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Mutagenic Impurities: Precompetitive/Competitive Collaborative and Data Sharing Initiatives

Covey-Crump E; Elder DP; Harvey JS; Teasdale A; White A; Williams RV;

Precompetitive and competitive collaborations have flourished during the development of the ICH M7 guidelines (mutagenic impurities). The majority of these interactions are “honest broker” type arrangements, where an autonomous, independent third party is tasked with coordinating the activities of the consortium. Sometimes, more than one “honest broker” can be involved in the activity. Lhasa has been at the center of many of these collaborative initiatives; i.e., Derek Nexus Pharmaceutical Intermediates, Excipients, Zeneth, Mirabilis. The Product Quality Research Institute (PQRI) coordinated activities allowing a mechanistic understanding of the reaction mechanism for the formation of sulfonate esters, which after the Viracept withdrawal had been at the forefront of regulatory thinking. Other “not for profit” organizations that have played a role in the advancement of the greater understanding of mutagenic impurities include the various trade organizations, i.e., the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industry Associations (EFPIA). The other collaborative interactivity is the JDI (Just Do It). This is primarily focused on analytical collaborative efforts, where individuals have collaborated on areas of mutual interest. To a lesser extent, this has also been seen in the area of pharmaceutical intermediates, where individual companies have collaboratively pooled data on areas of common interest, e.g., acyl/sulfonyl halide false positives. The majority of the most significant JDI collaborations involve sharing feedback on the use and applicability of a second structure activity relationship system (SAR), analytical methodologies, and analytical strategies. One of the key outcomes of these collaborations are peer reviewed scientific publications whereby other interested parties (including regulators) can be made aware of the findings from the consortia. Going forward, the area of mutagenic impurities enshrined under ICH M7 will continue to be a fruitful area for precompetitive collaborations of all types building on the success of the previous initiatives described.