About IDEC
Mission
We facilitate access to new medicines for Japanese patients without delay through innovative development.
Experience
IDEC has extensive experience with development planning and implementation for drugs, devices and biologicals. We specialize in oncology and neuro-psychiatry, including pain.
Our strengths
- Successful PMDA consultation and negotiation
- Successful in- and out-licensing support
- International and Japanese regulatory expertise
- Gap analysis
- Predicting PMDA requirements vs. FDA and EMEA
- Clinical development planning, oversight and implementation
- Thorough understanding of the Japanese environment for new drugs
- Information analysis, intelligent risk management
- Extensive network of Japanese clinical and non-clinical experts
- KOL relationship management
- Product advocacy development
- Network of proven product development contractors
Key people
| Chris Brunger, MD | President & CEO, Chief Medical Officer |
| Naoya Kato, MSc | Director, Product Development & Regulatory Science |
| Naoki Ozawa, PhD | Director, Non-clinical Development & Clinical Pharmacology |
| Hiroyuki Kobayashi | Deputy Director, Non-clinical Development |
| Chio Takahisa, MSc | Senior Manager, Product Development Planning |
| Terry Noma | Senior Manager, Business Development |
| Phillipa Smith, MSc | Senior Consultant, Clinical Development, Medical Writing and QA |
IDEC staff members have worked abroad in senior management positions, giving them in-depth understanding of global drug development and regional requirements.