Around the Globe
Changing the Game in Oncology Development
DIA Global Oncology Development 2020
Eri Sekine
Novartis Pharma K.K.
he world surrounding cancer treatment continues to evolve rapidly. Emerging products now include immuno-oncology drugs and other new regenerative medicine and medical device therapies which further expand therapeutic choices in cancer treatment. Thanks to rapidly evolving digital applications, such as artificial intelligence (AI) and the Internet of Things (IoT), and their impact on clinical trial operations, clinical development in oncology faces both challenges and opportunities in keeping the evaluation of novel therapeutic products simple and reliable.
In his opening lecture, Expectation to Oncology Treatment Development, Tomomitsu Hotta (Honorary President, National Cancer Center Hospital) summarized efforts in Japan during the past decade to strengthen the bridge between basic research and clinical studies, and to accelerate the development of practical applications for cancer diagnosis and treatment. These examples include the Japan Cancer Research Project he leads for AMED (Japan Agency for Medical Research and Development), which has already generated positive outcomes in pediatric and other rare cancers. He urged a stronger collaboration on Japanese assets among professionals in academic research, regulatory science, and industry.
PMDA Direction for Oncology Drug Development
Innovation in Oncology Therapies
Operational Challenges in Oncology Clinical Trials
Decentralized clinical trials are a hot topic in Japan and interest is growing in the technologies required to implement them. Technology can also help improve efficiency in trials conducted with limited resources by supporting site staff with data exchange between systems, artificial intelligence (AI) navigation in data entry, remote data access, and electronic data archives. Research shows that 70 percent of patients currently enrolled in phase 1 studies travel from an area within one to two hours of that site. Patients who live farther away have fewer treatment options. The challenge is to identify truly transformational technologies, and where and how to implement them, to enable these trials and meet the needs of all these people.
A “patient-requested medical care system” is to be used as a “Ukezara study” for a short-term solution to individualized care. (“Ukezara” means a plate to save drops from falling when drinking coffee or tea.) For example, when oncology panel diagnostics identify a genomic mutation target in a patient, that patient often cannot find a suitable clinical trial in which to enroll. With no other clinical pathways, a “patient-requested medical care system” is one of a very small number of individualized treatment options. This solution cannot be sustained and highlights the need for more long-term solutions.
Panel Discussion
Utilization of real world data (RWD) in drug development is another “hot” topic in Japan, and this discussion centered around the reliability of RWD as a random sample from certain patient groups. Panelists also shared their experience with the difficulty of considering patient benefit and risk in cases of Conditional Approval using phase 2 study data, and the assumption that new drugs do not always improve the current standard of care.
Yasuhiro Fujiwara (PMDA), Fumi Yamamoto (Ministry of Health, Labour and Welfare), Toshihiko Doi (National Cancer Center Hospital East), and Toshio Shimizu (National Cancer Center Hospital), served as discussion panelists.
Program Co-Chairs Toshihiko Doi (National Cancer Center Hospital East) and Noboru Yamamoto (National Cancer Center Hospital)
Program Committee Members Masakazu Hirata (PMDA), Toshiko Ishibashi (Ono Pharmaceutical Co., Ltd.), Takuya Suzuki (Eisai Co., Ltd.), Tomoko Takami (MSD K.K.), and Atsushi Tsukamoto (Daiichi Sankyo Co., Ltd.)
Program Advisors Hironobu Saito (Daiichi Sankyo Co., Ltd.) and Junko Sato (PMDA)
DIA Japan Operations: Akina Takami (PMDA)
All DIA Global Oncology Development 2020 speakers