Abstract:

The case traces the development of a tripartite initiative—known as Project Carbetocin Hemorrhage Prevention (CHAMPION)—between Merck for Mothers, Ferring Pharmaceuticals, and the World Health Organization (WHO) that formed to help prevent postpartum hemorrhage (PPH), one of the leading causes of maternal mortality globally. After providing background on the global burden of maternal mortality and global efforts to amplify the issue and improve outcomes, the case highlights clinical trial results that show administering quality uterotonics (drugs that induce uterine contractions) immediately following childbirth was the most important measure in preventing PPH. However, the recommended therapy—oxytocin—was often compromised at the point of delivery in areas with unreliable cold-chain infrastructure, due to its sensitivity to heat. In this context, the case details how Project CHAMPION brought together three unique actors to advance the development and distribution of a uterotonic that could withstand temperature changes. The case describes negotiations around the undertaking, the large-scale clinical trial of the new drug—heat-stable carbetocin—that took place across 10 countries, enrolling 30,000 women, and the steps undertaken to prepare diverse markets for its debut. The case reveals tension between the mid-size pharmaceutical company, the multilateral World Health Organization, and Merck’s Merck for Mothers initiative. The case ends as a pandemic explodes onto the world stage in 2020, with Project CHAMPION team members wondering how the dilemmas, decisions, and dynamics they navigated could inform emerging COVID-19 vaccine discovery and development efforts working with urgency.  

Learning Objectives: This case will allow readers to appreciate:

1. The potential of public-private partnerships to accelerate drug discovery and development
2. The production and approval processes for a global health product
3. The complexity of developing and preparing a product to enter a fragmented market without clear demand or distribution channels
4. The advantages and drawbacks of investing in a point-of-care intervention for a public health issue that has multiple root causes

Supporting Content: Concept Note: Reproductive, Maternal, Newborn, and Child Health 

Keywords: public private partnership, maternal health, global health, pharmaceutical drug development, corporate social responsibility, postpartum hemorrhage, collaboration, COVID-19