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Accelerate Technology Transfer by Relaxing the Boundary between Freedom and Regulations2014.06.05
Regulatory Science for Medical Products
Professor Kennichi Yanagi, CREIL Center, Faculty of Medicine
12 (12 faculty members, 0 postdoctoral fellows, none from other organizations)
regulatory science, pharmaceuticals, medical devices
Various new drugs, medical devices, and innovative seeds have been produced based on ideas from free thinking researchers at universities. This has drawn attention to research achievements of universities. However, technology transfer from universities to companies remains delayed. This delayed technology transfer is partially explained by the strict safety and efficacy tests required for the approval of pharmaceuticals and medical devices. These regulations were set to avoid unexpected adverse effects. However, significant costs must be met to implement the tests. Our unit is trying to bridge the gap between freedom and regulation, two attitudes critical for rapidly utilizing the research achievements of universities to benefit society.
What can universities do to facilitate the development of pharmaceuticals and medical devices?
Regulatory science*1 is defined as “science to make accurate prediction, evaluation, and judgment based on evidence and benefit most from scientific and technological achievements to promote harmony between human life and society.” This is critical for utilizing the research achievements of universities for the development of pharmaceuticals and medical devices. This is because strict regulations are imposed by the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency (PMDA) on pharmaceuticals and medical devices that act directly on the human body, in order to avoid their unpredictable risks. Our unit is trying to facilitate the technology transfer of innovative seeds as research achievements from universities, while complying with these regulations. We consider that the most important objective is to demonstrate the clinical effects, and that non-clinical efficacy tests should be conducted by universities (Figure 1).
Accelerate technology transfer for the development of new drugs and medical devices
We face difficulties filling the gap between researchers who focus on their research achievements and companies that focus on quality and safety. At the stage of basic research at universities, researchers should focus on their investigations, and regulatory science should be gradually considered when seeds are obtained. Pharmaceuticals and medical devices should be developed from viewpoints different from those of research. Research should be discontinued at a certain stage to proceed to development. We are trying to establish a system by which the gap between researchers who always focus on their research achievements and companies that focus on quality and safety is filled to facilitate the development of new drugs and medical devices (Figure 2).
*1Regulatory science: A concept proposed by Mitsuru Uchiyama of the National Institute of Health Sciences. According to the 4th Science and Technology Basic Plan, regulatory science is defined as “science to make accurate prediction, evaluation, and judgment based on evidence and benefit most from scientific and technological achievements to promote harmony between human life and society, in order to utilize scientific and technological achievements for human life and society.”
● Development of world’s first multi-purpose adhesive artificial bone using phosphorylated pullulan
● Creation of innovative hard tissue regeneration and reconstruction systems
(Interviewed on June 17, 2013)