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SUMMARY:MIDD’s Growing Role in Global Health: A Case Study of Primaquine
  Exposures in Lactating Women and Breastfed Infants - Dr Karen Rowland-Yeo
  (Certara)\, Prof Joel Tarning (MORU)\, Dr Mellie Gilder (MORU)\, Dr Nada 
 Abla Geiser (Medicines for Malaria Venture)
DTSTART;VALUE=DATE-TIME:20250522T160000
DTEND;VALUE=DATE-TIME:20250522T170000
UID:https://talks.ox.ac.uk/talks/id/470f20f5-611c-4ccb-9971-7063deff3004/
DESCRIPTION:Model-informed drug development (MIDD) is increasingly adopted
  to support global health equity by providing guidance on the safe use of 
 medications in lactating women and their nursing infants. In this webinar\
 , we will explore how MIDD enhances clinical lactation studies to support 
 more informed decision-making regarding the safety of administering medica
 tion to lactating mothers.\n\nPlasmodium vivax malaria remains a global he
 alth issue\, with 6.9 million cases in 2022. Primaquine is a drug used to 
 prevent relapse and treat P. vivax malaria (radical cure). Until November 
 2024\, when the last WHO guidelines for malaria were published\, its use w
 as restricted for lactating women if their children were < 6 months\, fear
 ing infant harm from exposure via breast milk. A major change was implemen
 ted in the last guideline\, adjusting the restriction age to < 1 month. Th
 is was supported by a clinical lactation study\, which was conducted to me
 asure primaquine concentration in breastmilk and in nursing infants > 1 mo
 nth old. Results showed that primaquine concentrations in infant plasma we
 re extremely low\, with no measurable effects on infants.\n\nMany women in
  malaria endemic communities live far from healthcare facilities. The post
 partum period is an operationally strategic time to provide radical cure f
 or women who have vivax malaria in pregnancy\, but primaquine is still not
  recommended for women breastfeeding neonates. Planned follow-up studies i
 n the neonatal period have been delayed by concerns about neonatal safety 
 by ethical approval boards. Physiologically-based pharmacokinetic (PBPK) a
 nd population pharmacokinetic (PopPK) modeling approaches were used to com
 plement the clinical study by predicting risk from drug exposure in breast
  milk and extrapolating data to neonates < 1 month old.\n\nThe modeling re
 sults predicted negligible risk\, suggesting that studies during this phys
 iologically vulnerable time could safely be conducted\, and that expansion
  of radical cure to this group is likely possible.\nSpeakers:\nDr Karen Ro
 wland-Yeo (Certara)\, Prof Joel Tarning (MORU)\, Dr Mellie Gilder (MORU)\,
  Dr Nada Abla Geiser (Medicines for Malaria Venture)
LOCATION:Venue to be announced
TZID:Europe/London
URL:https://talks.ox.ac.uk/talks/id/470f20f5-611c-4ccb-9971-7063deff3004/
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DESCRIPTION:Talk:MIDD’s Growing Role in Global Health: A Case Study of P
 rimaquine Exposures in Lactating Women and Breastfed Infants - Dr Karen Ro
 wland-Yeo (Certara)\, Prof Joel Tarning (MORU)\, Dr Mellie Gilder (MORU)\,
  Dr Nada Abla Geiser (Medicines for Malaria Venture)
TRIGGER:-PT1H
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