Research On Project Management Optimization About Preclinical Toxicology Of New Drug In A Company

The research and development of new drugs reflects new achievements in the frontier fields of life science and biotechnology,and is one of the commanding heights in the current scientific and technological competition.The characteristic of new drug discovery is "three high and one long":namely high investment,high risk,high return and long cycle.We need to do cost management well due to high investment,do risk management well due to high risk,do time management well due to long cycle.At the same time,time,quality,cost and risk managements are also the most important four elements of project management.New drug discovery mainly contains four parts:identifying candidate compound,CMC,preclinical and clinical studies,of which,preclinical toxicology research is the bridge between non-clinical and clinical studies,is the last step of drug into clinical stage,the importance is self-evident.So,the research of preclinical toxicology project management is of great significance to the whole process of new drug discovery.A company,the study object of this paper,which is engaged in the preclinical toxicology contract research organization.The current project management situation of A company was analyzed based on the domastic and abroad theory of project management,and preclinical toxicology project management of A company was as the foothold when writing this paper.Problems of time,quality,cost,risk were mentioned during project management,current hot spot of COVID-19,rising monkey prices and drug policies were also discussed and analyzed.This paper puts forward specific optimization strategies about time,quality,cost,and risk management based on the existed problems and theory,and gives specific implementation measures to achieve optimization results.It is hoped that the completion of this paper can promote the smooth-running of preclinical toxicology discovery,and provide ideas for project management in the same industry.