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| Personnel |
| a. |
Shin Shimizu, Ph.D. (President of Toyobo Biologics
Inc. and Advisor to Pharmaceuticals Operations Division of Toyobo
Co. Ltd.)
Dr. Shimizu was previously General Manager of Pharmaceuticals Operation
Division of Toyobo and the Deputy Director from September 2000
to March 2004. He is a molecular biologist by training, and participated
in the molecular cloning of a number of important drug targets,
including acetylcholine receptor, sodium channel, HGF CRF, SCGF
and others. He was also directly engaged in the IND and NDA application
filed by Toyobo on two recombinant protein drugs (t-PA and EPO)
in Japan. Dr. Shimizu is now the councilor of the Japanese Association
for Animal Cell Technology, and was the director of the Japan Human
Sciences Foundation for five years until March 2004. He has significant
knowledge and experience in the development and manufacturing of
protein drugs using recombinant mammalian cell culture, and has
established a wide personal network within the Japanese pharmaceutical
industry, particularly within biopharmaceutical divisions, as a
result of marketing Toyobo’s and TBI ’s contract manufacturing
businesses for more than ten years. |
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| b. |
Shigeyasu Mannen, Ph.D. (Advisor to TBI Biologics Inc.)
Dr. Mannen was previously Deputy General Manager of Pharmaceutical
Development Division of Toyobo and Head of Pharmaceutical Planning
Department. Dr. Mannen was responsible for assessing in-licensing
opportunities for recombinant protein drug candidates internationally,
and was also directly engaged in recombinant drug development internally
as a research group leader. As a result, he has significant experience
in working with Japanese regulatory authorities, and in a variety
of legal matters. Dr. Mannen was also Head of Boehringer Ingelheim
Japan’s Research Institute for six years, and during this period
obtained Japanese NDA approval of four new drugs and two line extensions.
Dr. Mannen has developed an extensive knowledge of drug development,
including recombinant protein drugs, during his long and successful
career, and maintains relationships with senior officials in both
the Japanese pharmaceutical industry and regulatory agency. |
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| c. |
BioPharma Services, Inc. (US-based partner of PBI Consulting Group)
BioPharma Services, Inc. (BPSI) is a Boston-based consulting firm
that provides a range of business development, operational, and financial
services to small and medium-sized biotechnology companies. The two
principles of BPSI, Dr. Nancy Hsiung and Charles Keough, each have
over twenty years of experience in the healthcare industry, and have
worked closely with a number of early-stage and venture-backed biotech
companies. Both Dr. Hsiung and Mr. Keough also have extensive experience
working with the Japanese pharmaceutical industry. From 1990 - 1996,
Dr. Hsiung was responsible for strategic planning and technology
assessment for Toyobo’s biopharmaceutical division in the US.
Mr. Keough was a senior consultant in the cross-border strategic
advisory group at the Nomura Research Institute in Tokyo from 1990-1993,
and the Investment Manager for Life Sciences for JAFCO America Ventures
in New York from 1994-1997. |
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| 2007 Copyright Toyobo Biologics Inc. All Rights Reserved. |
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