Bridge GLP compliant drug development in the US & China

Press Releases

January 14, 2008 - Bridge Laboratories Receives $18 million Financial Backing

 

August 6, 2007 - Bridge Laboratories’ China Facility Receives Full AAALAC Accreditation: First Preclinical CRO with US and China Multispecies Capabilities

 

February 14, 2007 - Bridge Announces Closing of its $35 Million Series B Capital Raise to Accelerate its China and US ‘Hybrid’ CRO Model

 

February 1, 2007 - Bridge Announces the CRO Industry’s First China-US Visiting Scholar Program for Its Employees

 

December 15, 2007 - Bridge Acquires US-based Preclinical Study Company

 

October 6, 2006 - Wan Yang Feng, Ph.D. has been appointed Director of Bioanalytic and Metabolism of Bridge Pharmaceutical’s Preclinical Laboratory in Beijing

September 6, 2006 - Bridge Successfully Validates Beijing Preclinical Laboratory

 

June 12, 2006 - Bridge Announces $22 Million Series B Capital Raise

 

June 9, 2006 - Patrik Sebastian Jeanmonod has been appointed Vice President Finance of Bridge Laboratories, Inc.

 

June 12, 2006 - Bridge Laboratories Purchases Provantis Solution for New GLP Laboratory in China

 

November 22, 2005 - San Francisco Business Times: Bridging the biopharmaceutical gap with a new Chinese Lab

 

November 22, 2005 - Bridge Laboratories Dedicates Its Preclinical Drug
Development Laboratory in Beijing

 

Bridge Laboratories Receives $18 million Financial Backing

Gaithersburg, MD (January 14, 2008)

 

Bridge Global Pharmaceutical Services, Inc. receives significant new funding and
 changes its name to Bridge Laboratories.

 

 

Bridge Laboratories, which recently changed its name from Bridge Global Pharmaceutical Services, Inc., announced today that they have received $18 million in new funding.  The funding has been secured from returning Series B investors and several new global investors.  This new capital will enable Bridge Laboratories to execute their strategy of expanding their industry-leading toxicology lab in Beijing, China, and continue to grow their US operations.  It will also provide the company with the flexibility to consider acquisitions that would enhance Bridge’s facilities or capabilities.

“The involvement of new investors in Bridge affirms the validity of our strategy to revolutionize preclinical development by delivering high-quality services in China at significant savings, while providing a US-based service for clients that prefer this option,” said Tom Oakley, President and CEO of Bridge Laboratories.

Oakley continued, “We are excited about the possibilities this funding opens up for us and, ultimately, for our customers.  In the year ahead, we will be actively considering many different opportunities to expand our ability to serve our customers.”

 

Bridge announces its new company name—Bridge Laboratories—accompanied by a corporate-wide re-branding initiative to present a clearer message to the market about the type of work the company does.  The company made the decision to change its name to better describe the services it provides.  “While our company name and branding have changed, our customers and partners can be assured that we will continue to deliver the same high-quality service and support that they’ve come to expect,” said Oakley.

 

About Bridge Laboratories

 

Bridge Laboratories is a US-owned, preclinical contract research organization (CRO) that provides US-level regulatory compliant drug development services globally.  Bridge is headquartered in Gaithersburg, Maryland, with AAALAC accredited lab facilities in the US and Beijing, China.  Bridge is known for its extensive work in toxicology; including vaccines, developmental and reproductive toxicology, and safety pharmacology.  Bridge’s facility in China was among the first labs to perform GLP studies for clients worldwide.

 

For more information about Bridge Laboratories, call (240) 364-6300 or email info@bridgelaboratories.com.

 

 


Bridge Laboratories’ China Facility Receives Full AAALAC Accreditation: First Preclinical CRO with US and China Multispecies Capabilities

Gaithersburg, MD (August 6, 2007)

 

Bridge Global Pharmaceuticals, Inc. (Bridge) announced the awarding of full accreditation to its facility in Beijing, China by the Council on Accreditation of the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC International). Bridge’s facility in Beijing (Vital Bridge (China), Inc.) is one of only seven toxicology facilities in China to receive this recognition, and Bridge is the first US-based company to offer toxicology services in multispecies at both locations in the US and China. In the accreditation letter to Bridge dated June 28, 2007, AAALAC International states, "The management and staff are commended for providing quality facilities and programs for the care and use of laboratory animals. Especially noteworthy were the institution's strong administrative support for the animal care and use program as exemplified by the high quality facilities, the extensive investment in training and education of personnel, and the excellent teamwork noted among the staff [at Bridge]; as well as the extensive, well conceived, and thoroughly implemented occupational health and safety program."

Bridge’s Maryland facility has long maintained AAALAC accreditation. More than 30 countries recognize AAALAC accreditation as a demonstration of responsible, ethical lab animal care. AAALAC accreditation now acknowledges that Bridge’s China facility also maintains animal laboratories with the highest international standards.

 

 Bridge’s China facility was purpose built to exacting specifications (water systems, electricity, humidity control, HVAC, security, IT and data management systems) and staffed with experienced, English-speaking professionals. “Bridge has set the standard for China preclinical GLP labs,” said  the General Manager of Bridge’s facility in Beijing. “The AAALAC site inspectors cut no corners. They evaluated our overall physical plant, our animal husbandry and housing, plus waste management, the labs, our veterinary care, our procedures (SOP’s), IACUC and policies, staff training and education, our safety program—everything was scrutinized. Thanks to a great team effort and hard work by everyone, the first AAALAC site visit resulted in full accreditation. This is a monumental achievement.”

 

“AAALAC accreditation is what Bridge clients expect,” added the Bridge CEO. “They insist on preclinical drug development services that deliver superior quality scientific data. Now, whether customers choose preclinical drug development studies in our laboratories in the US or China, AAALAC accreditation assures them we will deliver data quality of the highest order.”

 

 


 

Bridge Announces Closing of its $35 Million Series B Capital Raise to Accelerate its China and US ‘Hybrid’ CRO Model

February 14, 2007 - So. San Francisco, CA

 

 

San Francisco, CA February 13, 2007 – Bridge Laboratories, the leading preclinical Contract Research Organization in China, announced today that it has recently closed a $35 million Series B round of financing. Returning investors were joined in this financing by new venture investor Granite Global Ventures (GGV).

Helen Wong, Director of Granite Global Ventures, has joined the Bridge board. Helen is a founding member of GGV and is based in its Shanghai office. In addition to her board seats at various other GGV portfolio companies, Helen has been involved in GGV’s healthcare investments and has helped several U.S. portfolio companies develop their China strategies. She was selected as the first international Kauffman Fellow, a fellowship sponsored by the Kauffman Center for Entrepreneurial Leadership.

The capital raised will be used to accelerate growth of Bridge’s preclinical operations in China, as well as to support M&A activities, including its recent acquisition of the Preclinical Division of Gene Logic Inc. in December, 2006. In addition, Bridge plans to initiate construction of a second vivarium in Beijing shortly.

About Granite Global Ventures

Granite Global Ventures is a leader in expansion-stage venture capital investments in the United States and Asia. Focused on expanding global innovation, GGV’s highly diverse team manages over $800 million from its offices in Silicon Valley, Shanghai, and Singapore. The firm invests across a range of sectors in information technology, services and healthcare, as well as emerging industry segments in Asia. GGV has provided capital and helped accelerate international business development for its worldwide portfolio of high-growth companies, particularly in the U.S. and China. GGV’s portfolio includes Alibaba.com (combined with Yahoo!), Xenoport (NASDAQ:XNPT), AAC Acoustics (HKSE:2018), Biosensors (B20.SI), Isilon (NASDAQ: ISLN), and Boston-Power. Recent exits include Sirna Therapeutics (acquired by Merck), Qpass (acquired by Amdocs), Xfire (acquired by Viacom), and Oculex (acquired by Allergan). The total market value of GGV’s exits since the firm’s formation in 2000 now exceeds $7 billion. For more information, please visit www.ggvc.com.
 

About Bridge Laboratories

 

Bridge is a preclinical CRO with state-of-the-art facilities in the US and Beijing, China, with over 300 employees, providing US GLP compliant pre-clinical contract pharmaceutical, biologics and vaccine development services. Services include general and specialized toxicology, developmental and reproductive toxicology (DART), safety pharmacology, carcinogenicity testing and vaccine development in support of IND and NDA submissions. Studies are backed by in-house bioanalytical chemistry, immunoassay as well as histopathology and clinical pathology services that are all under the direction of US board certified pathologists and toxicologists.

 

For more information, visit www.bridgecro.com.

 

 


 

Bridge Announces the CRO Industry’s First China-US Visiting Scholar Program for Its Employees

February 1, 2007 - So. San Francisco, CA

 

  • Bridge has the CRO industry’s leading preclinical CRO training program 

  • Bridge announces the first CRO Specific China-US Visiting Scholar Program

February 1, 2007, S. San Francisco, CA – Bridge Global Pharmaceuticals, Inc., a global leader in preclinical drug testing with facilities in the US and China, today announced initiation of a Visiting Scholar Program for its employees. This program will provide full support for qualified US employees to relocate and cross train in Bridge’s laboratories in Beijing, China or alternatively, for its qualified China employees to cross train in its laboratories in the US.

“People, process and passion—we believe people make the company, and we believe cross technical, regulatory, scientific and cultural training in China and the US will greatly facilitate our global integration” said the President of Bridge. “We encourage it, we nurture it, we believe in it—globalization is the future and we are not just talking it, we are living and evolving it- Bridge intends to lead this industry, and quite simply, our employees drive Bridge”.

Training of its technical staff is a top priority at Bridge. The Company is committed to assuring that every employee has all of the skills needed to deliver high quality results with preparation that goes well beyond just the basic requirements outlined in industry regulations. All laboratory employees spend their first 3-10 weeks in training to become certified in needed technical skills. In addition, Bridge is providing its employees many other industry leading benefits, including RQAP certification in the Quality Assurance arena, support for scientists seeking DABT, DACVP, and DACLAM board certification, support for Project Management Certificates for our Study Managers, English lessons in China and Mandarin lessons in the US; China Animal Veterinarian Care Certification; AALAS and other training certifications in the US and China, and support for continuing education. Bridge is also the first proctor site for AALAS certification in China. Bridge also has in place internal instruction on unique aspects of US FDA GLP versus China SFDA GLP regulations and practices, as well as the preclinical requirement prior to the start of clinical trial in China versus in the US, as well as training and education in the best business practices in the two different countries.

“Our employees are aggressively pioneering the globalization of drug development and they are embracing it, developing it, evolving it, and in the process, transforming this industry” said the President of Bridge. “From safety testing, bioanalytical testing, procurement, project management, regulatory affairs —they are becoming industry leading globalization experts. This program is intended to develop these skills even further. The Bridge Visiting Scholar Program and other associated in house training programs provide a unique advantage to our employees, and ultimately, a huge advantage to our clients”.

 

About Bridge Laboratories

 

Bridge is the first and only non clinical contract organization company to develop drugs to US level standards in Asia. Bridge is US-headquartered with laboratories in Beijing, PRC and in the US and is focused on providing cost effective, FDA compliant drug development services in Asia for US, EU and Asian- based clients. Bridge’s current capabilities encompass nearly all aspects of non clinical pharmaceutical and biotech drug development, including pharmacokinetics and ADME, safety pharmacology and GLP compliant toxicology. Bridge also provides regulatory and technical services for full IND compilation and submission, and is the first contract development company to receive US FDA approval for US Investigational New Drug Applications (IND’s), based entirely on Asian preclinical data packages. In the past two years, Bridge has raised over $39M in venture capital from leading US, Taiwan and Singapore investment banking and venture capital firms. For more information, visit www.bridgecro.com.

 

 


 

Bridge Acquires US-based Preclinical Study Company

December 15 - San Francisco, CA

 

Contact: Gil Bashe
Makovsky and Company
New York

212-508-9600

 

December 15, 2006, San Francisco, CA – Bridge Global Pharmaceuticals, Inc. a global leader in preclinical drug evaluation studies, today announced its acquisition of US-based Gene Logic Labs (GLL). Bridge will retain the services of all GLL employees, and the acquired unit’s name will become Bridge Global Pharmaceutical Services, Inc. (a subsidiary of Bridge Laboratories) on December 18, 2006. Simultaneously Bridge and Gene Logic Inc. entered into a preferred services agreement for preclinical drug development.

Acquisition of the Gene Logic Labs US facility enables Bridge to offer a complete IND suite of toxicology and pharmacology services on a global scale. Combining the experience, technical staff and resources of US operations with existing scientific staff in the new, purpose built facility in Beijing, China, Bridge will provide the pharma industry with the high quality data required for world wide regulatory submissions with very significant cost savings.

About Bridge Laboratories

 

Bridge is the first and only non clinical contract organization company to develop drugs to US level standards in Asia. Bridge is US-headquartered (S. San Francisco, CA) with laboratories in Beijing, and is focused on providing cost effective, FDA compliant drug development services in Asia for US, EU and Asian- based clients. Bridge’s current capabilities encompass nearly all aspects of non clinical pharmaceutical and biotech drug development, including pharmacokinetics and ADME, safety pharmacology and GLP compliant toxicology. Bridge also provides regulatory and technical services for full IND compilation and submission, and is the first contract development company to receive US FDA approval for US Investigational New Drug Applications (IND’s), based entirely on Asian preclinical data packages. In the past two years, Bridge has raised over $39M in venture capital from US, Taiwan and Singapore investment banking and venture capital firms.

 

 


 

Wan Yang Feng, Ph.D. has been appointed Director of Bioanalytic and Metabolism of Bridge Pharmaceutical’s Preclinical Laboratory in Beijing

October 6, 2006 - San Francisco, CA

 

Prior to joining Bridge, Dr. Feng worked in Novartis Institutes for BioMedical Research  (NIBR) (formerly Chiron) for more than five years. During his tenure at NIBR, he was responsible for drug metabolism, pharmacokinetics and bioanalytical chemistry. His work played critical roles in characterizing ADME/PK properties of antibacterial and cancerous drugs from hit-to-lead to IND filing, as well as early phase I and II clinical trials for several discovery and development projects. He was also a manager of Chiron’s large mass spectrometry laboratory.  “We are extremely pleased to have someone of  Dr. Feng’s caliber joining our scientific team in Beijing. His technical expertise and NIBR/Chiron experience reinforces our goal to provide fully FDA compliant preclinical studies in our US-level GLP laboratory in Beijing,” said the EVP and CTO of Bridge.

 

 


 

Bridge Successfully Validates Beijing Preclinical Laboratory

September 6, 2006 - San Francisco, CA

 

Bridge, with the assistance of Barry-Wehmiller Design Group and Instem, has successfully validated the first phase of instrumentation, HVAC/BMS systems and its Provantis data acquisition software for full FDA Part 11 compliance.


Bridge Laboratories, the leading preclinical Contract Research Organization in Asia, announced that its preclinical testing laboratory in Zhongguancun Life Science Park in Beijing, China has completed the first of two validation phases of all instrumentation, software and air handling and BMS systems. This state of the art facility, one of the largest and most advanced vivariums in China, is currently the only preclinical laboratory in China to have US level GLP validated systems and software.


“The validation of the instrumentation, air handling systems, environmental control systems and data acquisition software is a result of the tremendous effort and dedication of the management and staff of this facility along with the regulatory experts of BW Design Group and Instem’s Provantis validation team.” commented the EVP and CTO of Bridge. “This completes a major step for Bridge’s Beijing facility towards becoming the first and only US level GLP compliant preclinical laboratory in China.”


Bridge is dramatically lowering research and development costs for Western biopharmaceutical companies, while delivering the highest quality standards of study data that can be submitted to any regulatory agency in the world, including the U.S. Food & Drug Administration.


“Instem is pleased that we could provide a rapid deployment and validation plan for our latest Provantis data acquisition software to place Bridge at the forefront of preclinical drug development in China.” commented Phil Reason, CEO at Instem. “This is one of the fastest deployments on record of our system, and we are confident our relationship with Bridge will set the standard for the future of preclinical development in China.”


“Our team has worked interactively with the Bridge preclinical staff to assess a majority of the facility’s systems and instruments for full Part 11 compliance” commented Howard Treadaway, Manager of Regulatory Services for BW Design Group. “Upon completion of the remaining systems and instruments during the second phase in December, 2006 Bridge’s preclinical facility will meet western standards and comply with FDA Good Laboratory Practices and 21 CFR Part 11. More importantly, Bridge Preclinical Staff will have the skills and quality systems to maintain a validated facility. With the completion of the validation in Bridge’s outstanding new showcase facility, we are confident that it will be at, or exceed, the quality levels of western standards.”


About Bridge Laboratories

Instem is a world-leading information solutions provider for the Life Sciences - accelerating drug and chemical development by increasing client productivity and enhancing the processes that lead to safer, more effective products. For more information on Instem and its solutions, please visit www.instem-lss.com or contact them by email at info@instem-lss.com.

B-W Design Groupp is a leading supplier of Validation and Regulatory Services, Manufacturing Automation, Business Intelligence, and Process Instrumentation and Controls (PCS) to the Life Sciences Industries. Since 1986, Design Group has provided project leadership, technical insight and extensive professional resources to leading Pharma and Biotech companies.

 

For more information, visit www.bwdesigngroup.com, by email at Howard.Treadaway@bwdesigngroup.com or call 925-242-1070.

 

 

 


 

Bridge Announces $22 Million Series B Capital Raise

June 12, 2006 - San Francisco, CA

 

Bridge Laboratories, the leading preclinical Contract Research Organization in Asia, announced today that it has recently closed $22 million Series B round of financing. The investors were returning Series A investors and new venture and investment banking investors from the US.


The capital raised will be used to fund development of its core business and provide for funds for future potential acquisitions in Asia.

 

About Bridge Laboratories


Bridge Laboratories is a US-headquartered company focused on providing cost effective, FDA compliant drug development services in Asia for US, EU and Asian based clients. Bridge’s Beijing preclinical laboratory will be the first and only US level GLP and AAALAC designed facility in China. Bridge provides complete end-to-end drug development expertise including US IND submissions. The Zhongguancun facility provides services for FDA compliant GLP toxicology, pharmacology, predictive PK/ADMET, safety pharmacology, formulation and other services. Bridge has exclusive access to animal supplies from well known US breeder franchises in Asia. Bridge has a division, BridgeNet, which is an unprecedented network of 2500 pre-screened chemical and manufacturing service providers in China and Taiwan, which provides western clients with a single point of contact to access highly qualified and cost effective drug development services in Asia.

 

 

 


 

Patrik Sebastian Jeanmonod has been appointed Vice President Finance of Bridge Laboratories, Inc.

June 12, 2006 - San Francisco, CA

 

 

Bridge Laboratories announced today that Mr. Patrik Sebastian Jeanmonod has been appointed Vice President Finance effective June 9th, 2006. Mr. Jeanmonod areas of responsibility will include corporate finance, financial planning and analysis, treasury and taxes.

Prior to joining Bridge, Patrik served as VP Global Finance for the Covance Central Laboratory division with laboratory operations in Indianapolis USA, Geneva Switzerland, Cape Town South Africa, Australia and Singapore. His management responsibilities included general accounting, financial planning and analysis, legal and (CFS) client financial services. He also implemented adherence to the Sarbanes-Oxley Act of 2002.

Mr. Jeanmonod played a key role in globalizing the Finance group in the Central Laboratory division. Born in Geneva, Switzerland, Patrik Sebastian Jeanmonod has a Master’s Degree in Commercial and Industrial Sciences from the University of Geneva and an Entrepreneurship certificate from the University of Neuchatel.

Patrik brings a wealth of international experience; prior to joining Covance he held a variety of key management positions at Chopard, a Swiss luxury goods company, Megavoice offering international communication options. Mr. Jeanmonod also served as the controller for Bergerco International, division of ConAgra. Mr. Jeanmonod began his career as financial analyst with the United European Bank in Geneva, Switzerland.

Bridge Laboratories is a US-headquartered preclinical contract research organization (CRO) which focuses on providing FDA compliant drug development services in Asia for US and EU based clients. Bridge has been backed by top tier US, Taiwan and Singapore venture capital and investment banking firms and has recently raised over $26M in private equity capital for services development and expansion. Bridge's current capabilities include nearly all aspects of preclinical discovery and development, including, PK and ADME, safety pharmacology, and GLP compliant toxicology in all major testing species. Bridge also provides services for US IND compilation and submission and pre-IND meetings.

About Bridge Laboratories


Bridge Laboratories is a US-headquartered company focused on providing cost effective, FDA compliant drug development services in Asia for US, EU and Asian based clients. Bridge’s Beijing preclinical laboratory will be the first and only US level GLP and AAALAC designed facility in China. Bridge provides complete end-to-end drug development expertise including US IND submissions. The Zhongguancun facility provides services for FDA compliant GLP toxicology, pharmacology, predictive PK/ADMET, safety pharmacology, formulation and other services. Bridge has exclusive access to animal supplies from well known US breeder franchises in Asia. Bridge has a division, BridgeNet, which is an unprecedented network of 2500 pre-screened chemical and manufacturing service providers in China and Taiwan, which provides western clients with a single point of contact to access highly qualified and cost effective drug development services in Asia.

 

 


 

Bridge Laboratories Purchases Provantis Solution for New GLP Laboratory in China

June 9, 2006 - Conshohocken, PA

 

Instem’s Provantis Solution Chosen by Bridge After Rigorous Vendor Evaluation; Bridge Signs Multi-year License for Core Provantis Solution Suite

 

Instem, a premier global information solutions provider, announced today that Bridge Laboratories (Bridge), an international contract research organization, has chosen to deploy the ProvantisÔ system in their newly constructed state-of-the-art preclinical testing laboratory in Beijing.

 

Bridge has recently completed building one of the largest and most advanced vivariums in China. The building is undertaking US level GLP compliant preclinical development of pharmaceutical and biotech drugs for western clients.  Bridge began evaluating systems in early 2005 for their first facility, which is located in Beijing’s Zhongguancun Life Science Park. Using an integrated Toxicology-Pathology solution, this facility would be the first in China to meet and exceed U.S. regulatory standards for lab practices and preclinical safety testing.

 

“After having narrowed our technology selection to just two vendors, we took a closer look not only at the systems, but also at the organizations behind them,” commented the EVP and CTO of Bridge.  “We understand now why Instem has more users than all of the other vendors combined. Their system is superior in design and functionality, while their passion to meet client objectives as a partner is frankly, refreshing.”

 

Bridge is planning to dramatically lower research costs for western biopharmaceutical companies, while delivering high quality study data that can be submitted to any regulatory agency in the world, such as the U.S. Food & Drug Administration.

“Being chosen after a comprehensive competitive evaluation really says it all,” commented Gregor Grant, VP of Business Development at Instem. “Important to Bridge is that our team is attentive to their needs and that we delivered a rapid deployment plan that is clear, concise and cost effective. Although it takes time and effort, we encourage organizations to compare us and our system to other players in the market, before they make their final decision.”

Instem’s entrance into China marks their second major geographic market expansion this year. In March, through CTC Laboratory Systems, Instem announced it had launched Provantis into the Japanese Life Sciences R&D market.

 

Provantis is a modern, fully integrated Windows-based system for organizations and universities engaged in non-clinical evaluation studies. From single-user Pathologists to full-function global Toxicology/Pathology laboratories, Provantis streamlines processes and workflows with straightforward, intuitive functionality for simple and complex studies within a GLP or non-GLP environment.

 

Instem invests millions of dollars each year into its products and processes, protecting client investments and ensuring their systems are exceeding the demands of the markets they serve. Provantis is offered through traditional on-site deployment as well as Instem’s hosted application model, which is designed, priced and professionally managed for smaller laboratories or for clients wanting to reduce IT complexities.

Instem’s customer base consists of the leading pharmaceutical, chemical and contract research organizations, including government and privately funded programs across sites worldwide.

About Instem

 

Instem is a world-leading information solutions provider for the Life Sciences – accelerating drug and chemical development by increasing client productivity and enhancing the processes that lead to safer, more effective products.

 

Established in 1969, Instem has offices in the United States and Europe with its solutions supported in thirteen countries. Instem serves large multi-national corporations and smaller organizations in overcoming the challenges of managing information and provides solutions that help them further their missions while creating a competitive advantage.

 

For more information on Instem and its solutions, please visit www.instem-lss.com or contact them by email at info@instem-lss.com.

 

About Bridge Laboratories

 

Bridge Laboratories is a US-headquartered preclinical contract research organization (CRO), which focuses on providing lower cost, FDA compliant preclinical drug development services in Asia for American and European based clients.  Bridge has been backed by top tier US, Taiwan and Singapore venture capital and investment banking firms and has recently raised over $26M in private equity capital for services development and expansion.

 

 


 

San Francisco Business Times:
Bridging the biopharmaceutical gap with a new Chinese Lab

by Daniel S. Levine November 22nd 2005

 

A Menlo Park-based drug research company is opening a facility in Beijing next month, hoping to bring the cost benefits of outsourcing to the biopharmaceutical industry.

Fledgling Bridge Pharmaceutical Inc., will open the 100,000-square-foot facility in Beijing’s Zhong-guancun Life Science Park. The facility, designed from the ground up to meet U.S. regulatory standards for lab practice and animal testing, will be the first facility in China that meets those standards. It promises to provide western biopharmaceutical companies the benefits of the lower cost of research in China, while delivering the rigorous data quality needed to pass muster with the U.S. Food and Drug Administration and European regulators.

Already, through contract relationships, Bridge has been able to provide preclinical research for clients that led earlier this year to two drug candidates winning FDA clearances to begin human clinical trials.

With the cost of bringing a drug from discovery to the market in excess of $1 billion, the pharmaceutical industry is wrestling with new ways to cut costs. Industry watchers said drug company valuations have changed dramatically during the past decade. They are now finding, as TPG Ventures Managing Director Geoffrey Duyk said, that they must “run themselves as real businesses.”

“The pharmaceutical industry is one of the last vertically integrated industries and it’s slowly becoming more horizontally integrated… Certainly going offshore for selected aspects of the process is inevitable,” Mr. Duyk said. “It’s a logical next step. What’s interesting about the Bridge model is that they are linking existing know-how in CRO businesses to try to build something on an international platform.”

Similarly, the cost of primates in mainland China, which supplies about 80 percent of the primates used in preclinical testing of drugs, is about one-fifth the cost in the United States. Bridge said it is able to get its primates through a U.S. franchise in China that provides it with high-quality animals that are genetically identical to those supplied by the company in the United States.

DANIEL S. LEVINE covers biotechnology for the San Francisco Business Times, an affiliated publication.

 

 


 

Bridge Laboratories Dedicates Its Preclinical Drug
Development Laboratory in Beijing

November 22nd 2005

 

Bridge Laboratories Inc., Together with WI Harper and Vital Bridge,
Announce the Dedication of Its State –of-the –Art

Preclinical Drug Development Laboratory at
Zhongguancun Life Science Park in Beijing
.
 

 

San Francisco, Calif., November 22, 2005 – Bridge Laboratories announced today that it will be dedicating its recently completed Bridge Zhongguancun Preclinical Drug Development Laboratory I on Sunday, November 27, 2005. Expected to attend the dedication ceremony are: San Francisco Mayor Gavin Newsom; Deputy Mayor Beijing Municipal Office Hao Lu; Beijing Deputy Mayor Bo-Yuan Fan; US Embassy Senior Commercial Officer Craig Allen; Former Beijing Deputy Mayor Zhao-Guang Hu; Director of Beijing Municipal Industrial Development Bureau Lian-Yuan Cheng; Director of Beijing Municipal Science Technology Office Hai Feng; and Former San Francisco Mayor Frank Jordon.

This 7,800 m2 facility puts Bridge at the forefront of preclinical outsourcing to China and will be the first and only US level GLP and AAALAC designed facility in China. The Zhongguancum facility will house primates, rodents, canines, rabbits. Services will include: FDA compliant GLP toxicology, pharmacology, predictive PK/ADMET, safety pharmacology, formulation and other services. Through its Vital Bridge joint venture, Bridge has expert local partners in China that provide animal supplies from well known US breeder franchises in Asia.

For Bridge, the opening of this facility marks the next phase in outsourcing preclinical drug development to Asia. By controlling its own facility in China, Bridge will have the capacity and expertise to provide FDA compliant preclinical drug development services to pharmaceutical and biotech companies throughout the world. This new facility positions Bridge as the leading preclinical CRO in China targeting US and EU biopharmaceutical companies.

“The San Francisco bay area is the birthplace of biotech and has remained the worldwide leader in life sciences innovation. Escalation of the price of drugs, as evidenced by California’s recent ballot initiative, is an increasing hardship and concern,’’ said San Francisco Mayor Gavin Newsom. “By combining the technical resources and innovation of both the San Francisco bay area and Beijing’s life sciences community, this state of the art facility represents the next wave of global cooperation and evolution of life sciences development. Bridge and companies like Bridge will allow San Francisco to remain competitive in the life sciences, and cost effectively develop more drugs, for smaller markets, in the new era of personalized molecular medicine. We are pleased to see that a Bay Area company, Bridge Laboratories, is taking the lead in this exciting global evolution of the very best of the east and west.”

Founded in 2004, Bridge Laboratories develops preclinical service and drug development capabilities through leverage of the Asian market. To date, Bridge has been subcontracting work through laboratories in China and Taiwan (Beijing, Shanghai, Chengdu, Taipei and elsewhere). Bridge is the first company to successfully use all China preclinical and CMC data for successful filing of IND’s with the U.S. FDA and did so twice this year.

Press Releases

 

 

 

 

     
MEDIA CONTACT:

Vincent Lagrotteria, MBA

240-364-6300

info@bridgelaboratories.com

www.bridgelaboratories.com