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Oct 12 2013

Sheikh Zayed Institute at Children's National Receives US FDA Grant to Form Pediatric Device Innovation Consortium

Grant will bring important advances to medical devices for use in global children healthcare
Winning the grant is "testimony to the contributions the Institute has made to innovation in pediatric healthcare...which reflects the vision of the UAE's founding father, the late Sheikh Zayed bin Sultan Al Nahyan"


Abu Dhabi, October 12, 2013: The Washington, DC, based Sheikh Zayed Institute for Pediatric Surgical Innovation at Children's National Medical Center has received a grant from the US Food and Drug Administration (FDA) to form the National Capital Consortium for Pediatric Device Innovation (NCC-PDI). The grant is for $700,000 and is part of an anticipated five year award.

The Sheikh Zayed Institute, which was created in 2009 thanks to a $150 million gift from the Government of Abu Dhabi, is a global model for healthcare innovation in pediatrics, which aims to build an ecosystem where care, education, and research work simultaneously together. The Institute is the first pediatric institution in the world to implement this model of innovation. The Institute's work has already led to a breakthrough in pain management for children who suffer from long-term pain; in January 2013, the Institute established the outpatient Pain Medicine Care Complex which uses one-of-its-kind multisensory technology to treat pain among children. The Complex is the latest direct result of research and development undertaken at the Sheikh Zayed Institute and is a key accomplishment toward the vision of the Sheikh Zayed Institute, which aims to find ways to reduce or eliminate pain in children.

The FDA provides grants to consortia whose business model and approach to device development will either result in, or substantially contribute to, market approval of medical devices designed specifically for use in children. The program's goal is to support the development of a nonprofit consortia designed to stimulate projects which will promote pediatric device development.

Dr. Kurt Newman, MD, President and CEO of Children's National said: "This new consortium is an exciting, important advance in developing medical devices for children and toward fulfilling our vision of making pediatric surgery more precise, less invasive, and pain-free. Receiving this highly-competitive grant marks a key milestone in growth of the Sheikh Zayed Institute; it is testimony to the contributions the Institute has made to innovation in pediatric healthcare over the past four years which reflects the vision of the UAE's founding father, the late Sheikh Zayed bin Sultan Al Nahyan. We are proud to continue growing as a result of our partnership with the UAE and also to garner increasing support from key entities in the US."

The grant was awarded by the US FDA's Office of Orphan Products Development in its third round of funding since 2009 to consortia that advance the development of pediatric medical devices. The 2013 grants were awarded to consortia that brought together teams with excellence and expertise in delivering business, regulatory, legal, scientific, engineering, and clinical services for children. All consortia work collaboratively with the US FDA to help innovators effectively navigate existing laws, regulations and agency guidance to protect the health and safety of children.

Dr. Peter Kim, MD, CM, PhD, Vice President of the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children's National said: "We're delighted that the gift granted by the Government of Abu Dhabi that helped create the Sheikh Zayed Institute for Pediatric Surgical Innovation is enabling us to make strides in research and product development that can help improve the quality of life for children from around the world. We're looking forward to working with our distinguished partners and collaborators, to bring important advances to medical devices for use in children healthcare. In pediatrics, we know that children are not simply small adults, so the US FDA's support for this area of innovation is particularly important to address this critical, but largely unmet need."

The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) will address four primary goals:

  • Provide a platform of experienced regulatory, business planning and device development services (such as intellectual property counsel, prototyping, engineering, laboratory and animal testing, grant writing, and clinical trial design) to foster the advancement of medical devices for pediatric patients
  • Bring together individuals and institutions that can support pediatric medical device progression through all stages of development--ideation, concept formation, prototyping, preclinical, clinical, manufacturing, marketing, and commercialization
  • Support a mix of projects at all stages of development, particularly the later stages of clinical, manufacturing, and marketing
  • Provide counsel on accessing various federal and non-federal funding resources while assessing the scientific and medical merit of proposed pediatric device projects

The NCC-PDI will be a collaboration of Children's National with the University of Maryland A. James Clark School of Engineering and its flagship institute, the Maryland Technology Enterprise Institute (Mtech). The partnership will also involve the university's Fischell Department of Bioengineering, chaired by Fischell Distinguished Professor and Co-PI William Bentley, and the Maryland Industrial Partnerships (MIPS) program.

"We are very pleased to partner with Children's National on this important new initiative that will drive forward new innovations that help save children's lives," said Vice President and Chief Research Officer at the University of Maryland Patrick O'Shea.

-Ends-

About Children's National Medical Center
Children's National, based in Washington, DC, has been serving the nation's children since 1870. Children's National's hospital is Magnet® designated, and is consistently ranked among the top pediatric hospitals by U.S. News & World Report and the Leapfrog Group. Home to the Children's Research Institute and the Sheikh Zayed Institute for Pediatric Surgical Innovation, Children's National is one of the nation's top NIH-funded pediatric institutions. With a community-based pediatric network, eight regional outpatient centers, an ambulatory surgery center, two emergency rooms, an acute care hospital, and collaborations throughout the region, Children's National is recognized for its expertise and innovation in pediatric care and as an advocate for all children. For more information, visit ChildrensNational.org, or follow us on Facebook and Twitter.

About the Sheikh Zayed Institute for Pediatric Surgical Innovation
The creation of the Sheikh Zayed Institute for Pediatric Surgical Innovation was made possible by a $150 million gift from the government of Abu Dhabi, representing a shared vision to significantly and measurably advance medical innovation to create healthier and safer surgical outcomes for children worldwide. The government of Abu Dhabi made the gift in honor of the late Sheikh Zayed bin Sultan Al Nayhan, the founder of the United Arab Emirates and the country's president from 1971 until his death in 2004.

Launched in September 2009, the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children's National is redefining what is possible in surgery through innovative, integrated research. The Institute's physician-scientists apply their expertise in their specialized fields to pursue the common goal to make pediatric surgery more precise, less invasive, and pain-free. By combining research and clinical work in this area, the Institute is developing knowledge, tools, and procedures that will benefit children in the Washington region, across the country, and around the world.

© Press Release 2013


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