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William S. Hancock Award 2015
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2015 Hancock Award Winner Takao Hayakawa



CASSS Board member Wassim Nashabeh presented the award to Dr. Takao Hayakawa 
at the 19th Annual WCBP Symposium in Washington, DC, January 2015


The CASSS Board of Directors presented the 4th William Hancock Award for Outstanding Achievements in CMC Regulatory Science to Takao Hayakawa.  This annual award recognizes outstanding and sustained contributions in the field of regulatory science.

A nominee must have made significant contributions to the advancements of scientific principles, applied technologies and/or science based regulations in the areas of manufacturing, process/technology development, characterization, analysis and/or quality of biotechnology derived pharmaceuticals.  The awardee's achievements must have been instrumental in enabling the availability of high quality medicines derived from recombinant technology on a global basis.

Dr. Takao Hayakawa is currently a professor and the director of Pharmaceutical Research and Technology Institute, Kinki University of Japan. He is also a guest professor of School of Medicine, Osaka University of Japan. Dr. Hayakawa received his Ph.D. in Biochemistry from Osaka University. He developed his lifetime career in biotechnology and biologics in the National Institute of Health Sciences (NIHS) of Japan, serving as Division Director of Biological Chemistry and Biologicals (1991-2002), Deputy Director General of the NIHS (2002-2005), Director of the Osaka branch of the NIHS (Antecedent of National Institute of Biomedical Innovation) (2004-2005) and the first Emeritus investigator of the NIHS (2005).

Dr. Hayakawa was also a senior advisor of Pharmaceutical and Medical Devices Agency, PMDA (2005-2010) and still works for the PMDA as an ad hoc advisor. PMDA used to be a part of NIHS and became an independent agency in 2004, working together with Ministry of Health, Labour and Welfare of Japan (MHLW). Its mission is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices. It reviews marketing authorization application of pharmaceuticals and medical devices and monitors their post-marketing safety. It is also responsible for coordinating relief compensation for sufferers from adverse drug reaction and infections by pharmaceuticals or biological products.

One of Dr. Hayakawa’s current activities is developing 5 guidelines ensuring quality and safety of human stem cells (autologous or allogeneic human somatic cells, autologous or allogeneic human iPS cells, and ES cells) derived products for therapeutic use.

Among his many accolades, Dr. Hayakawa was awarded the Order of the Sacred Treasure, Gold Rays with Neck Ribbon by Emperor Akihito in the Spring of 2012. The Order of the Sacred Treasure is awarded to those who have made distinguished achievements in research fields, business industries, healthcare, social work, state/local government fields or the improvement of life for handicapped/impaired persons. Dr. Hayakawa is the only pharmaceutical scientist and is among the top 0.0006% of all of Japanese of the same age to receive this decoration. 





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