The MPRINT Hub Data, Model, Knowledge and Research Coordination Center: Bridging the gap in maternal-pediatric therapeutics research through data integration and pharmacometrics

Sara K Quinney; Robert R Bies; Shaun J Grannis; Christopher W Bartlett; Eneida Mendonca; Colin M Rogerson; Carl H Backes; Dhaval K Shah; Emma M Tillman; Maged M Costantine; Blessed W Aruldhas; Reva Allam; Amelia Grant; Mohammad Yaseen Abbasi; Murugesh Kandasamy; Yong Zang; Lei Wang; Aditi Shendre; Lang Li

doi:10.1002/phar.2765

The MPRINT Hub Data, Model, Knowledge and Research Coordination Center: Bridging the gap in maternal-pediatric therapeutics research through data integration and pharmacometrics

Pharmacotherapy. 2023 May;43(5):391-402. doi: 10.1002/phar.2765. Epub 2023 Jan 25.

Authors

Sara K Quinney^{1

2

3}, Robert R Bies^{4

5}, Shaun J Grannis^{6

7

8}, Christopher W Bartlett^{9

10}, Eneida Mendonca^{11

12

13

14}, Colin M Rogerson¹¹, Carl H Backes^{15

16

17

18}, Dhaval K Shah⁴, Emma M Tillman², Maged M Costantine¹⁹, Blessed W Aruldhas^{2

20}, Reva Allam², Amelia Grant², Mohammad Yaseen Abbasi², Murugesh Kandasamy², Yong Zang^{3

12}, Lei Wang²¹, Aditi Shendre²¹, Lang Li²¹

Affiliations

¹ Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indiana University, Indianapolis, Indiana, USA.
² Division of Clinical Pharmacology, Department of Medicine, Indiana University School of Medicine, Indiana University, Indianapolis, Indiana, USA.
³ Center for Computational Biology and Bioinformatics, Indiana University School of Medicine, Indianapolis, Indiana, USA.
⁴ Department of Pharmaceutical Sciences, University at Buffalo School of Pharmacy and Pharmaceutical Sciences, State University of New York at Buffalo, Buffalo, New York, USA.
⁵ Institute for Computational and Data Sciences, University at Buffalo, State University of New York at Buffalo, Buffalo, New York, USA.
⁶ Department of Family Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.
⁷ Center for Biomedical Informatics, Regenstrief Institute, Indianapolis, Indiana, USA.
⁸ Richard M. Fairbanks School of Public Health, Indiana University, Indianapolis, Indiana, USA.
⁹ The Steve & Cindy Rasmussen Institute for Genomic Medicine, Battelle Center for Computational Biology, Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, Ohio, USA.
¹⁰ Department of Pediatrics, College of Medicine, The Ohio State University, Columbus, Ohio, USA.
¹¹ Department of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana, USA.
¹² Department Biostatistics and Health Data Sciences, Indiana University School of Medicine, Indianapolis, Indiana, USA.
¹³ Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
¹⁴ Division of Biomedical Informatics, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
¹⁵ Division of Neonatology, Nationwide Children's Hospital, Columbus, Ohio, USA.
¹⁶ Departments of Pediatrics and Obstetrics and Gynecology, The Ohio State University College of Medicine, Columbus, Ohio, USA.
¹⁷ Center for Perinatal Research and The Ohio Perinatal Research Network, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, Ohio, USA.
¹⁸ The Heart Center at Nationwide Children's Hospital, Columbus, Ohio, USA.
¹⁹ Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio, USA.
²⁰ Department of Pharmacology and Clinical Pharmacology, Christian Medical College, Vellore, India.
²¹ Department of Biomedical Informatics, College of Medicine, The Ohio State University, Columbus, Ohio, USA.

Abstract

Maternal and pediatric populations have historically been considered "therapeutic orphans" due to their limited inclusion in clinical trials. Physiologic changes during pregnancy and lactation and growth and maturation of children alter pharmacokinetics (PK) and pharmacodynamics (PD) of drugs. Precision therapy in these populations requires knowledge of these effects. Efforts to enhance maternal and pediatric participation in clinical studies have increased over the past few decades. However, studies supporting precision therapeutics in these populations are often small and, in isolation, may have limited impact. Integration of data from various studies, for example through physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD) modeling or bioinformatics approaches, can augment the value of data from these studies, and help identify gaps in understanding. To catalyze research in maternal and pediatric precision therapeutics, the Obstetric and Pediatric Pharmacology and Therapeutics Branch of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) established the Maternal and Pediatric Precision in Therapeutics (MPRINT) Hub. Herein, we provide an overview of the status of maternal-pediatric therapeutics research and introduce the Indiana University-Ohio State University MPRINT Hub Data, Model, Knowledge and Research Coordination Center (DMKRCC), which aims to facilitate research in maternal and pediatric precision therapeutics through the integration and assessment of existing knowledge, supporting pharmacometrics and clinical trials design, development of new real-world evidence resources, educational initiatives, and building collaborations among public and private partners, including other NICHD-funded networks. By fostering use of existing data and resources, the DMKRCC will identify critical gaps in knowledge and support efforts to overcome these gaps to enhance maternal-pediatric precision therapeutics.

Keywords: bioinformatics; lactation; obstetric; pediatric; pharmacometrics; pharmacotherapy.

Publication types

Review
Research Support, N.I.H., Extramural

MeSH terms

Child
Female
Humans
Indiana
Models, Biological*
Ohio
Pregnancy

Grants and funding

P30 HD106451/HD/NICHD NIH HHS/United States