Elena Medo, M.B.A. is an entrepreneur, researcher, and inventor who has spent nearly 40 years transforming neonatal care through leadership and innovation. She has secured numerous patents, raised over $40 million across four companies, and built a legacy of firsts, including the first commercially available shelf-stable donor breast milk product; the first milk bank owned exclusively by nursing mothers; and the first medical device designed to analyze human milk. Today, as CEO and co-founder of Leonie Health PBC, established in 2023 with her daughter, Adrianne Weir, Elena is developing a revolutionary product that replicates the immune properties of colostrum to protect preterm infants against the three deadliest neonatal infections—necrotizing enterocolitis (NEC), ventilator-associated pneumonia (VAC), and sepsis—which together claim the lives of more than 30,000 hospitalized infants per year.

Elena's work is driven by an unwavering commitment to ensure that human milk's unparalleled bioactive benefits reach the world's most vulnerable patients. Companies she has founded—including Prolacta Bioscience, Medolac Laboratories, North American Instruments, and White River Concepts—have applied disruptive technologies to serve the 15 million preterm infants born each year. A frequent speaker at neonatal, women's health, and leadership conferences, Elena holds an M.B.A. degree in Healthcare Management from the University of California, Irvine's Paul Merage School of Business and is widely recognized for assembling world-class teams to solve critical challenges in infant health.

In this episode of Food Safety Matters, we speak with Elena [38:58] about:

Her work in human milk science and the founding of Leonie Health, which offers bioactive infant nutritional products mimicking colostrum to support neonatal health and early development
Reflections on the recent global infant formula recall due to cereulide contamination, which affected 99 countries and multiple brands
Why U.S. disease surveillance systems might miss or misclassify infant foodborne illness cases
What the cereulide incident reveals about risks for infants in neonatal intensive care (NICU) and donor milk settings
Improvements to public health and laboratory systems that would enable earlier detection and response to infant formula contamination incidents and related illnesses
The importance of infant-specific toxicological reference values for contaminants like cereulide, such as those recently established in the EU, and how the EU's response could influence regulatory approaches to other emerging hazards in infant foods
Leonie Health's process for verifying the safety of donor milk
Key principles for clinicians, hospitals, and parents to consider when making decisions about infant feeding when contamination events affect commercial formula products.

News and Resources

News

U.S. Cyclosporiasis outbreak [2:46]:

Codex Alimentarius news [28:30]

Following Infant Formula Incidents, FDA Urges Manufacturers to Implement Stronger, Substantive Supplier Oversight [29:53]

USDA-FSIS to Expand Testing for Metals in RTE Foods Under National Residue Program [33:59]

Resources

Infant formula cereulide contamination incident:

U.S. Cyclosporiasis outbreak:

"Cyclospora cayetanensis: An Emergent Public Health Threat and an Enigma for Traceback Investigation," Food Safety Magazine
"Please Don't Stop Eating Vegetables and Fruits Because of Cyclospora," The Washington Post
"Cyclospora Spreads Through Human Feces. How Did it Get Into Our Food Supply?" The New York Times
"Publisher's Platform: The Traceability Rule was Supposed to be Law in January. This Cyclospora Outbreak Started in May." Food Safety News

We Want to Hear from You!
Please send us your questions and suggestions to podcast@food-safety.com