A) Market Analysis & Medical Strategy

IDA provides strategic, medical and scientific consulting services to assist bio-pharmaceutical companies in assessing commercial potential and planning for optimal Japanese product development. Specifically, IDA assists clients with:

 

  • Estimation of target patient populations based on an expert analysis of epidemiological literature 
  • Assessment of product positioning and clinical utility through literature-based research of medical practices supplemented with qualitative KOL and physician interviews and interactions
  • Preparation of product development strategies based on a holistic evaluation of medical positioning and commercial potential as well as an assessment of regulatory and development feasibility
  • Validation of product development strategies through formal KOL Advisory Board meetings and informal regulatory consultations with PMDA

 

 

B) Product Development & Regulatory Strategy

Following a positive evaluation of Japanese product potential based upon the strategic assessment described above, IDA is able to gain endorsement of regulatory pathways to obtain approval of ideal Japanese product labeling through the following steps:

  • Preparation of a detailed development plan which, among other things, lays out the scientific rationale for maximizing the use of foreign data
  • Proposal of the design and supporting rationale for Japanese and Asian clinical trials integrated into the global development strategy
  • Full management of formal consultations with PMDA regarding; 1) product quality, 2) clinical trial design, and 3) CTD/ J-NDA content adequacy in order to gain full and official PMDA endorsement of development up through J-NDA submission. Preparation and execution of these consultations entail the following steps;

    • Preparation of documentation related to product quality for small molecule, biologics, and gene therapy products
    • Design and drafting of Japanese protocols and their scientific rationale
    • Preparation of Consultation Briefing Documents (CBD) laying out the issues and related company positions for discussion with PMDA
    • Translation of Investigator’s Brochures
    • Execution of formal PMDA consultations including Japanese translation/ interpretation, the Q&A process and all face-to-face interactions
    • Follow up with PMDA through finalization of meeting minutes

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