Adding Value to Biomarker Development from the Regulatory Perspective

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June 1, 2011

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  • The primary goal of most companies is to develop a biomarker to a stage where additional funding can be attracted or partnering becomes feasible. Therefore, the focus of the company should be to add as much value as possible through the biomarker development process. Value is partly based on the achievement of regulatory milestones. This session will provide practical advice towards maximising the potential of biomarker development programmes from the regulatory perspective. This session will highlight the importance of a global regulatory strategy and the opportunities this could offer to adding value, support biomarker development and ultimately making your company a more attractive proposition for investment and/or partnering. This session will discuss agency interactions, both in Europe and the USA, and ways in which to optimise these interactions. The latest developments and advice relating to the Biomarker Qualification Procedures in Europe and the USA will also be discussed, including the first public consultations from the European Qualification procedure released earlier this year.

    Molecular Biology

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