Identifying and Managing Technical Risks in the Process of Innovative Drugs Development in China

Abstract

Objective To identify technical risks in the process of innovative drug development, and to provide reference for technical risk management so as to reduce the uncertainties and improve the efficiency of research and development. Methods The initial risk index was investigated by literature research. Then, the Likert scale was used to design a questionnaire, and the experts’ opinion was used to analyze the risk factors affecting the different stages of the development of innovative drugs in China. Results and Conclusion Based on the analysis of questionnaire, 31 risk indicators of five key stages in the development of innovative drugs from drug discovery to marketing authorization were established. The key risk indicators constructed in this study can provide reference for technology-related risk management in the process of innovative drug development.

Keywords

innovative drug development / technology risk / risk management

References

[1] Kwak YH, Dixon CK. Risk management framework for pharmaceutical research and development projects[J]. International Journal of Managing Projects in Business, 2008, 1 (4): 552-565.

[2] Chen Jing, Luo Xiaofang, Qiu Huimin, et al. Drug discovery and drug marketing with the critical roles of modern administration[J]. American Journal of Translational Research, 2018, 10 (12): 4302.

[3] Jin Quanyuan. Research on the risk management in new drug development[D]. Shenyang Pharmaceutical University, 2006.

[4] Jin Quanyuan, Lian Guiyu, Huang Taikang. Research on technical risks of new drug research and development and its countermeasures[J]. China Pharmaceuticals, 2006, 20 (15): 14-15

[5] Wang Peng, Xu Huaifu. Pre-marketing risk analysis and countermeasures of new drugs[J]. China Pharmaceutical Technology Economics and Management, 2008, 10 (11): 82-86.

[6] Yu Xin, Chen Yuwen. Risk and control in research and development of new chemical drugs[J]. Guangdong Chemical Industry, 2017, 44 (22): 80-82.

[7] Yang Xiaoyan, Han Qican. Management risk and strategy analysis of new drug research and development projects[J]. China Health Industry, 2020, 17 (16): 62-63+66.

[8] Schuhmacher A, Brieke C, Gassmann O, et al. Systematic risk identification and assessment using a new risk map in pharmaceutical R&D[J]. Drug Discovery Today, 2021, 26 (12): 2786-2793.

[9] FDA. Stagnation or innovation: Challenge and opportunity on the critical path to new medical products[R]. New Hampshire Ave: FDA, 2004.

[10] Baker A, Gill J. Rethinking innovation in pharmaceutical R&D[J]. Journal of Commercial Biotechnology, 2005, 12: 45-49.

[11] Schmid EF, Smith DA. Managing innovation in the pharmaceutical industry[J]. Journal of Commercial Biotechnology, 2005, 12: 50-57.

[12] National Medical Products Administration. Technical Guidelines for Application of Phase I Clinical Trials of New Drugs (2018 NO.16)[EB/OL]. (2018-01-11)[2023-05-01]. https://www.cde.org.cn/main/news/viewInfoCommon/b7fc4c73468462af0bc5ab928d177cc7.

[13] Gong Zhaolong. Pre-clinical development strategy of new drugs that meet the FDA declaration requirements of China and the United States[R]. 2012 National Conference on Pharmacotoxicology, 2012.

[14] Liu Jin, Yang Jiaying, Zhu Wenbo, et al. Exploration and design method of dose in phase I clinical trials of innovative drugs abroad and its enlightenment to China[J]. China Journal of New Drugs, 2020, 29 (15): 1746-1751.

[15] Gong Zhaolong, Du Tao. Discussion on risk control of new drug research and development from the perspective of FDA review[J]. Pharmaceutical Progress, 2015, 39 (11): 823-826.

[16] National Medical Products Administration. General pharmaceutical problems and related technical requirements before the phase III clinical trial of innovative chemicals[EB/OL]. (2018-03-09)[2023-05-01]. https://www.cde.org.cn/main/fullsearch//fullsearchpage.

[17] Yuan Yi, Chen Yuwen. Analysis of risk factors and coping strategies of new drug research and development[J]. China Medical Science, 2020, 10 (8): 201-203+222.

[18] Yang Zhimin, Yang Jinbo, Yi Feng. Discussion on key technical factors to promote the research and development of innovative drugs in China[J]. China Journal of New Drugs, 2010, 19 (7): 558-560.

[19] Schuhmacher A, Brieke C, Gassmann O, et al. Systematic risk identification and assessment using a new risk map in pharmaceutical R&D[J]. Drug Discovery Today, 2021, 26 (12): 2786-2793.

[20] Zhang Dingding. Descriptive statistical analysis and SPSS implementation[J]. Concord Medical Journal, 2018, 9 (5): 447.

[21] Yang Zaiyun. Research on the application of reliability analysis in environmental questionnaire[J]. Modern Industrial Economy and Informatization, 2015, 5 (21): 101-103.

[22] Li Can, Xin Ling. Research on evaluation methods of reliability and validity of questionnaires[J]. China Health Statistics, 2008 (5): 541-544.

[23] Joseph F, Hair JR. Multivariate Data Analysis with Readings (4th Edition)[M]. New Jersey: Prentice Hall, 1995.