The biomedical innovation ecosystem is a dynamic network of activity. Developing therapeutics is not a linear pathway, yet this process is often represented by the unidirectional “chevron” map, which oversimplifies and overlooks the multi-dimensional integration of activity between different steps. This complexity of the development pathway, along with the ad hoc and uncoordinated nature of stakeholder approaches to resolving barriers to innovation, can lead to redundancies and gaps, stalling progress toward developing innovative therapeutics for patients.

Standardizing and bringing clarity to this complex network could help to set a vocabulary and allow more fluid dialogue among ecosystem participants to encourage further innovation. It could also facilitate ongoing discussion to help frame, map, and synergize activities across the biomedical innovation ecosystem. Defining key terms, such as translational science and regulatory science, and locating complex activities within this landscape may help to articulate problem areas and provide opportunities to learn from local environments where the system is efficient and well-integrated with other areas.

As of December 2017, the collaborative has sunset as a formal convening activity. The Forum may continue to support the dissemination and use of the process maps and other derivative products or activities resulting from this activity.

Objectives

With the participation of external drug or biologic development experts and stakeholders, the Collaborative participants adopted the following objectives:

• Discuss, refine, and develop process maps for the development of small molecules and biologics to identify inputs, bottlenecks, and ecosystem needs.
• Provide a venue for stakeholders to share information and perspectives regarding barriers in the biomedical innovation process.
• Develop a paper to disseminate revised process maps.

Collaborative Activities

Collaborative participants developed two process maps—coined the Drug Discovery, Development, and Deployment Maps (4DM)—that diagram the development of small molecules and biologics, which are digitally hosted by the National Center for Advancing Translational Sciences at the National Institutes of Health (https://ncats.nih.gov/translation/maps).

The process maps served as the foundation for two complementary peer-reviewed journal articles co-authored by Collaborative participants to guide future dialogue and progress on this topic, released in December 2017. These articles describe the Collaborative’s efforts to identify rate-limiting steps in the ecosystem—informed and augmented by a diverse group of experts external to the Collaborative—and to develop accurate and dynamic maps to diagram the complex web of small molecule and biologics discovery, development, regulation, and delivery. The application of the process maps as customizable models and discussion tools for diverse stakeholders to explore the intricate and intertwined processes of drug development are also highlighted.

• A Dynamic Map For Learning, Communicating, Navigating, and Improving Therapeutic Development

Co-authors: John Wagner, Andrew M. Dahlem, Lynn D. Hudson, Sharon F. Terry, Russ B. Altman, C. Taylor Gilliland, Christopher DeFeo & Christopher P. Austin

Published in Nature Reviews Drug Discovery on December 22, 2017

• Application of a Dynamic Map for Learning, Communicating, Navigating, and Improving Therapeutic Development

Co-authors: John Wagner, Andrew M. Dahlem, Lynn D. Hudson, Sharon F. Terry, Russ B. Altman, C. Taylor Gilliland, Christopher DeFeo & Christopher P. Austin

Published in Clinical and Translational Science on December 22, 2017

The collaborative was an ad hoc activity associated with the Forum on Drug Discovery, Development, and Translation (the Forum) at the National Academies of Sciences, Engineering, and Medicine (the National Academies). The work of the collaborative does not necessarily represent the views of any one organization, the Forum, or the National Academies and was not subjected to the review procedures of, nor was it a report or product of, the National Academies.