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Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary
which also has been supported by NIH and industry and in which the FDA participates. Another is the Osteoarthritis Initiative, a prospective investigation of a large number of potential biomarkers. In addition, Woodcock noted that the FNIH helped establish the Biomarker Consortium, a major public–private biomedical research partnership with participation from a broad and diverse group of stakeholders, including government, industry, academia, and patient advocacy and other nonprofit private-sector organizations. The goal of the Biomarker Consortium is to collaborate in rapidly identifying, developing, and qualifying potential high-impact biomarkers.
Many workshop participants stressed that such collaboration among industry, the FDA, and academic researchers could yield much more rapid progress in the development of biomarkers. The question then becomes whether incentives could be established to promote such collaboration.
One important set of incentives, according to Frank Sistare, would be clear agreement on the data that could be generated in regulated phases of drug development that would not need to be submitted to regulatory authorities. When drug development is in its earliest stages, companies need freedom to operate without worrying about having to submit all such data to regulators, who may then decide that the development process should be slowed so that certain concerns can be probed more thoroughly. The FDA has offered guidance on these decisions, and there is an ongoing dialogue with the agency to clarify the issues involved. But the current lack of clarity continues to inhibit industry from generating data that could be extremely useful for fear that the data could be used to slow drug development.
Government and industry need to be creative in implementing incentives and removing disincentives, Sistare continued. For example, could a company be offered a reduction in user fees for the submission of data related to the discovery or development of safety biomarkers deemed critically important by regulatory authorities, or could it gain a period of added exclusivity for a product? Although both of these steps would require legislation, they represent the kind of out-of-the-box thinking that is needed.
James Stevens of Eli Lilly suggested that incentives might include staggered goals for what can be done in 1 year, 3 years, and 5 years. Some research projects take relatively long to complete, and potential partners in collaboration may be unwilling to participate unless they know when particular goals should be achieved.
Other workshop participants questioned the practicality of establishing new financial incentives to foster partnerships. Given the many financial demands on the federal government, said Alastair Wood, incentives that require additional funding probably will not succeed. Unless collaborations have realistic objectives and expectations, the potential to make progress through cooperation may be forfeited. Wood also questioned why incentives are necessary if a partnership results in drugs being developed more