Clinical Development and Science A Survey of Scientific Sources of Pharmaceutical Innovation and Their Economic Impact (2)
Sadao Nagaoka (Professor, Tokyo Keizai University, Former Professor, Center for Innovation Research, Hitotsubashi University)
Junichi Nisihimura (Associate Professor, Faculty of Economics, Gakushuin University, The Office of Pharmaceutical Industry ResearchVisiting Researcher)
Koichi Genda (Former Senior Researcher, The Office of Pharmaceutical Industry Research )
(No. 67: Published in August 2015)
This paper summarizes the results of a survey of the scientific sources of pharmaceutical innovation and their economic effects, which targeted clinical development. The main findings of the survey for clinical development are as follows. First, to measure the contribution of science to the novelty and innovation of pharmaceuticals per se and the use of science in the conduct of clinical development. Second, to analyze the relationship between science and the choice of countries for clinical development. Third, we will examine the contribution of science to the economic impact and its reflection in the calculation of drug prices. Fourth, we will examine the relationship between science and regulatory involvement. Finally, we analyze science and uncertainty.
The main conclusions from the survey in this paper are as follows. First, the results of scientific knowledge (science) make an important contribution not only in the search for novel and innovative drugs, but also in the conduct of clinical development. Seventy-one of the 180 pharmaceutical projects included in our survey had significant science contributions in both discovery and clinical development. Second, we found that the ability of the country's regulatory authorities to evaluate the science is important in the conduct of H-type clinical development, which is highly science-intensive. This is one of the reasons for conducting the first clinical development outside of Japan. For that matter, Japan may have been inferior to the U.S. regulators at the time in terms of their understanding of the science. Third, although Type H is prone to unexpected events due to its high degree of uncertainty, the probability of success is not necessarily lower than that of Type L, which is less science-intensive. This is because of the innovative nature of Type H, which is superior to Type L in terms of economic effect, comparison with existing drugs, and reflection in drug prices.