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Oncology Development

Project Managers -Acquainted with Oncology-

PM1

Summary of Career

Monitoring operation:

• CRA Manager／Monitoring Manager（PhaseI-PhaseIII）
• CRA Leader
• General management for studies and CRAs as Playing Manager
* Breast Cancer: No findings in written form from PMDA at document analysis and on-site survey. As a Study leader, he reviewed the development strategy, drafted the protocol, relied to PMDA’s inquiries, and other development planning. He was involved in communication with APAC region and Head quarter.
* Many experiences in GCP Compliance Inspection (Documents/On-site), Multinational studies, EDC/English, CRO management G

Experienced Therapeutic area:

Non-small-cell lung cancer (NSCLC): 2 protocols
Prostate cancer: 3 protocols
Breast cancer: 8 protocols
Cancer pain: 1 protocol

Japan team’s Performance in multinational studies:

As his experiences, he was involved in 5 multinational studies

• Study A：No. 1 recruitment by country
• Study B: FPI/FD in global, No.1 recruitment by country
　　　　　　　　-> He contributed to catch up on the last 3 months at study planning

PM2

Summary of Career

• He had been involved in anti-cancer drug developments at pharmaceutical companies for 10-odd-year.
He has experiences as mentioned below:
• Project leader and Study manager experiences more than 6 years.
• Many experiences in Phase I study.
• Working experience as Global Core Manager at foreign-based pharmaceutical company
• Experiences in Asian study (Japan, Korea and Taiwan) as Project Head at Japan-based pharmaceutical company
• CRO management
• GCP Compliance Survey (Documents and on-site) experience (no findings→approved）
• Experiences with RECIST version 1.0 and 1.1 and CTCAE version 3.0 and 4.0 as PL
• Experience in trainer for Oncology Introduction Training (focus on Clinical Operation) to inexperienced CRAs
• Experiences using EDC (Inform and Rave) as PL, and experience in CRF Design
• Experiences of OJT at the institution (SDV, communication with KOL and others) to CRAs In Oncology Study

Experienced Therapeutic area:

Non-small-cell lung cancer (NSCLC), Breast cancer, Colon cancer, Renal Carcinoma, Thyroid cancer, Gastrointestinal stromal tumor, Advanced solid tumor (Phase I), non-Hodgkin's lymphoma, Multiple Myeloma

The latest products he was involved in:

• Project Manager for molecular target drug (Colon cancer), Global Phase III study
• Project Head for newly developing anti-cancer drug (Breast cancer), Asian Phase III study
• Project Manager for molecular target drug (Multiple Myeloma and Non-Hodgkin’s Lymphoma), Phase II study
• Project Leader for VEGFR-TKI (NSCLC), Phase I/II study

Affiliated Academic Societies:

Full member of Japanese Society of Medical Oncology and Drug Information Association (DIA)

Our team members who are acquainted with Oncology will support your Oncology development.