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GEN News Highlights : Feb 6, 2013
Experts Push for Drug Development Reform
As the industrial age has given way to the age of information, so the current drug development system needs to move toward an open, collaborative, and coordinated approach that holds promise for bringing more medicines to market quicker and less expensively, seven stakeholders concluded in a commentary published today.
Writing in Science Translational Medicine, the seven proposed a model for drug development that envisions a set of interconnected processes rather than a straight-line path from lab to trials to patient. Each process within the Navigating the Ecosystem of Translational Sciences (NETS) model is part of a greater whole, much as systems biology may entail study of molecules, cells, organisms, or entire species.
“Drug development needs a sustainable system that requires and rewards precompetitive collaborations with well-aligned incentives that benefit all participants,” the co-authors concluded, before acknowledging: “Enacting these dramatic changes, however, will not be simple and will require that we make equally dramatic changes to the incentives and reward structure that drives drug development.”
The co-authors cited SEMATECH, through which about manufacturers carrying out about half the world’s semiconductor production work with partners—equipment and material suppliers, universities, research institutes, consortia, start-up companies, and government—on precompetitive collaborations designed to accelerate development of new technologies in less time while controling costs.
NETS or some variation thereof would likely be similar to SEMATECH in some ways, Sharon F. Terry, the commentary’s corresponding author and president and CEO of the Genetic Alliance, told GEN.
In drug development, as with semiconductors, industry has long operated through silos (think disease), has long sought to preserve the status quo despite declining returns, and faces pressures to change. While semicon makers have scrambled to regain competitiveness lost to Japan, today’s biopharmas are scrambling to make up revenue lost, or set to be lost, as blockbusters lose patent protection and give way to smaller-revenue niche drugs.
Terry also identified a key difference that biopharma will need to overcome: “For some reason, the urgency to stay competitive was stronger and more tangible than the urge to find treatments for suffering individuals. Perhaps because in the case of the semiconductors, there loomed a cliff, while in the case of health, the sick are with us always. We forget [the need for treatment] is urgent, until it is our loved one.”
Terry similarly called for a systems approach to bridging gaps that hinder drug development, in a 2010 paper published in Genetic Testing and Molecular Biomarkers, a journal published by GEN publisher Mary Ann Liebert Inc.: “Genetic testing and molecular biomarkers are ripe candidates for being part of the solution.”
There’s reason for hope that biopharma can evolve toward a NETS model or a variation, Terry said, given Sage Bionetworks’ two open collaborative initiatives. Sage’s Archipelago to Proof of Concept in Medicine (Arch2POCM) is a public-private partnership created to organize an open-access distributed scientific and clinical network intended to advance disease targets deemed too risky for industry through to clinical validation of mechanism. Sage’s Synapse system, now in beta development, is designed to provide scalable access to clinical genomics data and computing resources to scientists at Sage and worldwide. Comparator arms of clinical trial data, for example, could be shared, minimizing duplication during costly clinical trials.
Drugs can take more than a decade to develop, at costs estimated from $1 billion (Tufts Center for the Study of Drug Development) to between $4 billion and $11 billion (InnoThink Center for Research In Biomedical Innovation).
Co-authors of the commentary include one each from NIH’s National Center for Advancing Translational Sciences and PXE International, an advocacy group for PXE (pseudoxanthoma elasticum) founded by Terry. The other five are affiliated with Genetic Alliance, which promotes patient participation in translational research and services, and consists of more than 10,000 organizations, including 1,200 disease advocacy organizations (DAOs).
DAOs should serve as stewards of registries and repositories, and be engaged by researchers in early drug discovery and preclinical development, the co-authors recommended. They cited the DAOs’ disease-specific knowledge, trusted relationship with their disease communities, and ability to provide funding, develop tools, and generate hypotheses.
Citing a 2010 study, they argued that shortening clinical trial Phases II and III, where delays often occur as researchers struggle to meet targeted enrollment numbers, “could potentially reduce the cost of new molecular entities by $200 million or more.”
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