For Potential Clients in Asia
De Young & Hayden, LLC provides support for Asian pharmaceutical companies in many
ways, including mentoring and training of employees to expedite clinical studies
and thereby shorten time to NDA submission. We can also help pharmaceutical companies in Asia
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
Asian companies wishing to expand their business into Western markets. In the past De Young &
Hayden have been major sponsors and supporters of the Sino-America Conference on Medicine.
Conversely, we can help Western companies trying to bridge to Asia, as well help them speed up
the drug development process.
Specific to Japan:
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. Link to Word document in Japanese
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)
Dept. of Pharmacology, Nippon Roche Co., Ltd., Kamakura Research Center, 1982 to 1994
(Research Division, F. Hoffmann-La Roche AG, Basle, Switzerland,1989 to 1990)
Clinical Research and Development 10 years
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.








