Toshiaki Nagafuji Ph.D.,R.Ph.

Senior Executive Officer
Head of Innovative Drug Development Business Unit

Toshiaki Nagafuji Ph.D.,R.Ph.

Supporting Biotechnology companies from the earliest phase of development

Supporting Biotechnology companies from the earliest phase of development

Following on from its existing CRO Business and Contract Medical Affairs Business, Linical’s third focus of activity is its Innovative Drug Development Business. More specifically, we are offering the three consulting services outlined below, which provide a one-stop service for high-quality, efficient development and life cycle management, which are Linical’s great strengths. Through our Innovative Drug Development Business, we do not just support pharmaceutical companies that already possess the in-house functionalities of clinical development, pharmaceutical development, marketing, licensing and business development, but both inside and outside Japan, we also support biotechnology companies who lack these functionalities, from the earliest phase of development.

1. Market Analysis
・Patient forecast
・Current market value and forecast
・Current treatment algorithm and guidelines
・Approved products and major pipelines
・Target product profile
・Price and Sales forecast of the client’s product

2. Development & Regulatory Strategy/PMDA Consultation/MW
・Proposal of the development and regulatory strategy
・Application of the meeting to PMDA and preparation of the materials
・Presence at the meeting with PMDA w/wo the client
・Writing the IB, Protocol and ICF
・In-Country Clinical Caretaker
・Response to queries from MHLW/PMDA
・Orphan designation registration
・Master File registration

3. Strategic Partnering/Licensing
・Search and analysis of potential partners
・Approach to potential partners and introduction of the client’s product
・Arranging the meeting and mediating communication between the client and potential partners
・Attendance of partnering conferences such as Bio Intl. Convention w/wo the client
・Support of due diligence and term discussion

Linical also participates as a limited partner (LP) in drug development venture capital funds and actively supports innovative drug development by means of investment in bioventures in, and outside of, Japan, and startup ventures focused on promising technology platforms.