• Ascent’s Value Proposition
    US/EU Early Development
    POC Data Readout
    FDA / EMA MTG
    Japan Development Planning
    Informal PMDA / KOL MTG
    Formal PMDA MTG
    China Development Planning
    Pre-IND Submission
    Pre-IND MTG
    Asian Phase 1 Bridging
    Study Plan
    Study Start
    Study Complete
    Global Pivotal Trial Including Japan & China
    Study Start
    Recruitment Complete
    Last Patient Out
    Data Readout
    US NDA
    Japan NDA
    China NDA
    Asian Value Inflection Milestones
    ASIAN PRODUCT VALUE

Strategic Planning for Japan & China

Ascent’s step-wise approach begins with literature-based medical research and investigation of regulatory precedents to prepare clinical development strategies that align regulatory and commercial objectives for Japan and China with the US and/or the EU.

Ascent then arranges meetings with leading KOLs and coordinates informal interactions with regulators to ascertain preliminary medical and regulatory feasibility of the proposed strategy. Note that a Phase 1 “bridging study” is often a critical element of global development programs for Japan and China. Ascent provides expert support in developing study designs that will generate the safety, tolerability, and PK/PD data required by PMDA and NMPA to initiate clinical trials in Japanese and Chinese patients.

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