Mapping and Connecting the Biomedical Innovation Ecosystem
The goal of Mapping and Connecting the Biomedical Innovation Ecosystem Collaborative (the Collaborative) is to enable discussion and to identify rate-limiting steps in order to facilitate process improvement efforts within the biomedical innovation ecosystem.
The Collaborative is 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 it produces does not necessarily represent the views of any one organization, the Collaborative, the Forum, or the National Academies and is not subjected to the review procedures of, nor is it a report or product of, the National Academies.
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.
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. [completed 2015]
- Provide a venue for stakeholders to share information and perspectives regarding barriers in the biomedical innovation process. [completed 2015]
- Develop a paper to disseminate revised process maps. [in progress]