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| 680 | Events | h5 { font-weight: bold; } May 2023 Showcase and Ideas Exchange About Bias in Health Care Artificial Intelligence Webinar NCATS Strategic Planning Roundtable Discussions NCATS Advisory Council Meeting June 2023 2023 AGM Preclinical Translational Science Webinar Series May 2023 Showcase and Ideas Exchange About Bias in Health Care Artificial Intelligence Webinar May 5 12:30 p.m. EDT NCATS will be announcing the winners of the Bias Detection Tools for Clinical Decision-Making Challenge at a webinar on May 5, 2023, at 12:30 p.m. EDT. The bias detection challenge — launched in October 2022 — will award up to $700,000 to those teams best able to create an open-source solution that detects and mitigates bias in artificial intelligence/machine learning (AI/ML) models used in health care settings. More than 200 people signed up to compete in this challenge, and the resources and webinars provided during the challenge aimed to offer context and cross-training for this complex issue that includes AI/ML, health care, and bias and ethics. Attendees will: Learn from competitors about issues that surfaced and discoveries that were made while developing their solutions. Share their thoughts and ideas with NCATS on how to continue to propel the field of bias detection and mitigation in health care AI forward. Discover how they can join future efforts to improve health care and mitigate bias through AI. Webinar Registration NCATS Strategic Planning Roundtable Discussions May 9 Session: 12 to 1:30 p.m. EDT May 10 Session: 9:30 to 11 a.m. EDT NCATS will host two virtual stakeholder roundtable discussions on the topic of strategic planning for 2024 through 2029. The meetings will include an overview of the vision for the center from NCATS Director Joni L. Rutter, Ph.D.; information on the strategic planning process; and small group discussion. NCATS’ stakeholders include, but are not limited to, patients and members of the health advocacy community; basic, translational and clinical scientists at universities and research institutions; health care providers; biotechnology, venture capital and pharmaceutical industry members; colleagues at other NIH institutes, centers and offices; partners at other government agencies; policymakers; and the public. Registration NCATS Advisory Council Meeting May 25 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. For more information about the Advisory Council, visit the NCATS Advisory Council page of this site. Federal Register Notice June 2023 2023 AGM Preclinical Translational Science Webinar Series June 2 11 a.m. to 12 p.m. EDT NCATS’ Assay Guidance Manual (AGM) program will host a quarterly virtual webinar series in conjunction with the center’s Office of Policy, Communications and Education and Office of Drug Development Partnership Programs. This series, featuring prominent speakers in the field, is designed to communicate critical information about preclinical translational science and is particularly relevant for biomedical researchers who are conducting preclinical studies to advance research leading to interventions that will impact human health. The webinar series will convey best practices in preclinical translational science to help bridge the gap between research discoveries and the delivery of new therapies. Participants will discuss topics relevant to preclinical translational science, including reproducibility, assay development, new and emerging modalities in drug discovery, and entrepreneurship. Participants also will dissect case studies about successful and unsuccessful drug discovery campaigns, with the goal of learning about strategies, methods, and approaches for accelerating drug development. Presenters will provide an overview of the AGM e-book, an important resource for detailed information about robust assay methods and best practices in quantitative biology. They also will disseminate the principles of translational science among scientists in biomedical research and demonstrate how these are applied in preclinical research. Website/Agenda • Registration !function(c,h,i,m,p){m=c.createElement(h),p=c.getElementsByTagName(h)[0],m.async=1,m.src=i,p.parentNode.insertBefore(m,p)}(document,"script","https://chimpstatic.com/mcjs-connected/js/users/e06bd55ccbb41f1a362306dff/9c199175ea7b167e2bdb5384e.js"); | View NCATS' events, including webinars, health observations, and press conferences. | Events | View NCATS' events, including webinars, health observations, and press conferences. | Events | ||||
| 673 | Videos | Watch videos of NCATS leadership, researchers and grantees in action, including high-quality b-roll of the Center’s robotic screening platform. The media player works best when viewed in Chrome or Internet Explorer browsers. I Am Translational Science Video Series Perspectives from NCATS Intramural Research Fellows Program Videos Rare Disease Patient Videos B-Roll Additional videos are available on the NCATS YouTube channel. | ||||||||
| 662 | Photos | Visit the NCATS Image Gallery on Flickr to browse the Center’s collection of public images, including photos of NCATS leadership and past meetings and events, plus visuals of ongoing work in the laboratory and clinic. Featured Albums Leadership and Key Staff Clinical and Translational Science Preclinical Science | ||||||||
| 635 | Joint NIH-Pfizer CTI Steering Committee | The CTI network pairs leading researchers with Pfizer resources to pursue scientific and medical advances through joint therapeutic development. The NIH-Pfizer CTI collaboration is governed by a steering committee with equal representation from NIH and Pfizer. The committee selects research projects and makes decisions about their progress. Co-Chairs Uwe Schoenbeck, Ph.D. Senior Vice President and Chief Scientific Officer Centers for Therapeutic Innovation Pfizer Worldwide Research & Development Boston, Massachusetts Anton Simeonov, Ph.D. Scientific Director National Center for Advancing Translational Sciences National Institutes of Health Bethesda, Maryland Members Jeremy Gale, Ph.D. Executive Director Inflammation and Remodeling Pfizer Worldwide Biotherapeutics Research & Development Cambridge, Massachusetts Ronald N. Germain, M.D., Ph. D. Chief, Laboratory of Systems Biology Chief, Lymphocyte Biology Section Acting Chief, Laboratory of Immunology National Institute of Allergy and Infectious Diseases National Institutes of Health Bethesda, Maryland Raffit Hassan, M.D. Co-Chief Thoracic and Gastrointestinal Oncology Branch Center for Cancer Research National Cancer Institute National Institutes of Health Bethesda, Maryland John J. O’Shea, M.D. Scientific Director National Institute of Arthritis and Musculoskeletal and Skin Diseases National Institutes of Health Bethesda, Maryland David Shields, Ph.D. CTI East Coast Site Head External Science & Innovation Executive Director, Pfizer Worldwide Research & Development Pfizer, Inc. Cambridge, Massachusetts Will Somers, Ph.D. Vice President and Head Global BioTherapeutics Pfizer Worldwide Research & Development Cambridge, Massachusetts Non-Voting Liaisons Lili Portilla, M.P.A. Director of Strategic Alliances Office of Strategic Alliances National Center for Advancing Translational Sciences National Institutes of Health Bethesda, Maryland Samantha O’Connor, M.B.A. Executive Director and Head Strategy and Business Planning Centers for Therapeutic Innovation Pfizer Worldwide Research & Development Boston, Massachusetts | ||||||||
| 634 | CTI Call for Proposals | Pfizer’s CTI for NIH has two calls for proposals each year. Learn more about the therapeutic areas of interest for this proposal cycle. Advantages to Collaborating with CTI A cooperative research and development agreement (CRADA) collaboration with CTI includes, among other things, access to Pfizer’s drug development expertise and publishing rights. CTI’s foundation partners include: Lupus Research Alliance Crohn’s and Colitis Foundation of America Jeffrey Modell Foundation View frequently asked questions about the CTI program for NIH researchers. See the therapeutic areas of interest. Project Scope As a general rule, CTI does not accept therapeutics of the following kinds: small molecule, radiotherapy, nanoparticle delivery systems and vaccines. Pre-proposals for collaboration will be evaluated initially on the basis of fit with Pfizer internal program portfolios, other CTI collaborations, and business and technical feasibility specific to each project. RNAi, CRISPR technologies and nanoparticles are not in the scope for the current CTI call for proposals. Success Factors: What We Look For Strong project rationale Demonstrated association between target biology pathway and disease mechanism Target validation as demonstrated by genetic or pharmacologic evidence Ability to address unmet medical needs Validated therapeutic drug target Tractable target relative to proposed drug modalities (antibodies, proteins and peptides) Novel target, novel therapeutic strategy or new insight into target patient population Defined target Understanding of desired pharmacology Demonstrated cause-effect relationship to disease mechanism Project feasibility Clear path to candidate development (biochemical/cell-free/cellular assays, disease models, preclinical testing, etc.) Clear path for translation into clinical trials (approach for proof-of-mechanism in humans, accessible patient population, time frame, safety issues, etc.) Clinical differentiation Therapeutic strategies including personalized medicine, patient stratification, molecular signatures, genetic associations and biomarkers Modalities Large molecules (antibodies, proteins, antibody conjugates and fusion proteins) Proposal Submission Process All intramural NIH researchers and clinicians whose work meets these criteria are invited to apply to CTI. The first step is submitting a pre-proposal brief (Word - 39KB), which is a non-confidential two- to three-page overview of the target, mechanism (including evidence for disease linkage), and the proposed therapeutic drug. At a high level, the pre-proposal should explain how the therapeutic hypothesis could be tested in the clinic. Investigators then must submit this pre-proposal to their NIH Institute or Center's technology transfer office for initial review and for submission to the Pfizer CTI Portal. For more information, contact Manjula Donepudi, Ph.D., or Lili Portilla, M.P.A. The NIH-Pfizer Joint Steering Committee reviews all submitted proposals. For selected projects, a team of scientists from CTI and NIH will work together to submit a full proposal and project plan to advance the research. Proposal Stages Stage I: Pre-proposal submission and non-confidential review Stage II: Full proposal submission and confidential review Stage III: Work plan and budget | ||||||||
| 629 | BrIDGs Projects | BrIDGs provides critical resources needed for the development of new therapeutic agents. Successful applicants receive access to NIH contractors who conduct preclinical synthesis, formulation, pharmacokinetic and toxicology services at no cost to the investigator. Browse active projects and completed projects. | ||||||||
| 625 | Completed BrIDGs Projects | Click on the links below to view completed BrIDGs projects: Advanced Studies with 5HMF — Most Potent Anti-Sickling Agent A Pharmacological and Toxicological Evaluation of the Gene Transfer Vectors sc-rAAV2.5IL-1Ra (Rat) and scr-AAV2.5IL-1Ra (Human) in Rats Alternative Formulations of Decitabine to Reactivate Fetal Hemoglobin Production Biomimetic Actinide Decorporation Agents: Enabling Availability cGMP Synthesis of the Selective Kappa Opioid Receptor Antagonist JDTic Developing SRX246 for Stress-Related Affective Illness Development of an ApoA-1 Mimetic Peptide for Treatment of Atherosclerosis Development of Assays to Detect Anti-Drug Antibodies Against ACP-501 Development of Bone Morphogenetic Protein Inhibitors to Treat Blood and Bone Disorders Development of Exendin-(9-39) for the Treatment of Congenital Hyperinsulinism Development of HGF Mimetic (Refanalin) for Hepatic Fibrosis Development of Minihepcidins for the Treatment of Beta Thalassemia Development of Neurosteroids for Lysosomal Storage Disorders Development of P-321 for Chronic Dry Eye Development of Propofol Hemisuccinate for the Treatment of Epilepsy HBN-1 Regulated Hypothermia Formulation and Evaluation of Toxicity IND-Enabling Studies on AAV2-GDNF for Parkinson’s Disease IND-Enabling Toxicology and Safety Pharmacology Studies for a First-in-Class CPG-Activating Drug Treatment (SPINALON) Against Chronic Spinal Cord Injury IND-Enabling Toxicology and Safety Pharmacology Studies of ATN-161 for the Treatment of Crohn’s Disease Inhibitors of Glutaminase 2 as Therapeutic Agents for Neuro-Oncological Diseases and Celiac Sprue Large-Scale Synthesis of Clozapine-N-Oxide Long-Acting Parathyroid Hormone Analog for Treatment of Hypoparathyroidism Manufacture of AAV2-AADC for the Treatment of AADC Deficiency Manufacture of RLIP76-LyoPL for Acute Radiation Syndrome Metarrestin for the Treatment of Pancreatic Cancer Metastin Administration in Humans: Support for Preclinical Toxicology Studies A Novel Drug Candidate for the Treatment of Diabetic Retinopathy Novel PDE Inhibitors for Treatment of Cognitive Dysfunction in Schizophrenia Novel Pre-Hospital Therapy of Myocardial Infarction A Potent Oral Therapy for Cytomegalovirus Infection Preclinical Development of CDD-0102 for the Treatment of Alzheimer’s Disease Preclinical Development of EDN-OL1 for Alzheimer’s Disease Redox Encrypted Therapeutics for Treatment of Friedreich’s Ataxia Safety Pharmacology Studies for Beta Thalassemia Single-Chain Urokinase Plasminogen-Activating Factor Small Molecule Treatment for Rheumatoid Arthritis Using the Preimplantation Factor (PIF) to Treat Graft-Versus-Host Disease | ||||||||
| 624 | BrIDGs Resources | Through the BrIDGs program, researchers partner with NCATS scientists to produce preclinical data as well as research and clinical material. Data and material are generated by NIH contractors under the direction of NCATS intramural researchers with expertise in the following development areas: Synthetic process development Scale-up and manufacture of active pharmaceutical ingredients Development of analytical methods Development of suitable formulations Pharmacokinetic/ADME (absorption, distribution, metabolism and excretion) studies, including bioanalytical method transfer and validation Range-finding initial toxicology studies Investigational New Drug (IND)-directed toxicology studies Manufacture of clinical trial supplies Product development planning and advice in IND preparation BrIDGs collaborations are completed using the contract resources of NCATS and the National Cancer Institute. | ||||||||
| 623 | Work with BrIDGs | The BrIDGs program is accepting new proposals to collaborate. Proposals are due Sept. 30. Review How to Request a Collaboration to begin the process. Collaborators leverage BrIDGs expertise and resources to generate data for a Investigational New Drug applications to a regulatory authority such as the U.S. Food and Drug Administration.BrIDGs enables collaborations on potential therapies for any disease or disorder. Eligible collaborating organizations include academic institutions, not-for-profit organizations and small businesses that meet the criteria for the Small Business Innovation Research program. Foreign academic and nonprofit institutions, as well as NIH intramural researchers, can work with BrIDGs.Learn more about working with BrIDGs: How to Request a Collaboration: Overview of the request process and detailed instructions for investigatorsConsiderations for Collaborators: Minimum data requirements and scope limitations for collaborationsIntellectual Property: How BrIDGs handles background versus new intellectual property created during the projectProject Implementation and Conduct: Project management, oversight and governanceResubmission of Prior Proposals: How to reapply and what must be achieved in the interimBrIDGs Operational ModelBrIDGs staff partner with researchers in need of preclinical therapeutics development expertise and resources to advance candidate therapeutics into clinical trials. Researchers with enough preliminary data can use BrIDGs capabilities to put a preclinical product development plan into action. In general, available expertise and contract resources include synthesis, formulation, pharmacokinetic and toxicology services. Pre-existing intellectual property (IP) rights are retained by the owner, which allows BrIDGs to function as a non-dilutive investment in exciting preclinical therapeutics development projects and to maximize the competitiveness of therapeutic agents for more private-sector funding. | ||||||||
| 617 | Tox21 Collaboration Generates an Innovative Platform for Testing Individual Differences in Chemical Sensitivity | What if we could predict whether an individual will have an adverse reaction to everyday chemicals, such as those in laundry detergent or perfume? Or whether a particular chemical factory worker will fall ill upon exposure to a particular substance? With the publication of a study from a team of researchers that included NCATS experts, science is one step closer to such a scenario. More than 80,000 chemical compounds are registered for use in the U.S., and for the vast majority of them, there has been no toxicity testing in humans to inform us about their effects on health. Just as genetic differences make each of us more or less susceptible to developing conditions such as heart disease, these differences also could determine how sensitive we are to chemicals in the environment. To establish safe levels of chemicals for human use, regulatory officials traditionally have used animal toxicology data to predict human responses to chemicals. This imperfect practice highlights a critical translational science and public health problem: until now, there has been no way to accurately measure human differences in sensitivity to the chemicals in our environment. A new study, published in the Jan. 13, 2015, issue of Environmental Health Perspectives, introduces a new way around this obstacle, using NCATS’ robotic screening capabilities to test the cells of more than 1,000 individuals with different genetic backgrounds for sensitivity to 179 chemicals. “To fully achieve the promise of precision medicine, we will not only have to understand the extent and genetic basis for human variation in response to therapeutics, but also for sensitivity to chemical toxicity and adverse drug reactions,” said John R. Bucher, Ph.D., associate director of the National Toxicology Program at the National Institute of Environmental Health Sciences (NIEHS), one of the collaborating institutions in the study. “This work provides a possible approach using technologies already in hand.” Addressing a Knowledge Gap Several years ago, experts in the Toxicology in the 21st Century (Tox21) program recognized a critical scientific need not yet addressed by the initiative. Tox21 is a collaboration among researchers from NCATS, NIEHS, the Environmental Protection Agency, and the Food and Drug Administration. Tox21 scientists use a robotic system located at NCATS’ laboratories in Rockville, Maryland, to perform automated tests, or assays, which expose cells and proteins to thousands of chemicals in a short time. This process is called high-throughput screening (HTS). Tox21 experts, including Raymond Tice, Ph.D., now retired from NIEHS, knew that the initiative’s approach yielded valuable information about cell functions affected by chemical toxicity. However, the tested cells all came from only a few cell lines, so the test results had few details about the range of sensitivity to a chemical’s toxicity in the human population as well as which genes affect that variability. But the team suspected that adapting the Tox21 HTS platform to test specific chemicals with known toxicity using cells from hundreds or thousands of people could produce that missing information. To get started, the Tox21 team partnered with scientists at the University of North Carolina at Chapel Hill — toxicology researcher Ivan Rusyn, M.D., Ph.D., now at Texas A&M University, and statistician Fred Wright, Ph.D., now at North Carolina State University, both authors on the paper — who had experience with small-scale testing of cells for genetic variations in toxicity. To draw reliable conclusions about how genes affect chemical sensitivity, the group needed cells that represented a large number of genetically diverse people. Luckily, they were able to acquire lymphoblastoid cells, a type of engineered white blood cell, together with related genetic information from 1,086 people from nine ethnic populations as part of the publically funded 1000 Genomes Project. The initiative is an international effort to catalog human genetic variation by sequencing (i.e., determining the sequence of “letters” in a person’s DNA) the genomes of more than 1,000 people. The researchers were ready to test chemicals on these cells grown in culture (also called in vitro) on a large-scale. Making the Most of NCATS’ Robotic Capabilities With help from automation experts in NCATS’ Division of Preclinical Innovation, the Tox21 team tested the toxicity of 179 chemicals using the cells of those 1,086 people and a technique called quantitative HTS. This innovative method, developed at NCATS, enabled the researchers to run each compound through the assay at eight different concentrations. This approach is more likely to capture the full range of responses from the most to the least sensitive individual. The chemicals tested were substances to which people regularly are exposed, including pesticides, industrial chemicals, food additives and drugs. The study, a massive logistical undertaking, was unprecedented in its scope. “It is the largest population-based, in vitro test with the largest number of cell lines ever done,” Rusyn said. The team found that for about half of the chemicals tested, the range of variability among individual responses was larger than previously assumed. When making regulatory decisions about safe levels of chemicals, environmental experts generally assume that reducing exposure by an extra 10-fold is sufficient to protect people who may be more sensitive to the toxic effects of a given chemical. Specifically, exposure is reduced first by a “toxicokinetic” factor of 3.2, which accounts for differences in how a chemical reaches cells in the body, and then by a “toxicodynamic” factor of 3.2, which accounts for differences in biological responses after a chemical interacts with cells in the body. Although some approaches have addressed the first factor, few researchers have evaluated the second factor, and only at a much smaller scale. This larger study’s findings suggest that the standard toxicodynamic factor is generally applicable, but for about half of the chemicals examined, a larger factor — in some cases greater than 10 — may be more appropriate. This result paves the way for a strategy to develop more precise, chemical-specific exposure factors, rather than the currently used “one-size-fits-all” approach. The researchers also examined the relationship between gene variations (polymorphisms) and cells’ sensitivity to toxicity. They discovered sensitivity-related polymorphisms in several genes involved in transporting substances across the cell membrane. The study was the first to highlight the role of this gene family in susceptibility differences for a range of chemicals. It may point to mechanisms by which chemicals affect human health. Disseminating a New Approach to Protecting Public Health Prior to the paper’s publication, the team released portions of the data to the international scientific community in the form of a data challenge called the DREAM Toxicogenetics Challenge. Such a competition harnesses the power of crowdsourcing to invite scientists to use Tox21 data to develop innovative predictive models for chemical toxicity across populations. The results from this paper, as well as from crowdsourced analyses, could help regulators devise a more accurate way of determining safe levels of environmental chemicals. They also may enable the identification of people who are especially sensitive to certain chemicals. “This work personifies the NCATS 3Ds,” said Christopher P. Austin, M.D., NCATS director. “Our team collaboratively developed a new way to address the problem of individual differences in sensitivity to chemicals; through this paper, we demonstrated that our method works, and we disseminated the results so that scientists can generate their own hypotheses and use the techniques in their own toxicological studies. This approach to studying personalized effects of environmental exposures, like that of precision medicine, embodies NCATS’ mission of finding translational solutions to improve human health.” Posted March 2015 |
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