Context: MMV is hosting a consultation with pharmaceutical industry partners on the topic of gender-inclusive R&D. The aim is to identify scientific approaches, lessons learned, opportunities and barriers to fully address the needs of women throughout their lifecycle, including when they are pregnant or lactating. In recent years, the practice of excluding pregnant and lactating women and women of childbearing potential from biomedical research has generated much attention. When women are excluded from research, they are unlikely to have equitable and timely access to critical interventions. At this consultation, we will place particular emphasis on strategies to develop new safe medicines with an aim of making them accessible to pregnant and lactating individuals more expeditiously than the current practice allows.

Agenda: 

I. Introduction

• Welcome and introduction of participants
• Context and objectives for this consultation - Wiweka Kaszubska, Head of Product Development, MMV
• General momentum and learnings from other therapeutic areas or interventions - Annemiek de Ruiter, Head of Global Medical Sciences, ViiV GSK
• Enhanced safety data collection and pharmacovigilance - Lisa Prach, Associate Director, Epidemiology, Novartis

II. Specific scientific approaches to include pregnant and lactating individuals in anti-malarial R&D

Current status of treatment for malaria in pregnancy

• Presentation: AL path to inclusion of 1^st trimester use on WHO Guidelines - Stephanie Dellicour, Technical Lead, Liverpool School of Tropical Medicine
• Discussion

Gathering data early with non-clinical models

• Presentation: Early DART Strategy to Manage Pregnancy Risks in Drug Development - Dinesh Stanislaus, Director, Worldwide Reproductive Toxicology, Safety Assessment, GSK
• Presentation: Zebra Fish and the human stem cell models - Claudia Demarta, Global Health Scientist, Merck Group
• Discussion

Leveraging translational models

• Presentation: PBPK modeling approaches - Nada Abla Geiser, Associate Director, Drug Disposition & PBPK Modelling, MMV
• Discussion

Including pregnant and lactating individuals in clinical development

• Presentation: Proposals for the earlier inclusion of pregnant and lactating women in clinical pharmacology studies & safety/efficacy studies - Myriam El Gaaloul, Director Clinical Sciences, MMV
• Discussion

Challenges

• Presentation: Liability and reputational risk - Metin Gülmezoglu, CEO, Concept Foundation
• Discussion

For each discussion, the participants are encouraged to share

• Challenges faced and lessons learned in carrying out gender-inclusive research
• Examples of successful scientific approaches aimed at developing tools to meet the medical needs of individuals while they are pregnant or lactating
• Opportunities to be seized for gender-inclusive R&D, based on new scientific approaches
• Questions for other participants

III. Summary and next steps- Wiweka Kaszubska