Our Three Core Businesses

Innovative Drug Development Business

Innovative Drug Development Business

Even as Linical continues to pursue its more established Clinical Research and Development, and Contract Medical Affairs Businesses, it is also developing a third major sphere of business — its Innovative Drug Development Business. The Linical personnel who work in this area have been involved in licensing, business development, clinical development, regulatory affairs and marketing at major Japanese pharmaceutical companies, with many successes and much experience under their belt, ranging from expert judgment of potential products for development to negotiation of in-licensing, out-licensing and clinical development. Linical’s Innovative Drug Development Business offers three main kinds of consulting services, as outlined below.

  • (1) Market analysis of products in development
  • (2) Regulatory affairs consultation support
  • (3) Licensing support

On the basis of this experience, Linical is currently supporting the product development efforts of Japanese, Korean, and Taiwanese pharmaceutical and biotechnology companies, from the initial stages of development. Looking ahead, we are also working to forge stronger links between Linical’s international bases of operation, to develop a system that enables us to deliver total support, right across the globe.

Searching for “seeds”

Linical participates as a limited partner (LP) in drug development venture capital funds and actively implements innovative drug development support in a variety of ways — e.g., investing in Bio-ventures both within and outside of Japan and launching ventures focused on promising technology platforms. It also supports proposals for risk-free development of compounds that can become the “seed of a pharmaceutical product” at the earliest stage of development.

Assessment of commercial feasibility

Linical’s Innovative Drug Development Business supports pharmaceutical companies that are equipped with in-house capabilities such as clinical development, regulatory affairs, marketing, licensing, and business development. We also provide early-stage development support to biotechnology companies both within and outside of Japan that do not have these capabilities.
More specifically, we implement CDAs (Confidential Disclosure Agreements) for products in development, discovered at the seed investigation stage. We also offer a range of services relating to intellectual property (IP), competitive advantage relative to prior art and existing products, positioning, possibilities for clinical trial implementation, marketability, sales forecasting, and exit strategy proposals.

Development strategy formulation

Linical’s Innovative Drug Development Business supports biotechnology companies both within and outside of Japan that are not equipped with capabilities for clinical development, regulatory affairs, marketing, licensing, and business development from the earliest stages of product development.
More specifically, we offer services such as formulating and creating CDPs (Clinical Development Plans), formulating regulatory affairs strategies, designing clinical trials, and creating synopses of clinical study protocols.

Regulatory affairs consulting

Linical’s Innovative Drug Development Business supports biotechnology companies both within and outside of Japan that are not equipped with capabilities for clinical development, regulatory affairs, marketing, licensing, and business development from the earliest stages of product development.
More specifically, we offer services such as formulating regulatory affairs strategies, and regulatory science (RS) related general and strategic consultation with PMDA (e.g., applying for interviews, interview materials support, attendance at interviews, and notetaking at interviews).

In-licensing research

Linical’s Innovative Drug Development Business supports biotechnology companies both within and outside of Japan that are not equipped with capabilities for clinical development, regulatory affairs, marketing, licensing, and business development from the earliest stages of product development.
More specifically, we offer services such as proposing business models, proposing exit strategies, selecting and approaching licensing candidates, and interviewing and conducting contract negotiations.

Application process support

Linical’s Innovative Drug Development Business supports biotechnology companies both within and outside of Japan that are not equipped with capabilities for clinical development, regulatory affairs, marketing, licensing, and business development from the earliest stages of product development. We also offer a one-stop service from application to approval.
More specifically, we offer services such as consulting on the entire application process, preparing application documents, and creating or assisting with responses to inquiries and opinions.