Nonprofits: A Growing Force in Drug Development

SHEPHERDING A DRUG from discovery to the market is a complex process that involves many actors. The process often begins with academic researchers making a breakthrough discovery in the lab and ends with pharmaceutical companies running large-scale clinical trials to demonstrate that the drug is safe and effective. But what about the middle of this process—the point at which the discovery is translated into something that could be meaningful for treating patients? Who is responsible for the translational, or preclinical, part of the process?

There is a lack of clarity about who should assume that role; translational research is often too expensive for academics to perform by themselves, but it is too risky for pharmaceutical companies given the uncertainty about the discovery’s safety and market worthiness.


Overview

In this paper, we explore the multitude of methods that nonprofits use to support the translational drug development process in addition to when and where these models are most appropriate. This work has led to the creation of a catalogue of activities for nonprofits to support drug development in their specific fields and of the financial mechanisms best suited to fund these activities. This catalogue includes six main activities: academic support, supporter, incubator, contract research organization (CRO), in-house research and development (R&D), and for-profit development. Each of these activities provides the resources most needed to investigators, companies, or nonprofits themselves to drive drug development efforts forward.

In summary, this work showcases how nonprofits are tackling some of the most significant problems in R&D and bridging gaps in the pipeline to kick-start the development of new cures for the patient community.