Summit I 17–18 Oct·Summit II 24–25 Oct·Finale 26 Oct

Japan is the best global ecosystem for frontier biotech.

Summit II and the finale, October 24–26 on Port Island. The only developed country where a therapy can sell on Phase 1 safety data, and where the fastest route to market is the official one.

$900 Summit II · Demo Day · Oct 24–26

Get a ticket Email us

56Confirmed speakers

370Organisations on Port Island

31Days in October

Five reasons to be in Kobe.

A researcher working inside a laminar-flow cabinet

6–12 Months to first revenue

A cell or gene therapy can be sold on a self-pay basis once it has Phase 1 safety data.

An automated sample-handling robot in a Japanese research institute

2 Agencies, one dataset

Data generated in Japan files straight into the FDA and the EMA.

Port Island from the air, the Kobe Biomedical Innovation Cluster on reclaimed land

17 National strategic sectors

Japan named biotech one of them. Learn the route from the institutions that built it.

56 Confirmed speakers

Two summit weekends and a finale, all inside the cluster on Port Island.

31 Days in October

The whole month on Port Island, with the weeks between the weekends to work.

Kobe at twilight from the Venus Bridge, the bay and the city lights below

Two summit weekends and a demo day, in Kobe this October.

Mirai Tech City connects US, EU and Japanese companies, scientists, investors and legislators, on Port Island, for a month.

With support of

KBIC, Kobe Biomedical Innovation Cluster

MedTech Innovation Center, Kobe University

LEVFoundation

and many others

Why Japan

A year to market, not a decade.

Under the Act on the Safety of Regenerative Medicine¹, a cell or gene therapy can be sold on a self-pay basis once it has Phase 1 safety data, in six to twelve months. For small molecules, biologics and devices, Conditional Early Approval² does the same nationally, around four years ahead of the FDA. Japan designed both routes deliberately, and founders arrive to learn them.

A researcher silhouetted at a microscope, lit from behind

Research base

Nobel-winning researchers

At Kyoto and Osaka, RIKEN's labs, purpose-built clinical clusters.

Conditional Early Approval 4 years ahead of the FDA

A scientist at a laminar flow hood, handling culture vessels

Where the field began

Japan invented iPS cells

The first therapies reached market here in 2026.

Act on the Safety of Regenerative Medicine 6–12 months

A robotic arm moving sample plates in an automated laboratory

Patient follow-up

One national database

Every patient is followed for life, to a standard the FDA and EMA accept.

Kansai at night from above, the city lit to the horizon

Health market, per year $146B⁵

¥23.8 trillion. 3.7% of GDP, the third-largest pharmaceutical market and R&D spender on earth. Biotech R&D up 32% last year.

Kobe's port islands from the air, engineered land in Osaka Bay

AMED grants match registered VC 2:1⁶

Non-dilutive. Raise a round and the state matches it twice over.

The Port Liner train crossing Kobe's red Port Island bridge

National insurance covers 70–90%⁷

Of what a patient pays, with a monthly cap. Demand does not wait on reimbursement fights.

An elevated expressway through a Japanese city at night, traffic drawn into one unbroken line

What the route returns

10×To first revenue
Faster

100×Than the Phase 3 route
Cheaper

+61%From the same patent
Commercial value

The path, the standard & the demand

Why now.

2025: ICH E6(R3)³ becomes the global clinical-data standard
Feb 2026: Biotech named one of Japan's seventeen national strategic sectors
The strategy. Two-thirds of the drugs approved in the US and Europe over the last decade never began development in Japan. Japan set out to change that, backed by long-term national strategy.
: The standard. Data generated here to ICH E6(R3) can be used directly in FDA and EMA filings. Start in Japan and the work counts everywhere.
Jun 2026: Annex 2⁴ adopted: real-world data counts as evidence
Oct 2026: You are in Kobe
The demand. GLP-1s reached tens of millions of people in a few years. When approval lags, patients buy unregulated copies. MHLW's approach: safety first, then commercialization on the way to efficacy.
Jan 2027: Annex 2 in force in Europe; Japanese data files directly into the FDA and the EMA

Who it's for

Pre-trial, or post Phase 1b.

Biotech startups aiming to reach patients ten times faster at a fraction of the cost, in three areas.

Bio

RegenerativeGene therapyCell therapyBiologics · RNASenolyticsReprogrammingOrgan replacement

The first three reach market via the Act on the Safety of Regenerative Medicine. The rest via Conditional Early Approval.

Human-machine

BCIsNeuromodulationBionicsCare roboticsImplantable sensorsSensory augmentation

No paralysis implant holds full market approval anywhere. Japan's conditional route already covers devices.

AI & digital twins

Protein designIn-silico trialsDigital twinsN-of-1Preventive monitoringFoundation modelsData sovereignty

A one-patient therapy cannot run a thousand-patient trial. Japan's lifetime national database can.

Speakers · Science

The scientists and communicators.

Twenty-two researchers, clinicians and science communicators across two summit weekends.

S1 Oct 17–18 S2 Oct 24–25 F Finale Oct 26 Online joins remotely — session to be announced

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Kobe

A month on the water.

Accommodation is booked separately; we point you to the options once you have your pass. Cluster tours, izakaya nights, onsens, Rokko, and the weeks between the weekends to work.