Abstract:

The world’s top ten pharmaceutical companies continue to reorient their strategies toward greater focus on core therapeutic segments and continuous improvement of efficiency in the development and marketing of their new chemical entities (NCE). Shortening development times while simultaneously maintaining product quality is perceived to be essential in competing effectively on a global basis. Nevertheless even these major companies have experienced great difficulties in realizing significant improvements. Even with the benefit of cross-functional project team organizations, management review committees and well-structured development processes it remains a continuous challenge to maximize both development speed and development quality. As a consequence, benchmarking the various parts of the development process has become very popular to rejuvenate competitive skills in this respect.