Collaboration In Biomarker Qualification

Clearly, the number of preclinical and clinical studies and resources required to qualify a biomarker as a characterization biomarker appropriate for regulatory decision making are significant. Thus, it is no surprise that in their Critical Path Opportunities List the FDA called for "collaborations among sponsors to share what is known about existing safety assays" [55]. Collaborations of this type have indeed played key roles in addressing technological problems common to a competitive industry. Thus, Sematech, a consortium formed in 1987 and made up of 14 leading U.S. semiconductor producers, addressed common issues in semiconductor manufacture and increased research and development (R&D) efficiency by avoiding duplicative research [56]. Sematech demonstrates that consortia can provide an opportunity for industry scientists to pool their expertise and experience to confront mutual questions collectively. The International Life Sciences Institute has for several years served as a forum for collaborative efforts between industry and academia [57], and for the past six years a Biomarkers Technical Committee has been pursuing assay development and evaluation of biomarkers of nephrotoxicity and car-diotoxicity [ 58]. Recently, the Critical Path Institute was incorporated as a "neutral, third party" to serve as a consortium organizer [59] and interface between industry members and the FDA. One of its first efforts was the Predictive Safety Testing Consortium (PSTC) [60,61], with a specific focus on qualification of biomarkers for regulatory use. The PSTC legal agreement addresses issues, such as intellectual property, antitrust concerns, and confidentiality, and thus assures open collaboration in a manner consistent with applicable legal requirements. The PSTC solicited representatives from the FDA and the European Medicines Agency (EMEA) to serve as advisors. As experts in various areas of toxicity, these advisors bring not only their expertise but also the experience of how problems of a given target-organ toxicity are confronted and could be addressed in a regulatory setting. Thus, the development of qualification data is targeted with a keen eye toward what will ultimately support safety decisions in the regulated drug development and regulatory review process.

Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

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