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Nominations Open for ACTS Board Officer Director-At-Large

Do you know an individual that is dedicated to advancing the field of Clinical and Translational Science? Are they looking to take their passion and experience to the next level? Or perhaps you are interested in getting more involved in your organization. The new director(s) will join a group of 16 actively engaged board members to steer ACTS' leadership roles in advancing the disciplines of Translational Science.  For more information, click here.

Click here to submit a nomination.

 

News From the Hill: FY 2016-2017 Budget Update

Speaker of the House John Boehner made good on his promise to “clean up the barn” this week and his final act was to negotiate a comprehensive fiscal year (FY) 2016-2017 budget deal with Senate leadership and the White House. The agreement averts a federal default on the national debt through March of 2017, paves the way for Congress to finish up appropriations bills for FY 2016, and sets overall budget numbers for FY 2017. Before transitioning the Speakership to Paul Ryan on Thursday, the comprehensive budget deal was passed by the House. The Senate approved the agreement early this morning and the President is expected to sign the measure.  

Please visit the ACTS Advocacy page for more information on this update.
  


Action Requested: Common Rule Update

 The U.S. Department of Health and Human Services (HHS) has announced proposed revisions to what is generally referred to as the Common Rule. The Common Rule contains regulations that protect individuals who participate in research and is followed by 18 federal agencies. The purpose of the proposed revisions to the Common Rule are to modernize and improve the current regulations which have not been updated since 1991. 

 
The proposed changes to the Common Rule include:
  • Strengthened informed consent provisions to ensure that individuals have a clearer understanding of the study's scope, including its risks and benefits, as well as alternatives to participating in the study.
  • Requirements for administrative or IRB review that would align better with the risks of the proposed research, thus increasing efficiency.
  • New data security and information protection standards that would reduce the potential for violations of privacy and confidentiality.
  • Requirements for written consent for use of an individual's biological samples, for example, blood or urine, for research with the option to consent to their future use for unspecified studies.
  • Requirement, in most cases, to use a single institutional review board for multisite research studies.
The proposed rule would apply to all clinical trials, regardless of funding source, if they are conducted in a U.S. institution that receives funding for research involving human participants from a Common Rule agency. 
Please visit the ACTS Advocacy page to find a full summary of the meeting. 

 

Duke Uses Modified Poliovirus to Fight Prostate Cancer

Using a modified poliovirus to fight deadly brain cancer recently received national media attention. Now, with support from Duke University's NIH Clinical and Translational Science Award, researchers are investigating whether this new therapy can be used on incurable metastatic prostate cancer. 

To read more, please click here. Written by Kendall Morgan for the Duke University CTSA. 

 

CTSA Hub Awards Announced

NCATS announces 18 Clinical and Translational Science Awards (CTSA) Program Hub Awards. Congratulations to ACTS Member Institutions receiving this award!

  • Boston University
  • Georgetown-Howard Universities, Washington, D.C.
  • Medical College of Wisconsin, Milwaukee
  • Medical University of South Carolina, Charleston
  • Mount Sinai School of Medicine, New York City
  • New York University Langone Medical Center, New York City
  • Northwestern University, Chicago
  • State University of New York at Buffalo
  • University of Alabama at Birmingham
  • University of California, Irvine
  • University of California, San Diego
  • University of Cincinnati
  • University of Florida, Gainesville
  • University of Iowa, Iowa City
  • University of Massachusetts Medical School, Worcester
  • University of New Mexico Health Sciences Center, Albuquerque
  • University of Texas Medical Branch at Galveston
  • Wake Forest University Health Sciences, Winston-Salem, North Carolina

 

 

SC CTSI-Supported Researchers Develop First Fully-Implantable Micropacemaker Designed for Fetal Use

A team of investigators at Children’s Hospital Los Angeles and the University of Southern California have developed the first fully implantable micropacemaker designed for use in a fetus with complete heart block. The team has done preclinical testing and optimization as reported in a recent issue of the journal Heart Rhythm, and the micropacemaker has been designated a Humanitarian Use Device by the US Food & Drug Administration (FDA). The investigators anticipate the first human use of the device in the near future. “Up until now, the pacemaker devices that have been used in an attempt to treat this condition in a fetus were designed for adults,” said Yaniv Bar-Cohen, MD, pediatric cardiologist at CHLA and lead author on the paper. “We have lacked an effective treatment option for fetuses.”

This article is written by Children's Hospital Los Angeles. For more information, please click here for details on this story.



Stanford University Develops Photovoltaic Retinal Implant to Possibly Restore Functional Sight 

 

Photovoltaic retinal implant could restore functional sight, researchers say. So far, the researchers have tested the device only in animals, but a clinical trial is planned next year in France. A team led by Stanford University researchers has developed a wireless retinal implant that they say could restore vision five times better than existing devices. Results in rat studies suggest it could provide functional vision to patients with retinal degenerative diseases, such as retinitis pigmentosa or macular degeneration. A paper describing the implant was published online April 27 in Nature Medicine.“The performance we’re observing at the moment is very encouraging,” said Georges Goetz, a lead author of the paper and graduate student in electrical engineering at Stanford. “Based on our current results, we hope that human recipients of this implant will be able to recognize objects and move about.”Republished with permission from the Stanford School of Medicine's Office of Communication & Public Affairs.To read more about Stanford's clinical trial, please click here.

 


 

Janice Gabrilove, ACTS Program Committee Chair for Translational Science 2016

Janice L. Gabrilove, M.D., is a world-renowned expert on the role of hematopoietic  growth factors in normal and malignant hematopoiesis and the role of these cytokines in ameliorating disease and treatment-related myelosupression.

Dr. Gabrilove and her colleagues were the first to purify, characterize, and obtain a patent for the invention of granulocyte colony stimulating factor (G-CSF), and to demonstrate that it could alleviate certain harmful effects of chemotherapy on blood-cell production. G-CSF, now produced commercially by Amgen, Inc. under the trade-name Neupogen & Neulasta, is used worldwide as a supplement to chemotherapy. It was also a central factor in revolutionizing the way in which bone-marrow transplantation is performed with the development of peripheral blood stem-cell transplants. Dr. Gabrilove is also a patent awarded inventor of arsenic trioxide, currently an FDA approved curative treatment of acute promelocytic leukemia. More recently her work has focused on the role of basic fibroblast (connective tissue) growth factor in normal blood cell development and specific malignant blood cell diseases.

Dr. Gabrilove has received numerous awards and presently holds four patents related to her work. She is a member of the American Society of Clinical Investigation, having been elected as a Young Turk. She has served in numerous capacities related to her research, including previous membership on the Food and Drug Administration Advisory Committee for the Approval of Biologics, the NIH Hematology-2, and Department of Defense Study Sections, as well as on the Editorial Boards of the American Society of Hematology’s prestigious journal Blood, UpToDate, and Clinical Cancer Research and Leukemia. She also served as an elected councilor on the Executive Committee of The American Society of Hematology.

She was a member of the faculty at Memorial Sloan-Kettering Cancer Center, where she rose to the rank of Associate Professor of Medicine. In 1998, she was recruited to The Mount Sinai School of Medicine as The James F. Holland Professor of Medicine and Chief of the Division of Medical Oncology. She presently serves as the Director of the Clinical Research Education Program in the Graduate School of Biomedical Sciences at the Icahn School of Medicine at Mount Sinai.



 

ACTS and AFMR Collaborate for a Successful 2015 Annual Meeting

 

WASHINGTON, DC – April 18, 2015 The Association for Clinical and Translational Science (ACTS) and the American Federation for Medical Research (AFMR) hosted their annual event, Translational Science 2015, from Thursday, April 16 to Saturday, April 18. This year’s meeting drew an audience of over 800, including 400 first time attendees, trainees, researchers, and federal program officers.

 

“We were extremely pleased with the turnout, diversity, and scope of science this year,” said ACTS President Michael Lichtenstein and AFMR President MingMing Ning in a joint statement. “Overall, it was clear that our attendees embodied this year’s conference theme, ‘Explore, Collaborate, Educate, Innovate’. We look forward to deepening the partnership between our organizations and building on the success of this event for next year’s meeting.”

 


 

BREAKING NEWS: Rare Disease Day at NIH to Feature Community Building and Research Advances

 

Why/What: 
Rare diseases affect an estimated 25 million people in the United States. On Feb. 27, 2015, the National Institutes of Health will recognize Rare Disease Day with a free event to raise awareness about these diseases, the challenges that patients face, and the importance of research collaborations. The event will feature tours; posters and exhibits; and presentations on successful team and community building, the critical role of technology transfer and strategic alliances, and advances from the National Center for Advancing Translational Sciences' (NCATS) Rare Diseases Clinical Research Network. 

When/Where: 
February, 27, 2015 
8:30 a.m. - 5 p.m.
NIH Clinical Center (Building 10) Masur Auditorium, 10 Center Dr., Bethesda, Maryland. 

Who: 
The event is hosted by NCATS and the NIH Clinical Center. Speakers include:

Congressman Leonard Lance, (NJ-07), co-chair of the Rare Disease Caucus; NIH Director Francis S. Collins, M.D., Ph.D.; NCATS Director Christopher P. Austin, M.D.; and NIH Clinical Center Director John I. Gallin, M.D. Partner organizations include the U.S. Food and Drug Administration, National Organization for Rare Disorders, Genetic Alliance, Global Genes and Uplifting Athletes.



 

Meet Our Plenary Speakers!

Are you ready to learn about the latest discoveries in the field of translational science? Register now and join a diverse audience of trainees, junior and senior investigators, and NIH program officers for Translational Science 2015April 16-18 in Washington, DC!

2015 Plenary Speakers
We're bringing together leading minds in the field to update you on hot topics and teach you how to take your research to the next level! This year's plenary speakers are:


Robert Califf, MD

Deputy Commissioner, Medical
Products and Tobacco, FDA


Garret FitzGerald, MD, FRS

Professor, Medicine and Pharmacology; McNeil Professor in Translational Medicine and Therapeutics; Chair, Department of Pharmacology; Director, Institute for Translational Medicine and Therapeutics, Perelman School of Medicine, University of Pennsylvania

 

 


Roy Herbst, MD, PhD

Chief, Medical Oncology, Yale Cancer Center; Associate Director, Translational Research, Yale Cancer Center; Clinical Research Program Leader, Thoracic Oncology Program, Yale Cancer Center


Petra Kaufmann, MD, MSc

Clinical Innovations Director
NCATS Division of Clinical Innovation

 

 

 


Geoffrey Smith, JD

Managing Director
Mars Grand Challenge Ventures


Christopher Wilson, PhD

Associate Professor, Basic Sciences, Division of Physiology, School of Medicine, Loma Linda University



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