SANBIO - Key Persons
Principal, Palisades Associates, a merchant banking firm. A founding principal of The Beta Group, a Silicon Valley business development organization.
Dr. Bates is a board certified reconstructive surgeon who has held senior positions in clinical development and medical affairs at Baxter, Organogenesis, and Allergan. In these roles, Dr. Bates specialized in the surgical applications of regenerative medicine and has the distinction of leading the first and only successful regulatory approval of an allogeneic cell therapy product in the US. Dr. Bates received his medical degree from the University of Sydney, his PhD in Developmental Biology from the University of Melbourne, and his MBA from the Wharton Business School.
Job Titles:
- Director
- Leadership Founding Scientist
- Professor of Keio Medical School
Professor, Department of Physiology at Keio University School of Medicine. Dr. Okano is a world-recognized expert in regulatory mechanisms of neuronal development and stem cell biology.
Job Titles:
- Corporate Officer, Head of Japan Regulatory Affairs & Quality Compliance Japan
Upon earning her Ph.D. in Pharmacokinetics, Dr. Sawaguchi worked in project management for new drug development at both domestic and foreign pharmaceutical companies, participating in a wide range of development work from the launch of clinical trials to the approval stage. Thereafter, she worked for foreign pharmaceutical companies and CROs in development and regulatory affairs, and has extensive experience in PMDA consultation and application for and acquisition of approval. Dr. Sawaguchi has served as Vice president of Regulatory Affairs, Intelligence/Policy, and Quality Assurance Unit at Konica Minolta Precision Medicine Japan, Head of Regulatory Affairs at PAREXEL Consulting Japan, Head of Regulatory Affairs at Mylan Seiyaku/Mylan EPD, Senior Manager, Project Management Department at Janssen Pharmaceutical, Senior Manager, Development Strategy Office at Eisai, Senior Manager, Development Department at Daiichi Sankyo, and Executive Director at Kansai Pharmaceutical Association.
Mr. Mori has been Co-Chief Executive Officer and has served as a member of the Board since SanBio's inception in 2001. Prior to founding SanBio, Mr. Mori was Head of New Product Development from 2000 to 2001 at Xuma, an informatics startup in San Francisco. From 1993 to 1999, Mr. Mori held positions of increasing responsibility in R&D and Manufacturing at Kirin Holdings, Ltd. in Japan. Mr. Mori holds an MBA degree from the University of California, Berkeley and a master's degree in Biochemistry from the University of Tokyo.
Job Titles:
- Corporate Officer
- Head of Production
As a general manager of global manufacturing plants at organizations such as Santen Pharmaceutical Co., Ltd., Mr. Nakada oversaw the start-up of plants in China and assumed responsibility for supply capacity enhancement and productivity improvement. At Taiko Pharmaceutical Co., Ltd., Mr. Nakada played a vital role in setting up a plant within a short period of time. Meanwhile, he supervised logistics, quality control, and engineering technology, overseeing the entire supply chain for products produced both internally and by third-party manufacturers. Mr. Nakada has abundant knowledge and on-site experience related to the stable production and supply of quality pharmaceutical products.
Job Titles:
- Senior Production Development Fellow
Dr. McGrogan joined SanBio in 2003. Dr. McGrogan has over 25 years of biopharmaceutical R&D and production development experience. Prior to joining SanBio, Dr. McGrogan was Vice President of Research and Development at Layton BioScience (1996 to 2003). At Layton, Dr. McGrogan successfully managed the first cell therapy product to enter clinical trials for a CNS application, LBS-Neuron, from inception through a Phase II clinical trial. Prior to Layton, Dr. McGrogan held positions of increasing responsibility at several biotech companies including Berlex Biosciences, Invitron, and Cetus. Dr. McGrogan holds a Ph.D. in Molecular and Cellular Biology from Washington University School of Medicine, St. Louis, Missouri.
Dr. El-Kalay has one of the extensive background in the development and manufacturing of cell therapies. He served as a key team member in pioneering companies such as Applied Immune Sciences, Systemix, and Osiris Therapeutics, then led technical operations teams in Vice President roles at Morphogen Pharmaceuticals, Telos Pharmaceuticals, and MicroIslet. Dr. El-Kalay founded a cellular therapy company EyeCyte, focusing on retinal diseases, and served as its Chief Executive Officer until 2013. Recently he served as Vice President of Process Development and Manufacturing at StemCells, Inc. and as Vice President of Technical Operations at Sangamo Therapeutics.
Mr. Tsukahara has extensive experience in the healthcare industry, leading successful global and Japanese launches and the turnarounds of several products in a variety of therapeutic areas, including osteoporosis, rheumatoid arthritis, blood cancer, and diabetes. Previously the Head of Commercial Excellence at Abbott Japan and Worldwide Commercial Lead (Executive Director) at Bristol Myers Squibb, Mr. Tsukahara graduated from Waseda University and holds an MBA from the Kelley School of Business at Indiana University.
Mr. Kotani previously worked for the Boston Consulting Group (BCG), a management consulting firm, where he developed business strategies for research and development, manufacturing, new businesses, marketing, sales, organizational structuring, and project management in a variety of businesses, including pharmaceuticals, automobiles, and consumer goods. Mr. Kotani was formerly a BCG senior vice president, a core member of the BCG Worldwide Health Care Practice Group (advisory committee on pharmaceutical businesses). Mr. Kotani established Dream Incubator Inc., a management consulting and a venture capital firm which was listed on the Mothers Section of Tokyo Stock Exchange in its 2nd year, and on the First Section of Tokyo Stock Exchange (TSE, First Section: 4310) in the 6th year after founding. Mr. Kotani has served as an outside director at a number of companies such as Santen Pharmaceutical Co., Ltd. [TSE, First Section: 4536], JINS Inc. [TSE, First Section: 3046], and Combi Corporation). Mr. Kotani graduated from the Faculty of Engineering and completed bachelor's degree requirements in the Department of Mathematical Engineering and Information Physics, School of Engineering, the University of Tokyo. Mr. Kotani received a Master's degree in Management Science and Engineering from Stanford University.
Job Titles:
- Corporate Officer, Head of Research and Development
After being involved in drug discovery and pharmacological research as a researcher at Kaken Pharmaceutical and other companies, Mr. Hirata became a medical science liaison. Mr. Hirata has extensive knowledge and experience in the medical affairs field, amassed through his role in the management of investigator-initiated clinical trials, supervision of medical teams, and KOL management in the fields of ophthalmology and immuno-inflammatory diseases at Otsuka Pharmaceutical, Takeda Pharmaceutical, and Celgene.
Job Titles:
- Director
- Executive Chairman / Founding Scientist
Mr. Kawanishi served as SanBio's Chairman of the Board from 2001 to 2005 and has been Co-Chief Executive Officer and a member of the Board since 2005. Prior to founding SanBio, Mr. Kawanishi co-founded CareNet, Inc. (TSE: 2150) and was Executive Vice President from 1996 to 1999. At CareNet, Mr. Kawanishi established eHealthcare in Japan. From 1993 to 1996, Mr. Kawanishi was a management consultant at the Boston Consulting Group. Mr. Kawanishi has a master's degree in Biochemistry from the University of Tokyo.
Mr. Ueda worked for ChuoAoyama Audit Corporation, IPO Department of Daiwa Securities, AnGes MG, Inc. (TSE, Mothers: 4563). He currently serves as a partner in HIBIKI Partners Co., Ltd., an IPO consulting firm. Mr. Ueda was former Executive Officer of AnGes MG, Inc. Mr. Ueda graduated from the Faculty of Business and Commerce, Keio University. Mr. Ueda is a Certified Public Accountant.
Mr. Sato previously participated in R&D of pharmaceuticals at Kirin Brewery Company, Ltd. He served as Head of Development Division at Kirin Pharma Company, Ltd., and as Head of Pharmacovigilance and Quality Assurance Division, Head of Development Division, and Head of Research and Development Division at Kyowa Hakko Kirin Co., Ltd. (TSE, First Section: 4151). Mr. Sato was former member of the Board, Senior Corporate Officer, and Head of Research and Development Division at Kyowa Hakko Kirin. Mr. Sato graduated with a bachelor's degree in Political Science and Economics from Waseda University. He is a veterinary physician with a D.V.M. degree from the Faculty of Veterinary Medicine, Nippon Veterinary and Animal Science University (currently Nippon Veterinary and Life Science University).
Job Titles:
- Corporate Officer, Management Administration
Previously, Mr. Kakutani was Executive Officer and General Manager of Finance Department of CareNet, Inc. (TSE, Mothers: 2150). Mr. Kakutani is a US Certified Public Accountant.