Mid-Term Business Plan #pharma #rep


Posted On Aug 11 2017 by

#pharmaceutical business plan

#

Mid-Term Business Plan

Promotion of early launch and quick market penetration based on global top-class translational clinical research (TCR) *5 and development activities

Acceleration of emicizumab and atezolizumab development as a top priority

  • Prioritize resources for executing the clinical development plan and promoting the medical plan

Realization of early PoC *6 with TCR

  • Execute with global top-class quality and speed in Japan, US, and Europe
  • Focus resources on early development to acquire PoC

Proof process for medical/economic value

  • Develop and promote IDCP *7 which aims to maximize the product value in the market
  • Accelerate late-stage development through the realization of smooth out-licensing to Roche or third parties
  • Further enhance speed and efficiency in development in Japan

Translational clinical research: Clinical research ranging from preclinical research to PoC that clinically verifies the scientific concept of compounds created in drug discovery operations

A demonstration that the therapeutic effect conceived in the research stage is effective in humans.

Strengthening of pharmaceutical technology system for multiple and simultaneous global development, fast global launch and cost reduction

Enhancement of CMC *8 development infrastructure for early PoC achievement

  • Develop a system for investigational new drug supply of antibodies and highly active small molecule compounds to execute “Multiple and simultaneous global development” and “Fast global launch”
  • Establish highly difficult formulation technology corresponding to middle molecules, etc.

Strengthening competitive advantages from late development to initial commercial production

  • Strengthen the system for seamless supply promptly after PoC
  • Realize the development and supply of high-value-added and low-cost formulations
  • Plan and promote a future production system concept aiming for a global competitive advantage

Strengthening QC, QA and Regulatory functions

  • Implement QC/QA activities at a global top level
  • Realize a strategic regulatory promotion system to accelerate development and submission of NDA

Chemistry, Manufacturing and Controls: a concept that integrates API process research and pharmaceutical development research with quality evaluation research


Last Updated on: August 11th, 2017 at 2:10 pm, by


Written by admin


Leave a Reply

Your email address will not be published. Required fields are marked *