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Visit our collection of videos or browse our fact sheets and infographics to learn more about us and download them to share our resources and activities with others.

Videos

Watch our collection of videos to learn more about NCATS and get a behind-the-scenes look at our research activities.

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Videos

Our videos feature informative interviews with NCATS leadership and staff, inspiring patient stories, virtual lab tours, helpful grantee resources and more.

Visit the NCATS YouTube Channel

NCATS Infographics & Fact Sheets

View our fact sheets to learn more about us and download them to share our resources and activities with others.

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3-D Tissue Models

NCATS designs and helps develop 3-D tissue models to help researchers better predict which promising treatments will move from the lab to success in clinical trials in people.

Read About 3-D Tissue Models (PDF - 222KB)

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About NCATS

NCATS is speeding the translation of scientific discoveries into health solutions. The center supports a range of initiatives to achieve a future that offers more treatments for all people more quickly.

Read About NCATS (PDF - 177KB)

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Assay Guidance Manual

The Assay Guidance Manual is a free, best-practices online resource devoted to the successful development of robust, early-stage drug discovery assays.

Read About AGM (PDF - 228KB)

A researcher types into the computer screen “predict treatments for disease y.” The query is sent to the Translator’s Autonomous Relay Agents (ARAs) to determine how best to answer the query. The ARA will then break the query into smaller tasks that are transmitted to rich, specialty knowledge bases called Knowledge Providers (KPs). This process will be iterative, such that the ARAs and KPs can build on information from the others. The last sequence is the results of the query showing up on the computer screen of the researcher.

Biomedical Data Translator

This program brings together teams of experts from leading universities and research institutions to combine vast amounts of current medical research data and speed the development of new treatments.

Learn More About Translator Projects

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Clinical and Translational Science Awards (CTSA) Program

The CTSA Program supports a national network of medical research institutions that work together to improve the translational research process to get more treatments to all people more quickly.

Read About the CTSA Program (PDF - 344KB)

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Community Engagement

CTSA Program hubs work hand in hand with community leaders to build strong relationships, understand community needs and improve community health.

Read About Community Engagement Through the CTSA Program (PDF - 404KB)

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Congressional Justification

The budget for NCATS is based on the fiscal year appropriation provided by Congress and the U.S. President. The Congressional Justification provides Congress detailed estimates and justifications for research.

Read About the Congressional Justification (PDF - 843KB)

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Core Technologies

NCATS uses state-of-the-art resources and core technologies to enable the ongoing operation of all translational research activities happening at the Center.

Read About Core Technologies (PDF - 250KB)

Depiction of the drug development process as a metaphorical journey through a canyon with a central river. The process begins with selecting a drug candidate and assembling a multidisciplinary research team. The journey encompasses preclinical development through to investigational new drug (IND) application. The river emphasizes that equity, community engagement and patient advocacy run through all steps in the journey to New Drug Application (NDA). A kayak and canoe in the river indicate optional paths for repurposed or repositioned drugs. Key team members making the journey include Toxicology, (Tox) Chemistry, Manufacturing & Controls (CMC), Drug Metabolism and Pharmacokinetics (DMPK), Proof of Concept, (PoC) and Project Management (PM). After crossing the river, the team arrives at the pre-investigational new drug (pIND) milestone. Following directional signs for regulatory, IND-enabling activities, Good Laboratory Practice (GLP) Toxicology, and Good Manufacturing Practice (GMP) Drug Substance/Drug Product (DS/DP), team members climb up a cliff. When they arrive at the top, they are greeted by a helicopter representing the IND milestone. On distant canyon peaks, clinical trial Phases 1 through 3 are featured. A hot air balloon on the horizon symbolizes the ultimate NDA for approval for human use in clinical care.
Key Concepts and Ecosystem. 'Key Concepts Ecosystem' outlines essential functions and activities in preclinical research and development. The left side of the graphic is labeled “Key Concepts” and includes the following activities: Target Product Profile (TPP): A document describing the important features of a drug to effectively treat a disease in a specific population. The TPP helps guide preclinical development strategy. Regulatory Strategy: The steps and processes taken for a drug candidate to meet the requirements of regulatory agencies like the U.S. Food and Drug Administration during development and that safely allow for further testing in people. Good Laboratory Practice (GLP): The rules and guidelines that ensure the data collected during laboratory studies are high quality and trustworthy. Project Plan: A document that lists the key steps and research studies needed to develop a drug. It includes who is responsible for which steps, the overall timeline and important decision points along the way. Research Team: A group of researchers from multiple specialized fields (e.g., process chemistry, pharmacokinetics, toxicology) who work together to develop a drug. Clinical Plan: A document that outlines how a potential treatment will be tested in people. It proposes the type and number of participants, how the study will be conducted and what data will be collected. It informs the preclinical research project plan. Good Manufacturing Practice (GMP): The rules and guidelines that ensure a drug is produced safely and consistently and meets the highest quality-control standards. Reposition: Take a drug that has been developed to treat one condition — but has not yet been approved by a regulatory agency — and develop it to treat another. Repurpose: Take a drug that has already been approved by a regulatory agency to treat one condition and develop it to treat another. The right side of the graphic is labeled “Ecosystem” and includes a heading describing equity and the following elements and activities: Equity: Infusing equity in preclinical research and development creates an environment where all people can participate and can access and benefit from drug development and therapies. It also means the needs of historically underrepresented populations are considered and deliberate care is taken to avoid causing harm. Investing in equity-driven research enhances preclinical innovation by including diverse factors influencing health, such as genetics and environment. Resources: The funding, personnel, equipment and facilities required for drug development. Representation: The inclusion of the priorities and perspectives of diverse populations in drug development studies to ensure the medicinal product is not only safe but beneficially effective for all patients, particularly those who have been underserved by research. Genetic Diversity: The differences among people in genes and their expression that can cause various diseases and affect how they respond to the drug. Knowledge: Public access to clear and comprehensive information about processes, regulations and research. Providing this access includes publishing scientific findings and results, as well as creating educational materials and resources for all. Rare Disorders: Diseases or conditions affecting fewer than 200,000 individuals in the United States. Community Engagement: The involvement of patients, caregivers and other partners in drug development to ensure that their needs, perspectives and priorities are considered. Project Management: Planning, organizing and coordinating resources and communication to help a research project team realize specific goals in drug development. Patient Advocacy: The support and representation of patient interests, perspectives and priorities in drug development. Collaboration: The joint efforts of individuals or groups working together to achieve a common research goal or solve a scientific problem.
Preclinical Drug Development: Stages and Milestones Infographic. The ecosystem of preclinical drug development, divided into early and late preclinical stages. Emphasis is on the iterative nature of drug development, ensuring regulatory compliance and safety before human clinical trials. Early Preclinical Stage: Scientists carry out more rigorous studies of the selected drug candidate in cells, tissues and animals to better understand its effectiveness, movement in the body, metabolism and general safety. In parallel, processes to manufacture and formulate the drug at scale are explored. Efficacy/Proof of Concept (PoC): The ability of a drug to produce the desired therapeutic effect. These robust studies in relevant disease models confirm preliminary discovery data. Process Development (CMC): The design and optimization of manufacturing steps to scale production of a drug. An environmentally friendly process, increased production efficiency and lowered cost are the objectives. Drug Metabolism & Pharmacokinetics (DMPK): Studies of the absorption, distribution, metabolism and elimination of a drug by the body. They show where the drug goes in the body and what the body does to the drug. Formulation Development (CMC): The selection and optimization of dosage form (e.g., tablet, liquid). This balances factors like route of administration, DMPK properties and shelf life of the clinical product. Dose Range Finding Toxicology: Exploratory study to establish the relationship among efficacy, clinical response and safety across a range of doses. It informs design of the later stage GLP toxicology assessments. Early Preclinical Milestone: Pre-Investigational New Drug (pIND): A formal interaction with regulatory agencies (e.g., U.S. Food and Drug Administration [FDA]) to discuss further development plans to enable filing an IND application. Guidance is provided to ensure compliance with regulatory standards. Late Preclinical Stage includes: GLP Toxicology & Safety Evaluation: Animal and cell-based studies conducted in compliance with Good Laboratory Practice (GLP) regulations to determine how different amounts of the drug may affect the body and identify any risks that could come with using the drug. These animal studies predict the overall safety of the drug. GMP Manufacture of a Formulated Drug Product: The production of the final dosage form including the use of any device for the drug product. This is done in compliance with current Good Manufacturing Practices (GMP) regulations to ensure that all registered specifications are met consistently. GMP Manufacture of a Drug Substance: The production of the active pharmaceutical ingredient in compliance with GMP regulations. This ensures the safe and reliable manufacturing of a well-characterized product. Late Preclinical Milestone: IND: A formal application submitted to regulatory agencies (e.g., FDA) for review of all the preclinical data. The agencies will communicate whether it is safe to proceed to human clinical trials. The stage of development in which the drug is manufactured at commercial scale and its safety and toxicology are assessed in accordance with stringent regulatory requirements. These activities are IND-enabling, in preparation for human clinical trials. This is a general representation of small molecule developments. Other modalities of drug development may differ in some details. Note: This content was generated with some assistance from ChatGPT-4o, an AI language model developed by OpenAI.

Drug Development Illustrated: Infusing Equity Into Preclinical Research

These images are from a translational science resource NCATS created to help partners become familiar with the preclinical phase of the drug development process and to help advance equity, especially in rare disorders and for those underserved and historically underrepresented in biomedical research.

View the Drug Development Journey 
View the Key Concepts and Ecosystem 
View the Stages and Milestones

Infusing Equity Into Preclinical Drug Development

Depiction of the drug development process as a metaphorical journey through a canyon with a central river. The process begins with selecting a drug candidate and assembling a multidisciplinary research team. The journey encompasses preclinical development through to investigational new drug (IND) application. The river emphasizes that equity, community engagement and patient advocacy run through all steps in the journey to New Drug Application (NDA). A kayak and canoe in the river indicate optional paths for repurposed or repositioned drugs. Key team members making the journey include Toxicology, (Tox) Chemistry, Manufacturing & Controls (CMC), Drug Metabolism and Pharmacokinetics (DMPK), Proof of Concept, (PoC) and Project Management (PM). After crossing the river, the team arrives at the pre-investigational new drug (pIND) milestone. Following directional signs for regulatory, IND-enabling activities, Good Laboratory Practice (GLP) Toxicology, and Good Manufacturing Practice (GMP) Drug Substance/Drug Product (DS/DP), team members climb up a cliff. When they arrive at the top, they are greeted by a helicopter representing the IND milestone. On distant canyon peaks, clinical trial Phases 1 through 3 are featured. A hot air balloon on the horizon symbolizes the ultimate NDA for approval for human use in clinical care.
NCATS is making these materials available for use via a CC BY-ND 4.0 License.
https://creativecommons.org/licenses/by-nd/4.0/

Key Concepts and Ecosystem

Key Concepts and Ecosystem. 'Key Concepts Ecosystem' outlines essential functions and activities in preclinical research and development. The left side of the graphic is labeled “Key Concepts” and includes the following activities: Target Product Profile (TPP): A document describing the important features of a drug to effectively treat a disease in a specific population. The TPP helps guide preclinical development strategy. Regulatory Strategy: The steps and processes taken for a drug candidate to meet the requirements of regulatory agencies like the U.S. Food and Drug Administration during development and that safely allow for further testing in people. Good Laboratory Practice (GLP): The rules and guidelines that ensure the data collected during laboratory studies are high quality and trustworthy. Project Plan: A document that lists the key steps and research studies needed to develop a drug. It includes who is responsible for which steps, the overall timeline and important decision points along the way. Research Team: A group of researchers from multiple specialized fields (e.g., process chemistry, pharmacokinetics, toxicology) who work together to develop a drug. Clinical Plan: A document that outlines how a potential treatment will be tested in people. It proposes the type and number of participants, how the study will be conducted and what data will be collected. It informs the preclinical research project plan. Good Manufacturing Practice (GMP): The rules and guidelines that ensure a drug is produced safely and consistently and meets the highest quality-control standards. Reposition: Take a drug that has been developed to treat one condition — but has not yet been approved by a regulatory agency — and develop it to treat another. Repurpose: Take a drug that has already been approved by a regulatory agency to treat one condition and develop it to treat another. The right side of the graphic is labeled “Ecosystem” and includes a heading describing equity and the following elements and activities: Equity: Infusing equity in preclinical research and development creates an environment where all people can participate and can access and benefit from drug development and therapies. It also means the needs of historically underrepresented populations are considered and deliberate care is taken to avoid causing harm. Investing in equity-driven research enhances preclinical innovation by including diverse factors influencing health, such as genetics and environment. Resources: The funding, personnel, equipment and facilities required for drug development. Representation: The inclusion of the priorities and perspectives of diverse populations in drug development studies to ensure the medicinal product is not only safe but beneficially effective for all patients, particularly those who have been underserved by research. Genetic Diversity: The differences among people in genes and their expression that can cause various diseases and affect how they respond to the drug. Knowledge: Public access to clear and comprehensive information about processes, regulations and research. Providing this access includes publishing scientific findings and results, as well as creating educational materials and resources for all. Rare Disorders: Diseases or conditions affecting fewer than 200,000 individuals in the United States. Community Engagement: The involvement of patients, caregivers and other partners in drug development to ensure that their needs, perspectives and priorities are considered. Project Management: Planning, organizing and coordinating resources and communication to help a research project team realize specific goals in drug development. Patient Advocacy: The support and representation of patient interests, perspectives and priorities in drug development. Collaboration: The joint efforts of individuals or groups working together to achieve a common research goal or solve a scientific problem.
NCATS is making these materials available for use via a CC BY-ND 4.0 License.
https://creativecommons.org/licenses/by-nd/4.0/

Preclinical Drug Development: Stages and Milestones Infographic

Preclinical Drug Development: Stages and Milestones Infographic. The ecosystem of preclinical drug development, divided into early and late preclinical stages. Emphasis is on the iterative nature of drug development, ensuring regulatory compliance and safety before human clinical trials. Early Preclinical Stage: Scientists carry out more rigorous studies of the selected drug candidate in cells, tissues and animals to better understand its effectiveness, movement in the body, metabolism and general safety. In parallel, processes to manufacture and formulate the drug at scale are explored. Efficacy/Proof of Concept (PoC): The ability of a drug to produce the desired therapeutic effect. These robust studies in relevant disease models confirm preliminary discovery data. Process Development (CMC): The design and optimization of manufacturing steps to scale production of a drug. An environmentally friendly process, increased production efficiency and lowered cost are the objectives. Drug Metabolism & Pharmacokinetics (DMPK): Studies of the absorption, distribution, metabolism and elimination of a drug by the body. They show where the drug goes in the body and what the body does to the drug. Formulation Development (CMC): The selection and optimization of dosage form (e.g., tablet, liquid). This balances factors like route of administration, DMPK properties and shelf life of the clinical product. Dose Range Finding Toxicology: Exploratory study to establish the relationship among efficacy, clinical response and safety across a range of doses. It informs design of the later stage GLP toxicology assessments. Early Preclinical Milestone: Pre-Investigational New Drug (pIND): A formal interaction with regulatory agencies (e.g., U.S. Food and Drug Administration [FDA]) to discuss further development plans to enable filing an IND application. Guidance is provided to ensure compliance with regulatory standards. Late Preclinical Stage includes: GLP Toxicology & Safety Evaluation: Animal and cell-based studies conducted in compliance with Good Laboratory Practice (GLP) regulations to determine how different amounts of the drug may affect the body and identify any risks that could come with using the drug. These animal studies predict the overall safety of the drug. GMP Manufacture of a Formulated Drug Product: The production of the final dosage form including the use of any device for the drug product. This is done in compliance with current Good Manufacturing Practices (GMP) regulations to ensure that all registered specifications are met consistently. GMP Manufacture of a Drug Substance: The production of the active pharmaceutical ingredient in compliance with GMP regulations. This ensures the safe and reliable manufacturing of a well-characterized product. Late Preclinical Milestone: IND: A formal application submitted to regulatory agencies (e.g., FDA) for review of all the preclinical data. The agencies will communicate whether it is safe to proceed to human clinical trials. The stage of development in which the drug is manufactured at commercial scale and its safety and toxicology are assessed in accordance with stringent regulatory requirements. These activities are IND-enabling, in preparation for human clinical trials. This is a general representation of small molecule developments. Other modalities of drug development may differ in some details. Note: This content was generated with some assistance from ChatGPT-4o, an AI language model developed by OpenAI.
NCATS is making these materials available for use via a CC BY-ND 4.0 License.
https://creativecommons.org/licenses/by-nd/4.0/
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Economic Burden of Rare Diseases

A study led by NCATS estimates the direct medical costs of rare diseases and the lengthy journey some people with rare diseases travel to an accurate diagnosis.

Read About the Economic Burden of Rare Diseases (PDF - 675KB)

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National COVID Cohort Collaborative

The National COVID Cohort Collaborative (N3C) maintains one of the largest collections of secure and deidentified clinical data in the United States for COVID-19 research.

Read About N3C (PDF - 296KB)

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NCATS Drug Repurposing

Drug repurposing finds approved drugs and investigational compounds that might be able to treat other diseases and conditions. We use drug repurposing as a key strategy for bringing more treatments for all people more quickly.

Read About NCATS Drug Repurposing (PDF - 688KB)

The NCATS Pharmaceutical Collection (NPC) is a storehouse of approved drugs. Scientists use the collection to identify potential ways to repurpose drugs for new uses. Over the past 10 years, researchers used the NPC to study an array of pathways and disease models, generating an unparalleled amount of data. A number of projects produced drugs with new potential uses that have entered clinical trials, or have shown activity in testing, for several diseases and viruses. The NPC contains nearly 3,000 small molecule drugs. More than 300 requests for collaborations to screen the NPC resulted in 200 plus collaborative projects in such areas as rare and neglected diseases, infectious diseases and cancer. Illustration of a human body surrounded by names of several diseases that point to a specific location in the body.

NCATS National Pharmaceutical Collection

The NCATS National Pharmaceutical Collection is a complete, publicly available collection of approved molecular parts for high-throughput screening. The collection provides a valuable resource for validating new models of disease and understanding the molecular basis of diseases and interventions better.

Learn More About the Pharmaceutical Collection (PDF - 451KB)

NCATS OpenData Portal

The OpenData Portal offers real-time information about how individual SARS-CoV-2 variants may respond to known therapeutics. It also focuses on NCATS’ broader drug repurposing findings and other pandemic threats.

Read About the OpenData Portal (PDF - 241KB)

NCATS Strategic Framework

NCATS Strategic Plan Framework

The Strategic Plan Framework includes 5 goals with supporting objectives to bring more treatments for all people more quickly.

View the NCATS Strategic Plan Framework (PDF - 1.22 MB)

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Rare Diseases

NCATS supports a range of innovative approaches for understanding and treating rare diseases, which affect about 30 million people in this country.

Read About Rare Diseases (PDF - 330KB)

Rare Diseases: Individually Rare, Collectively Common. NCATS is developing new approaches to diagnose and treat people with rare diseases more quickly. NCATS logo. Resources. Providing high-quality, widely used resources like the Genetic and Rare Diseases Information Center (GARD), to educate, engage and empower the rare diseases community. Getting an accurate rare disease diagnosis can take more than 6 years, on average, leading to higher healthcare costs. GARD staff have answered about 120,000 questions. Capabilities. Developing platform technologies like high-throughput drug screening and gene-targeted therapies, that address many rare diseases at a time. Funding. Funding nationwide and international programs, like the Rare Diseases Clinical Research Network (RDCRN), to accelerate medical research across rare diseases. There are more than 10,000 rare diseases and only 5% of them have treatments. The RDCRN has helped move 12 rare disease treatments to the clinic.

Rare Diseases Overview

NCATS is developing new approaches to diagnose and treat people with rare diseases more quickly.

View the Rare Diseases Infographic (PDF - 110.14 KB)

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Research Supplements to Promote Diversity and Re-entry

The CTSA Program diversity and re-entry research supplements opportunities promote diversity in health-related research and re-entry into biomedical and behavioral research careers.

Read About Research Supplements to Promote Diversity and Re-entry (PDF - 513KB)

Seven characteristics of a translational scientist include: boundary crosser, team player, process innovator, domain expert, rigorous researcher, skilled communicator and systems thinker

Seven Characteristics of a Translational Scientist

Translational scientists are innovative and collaborative, searching for ways to break down barriers in the translation process.

Learn More About the Characteristics of a Translational Scientist

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Small Business Innovation

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs engage U.S. small businesses and research organizations in research and development that has the potential for commercialization and public benefit.

Read About SBIR/STTR Programs (PDF - 250KB)

Picture of person called “chip” with 13 clickable icons representing tissues and organ systems they represent, 2 icons are not clickable. The clickable icons are: brain; lungs, heart, muscle, liver, kidneys, gastrointestinal system, female reproductive system, blood vessels, fat, joints, skin and disease models. The two unclickable icons represent the ear and male reproductive system.

Tissue Chips for Drug Screening

Developing new treatments for patients is a long and hard process. Often tests conducted in the early stages of research do not accurately predict how well a treatment will work or if it will cause any harm to humans. This leads to long delays and enormous costs while patients eagerly await effective treatments. The Tissue Chip for Drug Screening program at NCATS brings innovation to the table. By using specialized chips, this program is making exciting advancements in drug testing.

Learn More About Tissue Chips

Infographic displaying the badges that represent the eight Translational Science Principles.

Translational Science Principles

Our eight translational science principles describe core approaches for effective translational science.

View the Translational Science Principles

Infographic displaying the badges that represent the eight Translational Science Principles.

Translational Science

Translational science looks at the entire translational research ecosystem to identify common pitfalls and develop innovative solutions.

View the Translational Science Infographic

Infographic displaying the Translational Science Spectrum.

Translational Science Spectrum

The translational science spectrum covers all stages of research from basic research to public health.

View the Translational Science Spectrum

Copyright and Reuse of Graphics

The NCATS website uses a mix of copyrighted and copyright-free graphics (including illustrations and photos). If you want to reuse a graphic, please follow these guidelines:

  • Copyrighted graphics will usually be credited to individuals or organizations. Permission to reuse these must be negotiated directly with the creators, and not NCATS.
  • Graphics explicitly credited to NCATS are copyright-free and may be used without our permission. Please credit the National Center for Advancing Translational Sciences as the source.

If you are not sure who created a graphic or have other questions about reusing a graphic on the NCATS website, email NCATS at ncatsinfo@nih.gov. Please include the URL and file name in your email.

Last updated on November 14, 2024