SHIONOGI Group Global Development Policy
SHIONOGI Group Global Development consists of development experts from Shionogi & Co. Ltd., Shionogi Inc., Shionogi B.V. and other group companies, and together contributes to SHIONOGI Group’s success by generating the best possible medicines which are truly needed to protect the health and well-being of the patients we serve around the world through total healthcare initiatives and the innovation.
To this end, we, as members of Global Development, whether at the headquarters or in any region, aim to maintain stringent ethics standards, pursue solid sciences, and ensure regulatory/legal reliability. Moreover we strive to introduce innovative scientific methods, constantly improve management practices, and optimize our development strategy and operations on the global scale.
We will continue to collect evidence about our medicines after regulatory approval. The collected evidence will enhance the value of the medicines and contribute to the continuous improvement of human health and quality of life.
In order to achieve these objectives, we have established the following six principles.
- 1This global development policy is valid throughout the drug development process which begins when a compound becomes a candidate for development, and continues throughout the regulatory approval process (including supplemental application for approval) until the end of product life.
- 2In order to execute the development of a compound, a project team is assembled from among professionals responsible for relevant functions with their roles and responsibilities appropriately assigned. Each member of the project team has authority over his or her area of assigned responsibility.
- 3Two types of project sub-teams are organized: the strategy planning team and the operation team. The first is responsible for formulating the full global project strategy, and the second for implementing the formulated strategy. The separation of strategy formulation and operational execution makes it possible to clearly define responsibilities. This enables rapid and proper strategy formulation and decision-making, and promotes operational excellence. Continuous cooperation of the two teams is indispensable for the project success.
- 4The strategy planning team is set up to build the global development strategy taking into consideration the regulatory requirements of each region, and aim to maximize the value of the compound. Its mission is to formulate a global drug development plan that has a high likelihood of success which will have the optimal indication at launch accompanied by a future life cycle management plan. The drug to be developed is to be clearly differentiated from competitors and is to be approved as swiftly as possible while maintaining a transparent and healthy relationship with related ministries and agencies as well as external organizations.
- 5The operation team is established for each of the clinical studies and is responsible for the execution of the high-quality clinical studies within the agreed budget and timelines. The operational team should continuously aim to improve efficiencies to reduce spending and speed up timelines while keeping the quality of study data and ensuring patients/subjects’ wellbeing and safety. It gives top priority to ensuring the safety of patients and subjects of clinical studies and should maintain the quality of study data. Furthermore, it aims to continuously improve efficiency in order to conduct clinical studies quickly and at an appropriate cost.
- 6Although a distinction is made between line management and the project team management within the development management organization, these two groups should maintain a complementary and collaborative working relationship at all times. The line manager has the responsibility to empower the project team appropriately and to provide adequate support. It also promotes capacity building and career development for project team members. The project team has the responsibility to update project activities appropriately and in a timely manner to the line manager and to obtain guidance and support from the line manager.
SHIONOGI Group Global Development will thus contribute, as a member of the global team, to maximizing the value of our medicines for patients worldwide and SHIONOGI Group.
(Established on 15 January 2016)
(Revised on 1 January 2022)