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| 3605 | GRDR® Program Goals | The GRDR program goal is to build a Web-based resource that integrates, secures and stores de-identified patient information from many different registries for rare diseases, all in one place. To accomplish these goals and to better serve the rare diseases community, NCATS collaborates with organizations including RD-Connect, IRDiRC and Orphanet. The ultimate goal of the program is to provide a “one-stop shop” for rare disease data from registries across the world. Through the program, NCATS will give patients, health care professionals and researchers access to information about multiple rare diseases through one central resource. Studies fueled by GRDR data could lead to improved therapeutic development and quality of life for the many millions of people who have rare diseases. In addition to building the repository, GRDR program staff aim to create a number of related tools and resources. These could include developing a GRDR program data model; an institutional review board; and additional common data elements, data policies, informed consent templates and patient registry template software. Learn more about available program resources. | ||||||||
| 3592 | CTSA Program in Action | .text-box { background-color: #E3EBED; padding: 20px; } .text-box a { font-weight: normal; } .text-box .action { font-weight: bold; color: #30787D; font-size: 15px; text-decoration-color:#30787D; } section > p { margin-left: 40px; } The CTSA Program supports new clinical and translational science research to remove health roadblocks and find health answers for all people. Through its network of research and community partners, the CTSA Program also improves the research field and helps clinical and translational research trainees learn to address public health needs. Learn about CTSA Program activities and how they are making a difference. Urgent Public Health Needs Developing, Demonstrating and Disseminating Innovations That Turn Science into Medicine Faster Clinical Research Resources Nurturing the Field of Translational Science Urgent Public Health Needs Previous Common Colds Could Boost Risks of More Severe COVID-19 Having a common cold caused by seasonal coronaviruses may cause immune distraction, making some people’s immune systems respond less effectively to SARS-CoV-2 infection and increase their risk of more severe COVID-19. Learn more about how the CTSA community works to address urgent public health needs. Developing, Demonstrating and Disseminating Innovations That Turn Science into Medicine Faster Community Engagement Approach Targets Louisville’s Colorectal Cancer Disparities An innovative study conducted in partnership with Black churches highlights the need for additional outreach and education to reduce colorectal cancer screening disparities in Black communities. Researchers will apply lessons learned to develop community-based interventions that target disparities in an upcoming study. Learn more about how the CTSA community works to turn science into medicine faster. Clinical Research Resources Nationwide IRB Reliance Agreement Aimed at Speeding Research Reaches 1,000 Signatories The Streamlined, Multisite, Accelerated Resources for Trials (SMART) Institutional Review Board (IRB) agreement has reached 1,000 participating sites, making it one of the largest medical research study reliance agreements in the United States. Learn more about the clinical research resources that aid the CTSA community. Nurturing the Field of Translational Science CTSA Program Supports Emerging Research on Health Effects of Plastics An early-career investigator has developed techniques to study how chemicals used in medical devices affect the still-developing hearts of pediatric patients. Learn more about how the CTSA community nurtures and advances the field of translational science. | NCATS-supported scientists are engaged in cutting-edge translational research activities across the United States. Read the latest news about CTSA Program researchers. | /sites/default/files/goal1_1260x630.jpg | CTSA Program in Action | NCATS-supported scientists are engaged in cutting-edge translational research activities across the United States. Read the latest news about CTSA Program researchers. | /sites/default/files/goal1_1260x630.jpg | CTSA Program in Action | ||
| 3593 | CTSA Program Contacts | Contact the NCATS staff listed below for more information about the CTSA Program. Contacts by Program Goals Area of Expertise Name Phone Number Community Engagement Patricia Lynn Jones, Dr.P.H., M.P.H. (301) 435-0792 Informatics Ken Gersing, M.D. (301) 827-2511 Methods and Processes Redonna Chandler, Ph.D. (301) 827-6371 Pediatrics/Lifespan Mary Purucker, M.D., Ph.D. (301) 435-0741 Training and Workforce Development Carol Merchant, M.D., Ph.D. Joan Nagel, M.D., M.P.H. David Wilde, M.D., Ph.D. (301) 435-0605 (301) 827-2512 (301) 435-0799 Other Key Contacts Area of Expertise Name Phone Number Administrative Supplements Erica Rosemond, Ph.D. (301) 594-8927 Collaborative Innovation Awards Philip John (P.J.) Brooks, Ph.D. (301) 443-0513 Director of Program Hubs Mary Purucker, M.D., Ph.D. (301) 435-0741 Diversity Supplements Erica Rosemond, Ph.D. (301) 594-8927 Recruitment Innovation Center Mary Purucker, M.D., Ph.D. (301) 435-0741 Trial Innovation Centers Rashmi Gopal-Srivastava, M.Sc., Ph.D. (301) 402-4336 For more information about PAR -15-304: Clinical and Translational Science Award U54, send an email to NCATS_DCI@mail.nih.gov. | ||||||||
| 3594 | Division of Clinical Innovation Staff | .row { padding: .9em; margin: 5px 0; } .row:nth-child(odd) { background-color: #d1d1d1; } .row:nth-child(even) { background-color: #e7e7e7; } .list-header { background-color: #662e6b !important; color: #fff !important; margin-top: 0; } .section-header { background-color: rgb(0,100,120) !important; color: #fff !important; margin-top: 0; } .section-header h3 { color: #fff !important; margin-top: 0; } .section-header p { color: #fff !important; margin-bottom: 0; } @media (max-width: 576px) { section { font-size: 12px; } } @media (max-width: 500px) { section { font-size: 11px; } } Contact the staff listed below for more information about the NCATS Division of Clinical Innovation (DCI). Office of the Director The Office of the Director plans, conducts and supports research across the clinical phases of the translational science spectrum and oversees the Clinical and Translational Science Award (CTSA) Program. Name Email Title Michael Gregory Kurilla, M.D., Ph.D. michael.kurilla@nih.gov Division Director Erica Rosemond, Ph.D. rosemonde@mail.nih.gov Acting Deputy Director Ken Gersing, M.D. kenneth.gersing@nih.gov Director of Informatics Josh Fessel, M.D., Ph.D. josh.fessel@nih.gov Senior Clinical Advisor Jane C. Atkinson, D.D.S. jatkinso@mail.nih.gov Senior Scientific Program Manager Stephanie H. Ezequiel, M.P.S. stephanie.ezequiel@nih.gov Staff Assistant Scherri Jacobsen scherri.jacobsen@nih.gov Staff Assistant Rebecca Katz, M.F.A. katzrd@mail.nih.gov Staff Assistant Office of Program Evaluation, Analysis & Reporting The Office of Program Evaluation, Analysis & Reporting plans, conducts, and supports evaluation, analysis and reporting for the Division of Clinical Innovation (DCI), coordinates, provides and supports communications for DCI; and liaises with offices within NCATS and across NIH to accomplish synergistic goals. Name Email Title Vacant Office Director Heather L. Baker heather.baker2@nih.gov Team Lead Monica L. Carter-Donerson, M.B.A. monica.carter@nih.gov Program Analyst Sanae ElShourbagy Ferreira, Ph.D., M.A. sanae.elshourbagy.ferreira@nih.gov Communications Coordinator Munziba T. Khan, M.P.H., M.S.H.S. munziba.khan@nih.gov Health Specialist Miriam Perkins, M.A.T. miriam.perkins@nih.gov Program Analyst Andie Vaught, M.P.H. andie.vaught@nih.gov Program Analyst CTSA Program Branch The CTSA Program Branch manages and coordinates the CTSA Program. Name Email Title Erica Rosemond, Ph.D. rosemonde@mail.nih.gov Branch Chief Jennifer Greene jennifer.greene@nih.gov Staff Assistant CTSA Program Branch, Education and Training Section The Education and Training Section plans, conducts and supports the CTSA Education and Training Program to train and cultivate the translational science workforce and foster the development of the field of translational science. Patrick H. Brown, Ph.D. patrick.brown@nih.gov Section Chief Jamie Mihoko Doyle, Ph.D. jamie.doyle@nih.gov Program Director Andrew N. Louden, Ph.D., M.S. andrew.louden@nih.gov Program Director Vacant Program Director CTSA Program Branch, Initiatives & Consortium-Wide Activities Section 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. Soju Chang, M.D., M.P.H., FACPM soju.chang@nih.gov Chief Vacant Medical Officer / Program Director Jennie L. Conroy, Ph.D. Jennie.Conroy@NIH.gov Program Director Gallya Gannot, D.M.D., Ph.D. gallya.gannot@nih.gov Program Director Rashmi Gopal-Srivastava, M.Sc., Ph.D. Rashmi.gopal-srivastava@nih.gov Program Director Carol Merchant, M.D. merchantc@mail.nih.gov Medical Officer / Program Director Joan Nagel, M.D., Ph.D. joan.nagel@nih.gov Medical Officer / Program Director CTSA Program Branch, Digital & Mobile Technologies Section The Digital & Mobile Technologies Section advances the use of cutting-edge informatics and technology, promotes telehealth and telemedicine initiatives, and develops, implements, and disseminates novel mobile technologies. Christopher M. Hartshorn, Ph.D. christopher.hartshorn@nih.gov Section Chief Audie Atienza, Ph.D. audie.atienza@nih.gov Program Director Pablo Cure, M.D., M.P.H. pablo.cure@nih.gov Program Director Leonie Misquitta, Ph.D. leonie.misquitta@nih.gov Program Director Thomas C. Radman, Ph.D. thomas.radman@nih.gov Program Director Clinical Affairs Branch The Clinical Affairs Branch provides a national resource for rapid response to public health emergencies, promotes the identification, development, and dissemination of innovative clinical trial and recruitment designs, promotes clinical research quality standards, and provides policy, oversight, and guidance for human subjects research protection. Name Email Title Salina P. Waddy, M.D., FAHA salina.waddy@nih.gov Chief Brittany Crawford brittany.crawford@nih.gov Staff Assistant Clinical Affairs Branch, Trial Innovation Network Section The Trial Innovation Network Section provides a national resource for rapid response to public health emergencies via the Trial Innovation Network, promotes identification, development, and dissemination of innovative clinical trial designs, and promotes identification, development, and dissemination of innovative recruitment strategies. Vacant Section Chief Sarah Dunsmore, Ph.D. dunsmores@mail.nih.gov Program Director Jessica Springer, R.N., M.P.H./M.P.A. jessica.springer@nih.gov Clinical Trials Specialist Yolanda Vallejo, Ph.D. yolanda.vallejo@nih.gov Program Director Clinical Affairs Branch, Clinical Research Resources Section The Clinical Research Resources Section promotes clinical research quality standards, ensures protection of human subjects research in CTSA Program projects, and develops, implements, and monitors human subjects research protection policy. Ken Wiley, Jr., Ph.D. ken.wiley@nih.gov Section Chief Guadalupe (Lupe) V. Aquino lupe.aquino@nih.gov Clinical Trials Specialist Cynthia Gonzalez, M.S. Cynthia.Gonzalez@nih.gov Senior Clinical Research Coordinator Melissa Sinkiewicz, D.O., FAAPMR melissa.sinkiewicz@nih.gov Physician / Medical Consultant David Wilde, M.D., Ph.D wilded@mail.nih.gov Medical Officer / Program Director | Contact the staff listed for more information about the NCATS Division of Clinical Innovation (DCI). | Division of Clinical Innovation Staff | Contact the staff listed for more information about the NCATS Division of Clinical Innovation (DCI). | Division of Clinical Innovation Staff | ||||
| 3571 | NCATS Seeks Applications to Repurpose Existing Drugs | NCATS is seeking applications for rigorous, preclinical research projects that are based on repurposing existing drugs or biologics. Through this new funding opportunity, NCATS anticipates committing $4.3 million in fiscal year 2016 to issue 10 to 15 awards in support of studies that establish the rationale for a clinical trial. Preclinical studies funded through this initiative will serve as “use cases” to demonstrate the utility of an independent crowdsourcing effort or of a computational algorithm to predict new therapeutic uses of an existing drug or biologic. The goal of an individual project must be to explore the potential new use of an existing investigational therapeutic or one already approved by the Food and Drug Administration to treat another disease. Interested researchers should submit a letter of intent by Dec. 13, 2015. Applications are due Jan. 13, 2016. To learn more about RFA-TR-16-001, contact Therapeutics.Discovery@nih.gov. Posted November 2015 | ||||||||
| 3561 | RFA-TR-16-001 Frequently Asked Questions | NCATS is seeking applications for rigorous, preclinical research projects that are based on repurposing existing drugs or biologics (therapeutics). Preclinical studies funded through this initiative will serve as “use cases” to demonstrate the utility of an independent crowdsourcing effort or of a computational algorithm to predict new therapeutic uses of an existing drug or biologic. The goal of an individual project must be to explore the potential new use of an existing investigational therapeutic or one already approved by the Food and Drug Administration to treat another disease. Applications are due Jan. 13, 2016. General Information How does NCATS define “published or publically available method” for identifying a therapeutic/indication pair or combination therapy? How does NCATS define “computational algorithm”? How does NCATS define “crowdsourcing”? What is an example of a successful crowdsourcing approach? How does NCATS define “rigorous” preclinical studies? Project Approaches Are any research areas of higher interest to NCATS than others? Can applicants request funding to conduct a virtual screen to identify the therapeutic/indication pair? Literature indicates that the proposed drug or biologic of interest would be effective in treating a disease different than that for which it was developed. Can one submit an application to conduct the preclinical studies to test this? Are there any restrictions on the type of drugs or biologics that can be repurposed? How does NCATS define “Phase IIa-ready”? Why is that important? Can NCATS help applicants access an investigational drug or biologic from a pharmaceutical company? Can applicants access assets from companies that participated in prior NCATS crowdsourcing initiatives? If a drug or biologic commonly is used off-label and, through use of a computational algorithm for predicting new therapeutic uses the compound shows up as a candidate for the common off-label indication, is the application eligible? Does this opportunity support reformulation of existing drugs? Is NCATS testing process improvements or providing support for repurposing? Is the inclusion of proprietary information in an application considered disclosure that would disqualify my company from applying for patents? Budget/Funding How does the consortium budget affect the direct cost limit? Can asset providers offer supplemental funding and resources if needed to complete the project? Can applicants include cost for manufacturing the active pharmaceutical ingredient? How many awards does NCATS anticipate making? How much money is available? Application Review Will reviewers assess the novelty of the method to identify the therapeutic/indication pair? General Information How does NCATS define “published or publically available method” for identifying a therapeutic/indication pair or combination therapy? Investigators may submit ideas to test new therapeutic uses for projects where the hypothesis originates from use of a published or publicly available computational strategy or a published or publicly available crowdsourcing site. How does NCATS define “computational algorithm”? NCATS is interested in applications that have an identified therapeutic/indication pair for drug repurposing using an existing computational algorithm. NCATS is not interested in applications that seek to develop or test a new computational algorithm. NCATS seeks use cases that test methods with the potential to improve prediction of successful therapeutic/indication pairs, which can be demonstrated fully at the clinical testing stage. How does NCATS define “crowdsourcing”? Crowdsourcing occurs when an investigational drug is publicly posted for investigators to propose ideas for new therapeutic uses. Generally, crowdsourcing is an approach used for investigational therapeutics, not therapeutics approved by the Food and Drug Administration (FDA), since approved drugs already are known to the public. An example of crowdsourcing is how NCATS matches researchers with a selection of pharmaceutical industry assets to test ideas for new therapeutic uses, with the ultimate goal of identifying promising new treatments for patients. Another example of a crowdsourcing approach is AstraZeneca’s Open Innovation program or any independent website that lists investigational drugs available for repurposing. What is an example of a successful crowdsourcing approach? NCATS has demonstrated that public posting of industry assets to crowdsource ideas for new therapeutic uses from the academic community is an effective way to launch new collaborations. NCATS serves as a matchmaker between academic experts and pharmaceutical partners, enabling successful projects like one at Yale University that demonstrated a compound originally developed as a cancer therapy could be used to treat Alzheimer’s disease. The Yale scientists gave the compound to mice with Alzheimer’s disease. After four to six weeks, the mice showed reversal of Alzheimer’s symptoms such as spatial learning impairments and memory loss. The drug already was tested for safety in humans and passed key steps in the development process before the project began. By repurposing an existing drug, investigators began testing the drug in humans within three months; it would typically take a decade from the discovery of a promising compound to a drug ready for clinical trials. How does NCATS define “rigorous” preclinical studies? Rigor ensures robust and unbiased experimental design, methodology, analysis, interpretation and reporting of results. When a result can be reproduced by multiple scientists, it validates the original results and readiness to progress to the next phase of research. Reproducibility is especially important for clinical trials involving humans; these trials are built on studies that have demonstrated a particular effect or outcome. Learn more about rigor and reproducibility. In October 2015, NIH published guidance about rigor and reproducibility for grant applications due on or after Jan. 25, 2016. Applicants for this funding opportunity may choose to follow the new guidance, even though applications are due before the requirements go into effect for all grant applications. Back to top Project Approaches Are any research areas of higher interest to NCATS than others? NCATS is “disease agnostic.” Rather than focusing on a single disease or biological system, NCATS focuses on improving the translational science process. Therefore, NCATS is interested in funding applications that demonstrate an approach to identifying the therapeutic/indication pair that, if successful, could be applied to other diseases and improve the efficiency of predicting new repurposing targets. This funding opportunity supports projects that have scientifically supported rationales with measurable, objective, quantifiable effects of the drug or biologic (therapeutic). NCATS will consider funding projects that address disease(s) that have no available treatment or an inadequate treatment, with strong scientific rationale for the new therapeutic use. Use cases that repurpose a drug or biologic originally developed or approved for a completely different disease indication are of high interest. For example, a computational prediction that a drug originally developed to treat melanoma may be effective in treating rheumatoid arthritis would be of greater interest than if that same drug may be effective in a different solid tumor cancer. Can applicants request funding to conduct a virtual screen to identify the therapeutic/indication pair? No. Applicants must identify a therapeutic/indication pair in the application. Literature indicates that the proposed drug or biologic of interest would be effective in treating a disease different than that for which it was developed. Can one submit an application to conduct the preclinical studies to test this? Although repurposing projects that are solely the result of traditional experimental methods and literature searches are important, they would not demonstrate the utility of a method for repurposing that could ultimately be broadly disseminated and therefore would not be responsive to this funding opportunity. However, if a drug is available through independent crowdsourcing, it may be eligible. Are there any restrictions on the type of drugs or biologics that can be repurposed? Applicants may propose to test an experimental or a Food and Drug Administration (FDA)-approved drug or biologic. Additionally, the drug or biologic should have been tested in a Phase I clinical trial (Phase IIa-ready). Applicants can propose testing a drug or biologic combination for which the combination therapy was identified through an innovative process. However, this funding mechanism can support only proof-of-concept testing, rather than all the required preclinical testing to determine toxicity as a combination product. Applications for testing the effectiveness of a dietary supplement are not of interest. How does NCATS define “Phase IIa-ready”? Why is that important? Starting with investigational or FDA-approved drugs and biologics that already have passed key steps in the therapeutics development process speeds the pace of development. These compounds already have advanced to clinical studies with established pharmacokinetics and a safety profile, which enable further clinical investigation for other potential therapeutic uses. Can NCATS help applicants access an investigational drug or biologic from a pharmaceutical company? If an applicant knows that the asset exists but is not available for purchase, NCATS may be able to facilitate initial contact with the company. Can applicants access assets from companies that participated in prior NCATS crowdsourcing initiatives? Potentially. Companies that participated in the Discovering New Therapeutic Uses for Existing Molecules program are not obligated to provide access to assets from that program. However, if the company is willing to consider making the asset available, NCATS can connect interested applicants with representatives from the company. To find out more, refer to the tables on the Industry-Provided Assets page. Refer to the FOA section “Letters of Support” for confirmation of drug access assurance. If a drug or biologic commonly is used off-label and, through use of a computational algorithm for predicting new therapeutic uses the compound shows up as a candidate for the common off-label indication, is the application eligible? Although the application would meet the technical qualifications for the funding opportunity, such an application likely would receive low program priority. Applicants in this situation are strongly encouraged to speak with program staff before preparing an application. Does this opportunity support reformulation of existing drugs? Because investigational therapies explored through this funding opportunity must be Phase IIa-ready, NCATS expects that applicants already will have determined a drug or biologic’s toxicity through Investigational New Drug-enabling preclinical studies. Changes in formulation that require additional Phase I studies would not be supported through this opportunity. If applicants have existing proof that the FDA would accept the available preclinical and Phase I data despite the formulation change, NCATS would consider the proposed therapeutic Phase IIa-ready. Is NCATS testing process improvements or providing support for repurposing? A preclinical study funded through this funding opportunity will serve as a “use case” to demonstrate the utility of an independent crowdsourcing effort or of a computational algorithm to predict new uses of a drug or biologic. For therapeutics that are not offered through crowdsourcing, investigators must specifically state the published, publicly available or commercially available systematic computational method used to identify the therapeutic/indication pair. Applications considered non-responsive will not proceed to review. Over time, NCATS anticipates being able to evaluate if some strategies are more predictive than others for identifying new therapeutic/indication pairs. Is the inclusion of proprietary information in an application considered disclosure that would disqualify my company from applying for patents? Refer to the NIH Small Business Innovation Research program website for more information about intellectual property and applications. Back to top Budget/Funding How does the consortium budget affect the direct cost limit? Pursuant to the NIH Grants Policy Statement, the direct cost limit excludes the consortium indirect costs. Questions about consortium budget should be directed to the Grants Management Specialist point of contact in the FOA. Can asset providers offer supplemental funding and resources if needed to complete the project? Yes. NCATS encourages multiparty collaborations to maximize the use of federal funds; however, such additional support is not required and will not be used as a factor during the application review. Can applicants include cost for manufacturing the active pharmaceutical ingredient? Yes. Application budgets are limited to $400,000 in direct costs over a two-year period and no more than $250,000 direct costs in any single year. How many awards does NCATS anticipate making? How much money is available? NCATS anticipates committing $4.3 million in fiscal year 2016 to fund 10 to 15 preclinical awards. The actual number of applications funded depends on the quality of applications received, budgets required for individual applications and programmatic priorities. Back to top Application Review Will reviewers assess the novelty of the method to identify the therapeutic/indication pair? Reviewers will assess the proposed project according to the review criteria as stated in the FOA. | ||||||||
| 3532 | NCATS’ Preclinical Programs Now Accepting Collaborative Proposals | NCATS is now accepting proposals on a rolling basis to collaborate with Bridging Interventional Development Gaps (BrIDGs) and Therapeutics for Rare and Neglected Diseases (TRND) program scientists. BrIDGs program scientists collaborate with researchers to advance candidate therapeutics for both common and rare diseases into clinical testing. Selected researchers partner with NCATS experts to generate preclinical data and clinical-grade material through government contracts to use in Investigational New Drug (IND) applications to regulatory agencies, such as the Food and Drug Administration. Investigators do not receive grant funds through this program. In general, BrIDGs staff provide synthesis, formulation, pharmacokinetic and toxicology expertise and resources to its collaborators. An NCATS medicinal chemist works under a laboratory hood. The goal of the TRND program is to encourage and speed the development of new treatments for rare conditions and neglected tropical infectious diseases with high unmet medical needs. TRND program scientists and their collaborators move new therapeutic candidates through preclinical testing, from lead optimization to submission of an IND application. On a case-by-case basis, TRND supports clinical testing to demonstrate safety and proof-of-concept of investigational drug effectiveness in patients. These efforts effectively “de-risk” therapeutic candidates and make them more attractive for adoption by outside partners. Learn more about these programs, including how to submit a collaborative proposal to BrIDGs or TRND. Posted October 2015 | ||||||||
| 3510 | Ramsey-Ewing Joins NCATS as OGMSR Director | On Sept. 20, 2015, Anna L. Ramsey-Ewing, Ph.D., joined NCATS as director of the Office of Grants Management and Scientific Review (OGMSR). She previously was the Office of Extramural Research Policy and Operations director at NIH’s National Institute of Allergy and Infectious Diseases (NIAID). Ramsey-Ewing began her NIH career in 1991 as a research fellow at NIAID, and she later became a Fellows Award for Research Excellence recipient and senior staff fellow in NIAID’s Laboratory of Viral Diseases. She subsequently served as NIAID’s associate director for extramural science policy within the Division of Extramural Activities (DEA). In that role, Ramsey-Ewing was responsible for policy development and integration as well as dissemination and staff training in all facets of extramural policies and procedures. Her other DEA roles included serving as a special assistant to the DEA director and as a scientific review officer (SRO); as part of the latter role, she was instrumental in setting up a formal SRO training program. "Anna’s extensive and impressive track record of effective leadership and expertise in laboratory science and in NIH extramural activities make her the ideal person to lead NCATS’ OGMSR," said NCATS Director Christopher P. Austin, M.D. "I look forward to working with her to fund resources and projects that catalyze innovation in translational science and operations and get more treatments to more patients more quickly." Ramsey-Ewing has been recognized for her work multiple times, including with NIH Director’s Awards and NIAID Merit Awards. She has served on many key NIH committees that have, among other endeavors, helped to build consensus, mitigate risks and advance consensus on topics including investigator-initiated clinical trials, human subjects protections, vertebrate animal welfare, and biosafety and security. She has completed numerous NIH continuing education programs and courses, including the prestigious NIH Executive Leadership Program. "I am delighted to have the opportunity to work with the talented and dedicated OGMSR team at NCATS to provide grants management, scientific review and conference management services that bolster the Center’s efforts to develop, demonstrate and disseminate innovations in the translational research process," Ramsey-Ewing said. The co-author of numerous scientific publications, Ramsey-Ewing earned her Ph.D. in medical microbiology and immunology from the University of Florida College of Medicine and her B.S. in microbiology from the University of Miami. Posted October 2015 | ||||||||
| 3500 | NCATS Director Statement on the Strategic Plan | Several thousand diseases affect humans, of which only about 500 have approved treatments. Thanks to our growing understanding of human biology, along with increased availability of innovative technologies, there is now an unprecedented opportunity to translate scientific discoveries more efficiently into new, more effective and safer health interventions. To empower the realization of this opportunity, NCATS develops innovations that reduce, remove or bypass costly and time-consuming bottlenecks in the translational science process, to speed the development and delivery of new drugs, diagnostics, medical devices and behavioral interventions to patients. Since NCATS was established in late 2011, an enormous amount has been accomplished scientifically and organizationally to begin the transformation of translational science that is NCATS’ mission. Building on that strong foundation, we now are embarking on a strategic planning process to help determine the greatest needs and opportunities that will become our priorities for the next five years. Since becoming director in 2012, I have made continuous engagement with our many collaborators and stakeholders a central part of the NCATS culture, positioning us well to begin this important planning process for the next stage of the Center’s evolution. NCATS stakeholders are many and varied, including patients and members of the health advocacy community; basic, translational and clinical scientists at universities and other research institutions; health care providers; biotechnology, venture capital and pharmaceutical industry representatives; colleagues at other NIH Institutes, Centers and Offices; partners at other government agencies (e.g., the Food and Drug Administration and other Department of Health and Human Services agencies, the Environmental Protection Agency, and the Department of Defense); policymakers and funders; and the general public. As I’ve often said, a key distinguishing feature of translational research is that it is a “team sport.” The translational process is so multifaceted that no one individual or organization, no matter how committed or talented, can be maximally successful by itself. NCATS is no different, and for this reason, I personally encourage all of our stakeholders to enthusiastically participate in our strategic planning process. It is of utmost importance that all are included in this endeavor so that we comprehensively assemble the best ideas from many points of view to shape the future of translational science, and thus fulfill our mission to bring more treatments to more patients more quickly. Please join me and NCATS on this exciting journey. Christopher P. Austin, M.D. Director, NCATS Posted October 2015 | ||||||||
| 3501 | September 2015 Council/CAN Review Board Meeting | The Sept. 3, 2015, joint meeting of the NCATS Advisory Council and the Cures Acceleration Network Review Board featured the following meeting materials. Presentations NCATS Director’s Report (PDF - 2MB) – Christopher P. Austin, M.D., director, NCATS Developing the NIH-wide Strategic Plan (PDF - 2MB) - Lawrence A. Tabak, D.D.S., Ph.D., principal deputy director, NIH Development of an Integrated Ex Vivo Female Reproductive Tract: Drug Discovery and Testing for the Future (PDF - 5MB) - Teresa K. Woodruff, Ph.D., director, Women’s Health Research Institute; chief, Division of Obstetrics and Gynecology-Fertility Preservation; professor, Northwestern University Concept Clearance: Drug Repurposing/Repositioning (PDF - 131KB) - Christine M. Colvis, Ph.D., director, Drug Development Partnership Programs, NCATS Concept Clearance: Translational Research Informatics and Operations Support (PDF - 113KB) - Michelle A. Culp, B.S.N., M.P.H., director, Office of Clinical Trials Operations and Management, NCATS Concept Clearance: Bioethics Research in Biomedical and Translational Science (PDF - 107KB) - Elaine Collier, M.D., senior advisor, Office of the Director, NCATS NCATS Strategic Planning (PDF - 1MB) - Dorit Zuk, Ph.D., director, Office of Policy, Communications and Strategic Alliances, NCATS The CTSA Program: Collaborative Innovation for Translational Research (PDF - 1MB) - Petra Kaufmann, M.D., M.Sc., director, Division of Clinical Innovation and Office of Rare Diseases Research, NCATS Additional Meeting Information Agenda (PDF - 135KB) Videocast Minutes (PDF - 180KB) Federal Register Notice Concept Clearances |
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