| 1.Research purposeAs the management regulations of new drug research and development of all countries becoming more and more strictly and perfectly constantly,Drug research and development process is becoming more and more complex,Time-consuming and expensive.In order to survive and develop in such a environment of manage increasingly strictly and compete increasingly fiercely, pharmaceutical companies must try best to shorten the time required for new drug research and development, at the same time, must control the cost and reduce the risk of failure.Under this background, the scale of the market of biological medicine research and development outsourcing service is growing, presented a trend that moving quickly from the developed countries to the developing countries.The CRO(Contact Research Organization) as the main form of biological medicine Research and development outsourcing service industry develops rapidly, much attention has been paid to the situation. While the main task of the drug research and development is to prevent and treat the human diseases, safeguarding the people’s health. Clinical and laboratory research are two primarily basic ways to realize the drug research and development, which the both two studies are inseparable from the use of experimental animals. Experimental animal and animal experiment becomes more and more important, especially the development of medical science has developed from the stage of experience medicine to the laboratory medicine. Due to Similar degree among the lower model organism, the lower level of rodents and humans is low, which can’t meet the requirements of biomedical research, and similar degree between large experimental animals and human is high, the superiority is irreplaceable by other animals. Laboratory animal resources, especially the large experimental animals (monkey,dog,Tibet miniature pig) resource of Guangdong province has a dominant position in the whole country. Having the three large experimental animals at the same time, made Guangdong province have a unique advantage in the experimental animal resources.Take full advantage of the characteristics and advantages of laboratory animal resources of Guangdong province,then, establish biomedical animal experiments outsourcing service base in Guangdong province and analysis the base operation mechanism,which laid a solid foundation to better carry on biomedical outsourcing service.2.Research significance2.1The market of biological medicine research and development outsourcing service is hugeGuangdong province is one of the largest import and export base of pharmaceutical commodity production in the country. The outline of the pearl river delta region reform development plan put forward to develop the biological medicine industry in Guangdong province clearly.The Core competence of biological medicine industry is the new drug research and development. Before application,the new drug must pass a complicated process such as drug screening, preclinical evaluation, clinical research which need a lot of money and involve multidisciplinary system engineering. In order to save money, shorten the cycle and increase profits, more and more pharmaceutical companies will be see the pharmaceutical R&D outsourcing services as the fast way to make the drug to market, through the he contract service organization (CRO) to carry out the drug screening, preclinical studies and clinical trials research has become a trend in global pharmaceutical industry.So, research on biomedical outsourcing service is of great significance.2.2The advantage of large experimental animal resources will provide opportunities to undertake biomedical outsourcing servicesBiological medicine research and development outsourcing service is a key content of drug evaluation. Drug evaluation is the key link in the chain of drug research and development. Only good experimental animals can guarantee the reliability of the drug evaluation experiment. Many innovative new drugs, including the new drugs of biological engineering must use large animals such as Beagle dogs, primates and miniature pigs to evaluate.So that the quality of the large animals is especially important, which is the extremely important model organisms from the basic research to clinical research. Because of the scarcity of the experimental animal resource in the most developed countries, together with the restrictions on animal protection, international well-known pharmaceutical companies are increasingly outsourcing the medical animal experiments, especially large experimental animal pre-clinical studies to developing countries, including China, India, bring the opportunity to undertake the outsourcing service of biological medicine and animal experiments of China.2.3Establish standard, canonical and scientific management system of experimental animals is the premise to undertake biological medicine research and development outsourcing service.Laboratory animal resources, especially the large experimental animals (monkeys, dogs, Tibetan miniature pig) resources of Guangdong province has a dominant position in the whole country, And presents the unique of having the three large experimental animals at the same time. At present, amount of captivity and the supply of experimental animal of monkeys, dogs, Tibetan miniature pig of Guangdong province accounts for more than a third of the country, the monkey in the international market share of more than25%.Moreover, the only export experimental primate center exempted from inspection, the only experimental center of dog seed and the largest base of experimental miniature pigs in the country are all in Guangdong province.Besides,drug non-clinical safety evaluation (GLP) key laboratory of the Guangzhou pharmaceutical industry research institute has inspected by the state food and drug supervision and administration commission, becoming the China’s first batch and the south China’s first to pass the GLP certification. Establish a standardized, normalized, scientific management system of experimental animals is the premise to undertake biological medicine research and development outsourcing service. But at present, the standardized construction and management of the large laboratory animal of Guangdong province is still in a fledging period, which needs to improved and enhanced urgently.Therefore, the research of the operation and management mechanism of the bio-pharmaceutical animal outsourcing service base has very important practical significance for the life science research, biological medicine industry development and the major disease and human health research.3.Research methods3.1.literature researchMake full use of the electronic resources of the library of the colleges and universities in the province,study the related literature and books, and browse the biological medicine research and development outsourcing related websites, such as the experimental animal of the public service platform of the provinces, relevant documents issued by provinces and cities to access to the related literature about operation management and personnel training of the biological medicine research and development outsourcing service, analyzing it and using it systematically.3.2Expert interviewsThrough having a interview with the relative person of biological medicine research and development outsourcing organization in Yangtze river delta such as Wuxi APPTEC, Tigermed, SLRC Laboratory animal and the Dongguan songshan lake pearl of laboratory animal science and technology co.LTD to understand construction and the operation mechanism of the base.3.3Case study methodThrough having a case study of biological medicine research and development outsourcing organization in Yangtze river delta such as Wuxi APPTEC, Tigermed, SLRC Laboratory animal in shanghai and the Dongguan songshan lake pearl of laboratory animal science and technology co.LTD relatively, make a in-depth research and analysis on the background, service features and advantages, organization operating mechanism.3.4Comparative researchCompare the operating mechanism of biomedical outsourcing service between the Yangtze river delta such as Wuxi APPTEC, Tigermed, SLRC Laboratory animal in shanghai and the Dongguan songshan lake pearl of laboratory animal science and technology co.LTD, finding out what are the difference between them and the place we can learn from.3.5System analyzeSee the organization of the biological medicine animal experiment outsourcing service as a whole system to be studied. 4Research results4.1Analyzed the biomedical animal outsourcing service organization structure of the Guangdong province systematically and then analyzed the operating mechanism of the organizationThrough the comparative analysis of the characteristics of the structure and operating management of WUXI APPTEC,TIGERMED and SLRC laboratory animals in Shanghai and the Donggguan lake pearl, found out the advantage of the organization of biological medicine outsourcing service in Guangdong province, making full use of the advantages of large experimental animals in Guangdong province to construct the structure of the organization of the biological medicine animal experiment outsourcing service in Guangdong province. The system of the organization mainly consists of the following five subsystems:network technology system, support services system, professional services systems, innovation service system and acting subjects system. Under the structure of the system framework,the operating mechanism of the biological medicine animal experiment organization for outsourcing service mainly includes the motivity mechanism,mechanism of customer credit management, information integration and payment mechanism, synergy mechanism self-reinforcing mechanism, innovation mechanism and quality control mechanism.4.2Analyze the incentive mechanism of the biomedical animal outsourcing service base in depth.The professionalism of the experimental animal and animal experiment, determine the animal experiment outsourcing service organization having the characteristics of high specificity of human capital. So in the incentive practice to clients in outsourcing services organization, material incentives, career incentives, feelings incentives and cultural incentives are necessary on a macro level. On a micro level, the ownership of leasing arrangements and reasonable configuration of leasing access can better promote the specificity of human capital investment, better complete animal experiments outsourcing services.4.3Put forward the countermeasures and suggestions about the biological medicine animal outsourcing service organization operating management in conclusion.In summary, countermeasures and suggestions were put forward from two sides. On the macro level, countermeasures and suggestions of the operating management of biomedical animal experiments outsourcing service organization are put forward from the angle of government and industry association of Guangdong province. On the micro level, from the side of the biological medicine animal experiments outsourcing service organization itself.5Research conclusion5.1Constructed the structure of bio-medical animal experiment outsourcing service organization, we need to follow certain principles and use the application systematic principles grasp its system structure and operation mechanism essentially.5.2As the professional outsourcing service of experimental animals and animal experiment, the demand of the talent is higher, in the practice of outsourcing services of the animal experiment, we should adopt a macro level and micro level incentive mechanism.5.3The status of the base development depend on two sides,On the one hand depends on its establishment and improvement of the internal mechanism.On the other hand also depends on its external environment, biomedical animal experiments outsourcing services need to constantly learning new knowledge, adhere to innovation, constantly exchange the material,energy and information with the environment, promoting the continuous development of biomedical animal experiments outsourcing service base. Therefore, the government should perfect the policy of experimental animals outsourcing service, promote the development of biomedical experiments on animals outsourcing services. |
PDF Full Text Request