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The BIO Delegation (pictured from left): Tasuku Kitada (Strand Therapeutics), Adam Roach (BeOne Medicines, formerly Beigene), Jacob Becraft (Strand Therapeutics), John F. Crowley (BIO), Eric Dube (Travere Therapeutics), Ambassador Kurt Tong (The Asia Group, Consultant for BIO), Juan Camilo Arjona Ferreira (Organon), John Glasspool (VarmX), Chris Leibman (Biogen), Kate Madigan (Eisai),
The U.S. and Japanese biotechnology sectors have a longstanding and dynamic partnership, and this past week, a delegation of Biotechnology Innovation Organization (BIO) members traveled to Tokyo to further strengthen this collaboration.
Led by BIO President & CEO John F. Crowley, the delegation engaged with industry partners, government officials, and patient groups to reinforce ties with this key ally. Their efforts focused on enhancing U.S.-Japan cooperation in drug development and bolstering supply chains to benefit patients and support shared national security objectives. Additionally, they addressed critical market access challenges that BIO members encounter in the Japanese market.
With BIO members like Eisai based in Japan, and years of cooperation with the Japan BioIndustry Association (JBA), BIO has developed strong U.S.-Japanese ties and has held several previous delegations to encourage collaboration. This recent delegation, held between March 17-19, was the first delegation led by Crowley in his tenure as CEO of BIO, highlighting the strategic relationship between Japan and the United States.
“One of the reasons we came here in our first international delegation under my leadership at BIO was because of the importance of the relationship between the United States and Japan,” Crowley said. “There’s not only a great shared history in the development of medicines, there’s a great vision..”
Crowley emphasized the importance of working for patients, a group that received special attention during BIO’s visit. For the first time, BIO’s mission to Japan featured a patient roundtable, which was led by Crowley.
“We discussed how to involve patients in drug development, including enhanced cooperation with Japan’s regulatory agency,” said Hilary Stiss, Senior Director of International Affairs at BIO.
Osamu Nagayama, chairman of the JBA, which is BIO’s counterpart and partner in Japan, addressed the mission. Nagayama explained that Japan is building its ecosystem for innovative drug development.
“In Japan, the government has been very promotive of creating the ecosystem that’s needed for biopharmaceuticals,” he said, adding that the U.S. government also supports a biotech ecosystem with good results. “In America, there have been a lot of startups that develop novel medicines and they are not doing everything on their own.”
Nagayama added that Japan’s strategic focus in this area has helped. He was encouraged by the creation of new Contract Development and Manufacturing Organizations (CDMOs), but said more ecosystem building is needed.
Concerns and collaboration
The delegation also included discussion of policy and regulatory issues.
Among the high-level officials who met and discussed these matters with the group were State Minister of Economy, Trade and Industry Yuichiro Koga; Minister of Health, Labor, and Welfare Takamaro Fukuoka; and the head of the regulatory agency, Dr. Yasuhiro Fujiwara, MD, Chief Executive Pharmaceuticals and Medical Devices Agency (PMDA).
Regulatory concerns that were covered included long wait times for clinical trial approval and the need to increase access to expedited pathways for approval in Japan. One positive step in this area is the opening of a new PDMA office in Washington, D.C. BIO has said it’s eager to partner with that office.
Another issue of concern for biopharmas in Japan is the government’s involvement in setting drug prices. In particular, a lack of predictability in drug price cuts makes market entry challenging, BIO has noted.
There was also discussion of building on the strong collaboration that exists between the U.S. and Japanese biotech industries in research and development, regulatory harmonization, biomanufacturing, investment flows, and supply chain resiliency.
Regarding supply chains, industry members and government officials agreed that strengthening supply chains is critical for national security for both the U.S. and Japan. As allies, it is critical that we continue to collaborate in drug development and supply chain strengthening.
