Clinical Development Strategies

Preparing local activities early in a globally integrated development plan for new drugs is particularly important in addressing a market such as Japan which requires local registrational studies. Our team of experts have extensive experience in putting together development strategies in Japan in line with the global program in the most efficient way.
We help our international clients trigger thoughts about from which stage they should start to involve activities in Japan.

Ticking the boxes

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Assessment of target product profiles

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Design a strategic development plan

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Matching solutions to unmet medical needs

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Leader

Shojiro Takagi

MD, PhD, MBA, Chief Medical Officer

Dr. Takagi has over 10 years of business experience in the pharma-industry including Sanofi, GlaxoSmithKline, Novartis, and Mundipharma.
He brings expertise in planning and executing R&D and medical strategies.
He has a wide network in Japan as the former head of medical affairs, the medical director, and medical advisor. During his tenure, he led multiple blockbuster projects, including Revolade (Eltrombopag), Allegra (Fexofenadine), and Myslee (Zolpidem).
Dr. Takagi also has over 25 years of clinical expertise in hematology and research experience in tumor immunology at Jichi Medical School, Japan and the University of Pittsburgh, USA.
He authored numerous publications accepted by top medical journals including Lancet, Journal of Clinical Oncology, and Blood, as well as contributed manuscripts to various medical books and review articles.
Dr. Takagi holds an MBA from Nihon University, a PhD from Jichi Medical School and MD from Juntendo University School of Medicine, Japan.

Case

Validation of Clinical Development and Pricing Strategy

A German-based biotech in discussion with a Japanese company about the potential licensing of its product. The product targets the treatment of a disease with large unmet medical need currently receiving little treatment.
The product was finishing its Phase III program in Europe with plans to submit the application for approval to the authorities.

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Evaluation of Clinical Value Over Competitors

Swiss-based pharmaceutical company seeking business opportunity to develop their product in Japan. Competitive products for the same disease already existed in the Japanese market. Client needed to assess the clinical value of their product and its potential to succeed in Japan, including any advantage over competitors.

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Ticking the boxes

Our team of experts can guide our clients who are willing to understand how best can she/he approach the Japanese market in the most efficient way. That will include guidelines for bridging studies overcoming the racial differences and differences in average body weights, what are the necessary elements for the Japan arm in the global development plan, and what to keep in mind when carrying out a standalone clinical study.

Assessment of target product profiles

One of our extraordinary capabilities is that we can prepare a comprehensive development plan embedding commercial and pricing & market access implications into the program which will consist of a unique and meaningful value proposition of your product in the Japan market.
We can design or configure the target product profile such that the product will best adapt to the local market needs while not having to make significant changes in the manufacturing process.

Design a strategic development plan

e-Projection provides alternative development plans to maximize the value of the product in Japan to our clients, different from protocols which focus only on regulatory approvals of the product.
We can quantify the impact by comparing an ordinary plan and a creative and innovative strategy.

Matching solutions to unmet medical needs

Identifying market specific unmet medical needs requires a deep dive into the medical community. We can figure out which challenges the physicians and patients are currently facing in their treatment and the gaps needed to be filled in the current treatment paradigm, and how different they are from what is happening in the rest of the world.

We help non-Japanese pharma/biotech companies
understand and expand into the Japanese market.