[국외CRO]Shin Nippon Biomedical Laboratories(SNBL)

[국외CRO]Shin Nippon Biomedical Laboratories(SNBL) : 작성자, 작성일, 조회수, 원문,출처, 정보 제공
작성자	관리자
작성일	2014-11-05	조회수	213
원문	한국보건산업진흥원
출처

Corporate General Information

Corporate Name

Shin Nippon Biomedical Laboratories, Ltd. (SNBL)

Corporate Ownership

Public company

Head Office Address

St Luke's Tower 12F, 8-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan.

Facilities City & Country

1. Tokyo Head Office

St Luke's Tower 12F, 8-1 Akashi-cho, Chuo-ku, Tokyo 104-0044, Japan.

Tel: 81-3-5565-6140, Fax: 81-3-5565-6140

2. Headquarters, Drug Safety Research Laboratories

2438 Miyanoura, Kagoshima 891-1394, Japan.

Tel: 81-99-294-2600, Fax: 81-99-294-3619

3. Pharmacokinetics and Bioanalysis Center (PBC)

Kainan Intelligence Park, 16-1 Minami-Akasaka, Kainan, Wakayama 642-0017, Japan.

Tel: 81-73-483-8881, Fax: 81-73-483-7377

4. SNBL USA

6605 Merrill Creek Parkway, Everett, Washington 98203, USA.

Tel: +1-425-407-0121, Fax: +1-425-407-8601

5. SNBL Clinical Pharmacology Center, Ltd. (SNBL SMO)

Sumitomo Mitsui Banking Corporation Korai-bashi Building, 9F.

2-1-1 Fushimi-machi, Chuo-ku, Osaka 541-0044, Japan.

Tel: +81-6-4706-7630, Fax: +81-6-4706-7640.

6. SNBL Clinical Pharmacology Center, Inc.

800 West Baltimore Street, 5th floor, Baltimore, Maryland 21201, USA.

Tel: +1-800-690-9110, Fax: +1-410-706-8963.

Korean Business Office

WOOJUNGBSC

A-8F, Advanced Institutes of Convergence Technology,

145, Gwanggyo-ro, 443-270, Korea

Web-site Address

http://snbl.com

No. of Employees

Over 2,200

Financial Status

Sales Revenue in 2010
(US K$)

Capital
(US K$)

Dept-equity Ratio
(%)

16,926,000,000 (JPY).

About 148,918k (US K$)

Contact
(Korean Business)

Name

WOOJUNGBSC

Address

A-8F, Advanced Institutes of Convergence Technology,

145, Gwanggyo-do, 443-270, Korea

Telephone

031-888-9372, 031-888-9269

E-mail

srkim@woojungbsc.co.kr
james@woojungbsc.co.kr
kbkwon@woojungbsc.co.kr

Company History

1957. The Minami-Nippon Dog Center in Kagoshima city, Japan was founded.

1974. Renamed Shin Nippon Biomedical Laboratories, Ltd.

1982. MITOX, the industry's first networked data-handling system implemented.

1983. GLP-compliant studies initiated (Ministry of Health and Welfare standards).

1988. The U.S.A. Representative Office was established.

1989. The Osaka Branch Office was established.

1990. The U.K. Representative Office was established (SNBL Europe, Ltd.).

1993. SNBL Clinical Pharmacology Center (CPC clinic) was established in Kagoshima, and contract clinical pharmacology trials started.

1998. Pharmacokinetics and Bioanalysis Center was established in Kainan City, Wakayama, Japan.

1999. Drug Safety Laboratory was established in Washington (SNBL USA, Ltd.).

1999. The Clinical Development Division was established and Phase II and III studies began.

2000. University Medicines International LLC. (UMI) established to perform contract Phase II and III clinical trials in Maryland.

2002. Expansion of research facility at the Pharmacokinetics and Bioanalysis Center (PBC).

2003. SNBL China, Ltd. established in Guangdong, China, and breeding, maintenance, and quarantine of experimental animals began.

2005. SNBL Clinical Pharmacology Center, Inc. (SNBL CPC, Inc.) established in Baltimore, Maryland, and Phase I and IIa studies began.

2007. SNBL Cambodia Ltd. established in Cambodia, and breeding, maintenance, and quarantine of experimental animals began.

2011. SNBL DSR (Preclinical Drug Safety Research) was fully accredited by AAALAC International.

2013. Grade 'A' at most recent (MHLW) GLP regulatory inspection.

Company Description & Organization

For more than 57 years, SNBL (Shin Nippon Biomedical Laboratories, Ltd) has been a leader in helping biopharmaceutical companies generate high quality data with the exceptional precision needed to rapidly advance new medical therapies and innovations that improve patients’ lives, SNBL has facilities in Japan, the United States, China, and Cambodia. Our international footprint enables us to meet the research needs of clients around the globe. We are committed to providing our customers with fast and precise results across the entire drug development spectrum, from early discovery research to late-stage clinical trials.

The SNBL team is dedicated as a company and as individuals in working with our clients to improve patient care and treatment outcomes. This is a cornerstone in our drive for excellence across all aspects of our business.

Corporate Service & Business Area

Corporate Main Service Area	Contract Research & Development		Contract Manufacturing		Contract Sales & Marketing		Consulting
	○		-		-		○
Geographical Business Area	Contract Research & Development		Contract Manufacturing		Contract Sales & Marketing		Consulting
	US	○	US	-	US		US	○
	Canada	○	Canada	-	Canada	-	Canada	-
	EU	○	EU	-	EU	-	EU	-
	Asia	○	Asia	-	Asia	-	Asia	○
	Global	○	Global	-	Global	-	Global	-
	Other	○	Other	-	Other	-	Other	-
Focusing Contract Service Area	Contract Research & Development		Contract Manufacturing		Contract Sales & Marketing		Consulting
	Research	○	API	-	APIs	-	R&D	-

	Pre-Clinical	○					R&D Strategy & Management	○
			Pre-clinical Test Sample	-
	Phase I	○					Clinical Trials	-

	Phase II	○	Clinical Test Sample	-	Finished Products	-	Regulatory Affairs	-

	Phase III	○					Business Development	-
			Finished Product	-
	Phase IV	○					Sales & Marketing	-

Corporate Product Area	New Drug		Biologics		Herbal Medicine		Biosimilars
	NCE	NME
	○	○	○		○		○
	Generics		APIs		Devices		Others
	○		-		○		-

Corporate Business Overview

Clients' Composition (%)	Big Pharmas		Mid or Small -Size Pharmas		Biotech Companies		Start-ups
	-		-		-		-

In-house Facilities	Research & Development	Preclinical		Clinical		Custom Manufacturing		Custom Sales
	○	○		○		-		-
Focusing Therapeutic Area	All therapeutics areas
General Overview of Corporate's Key Contract Services	We can provide the following services. Preclinical research services: General Toxicity Studies (General single and repeated dose toxicity studies and pharmacokinetics studies), Carcinogenicity Studies, Reproductive and Developmental Toxicity, Specific Toxicity Studies (Local irritation Studies, Antigenicity / Sensitization Studies, Biological Safety Studies for Medical Devices, Mutagenicity, Sperm Morphology), Pharmacology (Safety Pharmacology Core Battery Studies, Other Safety Pharmacology Studies, Safety Efficacy Studies Using Disease Models), Immunotoxicology, Infection Studies, Pharmacokinetics and Bioanalysis, etc. Clinical research services: Phase I, IIa studies, BE / BA studies, Monitoring & Quality Control, Data Management & Bio-Statistics, Medical Writing & Quality Assurance, Education / Training & Consulting, SMO. Translational Research: Nasal Delivery System, Nucleic Acid Drug Development, Chiral Oligonucleotide Adjuvant.
Contract Service Capacity Affordable by Service Area
Communication with Clients	Dispositoion of Project Manager Responsible
	Providing Realtime Service Delivery		SNBL DSR and SNBL PBC can respond quickly to communications from South Korea as there is no time difference. There are direct flight connections to Incheon airport (flight time about 90 minutes), which means that Korean partners and SNBL can readily make exchange visits in both directions. SNBL has Korean employees, so communication in Korean is possible.
	Realtime Feed-back

Corporate Competitiveness

Corporate Competitiveness	Since its foundation in 1957, SNBL has unique procedure cages (international patents) and techniques for reproductive data capture from reduced numbers of primates with minimized stress. As short as 4-Week turnaround from Necropsy to Peer Review. High Quality Histopathological Specimens including Eyes. Large number of NHPs Including Sexually Matured NHPs Available for: Juvenile Toxicity Studies, Testicular Toxicity Studies (ePPND). We have much experience in Large molecules. Disease models in non-human primates: Collagen-induced arthritis (CIA) model, Osteoporosis models, Parkinson model, Acute respiratory distress syndrome (ARDS), Spontaneous Hyperuricemia, Macular degeneration model, Glaucoma model, Learning Memory (CANTAB), etc. P3 Facility.
No. of Regulatory Inspections	Classification	FDA(US)	EMA(EU)	PMDA(Japan)	Others
	Pre-Clinical Area	○	-	○	-
	Clinical Area	-	-	○	-
	Manufacturing Area	-	-	-	-
	Others	-	-	-	-
Current Status of Accredited Certification	GLP (FDA, MHLW, OECD) / GCP (JGCP, ICH GCP) / ISO / AAALAC

Collaboration Experiences with Asian Pharmaceutical & Biotech Companies
in recent 3 years

Countries which clients belong to	Including Korea, Japan, and China.
Asian Clients' Composition (%)	Big Pharmas		Mid or Small -Size Pharmas		Biotech Companies		Start-ups
	○		○		○		○

No. of Asian Clients in recent 3 years	-
Major Service Range with Asian Companies	Contract Research & Development		Contract Manufacturing		Contract Sales & Marketing		Consulting
	Research	○	API	-	APIs	-	R&D	-

	Pre-Clinical	○					R&D Strategy & Management	○
			Pre-clinical Test Sample	-
	Phase I	○					Clinical Trials	-

	Phase II	○	Clinical Test Sample	-	Finished Products	-	Regulatory Affairs	-

	Phase III	○					Business Development	-
			Finished Product	-
	Phase IV	○					Sales & Marketing	-

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[국외CRO]Shin Nippon Biomedical Laboratories(SNBL)

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