Abstract
This book provides detailed case studies of 12 groups of 15 major innovative drugs discovered in Japan, and in doing so investigates the sources of their innovations. It discusses: (1) the knowledge sources of the drug-discovery projects; (2) the dynamic interaction between drug discovery and scientific progress; (3) the causes of unexpected difficulties; (4) the capture of serendipity and luck; and (5) the uniqueness and competition of discovery research. The case studies cover the following drugs (generic name of molecules followed by product names): compactin/pravastatin (Mevalotin, Pravachol), rosuvastatin (Crestor), leuprorelin (Leuplin, Leupron, Viadur), ofloxacin (Tarivid, Floxin) and levofloxacin (Cravit, Levaquin), tamsulosin (Harnal, Flomax), pranlukast (Onon), tacrolimus (Prograf), pioglitazone (Actos, Glustin), donepezil (Aricept), candesartan (Blopress, Atacand, Amitas), tocilizumab (Actemra), and nivolumab (Opdivo). It elucidates the concrete mechanism by which science becomes a source of innovation, especially given that science is often incomplete when the discovery project starts. It clarifies the sources and consequences of uncertainties in drug discovery. It expands our understanding of competitive mechanism of drug discovery.
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Notes
- 1.
According to DATA BOOK 2011 by the Japan Pharmaceutical Manufacturers Association (JPMA), the number of lead compounds discovered by 20 member companies of the JPMA during the period from 2005 to 2009 was approximately 650,000, and the number of optimized lead compounds (those included in preclinical studies) was 203. The number of compounds that entered clinical studies was 75, and 21 were approved.
- 2.
The priority year is the year in which the invention was first applied for a patent.
- 3.
According to a patient survey conducted by Ministry of Health, Labour and Welfare in 2014.
- 4.
It is important to note that the distinction between basic research on disease mechanisms and targeted discovery research on specific drugs is ambiguous and that there are uncertainties in deciding the first year of the discovery research.
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Nagaoka, S. (2019). Introduction. In: Nagaoka, S. (eds) Drug Discovery in Japan. Springer, Singapore. https://doi.org/10.1007/978-981-13-8906-1_1
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