An open source pharma roadmap

Abstract

In an Essay, Matthew Todd and colleagues discuss an open source approach to drug development. This Essay outlines how open source methods of working could be applied to the discovery and development of new medicines. There are many potential advantages of an open source approach, such as improved efficiency, the quality and relevance of the research, and wider participation by the scientific and patient communities; a blend of traditional and innovative financing mechanisms will have to be adopted. To evaluate properly the effectiveness of an open source methodology and its potential as an alternative model of drug discovery and development, we recommend that new projects be trialed and existing projects scaled up. Where we stand The scientific and medical community has discovered and developed many groundbreaking medicines that have had a major impact on public health. However, drug development is challenged by a widening gap between health needs and the pharmaceutical industry’s motives and business model, alongside a decrease in efficiency per research dollar spent in medicinal product research and development (R&D), a trend known colloquially as Eroom’s Law. Such fundamental challenges result in frequent high-level calls for new initiatives to develop therapeutics and bring them to market. These include market push and pull mechanisms such as priority review vouchers, advance market commitments, and public R&D funding. New organizational models have also emerged, including public–private partnerships (PPPs) and not-for-profit product development partnerships (PDPs) (for example, the Drugs for Neglected Diseases Initiative [DNDi], the Medicines for Malaria Venture [MMV], and the Global Alliance for Tuberculosis Drug Development [TB Alliance]) that often apply a full “de-linkage” model in which the price of medicines and the cost of R&D are uncoupled.