For Potential Clients in Japan
De Young & Hayden, LLC provides support for Japanese pharmaceutical companies in many
ways, including mentoring and training of Japanese employees to expedite clinical studies
and thereby shorten time to NDA submission. We can also help pharmaceutical companies in
Japan to develop their NCEs in Western countries and thereby open new markets. We provide the
know-how to sort out their NCEs under global standards, develop effective supportive
documentation to introduce themselves to potential partners for R&D collaborations. We can serve
as agents for Japanese companies wishing to expand their business into Western markets.
Conversely, we can help Western companies trying to bridge to Japan, as well help them speed up
the approval process with the Ministry of Health, Labor and Welfare (MHLW).
Link to Word document in Japanese:
Norio Himori, Ph. D.
Representing De Young & Hayden, LLC, in Japan is Dr. Norio Himori, who has a broad and
distinguished background in Japanese pharmaceutical developments. Dr. Himori-san has long
devoted himself to preclinical and clinical drug development at both a Japanese pharmaceutical
company and a foreign affiliate company, as seen below.
Background
Preclinical Research and Development 23 years
Dept. of Pharmacology, Teikoku-Zoki Pharmaceutical Co., Ltd.,1971 - 1982
Dept. of Clinical Pharmacology, Nippon Roche/Chugai Co., Ltd.,1994 - 2004
Experience & Expertise
Dr. Himori-san has an extensive background as a research scientist, and has served as
department head in both preclinical and clinical capacities. He has a broad range of experience in
many therapeutic areas and drug products. Following are some of the products he has worked on:
antihypertensive/vasodilatory beta-blocking agent, prostaglandin analog, ACE inhibitor, calcium
antagonist, antiarrhythmia, anti-inflammatory agent, anti-cancer products, antibiotic, sleep
inducers, pegylated interferon alfa-2a agent, anti-virals, erythropoietin receptor activator, active
vitamin, bisphosphonate, anti-Her2 humanized monoclonal antibody, 5-FU prodrug, anti-flu, anti-
immune agent.
Working in collaboration with Dr. Himori-san, De Young & Hayden, LLC, can provide expert support
in a number of areas, such as:
De Young & Hayden, LLC is in a unique position to serve as a mediary for Japanese companies to
learn and apply skills and processes demonstrated to improve pharmaceutical development,
clinical study design, and regulatory documentation.
De Young & Hayden, LLC provides support for Japanese pharmaceutical companies in many
ways, including mentoring and training of Japanese employees to expedite clinical studies
and thereby shorten time to NDA submission. We can also help pharmaceutical companies in
Japan to develop their NCEs in Western countries and thereby open new markets. We provide the
know-how to sort out their NCEs under global standards, develop effective supportive
documentation to introduce themselves to potential partners for R&D collaborations. We can serve
as agents for Japanese companies wishing to expand their business into Western markets.
Conversely, we can help Western companies trying to bridge to Japan, as well help them speed up
the approval process with the Ministry of Health, Labor and Welfare (MHLW).
Link to Word document in Japanese:
Norio Himori, Ph. D.
Representing De Young & Hayden, LLC, in Japan is Dr. Norio Himori, who has a broad and
distinguished background in Japanese pharmaceutical developments. Dr. Himori-san has long
devoted himself to preclinical and clinical drug development at both a Japanese pharmaceutical
company and a foreign affiliate company, as seen below.
Background
Preclinical Research and Development 23 years
Dept. of Pharmacology, Teikoku-Zoki Pharmaceutical Co., Ltd.,1971 - 1982
- (Dept. of Pharmacology, School of Medicine, Tohoku University, 1973 - 1975)
(Dept. of Pharmacology, Ohio State University, USA, 1979 - 1981)
- (Research Division, F. Hoffmann-La Roche AG, Basle, Switzerland,1989 to 1990)
Dept. of Clinical Pharmacology, Nippon Roche/Chugai Co., Ltd.,1994 - 2004
Experience & Expertise
Dr. Himori-san has an extensive background as a research scientist, and has served as
department head in both preclinical and clinical capacities. He has a broad range of experience in
many therapeutic areas and drug products. Following are some of the products he has worked on:
antihypertensive/vasodilatory beta-blocking agent, prostaglandin analog, ACE inhibitor, calcium
antagonist, antiarrhythmia, anti-inflammatory agent, anti-cancer products, antibiotic, sleep
inducers, pegylated interferon alfa-2a agent, anti-virals, erythropoietin receptor activator, active
vitamin, bisphosphonate, anti-Her2 humanized monoclonal antibody, 5-FU prodrug, anti-flu, anti-
immune agent.
Working in collaboration with Dr. Himori-san, De Young & Hayden, LLC, can provide expert support
in a number of areas, such as:
- Preclinical efficacy/safety evaluation
- Clinical efficacy/safety evaluation
- Clinical development strategy construction and study design review
- Review of pipeline, portfolio and project
- NDA submission dossier compilation
- Review/Approval of protocol and NDA submission documents
- Global development coordination
- Matching new products with the most commercially attractive unmet needs
- Streamlining clinical studies
- Improving NDA documentation
- Shortening of approval times
- Leveraging the product pipeline and portfolio for maximal benefit
De Young & Hayden, LLC is in a unique position to serve as a mediary for Japanese companies to
learn and apply skills and processes demonstrated to improve pharmaceutical development,
clinical study design, and regulatory documentation.
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