Tokyo-based Astellas Pharma has announced plans to reshape its research framework by introducing new initiatives to enhance the ability to generate innovative drugs.
By optimizing the allocation of resources for its R&D function, Astellas aims to achieve the following objectives: Utilize more external capabilities and resources; undertake initiatives related to new therapeutic areas and innovative technologies including regenerative medicine and vaccines; accelerate development of Astellas' promising preclinical pipeline; and ensure sufficient investment in late-stage clinical pipeline.
A number of reshaping initiatives will be carried out to reallocate resources and realize operational excellence. These include closing or scaling back research functions during fiscal 2013, with some of the functions transferring to the Tsukuba Research Center. Both U.S.-based OSI Pharmaceuticals and U.S.-based Perseid Therapeutics are scheduled to close. The Astellas Research Institute of America is scheduled to be scaled back and focus on CNS therapies. Astellas also will cease in-house fermentation research and close its Kashima facility in Osaka in fiscal 2015. The multiple functions of the Kashima facility will be integrated and transferred to appropriate sites, including the Tsukuba Research Center.
In conjunction with the reshaping of Astellas' research framework, in April 2014 functions including the Clinical Development, QA (Quality Assurance) and RA (Regulatory Affairs) and Pharmacovigilance currently located in Tokyo will be relocated and consolidated closer to Astellas' Tokyo headquarters.
To enhance the process of screening external opportunities to strengthen innovation during the preclinical stage, activities currently undertaken by multiple departments, including Astellas Venture Management, will be integrated with the establishment of Astellas Innovation Management (AIM), scheduled for October 2013. By integrating functions under AIM, Astellas will be able to draw more widely and systematically on innovation opportunities in areas such as bio-venture companies and academia.
The research units for each therapeutic area will be assigned broader authority and responsibility to promote the autonomy and agility of each unit. Through a closer alliance with AIM, the active integration of internal and external knowledge and other such activities, Astellas will transform the way it carries out research to further employ cutting-edge science, including new therapeutic areas and innovative technologies.
The current "Multi-Track R&D" process will be implemented at an earlier stage of the research process. Highly prioritized research projects will be classified as "Fast Track," and R&D time will be minimized through the focused investment of capabilities and resources. In addition, the "External/Expedite/Exploratory Track" approach will be applied to unique and challenging projects, to obtain Proof of Concept more efficiently through the flexible use of internal and external capabilities and resources.
Through this reshaping research program, Astellas will enhance its ability to generate innovative drugs by deploying cutting-edge science (Best Science), accessing distinguished internal and external talents (Best Talent) and utilizing the optimal research environment (Best Place).