he US Food and Drug Administration’s (FDA’s) controversial approval of the Alzheimer’s drug aducanumab (Aduhelm^TM) has kicked off a firestorm of debate, placing the Accelerated Approval Program (AAP) in the hot seat. The AAP seeks to balance the need for evidence of clinical efficacy with the need for access to novel drugs for seriously ill patients with no adequate options, a high-risk but potentially high-reward proposition.

While it is clear that FDA and drug sponsors must work together to proactively plan and diligently implement clinical trials for the collection of data sufficient to “convert” accelerated approval into traditional approval, equally important is ensuring that while clinical trials are pending, patients who receive AAP-approved drugs in the clinical setting fully understand the program, its limitations, and the tradeoffs they are making.

atient entrepreneurs are another emerging category of patients, along with groups like patient influencers, who are changing the landscape of healthcare and drug development. They are a new driving force behind the development of health solutions that are “by the patient, for the patient.” Industry partnerships with patient entrepreneurs are growing, and they are increasingly paving the way for further embedding patient-centricity into the healthcare ecosystem. But how and why is this happening?

n December 2018, the first AI-based medical device–the AI software to support discrimination between tumor/nontumor colorectal lesions using endoscopic images–was approved in Japan. Although nearly three years have passed since then, the number of AI-based medical devices approved in Japan is still low compared to Europe and the US.

he COVID pandemic precipitated sweeping changes in established policies and practices and emphasized the confluent dynamics of disease burdens, optimized healthcare systems, and the socio-economic influences of globalization. We now stand at the crossroads of an unprecedented global challenge which demands that researchers, regulators, policy makers, and governments address multiple dimensions that go far beyond the implications of any one healthcare scenario.

early two years have passed since we began to face the COVID-19 pandemic, and while its global consequences have been catastrophic, the situation has also catalyzed profound change in our overall health ecosystem. The progress we have experienced in drug development, transformative therapeutic innovation, and regulatory cooperation and harmonization continues to spread. Global health awareness has grown significantly, and global stakeholders continue to focus on exploring new areas of health science and technology for innovation, framing regulatory strategies and policies, and developing new leadership for this changing healthcare world.

IA honors the life and work of Tatsuya Kondo, a long-time leader, mentor, and friend of many in our community, who died on September 26, 2021.

Our 2021 Japan Inspire Award Winners