Drug Discovery, Development and Deployment Maps

The Drug Discovery, Development and Deployment Maps (4DM) provide dynamic representations of the modern therapeutic development process to more easily identify inefficiencies and integrate efforts to expedite new therapies for patients. The maps provide a common framework for discussing the therapeutic development process and serve as an education tool for those who are new to it. A common language and collective knowledge base for therapeutic development is essential to enable systemwide improvements that will benefit patients. The 4DM can help facilitate dialogue among those interested or participating in drug development to explore innovative solutions to existing bottlenecks and potential collaborative action to overcome those barriers and accelerate new medicine discovery.

An expanded, interactive version of the 4DM provides a more dynamic map interface for enhanced usability and an interactive experience compared with the static version below. Users can zoom into and out of areas of the process to view different levels of complexity, find information and best practices, and connect to relevant NCATS programs and resources.

Two versions of the 4DM are available below: one for small molecules (Figure A), and another for biologics, using monoclonal antibodies as the representative therapeutic (Figure B). Small molecule drugs are chemically manufactured compounds of relatively low molecular size that make up the vast majority of drugs on the market today. Biologic drugs are large complex molecules manufactured by a living system, such as a microorganism, or plant or animal cells, and include antibodies and vaccines. These two maps illustrate some of the unique differences between the development of biological drugs and that of more traditional small molecule therapeutics. Both files are licensed to the public under the Creative Commons Attribution-Share Alike International 4.0 (CC BY-SA 4.0) license, which allows use and adaption as long as the user provides attribution and shares any adaptations back to the public under the same license.

The 4DM were developed by members of an Action Collaborative of the Forum on Drug Discovery, Development, and Translation (the Forum) of the National Academies of Sciences, Engineering, and Medicine. The Forum includes leaders from private sector sponsors of biomedical and clinical research; federal agencies sponsoring and regulating biomedical and clinical research; foundations; the academic community; consumers; and federal and private health plans.

More detailed information regarding the 4DM and its development was published on December 22, 2017 in both Nature Reviews Drug Discovery and Clinical and Translational Science.

Figure A. 4DM Small Molecule Map. Map depicting the interconnected nature of key steps in the drug development lifecycle for small molecules. The steps are grouped into eight identified neighborhoods, each depicting the steps and processes necessary to advance within a particular stage of development. Steps within each individual neighborhood are frequently dependent upon both other steps within that neighborhood as well as with steps in other neighborhoods, resulting in a complex and nonlinear development process. This file is licensed to the public under the Creative Commons Attribution-Share Alike 4.0 license, which allows use and adaption as long as the user provides attribution and shares any adaptations back to the public under the same license. The figure should be attributed to: Wagner JA, Dahlem AM, Hudson LD, Terry SF, Altman RB, Gilliland CT, DeFeo C, and Austin CP. Drug Discovery, Development and Deployment Map (4DM): Small Molecules. Available at https://ncats.nih.gov/translation/maps. Last updated November 2017.

Figure B. 4DM Biologics Map. Map depicting the interconnected nature of key steps in the drug development lifecycle for biologics. The steps are grouped into eight identified neighborhoods, each depicting the steps and processes necessary to advance within a particular stage of development. Steps within each individual neighborhood are frequently dependent upon both other steps within that neighborhood as well as with steps in other neighborhoods, resulting in a complex and nonlinear development process. The figure should be attributed to: Wagner JA, Dahlem AM, Hudson LD, Terry SF, Altman RB, Gilliland CT, DeFeo C, and Austin CP. Drug Discovery, Development and Deployment Map (4DM): Biologics.

Read more