Advancing Pediatric Medical Countermeasures Through the Newly BARDA-Funded Accelerator, SPARK for Innovations in Pediatrics
This article originally appeared in the Association for the Advancement of Medical Instrumentation’s (AAMI) new Insights into Innovation series is authored by Kolaleh Eskandanian, Ph.D., M.B.A., P.M.P., vice president and chief innovation officer at Children’s National and principal investigator of SPARK Innovations in Pediatrics, the BARDA Accelerator Network Hub for Special Populations.
October 21, 2024
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In the realm of public health and emergency preparedness, one of the most pressing challenges is ensuring that children and special populations are adequately protected. The ongoing global threats—whether pandemics, natural disasters, or acts of terrorism—have highlighted the vulnerability of these groups. Children in particular face unique physiological and developmental risks that necessitate specialized medical countermeasures (MCMs). Yet, the development of pediatric-specific MCMs has long been hindered by significant regulatory, ethical, and financial challenges.
Addressing these concerns, the SPARK Accelerator, led by Children’s National Hospital in partnership with the Biomedical Advanced Research and Development Authority (BARDA), is poised to accelerate the development of medical countermeasures tailored to the pediatric population. With a consortium of partners, including BioHealth Innovation (BHI), CIMIT, University Hospitals Rainbow Babies and Children’s Hospital, and strategic industry players such as Johnson & Johnson Innovation JLABS, SPARK is creating a global hub that primarily focuses on innovations for children.
The Unmet Need in Pediatric Medical Countermeasures
Medical countermeasures (MCMs) are essential for protecting against chemical, biological, radiological, and nuclear (CBRN) threats. They encompass a wide range of tools, including vaccines, medications, medical devices, and life-saving equipment. However, a striking gap persists in the development of MCMs specifically designed for pediatric populations. According to a 2013 report from the U.S. Government Accountability Office, nearly 40% of the MCMs in the Strategic National Stockpile (SNS) lack pediatric indications altogether, and many that are approved are only suitable for specific age groups.
This lack of pediatric-specific MCMs poses significant ethical and operational challenges during public health emergencies. Medical professionals often face the difficult decision of whether to administer off-label treatments to children during emergencies, with limited data on their safety, efficacy, or dosing for younger populations. Pediatric populations, particularly those under the age of two, are vulnerable to inadequate protection during crises such as radiation exposure or pandemics. Current gaps in MCMs include the lack of pediatric dosing instructions for treatments like Prussian Blue (used for radiation emergencies) and anthrax vaccines, as well as devices such as respirators, which are typically designed for adult use.
The Regulatory and Ethical Hurdles
The development of pediatric MCMs faces several barriers, with regulatory and ethical considerations at the forefront. Pediatric clinical trials are challenging to conduct due to the special safeguards in place for research on children. The ethical concerns revolve around exposing children to risks when there is no direct benefit to them, leading researchers to rely heavily on data extrapolated from adult studies. This practice of using weight-based dosing from adult data has serious implications for children, who may either receive ineffective doses or experience adverse effects unique to their physiology.
Moreover, the traditional regulatory pathways for approving MCMs demand rigorous clinical trials, making it difficult to advance pediatric-specific solutions. Without sufficient funding, coordination, or incentives, pediatric MCMs continue to lag behind those developed for adult populations. This is particularly true for low-probability, high-consequence events like CBRN threats, where the commercial market for pediatric MCMs is too small to justify large-scale investments from the private sector.
SPARK Accelerator: A Transformative Solution
The SPARK Accelerator was conceived as a response to these persistent challenges. By leveraging the expertise and resources of its consortium partners, the accelerator is positioned to fast-track the development of medical countermeasures that meet the unique needs of children and other vulnerable populations, such as those with immunocompromised conditions.
Leveraging knowledge and programs within BARDA, SPARK is poised to address the gaps in pediatric MCMs by developing and implementing adaptive clinical trial designs, master protocols, and real-world evidence (RWE) platforms. These efforts will enable faster and more efficient testing of MCMs across multiple pediatric subpopulations and threat agents.
Collaboration for Impact
The collaborative framework of SPARK is its greatest strength. By integrating the expertise of leading healthcare, academic, and industry partners, the accelerator provides comprehensive support to innovators and startups. From ideation to FDA authorization, the SPARK accelerator offers resources for every stage of product development. It also supports clinical trials and regulatory pathways, ensuring that pediatric MCMs can quickly move from concept to market.
Children’s National Hospital, with its established reputation in pediatric research and innovation, plays a critical role in this consortium. Its facilities at the Children’s National Research and Innovation Campus and the Sheikh Zayed Institute for Pediatric Surgical Innovation are dedicated to advancing pediatric-specific healthcare innovation.
By fostering collaboration across the public and private sectors, leveraging the latest in medical and technological innovation, and aligning closely with BARDA’s strategic priorities, SPARK is poised to protect the most vulnerable members of our society—children and special populations—during public health emergencies. Through its commitment to advancing pediatric health security, SPARK will not only drive scientific innovation but also ensure that no child is left behind in the fight against 21st-century health threats.
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