Director's Message
NCATS works to make translation more efficient and effective through new collaborative structures, innovation in technology and methods, and a relentless focus on deliverables that are useful to patients. I'm pleased to announce NCATS' latest success, which embodies all of these approaches: The National Institutes of Health is joining the Centers for Therapeutic Innovation network of Pfizer, Inc.
Read more in the latest Director's Message.
Christopher P. Austin, M.D.
What's New at NCATS?
NCATS Repurposing Test Identifies 53 Drugs that May Block Ebola Infection
NCATS Hosts First Meeting of Global Translational Research Collaborators
Establishing Good Clinical Practice Standards in the CTSA Program and Beyond
NCATS Holds Cures Acceleration Network (CAN) Review Board Meeting
Update on Standards for Federally Supported Clinical Research
Collaborate with NCATS Scientists
NCATS Repurposing Test Identifies 53 Drugs that May Block Ebola Infection
The world has witnessed an unprecedented outbreak of the Ebola virus in West Africa, and Americans have felt the fear brought on by documented cases of the virus within the United States. Time- and money-saving efforts become critical in such public health crises, and drug repurposing research is a viable option that has great potential. A team of researchers from NCATS and the Icahn School of Medicine at Mount Sinai worked to approach the problem in precisely that way: by testing existing drugs. The results yielded 53 drugs that may block Ebola virus-like particles from entering and infecting cells. Read the full feature.
NCATS Hosts First Meeting of Global Translational Research Collaborators
Addressing key challenges in translational science, such as increasing the reproducibility of pre-clinical research and reducing the failure rate of drugs in development, requires a collaborative approach. On Dec. 9–10, 2014, NCATS hosted the first meeting of a new collaboration among leading translational science organizations from around the world. The "Translational Science on the Global Stage" event brought together representatives from the European Infrastructure for Translational Medicine, Therapeutic Innovation Australia, and the Canadian Centre for Drug Research and Development for a two-day meeting in Bethesda, Maryland. The purpose of the gathering was twofold: (1) to become acquainted with the mission, structure and activities of each organization and (2) to explore how the group collectively could address some of the most significant hurdles in translation. Each organization presented snapshots of its efforts to overcome barriers and shared best practices.
Representatives from NCATS included Nora Yang, Ph.D., who discussed the Therapeutics for Rare and Neglected Diseases program's due diligence review process; Dan Tagle, Ph.D., who explained how the Tissue Chip for Drug Screening program could help screen for drug toxicity; and Petra Kaufmann, M.D., M.Sc., who said that changes to the Clinical and Translational Science Awards program could increase the efficiency of clinical trials. The collaborators will continue to work together on the fundamental principles for good translational science and will coordinate opportunities for collective organizational growth.
Establishing Good Clinical Practice Standards in the CTSA Program and Beyond
In response to the NIH Clinical Trial Working Group recommendation to standardize training, NCATS is leading a Clinical and Translational Science Awards (CTSA)-wide initiative to promote Good Clinical Practice (GCP) training for clinical trial personnel. GCP is a process that incorporates established ethical and scientific quality standards for the design, conduct, recording and reporting of clinical research involving the participation of human subjects.
The goals of the CTSA initiative are to streamline and standardize GCP training for clinical study personnel across the CTSA consortium, eliminate redundant training requirements and measure the impact of the changes. The initiative was unveiled at a meeting in Chicago on Nov. 3–4, 2014, that included 120 participants representing all 62 funded CTSA hubs, the Food and Drug Administration and the pharmaceutical industry. Meeting participants gathered to address the following key questions:
- Who should receive GCP training?
- What training should these individuals receive?
- How should they receive the training?
- At what intervals should retraining occur?
Once the group reaches consensus, staff at the CTSA hubs will demonstrate the effectiveness of the GCP training standards within their institutions and then broadly disseminate them with the goal of establishing the standards for all NIH-supported studies and beyond. This initiative is a good example of the 62 CTSA hubs collaborating together toward a common goal. Stay tuned for more information about this and other CTSA consortium-wide collaborations to advance clinical and translational research. Read the news release.
NCATS Holds Cures Acceleration Network (CAN) Review Board Meeting
On Dec. 12, 2014, NCATS convened a virtual meeting of the CAN Review Board. Freda C. Lewis-Hall, M.D., CAN Review Board chair, led the meeting, which featured presentations by NCATS leadership and discussions by the CAN Review Board and meeting participants.
NCATS Director, Christopher P. Austin, M.D., provided updates on the NCATS budget, CAN concept clearances presented at the September joint meeting of the NCATS Advisory Council and CAN Review Board, and the latest information on the NIH collaborative agreement to conduct research through Pfizer's Centers for Therapeutic Innovation network. Led by NCATS, this partnership is designed to help bridge the gap between early scientific discovery and its translation into new medicines through public-private resource sharing.
Danilo A. Tagle, Ph.D., M.S., associate director for special initiatives and executive secretary of the CAN Review Board, discussed the next phase of the Tissue Chip for Drug Screening program, during which researchers will refine existing 3-D human tissue chips and combine them into an integrated system that can mimic the complex functions of the human body. Tagle also addressed issues related to commercialization and the regulatory path for clinical development.
General discussion among the CAN Review Board members and meeting participants centered on technology transfer opportunities and alternative funding models.
Update on Standards for Federally Supported Clinical Research
The federal government recently announced new guidance aimed to speed the start of clinical research and better protect human research participants. On Dec. 3, 2014, NIH issued a draft policy that encourages the use of single institutional review boards (IRBs) in multisite clinical research studies. IRBs help ensure, before studies begin, that human subjects research will be conducted ethically. The IRB review process can be cumbersome when it involves multiple institutions, each with its own IRB. This new policy proposes that all NIH-funded, U.S. multisite studies use a single IRB. Read the NIH news release and comment on the draft policy.
The Department of Health and Human Services' Office for Human Research Protections also released the 2015 Edition of International Compilation of Human Research Standards. Designed for organizations that conduct international human subjects research, the guide outlines many of the laws, regulations and guidelines that govern this research in more than 100 countries worldwide, as well as describing international and regional organization standards. Read the standards.
Upcoming Events
January
NCATS Advisory Council/CAN Review Board to Meet January 15
On Jan. 15, 2015, NCATS will hold a joint meeting of the NCATS Advisory Council and the CAN Review Board on the NIH campus in Bethesda, Maryland. The meeting will feature reports from NCATS Director Christopher P. Austin, M.D., and other presenters about the Center's initiatives, policies, programs and future direction. For more information, visit the NCATS Advisory Council and CAN Review Board pages of the NCATS website.
February
Society for Laboratory Automation and Screening (SLAS) 4th Annual Conference & Exhibition
On Feb. 7–11, 2015, SLAS will convene its 4th annual conference in Washington, D.C. Presenters include NIH Director Francis S. Collins, M.D., Ph.D., and NCATS Director Christopher P. Austin, M.D. On Feb. 9, 2015, Austin will chair a special conference session titled An Evening with NIH, focused on showcasing NIH's programs, services and capabilities.
Rare Disease Day 2015
NIH will celebrate Rare Disease Day with a daylong event from 8:30 a.m. to 5 p.m. on Friday, Feb. 27, 2015. The event, which is sponsored by NCATS and the NIH Clinical Center, is free and open to the public. Details about the event are forthcoming and will be available on the NCATS Events page soon.
NCATS in the News
- There Are 53 Drugs That Could Treat Ebola • Time • Dec. 17, 2014
- Mining Existing Drugs for Ebola Treatments • The Scientist • Dec. 17, 2014
- Existing Drugs Block Ebola, Researchers Find • Laboratory Talk • Dec. 17, 2014
- Study Identifies 53 Approved Drugs That May Block Ebola Infection • Infection Control Today • Dec. 17, 2014
- The Alpha-1 Project Awards NCATS Fellowship to Michael Iannotti • Alpha-1 Foundation • Dec. 17, 2014
- Genome Sequencing: Exploring the Diagnostic Promise • NIH Director's Blog • Dec. 16, 2014
- Bone Drugs May Thwart HER-Driven Tumors • MedPage Today • Dec. 11, 2014
- Scripps Researchers Use DNA to Explore Mystery of Sudden Death • KPBS • Dec. 11, 2014
- New Clinic Software to Advance Rare Disease Treatment • Marshfield News-Herald • Dec. 6, 2014
- The Shape of Things to Come: 3D Printing in Medicine • JAMA • Dec. 3, 2014
- Spine Disease: CVD Risk and New Variant • MedPage Today • Dec. 3, 2014
- Choosing Niche Might Be Key to Success for Health Care Accelerators • California Healthline • Dec. 1, 2014
- Drug Discoverers Chart Path to Tackling Data Irreproducibility • Nature Reviews Drug Discovery • Dec. 1, 2014
- Does Diet Matter in Multiple Sclerosis? • Multiple Sclerosis Discovery Forum • Nov. 25, 2014
Collaborate with NCATS Scientists
NCATS researchers are seeking collaborators in the following areas:
NCATS Chemical Genomics Center (NCGC)
NCGC offers biomedical researchers access to large-scale screening capacity along with the medicinal chemistry and informatics expertise necessary to develop chemical probe molecules and to study the functions of genes, cells and biochemical pathways. For inquiries or to obtain NCGC probe molecules, contact Ajit Jadhav.
NCGC researchers also seek collaborators for assay development and high-throughput screening, chemistry and chemistry technology, automation, and informatics. Learn more.
NIH RNA Interference (RNAi) Initiative
The NIH RNAi initiative, administered by NCATS, provides state-of-the-art, high-throughput RNAi genome-wide screens for humans and mice. This resource is available only to NIH researchers. Scientists interested in performing high-throughput RNAi screens can contact Scott Martin, Ph.D., for more information.
Toxicology in the 21st Century (Tox21) Program
The Tox21 program aims to test 10,000 chemicals and evaluate their potential to cause health problems. Any investigator may propose the development of biological assays for high-throughput screening.
To suggest an assay, submit an assay nomination form to Menghang Xia, Ph.D. Proposed assays must be compatible with the high-throughput screening guidelines as described in the assay guidance criteria.