Listed as "Leading Scientific and Technological Innovative Talents" in the National Special Support Programme for High-Talents; listed as "Leading Young and Middle-aged Scientific and Technological Innovative Talents" by Ministry of Science and Technology; listed as "Young Scientists" by Ministry of Science and Technology-Bill & Melinda Gates Foundation; national new drug review expert; academic and technology leader of Sichuan province; science and technology innovation team leader of Sichuan province  

He is currently the director of National Chengdu New Drug Safety Evaluation Center and has presided over 3 major national scientific projects on new drug creation, and 1 key national scientific breakthrough plan.  He has won 1 National Prize for Progress in Science and Technology (2nd Prize) and 2 Sichuan Prizes for Progress in Science and Technology (1st Prize).  

In December 1993, the National Science and Technology Commission issued the first non-clinical drug quality management guidelines: Good Laboratory Practice (Trial) (GLP).  China then carried out "1035 Project", whose objectives include support to establish 5 drug safety evaluation centers.

When China started organizing the establishment of 5 drug safety evaluation centers at the national level, West China Hospital, Sichuan University took the lead in constructing Chengdu Drug Safety Evaluation Center, Cen said.

In 2000, WestChina-Frontier PharmaTech Co., Ltd. (National Chengdu New Drug Safety Evaluation Center, hereinafter referred to as "WestChina-Frontier PharmaTech") was successfully established and approved by the Ministry of Science and Technology to become a national center for pre-clinical research and safety evaluation of new drugs.

As the only national GLP center in Central and Western China, WestChina-Frontier PharmaTech has been committed to providing high quality research and evaluation in pharmacodynamics, toxicologics, pharmacokinetics and biological analysis for many years to support the global registration of drugs such as in China, North America, Europe, Japan, South Korea and Australia.  Its supportive cluster effect on the biopharmaceutical industry in China, especially in the Yangtze River Delta and Southwest China, also becomes more and more prominent.

WestChina-Frontier PharmaTech

The development of GLP industry has been accompanied by the development of the national biopharmaceutical industry. From 2000, with the rapid development of its biopharmaceutical industry, China began to develop policies to promote GLP. As the source of drug quality and safety control in China, Good Laboratory Practice was officially issued and implemented on September 1, 2003.

However, there is a large gap in the research hardware facilities of many state-accredited GLP institutions, and only a few GLP institutions can meet the international declaration standards and are in good operating conditions.  The vast majority of GLP institutions has stagnated or even failed to make profits.

Cen Xiaobo pays attention to this phenomenon, and summarizes the following characteristics of well-run GLP institutions:

First, their research is in line with the international level. Their hardware facilities, matching software and talent team construction have all reached the international level.  

Second, their growth process conforms to the law of international GLP development.They follow the development pace of advanced international CRO and GLP institutions, and actively grow to a large-scale intensive institution with a strong information processing ability and strong logistics.

Third, they occupy the strategic heights of the market with leading technology.

Although currently 96 laboratories have passed the national drug GLP certification, China's GLP industry is still limited in international influence, as there are very few GLP institutions supporting the global drug registration and application such as in China, North America, Europe and Australia as WestChina-Frontier PharmaTech does.

At present, WestChina-Frontier PharmaTech has successfully submitted nearly 100 sets of IND application materials for drug administration in the United States, Europe, Australia, Japan and South Korea, and its data quality has been highly recognized and evaluated in the world. So has its pre-clinical research of new drugs.

When it comes to the advantages of WestChina-Frontier PharmaTech, Cen Xiaobo introduces as follows:  

First, it provides professional and scientific services. WestChina-Frontier PharmaTech has accumulated rich industry experience by completing research and evaluation of thousands of new drugs for domestic and foreign approval. It enjoys a pass rate of 100% both in foreign and domestic approval, playing a good leading role in this field.  In addition, the "blood relationship" between WestChina-Frontier PharmaTech and West China Hospital makes WestChina-Frontier PharmaTech get the strong support of modern clinical resources such as clinicians and clinical skills.

Second, it provides innovative services. While providing GLP services for pharmaceutical companies, it also creates a lot of added value for customers.

Third, it has advanced laboratory information systems.  At present, WestChina-Frontier PharmaTech has its own service information construction team. As all its data are traceable and in line with international standards, it has achieved the organic integration of experimental data.  With a data conversion system which meets SEND (Standard for Exchange of Nonclinical Data) required by FDA of the US to support new drug applications in the US, WestChina-Frontier PharmaTech becomes China's first non-clinical CRO.  

Fourth, it is a state holding institution.  WestChina-Frontier PharmaTech is a state-owned enterprise and serves as an important technical support system for new drug research and development in China. With a strong sense of mission and responsibility, it adheres to the belief of "remaining true to our original aspiration and keeping our mission firmly in mind" to ensure the safety and effectiveness of drugs for the health and safety of the people.  In the time of the outbreak of COVID-19, WestChina-Frontier PharmaTech is making every effort to overcome difficulties and seize time to develop new drugs against COVID-19.

On June 27, 2019, the National Medical Products Administration (NMPA) established the highest academic professional committee at the national level — NMPA's Expert Committee of  Supervision Science Research Center for Traditional Chinese Medicine. As one of the members of the expert committee, Cen Xiaobo has participated in the formulation of a number of technical standards at the national or industry level and guidelines at the national level in the field of traditional Chinese medicine.

How to establish a safety evaluation technology system in line with the characteristics of traditional Chinese medicine?

He said that , in the safety evaluation of traditional Chinese medicine, we should not copy the current technical standards for biopharmaceuticals and chemical drugs.  If the pre-clinical safety evaluation of traditional Chinese medicine is carried out according to ICH guidelines, it is difficult for traditional Chinese medicine to meet its technical requirements.

Based on the characteristics of traditional Chinese medicine, whose long history of clinical application has preliminarily proved its safety and effectiveness, less and simple requirements are stipulated in China's current regulations on safety evaluation of traditional Chinese medicine. The loose safety research and evaluation system of traditional Chinese medicine has also been questioned internationally.

For example, drugs taken by women during pregnancy/fertility are theoretically subject to reproductive toxicity tests; drugs for use of more than six months or for life-long use are theoretically subject to carcinogenic tests. How to implement these technical requirements scientifically in the field of R&D and review of traditional Chinese medicine still requires us to pool our wisdom.

How to build a safety evaluation system with the characteristics of traditional Chinese medicine?

In his view, relevant policies must be introduced in a very cautious way, and a careless introduction may hinder the inheritance and development of traditional Chinese medicine in China.  Although WestChina-Frontier PharmaTech has accumulated rich experience in preclinical research and evaluation of traditional Chinese medicine, how to establish a more scientific evaluation system for traditional Chinese medicine which can obtain global recognition is a long way to go.  Cen Xiaobo also said that strengthening the objective and fair evaluation of traditional Chinese medicine in clinical trials using innovative evaluation methods is very important for the development of traditional Chinese medicine and the safety of drug use by the people.

Attracted by active capital and flexible government support when they return to start their own businesses, most overseas returned scientists prefer to choose Shanghai, Beijing, Jiangsu and Zhejiang as their starting points. Therefore, a complete enterprise cluster of industrial chain and technology chain has formed in these regions.

In recent years, Chengdu has made great efforts to create a good environment for the development of biopharmaceutical industry. The National Key Laboratory Team of Biotherapy of Sichuan University, Kelun Industry Group, Haisco Pharmaceutical Group, HitGen, Conmed Biosciences Inc, Hinova, Maccura Biotechnology and other benchmarking units have been successively established in Chengdu. However, Chengdu's proportion of innovative enterprises is far lower than that of  the coastal regions.

Cen Xiaobo believes that Chengdu still needs to create a good pattern for the innovative pharmaceutical industry, accelerate the formation of a good ecological circle, and cultivate enterprises at the upstream and downstream of the industrial chain to provide matching services.  

Cen Xiaobo also notes that the development speed of the pharmaceutical industry in Chengdu has been significantly improved in recent years.   He said that from the business volume of WestChina-Frontier PharmaTech, we can see it has been commissioned to carry out  more and more projects by enterprises in Chengdu (accounting for about 10% in 2017 and 30% in 2019).

In the future, he hopes that Tianfu Life Science Park and other scientific innovation incubator parks can help more entrepreneurs realize their dream of running their own businesses and improve the industry chain of new drug research and development in Chengdu, with the policy and fund support from both Chengdu City and Sichuan province.