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Dr. Kurt Newman in front of the capitol building

Children’s National leaders provide expertise and support to advance SHIP-MD pediatric innovation initiative

Dr. Kurt Newman in front of the capitol building

“Having spent 30 years on the frontlines of pediatric healthcare as a surgeon, I saw so much innovation focused on adult medicine and not on pediatric populations. Instead, we were trying to adapt adult devices for use in children, which is not an effective solution,” says Dr. Newman.

The advancement of children’s medical devices in the U.S. continues to significantly lag behind adult devices for many reasons. A dedicated group of public and private sector healthcare leaders are working together to change that trend. In culmination of its first stage of work, the System of Hospitals for Innovation in Pediatrics – Medical Devices (SHIP-MD) initiative recently held a dynamic 3-day public workshop to further develop this groundbreaking public-private partnership, which is currently in its pre-consortium/conceptual phase.

Children’s National leaders and clinicians were among the pediatric healthcare experts who contributed to robust discussions about how to build and nurture a public-private partnership system that will safely accelerate the advancement of pediatric medical devices.

The workshop was developed and guided by a multi-stakeholder group including the Critical Path Institute (C-Path), the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), AdvaMed, the American Academy of Pediatrics (AAP) and leaders of pediatric health systems.

Lee Beers

“We must strive to improve medical devices for children, which historically lag five to 10 years behind adults. For many children, that can be a lifetime,” says Dr. Beers.

Reflecting its ongoing commitment to bridging the pediatric innovation gap, Children’s National Hospital experts co-led discussions throughout the program, which explored ways to improve children’s health by transforming the existing medical device ecosystem to stimulate investment and innovation in pediatric devices.

Children’s National Hospital President and CEO Kurt Newman, M.D., and Lee Beers, M.D., medical director for the Child Health Advocacy Institute at Children’s National Hospital served as opening session speakers, providing their insights into the current state of innovation in pediatric devices and why a new approach, such as SHIP-MD, is vitally needed.

“Having spent 30 years on the frontlines of pediatric healthcare as a surgeon, I saw so much innovation focused on adult medicine and not on pediatric populations. Instead, we were trying to adapt adult devices for use in children, which is not an effective solution,” says Dr. Newman. “Children’s National Hospital is proud to contribute to SHIP-MD’s pioneering efforts to address this critical disparity and reform pediatric device development in order to ensure that children, regardless of their age or condition, have access to the life-changing treatments and technologies they need to grow up stronger.”

An op-ed recently penned by Dr. Newman in STAT further explores the importance of public-private partnerships like SHIP-MD that are focused on fast-tracking innovation in medical devices for children.

Beers, who also serves as president of AAP, highlighted the fact that, as medical technology continues to advance, children are not reaping the benefits.

Kolaleh-Eskandanian

“Through the SHIP-MD initiative, we can work to ensure that the discipline of medical device development is equally understood and appreciated by its participating hospitals,” says Dr. Eskandanian.

“We must strive to improve medical devices for children, which historically lag five to 10 years behind adults. For many children, that can be a lifetime,” says Beers. “Much more needs to be done to address the countless hurdles that prohibit children from accessing the technology they need. The disproportionate rate of disease in minority children is another indicator that we must not cut corners as we look to improve pediatric innovation access.”

Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National Hospital and principal investigator for the FDA-funded National Capital Consortium for Pediatric Device Innovation (NCC-PDI), co-led the Qualifying Hospital Criteria panel, which addressed the importance of expanding the SHIP-MD network to medical institutions that have the infrastructure for the safe conduct of research.

“Through the SHIP-MD initiative, we can work to ensure that the discipline of medical device development is equally understood and appreciated by its participating hospitals. As champions of pediatric innovation, we must work to provide equitable access to device trials for every patient that qualifies,” says Eskandanian. “The goal of the Qualifying Hospital Criteria group is to introduce criteria that hospitals must meet in order to provide a safe environment to conduct pediatric medical device research and trials.”

Co-leading the Regulatory panel was Francesca Joseph, M.D., FAAP, a pediatrician at Children’s National Hospital and co-investigator for NCC-PDI. This workshop explored opportunities to address regulatory needs by refining current processes and considering new options to promote advancement of pediatric medical devices.

Francesca Joseph

Co-leading the Regulatory panel was Dr. Francesca Joseph, a pediatrician at Children’s National Hospital and co-investigator for NCC-PDI.

In the closing session, Eskandanian and other panel experts recapped the workshop and discussed core factors that will help determine whether or not SHIP-MD’s network is prepared to enter Phase II, the consortium phase. This phase includes the development of a strategic plan that incorporates the short, medium and long-term goals needed to create and implement the framework enabling the official launch of SHIP-MD.

During his talk, Dr. Newman also shared the strategic steps being taken by Children’s National that complement the SHIP-MD initiative in advancing pediatric device innovation. Among these is the creation of the Children’s National Research & Innovation Campus (CNRIC), the first-of-its-kind pediatric research and innovation hub located in Washington, D.C., which includes on-site partners JLABS, Johnson & Johnson Innovation’s life science incubator, and Virginia Tech University. The campus will nurture a rich ecosystem for pediatric innovation in the nation’s capital.

happy children running with kite

Spurring innovation to support pediatric preparedness

happy children running with kite

There are many lessons to be learned from the response to the COVID-19 pandemic, but one that is at the forefront is to be prepared for anything and to strengthen readiness even in the unlikeliest circumstances.

This was the focus of a recent panel discussion featuring Lee Beers, M.D., F.A.A.P, medical director of Community Health and Advocacy within the Goldberg Center for Community Pediatric Health and Child Health Advocacy Institute at Children’s National Hospital. Dr. Beers is also president of the American Academy of Pediatrics.

The webinar entitled, “Protecting Our Future: Spurring Innovation to Support Pediatric Preparedness,” was hosted by Johnson & Johnson Innovation – JLABS (JLABS) as a product of BLUE KNIGHT™, a collaboration between JLABS and the Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services.

This event focused on what innovators can do to develop therapeutics, diagnostics, vaccines and other technologies that may protect our future, our children. Experts shared what has been done to develop groundbreaking medical countermeasures that aim to prepare and protect pediatric populations from the health threats of today and those of tomorrow. The main discussions were on ecosystems readiness, adaptations for the pediatric population and the way forward in 2021.

“One size does not fit all for pediatrics when it comes to treatments and personal protective equipment,” said Dr. Beers “We need to know the need and how to do the roll-out.” Fellow panelists agreed.

Dr. Beers went on to say that mental health is the pandemic within the pandemic for our nation’s youth. There are increased cases and severity now for children who struggle to cope with the lockdowns. “We cannot have our children bear the burdens of our challenges.”

After robust questions and answers from everything from the role of artificial intelligence in preparing for future pandemics to the inclusion of families in research and decisions, the panelists walked away with a good feeling about the future with the unprecedented speed of vaccines aimed to counter the effects of the 2020 virus crisis.

The consensus priorities of 2021 should be to develop specifics for children and not just adaptations from adults, with the aim to advance equity, diversity and inclusion in treatment goals, and to build on the success of telemedicine.

Nationally, funding for pediatric research continues to trail efforts targeted for adults. That’s why Children’s National is creating a one-of-a-kind pediatric research and innovation hub. The Children’s National Research & Innovation Campus is set to open in 2021, located on a nearly 12-acre portion of the former Walter Reed Army Medical Center campus. The campus will combine the strengths of Children’s National with those of public and private partners who share the vision of accelerating new discoveries that save and improve the lives of children. At the new campus, breakthrough innovations can more quickly be translated into new treatments and technologies benefitting kids.

Sally Allain, Head of Johnson & Johnson Innovation – JLABS @ Washington, D.C., highlighted the opening of a 32,000 square-foot facility on the Research & Innovation Campus with a residency capacity for up to 50 companies. This will be the first JLABS site anchored with a children’s hospital and research institute working to bring recognition to the need for more early-stage research and innovation in pediatrics for our smallest patients.

The new site will serve as an incubator for pharmaceutical, medical device, consumer and health technology companies, and serve as the hub for BLUE KNIGHT™. BLUE KNIGHT™ aims to stimulate innovation and incubation of technologies that improve health security and response through companies focused on public health threats and emerging infectious diseases. At JLABS @ Washington, DC, companies selected for BLUE KNIGHT™ will have access to the JLABS ecosystem and being a part of the Research & Innovation Campus, as well as fee assistance for certain costs associated with access, mentorship for BARDA, and dedicated equipment for BLUE KNIGHT™ companies.

Lee Beers

Lee Beers, M.D., F.A.A.P, begins term as AAP president

Lee Beers

“The past year has been a stark reminder about the importance of partnership and working together toward common goals,” says Dr. Beers. “I am humbled and honored to be taking on this role at such a pivotal moment for the future health and safety of not only children, but the community at large.”

Lee Savio Beers, M.D., F.A.A.P., medical director of Community Health and Advocacy at the Child Health Advocacy Institute (CHAI) at Children’s National Hospital, has begun her term as president of the American Academy of Pediatrics (AAP). The AAP is an organization of 67,000 pediatricians committed to the optimal physical, mental and social health and well-being for all children – from infancy to adulthood.

“The past year has been a stark reminder about the importance of partnership and working together toward common goals,” says Dr. Beers. “I am humbled and honored to be taking on this role at such a pivotal moment for the future health and safety of not only children, but the community at large.”

Dr. Beers has pledged to continue AAP’s advocacy and public policy efforts and to further enhance membership diversity and inclusion. Among her signature issues:

  • Partnering with patients, families, communities, mental health providers and pediatricians to co-design systems to bolster children’s resiliency and to alleviate growing pediatric mental health concerns.
  • Continuing to support pediatricians during the COVID-19 pandemic with a focus on education, pediatric practice support, vaccine delivery systems and physician wellness.
  • Implementation of the AAP’s Equity Agenda and Year 1 Equity Workplan.

Dr. Beers is looking forward to continuing her work bringing together the diverse voices of pediatricians, children and families as well as other organizations to support improving the health of all children.

“Dr. Beers has devoted her career to helping children,” says Kurt Newman, M.D., president and chief executive officer of Children’s National. “She has developed a national advocacy platform for children and will be of tremendous service to children within AAP national leadership.”

Read more about Dr. Beer’s career and appointment as president of the AAP.