Liza Vertinsky- Using the Law to Align Incentives with Needs in

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Using the Law to Align Incentives with Needs in Public Private Partnerships for Drug Discovery and
Development: Insights from the Emory Drug Discovery Institute
Liza Vertinsky
This Article uses the Emory Drug Discovery Institute (EDDI) as a focal point for analyzing the current
problems with drug discovery and development – often referred to as the ‘valley of death’
phenomenon, and the ability to address these problems through organizational innovations within the
existing legal framework. Academic researchers, supported by public funds, have traditionally focused
on early stages of molecular and medicinal research. Industry is left to pick up the development of
promising discoveries into new commercial products. But many important discoveries remain
underdeveloped or undeveloped because of a variety of barriers in moving fundamental discoveries into
effective programs for further development. One of the biggest barriers is the cost of moving beyond
early stage pre-clinical phases of drug discovery. A related, barrier is the need to involve a
multidisciplinary team, along with their related space and resource needs, at increasingly early stages of
discovery and development. Few academic institutions have developed the capacity to move
development of promising molecules beyond early and comparatively low cost pre-clinical stages, and
the private sector has shown increasingly less interest in becoming involved in projects that have not
reached a clinical stage of development. Nobody wants to be in charge of moving through this
intermediate world of expensive incremental improvements.
The EDDI provides an example of the ways in which universities can be used to provide innovative
solutions to these problems. The EDDI has as its goal the creation of a continuous progression from
early discoveries through pre-clinical phases of development to clinical settings where they are ready for
regulatory approval to enter human clinical evaluation. Current challenges with making the EDDI work
highlight important changes in the legal and regulatory framework that will be needed to make broader
strategies for translational research and development succeed. Sustainability of this approach is one of
the biggest challenges. Finding ways to reward incremental improvements in this university setting also
remain challenging. I argue that while experiments such as the EDDI can address some of the
challenges that are contributing to the valley of death, success at a broader scale will require changes in
the regulatory and legal structure supporting academic biomedical research. I argue that achieving
public health objectives needs to be better articulated by the law as part of the mandate of universities
receiving public funds. I also argue that this needs to be a funded mandate in the sense that proper
incentives, such as priority in certain kinds of grant funding, need to be provided for those universities
that are investing in this middle ground of incremental improvements.
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