Bridge GLP compliant drug development in China

Articles

Pharmaron Expands Portfolio of Services with Acquisition of Bridge Laboratories China

January 11, 2010


 

IRVINE, CALIF. AND BEIJING – January 11, 2009 –Pharmaron Holdings Limited, today announced it completed the acquisition of Bridge Laboratories China. Bridge Laboratories China is the leading contract research organization (CRO) in China providing western standard GLP-compliant toxicology services to pharmaceutical and biotech companies from around the world. With this acquisition, Pharmaron becomes the first integrated CRO in China supporting clients with drug discovery and development processes in support of IND filings. This strategic acquisition strengthens Pharmaron’s leading position in the fast-growing, highly dynamic pharmaceutical CRO industry. Read more...

CRO Industry Update, Opportunities in uncertain times

June 2009

By Kristin Brooks
Associate Editor, Contract Pharma

 

The Pharmaceutical industry is undergoing significant change, from drug development philosophy and tightening of regulations, to restructuring, consolidation and mergers and acquisitions — all in the midst of an economic downturn. These changes impact CROs, the services they provide, from where, and for whom. The drop in R&D spending during the last few quarters has taken its toll on preclinical CROs, which are experiencing heavy discounting, delays, and cancellations. These changes may however present some opportunities for CROs. Although R&D spend has been down, many in the industry feel outsourcing will inevitably rise. Despite the financial crunch and a drop in early-stage research, a new report conducted by Business Insights states that the global CRO market is expected to grow 14% per year during the next three years, making contract research a $35 billion industry by 2013. Read more...

Placing Preclinical GLP Studies in China: Questions and Answers to Help You Decide

September 8, 2008

A White Paper Presented by
Ronald J. Marler, DVM, PhD
Chief Scientific Officer
Bridge Laboratories

 

Whereas 10 years ago no one thought about placing GLP-compliant preclinical studies in China, soon every biopharma company preparing an IND will take China into account, where GLP study costs are lower, studies can often start sooner, and access to animal models is easier. Right now, however, with GLP studies in China so new, companies considering China have many questions. For example, “Can China really meet western GLP standards?” Answer: Absolutely. The FDA recently accepted a GLP nonhuman primate toxicology study performed at Bridge China. “Are reports in clear, standard English?” Yes. “Is it easy to ship bioanalytical samples from China to the US?” Answer: Usually, yes, but shipping samples for certain species requires a special permit and careful planning to avoid delaying your schedule. As the first company to offer western-level GLP-compliant preclinical study services in China, Bridge Laboratories receives these questions and many others every day. To help you consider your China options from an informed perspective, this white paper contains our answers to the questions we receive most often. Read more...

Updates on Preclinical Development in China

The Rise of China’s Contract Research Sector: Evaluating Quality and Cost Benefits

August 19, 2008

By: Ernie Bush, PhD and Eric Meyers, MBA       

Cambridge Healthtech Associates (CHA)  

 

Three years ago there were few if any western firms doing preclinical testing in China, but today there are already dozens, and within the next few years this will be commonplace – much as chemistry outsourcing is today.

Drug developers of all sizes are re-examining their assumptions about their true core competencies, i.e., what should be done internally and what can be better accomplished through specific outsourcing relationships (see the recent Lilly-Covance deal). Read more...

There's More Than Meets the Eye to China's CRO Sector - Experts

July 9, 2008

By: Karen Tye

interfax

 

Part of China's appeal to foreign investors has always been its cost advantage, but according to pharmaceutical industry experts, the contract research organization (CRO) sector in China is more that just a cheaper outsourcing destination.

R. Stephen Porter, CSO of Medicilon-PI Preclinical Research Shanghai, explained that most venture capitalists and multinational companies that have established their own R & D centers in China are not here for the cheap labor.  Read more...

Offshore Opportunity on the Rise

Mar 1, 2008

By:Jim Miller

BioPharm International

 

China continues to get a lot of bad press for quality problems with some medications and other consumer products manufactured there, but its popularity as a place to conduct biopharmaceutical research continues to grow. The major clinical research organizations (CROs) are racing to get established there, as much to stay a step ahead of the competition as for the immediate opportunity.  Read more...