Highlights from ongoing and previous mandates
case study 1
Licensing Deal between a large US Biotech and a local Company in Japan
Finding a suitable local Japanese company to license a large US biotech companies products.
Yakumed developed a strategy to approach the Japanese market, screened a dozen of local companies based on a systematic analysis of the Japanese market and meetings with potential partners. Finally a couple of companies were shortlisted based on Yakumed’s recommendation. The top company in Yakumed’s list was eventually selected and a deal was signed. The relationship between both companies is excellent and ongoing.
case study 2
Japan Entry & NDA
Japan Entry set-up, NDA submission and negotiation with PMDA until approval
The US company with no prior experience in Japan needed urgently to set up a local affiliate in order to submit NDA in Japan before a competitor drug hits the market.
Yakumed has provided the company with deep strategic advice and creative plan to reach its objectives. On the operational aspects, Yakumed immobilized its seasoned team of experts to set up a local entity in Japan, obtain Business Marketing License, submit a new drug application and obtain approval in a short time without impacting the quality of the submission.
case study 3
Japanese CMC section of CTD
Preparation of CMC sections of CTD
A global Company has approached Yakumed to prepare CMC sections of CTD (M3.2, M2.3 and M1.2) for submission in Japan.
Yakumed has supported the company in preparing the CMC sections in English for M3.2 and also in Japanese for M2.3. Throughout the project, Yakumed has educated the company on the unique Japanese CMC requirements and clarified the differences with the European and US regulations. Yakumed has also supported the company in responding to CMC queries from PMDA.
case study 4
Making sense of Conflicting Information on Regulatory and Drug Development Strategy
Some European and American Pharmaceutical companies were receiving conflicting information on the Japanese regulatory and clinical development pathways.
We have carefully assessed each case and provided independent in-depth analyses based on the Japanese regulatory requirements and the scrutiny of precedence in Japan. We have provided a thorough analyses and presented our recommendations. Our detailed assessment reports and follow-up discussions have been useful for these companies to make a decision.
case study 5
Integrate Japan Into Global Clinical Development
Japan regulatory development strategy and PMDA consultation for US-based oncology company
The company has already reached agreement with FDA and EMA with regards to global clinical trial for an oncology treatment. In order to develop its product in Japan as well, the company has reached out to Yakumed for advice and support on the most suitable approach to develop its product in Japan.
Yakumed has put together an in-depth independent assessment analysis highlighting the path forward in Japan and the potential risks. Yakumed has also led the preparation for PMDA consultation, the negotiation with PMDA and along the way Yakumed has provided valuable advice (on the strategic and tactical levels) to ensure a positive outcome in PMDA consultation meeting. The interaction with PMDA through Yakumed has been very positive and it helped Japan to join the global clinical study.
case study 6
Several companies requested our support to obtain orphan designation in Japan.
We supported the company to receive orphan designation in Japan in a short time. Yakumed has prepared and led the regulatory strategy and its execution. We arranged and led the meeting with MHLW, prepared and submitted all the required documents and responded to queries from MHLW until orphan drug designation is received in Japan.