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Takao Hayakawa, Ph Biography of Dr. Takao Hayakawa Dr. Takao Hayakawa is a professor and the director of Pharmaceutical Research and Technology Institute, Kinki University of Japan. He is also a guest professor of Medical Center for Translational Research of Osaka University Hospital. Dr. Hayakawa received his Ph.D. in Biochemistry from Osaka University of Japan. 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) and an Emeritus investigator from 2005 on. He 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. He is the author or coauthor of over 550 publications in biochemistry, biotechnology, cell biology and the pharmaceutical sciences. Dr. Hayakawa has been involved in more than 80 kinds of activities relative to public health and is still in about 40 under various Ministries of Japan including Ministry of Health, labour and Welfare (MHLW), Cabinet Office of Japan, Ministry of Education, Culture, Sports, Science and Technology (MEXT) and Ministry of Economy, Trade and Industry (METI). He chaired a number of committees like Committee of Japanese Pharmacopoeia (2003-2011), Committee on Biotechnology Products (2003-2011) of the MHLW’s Council, and has been chairing Expert Committee on Genetically Modified Foods (2003-2007) and followed by the Planning Expert Committee of the Food Safety Commission of Japan. He also chaired the Japanese Biologics Forum (2005-2011). One of his current activities is to develop draft guidance on ensuring quality and safety of stem cell derived products for therapeutic use. Characterization and utilization of pluripotent stem cells for medical and pharmaceutical researches are the subjects of his special interest. He also serves as a chairperson and/or referee for evaluating various national research projects on medical/pharmaceutical sciences, which are sponsored by relevant Ministries of Japanese Government including MEXT, MHLW and METI. Dr. Hayakawa has been playing an active role in various international activities, as an Expert Working Group member of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), which is cosponsored by interested parties including competent government office of United State, European Union and Japan, Expert Working Group member, WHO temporal advisor, Pharmacopoeia Discussion Group (USP/EP/JP) member, Board member of International Alliance for Biologicals (IABS) and an Editor of journal “Biologicals”. Especially, since ICH 1 in 1991, representing the MHLW he has been energetically involved in the activities on biotechnological/biological products (Q5A, Q5B, Q5C, Q5D, Q5E and Q6B), Common Technical Document (CTD)and pharmacopoeial interchangeability (Q4B). He also served as the rapporteur of ICH expert working groups for two topics, Viral Safety (Q5A) and Comparability (Q5E). Very recently, a decoration has been conferred on Dr. Hayakawa by Japanese Emperor. He received the 0rder of the Sacred Treasure, Gold Rays with Neck Ribbon (as being only one pharmaceutical scientist and top 0.0007% of all of Japanese at the same age). He has been decorated for great distinguished services and contributions over many years to public health. .
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