本セッションは、ハイブリッド(現地&オンライン)セッションです。
This session will be held in a hybrid format (onsite and online).
※Please note that the program is subject to change without prior notice. We appreciate your understanding.
Organizer: Frontier Humans
Venue: Tech Hub Yokohama (Landmark Tower, 2-2-1 Minatomirai, Nishi-ku, Yokohama)
Language: English
*同時翻訳ツールあり(テキストのみ)| Simultaneous translation tool available (text only)
Description:
This session examines how existing Japanese therapeutic pathways, including ASRM and adjacent frameworks, can deliver earlier approvals than the US route, and how that early Japanese clinical data can be bridged back into the FDA process. For Japan-based biotech startups, this sequencing is a structural advantage that remains under-exploited.
We'll also look at what other jurisdictions like the UK, Singapore & the UAE, are doing to compress time-to-patient and push the regulatory frontier, and why this competition for frontier medicine is rapidly becoming a defining axis of national biotech strategy.
Note: We aim to select a few companies as examples for regulatory pathways alternatives. We welcome companies to submit a short description of their therapy and challenges and contact details to revise them. We will be in touch with the selected therapies. This exercise will not be legal advice, rather will serve as examples to guide the attendees in new ways of thinking about strategies of going to market early with real-life examples.
If you would like to be considered, please register to this session and send the information below about your therapies to team@frontierhumans.com by June 8(Mon) the latest.
Name of your therapy
Current approval stage
Brief explanation of your therapy
Current challenges for approval or commercialization
Speaker:
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■オンライン参加方法 | How to join the session online