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| 571 | Patients with Rare Muscle Disorder Benefit from Repurposed Heart Drug | Patients with nondystrophic myotonia, a rare genetic muscle disorder, often have problems with debilitating muscle stiffness, fatigue, and sometimes even episodes of paralysis. Now, these patients have new help: a drug called mexiletine, normally used to treat heart disorders. With assistance from NIH’s Rare Diseases Clinical Research Network (RDCRN) and Clinical and Translational Science Awards (CTSA) program, researchers at seven institutions in four countries collaborated to demonstrate in a clinical trial that the heart drug is effective in treating patients with this rare disease. In a study published in JAMA in October 2012, a research team led by Jeffrey Statland, M.D., a neurologist at the University of Rochester Medical Center, found that mexiletine significantly improved patient-reported muscle stiffness. Jaya Trivedi, M.D., at UT Southwestern Medical Center in Dallas, one of the authors of the study, said, “Nondystrophic myotonia is not as debilitating as some forms of muscular dystrophy that lead to a wheelchair-confined state, but the symptoms it produces significantly impair patients’ daily living activities.” Symptoms may be triggered by cold, exercise or other exposures. Last summer, she said, she saw a 14-year-old boy with the disease who plays baseball, but if he isn’t warmed up, he can’t even run to first base. Rare diseases such as this one are a focus of the RDCRN’s Consortium for Clinical Investigation of Neurologic Channelopathies (CINCH). The RDCRN, which is managed by NCATS’ Office of Rare Diseases Research (ORDR) and supported by several NIH Institutes and Centers, facilitates collaboration among experts to explore the natural history, epidemiology, diagnosis and treatment of nearly 100 rare diseases. The RDCRN consists of a Data Management and Coordinating Center and 17 distinct clinical research consortia ― each of which studies a minimum of three related diseases. For each disease, consortia members work together to implement a natural history study that describes the disease and its symptoms over time, then they carry out other studies such as drug or other treatment trials. CINCH researchers already had completed a natural history study of nondystrophic myotonia, and the next step was a study of mexiletine, a generic drug normally used to treat cardiac arrhythmias or seriously irregular heartbeats. Since the 1980s, doctors have prescribed mexiletine off-label for nondystrophic myotonia, and it seemed to help some patients. But since the disease is so uncommon, no one had been able to study the drug in enough patients to find out if it actually worked in a large study. Through the RDCRN, researchers were able to find the 60 patients needed for the evaluation. The RDCRN has centers in multiple locations around the world and provides tools and resources to support a broad, international collaboration. Patients in this study were at four sites in the United States, and at one site each in Canada, the United Kingdom, and Italy. To collect and manage the study data from the seven sites, the research team used the RDCRN’s Data Management Coordinating Center at the University of South Florida. Additionally, each of the four U.S. sites has a Clinical and Translational Science Award that provides resources and services to medical researchers. For this study, the team used a variety of CTSA resources for lab tests, electrocardiograms, muscle tests, and pharmacy services. Primary funding for the study was provided by the U.S. Food and Drug Administration’s Office of Orphan Products Development, and by NIH’s National Institute of Neurological Disorders and Stroke (NINDS). Based upon the earlier natural history study, researchers identified some potential study participants, but more were needed. Richard Barohn, M.D., CINCH co-investigator and principal investigator for the CTSA grant at the University of Kansas Medical Center, took advantage of the CTSA’s resources for recruiting participants. “It’s a challenge to find these patients,” he said. “The CTSA helps get the word out to local doctors about the study.” During the double-blind study, patients took either mexiletine or a placebo for four weeks, and then had a one-week break followed by four weeks of the opposite intervention. Mexiletine improved muscle stiffness in these patients significantly, but, since the drug has some side effects, the research team is continuing to look for other ways to treat people with nondystrophic myotonia. According to an editorial in the same issue of JAMA as the published research, the study was hailed as a “triumph for rare disease networks.” It also indicated that the study was completed in only 28 months, which was “noteworthy for a group of diseases with a worldwide estimated prevalence of one per 100,000.” ORDR Director Stephen Groft, Pharm.D., said that the mexiletine story is a perfect example of how NCATS facilitates rare disease research: “Responding to the needs of patients who have one of the estimated 6,800 rare diseases known today is paramount. We were able to leverage diverse resources to complete a successful study that will make a real difference in the lives of patients with nondystrophic myotonia.” Meanwhile, the drug has made a difference in the life of that young patient of Dr. Trivedi’s. “When he takes this drug, he performs better in baseball, which is important to him,” she said. Posted December 2012 | ||||||||
| 570 | NCATS Announces New Research Projects to Improve Treatments for Rare and Neglected Diseases | NCATS recently began work on three new preclinical drug development projects aimed at finding treatments for rare blood disorders and infectious diseases. The research, supported through the Center's Therapeutics for Rare and Neglected Diseases (TRND) program, also is designed to provide insights that will broadly improve and accelerate the translational science process. TRND researchers will work on projects to develop treatments for malaria and Lassa fever, two infectious diseases that affect hundreds of thousands of people each year around the world, predominantly in developing countries. Malaria is a parasitic disease that spreads through the bite of an infected mosquito, and Lassa fever is a viral hemorrhagic virus, one of a group of viruses that also includes Ebola. The third project is designed to develop a drug candidate with the potential to treat two blood disorders: beta-thalassemia and sickle cell disease. Both are caused by defects in hemoglobin, the protein in red blood cells that carries oxygen throughout the body. Often, there is a perceived high risk of developing treatments for rare or neglected diseases due to anticipated lower returns on investment. TRND researchers seek to advance preclinical drug development projects to first-in-human trials, an approach known as "de-risking." This strategy aims to make candidate drugs more commercially viable and thus attractive to outside partners who can invest in their further development. For example, a sickle cell drug called Aes-103 that advanced to clinical testing with TRND program resources was acquired in July 2014 by Baxter International's BioScience business for further clinical development. "The success of Aes-103 is a validation of the NCATS model, which fosters a novel collaborative approach designed to de-risk therapeutic development programs and attract private-sector investment," said NCATS Director Christopher P. Austin, M.D. "We look forward to applying this model to the new TRND projects in hopes of advancing additional treatment candidates for patients." TRND researchers also have advanced three other projects to human clinical trials. These included studies to evaluate treatments for chronic lymphocytic leukemia, hereditary inclusion body myopathy and Niemann-Pick disease type C. These projects have reached the stage at which partners, such as pharmaceutical, biotechnology or disease advocacy groups, are being sought to move the treatments into the next phases of clinical development. "With so much recent success, TRND researchers are highly motivated to tackle these new projects," said John C. McKew, Ph.D., director of the TRND program. "With millions of patients in need of better treatments, our team is excited to continue this important work." A rare disease is one that affects fewer than 200,000 Americans. It is estimated that there are more than 6,000 rare diseases. However, effective pharmacologic treatments exist for only about 200 of these illnesses. Neglected diseases are conditions that inflict severe health burdens on low-income populations. Many of these conditions are infectious diseases that are most prevalent in tropical climates, particularly in areas with unsafe drinking water, poor sanitation, substandard housing, and little or no access to health care. TRND collaborations offer an opportunity to partner with TRND researchers and gain access to rare and neglected disease drug development capabilities, expertise and clinical/regulatory resources in a collaborative environment with the goal of moving promising therapeutics into human clinical trials. TRND projects are adopted through a formal solicitation process. To learn more about TRND, its projects and clinical research studies, and how to apply, visit the TRND page. Posted October 2014 | ||||||||
| 569 | NCATS Announces Funding Opportunities to Repurpose Drug Candidates from Industry | NCATS now is accepting applications for its Discovering New Therapeutic Uses for Existing Molecules (New Therapeutic Uses) program. Today, NCATS issued funding announcements and provided information about partially developed therapeutic candidates — referred to as “agents” — for researchers to crowdsource ideas for new uses. Launched in 2012 as a pilot initiative, New Therapeutic Uses matches researchers with a selection of pharmaceutical industry agents to explore new treatments for patients. For the new funding opportunities, NCATS is collaborating with AstraZeneca, Janssen Research & Development, L.L.C., Pfizer Inc. and Sanofi to make 26 agents available. For the first time, the participating pharmaceutical companies have made available agents that are suitable for exploring pediatric indications. For those agents, NCATS will provide an extra year of support — as compared to agents for adult indications — to complete additional studies evaluating safety, dosage and side effects in healthy volunteers, as well as juvenile toxicity studies, which are required before pediatric clinical trials can begin. The New Therapeutic Uses program is a breakthrough approach to speeding new therapies to patients in need. Since the failure rate of new therapeutic development is more than 95 percent, many candidate agents exist at pharmaceutical companies that have cleared many key steps in the drug development process, including safety testing in humans. Repurposing these agents, which have known human safety profiles, for a new use offers the potential for rapid completion of development and ultimate regulatory approval. “New Therapeutic Uses addresses the common problem of failure in therapeutic development by turning it into an opportunity for the ‘wisdom of the crowd’ to suggest new conditions that candidate agents might treat,” said NCATS Director Christopher P. Austin, M.D. “By working together with our industry and academic partners to further develop these agents, we can meet the goal of speeding treatments to patients in need.” New Therapeutic Uses accelerates these partnerships through innovative template agreements designed to streamline the legal and administrative process for research collaboration across organizations. During the New Therapeutic Uses pilot phase, these agreements reduced the time required to establish collaborations between industry and academia to about three months from the more typical 9 months to a year. In June 2013 as part of the pilot, NIH awarded $12.7 million to nine academic research groups for projects to explore new treatments for patients in eight disease areas, including two rare diseases: Duchenne muscular dystrophy and the progressive lung disease lymphangioleiomyomatosis. Within three months, one third of the project investigators were testing compounds in humans for new uses, including potential treatments for schizophrenia (two agents) and Alzheimer’s disease. “The progress we have made on our collaborative projects is remarkable given the complexities of initiating clinical trials,” said AstraZeneca Vice President of Emerging Innovations, Scientific Partnering and Alliances Don Frail. “The knowledge of the investigators, together with the tools, resources and expertise made available by our company, allowed the projects to move forward very quickly, and quality preclinical and/or clinical data have already emerged.” Interested researchers can submit a pre-application by July 15, 2014, in response to the funding announcements on NCATS’ New Therapeutics Funding Information page. Applicants must describe how they would explore specific hypotheses for an agent available through the program and how it might be used in a specific disease. Pre-applications will undergo NIH review, and successful applicants will be placed in contact with the pharmaceutical company providing the agent to discuss the submission of an application for funding that would begin in July 2015. In addition to NCATS, multiple NIH Institutes and Centers and the Food and Drug Administration’s Office of Orphan Products Development are contributing funding for these announcements. A technical assistance teleconference will be held on May 29, 2014, from 1:00 to 2:30 p.m. ET. All prospective applicants are invited to participate. Participants are encouraged to register via the NCATS Events Web page, and to submit questions on or before May 27 to be addressed during the teleconference. Posted May 2014 | ||||||||
| 568 | CTSA Program Funding Opportunity Now Available | On Sept. 12, 2014, NCATS released a new funding opportunity for the Clinical and Translational Science Awards (CTSA) program, a national network of medical research institutions collaborating to transform how clinical and translational science is conducted nationwide. Applications are due Jan. 15, 2015. CTSA hubs — the medical research centers that make up the CTSA network — support high-quality clinical and translational research locally, regionally and nationally, fostering innovation in training, collaboration and new methodologies. NCATS is continuing to develop the CTSA program to meet the evolving needs of clinical and translational investigators and the communities they serve. “The CTSA program is a unique national resource through which we have the capability to transform the translational landscape to get more treatments to more patients more quickly,” said NCATS Director Christopher P. Austin, M.D. “This new funding opportunity represents a key step in addressing the national need for resources and support to improve and accelerate translation.” For this latest opportunity, NCATS considered the Institute of Medicine findings on the CTSA program and a subsequent NCATS Advisory Council Working Group report (PDF - 414KB) in response to the IOM’s findings, as well as input from CTSA principal investigators and others in the broader research community. There is new emphasis on: Aligning the CTSA program more directly with NCATS’ overall goals;Building a collaborative, national network to achieve strategic translational science goals;Overall workforce development to train a new generation of clinical and translational scientists; andEvaluation and accountability with defined criteria for measurement and metrics.“We are excited to advance the CTSA program by building on its many successes to date,” said Petra Kaufmann, M.D., M.Sc., director of NCATS’ Division of Clinical Innovation. “The evolved CTSAs will better enable the realization of the program’s full potential for transforming clinical and translational science with the ultimate goal of improving human health.” Posted September 2014 | ||||||||
| 567 | Website Disclaimers | Exit Notification — Endorsement Disclaimer Links with this icon () indicate that you are leaving a U.S. federal government website. The link will lead to a non-federal site but provide additional information that is consistent with the intended purpose of a federal site. The U.S. Department of Health and Human Services (HHS), which includes the National Institutes of Health (NIH), cannot attest to the accuracy of a non-federal site. References to any specific commercial products, process, service, manufacturer or company does not constitute HHS endorsement, or recommendation by any HHS employees. You will be subject to the destination site’s privacy policy when you follow the link. For more information on exit notifications and disclaimers for non-federal websites, the following resources may be helpful: HHS Digital Communications DigitalGov Pop-Up Advertisements — Endorsement Disclaimer When visiting the NCATS website, your Web browser may produce pop-up advertisements. These advertisements most likely were produced by other websites you visited or by third-party software installed on your computer. NCATS and the NIH do not endorse or recommend products or services for which you may view a pop-up advertisement on your computer screen while visiting this site. Information Disclaimer The information provided on the NCATS website is only intended to be general summary information for the public. It is not intended to take the place of either the written law or regulations. It is not NCATS’ intention to provide specific medical advice to users of the NCATS website; instead, the site provides information to help users better understand their health; diagnosed conditions; and current approaches related to treatment, prevention, screening and supportive care. NCATS urges users to consult with a qualified health care professional for diagnosis and answers to personal medical questions. Intrusion Detection This site is maintained by the U.S. federal government. It is protected by various provisions of Title 18, U.S. Code. Violations of Title 18 are subject to criminal prosecution in federal court. For site security purposes and to ensure that this service remains available to all users, we employ software programs to monitor traffic to identify unauthorized attempts to upload or change information, or otherwise cause damage. In the event of authorized law enforcement investigations and pursuant to any required legal process, information from these sources may be used to help identify an individual. | ||||||||
| 566 | Privacy Notice | Protecting your privacy is important to NCATS. This website links to other National Institutes of Health (NIH) sites, federal agency sites and private organization sites. Once you leave the primary ncats.nih.gov website, you are subject to the privacy policy for the site(s) you visit. NCATS does not collect any personally identifiable information (PII) about you during your visit to this site unless you choose to provide it. NCATS does, however, collect some data about your visit to better understand how the public uses the site and how to make it more helpful. NCATS collects information from visitors who read, browse and/or download information from this site. NCATS never collects information for commercial marketing or any purpose unrelated to the center’s mission and goals.When visitors send email messages containing personal information to the Public Information Officer general, NCATS responds to and files the messages. Only designated staff and contractors requiring access to the emails to respond may view or answer them.Types of Information CollectedWhen you browse through any website, certain information about your visit can be collected. NCATS automatically collects and temporarily stores the following type of information about your visit:Domain from which you access the Internet.IP address (an IP address is a number that is automatically assigned to a computer when surfing the web).Operating system and information about the browser used when visiting the site.Date and time of your visit.Pages you visited.Address of the website that connected you to NCATS (such as google.com or bing.com).NCATS uses this information to measure the number of visitors to our site and its various sections and to help make our site more useful to visitors.How NCATS Collects InformationThis website uses Google Analytics measurement software to collect the information in the bulleted list under Types of Information Collected. Google Analytics collect information automatically and continuously. No PII is collected. NCATS staff and contractors conduct analyses and report on the aggregated data from Google Analytics. The reports are only available to the website’s managers and other designated staff who require this information to perform their duties. NCATS retains the data from Google Analytics as long as needed to support the mission of this website.How NCATS Uses CookiesThe Office of Management and Budget (OMB) memo M-10-22, Guidance for Online Use of Web Measurement and Customization Technologies allows federal agencies to use session and persistent cookies.When you visit any website, its server may generate a piece of text known as a “cookie” to place on your computer. The cookie allows the server to “remember” specific information about your visit while you are connected.The cookie makes it easier for you to use the dynamic features of web pages. Cookies from NCATS web pages only collect information about your browser’s visit to the site; they do not collect personal information about you.There are two types of cookies, single session (temporary) and multi-session (persistent). Session cookies last only as long as your web browser is open. Once you close your browser, the cookie disappears. Persistent cookies are stored on your computer for longer periods.Session Cookies: We use session cookies for technical purposes, such as to enable better navigation through our site. These cookies let our server know that you are continuing a visit to our site. The OMB memo 10-22 guidance defines use of session cookies as "Usage Tier 1—Single Session.” The policy says, “This tier encompasses any use of single session Web measurement and customization technologies.”Persistent Cookies: We use persistent cookies to enable Google Analytics to differentiate between new and returning ncats.nih.gov visitors. Persistent cookies remain on your computer between visits to this website until they expire. The OMB memo 10-22 guidance defines use of persistent cookies as "Usage Tier 2—Multi-session without Personally Identifiable Information (PII).” The policy says, “This tier encompasses any use of multi-session Web measurement and customization technologies when no PII is collected.”Opt Out or Disable Cookies: If you do not wish to have session or persistent cookies placed on your computer, you can disable them using your web browser. If you opt out of cookies, you will still have access to all information and resources at ncats.nih.gov. Find instructions for disabling or opting out of cookies in the most popular browsers. Note: By following the instructions to opt-out of cookies, you will disable cookies from all sources, not just those from ncats.nih.gov.How Personal Information is ProtectedYou do not have to give NCATS personal information to visit this website. However, if you choose to receive announcements or e-newsletters, NCATS collects your name and email address to complete the subscription process.If you choose to provide PII (information that is personal in nature and which may be used to identify you) through an email message, request for information, paper or electronic form, questionnaire, epidemiology research study, etc., NCATS will maintain the information you provide only as long as needed to respond to your question or to fulfill the stated purpose of the communication. If NCATS stores your personal information in a record system designed to retrieve information about you by personal identifier (name, personal email address, home mailing address, personal or mobile phone number, etc.), so that NCATS can contact you, the Center will safeguard the information you provide in accordance with the Privacy Act of 1974, as amended (5 U.S.C. Section 552a).NCATS operates a record system designed to retrieve information about you in order to accomplish its mission, so a Privacy Act Notification Statement (this policy) is displayed on the public-facing website. The notice addresses the following five criteria:NCATS legal authorization to collect information about youPurpose of the information collectionRoutine uses for disclosure of information outside of NCATSWhether the request made of you is voluntary or mandatory under lawEffects of non-disclosure if you choose to not provide the requested informationFor further information about privacy at NIH, email the NIH Senior Official for Privacy, call 301-451-3426 or visit the NIH Office of Management Assessment.Data Safeguarding and PrivacyNCATS uses web measurement and customization technologies to help sites function better for visitors and to better understand how the public uses NCATS’ online resources. All uses of web-based technologies comply with existing policies with respect to privacy and data safeguarding standards. Information Technology (IT) systems owned and operated by NCATS are assessed using Privacy Impact Assessments (PIAs) posted for public view on the Department of Health and Human Services (DHHS) Privacy Impact Assessments web page. NCATS conducts and publishes a PIA for each use of a third-party website and application (TPWA) as they may have a different functionality or practice. TPWA PIAs are posted for public view on the DHHS website.When web measurement and customization technologies are used, a Privacy Notice displayed on the website must provide:Purpose of the web measurement and/or customization technology.Usage tier, session type, and technology used.Nature of the information collected.Purpose and use of the information.Whether and to whom the information will be disclosed.Privacy safeguards applied to the information.Data retention policy for the information.Whether the technology is enabled by default or not and why.How to opt-out of the Web measurement/customization technology.Statement that opting-out still permits users to access comparable information or services.Identities of all third-party vendors involved in the measurement and customization process.Data Retention and Access LimitsNCATS will retain collected data long enough to achieve the specified objective for which they were collected. The data generated from these activities falls under the National Archives and Records Administration (NARA) General Records Schedule (GRS) and will be handled per the requirements of that schedule.How NCATS Uses Third-Party Websites and ApplicationsAs part of OMB memo M-10-06, Open Government Directive, NCATS uses a variety of new technologies and social media options to communicate and interact with citizens. These sites and applications include popular social networking and media sites, open source software communities and more. TPWAs are web-based technologies that are not exclusively operated or controlled by NCATS, such as applications not hosted on a.gov domain or those that are embedded on NCATS web pages. Users of TPWAs often share information with the general public, user community, and/or the third-party operating the website. These actors may use this information in a variety of ways. TPWAs could cause PII to become available or accessible to NCATS and the public, regardless of whether the information is explicitly solicited or collected by NCATS.The following list includes some of the TPWAs that NCATS uses and their purposes. NCATS sometimes collects and uses PII made available through third-party websites. However, we do not share PII made available through third-party websites. Your activity on the third-party websites NCATS uses is governed by the security and privacy policy of those sites (linked below). Review the third-party privacy policies before using the sites and ensure that you understand how your information may be used. If you have an account with a third-party website and choose to follow, like, friend, or comment, certain PII associated with your account may be made available to NCATS based on the privacy policy of the third-party website and your privacy settings within that third-party website. Therefore, you should also adjust privacy settings on your account to match your preferences.For any NCATS TPWA that collects PII, the list below also includes details on the information NCATS collects and how the center protects your private information.Third-Party Websites and ApplicationsBit.ly: NCATS uses Bit.ly to shorten long URLs for use in email messages, in X feeds, on Facebook pages, and in linking to media stories and funding opportunities. Bit.ly collects and provides data on how often you, as an email recipient or Facebook/X user, click on the shortened URLs distributed by NCATS. Bit.ly analytics show how many people clicked on the URLs, compared to the total number of clicks on the shortened URLs. Bit.ly analytics do not provide any PII about the visitors who open the shortened links. Review the Bit.ly Privacy Policy.Facebook: NCATS has one Facebook page: National Center for Advancing Translational Sciences. NCATS Facebook pages are managed by NCATS staff and contractors, who post news and other items of interest to be consumed by the public. If you have a Facebook account, you can log in to your account to post comments and “like” the NCATS Facebook page and individual entries. If, after you click on the NCATS Facebook page, you comment or click the “like” button, your PII will be visible to NCATS staff and other Facebook site visitors. The amount of visible personal information displayed will depend on your own Facebook privacy settings. You can completely avoid displaying any PII by not creating a Facebook account, not posting comments, not clicking on the “like” options, or not interacting with the NCATS Facebook account in any way (i.e., private messaging, sharing posts, etc.). NCATS staff and contractors do not collect, use or disclose any information about visitors who comment or “like” the NCATS Facebook page. However, as a practice, the NCATS Comment Policy requires the removal from the NCATS Facebook page of any comments that contain spam or are improper, inflammatory, off-topic or offensive. Repeat offenders may be subject to banning. The information is then saved on a password-protected shared drive accessible to designated staff who require this information to perform their duties. Review the Facebook Privacy Policy.Flickr: NCATS uses Flickr to share photos and images related to the center’s mission and culture. NCATS is responsible for the uploaded images on NCATS-sponsored Flickr pages and must ensure the posted images meet quality standards and comply with all NIH, DHHS and federal policies. Images posted are produced by NCATS and may include medical illustrations and other scientific images. Photos posted may also include photos of NCATS employees at events or in labs for the purpose of promoting the center’s mission and culture. You do not need to register with Flickr to view the images on NCATS Flickr pages because all NCATS images posted on Flickr are visible in the public domain. However, if you choose to register, you will not provide PII directly to NCATS. The center has disabled the commenting feature on its Flickr pages. Therefore, PII cannot be collected or unintentionally received by NCATS via the Flickr site. Review the Flickr Privacy Policy.LinkedIn: NCATS has one LinkedIn page: National Center for Advancing Translational Sciences. NCATS uses LinkedIn to post news and other items of interest and to respond to comments and inquiries sent to NCATS via LinkedIn. You may read the NCATS LinkedIn feeds without subscribing to them. If you want to subscribe to (or follow) NCATS LinkedIn feeds, you must create a LinkedIn account at www.linkedin.com. To create an account, you must provide some personal information, such as your name, username, password and email address. You have the option to provide additional personal information, including a short work history, a location and a picture. Most information you provide for a LinkedIn account is available to the public, but you can modify how much of your information is visible by changing your privacy settings on LinkedIn.com. NCATS staff and contractors monitor the number of subscribers and respond to comments and queries via LinkedIn, but these individuals never take possession of the personal information belonging to you as a LinkedIn follower. However, as a practice, the NCATS Comment Policy requires the removal from the NCATS LinkedIn page of any comments that contain spam or are improper, inflammatory or offensive. The information is then saved on a password-protected shared drive accessible to designated staff who require this information to perform their duties. Review the LinkedIn Privacy Policy.MailChimp Subscription Management: NCATS uses MailChimp to send e-newsletters, announcements and other messages to users who subscribe to receive them. To subscribe to receive an NCATS product, you must provide your name and email address and indicate your subscription preferences, including the items you want to receive. The email subscriber lists are password protected by MailChimp. Only the NCATS managers who send newsletters, announcements or other communications via MailChimp and the staff and contractors who monitor the results of email initiatives have access to the subscriber lists. MailChimp never allows access to the subscriber lists to anyone outside of NCATS for any purpose. MailChimp collects and provides non-identifying information about the number of messages sent, clicks and open rates. This information is password-protected and only available to designated staff who require this information to perform their duties. Review the MailChimp Privacy Policy.X: NCATS has one X account: National Center for Advancing Translational Sciences. NCATS uses X to send short messages or “posts” (up to 240 characters) to share information about NCATS and respond to comments and inquiries sent via X to NCATS. You may read the NCATS X feed without subscribing to them. If you want to subscribe to (or follow) NCATS X feeds, you must create an X account at www.x.com. To create an account, you must provide some personal information, such as your name, username, password and email address. You have the option to provide additional personal information, including a short biography, location or a picture. Most information you provide for an X account is available to the public, but you can modify how much of your information is visible by changing your privacy settings on X.com. NCATS staff and contractors monitor the number of subscribers and respond to comments and queries via X, but these individuals never take possession of the personal information belonging to you as an X follower. However, as a practice, the NCATS Comment Policy requires the removal from the NCATS X page of any comments that contain spam or are improper, inflammatory or offensive. The information is then saved on a password-protected shared drive accessible to designated staff who require this information to perform their duties. Review the X Privacy Policy.YouTube: NCATS has one YouTube channel: National Center for Advancing Translational Sciences. NCATS posts videos on YouTube to make them available to the public. You do not need to register with either YouTube or Google (which owns YouTube) to watch NCATS YouTube videos. When you watch videos, YouTube may record non-personally identifiable information about their site usage, such as channels used, videos watched, and data transfer details to improve its services. If you log in to the YouTube site before watching NCATS videos, YouTube may associate information about your site usage with your YouTube account. If you log in to YouTube and comment on an NCATS video, any personal information you included on your YouTube profile page will be visible to visitors who click on the comment field. If you do not log in before watching NCATS videos posted on YouTube, you cannot comment on NCATS videos, and your site usage will not be associated with you or a YouTube account. Review the YouTube Privacy Policy.For more information on the uses of social and new media for which the General Services Administration has negotiated a federally friendly Terms of Service agreement, visit the DHHS Center for New Media.For further information about privacy at NIH, email the NIH Senior Official for Privacy, call 301-451-3426 or visit the NIH Office of Management Assessment. | ||||||||
| 565 | Contact Us | General Information NCATS Information Officer 301-594-8966 Use the NIH Staff Directory to find staff from NCATS and other NIH Institutes and Centers. Grants & Funding Submit NCATS Grant Inquiry 301-435-0809 Check the Funding & Notices section for current opportunities. Media/Press Bobbi Gardner Steve Benowitz 301-435-0888 Visit the Media Resources section for audio clips, videos, B-roll and other materials for the media. Policy Questions Penny Burgoon, Ph.D. 301-594-7328 Research Training Carrie Watkins 301-435-0717 Scientific Review Gregory P. Jarosik, Ph.D. 301-496-5735 Small Businesses Krishna (Balki) Balakrishnan, Ph.D., M.B.A. NCATS-SBIRSTTR@mail.nih.gov 301-827-7149 Technology Transfer, Licensing & Partnerships Krishna (Balki) Balakrishnan, Ph.D., M.B.A. NCATSPartnerships@mail.nih.gov 301-827-7149 Science & Programs Rare Diseases Division of Rare Diseases Research Innovation 301-402-4336 Preclinical Science Anton Simeonov, Ph.D. 301-217-5721 Clinical Science Division of Clinical Innovation 301-435-0790 Visit the NCATS Programs & Initiatives page to find program-specific contact information. More Resources Find current Job Opportunities at NCATS. Get information about Contributing to NCATS-Funded Research. Learn more about how to submit Freedom of Information Act Requests. Mailing Addresses 31 Center Drive, Suite 3B11 Bethesda, Maryland 20892-2128 One Democracy Plaza, 9th and 10th Floors 6701 Democracy Boulevard, MSC 4874 Bethesda, Maryland 20892-4874 (20817 for express mail) 9800 Medical Center Drive Rockville, Maryland 20850 | ||||||||
| 564 | NCATS Comment Policy | NCATS leadership and staff members encourage feedback and comments about all of our communications, including website and social media information. We aim to foster meaningful dialogue and public interaction and welcome all viewpoints.Public comments posted on our social media sites do not necessarily reflect the official views of the National Center for Advancing Translational Sciences, the National Institutes of Health, the U.S. Department of Health and Human Services, or other federal government entities. In addition, NCATS staff reserve the right to remove social media posts or comments that are inconsistent with the following guidelines:Do PostRespectful languageComments that are focused and to the pointThe truthInformation relevant to the topic at handDo Not PostVulgar, profane or abusive languagePersonal attacks of any kindInappropriate religious, sexual, political or racial referencesUnsupported accusationsMisleading, defamatory or false informationEndorsements of commercial products, services, organizations or other entitiesEndorsements of political parties, candidates or groupsSpam (includes repeated posts, comments and links to other sites)Content, images or graphics that infringe on copyrightsDocuments of any kindSolicitation of fundsComments on any sort of ongoing investigationComments or images that suggest illegal activity or that contain illegal contentProcurement-sensitive information related to any current/future NCATS acquisitionsSurveys, polls, questionnaires, etc., subject to OMB Paperwork Reduction Act clearanceReporters' questions — all media inquiries must be directed to the NCATS Information OfficerBy posting your comments or other work to a social media site owned or administered by NCATS, you irrevocably grant NCATS permission to copy, distribute, make derivatives, display or perform your work publicly and free-of-charge.Comments on social media are welcome at any time; however, NCATS staff will only moderate and respond to comments during regular business hours. NCATS staff may edit your comment for clarity or length or to remove inappropriate material. They may use the information you provide to contact you regarding changes or questions about your feedback.Remember that social media posts are public. Do not include any information that personally identifies you in a way you do not intend (e.g., social security numbers). Additional guidance can be found on the NIH Privacy and Security Policy page. | ||||||||
| 563 | NCATS Welcomes McInnes and Zuk to Leadership Team | NCATS Director Christopher P. Austin, M.D., kicked off 2014 by welcoming two new members of the Center’s leadership team. Pamela M. McInnes, D.D.S., M.Sc.(Dent.), began her new role as the NCATS deputy director on January 12, and Dorit Zuk, Ph.D., joined NCATS as director of the Office of Policy, Communications and Strategic Alliances just two weeks later. NCATS already is benefitting from the enormous expertise and experience they bring to the Center. Meet Pamela McInnes McInnes comes to NCATS with more than 25 years of NIH experience, including knowledge and expertise in clinical and translational research, extramural research management, and trans-NIH collaborations and public-private partnerships. “I am thrilled that Pamela is joining the NCATS leadership team,” Austin said. “Her recruitment is a key milestone in our building NCATS into a catalyst for transformational change that will get new treatments to more patients more quickly.” Before joining NCATS, McInnes served as director of the Division of Extramural Research at the National Institute of Dental and Craniofacial Research (NIDCR). There, she was responsible for all of the Institute’s extramural research, which ranges from basic through clinical studies, including large and complex clinical and population-based trials. McInnes brings a commitment to the conduct of clinical trials that adhere to the highest standards for human subjects protection and data quality. Her work in translational sciences has led to several product development and clinical evaluation programs, and she actively collaborates with the broader extramural research community on efforts to improve health. “I am excited to join NCATS, which is uniquely focused on solving translational process problems that aren’t a primary focus of disease-oriented programs,” McInnes said. “I look forward to collaborating with stakeholders in the government, academia, patient organizations and the private sector to revolutionize the way translational research is conducted nationwide.” Prior to her time at NIDCR, McInnes spent 16 years at the National Institute of Allergy and Infectious Diseases (NIAID), where she served in many capacities, including as deputy director for the Division of Microbiology and Infectious Diseases. In addition, she led the reorganization and oversight of NIAID’s complex and diverse Divisional Clinical Research Program as well as the scientific design and programmatic implementation of a Challenge Grant Program promoting joint ventures among NIH and biotechnology, pharmaceutical and medical device companies. Her work on contract awards to develop anthrax and smallpox vaccines required extensive collaboration and interactions with the Food and Drug Administration, Department of Defense (DOD) and Centers for Disease Control and Prevention. The author of more than 40 peer-reviewed articles and five books, McInnes first joined NIH in 1989 as a grants associate in the Office of Extramural Programs in the Office of the Director. Before coming to NIH, she served in academic and consulting roles at Louisiana State University Medical Center, Shreveport. McInnes earned her D.D.S. and M.Sc. degrees from the University of the Witwatersrand in Johannesburg, South Africa. Meet Dorit Zuk Zuk began oversight of NCATS’ policy, evaluation, reporting and communications functions on January 26. She takes the reins from Lili M. Portilla, M.P.A., who served as the office’s acting director for the prior 16 months and continues to lead partnerships and strategic alliances for NCATS. “Translational science brings with it unique policy and communication challenges and opportunities for which Dorit’s remarkable background and skills are ideally suited,” Austin said. With more than two decades of experience, Zuk has developed NIH extramural research policy, implemented NIH-wide strategic initiatives, and edited major scientific journals, including Cell and Molecular Cell. Zuk previously served as the science policy advisor in the Office of Extramural Research (OER) and as special assistant to the deputy director for extramural research at NIH, Sally Rockey, Ph.D. In these roles, Zuk developed, coordinated and disseminated policies and procedures on a variety of research-related issues, such as financial conflicts of interest and the strength and diversity of the biomedical research workforce. As executive secretary for the federal Research Business Models Committee, Zuk worked closely with other agencies, including the National Science Foundation and DOD, to address emerging policy issues related to the conduct of federally supported scientific research. “I am very excited about my new role at NCATS,” said Zuk, who began her career in basic science. “I started my career doing research on translation at the molecular level, and now, I am looking forward to facilitating translational science at the people level.” In 2007, Zuk first came to NIH as a one-year American Association for the Advancement of Science (AAAS) science and technology policy fellow. The following year, she served as a program officer for science policy at the American Academy of Arts and Sciences before joining OER. During 2000–2007, Zuk was the scientific editor at Cell Press, serving as the deputy editor of the journal Cell from 2000 to 2002 and the editor of Molecular Cell from 2003 to 2007. Zuk received a B.Sc. from Tel-Aviv University and an M.Sc. in biology and Ph.D. in cell biology from the Weizmann Institute of Science. She serves on the Education and Professional Development Committee of the American Society of Biochemists and Molecular Biologists and chairs the AAAS Fellowships Advisory Committee. Posted February 2014 | ||||||||
| 562 | NCATS Spotlight: Toxicology in the 21st Century (Tox21) Program | We are exposed to thousands of different chemicals during our lifetimes, from consumer products to food additives to pharmaceutical drugs. Yet scientists lack the data to predict how these chemicals affect our bodies and their potential for harm. New system-wide methods for assessing chemical toxicity can improve the way scientists evaluate environmental chemicals and develop new medicines. The Tox21 program, a collaborative initiative among NIH, the Food and Drug Administration, and the Environmental Protection Agency, aims to test 10,000 chemicals and evaluate their potential to cause health problems. The compounds undergo testing in the high-throughput robotic screening system at the NCATS Division of Preclinical Innovation. Program scientists design innovative methods to quickly and efficiently predict whether certain chemicals can disrupt processes in the human body, leading to adverse health effects. In July, partners on this project published an article in Environmental Health Perspectives that outlined progress made thus far, the methods and technologies used, potential problems, and possible solutions to those problems. Leaders from each of the Tox21 agencies, including NCATS Director Christopher P. Austin, M.D., described the project’s substantial progress in integrating data from diverse technologies and establishing end points that will contribute to a systems-biology approach to toxicology. The authors say that although Tox21 will likely take decades to fully achieve its goals, they believe the information acquired thus far is “foretelling the future of toxicology.” A month earlier, these same collaborators highlighted Tox21’s chemical screening progress in an article published online in Drug Discovery Today. In the paper, they described the robotic platform, which can screen the Tox21 library three times in a week. They also described the production phase of the screening process, compound library preparation, data processing and the methods used to prepare the robotic platform for full-scale screening. Tox21 work also is contributing to the NIEHS-NCATS-UNC DREAM Toxicogenetics Challenge. Launched earlier this summer, this innovative, crowdsourced computational contest aims to gain a greater understanding of how our individual genetics influence the toxic response of cells to chemical exposure. The data for the challenge come from a Tox21 study that used information from the 1000 Genomes Project. Leaders and organizers include scientists from NCATS, the National Institute of Environmental Health Sciences (NIEHS), Sage Bionetworks, Dialogue for Reverse Engineering Assessments and Methods (DREAM), and the University of North Carolina (UNC). Posted September 2013 |
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