Divisions & Offices

NCATS has several divisions and offices with diverse staff who guide the center’s research activities.

Office of the Director

The Office of the Director develops and provides leadership for the center’s translational science programs, manages and directs executive level activities, and provides policy guidance and coordination for each of the center’s components.

Division of Clinical Innovation

The Division of Clinical Innovation (DCI) plans, conducts and supports research across the clinical phases of the translational science spectrum. This division:

• Plans, conducts and supports research to develop new methods and technologies to enhance clinical processes.
• Plans, conducts and supports research to evaluate existing and developing approaches, technologies, and processes in the clinical spectrum.
• Supports training programs relevant to clinical phases of translational science.
• Allocates DCI resources to clinical and translational infrastructure and investigators.
• Collaborates with other NIH Institutes and Centers and the scientists they support.
• Consults with stakeholders, including patients, industry and regulators.

Division of Extramural Activities

The Division of Extramural Activities advises NCATS leadership on issues related to policy and procedures for extramural activities. Additionally, it oversees and directs scientific review and grants management activities at NCATS. The division also manages the operations of the NCATS Advisory Council and Cures Acceleration Network Review Board.

Division of Preclinical Innovation

The Division of Preclinical Innovation (DPI) plans and conducts collaborative research projects across the preclinical phases of the translational science spectrum, using both internal and contract resources to advance them. Specifically, this division:

• Plans, conducts and collaborates on research to develop new methods and technologies to enhance preclinical processes.
• Plans, conducts and collaborates on research to evaluate existing and developing approaches, technologies, and processes in the preclinical spectrum.
• Supports training programs relevant to preclinical phases of translational science.
• Allocates DPI resources to preclinical extramural and intramural investigators.
• Collaborates with other NIH Institutes and Centers and the scientists they support.
• Consults with stakeholders, including patients, industry and regulators.

Division of Rare Diseases Research Innovation

The Division of Rare Diseases Research Innovation facilitates and coordinates NIH-wide activities involving research for a broad array of rare diseases. Specific duties include:

• Develops and maintains a centralized database on rare diseases.
• Coordinates and provides liaison with organizations worldwide concerned with rare diseases research and orphan products development.
• Advises the Office of the Director on matters related to NIH-sponsored research involving rare diseases.
• Responds to information and policy requests about rare diseases.

The Division of Rare Diseases Research Innovation oversees NCATS programs, including:

• The Genetic and Rare Diseases (GARD) Information Center  provides up-to-date health information about numerous rare and genetic diseases.
• The Rare Diseases Registry Program (RaDaR), formerly known as the Global Rare Diseases Registry Data Repository program, aims to define best practices for patient registries. RaDaR also strives to identify and adopt standards to support high-quality registries for rare diseases therapeutics development.
• The Rare Diseases Clinical Research Network (RDCRN) program is designed to advance medical research on rare diseases by providing support for clinical studies and facilitating collaboration, study enrollment and data sharing.
• The Platform Vector Gene Therapy (PaVe-GT) pilot project will test whether it is possible to increase the efficiency of gene therapy clinical trial startup by using the same gene delivery system and manufacturing methods for multiple gene therapies.

Office of Administrative Management

The Office of Administrative Management directs the administrative and financial operations management of the center. Specifically, it develops, administers and oversees the center’s internal control processes, policy and procedures for administration, program management and information technology. It also oversees personnel management and workforce planning.

Office of Drug Development Partnership Programs

The Office of Drug Development Partnership Programs (ODDPP) promotes innovations that improve the efficiency of drug development from target identification — including expanding the target landscape — through early-stage clinical trials. Programs administered by the ODDPP often involve partnerships with the private sector, other parts of NIH or the U.S. Government, and NCATS’ own intramural scientists. ODDPP also works with national and international stakeholders, providing leadership for the national response to public health emergencies. ODDPP programs and initiatives are listed as follows:

• The Biomedical Data Translator program is a collaboration that aims to integrate data and knowledge from vastly different biomedical domains to enable the discovery of associations not reported previously.
• LitCoin will generate machine-readable scientific literature and support more complete sharing of scientific observations, knowledge and data through bona fide literature-based credit. LitCoin launched in the fall of 2021 with a natural language processing challenge.
• The New Therapeutic Uses program implements approaches to improve the translational research pipeline by finding new uses for existing therapeutics, with the ultimate goal of accelerating the pace at which discoveries are turned into new preventions, treatments and cures for human diseases.
• ODDPP supports the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, which is a nationwide effort to speed scientific solutions to stem the national opioid public health crisis. Researchers take a variety of approaches to tackle the opioid epidemic through understanding, managing and treating pain, as well as improving treatment for opioid misuse and addiction.
• The Illuminating the Druggable Genome (IDG) program is managed by the ODDPP in collaboration with the NIH Common Fund. IDG aims to expand the target landscape for drug development by providing foundational knowledge about understudied druggable proteins.

Office of Policy, Communications and Education

The Office of Policy, Communications and Education (OPCE) develops and communicates critical priorities for NCATS in a highly collaborative manner.

• The OPCE Policy Branch analyzes scientific and legislative issues relevant to translational science, works with NCATS stakeholders to develop and implement science policies, and addresses center-wide planning and strategic activities that are relevant to the spectrum of translational research.
• The OPCE Communications Branch develops and disseminates content that informs and engages a variety of audiences on NCATS programs, activities and impact.
• The OPCE Education Branch collaborates center-wide to develop and disseminate evidence-based tools and best practices to improve understanding of translational science, the skills necessary to become a translational scientist and the translational science spectrum.

Office of Special Initiatives

The Office of Special Initiatives (OSI) addresses translational problems with innovative solutions through the development and implementation of disruptive technologies using interdisciplinary approaches and novel public-private partnerships. The programs and initiatives within OSI are intended to be catalytic and transformative, resulting in a paradigm shift in the field. These efforts currently include the following programs and initiatives funded through NCATS’ Cures Acceleration Network:

• ASPIRE — A Specialized Platform for Innovative Research Exploration in automated chemistry initiative seeks to address biological targets with no known drugs by enlarging the chemical space universe via combining automation engineering and artificial intelligence/machine learning with synthetic chemistry and biological screening through novel collaborations between NCATS intramural laboratories and extramural scientists.
• ExTReMe — Exosome Therapy for Regenerative Medicine is a new program that seeks to catalyze the field of regenerative medicine through novel exosome-based therapeutics focusing on tissue repair and wound healing.
• Microfabricated tissues—
  • 3-D Bioprinting — This program promotes collaborative partnerships between the intramural NCATS 3-D Tissue Bioprinting Laboratory and extramural research laboratories to significantly improve the drug development process by developing novel, physiologically relevant 3-D biofabricated disease tissue models for drug screening.
  • Tissue Chips (Microphysiological Systems) for Drug Screening — This program develops an in vitro 3‑D culture system that emulates organ physiology and function using human cells and tissues through advances in stem cell biology, microfluidics and bioengineering for risk assessment to accurately evaluate the safety and efficacy of promising therapies and its use for precision medicine.
• National Science Foundation (NSF) collaborations — This trans-agency partnership between NIH and NSF involves two programs to support innovative research efforts: the National Robotics Initiative and Cyber-Physical Systems.
• SCENT — Screening for Conditions with Electronic Nose Technology is a new program designed to develop an electronic nose for disease diagnosis by detecting with high sensitivity and specificity the unique signatures of volatile organic compounds that are specific to every human disease or condition.
• START — Synthetic Technologies for Advancement of Research and Therapeutics is a new program that will use synthetic biology — along with newly available tools in genetic engineering, gene synthesis and metabolomics — to construct and incorporate new biosynthetic or artificial metabolic pathways to accelerate and enable the design and construction of engineered cell therapies for the production of compounds with strong therapeutic and disease relevance. 

The OSI also takes the lead on NIH-wide research activities that are supported through the NIH Common Fund. The current programs in which OSI plays an active role include the following:

• Extracellular RNA Communication for biomarker and therapy development
• SPARC — Stimulating Peripheral Activity to Relieve Conditions

The OSI has had the opportunity to develop programs in response to current national health emergencies.

• Through the ASPIRE initiative and its ASPIRE Challenge, the OSI is involved in the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, a trans-agency effort to speed scientific solutions to stem the national opioid public health crisis.
• NIH launched the Rapid Acceleration of Diagnostics (RADx®) initiative to speed innovation in the development, commercialization and implementation of technologies for COVID-19 testing. In particular, for RADx-rad: Rapid Acceleration of Diagnostics radical technologies, the OSI is involved in developing two nontraditional technologies toward detecting SARS-CoV-2 virus: Screening for COVID-19 by Electronic-Nose Technology (SCENT) and Exosome-Based Non-traditional Technologies Towards Multi-Parametric and Integrated Approaches for SARS-CoV-2.

Office of Strategic Alliances

The Office of Strategic Alliances establishes and advances public-private partnerships, as well as develops innovative approaches, policies and methods to reduce, remove or bypass bottlenecks in translational science collaborations.

Office of Translational Medicine

The Office of Translational Medicine (OTM) uses expertise across clinical and other relevant disciplines to amplify NCATS’ ability to foster innovative translational science and improve health. OTM serves many offices and divisions within NCATS, including the Division of Clinical Innovation; the Division of Preclinical Innovation; the Division of Extramural Activities; the Office of Policy, Communications and Education; and the Office of Strategic Alliances. It is a repository of specialized knowledge, interprets and implements research-related policies, convenes stakeholders, and, in certain circumstances, arbitrates or makes decisions. Topics of interest to the Office include human subjects; diversity, equity, inclusion and accessibility; regulation and drug development; clinical research, including clinical trials and clinical epidemiology; and ethics, for which the Office operates a grant program.