Pharmaceutical research and development (R & D) is one of the best examples of human ingenuity, attracting vast funding, employing brilliant minds, and deploying the most advanced technologies. Over the past century, it has enabled unprecedented advances for human health. Yet the pharmaceutical R & D system is struggling to keep up with society’s medical needs. High failure rates and prolonged research timelines for candidate drugs constitute a human tragedy, and have dramatically increased the cost of drug discovery over the last decades. More and better medicines are desperately needed at a time of global ageing and expanding populations, with new challenges such as antibiotic resistance on the horizon and many tropical infectious diseases still in need of adequate pharmaceutical solutions. To meet these challenges it is imperative that we rethink drug discovery
A new paper published today by the Oxford Martin School at the University of Oxford calls for ‘open science’ approaches to drug discovery and offers ways forward that would transform how the medical challenges of this century could be addressed more efficiently.
‘A New Pharmaceutical Commons: Transforming Drug Discovery ’, written by Professor Chas Bountra, Dr Wen Hwa Lee, and Dr Javier Lezaun, highlights the limits of traditional R&D models focussed on secrecy and the protection of Intellectual Property (IP) rights, and offers a set of recommendations for strengthening pre-competitive and open source practices that can accelerate the race for cures to the world’s most harmful diseases.
Ahead of the launch, Professor Chas Bountra, Co-Director of the Oxford Martin Programme on Affordable Medicines and Chief Scientist at the Structural Genomics Consortium, said:
“The pharmaceutical industry has made enormous strides in the production of potential therapies and medicines. But even today, close to 90% of candidate drugs that enter Phase 1 trials fail to make it to the market place. This is a system beset by duplication of effort and hence wastage of resources. No one lab or institution can do this on its own. We must urgently pool resources and expertise, minimise duplication, explore new drug targets, biomarkers, and technologies in order to generate new, effective, and more affordable drugs for patients more quickly.”
The new paper calls for the adoption of ‘open science’ principles that would allow for a less restrictive approach to the sharing of pharmaceutical tools and data, and would re-define the role of IP in pharmaceutical R&D. It also gives examples of where this is already working successfully.
“There has been a great deal of successful experimentation with the application of pre-competitive and open source approaches to drug discovery, not least here at Oxford with the Structural Genomics Consortium, which has shown how corporate pharmaceutical resources can be pooled and used to produce IP-free science” says co-author Dr Javier Lezaun at the Institute for Science, Innovation and Society.
Dr Wen Hwa Lee expands on this “Recent healthcare advances have been challenging what is becoming an obsolete way of working, in search of a more efficient configuration. At the centre of this soul-searching and restructuring is the matter of trust and cooperation which can be best established through open science and transparent frameworks.”
Although there is no simple one-size-fits-all solution to the challenges of the drug discovery process, the authors argue that open source R&D has the potential to have a significant impact. The paper outlines a number of recommendations aimed at enlarging and strengthening this crucial component of the drug discovery ecosystem.
“A New Pharmaceutical Commons: Transforming Drug Discovery” is published today Thursday 7 December on the Oxford Martin School website:
‘Open science drug discovery’ in this paper encompasses initiatives that make raw materials, data, and the outputs of scientific research freely available in an effort to avoid duplication of effort and/ or re-direct resources to neglected or high-risk areas of pharmaceutical R&D. The definition here includes two categories: pre-competitive R&D consortia, in which a defined number of parties agree to pool resources amongst themselves; and open-source pharma, when those resources are made available to anyone within the drug discovery ecosystem. The boundary between these two models is fluid, however. In some hybrid models, both categories are embraced – e.g. pre-competitive consortia generate open-source outputs that are freely available to anyone involved in the drug discovery process.
The Oxford Martin School at the University of Oxford is a world-leading centre of pioneering research that addresses global challenges. We invest in research that cuts across disciplines to tackle a wide range of issues such as climate change, disease and inequality. We support novel, high risk and multidisciplinary projects that may not fit within conventional funding channels. We do this because breaking boundaries can produce results that could dramatically improve the wellbeing of this and future generations. We seek to make an impact by taking new approaches to global problems, through scientific and intellectual discovery, by developing policy recommendations and working with a wide range of stakeholders to translate them into action.
The Oxford Martin Programme on Affordable Medicines was established in 2017 to address the challenge that, while humanity’s need for new medicines continues to grow unabated, the traditional systems for discovering new drugs are inefficient, costly and have high failure rates. In order to drive change, proof is needed of the benefits of new drug discovery models; the aim of the programme is to generate solid, data-backed and non-biased evidence upon which to base recommendations for policymaking and with which to stimulate innovation and collaboration. Its interdisciplinary team draws on wide-ranging academic and industry expertise.
For the past decade the Structural Genomics Consortium (SGC) has experimented with new approaches to pharmaceutical R&D, by pooling together resources and expertise from pharmaceutical companies, philanthropies and patient organisations in order to accelerate the discovery of new drug targets and chemical probes. It then places its full scientific output – knowledge and reagents (as tangible, physical entities, e.g. chemical compounds) - in the public domain, without any restriction on its use and in the absence of patents. By sharing both data and physical reagents, the SGC’s open science approach has already accelerated drug discovery processes in significant areas. For instance, its work on the role of bromodomains in NUT midline carcinoma (an incurable form of cancer) led to the registration by GlaxoSmithKline of the first clinical trial aimed at this class of proteins merely 16 months after the initial publication. To date (December 2017) the newly validated bromodomains family of targets has already attracted in excess of $1 billion in private investment for development of new medicines. Its openness also allows it to pioneer new ways of involving patient organisations in the R&D process, re-designing pre-clinical and clinical research programmes in collaboration with these stakeholders.