This week in Seattle, more than 500 of the best minds in global health will convene at the Global Health Product Development Forum to discuss how funders, researchers, NGOs, and private-sector companies can work together to accelerate the development and delivery of life-saving products. It promises to be an exciting three days.
At last year’s meeting, we established an ambitious goal: we made a commitment to double the output of our network to ensure the delivery of three to five new high-impact interventions annually. I’m thrilled to report that we have delivered five new interventions in the past year. Since May 2013, three vaccines, a new diagnostic, and a new medical device have received World Health Organization (WHO) prequalification or regulatory licensure, making them available for use by national health systems and UN agencies around the world. The potential health outcomes are impressive:
- In a historic milestone, the WHO provided prequalification for a Chinese-manufactured Japanese encephalitis (JE) vaccine that will cost about 30 cents per dose, or 1/1,000th the cost of other JE vaccines. What’s especially exciting about this landmark is that the JE vaccine was the first Chinese vaccine to be reviewed against WHO’s rigorous standards for quality, safety and efficacy, an achievement that positions China to become a leading producer of affordable vaccines for the world. JE disables or kills 30,000-50,000 people per year, and four billion people in Asia live at risk of infection. The new JE vaccine can now protect the health of millions.
- The WHO worked with support from the Gates Foundation and other partners to create a global stockpile of two million doses of oral cholera vaccine (OCV). In 2010, the disruption of water and sanitation services following a massive earthquake in Haiti led to a nationwide outbreak of cholera, a bacterial disease that can be easily prevented if populations have timely access to OCV. The new stockpile has already been put to use helping UN agencies limit the risk of cholera among displaced populations affected by civil unrest in South Sudan.
- The Indian government’s licensure of ROTAVAC™ will allow the country’s vaccine manufacturers to scale up the production and delivery of a safe and effective vaccine against rotavirus. Rotavirus is a leading cause of severe diarrheal disease among Indian infants and leads to nearly 100,000 child deaths in India each year. The introduction of the new vaccine can save the lives of thousands of children in the next decade.
- The European Community’s licensure of a simple new blood finger-prick diagnostic for human African trypanosomiasis (HAT) is helping to transform the fight against a disease that once killed millions in sub-Saharan Africa. Along with the development of more effective tsetse fly traps and a potential new oral cure for HAT, the introduction of the new diagnostic could remove barriers to effective prevention, diagnosis and treatment. Thanks to these innovations, the WHO has recently declared HAT elimination an achievable goal.
- WHO prequalification of PrePex™, a safe, non-surgical male circumcision device, could contribute to accelerating the delivery of voluntary medical male circumcision (VMMC) in sub-Saharan African countries with high HIV prevalence. Multiple randomized controlled trials have demonstrated that VMMC can reduce a male’s chance of acquiring and transmitting HIV by 60 percent, making the procedure one of the most effective HIV prevention interventions available.
How did we achieve these results? We did it by maximizing the power of partnership, by leveraging the power of innovation, and by tapping the individual strengths of partners across the global health sector.
But I believe that we can do more – and we can do better – in the decade to come. To accelerate the development and delivery of a new generation of lifesaving products, we need a strong commitment to innovation from all partners:
- Donors must create an enabling environment for product development by sustaining their funding for global health R&D, working collaboratively to identify and address existing funding gaps, and developing innovative financing mechanisms such as the Global Health Innovative Technology fund and the Global Health Investment Fund.
- We must build innovative functional platforms, including:
- Vaccine and drug accelerator programs that tap into research conducted by the pharmaceutical industry to identify promising new candidates for development;
- Access to experts in chemistry, manufacturing, and controls (CMC) to help partners pursue the safest, most effective, and most cost-efficient approaches to early phase product development;
- Access to experts in regulatory process who can help product developers identify clear pathways to securing timely regulatory approval; and
- Access to modeling experts who can help product developers conduct effective operational research for new products.
- We must also incorporate a high-level of rigor in the management of the candidate pipelines, using cutting-edge processes and tools.
Looking ahead to opportunities in the coming year, the Gates Foundation is especially eager to work with partners to use these new tools and resources to accelerate the development of next-generation drugs for tuberculosis, malaria, neglected infectious diseases, and other products. Working together, we can bring this new vision of a truly integrated product development network to life and play a role in giving millions around the world the opportunity to lead a healthy and productive life.
I look forward to following up early next week with a report on the outcomes of our conversations in Seattle.