The tours are designed to explore and evaluate top Chinese pre-clinical safety evaluation CROs, especially with regard to GLP toxicity studies. They provide a cost-effective, “hands-on” opportunity for group evaluation to determine whether these facilities are performing according to global standards, and provide assurance that they can conduct work for Western clients.

We will visit:
- 4 facilities (over a 2-day period) in the Beijing area before the conference

- 4 facilities (over a 2-day period) in the Shanghai area after the conference

This project is an extension to our hosted evaluations of Chinese CROs which has been on-going since late 2005. It is the successor project to the completed China Tox I & II Evaluation projects that have assessed Chinese CROs and their ability to perform according to Western expectations. These projects have successfully evaluated operational facilities, animal care and use practices, and GLP maturity of top-rated, pre-clinical safety facilities in China. However, the industry in general is not static and in China the rate of change and maturity of this segment has been quite dramatic. Thus, this project will focus on revisiting the question of whether these facilities have continued to develop their capacities and compliance to Western expectations. The tour will provide an opportunity to develop relationships with the test facilities, as well as provide feedback and insights for further development.

For more information about the tours, please contact Ernest Bush.

Download the full brochure 

Typically, when a molecule started an IND-enabling program and the submission either failed or was delayed, 80% of the time it was due to the nature of the molecule, e.g. the findings in the GLP enabling program.  In other words, the greatest risk to a molecule is the intrinsic properties of the molecule, not the GLP studies.  Compliance issues were very infrequently cited as a cause for delay or failure to open an IND.  These results are shown in the left bar in the graph below. 

• The center and right hand bars are simulated situations where results are assumed to increase or decrease risks associated with a Chinese CRO. 
• The center bar assumes that Chinese CROs are 33% more likely to have an execution error while performing a study (i.e. increasing from 12 to 15 the relative risk units) and more than doubling the risk of compliance issues ( i.e. increasing the compliance issue risk from <1 to 2).  This is a worst case scenario for illustrative purposes and we do not in fact believe either case is true, however even under these extreme assumptions, the overall increase in risk is still only 4%. 
• More important, the right bar assumes what happens if you use a third-party monitoring service, like CPMS, to “look over the shoulder” of the CRO (and the sponsor) to help ensure compliance and performance.  Even if this independent, third-party review/monitoring improves the situation by about 10% for each of the execution and compliance errors, the overall result is to reduce the total risk to a level where it is actually better than using a Western CRO without added monitoring.
  

by Ernest D Bush 

Track Record
• GLP toxicology data from Chinese CROs have been used to support more than 30 US INDs and a few NDAs since 2006. CPMS has monitored/conducted over 20 GLP studies at Chinese CROs and data from these studies has been used to support 3 US INDs.  Each of these INDs has been opened with no questions regarding the quality/validity of the GLP studies.

Audits in China
• Last summer staff from the US FDA (which has now opened permanent offices in China) audited all the CROs that have submitted GLP toxicology studies in support of INDs or NDAs.  These were audits of specific GLP studies and of facilities. No studies in any of the audits were disqualified for any reason, including compliance, and only minor findings were reported in the 483s issued (some facilities did not have any 483 issued).

Chinese versus Western Technicians
• How do Chinese technicians rank in comparison with their Western counterparts?   CPMS has been monitoring, conducting and training Chinese CROs since 2006 and we believe Chinese animal technicians at the major CROs are top quality; they are unusually well educated, highly trained, and very committed to their jobs.  To us they represent a major strength of the Chinese CRO system.

by Ernest D Bush 

Today, most of the attention is focused on GLP (Good Laboratory Practice) and non-GLP in vivo toxicology testing services.  The potential short- and long-term benefits for conducting these preclinical safety studies in China can be considerable. While these benefits to US-located companies are primarily based on economic considerations, the rapid expansion of in vivo toxicology testing capabilities and capacity in China has created an interesting leverage opportunity that is also attracting attention from those exploring long term strategic options. This expansion in capacity is the result of the fact that over the past five years the Chinese government and private sector resources have poured into this sector with the objective of making China a major venue for “Western quality” GLP toxicology testing services. The resulting leverage opportunity then becomes “why should I maintain the cost and resources of an expensive in-house GLP infrastructure when I can utilize the modern new capacities in China.

Unfortunately, Western drug development companies seeking to leverage the considerable build-up of this sector in China cannot simply view China as a new tool to the toolbox. To benefit from the emergence of this sector, Western companies conducting such studies in China will need to adopt a different paradigm for how they work with their China-based CRO partners. As a first step, each will need to understand in some detail the capabilities available in China and the role they can play in enhancing their specific operational portfolio. Realistic options and tradeoffs will then need to be weighed. Finally, the execution plans to support placing studies in China will need to be modified from what is standard practice when working with local Western CRO partners. In particular, changes to the management processes and mindset for working with China partners will be required. Additionally, processes will need to be established for monitoring and providing ongoing communication support and capability building. Astute managers will create additional value for their companies by thinking creatively about their strategy with China-based CROs which are especially eager to build relationships and capabilities during this early stage in their development.

By Ernest D Bush, PhD