Benefits of Pharmacogenomics in Drug Development—Earlier Launch of Drugs and Less Adverse Events
Currently, pharmaceutical companies are reluctant to introduce pharmacogenomics (PGx) in their practice, since cost–benefit of PGx is obscure and methodology to use PGx in drug development has not been fully established yet. The purpose of this study is to investigate advantages obtained by introducing PGx in clinical trials. Particularly, taking Warfarin as an example, we investigate benefits of Enrichment effect that raises response rate of the drug by PGx. When response rate is raised by only 5%, cost of a clinical trial can be reduced to about 40% of a conventional clinical trial. Furthermore, since period necessary for a trial also can be reduced, development period can be shortened by about 750 days. In summary, PGx enables earlier launch of a drug with less cost, representing benefit to pharmaceutical companies, patients and public as a whole.
KeywordsClinical trials Pharmacogenomics SNPs Personalized medicines Cost-effective Warfarin
- 3.Ernst, F. R., and Grizzle, A. J., Drug related morbidity and mortality: updating the cost-of-illness model. J. Am. Pharm. Assoc. 41:192–199, 2001.Google Scholar
- 8.Fung, M., Thornton, A., Mybeck, K., et al., Evaluation of the characteristics of safety withdrawal of prescription drugs from worldwide pharmaceutical markets—1960 to 1999. Drug Inf. J. 35:293–317, 2001.Google Scholar
- 14.McWilliam, A., Lutter, R., Nardinelli, C. et al., Health Care Savings from personalizing Medicine Using Genetic testing. AEI Bookings Joint Center for Regulatory Studies, Working Paper 6-23, 2006.Google Scholar
- 15.Ministry of Education, Culture, Sports, Science and Technology, Leading Project. Biobank Japan. http://www.biobankjp.org/info/IC0802.pdf. 2005.
- 16.Veenstra, D. L., Higashi, M. K., and Phillips, K. A., Assessing the cost-effectiveness of pharmacogenomics. AAPS. PharmSci. 29 (3)1–11, 2000.Google Scholar
- 17.Japan Pharmaceutical Manufacturers Association, Questionnaire about pharmacogenomics. https://www1.meteo-intergate.com/news/letter/119/, 2007
- 19.Gallen, C., Clinical research and development. Wyeth Pharmaceuticals, Collegeville, p. 19426, 2006.Google Scholar
- 20.Japan Pharmaceutical Manufacturers Association, Proposal for extension of patent period, February, 2009 http://www.jpo.go.jp/shiryou/toushin/shingikai/pdf/entyou-wg03_shiryou/entyou-wg_shiryou03.pdf.
- 22.Yatsuda Y., Sales rank of world medicines, Utobain News release, Jul 2007. http://www.utobrain.co.jp /news-release/2007/070700/NewsRelease0707.pdf
- 23.The calculation is based on the data in “Commission to facilitate marketing of effective and safe medicine”, MHLW, October 30, 2006. http://www.mhlw.go.jp/shingi/2007/07/dl/s0730-10a.pdf
- 24.Saito, H., Current Status and Issues of Drug Development Strategy in Japan. Drug Deliv. Syst. 1, 65–72, 2002.Google Scholar
- 25.Genelex. Pharmacogenetics: personalizing medicine today. In Health and DNA. Seattle, Washington U.S. 2007. http://www.healthanddna.com/professional/pharmacogenetics.html#2c9
- 26.Ernst, F. R., and Grizzle, A. J., Drug-related morbidity and mortality: updating the cost-of-illness model. J. Am. Pharm. Assoc. 41:192–199, 2001.Google Scholar
- 27.Bureau of Labor Statistics, Consumer price index for medical care, 2002–2006.Google Scholar
- 29.Genetic Information Nondiscrimination Act:GINA. http://www.house.gov/apps/list/speech/edlabor_dem/rel050108.html
- 30.SNP Genotyping and Analysis Markets. Kalorama Information, 2008. http://www.infoshop-japan.com/publisher/KL.shtml
- 31.Cabinet Office, Government of Japan, Act on the Protection of Personal Information, May, 2003, http://www5.cao.go.jp/seikatsu/kojin/houritsu/index.html
- 32.Ministry of Health, Labour and Welfare, Ethical Guidelines for Human Genome and Genetic Sequencing Research, December, 2004, http://www5.cao.go.jp/seikatsu/shingikai/kojin/20050127kojin-sanko2-3.pdf