Regulatory assessment

CoreMed evaluated their CMC, nonclinical and clinical data, and established a clinical development strategy for Japan.

PMDA consultation meeting

Based on the regulatory assessment, CoreMed organized a pre-Phase 1 consultation meeting with the PMDA on behalf of Company B. The main discussion points included:

• - If the nonclinical study data was enough to start a clinical study in Japan
• - Phase 1 protocol
• - Overall development plan for the J-NDA

The outcome of the meeting was very positive, and Company B started the Phase 1 in Japan by appointing an In-Country Clinical Trial Caretaker (ICCC) who ran the study. CoreMed helped them find an ICCC and prepare Clinical Trial Notification. Occasionally, CoreMed advised Company B.

Finding a Japanese partner

With the successful outcome and Phase 1 data, Company B found a Japanese partner who would be a future MAH.

Further development towards the J-NDA

Company B and the Japanese partner collaborated towards the J-NDA. CoreMed still served as a regulatory consultant and helped with some tasks for Company B.