Foreign-made drugs are often unavailable in Japan due to the country’s approval process, which requires clinical trial data from Japanese patients. To address this issue, known as “drug loss,” Japanese technology company Fujitsu is partnering with American start-up Paradigm Health to attract global clinical trials to the island nation.
The two will combine Paradigm’s clinical trial platform with Fujitsu’s medical data collection platform and AI tools to build a data ecosystem that can provide pharma companies with information needed to plan clinical trials, according to an Aug. 26 release. Fujitsu plans to launch these services to hospitals starting in September 2024.
“This collaboration will modernize the clinical trial model and provide unprecedented access to clinical trials for patients across Japan,” Paradigm CEO Kent Thoelke said in the release. “We believe that this collaboration will establish Japan as an essential part of the global clinical trials and drug development ecosystem while ensuring that Japanese patients have equitable access to the best possible care options.”
Clinical trials are costly in Japan due to patients being spread out across multiple hospitals and the country's drug pricing program, according to the release. These factors have also caused Japan to be excluded from many global clinical trials.
Under the partnership with Paradigm, Fujitsu will collect medical and genomic data from these dispersed medical institutions with its "healthy living" platform and then process it with the company's AI service to ensure it complies with Japan's laws and regulations. Data will then be provided to Paradigm, who will analyze and interpret the data for pharmas planning trials.
Paradigm launched in early 2023 with a massive $203 million series A and a goal to disrupt clinical trials with a platform to help boost patient recruitment and speed up drug development.
Fujitsu is also working to use a large-language model (LLM) to automatically create clinical trial documents, which in Japan are still largely made and managed manually. According to the release, the company was able to use AI to generate 80% of each document in a proof-of-concept with an unnamed pharmaceutical company. The tech firm has dubbed the LLM service "patient-centric clinical trials" and estimates the tool will cut the time needed to prepare documents in half.
The Japanese government has also taken steps to address the "drug loss" problem. In April, the Health, Labor and Welfare Ministry loosened the requirements for the approval of new drug applications for rare diseases, such as childhood cancers.