Every year, millions of people in low-and-middle-income countries (LMICs) continue to die of diseases, like tuberculosis and malaria, that few people now experience in high income countries. The importance of developing innovative solutions to tackle these diseases has been highlighted both by recent changes in government aid that will exacerbate the reach and lethality of these diseases as well as by the Covid pandemic which laid bare the inequitable access of many underserved communities to important preventative and therapeutic tools like vaccines. However, the investment incentives for discovery, development and manufacturing of innovative products that address significant global health needs are not always in place for traditional pharmaceutical and biotechnology companies.
The Gates Medical Research Institute is a non-profit medical research organization dedicated to the development and effective use of novel biomedical interventions to address substantial global health concerns. There are a number of key challenges to enable LMIC access to effective biopharmaceuticals, even with development funding. First, no single organization can do this work alone. Partnerships and collaboration models between companies, funding bodies, non-profits and international organizations are key to tackling the most devastating diseases. Our work with our tuberculosis products, both vaccine and therapeutics, illustrates the power of partnerships.
In addition, scientific approaches that work in high income countries or work for a similar disease may not be successful for LMIC diseases. Novel solutions, tested in the target populations, may be essential. Development of a shigella vaccine that is effective in the smallest children who are most vulnerable to that disease has proved particularly difficult. We developed robust manufacturing processes that allowed the production of a unique and promising synthetic glycoconjugate shigella vaccine, so it can now be tested by a partner in an endemic region. Furthermore, to ensure accessibility in LMICs, it is imperative to lower cost of goods (COGS). We are using a systematic approach to reduce the drug substance (DS) manufacturing cost of goods for our prophylactic monoclonal antibody (mAb) for malaria. By combining a “real-world” quote-based approach and detailed process economic modeling, we evaluated the feasibility and opportunities of achieving the cost target for this product. We believe that all lives have equal value and that inspires us to meet the challenges of delivering robust, effective, low cost healthcare solutions for those in greatest need.