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CLINICAL RESEARCH STEERING COMMITTEE

Meeting Minutes

PK Bridging Strategy Japan & China

Meeting Date:

16 October 2025

Meeting Type:

CRSC Meeting

Prepared By:

Lisa Mulder (Admin)

ATTENDEES

Suzanne Plezier

CRSC Chair

Hillary McKellar

CRSC member

Kenneth Adams

CRSC member

Nicole Leedom

CRSC member

Katerina Adragna

Guest

Lisa Mulder

Admin

AGENDA / KEY QUESTIONS

These questions relate to running pharmacokinetics (PK) bridging studies in Japanese and Chinese subjects in order to include those countries in a Phase 3 registrational trial. 

01

Do you have any experience working with CROs, Clinical Research Units (CRUs) with expertise in conducting PK bridging studies in Japanese and Chinese participants?

02

Any recommendations and/or lessons learned working with certain vendors?

03

In the absence of any substantial PK data in Japanese and Chinese participants, do you recommend seeking alignment with PMDA (pharmaceuticals and medical device agency Japan) and NMPA (national medical products administration China) on study participants (i.e. 1st generation, 2nd generation, etc.) and study design prior to conducting the bridging study(s)?

04

If Regulatory alignment is recommended, how much time should be planned from Stable protocol design to approval and first patient in (FPI)? 

05

Do you have experience conducting these as a single PK bridging study, or 2 separate studies?  Separate CROs, CRUs?

06

Does anyone have any additional considerations or risk mitigations related to planning the timing and resources for these bridging studies?

KEY TAKEAWAYS

Vendor Recommendations

US based CROs with a phase 1 unit in US and experience with PK bridging studies and investigational new drug application (IND) in the US
Parexel – (Phase 1 unit in Glendale, CA) reliable for bridging studies, good operational track record.

Vendor Recommendations

  • PPD – strong experience in phase 1; however, as CRO for later phase studies, has been known to deprioritize smaller sponsors; caution advised.
  • Alta sciences (LA California) – robust early-phase experience, capable of running ethno-bridging studies in the US.
  • WCCT (worldwide clinical trials, Southern California) – good access to Japanese first- and second-generation volunteers.
  • CenExel – smaller early-phase CRO with specific PK expertise.
    • Japanese CROs or APEC CROs with a good foodprint in Japan
  • A2 Healthcare – highly recommended; responsive and flexible on ICCC representation.
  • CMIC – reputable Japanese CRO; feedback mixed depending on relationship and size of sponsor.

Overall, it was recommended to either partner with a Sponsor in the APEC region or country of interest or invest in a CRO with significant experience in that region.

  • China:
  • Limited direct experience among committee members.
  • One member mentioned China Med (most likely China Med Device CMD) as a possible CRO for China-specific bridging.
Read MOre

Lesson Learned

Vendor selection tips:
For Japan, A2 Healthcare stands out for its flexibility and reliability.
Ensure CRO can act as In-Country Clinical Caretaker (ICCC);
PPD would not unless they are scoped as PV vendor.A2 Healthcare has shown to be more flexible regarding this aspect.

Lessons Learned

Lessons Learned

• A2 Healthcare has demonstrated greater flexibility regarding ICCC representation.

• One committee member shared a positive experience with A2 Healthcare, noting they assigned a dedicated translator embedded within the Clinical Operations (ClinOps) team who understood ClinOps processes and challenges.

• Smaller CROs often provide greater responsiveness than large global vendors.

• Establish relationships early, as local expertise is essential for navigating PMDA expectations.

Operational Insights

• U.S.-based ethno-bridging studies can be faster and more cost-effective.

• California is a preferred location due to its large population of first- and second-generation Japanese descendants.

• The first-generation Japanese population in California is gradually aging and decreasing.

• Current experience indicates that studies often include a mix of first- and second-generation participants, with enrollment speed being the primary consideration.

• To date, the PMDA has not provided specific guidance on the required distribution of first- versus second-generation participants.

• Example Timeline (Parexel Ethno-Bridging Study):
- Final Protocol: July 2021
- First Patient In (FPI): October 2021
- Clinical Study Report (CSR): October 2022

Read MOre

Regulatory Guidance

Early alignment with PMDA is strongly advised long before the start of a registrational study. Pre-meeting specific to PK/ ethno-bridging study is not necessary or common per the members’ experience.

Regulatory Guidance

  • Regulatory Guidance

    • PMDA does not need to be informed of a U.S. PK bridging study. However, early communication may be beneficial, particularly when discussing the inclusion of first- and second-generation Japanese participants.

    • For pivotal or registrational studies in Japan, pre-meetings with the PMDA are almost always conducted.

    • PK study design is typically discussed during PMDA meetings held at the End of Phase 2 (EoP2) or before Phase 3 to support the registrational study.

    • The PMDA approval process generally takes 12–18 months from a stable protocol to First Patient In (FPI).

    • Japanese PK studies can be conducted in the U.S. using participants of Japanese descent, and the PMDA generally accepts these data.

    • It was noted that male-only PK studies have not raised concerns with the PMDA.

    China (NMPA)

    • No first-hand regulatory experience was shared by committee members.

    • Regulatory requirements are expected to differ from Japan.

    • Local regulatory alignment or partnerships are likely necessary for successful study execution.

Read MOre

Timeline & Quality

Indicative timelines shared:
Ethno-bridging study (U.S.): ~18 months from final protocol to clinical study report (CSR).
PMDA process: 12–18 months from stable protocol to FPI, depending on meeting scheduling and expedited pathway eligibility.

Timeline & Quality

Risk Mitigation & Practical Recommendations

• Use interpreters with clinical research experience rather than general translators to minimize communication barriers.

• One committee member shared a very positive experience with an A2 Healthcare interpreter who was embedded within the Clinical Operations (ClinOps) team.

• Provide etiquette and cultural awareness training for staff working with Japanese collaborators, vendors, clinical sites, and regulators.

• Capture first- and second-generation Japanese ancestry data early in the clinical trial database.

• Establish early partnerships or local affiliates to facilitate PMDA interactions and regulatory engagement.

• Japan is approximately 20% more expensive per patient than the U.S.; however, data quality and site commitment are consistently excellent.

• Explore funding opportunities through AMED grants, which can provide significant financial support (one example cited was a US$40 million grant awarded to a U.S. sponsor).

• Carefully evaluate return on investment (ROI), particularly for rare diseases. Obtaining Orphan Drug Designation (ODD) can significantly improve development feasibility.

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Study Design

Consensus:

Overall approach for Japan / PMDA
Bridging study in US followed by a
Registrational study (PH2 or 3 in Japan)
It seems uncommon to combine both countries (Japan and China) in one study due to distinct regulatory frameworks and participant requirements.

Study Design

Study Design

• Combining Japan and China in a single clinical study is generally not recommended because:
- The two countries have different regulatory frameworks.
- Participant eligibility and population requirements differ.
- Clinical development pathways and approval expectations are not aligned.

• Japan
- Ethno-bridging studies conducted in the U.S. using participants of Japanese descent are generally accepted by the PMDA.

• China
- Early-phase development is typically conducted through local CROs.
- Partnerships with Chinese biotechnology companies are commonly used to support clinical development.

Read MOre

Risk Mitigation

Cultural and operational considerations:

Relationship-building is crucial; Japan is highly relationship-driven.
Face-to-face meetings are valued; personal connections accelerate progress.

Risk Mitigation

    • Use interpreters with clinical understanding, not just translators. Don’t underestimate the language barrier.
    • A committee member mentioned great experience with AZ health interpreter.
      • Etiquette training recommended for staff engaging with Japanese collaborators, vendors, sites and regulators.

    Practical recommendations:

    • Capture first-/second-generation ancestry data early in trial databases.
    • Establish early partnerships or local affiliates to support PMDA interactions.
    • Cost: Japan ~20% more expensive per patient than U.S.; data quality consistently excellent.
    • AMED grants can provide significant financial support (example: $40M U.S. sponsor grant).

    Evaluate ROI carefully, especially for rare diseases; ODD status can improve feasibility.

Read MOre
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