Industry Efforts on Simultaneous Global Development

Given the current size and complexity of pharmaceutical development programs, continued improvements to streamline the development of new and innovative medicines are critical. Despite significant operational challenges, the conduct of global studies using a single protocol across multiple regions is considered by the innovative pharmaceutical industry as an efficient approach to clinical development. This philosophy is in line with the drivers behind the creation of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH); specifically, the development of harmonized guideline documents, including ICH E5 (Ethnic Factors in the Acceptability of Foreign Clinical Data). However, despite very significant progress made with the implementation and acceptance of ICH guidelines, barriers to the conduct and acceptability of global development approaches still remain. The need for simultaneous global development has been recognized as significant, not only by the pharmaceutical industry, but also by a number of governmental agencies. Efforts exist now to evaluate the challenges associated with the conduct of global studies. To make recommendations to facilitate simultaneous global development, a multifunctional group of experts within the Scientific and Regulatory technical groups of PhRMA member companies was convened as the Simultaneous Global Development Committee. This article only describes the initial observations of the committee and is expected to be followed by future articles on a series of concrete recommendations to address issues inhibiting simultaneous global development. Initial activities of the committee have focused on developing a more rigorous identification and understanding of the barriers to simultaneous global development, and on initiation of communications with health authorities, beginning with the East Asian region, where the drug tag and related topics are currently actively discussed and addressed.