DAta | National Center for Advancing Translational Sciences

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334	Council Roster	Chairperson Joni L. Rutter, Ph.D. Director National Center for Advancing Translational Sciences National Institutes of Health Bethesda, Maryland Executive Secretary Anna L. Ramsey-Ewing, Ph.D. Director Division of Extramural Activities National Center for Advancing Translational Sciences National Institutes of Health Bethesda, Maryland Council Members *Pending appointment (Terms end 10/31 of designated year, unless otherwise noted.) Sergio A. Aguilar-Gaxiola, M.D., Ph.D. (2025) Professor of Clinical Internal Medicine Founding Director, Center for Reducing Health Disparities Director, Community Engagement Program, UC Davis Clinical and Translational Science Center School of Medicine University of California, Davis Sacramento, California Paul A. Harris, Ph.D. (2024) Director, Office of Research Informatics Professor, Department of Biomedical Informatics Engineering Vanderbilt Institute for Clinical and Translational Research Vanderbilt University Medical Center Nashville, Tennessee Annie M. Kennedy, B.S. (2024) Chief of Policy, Advocacy and Patient Engagement EveryLife Foundation for Rare Diseases Washington, D.C. Matthias Kretzler, M.D. (2023) Warner-Lambert/Parke-Davis Professor of Internal Medicine/Nephrology and Computational Medicine and Bioinformatics University of Michigan Ann Arbor, Michigan Andrew W. Lo, Ph.D. (2022) Charles E. and Susan T. Harris Professor Massachusetts Institute of Technology Cambridge, Massachusetts Kelly Marie McVearry, Ph.D., Ed.M. (2024) Chief Executive Officer The Hypatia Project Reston, Virginia Robin J. Mermelstein, Ph.D. (2025) Co-Director, UIC Center for Clinical and Translational Science Director, Institute for Health Research and Policy University of Illinois at Chicago Chicago, Illinois Keith J. Mueller, Ph.D. (2024) Gerhard Hartman Professor and Department Head Department of Health Management and Policy College of Public Health University of Iowa Iowa City, Iowa Rajesh Ranganathan, Ph.D. (2024) Vice President, Partnership and Portfolio Strategy SunPharma Advanced Research Company, Ltd. Princeton, New Jersey Paula K. Shireman, M.D., M.B.A. (2024) Executive Associate Dean College of Medicine Texas A&M University Bryan, Texas Marshall L. Summar, M.D. (2023) Rare Disease Institute Division of Genetics and Metabolism Margaret O’Malley Professor of Genetic Medicine Children's National Medical Center Washington, D.C. Annica M. Wayman, Ph.D. (2025) Associate Dean, Shady Grove Affairs Professor of the Practice, College of Natural and Mathematical Sciences University of Maryland, Baltimore County Rockville, Maryland Ex Officio Members Department of Health and Human Services Xavier Becerra, J.D. Secretary Washington, D.C. National Institutes of Health Lawrence A. Tabak, D.D.S., Ph.D. Performing the Duties of the NIH Director Bethesda, Maryland
332	NCATS Advisory Council	According to its charter (PDF - 28KB), the NCATS Advisory Council provides guidance, consults and makes recommendations to the secretary of Health and Human Services, the NIH director and to the NCATS director on Center initiatives, policies and programs. The NCATS Advisory Council is composed of appointed members who serve four-year terms. These members can serve on subcommittees and working groups to investigate and provide recommendations and guidance related to specific topics of interest to NCATS. Advisory Councils at NIH provide second-level review of all grant applications under consideration for Institute or Center funding. Each Council is required to establish general operating procedures for the review of grant applications. The NCATS Advisory Council also discusses concept clearances for potential NCATS initiatives. Next Meeting May 25, 2023 Closed Session: 11 a.m. to 12 p.m. EDT Open Session: 1-6 p.m. EDT The NCATS Advisory Council will convene a virtual meeting on May 25, 2023. The meeting will feature presentations from NCATS Director Joni L. Rutter, Ph.D., and others about the center’s initiatives, policies, programs and future direction. Federal Register Notice View more meeting information.
331	Genetic and Rare Diseases (GARD) Information Center	.modal-image-button { margin-left: 20px; margin-bottom: 15px; width: 20%; } .modal-image-button>input { border: 4px solid #30787D; position: relative; width: 100%; } The Genetic and Rare Diseases (GARD) Information Center is a public health resource for people living with a rare disease and their families. It provides free access to reliable, easy-to-understand information in English and Spanish. GARD information specialists are available by phone and email to discuss questions in English and Spanish. Sources of information on GARD include the National Library of Medicine, Orphanet, Human Phenotype Ontology, patient support groups and other NIH Institutes and Centers. Established by the Rare Diseases Act of 2002, GARD was created by the NIH Office of Rare Diseases Research and now is administered by NCATS’ Division of Rare Diseases Research Innovation. By improving access to research-based information about rare diseases and helping people learn about participating in clinical trials, GARD is using translational science to improve the research process to get more treatments to more people more quickly. GARD Materials Click to view/download the GARD handout. × GARD Handout CloseDownload PDF	NCATS supports GARD, a center designed to provide information about rare and genetic diseases.	/sites/default/files/GARD.jpeg	Genetic and Rare Diseases (GARD) Information Center	NCATS supports GARD, a center designed to provide information about rare and genetic diseases.	/sites/default/files/GARD_0.jpeg	Genetic and Rare Diseases (GARD) Information Center
330	Job Opportunities (old)	NCATS is looking for innovative partners to join its dynamic team. Learn more about current job opportunities at NCATS or across NIH and the U.S. Department of Health and Human Services (HHS). NIH and HHS are Equal Opportunity Employers. All information provided by candidates will remain confidential and will not be released outside the NCATS search process without a signed release from candidates. NIH encourages the application and nomination of qualified women, minorities and individuals with disabilities. DHHS and NIH are Equal Opportunity Employers. NIH is dedicated to building a diverse community in its training and employment programs. Current Vacancies Chief, Division of Extramural Activities, Scientific Review Branch Deputy Chief, Division of Extramural Activities, Scientific Review Branch Staff Scientist (Director), Division of Preclinical Innovation, Intramural Training and Education Office Initiatives & Consortium-Wide Activities Section Chief, Division of Clinical Innovation, CTSA Program Branch Staff Scientist (Project Manager), Division of Preclinical Innovation, Therapeutic Development Branch Staff Scientist (Senior Project Manager, Therapeutic Development), Division of Preclinical Innovation, Therapeutic Development Branch Full-Stack Developer (Global Substance Registration System and Biomedical Data Translator Programs), Division of Preclinical Innovation, Informatics Core Staff Scientist (Informatics Algorithms Engineer), Division of Preclinical Innovation, Informatics Core Research Associate (Biology), Division of Preclinical Innovation, Chemical Technologies Group Research Scientist (Virology) Position, Division of Preclinical Innovation, 3-D Tissue Bioprinting Laboratory Bioinformatician, Division of Preclinical Innovation, Chemical Genomics Branch, Stem Cell Translation Laboratory Postdoctoral Positions in the Division of Preclinical Innovation Neuroscientist Postdoctoral Fellow Positions, Division of Preclinical Innovation, 3-D Tissue Bioprinting Laboratory Computational Scientist (Cheminformatics) Postdoctoral Fellow, Division of Preclinical Innovation, Drug Metabolism and Pharmacokinetics Antiviral Discovery Informatics Postdoctoral Fellow Positions, Division of Preclinical Innovation, Antiviral Program for Pandemics Antiviral Discovery Informatics Postdoctoral Fellow Positions, Division of Preclinical Innovation, Antiviral Program for Pandemics Postdoctoral Bioinformatics Position, Division of Preclinical Innovation, Informatics Core Antiviral Discovery Biology – Target Validation/Discovery Postdoctoral Fellow Positions, Division of Preclinical Innovation, Antiviral Program for Pandemics Medicinal Chemistry Postdoctoral Fellow Positions, Division of Preclinical Innovation, Early Translation Branch Biology Postdoctoral Fellow Position, Division of Preclinical Innovation, Early Translation Branch Antiviral Medicinal Chemistry Postdoctoral Fellow Positions, Division of Preclinical Innovation, Antiviral Program for Pandemics Antiviral Discovery Biology Postdoctoral Fellow Positions, Division of Preclinical Innovation, Antiviral Program for Pandemics Postdoctoral Biomedical Engineer Position, Division of Preclinical Innovation, 3-D Tissue Bioprinting Laboratory Postdoctoral Antibody Discovery and Characterization Position, Division of Preclinical Innovation, Early Translation Branch Postdoctoral Medicinal Chemistry Position, Division of Preclinical Innovation, Early Translation Branch Postdoctoral Fellow in Clinical and Biomedical Informatics, Division of Preclinical Innovation, Informatics Core Postdoctoral Medicinal Chemistry Position, Division of Preclinical Innovation, Therapeutic Development Branch Postdoctoral Genomic Toxicology Position, Division of Preclinical Innovation, Genomic Toxicology Laboratory Postdoctoral Mass Spectrometry Position, Division of Preclinical Innovation, Analytical Chemistry Core Facility Postdoctoral Bioengineering Positions, Division of Preclinical Innovation 3-D Tissue Bioprinting Laboratory Postdoctoral Computational Biologist/Bioinformatician, Division of Preclinical Innovation, Therapeutic Development Branch Postdoctoral Informatics Scientist, Division of Preclinical Innovation, NCATS Chemical Genomics Center (NCGC), Adenine Informatics Group Postdoctoral Informatics Scientist Position, Division of Preclinical Innovation, Informatics Group Stem Cell Scientist and Postdoctoral Positions, Division of Preclinical Innovation, Chemical Genomics Branch, Stem Cell Translation Laboratory Chief, Division of Extramural Activities, Scientific Review Branch National Institutes of Health National Center for Advancing Translational Sciences Division of Extramural Activities Scientific Review Branch Bethesda, Maryland Description NCATS, a major research component of NIH, seeks applications from exceptional candidates to fill a branch chief position in the Center’s Scientific Review Branch within the Division of Extramural Activities (DEA). DEA advises NCATS leadership on issues related to policies and procedures for extramural activities. Additionally, DEA oversees and directs scientific review and grants management activities at the Center and manages the operations of the NCATS Advisory Council and Cures Acceleration Network Review Board. Core Responsibilities As a supervisory health scientist administrator, the branch chief will provide leadership, supervision and oversight of all phases of the peer review process, ensuring all grant applications and contract proposals submitted to NCATS receive a fair, rigorous and timely review. Additionally, the branch chief will be involved in initiative development, the formulation and implementation of peer review strategies and policies and will represent NCATS on NIH-wide activities and committees such as the NIH Review Policy Committee. The branch chief will be responsible for overseeing the training and mentoring as well as nurturing the professional development of branch staff. The successful candidate will be expected to establish and maintain cooperative, collaborative relationships with peers and colleagues at NIH and NCATS and will represent DEA and NCATS in grantsmanship/outreach activities. The branch chief will serve as a core member of the DEA Senior Leadership Team that is responsible for guiding and optimizing DEA operations. Qualifications The selected candidate should have a doctoral degree (M.D, Ph.D. or equivalent) with senior-level research experience in the life and/or biomedical sciences. Applicants should be experts in peer review practices and policies, exhibit exceptional leadership and communication skills, demonstrate the ability to develop and implement a vision through strategic planning, and possess supervisory experience. Experience with complex electronic systems and processes is essential. Salary/Benefits The current salary range is commensurate with experience and accomplishments; a full civil service benefits package — including retirement; health, life and long-term care insurance; Thrift Savings Plan (401K equivalent) participation, etc. — is available. How to Apply The NIH global vacancy announcements for Supervisory Health Scientist Administrators (Program Officer and Scientific Review Officer), GS-601-15, will be open on www.USAJobs.gov May 16–25, 2022. Please direct questions specific to the position to DEA Deputy Director Gregory P. Jarosik, Ph.D., via email at gregory.jarosik@nih.gov. For information on general qualification requirements, evaluation criteria and application instructions, please visit https://hr.nih.gov/jobs/announcement-links/health-scientist-administrator. Additional Information Employment is subject to the successful completion of the pre-appointment process (i.e., background investigation, verification of qualifications and job requirements, completion of onboarding forms, submission of required documents, etc.). Due to COVID-19, NCATS currently is operating in a maximum telework state. If selected, you may be expected to telework. As employees return to the office, you may be required to report to the location listed on this announcement within 30 calendar days of receiving notice, even if your home or temporary telework site is located outside of the local commuting area. At the discretion of the supervisor and NIH policy, you may be eligible for workplace flexibilities, which may include remote work or telework options and/or flexible work scheduling. These flexibilities may be requested in accordance with the NIH Workplace Flexibilities policy. Deputy Chief, Division of Extramural Activities, Scientific Review Branch National Institutes of Health National Center for Advancing Translational Sciences Division of Extramural Activities Scientific Review Branch Bethesda, Maryland Description NCATS, a major research component of NIH, seeks applications from exceptional candidates to fill a deputy branch chief position in the Center’s Scientific Review Branch (SRB) within the Division of Extramural Activities (DEA). DEA advises NCATS leadership on issues related to policies and procedures for extramural activities. Additionally, DEA oversees and directs scientific review and grants management activities at the Center and manages the operations of the NCATS Advisory Council and Cures Acceleration Network Review Board. Core Responsibilities As a supervisory health scientist administrator, the deputy branch chief will assist the branch chief in providing leadership, supervision and oversight of all phases of the peer review process, ensuring all grant applications and contract proposals submitted to NCATS receive a fair, rigorous and timely review. Additionally, the deputy branch chief will be involved in initiative development, the formulation and implementation of peer review strategies and policies and will plan and participate in DEA and NCATS grantsmanship/outreach activities. The deputy branch chief will be responsible for training branch staff, overseeing the day-to-day operations of the branch and taking the lead on determining SRB staff work assignments. The successful candidate also will represent DEA on NCATS- and NIH-wide activities and committees and will be expected to establish and maintain cooperative, collaborative relationships with peers and colleagues at NIH and NCATS. Qualifications The selected candidate should have a doctoral degree (M.D, Ph.D. or equivalent) with senior-level research experience in the life and/or biomedical sciences. Applicants should be experts in peer review practices and policies, exhibit exceptional leadership and communication skills, demonstrate the ability to develop and implement a vision through strategic planning, and possess supervisory experience. Experience with complex electronic systems and processes is essential. Salary/Benefits The current salary range is commensurate with experience and accomplishments; a full civil service benefits package — including retirement; health, life and long-term care insurance; Thrift Savings Plan (401K equivalent) participation, etc. — is available. How to Apply The NIH global vacancy announcements for Supervisory Health Scientist Administrators (Program Officer and Scientific Review Officer), GS-601-15, will be open on www.USAJobs.gov May 16–25, 2022. Please direct questions specific to the position to DEA Deputy Director Gregory P. Jarosik, Ph.D., via email at gregory.jarosik@nih.gov. For information on general qualification requirements, evaluation criteria and application instructions, please visit https://hr.nih.gov/jobs/announcement-links/health-scientist-administrator. Additional Information Employment is subject to the successful completion of the pre-appointment process (i.e., background investigation, verification of qualifications and job requirements, completion of onboarding forms, submission of required documents, etc.). Due to COVID-19, NCATS currently is operating in a maximum telework state. If selected, you may be expected to telework. As employees return to the office, you may be required to report to the location listed on this announcement within 30 calendar days of receiving notice, even if your home or temporary telework site is located outside of the local commuting area. At the discretion of the supervisor and NIH policy, you may be eligible for workplace flexibilities, which may include remote work or telework options and/or flexible work scheduling. These flexibilities may be requested in accordance with the NIH Workplace Flexibilities policy. Staff Scientist (Director), Division of Preclinical Innovation, Intramural Training and Education Office National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Intramural Training and Education Office Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from exceptional individuals to fill a staff scientist (director) position in the Intramural Training and Education (ITE) Office within its Division of Preclinical Innovation (DPI). DPI conducts intramural research, transforming therapeutic discovery approaches and tools, advancing the art of collaboration, and catalyzing the biomedical community to deliver the most effective therapies to treat human disease. This mission is accomplished by translating preclinical discoveries into therapeutic potential by providing innovative solutions to underexplored targets and therapeutic modalities and by conducting predictive efficacy and toxicity studies, as well as informatics analyses and tool development. DPI fosters innovative partnerships with academia, patient organizations and the private sector (e.g., pharmaceutical industry and biotechnology companies) to advance the science of translation. DPI also supports the development of the translational workforce by supporting a multifaceted intramural science training and career development program in a team science environment. This program provides a career roadmap for research trainees, which include summer students and postbaccalaureate, predoctoral and postdoctoral fellows, including visiting fellows. Core Responsibilities Working with the NCATS Education Branch, the director of the ITE Office will ensure that all trainees have an intensive, mentored research experience that prepares them for the next step in their careers. The director of the ITE Office will maintain an awareness of national training efforts; provide advice to the NCATS scientific director and staff regarding research in areas of training, diversity, inclusion and accessibility; and collaborate with other NIH organizations to achieve the goals of maintaining an outstanding training environment. In addition, the ITE Office director champions the NCATS intramural diversity and inclusion roadmap by cultivating a culture of inclusion, recruiting and retaining a diverse workforce, and supporting and nurturing talent. This director position is supervisory within the ITE Office. The director will initiate and direct management of activities with ITE Office staff, including overseeing and guiding strategic planning for NCATS’ ITE Office; setting goals and planning initiatives to attain these goals; supporting and advising on trainee recruitment efforts; attending regional and national conferences and career fairs; and visiting individual colleges to advance recruitment and networking activities. The director also will oversee the onboarding of new fellows, ensuring that they receive orientation and required safety and other mandatory training, including those related to the responsible conduct of research and research integrity; they are aware of all NCATS and NIH policies related to their appointments; and NCATS staff overseeing interns and fellows also receive this information. In collaboration with NCATS intramural leadership and the NCATS Education Branch, the selected candidate will create new and expand existing translational science education activities for DPI fellows using the Translational Science Principles; organize and moderate training events to prepare DPI fellows to become leaders in the field of translational science; provide individual mentoring to fellows regarding training and career development planning, including leading annual progress reviews for each fellow and ensuring all fellows complete independent development plans annually; and provide opportunities for learning about funding and career opportunities, including early-stage career grants, job opportunities and international issues (e.g., visas and requirements for U.S. employment). The ITE Office director will create professional development and networking opportunities for trainees by fostering and maintaining strategic relationships with the NIH Office of Intramural Training & Education, fellow alumni, training directors from other NIH Institutes/Centers and external employers (e.g., other government agencies, pharmaceutical/biotechnology industries, colleges/universities, professional organizations and science foundations). He or she will oversee the organization and implementation of the annual fellow’s retreat in collaboration with the National Human Genome Research Institute; orchestrate postbaccalaureate trainee participation in the NCATS and NIH postbaccalaureate poster days; facilitate postdoctoral participation in the annual Fellows Award for Research Excellence Award and the NIH Research Festival; and attend and provide guidance for the NCATS Fellows Committee monthly meetings. The director also will act as a point of contact for DPI scientific staff regarding the policies and procedures that govern the NCATS and NIH fellow community and work closely with the scientific director, deputy scientific director and the NCATS Education Branch to develop and recommend policies for the execution of DPI training programs, to determine their ongoing effectiveness, and to develop new or revised intramural research training programs. The ITE Office director will work with the Intramural Services Support administrative officer, budget officer and ITE staff in the formulation of training budget requests and justifications for the training programs, providing guidance to responsible officials and serving as a member of the DPI team leads group and other committees, as needed. This is a full-time, administrative position and does not include time or resources for the selected candidate to conduct biomedical research or provide clinical care. He or she would have the option to conduct research on such topics as methods to promote translational team science; guide career outcomes and factors influencing career decisions for DPI trainees; build the evidence basis for effective translational training models; and publish peer-reviewed manuscripts on the topics of training the translational workforce, team science and other training-related topics. Qualifications The selected candidate should have a doctoral degree in the biomedical sciences; a successful record and a minimum of three to five years of experience mentoring students and fellows at all levels in a laboratory and/or clinical setting; a successful record of leading training and mentoring efforts at a departmental or institutional level, including the recruitment of trainees and the use of such trainee outreach platforms as virtual communication and social media; and a successful record of leading and/or facilitating the completion of diversity and inclusion initiatives, preferably in an academic setting. This includes demonstration of an in-depth knowledge on issues of access, inclusion, diversity, equity and multiculturalism in a large, complex organizational setting. Candidates should demonstrate a clear pattern of successful collaboration in a team environment and with senior organizational leaders, possess a proven record of collecting and using data to assess the effectiveness of initiatives and to achieve measurable results, and be able to listen, communicate, build consensus, find support and reconcile competing interests. Salary/Benefits This position will be a Title 42, federal appointment (T42 appointments can be U.S. citizens, resident aliens [permanent residents], or nonresident aliens with a valid employment authorized visa). The current salary range is commensurate with experience and accomplishments and is subject to federal cost-of-living adjustments and merit-based pay increases. A full civil service benefits package — including retirement; health, life and long-term care insurance; Thrift Savings Plan (401K equivalent) participation, etc. — is available. How to Apply To apply, submit your curriculum vitae and cover letter to Ann R. Knebel, Ph.D., RN, NCATS deputy scientific director, Office of the Scientific Director, at DPITrainingDirector@mail.nih.gov with the subject heading “Application for Director, ITE Office Position.” In your application, please include a description of your mentoring and outreach activities, especially those involving women and persons from other underrepresented groups in biomedical research. Review of applications will begin on May 26, 2022. Applications will continue to be accepted and considered until the position is filled. Interested candidates may also contact Ann R. Knebel for additional information at ann.knebel@nih.gov. Additional Information Employment is subject to the successful completion of the pre-appointment process (i.e., background investigation, verification of qualifications and job requirements, completion of onboarding forms, submission of required documents, etc.). Due to COVID-19, NCATS currently is operating in a maximum telework state. If selected, you may be expected to telework. As employees return to the office, you may be required to report to the location listed on this announcement within 30 calendar days of receiving notice, even if your home or temporary telework site is located outside of the local commuting area. At the discretion of the supervisor and NIH policy, you may be eligible for workplace flexibilities, which may include remote work or telework options and/or flexible work scheduling. These flexibilities may be requested in accordance with the NIH Workplace Flexibilities policy. Initiatives & Consortium-Wide Activities Section Chief, Division of Clinical Innovation, CTSA Program Branch National Institutes of Health National Center for Advancing Translational Sciences Division of Clinical Innovation CTSA Program Branch Bethesda, Maryland Description NCATS, a major research component of NIH, is seeking applications from exceptional candidates with recognized leadership and demonstrated innovation and expertise in digital and mobile technologies to serve as the Initiatives & Consortium-Wide Activities Section chief in the CTSA Program Branch within the Division of Clinical Innovation (DCI). The CTSA Program is an innovative national network of 50+ medical research centers that aims to improve human health by transforming the research and training environment to enhance the efficiency and quality of clinical and translational research. The Initiatives & Consortium-Wide Activities Section plans and coordinates the development of strategic initiatives related to the CTSA Program, plans and coordinates the development of funding initiatives for the CTSA Program and provides evaluation activities related to CTSA Program goals and objectives. Core Responsibilities The Initiatives & Consortium-Wide Activities Section chief is responsible for the planning and coordinating the development of strategic initiatives related to the CTSA Program, planning and coordinating the development of funding initiatives for the CTSA Program and evaluating activities related to CTSA Program goals and objectives. The selected candidate will serve as a senior leader, representing DCI and NCATS in strategic and funding initiatives related to programs across NIH, with other government agencies, industry, academia and patient-support organizations. The Initiatives & Consortium-Wide Activities Section chief also will advise the DCI director on related matters. The selected candidate will provide authoritative leadership and oversight in implementing the focus areas of the CTSA Program, including overseeing and facilitating the broad strategic planning, development, implementation and evaluation of CTSA Program goals and objectives. Qualifications The selected candidate should have an M.D. and/or Ph.D. in a health allied field with knowledge of current developments in clinical and translational science research and contemporary challenges. The candidate should have extensive experience in: (1) leading a diverse, highly complex research program that supports innovative research in clinical research; (2) providing expert advice to senior leaders on related policies and programs; (3) developing innovative programs for advancing clinical and translational science research; (4) managing grants portfolios; and (5) leading teams. The candidate should appreciate emerging trends in clinical research, be aware of complex evaluation issues of large programs or networks be able to communicate and collaborate well with others. Candidates should demonstrate a clear pattern of success in setting, planning, implementing and analyzing research project or program objectives and priorities; the ability to communicate effectively with diverse scientific and lay audiences; and the ability to form collaborations with national and international organizations, as well as with individuals who represent wide-ranging disciplines and competing priorities. Salary/Benefits The current salary range is commensurate with experience and accomplishments; a full civil service benefits package — including retirement; health, life and long-term care insurance; Thrift Savings Plan (401K equivalent) participation,etc. — is available. How to Apply Applicants are directed to apply via USAJobs.gov to the next Health Science Administrators (Supervisory) announcement (tentative release in May 2022). This posting will be updated with the link when available. The USAjobs.gov announcement will include additional information regarding medical and scientific specialties, qualification requirements, evaluation criteria and application instructions. In the interim, interested individuals may send an email describing their interest in the position to Erica K. Rosemond, Ph.D., acting deputy director, Division of Clinical Innovation (rosemonde@mail.nih.gov) with their curriculum vitae and cover letter. Staff Scientist (Project Manager), Division of Preclinical Innovation, Therapeutic Development Branch National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Therapeutic Development Branch Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from exceptional individuals to fill a staff scientist (project manager) position in the Therapeutic Development Branch (TDB) within its Division of Preclinical Innovation (DPI). TDB partners with collaborators (e.g., academic institutions, foundations and private industry) to implement research and development projects leading to Investigational New Drug (IND) applications for new therapeutics. These projects play a leading role in NCATS’ mission to develop new ways to reduce, remove or bypass bottlenecks across the entire continuum of translational science and to address rare and neglected diseases. Project managers are critical to the success of TDB because they are the primary coordinators for project activities that cover all aspects of the research and development pipeline for a wide range of therapeutic entities (e.g., small molecules, biologics, gene and cell therapies, and devices). Core Responsibilities The project manager will work collaboratively with team members to evaluate, develop and implement assigned projects. Specific duties include monitoring and guiding project development and implementation, tracking relevant performance measures, reviewing relevant documents and reports, identifying problems and proposing corrective solutions, and serving as a contracting officer representative to provide support for the establishment of contracts and to coordinate project studies with contractors and vendors. Additionally, the project manager will contribute to the production of Research Collaboration Agreements and Cooperative Research and Development Agreements, as well as project plans, team meeting agendas, minutes, background papers and other reports. He or she will be responsible for maintaining the integrity and accuracy of project information to meet team, management and portfolio requirements, using collaboration management software, such as Microsoft Teams. Qualifications Applicants should hold a doctoral degree (M.D., Ph.D. or equivalent) in the life sciences (chemistry, biology or a related field is preferred) and be familiar with early discovery and preclinical candidate identification, validation, and drug development studies. A strong preference will be given to applicants with prior experience in preclinical studies of antiviral drugs and therapeutics or devices targeting viral agents of pandemic potential. The applicant also should be a recognized expert and accomplished leader in the field and have a minimum of five years of related research experience (post‑Ph.D.), demonstrating increased independence and overall responsibility for more complex projects. The selected candidate should possess strong oral and written communication skills, as well as excellent interpersonal, negotiation and facilitation skills. The selected candidate will be expected to demonstrate a proven ability to foster important relationships with collaborators and key stakeholders and to interact effectively with senior management in public forums and within project teams. Familiarity with the federal acquisition process and contract management is a plus. Salary/Benefits The current salary range is commensurate with experience and accomplishments; a full civil service benefits package — including retirement; health, life and long-term care insurance; Thrift Savings Plan (401K equivalent) participation, etc. — is available. How to Apply Please submit a cover letter describing your interest in the position, including a career synopsis (one to three pages), a current curriculum vitae and complete bibliography, and the names of and contact information for at least three references to NCATSTDBHiring@nih.gov. Please reference “NCATS695/725-2022: Application for Project Manager” in the subject line of your email. The review of applications will begin on Dec. 27, 2021, and will continue until the position is filled. Learn more about intramural research at NCATS. Staff Scientist (Senior Project Manager, Therapeutic Development), Division of Preclinical Innovation, Therapeutic Development Branch National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Therapeutic Development Branch Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from highly motivated individuals to fill a staff scientist (senior project manager, therapeutic development) position in the Therapeutic Development Branch within its Division of Preclinical Innovation (DPI). The selected applicant will manage Investigational New Drug (IND)–enabling drug development projects involving collaborations among NIH and academic scientists, industry, and nonprofit organizations. The scientists within DPI come from a broad range of scientific disciplines — including therapeutic discovery, medicinal chemistry, pharmacology and preclinical development — providing the resources to reduce, remove or bypass significant bottlenecks across the entire continuum of translation and to train the future translational science workforce. This position will require the expert application of management skills in project planning and execution and risk management. The senior project manager will work with development teams to define and monitor project goals and go/no-go criteria and participate in data-driven recommendations for project design and prioritization. Core Responsibilities The senior project manager will be responsible for effectively managing the project team and collaborators through project initiation, strategic planning, execution and closeout phases of projects; developing a comprehensive drug-development plan and budget while proactively monitoring the critical path toward IND filing and clinical trials; solving problems and making key decisions to meet multiple project goals and objectives; balancing scientific and administrative aspects of projects (e.g., contracting); and maintaining integrity and accuracy of project information to meet team, management and portfolio requirements, using collaboration management software, such as Microsoft Teams. Qualifications Applicants should hold a doctoral degree (M.D., Ph.D. or equivalent) in a relevant field, preferably in life sciences, chemistry, biology or a related field. Significant experience in drug development in the biopharmaceutical industry or equivalent is required. The selected candidate should have project management experience in cross-discipline drug development teams and proven leadership and management skills, with an in-depth understanding of project management best practices. The selected candidate should possess strong oral and written communication skills. They also should possess excellent interpersonal, negotiation and facilitation skills. The selected candidate will be expected to demonstrate a proven ability to foster important relationships with collaborators and key stakeholders and to interact effectively with senior management in public forums and within project teams. A strong preference will be given to applicants with experience in preclinical studies of antiviral drugs and therapeutics or devices targeting viral agents of pandemic potential. Salary/Benefits The current salary range is commensurate with experience and accomplishments; a full civil service benefits package — including retirement; health, life and long-term care insurance; Thrift Savings Plan (401K equivalent) participation, etc. — is available. How to Apply Please email a cover letter describing your interest in the position, including a career synopsis (one to three pages); a current curriculum vitae and complete bibliography; and the names of and contact information for at least three references to NCATSTDBHiring@nih.gov. Please reference “NCATS646-2002: Application for Senior Project Manager” in the subject line of your email. The review of applications will begin on Dec. 27, 2021, and will continue until the position is filled. Learn more about intramural research at NCATS. Full-Stack Developer (Global Substance Registration System and Biomedical Data Translator Programs), Division of Preclinical Innovation, Informatics Core National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Informatics Core Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from qualified candidates to fill the full-stack developer position in the Informatics (IFX) Core within its Division of Preclinical Innovation (DPI). The selected candidate will join the IFX Core’s program teams that support (i.e., design, build, and maintain data models and back-end infrastructure) the Global Substance Registration System (G-SRS) and the Biomedical Data Translator programs. These teams consist of informaticians, developers, testers, registrars, analysts, program management staff, external collaborators from regulatory agencies, and academic and research institutes. Team members work closely within the IFX Core and with collaborators to develop and distribute cutting-edge technologies. Core Responsibilities The selected candidate will design and develop algorithms to interrogate and integrate knowledge graphs from multiple components into a coherent “answer” graph for the Translator Autonomous Relay System. The candidate will use the best-of-breed technology stacks to implement and support NCATS scientific projects, including cheminformatics toolkits for G-SRS. Through these programs, the candidate will work with colleagues to establish, troubleshoot and document best practices for software development (e.g., continuous integration and continuous deployment) using technologies such as Jenkins, Travis, Docker, Kubernetes and cloud services (Amazon Web Services [AWS], Google Cloud) in support of the teams and collaborators (e.g., Translator Consortium, U.S. Food and Drug Administration, U.S. Pharmacopeia, and the European Medicines Agency). The candidate will collaborate closely with a diverse group of translational researchers (e.g., chemists, biologists and computational biologists) and external collaborators that use G-SRS, Translator or other DPI Informatics resources in their own projects. Qualifications The ideal candidate should possess a Master of Science in computer science (or a related discipline) or three years of specialized experience (JAVA 8+, Spring Boot, Python, Django) plus a bachelor's degree in computer science or relevant applied discipline. Experience should include a minimum of four years of research and software development experience, applying systems engineering, agile software development best practices, and data-centric principles to design, develop, and deploy software applications and services using core software development languages (JAVA 8+/Python), database technologies (Oracle, MySQL, PostgreSQL), web application development (HTML/CSS/JavaScript), GraphQL and Neo4j/Cypher query language, search services (Elasticsearch, Apache Solr, Apache Lucene), API development tools (Strapi/Swagger/OpenAPI), modern virtualization approaches (AWS/Docker), varied application architectural style (monolith, microservices [Spring Boot], event-driven [pub-sub]), and modern web application frameworks (Angular, TypeScript, Node.js). The selected candidate should have excellent interpersonal, verbal and written communication skills and should possess excellent analytical, organizational and time management skills. Experience is required in working with a team of software developers through agile sprints and tracking work through such tools as Jira and GitHub projects. The desire to learn new, cutting-edge technologies to write applications is expected. How to Apply Please submit (via email) a cover letter describing your career goals and interest in the position, a current curriculum vitae, and the names of and contact information for at least three references to Ewy A. Mathé, Ph.D., at ewy.mathe@nih.gov. The review of applications will begin immediately and will continue until the position is filled. Learn more about informatics research at NCATS. Staff Scientist (Informatics Algorithms Engineer), Division of Preclinical Innovation, Informatics Core National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Informatics Core Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from exceptional candidates to fill a staff scientist (informatics algorithms engineer) position in the Informatics Core (IFX) within the Division of Preclinical Innovation (DPI). The mission of IFX is to produce data-driven decisions and accelerate translation through innovative informatics methods and software and deep domain expertise in informatics and various translational research data types. This mission is achieved through our team science culture and collaborations that span DPI, extramural NCATS programs, other federal institutions, industry/biotech, and academic institutions nationally and internationally. IFX efforts and contributions are broadly organized into 1) Building Standards, Knowledge Sources, and Software; 2) Translational Data Analytics; 3) Scientific Computing Services and Research. These efforts are highly synergistic where outcomes from one category inform and are expanded into others. Core Responsibilities The successful candidate will develop novel informatics and statistical methods/workflows and proof-of-concept tools to support the integration, analysis and interpretation of translational research data and make these outcomes publicly available to the broader research community. These data result from efforts in basic research, patient-oriented research and population-based research. The selected candidate will interact closely with the IFX director, computational and noncomputational (e.g., biologists, chemists, clinicians) IFX and NCATS scientists and our academic collaborators. He or she will contribute to the strategic vision and to the mentoring of trainees. The selected candidate will be encouraged to seek NCATS, NIH or external collaborations to further amplify and improve the Center’s IFX informatics methods and software. He or she will elaborate on machine and deep learning and architectures from aggregation and cleaning of in-house translational research data (e.g., high-throughput screens, multi-omic, knowledge sources on chemical, biological, or disease annotations, etc.). To augment translational research efforts, the selected candidate will promote the use of and/or contribute to the development of chemical, biological and disease standards that help piece together complementary lines of information. The selected candidate will be expected to create and maintain documentation for methods/workflows to enable their reuse by IFX members or other researchers. Furthermore, he or she will contribute to the establishment of software development and deployment best practices for IFX, including acting as an owner/point of contact for repositories, data systems and servers. The selected candidate will contribute to building a consolidated scientific computing environment through integration and interoperability of libraries and software and will apply or develop appropriate, state-of-the art methods to support large-scale data-acquisition efforts within the DPI. Active participation in IFX and NCATS committees and meetings, as appropriate, will be encouraged to showcase and obtain feedback (e.g., user feedback) on methods and software developed. He or she will be expected to draft manuscripts and publish results in high-impact, peer-reviewed scientific journals and to present results at internal and external scientific meetings. Qualifications The ideal candidate should possess a doctoral degree (M.D., Ph.D. or equivalent) in a relevant field and be a recognized expert in the field. Applicants should possess a broad range of informatics experience that includes at least some of the following: Machine learning and/or deep learning (Bayesian inference, Probabilistic programming, NLP, TensorFlow, etc.); experience in graph, NoSQL and/or RDBMS databases and semantic data standards (e.g., OWL, RDF); scripting programming for high-throughput data processing and visualization (e.g., R, Python); Linux environments, high-computing servers, cloud computing; versioning systems (GitHub), full-stack software development. A strong preference will be given to applicants with knowledge in biology and/or chemistry and an understanding of data provenance (e.g., cell biology, methods for measuring multi-omic data, high throughput screens, biochemistry, genetics). Candidates should have proven experience in analyzing a broad range of data types across different diseases and exploit these data for therapeutic development. The selected candidate should have excellent interpersonal, verbal and written communication skills and should possess excellent analytical, organizational and time management skills. The desire and drive to seek out and master novel technologies and to develop new ones is expected. Salary/Benefits The current salary range is commensurate with experience and accomplishments; a full civil service benefits package — including retirement; health, life and long-term care insurance; Thrift Savings Plan (401K equivalent) participation, etc. — is available. How to Apply Please submit (via email) a cover letter describing your career goals and interest in the position, including a research summary (one to two pages), a current curriculum vitae with a complete bibliography, and the names of and contact information for at least three references to Ewy A. Mathé, Ph.D., at ewy.mathe@nih.gov. The review of applications will begin immediately and will continue until the position is filled. Learn more about informatics research at NCATS. Research Associate (Biology), Division of Preclinical Innovation, Chemical Technologies Group National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Chemical Technologies Group Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from qualified candidates to fill a research associate (biology) position in the Chemical Technology group within its Division of Preclinical Innovation (DPI). The DPI is home to approximately 230 biologists, medicinal and process chemists, and computational scientists who work on a broad portfolio of preclinical drug discovery projects, as well as programs that involve the development of innovative new technologies to enable the acceleration of biomedical research. The Chemical Technology group operates at the interface between chemistry and biology. A major focus of the team involves conducting large-scale chemogenomic screenings to identify novel targets and to develop novel strategies for therapeutic intervention, mostly focusing on oncologic indications. A second major focus of the team involves the discovery, optimization and advancement of novel biologically active small molecules. Core Responsibilities The selected candidate will maintain mammalian cell-line cultures and expand them to scale in preparation of high-throughput drug screening; prepare various media, stock supplies and other reagents for use in the laboratory; perform in vitro cell-based assays to support the molecular characterization of drugs’ mechanism of action. These include DNA/RNA extraction, PCR and western-blot. The selected applicant also will maintain accurate daily records of experiments and results and interpret, evaluate and discuss the result of each experiment as part of the experimental-planning process. The selected candidate will perform computer analysis of data and use various software to prepare data figures for both internal discussion and publication. Qualifications Applicants to this research associate (biology) position should possess a bachelor's degree in biology, biochemistry or other related life science discipline. A master’s in cell biology, immunology, biochemistry or other related life science discipline is preferred. The selected candidate should possess a conceptual understanding of cancer biology and knowledge of major oncogenic signaling pathways in human cancers, a strong background in cell biology, have at least two years of previous experience with standard molecular biology techniques (e.g., tissue culture, RNA and DNA extraction, PCR and western-blot) and be proficient at the bench. He or she should demonstrate attention to detail and possess strong organizational and interpersonal skills. Applicants also should possess excellent verbal and written communication skills, the ability to interpret, summarize and present scientific results in a clear, concise and accurate manner; and be able to work productively as a member of a diverse and dynamic multidisciplinary team. The ideal candidate will have previous experience with high-throughput drug screening, Illumina next-generation sequencing platforms and related library preparation procedures (especially RNA-Seq and single-cell analysis), as well as documented knowledge of the hippo signaling pathway. Previous experience in microscopy, immunocytochemistry and flow cytometry, as well as strong computer literacy and Microsoft Excel proficiency — particularly with respect to graph/plots generation and analysis of large data sets — will be considered a plus. Salary/Benefits The current salary range is commensurate with experience and accomplishments. How to Apply Please submit a cover letter describing your interest in the position, a current curriculum vitae with a complete bibliography, and the names of and contact information for three references to ncatspt3hiring@mail.nih.gov. The review of applications will begin immediately and will continue until the position is filled. Learn more about intramural research at NCATS. Research Scientist (Virology) Position, Division of Preclinical Innovation, 3-D Tissue Bioprinting Laboratory National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation 3-D Tissue Bioprinting Laboratory Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from qualified candidates to fill a research scientist (virology) position in the 3-D Tissue Bioprinting Laboratory within its Division of Preclinical Innovation. Core Responsibilities The selected candidate will work as part of a multidisciplinary team of innovative scientists, using cutting-edge technologies — including tissue biofabrication, tissue chips, quantitative cell imaging, histology, assay development, drug screening, data science and other -omics technologies (e.g., scRNAseq) — to develop advanced 3-D cellular models to study viral infections and drug screening. The selected candidate should be a self-motivated, driven, thorough and careful experimentalist with the ability to multitask, think independently and work in a highly creative, interactive and fast-paced environment. The selected candidate also will be expected to work independently as a well-trained problem solver in virology. Effective communication and presentation skills are required. The selected applicant will keep accurate and complete records of all scientific experiments according to established procedures and ensure that these records and raw data are properly retained. The selected candidate will draft technical reports, manuscripts and patent applications, and present work to internal and external collaborators as needed. The selected candidate also should be eligible to work in the U.S. with whomever NCATS collaborates worldwide. Qualifications Applicants to this research scientist position should possess a Ph.D. in virology, cell or molecular biology or pharmacology, and at least three years of postdoctoral experience. The selected candidate should have expertise in virology to help establish a portfolio of complex physiologically relevant 3-D tissue models as predictive screening platforms to study viral infections and drug testing. Applicants should have additional expertise in histology, fluorescence microscopy, flow cytometry, single-cell RNA sequencing (scRNAseq), and production of induced pluripotent stem cell-derived cells. Candidates with previous experience working in a BSL3 lab and in areas such as organoids, tissue chip, cell imaging, histology and engineering of cells with biosensors will be considered favorably. How to Apply Please submit, in PDF format, a cover letter that includes a research summary and describes your interest in the position, a current curriculum vitae with a complete bibliography, and the names of and contact information for 3 references, including your current supervisor, to NCATSbioprinting@mail.nih.gov. Selected applicants will be required to submit letters of reference to complete the hiring process. The review of applications will begin immediately and will continue until the position is filled. Learn more about intramural research at NCATS. Bioinformatician, Division of Preclinical Innovation, Chemical Genomics Branch, Stem Cell Translation Laboratory National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Chemical Genomics Branch Stem Cell Translation Laboratory Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from qualified candidates to fill a bioinformatician position in the Stem Cell Translation Laboratory (SCTL) within the Chemical Genomics Branch of the Center’s Division of Preclinical Innovation. The SCTL focuses on translating human pluripotent stem cells, such as induced pluripotent stem cells, into clinical applications and drug discovery by developing innovative technologies, methods and comprehensive multi-omics data sets through differentiation into relevant cell types in 2-D and 3-D cell culture systems. The successful candidate will have a chance to develop their skills in a highly dynamic environment, embedded in a team of passionate scientists working on a wide range of projects related to translational stem cell biology. They will have a chance to interact with experienced bioinformaticians at NCATS and collaborators at top academic institutions. Core Responsibilities Computational analysis is integral to the laboratory’s efforts in the deep characterization of stem cell states and functional cell types from different developmental lineages. The bioinformatician will be required to promptly turn around analysis results to respond to biologists’ ongoing projects, work on multiple projects in parallel, and coordinate and oversee data analysis with external service providers. Qualifications Applicants should have a master’s degree or higher in bioinformatics, computational biology or biomedical data science. The ideal candidate should have strong science communication skills; clear and effective data visualization skills; the ability to work well independently and in a team environment; creative problem-solving skills; and a proven ability to apply the cutting-edge, rigorous standards of the bioinformatics fields. Applicants should possess a solid knowledge of R statistical programming language; familiarity with the handling, management and storage of large-scale sequencing data; and experience querying public databases, including the SRA, GEO and dbGaP. Preferred qualifications include experience with next-generation sequencing methods on Illumina and 10x Genomics platforms (e.g., bulk and single-cell RNA-Seq; ChIP-seq methods, such as MeDIP-seq; bulk and single-cell ATAC-seq; and miRNA-seq). Experience with other ‑omics — such as WES, WGS and targeted sequencing methods — are a plus. The ideal candidate will have experience with pre-processing tools for alignment, counting or sequence analysis (e.g., Cell Ranger, STAR, HTSeq, featureCounts, salmon, GATK) and R packages designed for the above-mentioned methods (e.g., DESeq2, limma, Seurat). A solid understanding of clustering and dimensionality reduction techniques for big genomic datasets, experience with Python programming, and familiarity with Linux BASH scripting, which is necessary for proper utilization of NIH’s high-performance computing capabilities, are preferred. Salary/Benefits The current salary range is commensurate with experience and accomplishments. How to Apply Please submit a cover letter describing your interest in the position, a current curriculum vitae with a complete bibliography, and the names of and contact information for three references to NCATSstemcellhiring@mail.nih.gov. The review of applications will begin immediately and will continue until the position is filled. Postdoctoral Positions in the Division of Preclinical Innovation The Division of Preclinical Innovation (DPI) is the intramural (i.e., on-site) research program of NCATS and is located in Rockville, Maryland, a few miles from the main NIH campus in Bethesda, Maryland. DPI focuses on early stages of the translational process, from target validation to first-in-human studies. More than 200 scientists from a variety of disciplines and across the spectrum from early-career scientists to senior leaders are responsible for advancing the diverse research portfolio of DPI. In addition to conducting cutting-edge laboratory research, DPI scientists collaborate with more than 250 research organizations worldwide. DPI scientists work in a collaborative, team-based environment. The postdoctoral candidate will be recruited to work on the specific projects described below and will have ample opportunities to collaborate with scientists both within and outside of NCATS on additional projects. Candidates are expected to present results of ongoing work at meetings (such as internal group meetings and national conferences) and submit their work for publication in scientific journals. Postdoctoral fellows also gain additional professional skills and exposure to a variety of career paths through participation in the DPI training program. Neuroscientist Postdoctoral Fellow Positions, Division of Preclinical Innovation, 3-D Tissue Bioprinting Laboratory National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation 3-D Tissue Bioprinting Laboratory Rockville, Maryland Description NCATS’ Division of Preclinical Innovation seeks applications from qualified candidates to fill neuroscientist postdoctoral fellow positions in the Division’s 3-D Tissue Bioprinting Laboratory. The selected candidates will develop human functional neural 3-D tissue models as assay platforms for the discovery and development of new therapeutics for pain, addiction or overdose. Applicants with a background in neurosciences, in vitro neural organotypic models and neural stem cells will receive preferential consideration. Core Responsibilities The selected candidates will work as part of a multidisciplinary team of innovative scientists with expertise in bioengineering, 3-D bioprinting, quantitative cell imaging, electrophysiology, histology, assay development, drug screening, data science and other cutting-edge “omics” technologies. The selected candidates will develop and characterize functional 3-D neural organotypic assays for drug discovery and development. Qualifications Applicants to these postdoctoral fellow positions should possess a Ph.D. in neuroscience, cell biology, molecular biology, pharmacology, pathology or a related discipline with relevant experience in neuroscience, physiology and pathology of the nervous system to help establish a portfolio of assays to model neural circuitry of pain, addiction and overdose. The ideal candidates will be expected to work independently as well-trained problem solvers in the production of 3-D neural organotypic models, including architectural and physiological validation, and develop functional assay readouts for drug screening. They will keep accurate and complete records of all scientific experiments according to established procedures and ensure that these records and raw data are properly retained. They also will draft technical reports, manuscripts and patent applications and present work internally and externally to consultants and collaborators as needed. Experience in techniques necessary to develop CNS and PNS assays for drug testing using tissues, including extracellular electrophysiological recording (field potential or multi-unit), calcium imaging, neural stem cell and primary cell culture and associated analysis is required. Experience with techniques such as histology, quantitative analysis of microscopy images, time-lapse microscopy is highly desired. Candidates with additional experience in physiology and pathology of pain, addiction or overdose, optogenetics microscopy, or tissue engineering or bioprinting techniques will receive preferential consideration. Each candidate should be an independent thinker and team player able to work and multitask in a highly interactive, fast-paced environment. The ideal candidate should possess strong oral and written communication skills with a proven publication record in peer-reviewed journals. Applicants should be eligible to work in the United States for any employer. Stipends/Benefits Annual stipends commensurate with experience are provided and are based on the NIH Postdoctoral Intramural Research Training Award and Visiting Fellow scale; medical insurance coverage will be provided. The fellow also may take part in Foundation for Advanced Education in the Sciences courses at NIH. The position is renewable for up to five years. How to Apply Please submit (via email) a cover letter that includes a research summary and describes your interest in the position, a current curriculum vitae with a complete bibliography, and the names of and contact information of at least three references to NCATSbioprinting@mail.nih.gov. The review of applications will begin immediately and will continue until these positions are filled. Learn more about intramural research at NCATS. Computational Scientist (Cheminformatics) Postdoctoral Fellow, Division of Preclinical Innovation, Drug Metabolism and Pharmacokinetics National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Drug Metabolism and Pharmacokinetics Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from exceptional scientists to serve as a computational scientist (cheminformatics) postdoctoral fellow — for preclinical development projects involving drug metabolism and pharmacokinetics (DMPK) — within the Center’s Division of Preclinical Innovation. The DMPK Core partners with collaborators (academic institutions, foundations and private industry) to conduct preclinical discovery and development studies leading to Investigational New Drug (IND) applications for new therapeutics. These projects play a leading role in NCATS’ mission to develop new ways to reduce, remove or bypass bottlenecks across the entire continuum of translational science and to address rare and neglected diseases. Core Responsibilities The selected candidate will work collaboratively with team members to evaluate, develop and implement in silico absorption, distribution, metabolism and excretion (ADME) models for assigned projects. Specific duties include analyzing DMPK data using state-of-the-art methods and exploring new computational methodologies and approaches from the literature in a constant effort to improve existing models and reveal useful medicinal chemistry insights. The selected candidate also will be responsible for developing new structure-based computational models for predicting DMPK properties. They will collaborate with chemists and researchers across different teams within NCATS to address project-specific needs (e.g., development of local models for a particular project team). Additional duties include disseminating research via peer-reviewed publications and participating in scientific conferences and meetings. The selected candidate should possess strong oral and written communication skills. They also should possess excellent interpersonal skills, including the ability to communicate clearly and succinctly in a timely manner. The selected candidate will be expected to demonstrate a proven ability to work collaboratively with colleagues to achieve project, team and organizational goals. Qualifications Applicants to this postdoctoral fellow position should possess a Ph.D. in bioinformatics, cheminformatics, computational biology, pharmaceutical science, chemistry, structural biology or a related field. A proven track record of coding in Python and applying machine/deep learning techniques to drug discovery data using popular Python libraries (e.g., Scikit-learn, TensorFlow, Keras and PyTorch) is highly desired. Candidates with advanced knowledge and skills in graph neural networks or equivariant neural networks will receive preferential consideration. Experience working on cloud platforms — such as Amazon Web Services or Microsoft Azure (or a similar high-performance computing environment) — will be considered favorably. Applicants also should possess strong oral and written English communication skills and be able to work in a highly collaborative team setting. Stipends/Benefits The salary will be commensurate with experience, based on the NIH Postdoctoral Intramural Research Training Award and Visiting Fellow scale; medical insurance coverage will be provided. The position is renewable for up to five years. How to Apply Please email a cover letter describing your interest in the position, including a career synopsis (one to two pages); a current curriculum vitae with a complete bibliography; and the names of and contact information for at least three references to Pranav A. Shah, Ph.D., (pranav.shah@nih.gov) and Xin Xu, Ph.D. (xin.xu3@nih.gov). Review of applications will begin on Jan. 7, 2022, and will continue until the position is filled. Antiviral Discovery Informatics Postdoctoral Fellow Positions, Division of Preclinical Innovation, Antiviral Program for Pandemics National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Antiviral Program for Pandemics Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from qualified candidates to fill antiviral discovery informatics postdoctoral fellow positions in the Antiviral Program for Pandemics (APP) within the Center’s Division of Preclinical Innovation. Multiple positions are available for motivated individuals to work in a translational science laboratory team environment with a focus on multiple target-based programs, including assay development, high-throughput screening and drug lead optimization. Launched in June 2021 with more than $3 billion in funding from the American Rescue Plan, the APP will accelerate the development of a portfolio of promising antivirals that can move rapidly into later-stage clinical trials to combat future pandemics. Having safe and effective oral antiviral candidates ready for deployment in later-stage clinical trials against a newly emergent virus would save lives, reduce serious illness and prevent overwhelming surges in hospitalizations during a viral outbreak or pandemic. NCATS will partner with extramural scientists and the private sector to advance drug discovery and development programs for oral antiviral candidates. NCATS can collaborate on projects with entry points anywhere along the development pipeline — and with flexible project exit points — to accelerate discovery and overcome the scientific, technical and enterprise barriers to delivering drug candidates ready for Phase 2 clinical trials in future pandemics. Core Responsibilities The selected candidates will work as part of a multidisciplinary team of innovative scientists using cutting-edge technologies for the development of antiviral drugs. The postdoctoral fellows will be responsible for developing new algorithms for the prediction of protein–ligand interactions and deep generative models, developing and applying QSAR models and molecular modeling techniques for the virtual screening of compounds, and lead optimization efforts. Candidates should be self-motivated, driven, thorough and careful experimentalists with the ability to multitask, think independently and work in a highly creative, interactive and fast-paced environment. In addition to teamwork, they also will be expected to work independently as well-trained problem solvers. Effective communication and presentation skills are required. The selected candidate will keep accurate and complete records of all scientific experiments according to established procedures and ensure that these records and raw data are properly retained. They will draft technical reports, manuscripts and patent applications and present work to internal and external collaborators as needed. Qualifications Applicants to this postdoctoral fellow position should possess a Ph.D. in computational science or bioinformatics with a specialization in machine learning or computational chemistry. Candidates with previous experience with common cheminformatics libraries and data formats (e.g., RDKit, OpenBabel, SMILES, InChi), modern software packages (e.g., MOE/CCG, OpenEye tools), scientific programming (e.g., Python, JAVA) and data analytics (e.g., KNIME, Spotfire) are preferred. Stipends/Benefits The salary will be commensurate with experience, based on the NIH Postdoctoral Intramural Research Training Award and Visiting Fellow scale; medical insurance coverage will be provided. The position is renewable for up to five years. How to Apply Please email a cover letter describing your research and career goals, a current curriculum vitae with a complete bibliography, and the names of and contact information for three references to NCATS APP Hiring at NCATSAPPHiring@nih.gov. Applicants also should indicate when they are available to start. Please note that the starting date of the fellowship is flexible, preferably within 2021. The review of applications will begin immediately and will continue until the position is filled. Learn more about NCATS’ role in the APP. Antiviral Discovery Informatics Postdoctoral Fellow Positions, Division of Preclinical Innovation, Antiviral Program for Pandemics National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Antiviral Program for Pandemics Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from qualified candidates to fill antiviral discovery informatics postdoctoral fellow positions in the Antiviral Program for Pandemics (APP) within the Center’s Division of Preclinical Innovation. Multiple positions are available for motivated individuals to work in a translational science laboratory team environment with a focus on multiple target-based programs, including assay development, high-throughput screening and drug lead optimization. Launched in June 2021 with more than $3 billion in funding from the American Rescue Plan, the APP will accelerate the development of a portfolio of promising antivirals that can move rapidly into later-stage clinical trials to combat future pandemics. Having safe and effective oral antiviral candidates ready for deployment in later-stage clinical trials against a newly emergent virus would save lives, reduce serious illness and prevent overwhelming surges in hospitalizations during a viral outbreak or pandemic. NCATS will partner with extramural scientists and the private sector to advance drug discovery and development programs for oral antiviral candidates. NCATS can collaborate on projects with entry points anywhere along the development pipeline — and with flexible project exit points — to accelerate discovery and overcome the scientific, technical and enterprise barriers to delivering drug candidates ready for Phase 2 clinical trials in future pandemics. Core Responsibilities The candidates will work as part of a multidisciplinary team of innovative scientists using cutting-edge technologies for the development of antiviral drugs. The postdoctoral fellows will be responsible for prioritizing antiviral targets for therapeutic development, developing new algorithms for the detection of ligand binding sites, predicting their spectrum of activity against family members and assessing the potential for the development of resistance. Fellows also will support lead discovery work for prioritized targets. Candidates should be self-motivated, driven, thorough and careful experimentalists with the ability to multitask, think independently and work in a highly creative, interactive and fast-paced environment. In addition to teamwork, they also will be expected to work independently as well-trained problem solvers. Effective communication and presentation skills are required. The selected applicants will keep accurate and complete records of all scientific experiments according to established procedures and ensure that these records and raw data are properly retained. They will draft technical reports, manuscripts and patent applications and will present work to internal and external collaborators as needed. Qualifications Applicants to this postdoctoral fellow position should possess a Ph.D. in computational science or bioinformatics. Candidates with previous experience with bioinformatics (e.g., Blast, QIAGEN IPA), molecular modeling software packages (e.g., Maestro, MOE/CCG, OpenEye tools), scientific programming (e.g., Python, JAVA) and data analytics (e.g., KNIME, Spotfire) are preferred. Stipends/Benefits The salary will be commensurate with experience, based on the NIH Postdoctoral Intramural Research Training Award and Visiting Fellow scale; medical insurance coverage will be provided. The position is renewable for up to five years. How to Apply Please email a cover letter describing your research and career goals, a current curriculum vitae with a complete bibliography, and the names of and contact information for three references to NCATS APP Hiring at NCATSAPPHiring@nih.gov. Applicants also should indicate when they are available to start. Please note that the starting date of the fellowship is flexible, preferably within 2021. The review of applications will begin immediately and will continue until the position is filled. Learn more about NCATS’ role in the APP. Postdoctoral Bioinformatics Position, Division of Preclinical Innovation, Informatics Core National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Informatics Core Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from exceptional candidates to fill a postdoctoral bioinformatics position in the Informatics Core (IFX) within the Division of Preclinical Innovation. The IFX is an interdisciplinary team of bioinformaticians, clinical informaticians, cheminformaticians and software engineers who collaborate closely with molecular biologists to augment the use of metabolomics and multi-omics analysis approaches to identify dysregulated pathways and putative therapeutic targets. Core Responsibilities The selected candidate — a postdoctoral fellow in bioinformatics — will have a solid foundation in bioinformatics and biostatistics, including machine learning, and experience in cleaning, processing, and integrating metabolomic and other -omic datasets. He or she will develop novel bioinformatics methods to optimize the predictive capacity of metabolomics and -omic (e.g., proteomic, transcriptomic) profiles in differentiating groups (e.g., cell characteristics, individuals). These novel approaches will augment the bioinformatics field by addressing issues not addressed by standard approaches. The selected candidate will interact closely with computational and noncomputational (e.g., biologists, chemists, clinicians) IFX and NCATS scientists and our academic collaborators. In addition to working independently on collaborative translational research projects, the fellow also would be involved in building a computational infrastructure for the QC, analysis and interpretation of metabolomic and multi-omic profiles. He or she will be expected to draft manuscripts and publish results in high-impact, peer-reviewed scientific journals and to present results at internal and external scientific meetings. Qualifications The ideal candidate should possess a doctoral degree or equivalent in bioinformatics, biomedical informatics, or a related field and have demonstrated hands-on experience in leading the large-scale analysis of multi-omic data. Experience with metabolomics data is strongly preferred. He or she should have demonstrated experience leveraging publicly available datasets, including their organization, cleaning and preprocessing. Applicants also should have demonstrated experience in multivariable analyses and machine/deep learning. Basic knowledge and understanding of biology and chemistry is a plus. Knowledge of R and/or Python and working within a high-performance computing/cloud environment is required. The selected candidate should have excellent interpersonal, verbal and written communication skills in English and should possess strong collaborative, organizational and recordkeeping skills; the ability to work productively as a member of a diverse and dynamic multidisciplinary team, managing multiple research studies simultaneously; and the desire to acquire new skills as required for research studies. While the team is highly collaborative in nature, the pursuit of original computational research directions by the candidate is encouraged. Applicants should be eligible to work in the United States for any employer. Stipends/Benefits Annual stipends are provided and are based on the NIH Postdoctoral Intramural Research Training Award and Visiting Fellow scale; health insurance benefits are available. The fellow also may take part in Foundation for Advanced Education in the Sciences courses at NIH. The position is renewable for up to five years. How to Apply Please submit (via email) a cover letter describing your career goals and interest in the position, including a research summary (one to two pages), a current curriculum vitae with a complete bibliography, and the names of and contact information for at least three references to Ewy A. Mathé, Ph.D., at ewy.mathe@nih.gov. The review of applications will begin immediately and will continue until the position is filled. Learn more about informatics research at NCATS. Antiviral Discovery Biology – Target Validation/Discovery Postdoctoral Fellow Positions, Division of Preclinical Innovation, Antiviral Program for Pandemics National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Antiviral Program for Pandemics Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from qualified candidates to fill antiviral discovery biology – target validation/discovery postdoctoral fellow positions in the Antiviral Program for Pandemics (APP) within the Center’s Division of Preclinical Innovation. Multiple positions are available for motivated individuals to work in a translational science laboratory team environment with a focus on multiple target-based programs including assay development, high-throughput screening and drug lead optimization. Launched in June 2021 with more than $3 billion in funding from the American Rescue Plan, the APP will accelerate the development of a portfolio of promising antivirals that can move rapidly into later-stage clinical trials to combat future pandemics. Having safe and effective oral antiviral candidates ready for deployment in later-stage clinical trials against a newly emergent virus would save lives, reduce serious illness and prevent overwhelming surges in hospitalizations during a viral outbreak or pandemic. NCATS will partner with extramural scientists and the private sector to advance drug discovery and development programs for oral antiviral candidates. NCATS can collaborate on projects with entry points anywhere along the development pipeline — and with flexible project exit points — to accelerate discovery and overcome the scientific, technical and enterprise barriers to delivering drug candidates ready for Phase 2 clinical trials in future pandemics. Core Responsibilities The candidates will work in the Functional Genomics Laboratory using cutting-edge technologies to develop assays and study viral infections for drug discovery for SARS-CoV-2 and other viruses of pandemic potential. Candidates should keep abreast of current developments of functional genomics technologies (RNAi and CRISPR/Cas9) and antiviral research. Candidates should be self-motivated, driven, thorough and careful experimentalists with the ability to multitask, think independently and work in a highly creative, interactive and fast-paced environment. In addition to teamwork, they also will be expected to work independently as well-trained problem solvers. Effective communication and presentation skills are required. The selected applicants will keep accurate and complete records of all scientific experiments according to established procedures and ensure that these records and raw data are properly retained. They will draft technical reports, manuscripts and patent applications and present work to internal and external collaborators as needed. The selected candidate also should be eligible to work in the United States and with whomever NCATS collaborates worldwide. Qualifications Applicants to this postdoctoral fellow position should possess a Ph.D. in virology, cell or molecular biology, or pharmacology. Candidates with previous experience — including functional genomics (RNAi and CRISPR/Cas9), viral life cycle surrogate systems (viral pseudotyping, virus like particles, minigenome and budding systems), proficiency with establishing assay formats (e.g., flow cytometry, luminescence-/fluorescence-/FRET-based cellular readouts viability, proliferation, high-content imaging) and screen execution — will be preferred. Stipends/Benefits The salary will be commensurate with experience, based on the NIH Postdoctoral Intramural Research Training Award and Visiting Fellow scale; medical insurance coverage will be provided. The position is renewable for up to five years. How to Apply Please email a cover letter describing your research and career goals, a current curriculum vitae with a complete bibliography, and the names of and contact information for three references to NCATS APP Hiring at ncatsfglrecruitment@mail.nih.gov. Applicants also should indicate when they are available to start. Please note that the starting date of the fellowship is flexible, preferably within 2021. The review of applications will begin immediately and will continue until the position is filled. Learn more about NCATS’ role in the APP. Medicinal Chemistry Postdoctoral Fellow Positions, Division of Preclinical Innovation, Early Translation Branch National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Early Translation Branch Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from qualified candidates to fill three postdoctoral medicinal chemistry positions in the Early Translation Branch (ETB) within its Division of Preclinical Innovation. Based on their area of expertise, the selected candidates will join one of the ETB’s multidisciplinary teams that consist of scientists who are well versed in assay biology, high-throughput screening, informatics and medicinal chemistry. Team members work closely with biology and disease experts on multiple projects, tackling a range of translational science challenges. The ETB’s research goals include creating assay and discovery technologies to develop new chemical probes against understudied targets/phenotypes that validate new therapeutic approaches to cure or ameliorate diseases. The selected candidates will work in a highly creative medicinal chemistry environment and will design, synthesize and optimize potential probe molecules against a variety of targets, pathways and phenotypes. They will develop small molecules, leading to proof-of-concept studies that validate the therapeutic approach. Core Responsibilities The selected candidates should be well trained in the methods and concepts of organic chemistry with experience in organic synthesis (purification and analysis of reaction products, methodology development, design of novel analogs, design and testing of synthetic routes to novel compounds by proposing and reducing to practice multistep syntheses). Furthermore, experience in standard spectroscopic and purification methods, including nuclear magnetic resonance (routine pulse techniques for structure determination), and standard or automated liquid chromatography and high-performance liquid chromatography methods is required. The selected candidates will keep accurate and complete records of all scientific experiments, according to established procedures, and ensure that these records and raw data are properly retained. They will be expected to draft technical reports, manuscripts and patent applications and will present work to internal and external collaborators as needed. The selected candidates also will work under the mentorship of a chemistry team leader and be exposed to cutting-edge quantitative high-throughput screening, assay biology, bioinformatics, medicinal chemistry, chemical biology and disease-relevant biological models. They should have strong communication skills, which are necessary for working in a cross-disciplinary team environment. An understanding of and previous experience or exposure to structure–activity relationship studies and absorption, distribution, metabolism and excretion optimization is desirable but not necessary. Qualifications Applicants should have (or expect to receive) a Ph.D. in organic chemistry (i.e., synthesis, methodology development or medicinal chemistry) and have less than 10 years of postdoctoral experience in medicinal chemistry (academia, government or industry). Exceptional candidates completing their doctorate or postdoctoral training will be considered. Master’s degree candidates with extensive experience in industry also are encouraged to apply. Experience in proposing and reducing to practice multistep syntheses and in standard spectroscopic and purification methods is required. Experience in hit-to-lead or lead optimization is highly desirable. Each candidate should be an independent thinker and team player able to work in a highly interactive, fast-paced environment. Stipends/Benefits Annual stipends are provided commensurate with experience based on the NIH Postdoctoral Intramural Research Training Award and Visiting Fellow scale; medical insurance coverage will be provided. The fellow also may take part in Foundation for Advanced Education in the Sciences courses at NIH. The position is renewable for up to five years. How to Apply Please submit, in PDF format, a cover letter that includes a research summary and describes your interest in the position, a current curriculum vitae with a complete bibliography, and the names of and contact information for two to three references, including your current supervisor, to ETB Team Lead Ganesha Rai at NCATSETBCareers@nih.gov. The review of applications will begin immediately and will continue until the position is filled. Learn more about intramural research at NCATS. Biology Postdoctoral Fellow Position, Division of Preclinical Innovation, Early Translation Branch National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Early Translation Branch Rockville, Maryland Description NCATS, a major research component of NIH, is seeking applications from exceptional candidates to fill a postdoctoral position in the Early Translational Branch (ETB) of its Division of Preclinical Innovation. Part of the ETB’s mission is to develop new therapeutic approaches in areas of medical need. The branch partners with external collaborators who specialize in specific disorders, creating a multidisciplinary team of innovative scientists with expertise in assay development, high-throughput and high-content screening, automation engineering, bioinformatics, and various -omics technologies. The selected postdoctoral fellow will work under the mentorship of a biology team leader in an interactive laboratory environment within the ETB. He or she will use cutting-edge cell biology and bioassay technologies for the development of disease-relevant screening assays and will be involved in all aspects of the implementation of small-molecule screening programs, including assay design, assay development and optimization, high-throughput screening, data analysis, and mechanism-of-action studies, with the goal of developing assay technologies and novel pharmacological probes. Core Responsibilities The selected candidate should be able to work independently under team supervision. He or she will keep accurate and complete records of all scientific experiments according to established procedures and ensure that these records and raw data are retained properly. The candidate also will draft technical reports and manuscripts and will present their work internally and to external collaborators as needed. Qualifications Applicants should have (or expect to receive) a Ph.D. and have less than three years of postdoctoral experience in cell biology, molecular biology, pharmacology or a related discipline. Experience with cancer and epigenetics — including assays to assess chromatin organization and modifications — is highly desirable. Applicants interested in furthering their knowledge and exposure to translational science are encouraged to apply; prior high-throughput screening experience is not a prerequisite. The selected candidate should be an independent thinker, a team player, and able to work in an interactive, fast-paced environment. Applicants should be eligible to work in the United States for any employer. Stipends/Benefits Annual stipends are provided commensurate with experience based on the NIH Postdoctoral Intramural Research Training Award and Visiting Fellow scale; medical insurance coverage will be provided. The fellow also may take part in Foundation for Advanced Education in the Sciences courses at NIH. The position is renewable for up to five years. How to Apply Please email a cover letter describing your research and career goals, a current curriculum vitae with a complete bibliography, and the names of and contact information for three references to ETB Team Lead Mark J. Henderson, Ph.D., at hendersonmj@mail.nih.gov. Applicants also should indicate when they are available to start. Please note that the starting date of the fellowship is flexible, preferably within 2021. The review of applications review will begin immediately and will continue until the position is filled. Learn more about intramural research at NCATS. Antiviral Medicinal Chemistry Postdoctoral Fellow Positions, Division of Preclinical Innovation, Antiviral Program for Pandemics National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Antiviral Program for Pandemics Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from qualified candidates to fill postdoctoral positions in medicinal chemistry in the Antiviral Program for Pandemics (APP) within the Center’s Division of Preclinical Innovation. Multiple positions are available for motivated individuals to work in a translational science laboratory team environment. The program will include multiple target-based projects requiring medicinal chemistry support for lead generation and lead optimization. The selected candidates will join a multidisciplinary team with biology, chemistry, drug metabolism and pharmacokinetics (DMPK), toxicology, structural biology, and informatics expertise to identify preclinical drug development candidates active against novel targets and pathways associated with SARS-CoV-2 and other viruses of pandemic potential. The candidates will be assigned to a mentor and will be expected to design and synthesize biologically active drug molecules. Launched in June 2021 with more than $3 billion in funding from the American Rescue Plan, the APP will accelerate the development of a portfolio of promising antivirals that can move rapidly into late-stage clinical trials to combat future pandemics. Having safe and effective oral antiviral candidates ready for deployment against a newly emergent virus would save lives, reduce serious illness and prevent overwhelming surges in hospitalizations during a viral outbreak or pandemic. NCATS will partner with extramural scientists and the private sector to advance drug discovery and development programs for oral antiviral candidates. NCATS can collaborate on projects with entry points anywhere along the development pipeline — and with flexible project exit points — to accelerate discovery and overcome the scientific, technical and enterprise barriers to delivering drug candidates. Core Responsibilities The selected candidates should be able to work independently and be well trained in multistep organic synthesis with the ability to synthesize, purify, identify, characterize and analyze compounds using nuclear magnetic resonance (NMR) and mass spectrometry. The selected candidates will keep accurate and complete records of all scientific experiments according to established procedures and ensure that these records and raw data are retained properly. They will draft technical reports, manuscripts and patent applications and will present work internally and to external consultants and collaborators as needed. The understanding of and previous experience or exposure to Structure-Activity Relationship studies and DMPK property optimization is desirable but not necessary. The selected candidate will work under the mentorship of a chemistry team leader and will be expected to learn about the cutting-edge technologies and expertise used for lead optimization in a drug discovery program. Qualifications Applicants should have (or expect to receive) a Ph.D. and have less than three years of postdoctoral experience in organic chemistry and/or medicinal chemistry. Experience in drug discovery and lead optimization is desirable but not necessary. Candidates should be independent thinkers and team players and be able to work in an interactive, fast-paced environment. Applicants should be well trained in the methods and concepts of organic chemistry and have experience in the following: organic synthesis (experience in heterocyclic chemistry is desirable), purification and analysis of reaction products, and design and testing of synthetic routes to novel compounds by proposing and reducing to practice multistep syntheses. Experience in methodology development is desirable. Further, experience in standard spectroscopic and purification methods, including NMR (routine pulse techniques for structure determination) and standard or automated liquid chromatography and high-performance liquid chromatography methods is required. Stipends/Benefits Annual stipends are provided commensurate with experience based on the NIH Postdoctoral Intramural Research Training Award and Visiting Fellow scale; medical insurance coverage will be provided. The fellow also may take part in Foundation for Advanced Education in the Sciences courses at NIH. The position is renewable for up to five years. How to Apply Please email a cover letter describing your research and career goals, a current curriculum vitae with a complete bibliography, and the names of and contact information for three references to NCATS APP Hiring at NCATSAPPHiring@nih.gov. Applicants also should indicate when they are available to start. Please note that the starting date of the fellowship is flexible but preferably within 2021. The review of applications will begin immediately and will continue until the position is filled. Learn more about NCATS’ role in the APP. Antiviral Discovery Biology Postdoctoral Fellow Positions, Division of Preclinical Innovation, Antiviral Program for Pandemics National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Antiviral Program for Pandemics Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from qualified candidates to fill antiviral discovery biology postdoctoral fellow positions in the Antiviral Program for Pandemics (APP) within the Center’s Division of Preclinical Innovation. Multiple positions are available for motivated individuals to work in a translational science laboratory team environment with a focus on multiple target-based programs, including assay development, high-throughput screening and drug lead optimization. Launched in June 2021 with more than $3 billion in funding from the American Rescue Plan, the APP will accelerate the development of a portfolio of promising antivirals that can move rapidly into later-stage clinical trials to combat future pandemics. Having safe and effective oral antiviral candidates ready for deployment in later-stage clinical trials against a newly emergent virus would save lives, reduce serious illness and prevent overwhelming surges in hospitalizations during a viral outbreak or pandemic. NCATS will partner with extramural scientists and the private sector to advance drug discovery and development programs for oral antiviral candidates. NCATS can collaborate on projects with entry points anywhere along the development pipeline — and with flexible project exit points — to accelerate discovery and overcome the scientific, technical and enterprise barriers to delivering drug candidates ready for Phase 2 clinical trials in future pandemics. Core Responsibilities The candidates will work as part of a multidisciplinary team of innovative scientists using cutting-edge technologies to develop assays and study viral infections for drug discovery for SARS-CoV-2 and other viruses of pandemic potential. Candidates should be self-motivated, driven, thorough and careful experimentalists with the ability to multitask, think independently and work in a highly creative, interactive and fast-paced environment. In addition to teamwork, they also will be expected to work independently as well-trained problem solvers. Effective communication and presentation skills are required. The selected applicants will keep accurate and complete records of all scientific experiments according to established procedures and ensure that these records and raw data are properly retained. They will draft technical reports, manuscripts and patent applications and present work to internal and external collaborators as needed. The selected applicants also should be eligible to work in the United States and with whomever NCATS collaborates worldwide. Qualifications Applicants to this postdoctoral fellow position should possess a Ph.D. in virology, cell or molecular biology, or pharmacology. Candidates with previous experience with a variety of techniques — including molecular and cell biology, assay development, high-throughput screening, virology, biochemical assays and cell culture — are preferred. Stipends/Benefits Annual stipends are provided and are based on the NIH Postdoctoral Intramural Research Training Award and Visiting Fellow scale; medical insurance coverage will be provided. The fellow also may take part in Foundation for Advanced Education in the Sciences courses at NIH. The position is renewable for up to five years. How to Apply Please email a cover letter describing your research and career goals, a current curriculum vitae with a complete bibliography, and the names of and contact information for three references to NCATS APP Hiring at NCATSAPPHiring@nih.gov. Applicants also should indicate when they are available to start. Please note that the starting date of the fellowship is flexible, preferably within 2021. The review of applications review will begin immediately and will continue until the position is filled. Learn more about NCATS’ role in the APP. Postdoctoral Biomedical Engineer Position, Division of Preclinical Innovation, 3-D Tissue Bioprinting Laboratory National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation 3-D Tissue Bioprinting Laboratory Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from qualified candidates to fill a postdoctoral biomedical engineering position in the 3-D Tissue Bioprinting Laboratory within its Division of Preclinical Innovation. The selected candidate should have expertise in tissue biofabrication to help establish a portfolio of complex physiologically relevant 3-D tissue models as predictive screening platforms to study viral infections and conduct drug testing. Applicants should have additional expertise in histology, fluorescence microscopy and experience working with primary cells or induced pluripotent stem cell-derived cells. Core Responsibilities The selected candidate will work as part of a multidisciplinary team of innovative scientists, using cutting-edge biofabrication methodologies — including 3-D bioprinting, quantitative cell imaging, histology, assay development, drug screening, data science and other -omics technologies including scRNAseq — to develop advanced cellular models for drug discovery and development. The selected candidate should be a self-motivated, driven, thorough and careful experimentalist with the ability to multitask, think independently and work in a highly creative, interactive and fast-paced team environment. They also will be expected to work independently as well-trained problem solvers in tissue biofabrication, including architectural and physiological validation of the tissues. Effective communication and presentation skills are required. The selected applicants will keep accurate and complete records of all scientific experiments according to established procedures and ensure that these records and raw data are properly retained. They will draft technical reports, manuscripts and patent applications and present work to internal and external collaborators as needed. The selected candidates also should be eligible to work in the U.S. with whomever NCATS collaborates worldwide. Qualifications Each applicant to this postdoctoral position should possess a Ph.D. in bioengineering or biomedical engineering. Candidates with previous experience developing and characterizing complex 3-D cell-based functional assays — including work in areas such as organoids, tissue chip or biofabricated tissues, biomaterials, cell imaging, histology and engineering of cells with biosensors — will be considered favorably. Stipends/Benefits Annual stipends are provided and are based on the NIH Postdoctoral Intramural Research Training Award and Visiting Fellow scale; health insurance benefits are available. The fellow also may take part in Foundation for Advanced Education in the Sciences courses at NIH. How to Apply Please submit, in PDF format, a cover letter that includes a research summary and describes your interest in the position, a current curriculum vitae with a complete bibliography, and the names of and contact information for two to three references, including your current supervisor, to NCATSbioprinting@mail.nih.gov. The review of applications will begin immediately and will continue until the position is filled. Learn more about intramural research at NCATS. Postdoctoral Antibody Discovery and Characterization Position, Division of Preclinical Innovation, Early Translational Branch National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Early Translational Branch Rockville, Maryland Description NCATS, a major research component of NIH, is seeking applications from exceptional candidates to hold a postdoctoral position in antibody discovery and characterization in the Early Translational Branch (ETB) of its Division of Preclinical Innovation. Part of the ETB’s mission is to develop new therapeutic approaches in areas of medical need. The branch partners with external collaborators who specialize in specific disorders, creating a multidisciplinary team of innovative scientists with expertise in assay development, high-throughput and high-content screening, automation engineering, bioinformatics and various -omics technologies. The selected postdoctoral fellow will work under the mentorship of a biology team leader in an interactive laboratory environment and be exposed to cutting-edge high-throughput screening, assay biology, bioinformatics, medicinal chemistry and disease-relevant biological models. They will implement antibody discovery technologies (including phage display), directed evolution, and related technologies to produce and characterize antibodies relevant to diseases and conditions related to pain, addiction and overdose, and other public health emergencies, such as the SARS-CoV-2 pandemic. The selected applicant will apply cutting-edge cell biology and bioassay technologies for the development of disease-relevant antibody selection and screening assays and will be involved in all aspects of the implementation, including assay design, assay development and optimization, antibody screening, protein engineering, data analysis and mechanism-of-action studies. Core Responsibilities The selected candidate should be able to work independently under team supervision. The selected applicant will keep accurate and complete records of all scientific experiments according to established procedures and ensure that these records and raw data are properly retained. They will draft technical reports and manuscripts and will present work internally and to external collaborators as needed. Qualifications Applicants should have (or expect to receive) a Ph.D. and have less than three years of postdoctoral experience in cell biology, molecular biology, pharmacology or a related discipline. Experience with antibody phage display technologies — including panning, ELISA, and protein purification — and an understanding of antibody domain architecture are highly desirable. The candidate should be an independent thinker, a team player, and able to work in a very interactive, fast-paced environment. Applicants should be eligible to work in the United States for any employer. Stipends/Benefits Annual stipends are provided and are based on the NIH Postdoctoral Intramural Research Training Award and Visiting Fellow scale; health insurance benefits are available. The fellow also may take part in Foundation for Advanced Education in the Sciences courses at NIH. How to Apply Please submit, in PDF format, a cover letter that includes a research summary and describes your interest in the position, a current curriculum vitae with a complete bibliography, and the names of and contact information for three references to NCATSantibody_hiring@nih.gov. Selected applicants will be required to submit letters of reference to complete the hiring process. The review of applications will begin immediately and will continue until the position is filled. Learn more about intramural research at NCATS. Postdoctoral Fellow in Clinical and Biomedical Informatics, Division of Preclinical Innovation, Informatics Core National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Informatics Core Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from qualified candidates to fill a postdoctoral fellowship position in the Informatics Core within the Center’s Division of Preclinical Innovation. Applicants to this intramural program should have a background in clinical informatics with an interest in data science. The Informatics Core is a dynamic, interdisciplinary team of clinical, bio- and chem-informaticians, translational researchers, and project managers interested in evaluating drug–disease relationships. For these assessments, the team uses knowledge sources containing clinical, -omic and in vitro assay data (e.g., high-throughput screening) that are curated and/or supported and managed at NCATS. Relevant knowledge sources include but are not limited to the Genetic and Rare Diseases Information Center (GARD), Pharos and Inxight. The goal is to bridge preclinical and clinical assessments to find new putative targets. Candidates with a solid understanding in database management, integration of multiple data sources, data cleaning/processing/harmonization, interoperability and machine learning are preferred. Experience with various types of data sets as listed above is preferred. Although the team is highly collaborative in nature, the candidate’s pursuit of original research directions is strongly encouraged. Core Responsibilities The successful candidate will collect, analyze and curate data from clinical trials, U.S. Food and Drug Administration (FDA) drug labels and FDA orphan designations to elucidate the therapeutic development landscape of diseases, including rare diseases. He or she will identify relevant associations of clinical and molecular factors (e.g., genetic, -omics, etc.) and disease, including rare outcomes and response to treatments. Patient data will be accessed through various electronic health records systems, resources and programs available at NIH (e.g., Biomedical Translational Research Information System, NIH Clinical Center, Clinical and Translational Science Awards [CTSA] Program Data to Health Coordination Center [CD2H], National COVID Cohort Collaborative [N3C] and the Biomedical Data Translator program). The successful candidate then will develop new and robust code to automate the use — and augment data resources — of existing knowledge warehouses, including those developed within NCATS, and contribute to efforts for standardizing and developing new ontologies (e.g., GARD ontology, etc.). He or she is expected to use state-of-the-art linear and nonlinear multivariable modeling and machine learning to identify aforementioned relevant associations and to support clinical decision-making. The candidate will work closely with bioinformaticians, scientists and clinicians to interpret findings and identify areas that require further investigation (e.g., screening or molecular profiling). He or she will present results to the team and to the wider scientific community, draft manuscripts and publish results in peer-reviewed journals, and develop and implement novel approaches when standard approaches are not sufficient. Qualifications The ideal candidate should possess a doctoral degree or equivalent in clinical informatics, biomedical informatics, bioinformatics, or a related field and have demonstrated hands-on experience in leading the analysis of a large (multiple hundreds or greater) cohort data set. He or she should have demonstrated experience in organizing, cleaning and harmonizing large data sets, as well as in applying robust statistical methods, including multivariable analyses, machine learning, etc. Knowledge of R and/or Python is required, and basic knowledge and understanding of clinical and biological interpretation of molecular data (e.g., -omics, assay screening data, etc.) is preferred. The selected candidate should have excellent interpersonal, verbal and written communication skills in English and should possess strong collaborative, organizational and recordkeeping skills; the ability to work productively as a member of a diverse and dynamic multidisciplinary team, managing multiple research studies simultaneously; and the desire to acquire new skills as required for research studies. Applicants should be eligible to work in the United States for any employer. Stipends Annual stipends are provided and are based on the NIH Postdoctoral Intramural Research Training Award and Visiting Fellow scale. The position is renewable for up to five years. How to Apply Please submit (via email) a cover letter describing your career goals and interest in the position, including a research summary (one to two pages), a current curriculum vitae with a complete bibliography, and the names of and contact information for at least three references to Ewy A. Mathé, Ph.D., at ewy.mathe@nih.gov. The review of applications will begin immediately and will continue until the position is filled. Learn more about intramural research at NCATS. Postdoctoral Medicinal Chemistry Position, Division of Preclinical Innovation, Therapeutic Development Branch National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Therapeutic Development Branch Rockville, Maryland Description NCATS, a major research component of NIH, is seeking a highly motivated synthetic chemist to serve as a postdoctoral fellow for drug discovery projects within the Therapeutic Development Branch (TDB) of its Division of Preclinical Innovation. The selected candidate will work on a multidisciplinary team to identify clinical candidates to address unmet medical needs. Core Responsibilities The postdoctoral fellow will be responsible for designing and synthesizing compounds for structure-activity relationship and structure-property relationship studies, developing new technologies to accelerate drug discovery, presenting results in internal and external meetings, and writing reports and manuscripts. The research will be conducted in the TDB medicinal chemistry group. Qualifications Applicants should have (or expect to receive) a Ph.D. in organic chemistry or medicinal chemistry at the time of joining the laboratory. The ideal candidate should be self-motivated, possess a strong work ethic, have keen attention to detail, and be able to work on multiple projects simultaneously. The candidate should possess strong oral and written communication skills with a proven publication record in peer-reviewed journals. Applicants should be eligible to work in the United States for any employer. Stipends/Benefits Annual stipends are provided and are based on the NIH Postdoctoral Intramural Research Training Award and Visiting Fellow scale; health insurance benefits are available. The fellow can take part in Foundation for Advanced Education in the Sciences courses at NIH, as well. How to Apply Please submit a cover letter describing your interest in the position, including a research summary, a current curriculum vitae, and the names of and contact information for three references to Wenwei Huang, Ph.D. at huangwe@mail.nih.gov. The review of applications will begin immediately and will continue until the position is filled. Learn more about intramural research at NCATS. Postdoctoral Genomic Toxicology Position, Division of Preclinical Innovation, Genomic Toxicology Laboratory National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Genomic Toxicology Laboratory Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from qualified candidates to fill a postdoctoral position and apply genomic tools to toxicology and pharmacology in the Genomic Toxicology Laboratory within the Center’s Division of Preclinical Innovation (DPI). The Genomic Toxicology Laboratory, led by David L. Gerhold, Ph.D., participates in the Toxicology in the 21st Century (Tox21) program by developing methods to assess the effects of chemicals on human health, focusing on early stages of the translational process from target validation to first-in-human studies. This laboratory also develops novel human cellular 3-D and co-culture models to study cardiovascular disease, as well as neurological and renal diseases. DPI researchers collaborate closely with scientists in the 3-D Tissue Bioprinting Program, the Stem Cell Translational Laboratory, and the Therapeutics for Rare and Neglected Diseases program, as well as with other NIH Institutes and Centers and academic scientists. In addition to conducting cutting-edge laboratory research, DPI scientists work in a team-based environment and collaborate with more than 250 research organizations worldwide. Core Responsibilities The selected candidate — a self-motivated, collaborative postdoctoral fellow — will complete the development and implementation of a novel high-throughput screening method that quantifies the expression of selected genes in cultured mammalian cells. The unprecedented throughput of this method will enable the screening of large chemical libraries of environmental toxicants or drug candidates. Because quantitative high-throughput screening of large chemical libraries is NCATS’ core expertise, the collaborative opportunities to apply this method to identify drug candidates and to screen Tox21 toxicant libraries are abundant. The successful applicant will work with collaborators who have developed induced Pluripotent Stem Cell (iPSC)–derived endothelial cells, as well as 3-D endothelial cell models that incorporate shear flow and co-culture with vascular smooth muscle cells. The postdoctoral candidate also will have opportunities to collaborate with scientists both within and outside of NCATS on additional projects. The selected candidate is expected to present results of ongoing work at meetings (such as internal group meetings and national conferences) and submit their work for publication in scientific journals. Qualifications The ideal candidate will possess a doctoral degree (i.e., a Ph.D.) with a background in a relevant field of molecular or medical biology and have a strong record of high-impact publications. Applicants should possess molecular biology expertise and mammalian cell culture skills. Applicants also should possess strong oral and written English communication skills. Applicants with additional expertise in vascular biology or high-throughput screening will receive preferential consideration. Applicants should be U.S. citizens or legal residents or should hold a valid work permit to be considered for the position. How to Apply Please submit a cover letter describing your interest in the position, a current curriculum vitae with a complete bibliography, and the names of and contact information for three references to David L. Gerhold, Ph.D., at NCATSGenomicTox@mail.nih.gov. The review of applications will begin immediately and will continue until the position is filled. Postdoctoral Mass Spectrometry Position, Division of Preclinical Innovation, Analytical Chemistry Core Facility National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Analytical Chemistry Core Facility Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from qualified candidates to fill a postdoctoral mass spectrometry position in the Analytical Chemistry Core Facility within NCATS’ Division of Preclinical Innovation. The selected candidate should have expertise in mass spectrometry, high-performance liquid chromatography (HPLC) and proteomics fields. Applicants with additional expertise in protein biochemistry, automation systems and high-throughput screening will receive preferential consideration. The Analytical Chemistry Core Facility maintains a state-of-the-art laboratory, the mission of which is to support chemistry research throughout the Center. The laboratory has a variety of instrumentation utilizing various analytical techniques, including liquid chromatography-mass spectrometry, gas chromatography-mass spectrometry, high-resolution mass spectrometry and nuclear magnetic resonance to facilitate early-stage chemical development. Initially focused on small-molecule purification and analysis, the laboratory’s capabilities have expanded to other therapeutic modalities, such as peptides, proteins, antibody-drug conjugates and lipids. The laboratory manages several cutting-edge mass spectrometers with the capability to perform high-throughput sample analysis, peptide and protein analysis (top-down and bottom-up), post-translational modification analysis, multiple reaction monitoring (MRM), proteomics, metabolomics, and ultra-high-resolution analysis of small molecules. NCATS’ goal is to increase the productivity, efficiency and integrity of chemistry efforts by optimizing workflows and integrating automated processes. Core Responsibilities The postdoctoral fellow will work as part of a multidisciplinary team of innovative scientists using the available resources to develop novel methods and assays for high-throughput proteomics analysis and mass spectrometry-based compound screening. The postdoctoral fellow will be expected to work independently as a well-trained problem solver in the areas of mass spectrometry and HPLC. He or she will manage, troubleshoot and regularly maintain the instrumentation. The fellow will be expected to prepare samples of various modalities prior to analysis. The fellow also will be required to keep accurate and complete records of all scientific experiments according to established procedures and ensure that these records and raw data are properly retained. He or she will draft technical reports, manuscripts and patent applications, as well as present work at internal and external meetings. Qualifications The successful applicant should possess a Ph.D. in analytical chemistry, biochemistry or a related discipline, with a focus in mass spectrometry and have relevant research experience. Candidates should possess extensive proteomics experience, including sample preparation, post-translational modification analysis and data analysis, using Proteome Discoverer, MaxQuant, Mascot and/or Skyline. Direct experience with ultra-HPLC/nano-HPLC instrumentation is a preferred. Familiarity with the RapidFire high-throughput sampling system and protein biochemistry is necessary. Training in the areas of metabolomics, lipids analysis, MRM, intact protein and protein top-down analysis is desirable. The ideal candidate should be self-motivated, possess a strong work ethic, have a keen attention to detail, and be able to work on multiple projects simultaneously. Excellent analytical, organizational and time-management skills are required. The candidate should possess strong oral and written communication skills with a proven publication record in peer-reviewed journals. Applicants should be eligible to work in the United States for any employer. How to Apply Please submit a cover letter describing your interest in the position, including a research summary (one to two pages); a current curriculum vitae with a complete bibliography; and the names of and contact information for at least three references to Christopher A. LeClair, Ph.D., at ncats_info@mail.nih.gov. The review of applications will begin immediately and will continue until the position is filled. Postdoctoral Bioengineering Positions, Division of Preclinical Innovation, 3-D Tissue Bioprinting Laboratory National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation 3-D Tissue Bioprinting Laboratory Rockville, Maryland Description NCATS’ Division of Preclinical Innovation seeks applications from qualified candidates to fill postdoctoral bioengineering positions in the Division’s 3-D Tissue Bioprinting Laboratory. The selected candidates should have expertise in biofabrication, biomaterials or microfluidics to help establish a portfolio of functional, physiologically complex 3-D tissue models as predictive screening platforms for toxicity and efficacy drug testing. Applicants with additional expertise in microphysiological systems, immunology, neuroscience and production of induced pluripotent stem cell-derived cells will receive preferential consideration. Core Responsibilities The candidates will work as part of a multidisciplinary team of innovative scientists, using cutting-edge biofabrication methodologies—including 3-D bioprinting, quantitative cell imaging, histology, assay development, drug screening, data science and other cutting-edge -omics technologies — to develop advanced cellular models for drug discovery and development. Candidates should be self-motivated, driven, thorough and careful experimentalists with the ability to multitask, think independently and work in a highly creative, interactive and fast-paced environment. They also will be expected to work independently as well-trained problem solvers in biofabrication and microfluidics, including on architectural and physiological validation of the tissues. Effective communication and presentation skills are required. The successful candidates will keep accurate and complete records of all scientific experiments according to established procedures and ensure that these records and raw data are properly retained. They will draft technical reports, manuscripts and patent applications and will present work to internal and external collaborators as needed. Qualifications Each applicant for this postdoctoral position should possess a Ph.D. in bioengineering, biomedical engineering, immunology, neuroscience, cell/molecular biology, pharmacology, pathology or a related discipline relevant to 3-D tissue models. Candidates with previous experience developing and characterizing complex 3-D cell-based functional assays—including work in such areas as organoids or biofabricated tissues, biomaterials, microfluidic systems, cell imaging, histology and engineering of cells with biosensors—as well as experience using bioprinting techniques, will be considered favorably. Candidates with a strong background in immunology and tissue engineering with induced pluripotent stem cell-derived cells are encouraged to apply. Applicants should be eligible to work in the United States for any employer. How to Apply Please submit a cover letter, a curriculum vitae with a complete bibliography, a one-page research proposal/plan for a physiologically complex 3-D tissues for disease modeling and compound testing, and the contact information for at least three references to NCATSbioprinting@mail.nih.gov. The review of applications will begin immediately and will continue until these positions are filled. Postdoctoral Computational Biologist/Bioinformatician, Division of Preclinical Innovation, Therapeutic Development Branch National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Therapeutic Development Branch Rockville, Maryland Description NCATS, a major research component of NIH, seeks applications from exceptional candidates to fill a postdoctoral computational biologist/bioinformatician position in the NCATS Therapeutic Development Branch (TDB) within the Division of Preclinical Innovation. TDB develops new systems, novel approaches and methodologies to achieve conceptual breakthroughs in preclinical therapeutics. The branch also provides collaborative access to technology and expertise in the scientific disciplines of early-discovery biology and medicinal chemistry; drug metabolism and pharmacokinetics; toxicology; and chemistry, manufacturing and controls synthesis and formulation. Core Responsibilities The selected candidate — a self-motivated, collaborative postdoctoral fellow — will join an interdisciplinary team with a focus on profiling different cell types and responses in the context of rare genetic diseases, infectious diseases and drug treatments. He or she will be a bioinformatician/computational biologist with experience in bioinformatic analysis of NexGen sequencing datasets, with a strong emphasis in RNA-Seq analysis (bulk and single-cell). The fellow will collaborate with researchers in other universities and Institutes and will learn preclinical drug development from colleagues in multidisciplinary project teams. The fellow should obtain extensive experience and skills in this training program that can be applied toward translational research for therapeutics development. Qualifications The ideal candidate should possess a doctoral degree or equivalent in biology, computer sciences, bioinformatics or a related discipline, with one to three years of relevant research experience. Candidates should possess strong computer programming skills in R and other required languages (e.g., Python/Perl, Java, C/C++). Experience analyzing bulk and single-cell RNA-Seq data sets is essential. The candidate also should possess strong self-motivational and problem-solving skills, as well as outstanding interpersonal and teamwork skills. Excellent analytical, organizational and time management skills are required. Experience with proteomics data sets also is preferred, but not necessary. Applicants should be eligible to work in the United States for any employer. How to Apply Please submit a cover letter describing your interest in the position; a current curriculum vitae with a complete bibliography; and the names of and contact information for three references to Wei Zheng, Ph.D., at NCATSTDBBioHiring@mail.nih.gov. The review of applications will begin immediately and will continue until the position is filled. Postdoctoral Informatics Scientist, Division of Preclinical Innovation, NCATS Chemical Genomics Center (NCGC), Adenine Informatics Group National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation NCATS Chemical Genomics Center (NCGC), Adenine Informatics Group Rockville, Maryland Description NCATS is one of the 27 Institutes and Centers at NIH. The Informatics group collaborates closely with biologists and chemists to develop robust assay designs, analyze experimental outcomes and validate new hypothesis. NCATS’ informatics personnel perform a variety of ligand- and protein structure-related modeling tasks, support the drug discovery process and accelerate translational sciences. The team members also are developing infrastructure and software for the meta-analysis of high-content screens and for integration of the existing biomedical data to discover new hypothesis. NCATS’ Informatics group is seeking a creative, self-motivated postdoctoral informatics scientist to develop new algorithms for prediction of i) protein-ligand interactions; ii) chemical reactions and comprehensive support of drug discovery projects. Core Responsibilities The postdoctoral fellow will be responsible for uploading and analyzing pilot and quantitative high-throughput screening runs; analyzing assay reproducibility; analyzing confirmation and secondary screening assays; developing and applying QSAR models and molecular modeling for virtual screening of compounds; supporting medicinal chemistry efforts; and developing new algorithms for prediction of protein-ligand interactions and chemical reactions. Research will be conducted in the NCATS Informatics group. Qualifications The ideal candidate will possess a minimum of a Ph.D. in computational science/bioinformatics with specialization in machine learning. He or she will have published at least three research articles as first author. The successful candidate should have experience with common cheminformatics libraries and data formats (e.g., RDKit, OpenBabel, SMILES, InChi, etc.), modern software packages (e.g., MOE/CCG, OpenEye tools) and scientific programming (e.g., Python, JAVA) and data analytics (e.g., KNIME, Spotfire). He or she should be able to script work flows and implement new algorithms, have experience working with multi-disciplinary teams, and possess strong oral and written English communication skills. He or she should have experience using modern machine learning and deep learning frameworks (e.g., TensorFlow, Keras), as well as experience in developing algorithms for prediction of protein-ligand interactions and/or chemical reactions. Applicants should be U.S. citizens or legal residents or should hold a valid work permit to be considered for the position. How to Apply Please submit a cover letter describing your interest in this position, a current curriculum vitae with a complete bibliography to Alexey V. Zakharov, Ph.D., at alexey.zakharov@nih.gov. The review of applications will begin immediately and will continue until the position is filled. Postdoctoral Informatics Scientist Position, Division of Preclinical Innovation, Informatics Group National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Informatics Group Rockville, Maryland Description NCATS’ Informatics group seeks a creative, self-motivated, collaborative research scientist to develop new algorithms for predicting chemical reactions and to provide comprehensive support of the Center’s A Specialized Platform for Innovative Research Exploration (ASPIRE) initiative. NCATS proposes to transform chemistry from an individualized craft to a modern, information-based science through ASPIRE. By addressing long-standing challenges in the field of chemistry — including lack of standardization, low reproducibility and an inability to predict how new chemicals will behave — ASPIRE is designed to bring novel, safe and effective treatments to more patients more quickly at lower cost. The Informatics group collaborates closely with biologists, chemists, engineers and information technology professionals to develop robust assay designs, analyze experimental outcomes and to validate new hypothesis. The NCATS Informatics group performs a variety of ligand- and protein structure-related modeling tasks, supports the drug discovery process and accelerates translational sciences. The team members also are developing infrastructure and software for the meta-analysis of high-content screens and for integration of the existing biomedical data to discover new hypothesis. Core Responsibilities The successful candidate will be an integral team member for the creation and maintenance of a chemical reaction database, the development of new methods for reaction normalization and standardization, the analysis of reaction screens, and the development and application of AI/Machine learning approaches for prediction of synthetic routes and chemical reactions. He or she also should have experience working with multi-disciplinary teams. Qualifications Applicants should possess a minimum of a Ph.D. in computational chemistry or a related field with one to three years of industry or academic experience. He or she should have experience using modern machine learning and deep learning frameworks (e.g., TensorFlow, Keras, sklearn, PyTorch, etc.) Applicants also should have experience with common cheminformatics libraries and data formats (e.g., RDKit, Indigo, CDK, SMIRKS, SMARTS, SMILES, InChi, etc.), as well as experience in scientific programming (e.g., Python, JAVA), data analytics (e.g., KNIME, Spotfire) and relational databases (e.g., Oracle, SQL). Additionally, applicants should be able to script work flows and implement new algorithms. Applicants also should possess strong oral and written English communication skills. How to Apply Please submit a cover letter describing your interest in this position, a current curriculum vitae with a complete bibliography (all in PDF format), and three letters of reference to Alexey V. Zakharov, Ph.D., at NCATSAspire-Hires@nih.gov. The review of applications will begin immediately and will continue until the position is filled. Stem Cell Scientist and Postdoctoral Positions, Division of Preclinical Innovation, Chemical Genomics Branch, Stem Cell Translation Laboratory National Institutes of Health National Center for Advancing Translational Sciences Division of Preclinical Innovation Chemical Genomics Branch Stem Cell Translation Laboratory Rockville, Maryland Description NCATS, a major research component of the NIH, seeks applications from qualified candidates with expertise in developmental biology and human induced pluripotent stem cells (iPSCs) to fill stem cell scientist and postdoctoral positions in the Stem Cell Translation Laboratory (SCTL) within the Chemical Genomics Branch of the Center’s Division of Preclinical Innovation. The SCTL focuses on translating human pluripotent stem cells, such as iPSCs, into clinical applications and drug discovery by developing innovative technologies, methods and comprehensive multi-omics data sets through differentiation into relevant cell types in 2-D and 3-D cell culture systems. Successful candidates will have a chance to develop their skills in a highly dynamic environment, embedded in a team of passionate scientists working on a wide range of projects related to translational stem cell biology. They will have a chance to interact with experienced bioinformaticians at NCATS, external service providers and collaborators at top academic institutions. Core Responsibilities The selected candidates will join a multidisciplinary team of innovative scientists with expertise in assay development, high-throughput and high-content screening, compound management, automation engineering, bioinformatics, medicinal chemistry and various -omics technologies. They will work in a highly creative environment, focusing on important aspects of human pluripotency and cellular differentiation using cutting-edge technologies (e.g., single-cell analysis, deep sequencing, robotic cell culture, high-throughput electrophysiology, genome editing). They will keep accurate and complete records of all scientific experiments according to established procedures and ensure that these records and raw data are properly retained. They also will draft technical reports, manuscripts and patent applications and present work internally and externally to consultants and collaborators as needed. Qualifications Each applicant should possess an advanced degree (M.D. and/or Ph.D.) in a relevant field. Exceptional candidates with master’s degrees and strong backgrounds in stem cell biology will be considered. Candidates with experience in drug discovery, cell and tissue engineering, cell signaling, or quantitative biology are encouraged to apply. The ideal candidates should be team players with high scientific standards and have the ability to work in an interactive, fast-paced environment. They should be self-motivated to learn new technologies and be familiar with the methods and concepts of stem cell biology and regenerative medicine. Stipends/Benefits Annual stipends are provided and are based on the NIH Postdoctoral Intramural Research Training Award and Visiting Fellow scale; health insurance benefits are available. Fellows also are able to take part in Foundation for Advanced Education in the Sciences courses at NIH. How to Apply Please submit a cover letter describing your interest in the position, a current curriculum vitae with a complete bibliography, and the names of and contact information for three references to NCATSstemcellhiring@mail.nih.gov. The review of applications will begin immediately and will continue until the position is filled. { "@context": "https://schema.org/", "@type": "JobPosting", "title": "Postdoctoral Fellow: Antiviral Discovery Biology – Target Validation/Discovery", "datePosted": "2021-09-24", "hiringOrganization": { "@type": "Organization", "name": "National Institutes of Health, National Center for Advancing Translational Sciences", "sameAs": "https://ncats.nih.gov/", "logo": "https://ncats.nih.gov/sites/all/themes/ncats-2014/images/assets/ncats-logo.png" }, "jobLocation": { "@type": "Place", "address": { "@type": "PostalAddress", "streetAddress": "9800 Medical Center Dr", "addressLocality": "Rockville", "addressRegion": "MD", "postalCode": "20850", "addressCountry": "US" } }, "employmentType": "FULL_TIME", "description": "Description:NCATS, a major research component of NIH, seeks applications from qualified candidates to fill antiviral discovery biology – target validation/discovery postdoctoral fellow positions in the Antiviral Program for Pandemics (APP) within the Center’s Division of Preclinical Innovation. Multiple positions are available for motivated individuals to work in a translational science laboratory team environment with a focus on multiple target-based programs including assay development, high-throughput screening and drug lead optimization. Launched in June 2021 with more than $3 billion in funding from the American Rescue Plan, the APP will accelerate the development of a portfolio of promising antivirals that can move rapidly into later-stage clinical trials to combat future pandemics. Having safe and effective oral antiviral candidates ready for deployment in later-stage clinical trials against a newly emergent virus would save lives, reduce serious illness and prevent overwhelming surges in hospitalizations during a viral outbreak or pandemic. NCATS will partner with extramural scientists and the private sector to advance drug discovery and development programs for oral antiviral candidates. NCATS can collaborate on projects with entry points anywhere along the development pipeline — and with flexible project exit points — to accelerate discovery and overcome the scientific, technical and enterprise barriers to delivering drug candidates ready for Phase 2 clinical trials in future pandemics.Core Responsibilities:The candidates will work in the Functional Genomics Laboratory using cutting-edge technologies to develop assays and study viral infections for drug discovery for SARS-CoV-2 and other viruses of pandemic potential. Candidates should keep abreast of current developments of functional genomics technologies (RNAi and CRISPR/Cas9) and antiviral research. Candidates should be self-motivated, driven, thorough and careful experimentalists with the ability to multitask, think independently and work in a highly creative, interactive and fast-paced environment. In addition to teamwork, they also will be expected to work independently as well-trained problem solvers. Effective communication and presentation skills are required. The incumbents will keep accurate and complete records of all scientific experiments according to established procedures and ensure that these records and raw data are properly retained. They will draft technical reports, manuscripts and patent applications and present work to internal and external collaborators as needed. The incumbents also must be eligible to work in the United States and with whomever NCATS collaborates worldwide.Qualifications:Applicants to this postdoctoral fellow position must possess a Ph.D. in virology, cell or molecular biology, or pharmacology. Candidates with previous experience — including functional genomics (RNAi and CRISPR/Cas9), viral life cycle surrogate systems (viral pseudotyping, virus like particles, minigenome and budding systems), proficiency with establishing assay formats (e.g., flow cytometry, luminescence-/fluorescence-/FRET-based cellular readouts viability, proliferation, high-content imaging) and screen execution — will be preferred.Benefits:The salary will be commensurate with experience, based on the NIH Postdoctoral Intramural Research Training Award and Visiting Fellow scale; medical insurance coverage will be provided. The position is renewable for up to five years.How to Apply:Interested candidates should email a cover letter describing their research and career goals, a current curriculum vitae with a complete bibliography, and the names of and contact information for three references to NCATS APP Hiring at ncatsfglrecruitment@mail.nih.gov. Applicants also should indicate when they are available to start. Please note that the starting date of the fellowship is flexible, preferably within 2021. The review of applications will begin immediately and will continue until the position is filled." } { "@context": "http://schema.org/", "@type": "JobPosting", "title": "Postdoctoral Fellow: Medicinal Chemistry", "datePosted": "2021-09-20", "hiringOrganization": { "@type": "Organization", "name": "National Institutes of Health, National Center for Advancing Translational Sciences", "sameAs": "https://ncats.nih.gov/", "logo": "https://ncats.nih.gov/sites/all/themes/ncats-2014/images/assets/ncats-logo.png" }, "jobLocation": { "@type": "Place", "address": { "@type": "PostalAddress", "streetAddress": "9800 Medical Center Dr", "addressLocality": "Rockville", "addressRegion": "MD", "postalCode": "20850", "addressCountry": "US" } }, "employmentType": "FULL_TIME", "description": "Description:NCATS, a major research component of NIH, seeks applications from qualified candidates to fill three postdoctoral medicinal chemistry positions in the Early Translation Branch (ETB) within its Division of Preclinical Innovation in Rockville, Maryland. Based on their area of expertise, the selected candidates will join one of the ETB’s multidisciplinary teams that consist of scientists who are well versed in assay biology, high-throughput screening, informatics and medicinal chemistry. Team members work closely with biology and disease experts on multiple projects, tackling a range of translational science challenges. The ETB’s research goals include creating assay and discovery technologies to develop new chemical probes against understudied targets/phenotypes that validate new therapeutic approaches to cure or ameliorate diseases. The selected candidates will work in a highly creative medicinal chemistry environment and will design, synthesize and optimize potential probe molecules against a variety of targets, pathways and phenotypes. They will develop small molecules, leading to proof-of-concept studies that validate the therapeutic approach.Core Responsibilities:The selected candidates must be well trained in the methods and concepts of organic chemistry with experience in organic synthesis (purification and analysis of reaction products, methodology development, design of novel analogs, design and testing of synthetic routes to novel compounds by proposing and reducing to practice multistep syntheses). Furthermore, experience in standard spectroscopic and purification methods, including nuclear magnetic resonance (routine pulse techniques for structure determination), and standard or automated liquid chromatography and high-performance liquid chromatography methods is required. The selected candidates will keep accurate and complete records of all scientific experiments, according to established procedures, and ensure that these records and raw data are properly retained. They will be expected to draft technical reports, manuscripts and patent applications and will present work to internal and external collaborators as needed. The selected candidates also will work under the mentorship of a chemistry team leader and be exposed to cutting-edge quantitative high-throughput screening, assay biology, bioinformatics, medicinal chemistry, chemical biology and disease-relevant biological models. They should have strong communication skills, which are necessary for working in a cross-disciplinary team environment. An understanding of and previous experience or exposure to structure–activity relationship studies and absorption, distribution, metabolism and excretion optimization is desirable but not necessary.Qualifications:Applicants should have (or expect to receive) a Ph.D. in organic chemistry (i.e., synthesis, methodology development or medicinal chemistry) and have less than 10 years of postdoctoral experience in medicinal chemistry (academia, government or industry). Exceptional candidates completing their doctorate or postdoctoral training will be considered. Master’s degree candidates with extensive experience in industry also are encouraged to apply. Experience in proposing and reducing to practice multistep syntheses and in standard spectroscopic and purification methods is required. Experience in hit-to-lead or lead optimization is highly desirable. Each candidate should be an independent thinker and team player able to work in a highly interactive, fast-paced environment.Benefits:Annual stipends are provided commensurate with experience based on the NIH Postdoctoral Intramural Research Training Award and Visiting Fellow scale; medical insurance coverage will be provided. The fellow also may take part in Foundation for Advanced Education in the Sciences courses at NIH. The position is renewable for up to five years.How to Apply:Please submit, in PDF format, a cover letter that includes a research summary and describes your interest in the position, a current curriculum vitae with a complete bibliography, and the names of and contact information for two to three references, including your current supervisor, to ETB Team Lead Ganesha Rai at NCATSETBCareers@nih.gov. The review of applications will begin immediately and will continue until the position is filled. Learn more about intramural research at NCATS." }
329	NCATS Director Statement: Institute of Medicine Report on the CTSA Program at NIH	The following is a statement from NCATS Director Christopher P. Austin, M.D., on the Institute of Medicine report The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. June 25, 2013 In 2006, recognizing the need for a “new vision” (PDF - 70.96 KB) for translational and clinical science, the National Institutes of Health (NIH) established the Clinical and Translational Science Awards (CTSA) program. The institutions supported by the CTSA program have been transformative to the science and culture of those academic centers across the country, providing expertise, capacities, training and collaborations to advance clinical translational science as a discipline across the translational spectrum. In December 2011, the CTSA program became a part of the newly formed National Center for Advancing Translational Sciences (NCATS), and in July 2012, at the urging of Congress, NIH commissioned a study by the Institute of Medicine (IOM) to evaluate the CTSA program and recommend possible changes to its mission and operation. The IOM committee performed a thoughtful and measured review, which included input from a broad spectrum of internal and external stakeholders. This IOM committee now has issued its report, which is available on the IOM website. The report includes seven recommendations to build on the successes of the CTSA program and realize its full potential for transforming clinical and translational science for the benefit of human health. The recommendations are: Strengthen the leadership of the CTSA program by NCATS Reconfigure and streamline the CTSA Consortium Build on the strengths of individual CTSAs across the spectrum of clinical and translational research Formalize and standardize the evaluation processes for individual CTSAs and the CTSA program Advance innovation in education and training programs Ensure community engagement in all phases of research Strengthen clinical and translational research relevant to child health I found these recommendations to be compelling and have made the decision to implement them, beginning immediately. First, NCATS will increase its direct and active leadership of the program while assembling a working group of NCATS Advisory Council members and other key stakeholders to advise me on implementation of the report’s recommendations. Designation of clear, measurable goals and objectives that address critical issues across the full spectrum of clinical and translational research will be one of our first tasks. Second, the committee’s recommendation to reconfigure and streamline CTSA program governance will result in a more efficiently-managed program. This process also will begin immediately and in coordination with stakeholders. The recommendation to increase substantive collaboration across and beyond the CTSA Consortium is vital to realizing the system-wide changes that are needed in clinical and translational research. Ongoing engagement with partners in NIH Institutes and Centers, industry, research networks, foundations, patient groups and community organizations will accelerate translational and clinical research to the benefit of all, and maximize the adoption and expansion of CTSA program successes. The report’s recommendations in this area, including the concept of a deliverable-directed Innovations Fund, offer many opportunities to extend the reach of the program. The report appropriately emphasizes innovation in education and training of the translational workforce, community engagement in all phases of translation to ensure efficient and meaningful benefits to human health, and ensuring a focus on the particular needs of child health in the translational process. NCATS recognizes the importance of these key areas to the success of the CTSA program. I thank the IOM for its careful, cogent and inspiring vision for the future of the CTSA program. As NCATS’ — and NIH’s — largest program, charged with solving some of the most critical barriers to translational progress, the CTSA program has a unique role and responsibility to the research enterprise, and to those who matter most: patients and the public we serve. Drawing upon the enormous wisdom and enthusiasm of all our stakeholders and using this report as a roadmap, together we will realize the transformative potential of the CTSA program for science and health. Christopher P. Austin, M.D. Director National Center for Advancing Translational Sciences National Institutes of Health
327	About the CTSA Program	Under NCATS’ leadership, the Clinical and Translational Science Awards (CTSA) Program supports a national network of medical research institutions — called hubs ― that work together to improve the translational research process to get more treatments to more patients more quickly. The hubs collaborate locally and regionally to catalyze innovation in training, research tools and processes. CTSA Program support enables research teams including scientists, patient advocacy organizations and community members to tackle system-wide scientific and operational problems in clinical and translational research that no one team can overcome. NCATS amended the CTSA Program goals in response to the recent feedback and the maturation of the existing CTSA Program and will use a variety of mechanisms to achieve these goals (see CTSA Program Funding Information). The CTSA Program Goals are to: Advance clinical and translational science: develop, demonstrate and disseminate scientific and operational innovations that improve the efficiency and effectiveness of clinical translation from identification to first-in-human studies to medical practice implementation to community health dissemination. Promote partnerships and collaborations to facilitate and accelerate translational research projects locally, regionally and nationally. Create, provide, and disseminate innovative research programs and partnerships across institutions and communities to address health disparities and deliver the benefits of translational science to all. Create and implement scientific and operational innovations that increase the quality, safety, efficiency, effectiveness and informativeness of clinical research. Provide a national resource for the rapid response to urgent public health needs. Create, provide and disseminate clinical and translational science training programs for clinical research professionals of all disciplines on the research team. Create, provide and disseminate clinical and translational science training and career support programs for translational scientists. Foster the development of the emerging field of translational science. Read the latest stories highlighting CTSA research teams in action. CTSA Program Clinical Studies Through CTSA Program hubs, NCATS supports activities to test and develop innovative approaches to barriers in clinical research. One example is the, efficient recruitment of research participants and institutional review board (IRB) approvals for multisite clinical trials. Ongoing approaches include the following: The Trial Innovation Network is a collaborative initiative composed of three key organizational partners: Trial Innovation Centers Recruitment Innovation Center CTSA Program hubs NCATS’ vision for the Trial Innovation Network is to address critical roadblocks in clinical trials and to accelerate the translation of novel interventions into life-saving therapies. Features will include a single-IRB system, master contracting agreements, quality-by-design approaches and a focus on evidence-based strategies to recruitment and patient engagement. The NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) IRB Platform is a single-IRB reliance platform for multisite clinical studies. The goal is to provide flexible resources that investigators nationwide can use to harmonize and streamline IRB review for their own multisite studies. The platform is based on the successful experiences of NIH central IRB initiatives and on a CTSA Program demonstration project using a single-IRB reliance model called IRBrely. The NCATS SMART IRB Platform is designed to be a flexible option that can be used to set up a central IRB for a network of many studies or a single IRB for one multisite study. These and similar activities are intended to improve the quality and speed of clinical research in the CTSA Program network for a broad range of research studies, with the ultimate goal of bringing more evidence-based treatments to more patients more quickly.			About the CTSA Program			About the CTSA Program
326	2015 Director’s Messages	Select a 2015 message from the list below: Jan. 7, 2015: A New Year, a New Milestone for NCATS and Rare Disease Patients Feb. 25, 2015: Rare Diseases Research Illuminates a Path to Precision Medicine March 13, 2015: The Dose Makes the Poison, and the Genes Make the Difference April 30, 2015: A Senator Walks into a High-Throughput Screening Facility… May 28, 2015: Building a Next-Generation CTSA Program June 25, 2015: Innovating in Multisite Clinical Trials July 22, 2015: Discovering an Old Drug’s New Tricks Aug. 19, 2015: Starting Off Right: Creating Better Chemical Probes Sept. 23, 2015: Powering Precision Medicine Oct. 27, 2015: Exploring the Translational Science Spectrum Nov. 24, 2015: Making Surprise Family Connections Dec. 22, 2015: Small Businesses Thrive in Translational Science World Jan. 7, 2015: A New Year, a New Milestone for NCATS and Rare Disease Patients For people living with a rare disease called a lysosomal storage disorder, a tiny mistake in their DNA leads to big problems on the cellular level. Fatty materials called lipids build up in their cells and tissues, and those deposits can damage the brain, nerves, liver and other organs. Lysosomal storage disorders primarily affect children, who need daily help from parents and other caregivers to survive. Most of the 50 or so diseases in this group have no treatment, in part because they are so rare. It can take well over a decade and billions of dollars to develop a new drug — a tough commitment for a pharmaceutical company to make for a treatment that ultimately will reach only a few people per year. A key NCATS focus is finding new ways to understand and develop therapeutics for rare diseases. In an important demonstration of the effectiveness of the NCATS approach, new hope is on the horizon for young people living with the lysosomal storage disorder Niemann-Pick type C1 (NPC). NPC causes lipids to build up, mainly in brain cells, leading to impaired movement, seizures and dementia; patients usually die in their teenage years. Based on the collaborative work of a team including NCATS and other NIH researchers, patient advocacy groups, academic scientists, and a biotechnology company, a promising new treatment for NPC will continue to advance through clinical testing. The potential treatment is a drug called cyclodextrin, developed by a multi-institutional collaborative team catalyzed by NCATS Therapeutics for Rare and Neglected Diseases program. In collaboration with their partners, NCATS researchers “de-risked” cyclodextrin by developing the drug to the point where private industry — in this case, Vtesse, Inc. — will support further clinical development. This successful project illustrates several NCATS themes I have touched on in previous Director’s Messages. First, that translation is a team sport: More than 20 researchers from 10 different disciplines and 9 different organizations took part in cyclodextrin’s development: NCATS brought expertise in preclinical drug development; Physician-researchers at the Eunice Kennedy Shriver National Institute of Child Health and Human Development brought expertise in NPC biology and clinical care, as did NIH scientists from the Clinical Center, National Human Genome Research Institute, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, and National Institute on Deafness and Other Communication Disorders; and Collaborators from academia and industry, including Washington University in St. Louis, Albert Einstein College of Medicine, the University of Pennsylvania and Janssen Research & Development, LLC, contributed expertise in genetics, biochemistry, animal models and cyclodextrin pharmacology. The second theme illustrated by the NPC project is the effectiveness of patient involvement in translational research: At every step, multiple patient organizations played essential roles on the team, including funding some of the research. These groups included the Addi and Cassi Fund, Ara Parseghian Medical Research Foundation, Dana’s Angels Research Trust, Hadley Hope Fund, Hide & Seek Foundation for Lysosomal Disease Research, International Niemann-Pick Disease Alliance, John Paul II Medical Research Institute, National Niemann-Pick Disease Foundation, Niemann-Pick Disease Group (UK), and Support of Accelerated Research for Niemann-Pick type C. The third theme demonstrates NCATS’ commitment to searching for commonalities among diseases, which can help investigators develop therapeutics for more than one disease at a time. NCATS scientists have found that both cyclodextrin and delta-tocopherol — a form of vitamin E — show promise as treatments for NPC as well as other lysosomal storage disorders. The Vtesse collaboration will help NCATS and its partners pursue both of these promising drugs. With this wonderful news to kick off 2015, I look forward to sharing more exciting NCATS developments throughout the year. Stay tuned! Christopher P. Austin, M.D. Director National Center for Advancing Translational Sciences Feb. 25, 2015: Rare Diseases Research Illuminates a Path to Precision Medicine On January 30, I attended a White House event where President Obama announced plans for an ambitious new Precision Medicine Initiative. This exciting effort aims to build on recent successes in developing treatments for certain cancers and other conditions, including rare diseases, based on genetic information. The study of rare disorders has frequently led to new approaches to diagnosis, prevention and treatment that are applicable to more common diseases, and I expect that the Precision Medicine Initiative will be no different. Balancing excitement about these developments are the daunting challenges that remain for the estimated 25 million Americans and their families living with rare diseases. Although there are several thousand known rare diseases, only about 500 have an approved treatment. These disorders often are severe and difficult to diagnose, creating a substantial unmet medical need and consuming a disproportionate share of health care spending. It can be difficult for biopharmaceutical companies to justify the costs of developing treatments for poorly understood disorders affecting small, geographically dispersed populations, so most rare diseases remain understudied. NCATS is pursuing innovative approaches to address these obstacles in its Therapeutics for Rare and Neglected Diseases (TRND) and Bridging Interventional Development Gaps (BrIDGs) programs. Drug development experts at TRND and BrIDGs collaborate with outside researchers to advance the development of new therapeutics through scientific and technological innovations that improve drug development efficiency. These efforts “de-risk” therapeutic candidates and thus make them more attractive for adoption by biopharmaceutical companies. TRND and BrIDGs have achieved remarkable successes in individual diseases, including sickle cell disease and Niemann-Pick disease type C1. But NCATS’ mission to improve the efficiency of the translational process depends on rigorous measurement of aggregate outcomes and comparison with benchmarks. To assess whether TRND and BrIDGs are indeed increasing overall translational efficiency, NCATS teamed up with researchers at the Massachusetts Institute of Technology (MIT), and their analysis was published online in Science Translational Medicine today. The results are impressive, and they validate the NCATS innovation model in unprecedented ways. The MIT-NCATS team studied productivity data from nearly 30 TRND and BrIDGs rare diseases projects, then compared their success rates, costs and time to completion with published industry averages. The results show that TRND and BrIDGs projects have significantly lower costs and higher success rates, although somewhat longer preclinical timelines, than current industry averages. This is extraordinarily exciting because it demonstrates that focusing on scientific and operational innovation can make the translational process much more efficient, giving hope to the millions of rare disease patients waiting for translation to reach them. This advance is particularly timely in light of the eighth annual Rare Disease Day at NIH on February 27, co-sponsored by NCATS and the NIH Clinical Center. This day-long event is an opportunity for researchers, patients and patient advocates, health care providers, industry representatives, and others to hear about and celebrate progress made in rare diseases research. Planned activities include talks, posters and exhibits, and Clinical Center tours. As we move closer to the precision medicine vision of individualized data matching patients to therapies, rare diseases research will continue to lead the way, developing innovative evidence-based models for more efficient translation. Christopher P. Austin, M.D. Director National Center for Advancing Translational Sciences March 13, 2015: The Dose Makes the Poison, and the Genes Make the Difference Often in today’s world, the word “chemical” conjures up a toxic, man-made substance that is undoubtedly harmful to human health. The growing consumer demand for “natural” foods and cosmetics illustrates this trend. Similarly, the word “drug” can have a different meaning depending on whether it’s considered dangerous (heroin) or helpful (aspirin). In the scientific arena, however, the distinctions between these terms are largely artificial. For example, the widely used stroke and heart attack prevention drug warfarin (trade name Coumadin) has another common use as a rat poison. Despite the various popular definitions of “chemical” and “drug,” from a biological point of view, they are no different: substances in our environment that can alter how our bodies function in some way, whether beneficial, harmful or both depending on how they’re used and the dose. This commonality is important. From a translational science point of view, we need better methods to assess effects — positive and negative — of chemical substances on human health. I have written about several initiatives NCATS has to develop these methods in previous messages. Part of the challenge in defining these effects is that individual people can vary greatly in their responses to chemicals. Part of this variation is due to the variation in our genomes. Just as these differences make each of us more or less susceptible to developing conditions such as heart disease, genetic variation also can determine how sensitive we are to the helpful or toxic effects of chemicals. This is the crux of the recently announced Precision Medicine Initiative, which aims to use genetic data from individuals to personalize diagnostic and therapeutic strategies. The same approach might be used to assess individual sensitivity to effects of chemical compounds — but the technical challenges have been daunting. A multidisciplinary team including NCATS scientists recently demonstrated success in overcoming these roadblocks. In a study published in the Jan. 13, 2015, issue of Environmental Health Perspectives, academic and NIH scientists from the Toxicology in the 21st Century program utilized NCATS’ large-scale robotic screening capabilities to test the cells of more than 1,000 individuals with different genetic backgrounds for sensitivity to 179 different therapeutic and industrial chemical compounds. The study, the largest of its kind to date, not only provided new insights into biological mechanisms of human chemical sensitivity but also revealed that for many compounds, individual responses varied more than previously thought. This new information may help regulatory experts develop more accurate ways to determine safe levels of environmental chemicals. A better grasp of individual differences in sensitivity improves clinical care and public health, increasing the accuracy of predictions about exposure effects. This improved knowledge helps individuals expose themselves only to chemicals and drugs that are likely to be helpful and to avoid those that are not. That’s the promise of “precision environmental exposure,” much like precision medicine. Christopher P. Austin, M.D. Director National Center for Advancing Translational Sciences April 30, 2015: A Senator Walks into a High-Throughput Screening Facility… Last month, I was privileged to play one of my favorite roles — laboratory tour guide — for Maryland Sen. Barbara Mikulski, a longtime and vocal champion of biomedical research. During the tour of NCATS’ laboratories, I used three examples to illustrate our mission of developing translational technologies that will get more treatments to more patients more quickly. NIH Director Francis S. Collins, M.D., Ph.D., joined our walk-through of NCATS’ high-throughput screening facility and helped showcase our multi-armed robot, a machine that can perform tests of potential drugs in one week that would take a scientist 12 years to do manually. I then showed Mikulski an “organ on a chip” from the Tissue Chip for Drug Screening program, and I explained how these devices are designed to help scientists better understand disease and more accurately and efficiently test experimental therapies. We then held a press conference in the lab, and Collins announced an exciting development for the Discovering New Therapeutic Uses for Existing Molecules (New Therapeutic Uses) program: An experimental cancer drug was found to restore brain function in mouse models of Alzheimer’s disease. New Therapeutic Uses functions as a “matchmaker,” offering academic investigators an unprecedented opportunity to access investigational pharmaceutical industry assets to explore new ways to treat disease. To speed establishment of these public-private partnerships, NCATS developed template agreements that streamlined the required legal and administrative processes and thus shortened the time in establishing collaborations to about three months from the more typical nine months to one year. In the Alzheimer’s study, researchers at Yale University found that AstraZeneca’s drug saracatinib, originally intended to treat cancer, reversed learning and memory problems as well as brain abnormalities in mouse models of Alzheimer’s. The team has successfully completed a Phase 1b safety, tolerability and ideal-dosage study in humans and now is starting a Phase 2a clinical trial to test the drug’s effectiveness in older adults with the disease. We were delighted to share these NCATS accomplishments with the senator during her visit, enabling her to experience firsthand how NCATS is working to transform the long and expensive process of developing new interventions in the quest for improved human health. Christopher P. Austin, M.D. Director National Center for Advancing Translational Sciences May 28, 2015: Building a Next-Generation CTSA Program A Japanese proverb says, “None of us is as smart as all of us.” Solving the systemic and highly complex problems of translation will require that adage as a guiding principle. Bottlenecks in the road to clinical translation threaten this promising future. We know how to sequence billions of DNA base pairs (the “letters” that make up DNA), but we still don’t fully understand what all those data mean biologically or how to manage the resulting volume of information. Solving problems like these requires greater interconnectedness, information sharing and data handling across the scientific community. NCATS’ Clinical and Translational Science Awards (CTSA) program is designed to address roadblocks that slow the development of much-needed interventions. Just as scientists must innovate to overcome the challenges of translating genome sequencing information into clinical decisions, the CTSA program must evolve to address the challenges and realities of today’s clinical and translational research ecosystem — all with the aim to get more treatments to more patients more quickly. In continuing its work to evolve the program in this new era, NCATS released the Collaborative Innovation Awards funding opportunity announcements (FOAs) on April 2, 2015. Input from a broad range of stakeholders helped guide the development of this new FOA, which solicits proposals for innovative investigations among three or more CTSA hubs to develop, demonstrate and disseminate multisite experimental approaches that overcome translational barriers in science, operations and training to address high-priority translational science questions. At NCATS, we are excited to build on the enormous strengths of the CTSA hubs to create a network of unprecedented scope and creativity, suited to the extraordinary challenges — and opportunities — that will turbocharge the translational process to the benefit of science and health. Christopher P. Austin, M.D. Director National Center for Advancing Translational Sciences June 25, 2015: Innovating in Multisite Clinical Trials Although a great deal of painstaking work goes into creating and testing potential new treatments before they are administered to people, the most critical and complex stage of the translational process is the testing of interventions in humans for safety and effectiveness. Because these “clinical trials” often require testing in large numbers of people with a particular type of disease, multiple hospitals or other clinical sites usually are needed to study the intervention in a sufficient number of patients in a timely fashion. Similarly, large observational research projects such as cohort studies typically require the collaboration of multiple clinical sites. Unfortunately, scientific and operational problems currently limit the pace of multisite studies, leading to delays, failures and costs that ultimately slow or prevent treatments from reaching the people who need them. Among other challenges, failures in participant recruitment and delayed trial commencement due to duplicative institutional review board (IRB) reviews and contract negotiations frustrate researchers and patients alike. NCATS is tackling these system-wide problems head-on in multiple ways, most notably via our Clinical and Translational Science Awards (CTSA) program. Our two recently released funding opportunity announcements — for Recruitment Innovation Centers (RICs) and Trial Innovation Centers (TICs) — aim to transform multisite clinical research for the benefit of patients. Through the RICs, investigators will develop informatics-driven approaches to assessing the site-specific availability of potential participants during trial planning. These estimates will be based on de-identified, aggregated data derived from electronic health records at individual sites and across the CTSA consortium. Before and during the implementation phase of a clinical trial, the RICs also will collaborate with CTSA investigators to develop innovative strategies for engaging and enrolling research participants in a timely manner. The TICs will provide innovative infrastructure to establish reliance IRB agreements that allow for the designation of a single “IRB of record” for a given multisite study. An IRB — composed of scientific, nonscientific and community members — must review and approve each new study to ensure that safeguards are in place to protect human participants from harm and that research is conducted ethically. With multisite studies, typically each institution’s IRB would need to approve the study. A single IRB of record removes this need and speeds the trial process. TICs also will offer streamlined contracting to accelerate study start-up. Working together and across the CTSA hubs, the RICs and TICs will facilitate continuous improvement in research participant recruitment and study conduct across the CTSA network. The RICs and TICs will disseminate these approaches to the larger research community as well. In conjunction with the collaborative opportunities I discussed last month, these two new funding opportunities will help NCATS continue to evolve the CTSA program to address major roadblocks to efficient translation. The goal is to enable the scientific community to dramatically accelerate the process of translation and, most importantly, get more treatments to more patients more quickly. Christopher P. Austin, M.D. Director National Center for Advancing Translational Sciences July 22, 2015: Discovering an Old Drug’s New Tricks I often write about how the inefficiencies so prevalent in the translational process can be turned into opportunities when viewed through the lens of innovation. A striking example is a current statistic in drug development: 80 percent of drugs that enter human testing are never approved for use. One common reason is that clinical studies fail to show effectiveness in treating the disease or condition — the “indication” — the drug was designed to treat. This is frustrating to the patients who might benefit from the new drugs, the doctors who would use them and the pharmaceutical companies that developed them. But turned on its head, this problem presents a great opportunity to advance translation and health. It turns out that given the connectedness of human biology, a single drug might be effective in treating several different diseases. And the 80 percent statistic means that for every approved new drug, there are four investigational drugs that have undergone years of development and could be rapidly tested in a new indication. Many anecdotal examples of this “repurposing” strategy exist. But the question remains: How do we systematically identify new diseases that these approved and investigational drugs might treat? NCATS is taking multiple approaches to solving this problem, two of which reached milestones recently. For the first, scientists used the Center’s high-throughput screening capabilities to test every drug ever approved for human use as well as many investigational medicines — compiled in the NCATS Pharmaceutical Collection — to identify possible new treatments for hepatitis C infection and multiple sclerosis. A collaboration with researchers from NIH’s National Institute of Diabetes and Digestive and Kidney Diseases found that chlorcyclizine, an over-the-counter allergy drug, stopped hepatitis C virus infection in cells and animals, leading to a clinical trial now ongoing at the NIH Clinical Center. And through another collaboration with NIH-funded researchers at Case Western Reserve University, we discovered that a combination of two drugs currently used to treat fungal infections and eczema may hold promise as a treatment for multiple sclerosis. A second NCATS program focused on repurposing, Discovering New Therapeutic Uses for Existing Molecules, matches NIH-funded researchers with investigational pharmaceutical compounds to identify new indications. This month, NCATS is awarding nearly $3 million to four academic research groups to test whether drugs from pharmaceutical companies AstraZeneca and Sanofi may be effective for treating type 2 diabetes, acute myeloid leukemia (an aggressive blood cancer), glioblastoma (one of the most aggressive brain tumors in adults) and Chagas disease (a neglected tropical disease that causes heart, digestive and neurological problems). Drug repurposing has enormous potential to get more treatments to more patients more quickly; NCATS’ programs are making this potential a reality. Christopher P. Austin, M.D. Director National Center for Advancing Translational Sciences Aug. 19, 2015: Starting Off Right: Creating Better Chemical Probes Creating a new therapeutic is like constructing a building. Both are highly complex, multi-year endeavors that require the contributions of many different disciplines. In each case, a solid foundation is critical: A building constructed on sand and a drug developed on faulty science will both fail. A crucial part of the foundation for a new drug’s development comes from early tests of the scientific idea, when researchers use prototype drugs — termed “chemical probes” — in model testing systems. If either the chemical probe or the testing system is faulty, the drug’s development program will fail. I have written frequently about new testing systems NCATS is developing to more accurately predict a potential drug’s effects once it has entered the development pipeline, but I have not described our efforts to develop more accurate chemical probes more efficiently. Chemical probes interacting with their molecular targets have often been referred to in a “key and lock” analogy, with probes being the keys to molecular locks in the body. But the molecular locksmiths — those trying to identify a chemical probe “key” to a particular target “lock” — are at two enormous disadvantages. First, the general principles governing which types of “keys” fit into which types of “locks” are not known, making testing of potential keys trial-and-error. And second, the number of potential chemical “keys” is functionally infinite. The number of potential “drug-like” chemical compounds is 1060 — that’s 10 followed by 60 zeroes — or more than the number of grains of sand on Earth. (For those of you who like nomenclature, that’s a novemdecillion.) Even with the robots at the NCATS Chemical Genomics Center (NCGC), only about 1 million (106) compounds can be tested, leaving the overwhelming majority of chemical space unexplored. NCATS is taking multiple approaches to this important and exhilarating problem (for those of us brought up on Star Trek, chemical space exploration fires the imagination), and I will discuss these in the future. The end-goal of these efforts is to transform chemical probe (and eventually drug) identification from its current trial-and-error (mostly error) state into a predictive science, wherein a drug for any molecular disease target can be anticipated from informatics-driven computer models alone. Partially because probe development is so difficult, it has recently become clear that many commonly used chemical probes are actually unreliable experimental tools, leading to faulty foundations for subsequent drug development. The probes’ effects aren’t strong enough, they interact with proteins other than the target, or their biological activity is misleading. Fortunately, several collaborative efforts are underway to address this problem, both within and outside of NCATS. This month, I’m a co-author on a Nature Chemical Biology commentary outlining the promise and issues with many existing chemical probes and offering potential solutions, including a newly developed wiki site called the Chemical Probes Portal. The scientific community can use the portal to disseminate reliable information about small molecules and to crowdsource information about the compounds’ properties and best uses. The goal is for researchers to visit the portal, get answers to their questions, and discover the best probes to use as well as how to use them to generate reliable, reproducible data. Here at NCATS, the NCGC has developed and disseminated many chemical probes, working with disease-focused collaborators across the globe. The Chemical Probes Portal complements an existing public resource at NCATS, the Assay Guidance Manual, which disseminates information from experts around the world on the best methods to produce and validate chemical probes. Through these and related efforts, NCATS is helping to put translational science on a solid foundation. And that will help get more treatments to more patients more quickly. Christopher P. Austin, M.D. Director National Center for Advancing Translational Sciences Sept. 23, 2015: Powering Precision Medicine This past January, President Obama announced his intention to launch a Precision Medicine Initiative (PMI) that would enable clinicians to tailor disease prevention and treatment recommendations to each individual based on their particular genetics, environment and lifestyle. Last week, a working group of the NIH Advisory Committee to the Director released a report (PDF - 2MB) that includes a PMI vision for a cohort of more than 1 million Americans participating as active partners in the research process. Although work has just begun to make PMI a reality, a few thoughts from an NCATS perspective immediately come to mind. PMI has the potential to be a game-changer for translational science by allowing decisions on therapeutic targets, design of clinical trials for new interventions like drugs and medical procedures, and the use of these interventions in wider populations to be more scientifically based. Typical of translational initiatives, PMI will have both scientific and operational challenges requiring innovative solutions. Finally, PMI is designed as a partnership between researchers and the participants who will contribute their data; as I wrote last fall, this kind of patient and community engagement is central to NCATS’ efforts to make translation more efficient and effective. Beyond the confluence of PMI and NCATS perspectives, the science of precision medicine makes NCATS’ efforts to identify commonalities among diseases and within the translational research process even more timely. A pair of seeming contradictions illustrate this point. First, a focus on commonalities leads to specificity and vice versa. Increasingly, researchers are recognizing that distinct diseases are really different manifestations of the same underlying cause. For example, the recently initiated NCI-Molecular Analysis for Therapy Choice (NCI-MATCH) Trial will treat patients with drugs specific to their tumors’ genetic mutations, regardless of the organ or system in which the cancer appears. Conversely, scientists are reclassifying many common diseases into smaller and more specific groups, each with a different underlying cause and potential treatment. Grouping people by narrowly defined factors means scientists can tailor interventions to the individuals who can benefit most, but it also means that many common diseases must now be treated like rare diseases. NCATS’ focus on rare diseases research has advanced new methods both to discover commonalities among disorders and to diagnose and test interventions in rarer disorders. These paradigms are tailor-made for the precision medicine era. Second, although precision medicine studies will include fewer patients, this research actually requires a larger population. Because individuals with specific genetic or other characteristics required for a precision medicine study generally will be widely dispersed, researchers must identify and engage more people with a particular condition to find the few who have the “precise” characteristics. NCATS’ two national clinical networks — the Rare Diseases Clinical Research Network and the Clinical and Translational Science Awards (CTSA) Program — are ideally suited for precision medicine given their scale; access to diverse populations; and ongoing efforts to make participant recruitment, human subjects study review and other translational processes more effective and efficient. For example, the CTSA Program Recruitment and Trial Innovation Centers are designed to transform multisite clinical research by reducing delays in trial start-up and developing innovative participant recruitment strategies. NCATS looks forward to helping lead the precision medicine charge and thus deliver more treatments to more patients more quickly. Precisely. Christopher P. Austin, M.D. Director National Center for Advancing Translational Sciences Oct. 27, 2015: Exploring the Translational Science Spectrum I often write about the NCATS goal to develop, demonstrate and disseminate innovations that speed the translational research process. But what is this “translational science process,” and why is improving it so difficult? Envision each stage of scientific research, from knowledge about the biological basis of health and disease to delivery of interventions that improve the health of individuals and the public. Traditionally, scientists have thought of these stages as a linear path or “pipeline” moving in one direction: Basic Research > Preclinical Research > Clinical Research > Clinical Implementation > Public Health At first glance, this progression makes logical sense. Basic discoveries inform testing in preclinical models, and preclinical success enables clinical testing. Promising clinical trial results lead to wider adoption of interventions in the clinic, and widespread uptake drives improvements in overall public health. Each step builds on the progress of the previous stage. Contrary to this unidirectional, linear conceptualization, the history of medical discovery shows that the translational process can in fact start at any stage and go directly to any other stage, with progress often occuring in multiple directions at once. This multidirectional, nonlinear process is represented by the NCATS “translational science spectrum” diagram. Understanding the dynamics of this system is critical because translational innovation relies on an accurate “mental map” of the process possibilities, as does creating a translational ecosystem that is purpose-built to recognize and capitalize on the many ways translation can occur. A couple of recent examples help illustrate this nonlinear, multidirectional process. Last month, NCATS researchers and collaborators working in the “Preclinical Research” stage used the Center’s state-of-the-art high-throughput combination drug screening platform to test 13,910 combinations of known and newly identified drugs to treat malaria. Current medications for this deadly infection are remarkably effective, but drug resistance to the treatments is on the rise, creating an urgent need for better therapies. The results were published in the Sept. 25, 2015, issue of Scientific Reports. The entire dataset, including information on 4,600 drug combinations, is available online. The analyses not only led to the identification of new potential treatments (moving from the Preclinical to Clinical Research stage) but also shed light on the underlying biology of malaria (moving from the Preclinical to Basic Research stage). This bidirectional translational effort produced two simultaneous advances in the fields of malaria research and drug resistance. In another recent combination drug screening study, NCATS and other NIH researchers combined the approved adult T-cell leukemia (ATL) drug ruxolitinib with more than 450 potential therapeutic agents to observe their combined effects on ATL cell lines. The team identified another agent that works similarly to ruxolitinib; independently, the agents showed modest tumor-fighting effects, but their combined effect was much greater. The treatment extended survival in animal models and blocked growth of cancerous cells from human patients with ATL. Studying the compounds alone and in combination in ATL cells also shed light on the cancer’s molecular pathways. The group published these results in the Oct. 6, 2015, issue of Proceedings of the National Academy of Sciences. Again, these findings provide new knowledge in two directions, enhancing both basic science and clinical research. NCATS’ focus on not only improving the efficiency of each stage in the translational process, but also creating a translational ecosystem that provides ready pathways among these stages, is key to our strategy for getting more treatments for more patients more quickly. Christopher P. Austin, M.D. Director National Center for Advancing Translational Sciences Nov. 24, 2015: Making Surprise Family Connections At this Thanksgiving time of year, we turn our attention to how very different our family members can be despite sharing the same genes. Diseases turn out to be like families this way — a discovery with profound implications for translational science. Traditionally, doctors and researchers have organized their thinking about diseases around symptoms, or the organs and tissues they affect, rather than underlying biological mechanisms. By contrast, NCATS’ system-wide approach to translation starts with genetic or cellular mechanisms and considers what symptoms or diseases appear in any organ or tissue when those mechanisms break down. When applied to therapeutic development, this approach can lead to rapid advances via sometimes surprising connections, as it turns out that Mother Nature is the original “repurposer.” A given mechanism or pathway is often used to produce a variety of functions in different organs. Thus, a drug with a particular mechanism often can treat multiple different diseases, saving critical time and effort to get more treatments to more patients more quickly. Recent studies supported by NCATS illustrate the potential of this mechanism-first approach. Several years ago, the pharmaceutical company AstraZeneca developed saracatinib, an investigational drug that blocks the function of a family of proteins called Src kinases, which are involved in cancer formation. (Src is short for “sarcoma,” a kind of cancer.) Clinical trials demonstrated that the compound was safe for cancer patients, but it did not appear to be an effective treatment. Enter NCATS’ Discovering New Therapeutic Uses for Existing Molecules (New Therapeutic Uses) program, which matches pharmaceutical companies with investigational drugs that have particular mechanisms with academic researchers who have ideas about other diseases that a drug with one of those mechanisms might treat. Although Src kinases were initially identified through their connection to cancer, more recent research shows their involvement in a neurological condition — Alzheimer’s disease — and a rare lung disease called lymphangioleiomyomatosis (LAM). Two New Therapeutic Uses project teams are testing saracatinib as a treatment for both Alzheimer’s disease and LAM. NCATS-supported scientists at Yale University have shown that the compound reverses brain problems in a mouse model of Alzheimer’s disease and is safe in patients; a large trial of the drug’s effectiveness in Alzheimer’s disease is ongoing now. Additionally, NCATS-supported scientists at Baylor College of Medicine are testing whether blocking Src activity with saracatinib can reduce disease progression in LAM patients. If successful, these projects will have cut many years and millions of dollars off the cost of developing a new drug for these diseases. This example — the potential of treating three different illnesses on the basis of a molecular characteristic they share — illustrates the importance and power of NCATS’ holistic approach to understanding health and disease and to developing new therapies. So as you sit down to your family’s Thanksgiving dinner with your seemingly disparate relatives, know that diseases also are being reconciled through unexpected biological connections they share, promising a rich translational harvest. Christopher P. Austin, M.D. Director National Center for Advancing Translational Sciences Dec. 22, 2015: Small Businesses Thrive in Translational Science World During the holiday season, Small Business Saturday promotes shopping at individually owned businesses to recognize and promote their significant community contributions. It’s always Small Business Day at NCATS, since throughout the year, the Center supports entrepreneurship as an integral part of advancing translational science to get more treatments to more patients more quickly. NCATS kicked off 2015 with a new small business collaboration: Biotechnology company Vtesse, Inc., of Gaithersburg, Maryland, agreed to support preclinical studies led by researchers from the NCATS Division of Preclinical Innovation to develop treatments for lysosomal storage disorders including Niemann-Pick disease type C. Vtesse has exclusively licensed several NCATS patent applications specifically for their use in the treatment of these disorders, and I look forward to sharing updates from this collaboration’s progress. On an ongoing basis, NCATS’ Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs support the development and commercialization of new translational technologies, including those from minority- and women-owned businesses. A notable success is the plate-washing technology for cleaning high-throughput screening plates, which are usually thrown away after a single use. This process improvement was developed and demonstrated at our Center, then expanded for dissemination to the research community through an SBIR contract award to IonField Systems, in Moorestown, New Jersey. Ten pharmaceutical companies, biotechnology organizations, research universities and other institutes — as well as NCATS — have validated the process’ effectiveness through multiple rounds of testing, and IonField Systems reports having doubled its business in the past year due to these advances made possible with NCATS support. The method already has saved NCATS almost half a million dollars and kept nearly 50,000 plastic plates out of landfills. Coming up, as the White House announced earlier this year, NCATS’ Clinical and Translational Science Awards (CTSA) Program will play an important role in expanding an existing small business-related effort: I-Corps at NIH, a pilot of the NSF Innovation Corps initiative tailored for biomedical research and designed to help scientists navigate complex business landscapes to bring new health products to market. As part of I-Corps at NIH, NSF’s “train-the-trainer” program will be offered to up to 10 institutions supported through the CTSA Program. Business partnerships also are vital to the success of NCATS’ Tissue Chip for Drug Screening program: Funded researchers and IQ Consortium members are working together to further test and develop tissue chip devices and discuss marketability and other industry logistics to enable commercial success. Several startups, such as 4Design Bio and Hesperos, have spun out of the Tissue Chip effort, and a number of existing small companies, such as DRAPER and Nortis, have benefited from the program’s progress. In particular, Hesperos and Nortis are developing a fee-for-service business model to support the research community’s need for better ways to predict drug toxicity. It’s been a great year for small business collaborations at NCATS, and we will continue to work closely and collaboratively with these entrepreneurs to advance translational science for the benefit of patients — in local communities and far beyond. Happy holidays! Christopher P. Austin, M.D. Director National Center for Advancing Translational Sciences
325	2013 ExRNA Projects: Therapies	NCATS is administering 18 of the 30 ExRNA Communication projects awarded in 2013. Researchers on eight of those projects are exploring new ways to use exRNA in clinical treatments. Investigators are designing exRNA-based therapies for several types of cancer, Huntington’s disease, multiple sclerosis, bone marrow disorders and kidney disease. Exosome-Based Therapeutics in Huntington’s Disease Exosome RNA — Therapeutics to Promote Central Nervous System Myelination Fruit Exosome-Like Particles for Therapeutic Delivery of Extracellular miRNAs HER2-Targeted Exosomal Delivery of Therapeutic mRNA for Enzyme Pro-Drug Therapy Novel Extracellular RNA-Based Combinatorial RNA Inhibition Therapy Regulation of Renal and Bone Marrow Injury by Extracellular Vesicle Non-Coding RNA Targeted Delivery of MicroRNA-Loaded Microvesicle for Cancer Therapy Targeting Tumor-Derived exRNA-Containing Microvesicles by High-Throughput Screening Exosome-Based Therapeutics in Huntington’s Disease Investigator: Neil Aronin, M.D., University of Massachusetts Medical School, Worcester Grant Number: UH2-TR000888 Huntington’s disease is an inherited disorder that causes memory and thinking problems, abnormal movements, and depression. The disease usually starts in adults between the ages of 30 and 40 and worsens throughout a person’s life. People with Huntington’s disease eventually become unable to take care of themselves and often must live in costly nursing facilities. Huntington’s disease is caused by a change, or mutation, in the gene that codes for a protein called huntingtin. The mutation causes the body to make abnormal versions of the huntingtin protein, which damages brain cells and produces symptoms of the disease. In animal models of Huntington’s disease, a type of exRNA called small interfering RNA (siRNA), when injected into the brain, can block production of the abnormal huntingtin protein, reducing symptoms of the disease. However, clinicians must directly inject this substance into the brain, which is not an ideal delivery method in humans. In this project, investigators will inject exosomes — tiny particles produced by most types of cells that can contain and transport exRNA — into the blood of mice with Huntington’s disease. The exosomes will travel through the blood to deliver the therapeutic siRNA to the brain. Eventually, researchers could use these siRNA-containing exosomes to treat humans with Huntington’s disease and to develop treatments for other brain diseases. Learn more about this project in the NIH RePORTER. Exosome RNA — Therapeutics to Promote Central Nervous System Myelination Investigator: Richard P. Kraig, M.D., Ph.D., University of Chicago Grant Number: UH2-TR000918 Multiple sclerosis (MS) is a disease in which the body’s immune system attacks and destroys the protective covering of the nerves, called the myelin sheath, through a process called demyelination. Over time, the brain, the spinal cord and the rest of the body lose the ability to communicate. Many people with MS eventually lose the ability to walk or speak clearly. MS affects about 2.5 million people worldwide, including 400,000 in the United States. Current MS therapies can slow the disease by reducing demyelination, but no treatment exists to restore the lost myelin, called remyelination. Research has shown that exosomes that contain a type of exRNA called microRNA (miRNA) can trigger remyelination. The investigators plan to develop exosomes containing miRNA as a therapy for brain remyelination and treatment of MS. Learn more about this project in the NIH RePORTER. Fruit Exosome-Like Particles for Therapeutic Delivery of Extracellular miRNAs Investigators: Huang-Ge Zhang, M.D., D.V.M., Ph.D., University of Louisville, Kentucky, and Peixuan Guo, Ph.D., University of Kentucky, Lexington Grant Number: UH2-TR000875 Exosomes from mammals can deliver drugs for chemotherapy. This method is not ideal because it is hard to produce the large numbers of exosomes needed and because a patient’s immune system could reject the exosomes. Researchers can, however, remove large amounts of edible exosome-like particles from grapes. These exosomes can transport chemotherapy drugs. Scientists can alter the exosomes so that they can travel to the brain and, when given orally, to the liver. This research team will determine whether these exosomes can deliver therapeutic miRNA to cancerous cells of the colon, breast and brain. The team also will determine if it is possible to produce large amounts of exosomes inexpensively for use in the clinic. The scientists hope to create a therapeutic delivery system that can be used more widely both for research and for treatment. Learn more about this project in the NIH RePORTER. HER2-Targeted Exosomal Delivery of Therapeutic mRNA for Enzyme Pro-Drug Therapy Investigator: A.C. Matin, Ph.D., Stanford University, California Grant Number: UH2-TR000902 HER2-positive breast cancer is an aggressive type of breast cancer that responds poorly to treatment because the cancer cells produce a protein that promotes tumor growth. The investigators plan to enhance the natural ability of exosomes to transport molecules by attaching them to a new drug that targets and kills HER2-positive breast cancer cells. The drug also becomes fluorescent when it attacks the cancer cells, so researchers can see it within a living animal. The research team will load exosomes with this drug and test it in animals. The team aims to develop a more effective treatment for aggressive HER2-positive breast cancer and improve outcomes for patients with this disease. Learn more about this project in the NIH RePORTER. Novel Extracellular RNA-Based Combinatorial RNA Inhibition Therapy Investigators: Anil K. Sood, M.D., George A. Calin, M.D., Ph.D., and Gabriel Lopez-Berestein, M.D., University of Texas M.D. Anderson Cancer Center, Houston Grant Number: UH2-TR000943 Ovarian cancer is the most deadly cancer of the female reproductive system. Because women usually have mild or no symptoms during the cancer’s early stages, it is often not diagnosed until it has spread to other organs in the body. By the time the cancer is advanced, treatments are effective only for short periods of time. One type of miRNA can enter ovarian cancer cells and enhance their growth. The investigators will develop a new treatment approach that removes this cancer-promoting miRNA from human tumor cells and blocks additional miRNA from entering them. Researchers could add this method to current ovarian cancer treatments to enhance their effects. The methods developed will apply to the treatment of many cancers. Learn more about this project in the NIH RePORTER. Regulation of Renal and Bone Marrow Injury by Extracellular Vesicle Non-Coding RNA Investigator: Peter J. Quesenberry, M.D., Rhode Island Hospital, Providence Grant Number: UH2-TR000880 Microvesicles are tiny particles that contain exRNA, are produced by most types of cells, and can contain and transport various types of exRNA through the body. Microvesicles from stem cells can heal injured kidney and bone marrow tissue by delivering a therapeutic type of exRNA called non-coding RNA. For this project, investigators will search for non-coding RNA in microvesicles from stem cells that can heal injured kidney and bone marrow stem cells. The investigators then will develop a way to deliver the non-coding RNA to help injured kidney or bone marrow tissue re-grow. This study could lead to the development of non-coding RNA therapy for bone marrow diseases and kidney damage in humans. Learn more about this project in the NIH RePORTER. Targeted Delivery of MicroRNA-Loaded Microvesicle for Cancer Therapy Investigators: Thomas D. Schmittgen, Ph.D., and Mitch A. Phelps, Ph.D., The Ohio State University, Columbus Grant Number: UH2-TR000914 Hepatocellular carcinoma (HCC) is the most common form of liver cancer and the third deadliest cancer, causing one in 10 cancer deaths worldwide. No effective therapy exists, and patients with advanced HCC ultimately die from the disease. Certain types of miRNA can block HCC tumor cell growth and represent a potential treatment for this deadly disease. However, miRNA is expensive to develop, degrades rapidly and is potentially toxic to healthy tissues, so development of miRNA-based therapies has been challenging. To address these problems, the investigators will develop naturally produced miRNA and package it into microvesicles that protect the miRNA and direct it to HCC tumors. The research team will program cells grown in the laboratory to produce the miRNA-loaded microvesicles. Then they will remove the microvesicles from the cells and test them in animals with HCC. Eventually, these microvesicles could be tested in HCC patients. This technology also could be used in the future to deliver other types of RNA drugs for a variety of other cancers and diseases. Learn more about this project in the NIH RePORTER. Targeting Tumor-Derived ExRNA-Containing Microvesicles by High-Throughput Screening Investigator: Asim Abdel-Mageed, D.V.M., M.S., Ph.D., Tulane University School of Medicine, New Orleans Grant Number: UH2-TR000928 Castration-resistant prostate cancer (CRPC) is cancer of the prostate gland that continues to grow despite treatments that stop the body from using testosterone, a hormone that some tumors rely on for growth. Unraveling the biology of tumor growth and spread is critical to developing treatments for CRPC. Recent findings show that certain types of exRNA released by CRPC tumors appear to cause further tumor growth. This exRNA is contained in microvesicles. Drugs that target and destroy these microvesicles could slow or stop tumor growth. This project will test thousands of already approved drugs for the ability to block the activity of microvesicles and slow the growth of tumors in cell cultures and animals. Testing already approved drugs reduces the time and high cost of drug development, allowing promising drug candidates to be used in patients sooner. Learn more about this project in the NIH RePORTER. Descriptions are distilled from grant application abstracts.
324	Data Transparency and Release	Making data publicly available can spur innovation and scientific discovery. NCATS aims to develop, demonstrate and disseminate tools and solutions for use by all translational researchers. One way NCATS arms the scientific community with translational science resources is by enabling the public release of new methods, data and information. Some of the resources NCATS uses to provide publically accessible data are listed below: The OpenData Portal is a resource created by NCATS to openly and quickly share COVID-19-related drug repurposing data and experiments for all approved drugs. PubChem is a free database maintained by the National Library of Medicine that stores information about small organic molecules and their activities against biological assays. NCATS Pharmaceutical Collection is a publicly available, Web-based application that provides complete information on active pharmaceutical ingredients, including small molecule drugs that have been approved by regulatory agencies from the United States, Canada, Europe and Japan, as well as all compounds that have been registered for human clinical trials. Small molecule probes developed by NCATS scientists, in collaboration with hundreds of extramural researchers, are freely accessible to the scientific community. Assay Guidance Manual developed by NCATS and Eli Lilly and Co. contains detailed information about developing appropriate assays for high-throughput screening projects. Learn more about other translational issues NCATS aims to address: Predictive efficacy and toxicology De-risking therapeutic development Clinical research efficiency Collaboration and partnerships
323	Collaboration and Partnerships	Collaborations among government, academia, industry and nonprofit patient organizations are crucial for successful translation; no one organization can succeed alone. To this end, NCATS leads innovative and collaborative approaches in translational science that are cross-cutting and applicable to the broad scientific community. NCATS encourages partnerships and collaborations across all disciplines and research sectors, including investigators from NIH, universities and medical centers, other federal agencies, small businesses and industry, and patient groups and advocacy organizations. The Center convenes expert teams from diverse fields — including efficacy, toxicity, data sharing, biomarkers and clinical application — to reduce, remove or bypass significant bottlenecks across the entire continuum of translation. For NCATS, patient engagement is vital for every step of the research process. Incorporating the patient perspective builds trust and improves the quality of the research by enabling investigators to design studies that measure outcomes of importance to patients. This engagement also provides researchers with better access to participants for clinical studies. Among other benefits, NCATS’ collaborative approach helps maximize public and private resources, expand scientific knowledge, and increase participation in clinical research — all of which help speed the drug development process and get treatments to patients faster. NCATS programs that focus on forming innovative collaborations and partnerships include: Assay Development and Screening Technologies Bridging Interventional Development Gaps Discovering New Therapeutic Uses for Existing Molecules Matrix Combination Screening NCATS Chemical Genomics Center RNA Interference Therapeutics for Rare and Neglected Diseases Tissue Chip for Drug Screening Toxicology in the 21st Century Learn more about other translational issues NCATS aims to address: Predictive efficacy and toxicology De-risking therapeutic development Clinical research efficiency Data transparency and release

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