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Takao Hayakawa Received Hancock Award in Regulatory Science

Friday, January 2, 2015   (0 Comments)
Posted by: Stephanie Flores
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On January 27, 2015 the CASSS Board of Directors presented the 4th William Hancock Award for Outstanding Achievements in CMC Regulatory Science to Takao Hayakawa.  The presentation took place in the opening session of the WCBP Symposium at the Renaissance Mayflower Hotel in Washington, DC.  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.

Takao was a very active participant in the ICH process and was a key contributor to the development of the core ICH documents that are the basis of most of what we do within Biotech CMC, namely Q5E and Q6B. This is a worthy contribution on its own given the global impact of these documents.

Takao's contributions to CASSS' mission, include but are not limited to his long-standing participation at WCBP.  In addition he was the main driving force from the Japanese Government end to bring the CMC Forum to Japan and truly help establish the first expansion for CASSS mission beyond US/EU. This was no small task and truly reflected Takao's commitment to bring the core messages of WCBP to a broad international audience, thus playing a key role in driving regulatory convergence globally based on core scientific principles.

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 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.

For more information contact Stephanie Flores -  For more information about the WCBP Symposium, click here.

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