"Striking a balance between safety and accelerating drug development is a common conundrum across the world." These words, from Daisaku Sato, chief management officer of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), were a central theme at the 2019 "Sino-Japan Advanced Medicine: New Drug R&D Summit Forum and the Conference on Achievement Transformation" held in November 2019, in Chengdu. Sato further noted that international communications and cooperation are essential to align and standardize each country’s pharmaceutical regulations. The conference was organized by the Translational Research Center for Medical Innovation (TRI), and the Sichuan International Medical Exchange & Promotion Association (SCIMEA).
The event, initiated by Professor Yuquan Wei of Sichuan University and Professor Masanori Fukushima, director of TRI, attracted more than 1,000 participants from Japan and China, representing government units, research and medical institutions, universities and enterprises, sharing research insights and studies with a focus on regenerative medicine and cell therapy.
In the opening presentation, Sato explained how the Japanese government’s sakigake system works. Promising drugs or therapies can receive a fast-tracked, conditional approval for early practical applications, which will allow for a post market efficacy analysis. This shortens the approval process and provides sufficient proof of safety and efficacy for a more comprehensive release.
By April 2019, more than 40 medicines and devices had received conditional approval under the sakigake system. This includes a stem cell therapy for spinal cord injury approved in 2019. Sato said regenerative medicines, such as this therapy, have led to substantial discussions about post-marketing safety and efficacy measures, hospital data collection, cost and product quality monitoring. Against this background, the Japanese Society for Regenerative Medicine has created the National Regenerative Medicine Database as a large-scale clinical data registry.
In his presentation, Fukushima emphasized the importance of standardization of AI-assisted clinical big data for global data sharing efforts. He described how a global disease specific consortium for therapeutic areas including cancer, Alzheimer’s disease, mild cognitive impairment (MCI), amyotrophic lateral sclerosis (ALS), and stroke, has been initiated by TRI, who are constructing an international collaborative framework designed especially for clinical trial networks. He also acknowledged the crucial role played by the Japanese government in providing funding and driving R&D.
Sharing Insights
The conference featured four sub-forums for researchers from Japanese and Chinese universities and hospitals to present their recent work on gene and cell therapy, stem cells and regenerative therapy, artificial intelligence for targeted drugs, and new technology. A video message by the Nobel laureate, and president of the Foundation for Biomedical Research and Innovation at Kobe (FBRI), Tasuku Honjo, was one of the highlights of the event.
Fusheng Wang of the Fifth Medical Center of PLA General Hospital of the Chinese People's Liberation Army delivered a talk on clinical research and cell therapy regulations. While standardization and efficacy measures are a challenge for personalized treatment approaches, Wang noted that effective collaborations among regulatory bodies, hospitals and research institutions can overcome such obstacles. He also discussed clinical studies on mesenchymal stem cell treatment for liver conditions, which are some of the most prevalent diseases in China.
“Biofunctionalization is a new direction, which will bring revolutionary change to the repair and replacement of damaged tissue or organs,” said Xingdong Zhang of Sichuan University. Zhang also discussed the development of biomaterials in osteogenics.
A series of speakers then discussed the progress of regenerative medicine in Japan. Kojiro Imai of Kyoto Prefectural University of Medicine discussed oral mucosal epithelium sheet transplantation (COMET) for the treatment of severe eye surface diseases. Shinichi Kanemaru of Kitano Hospital showcased regeneration treatment of tympanic membrane perforation using gelatin sponge with basic fibroblast growth factor. While for bone and joint regeneration, Ryosuke Kuroda of Kobe University presented medical results of regenerative medicines for patients with non-union, cartilage damage. Koichi Tanaka, ex-director of Kyoto University Hospital showcased the latest medical developments for liver transplants.
Bilateral cooperation
One of the main aims of the conference was to bring Chinese and Japanese scientists together and encourage bilateral cooperation in the field of advanced medicine.
The 21st century has experienced remarkable biomedical breakthroughs, said Wei He, vice chairman of the National Committee of the Chinese People’s Political Consultative Conference (CPPCC). He hoped that Japan and China would continue to join forces to promote medical R&D, building efficient bilateral platforms for medical research.
China’s National Medical Products Administration (NMPA) Commissioner Hong Jiao concurred, saying research institutions and pharmaceutical industries should enhance international communication and cooperation to allow for efficient transformation and application of innovations, in particular in gene and cell therapy, and regenerative engineering.
To further facilitate bilateral R&D cooperation, the conference launched the ‘Sino-Japan Biomedical Achievements Transformation Express’ program. This aims to improve applications and industrialization of biomedical achievements in both countries, in particular, to connect research institutions and investors efficiently for new drug development. More than 10 Chinese and Japanese enterprises have signed cooperative agreements for the transformation of pharmaceutical research and results. Through this, drugs developed in China could be accessed in Japan and vice versa, enabling patients to benefit from the medical innovations of both countries.
