. "3 Requisites for Successful Precompetitive Collaboration." Establishing Precompetitive Collaborations to Stimulate Genomics-Driven Drug Development: Workshop Summary. Washington, DC: The National Academies Press, 2011.
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Establishing Precompetitive Collaborations to Stimulate Genomics-Driven Product Development: Workshop Summary
all can be areas of precompetitive R&D, Power said. Pharmaceutical companies have recognized that they cannot develop a full understanding of these different facets of drug development on their own. Instead, related Power, they need to leverage the capabilities of many organizations, including government and academia. A few years ago, Pfizer would have considered the chemistry, the execution, and the quality of products to fall into the competitive arena, but even these areas may not be inviolate. Proposals to establish consortia that cover at least part of this territory have generated interest from pharmaceutical companies. However, some stakeholders may still view this research as strictly competitive. The line may be drawn differently between academia, diagnostic companies, and pharmaceutical companies, said Power.
Setting up consortia can also be labor intensive. As Power pointed out, “The political science precedes the real science.” Consortia such as the Biomarkers Consortium and the Serious Adverse Events Consortium took at least 18 months to get off the ground. To establish a contract, the views of multiple parties need to be reconciled.
Internal issues can illustrate inconsistencies regarding, for example, intellectual property. The legal departments of pharmaceutical companies are changing their definitions of what needs to be patented, but only under pressure. “It used to be the case that we patented everything. But establishing patents and continuing to uphold them is a very expensive business, and we can’t afford to do that anymore…. We are beginning to operate in a space that would have been inconceivable to us a few years ago.”
Establishing consortia also raises issues about decision-making and participation criteria. For example, asked Power, what happens when new members come into a consortium? What do they receive? What if their support is not equivalent to the other members? How can rules governing such events be established in advance?
A good example of the potential for collaboration involves the samples collected in clinical trials. If these samples and their related data could be pooled across companies and with academia, intellectual capabilities could be increased and very good research could be done. Another possibility for collaborative research, said Power, would be to look at whether compounds developed for one purpose have valuable uses with other diseases or disorders, since the pharmaceutical industry needs to improve its ability to identify effective compounds that target the appropriate biological mechanisms.
Regarding the future, the precompetitive space is likely to continue to expand at the cost of internal development, Power said, as Pfizer has decided to reduce internal infrastructure costs to free up funds to invest in these ventures. Pharmaceutical companies remain under great pressure to come up with new products, and fewer are becoming available from biotechnology companies than had been anticipated. Pharmaceutical com-