MPRINT CET

Maternal and Pediatric Precision in Therapeutics (MPRINT) Center of Excellence in Therapeutics (CET)

A New Hope for "Therapeutic Orphans"

The Challenge: Pregnant and lactating women are considered “therapeutic orphans” because they generally have been excluded from clinical drug research and the drug development process. As a consequence, most medications prescribed for pregnant and lactating women are used “off-label” because most of the clinically approved medications do not have appropriate drug labeling information for pregnant and lactating women.¹ Nonetheless, most women take one or more medications during pregnancy and lactation.

The Need: There is an urgent need for research at the very intersection of maternal and infant health, so that physicians and healthcare providers can make data-informed recommendations to pregnant and breastfeeding women. It is simply unacceptable that often the default recommendation is to stop breastfeeding just because of insufficient data.

The Initiative: The 2020 Strategic Plan of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at the National Institutes of Health (NIH) prioritizes the support of "research to test and evaluate therapeutics and medical devices used by pregnant and breastfeeding women." One key initiative is the establishment of the Maternal and Pediatric Precision in Therapeutics (MPRINT) Hub. The MPRINT Hub will serve "as a national resource for conducting and fostering therapeutics-focused research in obstetrics, lactation, and pediatrics while enhancing inclusion of people with disabilities."

UC San Diego School of Medicine selected as one of two MPRINT Centers of Excellence in Therapeutics (CETs)

The MPRINT Hub will comprise a Knowledge and Research Coordination Center (KRCC) and two Centers of Excellence in Therapeutics (CETs):

MOMI CORE will lead MPRINT's Human Milk Research Platform

The UC San Diego MPRINT CET involves a human milk-centered approach to investigate the role of maternal and pediatric therapeutics at intersections of the mother-milk-infant ‘triad’. Key among the overall goals of the MPRINT CET are to assess how maternal therapeutics impact human milk composition and how human milk components alter safety and efficacy of pediatric therapeutic agents.

MOMI CORE will provide overall guidance and advice to MPRINT CET investigators and staff as well as analytical services as part of a newly established and rapidly growing Milk Analytics Core (MAC).

Key objectives for MAC are to...

• provide the teams with advice and best-practices on how to collect, ship, and store human milk samples,
• perform milk composition analysis on samples provided by the project teams,
• expand the portfolio of validated assays for human milk-specific analytes that have been associated with infant health and development, and
• engage and activate UC San Diego network collaborators, including MOMI Seeds recipients, to apply their unique perspective, skills, and technologies to human milk research.

A Resource for the Global Research Community

We envision MOMI CORE's MAC to become a comprehensive milk analytics core with knowledge, skills, and technology that serves as a resource to the MPRINT Hub as well as the global biomedical research community at large. Together, we will be able to generate a better understanding of how therapeutics during pregnancy and lactation impact the mother-milk-infant ‘triad’, inform and adjust precision in therapeutics, and ultimately improve maternal and child health and development.

¹Ren, Bremer, Pawlyk. Drug development research in pregnant and lactating women. Am J Obstet Gynecol 2021