March 5, 2018: A New Map to Guide and Improve Therapeutics Development
Anyone embarking on an unfamiliar journey will want a map to help plan needs, anticipate problem spots and formulate contingency plans. This is all the more true if the journey being contemplated is known to take many years, be fraught with hazards and rarely be completed successfully. In this case, one would want a very good map indeed, one that could both guide new travelers and assist construction engineers in improving it.
The drug development process is such a journey, taking decades from idea to patient, during which hundreds of attempts fail and enormous costs are borne. The common moniker of a drug development “pipeline” is wildly and tragically misleading, implying as it does a simple and inevitably successful path from a laboratory observation to an available therapeutic. The pipeline misnomer engenders improbable expectations among patients, scientists, physicians, and policymakers and impedes efforts to improve the therapeutic development process.
NCATS took on the creation of a new and accurate map as central to our mission to develop solutions to translational roadblocks and disseminate them for use by the research community. I am glad to report that an exciting new map has now been produced and is publicly available on our website. In true NCATS fashion, we partnered with academics, pharmaceutical and biotech companies, regulators, foundations and patient groups to create the map under the auspices of a component of the National Academies of Sciences, Engineering, and Medicine. This Drug Discovery, Development and Deployment Map, or “4DM,” was described in two recent pieces in Nature Reviews Drug Discovery and Clinical and Translational Science.
Even the casual observer will note that the 4DM is complicated, with different phases, termed “neighborhoods,” and multiple steps within and between neighborhoods that may need to be attempted multiple times before success occurs. But a truly useful map not only indicates routes, it enables travelers to anticipate problem spots. So like the ubiquitous smartphone apps for road traffic we all use, the 4DM has a crowdsourced feature that indicates the steps in the process that previous drug developers have found particularly prone to failure, delays or high cost. Like road engineers, NCATS will use this “traffic” feature to focus our translational re-engineering efforts on the most problematic steps of the process.
In this initial version, the 4DM is static, but we have already begun developing additional features to make the map interactive. For example, future versions will enable users to locate their translational project on the map via a “GPS” feature based on answers to a series of questions, allowing them to identify next steps and options to best advance their efforts. We’ll also be adding connections to NCATS resources to help users through these steps. These resources include our Therapeutics for Rare and Neglected Diseases program for pre-clinical studies and our Clinical and Translational Science Awards Program in the clinical and implementation domains.
The 4DM is available under a Creative Commons license, so anyone in the world can download, adapt and display it for their own use. Please use the map and give us feedback on what features we should add next to make it even more useful. I hope you will find the 4DM to be as helpful as we have for education, planning, engineering and ultimately increasing successful outcomes in the translational journey.
Christopher P. Austin, M.D.
National Center for Advancing Translational Sciences