal chemists for the future with AI/ML and automation. What is needed? Are there cultural or perception issues in medicinal chemistry community to be addressed? If so, what are they? Closing Comments, Day 2* Anton Simeonov, Ph.D., Scientific Director, Department of Preclinical Innovation, NCATS $('.toggle').on('click', function(event) { if (!$(this).hasClass("open")) { $(this).parent().siblings(".event-content").slideDown(); $(this).children(".badge").text("Collapse"); $(this).addClass("open"); } else { $(this).parent().siblings(".event-content").slideUp(); $(this).removeClass("open"); $(this).children(".badge").text("Expand"); $(this).blur(); } }); $('.toggle-list').on('click', function(event) { if (!$(this).hasClass("open")) { $(this).parent().parent().parent().siblings(".event-content").slideDown(); $(this).children(".badge").text("Collapse"); $(this).addClass("open"); } else { $(this).parent().parent().parent().siblings(".event-content").slideUp(); $(this).removeClass("open"); $(this).children(".badge").text("Expand"); $(this).blur(); } });	NCATS held a symposium about progress made toward achieving ASPIRE’s ultimate goal: enabling real-time translational science. View a selection of project summaries and videos.	/sites/default/files/aspire_2_0.png	ASPIRE Day 2021	NCATS held a symposium about progress made toward achieving ASPIRE’s ultimate goal: enabling real-time translational science. View a selection of project summaries and videos.	/sites/default/files/aspire_2_1.png	ASPIRE Day 2021
21637	LitCoin NLP Challenge Terms and Conditions	(1) To be eligible to win a prize under this Challenge, a Participant (whether an individual, group of individuals, or entity) — Shall have registered to participate in the Challenge under the rules promulgated by the National Institutes of Health (NIH) as published in this announcement; Shall have complied with all the requirements set forth in this announcement; In the case of a private entity to win a cash prize, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual to win a cash prize — whether participating singly or in a group — shall be a citizen or permanent resident of the United States. Private entities not incorporated in or maintaining a primary place of business in the United States and non-U.S. citizens and non-permanent residents can either participate as a member of a team that includes a citizen or permanent resident of the United States, or they can participate on their own. However, such non-U.S. entities and citizens and non-permanent residents are not eligible to win a monetary prize (in whole or in part). Their participation as part of a winning team, if applicable, may be recognized when the results are announced. Similarly, if participating on their own, they may be eligible to win a non-cash recognition prize. May not be a federal entity or federal employee acting within the scope of their employment; May not be a federal employee of the U.S. Department of Health and Human Services (HHS), or any other component of HHS, acting in their personal capacity; Who is employed by a federal agency or entity other than HHS (or any component of HHS), should consult with an agency Ethics Official to determine whether the federal ethics rules will limit or prohibit the acceptance of a prize under this Challenge; May not be a judge of the Challenge, or any other party involved with the design, production, execution or distribution of the Challenge, or the immediate family of such a party (i.e., spouse, parent, step-parent, child, or step-child). Who is under age 18 must submit a signed copy of the parent/legal guardian consent form. The form can be found at https://ncats.nih.gov/files/LitCoin-Parental-Consent-Form-508.pdf. (2) Federal grantees may not use federal funds to develop their Challenge submissions unless use of such funds is consistent with the purpose of their grant award and specifically requested to do so due to the Challenge design as described in this announcement. Federal grantees who use federal funds to develop their Challenge submissions must also obtain written prior approval from the appropriate grants management or program officer and provide documentation of prior approval upon request by NIH. (3) Federal contractors may not use federal funds from a contract to develop their Challenge submissions or to fund efforts in support of their Challenge submissions. (4) Submissions must not infringe upon any copyright or any other rights of any third party. (5) By participating in this Challenge, each Participant (whether an individual, group of individuals, or entity) agrees to assume any and all risks and waive claims against the federal government and its related entities (as defined in the America COMPETES Reauthorization Act, as amended), except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue or profits, whether direct, indirect or consequential, arising from participation in this Challenge, whether the injury, death, damage or loss arises through negligence or otherwise. (6) Based on the subject matter of the Challenge, the type of work that it will possibly require, as well as an analysis of the likelihood of any claims for death, bodily injury, property damage or loss potentially resulting from Challenge participation, no Participant (whether an individual, group of individuals or entity) participating in the Challenge is required to obtain liability insurance or demonstrate financial responsibility in order to participate in this Challenge. (7) By participating in this Challenge, each Participant (whether an individual, group of individuals or entity) agrees to indemnify the federal government against third-party claims for damages arising from or related to Challenge activities. (8) A Participant (whether an individual, group of individuals or entity) shall not be deemed ineligible because the Participant used federal facilities or consulted with federal employees during the Challenge if the facilities and employees are made available to all Participants participating in the Challenge on an equitable basis. (9) By participating in this Challenge, each Participant (whether an individual, group of individuals or entity) warrants that he, she or it is the sole author or owner of, or has the right to use, any copyrightable works that the submission comprises, that the works are wholly original with the Participant (or is an improved version of an existing work that the Participant has sufficient rights to use and improve), and that the submission does not infringe any copyright or any other rights of any third party of which the Participant is aware. In addition, each Participant grants to NIH an irrevocable, paid-up, royalty-free nonexclusive worldwide license to reproduce, publish, post, link to, share and display publicly the submission on the web or elsewhere. Additionally, competition prize winners (both cash and noncash prize winners) will grant a license to NIH and NCATS to use, disclose, reproduce, prepare derivative works, distribute copies to the public, and perform and display publicly, in any manner and for any purpose, and to have or permit others to do so, the software created as part of their submission, in perpetuity. Submitted software shall have no dependencies on commercial products (including software libraries). Each Participant will retain all other intellectual property rights in their submissions, as applicable. To participate in the Challenge, each Participant must warrant that there are no legal obstacles to providing the above-referenced nonexclusive licenses of the Participant’s rights to the federal government. To receive an award, Participants will not be required to transfer their intellectual property rights to NIH, but Participants must grant to the federal government the nonexclusive licenses recited herein. (10) NIH reserves the right, in its sole discretion, to (a) cancel, suspend or modify the Challenge, and/or (b) not award any prizes if no entries are deemed worthy. (11) Each Participant (whether an individual, group of individuals or entity) agrees to follow all applicable federal, state and local laws, regulations and policies. (12) Each Participant (whether an individual, group of individuals or entity) participating in this Challenge must comply with all terms and conditions of these rules, and participation in this Challenge constitutes each such Participant’s full and unconditional agreement to abide by these rules. Winning is contingent upon fulfilling all requirements herein. In addition, An application may be disqualified if it fails to function as expressed in the description provided by the participant, if it provides inaccurate or incomplete information, or if any components of the application are missing. Submissions must be free of malware. Participants agree that NCATS may conduct testing on the application(s) to determine whether malware or other security threats may be present. NCATS may disqualify the application(s) if, in NCATS’ judgment, the application may damage government or others’ equipment, operating environment or security posture. The submissions must not use government logos or official seals and must not claim endorsement by NIH or NCATS.	On this page, find the terms and conditions for the LitCoin NLP Challenge.	/sites/default/files/LITCOIN-Graphic_Approved_341x160px_FV.jpg	LitCoin NLP Challenge Terms and Conditions	On this page, find the terms and conditions for the LitCoin NLP Challenge.	/sites/default/files/LITCOIN-Graphic_Approved_341x160px_FV_0.jpg	LitCoin NLP Challenge Terms and Conditions
21631	LitCoin Natural Language Processing (NLP) Challenge	Key DatesBackgroundThe ProblemChallenge GoalsStatutory Authority to Conduct the ChallengeRules and Submission RequirementsJudging CriteriaPrizesHow to EnterAcknowledgementsPoint of ContactKey DatesNote: Dates are subject to change as necessary.September 20, 2021: Challenge announcementNovember 9, 2021: Competition launchDecember 23, 2021: End of first challenge phaseDecember 27, 2021: Start of second challenge phaseFebruary 28, 2022: End of second challenge phaseMarch 11, 2022: Final source code submission deadlineApril 12, 2022: Winners announcedBackgroundWith an ever-growing number of scientific studies in various subject domains, there is a vast landscape of biomedical information which is not easily accessible in open data repositories to the public. Open scientific data repositories can be incomplete or too vast to be explored to their potential without a consolidated linkage map that relates all scientific discoveries. This massive amount of medical knowledge can often be computationally transformed into knowledge graphs that can be used in an open data repository and has the potential to assist in identifying gaps in medical research and accelerating research for unexplored medical domains through scientific investigations.However, open medical data on its own is not enough to deliver its full potential for public health. By engaging technologists, members of the scientific and medical community and the public in creating tools with open data repositories, funders can exponentially increase utility and value of those data to help solve pressing national health issues. The LitCoin Natural Language Processing (NLP) Challenge seeks to spur innovation by rewarding the most creative and high-impact uses of biomedical, publication-free text to create knowledge graphs that can link concepts within existing research to allow researchers to find connections that may have been difficult to discover without them. This challenge is part of a broader conceptual initiative at NCATS to change the “currency” of biomedical research. NCATS held a Stakeholder Feedback Workshop in June 2021 to solicit feedback on this concept and its implications for researchers, publishers and the broader scientific community.This challenge brings together government, medical research communities and data scientists to create data-driven knowledge graphs that consolidate medical scientific data across domains. With an approximately four (4)-month development cycle for the challenge, data scientists will be challenged to develop NLP systems with the ability to identify concepts from a biomedical publication and link them together into relationships to create well-linked and carefully defined knowledge graphs for each publication. To learn more about the LitCoin NLP Challenge and to sign up as a participant, visit https://bitgrit.net/competition/13?utm_source=NCATS&utm_medium=organic&utm_campaign=litcoin.Back to TopThe ProblemBiomedical researchers need to be able to use open scientific data to create new research hypotheses and lead to more treatments for more people more quickly. Reading all of the literature that could be relevant to their research topic can be daunting or even impossible, and this can lead to gaps in knowledge and duplication of effort. Transforming knowledge from biomedical literature into knowledge graphs can improve researchers’ ability to connect disparate concepts and build new hypotheses, and can allow them to discover work done by others which may be difficult to surface otherwise.To advance some of the most promising technology solutions built with knowledge graphs, the National Institutes of Health (NIH) and its collaborators are launching the LitCoin NLP Challenge. This challenge aims to (1) help data scientists better deploy their data-driven technology solutions towards accelerating scientific research in medicine and (2) ensure that data from biomedical publications can be maximally leveraged and reach a wide range of biomedical researchers; together this will drive toward solutions for the critical problems these scientists aim to solve.Back to TopChallenge GoalsThe challenge will spur the creation of innovative strategies in NLP by allowing participants across academia and the private sector to participate in teams or in an individual capacity. Prizes will be awarded to the top-ranking data science contestants or teams that create NLP systems that accurately capture the information denoted in free text and provide output of this information through knowledge graphs.NCATS will share with the participants an open repository containing abstracts derived from published scientific research articles and knowledge assertions between concepts within these abstracts. The participants will use this data repository to design and train their NLP systems to generate knowledge assertions from the text of abstracts and other short biomedical publication formats. Other open biomedical data sources may be used to supplement this training data at the participants’ discretion. In addition to creating these assertions, successful participants’ NLP systems should be able to recognize which assertions are novel findings that represent the fundamental reason that the manuscript was published, as opposed to background or ancillary assertions that can be found elsewhere.Back to TopStatutory Authority to Conduct the ChallengeNCATS is conducting this challenge under the America Creating Opportunities to Meaningfully Promote Excellence in Technology, Education, and Science (COMPETES) Reauthorization Act of 2010, as amended [15 U.S.C. § 3719].NCATS was established to coordinate and develop resources that leverage basic research in support of translational science and to develop partnerships and work cooperatively to foster synergy in ways that do not create duplication, redundancy and competition with industry activities. This challenge will spur innovation in NLP to advance the field and allow the generation of more accurate and useful data from biomedical publications, which will enhance the ability for data scientists to create tools to foster discovery and generate new hypotheses. This promotes the development of resources for basic science research, as well as developing partnerships with software designers in the NLP space.Back to TopRules and Submission RequirementsWho Can ParticipateThis challenge is open to all U.S. citizens and permanent residents and to U.S.-based private entities. Private entities not incorporated in or maintaining a primary place of business in the U.S. and non-U.S. citizens and non-permanent residents can either participate as a member of a team that includes a citizen or permanent resident of the U.S., or they can participate on their own. However, such non-U.S. entities, citizens, and non-permanent residents are not eligible to win a monetary prize (in whole or in part). Their participation as part of a winning team, if applicable, may be recognized when the results are announced. Similarly, if participating on their own, they may be eligible to win a non-cash recognition prize.What to SubmitParticipants must sign up for this competition through a joint page created by the challenge administrator, CrowdPlat, and its partner, bitgrit.To sign up, participants must use the following link: https://bitgrit.net/competition/13?utm_source=NCATS&utm_medium=organic&utm_campaign=litcoin.PART 1: Participant InformationFor individuals:Provide contact information, including name, phone number, email address, and employer or academic institution (if applicable).For participants signing up as a team or for private entities:Lead Individual: Provide contact information, including name, phone number, email address, and employer or academic institution (if applicable) for the individual who will serve as Team Lead.Contributors: List the individuals that will contribute to the technical team that builds the final product. For each individual, please provide their name, email address, employer or academic institution (if applicable), and role in developing the product.PART 2: Project DescriptionChallenge Participants who are in the top fifteen (15) participants on the public leaderboard at the conclusion of the challenge period must submit a model summary through a webform which will be provided by bitgrit at the time that the participant is requested to submit their source code for evaluation. This summary will include the following sections:Background: Provide your professional/academic background and any prior experience that your team had which may have helped you succeed in this competition.Summary of Submission: Provide a short summary of how your tool works and how you feel it may impact the field of natural language processing in biomedical science.Data Processing: Provide what data, if any, were used to train your system other than those provided by the challenge management team, why you felt that this data would help improve your tool’s performance, and details on how your processed this data for incorporation.Features Selection: Provide what you feel are the most important features of your tool, and what you believe will distinguish it from other competitors’ tools.Training method: Provide what training methods you used here and any important weights and parameters which went into this training.User Interaction: Did your team include any user-centered design in your development process, and if so, how was this accomplished?Interesting Findings: Provide any interesting and/or innovative aspects of your tool that may set it apart from others in the competition, and any interesting relationships within the data as you were training the system.Model Execution Time: Provide information on how long it takes to train your system and how long it takes to generate results.References: Include citations to articles, websites, blog posts, and any other appropriate external sources of information.Future Steps: If you were continue work on this problem, what would you do next?Additional Submission Guidelines and RequirementsApplications must be written in English and follow all page limits and documentation specifications (as noted above, for Part 3, this must be single-spaced, minimum 11-point font, 1-inch margins, page dimensions of 8.5 x 11 inches, submitted as a .doc/.docx or PDF file).Any material that does not follow the submission guidelines provided may not be considered.Applicants must submit a working natural language processing system that uses open biomedical data to address the challenge described above.“Working product” indicates that the intended features of the product have been created and currently are functional and usable by NCATS upon delivery of the final product.The product must be capable of being installed successfully and running consistently on the platform for which it is intended and must function as depicted or expressed in the text description.Applicants must:Demonstrate participation eligibility at the time of signing up for the challenge. (For eligibility criteria, see the LitCoin NLP Challenge Terms and Conditions page, linked below.)Provide final products that use provided competition data, data schema, or data standards. Submissions that fail to do so are not eligible for this competition.Read the LitCoin NLP Challenge Terms and Conditions.Back to TopJudging CriteriaThis competition will run in two phases, with a defined task for each phase. The first phase will focus on the annotation of biomedical concepts from free text, and the second phase will focus on creating knowledge assertions between annotated concepts. During the competition, each submission will be tested using an automated custom evaluator which will compare the accuracy of results from provided test data with the results from industry standard natural language processing applications to create an accuracy score. This score will be continually updated on a public scoreboard during the challenge period, as participants continue to refine their software to improve their scores. At the end of the challenge period, participants will submit their final results and transfer the source code, along with a functional, installable copy of their software, to the challenge vendor for adjudication.Source code submissions will be evaluated for compliance to competition rules by the CrowdPlat and bitgrit team on the following criteria:Quality of codeScore reproducibilityAppropriate code documentationNo code was plagiarized from another groupScores from these two phases will be combined into a weighted average in order to determine the final winning submissions, with phase 1 contributing 30% of the final score, and phase 2 contributing 70% of the final score. Submissions with the highest final scores at the end of the challenge that pass the above quality control evaluations will be directly evaluated by judges from federal agencies as well as potentially from non-governmental organizations, with expertise in technology, open data, product development, community engagement and user-centered design . These judges will evaluate the submissions for originality, innovation, and practical considerations of design, and will determine the winners of the competition accordingly.Back to TopPrizesTotal Cash Prize PoolThis is a single-phase competition in which up to $100,000 will be awarded by NCATS directly to participants who are among the highest scores in the evaluation of their NLP systems for accuracy of assertions.Prize BreakdownA total of up to $100,000 will be awarded by NCATS to the top performers of this challenge.At this stage, NCATS anticipates that cash prizes will be awarded to seven (7) of the top performing NLP systems as follows:First prize: $35,000Second prize: $25,000Third prize: $20,000Four runner-up prizes: $5,000 eachIn the case that a team, entity or individual who does not qualify to win a cash prize is selected as a prize winner, NCATS will award said winner a recognition-only prize.NCATS may choose to award different cash prize amounts, or no prize at all, at their discretion.Cash prizes awarded under this challenge will be paid by electronic funds transfer and may be subject to federal income taxes. The U.S. Department of Health and Human Services and NIH will comply with the Internal Revenue Service withholding and reporting requirements, where applicable.Back to TopHow to EnterTeams or individuals interested in signing up for the challenge must sign up through our challenge platform partners, CrowdPlat and bitgrit, using the URL that is provided above. The challenge platform will provide full competition details including but not limited to:Challenge DescriptionParticipation RulesChallenge TimelinePrize StructureSubmission GuidelinesEvaluation CriteriaAlgorithm Selection ParametersOnce the competition is complete, some participants will be required to submit their source code through the platform for evaluation.Back to TopAcknowledgementsWe would like to thank Dr. Zhiyong Lu, Senior Investigator at the National Library of Medicine (NLM) Intramural Research Program and his entire research team, as well as their collaborator Dr. Cecilia Arighi, Research Associate Professor in the Department of Computer and Information Sciences at the University of Delaware, for providing annotated data sets for use in the execution of this challenge.Point of ContactHave feedback or questions about this challenge? Please reach out to Tyler Beck at litcoin-questions@mail.nih.gov.Back to Top	A challenge to create unique and innovative solutions to find biomedical concepts in free text and connect them into accurate knowledge statements.		LitCoin Natural Language Processing (NLP) Challenge	A challenge to create unique and innovative solutions to find biomedical concepts in free text and connect them into accurate knowledge statements.		LitCoin Natural Language Processing (NLP) Challenge
21586	CTSA Program Diversity, Re-entry and Reintegration Supplements	p { color: rgb(51, 51, 51); } h2 { font-size: 26px; } .info-box { background-color: #E3EBED; padding: 20px; margin-bottom: 20px; } .info-box > p:first-child { margin-top: 0; } .info-box > p:last-child { margin-bottom: 0; } .info-box > .header { font-weight: bold; color: #30787D; font-size: 18px; text-decoration-color: #30787D; line-height: 22px; } .table-title { background-color:rgb(255, 190, 76); /* background-color: rgb(0, 100, 120); / border-bottom: 1px solid white !important; font-size: 18px; text-align: center; } .left-header, .right-header { border-bottom: 1px solid white !important; font-size: 16px; text-align: center; } .left-header { background-color:rgb(255, 190, 76); / background-color: rgb(0, 100, 120); / width: 14%; } .right-header { background-color:rgb(255, 234, 194); / background-color: #E3EBED; / } .table > tbody > tr > th { text-align: center; } .table > tbody > tr > td { text-align: left; } .footnote { font-size: 12px; } .panel-heading, p>strong, li>strong { color: #333; } .panel-heading { color: #fff !important; background-color: #006478 !important; / background-color:rgb(255, 190, 76) !important; / padding: 5px 15px; } .panel-heading h2 { font-size: 20px; } .panel-body > .collapse { margin-bottom: 12px; } .panel-body > .collapse, .panel-body > .collapsed, .panel-body > .collapsing { padding: 6px; background-color: #f9f9f9; border-color: rgb(221, 221, 221); border-style: solid; border-width: 1px 0 1px 0; } .panel-body > .collapse > .table, .panel-body > .collapsed > .table, .panel-body > .collapsing > .table { background-color: white; } ul.chev-list { list-style: none; } / ul.chev-list a { text-decoration: none; color: rgb(51, 51, 51); } */ ul.chev-list .chev-list-toggle:before { font-family: 'Glyphicons Halflings'; content: "\e114"; transition: transform 0.75s; float: left; color: rgb(51, 51, 51); margin-left: -17px; font-size: 12px; } ul.chev-list .chev-list-toggle.collapsed:before { transform: rotate(-90deg); } ul.chev-list div.collapse, ul.chev-list div.collapsed, ul.chev-list div.collapsing { background-color: #f9f9f9; border-color: rgb(221, 221, 221); border-style: solid; border-width: 1px 0 1px 0; } ul.chev-list div ul:first-child { padding-top: 6px; padding-bottom: 6px; padding-right: 10px; } ul.chev-list div p { padding-left: 30px; padding-right: 10px; margin-top: 12px; } ul.chev-list div p:first-child { padding-top: 6px; margin-bottom: 0; margin-top: 0; } CTSA Program Diversity, Re-Entry and Reintegration Supplement Awardee Profiles Learn more about the success stories of outstanding clinical and translational scientists who have benefited from NCATS CTSA Program Diversity and Re-entry and Reintegration research supplements. NCATS CTSA Program Statement on Diversity — Great Minds Think Differently. Advancing the burgeoning field of translational science relies on a highly skilled, creative and diverse translational science workforce. The NCATS CTSA Program is committed to ensuring that the translational science workforce is broadly representative across racial, ethnic, sex, gender, age, socioeconomic, geographic and disability status (see Notice of NIH’s Interest in Diversity NOT-OD-20-031 and NOT-OD-22-019). While there are many benefits of a diverse scientific workforce, key among them is the ability to enhance scientific innovation through different perspectives, creativity and individual talents. Translation is a team sport. Promoting and enhancing diversity in science is critical to successful translation and contributes to NCATS’ CTSA Program ultimate goal of getting more treatments to all patients more quickly. Overview of NCATS CTSA Program Diversity, Re-entry and Reintegration Supplements See More NCATS CTSA Diversity, Re-Entry and Reintegration Supplements at a Glance Topic Description Submission Deadlines September 15 (or the following business day if September 15 falls on a holiday or weekend) Programs Diversity Supplements (PA-21-071) provide funding (salary, fringe benefits, travel, and supplies) to improve the diversity of the research clinical and translational science workforce by recruiting and supporting graduate and health professional students, post-doctorates and/or investigators developing independent research careers from diverse backgrounds, including those from groups that have been shown to be underrepresented in health-related research. Allowable costs under this program also include reasonable accommodations—such as specialized equipment, assistive devices, and personnel—to allow individuals with disabilities to perform the essential functions associated with their proposed project. Re-Entry and Reintegration Supplements (NOT-OD-21-134) provide funding (salary, fringe benefits, travel, and supplies) to support individuals with high potential to re-enter an active research career after an interruption for family responsibilities or other qualifying circumstances. The Reintegration program specifically addresses the need to provide individuals who are affected by unsafe or discriminatory environments as a result of harassment to transition to safer, supportive research environments. NCATS will accept up to two applications under the Diversity supplement and two applications under the Re-Entry and Reintegration research supplement for review consideration during a fiscal year from any one CTSA Program hub award. Clinical Trial Independent or ancillary clinical trials are not allowed. Applicants are permitted to propose research experiences and activities in clinical trials led by a mentor or co-mentor. Visit this link to determine whether the applicant’s proposed project would be considered a clinical trial. Parent Grant The NCATS CTSA UL1 and UM1 are the only eligible parent grants for Diversity, Re-entry and Reintegration supplements associated with the CTSA program. The parent grant must have at least two years of active status left at the time of supplement application. Supplements are not considered for grants in a no-cost extension. Candidates Consistent with the Notice of NIH’s Interest in Diversity (NOT-OD-20-031), eligibility for the Diversity Supplement program includes candidates from groups that are underrepresented in the biomedical, clinical, behavioral and social sciences, such as, individuals from underrepresented racial/ethnic groups, individuals with a disability, or from disadvantaged backgrounds. The NCATS CTSA Program accepts Diversity, Re-entry and Reintegration supplement applications to support pre-doctoral, postdoctoral, and eligible new investigator candidates who are developing their independent research careers. Candidates must be U.S. citizens or permanent residents at the time of application. Award Budget Varies based on the career level of the candidate Award Duration 2 years In alignment with the respective funding opportunity announcements (PA-21-071) and (NOT-OD-21-134), the NCATS CTSA Program's Diversity, Re-Entry and Reintegration programs are not intended to provide additional or alternative means for supporting individuals who are receiving funding from other Public Health Service (PHS) sources. Removing an individual from current PHS funding does not confer eligibility for support. The only exception is where current funding is term-limited and does not exceed 6 months in its entirety. Details specifying current PHS funding must be included, e.g., in the candidate eligibility statement, at the time of submission of the supplement application. Supplements are one of many possible options for mentoring and developing careers of candidates who are underrepresented in the health-related research workforce. Therefore, the Program Director /Principal Investigator (PD/PI) should consider all potential sources, federal and non-federal, of support for a candidate, including KL2/K12 and TL1/T32 appointments. Graduate students, postdoctoral fellows, and faculty trainees should be encouraged to submit independent applications for fellowships (e.g., F31, F32), career development awards (K awards), or research project grant applications as appropriate. Application Procedures See More Applications must be submitted electronically as described in PA-21-071 and NOT-OD-21-134. Prepare applications using the SF424 (R&R) forms associated with the chosen package. Please note that some forms marked optional in the application package are required for submission of applications for this announcement. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate required and optional forms, with the following additional guidance: R&R Cover Form Select “Revision” in the “Type of Application” field. Application Information Guidance Project Title Enter title of the proposed research project conducted by the Diversity/Re-Entry/Reintegration supplement candidate. Do not enter the project title of the UL1/UM1 award. Example: Individual and Environmental Risk Factors for Injuries among Hispanic Adolescents—[Insert Candidate First Name and Last Name] Project Period If awarded, the budget period for the supplement will sync with the budget period of the parent grant (e.g., UL1 or UM1 award) during the first 12 months. For example, if the parent grant budget period ends on June 30 of each year, and the supplement is awarded starting March 1, then the first budget period of the supplement will be only 4 months, March 1 – June 30 of the same year, and the second budget period will be a full 12 months, July 1 – June 30 (of the next year). In addition, please note that any one budget period must be 12 months or less. Please configure your budget request accordingly. Senior/Key Personnel List the PD/PI of the UL1/UM1 award as the first person (regardless of their role on the supplement activities). The UL1/UM1 award principal investigator should have the role category of “PD/PI.” List the Diversity/Re-Entry/Reintegration candidate to be supported through this supplement as the second person. Select “Other” for the Project Role and enter “Candidate” in the Other Project Role Category. Do not include other Sr/Key persons from the parent project unless they are directly involved in the candidate's research directly involved in the candidate's research or training experience. Candidates for supplement support must have an eRA Commons account and the candidate's Commons Username must be entered in the Credential field. Under the Degree field, designate the candidate's current educational/career level using one of the abbreviations from the bulleted list below (e.g., “Grad” for a predoctoral candidate). Enter the relevant abbreviation and no additional text. Because a candidate's compensation level is determined by his or her current educational/career level, this information is required. Grad – Predoctorate PD – Postdoctorate Fac – Faculty In keeping with NIH's goal of gaining a better understanding of the size and characteristics of the biomedical research workforce, described in NOT-OD-13-097, Diversity supplement candidates are encouraged to provide demographic and educational or applicable degree information in their eRA Commons Personal Profiles. Project Summary/Abstract (Description) (not to exceed 1 page) Summary or abstract of the funded parent award or project. A separate project summary of the parent award and for the Diversity/Re-Entry/Reintegration project can be included, but together cannot exceed 1 page. Project Narrative (not to exceed 3 sentences) Describe the relevance of this research to public health in, at most, three sentences. For example, applicants can describe how, in the short or long term, the research would contribute to fundamental knowledge about the nature and behavior of living systems and / or the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. Research Plan (not to exceed 10 pages) Overall, the candidate’s strengths and weaknesses and short- and long-term goals should be stated in the Research 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 Research Plan should also provide a brief overview of the CTSA Program resources the candidate will use and a plan for how they will be incorporated into their research training plan. Specific Aims (not to exceed 1 page): Description of the Specific Aims of the entire supplement, including the career development aims. Research Strategy (not to exceed 4 pages): Description of the candidate’s proposed research strategy within the scope of the funded parent award or project. Organize the Research Strategy section using the following sections: Significance, Research Aims, Innovation and Approach. Applicants are encouraged to use NIH’s guidance for fellowships or career development applications. Mentoring Plan (not to exceed 3 pages): A mentoring plan for the candidate must include a plan for the candidate to contribute intellectually to the research; to enhance the candidate’s research skills and knowledge regarding the selected area of biomedical, behavioral, clinical or social sciences; and to interact with other individuals on the parent UL1/UM1 grant that will contribute to their research and career development plan. It also must provide evidence regarding translational research in the selected areas of biomedical, behavioral, clinical or social sciences. In addition, the Mentoring Plan must demonstrate that the CTSA Program UL1/UM1 PD(s)/PI(s) are willing to provide appropriate mentorship. The mentoring plan must include a description on developing an individual development plan for the candidate (see NOT-OD-14-113). The selected mentor(s) should be an active investigator in the area of the proposed research, committed to the career development of the candidate, and able to directly supervise the candidate’s research. Candidates are encouraged to identify more than one mentor, (i.e., a mentoring team [or advisory committee]), because this is deemed advantageous for providing expert advice in all aspects of the research career development plan. Additionally, a plan for the candidate’s next source of funding is required. Objectives for helping the candidate transition to the next stage of his/her research career (e.g., routine meetings, supervision in writing, publishing, etc.). Details of the mentor-candidate interactions: The plan should go well beyond simple supervision plans or stating that the candidate will attend seminars or meetings. The career development plan should be structured, specific and stage-appropriate for the candidate and include parameters, such as the frequency of meetings, topics to be discussed, and how progress will be monitored. Summary of mentoring experience of the CTSA Program UL1/UM1 PI and selected mentors (not to exceed 1 page). If a team of mentors is proposed, the team structure should be well-justified for the mentored training plan and the roles of the individual members appropriate and clearly defined. A timeline for the research and career development experiences proposed (not to exceed 1 page). Include an individualized career development plan that is consistent with the goals described in candidate’s personal statement, the candidate’s short- and long-term career aspirations, and the proposed mentored research experiences. A timeline in Gantt-style format delineating specific research milestones and other activities that will facilitate progress toward independent research funding (i.e., anticipated publications, grantsmanship workshops, timeframe for grant application submissions) is strongly encouraged. Grant applications should be career stage-appropriate (see Choose an Award by Career Stage). Project/Performance Site Locations Include the primary site where the proposed 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. 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 biosketch of the PI and mentors should include: A personal statement that describes a commitment to (1) diversity, (2) training, mentoring and promoting inclusive and supportive scientific research environments, and (3) supporting mentee participation in activities required to identify and transition into careers in the biomedical research workforce that are consistent with the mentees’ skills, interests and values. Include a table of current and previous mentees, their degree(s), career level at time of mentorship, and their subsequent career/professional outcomes. Inclusion of the percent of individuals mentored whose background is consistent with the Notice of NIH’s Interest in Diversity (NOT-OD-20-03) is encouraged. The primary mentor should have a successful track record of mentoring individuals at the candidate’s career stage and be appropriate for the needs of the candidate. Evidence of scientific achievement or interest. Any source(s) of current funding. The biosketch of the candidate should include: Research experience that demonstrates the candidate’s translational science research interest and experience. Include published manuscripts and those in preparation. If Re-Entry, the length of and reason for any career hiatus and a description of how the candidate has kept current or attempted to keep current in their field. Research objectives and career goals: The candidate should discuss how the planned activities are related to or will facilitate achievement of their future career goals, outlining his/her short- and long-term research objectives and include evidence of scientific achievement or interest in the area of clinical and translational science research. All candidates must provide their ORCID iD (Open Researcher and Contributor Identifiers) to allow for greater long-term tracking of applicants. (Additional information about the ORCID iD can be found at NIH NOT-OD-19-109.) The ORCID iD should be placed in the Contributions in Science section. 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 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 1 page) A signed statement from an institutional official establishing the eligibility of the candidate for support under this program. The statement must include: Citizenship: Clearly presented information on citizenship of the candidate. Supplement awards 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 Permanent Resident Card, Form I-551) or some other legal evidence of admission for permanent residence at the time of application. Eligibility under the funding opportunity: A description of how the appointment of this specific candidate would further the goals of the Diversity, Re-Entry or Reintegration Supplement funding opportunities (NOT-OD-21-134 or PA-20-222). The strength of this statement will be considered by the NIH administrative review committee along with all other material provided. 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 Diversity supplements: The statement must clearly establish the basis (e.g., race, ethnicity, disability, or disadvantaged status) for the candidate’s eligibility as an individual from an underrepresented background consistent with the Notice of NIH’s Interest in Diversity (NOT-OD-20-031). Institutions are encouraged to identify candidates who will enhance diversity in the biomedical research workforce. 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. Eligibility for Re-Entry supplements: The statement must describe the nature and duration of the career interruption. 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: The statement must certify eligibility consistent with the notice and state that a new, safe research environment has been identified for the candidate. 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 to continue research training as soon as a new and safe research environment has been identified. Protected time: A statement indicating that the candidate would receive a minimum of 75% protected time. As a reminder, 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. Career level: Intended academic/career level of the candidate during the requested supplement support. For candidates who are investigators developing independent research careers, the institution should include the position of the candidate, including the title, the duration, a brief description and any institutional commitment. Other Project Information IRB and IACUC: 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/UM1 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/UM1 and the Subsite PD/PI, and the appropriate institutional business official. Reasonable Accommodations: 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 the accommodation might be used. The relationship of the proposed accommodation to the proposed project must be described. Review and Funding See More Review Process Applications are administratively reviewed by NCATS program staff. Program staff will examine the appropriateness of the research project, career development plan and mentorship as they relate to the candidate’s career goals. The strength of the PI/PD’s demonstrated commitment and contributions to enhancing diversity, equity, inclusion and accessibility in the biomedical sciences will be considered. Applications will also be reviewed for relevance to the NCATS mission to transform the translational science process and the goals of the CTSA program. In addition, a second level of review is conducted by NCATS and DCI leadership before final funding decisions are made. Decisions will be based on the potential of the proposed research and mentorship to enhance the candidate’s professional development, program balance and availability of funds. In general, NCATS will make funding decisions within 12 weeks of the published receipt date (September 15). During fiscal years when NIH is operating under a continuing resolution, there may be a delay in funding decisions. Applicants receive notification of administrative supplement funding approval via an official Notice of Award. Supplement award decisions are not appealable. No announcement or commitment of funding support should be made prior to receipt of the official Notice of Award. The program official of the parent grant will notify the PDs/PIs on applications that are not approved for funding and may provide application feedback, upon request. Considerations for Prioritizing Applications Is the training and mentoring plan specifically tailored to the needs of the candidate? What is the potential impact and added value of the supplement to the candidate’s training, mentoring and career development experiences? Is the research project considered clinical and translational science? Are the proposed research question, design and methodology of significant scientific and technical merit? Is the research plan relevant to the candidate’s research career objectives? Is the research plan appropriate for the career stage? Is the plan appropriate for advancing the candidate in a research career in clinical and translational science? Can the supplement project feasibly be performed within the proposed time frame? What is the likelihood that the proposed career development and research plan will enhance the candidate’s potential for a productive, independent scientific research career in clinical and translational science? What is the mentor’s commitment to mentees’/trainees’ scientific and professional development and career progress within the biomedical research enterprise? What is the degree to which the mentor engages in mentoring especially involving groups underrepresented in biomedical research? Does the mentor engage in service-oriented efforts beyond the needs of their own research programs? Has the mentor received awards or recognition for outstanding mentorship? Are there demonstrable positive outcomes and a meaningful impact of mentoring? Strength of prior training and how it relates to the objectives and long-term career plans of the candidate. Does the candidate have the potential to develop as an independent and productive clinical and translational science researcher? How well does prior training relate to the candidate’s current objectives and long-term career plans? How well will the candidate be integrated in the hub’s infrastructure? To what extent will the candidate interact with key investigators? Hub‘s commitment to enhancing diversity, equity, inclusion and accessibility in the biomedical sciences, and any past or present leadership, mentoring and outreach activities to enhance diversity, equity, inclusion and accessibility, especially involving groups underrepresented in the biomedical research enterprise. Strength of the hub’s demonstrated contributions to enhancing diversity, equity, inclusion and accessibility in the biomedical sciences. Frequently Asked Questions (FAQs) See More Eligibility 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 wish to pursue a career in clinical and translational science research. Principal investigators of UL1/UM1 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, UM1, 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? According to NIH’s Interest in Diversity notice, women are underrepresented at senior faculty level in biomedical fields. Applicants must provide a convincing case that women are underrepresented at the candidate’s career stage and in their field of study (e.g., physics, chemistry, computer science, surgery). 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 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/UM1 PD/PI should contact NCATS program staff to discuss such a situation before submitting an application for a Diversity supplement. How does the availability of KL2/K12 or TL1/T32 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/K12) and to Institutional Training Awards (TL1/T32) as these provide a clear, mentored program and strong oversight for training students. As both the KL2/K12 and the TL1/T32 components require plans for recruitment and retention to enhance diversity it would be expected that programs would attempt to fill KL2/K12 and/or TL1/T32 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/K12 or TL1/T32 number of scholars or trainees approved by NCATS Advisory Council; however, the supplement may not be awarded if the KL2/K12 or TL1/T32 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/K12 or TL1/T32. It is possible that the timing of appointments and the applicants’ availability may restrict the appointment on the KL2/K12 and/or TL1/T32 and the supplement may be used prior to or instead of the appointment on the KL2/K12 and/or TL1/T32. There may be other situations that may be justified. If there are unused slots on the KL2/K12 or TL1/T32 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/UM1 cooperative agreements are eligible for Diversity supplements. Institutional Career Development Core (KL2/K12) Training Core (TL1/T32) 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/UM1 PI to apply. Supplements to CCIA grants will not be considered. Overall Application Questions Who submits the application, the person to be supported or the PI of the grant? The CTSA Program UL1/UM1 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 12 weeks, 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 12 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/ UM1 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 supplement, two Re-Entry, and two Reintegration supplement applications. However, there should be only one candidate for each application. Applicants are encouraged to alert the PO and Grants Management Specialist once the application has been submitted. Will NCATS consider supporting more than one diversity, re-entry and Reintegration 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 from any one CTSA Program hub award, for each of the diversity, re-entry and Reintegration Supplements for review consideration during a fiscal year. Budget 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 much time can be requested for a supplement candidate? The request cannot exceed the length of time remaining for the UL1/UM1 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. Can a PI's/mentor’s salary be requested on a Diversity Supplement/ Re-Entry/ Reintegration 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. Mentors and Mentoring Plan Who would be an eligible mentor under the UL1/UM1 cooperative agreement? The CTSA Program UL1/UM1 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/K12 and/or TL1/T32 programs, 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, 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 provide 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, re-entry and Reintegration 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. Research Strategy The UL1/UM1 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 conduct 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, KL2/K12 or TL1/T32 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. 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 NCATS review of the research. See the parent funding opportunity for further instructions about required supporting documentation. Other How should a Supplement awardee be supported once the 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 Supplement? 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 candidate's personal statement? The candidate should describe their long-term education and career goals and why they wish to pursue a research career in clinical and translational science. What are the chances of success in obtaining funding? Applications that are considered to be strong have a high success rate. However, the supplement programs are competitive programs and there may be more applications than funds available. Contact Information Prospective applicants and their mentors are strongly encouraged to contact their respective NCATS program officer and/or the scientific contact listed below during the initial preparation of a supplement application and prior to its submission to discuss the goals and objectives of the supplement application. Scientific Contact: Andrew Louden, Ph.D. Grants Management Contact: Leslie Le 301-435-0856 function toggleText(pn) { var elem = document.querySelector(pn); if (elem.textContent === 'See More') { elem.textContent = 'See Less'; } else { elem.textContent = 'See More'; } }	The supplements promote diversity in health-related research, re-entry, and reintegration into research careers.	/sites/default/files/diversity_reentry_reintegration_landing_social-image_400x400.jpg	CTSA Program Diversity, Re-entry and Reintegration Supplements	The supplements promote diversity in health-related research, re-entry, and reintegration into research careers.	/sites/default/files/diversity_reentry_reintegration_landing_social-image_400x400_0.jpg	CTSA Program Diversity, Re-entry and Reintegration Supplements
21240	CTSA Program UM1 Budget Request Tables (old content type)	CTSA Program PAR-24-272 Application InformationDetermination of Allowable Budget Request AmountCTSA UM1 hub applications submitted in response to PAR-24-272 must be submitted by a single applicant institution, plus the option of one or more partnering institutions and one or more collaborating institutions.As per PAR-24-272:Collaborator/Collaborating Institution(s): Have a significant role in one or more aspects of the CTSA UM1 hub and may be included in more than one CTSA UM1 hub application. For the purposes of this NOFO, NIH funding to the collaborating institution is not included for determination of maximum direct cost budget requests.Partner/Partnering Institution(s): Must be effectively integrated into the proposed activities of the CTSA UM1 hub are necessary for attaining its strategic goals and research priorities. A Partnering Institution may be included as a partner in only one CTSA UM1 hub application. For the purposes of this NOFO, NIH funding to the partner/partnering institution is used for determination of maximum direct cost budget requests.Applications to PAR-24-272 must include the following Other Attachment in the SF424(R&R) Other Project Information “Information on Hub Partners and Collaborators”. This other attachment provides a table listing all partnering and collaborating institutions with contributions and justifications for the participation of each; justifications must be commensurate with the specified role. (See: CTSA Program Summary Data Guide.)For the purposes of PAR-24-272, NIH funding to the Partner/Partnering Institution must be included for determination of maximum direct cost budget requests. Partner/Partnering Institution(s) must be effectively integrated into the proposed activities of the CTSA UM1 hub and are necessary for attaining its strategic goals and research priorities. An organization named as Partner/Partnering Institution in a CTSA UM1 application including a subsequent UM1 award (under either PAR-21-293 or PAR-24-272), or a CTSA UL1 award funded previously under PAR-18-940, PAR-18-464 or PAR-15-304 may be listed as a Partner with only one UM1 or UL1 unless the UM1 and UL1 are from the same organization.The list of Institutions that are partners of CTSA Program hubs in FY24 are the following:CTSA Partner List - FY24 (PDF - 98KB)An organization named as a Partner Institution in a CTSA UM1 application, UM1 award, or a CTSA UL1 award funded previously under PAR-18-940, PAR-18-464, PAR-15-304 or PAR-21-293, may not apply as an applicant organization to PAR-24-272 under the following scenarios:While the UM1 or U54 application on which they are listed as a Partner is under review considerationWhile the UM1or U54 application on which they are listed as a Partner is under consideration for fundingWhile the UM1 or UL1 award on which they are listed as a Partner is fundedCTSA UM1 applications from organizations named as a Partner Institution in a funded CTSA UM1 or CTSA UL1 award are not allowed, except under rare circumstances with compelling justification.The maximum direct cost amount (DC) that may be requested for the UM1 budget is based on the sum of two NIH funding components: A) 5-year average of the most current NIH DC funding of the applicant institution, plus B) 5-year average of the most current NIH DC funding of any partner(s).CTSA UL1 award recipients funded previously under PAR-18-940, PAR-18-464, PAR-15-304 or RFA-TR-12-006, may request the appropriate tiered UM1 threshold shown on Table B but will not receive more than a 5% reduction in DC annual support for the core hub responsibilities (UM1) relative to the last budget period of the previous competitive project period of their UL1 award, exclusive of administrative supplements/competitive revisions and subaward F&A. Thus, those CTSA UL1 award recipients whose UM1 DC Tier calculation is more than a 5% reduction in DC annual support may submit a budget request at 95% of the DC level of the last budget period of the previous competitive project period of their UL1 award, exclusive of administrative supplements/competitive revisions and subaward F&A.NIH aggregate fiscal year (FY) funding tables with the most current 5-year average of FY costs and the four maximum DC award tiers for CTSA UM1 hubs will be provided on an annual basis. Applicants are strongly encouraged to use the provided tables to generate a combined funding amount that defines their maximum DC amount allowable for the annual award (see PAR-24-272 for tiers). Applications for the following due dates must use the following tables:Application due datesMust Use TablesMust Use TablesMarch 13, May 28, Sept. 29, 2025A) Institutional NIH Direct Cost (DC) Funding Table FY19-23 and B) Maximum Direct Cost (DC) Budget Requests for CTSA UM1 hubsFY26 AwardsNote that:Applications received during a particular FY must use the same tables (as stated directly above). Table A: Institutional NIH Direct Cost (DC) Funding Table: Data is released by the NIH in late December of each year. NCATS will release Table A when the Institutional NIH DC Funding Table is available.Table B: Maximum Direct Cost (DC) Budget Requests for CTSA UM1 hubs: The four maximum DC award tiers for CTSA UM1 hubs will be provided on an annual basis. Verification of Funding Tier Calculation:Applicants are strongly encouraged to verify their funding tier calculation with NCATS in advance of application submission by sending an email to CTSA NOFO Questions. Applicants should list the primary applicant organization and any partner institution(s) that contribute to the funding tier calculation. Requests to verify the funding tier calculation should be submitted by the institution’s authorized organization representative. Once NCATS verification is received and recorded, the applicant should include a note in the R&R Budget Section of the application that NCATS has reviewed and accepted the funding calculation prior to submission.Applicants are strongly encouraged to use the following NOFO tables and information:FY26 Awards: For PAR-24-272 receipt dates March 13, 2025, May 28, 2025, Sept. 29, 2025: PAR-24-272Table A: Institutional NIH Direct Cost (DC) Funding Table FY19-23 (Excel - 160.72 KB)Table B: Maximum Direct Cost (DC) Budget Requests for CTSA UM1 hubs Size Eligibility Budget Tiers for NOFO Applicants(NOFO receipt dates March 13, 2025, May 28, 2025, Sept. 29, 2025)Maximum Direct Cost Budget Requests for UM1Hub Tier5-year average of the most current NIH Direct Cost (DC) Funding of the applicant institution, PLUS 5-year average of the most current NIH Direct Cost (DC) funding of any partner(s)*(based on FY2019-FY2023 NIH Funding data)UM1A>$385,000,000$6,500,000C$250,000,000 - $384,999,999$5,000,000T$175,000,000 - $249,999,999$3,600,000G<$175,000,000$2,600,000Notes about NIH Direct Cost (DC) Funding Table:The data contained in this table is imported directly from the NIH RePORT NIH Awards by Location & Organization webpage and consolidated and tabulated for your convenience. Instructions to manually download funding data for an individual organization are provided below. Applicants are free to verify table data via their own customized download; however, the 5-year funding average totals contained in this table must be used to calculate budget tier eligibility. If discrepancies exist between this table and your individual download, please notify NCATS Program staff immediately by sending an email to CTSA NOFO Questions.Organizations may have NIH funding listed under different names for different FY if organizational name changes have occurred. Applicants are reminded to review the contents of this table carefully to identify all former names associated with a parent organization. If name changes exist, your application should include a brief note in the budget justification explaining the current and former names that support its use in determining the application's eligible budget tier (see PAR-24-272 Section IV. Application & Submission Information, 2. Content and Form of Application Submission, R&R Budget, Award Budget).In rare instances, the dataset may include typos (e.g., added spaces, commas or abbreviations) in the Organization's Name. Again, applicants are reminded to thoroughly review this list to identify all funding components associated with parent and partner support.Data download instructions to Applicants: In order to download NIH Awards by Location & Organization funding data directly from NIH RePORT, applicants can go to the NIH RePORT webpage and filter by Fiscal Year and by Organization. Once the filter query is complete, applicants should click on the "Data" hyperlink to access and download a dataset containing Direct Cost amounts for individual NIH awards made to the specific organization during a particular fiscal year (FY). The data in Table A has been generated to consolidate and tabulate the NIH Direct Cost Spending amounts by organization and fiscal year. Institutional NIH Direct Cost (DC) Funding tables (Table A) for prior years may be found here:Institutional NIH Direct Cost (DC) Funding Table FY18-22 (Excel - 52KB)Institutional NIH Direct Cost (DC) Funding Table FY17-20 (Excel - 49KB)Institutional NIH Direct Cost (DC) Funding Table FY16-20 (Excel - 64KB)	CTSA Program UM1 Budget Request Tables for determining allowable budget request amount for CTSA Program PAR-21-293 Application Information		CTSA Program UM1 Budget Request Tables for CTSA Program PAR-21-293	CTSA Program UM1 Budget Request Tables for determining allowable budget request amount for CTSA Program PAR-21-293 Application Information		CTSA Program UM1 Budget Request Tables
21234	CTSA Program Summary Data Guide (old content type)	CTSA Program PAR-24-272 Application InformationPurposeFor use with PAR-24-272. The following "Other Attachments" must be included to aid in the review of applications. The filename provided for each attachment will be the name used for the bookmark in the application image. Except for Attachments 1&7, supportive data should be in a table format; applicants may use suggested Template Data Table formats described below or similar table formats that address all fields shown below; specified page limits apply to Template Data Table or similar table formats and Attachments 1&7 documents.InstructionsFor each document, please use a separate attachment and title as suggested. Required attachments should be uploaded only once. Information provided in the required attachments should not be repeated in the narrative. Applications that lack any specified attachment will be considered incomplete and will not be reviewed.Attachments 1-7Tables may be used to provide data on the capabilities and available resources for specific activities anticipated to be undertaken during the period of performance of the UM1 for attachments 2-6. Use of the Template Data Tables is optional but all fields must be addressed if another table format is used.Institution (use filename Hub Institution Organization): Include a description of the following in a single attachment: Provide 1) a chart/diagram indicating the hub’s organizational status within the institution and how the hub leadership is integrated within the institution and 2) a chart/diagram indicating the working relationships between the hub and included partnering institution(s).Hub’s Senior Leadership (use filename Hub Senior Leadership): Information and role of each Contact PD/PI, Other PDs/PIs, Module, and Program Leaders and Co-Leaders. Limited to ONE page. Template Data Table. Hub’s Senior Leadership - BLANK Template Data Table. Hub’s Senior Leadership - EXAMPLEInformation on Hub Partners and Collaborators (use filename Hub Partners and Collaborators): A table listing of all partnering and collaborating institutions with contributions and justifications for the participation of each; justifications must be commensurate with the specified role. Partnering institutions must be effectively integrated into the proposed activities of the CTSA UM1 hub and are necessary for attaining its strategic goals and research priorities. Collaborating institutions have a significant role in one or more aspects of the CTSA UM1 hub. Limited to THREE pages. Template Data Table. Information on Hub Partnering and Collaborating Institutions – BLANK Template Data Table. Information on Hub Partnering and Collaborating Institutions - EXAMPLEResources to Achieve CTSA Objectives (use file name Resources to Achieve CTSA Objectives): A table listing of SPECIFIC resources that are anticipated to be used during the performance period of the UM1. Limited to FIVE pages.Template Data Table. Resources to Achieve CTSA Objectives - BLANKTemplate Data Table. Resources to Achieve CTSA Objectives - EXAMPLEClinical Trial Experience (use filename Clinical Trial Experience): A brief description of all NIH–funded single and multi-site clinical trials with site activation during the 6 months up to and prior to the application from the hub and participating partners and collaborators. Limited to FIVE pages. Template Data Table. Selected Clinical Trial Experience - BLANK Template Data Table. Selected Clinical Trial Experience - EXAMPLEClinical and Translational Science Track Record (use filename CTS Track Record): Institution, partners, and collaborators’ accomplishments and progress in CTS research efforts and high impact achievements that are generalizable to the advancement of CTS over the past 5 years; emphasize those that have advanced better methods and/or improved health. Limited to FIVE pages. Template Data Table. Selected Clinical and Translational Science Track Record - BLANK Template Data Table. Selected Clinical and Translational Science Track Record - EXAMPLECoordination and Integration Plan (use filename Coordination and Integration Plan). The application must include a specific plan describing the partnership between the UM1, the required K12 and any optional components, such as the research education (R25), and/or pre-and post-doctoral training (T32) awards. The UM1 application must describe the overarching goals of each component and the coordination, integration, synergy, and mutual reinforcement of resources between the components. Include a description of the roles of any shared partners and/or collaborators. Limited to THREE pages.ol li {margin-bottom:1em;}	CTSA Program Summary Data Guide for CTSA Program PAR-21-293 application information.		CTSA Program PAR-21-293 Application Information	CTSA Program Summary Data Guide for CTSA Program PAR-21-293 application information.		CTSA Program PAR-21-293 Application Information

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