tiple gene-environment interactions, incomplete gene penetrance, and the dynamics of biological networks. However this gap also results from a lack of funding to substantiate the clinical relevance of basic discoveries and the increasing time and cost required to convert discoveries into commercial applications.
One way to bridge this growing divide in the translational pathway is through partnerships that distribute the risks involved in research and development (R&D) among multiple parties in a precompetitive manner. Industry, academia, and government all hold tools, knowledge, and biological materials that could be used collaboratively to speed the development of new drugs, diagnostics, and preventive measures. In particular, the sharing of biological specimens (biospecimens) and the data derived from those biospecimens through large-scale precompetitive collaborations could offer substantial benefits to all parties involved and the public at large.
However, numerous issues such as intellectual property (IP) protections and funding can be cumbersome or completely inhibitory to establishing collaborative ventures and must be overcome to facilitate this process and realize the potentially immense benefits. To explore these issues and develop potential solutions, the Roundtable on Translating Genomic-Based Research for Health held a workshop on July 22, 2010, entitled “Establishing Precompetitive Collaborations to Stimulate Genomics-Driven Drug Development” (see Appendix A for the full agenda). Representatives of government, industry, academia, and nonprofit organizations participated. Speakers and workshop participants sought to:
Examine specific examples from other industries that have engaged in precompetitive collaborations;
Identify how the best practices from other successful collaborations can be applied to genomics;
Clarify the rules of engagement for each stakeholder that would allow for genomics-based collaboration; and
Elucidate a conceptual framework for the precompetitive sharing of biological resources from many different stakeholders—academia, industry, government, and others.
While the workshop had a particular focus on stored biospecimens and the data derived from those samples, most of the observations could apply much more broadly in the development of drugs, diagnostics, and preventive measures in biomedicine. However, the goal of the workshop was not to solve the problems surrounding the establishment of precompetitive collaborations but rather to foster discussions that could clarify the issues and identify potential solutions.