New Development Paradigms for Japan

Concerns about the complexity and risks associated with drug development in Japan have resulted in small and mid-size foreign companies relying upon local Japanese partners for the preparation and implementation of drug development strategies. Unfortunately, this usually means they must depend on the precedent-oriented development approaches of conservative Japanese companies with little or no global drug development experience.

The skills and sensibilities that were suited to an era of stand alone development for Japan lack relevance in today's age of global drug development. So while small to mid-size companies need the infrastructural support that a local partner can provide, it is also important for them to retain some leadership and control of strategy in order to avoid missing opportunities to utilize new paradigms to integrate Japan into global development and accelerate approvals.

IDA has developed a unique step-wise approach that allows small to mid-size companies, without a Japanese base of operations, to take advantage of new development paradigms. Using the IDA approach, our clients can:

  • Independently assess potential Japanese product value.
  • Prepare medical and regulatory strategies.
  • Conduct ex-Japan bridging trials.
  • Obtain regulatory endorsement of a pathway to approval.
  • Implement clinical trials.

    All while conducting partnering activities in parallel.


    >> Next: IDA's Value Proposition