New drug candidates identified during basic research must demonstrate the envisioned medicinal concept 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 drugʼs 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. The Division works with the Discovery and Preclinical Research Division to establish a target product profile for new compounds in the basic research stage. The Division also works with the Ethical Drug Sales & Marketing Division and the Medical Affairs Division to establish methods of proper use and provide safety information to healthcare professionals and patients to maximize the value of the new drugs. In addition, the Division designs and conducts clinical trials for new indications seeking regulatory approval and post-marketing clinical studies.
Furthermore, the 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 role in delivering new Taiho brand drugs to patients quickly and efficiently around the world. In the course of the global development of new drugs, the staff members of the Division play many important roles, not only discussing with counterparts at Taiho subsidiaries, but also gathering the latest information relating to treatment methodologies at international conferences. It is very important for them to have an ability to hold discussions with experts from various countries about medical needs, trial designs, and statistical methods, as well as ensure trial quality by maintaining good communication with related parties in each country. As such, the Divisionʼs staff members are required to have a global mindset. The number of people involved in clinical development in Asia, the U.S., and Europe has also been increasing year-by-year. In order to deliver even better medications to patients with even greater speed, the Division always aims for a high degree of reliability as well as scientific and ethical soundness when designing and conducting clinical trials, producing data, applying for drug approval, and developing human resources. It serves as a professional organization that continues to embrace challenges and pushes forward with a global perspective to develop new drugs that can contribute to the health of people worldwide.