Integrated Innovation
Service Center (“IISC”)

Integrated Innovation Service Center (“IISC”)

Integrated Innovation
Service Center (“IISC”)

In the midst of Japan's Pharmaceutical Renaissance focusing on Strategic Partnerships and Innovation in the Biotech Sphere, the Integrated Innovation Service Center (“IISC”) at Mediscience Planning Inc. is stepping up their effort to support biopharma companies to bring to Japan their innovative products and technologies

Background

Over the decades, Japan has emerged as a global leader in both pharmaceutical and biotechnology research and development. The growth in Japan in is primarily driven by strategic partnerships, mergers, and collaborations, fostering a vibrant culture of knowledge sharing and continuous technological innovation.

Throughout its various growth phases, Japan’s pharmaceutical industry has encountered novel and unique challenges, yet actively identifying opportunities for innovation, diversification, strategic adaptation, and early involvement in the global product development scheme.

In July 2024, PMDA reported that, approximately 60% of the products approved in Europe and the US have not yet started development in Japan. Venture-origin medicines, orphan drugs and pediatric drugs account for a substantial proportion of these medicines/ treatments. Improving the new drug discovery and development capability of the Japanese pharmaceutical industry has become the center of discussions on “drug lag/drug loss” amongst the Japanese regulatory authorities, the biopharmaceutical/ medical device industry, the multinational companies, and the clinical research companies at large. In addition, all approved drugs in Japan were developed by old incumbent pharmaceutical companies, which suggests the presence of an urgent need to foster start-ups that link scientific discoveries and technologies in academia to drug discovery.

With Japan’s growing involvement in multinational, multi-center clinical studies, the general agreement within the pharma/biotech community is that there continues to be challenges (along with an abundance of opportunities) for global sponsors in Japan. While some may hesitate due to regulatory complexity and limited local resources, others opt to assess the Japanese market, especially for their Regenerative Medicine products as well as Orphan and Pediatric drugs, explore regulatory requirements, and utilize available resources with proven expertise from dependable solutions providers (such as CROs) or strategic partners.

With a presence in Japan since 1982 as a CRO service provider, MPI, supported by M3 Inc. and its affiliated group companies*, is well-positioned to cater to the requirements of global sponsors lacking sufficient resources or representation in Japan.

IISC at MPI

IISC is a service unit committed to assisting customers from biopharma and biotechnology sectors, especially those of Emerging nature (emerging biopharma’s or EBPs), planning to introduce their products into Japan.

Using the dedicated cross-functional team approach, MPI’s IISC collaborates with the customers and provides comprehensive consulting services on IND/CTN** (Clinical Trial Notification), NDA (New Drug Application) or Orphan Drug Designation (ODD), and the associated pre-clinical and clinical matters, streamlining the development strategies to achieve market authorization through effectively preparing and managing submission programs.

IISC areas of expertise

  • Consolidating resources and streamlining processes in support of Regulatory consultations

    1. IND & NDA/ ODD

      1. From preparation and submission of dossiers

      2. From planning to execution of PMDA consultation meetings

    2. Clinical Development package

      1. Preparation of Clinical Development package based on feedback from PMDA and Thought Leaders, as well as regulatory guidance documents such as the “Basic Policy on Conducting Phase I Trials in Japanese Patients Prior to the Start of Global Clinical Trials for Drugs Whose Clinical Development Has Been Pioneered Overseas.”

    3. Identification of collaborating Thought Leaders/ Key Opinion Leaders, study institutions, professional or academic societies, and subject matter experts to support clinical development and IND & NDA/ ODD needs in Japan.

  • Planning and managing clinical trials in support of product development of Pharmaceuticals, Biologics, Cell and gene/ CAR-T therapies, Medial Device/ SaMD in Japan

    1. Based on requirements from PMDA and recommendations from Thought Leaders to support Japan NDA/ ODD.

    2. Following relevant MPI standard procedures on Clinical Development

  • Using Real World solutions (data or evidence) to support NDA in Japan

    1. From evaluations of available non-clinical and clinical data to collection of feedback from local Thought Leaders/ Subject Matter Experts and guidance from PMDA.

Contact

CONTACT US

  • *MPI is fully owned by M3 Inc. (https://corporate.m3.com/en/corporate). M3 is a one-of-a-kind venture company that operates a multitude of global services centered around its physician platform such as m3.com . M3 is the first company incorporated after the year 2000 to be included in the Nikkei 225 Index. Its 330,000+ Japanese and 6,500,000+ global physician member panel serves as a central platform in advancing innovation and reform across healthcare worldwide.

  • ** CTN is in essence the IND (Investigational New Drug) application in Japan. It may probably take 30 days for initial IND and 14 days for the second and consecutive INDs.