New drug candidate compounds identified during basic research must first demonstrate the envisioned medicinal effect with minimal risk to patients before they can go on to benefit patients worldwide who are waiting for new drugs. To accomplish this, it is essential that pharmaceutical companies collect high quality clinical data by carefully managing clinical trials. Data on the hypothesized mechanism of action, clinical effects, and pharmacokinetics must be scientifically and efficiently collected and assessed while paying the utmost attention to the rights, safety, and well-being of patients who cooperate in trials.
There are numerous steps in the new drug development process—from the stage of exploratory trials when a candidate compound is first given to human subjects, to the stage of confirmatory trials to identify the specific target illness and elucidate the drug’s exact position in a clinical treatment, to the stage of submitting a new drug application to regulatory authorities and corresponding to answer questions from the authorities. The Clinical Development & Medical Affairs Division is responsible for this series of steps. It works with the Discovery and Preclinical Research Division to establish a target product profile for new compounds in the basic research stage. The Clinical Development & Medical Affairs Division also works with the Ethical Drug Sales & Marketing Division and the Pharmacovigilance Department to establish methods of proper use and to provide safety information to healthcare professionals and raise patient awareness through patient brochures to maximize the value of the new drugs. In addition, the Clinical Development & Medical Affairs Division designs and conducts clinical trials for new indications seeking regulatory approval and post-marketing clinical studies.
Furthermore, the Clinical Development & Medical Affairs Division shares a role in global drug development in collaboration with Taiho Pharmaceutical subsidiaries in the U.S., Europe, and Asia. The Division has an important mission in delivering new Taiho brand drugs to patients quickly and efficiently around the world. It places great emphasis on gathering the latest information relating to treatment methodologies at international conferences and on discussing medical needs, trial designs, and statistical methods with experts from various countries. In this way, it ensures trial quality by maintaining good communication with related parties in each country. The Division is a team of people who are committed to challenging themselves to deliver new drugs that meet medical needs to patients worldwide.