Kolaleh Eskandanian, PhD, MBA
Senior Research Scientist
MedStar-Georgetown AI CoLab
MedStar Health Research Institute
Kolaleh Eskandanian, PhD, MBA, is a Senior Research Scientist at MedStar Health Research Institute (MHRI) and a leader within the MedStar-Georgetown AI CoLab. She focuses on accelerating the generation of high-quality evidence needed to advance innovative therapies, devices, diagnostics, and digital health technologies from development to clinical adoption. Her work spans artificial intelligence, regulatory science, clinical trials, real-world evidence, digital health, and medical device innovation.
At MHRI, Dr. Eskandanian conceived and is building the Evidence Generation Engine, a new institutional capability that applies AI-enabled and computational methods to support regulatory-grade evidence generation. The initiative helps generate regulatory-grade evidence to support FDA submissions for medical products developed by our internal investigators and by the external developers who collaborate with us. It places particular emphasis on populations traditionally underrepresented in research, including children, pregnant and lactating patients, and individuals with rare diseases.
Dr. Eskandanian has served as principal investigator and program leader on multiple federally funded initiatives supported by the FDA, NIH, BARDA, and HRSA. Since 2013, she has led the FDA-funded Alliance for Pediatric Device Innovation and its predecessor consortium, supporting hundreds of innovation projects that have resulted in more than two dozen FDA and European regulatory authorizations and multiple company acquisitions. In 2024, she founded the SPARK Accelerator Hub for Innovations in Pediatrics as principal investigator. The only BARDA Accelerator Hub dedicated to advancing medical countermeasures for pediatric populations, the program is led by Dr. Eskandanian in her role as program director.
Before joining MedStar Health, Dr. Eskandanian served as Vice President and Chief Innovation Officer at Children's National Hospital, where she led innovation, technology development, commercialization, and strategic partnerships. Throughout her career, she has focused on building programs and partnerships that help promising healthcare innovations reach patients more quickly while expanding access to research and innovation for populations often overlooked by traditional development models.
Research interests
- Artificial intelligence in healthcare
- Evidence generation and regulatory science
- Clinical trials and real-world evidence
- Digital health technologies
- Medical device innovation
- Pediatric innovation
- Translational research and commercialization
- Special populations research, including pediatric, rare disease, and maternal health populations
Selected research studies
Evidence Generation Engine: Dr. Eskandanian is developing the Evidence Generation Engine within the MedStar-Georgetown AI CoLab, an institutional capability that leverages artificial intelligence, computational modeling, real-world data, and innovative study designs to accelerate the generation of regulatory-grade evidence for healthcare innovations.
Alliance for Pediatric Device Innovation: As founding principal investigator, Dr. Eskandanian leads one of the nation's leading pediatric innovation programs, supporting the development, evaluation, and commercialization of technologies designed to address unmet clinical needs in children. Since 2013, the program has contributed to more than two dozen FDA and European regulatory authorizations and multiple company acquisitions.
SPARK Accelerator Hub for Innovations in Pediatrics: Dr. Eskandanian founded the only BARDA Accelerator Hub focused on pediatric populations. The program supports the development of drugs, biologics, diagnostics, devices, and digital health technologies that strengthen preparedness and response capabilities during public health emergencies.
Education
- PhD, Management Science and Economics, Plekhanov Russian University of Economics, Moscow, Russia
- MBA, Kogod School of Business, American University, Washington, DC
- BS/MS, Physics and Mechanical Engineering, Moscow University, Moscow, Russia
Leadership and impact
- Founder, SPARK Accelerator Hub for Innovations in Pediatrics
- Founding Principal Investigator, Alliance for Pediatric Device Innovation
- More than $35 million secured in federal funding as principal investigator
- Led programs supporting more than 400 innovation projects across drugs, biologics, devices, diagnostics, and digital health
- Contributed to over two dozen FDA or European regulatory authorizations and multiple company acquisitions supporting commercialization and scale-up of healthcare technologies