CONTACT US
Register Now
CONTACT US

Clinical Research Steering Committee

Clinical Research Steering Committee

Meeting Date: 16 October 2025

Attendees

Role

Suzanne Plezier

CRSC Chair

Hillary McKellar

CRSC member

Kenneth Adams

CRSC member

CRSC member

Attendees

Role

Nicole Leedom

CRSC member

Katerina Adragna

Guest

Lisa Mulder

Admin

Agenda/ 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. 

Question #1: Do you have any experience working with CROs, Clinical Research Units (CRUs) with expertise in conducting PK bridging studies in Japanese and Chinese participants?

Question #2: Any recommendations and/or lessons learned working with certain vendors?

Question #3: 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)?

Question #4: If Regulatory alignment is recommended, how much time should be planned from Stable protocol design to approval and first patient in (FPI)? 

Question #5: Do you have experience conducting these as a single PK bridging study, or 2 separate studies?  Separate CROs, CRUs?

Question #6: Does anyone have any additional considerations or risk mitigations related to planning the timing and resources for these bridging studies?

Summary

1) Experiences: CROs/CRUs with ability to support patient with Japanese ethnic background:

  • 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. Best experience with their biotech division.
  • 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.

2) 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.

Anecdotally, a committee member who worked with A2 as the CRO greatly appreciated that they assigned a translator to the team who was embedded within the ClinOps team and knowledgeable about ClinOps processes and challenges.

  • A smaller CRO often offers more responsiveness than large global vendors.
  • Establish relationships early; local expertise critical for navigating PMDA expectations.

 

Operational insights:

  • S.-based bridging can be faster and more cost-effective.
  • California is of interest because it has a large population of first- and second-generation Japanese descendants. Note The first generation in California is gradually aging out and/or passing away.
  • Experience is that the population can be mixed (first and second) and enrollment pace has been the driver. So far PMDA has not defined nor guided on distribution first vs second generation participants.

Example shared: For ethnobridging study w/ Parexel from Final Protocol (July 2021) → FPI (Oct 2021) → CSR (Oct 2022).

3) Regulatory Alignment Japan (PMDA):

  • 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.
  • PMDA does not need to be informed of a US PK bridging study, however it could be advantageous to do so especially regarding 1st or 2nd generation patient population inclusion.
  • For pivotal/registrational studies in Japan, pre-meetings with the PMDA are almost always done.
  • Details of the PK study design have been included in the meetings with PMDA to discuss the registrational study (end of phase 2 [EoP2] or pre phase 3)
  • PMDA approval process typically 12–18 months from stable protocol to first patient in (FPI).
  • Possible to perform Japanese PK studies in the U.S. if subjects are of Japanese descent; PMDA generally accepts such data. It was mentioned that male only studies have not flagged any problems with the PMDA.
  • China (NMPA):
    No first-hand experience shared; regulatory requirements expected to differ.
    Local alignment or partnerships are likely necessary.

4) Timeline, Costs and 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.
    • Example: PMDA pre-meetings started Sept 2023 (request for EoP2 meeting) → FPI Aug 2025 (24 months total, including prep time).
  • Overall timelines for Japan take longer.  “It always takes longer than you plan for.”

Key factors influencing duration:

  • Pre-meeting sequence and PMDA feedback rounds.
  • Complexity of dose rationale and PK justification.

Other

  • Orphan drug designation (ODD) may shorten review times.
  • Japan Agency for Medical Research and Development (AMED) was established in 2015 and supports medical R&D to advance health and longevity in Japan. Committee members mentioned the benefit of an AMED grant.

 

Costs

  • Average per patient fee seems to be ~20% higher vs per patient fee for full study cost in Japan compared to in the US. Not per se due to the investigator grants but due to increased CRO services fees
    • Intense sponsor involvement (handholding)

 

Quality

  • The site commitment and data quality seem to be very good.

 

Summary notes:

Clinical trials in Japan take longer, are more expensive and in return you get good quality data and enrollment as projected by the sites.  

5) Experience with Single vs. Separate PK Bridging Studies

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.

Examples shared:

  • Japan: Ethno-bridging in Japanese descendants in the U.S., accepted by PMDA.

China: Early-phase collaboration through local CROs or biotech partnerships.

6) Additional Considerations and 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.
  • 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.

Scroll to Top