Global harmonization represents effort to promote convergence of new therapeutics evaluation that could promote faster patient access, better safety information and lower research & development costs while preserving local regulatory jurisdictions, markets and practice patterns. The success of these efforts depends on collaboration between regulatory authorities, industry leaders, and academic clinicians, clinical trialists and statisticians.

Academia provides an important, independent locus of theoretical, scientific and clinical knowledge. In academic research environments, this knowledge may be augmented by familiarity with both key regulatory objectives and processes as well as with insight into key features supporting successful innovation on the industry side. With sufficient distance from conflict of interest issues, academia can provide a critical “neutral ground” in whi