AN INTERVIEW WITH...Charles River Endotoxin and Microbial Detection

Q: You recently celebrated the one year anniversary of Charles River's Shanghai facility. What have you learned about the Asian market since opening last October?

First, let me update you on a huge milestone for the Shanghai facility. The site received accreditations from the Association for Assessment and Accreditation of Laboratory Animal Care, (AAALAC) the Canadian Council on Animal Care (CCAC) and the Shanghai Laboratory Animal Commission (SLAC). These accreditations confirm our ability to provide clients with superior service in a regulatory compliant environment.

The interest in working in China continues to expand across our customer base. Multinational companies are developing R & D centers in China as part of their strategy to develop, license and distribute medicines globally. There is tremendous interest in not only the early discovery work to support the strong chemistry-based expertise that pharma companies are already utilizing in China, but also a desire to extend into the regulatory compliant studies necessary for regulatory approval. Finally we are also seeing an increased interest in large molecule and vaccine development in this region.

Q: What is next for Charles River in China?

Now that we have established ourselves in the Shanghai facility, we are currently exploring the option of opening a second China facility.

Q: You recently made several acquisitions in the discovery and imaging space. Why are you investing in this area?

In the past the year, we have acquired four organizations - MIR, Cerebricon, Piedmont Research Center and Systems Pathology Company, which have enabled us to provide unparalleled discovery support. We are really seeing the discovery and imaging space as the next frontier for outsourcing.

Our clients are interested in using outsourcing partners earlier in drug discovery than ever before. We have selectively identified and acquired companies with acknowledged international reputations in specific therapeutic areas. Through these acquisitions, we are able to accelerate the drug discovery process by providing more highly predictive in-vivo data to facilitate clinical translation using increasingly realistic models of disease. In particular, we see the power of imaging, benefiting the process by providing more highly quantitative information that improves the quality of the data procured to answer key questions.

Q: What was the strategic rationale for the recent acquisition of Systems Pathology Company?

Systems Pathology Company (SPC) is a pathology-based software company focused on developing state-of-the-art analytical imaging technologies to automate the labor-intensive tissue evaluation process. This technology, which is referred to as CAPSTM (Computer Assisted Pathology System), is being designed to complement and support the pathologist, by enhancing objectivity, accuracy, consistency and therefore slide review throughput, by automating the routine aspects of tissue evaluation. When fully developed, this tool will allow high value pathologist time and expertise to be focused on decision making, thereby speeding up time to report initiation, and supporting our goal of helping accelerate our clients' drug development programs.

Q: Pharmaceutical and biotech companies are narrowing their therapeutic areas. What is Charles River doing to support these efforts?

As our customers continue to narrow their focus, we are continuing to broaden our therapeutic area expertise. We have unmatched expertise in oncology, CNS, cardiovascular, metabolism, and inflammation which enables us to help reengineer the R&D process with our clients. Our expertise in these therapeutic areas enables us to identify the best models and study designs for our clients not only in early discovery, but also in development by optimizing the program design for regulatory approval of unique therapeutics.

Q: How can a CRO help optimize the drug development process?

CROs like Charles River work with customers as strategic partners helping to accelerate their drug development programs. We provide a global network of scientific expertise in preclinical and clinical R&D across broad therapeutic areas, which gives clients a competitive advantage. The breadth and depth of our experience enables us to deliver insight from a unique vantage point, which greatly helps to shape drug development programs for optimal results. As a CRO we have experience working with a variety of different drug development programs and can share this insight with our clients.

Q: How has the role of CROs changed?

The changing industry landscape is transforming traditional pharma-contract research organization relationships from a transactional base into strategic partnerships. Increasingly, CROs are evolving to become extensions of the customer's team. When selecting a CRO, organizations are making an investment in people and key scientific talent who will play a critical role in the company's drug development process.

We are also seeing our clients engage us earlier in the R&D process and leveraging our global network as their own team of consultants.

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